Policy & Compliance
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May 03, 2024
Ohio Statehouse Catch-Up: Trans, Abortion Laws Face Battles
Ohio lawmakers have shepherded controversial bills impacting healthcare, social media and other matters into law in recent months, prompting lawsuits and even a veto from Gov. Mike DeWine.
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May 03, 2024
6 States Strike $270M Opioid Deal With Amneal
The New York state attorney general on Friday said that a $270 million multistate deal had been reached with opioid manufacturer Amneal Pharmaceuticals for its role in the addiction epidemic over allegations that the company failed to report suspicious orders of the narcotics.
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May 02, 2024
7th Circ. Mostly Backs Ill. Home Health Kickbacks Judgment
The Seventh Circuit on Thursday largely left intact an Illinois federal judge's $6 million ruling that a home health care company broke federal kickback laws, refusing to reverse the lower court's liability finding but directing it to ensure its damages award was calculated correctly.
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May 02, 2024
Endo Judge Hopes Criminal Sentence Warns Opioid Makers
A Michigan federal judge said Thursday she hoped Endo's criminal sentence for falsely advertising a pain medication as "abuse deterrent" would itself be a deterrent for other opioid makers, as she accepted the company's recent $200 million settlement deal with federal prosecutors.
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May 02, 2024
Feds Call Out Gilead's Efforts To Revise HIV Drug IP Judgment
The U.S. Department of Justice has asked a Delaware federal judge to reject Gilead Sciences' motion to modify a judgment finding that two medications in its HIV prevention regimen directly infringe voided patents owned by the government, arguing that the pharmaceutical company's attempt to rewrite the judgment is "unnecessary as well as improper."
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May 02, 2024
Lawmaker Wants Antitrust Probe Of Health Insurance Data Co.
Sen. Amy Klobuchar, D-Minn., is calling for antitrust enforcers to investigate concerns that MultiPlan and other healthcare data companies are hurting competition by helping health insurers effectively collude when making pricing decisions.
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May 02, 2024
Biden Announces $3B To Fund Lead Pipe Replacement
The Biden administration is distributing $3 billion to states so they can replace lead water pipes that pose a health risk to those who rely on them for drinking water, as part of the larger goal to remove all lead service lines nationwide.
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May 02, 2024
State Legislators Urge Feds To Change Cannabis' Status
A coalition of state lawmakers on Thursday urged the heads of the U.S. Department of Justice and its drug enforcement agency to prioritize changing cannabis' status as a highly restricted drug.
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May 01, 2024
Sens. Slam UnitedHealth's Security Lapses, Breach Response
UnitedHealth's top executive faced heavy criticism during his first appearance before a U.S. Senate committee since a cyberattack rocked its Change Healthcare subsidiary, with lawmakers blasting the company for lacking basic security measures and for still not being able to confirm the scale and scope of the incident.
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May 01, 2024
Ariz. AG Warns Repeal Of 1864 Abortion Ban May Be Too Late
Legislation narrowly adopted Wednesday to repeal Arizona's 1864 abortion law won't be enough on its own to keep the near-total ban from taking effect this summer, the state attorney general warned, because the bill lacks an emergency clause.
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May 01, 2024
J&J Unit Cuts Deal To End Cancer Drug Trade Secret Fight
A New Jersey federal judge has signed off on a consent judgment that permanently bars Chinese drugmaker Jiangsu Hengrui Pharmaceuticals Co. from misappropriating Johnson and Johnson's pharmaceutical subsidiary Janssen's trade secrets for its popular chemotherapy drug Yondelis.
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May 01, 2024
5th Circ. Judge Skeptical Of Medicare Drug 'Price-Setting'
A Fifth Circuit judge on Wednesday sharply criticized the Biden administration's Medicare drug pricing program, characterizing it as government "price-setting" and questioning "what possible procompetitive justification" there can be for penalizing companies that don't participate.
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April 30, 2024
Ex-Olympus Exec Says He Was Fired For Flagging FDA Issue
The former global head of product development at medical manufacturer Olympus Corp. said he was fired earlier this year after he reported multiple compliance concerns regarding the company's practices and related to nearly 100 products, according to a suit filed Monday in Pennsylvania federal court.
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April 30, 2024
Judge Strikes Parts Of NC Law Restricting Abortion Drug
A North Carolina federal judge struck down parts of a state law Tuesday that restricts access to the abortion medication mifepristone, finding some provisions violate the U.S. Constitution's supremacy clause by enacting safety regulations already considered by the U.S. Food and Drug Administration, such as requiring in-person prescribing, dispensing and scheduling around the drug.
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April 30, 2024
BCBS Says Federal Drug Law Preempts NM Medical Weed Row
A group of insurers, including Blue Cross and Blue Shield of New Mexico, urged a New Mexico federal judge to reject a proposed class action seeking to compel them to cover their policyholders' medical marijuana costs, arguing that state law doesn't require it and federal law forbids it.
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April 30, 2024
Aetna Resists State Court Remand In Provider Payment Suit
A lawsuit alleging Aetna units have underpaid emergency healthcare workers' benefit claims should be heard in an Ohio federal court, the insurer said in opposing a remand to the state level, based in part on the argument that two of the corporate defendants don't belong in the case.
