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[ADD DATE]Dr. [ADD PHYSICIAN FIRST/LAST NAME], [ADD PHYSICIAN CREDENTIALS][ADD CLINIC NAME][ADD CLINIC STREET][ADD CITY/STATE/ZIP]RE: Laboratory Compliance – Physicians NoticeDear Dr. [ADD PHYSICIAN LAST NAME]: In its compliance guidance for clinical laboratories the Office of the Inspector General (OIG) recommends that all clinical laboratories distribute a physician notice to its ordering clients at a minimum once per year. In an effort to comply with these recommendations, we are providing this Physicians Notice delineating the guidelines used by us for submitting claims to Medicare, Medicaid and other federally funded healthcare programs.We are committed to full compliance with all applicable federal and state laws and regulations, third party payer requirements, and industry best practices. It is our hope that this letter provides helpful information regarding important laboratory practices including the ordering and processing of clinical laboratory tests.Medical NecessityHealth care providers have the right to order any tests believed to be appropriate in the treatment of their patients. However, many insurers will only reimburse for the service if it is “covered, reasonable, and necessary” as defined by their payer-specific criteria which is based on ICD-10 codes supplied for each test ordered. This requires that lab tests ordered must be documented in the patient’s medical record, along with the ICD-10 code submitted on the lab order and signed by the ordering physician. Consistent with documentation requirements issued by the Centers for Medicare and Medicaid Services (“CMS”), we require a completed laboratory test requisition form with each specimen submitted to us for testing that includes a diagnosis from the ordering physician supporting medical necessity before we can perform a laboratory test. In addition, we may require additional information in the form of documentation from the patient’s medical record supporting the medical necessity of the test.If our laboratory receives an order that is missing this essential information, or if we are not able to bill for the test because the ICD-10 codes supplied do not meet medical necessity definitions, we will contact your office to obtain additional coding information. Our lab cannot assign ICD-10 codes to the lab order. Lab tests can only be ordered by a licensed medical provider. If ordering lab tests for Medicare/Medicaid patients, the provider must be eligible to order such testing by their provider type guidelines.Order RequirementsLab orders must include the following information:The patient’s full legal name or other unique identifier as well as date of birth and gender;The patient’s insurance information;The name and phone number or other suitable identifiers of the physician (or other authorized individual) ordering the test and, if applicable the individual responsible for utilizing the test results or the name and address of the laboratory submitting the specimen, including a contact person to enable the report of imminent life-threatening laboratory results or panic value;The name of the tests(s) to be performed;The patient’s current ICD-10 code(s) or indications as to the medical necessity of the test;The date and time of specimen collection;The specimen type; andThe signature of the physician (or other authorized individual) ordering the test, which in the event of a paper requisition must be a wet signature. While not all orders are required to be signed by the physician, in the absence of a wet signature, we must receive sufficient written documentation that the progress notes support the physician’s intent to order the test. Should we receive a lab order that does not contain all the necessary information list above, we will contact your office and/or send the form back to your office for completion. Verbal OrdersMedicare 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, Qitek 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 Qitek requisition form is returned to the laboratory.RequisitionsQitek Labs USA, LLC (“Qitek”) may provide the Provider with requisition forms respecting services, but it is the Provider’s responsibility to use the correct requisition form for the tests requested consistent with both the National Coverage Determinations (“NCDs”) issued by the Centers for Medicare and Medicaid Services (CMS) and Local Coverage Determinations (“LCDs”) issued by National Government Services (NGS). Qitek Labs USA, LLC (“Qitek”) owns two independent and separately-licensed laboratories, Qitek Labs, LLC, located at 4375 River Green Parkway, Suite 200, Duluth, Georgia 30096 (the “Georgia Lab”) and Qitek Labs of Oklahoma, LLC, located at 3636 NW 63rd Street, Suite C, Oklahoma City, Oklahoma, 73116 (the “Oklahoma Lab”). The Oklahoma Lab and Georgia Lab do not provide the same services. Please see Qitek’s website for further information. Medicare National and Local Coverage DeterminationsTests ordered are screened against diagnoses provided by the physician according to NCDs and LCDs. Laboratory tests that do not meet applicable NCD or LCD coverage requirements are considered “non-covered tests” and, depending on the circumstances, the patient may be financially responsible. Qitek may also reject the test and discard of it with notice to you.Advanced Beneficiary NoticeIf a particular test that is ordered for a Medicare patient does not meet the NCD or LCD medical necessity guidelines, or is frequently restricted, the patient will be provided with an Advance Beneficiary Notice (“ABN”) if one was not already assigned at the time of ordering the services. This informs the patient of his/her potential financial responsibility for the tests if Medicare denies the service. If an ABN is provided to and signed by the patient, unless the patient waives billing Medicare, the tests will first be submitted to Medicare for an initial determination. If Medicare denies the test, the patient will then be billed for the test. Your patients will also be provided the opportunity to refuse the test if it is not likely to be covered by Medicare.Specimen CollectionPlease reference the specimen collection instructions that have been provided to you by your Qitek representative for guidance in proper collection and shipping to ensure the specimen is viable when it arrives at our lab. These are also online on our website. Our Resources page is extremely comprehensive. PreauthorizationProviders