Prohibition on paid referrals not limited to ‘relevant decisionmakers’

The Seventh Circuit affirmed the conviction of an individual under the Anti-Kickback Statute (AKS) (42 U.S.C. § 1320a-7b) whose referral agency had provided referrals to a home health company in exchange for $500 per referral. In affirming the lower court’s decision, the Seventh Circuit found that criminal liability under the AKS is not limited to relevant decisionmakers and that no safe harbors applied (U.S. v. George, August 14, 2018, Rovner, I.).

Referrals for money

The referrer was a certified homemaker employed by Help at Home, a home healthcare agency, beginning in 2007. In 2010, she decided to start a referral agency and signed a work for hire agreement with another home health service, Rosner Home Health Care, Inc. (Rosner), in which she agreed to convince providers, including doctors, case managers, discharge planners, and social workers, to refer patients to Rosner. In exchange, Rosner paid the referrer $500 for each patient referred. In 2015, the referrer was indicted and then found guilty of two counts of violating the AKS and one count of violating the general conspiracy statute (see Receipt of per-patient referrals, knowledge of illegality enough to overcome doubt, Health Law Daily, March 25, 2016).

Appeal

Under the AKS, the government must demonstrate that the referrer knowingly and willfully solicited or received remuneration in return for referring an individual to Rosner to provide or arrange services paid at least in part under Medicare. The referrer appealed her conviction arguing that there was insufficient evidence to support the substantive counts of her conviction falling under the AKS. According to the court, rather than merely demonstrate that evidence could have supported a finding of innocence, the referrer must demonstrate on appeal that the evidence could not have allowed a reasonable trier of fact to find her guilty.

Relevant decisionmakers

The referrer argued that she could not be held liable, as the statute applied only to “relevant decisionmakers,” which she was not. In making this argument, the referrer relied on a previous Fifth Circuit decision in which the court held that payments to a marketing firm distributing advertisement brochures of a provider to physicians did not fall within the AKS because they were not payments made to the relevant decisionmaker in exchange for sending patients to the provider. However, the court cited a subsequent case rejecting an interpretation of that case limiting criminal liability to persons would could be deemed relevant decisionmakers.

Safe harbors

The referrer also argued that she had a reasonable basis to believe she fell within the safe harbor provision of the AKS applying to “any amount paid by an employer to an employee (who has a bona fide employment relationship with such employer) for employment in the provision of covered items or services. However, her written agreement with Rosner specifies that she was acting as an independent referral agency, not an employee. The court also noted that the referrer was paid for referrals, not for the provision of items or services covered by Medicare. Thus, the safe harbor provision did not apply.

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.

Former Tuomey CEO faces the ‘Stark’ reality of referral scheme

The former CEO of Tuomey Healthcare System agreed to a four-year period of exclusion and a $1 million settlement as a result of his involvement in a physician-referral scheme. The former executive’s exclusion and settlement follow a jury finding that Tuomey defrauded Medicare by filing false claims based upon illegally referred services.

Fraud

The government alleged that, due to fears that Tuomey would lose outpatient procedure referrals to a new surgery center, the former CEO entered into contracts with 19 specialist physicians, requiring the physicians to refer patients to Tuomey in exchange for compensation greatly in excess of fair market value. During the trail against Tuomey, the government asserted that the former CEO ignored warnings from the hospital’s attorneys that the physician contracts were “risky.”

Tuomey judgment

 After a month long trial, a South Carolina jury determined that the referral arrangement violated the Stark Law (42 U.S.C. § 1395nn). The illegal arrangement resulted in a $237.4 million judgment against Tuomey. Subsequently, the U.S. resolved its judgment against the health care system for $72.4 million and Tuomey was sold to Palmetto Health, a multi-hospital health care system. Prior to the CEO’s termination, the jury concluded that Tuomey filed more than 21,000 false claims with Medicare (see Tuorney saga punctuated with DOJ settlement, Health Law Daily, October 19, 2015). 

Settlement

The settlement with the former CEO is based upon allegations that, as a key decision maker, he led or participated in the scheme to defraud Medicare. Under the terms of the agreement, in addition to the $1 million payment, the former CEO will be excluded from federal health care program participation for a period of four years. His exclusion prohibits him from providing management or administrative services paid for by federal health care programs.