Glossary B-Cl

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Best Price Fraud – a figure reported by the manufacturer to CMS in quarterly reports under the Medicaid Rebate Program, it is used to calculate the Medicaid reimbursement rate. It is defined as the lowest price available to any wholesaler, retailer, provider, health maintenance organization (HMO), nonprofit entity, or the government. BP excludes prices to the Indian Health Service (IHS), Department of Veterans Affairs (DVA), Department of Defense (DOD), the Public Health Service (PHS), 340B covered entities, Federal Supply Schedule (FSS), state pharmaceutical assistance programs, depot prices, and nominal pricing. BP includes cash discounts and free goods that are contingent upon purchase, volume discounts, and rebates. There have been and will continue to be several successful Best Price False Claims Act cases. The fraud occurs as the manufacturer falsely self-reports its Best Price.

BP Fraud – See Best Price Fraud in this Glossary.

Certificate of Medical Necessity Fraud– CMN is a form that is signed by a physician to substantiate the medical necessity of an item of durable medical equipment furnished to a Medicare beneficiary. It contains far more details than a prescription, and DME suppliers must have it in their possession prior to submitting a claim to Medicare. The document not only indicates specific medical conditions, but details certain diagnoses, and the length of time the product is to be used. Fraud often occurs with unscrupulous providers forging CMN’s and/or providing kickbacks to physicians in exchange for their signatures.

CLIA Fraud – See Clinical Laboratory Improvements Amendments of 1988 (“CLIA”) Fraud in this Glossary.

Clinical Laboratory Improvements Amendments of 1988 (“CLIA”) Fraud– CLIA was intended by Congress to establish a single set of standards which govern all providers of laboratory services to Medicare beneficiaries. CLIA authorizes the Secretary of the United States Department of Health and Human Services (Secretary) to inspect clinical laboratories. The Act directs the Secretary to establish standards to assure that clinical laboratories certified by the Secretary perform tests that are valid and accurate. Fraud occurs where violations of CLIA are covered up during the inspection process.

Clinical Laboratory Fraud – Clinical laboratory reimbursement is delineated by a list of CPT/HCPCS Codes. The code billed must correlate to the lab test(s) conducted. Clinical laboratory services are literally defined as the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings, including procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Violations of the False Claims Act in the laboratory setting include but are not limited to billing for tests on expired medium, billing for compromised specimens, billing for identical tests on multiple specimens, and billing for tests neither supported by a diagnosis nor ordered by a physician, and billing for tests ordered as a result of kickbacks.

Clinical Research Fraud – See Clinical Trial Fraud in this Glossary.

Clinical Trial Fraud – occurs when data from a human research study (clinical trial) is fabricated in order to show a more favorable efficacy or safety result. See New Drug Application Fraud in this Glossary.