Advocacy

*Please note, this article was updated on September 5, 2024:

*After STS submitted letters to the Centers for Medicare & Medicaid Services  and the United States Preventive Services Task Force, the Centers for Medicare & Medicaid Services (CMS) responded, stating they cannot reconsider the National Coverage Determination (NCD) at this time. Following this, STS, the GO2 Foundation for Lung Cancer, and the American College of Radiology (ACR) met with CMS and had a productive conversation about the steps that need to occur, and the data needed to reconsider the NCD. USPSTF has also responded, indicating that this issue will be considered at their Topic Prioritization Workshop in the fall.

On June 21, 2024, The Society of Thoracic Surgeons, The American College of Radiology®, and the GO2 Foundation for Lung Cancer submitted joint letters to the Centers for Medicare & Medicaid Services and the US Preventive Services Taskforce that include recommendations to improve existing lung cancer screening eligibility requirements. 

The organizations formally requested reconsideration of the National Coverage Determination (NCD) for screening lung cancer with low-dose computed tomography and asked to eliminate the exclusion criteria of current smokers or people who have quit smoking within the last 15 years and the upper age limit. This would align the NCD with the updated American Cancer Society and the National Comprehensive Care Network evidence-based guidelines. 

Removing these criteria would significantly increase the number of high-risk individuals eligible for screening from 14.2 million to 19.2 million. Annual lung cancer screening with low-dose computed tomography in high-risk patients significantly reduces lung cancer deaths and may help identify cancers at an early, treatable, and curable stage.  

If you have questions about STS’s lung cancer screening advocacy efforts, contact Haley Brown, senior manager, political affairs and advocacy. 

Today, the Federal Trade Commission (FTC) announced the enactment of a final rule to ban non-compete clauses as an unfair method of competition. This groundbreaking rule prohibits employers from entering into or maintaining non-compete agreements with workers, with limited exceptions. The Society of Thoracic Surgeons has been a strong advocate for this ban, recognizing that non-compete clauses significantly hinder cardiothoracic surgeons by limiting their ability to serve their communities, maintain continuity of care, and ensure patient access to specialized surgical services.  

"STS members and the broader physician community will benefit from the ban on non-competes," says STS President Jennifer C. Romano, MD, MS, and a practicing cardiothoracic surgeon. "Eliminating non-compete clauses removes major barriers for cardiothoracic surgeons, enhancing their ability to decide where and how they practice without undue restrictions. This change is especially crucial in improving access to specialized surgical care across various regions, fostering a more dynamic and responsive healthcare system." 

The unfortunate exclusion of most non-profit hospitals from this rule significantly constrains its benefits. We encourage Congress to continue the momentum on this important issue by enacting S. 220 / H.R. 731, the Workforce Mobility Act, which would extend these crucial protections to all healthcare providers, ensuring a truly competitive and patient-centered healthcare environment.  

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for nearly 14,000 Abbott and Thoratec HeartMate left ventricular assist devices (LVADs). This recall comes after reports of multiple deaths and injuries associated with these devices, which are used to aid patients with advanced heart failure. 

The recalled devices include: 

• Product names: HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) 
• Product codes: DSQ 
  • Class 1 Device Recall HeartMate II Left Ventricular Assist System (fda.gov) 
  • Class 1 Device Recall HeartMate 3 Left Ventricular Assist System (fda.gov) 
• Model numbers:  Full List of Affected Devices 
• Distribution dates: Starting April 21, 2008 

The problem at the center of this recall is the gradual buildup of biological material in these devices develops over 2 or more years, potentially obstructing the device and diminishing its ability to support the heart's pumping action. This issue can trigger alarms for low blood flow and impair the device's effectiveness. 

Recall Action: This recall is classified as a correction rather than a complete product withdrawal. The FDA has not advised the return of all affected devices. However, heightened vigilance concerning low-flow alarms, which may indicate significant outflow obstructions, is recommended. 

Customers should have received an Urgent Medical Device Correction letter on February 19, 2024, providing detailed guidance on monitoring for and addressing potential obstructions. 

Abbott and Thoratec have made efforts to educate physicians on the importance of heeding persistent low-flow alarms as early indicators of potential obstructions and have shared diagnostic recommendations to identify obstructions and discussed treatment options available for managing such issues.  

If you have questions about this recall, contact Abbott and Thoratec directly at (844) 692-6367. To report a problem with these devices, complete the FDA reporting form

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. 

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.