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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.

DOJ Expands New Enforcement Tactic – Obtains TRO to Prevent Pharmacy From Dispensing Opioids


By on Feb 13, 2019
Posted In Government investigation, Pharmaceuticals

On February 8, 2019, the Department of Justice (DOJ) announced that it obtained a temporary restraining order (TRO) in the Middle District of Tennessee against two pharmacies, their owner and three pharmacists from dispensing controlled substances, including opioids. The DOJ simultaneously unsealed a complaint alleging violations of the False Claims Act and Controlled Substances Act...

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Health Care Enforcement Quarterly Roundup | Q4 2018


By , , , , , , , , , , and on Jan 30, 2019
Posted In Compliance Developments, Other Notable Enforcement Actions, Yates Memorandum

This latest installment of the Health Care Enforcement Quarterly Roundup reflects on trends that persisted in 2018 and those emerging trends that will carry us into 2019 and beyond. Leading off with the US Department of Justice’s (DOJ) December announcement of its fiscal year 2018 False Claims Act (FCA) recoveries, it remains clear that the...

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Health Care Dominates FCA Judgments and Settlements in 2018


By on Dec 31, 2018
Posted In Damages and Penalties

On December 21, just before the government shutdown began, the Civil Division of the US Department of Justice (DOJ) announced its fiscal 2018 False Claims Act (FCA) statistics.  According to DOJ, FCA judgments and settlements totaled over $2.8 billion for the year. While this number is the lowest total since 2009, the reason for this result...

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OIG Dusts off the Old Rule Book to Say No to Free Expensive Drugs to Hospitals


By and on Dec 11, 2018
Posted In Pharmaceuticals

The Office of Inspector General, Department of Health and Human Services posted an unusual negative Advisory Opinion (AO 18-14) on a drug company’s proposal to provide free drugs to hospitals for use with pediatric patients suffering from a form of epilepsy. Of particular interest is OIG’s reliance on a longstanding, but rarely used, authority to...

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Health Care Enforcement Quarterly Roundup | Q3 | September 2018


By , , , , , , , , , , , and on Oct 8, 2018
Posted In Compliance Developments, Other Notable Enforcement Actions

In the latest installment of Health Care Enforcement Quarterly Roundup, we examine key enforcement trends in the health care industry that we have observed over the past few months. In this issue, we report on: Practical applications of recent guidance from the US Department of Justice (DOJ) A recent blow to DOJ’s effort to use...

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Sixth Circuit Declines to Revisit Materiality Ruling


By on Aug 29, 2018
Posted In Compliance Developments, Materiality, Rule 9(b) Particularity

This week, the Sixth Circuit declined the en banc petition of Brookdale Senior Living Communities to revisit a three-judge panel’s two-to-one decision to permit the Relator’s third amended complaint to move forward. We previously analyzed this decision here. The court’s one-page order did not explain the reasoning for declining the petition, although it noted that...

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OIG Seeks Comments on Anti-Kickback Statute and Beneficiary Inducements as Part of its Regulatory Sprint to Coordinated Care


By , , , , , and on Aug 27, 2018
Posted In Anti-Kickback Statute / Stark Law, Compliance Developments

On August 24, 2018, the Office of Inspector General (OIG), Department of Health and Human Services (HHS) published a request for information, seeking input from the public on potential new safe harbors to the Anti-Kickback Statute and exceptions to the beneficiary inducement prohibition in the Civil Monetary Penalty (CMP) Law to remove impediments to care...

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Circuit Court Affirms Payments for Referrals Made to Employees are Protected by the AKS Safe Harbor


By and on Aug 24, 2018
Posted In Anti-Kickback Statute / Stark Law

On August 7, 2018, the 11th Circuit Court of Appeals affirmed a ruling by the United States District Court for the Southern District of Florida dismissing a qui tam suit against the AIDS Healthcare Foundation, Inc. (AHF), finding that the payments made to AHF employees for referring patients to AHF were protected by the employment...

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HHS Will Soon Seek Public Comment on Anti-Kickback Statute Reform


By on Jul 23, 2018
Posted In Anti-Kickback Statute / Stark Law, Stark

During a July 17, 2018, hearing before the House Ways and Means Subcommittee on Health, United States Department of Health and Human Services (HHS) Deputy Secretary Eric Hargan testified about HHS’ efforts to review and address obstacles that longstanding fraud and abuse laws pose to shifting the Medicare payment system to a value-based, coordinated care...

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Health Care Enforcement Quarterly Roundup | Q2 | July 2018


By , , , , , , , , , , , , and on Jul 18, 2018
Posted In Compliance Developments, Other Notable Enforcement Actions

How will key trends and developments in health care policy and enforcement impact future litigants? In the latest Health Care Enforcement Quarterly Roundup, we address this question in the context of: Continued interpretations of the landmark Escobar case The latest guidance from US Department of Justice (DOJ) leadership regarding enforcement priorities The uptick in state...

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