Weekly Spotlight
While Dems feted Kamala at the “Big (Party) Tent” Democratic National Convention in Chicago, DC enjoyed “False Fall,” one of 15 annual seasons here that are really subvariants of two actual seasons: “Burrr” and “the inside of a dragon’s mouth.”
While pharma pivoted to the next round of drug price negotiations, hospitals and others published their Q2 earnings.
At SHP, we are pausing to reflect on the health care legacy and public service of Rep. Bill Pascrell, (D-NJ), who passed away this week at the age of 87.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
Is Medicare’s Negotiated Drug Price List Worth Celebrating? Depends on Whom You Ask.
Physician and consumer groups expressed positive responses to Medicare’s release of its price list for the first 10 negotiated drugs under its Drug Price Negotiation program, but the pharmaceutical industry was not so pleased.
#Drug
Researchers Challenge USPSTF’s Lung Cancer Screening Criteria
Alternative criteria for lung cancer screening identified high-benefit groups who were not covered by U.S. Preventive Services Task Force (USPSTF) criteria, according to results based on model projections.
#Patient
What insurers got wrong about Medicare Advantage costs
A confluence of issues over more than a year made it difficult for Humana, UnitedHealthcare, Aetna and others to accurately predict Medicare Advantage costs and utilization.
#Payer
What cardiologists should expect as U.S. healthcare payment models evolve
Cardiologist Dan Blumenthal, MD, MBA, explains how changes in Medicare payments will greatly impact cardiology in the years ahead. In just a few short years, the business side of cardiology could look substantially different than it does today.
#Provider
Cardiology groups push for Medicare reform in face of ‘unsustainable’ payment cuts
Nearly 130 healthcare groups are urging Congress to pass legislation that would provide relief to U.S. physicians struggling to keep up with wave after wave of payment reductions.
#Provider
Food and Drug Administration (FDA)
GAO: FDA Has Begun Building an Active Postmarket Surveillance System
According to a new GAO report, FDA has begun building a surveillance system to look for potential safety issues in such devices. It plans to start with a few devices and expand over time. However, it has had problems getting funding and identifying patients who are using the devices. FDA is taking steps to overcome these challenges.
#Device
A broad range of stakeholders have recommended significant changes to the FDA’s advisory committee system and meetings,
Some commenters argued that the agency should increase requirements for participating on the panels and ensure panelists continue voting on key issues such as the safety and efficacy of the products. However, others said the panel requirements are too restrictive
#Device, #Drug. #PATIENT, #PROVIDER
FDA clears AI-powered POCUS platform for structural heart disease, heart failure
The cloud-based platform was designed to help even inexperienced users scan and diagnose a majority of common heart issues within minutes without leaving the patient’s side.
#Patient, #Provider, #Device
Health and Human Services (HHS)
Walgreens, BARDA team to strengthen clinical trials
Walgreens and HHS’ Biomedical Advanced Research and Development Authority launched a partnership Monday to promote decentralized clinical research in hopes of better diversifying trials.
#Patient, #Device, #Drug
US judge strikes down Biden administration ban on worker ‘noncompete’ agreements
A federal judge in Texas on Tuesday barred a US Federal Trade Commission rule from taking effect that would ban employers from requiring their workers to sign non-compete agreements. Chip Kahn of FAH says the judge made the right call.
#Provider, #Hospital
Hill Happenings
Bill Pascrell, fiery New Jersey Rep., dies at 87
New Jersey Democratic Rep. Bill Pascrell Jr., the second-oldest member of the House who brought an in-your-face Jersey attitude to the chamber, died Wednesday at age 87. Bill fought to his last breath to return to the job he cherished and to the people he loved,” the representative’s family said in a statement
#All
Congressional probe questions clinical trials run in China
A House committee is investigating drugmakers’ clinical trials involving hospitals affiliated with the Chinese military and trials run in the Xinjiang region, where the Chinese Communist Party has been accused of human rights abuses against Uyghurs and other ethnic minorities.
#All
Other Industry News
Cardiology
TEER with Abbott’s MitraClip linked to low stroke risk, new study confirms
Treating mitral regurgitation with transcatheter mitral edge-to-edge repair (TEER) using the MitraClip device is associated with a low risk of cerebrovascular accidents (CVAs) such as stroke and transient ischemic attack (TIA), according to new data published in The American Journal of Cardiology.[1]
#Device
New TAVR valve for native aortic regurgitation linked to positive 30-day outcomes
The J Valve from JC Medical was linked to positive outcomes and “excellent” hemodynamic data after 30 days in an early feasibility study published in JACC.
#Device
Edwards Lifesciences agrees to acquire JenaValve, Endotronix for $1.2B
The moves make it crystal clear that Edwards remains focused on pursuing advanced TAVR technologies. While JenaValve is known for its Trilogy Heart Valve System, a device designed specifically to treat aortic regurgitation, Endotronix specializes in developing heart failure technologies. The news comes after Edwards sold its critical care business for $4.2 billion in June, saying it would double down on its structural heart portfolio.
#Device
Transcatheter mitral valve-in-valve replacement benefits intermediate-risk patients
New one-year data suggests transseptal MViV with a Sapien 3 heart valve is a “favorable and safe procedure.” Researchers plan to follow patients for a total of 10 years.
#Device, #Patient
Cardiologists first in world to use new heart valve for TMVR, TTVR on same patient
Identical Cardiovalve systems were used to perform the procedures 18 months apart on a high-risk heart patient.
#Device, #Provider, #Patient
Women in interventional cardiology much more likely to leave practice than men
Why are so many female interventional cardiologists saying goodbye to the specialty? Researchers explored this troubling trend in JAMA Cardiology.
#Provider
New imaging protocols proposed to curb rise of cardiovascular infections
Eleven professional medical societies have jointly released recommendations for standardizing the use of PET/CT and SPECT/CT imaging techniques when evaluating patients with suspected cardiovascular infections. With the increasing prevalence of infections due to prosthetic heart valves and implanted devices, improving outcomes for patients relies on rapid identification.
#Provider
Cancer
Genentech to shut down cancer immunology research department amid broader R&D rethink
Genentech will close its cancer immunology research department, and unit head and renowned cell biologist Ira Mellman, who has been with the company for 17 years, will depart in the coming months.
#Drug
HIV/AIDS
PrEP Scripts Most Likely to Be Filled When Prescribed by ID Specialists
Clinicians not specializing in ID could benefit from more PrEP training, researchers say
#Patient, #Provider
Notable Notes
Hospital Q2 Earnings
Stat reported on hospital Q2 earnings including Allina Health BayCare Health System, Cleveland Clinic, Henry Ford Health, Houston Methodist, Kaiser Permanente, Memorial Sloan Kettering, Sentara Health
#Hospital
California Bill Would Require State Review of Private Equity Deals in Healthcare
Consumer advocates and labor unions are enthusiastic about the plans, but hospitals are not
#Hospital, #Patient, #Provider
Clinical trials exclude disabled Americans because federal agencies failed them, new report finds
A new report indicates that federal agencies implicitly and explicitly exclude people with disabilities from clinical trials
#Patient
CVS legal defeat shows quiet ways PBMs try to influence care
A recent court defeat for CVS Health Corp. is shining a light on how healthcare corporations wield their financial might over doctors and pharmacies in ways that can put profits over patient care.
With more than a dozen similar cases still pending in private arbitration, the pharmacy giant has millions of dollars on the line.
#Patient, #Drug
Epic unveils new AI, prior authorization features
Epic is working with large insurers such as Aetna and Elevance to streamline prior authorization requests.
#Provider, #Payer
