Abiomed is recalling the instructions for use of its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. The FDA has identified this as a Class I recall-- the most urgent type of recall-- where use of or exposure to a violative product will cause serious adverse health consequences or death. 

The recalled devices include: 

  • US Available Product Names: Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist ; Impella LD 
  • Product Codes:  See Recall Database Entry 
  • Distribution Dates: October 10, 2021 to October 10, 2023 

During operations, the recalled Impella device could cut through the wall of the left ventricle. Use of the pumps could cause left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death. The FDA stated that there have been 129 reported serious injuries, including 49 reports of death. 

Customers of Impella devices should have received an Urgent Medical Device Correction letter from Abiomed on December 27, 2023. The letter requested customers adhere to the following new and revised warnings: 

  • Carefully position the pump catheter during operative procedures 
  • Use imaging when advancing or torquing the pump catheter 
  • Use special care when inserting the pump catheter in patients with certain high-risk conditions or during active CPR 
  • Review the updated warnings in the device’s Instructions for Use 
  • Notify everyone at your facility who needs to be informed of this recall correction 
  • Notify any other facilities where the products have been forwarded the updated Instructions for Use  

If you have questions about this recall, contact Abiomed, Inc. at (978) 646-1400. To report a problem, complete the FDA reporting form

Mar 26, 2024
2 min read
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advocacy
STS explains Change Healthcare's recent cyberattack – and how it impacted claims submission and payment.
2 min read
Molly Peltzman, STS Advocacy

The House and Senate just approved a new government funding bill that provides $730 million in relief from Medicare physician payment cuts, boosting reimbursements by 1.68% starting on March 9 and lasting through the end of 2024. 
 
STS has vigorously advocated for this relief, yet the total amount is less than what many stakeholders demanded, including STS, 30 members of the U.S. Senate, and nearly 200 members of the U.S. House of Representatives. We will continue to advocate for the elimination of all payment cuts and insist on systematic reforms that eliminate this threat. This includes H.R. 2474, a bipartisan bill with broad support that would create automatic annual inflation adjustments for Medicare physician payments. Contact Congress on this important issue
 
Additional Details

  • The relief will apply to services rendered between March 9 and Dec. 31, 2024. 
  • After applying the relief, Medicare payments will remain 1.69% lower than in 2023. 
  • The payment reduction relief will not apply to claims between Jan. 1 and March 8, 2024. 
  • On Jan. 1, 2025, an additional reduction of at least 2.93% will occur, absent congressional action, due to the expiration of temporary relief.

If you have questions, contact advocacy@sts.org.

Mar 7, 2024
1 min read
A virtual conversation with U.S. Rep. Greg Murphy, MD. Learn more and reserve your spot.
Date
6 p.m. ET
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Advocacy alert
Last week, the Centers for Medicare & Medicaid Services (CMS) issued a final rule aimed at reforming the prior authorization (PA) process. The U.S. Department of Health and Human Services (HHS) estimates that these changes will result in approximately $15 billion in savings for physician practices over the next decade. 
2 min read
Molly Peltzman, STS Advocacy

Join Representative Mariannette Miller-Meeks and members of the STS Council on Health Policy and Relationships for this 1-hour long exclusive webinar specially dedicated for STS-PAC contributors. 

Date

In observance of Lung Cancer Awareness Month, STS participated in a congressional press conference focused on the importance of lung cancer screening hosted on the U.S. Capitol grounds on Thursday, November 16. The event, hosted by Congresswoman Kathy Castor (D-FL), aimed to bring attention to the urgent need to get more people screened for lung cancer. 

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Dr. Keith Mortman with Congresswoman Debbie Wasserman Schultz
Dr. Keith Mortman with Congresswoman Debbie Wasserman Schultz

STS joined other key stakeholders in the lung cancer community at this event, including LUNGevity Foundation, American Lung Association, GO2 for Lung Cancer, Moffitt Cancer Center, the Roswell Park Comprehensive Cancer Center, and Rep. Debbie Wasserman Schultz (D-FL).  

STS has a long history of advocating for robust patient access to lung cancer prevention, screenings, and treatment. “Over the past decade, significant progress has been made to expand insurance coverage of lung cancer screening, yet this press conference highlighted that significant challenges remain to increasing screening rates among at-risk individuals,” said Keith Mortman, MD, who participated in the press conference and is a member of the STS Workforce on Health Policy, Reform, and Advocacy. “While innovative treatments for lung cancer are rapidly emerging, not everyone has equal access to these cutting-edge treatments. STS is relentlessly advocating with policymakers in Washington to remove barriers and increase access so our members can offer the highest quality lung cancer care possible.”

To advance this priority, STS has advocated for H.R. 4286, Increasing Access to Lung Cancer Screening Act, a bipartisan bill introduced by Reps. Brian Higgins (D-NY), Brian Fitzpatrick (R-PA), and Kathy Castor (D-FL), that would require all state Medicaid programs to cover lung cancer screenings for eligible enrollees as recommended by the U.S. Preventative Services Task Force (USPSTF). Urge your lawmakers to support this legislation today.

Nov 16, 2023
2 min read
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advocacy
As long as the values of the STS-PAC remain in line with my own, I will continue to contribute to it.
3 min read
David Blitzer, MD

On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) published the Medicare Physician Fee Schedule final rule. Despite vocal opposition from The Society of Thoracic Surgeons (STS) and many others in the physician community, this rule finalizes a greater than 3% reduction to physician reimbursement beginning January 1, 2024.

When adjusted for inflation, Medicare physician payments have declined by 26% since 2001. This latest reduction is the most recent example of a trend that is unsustainable and impacts patient access to care. These cuts are due to the implementation of the flawed complexity add-on code G2211, combined with expiring temporary relief previously enacted by Congress. The final rule also contains a few positive developments. CMS agreed with STS’s concerns that raising the required threshold to avoid a penalty in the Merit-based Incentive Payment System (MIPS) from 75 to 82 points was inappropriate at this time because the MIPS program has been largely paused since 2019 due the COVID-19 pandemic. CMS also approved several new intraoperative cardiac ultrasound CPT codes (76987–76989) at higher levels than in the proposed rule, which will be available to cardiothoracic surgeons next year.

Fortunately, the Senate Finance Committee recently released a draft legislative proposal that seeks to extend relief payments for physicians that are slated to expire this year. If enacted, this would help counteract a portion of the cuts slated for 2023. STS will continue to urge Congress to halt this unsustainable cut and to enact policies such as H.R. 2474, the Strengthening Medicare for Patients and Providers Act, which would provide an annual automatic inflation update for physician payments going forward. Help us maintain adequate Medicare reimbursements by contacting your lawmakers now!

Learn more about STS’s advocacy efforts focused on the 2024 Medicare Physician Fee Schedule.

Nov 3, 2023
2 min read