James A. Cannatti III James A. Cannatti III

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James A. Cannatti III* practices at the intersection of today's most pertinent health care issues, including digital health, health IT policy, and fraud and abuse, including Anti-Kickback Statute/Stark Law matters. With more than 10 years of experience in the US Department of Health & Human Services’ (HHS) Office of Inspector General (OIG), most recently as Senior Counselor for Health Information Technology, James is well-attuned to the regulatory issues impacting the rapidly evolving digital health landscape. Read James A. Cannatti III's full bio.  *Not admitted to practice in the District of Columbia; admitted only in Ohio. Supervised by principals of the Firm who are members of the District of Columbia Bar.

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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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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HHS Proposes to Revise Discount Safe Harbor Protections for Drug Rebates


By and on Feb 7, 2019
Posted In Anti-Kickback Statute / Stark Law, Pharmaceuticals

On January 31, 2019, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (the Proposed Rule) as part of ongoing administration drug pricing reform efforts. The Proposed Rule would modify a regulatory provision that had previously protected certain pharmaceutical manufacturer rebates from criminal prosecution and financial penalties under the federal...

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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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