Indiana

Yes

Allison Taylor
Director of Medicaid
Indiana Family and Social Services Administration
402 West Washington Street, Room W461, MS 25
Indianapolis, IN 46204
Phone: (317) 234-8725

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

All the following general criteria must be met for any genetic testing service to be covered:

1. The genetic disorder must be associated with a potentially significant disability.
2. The risk of the significant disability from the genetic disorder cannot be identified through biochemical or other testing (for example, ultrasound screening for aortic disease in Marfan’s syndrome).
3. A specific mutation, or set of mutations, has been established in scientific literature to be reliably associated with the disease.
4. The results of the genetic test could impact the medical management of the member with improved net-health outcomes.
5. No determinable diagnosis can be gathered from the history, physical examination, pedigree analysis, genetic counseling and completion of conventional diagnostic studies.
6. Prior authorization (PA) is obtained, if required.

Genetic testing services are not covered under the following circumstances:

1.  For the sole convenience of information for the patient without impacting treatment
2. For the medical management of other family members, unless otherwise specified in policy
3. For the establishment of paternity
4. All screening tests, except the screening tests listed under the state’s required newborn screening policy (see Indiana Administrative Code 410 IAC 3-3-3 and the Inpatient Hospital Services module)
5.  If history, physical examination, pedigree analysis, genetic counseling or completion of conventional diagnostic studies has given a definitive diagnosis
6. If a genetic test has previously been performed to provide a conclusive diagnosis of the same genetic disorder

Reimbursement for genetic tests specific to a gene or a condition is limited to once per member per lifetime, unless otherwise specified in a test-specific coverage policy. For genetic tests not specific to a gene or a condition, providers must have medical documentation on file indicating that each testing procedure is for a separate and distinct diagnosis. The IHCP does not cover genetic testing panels unless otherwise stated.

Gene expression profiling as a technique of managing the treatment of breast cancer is considered investigational and not medically necessary when a gene profiling test other than the EndoPredict Breast Cancer Assay or Oncotype DX Breast Recurrence Score is being used.

Gene expression profiling as a technique of managing the treatment of ductal carcinoma in situ (DCIS) is considered investigational and not medically necessary under all circumstances.

Repeat gene expression profiling with the Oncotype DX Breast Recurrence Score for the same tumor, such as a metastatic focus, or from more than one site when the primary tumor is multifocal, is considered investigational and not medically necessary. The IHCP does not cover more than one EndoPredict Breast Cancer Assay per member per lifetime.

According to the National Human Genome Research Institute, the term genetic testing covers an array of techniques, including analysis of human DNA, RNA or protein. In the clinical setting, genetic tests can be performed to do the following:

1. Confirm a suspected diagnosis.
2. Predict the possibility of future illness.
3.  Detect the presence of a carrier state in unaffected individuals whose children may be at risk.
4. Predict response to therapy.

Genetic tests are also performed to screen for genetic defects in fetuses, newborns or embryos used in in-vitro fertilization.

Chromosomal microarray analysis (CMA) is covered for children when it is determined to be medically necessary for diagnosing a genetic abnormality. See Microarrray Testing for more information.

IC 25-17.3-4-1
Sec. 1. To qualify for licensure as a genetic counselor, an applicant must:

1. submit an application on a form developed by the board;
2. pay the licensure fee determined by the board;
3.  provide written evidence that the applicant has earned:
   1.  a master’s degree from a genetic counseling training program accredited by the American Board of Genetic Counseling or its successor; or
   2. a doctoral degree from a medical genetics training program that is accredited by the American Board of Medical Genetics or its successor; and
4.  meet the examination requirement for certification as:
   1.  a genetic counselor by the American Board of Genetic Counseling or the American Board of Medical Genetics or the successor of these entities; or
   2.  a medical geneticist by the American Board of Medical Genetics or its successor.
      As added by P.L.177-2009, SEC.35.

 

Yes, documentation that genetic counseling has been performed prior to genetic testing is required.

