California has long maintained one of the country’s most stringent prohibitions against the corporate practice of licensed professions, including medicine and dentistry. Under that doctrine, only licensed professionals may own and operate their practices. So, to participate in the practice, non-professional investors have historically utilized the so-called “friendly PC” model in which a management services … Continue Reading
The “Putting Georgia’s Patients First Act” (Senate Bill 220 or the Act) brought sweeping changes to the state’s medical cannabis program on July 1, 2026, significantly expanding what had been one of the most restrictive medical cannabis programs in the country for more than a decade. Here’s what it means for the patients the program … Continue Reading
In November 2025 we published From Biologics to Bandages, Skin Substitutes Are No Longer the Biologics You Think They Are, flagging an unmistakable shift at the Centers for Medicare & Medicaid Services (CMS) toward constraining a massive increase in government spending on skin substitutes (the biological-based wound coverings used for burns, trauma, and chronic conditions … Continue Reading
A recent decision by Florida’s First District Court of Appeal (DCA) has significant implications for physicians and other practitioners who dispense medications to injured workers. In No. 1D2023-0941, 2026 WL 513788 (Fla. 1st DCA Feb. 25, 2026), the court invalidated two rules issued by the Florida Department of Financial Services (DFS) that made it harder … Continue Reading
The U.S. Department of Justice (DOJ) recently released its first-ever Department-wide Corporate Enforcement and Voluntary Self-Disclosure Policy (CEP) for criminal matters. The new CEP creates a uniform national policy for how the DOJ rewards companies that voluntarily self-report criminal conduct. Building on the 2025 CEP of the DOJ’s Criminal Division, the new CEP supersedes all … Continue Reading
During its recently adjourned regular session, the Florida Legislature passed several bills that affect the state’s healthcare industry, including legislation that creates a new specialty license type for Assisted Living Facilities (ALFs) providing memory care services, reestablishes the licensure and regulation of naturopathic doctors, and prohibits pharmacy benefits managers (PBMs) from requiring pharmacies to dispense … Continue Reading
The Florida Legislature has identified a regulatory gap. As Florida’s population experiences a “silver tsunami,” the number of people who currently live with Alzheimer’s disease or related dementias (collectively, Dementia) is expected to increase sharply. Lawmakers concluded that existing Assisted Living Facility (ALF) regulations are insufficient for this growing and vulnerable population that requires specialized … Continue Reading
As healthcare organizations ring in 2026, they will also be ringing in a new era of AI regulation. With Congress yet to pass comprehensive AI legislation and federal regulatory guidance in flux, states have stepped in to fill the void. The new year will see several new laws imposing disclosure, transparency, and data protection requirements … Continue Reading
In a September 3 Press Release, the U.S. Department of Health and Human Services (HHS) announced that it is increasing efforts to curb information blocking. This was quickly followed by a September 4 Enforcement Alert issued jointly by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) and the HHS … Continue Reading
The Florida Agency for Health Care Administration (AHCA or the Agency) recently issued a new proposed rule that would require all “providers” licensed by AHCA to have a “continuity plan” for data and information technology disruptions. The proposed rule would also mandate the reporting of certain information to AHCA upon the occurrence of an “information … Continue Reading
The three federal agencies tasked with enforcement of the Mental Health Parity and Addiction Equity Act (MHPAEA) — the Departments of Labor, Health & Human Services (through CMS), and Treasury (the Departments) — issued their Final Rule to implement the MHPAEA on September 9, 2024, to mixed reviews. Groups composed of providers, such as the … Continue Reading
Applicants for a health maintenance organization (HMO) certificate of authority (COA) in Florida must use a new application form effective January 28, 2024. After rule development by the Florida Office of Insurance Regulation, the Florida Department of Financial Services adopted amendments to Rule 69O-C1-942, F.A.C. The amendment incorporates changes to the Florida HMO COA application … Continue Reading
Pharmacy Benefit Managers (PBMs) take note! Under Florida’s new Prescription Drug Reform Act, PBMs must be licensed as an insurance administrator (also known as a third-party administrator, or TPA). Under this new law, any entity that wishes to provide PBM services after January 1, 2024, must be licensed as a TPA.… Continue Reading
On May 3, 2023, the Florida governor signed a comprehensive law (SB 1550) regarding pharmacy benefit managers (PBMs). This new law imposes significant new requirements on PBMs. This article discusses only one of these new requirements: a PBM must obtain a license, called a certificate of authority, to act as an insurance administrator, which is … Continue Reading
Chapter 2022-60, Laws of Florida (http://laws.flrules.org/2022/60), that went into effect July 1, 2022, allows registered pharmacy technicians to seek certification to provide immunizations and become “Certified Registered Pharmacy Technicians.” These pharmacy technicians will be allowed to administer all of the vaccines listed by the CDC in the Adult Immunization Schedule or recommended by the CDC … Continue Reading
The Biden Administration’s proposed budget for fiscal year 2023 serves as a warning to all plan issuers and administrators that enforcement of the Mental Health Parity and Addiction Equity Act (MHPAEA) is a top priority for the federal government. The proposed budget reflects a substantial and sustained commitment to ramp up enforcement efforts, with specific … Continue Reading
As a condition of doing business in the healthcare field, persons and companies must generally obtain the appropriate licenses or approvals. In addition to requirements that apply to all businesses, such as registering corporate entities with the Secretary of State or obtaining local business licenses known as business tax receipts, there are also substantive requirements … Continue Reading
Good news is here for healthcare providers worried about being left out of COVID-19-related liability protections during the 2021 Florida Legislative Session! The Republican-led Legislature, supported by Governor Ron DeSantis, is upholding its commitment to protect businesses, including healthcare providers, from frivolous lawsuits filed because of exposure to COVID-19. While only a Senate-version of legislation … Continue Reading
In early February, Senator Amy Klobuchar, new Chair of the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, introduced the “Competition and Antitrust Law Enforcement Reform Act of 2021″(S225). While the legislation is widely understood to be intended to address perceived shortcomings in the ability of federal authorities to regulate the largest and … Continue Reading
The year 2020 was an eventful one in the world of healthcare antitrust. The year began with the announcement of the precedent-setting settlement of the California Attorney General’s action against Sutter Health and ended with the settlement of multi-district antitrust litigation against the Blue Cross Blue Shield Association (and its member Blues). Along the way, … Continue Reading
The Federal Trade Commission (“FTC”) has failed – at least for now – in its efforts to derail a merger between Thomas Jefferson University Health System and Albert Einstein Health System, two Philadelphia-area health systems. In a decision announced on December 8, Judge Pappert, District Judge for the Eastern District of Pennsylvania, ruled that the … Continue Reading
The U.S. House of Representatives passed H.R. 1418, the “Competitive Health Insurance Reform Act,” by a voice vote on September 21. The legislation, which was introduced back in early 2019 by Congressman Peter DeFazio (D-Oregon), would reduce the scope of the McCarran Ferguson Act’s antitrust exemption, which currently provides insurers with an exemption from the … Continue Reading
The Department of Justice Antitrust Division has advised several pharmaceutical companies that they can share competitive information regarding the status of their respective efforts to develop a COVID-19 treatment without running afoul of the federal antitrust laws. Specifically, in a letter issued on July 23, the Antitrust Division stated that it had no intention to … Continue Reading
As healthcare providers around the country struggle to respond to patient needs during the Covid-19 crisis, many are reportedly struggling financially as well. In the past, this scenario has led to an increase in merger and acquisition activity, and many healthcare analysts are predicting an increase in such activity for the second half of the … Continue Reading
