Florida Pharmacy Collaborative Practice Agreements: Defining the Scope of Practice

Posted in Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment, Physicians

While the COVID-19 pandemic made 2020 a trying year, one unintended benefit was that the Florida legislature allowed pharmacists to further expand their scope of practice to help patients with certain chronic conditions through collaborative practice agreements. Though, as discussed below, they did not make it easy. Continue Reading

Physicians: Beware of FTC Rules for Product Endorsements

Posted in Pharmacy, Drugs, Medical Devices & Equipment, Physicians

It has become increasingly common for physicians and other healthcare professionals to share medical information with the public via video platforms, blogs, and social media sites. That can be a great public service, especially during the pandemic, but when public communications include a positive review or other favorable mention of medical products or services, such statements can unwittingly come within the purview of the Federal Trade Commission (“FTC”).

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Healthcare Antitrust – What to Expect in 2021

Posted in Antitrust, Government Affairs, Licensure & Regulatory

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, Congress passed legislation repealing the antitrust protections that health insurers had enjoyed for 75 years under the McCarran Ferguson Act, the Federal Trade Commission lost its first hospital merger challenge in many years, and the Department of Justice Antitrust Division made good on its threats to bring criminal antitrust actions in healthcare. After such an eventful year, what is 2021 likely to bring in the way of further developments? Look for these issues to dominate the healthcare antitrust headlines in 2021:

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Second Circuit Sends PBM “Clawback” Litigation Plaintiffs Back to the Drawing Board

Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

Anthem, Inc., (Anthem) and Express Scripts, Inc., (Express Scripts) had a big win this week, creating another setback for plaintiffs filing ERISA lawsuits against pharmacy benefits managers (PBMs). On December 7, 2020, the Second Circuit Court of Appeals upheld U.S. District Judge Edgardo Ramos’s decision that Anthem and Express Scripts did not violate fiduciary obligations under the Employer Retirement Income Security Act (ERISA) because neither party acted as an ERISA fiduciary with regard to decisions that allegedly led to higher prescription drug prices for patients and plans. (See Doe v. Express Scripts, Inc., 2020 WL 7133860, (C.A.2 (N.Y.), 2020)).

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Healthcare Providers: Please Be Wary of Accepting Those Gifts!

Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

There has been a longstanding and regrettable practice in the healthcare industry of pharmaceutical and medical device companies giving physicians gifts as illegal inducements. Concerned about this continued trend, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services’ Office of Inspector General (OIG) issued important warnings regarding providing inducements to healthcare providers (HCPs) – just in time for the holiday season! On October 29, 2020, the DOJ announced its first-ever enforcement action for a violation of the Open Payments Program reporting requirements. On November 16, 2020, the OIG issued a Special Fraud Alert regarding the potential Anti-Kickback Statute implications inherent in speaker programs. Pharmaceutical manufacturers, medical device companies, and HCPs should read the guidance carefully and be extremely cautious before accepting or offering any remuneration this holiday season and beyond. Continue Reading

Federal Trade Commission Challenge to Northern Philadelphia Hospital Merger Fails

Posted in Antitrust, Government Affairs, Licensure & Regulatory, Healthcare Law, Healthcare M&A, Joint Ventures, Transactions & Health Ventures, Hospitals & Health Systems

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 FTC, which was joined in the action by the Pennsylvania Office of the Attorney General (“PA AG”), had failed to demonstrate that the merger should be enjoined. In reaching this decision, the Court held that the FTC had failed to show that there would be an insufficient number of alternative providers of hospital services in the region to limit the ability of the merged entity to increase prices post-merger. Accordingly, absent an appeal by the FTC and/or the PA AG to the Third Circuit, and a successful request for a stay of the lower Court’s ruling, the merging parties will likely complete their merger in the coming weeks. Continue Reading

A Glossary of Commonly Used Acronyms in Florida Managed Care

Posted in Accountable Care Organizations, Health Care Providers, Health Insurers & Managed Care Organizations, Healthcare Law

Anyone who interacts with third party payors encounter acronyms on a regular basis. While acronyms are intended to facilitate efficient communication, their use often instead leads to confusion. This blog is intended to provide a brief overview of some commonly used acronyms in managed care. Please note that, although some of the acronyms are specifically applicable to Florida, most are used throughout the country. Also note that the following are general descriptions intended to provide a high-level understanding of the acronyms. Please refer to your specific jurisdiction for more detailed definitions. For ease of reference, we have included links to the 2020 Florida statutory definitions where applicable. Continue Reading

COVID-19 and Possible Silver Bullets: Update on Vaccine Development

Posted in Healthcare Law, Hospitals & Health Systems, Laboratories, Pharmacy, Drugs, Medical Devices & Equipment

As the world continues to grapple with the COVID-19 pandemic that has taken the lives of over 250,000 Americans, and worldwide over 1 million people, this year, an effective vaccine has emerged as our silver bullet – a way for the nation, and the world, to fight back and, in time, begin to return to some semblance of normalcy. There is some encouraging news on that front, as there are two promising separate clinical trials that have produced potentially viable vaccine candidates in the pipeline for potential emergency approval by the US Food and Drug Administration (FDA), with others possibly coming soon as well. Continue Reading

Florida: Do You Know Where Your “Minor” Is?

Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

During the COVID-19 pandemic, telehealth usage has dramatically increased, as discussed in a recent Health Law Rx post. Telehealth makes it easier for individuals who cannot drive, including many minors, to seek necessary care, leading to many questions regarding when “minors” (individuals under 18 years of age) can consent to treatment – when the “disability of nonage” has been removed. Read more here and here. The following overview of the relevant Florida laws is meant to help healthcare providers determine when minors can and cannot consent to their own treatment.

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