Policy & Compliance
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June 26, 2024
Nurses Say Mich. Hospitals Owe OT For Meal Break Work
Two locations of a Michigan healthcare system unlawfully require employees to work through their meal breaks without pay in violation of federal wage law, according to two separate proposed collective actions filed in federal court.
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June 26, 2024
Feds' 5th Circ. Win On Preventive Care May Imperil ACA
The Fifth Circuit's decision to knock out a national injunction against preventive services coverage requirements under the Affordable Care Act left healthcare advocates breathing a sigh of relief, but attorneys say even more of those requirements may be on the chopping block.
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June 26, 2024
High Court 'Inadvertently' Posts Order Punting Abortion Case
The U.S. Supreme Court mistakenly released a draft order Wednesday that would allow emergency abortions in Idaho, with a majority saying the court was wrong to consider a state challenge at this time.
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June 26, 2024
High Court Axes Challenge To Biden Admin's Social Media Work
The U.S. Supreme Court wiped out a Fifth Circuit order prohibiting the Biden administration and several federal agencies from working with social media platforms to combat the spread of misinformation Wednesday, finding the states and individuals challenging the collaboration don't have standing to sue.
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June 25, 2024
Mich. Judge Blocks State Abortion Waiting Period, Counseling
A Michigan state judge on Tuesday temporarily blocked a 24-hour waiting period, mandatory counseling and other requirements on people seeking abortions in the state, finding they likely violate an amendment in the state constitution guaranteeing the right to an abortion.
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June 25, 2024
Supreme Court Sets Stage For Crucial Ruling On Trans Rights
The U.S. Supreme Court's plunge into the legal clash over gender-affirming care for minors could determine the fate of restrictions enacted in 25 states and shape the future of transgender rights for years to come.
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June 25, 2024
NBA Fraud Trial, An HHS Loss, And An Ivy League Doc Settles
A Texas federal judge dinged the Biden administration over a rule restricting hospitals' use of online tracking technology. The NBA healthcare fraud scheme saga continues. A Harvard fertility doc settled claims he used his own sperm to impregnate a patient. Law360 Healthcare Authority examines the lawsuits and decisions that have shaped the industry over the last week.
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June 25, 2024
In High Court Loss, Anti-Abortion Atty Sees Win For Objectors
Erin Hawley of Alliance Defending Freedom, a top attorney of the anti-abortion movement, sees a "silver lining" in the recent U.S. Supreme Court opinion that maintained broad access to the abortion medication mifepristone: an endorsement of robust conscience protections for healthcare providers.
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June 25, 2024
For Pharma, High Court Abortion Drug Ruling Averts 'Chaos'
The pharmaceutical industry's relief over the recent U.S. Supreme Court decision on mifepristone goes well beyond the abortion medication at the center of the case.
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June 25, 2024
Tracking The FTC's Latest Moves In Healthcare
The Federal Trade Commission has its eye on the healthcare industry, targeting a range of deals the agency says would hurt competition and drive up prices. Law360 Healthcare Authority tracks recent FTC actions targeting hospital systems, digital health entities and pharmaceutical companies.
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June 25, 2024
Gov't Asks Ala. Fed. Court To Stay Gender Care Case
The Biden administration has asked an Alabama federal court to stay a suit challenging a state law criminalizing gender-affirming care for transgender youth, which has drawn attention because of judge-shopping allegations leveled against plaintiff's counsel, as the U.S. Supreme Court has agreed to hear a separate but potentially precedential suit.
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June 25, 2024
The Federal Judge At The Center Of NC Abortion Battles
A lone federal judge in North Carolina is playing an outsize role in abortion access cases critical to women seeking the procedures across much of the American South.
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June 25, 2024
Longtime Pediatrix Atty Joins Envision Healthcare As GC
The longtime top attorney for Pediatrix Medical Group Inc. has joined Nashville, Tennessee-based national medical group Envision Healthcare as its new general counsel.
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June 24, 2024
NYC Pharmacy Owners Get Jail Time For $18M Med Fraud
Two brothers who own several New York pharmacies will each have to pay over $18 million in restitution in addition to serving jail time for submitting fraudulent claims to Medicare for pricey cancer medication and funneling illicit proceeds through several shell companies, the U.S. Department of Justice announced Monday.
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June 24, 2024
Health Co. Narrows Doctor's Reneged Benefits Suit
An Arizona federal judge trimmed a doctor's suit claiming her healthcare system employer refused to let her use her benefits to take time off to undergo cancer treatments, but kept alive claims that the company violated state and federal law by misleading her about paid leave.
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June 24, 2024
LA Schools Says Pseudoscience Infected 9th Circ. Vax Ruling
The Los Angeles Unified School District said Friday that a split Ninth Circuit panel leaned on pseudoscience when ruling that a rescinded employee COVID-19 vaccination mandate implicated the right of district employees to refuse medical treatment, urging an en banc panel to correct the "fatally flawed" decision.
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June 24, 2024
Ark. AG Sues Pharmacy Benefit Managers Over Opioids
The Arkansas attorney general said Monday that he had sued pharmacy benefit managers Optum Inc. and Express Scripts Inc. in state court, claiming they contributed to the opioid crisis and profited from the drug epidemic.
