Policy & Compliance
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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.
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July 02, 2024
Chamber, Pharma Slam Colorado Drug Price Controls
The U.S. Chamber of Commerce and a prominent pharmaceutical industry group have urged a Colorado federal court to bar a state review board from setting price controls on prescription drugs, arguing that the practice is "irreconcilable" with federal patent law.
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July 02, 2024
Ga. Justices Say COVID Order Tolls Med Mal Repose Statute
The Georgia Supreme Court on Tuesday said that a judicial emergency order handed down during the COVID-19 pandemic can be used to toll the state's five-year medical malpractice statute of repose.
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July 02, 2024
Abortion, Trans Healthcare Top Lower Court Litigation
Major healthcare decisions at the U.S. Supreme Court dominated the headlines in recent weeks. But there has also been significant movement in state and other appellate courts on the Affordable Care Act, Medicaid coverage, and transgender care, and among other weighty matters. Law360 Healthcare Authority looks at the significant disputes and decisions that shaped the industry over the last week.
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July 02, 2024
Arizona AG Abortion Opinion May Influence Courts, Doctors
A new advisory opinion reassuring Arizona doctors they can use their good-faith judgment to provide an emergency abortion, despite a 15-week state ban, isn’t binding on the courts. But it may still exert influence on judges and prosecutors in a state with a fast-changing abortion landscape.
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July 02, 2024
Veteran Medicare Advocate Judy Stein Welcomes 'New Cadre'
In 1986, Connecticut attorney Judy Stein took out a loan to launch the Center for Medicare Advocacy in a one-room office above a bakery. Today, she's reflecting on a career fighting for people in need of healthcare support, including the landmark Jimmo settlement, as she welcomes new leadership to the group.
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July 02, 2024
3rd Circ. Asked To Remand OT Suit After Justices' Ruling
Three home care companies in overtime disputes with the U.S. Department of Labor urged the Third Circuit to reverse and remand a ruling that they waited too long to challenge a 2013 ruling on in-home caregivers' ability to earn minimum wage under a new U.S. Supreme Court precedent.
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July 01, 2024
Ill., Northshore Say Anti-Vax Case Not About Religious Liberty
A nurse working for a Northshore Health unit in Illinois should be permanently blocked from pursuing employment deprivation claims over her initial denial of a COVD-19 religious vaccine exemption, the health facility said, arguing she is using a state conscience law as a "sword" against COVID-19 protections.
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July 01, 2024
House Republicans Call For ACA Enrollment Probe
Three House Republican committee chairs are asking government watchdogs to investigate Affordable Care Act enrollments after a third-party report alleged a significant number of Americans are fraudulently accessing low-income healthcare subsidies.
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July 01, 2024
NC Doctor Takes Abortion Drug Limits Fight To 4th Circ.
A North Carolina doctor who challenged the state's restrictions on abortion drug mifepristone asked the Fourth Circuit to review a district court's decision to allow certain limits to stand.
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July 01, 2024
Jury Sides With Amazon In Suit Over Post-Surgery Leave
Amazon didn't have to give a former employee additional time off after gum disease surgery because she wasn't entitled to medical leave and didn't have a disability under federal law, a Florida federal jury found as it sided with the company.
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June 28, 2024
Chevron's End Is Just The Start For Energized Agency Foes
By knocking down a powerful precedent that has towered over administrative law for 40 years, the U.S. Supreme Court's right wing Friday gave a crowning achievement to anti-agency attorneys. But for those attorneys, the achievement is merely a means to an end, and experts expect a litigation blitzkrieg to materialize quickly in the aftermath.
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June 28, 2024
Texas Justices Back Ban On Gender Affirming Care For Minors
The Texas Supreme Court upheld a state ban on medical treatments that affirm the gender identity of transgender youths, saying Friday that the legislature "made a permissible, rational policy choice," though a dissenting justice said the court allowed the state "to legislate away fundamental parental rights."
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June 28, 2024
In Chevron Case, Justices Trade One Unknown For Another
The U.S. Supreme Court's decision to overrule a decades-old judicial deference doctrine may cause the "eternal fog of uncertainty" surrounding federal agency actions to dissipate and level the playing field in challenges of government policies, but lawyers warn it raises new questions over what rules courts must follow and how judges will implement them.
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June 28, 2024
Ontrak Exec Conviction Shows Trading Plans Aren't Shields
Executives who use so-called Rule 10b5-1 trading plans to buy and sell shares of their company's stock don't have an automatic shield against insider trading charges, attorneys said following the first criminal conviction of an executive based exclusively on his use of the plans, which are facing increased scrutiny from financial regulators.
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June 28, 2024
Health Regulators Likely To Tread Carefully Post-Chevron
The demise of Chevron deference at the U.S. Supreme Court on Friday will likely encourage or fortify challenges to agency rulemaking on matters of health policy in the U.S., from Medicare reimbursement decisions to FDA rules on laboratory-developed tests.
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June 28, 2024
Shifting Legal Positions Behind High Court Abortion Punt
Rapid developments in Idaho abortion law paved the way for a fractured U.S. Supreme Court decision that leaves doctors in the state in murky legal waters around providing abortions to patients in medical crisis.
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June 28, 2024
Iowa Supreme Court Approves 6-Week Abortion Ban
The Iowa Supreme Court narrowly ruled Friday that the state can enforce a law restricting abortion after about six weeks of pregnancy, finding the state has a "legitimate interest in protecting unborn life," according to the majority opinion.
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June 28, 2024
Supreme Court Strikes Down Chevron Deference
The U.S. Supreme Court on Friday overturned a decades-old precedent that instructed judges about when they could defer to federal agencies' interpretations of law in rulemaking, depriving courts of a commonly used analytic tool and leaving lots of questions about what comes next.
