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Conor Duffy

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Conor Duffy is co-chair of Robinson+Cole's Health Law Group and a member of the firm's Data Privacy + Security Team. Mr. Duffy advises hospitals, physician groups, accountable care organizations, community providers, post-acute care providers, and other health care entities on general corporate matters and health care issues. He provides legal counsel on a full range of transactional and regulatory health law issues, including contracting, licensure, mergers and acquisitions, the False Claims Act, the Stark Law, Medicare and Medicaid fraud and abuse laws and regulations, HIPAA compliance, state breach notification requirements, and other health care regulatory matters. Read his full rc.com bio here.

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On May 7, 2019, the U.S. Department of Justice (DOJ) provided important new guidance addressing cooperation credit that may be available to defendants in False Claims Act (FCA) investigations (Guidance).  The Guidance – issued in the form of an update to DOJ’s Justice Manual – explains how defendants in an FCA investigation may be awarded credit by DOJ for certain disclosures, cooperation, and remedial activities.

The Guidance is intended to incentivize companies and individuals to (i) be forthcoming with the government upon discovery of potential FCA violations, (ii) aid ongoing FCA investigations, and (iii) undertake appropriate remedial actions in response to misconduct. The Guidance provides examples of actions that FCA defendants may be able to take to reduce potential penalties under the FCA. As discussed below, DOJ’s examples appear to re-emphasize DOJ’s focus on individual accountability for corporate wrongdoing.
Continue Reading Seeking to Incentivize Self-Disclosures, DOJ Issues Guidance on Credit for Cooperation with FCA Investigations

On April 30, 2019, the Office of the Attorney General of Massachusetts (AG) announced that it had entered into two settlements totaling over $10 million with home health care companies to resolve allegations of submission of false claims to MassHealth – the Commonwealth’s Medicaid program. The AG entered into an $8.3 million settlement with Avenue Homecare Services of Dracut, and a $2.13 million settlement with Amigos Homecare of Lawrence, to resolve allegations that they billed MassHealth for unauthorized home health services.
Continue Reading Massachusetts Reaches $10 Million in Settlements Tied to Medicaid Billing for Home Health Services

On April 26, 2019, the U.S. Department of Health and Human Services (HHS) issued a Notification of Enforcement Discretion (Notice) regarding imposition of Civil Money Penalties (CMPs) under HIPAA. In the Notice, HHS announces that it has revisited its prior interpretation of the standards for assessment of CMPs under the HITECH Act, and is exercising its discretion to reduce the maximum amount of CMPs that may be assessed annually for HIPAA violations based on culpability.

The official version of the Notice is dated April 30, 2019 and is available here.
Continue Reading HHS Exercises Discretion to Reduce Maximum Annual Civil Money Penalties for Certain HIPAA Violations

On April 8, 2019, The University of Texas MD Anderson Cancer Center (MDA) filed a petition with the U.S. Court of Appeals for the Fifth Circuit seeking review of a decision by the Department of Health & Human Services’s (HHS) Departmental Appeals Board (DAB) Appellate Division to uphold $4.35 million in civil money penalties (CMPs) assessed against MDA by HHS for alleged violations of HIPAA’s Security and Privacy Rules.

The DAB’s decision, issued on February 8, 2019, affirmed a 2018 decision by an Administrative Law Judge that sustained CMPs issued against MDA arising from three HIPAA breaches in 2011 and 2012 (see our previous analysis of the ALJ’s decision here).
Continue Reading Texas Health System MD Anderson Seeks 5th Circuit Review of HHS Determination that HIPAA Required Encryption of its ePHI

On March 6, 2019, the U.S. Department of Health & Human Services Office of Inspector General (OIG) issued a favorable advisory opinion that allows a nonprofit medical center (“Center”) to offer free, in-home follow-up care after a recent hospital admission for qualifying patients (the “In-Home Program”). In Advisory Opinion No. 19-03, the OIG concluded that although services furnished to qualifying patients under the In-Home Program would constitute remuneration to patients under the Anti-Kickback Statute (AKS) and the Civil Monetary Penalties law (CMP), the OIG would not impose sanctions on the Provider due to the low-risk nature of the In-Home Program.