Professionally licensed genetic counselors can enroll in the IHCP as provider type 36 – Genetic Counselor, as described in the Provider Enrollment module. Genetic counselors are limited to providing only genetic counseling services and to billing only the following procedure codes:

1. 96040 – Medical genetic patient or family counseling services each 30 minutes
2. S9981 SE – Medical records copying fee, administrative

This restriction applies to all billing, group and rendering providers enrolled under the genetic counselor provider type.
Other provider types enrolled with the IHCP that have genetic counseling within their scope of practice should bill for these services following standard billing guidance.

Per 405 IAC 5-24-9, the IHCP provides coverage for food supplements, nutritional supplements and infant formulas when no other means of nutrition is feasible or reasonable

Both enteral and parenteral nutrition products require a DME Information Form CMS-10126 – Enteral and Parenteral Nutrition (available on the Forms page at in.gov/medicaid/providers) be completed and kept on file in the patient’s medical records, as a certification of medical necessity (CMN). Someone other than the ordering physician is allowed to complete Form CMS-10126; however, the ordering physician must review the information for the accuracy, sign and date the form to indicate agreement.

The IHCP requires PA for enteral nutrition. After the initial PA of enteral nutrition items, the IHCP requires subsequent PA after three, nine and 18 months of therapy to document the member’s continued need for therapy. After two years, the IHCP determines the need for further PA on a case-by-case basis. If the member does not medically require enteral nutrition services for two consecutive months, the IHCP requires a new PA, and the required extension schedule starts again. Each PA request for enteral nutrition items must include a copy of the completed CMN (Form CMS-10126). Providers must include additional documentation with the initial and subsequent PA request to support medical necessity of the following orders:

• The need for special nutrients
• The need for total caloric intake less than 20 cal/kg/day or greater than 35 cal/kg/day
• The need for a pump (see the Parenteral and Enteral Nutrition Pumps for Home Infusion section)

The IHCP does not require PA for total parenteral nutrition (TPN) products when used in conjunction with parenteral hyperalimentation, including central venous catheters.

PA is required for all digestive enzyme cartridges for use with enteral tube feeding. For IHCP approval and coverage of initial requests up to three months, all the following criteria must be met:

• Diagnosis of cystic fibrosis and exocrine pancreatic insufficiency (EPI)
• Evidence of failed standard pancreatic enzyme therapy (defined as not meeting target weight gain
  for a minimum period of six weeks)
• Requires nightly continuous tube feedings through gastrostomy tube no less than three times weekly
  to achieve goal caloric intake

PA is required for all genetic testing, unless otherwise noted within the Outpatient Fee Schedule or Professional Fee Schedule.

https://www.in.gov/medicaid/providers/files/pa-form.pdf

https://www.in.gov/medicaid/providers/business-transactions/billing-and-remittance/ihcp-fee-schedules/

Yes, the IHCP covers BRCA1 and BRCA2 testing when it is determined to be medically necessary based on
personal history or family history, as described in this section. Prior authorization is required.
IHCP members referred to an oncologist or geneticist for BRCA1 and BRCA2 testing must have a
completed personal and family cancer history that should include three generations on both maternal and
paternal sides of the family in the member’s medical record to include the following:

• Relatives with breast, ovarian and other relevant cancers, such as prostate and colon cancer
• Age at diagnosis in affected family members
•  Other significant factors, such as ethnic background

BRCA1 and BRCA2 genetic testing is considered medically necessary for members with a personal
history of at least one of the following:

1. Breast cancer diagnosis at age 45 or younger
2. Breast cancer diagnosis at age 50 or younger and one or more of the following:
   1. Two breast primary cancers, with the first breast cancer diagnosis occurring at age 50 or younger
   2. At least one close blood relative with breast cancer at age 50 or younger
   3. At least one close blood relative with epithelial ovarian/fallopian tube/primary peritoneal cancer
      diagnosed at any age
   4. A limited family history or adopted
3. Triple-negative (ER–, PR– and HER2–) breast cancer diagnosis at age 60 or younger
4. Breast cancer diagnosis at any age and one or more of the following:
   1. Two breast primary cancers in a single individual with at least one close blood relative with
      breast cancer diagnosed at age 50 or younger
   2. Two breast primary cancers in a single individual with at least one close blood relative with
      epithelial ovarian/fallopian tube/primary peritoneal cancer diagnosed at any age
   3. Two or more close blood relatives with breast and/or epithelial ovarian/fallopian tube/primary
      peritoneal cancer diagnosed at any age
   4. Two or more close blood relatives with pancreatic cancer diagnosed at any age
   5. Two or more close blood relatives with prostate cancer (Gleason score of 7 or greater) diagnosed
      at any age
   6. First-degree or second-degree relative with male breast cancer
   7. A close relative with a known BRCA1 or BRCA2 gene mutation
   8.  At least two close blood relatives on the same side of the family with other hereditary breast and
      ovarian cancer (HBOC)-syndrome-associated malignancies (prostate, pancreatic, melanoma)
   9. Ethnicity associated with deleterious mutations, including Ashkenazi Jewish, Icelandic,
      Hungarian, Swedish and Dutch
5. Pancreatic, prostate (Gleason score of 7 or greater), or epithelial ovarian/fallopian-tube/primary
   peritoneal cancer diagnosis and two or more close blood relatives with at least one of the following:
   1. Breast cancer diagnosed at any age
   2. Ovarian cancer diagnosed at any age
   3. Pancreatic cancer diagnosed at any age
   4. Prostate cancer (Gleason score of 7 or greater) diagnosed at any age
6. Male breast cancer diagnosis

BRCA1 and BRCA2 genetic testing is considered medically necessary to assess the risk of female breast cancer for members with a family history of at least one of the following (no personal history required):

1. Member has a relative with known BRCA1 or BRCA2 mutation
2. Member of Ashkenazi Jewish, Icelandic, Hungarian, Swedish or Dutch ancestry has one or more of
   the following:
   1.  One or more close blood relatives with male breast cancer
   2. One or more first-degree relative with breast cancer or epithelial ovarian cancer
   3. Two or more second-degree relative on same side of family with breast cancer
   4. Two or more second-degree relative on same side of family with epithelial ovarian cancer
3. Member not of Ashkenazi Jewish, Icelandic, Hungarian, Swedish or Dutch ancestry has one or more
   of the following:
   1. First-degree or second-degree relative with breast cancer and one or more of the following:
      1.  Diagnosed at age 45 or younger
      2. Diagnosed at age 50 or younger with unknown or limited family history
      3.  Diagnosed at age 50 or younger with one or more close blood relatives with breast cancer
         diagnosed at any age
      4.  Diagnosed at age 60 or younger with triple-negative breast cancer
   2. First-degree or second-degree relative with two breast primary cancers with the first primary
      diagnosed at age 50 or younger
   3. First-degree or second-degree relative with breast cancer diagnosed at any age, who in turn has
      one or more of the following:
      1. One or more close blood relatives with breast cancer diagnosed at age 50 or younger
      2. One or more close male blood relatives with breast cancer diagnosed at any age
      3. One or more close blood relatives with epithelial ovarian cancer diagnosed at any age
      4. Two or more close blood relatives with breast cancer diagnosed at any age
      5.  Two or more close blood relative with pancreatic cancer diagnosed at any age
      6. Two or more close blood relative with prostate cancer (Gleason score of 7 or greater)
         diagnosed at any age
   4. First-degree or second-degree relative with male breast cancer diagnosed at any age
   5. First-degree or second-degree relative with breast cancer who is of ethnicity associated with
      deleterious mutations, including Ashkenazi Jewish, Icelandic, Hungarian, Swedish or Dutch
   6.  First degree or second-degree relative with epithelial ovarian cancer diagnosed at any age
   7. First-degree or second-degree relative with pancreatic cancer diagnosed at any age who in turn
      has two or more close blood relative with one or more of the following:
      1. Breast cancer diagnosed at any age
      2.  Ovarian cancer diagnosed at any age
      3. Pancreatic cancer diagnosed at any age
      4. Prostate cancer (Gleason score of 7 or greater) diagnosed at any age
   8. First-degree or second-degree relative with prostate cancer (Gleason score of 7 or greater)
      diagnosed at any age, who in turn has two or more close blood relatives with one or more of the
      following:
      1. Breast cancer diagnosed at any age
      2. Ovarian cancer diagnosed at any age
      3. Pancreatic cancer diagnosed at any age
      4. Prostate cancer (Gleason score of 7 or greater) diagnosed at any age
   9. Third-degree relative with breast or epithelial ovarian cancer, who in turn has one or more of the
      following:
      1. One close blood relative with epithelial ovarian cancer and another close blood relative with
         breast cancer diagnosed at age 50 or younger
      2. Two or more close blood relatives with breast cancer with at least one diagnosed at age 50 or
         younger
      3. Two or more close blood relatives with epithelial ovarian cancer diagnosed at any age

