Policy & Compliance
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July 09, 2024
Jarkesy Decision May Hit Key Healthcare Enforcement Tool
Healthcare companies battling civil fines imposed by federal health regulators are already embracing a U.S. Supreme Court decision weakening agencies' power to impose monetary penalties without a jury trial. Many healthcare attorneys predict that a first wave of industry pushback will build to something seismic for civil penalties and federal health regulation.
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July 09, 2024
Calif. Health Players Back Managed Care Tax Amid Uncertainty
A ballot measure backed by some of the biggest healthcare players in California is designed to protect billions of dollars in revenue for the state's Medicaid program. Its impact may hinge on persuading more doctors to serve low-income patients.
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July 09, 2024
FTC Says Drug Middlemen Inflate Costs, Squeeze Pharmacies
The Federal Trade Commission said Tuesday that its study of pharmacy benefit managers has shown that six large companies now control 95% of all prescriptions filled in the U.S., allowing them to profit at the expense of patients and independent pharmacies.
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July 09, 2024
Ga. Doc Can't Get Emergency Protection In Med Mal Death Suit
In a split opinion, the Georgia Court of Appeals revived a medical malpractice case against a doctor who allegedly misdiagnosed a patient's brain condition, finding he's not shielded by a statute that sets a gross negligence standard for liability in emergency medical situations.
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July 09, 2024
Independence Blue Cross Elevates Atty To Deputy GC
Independence Blue Cross has promoted an attorney who has worked for more than 13 years for the Philadelphia-based insurance provider to serve as vice president and deputy general counsel.
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July 08, 2024
Ex-Ga. Insurance Chief Wants Lighter Term In Kickback Case
Former Georgia Insurance Commissioner John Oxendine has objected to the government's recommendation that he serve 44 months in prison and pay a $700,000 fine for his role in a multimillion-dollar medical testing kickback scheme, arguing that he is deserving of a lesser sentence.
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July 08, 2024
Ohio Woman Says Clinic Fired Her Because Of Disabled Son
A Cleveland-based kidney dialysis clinic allegedly fired a technician for telling it she might have to return to a less demanding work schedule to help treat her son's medical condition, according to a complaint filed Monday.
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July 08, 2024
DC Circ. Supports NLRB Order Against Puerto Rico Hospital
The National Labor Relations Board rightly found that a hospital in Puerto Rico violated federal labor law by unilaterally slashing workers' hours, the D.C. Circuit ruled, saying the hospital can't excuse its actions with claims about financial effects from the pandemic.
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July 08, 2024
Hospital Must Face Ex-Worker's Religious Bias Suit
An Oregon federal judge refused to release a hospital from a former employee's suit claiming she was fired because she objected to receiving a COVID-19 vaccine in light of her Christian beliefs, saying a jury is best suited to decide if there was bias when the company refused to accommodate her.
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July 05, 2024
9th Circ. Backs Remand Of Cedars-Sinai Patient Data Suits
The Ninth Circuit held Friday that a trio of proposed class actions accusing Cedars-Sinai of improperly sharing patients' personal information with tech companies indeed belong in California state court, agreeing with a lower court that the health provider wasn't acting at the direction of the federal government.
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July 05, 2024
How Reshaped Circuit Courts Are Faring At The High Court
Seminal rulings from the U.S. Supreme Court's latest term will reshape many facets of American society in the coming years. Already, however, the rulings offer glimpses of how the justices view specific circuit courts, which have themselves been reshaped by an abundance of new judges.
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July 05, 2024
Breaking Down The Vote: The High Court Term In Review
The U.S. Supreme Court's lethargic pace of decision-making this term left the justices to issue a slew of highly anticipated and controversial rulings during the term's final week — rulings that put the court's ideological divisions on vivid display. Here, Law360 takes a data dive into the numbers behind this court term.
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July 05, 2024
High Court Flexes Muscle To Limit Administrative State
The U.S. Supreme Court's dismantling of a 40-year-old judicial deference doctrine, coupled with rulings stripping federal agencies of certain enforcement powers and exposing them to additional litigation, has established the October 2023 term as likely the most consequential in administrative law history.
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July 05, 2024
The Sharpest Dissents From The Supreme Court Term
The U.S. Supreme Court's session ended with a series of blockbuster cases that granted the president broad immunity, changed federal gun policy and kneecapped administrative agencies. And many of the biggest decisions fell along partisan lines.
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July 05, 2024
5 Moments That Shaped The Supreme Court's Jan. 6 Decision
When the high court limited the scope of a federal obstruction statute used to charge hundreds of rioters who stormed the Capitol, the justices did not vote along ideological lines. In a year marked by 6-3 splits, what accounts for the departure? Here are some moments from oral arguments that may have swayed the justices.
