Annual Provider Notice

2025 Annual Provider Notice of
Laboratory Compliance

January 2025

To our Valued Healthcare Providers:

We appreciate you allowing Baylor Genetics the opportunity to serve the healthcare needs of your patients. We are dedicated to providing you and your patients with timely, high quality genetic testing services. We are also committed to complying with all applicable federal and state healthcare laws, rules, and regulations in providing these services.

The United States Department of Health and Human Services’ Office of Inspector General (OIG) has issued guidance that recommends
laboratories provide annual notice to ordering providers as part of an effective compliance program. The following information covers Baylor Genetics’ policies and procedures for ordering providers to meet federal, state, and private health plan requirements.

AUTHORIZED ORDERING PROVIDERS

Baylor Genetics can only bill third-party payers, including federal healthcare programs, for testing ordered by or on behalf of a licensed physician or other non-physician practitioner authorized by state law to order laboratory tests. If your license has been revoked or suspended, it is your responsibility to notify our laboratory immediately. You represent and warrant that neither you, nor any employee, contractor or agent performing services on behalf of you has been excluded, debarred, suspended, proposed for debarment, or otherwise declared ineligible from any federal healthcare program or federal procurement or non-procurement program or convicted of a criminal offense that falls with the scope of 42 U.S.C. §1320a-7a. You further agree that you will immediately disclose any such debarment, suspension, exclusion, proposed debarment or ineligibility to Baylor Genetics upon discovery and not attempt to order any tests from Baylor Genetics.

Providers ordering laboratory testing on Medicare beneficiaries must be registered in the Centers for Medicare and Medicaid Services (“CMS”) Provider Enrollment, Chain and Ownership System (“PECOS”). It is Baylor Genetics’ policy to only bill Medicare for laboratory testing ordered by or on behalf of a PECOS enrolled provider and performed by Baylor Genetics, when required by Medicare regulations. Additional information can be found at: https://pecos.cms.hhs.gov.

MEDICAL NECESSITY POLICY

Baylor Genetics has an obligation to make a good-faith effort to ensure all tests ordered are performed and billed in a manner consistent with all federal and state laws and regulations. Third-party payers, including federal healthcare programs, will only pay for tests that are medically necessary for the diagnosis or treatment of the individual patient. Criteria to establish medical necessity for testing must be based on patient-specific elements identified during the clinical assessment and documented by the ordering provider in the patient’s medical record. As the ordering provider, you are responsible for documenting medical necessity in the patient’s medical record (including your signature) and for providing appropriate diagnostic information in the form of ICD-10-CM code(s) to the highest level of specificity or a narrative to Baylor Genetics when ordering laboratory testing services.

The OIG takes the position that providers who order medically unnecessary tests for which federal healthcare program reimbursement
is claimed may be subject to criminal, civil and administrative penalties.

MEDICARE NATIONAL AND LOCAL COVERAGE AND
REIMBURSEMENT POLICY

Medicare and Medicare Administrative Contractors (MAC), Medicare contractors, have developed National and Local Coverage Determinations (NCDs and LCDs) that provide guidelines regarding Medicare coverage of certain laboratory tests. These policies identify
the conditions for which the included tests are or are not covered or reimbursed by Medicare, typically by reference to specific ICD-10-CM
code(s) that support coverage.

You can find NCDs in the Medicare Coverage Database at:

• https://www.cms.gov/medicare-coverage-database/search.aspx

You can find LCDs through your regional MAC. Information regarding LCDs is located at:

• https://www.cms.gov/medicare/coverage/determinationprocess/lcds

Medicare reimbursement for laboratory tests can be found in the most current Medicare Clinical Laboratory Fee Schedule (https://www.cms.gov/medicare/medicare-fee-for-service-payment/clinicallabfeesched) or the most current Physician Fee Schedule (https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched).

State Medicaid reimbursement amounts will be equal to or lower than the amount of Medicare reimbursement and are available through the state Medicaid agency.

MEDICARE ADVANCE BENEFICIARY NOTICE (ABN)

If laboratory testing is ordered for a Medicare beneficiary that is a “non-covered” service based on Medicare coverage criteria (see
previous information), the Medicare beneficiary must be notified prior to specimen collection and given the opportunity to sign an ABN. The most current Fee For Service (FFS) CMS ABN Form (CMS-R-131) must be completed for any Medicare patient where denial of reimbursement is suspected based on Medicare payment policies, including any applicable NCDs and LCDs. The most current CMS ABN form can be found on the CMS website at https://go.cms.gov/44SpuoF.

TEST ORDERING OPTIONS

The Clinical Laboratory Improvement Amendments (CLIA) regulations require that the performing laboratory have a written or electronic
request for patient testing from an authorized person. The Baylor Genetics’ test requisition forms are designed to emphasize provider
choice and encourage authorized ordering providers to order only those tests which they believe are appropriate and medically necessary for the diagnosis or treatment of each patient. Baylor Genetics has two (2) options available by which an authorized provider may order testing which are: 1) manual paper test requisitions; or 2) online test ordering via the secure Baylor Genetics’ electronic ordering system located at https://www.baylorgenetics.com/. Failure to provide a complete, clear, and accurate test requisition may result in a delay in processing of a test order.

BILLING INFORMATION

Baylor Genetics requires the following information to bill third party payers. The paper requisition and online portal contain adequate, clearly labeled spaces to provide this information:

• Patient’s full name
• Patient’s complete address, city, state, and zip code
• Patient’s date of birth and sex
• Patient’s insurance company name, ID number including
  prefix/suffix, if applicable
• Ordering provider’s name and NPI number
• Valid ICD-10-CM diagnosis code(s) for each test or component
  thereof, if required; and
• Evidence of a valid ABN when applicable under Medicare payment
  policies, including NCD/LCD policies.

SIGNED REQUISITION

Although the ordering provider’s signature is not required on laboratory requisitions, if signed, the requisition will serve as acceptable
documentation of a provider’s order for the test. This will reduce the risk of us reaching out to your staff to obtain evidence of the signed test order, so we strongly encourage providing a signed requisition. In the absence of a signed requisition, documentation of your intent to order each laboratory test must be documented in the patient’s medical record and made available, upon request, to Baylor Genetics.
Documentation must accurately describe the individual tests ordered; it is sufficient to state ‘labs ordered’. Upon request, ordering providers are required to provide all documentation (including provider signature) that reflects the actual order for the test(s) and supports the medical necessity of the order submitted to Baylor Genetics.

CLINICAL CONSULTANT

Baylor Genetics’ Laboratory Director, Dr. Christine Eng, is available to discuss appropriate testing and test ordering. If you have any questions, please contact Customer Service at: [email protected].