Policy & Compliance
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December 03, 2024
VA Announces Study On MDMA-Assisted Therapy For Vets
The U.S. Department of Veterans Affairs announced Tuesday it will fund a study on psychedelic-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder, alongside researchers from Brown University and Yale University.
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December 03, 2024
FCA Whistleblower Provisions Could Face Peril Under Trump
Over 160 years after enactment of the False Claims Act and its qui tam provisions, the confluence of a conservative U.S. Supreme Court and a second Trump administration has attorneys contemplating a future without whistleblower-led litigation.
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December 03, 2024
Veterans Group Challenges Exclusion From DEA Pot Hearing
A veterans group is challenging the U.S. Drug Enforcement Administration's decision to deny it a spot among 25 participants in hearings exploring whether to reschedule cannabis under the Controlled Substances Act, saying veterans have been deprived of an advocate for a conclusion that would best suit their needs.
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December 03, 2024
GOP-Backed Medicaid Job Mandate Could Reshuffle Care
Medicaid work requirements — a much-debated idea expected to get fresh support in the next Trump administration — could jolt the nation's healthcare system by shrinking the number of people with health coverage and boosting uncompensated care at hospitals.
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December 02, 2024
House COVID-19 Probe Points to China 'Lab Leak'
The Republican-led House Select Subcommittee on the Coronavirus Pandemic published the results of its two-year investigation into the origins of the COVID-19 pandemic Monday, concluding that COVID-19 "most likely" emerged from a laboratory in Wuhan, China, and heavily criticizing the Biden administration, Anthony Fauci and left-leaning organizations for their responses.
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December 02, 2024
Newsom Wants $25M For Expected Legal Fights With Trump
California Gov. Gavin Newsom announced Monday that he wants up to $25 million for litigation and legal fights he foresees with the administration of President-elect Donald Trump, kicking off the first day of a special session the state Legislature held at the governor's request after Trump's win.
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December 02, 2024
9th Circ. Partially Upholds Block Of Idaho Abortion Travel Ban
A split Ninth Circuit panel on Monday upheld part of a lower court's temporary injunction to an Idaho law that criminalizes helping minors travel out of state to receive abortions without parental permission, finding the "recruiting" portion of the law is unconstitutional.
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November 27, 2024
Split Ohio High Court Revives Death Suit Against Pa. Doctor
An Ohio law that pauses the statute of limitations for lawsuits against parties who leave the state does not violate the dormant commerce clause of the U.S. Constitution because it neither facially discriminates against out-of-state entities nor has some economic protectionist purpose, the state Supreme Court ruled Wednesday.
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November 27, 2024
PBM Says Opioid Ruling Ignored High Court's Privilege Stance
A special master's ruling that internal audit records from Express Scripts Inc. are not protected by attorney-client privilege should be overturned because it contradicts nearly 40 years of U.S. Supreme Court precedent, the pharmacy benefit manager told an Ohio federal court overseeing multidistrict opioid litigation.
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November 27, 2024
Nonprofit Warns 3rd Circ. Against 'Abuse' In Merck Vax Case
The anti-monopoly think tank Open Markets Institute urged the full Third Circuit to rethink a panel's immunization of Merck & Co. Inc. from antitrust claims over its mumps vaccine, arguing in an amicus brief that the doctrine cementing the right to petition the government doesn't justify the use of courts and administration as a "competitive weapon."
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November 27, 2024
Up Next At The High Court: Transgender Care, Holocaust Art
The U.S. Supreme Court will return to the bench Monday for its December arguments session, which will include blockbuster questions about the constitutionality of state laws banning gender-affirming care for transgender minors and whether Hungary can be held liable for property stolen during World War II.
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November 27, 2024
Hospital Sued For Firing Tech Who Reported Lax Drugmaking
A pharmacy technician claims in Illinois state court that she was fired from Lurie Children's Hospital in Chicago for making complaints both internally and to state regulators that the medications for pediatric patients were being compounded in an unsanitary manner and that the facilities weren't being properly cleaned.
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November 26, 2024
Trump Taps Bhattacharya For National Institutes Of Health
President-elect Donald Trump announced Tuesday that he has selected Dr. Jay Bhattacharya, a physician who opposed the use of lockdowns and mask mandates to contain the spread of COVID-19, to lead the National Institutes of Health.
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November 26, 2024
NIH Beats 4th Circ. Bid To Unmask COVID Researcher
National Institutes of Health on Tuesday defeated a circuit court appeal by a whistleblower organization which had sought to uncover the identity of a Wuhan University researcher who submitted sequencing data to an open-access NIH archive.
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November 26, 2024
Colo. Panel Weighs In On Faulty Genetic Test Damages
A long-standing Colorado law limiting healthcare provider liability in certain negligence actions got its first interpretation, issued by a state appellate court panel.
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November 26, 2024
In Court: Abortion, Gender Care, PBMs and Insulin Pricing
An abortion ban bench trial in Idaho. A Texas high court decision on a "heartbeat" ban. A consumer protection agency delays medical debt guidance amid a legal challenge. Law360 Healthcare Authority looks at those and other significant decisions shaping the healthcare industry.
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November 26, 2024
Trump FDA Pick Devoted To Healthcare Price Transparency
The nomination of surgeon Marty Makary to lead the U.S. Food and Drug Administration elevates a healthcare transparency advocate who authored books on the subject and pushed for hospitals to disclose their standard prices during the first Trump administration.
