Policy & Compliance
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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.
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August 28, 2024
CVS Can't Avoid Federal Claims In $200M FCA Suit
A former CVS Health compliance director can pursue claims the company and its subsidiaries pocketed more than $200 million in overpayments, after an Illinois federal judge on Monday tossed several other claims from a qui tam suit alleging various schemes by CVS to take money from the government.
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August 28, 2024
9th Circ. Overturns Rule Mandating Sealing Of Health Records
A Ninth Circuit panel found Wednesday that Hawaii state court rules mandating the automatic sealing of medical and health records in civil and criminal proceedings are unconstitutionally overbroad.
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August 28, 2024
Dr.'s Suit Blames Practice's Buyer For Chaos After Sale
A North Carolina doctor struck back in a lawsuit blaming him for business challenges following the sale of his practice to another physician, alleging in counterclaims that the purchasing physician lied about his intentions for the practice and ultimately led it to ruin.
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August 28, 2024
Jazz, Hikma Must Face Bulk Of Xyrem Antitrust Suit
Jazz Pharmaceuticals and Hikma Pharmaceuticals appear bound for trial against most solo insurer and class action antitrust claims over alleged efforts to block generic competitors to Jazz's Xyrem narcolepsy drug, under a newly unsealed California federal court order largely rejecting competing motions for summary judgment.
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August 28, 2024
Mont. Hospital Pays $11M In FCA Case For Doc's Fake Billing
Nonprofit healthcare center St. Peter's Health will pay nearly $11 million to settle alleged False Claims Act violations stemming from conduct by a former oncology doctor who submitted fraudulent claims to government programs for up-coded cancer treatment services and who double-billed office visits to boost his own salary, according to the U.S. Attorney's Office for the District of Montana.
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August 27, 2024
Justices Told Gender Care Ban Defies Decades-Old Precedent
A group of transgender adolescents on Tuesday urged the U.S. Supreme Court to overturn a Sixth Circuit decision allowing Tennessee to enforce a state ban on certain medical procedures that they say treats individuals differently based on their assigned sex at birth.
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August 27, 2024
Tenn. Medicaid Program Illegally Cut Off Health Coverage
Tennessee's Medicaid program violated the Medicaid Act, the 14th Amendment and the Americans With Disabilities Act by depriving residents of healthcare coverage, a federal judge has ruled, saying the agency was "lethargic in its response and attempts" to fix an eligibility system replete with issues.
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August 27, 2024
Medicare Fraud Case Puts Target On Qui Tam Provisions
In a federal court in Florida, a judge is weighing what was once a pipe dream for the False Claims Act defense bar: the possible invalidation of federal law allowing private parties to bring suits on behalf of the government.
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August 27, 2024
Docs Foggy On Abortion Laws Amid Heated Legal Battles
When Texan Kyleigh Thurman showed up at a hospital in central Texas with an ectopic pregnancy, she alleges that physicians' confusion over the state's strict abortion ban led to inaction and delays in her federally protected care.
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August 27, 2024
6th Circ. Affirms HHS' Denial Of Title X Funds To Tenn.
The Sixth Circuit has upheld the Biden administration's authority to end a family-planning grant awarded to Tennessee after the state refused to offer abortion referrals, saying the state knew the rules when it accepted the grant.
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August 26, 2024
Care.com To Pay $8.5M To Settle FTC's Deception Claims
Caregiver job website Care.com has agreed to shell out $8.5 million in refunds to put to rest allegations it misled caregivers about wages and job availability and also made it difficult for families to cancel paid memberships, the U.S. Federal Trade Commission announced Monday.
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August 26, 2024
Class Attys Get $1.2M In Wash. Health Workers' Wage Deal
A Washington federal judge has awarded two plaintiffs firms almost $1.2 million of a $4.4 million class and collective wage deal ending a group of Evergreen state hospital workers' claims that their employers deducted pay for meal breaks they never took.
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August 26, 2024
Rival Can't Avoid Drugmaker's False Ad Claim Over Pain Med
A Texas federal magistrate on Monday advised against dismissing Pacira Biosciences Inc.'s suit against a rival, finding that Pacira had alleged enough facts to show QuVa Pharma Inc.'s advertising is deceptive in a suit over the former company's compounded drug for pain.
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August 26, 2024
FTC Mulls Proposal To Alter Puerto Rican Pharmacy Deal
The Federal Trade Commission is considering a plan to allow Puerto Rico's largest independent pharmacy cooperative to resume collective negotiations with payors, reexamining a 2012 settlement agreement that the cooperative says is now unnecessary because of changes in the commonwealth's law and pharmacy market.
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August 26, 2024
NY Nursing Homes Can't Duck AG's $83M Fraud Suit
A New York judge shot down a bid by four nursing homes and their operators to dismiss the state attorney general's claims that they defrauded Medicare and Medicaid and neglected residents.
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August 23, 2024
NY Can't Sue Groups Over Abortion 'Reversal' Ads, For Now
A New York federal judge temporarily blocked the state's attorney general from taking enforcement action against certain pregnancy counseling centers for promoting a method of "reversing" medication abortions that medical associations say is not backed by science, saying the groups' conduct is likely protected by the First Amendment.
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August 23, 2024
Ohio Constitution Dooms 24-Hour Abortion Waiting Period
An Ohio state judge on Friday preliminarily blocked multiple Ohio civil and criminal abortion-related statutes requiring informed consent and a 24-hour waiting period, among other restrictions, finding that the statutes likely run afoul of the recently passed voter-backed state constitutional amendment enshrining the right to abortion.
Expert Analysis
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DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges
The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.
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FTC Focus: Exploring The Meaning Of Orange Book Letters
The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.
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3rd Circ.'s Geico Ruling May Encourage Healthcare Arbitration
The Third Circuit's recent decision in Geico v. Mount Prospect, finding that claims under New Jersey's Insurance Fraud Prevention Act can be arbitrated, strengthens arbitration as a viable alternative to litigation, even though it is not necessarily always a more favorable forum, say Khaled Klele and Jessica Osterlof at McCarter & English.
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Proposed Cannabis Reschedule Sidesteps State Law Effects
The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.
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A Changing Regulatory Landscape For Weight Loss Drugs
As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.
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Opioid Suits Offer Case Study In Abatement Expert Testimony
Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.
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How HHS Discrimination Rule Affects Gender-Affirming Care
The U.S. Department of Health and Human Services' new final rule, which reinterprets the Affordable Care Act's anti-discrimination provision, greatly clarifies protections for gender-affirming care and will require compliance considerations from sponsors and administrators of most group health plans, say attorneys at McDermott.
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FTC Noncompete Rule's Impact On Healthcare Nonprofits
Healthcare entities that are nonprofit or tax-exempt and thus outside of the pending Federal Trade Commission noncompete rule's reach should evaluate a number of potential risk factors and impacts, starting by assessing their own status, say Ben Shook and Tania Archer at Moore & Van Allen.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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8 Questions To Ask Before Final CISA Breach Reporting Rule
The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.