Weekly Spotlight
As we happily send this final update for 2024, SHP would like to invite you to share this publication with others in your sphere who might benefit from regular policy news and (from time to time) snarky insights. Please always feel free to share any feedback to info@shpconsulting.llc. What would you like to see more/less of in 2025? Anything you’re particularly focused on in the New Year.
From our family to your, wishing you a warm and restful holiday season. We’ll see you back here on the flip side!
Happy Holidays!
-SHP
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
Using the Inflation Reduction Act to Rein in Patenting & Evergreening Abuses
Public Citizen Report: Public Citizen urges CMS to account for patent abuses by manufacturers that enable price gouging on the drugs selected for Medicare price negotiation. As discussed in our analysis below, nine of the ten drugs subject to negotiation demonstrate evidence of patenting tactics designed to unfairly lengthen monopoly protections on the drugs to the detriment of American patients.
#Drug
Experts Weigh Benefits of Drug Price Negotiation and Other Price-Curbing Strategies
Policy experts punched holes in drug companies’ claims that the Medicare Drug Price Negotiation Program will stunt innovation and weighed in on other drug price-curbing strategies during a webinar hosted by the National Institute…
#Drug, #Patient
8 changes coming to HCAHPS in 2025
Numerous HCAHPS changes are set to take effect Jan. 1, aiming to modernize the survey and increase patient response rates.
#Hospital, #Patient
Members leaving Medicare Advantage have higher expenses, KFF finds: 5 things to note
Medicare spends more on beneficiaries who switch from Medicare Advantage to traditional Medicare compared to those who remained enrolled in traditional Medicare, a report from KFF found.
#Payer, #Patient
CMMI Report to Congress
Section 1115A(g) of the Act requires the Secretary to submit to Congress a report on the CMS Innovation Center’s activities at least once every other year beginning in 2012. The CMS Innovation Center is submitting this seventh biennial report covering model activities conducted between October 1, 2022 and September 30, 2024 (the period of report).
#Provider
Mandatory Medicare Bundled Payment and the Future of Hospital Reimbursement – AJMC.com Managed Markets Network
The most potentially disruptive aspect of TEAM is that target prices are based on average regional spending. Although this reduces administrative complexity, it means that high-cost hospitals will be under intense pressure to improve efficiency to avoid losses.
#Hospital
Food and Drug Administration (FDA)
With Makary set to face FDA commissioner hearings, how deep do his industry ties run? – PharmaVoice
Dr. Marty Makary’s conflicts of interest could come into question before he is confirmed as the next FDA commissioner.
#All
FDA commissioner, a veteran cardiologist, highlights ongoing issues with US healthcare system
FDA Commissioner Robert Califf, MD, talked to Cardiovascular Business about healthcare spending, inconsistent patient outcomes and much more
#All
Microbot Medical announces US FDA submission for commercialisation of Liberty endovascular robotic system – Vascular News
A press release details that Liberty is the world’s first single-use, fully disposable robotic system for endovascular procedures. The 510(k) submission follows the successful completion of Microbot Medical’s multicentre, single-arm trial to evaluate the performance and safety of Liberty in human subjects undergoing peripheral vascular interventions.
#Device
CDER Center for Real-World Evidence Innovation (CCRI)
The Center for Drug Evaluation and Research (CDER) Center for Real-World Evidence Innovation (CCRI) is the focal point to promote more efficient and consistent communication across CDER offices regarding real-world data (RWD)/real-world evidence (RWE). The goal of CCRI is to expand, coordinate, and promote consistency across RWD- and RWE-related activities in CDER—including related uses of emerging technologies—in both internal and external FDA activities.
#Device
Health and Human Services (HHS)
75+ Nobel Prize winners urge senators to reject RFK Jr.’s HHS nomination
Over 75 Nobel Prize winners have signed a letter urging U.S. senators to reject Robert F. Kennedy Jr.’s nomination as HHS Secretary, The New York Times reported Dec. 9.
#All
Hill Happenings
Warren, Democrats demand answers from Dr. Oz about Medicare privatization – The Hill
Leading Democratic lawmakers are demanding answers from Dr. Mehmet Oz on his previous support for eliminating traditional Medicare in favor of private Medicare Advantage plans.
#All
House Republicans launch investigation into CVS Caremark for potential antitrust violations
House Republicans want to know whether pharmacy benefit manager (PBM) CVS Caremark violated federal antitrust laws by threatening independent pharmacies to keep them from using money-saving tools outside the PBM’s network.
#Drug
Should Hospitals Be Paid the Same as Doctors’ Offices for the Same Service?
