This year is on track be a record-breaking one for government recoveries in the healthcare industry, with several cases alleging violations of the False Claims Act, Stark Law or the Anti-Kickback Statute already settling for substantial amounts.
Here is a list of the healthcare industry's 10 largest legal settlements involving cases that alleged violations of the False Claims Act, Stark Law or the Anti-Kickback Statute so far in 2014.
1. Endo Health Solutions — a pharmaceutical company — and its subsidiary, Endo Pharmaceuticals, agreed to pay $192.7 million to resolve criminal and civil claims stemming from Endo's marketing of Liboderm for uses not approved by the Food and Drug Administration. The settlement included a deferred prosecution agreement and forfeiture totaling $20.8 million and $171.9 million to be paid to the federal government, the states and the District of Columbia.
2. Baton Rouge, La.-based Amedisys, one of the country's largest providers of home health services, and its affiliates agreed to pay $150 million to resolve allegations brought under the False Claims Act, Stark Law and the Anti-Kickback Statute. The lawsuit filed against Amedisys was brought under the qui tam, or whistle-blower, provision of the False Claims Act by former employees of the company. The lawsuit alleged Amedisys submitted improper claims to Medicare for reimbursement from 2008 to 2010 for therapy and nursing services that were medically unnecessary or provided to patients who were not homebound. The lawsuit also alleged the company engaged in improper financial relationships with referring physicians.
3. Cincinnati, Ohio-based Omnicare — the nation's largest provider of pharmaceuticals and pharmacy services to nursing homes — agreed to pay $124.24 million to settle allegations that it violated the False Claims and Anti-Kickback Statute. The government alleged Omnicare offered improper financial incentives to skilled nursing facilities in return for their continued selection of Omnicare to supply drugs to elderly Medicare and Medicaid beneficiaries. The government also alleged the improper relationship resulted in Omnicare and the facilities submitting fraudulent claims for reimbursement to Medicare and Medicaid.
4. Daytona, Fla.-based Halifax Hospital Medical Center and Halifax Staffing agreed to pay $85 million to resolve allegations they violated the False Claims Act and the Stark Law. The government alleged Halifax knowingly violated the Stark Law by executing contracts with six medical oncologists that included an incentive bonus that improperly included the value of prescription drugs and tests the oncologists ordered and Halifax billed to Medicare. The government also alleged Halifax knowingly violated the Stark Law by paying three neurosurgeons more than fair market value for their work, and the hospital admitted patients who did not need to be admitted, then billed Medicare for their care.
5. Ashland, Ky.-based King's Daughters Medical Center agreed to pay $40.9 million to resolve allegations it acted in violation of the False Claims and the Stark Law. The government alleged KDMC physicians performed numerous unnecessary coronary stents and diagnostic catheterizations on patients from 2006 to 2011. The government further alleged the physicians falsified patients' medical records to justify the medically unnecessary heart procedures, which allowed KDMC to receive millions of dollars in fraudulent reimbursements from Medicare and Medicaid. The settlement also claimed KDMC engaged in improper financial relationships with physicians in violation of the Stark Law.
6. Clayton, Mo.-based RehabCare Group, RehabCare Group East and Rehab Systems of Missouri along with nursing home management company Health System Inc., agreed to pay $30 million to resolve allegations they violated the False Claims Act and the Anti-Kickback Statute by engaging in a kickback scheme related to nursing home business referrals. The government's lawsuit alleged RehabCare began making payments in 2006 to Health System in exchange for a contract to provide therapy services.
7. Teva Pharmaceuticals USA and a subsidiary agreed to pay $27.6 million to resolve False Claims Act and Anti-Kickback Statute allegations. Teva Pharmaceuticals allegedly made payments to a Chicago physician in return for prescribing generic clozapine, an anti-psychotic medication, to thousands of Medicare and Medicaid patients. The alleged scheme resulted in more than 100,000 false claims being submitted to government health programs. Under the settlement, Teva Pharmaceuticals agreed to pay the federal government close to $15.5 million and the state of Illinois more than $12.1 million.
8. Cambridge, Mass.-based Genzyme Corp. — a biotechnology company — agreed to pay $22.28 million to resolve allegations that it marketed a "slurry" version of its Seprafilm adhesion barrier, which led to false claims being submitted to federal and state healthcare programs. The government alleged sales representatives from Genzyme instructed physicians and other medical staff to cut the Seprafilm sheets into small pieces, add saline and allow the pieces to dissolve until the desired consistency was reached. This mixture was referred to as "slurry." The mixture was used in laproscopic surgeries, which is an unapproved use by the FDA.
9. London, Ky.-based Saint Joseph Health System agreed to pay $16.5 million to resolve allegations it violated the False Claims Act, Stark Law, and the Anti-Kickback Statute. The government alleged the health system submitted false claims to Medicare and Medicaid for a variety of medically unnecessary cardiac procedures. The government also alleged Saint Joseph Health System entered into improper sham management agreements with two physicians.
10. Seaford, N.Y.-based Diagnostic Imaging Group agreed to pay $15.5 million to resolve allegations that the company acted in violation of the False Claims Act and the Anti-Kickback Statute by submitting fraudulent claims to Medicare and Medicaid for medically unnecessary tests and paying kickbacks to physicians for the referral of diagnostic tests.
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