As we anticipated in our October 17, 2024, blog, both the Government and the Relator have appealed the district court’s decision in U.S. ex rel. Zafirov v. Florida Medical Associates, LLC, et al. (Zafirov), the first case to hold that the qui tam provision of the federal False Claims Act violates the Appointments Clause of … Continue Reading
For the first time ever, a judge has ruled that the qui tam provision of the False Claims Act (FCA), which whistleblowers have used to recover $52 billion on behalf of the government since 1986, is unconstitutional. … Continue Reading
Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand name: Mifeprex), a drug used to terminate pregnancies through ten weeks gestation. Avoiding a substantive decision on the merits … Continue Reading
On April 23, 2024, the Federal Trade Commission (FTC), through a 3-2 vote, approved a final rule (the Final Rule), banning most forms of non-compete clauses with workers. A non-compete clause generally prevents a worker from getting a different job or starting a new business that competes with the employer after the conclusion of their … Continue Reading
Hospitals, urgent care clinics, doctors’ offices — these are the places we go when we are sick and want to get better. Doctors, nurses, and other healthcare workers are the people who treat us, help us recover, and even save our lives in medical emergencies.… Continue Reading
By maintaining a robust compliance program, healthcare companies are better able to identify potential red flags early and to prevent violations of fraud and abuse laws. A failure to maintain an effective compliance program may become particularly problematic for companies with business transactions on the horizon as the government increasingly incentivizes business professionals to give … Continue Reading
The Office of Inspector General of the U.S. Department of Health and Human Services (the OIG) recently released an updated General Compliance Program Guidance document (GCPG). The GCPG has been anticipated since the OIG announced on April 25, 2023, that it planned to modernize the accessibility and usability of its publicly available resources, including the … Continue Reading
By looking at the events that have transpired since the Consolidated Appropriations Act, 2021, which includes the No Surprises Act (the Act), was signed into law, it is clear that the Departments of Health and Human Services, Labor, and Treasury (collectively, the Departments) have lost their way. The United States District Court for the Eastern … Continue Reading
Providers finally obtained court ordered relief to the $350 administrative fee each party was required to pay as part of the Federal Independent Dispute Resolution (IDR) Process under the No Surprises Act. Until the Departments of Health and Human Services, Labor, and the Treasury (collectively, the Departments) set a new administrative fee amount, the administrative … Continue Reading
How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District Court for the District of Massachusetts. In its ruling denying the motion for summary judgment filed by defendants … Continue Reading
Yesterday, the United States Supreme Court held that a False Claims Act (FCA) defendant cannot rely on an objectively reasonable interpretation of a law, regulation, or rule to negate the scienter element of the FCA. In United States ex rel. Schutte v. SuperValu Inc., the Court emphasized the importance of a defendant’s subjective belief in … Continue Reading
There are multiple components to the risk defendants must consider when faced with going to trial for a matter involving the False Claims Act (FCA). Setting aside the incalculable impact that litigation can have on business operations, the statute itself anticipates repayment of the proven overpayment, treble damages, and exposure to a civil statutory penalty … Continue Reading
We are not surprised by the continued stop-and-go regarding guidance surrounding the No Surprises Act. Most recently, a Texas court vacated portions of the No Surprises Act’s updated final rule (the final rules were discussed in our most recent blog on the subject). This created a domino effect, leading to the Departments of the Treasury, … Continue Reading
Ruling on the State of Georgia’s November 18, 2022 Emergency Petition for Supersedeas, this past Wednesday (November 23, 2022) the Georgia Supreme Court enjoined the lower court’s decision thereby reinstating the prohibitions on abortion in Georgia codified by the LIFE Act. Briefly, the LIFE Act prohibits abortive care once cardiac activity is detectable in an … Continue Reading
On June 24, 2022, the United States Supreme Court issued its seminal decision on abortion, Dobbs v. Jackson Women’s Health Organization, overturning Roe v. Wade and the right to terminate a pregnancy before viability, which Roe had seemingly codified. The Supreme Court’s decision fundamentally altered the constitutional landscape of a woman’s right to make reproductive … Continue Reading
The Departments of the Treasury, Labor, and Health and Human Services (the Departments) issued final rules related to the No Surprises Act on August 26, 2022, to be effective October 25, 2022 (Final Rules). These Final Rules come after months of uncertainty and legal battles regarding the Federal Independent Dispute Resolution (IDR) process, as we … Continue Reading
Given the trajectory, it is no longer surprising that the No Surprises Act (the Act) continues its turbulent path through implementation. The U.S. District Court for the Eastern District of Texas, on July 26, 2022, again vacated provisions of the Federal Independent Dispute Resolution (IDR) process, this time relating to air ambulance payment disputes. (LifeNet, … Continue Reading
Healthcare breaches, including ransomware attacks, continue to increase. As a result, many healthcare organizations seeking cyber coverage to help defray the costs associated with a ransomware attack or other data incident may find that carriers have increased premiums, reduced coverage, and tightened underwriting requirements. Healthcare organization leaders should understand that implementing reasonable administrative, technical, and … Continue Reading
Healthcare facilities and other entities receiving federal financial assistance can breathe a little easier after a U.S. Supreme Court decision issued last week barring the recovery of emotional damages for certain discrimination claims. Many federal anti-discrimination statutes allow recovery for “emotional injuries” that include humiliation, trauma, mental anguish, anxiety, depression, and other non-physical symptoms a … Continue Reading
The No Surprises Act (the “Act”) continues muddling through its implementation period. We have discussed the Act in prior posts, and most recently on March 8, 2022. The surprises have continued, with new updates coming out almost daily! There has been legal movement as health care providers and facilities (collectively, “Providers”) have brought lawsuits against … Continue Reading
The No Surprises Act (the Act) continues to bump through its initial implementation phase. As we discussed in our prior blog, out-of-network physicians and facilities (OON Providers), and their allies, are pushing back against portions of the recently issued interim final rule with comment period (the Interim Rule). Most recently, they succeeded in doing so … Continue Reading
It may seem as though the pandemic is coming to an end, but while COVID cases are declining, they have not ceased. As the pandemic continues, the Department of Health and Human Services (HHS) Office for Civil Rights issued new guidance on February 4, 2022 to remind healthcare providers that federal disability laws remain in … Continue Reading
Florida is continuing its efforts to improve patient safety in hospitals and ambulatory surgical centers (ASCs). The Florida Legislature previously approved a requirement that hospitals and ambulatory surgical centers (ASCs) conduct patient safety surveys and tasked the Agency for Health Care Administration (AHCA) with implementing a rule specifying the submission process for these surveys. AHCA’s … Continue Reading
Effective January 1, 2022, new billing protections went into effect that have the goal of providing greater protections for patients against surprise medical bills. As we discussed in our prior blog, the Departments of Health and Human Services, Labor, and Treasury, and the Office of Personnel Management (collectively, the Departments) implemented these additional protections that … Continue Reading
