The Department of Justice announced that it has resolved a $237 million judgment against Tuomey Healthcare System for illegally billing the Medicare program for services referred by physicians with whom the hospital had improper financial relationships. Under the terms of the settlement agreement, the United States will receive $72.4 million and Tuomey, based in Sumter, South Carolina, will be sold to Palmetto Health, a multi-hospital healthcare system based in Columbia, South Carolina.
The judgment against Tuomey related to violations of the Stark Law, a statute that prohibits hospitals from billing Medicare for certain services (including inpatient and outpatient hospital care) that have been referred by physicians with whom the hospital has an improper financial relationship. The Stark Law includes exceptions for many common hospital-physician arrangements, but generally requires that any payments that a hospital makes to a referring physician be at fair market value for the physician’s actual services, and not take into account the volume or value of the physician’s referrals to the hospital.
The government argued in this case that Tuomey, fearing that it could lose lucrative outpatient procedure referrals to a new freestanding surgery center, entered into contracts with 19 specialist physicians that required the physicians to refer their outpatient procedures to Tuomey and, in exchange, paid them compensation that far exceeded fair market value and included part of the money Tuomey received from Medicare for the referred procedures. The government argued that Tuomey ignored and suppressed warnings from one of its attorneys that the physician contracts were “risky” and raised “red flags.”
On May 8, 2013, after a month-long trial, a South Carolina jury determined that the contracts violated the Stark Law. The jury also concluded that Tuomey had filed more than 21,000 false claims with Medicare. On Oct. 2, 2013, the trial court entered a judgment under the False Claims Act in favor of the United States for more than $237 million. The United States Court of Appeals for the Fourth Circuit affirmed the judgment on July 2, 2015.
The case came from a lawsuit filed on Oct. 4, 2005, by Dr. Michael K. Drakeford, an orthopedic surgeon who was offered, but refused to sign, one of the illegal contracts. The lawsuit was filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private individuals to sue on behalf of the government for false claims and to share in any recovery. The act allows the government to intervene and take over the action, as it did in this case. Dr. Drakeford will receive approximately $18.1 million under the settlement.
As part of the settlement, Tuomey will be required to retain an independent review organization to monitor any arrangements it makes with physicians or other sources of referrals for the duration of the five-year Corporate Integrity Agreement.
A permanent injunction has been granted to the Food and Drug Administration (FDA) against Robert “Larry” Lytle, doing business as QLasers PMA and 2035 PMA based on evidence of false and misleading claims regarding the health benefits of these lasers, which in some cases, reportedly cause health problems.
According to the complaint for injunction filed by the Department of Justice on behalf of the FDA, Lytle has been manufacturing and distributing QLaser devices for more than a decade and markets the devices through private membership associations. Lytle and his businesses promote the devices with false and misleading claims that they treat cancer, cardiac arrest, HIV/AIDS, diseases and disorders of the eye and ear, venereal disease, diabetes and many other health conditions.
Although the FDA cleared two of the QLaser devices for providing temporary relief of pain associated with osteoarthritis of the hand (as diagnosed by a physician or other licensed medical professional), the FDA has not cleared or approved any of the devices to treat any other medical conditions. Further, as demonstrated by the evidence presented at trial, use of the QLaser devices according to the labeling could be dangerous to the health of the consumer.