The idea of requiring site-neutral payments in Medicare — in which providers would be reimbursed at the same rate for performing the same service, regardless of where it’s performed — appears to be gaining steam on Capitol Hill
#Hospital, #Provider
A significant step forward’: Advocates cheer as heart health bill passes Senate
The HEARTS Act is focused on improving cardiomyopathy education and awareness while getting more AEDs in schools. The ACC, AHA and other medical societies have supported the bipartisan bill, which now heads to the president’s desk to be signed into law.
#Patient
MedPAC Members Supportive of Upping Medicare Pay Rates Close to the Inflation Rate
Members of the Medicare Payment Advisory Commission (MedPAC) seemed favorable Thursday to a proposed recommendation to Congress that Medicare should pay physicians based on the rate of medical inflation.
#Provider
Notable Notes
Musk Cost-Cutting Effort Is Being Guided by Health Entrepreneur
The inclusion of Brad Smith in Trump’s efficiency panel suggests that the team is preparing to focus particularly on the nation’s health care system.
#All
Outpatient pharmacy costs outpace total spend by 52%
Historically viewed as cost centers, hospitals and health systems are increasingly identifying their pharmacy departments as “revenue engines,” according to Vizient.
#Drug
ICER Identifies 5 Drugs with Unsupported Price Increases
The Institute for Clinical and Economic Review has identified five drugs — Biktarvy, Darzalex, Entresto, Cabometyx, and Xeljanz — with prices increases that are not supported by new clinical evidence, with a total of $815 million in added costs to U.S. payers in 2023.
#Drug
More vulnerable, but still treatable: Frail heart patients benefit from PCI, CABG
High-risk patients are often treated with medical therapy alone instead of revascularization. However, new data make it clear that these patients can live much longer when treated with PCI or CABG.
#Patient
Where systems fail female physicians in career training: 8 notes
Only eighteen percent of female physicians said their employer prioritizes their career growth, according to a recent Medscape report.
#Provider
Interventional cardiology’s first Match Day celebrated as a ‘historic achievement’
This was a moment years in the making for interventional cardiology. A total of 164 training programs participated, and 94% of applicants secured a position.
#Provider
Why private equity healthcare investment may rise in 2025
Private equity-linked healthcare transactions are poised to rebound as interest rates cool and a new presidential administration takes over.
#Provider
Robotic AVR
Q&A: Pioneer heart surgeon on the development and long-term potential of robotic aortic valve replacement
It’s early for RAVR, but the minimally invasive technique has already started gaining momentum as an alternative to both SAVR and TAVR. We spoke to Vinay Badhwar, MD, one of the world’s leading voices in robotic heart surgery.
#Provider, #Device
Heart surgeons perform world’s first combined robotic AVR and CABG
The entire robotic procedure was performed through one small incision. Surgeons originally recommended the 73-year-old patient undergo open-heart surgery, but she requested a less invasive alternative.
#Provider, #Device, #Patient
Heart surgeons detail world’s first robotic heart procedure of its kind
The care team behind the very first robotic aortic valve replacement and coronary artery bypass surgery has written about the experience in The Annals of Thoracic Surgery. The group discussed the development of the technique, how the patient was chosen for treatment and other key details.
#Provider, #Patient, #Device
TAVR News
Medtronic TAVR valves at heart of key studies presented during PCR London Valves 2024
One study presented during the three-day conference focused on the potential benefits of an optimized TAVR pathway. Another study, meanwhile, tracked changes in paravalvular leak severity over time.
#Device
Years of progress have made TAVR more effective when treating concomitant mitral stenosis
Newer balloon-expandable TAVR valves are associated with much better outcomes for patients presenting with both severe AS and severe MS than older models.
#Device, #Patient
Q&A: How supra-annular, self-expanding TAVR valves open up options for future interventions
TAVR procedures have surged more than 30% since 2020, with more than 107,000 patients receiving a new prosthetic valve in 2023 alone. As this trend continues, it’s increasingly important that cardiologists consider the long-term impact on future coronary interventions patients may need.
#Device, #Patient
TAVR/PCI bests SAVR/CABG when treating severe AS and complex CAD
Percutaneous treatment was linked to improved survival and fewer adverse events than surgery when patients presented with both symptomatic severe aortic stenosis and complex coronary artery disease.
#Device, #Provider, #Patient
TAVR technology keeps evolving, improving outcomes without compromising valve performance
TAVR is a go-to treatment for symptomatic severe aortic stenosis in much of the world, thanks in large part to the hard work of research teams that never stop looking for new, innovative ways to make the technology more effective.
#Device, #Provider, #Patient
TAVR survival less likely when patients are depressed
Screening TAVR patients for signs of depression prior to treatment could help providers adapt as necessary and deliver better patient care.
#Patient
