4月1日，美国司法部表示，两名实验室营销人员和五名医生已同意支付总计150万美元（约1085万人民币），以解决实验室回扣计划违反《虚假申报法》的问题。

根据协议，加利福尼亚州约巴林达市的实验室营销人员George Carralejo 和南卡罗来纳州丹尼尔岛的Michael Jeresaty及其营销公司，以及德克萨斯州普莱诺市的医生Paul Bierig；圣路易斯的Mohd Azfar Malik、Barry Feinberg和Rachel Feinberg；堪萨斯州威奇托市的罗伯特·艾因 (Robert Ain) 将支付150万美元的罚款，并配合司法部对涉嫌计划的其他参与者进行调查。

据司法部称，2020年8月至2021年9月期间，Carralejo和他的公司OC Genetic Consultants与Jeresaty的营销公司Ralston Health Group合谋，向休斯顿的一名医生支付回扣，诱使他从RDx Bioscience和Next Bio 实验室订购实验室检测-研究服务。据称，这两家营销公司都从RDx和 Next Bio-Research为测试推荐支付的佣金中获利。

此外，司法部还称，2021年10月至2022年10月期间，Carralejo和OC Genetic Consultants与德克萨斯州营销商BeauMed Consultants合谋向阿肯色州小石城的一名医生支付回扣，诱使她从RDx订购检测。

根据与DOJ达成的协议，Carralejo及其公司将支付40万美元来解决《虚假申报法》指控，Jeresaty和Ralston将支付32万美元。

这五名医生正在付费以和解有关他们因从某些机构订购实验室检测而收到付款的指控。

Bierig将支付120,634美元来解决指控，即从2016年10月到2022年6 月，他从Avior Group和其他据称的管理服务组织（包括Infinity One Health Group MSO和Infinity Three Health Group MSO）收到了数千美元的付款，以换取订购实验室的费用RDx和InHealth Diagnostic的测试以RealLab名义开展业务，RealLab是达拉斯的一家临床实验室。

Malik同意支付217,430美元，以解决有关从2019年1月到2020年3月期间，他从Alari Group收到数千美元的指控，以换取从佛罗里达州奥兰多临床实验室Genesis Reference Laboratories和InHealth订购实验室检测的回报。

Ain 同意支付100,632美元，以解决有关从2017年5月到2019年2月期间，他从所谓的MSO Ruthenium Management收到数千美元付款的指控，以换取从休斯敦临床实验室Landmark Diagnostics订购实验室测试的回报。

Feinberg夫妇已同意支付342,466美元，以解决有关从2016年1月到2018年12月期间，他们从名为ESA Toxicology和Beachwood Services 的所谓MSO收到数千美元的指控，以换取从Landmark订购实验室测试的费用。

美国司法部表示，这些和解解决的索赔只是指控，尚未确定责任。

在这起涉及实验室营销人员和医生的回扣计划案件中，参与者同意支付总计150万美元的和解金，以解决违反《虚假申报法》的指控，标志着美国医疗保健行业中不法行为的一次重要查处。这不仅展示了监管机构对遏制医疗领域不正当行为的决心，而且也向行业从业者发出了一个明确的警示：追求利润不能以牺牲伦理和合规为代价。

这起事件揭示了医疗保健行业在确保透明度和合规性方面仍面临的挑战。它强调了加强内部监控、教育和培训的必要性，以防止此类违规行为的发生。同时，也暴露了现有制度和监管措施在预防、发现和惩处违法行为方面的不足。

面向未来，行业需加强合规教育，提高从业者对医疗伦理和法规的认识，同时，监管机构应持续优化监管策略，利用技术手段提高监管效率，以确保医疗服务的质量和安全，保护患者利益。此外，加强跨机构间的合作，共享信息，形成合力，对于构建一个更加公正、透明的医疗保健环境至关重要。

通过这次事件，行业和监管机构得到了自省和改进的契机，从而推动医疗保健行业朝着更加健康、合规的方向发展。

下附原文：

Two laboratory marketers, George Carralejo of Yorba Linda, California, and Michael Jeresaty of Daniel Island, South Carolina and their marketing companies, as well as five physicians, Dr. Paul Bierig of Plano, Texas, Dr. Mohd Azfar Malik of St. Louis, Missouri, Dr. Robert Ain of Wichita, Kansas and Drs. Barry Feinberg and Rachel Feinberg also of St. Louis, and certain affiliated entities have agreed to pay a total of $1,501,162 to resolve alleged False Claims Act violations arising from their involvement in laboratory kickback schemes. The parties have agreed to cooperate with the Justice Department’s investigations of other participants in the alleged schemes.

“Kickbacks can harm taxpayer-funded healthcare programs, distort the market for healthcare services and improperly influence healthcare providers’ medical decisions,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “We will continue to pursue those involved in illegal kickback schemes, including marketers, doctors and medical practices.”

The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by Medicare and other federally funded healthcare programs. The settlements announced today resolve allegations that laboratory marketers and their companies paid or conspired to pay kickbacks to doctors, and that doctors and their companies received kickbacks in return for laboratory referrals. The alleged kickbacks resulted in the submission of false or fraudulent laboratory testing claims to Medicare in violation of the False Claims Act.

