CIAN Diagnostics is providing this notice in accordance with the recommendation made by the Office of Inspector General (OIG) as part of our Compliance Program. CIAN Diagnostics advises its physicians and clients about program changes and information related to federally-funded healthcare programs that affect both the physician and laboratory. Please note that these notices are intended to help both the physician client and the laboratory comply with these regulations and mitigate the risks for all parties.

Please review this compilation of important Medicare regulations, billing rules, and other related compliance guidelines. If you have questions about any content in this notice, we encourage you to contact us for more information.

When ordering tests for which Medicare reimbursement will be sought, the following policies apply:

Permission to order labs for Medicare Patients:

All healthcare providers are required to have a valid National Provider Identifier (NPI#). Additionally, Medicare requires that all providers be registered in the CMS Provider Enrollment, Chain and Ownership System (PECOS). All eligible providers must enroll or officially ‘opt-out’

Testing not ordered by licensed, enrolled physicians or other qualified nonphysician practitioners acting within the scope of their practice, and in compliance with Medicare requirements will be denied as not reasonable and necessary.

Submitting a valid Laboratory Orders/Requisitions:

Each valid order must be accurately documented in the patient’s medical record and signed by the ordering provider. To ensure accurate patient identification, timely reporting of lab results, and compliance with state law, all valid lab requisitions must include the ordering practitioner’s name with credential, practice address and NPI number, the patient’s full legal name, date of birth, gender, date and time of collection, and specimen source (where applicable). Any hand-written requisitions (i.e., ‘script’) must be legibly signed and dated by the ordering provider.

Correct Coding:

The laboratory depends on the diagnosis or clinical history information submitted on the request for testing. All lab tests must be submitted with a valid diagnosis code to the highest level of specificity or comparable narrative. The laboratory cannot assign coding. The laboratory relies on the practitioner to code the condition to the highest degree of certainty for that visit, such as signs, symptoms, previous abnormal test results, or other reason for visit. Coding MUST NOT be assigned specifically to garner reimbursement or increase the patient’s benefit level.

ICD-10 codes are reviewed and updated annually, with new/updated/more-specific codes becoming effective October 1st of each year. Please research them annually to ensure accurate code submission to the highest level of specificity required.

Communicating the Medicare Medical Necessity Policy:

Tests that are medically necessary for the diagnosis or treatment of a Medicare patient are covered and may be reimbursed by Medicare. An approved test panel must only be ordered when every test in that panel is medically necessary. If all components of the panel are not medically necessary, you should order individual tests or a panel that contains only the medically necessary tests. Screening or Investigational Use Only tests are generally not covered by Medicare, with some exceptions for Wellness Screens. As a Medicare participating provider, CIAN Diagnostics has a responsibility to make good faith efforts to ensure that all tests requested are performed and billed in a manner consistent with all federal and state laws and regulations. The medical necessity of each test must be specifically documented in the patient’s permanent medical record/chart, must reflect any ICD10 codes or narratives submitted on the lab requisition, and must be signed by the ordering physician. Remember that providing evidence of medical necessity for each test ordered is a requirement for your participation with Medicare, Medicaid and other insurance plans. *The OIG takes the position that physicians or other individuals authorized by law to order laboratory tests, who knowingly cause a false claim to be submitted to any federally funded program, may be subject to sanctions or remedies available under civil, criminal and administrative law, such as the False Claims Act.

Diagnostic, Screening, Preventative, or Routine Tests:

• Diagnostic tests are for people believed to have a problem and to establish the presence (or absence) of disease as a basis for treatment decisions in symptomatic or screen positive individuals
• Screening/Preventive tests are for people believed to be healthy and performed in the absence of signs, symptoms, complaints or personal history of disease or injury
• Individual tests cannot be coded with both diagnostic and routine/screening codes. Once a patient has been diagnosed with a relevant condition, screening codes are no longer appropriate

Statutorily, Medicare does NOT cover any lab testing for routine and/or screening purposes. However, Medicare does cover some Preventive lab tests (PSA, Glucose, Lipids, etc.) if ordered as required by Medicare. For Preventive benefit information including test names, specific CPT codes, required ICD-10 code(s) and frequency limitations.

If a patient requests certain lab testing and it is determined that the testing is NOT medically necessary. The test cannot be billed to any patient insurance; it must be billed directly to the patient. If a provider decides to move forward with the patients request, inform the patient they will be financially responsible for the tests. Please indicate “PATIENT REQUESTED” on the requisition. Do not submit diagnosis coding for this type of testing.

Local Coverage Determination:

CMS has developed National Coverage Determination (NCD) Policies that restrict Medicare coverage for certain lab tests on a national basis. In addition, Noridian Administrative Services, LLC (02402, MAC-Part B) continues to develop Local Coverage Determination (LCD) Policies that restrict Medicare coverage for an additional list of tests. Any CPT contained in one of these NCD or LCD policies must be screened for medical necessity based on the applicable policy and the primary diagnosis code assigned.

If a ‘non-covered’ diagnosis is used when ordering any lab test covered by NCD/LCD policy, the patient must be notified of their potential financial liability prior to specimen collection and given the opportunity to sign the Advance Beneficiary Notice (ABN). The ABN must be completed for any Medicare patient where claim denial is suspected based on medical necessity or frequency limitations. The completed, signed original ABN must be attached to the original lab order prior to specimen submission. Completing an ABN for every Medicare beneficiary is an unacceptable practice and is not permitted.

Organ/Disease Panels or Lab/Client Customized Panel:

Only order any panel if each/every individual component of the panel is medically necessary as determined by specific ICD-10 code(s) and documented in the patient’s medical record/chart. If any panel component is not medically necessary, do not order the panel.

Compliance Program Additional Information:

• The OIG/Department of Justice takes the position that an individual who knowingly causes a false claim to be submitted may be subject to sanctions or remedies available under civil, criminal and administrative law. The laboratory will not knowingly bill Medicare for testing that is noncovered, unreasonable and/or unnecessary.
• If the laboratory receives an order without the required diagnosis information, or is unable to bill for testing performed because the coding supplied doesn’t meet medical-necessity requirements, we will attempt to contact the ordering provider to gather any additional coding information documented in the patient’s chart but inadvertently not submitted on the original lab requisition. Again, it is illegal to code solely for reimbursement purposes.
• Supplies required for the collection of specimens sent to our laboratory will be provided upon request. Due to Stark Law/Anti-Kickback statutes, supply volumes must reasonably match volumes of testing received.

CIAN Diagnostics has an active Compliance Program that reflects our commitment to conduct business in compliance with all federal, state and local laws, and to adhere to all program requirements for federal, state and contracted private health plans.

We appreciate your cooperation and ongoing participation in our compliance program as your partnership with CIAN Diagnostics is essential to its success. If you have any questions about information contained in this notice, or other issues/concerns related to laboratory financial compliance, or lab coding, please contact: Compliance/Ashley Graham, JD, CHC, LLM @ ashley.graham@ciandx.com or info@ciandx.com