Policy & Compliance
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March 11, 2025
HHS Comment Reversal Sets Stage For Quick Policy Changes
The sudden reversal at the U.S. Department of Health and Human Services of a longstanding commitment to robust public engagement clears the way for fast-paced changes to Medicaid and other massive programs, putting more pressure on compliance officers and sending more lobbying work behind closed doors.
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March 11, 2025
CEO, Staff Charged After Fatal Oxygen Chamber Explosion
Three people, including the CEO of a treatment center, have been charged with murder in connection with a hyperbaric oxygen chamber explosion that killed a 5-year-old boy, Michigan's attorney general announced Tuesday.
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March 11, 2025
Advocates Fear Abortion Drug U-Turn Under FDA Nominee
Ahead of a key Senate confirmation vote on Thursday, abortion rights advocates are sounding alarms about Marty Makary and indications that he may roll back expanded access to abortion medications as commissioner of the U.S. Food and Drug Administration.
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March 10, 2025
Justices Seen Resolving Circuit Split Over Med Mal Law
The U.S. Supreme Court said Monday it will decide whether a Delaware medical malpractice statute requiring an expert affidavit can apply in federal court, which experts said will give the justices the opportunity to reassess the so-called Erie doctrine and the relationship between state and federal courts.
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March 10, 2025
11th Circ. Urged To Find Qui Tam Cases Unconstitutional
A group of defendants accused of Medicare Advantage fraud urged the Eleventh Circuit on Monday to uphold a decision finding the False Claims Act's whistleblower provision unconstitutional, saying the statutory clause violates the Constitution in multiple ways.
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March 10, 2025
Medtronic Compliance Officer's Journey To State Senate Seat
A Medtronic compliance officer is taking on a role making different kinds of policies at the Minnesota State Capitol, following his successful bid for a state senate seat in late January. He told Law360 his compliance background is a natural fit for his new role in the public sector.
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March 10, 2025
Ga. Health System Says 'Vague,' 'Disorganized' Bias Suit Fails
A Georgia urologists' practice group on Monday hit back at a civil rights lawsuit from three doctors who said they were the victims of anti-Indian discrimination, arguing that their "shoot first and aim later" complaint fails to tie the company at all to their allegations.
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March 10, 2025
CVS PBM Caused Up To $330M In Part D Damages, Judge Told
A CVS-owned pharmacy benefits manager caused anywhere from $240 million to $330 million in damages by overbilling the government for Medicare Part D sponsored drugs, counsel for a whistleblower told a Pennsylvania federal judge at the beginning of a False Claims Act bench trial on Monday.
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March 10, 2025
AFL-CIO, Unions Defend Fight Against DOGE Access
The AFL-CIO and a group of unions sought to keep alive their claims that Elon Musk's Department of Government Efficiency can't legally access data from the U.S. Department of Labor and other federal agencies, telling a D.C. federal judge they have standing to file their suit.
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March 10, 2025
DOJ Defends Musk's Influence Against States' Challenge
The U.S. Department of Justice is defending Elon Musk's influence in the federal government against a constitutional challenge brought by 14 states, telling D.C. federal court that the "special government employee" does not occupy an official office that would be subject to the Constitution's appointments clause.
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March 10, 2025
High Court Will Review Colo.'s Conversion Therapy Ban
The U.S. Supreme Court announced Monday that it will review a challenge to Colorado's ban on licensed therapists providing conversion therapy to transgender minors, in a case that asks whether the state's law is a permissible regulation of professional conduct or an unconstitutional restriction of speech.
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March 10, 2025
Ex-Magellan CEO Pleads Guilty Over Faulty Lead Tests
The former CEO of Magellan Diagnostics Inc. admitted Monday to selling faulty devices that tested blood lead levels, the final of three defendants to plead guilty ahead of a jury trial scheduled for April.
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March 10, 2025
Justices To Weigh If Del. Expert Law Applies In Federal Court
The U.S. Supreme Court on Monday agreed to review whether federal courts must apply a Delaware state law requiring an expert affidavit for all medical malpractice complaints.