The Marketer Settlements

George Carralejo and his marketing company, OC Genetic Consultants Inc. agreed to pay $400,000 to resolve allegations that they entered into two illegal schemes to pay kickbacks to doctors for their laboratory referrals. First, from August 2020 to September 2021, Carralejo and his company allegedly conspired with a South Carolina marketer, Ralston Health Group Inc. (Ralston), to pay kickbacks disguised as consulting and medical director fees to a doctor in Houston to induce him to order laboratory testing from RDx Bioscience Inc. (RDx), a clinical laboratory in Kenilworth, New Jersey, and NEXT Bio-Research Services LLC, doing business as NEXT Molecular Analytics (Next Molecular), a clinical laboratory in Chester, Virginia. Carralejo’s company and Ralston allegedly profited from the kickback scheme in the form of commissions from RDx and Next Molecular based on the Houston doctor’s referrals.

Second, from October 2021 to October 2022, Carralejo and his company allegedly conspired with a Texas marketer, BeauMed Consultants LLC, to pay kickbacks disguised as consulting fees to a doctor in Little Rock, Arkansas, to induce her to order laboratory tests from RDx. Carralejo allegedly provided commission numbers to the Arkansas physician or her staff, to allow for the preparation of false consulting invoices disguising that the Texas marketer’s payments were designed to reimburse for referrals rather than consulting work and were calculated based on the amount generated by those referrals. Carralejo allegedly tried to hide his role in the fraud scheme by deleting related text messages on the day he and the Texas marketer received subpoenas from the Justice Department.

In addition, Michael Jeresaty and his company, Ralston, agreed to pay $320,000 for allegedly paying kickbacks to the Houston physician referenced above and to a South Carolina doctor who previously settled related allegations involving referrals to RDx. The Justice Department previously settled with RDx allegations relating to Carralejo’s and Jeresaty’s kickback schemes.

The Physician Settlements

The settlements announced today also resolve allegations that five physicians and related entities received kickbacks in violation of the Anti-Kickback Statute from laboratory marketers’ purported management service organizations (MSOs) in return for making referrals to RDx and other laboratories.

• Paul Bierig: Dr. Bierig agreed to pay $120,634 to resolve allegations that from October 2016 to June 2022, he and his medical practice, Paul C. Bierig M.D., P.A., received thousands of dollars in payments from Avior Group LLC and other purported MSOs, including Infinity One Health Group MSO LLC and Infinity Three Health Group MSO LLC, in return for ordering laboratory tests from RDx and InHealth Diagnostic LLC doing business as RealLab (InHealth), a clinical laboratory in Dallas, Texas.

• Mohd Azfar Malik: Dr. Malik agreed to pay $217,430 to resolve allegations that from January 2019 to March 2020, he caused his medical practice, Psych Care Consultants LLC (PCC), to receive thousands of dollars in payments from Alari Group LLC (Alari) in return for ordering laboratory tests from Genesis Reference Laboratories LLC (Genesis), a clinical laboratory in Orlando, Florida, and InHealth. Genesis and InHealth allegedly paid commissions to an independent contractor recruiter, Corum Group LLC (Corum), which used Alari to pay kickbacks to Dr. Malik and other healthcare providers in return for their referrals. The Justice Department previously settled related allegations with Genesis and PCC.

• Robert Ain and Comprehensive Pain Treatment LLC: Dr. Ain and his pain management practice agreed to pay $100,632 to resolve allegations that from May 2017 to February 2019, they received thousands of dollars in payments from a purported MSO named Ruthenium Management LLC in return for ordering laboratory tests from Landmark Diagnostics LLC (Landmark), a clinical laboratory in Houston.

• Barry Feinberg, Dr. Rachel Feinberg and BIF Family Trust: Drs. Feinberg and Feinberg and a family trust agreed to pay $342,466 to resolve allegations that from January 2016 to December 2018, they received thousands of dollars in payments from purported MSOs named ESA Toxicology LLC and Beachwood Services LLC in return for ordering laboratory tests from Landmark.

“The kickbacks resulted in the submission of fraudulent laboratory testing claims to Medicare,” said U.S. Attorney Philip R. Sellinger for the District of New Jersey. “Clinical laboratories, marketing companies and health care practitioners are on notice that kickback arrangements in any form are not acceptable. No matter how they are named – as a ‘consulting fee,’ ‘commission’ or otherwise – or whether they are paid through intermediaries, kickbacks undermine the integrity of medical decision making and have no place in our healthcare system. Today’s agreement is yet another example of my office’s commitment to enforcing the False Claims Act and the Anti-Kickback Statute and protecting Medicare from shelling out taxpayer money for reimbursements tainted by improper kickbacks.”

“Violations of the Anti-Kickback Statute can induce medically unnecessary testing and inappropriately steer medical tests to providers who may not return timely or quality results,” said Special Agent in Charge Naomi D. Gruchacz of the Department of Health and Human Services, Office of Inspector General (HHS-OIG). “We will continue to work with our law enforcement partners to seek resolutions and effect change to preserve the integrity of the federal health care system.”

The settlements were the result of a coordinated effort between the Civil Division’s Commercial Litigation Branch, Fraud Section and the U.S. Attorney’s Office for the District of New Jersey, with assistance from HHS-OIG. Senior Trial Counsel Christopher Terranova of the Civil Division’s Commercial Litigation Branch (Fraud Section) and Assistant U.S. Attorney Kruti Dharia for the District of New Jersey handled the settlements. The United States has recovered over $47 million relating to conduct involving MSO kickbacks to healthcare providers, including False Claims Act settlements with 46 physicians.

The government’s pursuit of these matters illustrates the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to HHS at 1-800-HHS-TIPS (800-447-8477).

来源：体外诊断观察、360Dx