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.

Subscribe to all posts by Conor Duffy

OCR Issues Additional Guidance on HIPAA for Providers and First Responders on COVID-19 Front Lines

On March 24, 2020, the U.S. Department of Health & Human Services (HHS) Office for Civil Rights (OCR) issued new HIPAA guidance to help providers and first responders in efforts to combat the COVID-19 pandemic. …

DOJ and FTC Issue Joint Statement on Antitrust Enforcement and the COVID-19 Pandemic

On March 24, 2020, the Department of Justice (DOJ) and Federal Trade Commission (FTC) issued a joint statement on COVID-19-related antitrust enforcement highlighting ways “firms, including competitors, can engage in procompetitive collaboration that does not violate the antitrust laws” to protect public health and safety. The DOJ and FTC emphasized their commitment to facilitating antitrust compliance for businesses that are responding to the national emergency. In furtherance of this position, the agencies gave examples of collaborative activities designed to improve health and safety during the COVID-19 pandemic that are unlikely …

OHS Streamlines Application Process for CON Waivers to Respond to COVID-19

On March 20, the Connecticut Office of Health Strategy (OHS) issued new guidance (Guidance) on the process for requesting a certificate of need (CON) waiver for projects related to the COVID-19 response. See our analysis of the initial OHS guidance on CON waivers here.…

COVID-19: HHS Issues FAQs on HIPAA and Telehealth to Help Providers Maintain Access to Care During the Pandemic

On March 20, the U.S. Department of Health and Human Services (HHS) issued additional guidance in the form of Frequently Asked Questions (FAQs) on HIPAA and telehealth services to help providers furnish care during the COVID-19 pandemic.

The FAQs follow and provide further information on the Notification of Enforcement Discretion issued by HHS on March 17 (Notification), in which HHS indicated that it would not penalize providers for using popular video chat applications, such as FaceTime and Skype, in good faith to provide telehealth services amid the COVID-19 …

Connecticut Governor Lamont Expands Access to Telehealth Services In Response to COVID-19 Pandemic

On March 19, Connecticut Governor Ned Lamont issued Executive Order No. 7G, which is intended to expand access to telehealth services for Connecticut residents amidst the COVID-19 pandemic.  Notably for health care providers, the Order waives or modifies provisions of Conn. Gen. Stat. § 19a-906 and any associated regulations, rules and policies regarding the delivery of telehealth services as follows:

  • Allows telehealth providers enrolled in Medicaid or in-network in fully-insured commercial plans to provide covered telehealth services via audio-only telephone to established patients (i.e., those with an existing provider-patient

COVID-19: Lamont Authorizes DSS to Expand Access to Telehealth Services for Medicaid Beneficiaries in Response to Coronavirus Pandemic

As part of Executive Order No. 7F issued on March 18, Connecticut Governor Ned Lamont authorized the Commissioner of the Department Social Services (DSS) to “temporarily waive any requirements” set forth in state law, regulations, rules, policies or other directives concerning telehealth as is necessary to enable the Medicaid program “to cover applicable services provided through audio-only telehealth services.”  As a result, DSS will be able to expand Medicaid coverage for telehealth services that are provided by phone, and not just audio-video technology.…

Federal Government Significantly Expands Telehealth Reimbursement During COVID-19 Public Health Emergency

On March 17, the Trump Administration announced expanded reimbursement for clinicians providing telehealth services for Medicare beneficiaries during the COVID-19 Public Health Emergency. The Centers for Medicare and Medicaid Services (CMS) published an announcement, a fact sheet and Frequently Asked Questions.  To further facilitate telehealth services, the Office for Civil Rights (OCR) issued a notification describing certain technologies that would be permitted to be used for telehealth without being subject to penalties under the Health Insurance Portability and Accountability Act regulations (HIPAA). In addition, the Office of Inspector …

COVID-19: Connecticut Issues Expedited CON Review Guidelines and Provider Guidance to Help Response Efforts

On March 16, Connecticut agencies released two important guidance documents for state health care providers and organizations confronting the COVID-19 pandemic:

  1. The Connecticut Office of Health Strategy (OHS) – the entity responsible for overseeing Certificate of Need reviews and approvals – issued new CON Guidance that allows OHS to temporarily waive CON review requirements of transactions intended to promote the State’s response and management of COVID-19. The Guidance also mandates that all public hearings related to pending CON projects will be conducted remotely until further notice, with further guidance to

HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) Emergency

Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (full text available here) that waives or modifies certain health care laws and regulations in connection with the COVID-19 pandemic.  This “1135 Waiver” applies nationwide and took effect on March 15 at 6:00 p.m., but its applicability is retroactive to March 1, 2020.  The 1135 Waiver applies …

Connecticut Governor’s COVID-19 Executive Order Impacts Behavioral Health Facilities

Over the weekend, Connecticut Governor Ned Lamont issued a new Executive Order 7C, which has significant implications for facilities in Connecticut that provide mental health treatment amidst the COVID-19 outbreak.

