Annual Laboratory Compliance Notice to Physicians and Providers 2023-2024
To: Physicians and Providers
From: Flow Health
Re: Annual Laboratory Compliance Notice to Physicians and Providers
The Office of the Inspector General (OIG) of the Department of Health and Human Services (DHHS) believes that compliance plans can facilitate significant reductions in fraud and abuse. Therefore, following the OIG’s guidelines for a model compliance plan for clinical laboratories, Flow Health has chosen to incorporate those recommendations in our current compliance plan.
Medicare Medical Necessity Policy: Laboratory tests are reimbursed under federally funded programs if they are deemed “medically necessary” for the diagnosis and treatment of the patient. The Centers for Medicare and Medicaid Services (CMS) has developed national and local coverage decisions that identify those tests that CMS determined will be covered under the Medicare program. Coverage for these services is based on the diagnosis/sign/symptom assigned at the office visits. CMS’ Medical Coverage Database can be accessed at: cmhttps://www.cms.gov/medicare-coverage-database/search.aspxs.gov. It is a requirement that a numeric (ICD-10) code is linked to each test ordered.
Standing Order: Flow Health may permit the use of standing orders in connection with an extended course of treatment. However, Flow Health may monitor existing standing orders to ensure their continuing validity to prevent possible fraud and abuse. Consistent with state law requirements, Flow Health may contact all standing orders received on an annual basis and request confirmation in writing of the validity of all standing orders. Flow Health may also verify the validity of standing orders relied upon at draw stations with the physician, physician’s office staff, or other such persons authorized by law to order tests who have provided the standing orders to Flow Health.
Ordering Diagnostic Tests: The federal government describes the conditions for ordering laboratory tests in 42 C.F.R. § 410.32. All diagnostic laboratory tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary.
Advanced Beneficiary Notice (ABN): If a particular test that is ordered for a Medicare patient does not meet the National Coverage Determination (NCD) or Local Coverage Determination (LCD) medical necessity guidelines, or is frequency restricted, the patient should be provided an ABN by the requesting physician or provider. The ABN informs the patient of his/her potential financial responsibility for the tests if Medicare denies the service. The patient has the right to waive billing Medicare, assume the expense of the test, or refuse the test that is not covered by Medicare payment.
Flow Health Clinical Consultant:
Dr. Hong Li, is the Lab Director and clinical consultant for Flow Health. She is available to assist with laboratory testing questions, including ordering and interpretation, and may be contacted at: firstname.lastname@example.org and +1 (714) 726-8888.
Important information for Customized Test Panels:
Medicare reimbursement is paid at the panel component level
Medicare will reimburse only tests that are medically necessary for each patient
Using a customized test panel may result in the ordering of tests which are not covered, reasonable or necessary and the tests may not be billed
The OIG 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.
Flow Health may request physician signature when customized test panels are requested to acknowledge his/her understanding of ordering such panel types.
Additional Information for Medicare and Medical Assistance Billing:
Medicare Secondary Payer (MSP) Screening: Medicare requires that all healthcare providers make a good faith effort and have procedures in place to ensure that Medicare is the primary payer.
Medical Assistance (or Medicaid) reimbursement for laboratory services is equal to or less than the amount Medicare reimburses.
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