The IHCP covers the following carrier screening for cystic fibrosis, which, for dates of service on or after Dec. 1, 2022, is available without prior authorization and is subject to a limit of one screening per lifetime per member:
1. 81220 – Gene analysis (cystic fibrosis transmembrane conductance regular) common variants

These cystic fibrosis carrier screenings are available to all IHCP members of reproductive age who have the capacity for pregnancy. The screenings are also available to an affiliated sperm-producing IHCP member, if the member who can become pregnant tests positive for a given carrier screen.

Yes, it is covered. See Lynch Syndrome Testing Coverage for more information.

Yes, it is covered.
Several genetic tests exist for a determination of risk (or risk score) associated with inheritable cancer susceptibility, such as for breast and ovarian cancer or hereditary nonpolyposis colorectal cancer (HNPCC).

For coverage of specific tests, providers should check the appropriate fee schedule; both the Outpatient Fee Schedule and Professional Fee Schedule are accessible from the IHCP Fee Schedules page at in.gov/medicaid/providers.

Cancer-susceptibility genetic testing is a covered service when the general criteria and both the following conditions are met:

1. A specific mutation, or set of mutations, has been established in the scientific literature to be reliably associated with the risk of developing malignancy.
2. The results of the genetic test potentially affect at least one of the management options considered by the physician, in accordance with accepted standards of medical care, including any one of the following:
   1. Surgery, or the extent of surgery
   2. A change in surveillance
   3. Hormonal manipulation
   4. A change in standard therapeutic or adjuvant chemotherapy

The IHCP covers chromosomal microarray analysis (CMA), also known as cytogenomic microarray
analysis, when it is determined to be medically necessary for diagnosing a genetic abnormality in children
with apparent nonsyndromic cognitive developmental delay/intellectual delay (DD/ID) or autism spectrum
disorder (ASD), according to the latest accepted Diagnostic and Statistical Manual of Mental Disorders
(DSM) guidelines. Prior authorization is required.

Prior authorization for CMA testing requires documentation of all the following:

• The child has been diagnosed with nonsyndromic DD/ID or ASD.
• The child has one or more of the following:
  • Two or more major malformations
    • A single major malformation or multiple minor malformations in an infant or child who is also
      small-for-dates
    • A single major malformation and multiple minor malformations
• Any indicated biochemical tests for metabolic disease have been performed, and results are nondiagnostic.
• FMR1 gene analysis (for Fragile X), when clinically indicated, is negative.
• The results for the genetic testing have the potential to impact the clinical management of the patient.
• Testing is requested after the parent(s) engaged in face-to-face genetic counseling with a healthcare
  professional licensed under Indiana Code IC 25-17.3.

Oncotype DX Breast Recurrence Score – The Oncotype DX Breast Recurrence Score is a 21-gene RT-PCR assay that should be ordered only after surgery and subsequent pathological examination of the tumor have been completed. Oncotype DX Breast Recurrence Score testing is billed using procedure code 81519 – Test for detecting genes associated with breast cancer.

EndoPredict Breast Cancer Assay – The IHCP covers the EndoPredict Breast Cancer Assay for breast cancer recurrence. This gene assay looks specifically at patients who have been diagnosed with estrogen receptor positive and HER2 negative breast cancer. The test is used to determine the likelihood of distant recurrence and the probability of response to chemotherapy in patients. The EndoPredict Breast Cancer Assay is billed with procedure code 81522 – Oncology (breast), mRNA gene expression analysis of 12 genes in breast tumor tissue. This test is limited to once in a lifetime per member.