have the option of ordering a panel or individual tests, depending on medical necessity. Certain lab tests may require pre-authorization according to the patient’s insurance provider’s guidelines. Any required pre-authorization paperwork should be completed by the ordering provider’s office before the lab test order is submitted. Please include the pre-authorization paperwork with the lab requisition form, when applicable, along with any related documentation. If the laboratory determines that pre-authorization is needed, and there is not enough information included on the patient paperwork to obtain it, we will contact the ordering physician’s office before testing and request more clinical information for this purpose.Medical Laboratory Fee ScheduleMedicare reimburses laboratory testing services through either the Physician Fee Schedule or the Clinical Lab Fee Schedule, depending on the type of test. If you would like of copy of these fee schedules, please refer to the Medicare Fee-for-Service Payment section of CMS’s website at . Medicaid reimburses laboratory testing services in accordance with applicable laws and Medicaid manuals as set forth by the state in which the patient resides. Reflex Laboratory TestsUpon results of an initial laboratory test, Qitek may perform additional testing which can result in an additional charge. Relevant practices in laboratory medicine and the avoidance of performing unnecessary testing help dictate which tests are subject to this policy. Our test directory states that additional testing may be performed, depending on the results of this test. An additional fee may be added for the reflex testing. Please contact the laboratory if you have any questions about reflex tests.Custom PanelsThe American Medical Association has grouped certain tests into panels for coding purposes only. Using a custom panel may result in the ordering of tests which are not covered, reasonable or necessary and that may not be billed. Providers should consider the medical necessity of all tests associated with a panel. Informed Consent Some state laws require physicians ordering genetic testing and/or releasing such test results to obtain informed consent from the patient (or legally authorized representative). Although the requirements vary by state, typically, these requirements relate to hereditary or germline cancer tests. These requirements are posted on Qitek’s website. Among such requirements, Qitek may require an informed consent from time to time for certain cancer genomics, familial hypercholesterolemia, cardiomyopathy, Parkinson’s, Alzheimer’s, dementia, and carrier screening tests. It is the treating physician’s responsibility to be knowledgeable of all state laws and/or regulations regarding the appropriate disclosure and documentation necessary for obtaining a patient’s informed consent and the ordering physician should be aware that, in some instances, a genetic counseling session may be required. Prohibited Referrals and InducementsIt is the policy of Qitek to comply with both the Physician Self-Referral Law (Stark) and the Anti-Kickback Statute. Stark Law states that if a financial relationship exists between a physician (or their immediate family member) and a laboratory, the physician may not refer Medicare beneficiaries to the laboratory, and the laboratory may not bill Medicare for any services referred by the physician unless the financial relationship between the parties falls into one of the law’s exceptions. The Anti-Kickback Statute prohibits the knowing or willful offer, payment, solicitation, or receipt of remuneration in order to induce business reimbursed under the Medicare or Medicaid programs. Any form of kickback or inducement to secure Medicare or Medicaid referrals is strictly prohibited.Patient PrivacyUnder the Health Insurance Portability and Accountability Act (HIPAA), Qitek is a healthcare provider and a covered entity. We are committed to compliance with all HIPAA privacy and security standards. From time to time, we make de-identified test result data available to pharmaceutical companies and other entities engaged in healthcare research. In accordance with applicable regulations under HIPAA, we are permitted to de-identify protected health information (“PHI”) and provide such de-identified information to third parties. None of the data we provide to third parties contains any PHI protected under HIPAA.Qitek’s Reliance on ProviderQitek is relying on the following when we perform tests that you order: The information you submit on the order/requisition accurately reflects the medical reasons for requesting the specified tests.The medical necessity and order for each of the individual tests submitted has been appropriately documented in the patient’s medical record in your office.Tests will only be ordered when each individual test is medically necessary for the diagnosis and/or treatment of the patient or the criteria in item #5 below are satisfied.You are treating the patient in connection with the diagnoses, complaints or reasons listed on the order/requisition.When you order tests for purposes of screening for asymptomatic patients that you believe are appropriate even though the payor may not allow reimbursement, you acknowledge the fact that Medicare generally does not cover screening tests and that you or your staff have explained this to the patient and the order/requisition notes that the test is for screening purposes.Upon request of the hospital or its payors, you agree to provide documentation from your office that reflects that the test ordered was medically necessary for the patient.False ClaimsThe OIG states that any individual who knowingly causes a false claim to be submitted may be subject to sanctions or remedies available under civil, criminal, and administrative law. Qitek will not knowingly bill Medicare for testing that is non-covered, unreasonable, and/or unnecessary.We greatly appreciate your support in providing quality care to patients and complying with our policies. If you have any questions or comments regarding any of Qitek’s compliance, please do not hesitate to contact us at the numbers listed below. Please sign and date this letter to acknowledge your understanding and agreement to comply with Qitek’s policies. Sincerely, _______________________Zachary Husk, CEO678-523-8759Provider: _________________________ Date: ______________________________ ................
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