Weekly Spotlight

Congress has taken up a fair number of lingering health policy priorities in the last few weeks. From renewed hope for legislation that would codify Biden Administration changes to how Medicare Advantage programs treat prior authorization, to House Committee’s of jurisdiction (identifying common ground and a path to ensure Medicare payment for telehealth services for at least the next two years, one could be forgiven for acquiescing to a faint feeling of hope.

The reality is that, even on issues like telehealth and prior authorization, where there is broad, bipartisan agreement and where steps have been taken to mitigate or eliminate cost concerns, the future is still very much in the air. We can expect Congress to begin thinking about summer recess and the campaign trail very soon, and even the strongest alliances can be shattered by election politics. We don’t yet know how many real weeks of work we can expect from Congress this year, but let’s all stay cautiously optimistic.

In case you were shocked by these shining examples of not-quite-partisan almost-cooperation, not to worry. A House Oversight Committee hearing devolved into name calling and the appropriations process is shaping up to be just as much of a mess for FY 2025 as it was for 2024.

Government funding runs out in 137 days and the election is in 171 days… do you know where your members of Congress are?

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Prices Paid to Hospitals by Private Health Plans: Findings from Round 5 of an Employer-Led Transparency Initiative

This study uses 2020–2022 medical claims data from a large population of privately insured individuals, including hospitals and other facilities from across the United States, to allow an easy comparison of hospital prices. An important innovation of this study is that hospitals and hospital systems (hospitals under joint ownership) are identified by name, which is usually not allowed under data use agreements. Because employer-sponsored spending comes from employee wages and benefits, employers have a fiduciary responsibility to administer benefits in the interest of participants. The lack of transparency of prices in the health care market limits employers’ ability to knowledgeably develop or implement benefit design decisions.

#All

Strata Performance Trends Report Market Analysis and Hospital & Patient Volume Benchmarks: 2-midnight rule could affect 20% of Medicare Advantage patients

Beckers explores a new report from Strata on CMS’ expansion of the two-midnight rule, which could affect more than 20% of Medicare Advantage patients this year, has led to increased inpatient volumes and revenue growth for hospitals in the first quarter,

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CVS is willing to dump 10% of its Medicare Advantage members next year

CVS Health is preparing to make significant changes to its 2025 Medicare Advantage plans, which could potentially drive away 10% of its membership, the company’s chief financial officer said at an investment banking conference Tuesday. “The goal for next year is margin over membership,” CVS CFO Tom Cowhey said at the conference, hosted by Bank of America. “Could we lose up to 10% of our existing Medicare members next year? That’s entirely possible. And that’s OK, because we need to get this business back on track.”

#All

Medical Device Sterilization Town Hall – Sterilization Method Selection for New and Existing Devices

The next Medical Device Serilization Town Hall will feature a panel discussion for what to consider when choosing a sterilization method or changing methods.

May 23, 2024, 1:00 PM – 2:15 PM ET

#Device

Food and Drug Administration (FDA)

Regan-Udall Real-World Evidence Webinar Series: Considerations Regarding Non-Interventional Studies for Drug and Biological Products

This latest session in the Regan-Udall webinar series will discuss the draft guidance, Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products. The draft guidance describes attributes regarding the design and analysis of a non-interventional study, also known as an observational study, that researchers should consider when proposing such a study for regulatory purposes. This guidance provides recommendations to sponsors and investigators who are considering submitting a non-interventional study to FDA to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of the safety of a drug.

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Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff

Abbott is recalling the HeartMate 3 LVAS after complaint reviews identified blood leakage or air entering the seal interface between the left ventricular assist device (LVAD) inflow cannula and the apical cuff. In all reported events, the issue was observed during implantation of the device.

Blood leakage or air entering the LVAD from this location will impact the integrity of the blood flow and may lead to longer than expected surgery, bleeding (hemorrhage), right heart failure, or air embolism. Use of these devices may cause serious injury or death. Abbott reports 81 incidents, including 70 injuries and two deaths related to this issue.