First, the Governor authorized the Commissioner of the Department of Public Health, and the Department of Mental Health and Addiction Services, respectively, to issue any and all orders to restrict entrance into any inpatient or outpatient hospital, clinic or other facility for the diagnosis, observation or treatment of persons with psychiatric disabilities (defined to include any children or adults …

FTC and Commonwealth of Pennsylvania Challenge Proposed Hospital Merger

On February 27, 2020, the Federal Trade Commission (FTC) announced an action to block a proposed transaction between Thomas Jefferson University d/b/a Jefferson Health (Jefferson) and Albert Einstein Healthcare Network (Einstein). Jefferson and Einstein entered into a “System Integration Agreement” in late 2018 under which Jefferson would become the sole member (i.e., owner) of Einstein and oversee a 14-hospital system (11 of which would be located in Pennsylvania). According to the FTC, Jefferson and Einstein are leading providers of inpatient general acute care (GAC) hospital services and inpatient acute rehabilitation …

DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company that resolves parallel criminal and civil investigations involving allegations of kickbacks, false claims, and non-compliance with federal EHR program requirements. We previously discussed a preliminary settlement in this case here, and in announcing the finalizing of that settlement the DOJ has shed more light on the allegedly improper conduct at issue. According to the DOJ, this is the first criminal action ever brought against …

OCR Announces Second $85,000 Settlement for Alleged Violations of the Individual Right of Access under HIPAA

On December 12, 2019, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced its second “HIPAA Right of Access Initiative” settlement of alleged HIPAA violations.

The HIPAA Right of Access Initiative is a recent effort by OCR to monitor compliance with HIPAA requirements addressing patient rights to prompt access to medical records, in a readily producible format, without being subject to excessive fees. OCR announced its first settlement under the Right of Access Initiative in September 2019 (see our analysis of that settlement here), …

CMS Proposes to Newly Define Commercially Reasonable, and Tweak Definition of Fair Market Value, in New Physician Self-Referral Law (Stark Law) Regulations

On October 17, 2019, the Centers for Medicare & Medicaid Services (CMS) formally published its proposed rule (PSR Rule) to update exceptions to the Physician Self-Referral Law (PSR Law, also known as the Stark Law). For our initial overview of the PSR Rule (and of the Office of Inspector General’s corresponding proposal to update the Anti-Kickback Statute) see here. The PSR Rule contains a number of important proposals to update the PSR Law, including putting forward a definition of the term “commercially reasonable” and revising the definition …

Government Releases Proposed Rules on Physician Self-Referral Law (Stark Law), Anti-Kickback Statute and CMP Law; Significant Regulatory Changes Intended to Encourage Care Coordination and Value-Based Care

On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions and safe harbors, for the federal Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS), and the beneficiary inducement Civil Monetary Penalties Law (CMP). The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update exceptions to the Physician Self-Referral Law (the PSR Rule), and the HHS Office of Inspector General (OIG) issued a proposed rule to update the …

DOJ Reaches $21.36 Million Agreement with Compounding Pharmacy, Two of its Executives, and Managing Private Equity Firm to Resolve FCA Allegations

On September 18, 2019, the Department of Justice (DOJ) announced a $21.36 million settlement with compounding pharmacy Patient Care America (PCA), as well as PCA’s Chief Executive, PCA’s former Vice President of Operations, and a private equity firm (PE Firm) that managed PCA on behalf of investors. The settlement resolves a False Claims Act (FCA) lawsuit alleging involvement in a kickback scheme designed to generate unnecessary referrals for prescription pain creams, scar creams, and vitamins reimbursed by TRICARE, the federal health care program for military members and their families. No …

Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

On September 4, 2019, the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two whistleblower suits filed under the False Claims Act (FCA). The settlement addresses allegations of AKS violations between 2009-2013 by sales representatives of a company later acquired by Mallinckrodt via the “wining and dining” of physicians to induce Medicare prescriptions of that company’s drug. Interestingly, the settlements do not cover related allegations within those FCA suits that Mallinckrodt improperly …

Eleventh Circuit Endorses Objective Falsehood Standard for False Claims Cases Concerning Physician Judgment of Hospice Eligibility

“A mere difference of opinion between physicians, without more, is not enough to show falsity.”

In a 3-0 decision issued September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed a three-year-old district court ruling in United States v. AseraCare, Inc. that a Medicare claim for hospice services cannot be deemed false under the False Claims Act (FCA) based on a difference in clinical judgment. This decision – apparently the first circuit-level determination of the “standard for falsity [under the FCA] in the context of the Medicare …

For First Time Ever, Government Brings HIPAA Enforcement Action Alleging Violations of Right to Access Medical Records

On September 9, 2019, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that it had settled its first ever HIPAA enforcement action arising from alleged violations of the individual right to access health information under HIPAA. OCR entered into a settlement with Bayfront Health St. Petersburg (Bayfront) in response to allegations that it failed to provide a mother with timely access to medical records concerning her unborn child. Under the terms of a resolution agreement, Bayfront agreed to pay $85,000, and enter into a …

Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to Facilitate Provision of Coordinated Care

On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder (SUD) confidentiality regulations at 42 C.F.R. Part 2 (Part 2) with the needs of providers and patients, and to “facilitate the provision of well-coordinated care” for individuals with SUD.…

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 potentially will affect current practices regarding the delegation of services to non-licensed individuals, procedures for obtaining informed consent, and other aspects of medical practice.…

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 …

LexBlog