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Tenth Circuit Rejects Request for Rehearing in Closely Watched FCA Medical Necessity Case
November 13, 2018 | Blog | By Samantha Kingsbury, Laurence Freedman
In a three-sentence order issued on October 29th, the Tenth Circuit Court of Appeals declined to grant a Request for Rehearing in the closely watched Polukoff case. One of the questions raised in the Request was whether, by submitting a claim for reimbursement and certifying the medical necessity of the charged service, providers also certify that the claim meets all of the standards set forth in the Medicare Program Integrity Manual (MPIM).
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Health Care Qui Tam Update
November 5, 2018 | Article | By Hope Foster, Kevin McGinty, Ellyn Sternfield, Benjamin Zegarelli
Read about health care qui tam litigation trends for the 12 months that ended on August 31 and significant cases, including two involving skilled nursing facilities.
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Six Initiatives States May Pursue to Curb Drug Prices and the 340B Factor
October 23, 2018 | Blog | By Ellyn Sternfield
For much of the past 18 months, the Trump Administration, and in particular CMS, have talked a good game regarding reducing pharmaceutical prices. On October 16, 2018, a key component of the Administration’s strategy was revealed in the form of CMS’ Proposed Rule requiring manufactures to include the “list price” for prescription drugs reimbursable by Medicaid or Medicare in television advertisements. While I do think that there will be new initiatives to address drug pricing, I believe most will come through the state and not the federal level. This post addresses six potential initiatives from a recently released report of the National Governors' Association.
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OIG Opinion Illustrates the Need for New AKS Safe Harbors
October 17, 2018 | Blog
The Department of Health and Human Services Office of the Inspector General (“OIG”) has issued an Advisory Opinion regarding a surgical device and wound care product manufacturer’s proposal to offer its hospital customers who purchase a suite of three joint replacement products a warranty program covering the Product Suite.
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The 2014 Overpayment Rule is Vacated: How We Got Here and Key Takeaways
September 26, 2018 | Blog | By Bridgette Keller
Medicare Advantage Organizations (MAOs) have been hailing a federal judge’s recent ruling to vacate the 2014 Overpayment Rule. But, how did we get here? And what does it really mean for MAOs?
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Tenth Circuit Revives FCA Claim Based on Alleged Lack of Medical Necessity
July 15, 2018 | Blog | By Brian Dunphy
The Tenth Circuit Court of Appeals has issued a significant decision, finding that a physician’s medical judgment about the medical necessity of heart procedures can be “false or fraudulent” under the federal False Claims Act (FCA).
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Mintz’s Health Care Enforcement Defense Group Publishes Latest Qui Tam Update
June 12, 2018 | Blog | By Samantha Kingsbury
Last week, Mintz’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 60 health care-related False Claims Act qui tam cases unsealed in December 2017 and January 2018 and the trends they reflect.
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The Hazards of Prescription Auto-Refill Programs
June 6, 2018 | Blog | By Lauren Moldawer
States may be starting to take aim at prescription automatic refill programs. Automatic refill programs have been proven to increase patient adherence, especially among patients with chronic conditions. However, regulators argue that automatic refill programs result in waste to the system, stockpiling, and federal program payment for unneeded prescriptions.
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DOJ Continues Aggressive Enforcement Action Against Opioid Manufacturers
May 22, 2018 | Blog | By Benjamin Zegarelli
Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc. and consolidated five separate qui tam cases into one case, U.S. ex rel Guzman v. Insys Therapeutics, Inc., filed in the U.S. District Court for the Central District of California.
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Warner Chilcott HIPAA Lesson Revisited – Mass. Physician Convicted of Criminal Violation
May 10, 2018 | Blog | By Ryan Cuthbertson
Back in late 2015, we blogged about the interesting twist in the $125 million Warner Chilcott settlement that a Massachusetts physician had been criminally charged with violating the Health Insurance Portability and Accountability Act (HIPAA). That physician has now been convicted of the HIPAA violation, as well as an unrelated charge of obstructing a federal health care investigation.