![(iStock.com/pcess609)](https://assets.law360news.com/1854000/1854477/0fcd19d657fd232307c7697ca6d2b0d534ec53a0-istock-1351646522-patient.jpg)
4 Takeaways From FDA's Clinical Trial Diversity Guidance
Long-awaited U.S. Food and Drug Administration guidance sheds new light on clinical trial action plans meant to improve health outcomes for more populations. Here are four takeaways from the FDA's latest clinical trial diversity guidelines.
![Trans Youth From Over 16 States Gather At The Nation's Capitol For The First Trans Youth Prom
WASHINGTON, DC - MAY 22: Trans kids and additional activists march to the U.S. Supreme Court following the end of the "Trans Youth Prom" on May 22, 2023 in Washington, DC. Trans and non-binary youth gathered outside of the U.S. Capitol Building to hold a Prom like event that included music, dancing and speeches. (Photo by Anna Moneymaker/Getty Images)](https://assets.law360news.com/1851000/1851094/e533f1d2f208c637fbed3cda9f389658bc606f9c-gettyimages-1492428949.jpg)
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.
![Adderall XR capsules are displayed on Feb. 24, 2023. Prescriptions for ADHD treatments surged among adults during the COVID-19 pandemic, helping to fuel lingering shortages that are frustrating parents and doctors. A study published Wednesday, Jan. 10, 2024 in JAMA Psychiatry says new prescriptions for stimulants used to treat the condition jumped 30% for young adults and women during a two-year window after the pandemic hit in March 2020. (AP Photo/Jenny Kane)](https://assets.law360news.com/1849000/1849233/13a25983821d8364167d764d8d9df3135e848602-drug_shortages-adhd_treatments_57633.jpg)
Adderall Indictment Shows DOJ Focus On Telehealth Drugs
The arrest of two digital health executives accused of conspiring to illegally distribute Adderall online is a "shot across the bow" from federal prosecutors ramping up enforcement of telehealth fraud.
Expert Analysis
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USPTO Disclaimer Rule Would Complicate Patent Prosecution
The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.
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Navigating Scrutiny Of Friendly Professional Corps. In Calif.
In light of ongoing scrutiny and challenges to private equity participation in the California healthcare marketplace, particularly surrounding the use of the friendly professional corporation model, management services organizations should consider implementing four best practices, say attorneys at Holland & Knight.
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Takeaways From New HHS Substance Use Disorder Info Rules
A new U.S. Department of Health and Human Services rule continues the agency's efforts to harmonize complex rules surrounding confidentiality provisions for substance use disorder patient records, though healthcare providers will need to remain mindful of different potentially applicable requirements and changes that their compliance structures may require, say attorneys at Ropes & Gray.
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Calif. Banking Brief: All The Notable Legal Updates In Q2
The second quarter of 2024 in California, which saw efforts to expand consumer protection legislation and enforcement actions in areas of federal focus like medical debt and student loans, demonstrated that the state's role as a trendsetter in consumer financial protection will continue for the foreseeable future, say attorneys at Sheppard Mullin.
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How Cannabis Rescheduling May Affect Current Operators
The U.S. Drug Enforcement Agency's proposal to reschedule marijuana to Schedule III provides relief in the form of federal policy from the stigma and burdens of Schedule I, but commercial cannabis operations will remain unchanged until the federal-state cannabis policy gap is remedied by Congress, say Meital Manzuri and Alexis Lazzeri at Manzuri Law.
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Air Ambulance Ruling Severely Undermines No Surprises Act
A Texas federal court's recent decision in Guardian Flight v. Health Care Service — that the No Surprises Act lacks a judicial remedy when a health insurer refuses to pay the amount established through an independent review — likely throws a huge monkey wrench into the elaborate protections the NSA was enacted to provide, says Mark DeBofsky at DeBofsky Law.
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Class Actions At The Circuit Courts: June Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers two recent decisions from the Third and Tenth Circuits, and identifies practice tips around class action settlements and standing in securities litigation.
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How Congress Is Tackling The US Healthcare Shortage
With healthcare shortages continuing across the U.S. despite industry efforts to improve patient access to care, increased Medicare support for graduate medical education could be a crucial component of the solution, say Sarah Crossan and Miranda Franco at Holland & Knight.
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The Current State Of Healthcare Transaction Reviews In Calif.
As of April, certain healthcare transactions in California have been subject to additional notification compliance requirements, and complying with these new rules could significantly delay and discourage some deals, says Andrew Demetriou at Husch Blackwell.
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High Court's Abortion Pill Ruling Shuts Out Future Challenges
The U.S. Supreme Court's unanimous ruling in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine maintains the status quo for mifepristone access and rejects the plaintiffs' standing theories so thoroughly that future challenges from states or other plaintiffs are unlikely to be viable, say Jaime Santos and Annaka Nava at Goodwin.
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Orange Book Warnings Highlight FTC's Drug Price Focus
In light of heightened regulatory scrutiny surrounding drug pricing and the Federal Trade Commission's activity in the recent Teva v. Amneal case, branded drug manufacturers should expect the FTC's campaign against allegedly improper Orange Book listings to continue, say attorneys at Ropes & Gray.
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A Plaintiffs-Side Approach To Cochlear Implant Cases
As the number of cochlear implants in the U.S. continues to grow, some will inevitably fail — especially considering that many recalled implants remain in use — plaintiffs attorneys should proactively prepare for litigation over defective implants, says David Shoop at Shoop.
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Inside Antitrust Agencies' Rollup And Serial Acquisition Moves
The recent request for public comments on serial acquisitions and rollup strategies from the Federal Trade Commission and U.S. Justice Department mark the antitrust agencies' continued focus on actions that fall below premerger reporting thresholds, say attorneys at Paul Weiss.