Weekly Spotlight

As the countdown to election day closes on single digits, policy types are holding their collective breath. If you haven’t gotten it done by now, it’s probably not going to happen. Aside from a couple of critical, must-pass items that will be addressed in the lame duck, it’s all over but the waiting.

News continues to trickle out about Medicare Advantage this past year with the last payment rules for the year still pending.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Why 3 Medicare Advantage insurers sued over star ratings

UnitedHealth Group, Humana and Centene allege CMS unfairly rated their Medicare Advantage call centers.

#Payer

UnitedHealth was top insurer collecting billions in questionable Medicare payments, federal watchdog finds

A federal watchdog found that Medicare Advantage insurers led by UnitedHealth Group collected billions of dollars in dubious payments from Medicare by using home visits and medical chart reviews to diagnose patients with conditions for which they received no follow-up care.  

#Payer

Doctors hate MIPS. They aren’t crazy about the alternative, either

Doctors are fed up with the system CMS uses to promote quality and set reimbursement rates. But they fear the agency’s new vision even more.

#Provider

Food and Drug Administration (FDA)

FDA grants AI-powered ECG screening tool for aortic stenosis its breakthrough device designation

AccurKardia, a New York-based healthcare technology company, has received the FDA’s breakthrough device designation for new screening software that uses artificial intelligence (AI) to evaluate electrocardiogram (ECG) data for signs of aortic stenosis (AS).

#Device

Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A

On October 9, 2024, the U.S Food and Drug Administration (FDA) held the Medical Device Sterilization Town Hall: Short Topics and Open Q&A. During this town hall, FDA discussed Predetermined Change Control Plans and hosted an open question and answer session.(summary, slides, and transcript available). Next Town Hall Meeting: Oct 30

#Device

Michelle Tarver to lead FDA medical device center

Tarver joined the Center for Devices and Radiological Health in 2009, eventually becoming the director of the Office of Transformation and helping to launch the agency’s patient engagement advisory committee. She has temporarily served in the role since Jeffrey Shuren announced his exit in July.

#Device

Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

In the last decade, cardiovascular devices have been involved in more Class I recalls than any other device type. What, exactly, has led to this trend? Should cardiologists or their patients be concerned? And what can be done to limit these recalls going forward? A team of researchers hoped to answer those questions, and many others, with a study recently published in Annals of Internal Medicine.[1] Tracking FDA data from 2013 to 2022, the group found that many recalled cardiovascular devices gained approval without ever submitting premarket or postmarket clinical data. Even when premarket testing was required, they explained, it often came in the form of a nonrandomized trial with no control arm, offering limited evidence of the device’s long-term safety or effectiveness. Cardiovascular Business spoke to that study’s corresponding author, Kushal T. Kadakia, MSc, a healthcare policy researcher with Harvard Medical School, to learn more about this topic.

#Device

Health and Human Services (HHS)

Sales from controversial drug discount program rose to $63 billion last year

Prescription medicines purchased in the U.S. under a controversial government discount program amounted to $66.3 billion in 2023, a 23.4% increase from the previous year, according to the Health Resources & Services Administration, which oversees the program.

#Drug

Hill Happenings

What’s on the docket for Congress post-election: Chinese biotech, Medicare payments, ACA subsidies

Regardless of what happens in this year’s election, next year will be huge for health care policy, in part because lawmakers need to address major expiring policies. Here are the policies STAT is keeping an eye on during the lame duck session and into next year.

#All

Notable Notes

Medtronic’s next-generation TAVR device receives CE mark approval

The Evolut FX+ TAVR system, which already received FDA approval in March, was designed with improved coronary access in mind. One cardiologist described the device as a “significant step forward” for patients with heart disease.

#Device

TAVR survival is down in recent years, leaving cardiologists stumped

Researchers tracked recent TAVR data from the STS/ACC TVT Registry, highlighting a “concerning” finding they were unable to explain.

#Patient, #Provider

New Category I CPT codes announced for treating heart failure with implantable Barostim device

CVRx, a Minneapolis-based healthcare technology company focused on heart failure treatments, announced that baroreflex activation therapy with its implantable Barostim device has received new Category I CPT codes from the American Medical Association (AMA).

#Device, #Provider

New Category I CPT code issued for AI-enabled coronary plaque analysis software

The news comes just days after CMS confirmed these technologies would start receiving expanded Medicare coverage in November. HeartFlow and other AI vendors have already shared their excitement over the decision.

#Device, #Provider

FAH CEO Chip Kahn: Insurers, unions need to take a seat

The Federation of American Hospitals will focus in 2025 on ensuring providers receive adequate payment for the care they provide.

#Hospital

Cardiologist compensation still rising, especially in invasive and interventional cardiology

Cardiologist compensation is still climbing, according to a new survey published by MedAxiom, an American College of Cardiology company. This is true for both cardiologists employed by a hospital or health system and those who still work with a private practice.

#Provider

Compensation jumps 6% for heart surgeons, hits all-time high for vascular surgeons

While production is relatively unchanged compared to the previous year, compensation is up significantly for cardiovascular surgeons in the United States.

#Provider

Society of Thoracic Surgeons shares 2 new risk calculators for guiding treatment decisions

The Society of Thoracic Surgeons (STS) has released two new risk calculators designed to help care teams and their patients make the most appropriate treatment decisions possible. While one is focused on esophagectomy, the other addresses pulmonary resection.

#Provider

Cardiothoracic surgeons unite to improve clinical practice guidelines

Four leading cardiothoracic surgery societies have joined forces in the name of developing clinical practice guidelines that are more thorough and consistent. The American Association for Thoracic Surgery (AATS), Society of Thoracic Surgeons (STS), European Association for Cardio-Thoracic Surgery (EACTS) and European Society of Thoracic Surgeons (ESTS) announced the new endeavor Tuesday, Oct. 22, highlighting the need for more standardization, transparency and collaboration between like-minded healthcare organizations.

#Provider

SCAI shares STEMI recommendations for cardiologists and cath labs

“This document represents a collective effort to refine and advance the standards of care in STEMI management,” according to one cardiologist behind the project.

#Provider, #Patient

How surprise billing arbitration strains physician groups

CMS received 675 complaints as of June 30 about late payments following third-party determinations.

#Provider, #Payer