Category Archives: Healthcare Litigation

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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 … 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 … 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 … 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 … 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, … 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 … 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 … 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 … 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 … 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, … 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 … 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 … 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 … 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 … Continue Reading

Limited Stark and Anti-Kickback Sanction Waivers Issued for Provider Payments During the Pandemic

The COVID-19 pandemic has led to urgent changes to how and where healthcare services are delivered. These changes could require expedited entry into new or modified arrangements for the delivery of essential healthcare goods and services, creating potential conflicts with the Stark Law (Section 1877 of the Social Security Act) and its regulations and potential … Continue Reading

SCOTUS Rules Government Must Pay $12 Billion to Unprofitable ACA Insurers

Despite Congress’ efforts to use riders to neutralize a provision of the Affordable Care Act (ACA or Act), the Federal government (Government) owes certain insurers $12 billion. On April 27, 2020, the Supreme Court of the United States (SCOTUS) ruled 8-1 that congressional riders added to appropriations bills that funded the Centers for Medicare & … Continue Reading

Accepting CARES Act Relief Funds for Health Care Providers? Tell Your Compliance Department

While the CARES Act signals relief for many healthcare providers, it is important to remember that there are strings attached and reasons for providers to involve their compliance departments in the use and tracking of the CARES Act relief funds. The CARES Act promised, through the Public Health and Social Services Emergency Fund, to provide … Continue Reading

Some Things Never Change: EMTALA in the Time of COVID-19

Even in this time of crisis, nothing has changed about a hospital’s obligation to comply with the Emergency Medical Treatment and Labor Act (EMTALA). However, the Centers for Medicare and Medicaid Services (CMS) has issued guidance (available here) to, and some flexibility for, hospitals on how to provide care to the growing influx of patients … Continue Reading

Taking Triage to Trial

The COVID 19 epidemic is bound to overwhelm available medical resources in the United States. Healthcare institutions and practitioners will be forced to make impossible life-or-death decisions regarding the allocation of manpower and supplies. They must also be ready to defend those decisions against a backlash of grief—and lawsuits—once the crisis has passed. A defensible … Continue Reading

Sutter Health Settles California Attorney General Antitrust Case With Cash and an Agreement to Make Significant Changes to its Operations

The terms of a settlement that resolved antitrust litigation between the State of California and Sutter Health, the largest health system in Northern California, have now become public, almost two months after the settlement put an end to the case. The settlement, which was inked only days before a trial in the case was set … Continue Reading

You Can’t Always Get What You Want

The Florida Fifth District Court of Appeal harmonized the interpretation of state statutory and constitutional language in the first post Amendment 7 case dealing with access to adverse medical incident reports and their use at trial. The Florida statutory prohibition against the use and admissibility of certain incident reports was postulated to conflict with the … Continue Reading
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