February 26, 2020

February 26, 2020

Subscribe to Latest Legal News and Analysis

February 25, 2020

Subscribe to Latest Legal News and Analysis

February 24, 2020

Subscribe to Latest Legal News and Analysis

Tenth Circuit Court Agrees Difference Of Opinion On Medical Necessity Is Insufficient to Show Falsity Under False Claims Act

Last month, the U.S. District Court for the District of Utah joined the AseraCare court and others in finding that a relator cannot successfully allege violations of the False Claims Act (“FCA”) based on a purported lack of medical necessity unless there is an objective standard articulated by Medicare.  In fact, District Judge Jill Parrish cited the AseraCare case and many federal appellate decisions when granting dismissal – with prejudice – in United States ex rel. Polukoff v. St. Mark’s et al., No. 16-cv-00304 (D. Utah 2017)

The relator in this case, Dr. Gerald Polukoff, was a colleague of Dr. Sherman Sorensen, whom he alleged performed medically unnecessary procedures, which were then fraudulently billed to federal health care programs. In addition to Dr. Sorensen, the relator also named as defendants two hospitals where Dr. Sorensen performed these procedures.  The procedures at issue were patent foramen ovale (“PFO”) closures.  The foramen ovale is a small opening in the wall separating the upper two chambers of the heart found in fetuses as they develop in the womb.  This opening closes soon after birth for a majority of the population.  For those people in whom the opening does not close, the condition is typically asymptomatic but can lead to an increased risk of stroke from blood clots that normally would have lodged in the lungs, but instead are able to travel to the brain due to the opening.  Dr. Sorensen performed PFO closures to prevent strokes in patients who had an elevated risk of stroke.

While guidelines issued by medical societies and private insurers varied over the years regarding the propriety of performing PFO closures in order to prevent strokes, the Medicare program never issued a National Coverage Determination (“NCD”) to set forth the circumstances under which such procedures would be considered “reasonable and necessary” for purposes of Medicare coverage.

One of the hospitals at which Dr. Sorensen had privileges (and which the relator named as a defendant) did, however, establish a policy in March 2011 stating that PFO closures may be considered for “patients with a single well-documented significant stroke or systemic emboli in a high risk patient who has been comprehensively evaluated for alternative cause of embolic stroke.”  These guidelines also required an independent neurology consult or other tests to confirm either the occurrence of a stroke or an embolism before performing a PFO closure.  They also stated that a PFO closure may only be performed to treat migraines in a clinical trial setting. The hospital first temporarily, and later permanently, suspended Dr. Sorensen’s medical privileges because he did not follow the hospital’s policy on PFO closures.  Dr. Sorensen continued to perform PFO closures at the second hospital named as a defendant in the complaint, until he retired.

The relator alleged that because Dr. Sorensen performed medically unnecessary PFO procedures and billed those procedures to federal health care programs, he and the hospitals where he performed these procedures (who billed related facility charges to federal health care programs) had violated the FCA. The defendants moved to dismiss the relator’s complaint on several grounds, including failure to meet Rule 9(b)’s heightened pleading requirements and failure to state a claim under Rule 12(b)(6).

The court found that although the relator satisfied Rule 9(b)’s requirements as to claims against the doctor and one hospital, his FCA claims failed as a matter of law because he had failed to show that the defendants “knowingly made an objectively false representation to the government that caused the government to remit payment” (emphasis added) for the PFO closures.  The court noted that the crux of the relator’s case was that the “defendants represented to the government that the PFO closures performed by Dr. Sorensen were medically reasonable and necessary and that this representation was objectively false.” However, the court found that such representations could not be proven to be “objectively false” because “opinions, medical judgments, and ‘conclusions about which reasonable minds may differ cannot be false’” for purposes of an FCA claim.

