Weekly Spotlight
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
New from MedPAC: 2024 Payment Basics Series
Payment Basics is a series of explainers on how Medicare’s payment systems function. These “basics” are typically no more than 5 pages long and feature handy diagrams that visually depict how the payment systems calculate providers’ payments. MedPAC produces “basics” for the major payment systems (20 in all), and updates the series once a year in the fall.
#All
NCA Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management
This NCA will focus on the clinical indications for use of implantable PA pressure sensors for HF management among Medicare beneficiaries. The scope of this NCA is limited to implantable PA pressure sensors for HF management.
#Device, #Patient, #Provider
I’m the director of the Center for Medicare. Here’s how we executed the first round of drug price negotiation
Opinion piece from Meena Seshamani, Deputy Administrator of CMS and Director of the Center for Medicare.
#Drug, #Patient
The Progressive Campaign Against Biomedical Innovation
An early modeling study from a group of University of Chicago economists found that the drug price controls in a legislative proposal similar to IRA would lead to an estimated $663 billion loss in research and development investment — leading to at least 135 fewer medications and more than 330 million life-years lost. Since the passage of IRA, the website Life Science Tracker notes that companies have discontinued an additional 36 research and over 21 drug development programs.
#Drug, #Patient
OIG – Medicare Advantage: Questionable Use of Health Risk Assessments Continues To Drive Up Payments to Plans by Billions
What OIG Found: Diagnoses reported only on enrollees’ HRAs and HRA-linked chart reviews, and not on any other 2022 service records, resulted in an estimated $7.5 billion in MA risk-adjusted payments for 2023. Just 20 MA companies drove 80 percent of the estimated $7.5 billion in payments. More from Stat.
#Payer. #Patient
CMS Announces New Participants in the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model
CMS announced that Rhode Island and s sub-section of New York have been selected to participate in Cohort 3 of the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model. The Cohort 3 pre-implementation period will begin January 1, 2025.
#Provider, #Hospital, #Payer, #Patient
Medicare Shared Savings Program Continues to Deliver Meaningful Savings and High-Quality Health Care
CMS announced that the Medicare Shared Savings Program (Shared Savings Program) continues to save Medicare money while supporting high-quality care. The Shared Savings Program yielded more than $2.1 billion in net savings in 2023 — the largest savings in the Shared Savings Program’s history. In addition, Shared Savings Program Accountable Care Organizations (ACOs) are providing higher-quality care and supporting policies CMS has adopted to enhance primary care, expand access to accountable care to underserved communities, and prioritize quality care for common chronic conditions
#Provider, #Patient
Food and Drug Administration (FDA)
Impella ECP confirmed to be safe for high-risk PCI—is FDA approval next?
The Impella ECP heart pump from Abiomed, part of Johnson & Johnson MedTech, is safe and effective to use during high-risk percutaneous coronary intervention (PCI) procedures, according to new data presented at TCT 2024 in Washington, D.C.
#Device, #Patient
Device Trial Participation Snapshots
The FDA’s Center for Devices and Radiological Health (CDRH) is piloting providing device trial participation snapshots to highlight certain information about the intended uses of a device, its benefits and risks, and the diversity of participants in clinical trials for certain new medical devices
#Device, #Patient
Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data
On December 13, 2024, the U.S. Food and Drug Administration (FDA) is hosting a virtual public workshop to discuss methodological challenges related to patient experience data, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other areas of greatest interest or concern to public stakeholders.
#Drug, #Patient
Hill Happenings
Backers of Prior Authorization Bill Hopeful for Passage by End of the Year
Hope remains that a bill that would further regulate the use of prior authorization in Medicare Advantage (MA) and other federal health programs will pass before year’s end. The bill’s cost estimate has dropped from $16 billion to $0, greatly hiking chances of passage
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Warren Wants Close FTC Scrutiny of Drug Distributors Buying Cancer Medical Groups
Sen. Elizabeth Warren (D-Mass.) is urging the Federal Trade Commission to scrutinize recent deals from McKesson and Cardinal Health to buy oncology practices, saying those transactions pose “clear, anticompetitive risks.”
