Policy & Compliance
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October 29, 2024
Senate Panel Targets 'Clever' Pharma Pricing
The Senate Judiciary Committee on Tuesday railed against drugmakers and pharmacy benefit managers for allegedly causing the high cost of prescription drugs, arguing that "Big Pharma" has used anticompetitive tactics through patenting to fleece American patients.
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October 29, 2024
HHS Hospital Pay Formula At High Court: 4 Things To Know
With Americans focused on a presidential election unlike any in U.S. history, all's forgiven if you're not up on the latest healthcare case headed to the U.S. Supreme Court next week. Here's what you need to know about a dispute over a key federal payment formula used to compensate "safety net" hospitals.
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October 29, 2024
Latham Partner Brings Clerk Lessons To Hospital Pay Case
When Latham & Watkins LLP partner Melissa Arbus Sherry steps in front of the U.S. Supreme Court for the 12th time, she plans to bring a lesson she learned from Justice John Paul Stevens about how to get past the legalese to the real ramifications of a case.
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October 28, 2024
Wash. AG Candidates Clash On Consumer Protection, Guns
The candidates vying to replace Washington Attorney General Bob Ferguson, who carved out a national reputation as an antitrust champion, present starkly different visions on whether to build upon his tenure or reverse course, clashing not just on consumer protection, but also gun safety and access to reproductive care.
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October 28, 2024
SEC Sues To Enforce Subpoena On Telehealth Co.
The U.S. Securities and Exchange Commission has asked a New York federal judge to order a weight loss-focused telehealth company to comply with a subpoena issued in connection with the SEC's investigation into whether the company violated federal securities laws.
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October 28, 2024
Ontrak Founder Can't Wipe Novel Insider Trading Verdict
A California federal judge has upheld Ontrak founder Terren Peizer's first-of-its-kind insider trading conviction, holding that jurors had "more than enough evidence" to determine he based a $20 million share sale on nonpublic information that the health tech company was about to lose its biggest client.
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October 28, 2024
Ohio Hospital Defeats Religious Bias Suit Over COVID Vaccine
An Ohio hospital defeated a former nurse's lawsuit claiming he was forced out after the medical center rejected his request for a religious exemption from its COVID-19 vaccination policy, with a federal judge finding he was never disciplined for failing to get the jab.
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October 28, 2024
HHS Says In-Home Evals Raised Insurers' Medicare Payments
Private Medicare insurers collected an estimated $4.2 billion in extra federal payments last year from in-home health assessments they conducted, even though the evaluations led to no treatment, according to a report by the U.S. Department of Health and Human Services' internal watchdog.
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October 25, 2024
Tenn. Hospitals Want Former Execs Nixed From Kickback Row
A hospital system on Friday urged a North Carolina federal court to dismiss whistleblower claims from former executives alleging the system excessively paid physicians to make referrals in order to receive Medicare and Medicaid money.
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October 25, 2024
Ga. Woman Gets 12 Years For $30M COVID Fraud Scheme
A Georgia woman was sentenced to 12 years in prison Thursday for her role in filing more than 5,000 fraudulent COVID-19 unemployment insurance claims with the Georgia Department of Labor, which resulted in at least $30 million in stolen benefits.
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October 25, 2024
Pharmacy Must Pay $39.2M In Conn. Kickback Case
A defunct compounding pharmacy must pay $39.2 million in damages and penalties for its role in a kickback scheme that made illegal payments to Connecticut state employees and retirees, a state court judge ruled Friday while letting the company's proprietor off the hook.
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October 24, 2024
11th Circ. Seeks Bias Test Briefing In Fla. Trans Patients' Suit
The Eleventh Circuit has ordered Florida health officials and transgender individuals to provide additional briefing in the state's appeal to reverse a ruling blocking its ban on Medicaid coverage for gender-affirming care, directing the parties to present their positions on whether hostile discrimination analysis applies to certain classes of people.
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October 24, 2024
2nd Circ. Says Healthcare Arbitrations Were Properly Halted
The Second Circuit affirmed Thursday that a lower court properly halted a group of healthcare providers from pursuing thousands of arbitrations against State Farm as part of an alleged massive fraudulent scheme, ruling in a novel opinion the injunction did not violate federal arbitration law.
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October 24, 2024
AMA Latest To Sue MultiPlan Over Out-of-Network Pricing
The American Medical Association and the Illinois State Medical Society are the latest to accuse MultiPlan and the nation's largest health insurers of colluding through the use of the data firm's pricing tools to systematically underpay out-of-network providers, alleging in Illinois federal court Thursday that the "far-reaching and unlawful cartel" inhibits its members from offering critical care.
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October 24, 2024
Judges Doubt 'Troublesome' Comments Warrant New Trial
Washington appellate judges appeared skeptical Thursday that a handful of comments could've triggered jury bias and tainted the trial of a Palestinian woman's medical malpractice case, though one judge called it "troublesome" that defense counsel told jurors the accused doctor was "from this part of the world."
