The Office of Inspector General (OIG) recommends clinical laboratories send notices to physicians and other health care providers who use their services, at least once a year, to inform the recipients of the laboratory’s policies for test ordering and billing and provide certain other information regarding the laws and regulations that govern laboratory services. This Annual Notice is provided pursuant to that recommendation.

The following information is intended to promote awareness of federal regulations and to explain the requirement for health care providers to furnish appropriate documentation when ordering testing services. If you have questions about the contents in this notice, we encourage you to contact us for more information.

Medical Necessity: Medicare will only pay for tests that meet the Medicare coverage criteria and are medically necessary for the diagnosis or treatment of the individual patient. Criteria to establish medical necessity for drug testing must be based on patient-specific elements identified during the clinical assessment and documented by the clinician in the patient’s medical record. Tests used for routine screening of patients without regard to their individual need are not usually covered by the Medicare Program, and therefore are not reimbursed. As a participating provider in the Medicare Program, Genetics Institute of America has a responsibility to make a good faith effort to ensure all tests requested are performed and billed in a manner consistent with all federal and state law regulations. As the physician, you are responsible for documenting medical necessity in the patient’s permanent medical record and for providing appropriate diagnostic information in the form of ICD-10 codes to the highest level of specificity or a narrative to Genetics Institute of America. The Office of Inspector General takes the position that a physician who orders medically unnecessary tests for which Medicare or Medicaid reimbursement is claimed may be subject to civil penalties under the False Claims Act.

Medicare National and Local Coverage Determinations: The Medicare Program publishes National Coverage Determinations
(NCDs) and local Medicare contractors publish Local Coverage Determinations (LCDs) for certain tests. These policies identify the conditions for which the included tests are or are not covered or reimbursed by Medicare with reference to specific ICD codes (diagnostic information). Medicare contractors have issued LCDs that apply to qualitative drug screens (presumptive tests), confirmatory or quantitative drug tests (definitive testing), and pharmacogenetic testing furnished within their region of jurisdiction. These policies are available upon request and can be found through the Medicare website at: http://www.cms.gov/Medicare/Coverage/DeterminationProcess/LCDs.html

Test Ordering: Genetics Institute of America’s web-based platform may be used to order tests from Genetics Institute of America. Genetics Institute of America assists health care providers track and view specimens as they progress through transit, testing and delivery of results. A standard Genetics Institute of America test requisition form (whether via the portal or in paper form) should always be used when ordering tests. The Genetics Institute of America requisition forms are designed to emphasize physician choice and encourage physicians to order only those tests which the physician believes are appropriate and medically necessary for the diagnosis or treatment of each patient. If Genetics Institute of America receives a test order on a non-Genetics Institute of America requisition form or an incomplete Genetics Institute of America requisition form, processing of your test order may be delayed. As necessary, Genetics Institute of America will contact physicians to have them resubmit the test order on a test requisition form or otherwise clarify each specific test being ordered.

Genetics Institute of America, under no circumstances, endorses duplicate billing of tests. If a provider performs a drug screen, and subsequently bills the insurer for that test, the provider should not order a separate screen from Genetics Institute of America. Provider’s should notify the laboratory of any change or addition in their point of care testing in order to avoid duplicate billing of tests. For any requested test(s) ordered by the provider, it should be expected that Genetics Institute of America will bill for that test, unless otherwise agreed upon.

Signatures & Intent: To stay within federal regulations for test ordering, Genetics Institute of America provides multiple options for referral sources to authorize the processing of specimen. By law, the referring physician must document that a test was ordered with intent, and that a signature must accompany this documentation. If the physician submits a paper requisition form to Genetics Institute of America the requisition must: (a) contain the signature of the physician, (b) be accompanied with signed medical notes containing intent for the test, or (c) the physician must retain the signed medical notes and make them available to Genetics Institute of America upon request. If the physician chooses to retain the documentation, Genetics Institute of America will need assurance that these supporting documents be retained for no less than the period required by law and contain clear intent for the test order and an appropriate signature of the physician. Electronically submitted requisitions must also abide by the intent, signature, and retention requirements of paper requisitions and Genetics Institute of America will make accommodations to facilitate this process for e-submitters.

Elimination of Physician Custom Profiles: Recent policy changes and guidance from Medicare Administrative Contractors, other government regulatory authorities and commercial insurers now discourage, if not outright prohibit, clinicians’ use of non- patient-specific panels, including “custom profiles,” when ordering laboratory drug testing . As such, Genetics Institute of America has minimized its use of Physician Custom Profiles. Custom profiles, at minimum, must be reviewed and verified annually to ensure the testing is medically necessary based on individual patient specific elements identified during the clinical assessment, and documented by the clinician in the patients’ medical record. As a clinical laboratory, Genetics Institute of America supports these efforts and has devoted substantial resources to developing processes that will seamlessly encourage that only medically necessary tests are ordered for each patient. Elimination of “custom profiles” and adoption of risk-based panels and patient specific ordering without panels is also important for physicians. Health plans and regulatory authorities are increasingly expecting physicians to strictly comply with new medical policies related to drug test ordering or risk network termination for non-compliance.

Verbal Test Orders: Medicare regulations require that all orders for laboratory tests be in writing. If a physician or his/her authorized representative orders a test by telephone or wishes to add a test to an existing order, a written order is required to support the verbal order. In these cases, Genetics Institute of America will send a confirmation of the verbal order request to the ordering physician, requesting it to be signed and sent back to the laboratory for its records. Testing will not be performed until the signed confirmation or a properly completed Genetics Institute of America requisition form is returned to the laboratory.

Patient Privacy (HIPAA): Under the Health Insurance Portability and Accountability Act (HIPAA), Genetics Institute of America is a health care provider and a covered entity. It is our policy to comply with the letter and intent of the HIPAA privacy and security standards. Our privacy policy is available upon request.

Inducements: Federal law prohibits offering or paying any remuneration – meaning anything of value – to induce the referral of tests that are covered by Medicare, Medicaid or other federal health care programs. Any form of kickback, payment or other remuneration that is intended to secure the referral of federal health care program testing business is strictly prohibited and should be reported to the Genetics Institute of America by calling (561) 455-2162.

Clinical Consultants: Physicians and other clinicians authorized to order tests have the services of clinical consultants and toxicologists available to ensure proper test ordering and answer questions.

Prohibited Referrals: It is the policy of Genetics Institute of America to comply with all aspects of the laws and regulations governing physician self-referral, most notably including the federal Stark law. The Stark law’s self-referral ban states that if a financial relationship exists between a physician (or an immediate family member) and a laboratory (or certain other kinds of healthcare providers), and the relationship does not fit squarely into one of the law’s exceptions, then (a) the physician may not refer Medicare patients to the laboratory, and (b) the laboratory may not bill Medicare for services referred by the physician. The kinds of relationships between laboratories and physicians that may be affected by these laws include the lease or rental of space or equipment and the purchase of medical or other services by a laboratory from a referring physician.

Financial Assistance Programs: Genetics Institute of America understands that providing quality patient care has a related cost, which in some situations may be burdensome for patients and result in some patients avoiding certain necessary services because they are concerned about the expense. Genetics Institute of America is committed to delivering the best patient care to all, and to meet this objective has established a financial support program. This financial support program helps ensure affordable access to Genetics Institute of America’s services. Patients with special financial needs may be eligible for support to help defray some of Genetics Institute of America’s testing costs. Genetics Institute of America encourages those patients who may not be able to pay fully for Genetics Institute of America’s services to contact us for an assessment of eligibility for financial support in accordance with federal guidelines.