The Provider furnishes a range of inpatient and outpatient hospital-based services, and currently offers in-home care to qualifying high-risk patients suffering from congestive heart failure (CHF) who (i) are currently admitted as inpatients of the Provider or (ii) were admitted within the previous 30 days and are being treated by the Provider’s outpatient cardiology department (“Current Arrangement”). Under the Current Arrangement, a clinical nurse leader must determine that the patient is a high risk for inpatient readmission using an industry-standard risk assessment tool, the patient must be willing to enroll in the program after consultation with the clinical nurse leader, the patient must seek follow-up care at the Provider’s CHF center, and the patient must live in the Provider’s service area.
Continue Reading OIG Approves of Free In-Home Follow-Up Care Program Targeting High Risk CHF and COPD Patients in Advisory Opinion

Since the beginning of 2019, federal and state authorities in Connecticut have announced a number of enforcement actions targeting alleged health care fraud in the state. These cases are a reminder to providers of heightened criminal and civil scrutiny of arrangements implicating health care fraud and abuse laws in the state, and also reflect the extensive federal-state cooperation between the Department of Justice (DOJ) and Office of the Attorney General (AG) in investigating fraud and abuse. That federal-state cooperation is part of Connecticut’s Interagency Fraud Task Force, an initiative started in 2013 to prosecute fraud that includes multiple Connecticut agencies, as well as DOJ and the Office of Inspector General (OIG) within the Department of Health & Human Services (HHS).
Continue Reading Series of 2019 Enforcement Actions Highlight Continued Federal and State Scrutiny of Health Care Billing in Connecticut

On March 26, 2019, the New York Court of Appeals upheld the state Department of Labor’s (the DOL) so-called “13-hour rule” governing payment of home health care aides who work 24-hour shifts. In a closely-watched decision with significant ramifications for the state’s home health industry,  New York’s highest court reversed two 2017 appellate decisions that had overturned the DOL’s  rule and caused substantial uncertainty for home health providers throughout the state.  In short, the New York Court of Appeals confirmed that New York home health care aides may be paid for 13 hours of a 24-hour shift, as long as the aides are given eight hours of sleep time (with five of those being uninterrupted hours) and three hours of meal breaks.

As background, in New York home health aides who work 24-hour shifts have been treated as “live-in employees” for purposes of New York’s Minimum Wage Order regulation (the Wage Order). Under the DOL’s interpretation of the Wage Order, employers were not required to pay an aide for each hour of a 24-hour shift as long as the aide was given up to eight hours of sleep time (with at least five of those hours uninterrupted) and three hours for meal breaks. The DOL most recently affirmed its interpretation via an opinion letter issued in March 2010, which states in pertinent part that “it is the opinion and policy of this Department that live-in employees must be paid not less than for 13 hours per 24-hour period provided that they are afforded at least eight hours for sleep and actually receive five hours of uninterrupted sleep, and that they are afforded three hours for meals.” This recognition of the 13-hour rule for live-in employees was consistent with positions taken by the DOL in previous decades.
Continue Reading New York Court of Appeals Upholds Thirteen-Hour Rule for Home Health Aide Pay

On February 25, 2019, the U.S. Department of Justice (DOJ) announced a settlement with a urology group practice to settle allegations of False Claims Act (FCA) violations tied to the alleged submission of improperly unbundled Medicare claims. The pursuit and settlement of this FCA suit by the DOJ represents at least the second recent enforcement action targeting allegations of improper unbundled billing of services to Medicare, and may therefore indicate heightened governmental interest in those billing practices. See here for our analysis of the previous unbundled billing case.
Continue Reading Group Practice to Pay $1.85 Million Settlement Tied to Allegations of Improper Unbundled Billing

On February 19, 2019, the Department of Justice (DOJ) announced that it had intervened in a False Claims Act (FCA) whistleblower suit filed against Arriva Medical LLC (Arriva) and its parent that allegedly involves the submission of false claims for medically unnecessary glucometers, and alleged kickbacks to Medicare beneficiaries in the form of free glucometers and copayment waivers.  This intervention is particularly noteworthy for the fact that in addition to joining the suit, DOJ announced that it was adding a reimbursement consultant used by Arriva as a defendant to the FCA suit.
Continue Reading Department of Justice Intervenes in False Claims Act Suit, Adding Reimbursement Consultant Defendant