Single Source Drug – relevant to both Medicaid and Medicare Outpatient prescription drug coverage, this term is defined as a covered outpatient drug which is produced or distributed under an original new drug application approved by the Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributors operating under the New Drug Application (NDA).” It also includes a Covered Outpatient Drug approved under a BLA, ELA or ADA.
Single-use device fraud – a device that is intended for one use, or on a single patient during a single procedure, A device approved for single-use, cannot be safely and reliably used more than once, and therefore using single use devices more than once may raise lack of safety or efficacy concerns, leading to a violation of the False Claims Act.
Skilled Nursing Facility Payment Fraud – Under the PPS system for SNF’s, each beneficiary is designated to over 40 resource utilization groups (RUGs), each containing patients with similar service needs that are expected to require similar amounts of resources. The daily rate for each RUG is calculated using the sum of three components: 1) a fixed amount for routine services (such as room and board, linens, and administrative services); 2) a variable amount reflecting the intensity of nursing care patients are expected to require; and 3) a variable amount for the expected intensity of therapy services. Much like the other PPS’s, the RUG rates are computed separately for urban and rural areas and a portion of the total rate is adjusted to reflect labor market conditions in each SNF’s location. Qui Tam lawsuits often arise from upcoded RUG rates. Questions to ask include, are the rehabilitation and infusion therapy services provided to Medicare beneficiaries in skilled nursing facilities medically necessary, adequately supported, and actually provided as ordered? What is the extent and nature of consecutive Medicare hospital inpatient stays for its patients in general? Is the SNF billing for services on the day of discharge? Is there a failure to submit no-pay bills (which could contribute to inappropriate calculations of Medicare SNF eligible benefit periods)?
Specialty hospital – a hospital that is primarily or exclusively engaged in the care and treatment of one of the following:(1) Patients with a cardiac condition;(2) Patients with an orthopedic condition;(3) Patients receiving a surgical procedure; or(4) Certain other specialized category of services as designated by HHS.
Specimen Processing Arrangements – Specimen Processing Arrangements typically involve payments from laboratories to physicians for certain specified duties, which may include collecting the blood specimens, centrifuging the specimens, maintaining the specimens at a particular temperature, and packaging the specimens so that they are not damaged in transport. Also see Laboratory Fraud.
Stark Kickback – See Kickback Violation and Stark Law in this Glossary
Stark Law – The Stark law, 42 U.S.C. §1395nn, is also known as the Physician Self-Referral Law. The Stark law acts to sanction improper physician referrals, and does so by providing penalties for illegal referrals prospectively. Analysis of the conduct of the defendants under the Stark Law requires three steps. First, is there a physician referral for a designated health service? Second, if the answer to the first question is “yes,” the court must ask: Does the referring physician have a financial relationship with the entity furnishing the designated health service? If the answer to the second question is also “yes,” then the court gets to the third question: If there is a financial relationship, does an exception apply? If no exception applies, the statute is violated.
Stark Law Fraud – See Kickback Violation and Stark Law Violation in this Glossary