Policy & Compliance
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December 20, 2024
Top NJ Cases Of 2024: COVID Test Kits And Political Favors
After failed attempts in previous years, 2024 was the year prosecutors secured convictions in separate cases against a longtime New Jersey senator and a healthcare software executive. In another closely watched white collar matter, a Garden State law firm executive met his fate for stealing from his employer.
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December 19, 2024
PhRMA Wins Bid To Halt W.Va. Drug Discount Expansion Law
The country's biggest pharmaceutical lobbying group has won preliminary injunctions against a West Virginia law that the Pharmaceutical Research and Manufacturers of America claims unconstitutionally expands a federal drug discount program, with a federal judge finding that the law threatens to create a situation where "the fox guards the henhouse."
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December 19, 2024
FTC Says PBMs Can't Get Preliminary Block In Insulin Case
The Federal Trade Commission urged a Missouri federal judge Thursday not to temporarily block its in-house case accusing pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes, arguing Congress clearly empowered such in-house adjudications and the officials who handle them.
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December 19, 2024
9 Charged In $20M Medicaid Fraud Linked To Philly Pharmacy
Nine people associated with a South Philadelphia pharmacy have been charged with an alleged five-year scheme to defraud Medicare and Medicaid out of $20 million by submitting false claims for prescription reimbursement of expensive medications like HIV drugs, the Pennsylvania Attorney General's Office said Thursday.
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December 19, 2024
Generic-Drug Cos. Get State AGs' Trial Order Flipped
A Connecticut federal court has sided with the generic-drug makers accused of price-fixing by state-level enforcers and will allow a narrower case involving 15 drugs to move ahead prior to a much broader case involving more than 100 medications.
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December 19, 2024
FDA Declaration May Restart Compounders' Shortage Suit
Federal regulators pulled Eli Lilly's lucrative weight-loss and diabetes drug off the national shortage list Thursday and gave compounding pharmacists two months to stop making copycat versions of the injectable medication, a move with the potential to reignite a Texas legal clash.
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December 19, 2024
Addiction Group Pays $2M In Mass. AG False Billing Probe
An addiction treatment physician group with offices across western Massachusetts will pay $2 million to settle allegations that it overcharged for visits and billed for tests that were not medically necessary, the state's attorney general said Thursday.
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December 19, 2024
NYU Langone Wrongly Exempts IT Workers From OT, Suit Says
New York University's academic medical center improperly classifies information technology workers as overtime-exempt despite their duties not falling under an exemption, causing them to lose out on extra wages, a proposed class and collective action filed in New York federal court said.
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December 18, 2024
Patent Limits For Biosimilar Litigation Lands In Spending Bill
Congress' spending package to keep the government open through March would also limit how many patents a biologics maker can assert when trying to prevent a competitor from getting on the market.
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December 18, 2024
FDA's Gastro Drug Fast-Track Denial Survives DC Circ.
A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.
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December 18, 2024
Destroyed Docs Merit Harsher Sanctions, Mich. Panel Says
A Michigan appellate panel on Tuesday said fees awarded to the estate of a man who died after choking in an adult foster care facility were likely too low, finding a lower court erred by limiting the scope of available sanctions over the destruction of "copious amounts" of digital evidence.
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December 18, 2024
Philip Morris Sues FDA Over New Cigarette Warning Labels
Tobacco giant Philip Morris and a group of Georgia convenience store interests have sued the U.S. Food and Drug Administration over a rule that would add graphic warnings to cigarette labels, alleging the agency is exceeding its statutory authority in a move that would mark a "sea change" for the industry.
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December 18, 2024
CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say
The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety.
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December 18, 2024
FTC Wants Express Scripts' Defamation Suit Tossed
The Federal Trade Commission told a Missouri federal court that Express Scripts Inc. has no basis to challenge an interim agency report that only offered "qualified conclusions" from an ongoing study about how pharmacy benefit managers affect prescription drug prices.
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December 18, 2024
Senate Sends $895B Defense Bill To Biden's Desk
The U.S. Senate on Wednesday easily passed an $895.2 billion defense policy and budget bill for 2025, despite criticism over a contentious clause effectively barring gender-affirming healthcare coverage for service members' transgender children.
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December 18, 2024
Top Conn. Cases Of 2024: Kickbacks, Paybacks And Bribes
Judges and juries in Connecticut awarded several multimillion-dollar verdicts against companies big and small in 2024, socking Johnson & Johnson in a talc case in which the already substantial damages could multiply and ordering a pharmacy that paid kickbacks to cough up nearly four times the money it cost the state.
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December 18, 2024
Justices Will Decide If Medicaid Recipients Can Pick Providers
The U.S. Supreme Court on Wednesday partially granted the state of South Carolina's petition to review a Fourth Circuit decision blocking its Medicaid program from ending its provider agreement with Planned Parenthood, agreeing to determine if the Medicaid Act allows a beneficiary to choose a specific provider.