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June 24, 2024
Justices Pass On Conn. School Vaccine Mandate Fight
The U.S. Supreme Court on Monday declined to review a Second Circuit decision that largely upheld the dismissal of a suit challenging a Connecticut law passed during the COVID-19 pandemic that revoked religious exemptions to student vaccine mandates.
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June 24, 2024
Justices Pass On Rutgers COVID-19 Vax Mandate Case
The U.S. Supreme Court declined on Monday to review a split Third Circuit ruling that Rutgers University students cannot challenge the school's COVID-19 vaccine policy because, under the high court's 1905 precedent in Jacobson v. Massachusetts, there is no fundamental right to refuse vaccinations.
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June 24, 2024
High Court To Review State Gender Care Bans
The U.S. Supreme Court on Monday agreed to review a Sixth Circuit decision that allowed Tennessee to keep in place a new ban on gender-affirming care for minors.
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June 24, 2024
Justices Won't Hear Objections To $2.67B BCBS Deal
The U.S. Supreme Court refused on Monday to review Home Depot's challenge of a $2.67 billion settlement in antitrust litigation targeting Blue Cross Blue Shield, along with a separate challenge of the attorney fees awarded for the deal.
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June 21, 2024
Texas Medical Board Adopts Abortion Records Requirement
Texas doctors who determine that an abortion is necessary during a pregnant patient's health crisis will face new recordkeeping requirements under a final rule issued Friday by the state's medical board.
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June 21, 2024
Attys Accused Of Judge Shopping Must Share Public Remarks
Attorneys accused of judge shopping two 2022 suits challenging an Alabama law criminalizing some gender-affirming care for transgender youths have been given 48 hours to turn over any public statements, releases or other information they or their organizations have shared about the disciplinary proceedings, just days ahead of a Monday hearing.
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June 21, 2024
5th Circ. Knocks Out National Block On ACA Preventive Care
The Fifth Circuit on Friday struck down a national injunction against Affordable Care Act requirements forcing insurers to cover a range of preventive treatments, but kept a block in place that prevents its application to the individuals and businesses in Texas that sued.
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June 21, 2024
Mount Sinai's Doctor Pacts Violate Labor Law, NLRB GC Says
New York's Mount Sinai Health System has illegally required part-time physicians to sign employment agreements with provisions that infringe on workers' rights, National Labor Relations Board prosecutors alleged, and the agency is seeking financial damages for affected employees.
Expert Analysis
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Patent Waiver For COVID Meds Would Harm US Biopharma
If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.
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New CMS Rule Will Change Nursing Facility Disclosures
A new rule from the Centers for Medicare & Medicaid Services significantly expands disclosure requirements for nursing facilities backed by private equity companies or real estate investment trusts, likely foreshadowing increased oversight that could include more targeted audits, say Janice Davis and Christopher Ronne at Morgan Lewis.
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Skirting Anti-Kickback Causation Standard Amid Circuit Split
Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.
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Gilead Ruling Signals That Innovating Can Lead To Liability
A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.
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Health Policy Legislative Landscape May Remain Frozen
With Congress again delaying the full resolution of fiscal year 2024 federal spending legislation, there is now an additional window in which Congress could work through several priority issues for healthcare stakeholders, though these issues are unlikely to be resolved in time, say attorneys at Faegre Drinker.
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Despite HHS Opinion, Gift Card Giveaways Require Caution
Though the U.S. Department of Health and Human Services' Office of Inspector General recently determined that a healthcare consulting firm's gift card plans do not violate the Anti-Kickback Statute, the opinion does not suggest blanket approval for providing gift cards in exchange for referrals, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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DOJ's Biopharma Settlement Raises Anti-Kickback Questions
In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.
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Where Justices Stand On Chevron Doctrine Post-Argument
Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.
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Bracing For Calif.'s New Health Transaction Framework
As California's new cost and market impact review regulations' April 1 date for its updated notice and review process approaches, healthcare entities should ready themselves for dramatic changes to the state's regulatory landscape and prepare for potentially substantial transaction delays, say Jordan Grushkin and Matthew Goldman at Sheppard Mullin.
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Uncharted Waters Ahead For FCA Litigation In 2024
Following a year of significant court decisions, settlements, recoveries and proposed amendments, 2024 promises to be a lively year for False Claims Act actions and litigation, and one that will hopefully provide more clarity as FCA jurisprudence evolves, say attorneys at Crowell & Moring.
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OIG Report Has Clues For 2024 Healthcare Fraud Enforcement
A recent report from the Health Department's Office of the Inspector General reveals healthcare fraud and abuse enforcement trends that will continue in 2024, from increased telehealth oversight to enhanced policing of managed care, say attorneys at Sheppard Mullin.
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FOIA Exemption Questions On Redacted HHS Cannabis Letter
The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.
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A Primer On New Calif. Health Transaction Reporting Rules
New California regulations regarding the reporting of certain transactions involving healthcare entities, which took effect on Jan. 1, address some industry feedback about overly broad requirements but still leave several areas of concern, says Andrew Demetriou at Husch Blackwell.