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Insights on Government Investigations

98 total results. Page 3 of 4.

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        Health Care Counsel Blog
        False Claims Act Penalties Set to Double, Far Exceeding Expected Increase
        May 6, 2016
        David S. Greenberg, D. Jacques Smith

        In a surprising move that could dramatically impact government enforcement actions against life science companies, the health care industry, and government contractors, a federal board has increased federal False Claims Act penalties by more than 100 percent. 

        Health Care Counsel Blog
        Don’t Discount the Discounts: Pfizer and Wyeth Reach Settlement Over Medicaid Drug Pricing Allegations
        May 4, 2016
        Stephanie Trunk, Hillary M. Stemple

        The Department of Justice recently announced it has reached a more than $780 million settlement with Pfizer Inc. and its subsidiary Wyeth to resolve reported false pricing allegations.

        News
        Supreme Court Weighs FCA Implied Certification Theory
        April 27, 2016
        D. Jacques Smith, David S. Greenberg

        Partners Jacques Smith and David Greenberg spoke with AHLA Weekly after the US Supreme Court heard oral argument on April 19 in a major False Claims Act case that has far-reaching implications for the health care industry and other highly-regulated sectors reliant on government funding.

        Health Care Counsel Blog
        Health Care Industry Braces for Major False Claims Act Case Before Supreme Court
        April 13, 2016
        David S. Greenberg

        The US Supreme Court is set to hear oral arguments on April 19 in Universal Health Services, Inc. v. United States ex rel. Escobar, a key case addressing the implied certification theory of liability under the False Claims Act. 

        Health Care Counsel Blog
        DOJ Attorneys Disclose Health Care Enforcement Trends for 2016
        March 17, 2016
        D. Jacques Smith

        Federal prosecutors appearing at the American Conference Institute’s 16th Annual Forum on Fraud and Abuse in the Sales and Marketing of Medical Devices earlier this month outlined recent enforcement trends that should catch the attention of the health care industry.

        Health Care Counsel Blog
        Administrative Law Judge Upholds Imposition of Civil Penalties on Health Care Provider for HIPAA Violations
        February 23, 2016
        Douglas A. Grimm, Thomas E. Jeffry, Jr., Jill A. Steinberg, Stephanie Trunk

        In a recent decision, a US Department of Health and Human Services (HHS) Administrative Law Judge (ALJ) agreed with the HHS Office of Civil Rights (OCR) that Lincare, Inc. d/b/a United Medical had violated HIPAA.

        Health Care Counsel Blog
        CVS Settles Controlled Substances Act Claim for $8 Million
        February 17, 2016
        Stephanie Trunk

        As part of the federal government’s multi-front attack on opioid abuse, the Department of Justice announced on Friday, February 12 that CVS Pharmacy, Inc. has agreed to pay $8 million to settle allegations that it violated the Controlled Substances Act (CSA).

        Health Care Counsel Blog
        New Law Allows Texas State Board of Pharmacy to Scrutinize Compounding Pharmacies’ Relationships with Physicians
        February 11, 2016
        Stephanie Trunk, Douglas A. Grimm

        The federal government has focused on compounding pharmacies and pharmacists for fraud and abuse investigations in recent years, and now the great state of Texas has joined in.

        Health Care Counsel Blog
        Providers Take Note: What the New Stark Regulations Mean to You
        December 8, 2015
        Hillary M. Stemple

        In an important development, the Centers for Medicare and Medicaid Services (CMS) has issued additional final regulations implementing the Stark Law as part of the Physician Fee Schedule for calendar year 2016 (see 80 Fed. Reg. 70,886 (Nov. 16, 2015)).

        Health Care Counsel Blog
        The End at Last: Tuomey Settles for $72.4 Million
        October 29, 2015
        Hillary M. Stemple

        The Department of Justice recently announced that Tuomey Healthcare System has agreed to pay $72.4 million and enter into a five-year Corporate Integrity Agreement to finally resolve the long-running U.S. ex rel., Drakeford v. Tuomey Healthcare System, Inc. False Claims Act/Stark Law litigation.

        Health Care Counsel Blog
        OIG Reminds Providers that the Donation of EHR Systems with Limited Interoperability May Violate the Federal Anti-Kickback Statute
        October 22, 2015
        Stephanie Trunk

        US Department of Health and Human Services Office of Inspector General released an OIG Alert reminding the public that electronic health records furnished to referral sources may not meet the federal anti-kickback statute’s EHR safe harbor if EHR system has limited or restricted interoperability.

        Health Care Counsel Blog
        Covered Entities and Business Associates Beware! New HIPAA Audits to Begin in Early 2016
        October 20, 2015
        Stephanie Trunk

        Health care providers and their contractors have been put on notice by the Office for Civil Rights (OCR) that the next round of HIPAA compliance audits will begin in early 2016.  The previous round of HIPAA audits was completed in 2014.

