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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.

New Guidance on Medicare Payment Rule Enforcement


By , , , and on Dec 5, 2019
Posted In Other Notable Enforcement Actions

A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and Medicaid Services (CMS). The memo expressed OGC’s views on the impact of the Supreme Court’s Azar v. Allina Health Services, et. al., No....

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Stark Law Proposed Change Affects Group Practice Special Rules for Productivity Bonuses, Profit Shares


By , , , , , and on Oct 22, 2019
Posted In Stark

On October 9, 2019, the US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published proposed changes to the physician self-referral law (Stark Law). Physician practices are subject to the Stark Law, and the proposed rule includes an important clarification affecting certain group practices’ compensation models. CMS proposes to revise...

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HHS Proposes Substantial Changes to the Stark Law and the Anti-Kickback Statute Regulations


By , , , , and on Oct 9, 2019
Posted In Anti-Kickback Statute / Stark Law, Stark

On October 9, 2019, the US Department of Health and Human Services (HHS) published proposed changes to the physician self-referral law (Stark Law) (Stark Proposed Rule) and the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Civil Monetary Penalty Law (CMPL) (AKS Proposed Rule). The proposed rules represent some of the most significant potential changes to...

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Third Circuit Perpetuates Tuomey’s Controversial Stark Law “Volume or Value” Standard


By , , and on Oct 2, 2019
Posted In Anti-Kickback Statute / Stark Law

In U.S. ex rel. J. William Bookwalter, III, M.D. et al. v. UPMC et al., the US Court of Appeals for the Third Circuit endorsed two controversial interpretations of the Stark Law’s “volume or value” standard, known as the correlation theory and the practice “loss” theory. Specifically, the court held that the relators had made out...

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Remuneration? Not If It’s Fair Market Value, Says Eleventh Circuit


By and on Sep 27, 2019
Posted In Anti-Kickback Statute / Stark Law

Bingham v. HCA, Inc., a recent Eleventh Circuit case, highlights the centrality of fair market value to Anti-Kickback Statute (AKS) analyses. This decision is significant for several reasons and we expect to see Bingham cited by many defendants in future False Claims Act cases. The case is also a reminder that the current regulatory and...

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Healthcare Enforcement Quarterly Roundup – Q2 2019


By , , , , , , , , , , , , , and on Aug 27, 2019
Posted In Additional Compliance Resources, Compliance Developments, Other Notable Enforcement Actions, Pharmaceuticals

In this second installment of the Healthcare Enforcement Quarterly Roundup for 2019, we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts for the remainder of this year and beyond. In this Quarterly Roundup, we discuss DOJ’s guidance on compliance programs and cooperation credit,...

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DOJ Preserves Its Options in Cooperation Credit Guidance


By and on Jun 21, 2019
Posted In Compliance Developments

Last month, the Civil Division of the Department of Justice (DOJ) announced the release of formal guidance to DOJ civil attorneys on how to award “cooperation credit” to defendants who cooperate with the Department during a False Claims Act (FCA) investigation. The formal policy, added to the Justice Manual Section 4-4.112, identifies the type of...

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DOJ Guidance on Evaluation of Corporate Compliance Programs: Key Takeaways


By , , , , and on May 9, 2019
Posted In Compliance Developments, Government investigation

Boards and management should make use of recent expanded guidance from the US Department of Justice to ensure that their compliance programs are considered “effective” if and when an investigation arises. Companies should affirmatively answer three fundamental questions in evaluating a compliance program: Is the compliance program well designed? Is the program being implemented effectively...

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Health Care Enforcement Quarterly Roundup – Q1 2019


By , , , , , , , , , , , , and on Apr 26, 2019
Posted In Additional Compliance Resources, Other Notable Enforcement Actions, Pharmaceuticals

In this first installment of the Health Care Enforcement Quarterly Roundup for 2019, we continue to monitor trends we identified in 2018 and introduce new enforcement efforts that are expected to persist in the coming year. In this Roundup, we focus on increased enforcement activity against electronic health record (EHR) companies, enforcement against individuals (with an acute focus...

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Questions Remain for the EHR Industry as a Second EHR Vendor, Greenway Health, Settles False Claims Act Allegations


By , and on Feb 26, 2019
Posted In Anti-Kickback Statute / Stark Law, Corporate Integrity Agreements, Government investigation, Other Notable Enforcement Actions

DOJ announced on February 6, 2019, the Settlement Agreement resolving allegations in DOJ’s Complaint that Greenway caused its customers to submit false Medicare and Medicaid claims for payments under the EHR Incentive Programs in violation of the FCA and that it paid illegal kickbacks to current customers to recommend Greenway products (that are used to...

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