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March 07, 2025
AGs Say Anti-Trans Admin Puts $367M Hospital Grants At Risk
Attorneys general from Washington and three other states told a federal court that the Trump administration has canceled thousands of dollars in grant funding for gender-affirming care — and threatened to strip up to nearly $370 million more — in violation of court injunctions.
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March 07, 2025
Hints Of A New High Court Majority Emerge In Trump Cases
The U.S. Supreme Court's recent rejection of President Donald Trump's bid to keep frozen nearly $2 billion in foreign aid funding gave court watchers a glimpse of a coalition majority that could end up thwarting some of the president's more aggressive and novel attempts to expand executive power.
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March 07, 2025
New Bellwethers Score Cert. In Generic Drug Price-Fixing MDL
The Pennsylvania federal court overseeing sprawling multidistrict litigation springing from claims that pharmaceutical giants worked together to hike the cost of off-brand drugs has certified several sets of classes for the cases for the MDL's latest bellwethers.
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March 06, 2025
FTC Challenges PE Firm's Medical Device Coatings Deal
The Federal Trade Commission moved Thursday to block private equity firm GTCR BC Holdings LLC's planned $627 million acquisition of Surmodics Inc. over concerns about competition for medical device coatings.
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March 06, 2025
9th Circ. Nixes Challenge To Wash. Abortion Coverage Law
A split Ninth Circuit panel on Thursday rejected a Christian church's challenge to a Washington state law requiring employer health plans to cover abortion services, saying the church could invoke its religious beliefs to skirt the challenged obligations.
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March 06, 2025
FDA Nominee Hedges On Job Cuts, Abortion Drug In Hearing
The nominee to lead the U.S. Food and Drug Administration, Dr. Marty Makary, repeatedly hedged about whether he would reconvene a flu vaccine committee, maintain access to the abortion drug mifepristone or control future job cuts during his confirmation hearing in front of a Senate panel on Thursday.
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March 06, 2025
DC Judge Won't Block USAID From Firing Contractors
A D.C. federal judge on Thursday declined to temporarily block the termination of personal services contractors working for the U.S. Agency for International Development, concluding their challenge to the dismantling of the agency is likely ill-suited for federal court.
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March 05, 2025
Arizona's 15-Week Abortion Ban Blocked As Unconstitutional
An Arizona state judge on Wednesday ruled that the state's abortion ban after 15 weeks of pregnancy is "unconstitutional" and cannot be enforced.
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March 05, 2025
Contractors Claim Constitutional Injury In USAID Cuts
A group representing U.S. citizen personal services contractors working for the U.S. Agency for International Development insisted before a D.C. federal judge on Wednesday that their challenge to the Trump administration's dismantling of the humanitarian agency differs from another brought by workers employed directly by USAID.
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March 05, 2025
SEC Asks To Toss Subpoena Suit Against Telehealth Co.
The U.S. Securities and Exchange Commission asked a New York federal judge Wednesday to dismiss its suit aimed at forcing a weight-loss-focused telehealth company to comply with a subpoena, saying the company has since provided the requested documents and otherwise complied with the subpoena.
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March 05, 2025
Pfizer Beats Claims Of Copay Aid Scheme For Good
Litigation firms accusing Pfizer of a scheme to inflate drug prices for Medicare and Medicaid plans saw their suit dismissed permanently, with a Washington, D.C., federal judge ruling they had been given "enough chances" to remedy pleading deficiencies in their claims.
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March 05, 2025
Nationwide Block Of Trump Trans Healthcare Orders Extended
A Maryland federal judge has extended a nationwide injunction that was set to expire this week prohibiting the Trump administration from enforcing executive orders banning federal funding for gender-affirming care for people under the age of 19, finding the harm inflicted by the orders is "non-speculative, concrete, and potentially catastrophic."
Expert Analysis
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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.
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Short-Term Takeaways From CMS' New Long-Term Care Rules
The Centers for Medicare & Medicaid Services' new final rule on nursing home staffing minimums imposes controversial regulatory challenges that will likely face significant litigation, but for now, stakeholders will need to prepare for increased staffing expectations and more specialized facility assessments without meaningful funding, say attorneys at Morgan Lewis.