A Missouri physician was sentenced in federal court after taking bribes from a drug manufacturer in exchange for prescribing its fentanyl drug to his patients so often that he ranked highest in the state in net sales of the product. He was sentenced to one year and one day in federal prison without parole. The court also ordered him to pay $400,565 in restitution to Medicare and to pay a fine of $150,000.
The licensed physician was employed by a community hospital clinic from 2004 to June 2019. He also was employed by several area skilled nursing facilities and residential care facilities.
According to court documents, he was only present at the hospital clinic, at most, two days of each week, as he was paid to provide care at several area nursing homes and regularly accepted additional money to travel and speak on behalf of pharmaceutical companies. One of the pharmaceutical companies he agreed to speak for was Insys, which produced a fentanyl medication named Subsys, that Medicare only approved for active cancer patients who were currently suffering from breakthrough cancer pain.
The physician accepted bribes from Insys in exchange for prescribing Subsys to his patients. His participation in the Insys speakers’ program was a front designed to conceal the bribes they paid to him and to other doctors. As long as he continued to prescribe Subsys to increasing numbers of patients and in increasing dosages, Insys paid him to speak for them, increasing his compensation over time due to his prescribing practices. There was a direct correlation between his payments received and his issued prescriptions.
He had the highest net sales of Subsys of any physician in the state of Missouri and ranked 38th in the United States at one time. Altogether, Insys paid him $92,225 in bribes during their relationship.
Fentanyl is a highly addictive synthetic opioid that is up to 50 times stronger than heroin and is a major contributor to fatal and nonfatal overdoses in the United States. The drug is so dangerous that all prescribers and their patients receiving Subsys must participate in a government-mandated Risk Evaluation and Mitigation Strategy program involving education, the prescriber’s contractual commitment to mandatory prescribing rules, and compulsory patient disclosures. The physician disregarded that danger to his patients.
Numerous patients received fentanyl they did not need and for which they did not qualify under Medicare. As a result, Medicare was defrauded of hundreds of thousands of dollars. In his plea agreement, the physician admitted that he prescribed Subsys to a patient and submitted a request to Medicare for payment coverage of the prescription, falsely stating that the patient had a diagnosis of cancer. He knew that the patient did not have cancer, and was not being treated for breakthrough cancer-related pain — two conditions required by Medicare for coverage of Subsys. Due to his false statement, Medicare paid a total of $11,945 to cover the patient’s prescription and subsequent prescriptions. He committed similar conduct with additional payments, leading Medicare to pay and additional hundreds of thousands of dollars for Subsys prescriptions. In addition, he conspired with his employees at the clinic to use his DEA registration number so they could provide prescription medication in his absence using prescriptions he had pre-signed.
Issue:
Under federal and state Anti-kickback Statutes, you may not knowingly and willfully offer, pay, solicit, or receive anything of value to induce or reward for referrals of federal or state healthcare program business. The prohibition against kickbacks applies to those who pay for referrals and to those who receive them. Kickbacks can take various forms, such as bribes or rebates. They can be given in cash or in kind. Failure to promptly report a kickback can result in lawsuits, fines, and other sanctions. According to F757 in the State Operations Manual, Appendix PP, each resident’s drug regimen must be free from unnecessary drugs. A resident’s medication regimen should only include those drugs that have adequate indications for use based on accurate diagnoses. Each resident’s entire drug/medication regimen must be managed and monitored to promote or maintain the resident’s highest practicable mental, physical, and psychosocial well-being.
Discussion Points:
- Review policies and procedures for preventing and reporting false claims and kickbacks. Also review policies and procedures regarding the managing and monitoring of residents’ medications. Update your policies and procedures as needed.
- Train all staff on federal and state anti-kickback statutes and what can be considered a kickback. Include information on how to report concerns and suspected violations, and make sure staff know that prompt reporting is mandatory. Provide education to nursing and business office personnel on their responsibility to identify and report any concerns that unnecessary medications, treatments, supplies, or equipment are being ordered for residents. Document that the trainings occurred and place in each employee’s education file.
- Periodically perform audits to ensure all staff are aware of their responsibility to identify and report compliance and ethics concerns and understand that it is their responsibility to report violations to their supervisor, the compliance officer, or via the anonymous hotline. Conduct audits of documentation and billing routinely to prevent and detect errors before they progress to a false claim.
