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Client Alerts 14 results

Client Alert | 2 min read | 02.21.25

First Circuit Clarifies “Resulting From” Standard Under Anti-Kickback Statute, Reshaping False Claims Act Litigation

The United States Court of Appeals for the First Circuit issued a pivotal ruling earlier this week, finding that in order to establish falsity in a False Claims Act (“FCA”) case premised on Anti-Kickback Statute (“AKS”) liability, the kickback must have been the “but-for” cause of the submission of the claim. The court’s decision hinged on the meaning of the phrase “resulting from” within the 2010 amendment to the AKS, which provided that a claim that includes items or services “resulting from” a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA. The meaning of “resulting from” for purposes of establishing such FCA liability has been hotly debated by courts. The First Circuit now joins the Sixth and Eighth Circuits in adopting this stricter but-for standard, while the Third Circuit has opted for a much looser approach.
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Client Alert | 2 min read | 01.17.25

Senator Ernst’s Directive on Chips Spending: Critical Insights for Fund Seekers

Senator Joni Ernst (R-IA) has issued a mandate to the Biden Administration: stop the spending spree with the remaining dollars in the CHIPs for America Program.  Senator Ernst’s missive is a direct response to Commerce Secretary Gina Raimondo’s push to have every employee in the Department of Commerce work overtime to spend billions of dollars in CHIPs funding before President Biden leaves office—a push that has already resulted in almost as much spending since the November 5thelection as was spent in the preceding two years since the CHIPs Act was passed.  Senator Ernst warned, the success of the CHIPs initiative “requires thoughtful planning and strategic spending, not binge buying shopping sprees by bureaucrats shoveling billions out the door before” Biden’s term expires. 
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Client Alert | 13 min read | 12.18.23

OIG Issues Updated General Compliance Program Guidance: Overview of Key Elements & Changes

The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published the General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG provides updated descriptions of the seven elements of an effective compliance program that health care entities have long relied upon. The new guidance also includes recommendations to conduct annual internal risk assessments, to consider quality of care as a component of the compliance program, and to emphasize the importance of a board’s and executive leadership’s oversight of compliance.
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Client Alert | 2 min read | 03.06.23

Hundreds of Millions of Potential Liability Result from Federal Jury False Claims Act Verdict Against Ophthalmology Product Distributor

In a prime example of the significant interplay between the Anti-Kickback Statute (“AKS”) and the False Claims Act (“FCA”), a federal jury has returned a verdict of more than $43 million in damages against Cameron-Ehlen Group, Inc., which does business as “Precision Lens,” and its owner.  The verdict in this long-running and closely watched fraud case out of the U.S. District Court for the District of Minnesota comes after a six-week trial, with the jury ultimately finding that the defendants paid kickbacks to ophthalmic surgeons to induce their use of defendants’ products in cataract surgeries reimbursed by Medicare, resulting in the submission of 64,575 false claims between 2006 and 2015.  While the jury calculated damages at the massive sum of $43 million, that number may grow exponentially after the court applies the FCA’s treble-damages calculation (increasing the liability to $129 million) and statutory penalties of between $5,500 and $11,000 for each of the 64,575 claims (resulting in additional penalties of $355 million to $710 million).  All told, the total FCA liability is expected to range between $485 million and $839 million.
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Client Alert | 7 min read | 02.06.23

The CDA and DMCA—Recent Developments and How they Work Together to Regulate Online Services

Section 230 of the Communications Decency Act (CDA, codified at 47 U.S.C. § 230) and Section 512 of the Digital Millennium Copyright Act (DMCA, codified at 17 U.S.C. § 512) are separate legal structures that work together to uphold certain protections for online service providers against claims arising out user-generated content.
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Client Alert | 2 min read | 06.22.22

U.S. Supreme Court Poised to Resolve Two FCA Circuit Splits

Yesterday, the U.S. Supreme Court granted certiorari in Polansky v. Executive Health Resources Inc., No. 19-3810 (3d Cir. Oct. 28, 2021), which involves the Government’s authority to dismiss a relator’s qui tam action pursuant to 31 U.S.C. § 3730(c)(2)(A) of the False Claims Act. In Polansky, the U.S. Court of Appeals for the Third Circuit held the Government must intervene in FCA suits before moving to dismiss and that, where responsive pleadings have been filed, a court has wide discretion to permit or deny the Government’s exercise of dismissal authority. This cemented two circuit splits. The first split is between the Third, Sixth, and Seventh Circuits, which require the Government to intervene before moving for dismissal of an FCA suit, and the D.C., Ninth, and Tenth Circuits, which do not require the Government to intervene before moving for dismissal of an FCA suit at any point in the litigation. The second is a three-way split among the Circuits regarding the standard of review a court must apply when determining whether the Government can dismiss a qui tam action over a relator’s objection: the Third and Seventh Circuits apply the Rule 41(b) standard, the D.C. Circuit considers the Government’s dismissal authority unfettered, and the Ninth Circuit applies a “rational relation” test requiring the Government to demonstrate a valid government purpose and a “rational relation” between the dismissal and that government purpose. The Supreme Court is now poised to resolve both of these splits.

