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 is expected to be prevalent. The employers will be chosen from the primary and secondary target lists as seen below:

a. Primary target list (Appendix A):

i. Healthcare industry (i.e., dentist, home health care, ambulance services, general medical and surgical hospitals, nursing care, retirement communities, assisted living facilities, etc.) Continue Reading

Providers: Cyberattacks Are Still Coming–Are You Prepared?

By Kirk S. Davis and Danielle C. Gordet on March 22, 2021 Posted in Health Care Providers, Healthcare Law, Healthcare Litigation, HIPAA, Privacy, and Data Security, Hospitals & Health Systems

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 Considerations” (ASPR Report).

The goal of the ASPR Report is to help providers understand what must occur before, during, and after a large-scale cybersecurity incident. We have provided below a brief overview of the major strategies discussed in the ASPR Report that various types of healthcare facilities can use for a range of cybersecurity incidents. The key points of the report can be summarized by three key concepts: Think, Remember, and Anticipate. Continue Reading

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

By Kirk S. Davis and Danielle C. Gordet on February 18, 2021 Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

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 CFR § 164.524(b). It is essential that providers take steps now to avoid future penalties. For purposes of this article the term “provider” refers to a “Covered Entity” under HIPAA, which includes health plans, health care providers (e.g., physicians, hospitals), and health care clearinghouses. Continue Reading

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

By Ashlee R. Tising and Bruce D. Platt on February 16, 2021 Posted in Government Affairs, Licensure & Regulatory, Health Care Providers, Healthcare Law, Hospitals & Health Systems

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 filed, the chair of the House Health & Human Services committee, Representative Colleen Burton (R-Lakeland), has unveiled a committee bill (PCB HHS 21-1) that has garnered early support from House Speaker Chris Sprowls (R-Palm Harbor).

In the meantime, Senate measure SB 74, recently-filed by Senator Jeff Brandes (R-St. Petersburg), was heard last week in its first committee of reference – Senate Judiciary, which is chaired by Senator Brandes. As filed, SB 74 provides immunity from civil liability for healthcare providers (including, but not limited to, hospitals, nursing homes, assisted living facilities, home health providers, and doctors) if supplies or personnel were not available to comply with government health standards or guidance related to the pandemic. Continue Reading

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

By Kirk S. Davis and Danielle C. Gordet on February 12, 2021 Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

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).

Klobuchar Antitrust Bill Could Have Significant Impact on Healthcare Industry

By James M. Burns on February 8, 2021 Posted in Antitrust, Government Affairs, Licensure & Regulatory, Hospitals & Health Systems

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 most dominant companies in the information technology industry (Big Tech) under the antitrust laws, the legislation is not limited to that industry, and if enacted, the legislation could have a significant impact on larger health systems and health insurers as well. Continue Reading

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

By Kirk S. Davis and Danielle C. Gordet on February 4, 2021 Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

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 health disparities, and lowered healthcare costs. Continue Reading

New Supreme Court Ruling Affirms State Regulation of PBM Reimbursement Pricing

By Danielle C. Gordet and Amber Roberts on January 28, 2021 Posted in Healthcare Law, Hospitals & Health Systems, Pharmacy, Drugs, Medical Devices & Equipment, Physicians

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 price equal to or higher than the pharmacy’s wholesale cost,” is not preempted by the Employee Retirement Income Security Act of 1974 (ERISA). Continue Reading

Florida Pharmacy Collaborative Practice Agreements: Defining the Scope of Practice

By Martin R. Dix on January 27, 2021 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

By Sheryl D. Rosen on January 25, 2021 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”).