The Department of Health and Human Services, Office of the Inspector General (OIG), modified its Work Plan to announce that the agency will be conducting a nationwide audit of hospitals that participated in the Medicare Electronic Health Records (EHR) Incentive Program (also known as the Meaningful Use Program). The OIG review is focusing on hospitals
John T. Brennan, Jr. is a partner at Crowell & Moring and a member of the firm's Health Care Group. His practice primarily focuses on health care fraud and abuse matters. He defends clients in federal litigation, investigations and enforcement actions, especially relating to the federal False Claims Act and the anti-kickback and physician self-referral (Stark Law) statutes. He deals frequently with the Department of Justice and Health & Human Services - Office of the Inspector General. In addition to his litigation practice, John often advises clients on compliance matters,and conducts internal investigations related to potential fraud and abuse issues. John's practice also includes advising clients on reimbursement, transactional, physician relations, licensure and certification, and other regulatory issues.
The Office of the Inspector General of the Department of Health and Human Services (OIG) last week replaced a 20-year old policy statement, and issued guidance on the criteria the agency will use to evaluate whether to exclude certain individuals and entities from billing or “participation in” Federal health programs under its permissive exclusion authority. The new guidelines supersede and replace the OIG’s December 24, 1997 policy statement and set forth “non-binding” criteria that the OIG may consider in exercising this authority under circumstances involving fraud, kickbacks and other prohibited conduct. The newly-memorialized policy is yet another effort by the agency to encourage healthcare providers to implement robust compliance mechanisms that can timely identify and voluntarily self-disclose to the government any unlawful conduct.
Under Sections 1128(b)(1)-(b)(15) of the Social Security Act (the “Act”), the Secretary, by delegation to the OIG, has discretion to exclude individuals and entities based on a number of grounds. This so-called “permissive exclusion” authority grants significant discretion to the OIG. The new policy provides guidelines for permissive exclusions that are based on Section 1128(b)(7) of the Act, which permits the OIG to exclude persons from participation in any Federal health care program if the OIG determines that the individual or the entity has engages in fraud, kickbacks and other prohibited activities.
On February 8, 2016, the United States District Court in the Southern District of Georgia approved the settlement agreement ending a whistleblower lawsuit initiated on March 9, 2011 against Memorial Health University Medical Center (“Memorial Medical Center”) and three affiliated entities in a case that highlights the Department of Justice’s (“DOJ”) vigorous scrutiny of physician compensation arrangements. The non-profit hospital, based in Savannah, Georgia, agreed to pay $9.89 million with $2.29 million going to the relator, the hospital’s former president and CEO, who initiated the action under the qui tam provision of the False Claims Act (“FCA”). The settlement is the largest civil healthcare fraud recovery recorded by the U.S. Attorney’s Office for the Southern District of Georgia.
The underlying lawsuit alleged that Memorial Medical Center acquired a physician practice for compensation in excess of fair market value (“FMV”), and that the acquisition resulted in a projected financial loss of approximately $670,000 per year over a five-year period. According to the complaint, the defendant hospital engaged in a complex scheme to compensate its employed and contracted physicians at rates above FMV in return for the promise of patient referrals–thereby violating both the federal Anti-Kickback Statute (“AKS”) and the physician self-referral law (“Stark Law”), and tainting Medicare and Medicaid payments.
In a December 10 decision, the United States District Court for the Southern District of Texas granted partial summary judgment in favor of a pharmaceutical company in a qui tam action – holding that the Relators’ discovery responses demonstrated that they could not prevail at trial on certain FCA claims.
Among other things, Relators alleged that Solvay Pharmaceutical, Inc. (SPI) violated federal and Texas false claims act statutes predicated on violation of the federal Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b(b). Relators alleged that SPI’s sales team paid physicians in gifts, lavish events, cash, gift cards, speaking engagements, and services, for over a decade, to induce them to write prescriptions for drugs that were reimbursed by the government.
After close of discovery, SPI filed a motion for partial summary judgment. SPI argued that: …
The Department of Justice (DOJ) has further focused its sights on individual executives as responsible parties for corporate misconduct. On September 9, 2015, Deputy Attorney General Sally Quillian Yates issued a strongly worded seven-page memorandum to all U.S. Attorneys and the Assistant Attorneys General of DOJ’s various divisions nationwide titled “Individual Accountability for Corporate Wrongdoing” (the “Memorandum”). Overall, the Memorandum imposes further expectations that government attorneys will investigate the acts of individual executives and management personnel before providing cooperation credit to or allowing the resolution of a civil or criminal case against a corporate entity. Moreover, the Memorandum serves as a tacit warning to defense counsel that it will be even harder to negotiate concessions for corporate liability without providing information about potentially responsible individuals that is satisfactory to the investigating agencies.…