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April 30, 2024
Biden Rocks Healthcare Space With Rule After Rule
Using federal agencies as its instrument, the Biden administration pumped out numerous healthcare and life sciences rules in the past week, ranging from addressing discrimination in healthcare to requiring health apps to report data breaches to consumers.
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April 30, 2024
FTC Continues To Target 'Junk' Drug Patents
Federal trade officials told a series of pharmaceutical companies — including the makers of the controversial diabetes and weight loss drug Ozempic — that they may have listed faulty patents in a key register of a federal drug database.
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April 30, 2024
High Court's Conscience Concerns Offer Docs Little Guidance
At oral arguments in both abortion cases to reach the nation's top court this term, justices parried with the federal government over the knotty topic of doctors raising a personal objection to providing an abortion to a patient suffering a medical crisis.
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April 30, 2024
'Global' Budgets May Fix Hospital Spending. Will States Try It?
An ambitious experiment is underway that could shake up healthcare spending by moving providers away from a traditional fee-for-service model in favor of "global" hospital budgets. But with deadlines looming, the voluntary, "total cost of care" model can't deliver without state buy-in.
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April 30, 2024
6th Circ. Weighs Merits, Procedure In NLRB Severance Case
The Sixth Circuit grappled Tuesday with a hospital's challenge to the National Labor Relations Board's ruling that it unlawfully offered severance agreements that muzzled workers, with one judge questioning how the agreements interfered with workers' rights and another whether the hospital was even entitled to oppose the new standard.
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April 30, 2024
New Staffing Minimums Rattle Nursing Home Industry
A new Biden administration rule that sets minimum staffing standards for nursing homes could reshape the industry, intensifying the competition to hire nurses and exposing the facilities to new litigation and financial risks, healthcare attorneys say.
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April 30, 2024
Tougher Privacy Rule Won't End Abortion Data Fight
Healthcare attorneys welcomed enhanced federal protections for patient abortion records. But the new rule likely won't release providers from the bind of complying with federal privacy law while potentially facing out-of-state probes into sensitive patient information.
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April 30, 2024
Texas, Washington Spar In Rare Interstate Gender Care Clash
An investigation launched by the Texas attorney general into medical care 1,700 miles away in Washington triggered an unusual burst of litigation and a settlement, illustrating a potential new front in the legal fight over transgender rights.
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April 29, 2024
ReNew Health To Pay $7M To Settle COVID-19 FCA Claims
ReNew Health Group LLC has agreed to pay the federal government and California $7 million to settle whistleblower allegations that the healthcare provider misused a COVID-19 waiver intended to free up hospital beds by submitting fraudulent claims for nursing home residents, the U.S. Department of Justice announced Friday.
Expert Analysis
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Lessons For Nursing Facilities From DOJ Fraud Settlement
The U.S. Department of Justice's recent settlement with the owner of skilled nursing and assisted living facilities in Florida provides a cautionary tale of potential fraud risks, and lessons on how facilities can mitigate government enforcement actions, say Callan Stein and Rebecca Younker at Troutman Pepper.
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HHS' Updated Tracking Tech Guidance Offers Little Clarity
The U.S. Department of Health and Human Services' Office for Civil Rights' updated guidance on the use of online tracking technologies appears more focused on legal issues raised in ongoing litigation with the American Hospital Association and less on practical guidance for covered entities, say attorneys at Sheppard Mullin.
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Takeaways From The 2023 DOJ Fraud Section Report
Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.
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NIST March-In Framework Is As Problematic As 2021 Proposal
While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.
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Spartan Arbitration Tactics Against Well-Funded Opponents
Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.
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The Road Ahead For Florida's Drug Importation Program
Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.
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Assessing CDC's Revised Guideline On Opioid Prescriptions
Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.
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Valeant Ruling May Pave Way For Patent-Based FCA Suits
The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.
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Suits Against Insulin Pricing Are Driven By Rebate Addiction
A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.
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When Physician Retirement Arrangements May Be Legal
A recent advisory opinion from the Office of Inspector General regarding physician retirement arrangements sheds light on key considerations and mitigating factors that may be useful when attempting to balance healthcare operational needs with statutory conformity, says Magda Rodriguez at Day Pitney.
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ESG Around The World: Gulf Cooperation Council
The Gulf Cooperation Council is in the early stages of ESG policy implementation, but recent commitments by both states and corporations — including increases in sustainable finance transactions, environmental commitments, female representation on boards and human rights enforcement — show continuing progress toward broader ESG goals, say attorneys at Cleary.
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Navigating ACA Reporting Nuances As Deadlines Loom
Stephanie Lowe at Liebert Cassidy walks employers through need-to-know elements of Affordable Care Act reporting, including two quickly approaching deadlines, the updated affordability threshold, strategies for choosing an affordability safe harbor, and common coding pitfalls.
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Lessons From Rare Post-Verdict Healthcare Fraud Acquittal
A Maryland federal court recently overturned a jury verdict that found a doctor guilty of healthcare fraud related to billing levels for COVID-19 tests, providing defense attorneys with potential strategies for obtaining acquittals in similar prosecutions, says attorney Andrew Feldman.