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October 24, 2024
McDonald's Customers File First Suits Over E. Coli Outbreak
A Colorado man and Nebraska woman have lodged the first lawsuits against McDonald's Corp. in the wake of the E. coli outbreak tied to its Quarter Pounder hamburgers, according to a pair of complaints filed in Illinois state court on Wednesday and Thursday.
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October 24, 2024
'Will Of The People' Upheld With Ohio Abortion Ban Quashed
An Ohio state court judge on Thursday permanently blocked the state's "heartbeat law" that prohibited abortion around six weeks of pregnancy, citing a 2023 ballot measure that enshrined the right to an abortion in the state constitution.
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October 24, 2024
PBMs Want Separate FTC Hearings Over Insulin Prices
Caremark Rx LLC, Express Scripts Inc. and OptumRx Inc. are calling for separate proceedings in the Federal Trade Commission's case accusing the pharmacy benefit managers of artificially inflating insulin prices through unfair rebate schemes.
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October 24, 2024
EEOC Reaches Deal With Rehab Center In Nurse's Bias Suit
A rehabilitation and assisted living facility has reached a deal with the U.S. Equal Employment Opportunity Commission to end a disability discrimination lawsuit by a nurse with a sleep disorder who the agency said was unlawfully fired, according to a filing in Texas federal court.
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October 24, 2024
Logistics Cos. Don't Let Workers Avert Tobacco Fee, Suit Says
Two Connecticut-based logistics companies unlawfully charge employees who use tobacco an extra fee for obtaining health insurance without offering full reimbursement if they complete a smoking cessation program, according to a proposed class action filed in federal court.
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October 24, 2024
Dems Urge HHS To Better Protect Wheelchair Users From PE
A pair of Democratic senators is pressing the U.S. Department of Health and Human Services to do more to protect the approximately 5.5 million wheelchair users in the country from private equity "abuses."
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October 23, 2024
3 Things To Know About Proposed OTC Contraception Regs
The Biden administration's proposal to require private health insurers to pick up the cost of over-the-counter contraception could increase access for an estimated 52 million women. Here are three things to know about the newly proposed regulations.
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October 23, 2024
Wash. Health System Says HHS Let J&J 'Abuse' 340B Program
A Washington safety net provider claims in a new suit that the federal government let Johnson & Johnson abuse the 340B drug discount program by allowing the manufacturer to pursue an "overbroad" and "intrusive" audit of the provider's drug purchases.
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October 23, 2024
5th Circ. Upholds Workers' Win In Health Co. Wage Suit
A group of workers for an at-home healthcare company are employees, not independent contractors, a Fifth Circuit panel ruled, affirming a Louisiana federal court decision in three consolidated cases claiming the company cheated workers out of overtime.
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October 22, 2024
CDC Links E. Coli Outbreak To McDonald's Quarter Pounders
The U.S. Centers for Disease Control and Prevention issued an alert Tuesday saying E. coli has been detected in McDonald's Corp.'s Quarter Pounder hamburgers, infecting nearly 50 people and killing one so far.
Expert Analysis
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What Drug Cos. Must Know About NY Price Transparency Law
Drug manufacturers must understand the contours of New York's recently implemented law requiring self-reporting of drug price increases, as well as best practices for compliance and challenges against similar laws in other states, say Elizabeth Bierut and Angie Garcia at Friedman Kaplan.
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Whistleblowers Must Note 5 Key Differences Of DOJ Program
The U.S. Department of Justice’s recently unveiled whistleblower awards program diverges in key ways from similar programs at other agencies, and individuals must weigh these differences and look first to programs with stronger, proven protections before blowing the whistle, say Stephen Kohn and Geoff Schweller at Kohn Kohn.
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The Licensure Landscape For Psychedelics Manufacturers
As the need for bulk manufacturing of psychedelic substances grows, organizations aiming to support clinical trials or become commercial suppliers must navigate a rigorous and multifaceted journey to obtaining a license from the U.S. Drug Enforcement Administration, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega Corp.
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OSHA Workplace Violence Citation Highlights Mitigation Steps
The Occupational Safety and Health Administration's recent citation against behavioral health company Circles of Care sheds light on the enforcement risks companies may face for failing to prevent workplace violence, and is a reminder of the concrete steps that can help improve workplace safety, say attorneys at Benesch.
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When Banks Unknowingly Become HIPAA Biz Associates
There appears to be significant confusion regarding the application of the Health Insurance Portability and Accountability Act to financial institutions when serving healthcare-related clients, so these institutions should consider undertaking several steps as a starting point in the effort to achieve compliance, say attorneys at Vorys.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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3 High Court Rulings May Shape Health Org. Litigation Tactics
Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.
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A New Way Forward For COVID Vaccine Lawsuit Immunity
As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.
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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.