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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Massachusetts Board of Registration in Medicine Makes Significant Changes to Regulations Governing Licensure and Practice of Medicine

The Massachusetts Board of Registration in Medicine (BORM) recently approved significant changes to regulations governing the licensure and practice of medicine. The new regulations became effective on August 9, 2019. Physicians and health care organizations in Massachusetts would be well-advised to review the updated regulations closely – among the new provisions are regulations that will potentially affect current practices regarding the delegation of services to non-licensed individuals, procedures for obtaining informed consent, and other aspects of medical practice.

BORM’s regulations concerning licensure (and discipline) of physicians and the practice of …

DOJ Intervenes in FCA Suit Against Spinal Device Manufacturer and Senior Executives that Allegedly Paid Kickbacks to Surgeons

In a complaint filed on July 22, 2019, the U.S. Attorney’s Office for the Southern District of New York (DOJ) intervened in a qui tam False Claims Act (FCA) suit against Life Spine Inc. (Life Spine), and senior executives of Life Spine. DOJ alleges that the company – a maker of spinal implants, devices and equipment – offered and paid kickbacks in the form of consulting fees, royalties, and intellectual property acquisition fees to surgeons to induce the use of its products in violation of the Anti-Kickback Statute (AKS). DOJ …

Rhode Island Removes Supervision Requirements for PAs in Favor of Expanded “Collaboration” Standard for PA Practice

On July 15, 2019, Rhode Island Governor Gina Raimondo signed into law “An Act Relating To Businesses and Professions – Physician Assistants” (H5572/S0443), which significantly revises the supervision requirements and expands certain aspects of the scope of practice for physician assistants (PAs) in Rhode Island, effective immediately. Among other things, the Act removes the current supervision requirements for PAs, changes the nature of the relationship between PAs and physicians to a “collaborative” arrangement, and removes the requirement that hospitals and other health care practices have written …

Eighth Circuit Affirms Preliminary Injunction Blocking Physician Practice Acquisition in North Dakota

On June 13, 2019, the U.S. Court of Appeals for the Eighth Circuit affirmed a preliminary injunction granted to the Federal Trade Commission (FTC) and North Dakota Attorney General (NDAG) blocking the proposed acquisition of Mid-Dakota Clinic, P.C. (MDC) – a multispecialty physician group in North Dakota – by Sanford Health, a large South Dakota-based health system (Sanford). This decision may foreclose continued pursuit of MDC by Sanford, and represents another success for the FTC in challenging health care consolidation (see our previous analysis of the granting of the injunction …

DOJ Enters into $225 Million Settlement with Opioid Manufacturer to Resolve Criminal and Civil Investigations

On June 5, 2019, the Department of Justice (DOJ) announced a global settlement with Insys Therapeutics (Insys) that preliminarily resolves criminal and civil cases against the opioid manufacturer in a number of jurisdictions. Under the terms of the settlement, Insys agreed to pay a total of $225 million – $195 million in civil remedies and $30 million in criminal restitution (comprising a $2 million fine and $28 million in forfeiture). In addition to the monetary penalties, Insys entered into a five year deferred prosecution agreement with DOJ, as well as …

Supreme Court Rejects HHS Proposal that Could Have Significantly Lowered Certain Medicare DSH Payments to Hospitals

In a 7-1 decision released June 3, 2019, the U.S. Supreme Court vacated a proposal of the U.S. Department of Health and Human Services (HHS) that would have had the effect of significantly reducing Disproportionate Share Hospital (DSH) payments to thousands of hospitals for care furnished to low income patients in 2012.

In Azar v. Allina Health Services, Et Al., the Supreme Court held that HHS needed to comply with statutory notice and comment rulemaking procedures under the Social Security Act (Act) when making interpretive changes, because HHS sought …

OIG Issues Alert to Warn of ‘Free’ Genetic Testing Scams Seeking to Steal Information

On June 3, 2019, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a fraud alert to notify consumers about genetic testing fraud schemes (the Alert). According to the OIG, fraudulent actors are using the provision of free genetic testing kits to obtain Medicare information from unwitting consumers, and then using the stolen information for purposes of fraudulent billing and/or identity theft.…

OCR Issues Fact Sheet Listing Circumstances in which Business Associates May Face Direct Liability for HIPAA Violations

In a development that may – understandably – have been overlooked by many heading into Memorial Day weekend, on May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Fact Sheet on Direct Liability of Business Associates under the Health Insurance Portability and Accountability Act (HIPAA).

