Policy & Compliance
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September 04, 2024
10th Circ. Partially Nixes Insurer Win In Liposuction Death Suit
The Tenth Circuit on Wednesday revived a health provider's bad faith claim against its insurer over coverage for a $60 million judgment stemming from a woman's fatal liposuction surgery, finding the claim fell within a four-year period of limitations for insurance bad faith claims.
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September 04, 2024
UBH Wins On Parity In Family's Mental Health Benefits Fight
A Utah federal judge has handed mixed results to United Behavioral Health and a father whose child was partially denied coverage for mental health treatment at two residential treatment centers.
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September 04, 2024
Chamber Backs Gilead's Immunity In COVID Appeal
The U.S. Chamber of Commerce and a trade association representing drug companies have urged a Michigan state appeals court to rule that Gilead Sciences is immune from a claim that a recalled batch of COVID-19 medication caused a man to suffer two strokes.
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September 04, 2024
Glenmark Will Pay $25M To End Feds' Price-Fixing Suit
Glenmark Pharmaceuticals USA will pay $25 million to resolve allegations that it violated the False Claims Act by conspiring to fix the price of a generic high cholesterol drug, federal prosecutors announced Wednesday.
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September 04, 2024
Arnold & Porter Adds Mintz Healthcare Enforcement Leader
After setting up shop in Boston a little less than a year ago, Arnold & Porter Kaye Scholer LLP announced Tuesday that it was welcoming the co-chair of Mintz Levin Cohn Ferris Glovsky and Popeo PC's healthcare enforcement defense group.
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September 03, 2024
Teva Investors Get Go-Ahead To Resume Kickbacks Class Suit
A shareholder's certified class action against pharmaceutical company Teva can resume after being paused for two years, as the company says it is working towards a settlement with the U.S. Department of Justice over related claims it used kickbacks to raise the price of its multiple sclerosis drug Copaxone, a Philadelphia federal judge has decided.
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September 03, 2024
5th Circ. Grills Feds On Congress' Intent In No Surprises Act
A Fifth Circuit panel on Tuesday challenged the federal government over its interpretation of how it applies a formula to calculate qualifying payments under a law meant to protect Americans from surprise medical bills and questioned the arbitration process over the payments that a medical association said favors insurers.
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September 03, 2024
Meet The Zuckerman Spaeder Attys In Drug Rebate Battle
A pair of Zuckerman Spaeder LLP attorneys who once oversaw changes to the 340B drug discount program during the Obama administration have teamed up again to defend the program from what they call an attempt by the pharmaceutical industry to weaken its benefits.
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September 03, 2024
Justices Deny Oklahoma's Bid To Block HHS Funding Cut
The U.S. Supreme Court on Tuesday denied Oklahoma's request to stop the U.S. Department of Health and Human Services from cutting funding over the state's refusal to refer family planning patients for abortion after the high court's Dobbs decision last year.
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September 03, 2024
2nd Circ. Won't Ax Dad's Removal Over Child's Mental Health
The Second Circuit ruled Tuesday that a man who entered the U.S. illegally more than two decades ago can't cancel his removal on the grounds that it would cause his daughter hardship, ruling that any adverse impacts would be typical of family separation.
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September 03, 2024
Ohio AG Asks Appeals Court To Affirm Trans Care Restrictions
Ohio lawmakers acted within their authority to regulate the practice of medicine when they passed a law this year that restricts gender-affirming care for minors and prohibits transgender girls from participating in girls sports, Ohio Attorney General Dave Yost told the state appeals court in a recent brief.
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September 03, 2024
Will Medicaid Incarceration Waivers Hit 'Cutting Room Floor'?
A bipartisan push to get incarcerated individuals covered by Medicaid before they're released could drastically reduce healthcare disparities and provide health equity to underrepresented populations. But shifting political winds and an upcoming election could lead to budget cuts that put the program on the "cutting room floor."
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September 03, 2024
'Showdown' Looms As J&J Pursues Rebates In 340B Program
Johnson & Johnson's plan to abandon upfront discounts and instead offer rebates for two popular medications under the 340B drug pricing law would fundamentally alter how the program has worked for decades. Federal enforcement efforts and other legal clashes are likely.
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September 03, 2024
Glenmark Hit With $50M Suit Over Potassium Pill Death
A proposed class of buyers is suing Glenmark Pharmaceuticals Inc. for more than $50 million, alleging that the company's extended-release potassium chloride capsules are defective and instead deliver the potassium too fast, which resulted in the death of the lead plaintiff's mother.
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August 30, 2024
Vets, Attys Urge Supreme Court To Topple Feres Doctrine
Veterans groups and lawmakers contend it's "high time" for the U.S. Supreme Court to scrap its 74-year-old doctrine prohibiting military service members and their families from suing the U.S. for negligence, arguing the vague rule has left soldiers with fewer rights than prisoners and noncitizens.
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August 30, 2024
Connecticut Judge Wants More Info In Doctors' Billing Row
A Connecticut federal judge on Friday declined to immediately dismiss a medical staffing company's lawsuit against Harvard Pilgrim Health Care of Connecticut Inc. after the state's highest court answered three certified questions in the insurer's favor, asking for briefs after the insurer countered with a demand for a judgment.
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August 30, 2024
HHS Wins Escape From Low-Income Hospital Payment Fight
A D.C. federal judge on Friday agreed to toss a lawsuit brought by a group of hospitals against the U.S. Department of Health and Human Services challenging its Medicare payment determinations for low-income patients, finding the hospitals didn't exhaust their administrative remedies.
