Annual Provider Notice

2024 Annual Provider Notice of
Laboratory Compliance

January 2024

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.


Baylor Genetics can only bill third-party payers, including federal
healthcare programs, for testing ordered by 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 If your license has been revoked or suspended, it is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 a PECOS enrolled provider and performed by Baylor Genetics,
per Medicare regulations. Additional information can be found at:


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 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:

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

Medicare reimbursement for laboratory tests can be found in the most
current Medicare Clinical Laboratory Fee Schedule
or the most current Physician Fee Schedule

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


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


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 Failure to provide a complete, clear,
and accurate test requisition may result in a delay in processing of a
test order.


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.


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.


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: