Policy & Compliance
-
June 04, 2024
Benefits Plan Inks Deal To End Mental Health Coverage Suit
The employee benefits plan at Mountain Area Health Education Center became the last remaining defendant to reach a settlement in a North Carolina district court lawsuit accusing an insurer and others of refusing to cover the cost of a patient's stay at a residential treatment center.
-
June 04, 2024
What Clinical Trial Attys Want From FDA Diversity Guidance
Impending federal guidance on diversifying clinical trial participation marks the latest push to address the historic homogeneity of clinical research. Here, clinical trial attorneys share with Law360 Healthcare Authority the questions they hope the FDA will answer.
-
June 04, 2024
White House Threatens Veto Over Policy Riders In VA Bill
The White House has threatened to veto a $147.5 billion bill funding military construction and the U.S. Department of Veterans Affairs, citing partisan policy proposals it said would harm minority groups and risk patient safety at VA medical facilities.
-
June 04, 2024
Ex-Keller & Heckman Scientist Joins K&L Gates In DC
K&L Gates LLP announced Tuesday that a longtime scientist at Keller and Heckman LLP joined its Washington, D.C., office as the firm's first senior scientific adviser.
-
June 04, 2024
NM Cannabis Co. Says Insurers Can't Toss Medical Weed Row
A group of insurers can't escape a proposed class action demanding they cover medical marijuana costs, a cannabis company and several of its patients said, telling a New Mexico federal court that medical cannabis is a medically necessary behavioral health service that must be covered.
-
June 04, 2024
Sens. Offer Stark Takes On Abortion Two Years Post-Dobbs
Republican and Democratic members of the Senate health committee on Tuesday offered two different views of abortion in America two years after the Dobbs Decision overturned the federal right to the procedure.
-
June 04, 2024
Recent Foley Hoag Addition Tapped As Life Sciences Co-Chair
Boston-based Foley Hoag LLP announced the appointment of a recently hired patent partner as co-chair of its life sciences industry group, the largest industry sector it services.
-
June 04, 2024
A Lawsuit 'Field Day' Over Calif. Healthcare Worker Wage Hike
Even before going into effect, California's new healthcare worker minimum wage is generating complex legal questions about its scope and predictions of legal clashes to come.
-
June 03, 2024
Colo. Gov Signs Compromise Bill Raising Damages Caps
Colorado Gov. Jared Polis on Monday signed a law that will increase statutory caps on noneconomic damages for wrongful death and injury claims, as part of a deal to avoid a ballot-box fight between medical providers and personal injury lawyers.
-
June 03, 2024
House COVID Panel Questions Fauci Over Pandemic Origins
Anthony Fauci, the former director of the National Institute of Allergy and Infectious Disease responsible for overseeing the pandemic response, was pressed by a U.S. House COVID-19 panel Monday about recent allegations that a senior official tried to evade open records laws regarding the origins of the pandemic.
-
June 03, 2024
Senate To Vote On Right To Contraception
The Senate will vote later this week on a bill to codify a statutory right to contraception, ahead of the two-year anniversary of the U.S. Supreme Court's overturning of Roe v. Wade.
-
June 01, 2024
Blockbuster Summer: 10 Big Issues Justices Still Must Decide
As the calendar flips over to June, the U.S. Supreme Court still has heaps of cases to decide on issues ranging from trademark registration rules to judicial deference and presidential immunity. Here, Law360 looks at 10 of the most important topics the court has yet to decide.
-
May 31, 2024
Final Defendant Gets 2 Years In Prison For DC Clinic Blockade
An anti-abortion activist was sentenced to two years incarceration in D.C. federal court Friday, the final defendant to be sentenced among nine others charged in a 2020 blockade at a reproductive health clinic.
-
May 31, 2024
Judge Doubts Okla. Can Stop Title X Cut Over Abortion Stance
A Tenth Circuit judge appeared skeptical Friday that Oklahoma could prevent federal officials from stripping $4.5 million in funding over the state's refusal to provide abortion referrals, suggesting the state's claim of anti-abortion discrimination is better suited to an attack on Title X writ large.
-
May 31, 2024
Judge Wonders If Wash. Social Media Ban Blocks Free Speech
A Washington appellate judge on Friday questioned the constitutionality of a state law barring injured workers from posting video of their state workers' compensation medical exams on social media, saying it could be cutting off someone's only way of communicating with the outside world.
-
May 31, 2024
15 States Sue To Block Biden's ACA Trans Discrimination Rule
The Biden administration was hit with a lawsuit on Friday over its rule clarifying the application of the Affordable Care Act's nondiscrimination protections to gender identity, with a group of 15 states claiming the guidance is an effort "to enshrine sweeping gender-identity mandates without congressional consent."
-
May 31, 2024
Texas Supreme Court Rejects Challenge To Abortion Ban
The Texas Supreme Court unanimously rejected a petition Friday that challenged the state's near-total ban on abortion, ruling the law's narrow exceptions for pregnant women in life-threatening emergencies are broad enough to withstand a constitutional challenge.
-
May 30, 2024
Physician, Health Cos. Spar Over Docs In Fla. Qui Tam Suit
A doctor and several healthcare businesses accused each other of withholding evidence in a Florida federal False Claims Act lawsuit, with the doctor saying several key Zoom meeting records were destroyed, although the businesses have alleged the doctor refused to provide a financial agreement she made with a cohort.
-
May 30, 2024
Ozempic Maker Says Texas Pharmacy Selling Knockoff Drug
The manufacturer behind the Ozempic weight loss drug has asked a federal court to prohibit a Houston-area pharmacy from selling compounded, non-FDA-approved medications that claim to contain the drug's key ingredient.
-
May 30, 2024
Sen. Warren Pushes CMS On 'Medical Loss Ratio' Data
Sen. Elizabeth Warren, D-Mass., is urging the Centers for Medicare & Medicaid Services to collect more data to determine whether private healthcare insurers in Medicare Advantage that employ vertical integration are evading a statutory requirement that they spend the bulk of their earnings on medical claims.
-
May 30, 2024
Dental Co., Ex-Worker Agree To Arbitrate OT Spat
A New York federal judge granted a former dental assistant's request to arbitrate her claims accusing a dental company of failing to pay hourly workers all their overtime wages owed or on a weekly basis as state law mandates for manual laborers.
-
May 29, 2024
FDA Sued Over Controversial Lab Test Rule
A clinical lab trade group that has been highly critical of the U.S. Food and Drug Administration's new final rule on laboratory-developed tests filed a lawsuit late Wednesday, saying the agency doesn't have the authority to regulate the tests as medical devices.
-
May 29, 2024
Acting Boston US Atty Says Fraud Cases Still High Priority
Prosecuting a range of fraud cases despite finite resources will remain a priority for Massachusetts acting U.S. Attorney Joshua Levy as he enters his second year in the job, he told reporters on Wednesday in a question and answer session at his office.
-
May 29, 2024
Whistleblower Counsel Can't Get 'Exorbitant' $11.5M Fee
A Boston federal judge slashed an "exorbitant" $11.5 million fee request made by counsel for a False Claims Act whistleblower in a case involving lab testing company Fresenius Medical Care, hammering the attorneys for inflated hourly rates, inflated time entries and a host of questionable billing practices.
-
May 28, 2024
Staffing Rule Suit, Mayo COVID Claims And An Oathless Expert
Nursing home trade groups sue over "nightmare" staffing rule, former Mayo Clinic workers get another shot at claims they were illegally fired over COVID-19 policy breaches, and an unsworn expert letter tanks a medical malpractice suit in Iowa. Law360 Healthcare Authority looks at those and other notable developments in healthcare litigation over the past week.
Expert Analysis
-
FDA's Lab-Developed Test Rule Faces High Hurdles
The U.S. Food and Drug Administration's recently announced plans to explicitly regulate lab-developed tests will likely face resistance from industry stakeholders and congressional actions, and lead to significant litigation, say attorneys at Hogan Lovells.
-
FTC's Health Co. Suit Indicates Agency's Private Equity Focus
The Federal Trade Commission's latest lawsuit against an anesthesia company and its private equity investor highlights the agency's willingness to regulate the health care industry even when relevant acquisitions are relatively dated or when the controlling entity's economic interest is under 50%, say attorneys at Simpson Thacher.
-
What Marijuana Status Change Would Mean For Industry
If the Drug Enforcement Administration accepts the U.S. Department of Health and Human Services’ recent recommendation to change marijuana’s classification under federal law, it would be a significant regulatory shift that could foster many industry benefits — but questions, risks and uncertainties at both the state and federal levels would remain, say attorneys at Neal Gerber.
-
Top 4 Antitrust Enforcement Issues In Health Care Today
The Federal Trade Commission's recent lawsuit against U.S. Anesthesia Partners exemplifies antitrust enforcement authorities' efforts to aggressively reshape the health care industry, ranging from new proposed rules to withdrawals of previous guidance, say attorneys at Fried Frank.
-
Calif. Climate Disclosure Bills Promise Challenges For Cos.
Two novel climate disclosure bills recently passed by the California Legislature will pose challenges for many businesses — especially private companies that are less familiar with climate-related reporting obligations — and will require investments of significant time and effort in processes, procedures and personnel, say John Rousakis and Chris Bowman at O'Melveny.
-
Maximizing Law Firm Profitability In Uncertain Times
As threats of an economic downturn loom, firms can boost profits by embracing the power of bottom-line management and creating an ecosystem where strategic financial oversight and robust timekeeping practices meet evolved client relations, says Shireen Hilal at Maior Strategic Consulting.
-
5th Circ. Ruling Reminds Attys That CBP Can Search Devices
The Fifth Circuit’s recent Malik v. Department of Homeland Security decision adds to the chorus of federal courts holding that border agents don’t need a warrant to search travelers’ electronic devices, so attorneys should consider certain special precautions to secure privileged information when reentering the U.S., says Jennifer Freel at Jackson Walker.
-
ESG Around The World: European Union
As the EU makes ESG regulation a priority, companies — both those based in the EU and others just doing business there — need to keep abreast of myriad new legislation that has either already taken effect or will in the near future, as noncompliance could result in fines, damages and director liability, say attorneys at Steptoe & Johnson.
-
Avoiding The Ethical Pitfalls Of Crowdfunded Legal Fees
The crowdfunding of legal fees has become increasingly common, providing a new way for people to afford legal services, but attorneys who accept crowdsourced funds must remember several key ethical obligations to mitigate their risks, say Hilary Gerzhoy and Julienne Pasichow at HWG.
-
4 Pharma Industry Arguments Against CMS Drug Pricing Plan
The Centers for Medicare & Medicaid Services is facing significant pushback regarding its plans for implementing the Inflation Reduction Act's Medicare drug price negotiation program, due to a number of potential repercussions for manufacturers, say attorneys at Mintz Levin.
-
Issues Ahead As Psychedelic Medicine Faces Pivotal Moment
Recent regulatory changes and decriminalization efforts have opened doors for research and development in psychedelic medicine, but challenges like stigma, access and funding persist, meaning companies will need to address these issues to support the industry’s credibility, say consultants at FTI Consulting.
-
An Overview Of 6 PBM Bills Moving Through Congress
As legislators turn to pharmacy benefit manager reform as a potential next step in addressing the cost of prescription drugs, six congressional committees have recently advanced PBM-related legislation with generally high bipartisan support, suggesting that a final package is likely to advance through Congress, say Rachel Stauffer and Katie Waldo at McDermott+Consulting.
-
10th Circ. ERISA Ruling Is Promising For Self-Funded Plans
Though some recent appellate decisions have seemingly narrowed application of Employee Retirement Income Security Act preemption, which generally helps protect self-funded health plans from state regulation, the Tenth Circuit's decision in PCMA v. Mulready takes a big step toward reaffirming preemption, say attorneys at Bass Berry.