To obtain PA for these tests (Oncotype DC Breast Recurrence Score and EndoPredict Breast Cancer Assay), all the following criteria must be met:

1. Individual has had surgery, and a full pathological evaluation of the specimen has been completed.
2. Histology is ductal, lobular, mixed or metaplastic.
3. Histology is not tubular or colloid.
4. Estrogen receptor is positive (ER+), or progesterone receptor is positive (PR+), or both.
5. HER2 receptor is negative.
6. pN0 (node negative) or pN1mi with axillary lymph node micrometastasis is less than or equal to 2mm.
7. Individual has one of the following:
   1. Tumor size 0.6–1.0 cm moderate/poorly differentiated
   2. Tumor size 0.6–1.0 cm well-differentiated with any of the following unfavorable features:
      angiolymphatic invasion, high nuclear grade or high histologic grade
   3. Tumor size greater than 1.0 cm and less than or equal to 4.0 cm
   4. Individual does not have a pT4 lesion.Chemotherapy is a therapeutic option being considered and will be supervised by the practitioner
      ordering the gene expression profile.

Gene expression profiling with the EndoPredict Breast Cancer Assay or Oncotype DX Breast Recurrence
Score as a technique of managing the treatment of breast cancer is considered not medically necessary
when the criteria listed have not been met.

CYP1A2 gene coverage is available.

The IHCP covers the following cell-free DNA prenatal screenings for aneuploidy (noninvasive prenatal testing [NIPT] and noninvasive prenatal screening [NIPS]) for all pregnant women, without prior authorization:

1. 81420 – Test for detecting genes associated with fetal disease, aneuploidy genomic sequence analysis panel
2. 81507 – DNA analysis using maternal plasma

Only one fetal chromosomal aneuploidy screening will be permitted per pregnancy per member.

Coverage is available.

The IHCP covers certain laboratory testing for HER2 protein overexpression and HER2/neu gene detection when medically necessary for members who have been diagnosed with a malignant neoplasm of the breast.
Prior authorization is not required for HER2 testing. However, documentation of medical necessity is required. The ordering physician must have documentation in the member’s medical records to support the
medical necessity of the tests ordered.

The IHCP covers genetic testing for managing the treatment of chronic myelogenous leukemia (CML). To determine whether a specific code is covered, see the Outpatient Fee Schedule or Professional Fee Schedule, accessible from the IHCP Fee Schedules page at in.gov/medicaid/providers.

The IHCP covers the following molecular pathology procedure codes when medically necessary for managing the treatment of metastatic colon cancer: 81403 (Molecular pathology procedure level 4) and 81404 Molecular pathology procedure level 5.

The IHCP covers the following molecular pathology procedure codes when medically necessary for detecting the presence of hemophilia in pregnant women: 81403 (Molecular pathology procedure level 4),
81405 (Molecular pathology procedure level 6), 81407 (Molecular pathology procedure level 8), 81479 (Unlisted molecular pathology procedure), and G0452* (Molecular pathology procedure; physician interpretation and report).

Effective for dates of service on or after Dec. 1, 2022, the IHCP covers the following routine carrier screenings for spinal muscular atrophy (SMA) and hemoglobinopathies without prior authorization. Each procedure code is subject to a limitation of one unit per lifetime per member:

1.  81329 – Gene analysis (survival of motor neuron 1, telomeric) for dosage/deletion
2.  81361 – Gene analysis (hemoglobin, subunit beta) for common variant

These SMA carrier screenings are available to all IHCP members of reproductive age who have the capacity for pregnancy. The screenings are also available to an affiliated sperm-producing IHCP member, if the member who can become pregnant tests positive for a given carrier screen

https://www.in.gov/medicaid/providers/files/modules/genetic-testing.pdf

https://law.justia.com/codes/indiana/2010/title25/ar17.3/ch4.html

https://www.in.gov/medicaid/providers/files/modules/epsdt.pdf

https://www.in.gov/medicaid/providers/files/modules/durable-and-home-medical-equipment-and-supplies.pdf