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
Category Archives: Healthcare Law
Subscribe to Healthcare Law RSS FeedHiding 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 Considerations… Continue 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
January 1, 2021: The Deadline for Hospitals to Make Transparency Clear
Hospitals that are not ready for the Centers for Medicare & Medicaid Services (CMS) new transparency requirement must act quickly. CMS has advised that the new year will begin with new auditing and monitoring of these requirements.… 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
Florida: Do You Know Where Your “Minor” Is?
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 … Continue Reading
“Historic” Settlement of Blue Cross Blue Shield Association Antitrust Action May Significantly Boost Competition in Health Insurance Markets in 2021
After over 8 years of hard-fought litigation, the Blue Cross and Blue Shield Association, together with its 36 Blue Cross/Blue Shield members (“the Blues”), recently announced a proposed settlement of class action antitrust litigation (In re Blue Cross Blue Shield Antitrust Litigation) brought against them by a nationwide class of subscriber members. The settlement terms, summarized in the … Continue Reading
Is A Safer Healthcare System Within Reach?
COVID-19 has made healthcare organizations acutely aware of the need to fine-tune their internal safety systems. The National Steering Committee for Patient Safety (NSC), comprised of 27 organizations, has come to the rescue. NSC recently released guidance entitled, “Safer Together: A National Action Plan to Advance Patient Safety” (the Plan). The Plan provides a methodology for improving safety … Continue Reading
HIPAA Says To Give Me My Medical Records…NOW!
Healthcare providers are generally required by HIPAA to provide patients or their legal representatives with the ability to inspect or obtain copies of their medical records within 30 days of a request (state specific requirements are not addressed herein.) The Office of Civil Rights (OCR) has been enforcing this requirement through its Right of Access Initiative, which it announced in … Continue Reading
What Consent for Which “Pelvic Examination”?
Healthcare practitioners, including medical students, are now prohibited from performing pelvic examinations on female patients without first obtaining written consent, but many specific, logistical questions were left unanswered. The new law became effective July 1, 2020. “[P]elvic exams will now require specific consent, except in cases of emergency, finally halting the wholly inappropriate practice of unapproved pelvic exams on unconscious … Continue Reading
Telehealth Physical Examinations: Turn on your camera and show me your “rash.”
Physician offices have seen a dramatic increase in telehealth visits during the COVID-19 pandemic. This development has raised questions regarding the appropriate standard of care when performing a telehealth examination, in particular the “physical examination.” Naturally this blog can never supplant the physician’s expertise in evaluating patients. As in other contexts, physicians practicing telemedicine should strive to act reasonably to … Continue Reading
House Passes Bill that Would Repeal Health Insurer Antitrust Exemption
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 federal antitrust laws. … Continue Reading
DOJ Antitrust Division Grants Green Light for Pharma Companies Sharing COVID-19 Treatment Drug Production Information
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 challenge a proposal by … Continue Reading