The court also rejected the relator’s attempt to rely on medical society guidelines and recommendations as proof that the procedures Dr. Sorensen performed were not medically necessary, noting that the Medicare program does not require compliance with an industry standard as a prerequisite to payment and that requesting payment for procedures that allegedly did not comply with a particular standard of care does not amount to a fraudulent scheme actionable under the FCA. Where, as here, the Medicare program had not established an objective standard for the circumstances under which it would pay for a PFO closure (i.e., through an NCD), the court refused to apply the FCA to claims where the relator’s claims were based on the “subjective and ambiguous ‘reasonable and necessary’” standard and relied upon “evidence of medical opinions and subjective standards of care rather than on objectively false representations.”

Finally, the court rejected the relator’s request for leave to amend, finding that amendment would be futile because the “fundamental legal defect [of the complaint was] that it [did] not identify an objectively false representation made by any of the defendants.”

The timing of this decision is interesting not only because the legal and medical communities have been closely following the issue of medical necessity in FCA cases, but also because the newly confirmed Secretary of HHS, Tom Price, recently commented that CMS should focus less on the issue of medical necessity and more on ferreting out true fraud, potentially signaling a change in enforcement priorities going forward.

©1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.


About this Author

Samantha P. Kingsbury Associate Health Care Compliance, Fraud & Abuse, and Regulatory Counseling

Samantha’s practice focuses on health care enforcement defense matters. These matters often involve criminal and administrative actions brought against health care providers and companies by state and federal governmental and regulatory agencies. She also has experience in assisting clients with internal investigations of potential violations of the federal anti-kickback statute, the Stark law, and the False Claims Act, among other statutes and regulations. Samantha also has experience preparing self-disclosures and other reports relating to such enforcement matters, as well as developing...

Laurence J. Freedman, Litigation Attorney, Mintz, Enforcement Defense Law

Larry has a deep understanding of what drives government enforcement actions, and how to defend against them, in the health care and life sciences industries. As a trial lawyer and then official in the Civil Fraud Section of the U.S. Department of Justice, he litigated and supervised hundreds of False Claims Act and qui tam cases nationally. In his litigation practice, Larry has successfully represented hospitals and health care systems, laboratories, pharmaceutical and device manufacturers, and health care executives against fraud and abuse allegations and investigations brought by federal and state agencies. He is consistently recognized among the nation’s leading health care defense attorneys.

Larry’s health care and life sciences litigation practice focuses on defending clients against allegations and investigations of fraud and abuse involving governmental programs. He is highly experienced in representing clients against actions brought by federal and state agencies including the US Department of Justice (DOJ), the Department of Health and Human Services Office of the Inspector General (HHS OIG), the United States Attorneys’ Offices, and state OIGs and Medicaid Fraud Control Units (MFCUs).

Larry’s practice is based on his 24-years of experience handling complex civil litigation, often in the context of parallel proceedings, and achieving global resolutions. In addition to enforcement defense, Larry counsels clients through internal investigations, corporate compliance, investor due diligence reviews, and health care bankruptcies involving governmental liabilities. His clients include hospitals and health systems, dialysis providers, clinical laboratories, medical equipment companies, pharmaceutical and device manufacturers, and health care executives.

Prior to private practice, Larry served as an Assistant Director with the Civil Fraud Section of the DOJ and focused solely on the False Claims Act and its qui tam provisions. At DOJ he supervised hundreds of qui tam cases filed in US district courts throughout the country, was part of the leadership team for the pharmaceutical enforcement initiative, and managed high-profile actions often involving multiple US Attorneys’ Offices and federal agencies.

Prior to his position as Assistant Director, Larry served with the Civil Fraud Section as a trial attorney focused on health care fraud and defense procurement. He co-led the notable investigation and prosecution of national independent clinical laboratories known as “Operation LABSCAM.” For his achievements, Larry was highly-recognized by the Attorney General with the Department’s highest and second highest awards, as well as multiple awards from the HHS OIG and the MFCUs.

Following law school, Larry served as a law clerk for the Honorable Richard Cardamone of the U.S. Court of Appeals for the Second Circuit.