Conor Duffy

Conor Duffy

Conor Duffy is a member of Robinson+Cole’s Health Law Group and 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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Fourth and Fifth Circuits Rely on Escobar to Render Important Fraud Decisions

Recent decisions in the Fourth and Fifth Circuit Courts of Appeals demonstrate the central role that the Supreme Court’s Escobar decision continues to play in fraud litigation despite, or as a result of, continued uncertainty as to the application of the “rigorous” and “demanding” materiality standard endorsed in that decision. The decisions discussed below provide additional circuit-level guidance for litigants, but also raise additional questions as to the scope of the Escobar ruling and the efficacy of the implied false certification theory of FCA liability.

First, on September 29, 2017 …

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that the district court did not have “the benefit of” the Supreme Court’s 2016 decision in Escobar at the time the suit was dismissed for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6).…

Third Circuit Recognizes Escobar “Heightened Materiality Standard” in Dismissal of False Claims Act Case Tied to Avastin

In May 2017, the U.S. Court of Appeals for the Third Circuit relied on the “heightened materiality standard” endorsed by the U.S. Supreme Court in its 2016 Escobar decision in dismissing a False Claims Act (FCA) whistleblower suit filed against pharmaceutical giant Genentech related to its billion dollar cancer drug Avastin. In Escobar, the Supreme Court upheld the validity—“at least in some circumstances”—of the “implied false certification” theory of FCA liability, and provided that this theory can attach where at least two conditions are met: a defendant must (1) …

FTC Intervenes in Physician Practice Acquisition in North Dakota

On June 22, 2017 the Federal Trade Commission (FTC) filed an administrative complaint and a request for a preliminary injunction in federal court to block a proposed physician practice acquisition in North Dakota (the Transaction), the agency’s latest intervention in opposition to consolidation at the physician practice level. In this case, the FTC (accompanied by the Attorney General of North Dakota) opposes a proposed acquisition of Mid Dakota Clinic, P.C. (MDC) by Sanford Bismarck (a subsidiary of multi-state health system Sanford Health, collectively Sanford) on the grounds that the Transaction, …

Anthem Terminates Cigna Merger Following D.C. Circuit Setback

On May 12, 2017, Anthem Inc. announced that it had terminated its merger agreement with Cigna Corporation, a deal that would have united the second and third largest sellers of health insurance to large companies in the country. Anthem’s termination of the merger came two weeks to the day after the U.S. Court of Appeals for the D.C. Circuit rejected Anthem’s appeal of an injunction blocking the merger issued by a U.S. District Court earlier this year. Anthem terminated the merger one week after filing a petition for a writ …

Court Rejects Health Care System’s Efforts to Dismiss Government’s Anti-Steering Managed Care Antitrust Case

On March 30, 2017, the U.S. District Court for the Western District of North Carolina rejected a motion for judgment on the pleadings (akin to a motion to dismiss) by Carolinas HealthCare System (CHS) in a novel health care antitrust suit brought by the Department of Justice (DOJ) and State of North Carolina (collectively, the Government).

The Government filed suit against CHS, a health system consisting of 10 hospitals in and around Charlotte, North Carolina, in June 2016, alleging that contractual provisions mandated by CHS in its contracts with health …

DOJ Increases Range of Per-Claim Penalties under False Claims Act for 2017

In a little-noticed development, on February 3, 2017, the Department of Justice (DOJ) increased the per-claim range of penalties under the federal False Claims Act (FCA) (31 U.S.C. § 3729 et seq.) for the second successive year, in accordance with a statutory requirement issued under the Bipartisan Budget Act of 2015. As a result, FCA defendants are now subject to monetary penalties ranging from $10,957 to $21,916 per claim submitted in violation of the FCA.

Section 701 of the Bipartisan Budget Act of 2015 revised federal requirements for determination …

NY AG Announces Settlements with 3 Mobile-Health App Developers Over Privacy, Marketing Concerns

On March 23, 2017, New York State Attorney General Eric T. Schneiderman announced settlements with three mobile health application (app) development companies aimed at curbing deceptive marketing practices and inadequate privacy disclosures to consumers. The settlements – reached with Cardiio, Inc., Matis Ltd., and Runtastic GmbH, respectively – target health measurement apps that “purport to measure vital signs or other indicators of health using only a smartphone’s camera and sensors, without any need for an external device.”

The Office of Attorney General (OAG) expressed concern that growing …

Fourth Circuit Upholds DOJ’s Absolute Veto Power but Declines to Address Validity of Statistical Sampling in FCA Case

The U.S. Court of Appeals for the Fourth Circuit recently declined to rule on the validity of statistical sampling as a method to establish liability and damages in a False Claims Act (FCA) whistleblower case that was closely watched within the FCA bar, U.S. ex rel. Michaels v. Agape Senior Community, Inc. et al. (Nos. 15-2145, 15-2147). In a victory for the government, however, the Court did hold that the FCA grants the Department of Justice (DOJ) an “unreviewable veto” over proposed settlements of FCA cases – even cases in …

11th Circuit Invalidates Key Provisions in Florida Law Prohibiting Physician Inquiries About Patient Firearm Ownership

In Wollschlaeger v. Florida, No. 12-14009 (Feb. 16, 2017), the U.S. Court of Appeals for the Eleventh Circuit invalidated provisions of the Florida Firearms Owners’ Privacy Act that prohibited physicians from (i) asking patients if they (or their family members) own firearms or ammunition, (ii) documenting firearm ownership in patient medical records, and (iii) harassing patients about firearm ownership during examinations. The appellate court did not invalidate the Act’s antidiscrimination provision that prohibits physicians from discriminating against patients based solely on firearm ownership. Physicians who violated the Act were …

Florida Supreme Court Rejects PSQIA Preemption of Florida Constitution

On January 31, 2017, the Florida Supreme Court held that adverse medical incident reports produced in accordance with Florida law cannot constitute confidential and privileged patient safety work product (PSWP) under the federal Patient Safety & Quality Improvement Act of 2005 (PSQIA). In Jean Charles, Jr. et al. v. Southern Baptist Hospital of Florida, Inc. (No. SC15-2180), the Court endorsed a broad right of access under the Florida Constitution for patients to obtain adverse medical incident reports from health care facilities, a right commonly exercised by plaintiffs in medical malpractice …

HHS Delays Effective Date of Key Provisions in CMS Final Rule “Advancing Care Coordination through Episode Payment Models”

On February 17, 2017, the U.S. Department of Health & Human Services (HHS) announced that it had delayed the effective date of provisions of a Centers for Medicare & Medicaid Services (CMS) Final Rule that were scheduled to take effect February 18, 2017.  The Final Rule – titled “Advancing Care Coordination through Episode Payment Models” – was issued January 3, 2017 (see our previous analysis here) and in pertinent part implements:

  • Three new Medicare episode payment models (EPMs) surrounding 90-day episodes of care arising from (a) an acute myocardial

HHS Delays Effective Date of New Part 2 Regulations

On February 15, 2017, the U.S. Department of Health & Human Services announced that it had delayed the effective date of the Substance Abuse and Mental Health Services final rule announced in January regarding the Confidentiality of Substance Abuse Disorder Patient Records (commonly known as the 42 C.F.R. Part 2 regulations).  The final rule – which had been scheduled to take effect February 17, 2017 – will now take effect March 21, 2017.

HHS made this delay in accordance with the new administration’s “Regulatory Freeze Pending Review” memorandum issued January …

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