Category Archives: Healthcare Law

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Medicare & Medicaid Facilities Are Put On Notice: Employees Must Be Vaccinated

Medicare and Medicaid certified facilities will be required to ensure that their employees are vaccinated for COVID-19, the Centers for Medicare & Medicaid Services (CMS) announced on September 9, 2021. Healthcare providers with 100 or more employees also may be subject to a forthcoming Emergency Temporary Standard (“ETS”) from the U.S. Department of Labor’s Occupational Safety and Health Administration (“OSHA”) … Continue Reading

Updated for Expanded DDC Interpretation: New Help for the Florida Healthcare Transaction Attorney- Temporary Drug, Device, and Cosmetic Permits

Whoever authored this new legislation (Chapter 2021-135, Laws of Florida) deserves a pat on the back for an idea whose time has come.  When an applicant files for a change of ownership (“CHOW”) or change of location for one of the permits authorized by the Florida Department of Business Professional Regulation, Division of Drugs, Devices, and Cosmetics (affectionately, … Continue Reading

New Help for the Florida Healthcare Transaction Attorney- Temporary Drug, Device, and Cosmetic Permits

Whoever authored this new legislation (Chapter 2021-135, Laws of Florida) deserves a pat on the back for an idea whose time has come. When an applicant files for a change of ownership (“CHOW”) or change of location for one of the permits authorized by the Florida Department of Business Professional Regulation, Division of Drugs, Devices, and Cosmetics (affectionately, … Continue Reading

Decision Reminds Providers of Limits on Restricting Employee Communications with Media

Hospitals and medical groups that bar staff from communicating with the media should take another look at those prohibitions following a recent federal appellate decision finding such a policy unlawful under the National Labor Relations Act (NLRA).

Multiple news accounts have detailed incidents where doctors and nurses were disciplined or fired for speaking out about staffing issues or inadequate Personal … Continue Reading

Have Paper Prescriptions Gone the Way of the Horse and Buggy? Almost.

For most Florida prescribers whose licenses haven’t renewed since 2019, it’s time to commence electronic prescribing. In 2019, the legislature enacted legislation that required electronic prescribing. However, this requirement became effective on the earlier of the prescriber’s license renewal date or July 1, 2021. Section 456.42(3), Florida Statutes requires health care practitioners to “electronically transmit prescription(s).”  This term is not … Continue Reading

New Florida Laws Focus on Health Care

Before closing its 2021 session, the Florida Legislature passed several bills that impact health care, summarized below.

The first bill discussed below regarding civil liability became effective on March 29, 2021. The majority of the other bills became effective on July 1, 2021.… Continue Reading

Pelvic Examination Law – Florida Takes a Second Look

The Florida medical community was left concerned and confused by the passage of the original 2020 pelvic examination law. As we discussed in our past blog, practitioners believed the law was overly burdensome, and they were unsure how to implement it. Senator Lauren Book’s new bill, SB 716, sought to make consent clear through an amendment to the … Continue Reading

Group Health Plan Sponsors are Getting Serious About Pricing Transparency – Are You Keeping Up?

In early July, the Department of Health and Human Services (HHS), the Department of Labor (Labor), and the Department of the Treasury (Treasury) (collectively, the Departments), along with the Office of Personnel Management (OPM) released an interim final rule related to the No Surprises Act, legislation designed to protect patients from unexpected medical bills.

The Departments’ interim final rule arrives … Continue Reading

OIG Weighs In On COVID-19 Vaccination Incentives

The media has widely reported that several governmental, non-profit, and private organizations, including entities in the healthcare sector, are offering a variety of incentives to encourage more individuals to take the COVID-19 vaccine. While this approach may increase the number of vaccinated individuals, it can also implicate the healthcare fraud and abuse laws when Federal healthcare program beneficiaries, e.g., Medicare … Continue Reading

Hiding Data: Hospitals Fail to Comply with Price Transparency Requirements

At first glance, it appeared that hospitals were complying with the Centers for Medicare & Medicaid Services’ (CMS) price transparency requirement, which became effective January 1, 2021. Upon a closer look; however, multiple deficiencies were found.

CMS previously advised that it would begin auditing compliance with the rule this past January. Interestingly, it was the published findings of … Continue Reading

Be Prepared For Increase In COVID-19 Inspections Under OSHA’s New National Emphasis Program

On March 12, 2021, the Occupational Safety and Health Administration (OSHA) announced a new National Emphasis Program (NEP) designed to significantly reduce worker exposure to COVID-19 by targeting industries and worksites where employees may have a high frequency of close-contact exposures. The new NEP on COVID-19 has two main components:

1. Increases OSHA inspections of high-hazard industries where COVID-19 exposure Continue Reading

Providers: Cyberattacks Are Still Coming–Are You Prepared?

Cyberattacks against healthcare providers accounted for 79% of all reported data breaches in 2020. (See here). The U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) responded last month by releasing a comprehensive guide to protect providers against this growing vulnerability entitled “Healthcare System Cybersecurity Readiness & Response ConsiderationsContinue Reading

Providers: Help is Here to Avoid HIPAA Right of Access Headaches

The Office of Civil Rights (OCR) continues to take seriously all allegations of violations of the HIPAA right of access to patient medical records. As discussed in a previous blog, the OCR is enforcing patient rights by issuing enforcement actions against healthcare providers who fail to provide patients with timely access to their medical records, in accordance with 45 Continue Reading

The Sun is Rising on COVID Liability Protection for Florida Healthcare Providers

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 for healthcare providers has been … Continue Reading

Valentine’s Day: Listen to Your Heart, But Not On a Cell Phone

Physicians at Henry Ford Hospital in Detroit made a “stunning” heart-altering discovery. New and improved magnets in the iPhone 12 (“12”) may cause heart defibrillators and pacemakers to malfunction, particularly when carried in a breast pocket (See publication).… Continue Reading

CMS Tells States and Providers: Value-Based Care is the Answer

The Centers for Medicare & Medicaid Services (CMS) has sent a clear message to states and providers: they already have the tools to improve healthcare. Through a combination of value-based arrangements and already existing services and supports, states and providers can address the social determinants of health (SDOH). This will lead to an improvement in health outcomes, a reduction in … Continue Reading

New Supreme Court Ruling Affirms State Regulation of PBM Reimbursement Pricing

The U.S. Supreme Court ruled against pharmacy benefit managers (“PBMs”) last month, in a decision that marks a major win for state regulators. (See Rutledge v. Pharmaceutical Care Management Association, 2020 WL 7250098 (U.S. 2020)). On December 10, 2020, the U.S. Supreme Court held that Arkansas’s Act 900, which “effectively requires PBMs to reimburse Arkansas pharmacies at a … Continue Reading

Florida Pharmacy Collaborative Practice Agreements: Defining the Scope of Practice

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

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

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 … Continue Reading

Healthcare Providers: Please Be Wary of Accepting Those Gifts!

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 … Continue Reading

Federal Trade Commission Challenge to Northern Philadelphia Hospital Merger Fails

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 … Continue Reading

A Glossary of Commonly Used Acronyms in Florida Managed Care

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 … Continue Reading

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

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 … Continue Reading

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