This document outlines the professional relationship and responsibilities between First Bio Genetics LLC and the undersigned physician or practitioner. By signing below, you agree to the following terms regarding the ordering and processing of laboratory tests for your patients.
1. Test Ordering Authority: I authorize First Bio Genetics LLC to perform diagnostic testing on my patients. I will provide test orders through individual requisition forms or, if I choose, by using a pre-established custom profile on file. I understand that the choice between these two methods is entirely my own.
2. Medical Necessity and Documentation: I certify that I will be responsible for the clinical oversight of all tests ordered. This includes determining the medical necessity, frequency, and duration of testing. I will ensure that each order is clinically indicated and documented appropriately. I agree to provide specific and accurate diagnosis codes for all tests to confirm medical necessity and to facilitate effective billing by First Bio Genetics LLC on my patients' behalf.
3. Medicare Guidelines for Drug Screening: I acknowledge the Medicare policy stating that confirmatory drug screens are necessary only when the initial screening results are inconsistent with the patient's medical history, clinical presentation, or self-reported information.
4. Use of Provided Equipment: I understand that if First Bio Genetics LLC provides any Point of Care (POC) testing devices, I must not bill for or collect fees related to POC testing without first purchasing the device from the lab at fair market value. I agree to use the device solely for the collection, transport, or storage of specimens intended for testing by the lab. I am aware that using the device for any other purpose or billing for POC tests without paying for the equipment could be viewed as a violation of the Anti-Kickback Statute (42 U.S.C. § 1320a-7b).
5. Payment for POC Devices: If I use a lab-provided POC device and receive any form of remuneration for services associated with it, I will be invoiced and will promptly pay for the device at its fair market value.
6. Compliance with OIG Warnings: I recognize the guidance from the Office of the Inspector General (OIG) cautioning that using custom test profiles may lead to ordering tests that are not covered or medically necessary. I understand that knowingly submitting or causing the submission of a false claim may result in legal consequences.
7. Billing and Records: I understand that First Bio Genetics LLC will bill third-party payers for the tests I order. I agree to provide signed written orders from the patient’s medical chart to First Bio Genetics LLC or any other requesting party within 72 hours of a request.
8. Designated Laboratory: I confirm that all testing I order under this agreement will be performed by First Bio Genetics LLC and its network of affiliated contracted laboratories.
9. Custom Profile Validity: My pre-defined custom profile will remain active for 180 days from the date of my signature. I understand that I can request modifications to this profile at any time. I am aware that all clinical laboratory testing is subject to applicable National and Local Coverage Determinations.
10. Adherence to CMS Policy: I acknowledge that First Bio Genetics LLC operates in accordance with the guidelines and recommendations of the CMS National Coverage Policy. I confirm that I have been provided with and am satisfied with the information regarding the lab’s testing policies.
11.Delegation of Orders: I certify that I have authorized the staff of __________________________________ (Facility name) to enter medically necessary test orders into our Laboratory Information Management system or EMR system. I will continuously oversee these orders to ensure that only medically necessary tests are being requested for each patient, in line with their documented treatment plan.
12. Signature Authorization: I grant First Bio Genetics LLC permission to upload my signature from this document to their online portal. I understand that this signature will be used for all laboratory and medical records requested by insurance companies. I can update, add, or remove my signature from the portal at any time.