Government Enforcement

On March 14, 2021, Connecticut Governor Lamont issued Executive Order 10C (EO 10C), which extends provisions of Public Act 20-2 (PA 20-2), a law passed by the Connecticut legislature in July 2020 that “provided additional flexibility for the delivery of telehealth services and insurance coverage of these services” but was scheduled to expire March 15, 2021. As a result of EO 10C, the provisions of PA 20-2 that were scheduled to expire on March 15 will remain in effect through April 20, 2021, in part to give the state legislature more time to “address the ongoing need for” expanded access to telehealth services.
Continue Reading Connecticut Extends Expansion of Access to Telehealth Services

On January 28, 2021, the Department of Health and Human Services (HHS) issued a Fifth Amendment to HHS’s Declaration under the Public Health Readiness and Emergency Preparedness Act (PREP Act) that provides liability immunity to certain individuals and entities arising from the manufacturing, distribution, administration or use of medical countermeasures (e.g., therapeutics and vaccines) against COVID-19.
Continue Reading COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP Act

On December 7, 2020, Connecticut Governor Ned Lamont signed Executive Order No. 9Q (the “Order”) in anticipation of the approval of COVID-19 vaccines. The Order addresses and expands COVID-19 vaccine administration, establishes flu vaccine reporting requirements for pharmacists, and limits out-of-network charges for administration of authorized COVID-19 vaccines. Specifically, the Order:
Continue Reading In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting

On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector General (OIG) published two final rules (available here: November 30 Final Rule and December 2 Final Rule) which modify the safe harbor regulations to the federal Anti-Kickback Statute (AKS) and codify a new exception to the Civil

On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) published its long-awaited and highly anticipated final rule updating regulations promulgated under the Physician Self-Referral or “Stark” law (the OIG simultaneously published updates to the Anti-Kickback Statute regulations). Among other things, CMS introduced new Stark exceptions for certain “value-based arrangements,” the donation

On November 3, 2020, a Massachusetts Federal District Court issued a notable decision on the applicability of the state’s medical peer review privilege in a federal proceeding, determining that the privilege does not apply to documents requested in discovery as part of a qui tam False Claims Act (FCA) case. In United States ex rel. Wollman v. Massachusetts General Hospital, Inc. et al., Case Number 1:15-cv-11890-ADB, the court reviewed the purpose of the peer review privilege and precedent addressing the applicability of state privileges under the Federal Rules of Evidence, and concluded that the privilege should not apply because the “goal of the peer review privilege would not be thwarted if it was not applied” in a case predicated on alleged billing fraud. The court’s decision is instructive for health care providers and whistleblowers in connection with discovery and the applicability of medical peer review privileges to FCA cases.
Continue Reading Massachusetts Federal Court Declines to Apply State Medical Peer Review Privilege in Federal Whistleblower Case

Excerpt of a contributed article published in Medical Economics on November 18, 2020.

Past Special Fraud Alerts have portended heightened enforcement activity.

On November 16, 2020, the Office of Inspector General of the Department of Health & Human Services (OIG) issued a Special Fraud Alert (Alert) highlighting the fraud and abuse risks posed by speaker

On August 24, 2020, the Centers for Medicare & Medicaid Services (CMS) announced an “extension of the timeline” for publication of a final rule addressing changes to the Physician Self-Referral Law (or Stark Law) regulations.  In its announcement, CMS set a new deadline of August 31, 2021 for publication of a final rule.
Continue Reading CMS Extends Timeline for Finalizing Changes to Physician Self-Referral (Stark) Law Regulations to August 2021

On July 14, 2020 Connecticut Governor Lamont issued Executive Order No. 7HHH, in which the Governor modified state law to enable the Commissioner of the Department of Public Health (DPH) to temporarily suspend licensure, registration and certification requirements for certain DPH-regulated practitioners for the duration of the state public health and civil preparedness emergency.  Notably, in that Executive Order, the Governor stated that “healthcare providers from outside Connecticut have greatly enhanced the provision of healthcare services in Connecticut during the COVID-19 pandemic and thereby fundamentally improved the state’s ability to protect public health at critical time.”
Continue Reading Connecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 Pandemic

On June 24, 2020 the New York State Department of Health (DOH) published formal notice of its June 5th emergency rule “necessary to clarify and strengthen the Department’s authority and that of the local health departments to take specific actions to control the spread of disease, including actions related to investigation and response to