On December 13, 2023, the Office of the National Coordinator for Health Information Technology (ONC) issued its final rule entitled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” and known as “HTI-1” (Final Rule). Among other issues addressed in the Final Rule, ONC revised the information blocking rules to add clarity and to create a new information blocking exception. We outline these changes in further detail below. The information blocking provisions of the Final Rule will be effective 30 days after it is published in the Federal Register.Continue Reading ONC’s HTI-1 Final Rule Updates Information Blocking Regulations
Physicians and Allied Health Professionals
DOJ Settlement Targets Owner and Management Company in Addition to Post-Acute Care Facilities
By Conor Duffy & Guest Contributor on
On November 15, 2023, the U.S Department of Justice (DOJ) announced a $45.6 million consent judgment (Settlement) with six skilled nursing facilities (SNFs), as well as the owner of the SNFs and its management company which managed the SNFs, to resolve alleged violations of the False Claims Act (FCA) tied to medical director arrangements violating the Anti-Kickback Statute (AKS). The Settlement is notable for its inclusion of the owner and the management company in addition to the SNFs, which indicates DOJ’s interest in scrutinizing the actions of individuals and management entities in connection with problematic arrangements under federal fraud and abuse laws.Continue Reading DOJ Settlement Targets Owner and Management Company in Addition to Post-Acute Care Facilities
HHS Proposes Disincentives for Providers that Commit Information Blocking
By Nathaniel Arden & Michael Lisitano on
On November 1, 2023, the U.S. Department of Health and Human Services (HHS) published a proposed rule titled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking” (the Proposed Rule). The Proposed Rule, if finalized, would create disincentives for health care providers that the HHS Office of Inspector General (OIG) determines have committed “information blocking” (as defined at 45 C.F.R. § 171.103).Continue Reading HHS Proposes Disincentives for Providers that Commit Information Blocking
DEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024
On October 10, 2023, the federal Drug Enforcement Administration (DEA) issued another extension (Second Temporary Rule) of its pandemic-era telehealth flexibilities “in light of the need to further evaluate the best course of action” with respect to the prescribing of controlled substances via telemedicine. DEA is issuing a limited extension in order to give itself more time to finalize new standards governing tele-prescribing of controlled substances.Continue Reading DEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024
OIG Issues Favorable Opinion Regarding Physician Group’s Proposal to Pay Bonuses to its Employed Physicians Based on Net Profits
On October 13, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-07 (Advisory Opinion), in which the OIG issued a favorable opinion regarding a physician group employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain procedures performed by the physicians at ambulatory surgery centers.Continue Reading OIG Issues Favorable Opinion Regarding Physician Group’s Proposal to Pay Bonuses to its Employed Physicians Based on Net Profits
Connecticut Supreme Court Addresses Contested Case Issue in Ruling on Certificate of Need Appeals
By Conor Duffy, Michael Lisitano & Guest Contributor on
This post was co-authored by Ben Jensen, member Robinson+Cole’s Technology Industry Team.
On July 25, 2023, the Connecticut Supreme Court issued an opinion in High Watch Recovery Center, Inc. v. Dept. of Public Health that addresses the subject of the right to file an appeal of a Certificate of Need (CON) decision under the Connecticut Uniform Administrative Procedure Act (APA). High Watch involved a case where a party was allowed to intervene in a CON proceeding after the state CON agency had already elected to hold a discretionary hearing on the application at issue. A trial court declined to hear the appeal, and the Appellate Court affirmed that declination, on the basis that there was no “contested case” and no right to appeal the decision in Superior Court because the intervenor never expressly requested a hearing. The Supreme Court reversed this holding, concluding that intervention in opposition to the application was sufficient to render the case contested without need for the intervenor to request a hearing that was already scheduled. The ruling is significant in that it rejects a rigid application of the statutes governing CON procedures and instead focuses on the substance of the public hearing at issue in assessing whether a contested case is presented. Understanding the distinction between mandatory and discretionary hearings is an essential consideration for parties to CON proceedings to avoid foreclosing potential appellate rights.Continue Reading Connecticut Supreme Court Addresses Contested Case Issue in Ruling on Certificate of Need Appeals
Connecticut Governor Signs Bill Introducing Programs to Improve Maternal Health
By Robinson+Cole's Health Law Group, Conor Duffy & Guest Contributor on
On June 26, 2023, Connecticut Governor Ned Lamont signed Public Act No. 23-147, “An Act Protecting Maternal Health.” The Act makes various changes aimed at bolstering health care access and services for maternal and infant health. Key elements of the Act are summarized below.Continue Reading Connecticut Governor Signs Bill Introducing Programs to Improve Maternal Health
Connecticut Expands Applicability of State False Claims Act
On June 26, 2023, Connecticut Governor Ned Lamont signed into law Public Act 23-129: “An Act Concerning Liability for False and Fraudulent Claims” (the Act). The Act expands application of Connecticut’s False Claims Act (CFCA) to all claims for money or property to the state of Connecticut (except as expressly provided in the CFCA) and accordingly expands the scope of conduct covered by the CFCA. The Act does so by removing the current limitation on the CFCA’s applicability to only state-administered health or human services programs. The Act took effect July 1, 2023.Continue Reading Connecticut Expands Applicability of State False Claims Act
Connecticut Governor Signs Health Care Bill Revising Connecticut’s Facility Fee Law
On June 27, 2023, Connecticut Governor Ned Lamont signed into law Public Act 23-171 entitled “An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (“the Act”), which includes changes to Connecticut’s facility fees law. The Act implements previously-announced legislative initiatives that are the product of collaboration between Governor Lamont and the Connecticut Hospital Association, as well as other health care stakeholders.Continue Reading Connecticut Governor Signs Health Care Bill Revising Connecticut’s Facility Fee Law
Connecticut Legislature Passes Law Limiting Physician, PA and APRN Non-Compete Agreements
By Robinson+Cole's Health Law Group, Stephen Aronson & Conor Duffy on
On June 5, 2023, the Connecticut Legislature passed Public Act No. 23-97, “An Act Concerning Health and Wellness for Connecticut Residents” (“the Act”). Sections 13 through 15 of the Act make important changes to Connecticut law governing physician, physician assistant (PA), and advanced practice registered nurse (APRN) non-compete agreements. These changes are summarized below and scheduled to take effect July 1, 2023. Governor Lamont is expected to sign the Act but has not done so as of the date of this publication.Continue Reading Connecticut Legislature Passes Law Limiting Physician, PA and APRN Non-Compete Agreements