Doctor, nurse indicted for fraudulent schemes involving unnecessary compounded medications

Separate indictments brought against a nurse practitioner and doctor by the Department of Justice (DOJ) alleged that the two individuals participated in separate but similar schemes to defraud TRICARE. Under the schemes, the nurse practitioner and doctor prescribed medically unnecessary compounded medications to individuals they had not examined, had a compounding pharmacy dispense the medications, and seek reimbursement from TRICARE.

The indictment against the nurse practitioner

According to the indictment, TRICARE reimbursed the compounding pharmacy more than $3.3 million for compounded medications prescribed by the nurse practitioner between February 2013 and October 2016, In addition, the nurse practitioner allegedly received more than $50,000 in kickback payments from a marketer for the compounding pharmacy in return for prescribing the compounded medications and making false statements to the FBI. The nurse practitioner was charged with conspiracy to commit health care fraud and wire fraud; wire fraud; conspiracy to distribute and dispense a controlled substance; distributing and dispensing of a controlled substance; conspiracy to solicit and receive health care kickbacks; soliciting and receiving health care kickbacks; and making false statements.

The indictment against the doctor

The indictment against the doctor stated that TRICARE reimbursed the compounding pharmacy more than $2.3 million for compounded medications prescribed by the doctor between October 2014 and December 2015. In response to an audit conducted by TRICARE, the doctor allegedly submitted falsified patient records to make it appear as though he had examined patients before prescribing the compounding medications. He was charged with conspiracy to commit health care fraud and wire fraud, wire fraud, conspiracy to distribute and dispense a controlled substance, distributing and dispensing a controlled substance, conspiracy to falsify records in a federal investigation and falsification of records in a federal investigation.

What compliance professionals should know about auditing physician compensation arrangements

In an environment of increasing integration and financial relationships with physicians; a rigid and technical regulatory framework; aggressive government enforcement; and disproportionate penalties and enterprise risk under the Stark Law (42 U.S.C §1395nn), it is incumbent for health care organizations to have an audit plan and process for physician compensation arrangements to ensure such arrangements comply with Stark law requirements. In a webinar presented by the Health Care Compliance Association (HCCA), Curtis H. Bernstein, Principal, Pinnacle Healthcare Consulting and Joseph N. Wolfe (Hall, Render, Killian, Heath & Lyman, P.C.) provided insight into considerations for managing risks, an overview of the Stark Law and its exceptions, and tips for planning an audit and the audit process.

Managing the risk

Wolfe stressed the importance of ensuring that compensation arrangements with referring physicians are defensible. When it comes to compensation arrangements, organizations should ask, “How will the organization defend itself?” Wolfe recommended that the organization focus on the Stark Law’s technical requirements, which were updated in 2016, and the three tenets of defensibility: (1) fair market value, (2) commercial reasonableness, and (3) not taking into account the value or volume of referrals. Wolfe emphasized the need for health care providers that enter into physician arrangements to ensure that individuals involved in the process have an in depth understanding the Stark regulations and the exceptions

The plan and the process

Bernstein explained that the scope of the audit depends on the size and complexity of the company, prior experience with the process under audit, recent changes in the company or company’s operations, and previously recognized deficiencies, as well as circumstances that may arise during the audit. The audit process involves several steps.

  • A list of currently executed physician contracts must be compiled.
  • Compliance personnel must interview individuals commonly involved in physician relationships. The individuals conducting the audit should understand interview processes, including strategy, documentation, approval, and selection of interviewees.
  • The interviews must be reconciled to currently executed physician contracts. Common issues arising in reconciliation include the use of space, office equipment, and other items by physicians for professional or personal use, and payment for services not provided.
  • Time sheets or other attestation forms must be reviewed for completeness and accuracy.
  • Fair market value and commercial reasonableness must be documented for each agreement. Consider:
    • Who is providing the service?
    • Why are the services required?
    • When are the services performed?
    • How are the services provided?
  • All other terms of agreement and necessary steps must be performed in executing agreements and verified.

Bernstein noted that other items to consider during the process include the compensation structure, the length of a fair market value opinion versus the length of the contract, whether the compensation was set in advance, if the agreements were executed, and whether the agreements expired.

The compliance component

While the basic elements of an effective compliance program apply to physician arrangements, Wolfe explained that as compliance applies specifically to physician arrangements, it should be compensation focused and documentation and governance should support defensibility. He recommended that organizations adopt a compensation philosophy, have a written compensation plan, establish parameters for monitoring compensation, and form a compensation committee. In addition, organizations should (1) ensure that policies align with the new Stark technical requirements; (2) establish a consistent process for obtaining third party valuation opinions; and (3) periodically audit physician compensation arrangements. Finally, organizations should continue to monitor the enforcement climate.

Behavioral health fraud perpetrators plead guilty to $1M Medicaid scheme

Two men, who created and managed a company that provided mental health care to Medicaid patients and collected over $1 million in Medicaid payments, pleaded guilty to conspiracy to commit health care fraud. The president of Coastal Bay Behavioral Health, Inc. (Coastal Bay) acknowledged in the plea agreements that the other participant was an “excluded provider,” who was prohibited from billing federal health care programs due to a 2011 conviction for health care fraud. Each man faces a maximum penalty of five years in prison and a fine of up to $250,000.

Although the president was aware that he was employing an excluded provider, he did not disclose this fact to the state Medicaid program. Using an alias, the provider performed a variety of functions, including hiring and firing individuals, seeing patients, and performing other managerial tasks. Coastal Bay received $1.2 million in reimbursements from Medicaid because of the provider’s alleged fraud, according to court papers.

The provider and his family received significant financial benefits due to his involvement in Coastal Bay. Specifically, the provider had access to a Coastal Bay credit card, which he used to make routine purchases at restaurants, furniture stores, gas stations, and other places in North Carolina, even though Coastal Bay had no operations in North Carolina. In addition, the provider and his immediate family received more than $10,000 in direct payment withdrawals from the Coastal Bay business account.

FDA effectively spends prescription drug user fee collections

After conducting its 2017 review of FDA policies and procedures and financial records related to the FDA’s use of prescription drug user fee collections, the Office of Inspector General (OIG) concluded that, overall, the FDA spent prescription drug user fee collections appropriately. Since the passage of the Prescription Drug User Fee Act (PDUFA) of 1992 (P.L. 102-571), prescription drug user fees have significantly helped in expediting the drug approval process and eliminating backlogs of pending human drug applications. The average approval time for an application prior to the PDUFA was two years (OIG Report, A-05-16-00040, September 2017).

The PDUFA

The PDUFA, which must be reauthorized by Congress every five years, authorizes the FDA to collect user fees from pharmaceutical and biotechnology companies that are seeking FDA approval of certain human drug and biological products to expedite the review of human drug applications. The user fees provide the FDA with resources, including the ability to hire more reviewers and support staff and upgrade information technology systems. According to the OIG, these resources help the FDA meet its goal of timely review of human drug and supplement applications.

Inadequate documentation

The OIG reviewed $796,065,980 in prescription drug user fees reported for October 1, 2014, through September 30, 2015, and determined that the FDA did not have adequate supporting documentation for $6,402 in travel expenses, made a duplicate payment for airfare of $1,213, and overpaid a traveler $587. The OIG attributed the inadequate documentation to oversight by FDA staff rather than a systemic issue. Therefore, the OIG made no recommendations.