Requirements for Prior Authorization for Hereditary Breast and Ovarian Cancer Genetic Testing in South Carolina

1. South Carolina KEPRO- Requirements for Requesting Prior Authorizations (PA) INTEGRATED CARE MANAGEMENT AND QUALITY IMPROVEMENT

2. TOPICs Hereditary Breast and Ovarian Cancer (HBOC) BRCA Genetic Testing Continuous Glucose Monitoring (CGM) Effective August 2019

3. Service types • BRCA Genetic Testing (LABORATORY) • CGM (Continuous Glucose Monitoring) • (DME)

4. Definition: Breast Cancer Susceptibility Gene 1 and 2 (BRCA) BRCA1 and BRCA2 genes encode for tumor suppressor proteins that function to preserve chromosome structure, repair damaged DNA, manage the cell cycle and transcription of DNA, and maintain the stability of genetic material.

5. Required documentation • Hereditary Breast and Ovarian Cancer (HBOC) Genetic Testing Prior Authorization Form: • Beneficiary Informed Consent for Hereditary Cancer Genetic Testing • Instructions: Prior authorization request for BRCA 1 and BRCA 2 genes and BRCA Analysis Rearrangement testing for breast and ovarian cancer must be submitted to KEPRO. The Hereditary Breast and Ovarian Cancer Genetic Testing Prior Authorization Form must be completed and signed as outlined in the instructions below. The completed form with the original dated signature must be retained by the requesting physician in the beneficiary’s medical record. The form is subject to retrospective review. • The following forms, documents, and information must be submitted with the prior authorization request to KEPRO: • The completed and signed Hereditary Breast and Ovarian Cancer Genetic Testing Prior Authorization Form • Medical necessity documentation, including documentation of the efforts made to obtain the test results of previous comprehensive sequencing when appropriate • Attestation for comprehensive testing. The attestation must indicate that familial BRCA testing results could not be obtained (as necessary). • Providers can refer to the South Carolina Department of Health and Human Services Physician Services Guide on the website at www.scdhhs.gov for specific information about coverage guidelines, prior authorization requirements and billing guidance.

6. DocumentationCont’d • The following documentation must be maintained in the beneficiary’s medical record: • The Hereditary Breast and Ovarian Cancer (HBOC) Genetic Testing Prior Authorization form • Pre-testing genetic counseling clinical notes, to include but not limited to the following: • Pre-test counseling date with the name and qualifications of the counseling professional • The risks, benefits and limitations discussed with the beneficiary • The beneficiary’s consent to proceed with specific gene mutation testing to be performed as attested by the beneficiary’s signature on the consent form • The beneficiary’s BRCA test results • Post-testing genetic counseling clinical notes, to include but not limited to the following: • Post-test counseling date with the name and qualifications of the counseling professional • The beneficiary’s acknowledgement of the test results.

7. CPT Codes Billing Guidance: The following CPT and HCPCS codes are covered for BRCA genetic testing and genetic counseling: :

8. CPT codes cont’d

9. criteria • Coverage Guidelines: • Criteria: • The South Carolina Department of Health and Human Services (SCDHHS) may cover BRCA • genetic testing for eligible men and women who meet medical necessity criteria. Medical • necessity criteria are based on the current National Comprehensive Cancer Network (NCCN) • Clinical Practice Guidelines in Oncology – Genetic/Familial High-Risk Assessment: Breast and • Ovarian and SCDHHS policy guidelines. To review the current NCCN guidelines you may visit: • https://www.nccn.org/professionals/physician_gls/pdf/genetics_screening.pdf

10. Age requirements: Recipients of BRCA genetic testing must be 18 years of age or older. SCDHHS will not cover BRCA testing or associated genetic counseling for minors.

11. Genetic counseling Genetic counseling must be received before and after genetic testing for BRCA1, BRCA2 and BRCA large cell rearrangement. Pre and post genetic counseling are considered medically necessary, and is a covered service in addition to genetic testing. Genetic counseling is required to inform beneficiaries about the risks and benefits of genetic testing. Genetic counseling must be performed by an appropriately trained genetic counselor.

12. Genetic Testing: • A blood test is performed on an individual to identify mutations in either of the two breast cancer susceptibility genes. The test will determine if an individual carries a mutated BRCA1 or BRCA2 gene. • Generally, genetic testing for a particular disease is limited to once in a lifetime; however, there may be exceptional instances that permit genetic testing more than once in a lifetime. SCDHHS will cover cases for additional BRCA testing for beneficiaries who: • Have previously been tested for BRCA1 and BRCA2 comprehensive sequencing gene mutation analysis testing and received negative results. Documentation of negative results for BRCA1 and BRCA2 comprehensive sequencing gene mutation analysis is required for medically necessary BRCA large cell rearrangement gene mutation testing. • Results are not available, and every reasonable attempt has been made to obtain the results. Documentation of reasonable attempts to obtain results from the genetic testing physician or the testing laboratory must be submitted to KEPRO when requesting prior authorization.

13. NOTE: Beneficiaries may also elect not to pursue treatment options. • Treatments include: • Increased cancer screenings: • Cancer screenings may be received if a beneficiary does or does not desire risk-reducing therapy. Screening and follow-up options should be discussed between the beneficiary and their provider. • Risk-reducing agent: • Risk-reducing agents may be covered for a beneficiary with a BRCA genetic mutation or compelling family history conferring a high risk for breast, ovarian, tubal, peritoneal, pancreatic, or prostate cancers. • Risk-reducing surgery: • Risk-reducing prophylactic mastectomy or oophorectomy may be covered for a beneficiary with a BRCA genetic mutation or a compelling family history conferring a high risk for breast or ovarian cancer.

14. Continuous Glucose monitoring

15. Definition: Continuous Glucose Monitoring Continuous glucose monitoring (CGM) measures glucose levels in real-time throughout the day and night. An electrode, called a sensor, is inserted under the skin to measure glucose levels in interstitial fluid. The sensor is connected to a transmitter which sends the information wirelessly to a monitoring and display device. The monitoring system may be either a stand-alone system or it may be integrated into an external insulin pump.

16. Coverage Guidelines • Coverage of CGM is limited to beneficiaries with: • Type 1, no age limitations • Insulin dependent pregnant women, any type diabetes

17. Medical Criteria • The following criteria must be met: • Documented self-monitoring of blood glucose at least 4x/day AND • Requires insulin injections 3 or more times/day or requires insulin pump for maintenance of blood sugar control AND • Prescribed by board certified endocrinologist • At least one of the following criteria must be met in addition to ALL of the above criteria: • Unexplained hypoglycemic episodes OR • Nocturnal hypoglycemic episodes OR • Hypoglycemic unawareness and/or frequent hypoglycemic episodes leading to impairment in activities of daily living (ADLs) OR • HbA1c 9% or greater with demonstrated compliance with insulin regimen and blood glucose monitoring at least 4x/day

18. The HCPCS codes that require PA for CGM are: A9276 A9277 A9278

19. Thank You!