The Department of Health and Human Services Office of Inspector General’s (OIG’s) activities during first half of fiscal year 2011 amounted to $3.4 billion in recoveries in the Medicare and Medicaid programs, and resulted in the exclusion of 883 individuals and entities from participating in federal health care programs, according to the OIG’s semiannual report to Congress
In the report, attention was drawn to the OIG’s large-scale health care fraud investigations conducted in collaboration with federal, state, and local law enforcement partners. Further attention was given to the broad and diverse nature of the OIG’s audit, evaluation, and investigative activities. The report also addressed important program vulnerabilities, such as questionable billing by skilled nursing facilities, improper payments for medical supplies, adverse events in hospitals, rebate concerns in the Medicare Part D program, institutional conflicts of interest by National Institutes of Health grantees, and alleged fraud by pharmaceutical manufacturers.
Further, two large recoveries were highlighted with expected recoveries of approximately $222 million from audits and $3.2 billion arising from 349 criminal and 197 civil actions that were concluded during the six-month period. Other highlights included GlaxoSmithKline’s agreement in October 2010 to pay $750 million, including criminal fines, as part of a global resolution of allegations under the False Claims Act and the Food, Drug, and Cosmetic Act that a now-closed subsidiary in Puerto Rico manufactured, distributed, and sold drugs that had higher or lower amounts of specified ingredients or that were nonsterile or contained microorganisms. The company agreed to plead guilty to one felony count of knowingly selling four drugs that were not of the strength, purity, or quality required. The penalty is the fourth-largest ever paid by a pharmaceutical company.
The OIG also highlighted the global criminal, civil, and administrative resolution of a second drug company case. Allergan Inc. agreed to pay $600 million to resolve allegations that it promoted the sale and use of Botox for a variety of conditions that were not approved by the Food and Drug Administration, misled physicians about drug safety and efficacy, instructed health care professionals to miscode claims to federal health care programs, and paid illegal remuneration to health care professionals as inducements to prescribe the drug. A comprehensive five-year corporate integrity agreement was a component of the settlement.