Kimberly Donovan

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42 C.F.R. Part 2 Final Rule to Align with the HIPAA Privacy Rules

The US Department of Health and Human Services, Office for Civil Rights (OCR)and the Substance Abuse and Mental Health Services Administration issued a Final Rule modifying the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations under 42 C.F.R. Part 2 (Part 2), applicable to certain federally assisted SUD treatment programs (Part 2 Programs), and … Continue Reading

Florida Electronic Health Records Exchange Act Amended – Health Records Maintained by Qualifying Health Care Providers Must Be Stored in the U.S., U.S. Territories, and Canada Only

On May 8, 2023, Governor Ron DeSantis of Florida signed CS/CS/SB 264, amending a suite of Florida statutes to impose heightened requirements on business activities involving foreign interests.  As related to the health care industry, CS/CS/SB 264 amended the Florida Electronic Health Records Exchange Act (“Act”) to, among other things, require “health care providers” that … Continue Reading

Supreme Court Rules that Arkansas Act 900, Affecting the Prices that PBMs Pay to Pharmacies, Is Not Preempted Under ERISA

On December 10, 2020, the Supreme Court released its decision in Rutledge v. Pharmaceutical Care Management Association. Justice Sotomayor wrote the Court’s opinion, which was joined by all Members of the Court except Justice Barrett, who did not participate. Justice Thomas filed a concurring opinion, which expressed his prior opinions that the Court’s ERISA preemption … Continue Reading

Supreme Court Rules in Favor of Health Insurers Under Affordable Care Act’s Risk Corridor Program

The United States Supreme Court ruled in an 8-1 decision Monday in favor of four health insurers seeking hundreds of millions of dollars from the federal government related to the Affordable Care Act’s “risk corridor” program, reversing a lower court’s decision that Congress had suspended the government’s obligation to make such payments. Collectively, the decision was a … Continue Reading

The Solicitor General Weighs In on ERISA Preemption Battle Over PBM State Statutes

In Rutledge v. Pharmaceutical Care Management Association, No. 18-540, the United States Supreme Court invited the Solicitor General to provide the position of the United States through what is often referred to as a “Call for the Views of the Solicitor General” or “CVSG.” The Supreme Court’s request for a CVSG could signal the Supreme … Continue Reading

Florida Proposes Pharmacy Audit Rights Legislation

The Florida legislature is currently considering proposed legislation that may affect the way in which managed care organizations, insurers, third-party payors, pharmacy benefit managers and other entities audit pharmacies in Florida.  The Florida House of Representatives, Health Innovation Subcommittee, is reviewing HB 745, which proposes to create a “Pharmacy audit bill of rights.”  The Health … Continue Reading
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