Legal
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CMS Lowers No Surprises Act Fee After Court Nixes Price Hike
CMS recently announced that it will change the administrative fee that providers and insurers must pay when initiating a reimbursement dispute under the No Surprises Act — the agency is lowering the fee from $350 to $50. This move came a week after the Texas Medical Association won a court case challenging HHS over its 600% price hike on the fee.
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House Reps Introduce Bill To Ease State Medicaid Staffing Shortages Amid Redeterminations
The Medicaid Staffing Flexibility and Protection Act was introduced by Representative Earl L. “Buddy” Carter (R-Georgia) and Representative Neal Dunn (R-Florida). It would allow state Medicaid agencies to hire outside contractors to help with Medicaid redeterminations, as many agencies don’t have the workforce to handle the return to the redetermination process.
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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.
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HHS Launches Civil Rights Investigation Into Vanderbilt’s Sharing of Transgender Patient Data
Vanderbilt University Medical Center is under federal investigation after it turned transgender patients’ medical records over to Tennessee’s attorney general. HHS launched the investigation a couple weeks after two VUMC patients filed a class-action lawsuit against the hospital for releasing their records to the attorney general.
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FDA Approves J&J Combo Drug for Prostate Cancers With Certain Genetic Signature
Johnson & Johnson’s Akeega is approved for treating advanced prostate cancer with a BRCA mutation. The drug, which interferes with a way cancer cells repair themselves, will compete against recently approved drugs from Pfizer and partners AstraZeneca and Merck.
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J&J Broadens Scope in Multiple Myeloma, Winning FDA Approval for New Drug
Johnson & Johnson’s stable of multiple myeloma drugs has grown to five products with the FDA approval of Talvey. The bispecific antibody is the first in a new class of new drugs designed to go after the novel multiple myeloma target GPRC5D.
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Artificial Intelligence, Health Tech, Hospitals, Legal
Senator Probes Google About ‘Premature Deployment of Unproven Technology’ In Healthcare Settings
Senator Mark Warner (D-Virginia) penned a letter to Google leadership expressing concerns about Med-PaLM 2 — the company’s generative AI tool for healthcare providers that is currently being used by Mayo Clinic and other health systems. The letter requested that Google provide more clarity about its chatbot’s training, accuracy, ethical considerations and deployment in healthcare settings.
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Nektar Sues Eli Lilly, Claiming the Big Pharma Breached Contract to Favor Another Drug
“Botched math” in calculating clinical data for an autoimmune disease drug is one of the allegations Nektar Therapeutics makes in a legal complaint against Eli Lilly. The biotech claims its former partner tried to disadvantage the asset in order to advance development of another drug it acquired in a billion dollar deal.
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Astellas Drug Acquired in $5.9B Deal Wins FDA Approval in Vision-Loss Disorder
Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.
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Sage, Biogen Drug Is Now the First Approved Oral Med for Postpartum Depression
Sage Therapeutics’ Zurzuvae is the biotech’s second FDA approved product for postpartum depression, following the 2019 nod for IV-infused Zulresso. But in a blow to the multi-billion dollar partnership between Sage and Biogen, Zurzuvae did not win an additional approval in major depressive disorder.
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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.
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GSK Patent Suit Aims to Halt Pfizer’s RSV Vaccine for Adults, But Not Infants
GSK claims that Pfizer’s FDA-approved vaccine for respiratory syncytial virus infringes on four patents protecting its own approved vaccine, Arexvy. The patent suit comes with the RSV season approaching.
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‘A Criminal Justice Approach to a Public Health Problem’: How the Justice System Can Improve SUD Support
There is inadequate substance use disorder support for people who are incarcerated or are leaving incarceration. But there are opportunities to make improvements, experts say.
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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.
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A Nonprofit Pharma Nabs FDA Nod for Nonprescription Naloxone Nasal Spray
The FDA approved RiVive, an over-the-counter version of naloxone nasal spray from Harm Reduction Therapeutics. It’s the second such approval from the FDA this year, following an affirmative decision in March for OTC Narcan.
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Senate Finance Committee Advances Bill Targeting PBMs
The Senate Finance Committee voted 26-1 to advance the Modernizing and Ensuring PBM Accountability Act. The bill has several provisions, including delinking PBM income from prescription drug prices under Medicare Part D and banning spread pricing in Medicaid.
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FDA Refuses to Review Biohaven Drug for Rare Neuromuscular Disease With No Treatments
Biohaven’s bid to bring to market the first drug for rare neuromuscular disorder spinocerebellar ataxia has hit a setback. The FDA is refusing to review the drug’s application, a decision that could indicate the agency wants another clinical trial.
Promoted
Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
