James A. Cannatti III

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.

Firm/Organization: McDermott Will & Emery

Blogs: Employee Benefits Blog, FCA Update, Health & Life Sciences News, Of Digital Interest

Latest Articles

Of Digital Interest

Can We Expect to See ONC’s Final Rule on Information Blocking Soon?

By James A. Cannatti III, Daniel F. Gottlieb, Karen S. Sealander & Scott Weinstein

October 30, 2019

A recent update to the Office of Management and Budget (OMB) website suggests that the answer is “yes”—though that depends on how one defines “soon.” According to its website, OMB received the Office of the National Coordinator for Health Information Technology’s (ONC’s) final rule, entitled 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, for review on October 28, 2019. Based on the rule title, it appears that ONC is…

FCA Update

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

By James A. Cannatti III, Dana Dombey, Tony Maida, Daniel H. Melvin, Monica Wallace, Nicholas Alarif & Chelsea M. Rutherford

October 22, 2019

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 its regulations to clarify the special rule for group practice distributions of income from Stark designated health services (DHS). Compliance…

FCA Update

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

By James A. Cannatti III, Tony Maida, Daniel H. Melvin, Joan Polacheck, Monica Wallace & Nicholas Alarif

October 9, 2019

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 these laws in the last decade. HHS Deputy Secretary Eric Hargan said that they “would be…

Employee Benefits Blog

DOJ’s Enforcement Activity Against Individuals: Acute Focus on Telemedicine

By James A. Cannatti III, Amandeep S. Sidhu, Theodore Alexander & Sophia A. Luby

June 12, 2019

DOJ’s focus on individual accountability is particularly important with respect to telemedicine. Telemedicine is a burgeoning field, with a projected market increase of 18% annually over the next six years, reaching $103 billion in 2024. In light of this recent surge in profitability, DOJ has begun paying extra attention to telemedicine, with at least one recent HHS-OIG report asserting that more than one-third of all telemedicine claims are improper. Continue reading.…

Of Digital Interest

Health Care Enforcement Roundup: Increased FCA Enforcement Against EHR Companies

By James A. Cannatti III, Amandeep S. Sidhu, Sophia A. Luby & Theodore Alexander

May 9, 2019

The federal government has offered substantial incentives to providers to adopt and use certified electronic health record (EHR) technology. As of October 2018, the federal government had paid over $38 billion in EHR incentive payments through the Promoting Interoperability Program (formerly, the Meaningful Use Program). Other federal health care program policies also encourage use of certified EHR technology through enhanced payments or avoidance of decreased reimbursement. These EHR-related payment policies, however, have triggered increased…

Of Digital Interest

DOJ’s Enforcement Activity Against Individuals: Acute Focus on Telemedicine

By James A. Cannatti III, Amandeep S. Sidhu, Sophia A. Luby & Theodore Alexander

May 6, 2019

DOJ’s focus on individual accountability is particularly important with respect to telemedicine. Telemedicine is a burgeoning field, with a projected market increase of 18 percent annually over the next six years, reaching $103 billion in 2024. In light of this recent surge in profitability, DOJ has begun paying extra attention to telemedicine, with at least one recent HHS-OIG report asserting that more than one-third of all telemedicine claims are improper. The report’s claim is…

FCA Update

Health Care Enforcement Quarterly Roundup – Q1 2019

By James A. Cannatti III, Tony Maida, Laura McLane, Amandeep S. Sidhu, T. Reed Stephens, Paul M. Thompson, Theodore Alexander, Irene A. Firippis, Matthew M. Girgenti, Sean Hennessy, Sophia A. Luby, Drew Elizabeth McCormick, Jennifer B. Routh & McDermott Will & Emery

April 26, 2019

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 on the telemedicine industry), lower court interpretations of the landmark Escobar ruling, developments related to the Granston Memo and dismissal of False…

FCA Update

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

By James A. Cannatti III, Daniel F. Gottlieb & Tony Maida

February 26, 2019

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 generate incentive payments or avoid penalties under the EHR Incentive Programs) to new customers. Under the Settlement Agreement, Greenway agreed…

FCA Update

HHS Proposes to Revise Discount Safe Harbor Protections for Drug Rebates

By James A. Cannatti III & Kate McDonald

February 7, 2019

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 Anti-Kickback Statute. Specifically, the Proposed Rule would exclude from “safe harbor” protection rebates and other discounts on prescription pharmaceutical products…

FCA Update

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

By James A. Cannatti III & Tony Maida

December 11, 2018

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 justify finding and relying on public information about the drug at issue, including pricing information, to support its unfavorable conclusion.…

James A. Cannatti III

Can We Expect to See ONC’s Final Rule on Information Blocking Soon?

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

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

DOJ’s Enforcement Activity Against Individuals: Acute Focus on Telemedicine

Health Care Enforcement Roundup: Increased FCA Enforcement Against EHR Companies

DOJ’s Enforcement Activity Against Individuals: Acute Focus on Telemedicine

Health Care Enforcement Quarterly Roundup – Q1 2019

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

HHS Proposes to Revise Discount Safe Harbor Protections for Drug Rebates

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

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