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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CMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health Emergency

On May 8, 2020, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period (the “Interim Rule”) in the Federal Register, setting forth additional regulatory waivers and other changes to healthcare regulations and policies in response to the COVID-19 public health emergency (PHE). At a high level, the Interim Rule encompasses topics including expansion of telehealth, support for and expansion of COVID-19 testing, allowing certain licensed professionals to practice at the top of their licenses, Medicare payments for teaching hospitals, changes to the Medicare …

CMS Broadens Telehealth Access Across the Board, Including Audio-Only Telephone Services

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period published in the Federal Register on May 8, 2020 (the April 30 Interim Rule) building on previous regulatory waivers and other revisions to regulations issued March 31, 2020 in an interim final rule (March 31 Interim Rule) in response to the COVID-19 public health emergency (PHE). Among other changes, the April 30 Interim Rule further broadens access to patient care provided via telehealth and other communication technology-based services and …

CMS Issues Explanatory Guidance of Blanket Physician Self-Referral (Stark) Law Waivers for COVID-19 in Response to Industry Feedback

Amidst the cavalcade of regulatory and policy changes from federal and state governments intended to help health care providers confront the COVID-19 pandemic, on April 21, 2020 the Centers for Medicare & Medicaid Services (CMS) published “Explanatory Guidance” (Guidance) of the applicability of the blanket waivers of the federal Physician Self-Referral Law (PSR Law) CMS previously issued on March 30, 2020. See our analysis of the PSR Law blanket waivers here.…

Connecticut Governor Expands Health Care Workforce, Access to Telehealth Services and Issues Other Important Health Care Updates in New Executive Orders

Connecticut Governor Ned Lamont recently issued four new executive orders to address the COVID-19 state of emergency (Executive Orders 7CC – 7FF) that contain provisions relevant to health care providers and facilities in the state.  Among other things, the Executive Orders (i) expand access to telehealth services, (ii) expand the available health care workforce, (iii) increase current reporting requirements for long-term care facilities, (iv) allow the Commissioner of the Department of Social Services (DSS) to scale back certain Medicaid program requirements, and (v) update requirements related to out-of-network emergency billing.  …

HHS Waives HIPAA Penalties for Operation of a Community-Based COVID-19 Testing Site

On April 9, 2020 the Department of Health & Human Services Office for Civil Rights (OCR) issued another Notification that it will exercise its enforcement discretion and not impose penalties for HIPAA violations in connection with good faith participation in the operation of COVID-19 testing sites during the COVID-19 emergency.…

OIG Will Not Impose Administrative Sanctions for AKS Violations for Conduct Covered by Certain Blanket Waivers of the Stark Law

On April 3, 2020 the Office of Inspector General (OIG) issued a Policy Statement to notify health care providers and other parties subject to the Anti-Kickback Statute (AKS) that the OIG will not impose administrative sanctions for potential AKS violations for COVID-19-related arrangements that are covered by some – but not all – of the Blanket Waivers of the Physician Self-Referral (Stark) Law issued on March 30 (see here for our analysis of the Blanket Waivers).…

Connecticut Governor Limits COVID-19 Liability for Providers and Facilities, Restricts Surprise Billing for COVID-19 Treatment, and Expands the Health Care Workforce in Recent Executive Orders.

Governor Lamont issued two new executive orders designed to expand the health care workforce, immunize providers from COVID-19-related liability, and protect patients from out-of-network bills for COVID-19 treatment. On April 5, 2020 Governor Lamont issued Executive Order 7U creating financial protections for uninsured patients and insured patients receiving out-of-network care. On April 7, 2020 Governor Lamont issued Executive Order 7V expanding temporary practice permits, allowing practice before licensure for certain health care profession graduates and applicants, and limiting civil liability for health care professionals and facilities for acts and omissions …

CMS Issues Blanket Waivers of Physician Self Referral (Stark) Law Penalties to Support COVID-19 Response Efforts

On March 30th, the Centers for Medicare and Medicaid Services (CMS) issued blanket waivers (Blanket Waivers) of sanctions under the federal physician self-referral law (Stark Law) to relax regulatory requirements related to health care providers’ response to the COVID-19 pandemic. The Blanket Waivers were issued under the Department of Health and Human Services Secretary’s authority in Section 1135 of the Social Security Act to ensure that (i) sufficient health care items and services are available to federal health care program beneficiaries, and (ii)  health care providers are reimbursed for providing …

Connecticut DCP Issues Guidance for Remotely Refilling Prescriptions

The Connecticut Department of Consumer Protection Drug Control Division (DCP) has issued guidance for health care providers regarding refills and reissuances of controlled substance prescriptions for patients without an in-person visit due to the COVID-19 pandemic. DCP explains that “practitioners may issue prescription refills for controlled substances using their professional discretion for a patient under their care without seeing the patient in-person within certain parameters.” The parameters are as follows:

  • Schedule-Specific Requirements for Controlled Substance Prescriptions
    • Schedule II prescriptions cannot be refilled; however, practitioners with a pre-existing relationship with a

Connecticut Waives CON Approval Requirements Entirely for Temporary Bed Expansions and Temporary Service Suspensions by Hospitals and Outpatient Surgical Facilities Related to COVID-19 Response Efforts

The Connecticut Office of Health Strategy (OHS) issued its third guidance document related to CON requirements related to the COVID-19 pandemic on March 25, in which OHS waives CON approval requirements for hospitals seeking to temporarily increase bed capacity or temporarily suspend (as opposed to terminate) inpatient or outpatient services in order to diagnose and treat COVID-19 patients. On March 31, OHS updated that guidance to expand its applicability to outpatient surgical facilities (OSFs) in Connecticut.…

CARES Act Provides Vital Financial Support for Health Care Providers on COVID-19 Front Lines

On March 27, Congress enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act, or the Act), Public Law 116-136, a trillion-dollar stimulus bill intended to provide financial assistance to individuals and business affected by the COVID-19 pandemic.  The Act contains a broad range of measures intended to bolster the economy in the midst of the COVID-19 pandemic.  Unsurprisingly, a central focus of the Act is the provision of relief and support for hospitals and health care providers on the front lines of the COVID-19 pandemic.  This article …

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), …

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