#Device, #Patient, #Provider

Hill Happenings

Durbin Accuses Amgen of Placing profits above patients with dosing for a cancer drug

Sen. Durbin is accusing Amgen of “putting profits before patients” over its decision to continue marketing a high dose of a pricey cancer treatment instead of a lower dose that is less expensive and not as toxic to patients. At issue is a medication called Lumakras, which is used to treat non-small cell lung cancer and won conditional regulatory approval three years ago. At the time, the Food and Drug Administration required Amgen to run a trial confirming earlier test results, as well as a so-called post-marketing study to examine safety and effectiveness at different dosages, in order to gain full approval.

#Drug, #Patient, #Provider

Cassidy, Whitehouse Introduce Legislation, Release RFI on Primary Care Provider Payment Reform

According to a joint statement, as part of their ongoing work to address primary care challenges and reform physician payment models, U.S. Senators Bill Cassidy, M.D. (R-LA) and Sheldon Whitehouse (D-RI) released a Request for Information (RFI) to accompany the introduction of the senators’ bipartisan Pay PCPs Act, legislation to better support and improve pay for high-quality primary care providers.Cassidy            

#Provider

Notable Notes

Flood of Fake Science Forces Multiple Journal Closures – Wiley to shutter 19 more journals, some tainted by fraud

Fake studies have flooded publishers of top scientific journals, leading to thousands of retractions and millions of dollars in lost revenue, The Wall Street Journal says. The biggest hit has come to Wiley, which is closing 19 journals, some of which were infected by large-scale research fraud. The sources of the fake science are “paper mills” — businesses or individuals that, for a price, will list a scientist as an author of a wholly or partially fabricated paper. The mill submits the work, generally avoiding the most prestigious journals in favor of publications such as one-off special editions that might not undergo as thorough a review and where there is a better chance of getting bogus work published.

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Joined Cath Procedures Turn the Table on SAVR-CABG – Small trial favors percutaneous approach to concomitant aortic stenosis and coronary disease

For patients with severe aortic stenosis (AS) and concomitant obstructive coronary artery disease (CAD), a percutaneous combined intervention worked surprisingly well relative to surgery, the TCW randomized trial found. In this study, the less invasive treatment strategy — comprising fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) atop transcatheter aortic valve replacement (TAVR) — resulted in fewer instances of all-cause mortality, myocardial infarction (MI), disabling stroke, unscheduled clinically-driven target vessel revascularization, valve re-intervention, and life-threatening or disabling bleeding at 1 year compared with the usual combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG; 4.4% vs 22.9% on intention-to-treat analysis, HR 0.17, 95% CI 0.06-0.51).

#DEVICE, #Patient, #Provider

More Patients Participate in Cancer Treatment Trials Than Previously Estimated – Study calculates rate at 7.1%, higher than historical estimate of less than 5%

According to a new study, participation in cancer treatment clinical trials was higher than historical estimates, according to a national sample of data from the Commission on Cancer.

From 2013 to 2017, the overall estimated participation rate in cancer treatment trials was 7.1%, which was higher than historical estimates of less than 5%, reported Joseph M. Unger, PhD, of the Fred Hutchinson Cancer Center in Seattle, and colleagues. Cancer treatment trial participation estimates have been based on studies of enrollment in National Cancer institute (NCI)-sponsored cooperative group trials, with estimates ranging from 1.5% to 4%, the authors noted in the Journal of Clinical Oncologyopens in a new tab or window.

#Drug, #Patient, #Provider

Abbott’s dissolvable stent, which failed heart disease patients, may help vascular patients

Abbott device that failed heart disease patients is getting a new life in patients with severe vascular disease. The device is a below-knee stent that widens clogged blood vessels, and then vanishes into the vessel’s walls over the course of three years. It also delivers a drug that prevents scar tissue from forming — a common risk factor with traditional metal stents that further narrow the vessel. This according to a new study published in the New England Journal of Medicine.

#Device, #Patient, #Provider