legal
-
HHS Will Likely Face More Lawsuits Against Drug Price Negotiation Now That It Has Named the First 10 Meds Included In the Plan
Novartis became the seventh drugmaker to legally challenge the White House’s Medicare drug pricing negotiation program. The company filed its lawsuit three days after HHS announced the first 10 drugs that were selected for the program — its heart failure medication Entresto was one on the list. HHS can expect to face more lawsuits from the manufacturers of the 10 drugs it named last week, experts have warned.
-
Consumer / Employer, Legal, Payers
Labor Department Sues UnitedHealth Group Over ‘Thousands’ of Claims Denials
The Labor Department recently sued UnitedHealth Group subsidiary UMR, alleging that it wrongfully denied claims for emergency room services and urinary drug screenings since 2015. UMR did not determine the medical necessity of the claims, denying them “based solely on diagnosis codes and not applying a prudent layperson standard,” according to the complaint.
-
Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
-
Startup Sues Athenahealth, Alleging Trade Secret Theft & Deceptive Practices
Digital health startup Dorsata filed a lawsuit against EHR provider athenahealth and women’s health company Unified Women’s Healthcare. The startup alleged that athenahealth stole trade secrets, used deceptive business practices and breached its contract — and that Unified aided and abetted these purported practices.
-
BioPharma, Hospitals, Legal, Payers, Policy
Hospitals Have Concerns About CMS’ Proposed $9B Lump Sum Payment for Illegal 340B Cuts
CMS recently proposed a $9 billion lump sum payment to remedy illegal payment cuts for 340B drugs from 2018 to 2022. In general, hospital groups have reacted positively to the fact that 340B providers will receive lump sum payments but have expressed concern about CMS’ methods for maintaining budget neutrality with this plan.
-
How Can Providers Respond to the Wave of Laws Banning Gender-Affirming Care for Minors?
LGBTQ advocacy groups and clinicians argue that healthcare providers have a responsibility to treat the recent wave of laws banning gender-affirming care for minors like the public health crisis that it is. To do this, providers must educate themselves about the laws in their state and nearby states, fight misinformation and collaborate with nonprofits to deliver care to kids in states where their access is under attack.
-
Lawsuits Against Medicare Drug Negotiations Are Mounting, But They Probably Won’t Be Able to Stop The Plan
Lawsuits filed in opposition to the White House’s drug pricing negotiation program are beginning to mount, but legal experts agree that the plaintiffs’ arguments probably won’t hold up during a court battle. However, these lawsuits still could delay when the government’s ability to negotiate price goes into effect.
-
How California’s New Legislation Could Affect Healthcare M&A Activity
Healthcare dealmakers must prepare for a new law and a recently-introduced bill in the California Senate, both of which aim to increase oversight in the healthcare M&A space. This is a legislative trend other states are beginning to participate in too — such as New York, Massachusetts and Connecticut.
-
Why One Healthcare Lawyer Thinks Merck’s Drug Pricing Lawsuit Defense ‘Makes No Sense’
Merck recently became the first drugmaker to sue the federal government over its Medicare drug price negotiation program. The company’s lawsuit argues that the program violates the Constitution’s First and Fifth Amendments, but healthcare law expert Robin Feldman said the defense doesn’t have any legs.
-
Former Outcome Health Execs Found Guilty of 47 Counts of Fraud
A federal jury found three former Outcome Health executives guilty of 47 counts of fraud. The convictions come after a 10-week trial that investigated the former leaders’ role in a billion-dollar scheme in which the company lied to its customers about how many physicians’ offices their advertisements would appear in.
-
Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
-
Labor Department Is Cracking Down on Providers’ Use of 1099 Contractors, Lawyer Warns
Before healthcare providers onboard workers sourced from staffing agencies, they should make sure these laborers are hired as W-2 employees rather than 1099 independent contractors, one lawyer recently warned. The Department of Labor is increasing its efforts to ensure healthcare facilities are complying with the law as it pertains to contract labor and overtime pay.
-
Health Tech, Hospitals, Legal, SYN
How Much of a Risk Is a Potential Class-action Lawsuit against CommonSpirit?
CommonSpirit Health is facing a proposed class-action lawsuit over a ransomware attack it suffered last fall that exposed 623,774 patients’ personal data. However, hospitals’ data breach lawsuits usually never make it court, a legal expert said.
-
Evernow CEO and founder shares why she started a healthcare startup focused on women over 40
In response to emailed questions, Alicia Jackson talked about her healthcare background and how the healthcare startup is responding to a shifting legal landscape for women’s health following the overturning of Roe v. Wade by the U.S. Supreme Court.
-
FDA warning letter puts maker of nicotine gummies in a sticky situation
The FDA issued a warning letter about nicotine gummies—the first ever notification sent for such a product. The agency’s concern is that the flavored gummies resemble candy and pose a toxicity risk to children.
-
Bluebird Bio gene therapy wins first FDA approval for rare blood disorder
FDA approval of Bluebird Bio’s Zynteglo makes it the first gene therapy in the U.S. for the rare blood disorder beta thalassemia. The biotech company set a $2.8 million price for the one-time treatment, but it also came up with a reimbursement strategy designed to ease the financial risk to payers.