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August 30, 2024
Nebraska Expected To Vote On Medical Marijuana Legalization
Medical marijuana advocates have met the requirements to put a legalization question before Nebraska voters on Election Day this November, the secretary of state announced Friday.
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November 17, 2023
HHS Seeks Exit From Low-Income Hospital Payment Rule Suit
The U.S. Department of Health and Human Services asked a D.C. federal court Thursday to dismiss a lawsuit from a group of hospitals challenging Medicare payment determinations for low-income patients, the same day the court rejected the hospitals' request to continue pausing the case.
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August 29, 2024
Sutter Health Kickback Fight Likely Headed To Nov. Trial
A California federal judge indicated Wednesday she's likely to send at least some claims in a whistleblower's kickback suit against Sutter Health and a surgical-practice group to a November trial, saying during a hearing there are disputes over the credibility of certain evidence and that's "the providence of the jury."
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August 29, 2024
Comer Tells PBMs To Correct Record On Role In Drug Pricing
Rep. James Comer, R-Ky., chair of the House Oversight and Accountability Committee, is demanding that the heads of three major pharmacy benefit managers "correct the record" on their testimony made before his committee in July about their roles in drug pricing, including company claims that the PBMs don't steer customers to in-house pharmacies and that they allow non-affiliated pharmacies to negotiate contracts.
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August 29, 2024
Conn. ER Docs Ask To Drop Harvard Pilgrim Insurance Fight
A staffing company covering six Connecticut emergency rooms has asked a federal judge to dismiss its lawsuit against Harvard Pilgrim Health Care of Connecticut Inc. after the state's highest court last week ruled in the insurer's favor on three certified questions of law regarding a surprise billing statute.
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August 29, 2024
HHS Withdraws Appeal In Hospital Web-Tracking Clash
The Biden administration on Thursday abandoned its appeal of a federal court decision that knocked down new guidance restricting how hospitals can use web-tracking tools, handing the American Hospital Association a victory in a closely watched case.
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August 29, 2024
Full 11th Circ. Won't Rehear Ala. Trans Care Ban Challenge
The Eleventh Circuit said it will not reconsider its ruling allowing Alabama to enact a ban on certain gender-affirming medical care for minors, knocking down a challenge brought by parents and those who received the treatment of the circuit's ruling, which found that the ban doesn't flout constitutional rights.
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August 29, 2024
GOP States Ask Justices To Undo Trans Patients' 4th Circ. Win
A group of two dozen Republican attorneys general told the U.S. Supreme Court it should review a Fourth Circuit decision barring West Virginia and North Carolina from excluding coverage of gender-affirming medical care for transgender people, arguing states need the power to control controversial nascent treatments.
Expert Analysis
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Why DOJ's Whistleblower Program May Have Limited Impact
The U.S. Department of Justice’s new whistleblower pilot program aims to incentivize individuals to report corporate misconduct, but the program's effectiveness may be undercut by its differences from other federal agencies’ whistleblower programs and its interplay with other DOJ policies, say attorneys at Milbank.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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What Cos. Should Note In DOJ's New Whistleblower Pilot
After the U.S. Department of Justice unveiled a new whistleblower pilot program last week — continuing its efforts to incentivize individual reporting of misconduct — companies should review the eligibility criteria, update their compliance programs and consider the risks and benefits of making their own self-disclosures, say attorneys at Skadden.
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Motion To Transfer Venue Considerations For FCA Cases
Several recent decisions highlight the importance for practitioners of analyzing as early as possible whether a False Claims Act case warrants a change of venue, and understanding how courts weigh certain factors for defendants versus whistleblowers, say Ellen London at London & Stout, and Li Yu and Corey Lipton at DiCello Levitt.
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.
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CFPB's Medical Debt Proposal May Have Side Effects
The Consumer Financial Protection Bureau’s recent proposal to prevent medical debt information from appearing on consumer reports and creditors from basing lending decisions on such information may have initial benefits for some consumers, but there are potential negative consequences that should also be considered, say attorneys at Cooley.
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15 Areas That Would Change Under Health Data Rule Proposal
If finalized, the Office of the National Coordinator for Health Information Technology's proposed rule will significantly progress its efforts to advance interoperability, respond to stakeholder concerns and clarify compliance with the health IT certification program, say attorneys at Ropes & Gray.
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3 Healthcare FCA Deals Provide Self-Disclosure Takeaways
Several civil False Claims Act settlements of alleged healthcare fraud violations over the past year demonstrate that healthcare providers may benefit substantially from voluntarily disclosing potential misconduct to both the U.S. Department of Justice and the U.S. Department of Health and Human Services, say Brian Albritton and Raquel Ramirez Jefferson at Phelps Dunbar.
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Takeaways From High Court's Tribal Health Admin Cost Ruling
The U.S. Supreme Court's recent determination that the government must reimburse two Native American tribes for administrative healthcare costs will help tribes maintain equal footing with the Indian Health Service when administering programs, and continues a pattern of how the current court aligns on tribal concerns, say attorneys at Lewis Roca.
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FTC Focus: Private Equity Investments In Healthcare
As the Federal Trade Commission is tightening its scrutiny of private equity investment in healthcare, the agency is finding novel grounds to challenge key focus areas, including rollup acquisitions, the flip-and-strip approach and minority investments in rival providers, say attorneys at Proskauer.
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High Court's Expert Ruling May Help Health Fraud Defendants
The U.S. Supreme Court's decision in Diaz v. U.S. appears to give the government a powerful new tool in calling its own agents as expert witnesses, but it could also benefit defense counsel in criminal healthcare fraud and other white collar criminal cases that arise in complex legal or regulatory environments, say attorneys at Holland & Knight.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.