The Fact Sheet provides an important reminder to covered entities, business associates, and their counselors regarding the circumstances in which OCR may – and may not – take enforcement actions directly against business associates for …

U.S. Supreme Court Clarifies Scope of False Claims Act Statutes of Limitations

In a unanimous decision issued on May 13, 2019, the U.S. Supreme Court sought to resolve lingering confusion over the statute of limitations under the False Claims Act (FCA) for qui tam suits in which the federal government declines to intervene. In Cochise Consultancy, Inc. v. United States Ex Rel. Hunt, the Court held that a relator’s claim may be brought within 3 years after the government was made aware of underlying material claims, even where the government did not intervene in the case, because 10 years had not …

Seeking to Incentivize Self-Disclosures, DOJ Issues Guidance on Credit for Cooperation with FCA Investigations

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 …

Massachusetts Reaches $10 Million in Settlements Tied to Medicaid Billing for Home Health Services

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.…

HHS Exercises Discretion to Reduce Maximum Annual Civil Money Penalties for Certain HIPAA Violations

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

OCR Issues Five New HIPAA FAQs on Health Information Apps

On April 18, 2019, the Department of Health & Human Services Office for Civil Rights (OCR) issued five new FAQs addressing the applicability of HIPAA to the use of software applications (apps) by individuals to receive health information from their providers.

The new FAQs are available here under the Header “Access Right, Apps and APIs.”

In the FAQs, OCR:

  • Emphasizes that an individual’s right to access her/his protected health information (“PHI” or “ePHI”) under HIPAA generally obligates a covered entity to send PHI to a designated app, even if the

Texas Health System MD Anderson Seeks 5th Circuit Review of HHS Determination that HIPAA Required Encryption of its ePHI

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 …

OIG Approves of Free In-Home Follow-Up Care Program Targeting High Risk CHF and COPD Patients in Advisory Opinion

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 …

Series of 2019 Enforcement Actions Highlight Continued Federal and State Scrutiny of Health Care Billing in Connecticut

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 …

New York Court of Appeals Upholds Thirteen-Hour Rule for Home Health Aide Pay

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 …

Group Practice to Pay $1.85 Million Settlement Tied to Allegations of Improper Unbundled Billing

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.…

Department of Justice Intervenes in False Claims Act Suit, Adding Reimbursement Consultant Defendant

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 …

Department of Justice Announces Significant False Claims Act Settlements Tied to Electronic Health Records Arrangements

The Department of Justice (DOJ) recently announced two high-dollar False Claims Act (FCA) enforcement actions involving allegedly fraudulent arrangements tied to the implementation and use of electronic health record systems (EHRs). The respective settlements enable recovery by DOJ of over $100 million, and immediately precede the government’s recent proposal of new rules to promote the interoperability of EHRs. The settlements thus serve as an important reminder of the importance of adhering to federal fraud and abuse laws and regulations as hospitals and other health care providers continue to implement EHR …

HHS Proposes to Amend AKS Safe Harbors to Exclude PBM Rebates and Incentivize Consumer Drug Discounts

On February 6, 2019, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a proposed rule (Proposed Rule) that would amend the safe harbor regulations under the Federal Anti-Kickback Statute. The Proposed Rule is intended to “address the modern prescription drug distribution model” and make sure that the safe harbors “extend only to arrangements that present a low risk of harm to the Federal health care programs and beneficiaries.” Specifically, in the Proposed Rule OIG proposes to alter the definition of  “discounts” under the so-called …

OIG Advisory Opinion No. 19-02 Allows Pharmaceutical Manufacturer to Temporarily Loan Smartphones to Financially Needy Patients to Receive Data from a Digestible Medication Sensor

On January 24, 2019, the Office of Inspector General (“OIG”) issued a favorable advisory opinion allowing a pharmaceutical manufacturer (“Manufacturer”) to temporarily loan limited-functionality smartphones to financially needy patients who lack the required technology to receive adherence data from a sensor embedded in a prescribed antipsychotic medication (“the Arrangement”). The OIG concluded that the Arrangement did not constitute grounds for penalties under the Civil Monetary Penalties law (“CMP”) and that although the Arrangement could potentially cause remuneration under the Anti-Kickback Statute (“AKS”), the OIG would not impose sanctions on the …

DOJ Enters Into $12.5 Million Settlement with For-Profit Health System and its CEO in Connection with Improper Unbundled Billing

On December 11, 2018, the U.S. Attorney’s Office for the Eastern District of Pennsylvania (DOJ) announced that it had entered into a $12.5 million dollar settlement with Pennsylvania-based health system Coordinated Health Holding Company, LLC and its Chief Executive Officer (CEO), to resolve allegations of improper billing for orthopedic procedures. Under the terms of the settlement, the CEO (who is also the founder and principal owner of the for-profit system) agreed to pay $1.25 million dollars personally, and the health system entered into a five-year Corporate Integrity Agreement with DOJ …

OCR Issues Request for Information Regarding Modification of HIPAA To Promote Care Coordination and Transition to Value-Based Care

On December 14, 2018 the Department of Health & Human Services Office for Civil Rights (OCR) published a Request for Information (RFI) soliciting public input on updates to regulations promulgated under the Health Insurance Portability and Accountability Act (HIPAA) with the goals of removing “regulatory obstacles” and decreasing “regulatory burdens” in furtherance of the health care industry’s transition to value-based care models.

In the RFI, OCR requests input on whether and how the HIPAA regulations (i) can be modified to remove regulatory obstacles and burdens to efficient care coordination and …

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