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Penalties For Health Care Law Violations Surge

September 21, 2016 | Blog | By Brian Dunphy

The civil monetary penalties for violations of myriad health care laws continue to rise. In June, we discussed the enormous increase in penalties under the federal False Claims Act (“FCA”). 
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HHS Office for Civil Rights will cast a wider net and increase its investigations into smaller HIPAA privacy breaches starting this month. OCR announced a new initiative to increase its efforts examining breaches that affect fewer than 500 individuals.
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Mintz’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update on August 4, 2016. This Update covers 31 health care-related False Claims Act cases that have been unsealed since the last Health Care Qui Tam Update.
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Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”) Yates Memo.
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The long-running test-referral prosecution against Biodiagnostic Laboratory Services, LLC (“BLS”), a New Jersey clinical blood testing laboratory; its owner and employees; and BLS’s referring physicians recently reached another milestone.
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On June 17, the Texas Medical Board (“Board”) filed a brief with the Fifth Circuit Court of Appeals reiterating that the Board’s rulemaking processes are protected under the state action immunity doctrine, noting that the case could significantly impair state agencies in carrying out their governmental functions.
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DOJ Announces Dramatic Increase in False Claims Act Penalties

June 30, 2016 | Blog | By Samantha Kingsbury, Laurence Freedman

On May 6th, we posted about the possibility that the Department of Justice (“DOJ”) might dramatically increase False Claims Act (“FCA”) penalties after the Railroad Retirement Board (“RRB”) nearly doubled the per-claim penalties it imposed under the FCA.
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On Monday, the U.S. Supreme Court issued summary dispositions vacating the judgments in three cases brought under the False Claims Act ("FCA"). The Court remanded the cases back to their respective circuit courts for reconsideration in light of the Court's decision in Universal Health Services, Inc. v. United States ex rel. Escobar, 579 U. S. ___ (2016).
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Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s commitment to investigating and prosecuting culpable individuals in cases involving suspected corporate fraud.
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Health Care Enforcement Defense Advisory on Escobar Holding

June 20, 2016 | Blog | By Bridgette Keller

Earlier today, my colleagues Tom Crane and Larry Freedman released a Health Care Enforcement Defense Advisory regarding the Supreme Court's long-awaited, unanimous decision in Universal Health Services v. United States ex rel. Escobar (“Escobar”).
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A unanimous Supreme Court issued its long-awaited and closely watched decision today on the scope of the False Claims Act (“FCA”), and the Court affirmed the FCA’s long reach. Universal Health Services, Inc. v. United States ex rel. Escobar et al., No 15-7.
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Recap: 2016 Mintz/ML Strategies Pharmacy Industry Summit

May 19, 2016 | Blog | By Theresa Carnegie

The pharmacy industry is under increasing scrutiny from all angles. Whether at the legislative or agency level, Washington as well as many states seem intent on addressing perceived issues surrounding drug pricing, reimbursement and program integrity.
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OIG Issues Favorable GPO Advisory Opinion

May 16, 2016 | Blog | By Ryan Cuthbertson

The OIG recently issued a favorable advisory opinion permitting a health system (the “Health System”) to become the sole owner of a Group Purchasing Organization (“GPO”), some of whose members were also owned by the Health System (the “Proposed Arrangement”).
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Already Enormous False Claims Act Penalties Set to Increase

May 6, 2016 | Blog | By Brian Dunphy, Samantha Kingsbury

The already enormous per-claim penalties under the federal False Claims Act (“FCA”) may nearly double by August 1, 2016, ratcheting up the stakes of FCA cases for health care providers, pharmaceutical and medical device manufacturers, and life sciences companies subject to the FCA.
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Last week the Supreme Court heard oral argument in a False Claims Act (“FCA”) case in which the Court is considering the validity of the so-called implied false certification theory. This theory attaches FCA liability when a person submits a claim for payment notwithstanding a violation of an underlying law or regulation, but without a factually false claim form.
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Yesterday, Mintz’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update.  This Update covers 42 health care-related False Claims Act qui tam cases that have been unsealed since the last Health Care Qui Tam Update.
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The pharmacy industry is under increasing scrutiny from all angles. Whether at the legislative or agency level, Washington as well as many states seem intent on addressing perceived issues surrounding drug pricing, reimbursement, and program integrity.
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Judge Sides with AseraCare, Grants Summary Judgment in $200 Million FCA Case

April 1, 2016 | Blog | By Laurence Freedman, Samantha Kingsbury

Much like the rest of the health care world, we have been following the AseraCare case since May of last year when the Alabama federal district court granted AseraCare’s motion to bifurcate its False Claims Act (FCA) trial into Phase I that would address “falsity” and Phase II that would address “knowledge” and other FCA elements.
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Acquittals in Vascular Solutions Case Deal Setback to DOJ

March 2, 2016 | Blog | By Bridget Rohde, Laurence Freedman

On February 26, 2016, a federal jury in Texas returned not guilty verdicts with respect to charges brought against Vascular Solutions Inc. (“VSI”) and its CEO by the U.S. Department of Justice (“DOJ”), dealing a decisive blow in a case brought before the Yates Memo was issued but touted even then as an effort to enforce corporate and individual accountability.
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Expanding on our recent discussion of CMS’s long-awaited Final Rule governing the return of Medicare Part A and Part B overpayments (“Overpayment Rule"), my colleague Larry Freedman and I published an article in BNA’s Medicare Report entitled The Medicare Overpayment Rule: Implications for Compliance and Health Care Enforcement.
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