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December 17, 2024
NC Panel Revives Negligence Suit Against State Health Dept.
An adult care center's constitutional claims accusing the North Carolina Department of Health and Human Services of negligently asserting bogus penalties and unfairly suspending admissions at the facility are timely, a North Carolina state appellate panel ruled Tuesday, reviving a case that previously landed before the North Carolina Supreme Court.
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December 17, 2024
3 Healthcare Decisions This Week You Don't Want To Miss
The Third Circuit issued a precedential ruling allowing Pennsylvania to dip into the $300 million budget surplus of an insurance fund for doctors facing medical malpractice claims. Meanwhile in Texas, a split appellate panel found that a member of a national hospital chain can enforce an arbitration agreement with an employee.
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December 17, 2024
Express Scripts, OptumRx Can't Ditch LA County Opioid Suit
A California judge ruled Tuesday that Los Angeles County can keep pursuing a lawsuit claiming pharmacy benefit managers Express Scripts and OptumRx colluded with drugmakers to fuel the opioid epidemic, though the county must rework its complaint to specify how regulators were allegedly deceived.
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December 17, 2024
House GOP Asks CVS How Its PBM Treats Smaller Pharmacies
Lawmakers on Capitol Hill are demanding documents from CVS on its pharmacy benefit manager's treatment of independent pharmacies, continuing to press the healthcare giant over potentially anticompetitive conduct.
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December 17, 2024
Feds Intervene In $200M FCA Case Against CVS
The federal government has intervened in a whistleblower case accusing CVS and its subsidiaries of pocketing more than $200 million in overpayments, in order to defend the constitutionality of the False Claims Act's whistleblower provisions.
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December 17, 2024
5th Circ. Preserves Feds' ACA Trans Health Policy
The Fifth Circuit upended a Texas court decision that invalidated a federal agency interpretation of the Affordable Care Act's provision on nondiscrimination in healthcare, keeping intact federal policy that prohibits insurers from discriminating against individuals seeking treatment for gender dysphoria.
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December 17, 2024
Nurse Survey Rule Case Sheds Light On Loper At 2nd Circ.
A legal challenge over a federal rule saying registered nurses aren’t required at Medicaid compliance inspections is at the center of a Second Circuit case that promises to shed light on how courts could use the Loper Bright decision.
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December 16, 2024
Pa. Malpractice Fund Belongs To State, 3rd Circ. Rules
The Third Circuit said Monday in a precedential ruling that Pennsylvania's medical malpractice insurance fund is an agency of the state and that it can dip into the fund's $300 million budget surplus.
Expert Analysis
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White House Activity Is A Band-Aid For Regulating AI In Health
In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.
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Understanding Discovery Obligations In Era Of Generative AI
Excerpt from Practical Guidance
Attorneys and businesses must adapt to the unique discovery challenges presented by generative artificial intelligence, such as chatbot content and prompts, while upholding the principles of fairness, transparency and compliance with legal obligations in federal civil litigation, say attorneys at King & Spalding.
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How Mental Health Ruling Paves Road For Equal Coverage
The Tenth Circuit’s recent ruling in E.W. v. Health Net, which clarified the pleading requirements necessary to establish a Mental Health Parity and Addiction Equity Act violation, is a win for plaintiffs as it opens the door to those who have been denied coverage for behavioral health treatment to prove a mental health parity violation, says Mark DeBofsky at DeBofsky Law.
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ESG Around The World: Mexico
ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.
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The Case For Post-Bar Clerk Training Programs At Law Firms
In today's competitive legal hiring market, an intentionally designed training program for law school graduates awaiting bar admission can be an effective way of creating a pipeline of qualified candidates, says Brent Daub at Gilson Daub.
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10 Takeaways From New HHS Federal Compliance Guidelines
The U.S. Department of Health and Human Services' recently issued general compliance program guidance is the first of its kind that would apply across all health care stakeholders, and signals the agency’s first step to improve and update existing compliance guidance, says Melissa Wong at Holland & Knight.
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2 HHS Warnings Highlight Anti-Kickback Risks For Physicians
Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.
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Attorneys Have An Ethical Duty To Protect The Judiciary
The tenor of public disagreement and debate has become increasingly hostile against judges, and though the legislative branch is trying to ameliorate this safety gap, lawyers have a moral imperative and professional requirement to stand with judges in defusing attacks against them and their rulings, says Deborah Winokur at Cozen O'Connor.
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Cross-Market Implications In FTC's Anesthesia Complaint
The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.
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AI Can Help Lawyers Overcome The Programming Barrier
Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.
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Preparing Law Students For A New, AI-Assisted Legal World
As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.
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ESG Around The World: South Korea
Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.
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General Counsel Need Data Literacy To Keep Up With AI
With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.