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
Pharmacists can now engage in a new role in the battle against COVID-19 – testing patients for the virus. Recognizing the advanced health care training that pharmacists receive and the unique consumer access to community pharmacies during the Pandemic, the Florida Department of Health has designated pharmacists as medical professionals authorized to order and provide … Continue Reading
Many employers are now making plans to have their employees return to the workplace. Based on recent alerts from the FBI, part of preparing to protect workers from COVID-19 at work should include protecting the company from falling prey to fraudsters. To do that, employers should put in place procedures to carefully screen vendors from … Continue Reading
Just like the dose makes the poison, the claim makes the drug. With a pandemic well underway, some marketers are offering products that they claim will treat or prevent COVID-19, the disease caused by the novel coronavirus. Without federal approval, however, anyone making claims about unapproved drugs risks is inviting a federal enforcement action. As … Continue Reading
While this period of crisis due to the pandemic has led competitors to cooperate, the crisis does not serve as an excuse for anticompetitve conduct. The Department of Justice Antitrust Division (the “Antitrust Division”) and the Federal Trade Commission (the “FTC” and with the Antitrust Division, the “Agencies”) have issued a warning to the healthcare … Continue Reading
California has joined the growing ranks of states, as well as the federal government, in efforts to facilitate the efficient provision of healthcare services during the pandemic. Accordingly, in response to federal agency updates with respect to relaxations to existing requirements related to telehealth services, California’s Governor Gavin Newsom issued an Executive Order No. 43-20 … Continue Reading
The Department of Justice Antitrust Division (the “Antitrust Division”) has granted its approval to a plan by a group of medical supply manufacturers to collaborate in response to the COVID-19 pandemic. In a business review letter issued on April 4, the Antitrust Division stated that McKesson Corp., Cardinal Health, Owens & Minor, Medline Industries and … Continue Reading
North Carolina has drastically expanded its telehealth services during the COVID-19 pandemic in order to give individuals increased access to remote care. The following article outlines many of the important changes implemented. Licensure On March 10, 2020, Governor Roy Cooper issued Executive Order No. 116 (available here) waiving the requirement that healthcare and behavioral healthcare … Continue Reading
Health and welfare benefit plans and insurers are affected by various provisions of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) passed on March 27, 2020. In addition to provisions impacting tax-qualified retirement plans and executive compensation (summarized here), the CARES Act affects coverage of diagnostic testing, preventive services, telehealth services, and drug reimbursement. … Continue Reading
As with other states, in response to the COVID-19 pandemic and the guidance that the federal government has issued (see here), Governor Abbott of Texas issued a disaster declaration on March 13, 2020 (the Disaster Declaration) resulting in the loosening of certain existing telemedicine and telehealth related requirements in Texas. Licensure. For current license holders, … Continue Reading
In an effort to preserve healthcare resources (e.g., personal protective equipment), limit potential contact with infected individuals, and free up healthcare practitioners to assist with those suffering from COVID-19, elective healthcare services must cease. Specifically, on March 20, 2020, Florida Governor Ron DeSantis issued Executive Order 20-72 (available here), requiring all Florida licensed healthcare practitioners … Continue Reading
In response to the public health emergency declared in Florida on March 1, 2020, Florida loosened existing licensure and other telehealth requirements in response to the COVID-19 pandemic, as outlined below. However, unless specifically waived or relaxed by the Orders (as defined below), all current minimum practice requirements and standards of care for telehealth services … Continue Reading