Client Alert | 3 min read | 05.10.22

Changing Hands, Not Washing Them: CMS’ First Report on Nursing Home M&A Data

Last week, the Centers for Medicare & Medicaid Services (CMS) released data—for the first time—reporting on mergers, acquisitions, consolidations, and changes of ownership of Medicare enrolled hospitals and nursing homes over the past six years. This data, expected to be updated on a quarterly basis moving forward, has been lauded as an important step in improving transparency around nursing facility ownership and enhancing nursing home safety and quality of care. In conjunction with the release of CMS’ data, HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a related report analyzing the data and examining trends in changes of ownership over the past six years. In its report, ASPE also offers preliminary insights into how the data on ownership changes can support implementing policies bolstering competition in health care as well as ensuring program integrity in Medicare and Medicaid.
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Client Alert | 2 min read | 04.20.22

Not-So-Charitable Donations: DOJ Achieves a $20 Million Settlement for a Backdoor Donation Scheme for Increased Medicaid Contributions

On April 6, 2022, BayCare Health System Inc. (BayCare) entered into a $20 million settlement under the False Claims Act with the U.S. Department of Justice (DOJ) to resolve allegations that it had made donations in order to improperly inflate the funding four of its hospitals received from the federal Medicaid program. According to the agreement, BayCare did not formally admit wrongdoing or liability; rather, BayCare settled in order to “avoid the delay, uncertainty, and expense of litigation.”
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Client Alert | 3 min read | 02.04.22

A False Claims Act First: Eleventh Circuit Holds That the Excessive Fines Clause Applies to Non-Intervened Cases

In an issue of first impression, the Eleventh Circuit Court of Appeals recently held that the Excessive Fines Clause of the Eighth Amendment to the Constitution applies in non-intervened False Claims Act (FCA) qui tam lawsuits in Yates v. Pinellas Hematology & Oncology, P.A., 21 F.4th 1288 (11th Cir. 2021).  While the Eleventh Circuit ultimately held that the specific facts before it did not violate the Excessive Fines Clause, the ruling provides support for defendants to challenge excessive awards, including required statutory penalties, in declined FCA matters.
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Client Alert | 4 min read | 11.09.21

Tipping the Scales: Third Circuit Weighs in on Circuit Split Regarding the Government’s Dismissal Authority Over False Claims Act Qui Tams

In its recent decision Polansky v. Executive Health Resources Inc., No. 19-3810 (3d Cir. Oct. 28, 2021), the U.S. Court of Appeals for the Third Circuit became the most recent to weigh in on the circuit split regarding the Government’s authority to dismiss False Claims Act (“FCA”) qui tam actions pursuant to 31 U.S.C. § 3730(c)(2)(A). Siding with the Seventh Circuit’s recently-adopted approach, the Third Circuit held that Federal Rule of Civil Procedure 41(a) applies to government dismissals in FCA qui tam actions the same as it would in any other suit. In doing so, the Third Circuit cemented what is now a three-way split regarding the standard the Government must meet to exercise its dismissal authority, rejecting both the D.C. Circuit’s approach, that the Government’s dismissal power is unfettered, and the Ninth Circuit’s approach that the motion to dismiss must have a “rational relation” to a valid government purpose. In the same opinion, the Third Circuit also entered the fray on a second, related split, siding with the Sixth and Seventh Circuits in finding that the Government must intervene in FCA suits before moving to dismiss. In contrast, the D.C., Ninth, and Tenth Circuits do not require the Government to intervene before moving for dismissal of an FCA suit at any point in the litigation.
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Client Alert | 4 min read | 07.27.21

Senator Grassley Introduces Long-Promised Proposed Amendments to the False Claims Act

On Monday, July 26, 2021, a bipartisan group of senators, led by Sen. Chuck Grassley (R-Iowa), introduced a bill titled “False Claims Amendments Act of 2021” aimed at “beef[ing[ up the government’s most potent tool to fight fraud.”
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Client Alert | 3 min read | 07.22.21

Fifth Circuit Declines to Take a Side in the FCA Circuit Split on DOJ’s Dismissal Authority Pursuant to 31 U.S.C. § 3730(c)(2)(A)

A panel of the U.S. Court of Appeals for the Fifth Circuit recently rejected an argument advanced by two subsidiaries of a nationwide health care “watchdog” that the government improperly moved to dismiss two False Claims Act (FCA) lawsuits in U.S. ex rel. Health Choice Alliance LLC et al. v. Eli Lilly & Co. Inc. et al., No. 19-40906 (5th Cir. Jul. 7, 2021).  The relators accused Bayer Corp. and Eli Lilly & Co. Inc. of participating in a kickback scheme by offering free patient-education services to providers in exchange for providers prescribing their products in violation of the Anti-Kickback Act and the FCA.  The government initially declined to intervene in the cases, then a year later, notified the relators that it intended to move to dismiss and detailed its concerns about the viability of the cases.  After two-and-a-half months of negotiations with the relators, the government moved to dismiss the cases pursuant to its authority under 31 U.S.C. § 3730(c)(2)(A), citing, among other things, its two-year investigation into the relators’ cases.  The District Court granted the motions and the relators appealed.
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Client Alert | 1 min read | 12.22.20

Stand Up: Third Parties May Challenge False Claims Act Civil Investigative Demands

In General Medicine, P.C. v. United States, No. 3:20-mc-00053, the District Court for the Southern District of Illinois held that a third party has standing to challenge a False Claims Act (FCA) civil investigative demand (CID) that is issued to another entity. In that case, General Medicine, a company that employs physicians and nurse practitioners, petitioned the Court to set aside certain CIDs that were issued under the FCA to nursing facilities for which General Medicine provided services. General Medicine was the target of the Government’s investigation, and each of the CIDs sought information about General Medicine’s practices and involvement with the facility. In its petition, General Medicine argued that the CIDs issued to the nursing facilities were not sufficiently specific under the requirements of the FCA, did not seek information relevant to an investigation, and were overbroad and harassing. General Medicine also asserted that the Government had not issued the CIDs in “good faith” because they sought information that the Government already had in its possession. In response, the Government denied General Medicine’s points and argued that General Medicine lacked standing to bring a challenge under the FCA at all because it was not the recipient of the CIDs.
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