Hospitals and Health Systems

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On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder (SUD) treatment records with the HIPAA privacy rule, and to make certain other changes. The regulations at 42…

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

On June 22, 2023, New York State Public Health Law § 2802-b, added a Health Equity Impact Assessment (HEIA) to the Certificate of Need (CON) process for certain health care facilities. The new requirement comes as part of larger legislative changes to the Public Health Laws passed in 2021. The new HEIA requirement applies to any CON applications submitted on or after June 22, 2023, except there is a partial carve out for Diagnostic and Treatment Centers whose patient population is 50 percent or more Medicaid eligible or uninsured. The Department of Health also issued regulations on June 29, 2023 (10 NYCRR 400.26). The purpose of the HEIA is to understand the health equity impact on a specific project, the impact it may have on medically underserved groups and to ensure community input and assessment are considered. The Department of Health has expressed that their vision is “to have health equity considerations meaningfully impact the planning and execution of health care facility projects.” (NYSDOH, Health Equity Impact Assessment, Webinar Series: Program Documents, September 14, 2023.)Continue Reading New York Implements Health Equity Impact Assessment as New Requirement for Certificate of Need Process

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

On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA requirement that off-site, outpatient facilities be (1) listed as reimbursable on the hospital’s Medicare Cost Report (MCR) prior to participating in the 340B Program; and (2) registered and listed in the Office of Pharmacy Affairs Information System (OPAIS) prior to participating in the 340B Program.Continue Reading HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics

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

On August 18, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-05 (Advisory Opinion), in which the OIG warned that it would likely issue sanctions under the Federal anti-kickback statute (AKS) if a proposed contractual joint venture for the provision of certain surgical monitoring services was carried out.Continue Reading Advisory Opinion 23-05: OIG Warns Sanctions Would Likely be Issued in Response to Certain Proposed Contractual Joint Venture

On August 8, 2023, the Connecticut Supreme Court issued opinions in Mills v. Hartford HealthCare Corp. and Manginelli v. Regency House of Wallingford, Inc. that addressed the scope of immunity for health care workers and facilities under Governor Ned Lamont’s Executive Order No. 7V. Executive Order No. 7V provided immunity for health care professionals and facilities from civil suits when providing health care services in support of the state’s COVID-19 response. Interestingly, the Mills ruling notes that this was the first time the Connecticut Supreme Court addressed the principles that govern interpretation of executive orders. Summaries of these two decisions appear below.Continue Reading Connecticut Supreme Court Issues Opinions Addressing Scope of Immunity for Health Care Workers Under Governor Lamont’s Executive Order No. 7V

On June 27, 2023, Connecticut Governor Ned Lamont signed into law Public Act 23-204, “An Act Concerning the State Budget for the Biennium Ending June 30, 2025, and Making Appropriations Therefor, and Provisions Related to Revenue and Other Items Implementing the State Budget” (the Act). Among other things, the Act includes provisions addressing hospitals’ obligations with regards to staffing, nurse overtime, and nurse scope of practice.Continue Reading Connecticut Expands Nurse Protections Relating to Hospital Nurse Staffing Plans, Scope of Practice, and Overtime

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