Dear Healthcare Provider:
The Office of Inspector General (“OIG”) of the Department of Health and Human Services recommends in its Compliance Program Guidance that laboratories send an annual notice to providers. This document serves as the annual notice for Aegis Sciences Corporation (“Aegis”), and provides helpful information regarding the ordering and processing of laboratory tests. Aegis has adopted and continues to enforce a comprehensive compliance program in order to adhere to applicable federal and state laws, as well as all program requirements for federal, state, and private health plans. We remind all providers requesting services from our laboratory that they are also responsible for abiding by all applicable federal and state laws, rules, and regulations concerning the provision of health care services.
Medical Necessity and Diagnostic Information Requirements
• Federally funded healthcare programs only pay for tests that meet the respective program’s definition of “medical necessity.” These programs may deny payment for a test that the provider believes is appropriate but which does not meet the federally funded healthcare program’s definition of medical necessity. It is the responsibility of the ordering provider to ensure that claims being submitted for payment to federally funded programs (and third party payers) only occur when services are covered, reasonable, and medically necessary. Therefore, you should only order those tests that you believe are covered, reasonable, and medically necessary for the diagnosis and treatment of your patients.
• The Centers for Medicare and Medicaid Services (“CMS”) has developed national and local coverage determinations that identify those tests that CMS determined will be covered under the Medicare program. CMS’s National Coverage Determinations (“NCDs”) may be found at http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd.
• CMS also has authorized its Medicare Administrative Contractors (“MACs”) to develop Local Coverage Determinations (“LCDs”), which may be found at https://www.cms.gov/medicare-coverage-database/indexes/national-and-local-indexes.aspx. These guidelines may supplement or be in addition to the National Coverage Determinations and give direction for medical necessity on selected tests. LCDs applicable to Aegis may be found under Palmetto Government Benefit Administrators, LLC, which is the Part B MAC for Jurisdiction J. Of particular note, Palmetto Government Benefit Administrator’s LCD on definitive drug testing1 specifies the following indications as supporting medical necessity for such testing, based upon individualized assessments of each patient:
o Identifying a specific substance or metabolite that is inadequately detected by a presumptive screen;
o Definitively identifying specific drugs in a large family of drugs;
o Identifying a specific substance or metabolite that is not detected by presumptive tests such as fentanyl, meperidine, synthetic cannabinoids and other synthetic/analog drugs;
o Identifying drugs when a definitive concentration of a drug is needed to guide management (e.g., discontinuation of THC use according to a treatment plan);
o Identifying a negative, or confirming a positive, presumptive test result that is inconsistent with a patient’s self-report, presentation, medical history, or current prescribed pain medication plan;
o Ruling out an error as the cause of an unexpected presumptive test result;
o Identifying non-prescribed medication or illicit use for ongoing safe prescribing of controlled substances; and
o Using results in a differential assessment of medication efficacy, side effects, or drug-drug interactions.
• Medicare generally does not pay for screening tests unless certain medical necessity criteria are met or other exceptions apply. You are encouraged to review applicable guidance (including NCD and LCD guidelines) to determine if the drug tests you order from Aegis are medically necessary.
• Aegis will bill a patient’s insurance and, when applicable, is obligated to collect any co-pays, deductibles, and amounts not covered by insurance from the patient. Aegis undertakes reasonable collection efforts in accordance with applicable requirements.
Ordering of Tests
To simplify the processing of tests, we request and encourage the use and completion of Aegis’s Laboratory Requisition. However, our laboratory will accept requisitions and orders that contain the following information, which is required by applicable regulations and/or is necessary to process the ordered tests:
2. Patient Name
3. Patient’s Date of Birth
4. Test(s) to be performed
5. Indications as to why the test is being ordered, such as a diagnosis code
6. Additional information relevant and necessary to a specific test to ensure accurate and timely testing and reporting of results as determined by the laboratory.
In the event that we receive an incomplete or ambiguous order, we will make every attempt to contact your office for the necessary information. If, however, we are unable to obtain the missing information, we will be required to postpone the requested service until the necessary information is provided. To help us provide the best possible service to your patients, we appreciate your cooperation in submitting complete, valid orders.
Ordering Particular Tests
Testing profiles should only be ordered when every component of the profile is medically necessary, as only medically necessary components will be covered. Individual tests or a less inclusive profile should be ordered for a patient when all of the tests in a larger test offering are not medically necessary. Aegis offers a la carte tests and tests that include sets of non-standard test profiles. Additional information on a la carte tests, the individual components of offered profiles, and the Medicare reimbursement paid for each component of a la carte tests and offered profiles may be found in the following link (the information in the link is updated on an annual basis): http://www.aegislabs.com/fee-schedule.
To the extent that you order a customized profile, you should note the following:
• The Medicare program provides to the testing laboratory tiered reimbursement based on the number of drugs/analytes tested and/or separate reimbursement for individual components contained in a customized profile;
• Ordering profiles may result in tests which are found not to be covered, reasonable, or medically necessary, and only those tests that are medically necessary should be ordered for each patient; and
• The OIG takes the position that a provider who orders medically unnecessary tests and who knowingly causes a false claim to be submitted may be subject to sanctions or remedies under federal civil, criminal, and administrative law.
Medicare Fee Schedule
Based upon the OIG’s recommendation, we are providing you with a link to the Medicare laboratory fee schedule, which may be found on the CMS webpage at http://www.cms.hhs.gov/ClinicalLabFeeSched. You should note that the Medicaid reimbursement amount may be equal to or less than the amount of Medicare reimbursement that Aegis will receive on the tests you order.
The information you provide on the test requisition should accurately reflect the medical reasons for requesting the specified tests. The patient’s record should include all required documentation to support the test order and the medical necessity of such tests. Specifically, providers should document within the patient record the need for each ordered test including, as applicable, the patient history, findings from physical exams, previous laboratory findings, the treatment plan, prescribed medications (and, in particular, medications with risk of abuse and/or diversion), the risk assessment, and any other reasoning in support of the ordered testing (e.g., aberrant behavior, patient admits to use of illicit or non-prescribed controlled substances, sudden changes in medical condition, side effect profile changes, patient response to prescribed medication changes, assessment for possible drug-drug interactions, etc.). Further, at the time of the test request, specific diagnostic information demonstrating the reason why the test was ordered should be documented in the patient’s record. ICD-10 coding is required.
In the event of a federally funded program or contractor, third party payer, or compliance audit or request for medical necessity documentation, Aegis may request a copy of your medical record documentation to support the medical necessity of the test that was ordered.
CMS does not require ordering providers to sign paper or electronic laboratory requisitions. However, in the absence of a signed laboratory requisition, CMS requires documentation within the beneficiary’s medical record maintained by the ordering provider to show such provider’s clear intent to order the performed testing. Aegis requests and encourages all ordering providers to sign laboratory requisitions to avoid some situations that otherwise could require the provider to undertake the administrative burden of supplying underlying progress notes upon Aegis’s request, as well as to ensure there is no question as to each provider’s intent to order the performed testing.
Aegis has consultants who are available to discuss provider questions about Aegis’s testing. These consultants can be contacted at (877) 552-3232.
If you have any questions or comments regarding the information contained in this notice, please do not hesitate to contact our Compliance Officer, Wells Johnson, at (615) 577-4568. You may also call our Compliance Hotline at 888-686-8385, or go online to https://aegis.alertline.com.
1. Palmetto Government Benefits Administrators, Local Coverage Determination, “Controlled Substance Monitoring and Drugs of Abuse Testing (L35724),” (eff. Dec. 27, 2018).