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Medically Unnecessary Procedures Harm Patients, Raise U.S. Healthcare Costs, Atlantic Feature Emphasizes

Posted  August 20, 2021

Unnecessary procedures have long plagued the U.S. healthcare system, costing taxpayers billions and subjecting thousands of patients to invasive procedures that sometimes do more harm than good. For decades, various government actors have acknowledged the problem.

Why then is it so difficult to prevent unnecessary procedures in the U.S.?

Reporter Chris Outcalt recently pondered in a piece for The Atlantic. The article spotlights Marian Simmons, whose journey underscores the human cost of unnecessary surgeries but also inspires hope for change, catalyzed by insiders with the integrity to report wrongdoing. The piece does not purport to definitively answer the question it poses, but offers possible explanations – loose regulatory oversight, profit incentives in physician reimbursement – and provides a useful framework for ongoing dialogue.

One patient’s painful story.

Simmons underwent an unnecessary heart procedure at age 21 and suffered years of complications – flu-like symptoms, blurred vision, night sweats, rashes – before she discovered the culprit was the device that was implanted in her heart during the first surgery, The Atlantic reported. She then endured a second, even riskier operation to remove it. Simmons, like an estimated 25 percent of the population, has a small hole in her heart that didn’t close after birth, known as “patent foramen ovale,” or PFO. Most people with the condition do not need treatment and never even know they have it. Surgical intervention to close the PFO is only considered appropriate in those who’ve had more than one confirmed stroke of unknown justification. Simmons now believes she never had a stroke at all, but instead experienced a bad migraine that Utah-based cardiologist Sherman Sorenson convinced her was a stroke, and a harbinger of more to come unless she allowed him to operate.

In Simmons’ case, the harm went far beyond the risk, stress, and expense of an unnecessary procedure. The device Dr. Sorenson implanted in her heart contained nickel, which she had specifically asked him about before the surgery because she is allergic to it. Her symptoms disappeared after the device was removed years later.

The insider who exposed it.

But for whistleblower Dr. Gerald Polukoff, Simmons might never have discovered her first surgery was unwarranted and responsible for her ongoing health issues. When he was a young surgeon working under Dr. Sorenson, Dr. Polukoff saw Sorensen convince patient after patient they were likely to have a stroke if they did not undergo PFO closure surgery. By this time, Dr. Sorenson was performing 15-20 of these procedures each week and had been allowed to return to work despite a hospital audit that found his “compliance with the guidelines for performing PFO procedures” was “less than ideal.”

Having seen enough, Dr. Polukoff filed suit under the False Claims Act, a civil statute that empowers whistleblowers to expose fraud that impacts government spending, true here because government-funded healthcare programs paid for some of the unnecessary surgeries Sherman performed. When Simmons saw a TV ad, run by the whistleblower’s legal team, that sought impacted patients, the pieces finally began to fall together. The whistleblower-initiated suit ultimately led to an $8 million settlement.

Stories like Simmons’ are too common. Prosecutors are paying attention.

Sadly, unnecessary procedures remain pervasive. According to a 2017 PLOS One journal publication cited by The Atlantic, roughly two-thirds of over 2,000 American doctors surveyed reported that 15 to 30 percent of all medical care was unnecessary, including an estimated 11 percent of all procedures. And most of the doctors said they believed profit was a motivating factor.

As of 2020, at least fourteen different hospitals and cardiologists had settled False Claims Act allegations over just one category of medically unnecessary cardiac procedures, according to an article in JAMA Internal Medicine. The procedures at issue in those cases are meant to treat clots and blockages in blood vessels but performing the surgeries can do more harm than good in patients whose blockages are not sufficiently significant.

The enforcement trend appears likely to continue. Just this week, prosecutors in Illinois announced a $2.82 million False Claims Act settlement over medically unnecessary cardiac catheterization procedures performed over a six-year period.

Whistleblowers can help expose the ongoing problem and lower healthcare spending.

“The best way to lower health-care costs in America is to stop doing things we don’t need,” one of the PLOS One study’s authors, Marty Makary, a professor at Johns Hopkins School of Public Health told The Atlantic.

But that has proven difficult to accomplish, in part due to physician profit motives in the U.S. healthcare reimbursement system. So long as any portion of surgeons’ income is tied to the surgery volume, the incentive to recommend and perform unnecessary procedures will remain.

Whistleblowers like Dr. Polukoff help to combat the problem of unnecessary medical procedures and hold accountable surgeons who exploit their expertise. If you know about unnecessary medical procedures, you may have a case under the False Claims Act. To contact our whistleblower attorney team to learn more, click here.

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Tagged in: FCA Federal, Healthcare Fraud, Importance of Whistleblowers, Lack of Medical Necessity, Whistleblower Case,