        Health Care Counsel Blog
        Stark Law is Coming: Adventist Health System Pays $118.7 Million in Third Large September Settlement
        October 5, 2015

        On September 21, 2015, the US DOJ and whistleblowers’ counsel announced that Florida-headquartered Adventist Health System (Adventist) had agreed to pay $118.7 million to resolve allegations that it violated the FCA by submitting claims in violation of the Stark law and by miscoding claims.

        Health Care Counsel Blog
        Deputy AG Branda Provides Insights into Department of Justice Enforcement Priorities at AHLA Fraud and Compliance Forum
        September 28, 2015
        David S. Greenberg

        Joyce Branda, the Deputy Assistant Attorney General for the Commercial Litigation Branch of the DOJ, gave the keynote address on September 28, 2015, at the American Health Lawyers Association Fraud and Compliance Forum in Baltimore, providing conference attendees with an update from DOJ.

        Health Care Counsel Blog
        Georgia Hospital System and Physician Agree to $35 Million Settlement with DOJ to Resolve Alleged False Claims Act and Stark Law Violations
        September 21, 2015
        Hillary M. Stemple

        The US Department of Justice (DOJ) recently announced that Columbus Regional Healthcare System (Columbus Regional) has agreed to pay up to $35 million and enter into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services Office of Inspector General.

        Press Release
        Arent Fox Represents North Broward Hospital District in High Profile False Claims Act Settlement
        September 18, 2015

        On September 15, the US Department of Justice announced that it reached a $69.5 million settlement with the North Broward Hospital District to resolve False Claims Act allegations that originated in 2010.

        Health Care Counsel Blog
        OIG Issues Favorable Advisory Opinion to Pharmaceutical Manufacturer Related to a Free Starter or Bridge Program
        August 17, 2015
        Stephanie Trunk

        On August 5, 2015, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 15-11.

        Health Care Counsel Blog
        Midsummer Nightmare: Opinion in Continuum Health Partners Case Suggests We Can Identify the Unknown
        August 7, 2015
        Thomas E. Jeffry, Jr.

        On Monday, a federal district court judge in New York issued a ruling that, if adopted broadly, will have a significant – and potentially nightmarish – impact on any provider who receives an overpayment from Medicare or Medicaid.  Kane v. Healthfirst, Inc. and U.S. v. Continuum Health Partners Inc. 

        Health Care Counsel Blog
        CMS to Providers: “We Hear You!” CMS Proposes Significant Changes to Stark Law Regulations that Could Benefit Providers
        July 27, 2015
        Hillary M. Stemple

        In an unexpected development, the Centers for Medicare and Medicaid Services recently proposed several changes that will generally add greater flexibility to Stark Law regulations in the proposed physician fee schedule for calendar year 2016, which was published on July 15, 2015.

        Alerts
        Paging Providers, CMS Changes To Stark Law May Help You
        July 27, 2015
        Hillary M. Stemple

        In an unexpected development, the Centers for Medicare and Medicaid Services recently proposed several changes that will generally add greater flexibility to Stark Law regulations in the proposed physician fee schedule for calendar year 2016, which was published on July 15, 2015.

        Alerts
        Ninth Circuit’s Kinetic Concepts Case Overrules Long-Standing, Defendant-Friendly False Claims Act Precedent
        July 21, 2015
        D. Jacques Smith

        On July 7, 2015, the US Court of Appeals for the Ninth Circuit overruled a 23-year-old False Claims Act precedent, relaxing its test for deciding when a whistleblower can overcome a motion to dismiss because the allegations in the complaint were publicly disclosed. 

        News
        Partner Tom Jeffry Analyzes Ninth Circuit’s Recent False Claims Act Ruling
        July 14, 2015
        Thomas E. Jeffry, Jr.

        Health care partner Tom Jeffry was interviewed by Law360 to discuss the implications of the Ninth Circuit’s recent ruling in a False Claims Act litigation against Kinetic Concepts Inc.

        Health Care Counsel Blog
        Physicians (and other Providers) Beware! OIG Announces New Enforcement Team Focused on CMPs and Exclusion
        July 10, 2015

        Last week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced the creation of a new litigation team focused solely on using the OIG’s authority to impose civil monetary penalties and exclude individuals and businesses from Medicare and Medicaid.

        Health Care Counsel Blog
        What the Obergefell v. Hodges Decision May Mean to the Health Care Industry
        July 9, 2015
        Thomas E. Jeffry, Jr.

        King v. Burwell understandably took the attention of the health care industry a couple of weeks ago when it upheld a key component of the ACA. A day later, the Supreme Court released another decision that may have a more significant going-forward impact on the health care industry: Obergefell.

        Health Care Counsel Blog
        Not What the Doctor (or Congress) Ordered: DC Circuit Rules that HHS Must Reconsider Its Stark Law Interpretation
        July 7, 2015
        Hillary M. Stemple

        The United States Court of Appeals for the District of Columbia Circuit released a decision requiring the Department of Health and Human Services to reconsider a 2008 rule prohibiting certain per-click leasing arrangements under the Stark Law.

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