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

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 on 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 on 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 on 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, Rebecca C. Martin, 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 on 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 on 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 on 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 on 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.…

Health & Life Sciences News

ONC Expected to Release Proposed Information Blocking Rule Soon

By James A. Cannatti III, Daniel F. Gottlieb & Karen S. Sealander on October 17, 2018

It has now been one month since the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) sent its proposed information blocking rule to the Office of Management and Budget (OMB) for required review. We expect OMB to approve the much-anticipated proposed rule and ONC to release it soon with the usual opportunity for public comment. While we wait, there are some things that health information…

Of Digital Interest

ONC Sends Information Blocking Proposed Rule to OMB

By James A. Cannatti III on September 19, 2018

The Office of the National Coordinator for Health Information Technology (ONC) is one step closer to issuing its long-awaited proposed rule to implement various provisions of the 21st Century Cures Act, including proposed regulations distinguishing between prohibited health information blocking among health care providers and health information technology vendors and other permissible restrictions on access to health information. According to its website, the Office of Management and Budget (OMB) received ONC’s proposed rule for…

James A. Cannatti III

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

ONC Expected to Release Proposed Information Blocking Rule Soon

ONC Sends Information Blocking Proposed Rule to OMB

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