#Drug, #Patient
Cassidy and Hassan Unveil Site Neutral Plan
U.S. Senators Bill Cassidy, M.D. and Maggie Hassan are working together on policy options for site-neutral payment reform. This paper explores policy options for payment reform that would reduce health care costs for patients and taxpayers, improve the financial stability of Medicare, reduce provider consolidation, and provide assistance to hospitals serving rural and high-needs communities.
#Hospital
Heart Rhythm Society launches new group focused on EP advocacy
#Patient, #Provider
House Members Introduce Bill to Reverse Pending Medicare Physician Fee Schedule Cut
A bipartisan group of House members introduced a bill that would reverse a proposed 2.8% Medicare Physician Fee Schedule payment cut and give physicians a raise equivalent to half of the increase in the Medicare Economic Index (MEI).
#Provider
Notable Notes
Major Win for Preemptive TAVR in Symptomless Aortic Stenosis
TAVR yielded clinical benefit when given early in the disease process while patients still had no symptoms or other indication for aortic valve replacement, according to the EARLY TAVR trial.
#Device, #Patient, #Provider
Progress in tricuspid valve care and TAVR on full display at TCT 2024
Harlan Krumholz, MD, editor-in-chief of the Journal of the American College of Cardiology, said tricuspid valve treatments are a popular topic among cardiologists right now. TAVR research, meanwhile, remains as important as ever.
#Device, #Patient
TTVR with Evoque device linked to substantial benefits after 1 year
Treating severe tricuspid regurgitation (TR) with the Evoque transcatheter tricuspid valve replacement (TTVR) system from Edwards Lifesciences is associated with significant improvements in symptoms and quality of life (QOL) after one year, according to new data presented at Transcatheter Cardiovascular Therapeutics (TCT) 2024 meeting in Washington, D.C.
#Device, #Patient, #Provider
Boston Scientific TAVR valve comes up short in comparison with Medtronic, Edwards devices
Boston Scientific’s Acurate neo2 Aortic Valve System is associated with worse patient outcomes after one year than other commercially available transcatheter aortic valve replacement (TAVR) valves on the U.S. market, according to new late-breaking data presented at TCT 2024 in Washington, D.C. Researchers think they have already discovered the primary reason why they were unable to prove noninferiority. Could learning from this mistake help Boston Scientific bounce back from the disappointing results?
#Device, #Patient, #Provider
Cardiologists make case for increasing use of device-based therapies for heart failure
Advanced device-based therapies are associated with significant benefits for heart failure patients and should be used alongside traditional pharmaceutical treatments, according to a new scientific statement from the Heart Failure Society of America (HFSA).
#Patient, #Provider
Rethinking Race and Ethnicity in Biomedical Research
In 2023, the National Academies convened an expert committee to assess the current use of racial and ethnic categories in biomedical research, review existing guidance for researchers, and provide new guidance for future use. The resulting 2024 report, Rethinking Race and Ethnicity in Biomedical Research, outlines nine actionable recommendations and associated resources for advancing the responsible use of race and ethnicity.
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A Look at the Supreme Court’s Upcoming Term
Public health is on the chopping block once again.
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In the era of GLP-1 drugs, demand for bariatric surgery plunges
For people with obesity, surgeries that shrink, reshape, or otherwise alter the anatomy of the stomach have long reigned supreme as the surest way to weight loss. But in the last few years, with the approval of GLP-1 drugs like Wegovy and Zepbound, more and more people are opting for obesity medicines over gold-standard surgical treatments.
#Drug, #Patient, #Provider
UVA Health Surgeons Sound Alarm on Upcoding
A news outlet obtained an audio recording from a meeting last November that was attended by surgeons, the department chair, and representatives for the health system’s billing and coding team. “You’re going to get in a lot of trouble if somebody tells [a surgeon] you need to bill 99291 on every one of these patients like that,” a surgeon said during the meeting. “That is what gets universities in trouble.”
#Hospital, #Provider