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July 05, 2024
The Funniest Moments Of The Supreme Court's Term
In a U.S. Supreme Court term teeming with serious showdowns, the august air at oral arguments filled with laughter after an attorney mentioned her plastic surgeon and a justice seemed to diss his colleagues, to cite just two of the term's mirthful moments. Here, we look at the funniest moments of the term.
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July 05, 2024
Hackensack Meridian Sues Feds, Citing Chevron Ruling
After the U.S. Supreme Court overturned the Chevron deference last month, making it easier to challenge federal regulators in court, New Jersey's largest healthcare network became one of the first to seek remedies citing the ruling.
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July 05, 2024
The Firms That Won Big At The Supreme Court
This U.S. Supreme Court term featured high-stakes oral arguments on issues including gerrymandering, abortion and federal agency authority, and a hot bench ever more willing to engage in a lengthy back-and-forth with advocates. Here's a look at the law firms that argued the most cases and how they fared.
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July 03, 2024
HHS Scores Early Win In Boehringer's Medicare Pricing Suit
A Connecticut federal judge on Wednesday sided with the U.S. Department of Health and Human Services in Boehringer Ingelheim's challenge to a new Medicare drug price negotiation program, rejecting the pharmaceutical company's claim that the program is unconstitutional.
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July 03, 2024
Red States Get ACA Trans Discrimination Rule Blocked
Federal judges in Mississippi and Texas granted conservatives states' requests Wednesday to freeze a new rule protecting access to healthcare for the LGBTQ+ community, with both judges ruling that states are likely to succeed in showing that the U.S. Department of Health and Human Services overstepped when it created the regulations.
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July 03, 2024
Contentious Ala. Gender Care Case Partly Paused
Favoring "judicial efficiency," an Alabama federal court has partially granted the Biden administration's opposed motion to stay a case challenging the state's ban on gender-affirming healthcare for transgender youth while the U.S. Supreme Court reviews a similar Tennessee ban, though some briefing, including for summary judgment, was permitted to proceed.
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July 03, 2024
4 Mass. Rulings You Might Have Missed In June
Massachusetts state courts last month dealt with thorny contract disputes, mistakenly disclosed emails between a defendant and an attorney, and a company's overtime policy change that may not have been spelled out to workers.
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July 03, 2024
Gov't Says Justices' Decision Doesn't Fully Solve OT Suit
The recent U.S. Supreme Court decision pushing deadlines to challenge federal regulations doesn't entirely solve an overtime dispute between three home care companies and the U.S. Department of Labor, the government told the Third Circuit.
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July 03, 2024
NC Appeals Court OKs Hospital's 'Facility Fees' For ER Patient
The North Carolina Court of Appeals has found that Novant Health was allowed to charge an emergency room patient "facility fees" because a contract she signed for healthcare included language requiring payment for anything not covered by insurance.
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July 03, 2024
Steward Health Downfall Prompts Calls For Tighter Regs
The magnitude of the financial troubles plaguing bankrupt hospital operator Steward Health Care has turned the Chapter 11 case into a flash point that should prompt a regulatory overhaul, according to a new report released by advocacy group Private Equity Stakeholder Project.
Expert Analysis
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DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges
The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.
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FTC Focus: Exploring The Meaning Of Orange Book Letters
The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.
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3rd Circ.'s Geico Ruling May Encourage Healthcare Arbitration
The Third Circuit's recent decision in Geico v. Mount Prospect, finding that claims under New Jersey's Insurance Fraud Prevention Act can be arbitrated, strengthens arbitration as a viable alternative to litigation, even though it is not necessarily always a more favorable forum, say Khaled Klele and Jessica Osterlof at McCarter & English.
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Proposed Cannabis Reschedule Sidesteps State Law Effects
The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.
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A Changing Regulatory Landscape For Weight Loss Drugs
As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.
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Opioid Suits Offer Case Study In Abatement Expert Testimony
Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.
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How HHS Discrimination Rule Affects Gender-Affirming Care
The U.S. Department of Health and Human Services' new final rule, which reinterprets the Affordable Care Act's anti-discrimination provision, greatly clarifies protections for gender-affirming care and will require compliance considerations from sponsors and administrators of most group health plans, say attorneys at McDermott.
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FTC Noncompete Rule's Impact On Healthcare Nonprofits
Healthcare entities that are nonprofit or tax-exempt and thus outside of the pending Federal Trade Commission noncompete rule's reach should evaluate a number of potential risk factors and impacts, starting by assessing their own status, say Ben Shook and Tania Archer at Moore & Van Allen.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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8 Questions To Ask Before Final CISA Breach Reporting Rule
The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.