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Tony Maida counsels health care and life sciences clients on government investigations, regulatory compliance and compliance program development. Having served as a government official, Tony has extensive experience in health care fraud and abuse and compliance issues, including the federal and state Anti-Kickback and Stark Laws and Medicare and Medicaid coverage and payment rules. He represents clients in False Claims Act (FCA) qui tam matters, government audits, civil monetary penalty and exclusion investigations, and Centers for Medicare and Medicaid Services (CMS) suspension, and revocation actions, negotiating and implementing corporate integrity agreements, and making government self-disclosures. Read Tony Maida's full bio.
By Tony Maida on Jul 16, 2018
Posted In Compliance Developments, Materiality, Rule 9(b) Particularity
The materiality test articulated in Escobar has become one of the most litigated issues in False Claims Act (FCA) practice. Most courts have taken to heart the Supreme Court’s direction that materiality is a “demanding” and “rigorous” test in which “minor or insubstantial” non-compliance would not qualify as material. However, a recent Sixth Circuit two-to-one...
By Amy H. Kearbey, Daniel H. Melvin, Eric B. Gordon, MD, Joan Polacheck, Kelsey Leingang, Monica Wallace and Tony Maida on Jul 3, 2018
Posted In Stark
On June 25, 2018, the Centers for Medicare and Medicaid Services (CMS) published a request for information, seeking input from the public on how to address any undue regulatory impact and burden of the physician self-referral law (Stark Law) on value-based and other coordinated care arrangements designed to improve quality and lower cost. While the...
By Amandeep S. Sidhu, Laura McLane, Paul M. Thompson and Tony Maida on Jul 2, 2018
Posted In Compliance Developments, Government investigation, Other Notable Enforcement Actions, Public Disclosure Bar
Health Care Enforcement Q2 Roundup Webinar Date: Tuesday, July 17, 2018 Time: 11:00 am PDT | 12:00 pm MDT | 1:00 pm CDT | 2:00 pm EDT REGISTER NOW How will recent developments and emerging trends related to health care fraud and abuse impact future investigation targets and litigants? Our upcoming Health Care Enforcement Quarterly...
By Tony Maida on Apr 24, 2018
Posted In Anti-Kickback Statute / Stark Law, Pharmaceuticals
A key area of dispute in False Claims Act (FCA) cases based on Anti-Kickback Statute (AKS) violations is what degree of connection plaintiffs must allege between alleged kickbacks and “false claims.” The AKS states that “a claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim...
By Tony Maida, Laura McLane and Drew Elizabeth McCormick on Feb 20, 2018
Posted In Anti-Kickback Statute / Stark Law, Compliance Developments, Damages and Penalties, Medical Necessity, Other Notable Enforcement Actions, Pharmaceuticals
In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions, including actions brought under the False Claims Act (FCA). The extent to which these policy changes ultimately create relief for health care...
By Tony Maida on Feb 5, 2018
Posted In Compliance Developments, Damages and Penalties, Government investigation, Government Knowledge, Medical Necessity, Other Notable Enforcement Actions, Pharmaceuticals
The government’s focus on the US opioid crisis has been consistently expanding over the past year beyond manufacturers to reach prescribers and health care providers who submit claims to federal health care programs for opioid prescriptions. These efforts increasingly include investigations under the False Claims Act and administrative actions, in addition to the more traditional...
By Tony Maida on Dec 28, 2017
Posted In Government investigation, Yates Memorandum
On December 21, the US Department of Justice (DOJ) obtained more than $3.7 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending Sept. 30, 2017. Recoveries since 1986, when Congress substantially amended the civil False Claims Act (FCA), now total more than $56 billion....
By Tony Maida on Oct 12, 2017
Posted In Uncategorized
Earlier this year, DOJ and OIG independently issued guides focused on evaluating compliance program effectiveness. The guides approach the topic from different perspectives but cover overlapping themes and work well in tandem. We reviewed the guides and compiled the reference tool to aid organization executives and boards of directors to measure compliance program effectiveness and,...
By Tony Maida on Aug 24, 2017
Posted In Materiality
One of the most litigated issues following the Supreme Court’s Escobar decision is whether the Court created a limited, two-part test to define the implied certification theory under the False Claims Act. In the US Court of Appeals for the Second Circuit, the prevailing view confirms that the proper interpretation of Escobar is that the...
By Tony Maida and Tiffany T. Mason on Jul 28, 2017
Posted In Uncategorized
Following on the Department of Health and Human Services Office of Inspector General’s (OIG) June announcement that it would begin updating its public-facing Work Plan on a monthly basis, OIG released its first update to add 14 new topics to the Work Plan on July 17. As the health care industry knows, OIG Work Plan...