Weekly Spotlight
While the major Committees of Jurisdiction take stock of their remaining priorities for the year, passing some (like telehealth extensions and pediatric rare disease vouchers) and leaving others (like doc pay) potentially twisting in the fickle winds of a lame duck Congress, Congressional leadership still struggles to fund the government. Although a continuing resolution, extending funding past the September 30 deadline, is still considered likely, it’s currently out of reach. Meanwhile, Axios puts it at 27 years since Congress did its job on time.
While PBMs might have dodged end-of-year activities in Congress, they remain squarely in others’ sights. Pharmacy benefit manager Express Scripts is fighting back against the ongoing Federal Trade Commission investigation into its industry’s business practices, filing a lawsuit that demands the FTC retract an interim report, which concluded the biggest PBMs profit from high drug prices, overcharge patients, harm independent pharmacies and restrict access to lower-cost medicines. At the same time, the FTC is targeting the three largest pharmacy benefit managers over rebate schemes that allegedly inflate insulin prices for some consumers. The commission said Friday it had filed an administrative complaint against CVS Health’s Caremark Rx, Cigna Group’s Express Scripts, and UnitedHealth Group’s OptumRx and their group purchasing organizations Zinc Health Services, Ascent Health Services and Emisar Pharma Services, respectively.
Bad news also abounds for the Medicare Advantage marketplace this year. Read more below…
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
How hospitals can prepare for TEAM bundled payments
The five-year demonstration begins in 2026, but industry experts say hospitals have to carry out myriad tasks to be ready, such as running claims data analyses and restructuring care design in partnership with post-acute care providers.
#Hospital
What to make of the 2025 MA enrollment season
The star-ratings bonuses paid to Medicare Advantage plans this year is expected to be around $11.8 billion, according to KFF researchers. That’d be down from $12.8 billion in 2023. This is just one of a number of negative factors that have put pressure on the MA marketplace. In four weeks, Medicare beneficiaries will be able to sign up for 2025 coverage. And for the roughly 34 million people who are in a Medicare Advantage plan, things likely will look a lot different (and be as confusing as ever. Cigna Group’s health insurance unit is scaling back Medicare Advantage offerings in eight states next year, according to a notice to third-party marketers published by the insurance brokerage Pinnacle Financial Services. Members in 36 health plans will be affected by Cigna Healthcare’s cuts and service area reductions in Colorado, Florida, Illinois, Missouri, North Carolina, Tennessee, Texas and Utah.
#Payer, #Patient
Food and Drug Administration (FDA)
FDA designates devices for heart surgery, smart knee implant as ‘breakthroughs’
The latest medical devices to receive breakthrough status from the Food and Drug Administration range across conditions, with several treating cardio and neurovascular conditions.
#Device
Unpacking the FDA’s Non-Recall Recalls
When it comes to medical devices, the Food and Drug Administration and manufacturers routinely allow doctors and hospitals to continue using equipment that, as the government sees it, could injure or kill the patients it’s supposed to help. KFF Health News recently highlighted the issue of non-recall recalls in an examination of MitraClip, a cardiac implant. Among cardiovascular devices that were deemed unsafe enough to warrant urgent regulatory action, many had been allowed to skip rigorous premarket clinical testing in the first place, a report showed. Researchers identified 137 Class I recalls affecting 157 unique cardiovascular devices logged by the FDA from 2013 to 2022. Of these recalled devices, just 19.1% had undergone premarket clinical testing as part of their 510(k), premarket approval (PMA), or PMA supplement applications, reported Claudia See, MD, MBA, of the University of California San Francisco, and colleagues.
#Device, #Patient
FDA Issues Guidance on Implementing Decentralized Elements in Clinical Trials
This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants. Decentralized elements can include, among other things, telehealth visits with trial personnel, in-home visits with remote trial personnel, or visits with local health care providers. In this guidance, a decentralized clinical trial refers to a clinical trial that includes decentralized elements where trial-related activities occur at locations other than traditional clinical trial sites.
#Drug, #Device, #Patient
FDA Issues Guidance on Integrating Randomized Controlled Trials Into Routine Clinical Practice
FDA is announcing the availability of a draft guidance for industry entitled “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice.” FDA is publishing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act to issue guidance about the use of RWE in regulatory decision-making. This draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that can integrate research into routine clinical practice.
#Drug, #Patient
Hill Happenings
Experts Debate Whether IRA Provisions Stifle Pharma Innovation at Senate Hearing
The Inflation Reduction Act (IRA) provisions aimed at lowering prescription drug prices will lead to more pharmaceutical innovation, not less, one witness said at a Senate Finance Committee hearing. Another cautioned, “Some biopharmaceutical company leaders have reassured their investors that they can manage the Inflation Reduction Act. But that does not mean the law is benign. In any business, when revenues decline, effort is shifted away from that activity.” This week, Sen. Bill Cassidy introduced a bill that would exempt “research and development-intensive small biotech manufacturers” from IRA drug price negotiations.
#Drug, #Patient
The ERISA Industry Committee Calls on Congress to Close Loophole and Deem PBMs as a “Fiduciary” under ERISA
The issue brief details how today’s unregulated PBM industry can increase their own profitability at the expense of employer-sponsored health plans, and calls on Congress to clarify that ERISA’s fiduciary duty standard to employer health benefit plans applies in full to PBMs performing services on behalf of the plan.
#Drug, #Payer
Senate committee votes to hold Steward’s De la Torre in contempt
The Senate panel investigating the bankruptcy of Steward Health Care voted Thursday to refer criminal and civil contempt cases to the full Senate.
#Hospital
Notable Notes
SAVR associated with several long-term benefits for patients with asymptomatic severe AS
Using surgical aortic valve replacement (SAVR) to treat patients with asymptomatic severe aortic stenosis (AS) is associated with better long-term outcomes than a more conservative approach, according to new findings published in European Heart Journal.
#Device
Asymmetrical valve expansion after TAVR a cause for concern
Calcified debris can sometimes lead to stent frame issues that cause a patient’s TAVR valve to expand asymmetrically. Few studies have explored the potential impact of valve asymmetry—until now.
#Device, #Patient
Pfizer drug shows promise in cancer-related condition that causes weight loss and weakness
On Saturday, Pfizer reported that an experimental antibody not only helped cancer patients with cachexia regain some weight versus placebo, but that it also seemed to increase their muscle mass and activity levels, signaling that the added weight translated into meaningful benefits.
#Drug, #Patient
Why private equity-linked sales of physician groups have slowed
Years of high interest rates, along with lower evaluations and tougher regulations, have scuttled potential private equity-led physician group deals.
#Provider
Is Healthcare Consolidation Fueling the Physician Burnout Crisis?
According to a survey of more than 1,700 physicians, residents, and medical students, burnout is tied to multiple factors, including mental health stigma in the medical field as well as how private equity acquisitions are changing healthcare. A large portion of physicians say they are toying with plans to leave their current position in the near future—a tough issue for healthcare organizations keenly aware of a practitioner shortage projected to worsen in the coming years.
#Provider
