administrative procedure act

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

The U.S. Food and Drug Administration (FDA) announced that it was delaying until March 19, 2018, a Final Rule that has been viewed as having a chilling effect on scientific speech in attempting to broaden FDA’s authority to find an “intended use” for an approved or cleared medical product.  FDA extended the effective date to allow additional public comments after a petition filed on behalf of various industry groups challenged the Final Rule (dockets FDA-2011-P-0512, FDA-2013-P-1079, FDA-2015-N-2002, and FDA-2016-N-1149).

In the Final Rule, FDA had amended the intended use regulations for drugs and devices at 21 C.F.R 201.128 (drugs) and 21 C.F.R. 801.4 (devices).  In announcing the delayed implementation, FDA attempted to clear up what it viewed as a misunderstanding about the Final Rule.  FDA emphasized that one of the revisions was meant to clarify that mere knowledge that the product was being prescribed or used by healthcare providers for an unapproved new use would not be sufficient on its own for FDA to find an unapproved new intended use for an approved or cleared drug or device.  In addition, the Final Rule was “intended to embody FDA’s longstanding position . . . that intended use can be based on ‘any relevant source of evidence,’ including a variety of direct and circumstantial evidence.”  The Final Rule used the phrase “the totality of the evidence” to accomplish this goal.Continue Reading FDA Delays Intended Use Regulations