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November 26, 2024
Meet The Attys Arguing Tenn. Trans Care Ban At High Court
Tennessee's solicitor general and the first openly transgender lawyer to appear before the U.S. Supreme Court are set to face off next week to debate the constitutionality of a state ban on gender-affirming care for minors.
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November 26, 2024
Pa. Nursing Home Eying Sale Seeks Fraud Sentencing Delay
The parent company for a troubled Western Pennsylvania nursing home asked a federal court to postpone a sentencing for defrauding state and federal healthcare programs so the company can keep trying to sell the facility, or at least relocate its residents over a longer period of time.
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November 25, 2024
At Trial, Ex-Clinic Head Accuses Seattle Hospital Of Race Bias
A Black ex-clinical director told a Washington state jury Monday that a Seattle hospital owes him millions of dollars for failing to address a "culture of racism" targeting him and the patients of color he advocated for while leading a clinic with a purported mission of advancing equity.
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November 25, 2024
Missouri Gender-Affirming Care Ban Upheld As Constitutional
A Missouri state judge rejected a legal challenge to the state's ban on providing gender-affirming care to minors and adults, finding Monday the court should defer to the Legislature given that challengers hadn't proven the restrictions violated the U.S. Constitution.
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November 25, 2024
5th Circ. Upholds Miss. Ban On Medical Pot Ads
Marijuana dispensaries do not have protections under the First Amendment to advertise their products because the drug is still illicit under federal law, the Fifth Circuit ruled, tossing a lawsuit that sought to upend the state's tight regulations on cannabis ads.
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November 22, 2024
MultiCare $2M Deal Ends Fed's ADA Missing Interpreter Probe
MultiCare Health Systems of Washington will set aside $2 million in compensation to end a federal civil rights investigation into complaints the hospital operator failed to provide interpreters for deaf-blind patients before and after surgery.
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November 22, 2024
Texas Justices Say Court Bungled Ruling In Abortion Case
The Texas Supreme Court said Friday a lower appellate court tried to "prematurely drag the judiciary into highly contentious and politicized debates" around abortion without analyzing a key standing issue, jeopardizing Planned Parenthood's and other abortion rights groups' bid to invalidate the controversial Texas Heartbeat Act.
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November 22, 2024
Texas Panel Says Gender-Affirming Surgery Suit Too Late
A Texas appellate court has backed a counselor's win in a lawsuit from a former client who came to regret undergoing a double mastectomy following the counselor's recommendation for gender-affirming surgery, finding the claims were time-barred.
Expert Analysis
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Plan Sponsors Must Prep For New Mental Health, Drug Rules
To comply with newly published health insurance rules requiring parity between access to mental health and substance use services compared to medical and surgical services, employers with self-insured plans will need to update third-party administrator agreements and collect data, among other compliance steps, say attorneys at Kilpatrick.
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A Primer On Navigating The Conrad 30 Immigration Program
As the Conrad 30 program opens its annual window to help place immigrant physicians in medically underserved areas, employers and physicians engaged in the process must carefully understand the program's nuanced requirements, say Andrew Desposito and Greg Berk at Sheppard Mullin.
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Class Actions At The Circuit Courts: September Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy identifies practice tips from four recent class certification rulings involving denial of Medicare reimbursements, automobile insurance disputes, veterans' rights and automobile defects.
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Proposed Legislation May Crack Down On Online Drug Ads
A bill recently proposed in Congress could serve as a sea change in how the U.S. Food and Drug Administration regulates drug-related speech, with significant trickle-down effects on various corners of not only the drug industry but also on consumers and providers themselves, say Dominick DiSabatino and Arushi Pandya at Sheppard Mullin.
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What To Expect From Calif. Bill Regulating PE In Healthcare
A California bill currently awaiting Gov. Gavin Newsom's approval, intended to increase oversight over private equity and hedge fund investments in healthcare, is emblematic of recent increased scrutiny of investments in the space, and may affect transactions and operations in California in a number of ways, say attorneys at Ropes & Gray.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.
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Managing Community Health Needs Assessments: A Checklist
Excerpt from Practical Guidance
To guide nonprofit hospitals and health systems through their required community health needs assessment every three years, this checklist outlines the steps for 12 phases of the process.
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Pa. Health Employers Must Prep For Noncompete Restrictions
Newly enacted legislation in Pennsylvania prohibits certain noncompete covenants for healthcare practitioners in the state beginning next year, creating compliance challenges that both employers and employees should be aware of, say attorneys at Buchanan Ingersoll.
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FTC Focus: What Access To Patent Settlements Would Mean
Settling parties should adopt a series of practice tips, including specifying rationales to support specific terms, as the Federal Trade Commission seeks to expand its access to settlements before the Patent Trial and Appeal Board, say Shannon McGowan and David Munkittrick at Proskauer.
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Agencies Should Reward Corporate Cyber Victim Cooperation
The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.
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Strategies To Defend Against Healthcare Nuclear Verdicts
The healthcare industry is increasingly the target of megaclaims, particularly those alleging medical malpractice, but attorneys representing providers can use a few tools to push back on flimsy litigation and reduce the likelihood of a nuclear verdict, says LaMar Jost at Wheeler Trigg.