Category Archives: Healthcare Litigation

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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

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 Office of Inspector General (OIG) … 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 & Medicaid Services (CMS) in 2014, … 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 $100 billion in relief funds … 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 during the COVID-19 pandemic.… 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 triage protocol must enable reasonable … 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 to begin, includes both the … 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 state constitutional access to adverse … Continue Reading

Direct Patient Billing Can Create Provider Liability in Florida

To bill or not to bill, that is the question. Or, more appropriately, who to bill and when to bill, that is the question. Providers who bill patients under the circumstances described below may face liability. What is a provider to do?

A patient was injured in the course of her employment in December 2013 and applied for workers’ compensation … Continue Reading

Addressing Acute Mental Health Concerns: Parkland’s Legacy – Florida’s Red Flag Law

We are all too aware of the horrors of the Parkland shooting. In response to that awful day, the Florida Legislature enacted Florida Statute Section 790.401 in 2018, “the Marjory Stoneman Douglas High School Safety Act.”  Part of this new law is the “red flag” provision which allows courts to proactively remove firearms from individuals who pose a significant danger … Continue Reading

Possible Relief for Hospitals in the Protection of PSO Information?

Last Thursday, September 5, 2019, Judge James Moody, Jr. of the United States District Court for the Middle District of Florida issued a positive ruling for hospitals dealing with patient safety organization (PSO) data. The opinion can be reviewed here. Note, while this decision is not binding on state courts, it is persuasive authority. It may be used to … Continue Reading

Supreme Court Resolves Statute of Limitation Circuit Split in False Claims Act Cases

Last month, in a unanimous decision, the U.S. Supreme Court ruled that the analysis of the applicable statute of limitations under the False Claims Act (FCA) as set forth in 31 U.S.C. § 3731 is the same regardless of whether the government intervenes in the action or not.  While the decision is not likely to affect either the government … Continue Reading

US Supreme Court to Hear FCA Statute of Limitations Case

The Eleventh Circuit Court of Appeals, in its ruling in Cochise Consultancy Inc. v. U.S. ex rel. Hunt, created a 3-way circuit split regarding the determination of the applicable statute of limitations period in a False Claims Act (FCA) case. On March 19, the United States Supreme Court will hear oral argument on the matter, hopefully ending the division … Continue Reading

Per se versus ‘Rule of Reason’ Standard: Judge in Blue Cross Antitrust MDL Proceeding Certifies His Decision For Interlocutory Appeal

In a somewhat unexpected but highly significant move, United States District Judge David Procter (Northern District of Alabama), who is presiding over the In re Blue Cross Blue Shield Antitrust Litigation (Case No. 2:13-cv-20000, N.D. Alabama), has granted defendants’ request that he certify his ruling that the defendants’ alleged conduct should be assessed under a per se standard (and not … Continue Reading

Pharmacies Accuse Drug Maker of Anticompetitive Contracting to Restrict Biosimilar Market

Walgreens and Kroger have filed an antitrust action in the United States District Court for the Eastern District of Pennsylvania accusing Johnson & Johnson (J&J) of engaging in anticompetitive conduct designed to stymie the growth of biosimilar alternatives to J&J’s Remicade, a biologic drug used to treat certain chronic immune disorders (Walgreen Co. v. Johnson & Johnson, Case … Continue Reading

U.S. Supreme Court Rules That Class Action Waivers Are Enforceable

Employers may require employees to enter into arbitration agreements that waive such employees’ ability to participate in a class or collective action lawsuit, the U.S. Supreme Court ruled this week. In a long-awaited decision that represents a significant victory for employers, the Court in Epic Systems Corp. v. Lewis held that such agreements do not violate the National Labor Relations … Continue Reading

Health Insurers Contend Allergy Test Maker’s Antitrust Claims Make No Economic Sense – Seek Early Dismissal on that Basis

Three health insurers accused of having violated the antitrust laws in Academy of Allergy & Asthma in Primary Care v. Blue Cross Blue Shield of Louisiana, et al. (Eastern District of Louisiana), have filed motions seeking a swift win in the matter prior to the commencement of discovery. In support of their request, Humana, Blue Cross Blue Shield of Louisiana … Continue Reading

Reversal of Fortune: Rhode Island Court Withdraws “Tentative” Decision to Grant Summary Judgment to Health Insurer in Health System Antitrust Case and Sets Matter for Trial

In what was a surprise result, on April 23, Judge William Smith (Chief Judge of the District of Rhode Island) reversed the “tentative” decision he had announced last November, in Steward Health v. Blue Cross & Blue Shield of Rhode Island, which would have granted defendant Blue Cross & Blue Shield of Rhode Island (BCBS-RI) summary judgment on all claims … Continue Reading

Partial Summary Judgment Granted to Plaintiffs in the In re Blue Cross Blue Shield Antitrust Litigation MDL Proceeding

On April 5, United States District Judge David Proctor (N.D. Alabama) granted partial summary judgment to the plaintiffs in the In re Blue Cross Blue Shield Antitrust Litigation, ruling that a network of trademark licensing agreements between the Blue Cross Blue Shield Association and its member insurance companies (referred to as the ‘Blues’), which plaintiffs characterized as “horizontal market allocation … Continue Reading

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