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Fifth Circuit Decision is Rare Victory Permitting District Court to Enjoin Recoupment Before Provider Exhausts Administrative Remedies
April 17, 2018 | Blog | By Samantha Kingsbury, Laurence Freedman
The all-too-common story of a healthcare company declaring bankruptcy in the face of aggressive Medicare recoupment actions before the company even has a hearing before an Administrative Law Judge (ALJ) may get a new ending – at least in the Fifth Circuit.
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Recent FCA Settlement Shows That What’s Old Is New in Health Care Fraud Enforcement
March 13, 2018 | Blog | By Samantha Kingsbury
Last week, the U.S. Attorney’s Office for the District of Massachusetts announced that it had entered into an agreement with a Massachusetts-based medical device manufacturer to settle allegations that the Company had violated the False Claims Act by purchasing lavish meals for physicians to induce them to use heart pumps manufactured by the Company.
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DOJ Intervenes in False Claims Act Case Against a Compounding Pharmacy and a Private Equity Firm
March 5, 2018 | Blog | By Xavier Hardy, Karen Lovitch
The Department of Justice (DOJ) recently intervened in a False Claims Act (FCA) case that raises a variety of interesting allegations, including payment of kickbacks by a compounding pharmacy to contracted marketing companies in the form of percentage-based compensation, to TRICARE beneficiaries in the form of co-payment waivers, and to physicians who submitted prescriptions without seeing patients.
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Federal Enforcement Actions Continue to Focus on Opioid-Related Misconduct
February 20, 2018 | Blog | By Samantha Kingsbury
As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices.
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Mintz’s Health Care Enforcement Defense Group Releases New Qui Tam Update
February 8, 2018 | Blog
Mintz’s Health Care Enforcement Defense Group recently published its most recent Health Care Qui Tam Update. This Update analyzes the 47 health care-related qui tam cases unsealed in August and September 2017.
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Fifth Circuit Decision in Highway Guardrails Case Provides Important Guidance on Materiality in False Claims Act Cases
November 28, 2017 | Advisory | By Sarah Beth Kuyers, Laurence Freedman, Samantha Kingsbury
The U.S. Court of Appeals for the Fifth Circuit recently decided a case that could have a substantial impact on False Claims Act (“FCA”) jurisprudence with respect to the element of “materiality.”
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Lawmakers May Not Spend Political Capital on Stand-Alone EB-5 Bill
September 28, 2017 | Alert | By Douglas Hauer, Alexander Hecht, R. Neal Martin
The chances of a stand-alone EB-5 bill gaining consensus with lawmakers on Capitol Hill are low. With the GOP failing to repeal the Affordable Care Act, lawmakers may be spending time readjusting priorities in unexpected ways for the remainder of 2017.
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Health Care Qui Tam Update - August 2017
August 16, 2017 | Article | By Hope Foster, Kevin McGinty, Amanda L. Clairmont
Read about health care qui tam litigation trends for the 12 months that ended on August 31st and significant cases, including two involving skilled nursing facilities.
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Health Care Enforcement Review & 2017 Outlook: Important Case Law Developments
January 5, 2017 | Advisory | By Karen Lovitch, Laurence Freedman, Samantha Kingsbury
In 2016, courts around the country heard cases involving a variety of False Claims Act (FCA) and other enforcement-related matters, and going forward these case law developments are expected to have an impact on both the scope of FCA liability and the means by which FCA liability can be proven at trial.
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The Twenty-Year Ascendancy of Health Care Qui Tam Litigation in Five Simple Graphs
December 8, 2015 | Advisory | By Kevin McGinty
Experienced practitioners are anecdotally aware of the growth in recent years in the volume of health care qui tam litigation. That perceived trend is validated quite graphically in the most recent Department of Justice (“DOJ”) statistics on False Claims Act filings.
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