The United States Court of Appeals for the Seventh Circuit recently reversed the conviction of Mark Sorensen, the owner of SyMed Inc., a Medicare-registered distributor of durable medical equipment (DME), for alleged violations of the federal Anti-Kickback Statute (“AKS”).  This case, described by the court as one that “tests some of the outer boundaries” of the AKS, highlights the distinction between illegal kickbacks and lawful advertising payments under the AKS.

USA v. Mark Sorensen involved a business arrangement between Sorensen; PakMed, a DME manufacturer; marketing agencies; and a billing agency.  Together, they agreed on a plan to advertise orthopedic braces to patients.  Specifically, the marketing agencies published advertisements for the braces, and interested patients responded with their doctors’ contact information.  After collecting additional information and with consent from patients, the marketing agencies would then fax a prefilled but unsigned prescription forms to patients’ physicians.  In what the court deemed “critical to [its] decision,” physicians retained discretion to approve or ignore these prescriptions, with nearly 80% being declined.  If a physician signed and approved a prescription, SyMed directed PakMed to ship the braces to patients. SyMed billed Medicare for the braces, and paid PakMed a percentage of the funds collected.  PakMed then paid the advertising firms based on the number of leads that each generated. The Seventh Circuit ultimately found insufficient evidence to convict Sorensen under the AKS, finding that Sorensen’s payments to the marketing agencies and manufacturer which promoted the orthopedic braces, did not constitute illegal referrals under the statute.  The Court explained that these businesses were “neither physicians in a position to refer their patients nor other decisionmakers in positions to ‘leverage fluid, informal power and influence’ over healthcare decisions.” The Court also emphasized that the physicians retained independent judgment in prescribing care.  Thus, the Court concluded that Sorensen’s payments thus were not made for “referring” patients within the meaning of the statute.  By distinguishing between payments for advertising services and those that exert undue influence over healthcare decisions, the court has set a precedent that underscores the importance of intent in such cases.  

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Photo of Michelle Chipetine Michelle Chipetine

Michelle Chipetine is a counsel in Crowell & Moring’s New York office and a member of the firm’s Intellectual Property and Health Care groups. Michelle’s practice focuses on patent litigation and representing health care entities and not-for-profit corporations on a wide range of…

Michelle Chipetine is a counsel in Crowell & Moring’s New York office and a member of the firm’s Intellectual Property and Health Care groups. Michelle’s practice focuses on patent litigation and representing health care entities and not-for-profit corporations on a wide range of transactional, corporate, and regulatory matters. Michelle also maintains an active pro bono practice.

Michelle graduated cum laude from Fordham University School of Law, where she was a legal writing and torts teaching assistant and actively involved with Fordham’s Neuroscience and Law Center. During law school, Michelle worked for Mount Sinai Innovation Partners, where she facilitated the transfer and commercialization of technologies developed by Mount Sinai researchers. Michelle also studied neuroscience at Vassar College, where she graduated cum laude.

Photo of Michael Shaheen Michael Shaheen

Michael Shaheen is a partner in the White Collar & Regulatory Enforcement and Health Care groups in the Washington, D.C. office of Crowell & Moring. His practice focuses on federal litigation, investigations, and enforcement actions. Michael has significant experience with the False Claims…

Michael Shaheen is a partner in the White Collar & Regulatory Enforcement and Health Care groups in the Washington, D.C. office of Crowell & Moring. His practice focuses on federal litigation, investigations, and enforcement actions. Michael has significant experience with the False Claims Act (FCA), with particular emphasis on health care fraud.

Before joining Crowell & Moring, Michael served as a Trial Attorney with the Fraud Section of the Department of Justice (DOJ), where his work primarily involved investigating and prosecuting FCA matters. At DOJ, he obtained judgments totaling hundreds of millions of dollars and was involved in the settlement of numerous false claims cases of similar magnitude. Michael served in a variety of roles in these cases, ranging from first-chair trial attorney to lead investigator.

Photo of Spencer Bruck Spencer Bruck

Spencer Bruck is counsel in Crowell & Moring’s Health Care group where he represents clients in litigation, fraud and abuse, and compliance matters. He recently joined the firm from the Office of the New York State Attorney General where he led civil health

Spencer Bruck is counsel in Crowell & Moring’s Health Care group where he represents clients in litigation, fraud and abuse, and compliance matters. He recently joined the firm from the Office of the New York State Attorney General where he led civil health care fraud and qui tam investigations involving managed care organizations, pharmaceutical companies, national pharmacies chains, hospital groups, nursing homes, independent medical groups, and other providers.

These investigations arose under the False Claims Act, Anti-Kickback Statute, Stark Law, the New York State Executive and Social Services laws, and managed care contracts. As part of his investigations, Spencer regularly liaised with CMS, HHS-OIG, DOJ, NYS DOH, NYS OMIG, and the New York State Comptroller. Spencer also negotiated self-disclosures with providers involving the HHS-OIG, the NYS OMIG, and the NYS MFCU protocols.

Spencer’s government experience helps him counsel health care entities on regulatory policy and guidance; represent health care entities responding to government surveys, audits, and investigations; conduct internal investigations or compliance reviews; advise on managed care contracts and reimbursement issues; and assist on administrative applications and matters before regulatory agencies; and represent entities in matters in state and federal courts, and in administrative proceedings.

Spencer also litigates complex commercial disputes federal, state, and arbitral forums with a focus on representing managed care companies.