Senators Demand Answers About “Alarming” Reports of Excessive and Risky Artery Procedures on Veterans

by Annie Waldman

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Just hours after ProPublica, in collaboration with The Wichita Eagle, revealed serious allegations of illegal kickbacks and alleged patient harm at a veterans hospital in Kansas, the state’s U.S. senators urged the Department of Veterans Affairs to contact impacted patients and say whether the involved doctors and medical device company have been held accountable. The U.S. congressman who represents the hospital’s district is also calling for answers.

In a letter sent on Thursday, “regarding the alarming reports of lapses in patient safety and improper use of taxpayer dollars,” the Republican senators, Jerry Moran and Dr. Roger Marshall, asked the VA for a “full timeline and accounting” of the agency’s knowledge of, and response to, the allegations, and to reach out to all veterans who had received care at the catheterization lab of Robert J. Dole Veterans Affairs Medical Center in Wichita between 2011 and 2018. During this period, according to a whistleblower lawsuit filed in 2017, representatives from Medtronic, the world’s largest medical device maker, treated health care workers to steakhouse dinners, Apple electronics and NASCAR tickets, and in turn, the company secured a lucrative contract with the veterans hospital.

Medtronic’s representatives also allegedly “groomed and trained” doctors at the hospital, who then deployed the company’s devices, even in cases when it was not medically necessary. The doctors in question were contract workers, paid hourly by the facility, according to the lawsuit, and thus were incentivized to do longer and more complex interventions, which would increase their payment.

In several of the procedures, the doctors deployed more than 15 devices at a time, deviating from best practices, according to an internal investigation. One used 33.

“I want to say the term ‘egregious’ was used,” former facility director Rick Ament testified last December in a deposition for the whistleblower suit.

These procedures were performed to treat blockages in the legs, a common medical condition that is also known as peripheral artery disease, which affects more than 6.5 million Americans over the age of 40. Each time a physician inserts a foreign device in a patient during one of these interventions, it carries a risk of complication, which can include clots or even require amputation.

An internal investigation at the Wichita hospital uncovered a number of clinical failings, including over-aggressive procedures and a disregard for best practices. It also found, according to an internal email, that amputations had increased sixfold during the time period in question. A VA spokesperson would not say whether those outcomes were linked to overuse of the devices and said that the agency’s review has found no “quality of care” issues yet. The review is expected to last several months. (Read the VA’s full statement in response to ProPublica’s story.)

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In 2018, the director of the Wichita facility shut down interventional radiology procedures at the hospital and shared the findings of his internal investigation with the VA’s Office of Inspector General. The next year, according to an investigation memo that was unearthed in the whistleblower suit, the OIG found that employees at the hospital “may have received improper gratuities, in the forms of paid lunches, dinners, etc., from sales representatives from Medtronic.”

Even though the VA has been aware of the allegations of kickbacks and excessive device use for about five years, the agency did not publicly acknowledge these findings outside of the lawsuit until ProPublica reached out. It is unclear if the VA has reached out to any patients who underwent these procedures during the time frame in question. ProPublica contacted more than half a dozen veteran community groups in the Wichita area, and none were aware of the allegations nor the internal investigation.

Following the publication of ProPublica’s story, U.S. Rep. Ron Estes, a Republican who serves the Wichita region, expressed concern and pushed for accountability within the VA. “The VA needs to get to [the] bottom of these serious allegations,” he said in an email. “Veterans in our community should reach out to my office here in Wichita with any issues they face.”

The Kansas senators urged the agency to inform impacted patients of the “steps VA has taken to assess the quality of the care they received there, and provide them with contact information for appropriate officials who can answer any questions or concerns they might have.”

Moran, the ranking member of the Senate Veterans’ Affairs Committee, and Marshall, a doctor who served seven years in the Army Reserve, are also demanding answers to the following questions:

• What steps did the VA take to “remove the contract employees in question from patient care duties, report them to appropriate authorities, hold them accountable for their malfeasance, and prevent them from practicing not just at the Dole VAMC but also at any other VA facilities or through VA’s community care networks”? (A VA spokesperson told ProPublica that neither it nor the hospital had taken formal action against the medical providers.)

• What steps did the VA take to “hold the contractor, Medtronic, accountable for the role they played in this incident”? (The VA found evidence that indicated the facility had purchased a large number of devices from Medtronic, which resulted in increased costs. The VA did not respond to ProPublica’s questions related to the reasons for the excessive purchase of devices, citing the ongoing whistleblower case and investigation by the OIG. The agency said that the Wichita facility no longer purchases Medtronic equipment and supplies for complex vascular procedures on lower extremities, but that it continues to purchase other types of the company’s products.Medtronic declined to respond to ProPublica’s questions, citing the ongoing litigation. “These allegations are false and Medtronic is defending against these claims in court,” said Boua Xiong, a spokesperson for the company. Medtronic did not respond to ProPublica’s request for comment in response to the letter from the Kansas senators.)

• What steps did the VA take to “identify and prevent similar incidents from occurring elsewhere in the VA healthcare system”?

• What are the agency’s “plans to communicate with veterans in Kansas and across the country about this issue”?

Aside from more details on the agency’s investigation, the senators have also asked the VA to assure patients at Wichita’s veterans hospital that “their safety is VA’s paramount concern,” and to “inform those who are understandably questioning whether it is safe for them to continue seeking care there of their right to request care in the community.”

Gary Kunich, a VA spokesperson, said that the agency had received the letter and that it is “working on a prompt and complete response to Senator Moran and Senator Marshall.”

Do You Have Experience With Peripheral Artery Disease? Have You Had a Procedure on Your Leg? Tell Us About It.

This content originally appeared on Articles and Investigations - ProPublica and was authored by by Annie Waldman.