The U.S. Department of Justice (DOJ) has reportedly reached financial settlements with “hundreds of hospitals” accused of failing to prevent the overuse of implantable cardioverter defibrillators (ICDs) in heart patients, which may be viewed as a form of medical malpractice.
According to a recent report in Modern Healthcare, a handful of hospitals have disclosed the settlements, but “the vast majority have not been made public.”
Among the known settlers is HCA, one of the largest hospital chains in the country, which disclosed in regulatory filings that it had agreed to pay $15.8 million to settle allegations of ICD overuse, according to Modern Healthcare.
What Is an Implantable Cardioverter Defibrillator (ICD)?
An ICD is a medical device implanted in a heart patient’s chest or abdomen. It is used to treat irregular heartbeat, or arrhythmia, by electrically shocking the heart to prevent sudden cardiac arrest. Not all arrhythmia is life-threatening, however, so an ICD is not necessary for every patient experiencing irregular heartbeat.
An ICD is not the same thing as a pacemaker. The latter provides the heart with continuous, low-energy electric pulses. An ICD, on the other hand, offers a sudden shock to prevent cardiac arrest. However, some newer ICD models can act as both a pacemaker and defibrillator.
When Is an ICD Necessary?
An ICD may be prescribed for children or adults. According to the National Heart, Lung and Blood Institute, a doctor may prescribe an ICD if a patient has previously suffered a life-threatening (ventricular) arrhythmia or a heart attack which has damaged the heart’s electrical system.
A heart doctor may perform a series of tests to determine if an ICD is appropriate, including an electrocardiogram (EKG), echocardiography (heart echo) or stress test.
Federal Medicaid and Medicare guidelines further specify that an ICD should not be implanted in any patient within the first 40 days following a heart attack or the first 90 days after any type of heart bypass surgery.
Are ICDs Overused?
The use of ICDs has increased substantially since 2005, when Medicare determined that the devices could be used as a “primary” treatment for the prevention of arrhythmia. However, significant questions remain as to whether such increased use is medically justified.
In January 2011, the Journal of the American Medical Association (JAMA) reviewed post-2005 Medicare data and reported that nearly 22.5 percent of ICD patients — more than 25,000 individuals — did not meet the “evidence-based criteria” for the receipt of such devices.
The JAMA study found “a substantial number of ICDs were implanted in patients who were similar to those who either were excluded from major clinical trials of primary prevention ICDs or shown not to benefit from ICD therapy in other trials.”
Consequently, these patients faced “a higher risk of in-hospital death and any post-procedure complication,” according to the study.
Justice Department Investigates ICD Use
The DOJ has been looking into reports of ICD overuse dating back to at least 2010. Specifically, the DOJ believes many hospitals implanted ICDs in patients too soon after a heart attack or bypass surgery, which would violate Medicare guidelines. This is not a minor oversight as far as Medicare is concerned. After all, Medicare must pay upwards of $40,000 per ICD.
What makes the DOJ’s investigation novel is its use of a law known as the False Claims Act (FCA). The FCA basically makes it a crime to defraud the government.
In other words, if a person or business presents the government with a bill for services that it knows to be false, the government may sue to recover any payments made on that bill. Depending on the nature of the violation, the government may collect triple damages.
Here, the DOJ has asserted that hospitals which performed and billed Medicare for ICDs implanted in violation of federal guidelines made false claims.
In conjunction with the American College of Cardiology and other medical groups, the DOJ developed a “Resolution Model.” The model helps to determine an individual hospital’s liability and whether it should be penalized under the FCA’s treble damages provisions.
The model looks at a number of criteria including:
- Harm to patients
- The hospital’s knowledge regarding its staff’s ICD overuse
- The hospital’s ongoing efforts to comply with Medicare guidelines.
The DOJ already has recovered millions of dollars through these FCA settlements. In 2013, more than 50 hospitals agreed to pay the DOJ more than $34 million. More recently, Tenet Healthcare agreed to pay more than $12 million. Altogether, legal experts believe more than 500 hospitals will ultimately settle ICD overuse charges with the government.
Have You Been the Victim of an Unnecessary Medical Procedure?
Individual patients are unlikely to receive any benefit from the DOJ’s ICD overuse settlements. Again, those settlements deal with allegations of overbilling Medicare, not harming ICD recipients.
Still, patients may have a cause for legal action against a physician or hospital which implanted an ICD without sufficient medical justification. As noted by the JAMA study, among others, any unnecessary surgical procedure can significantly increase a patient’s chances of complications, including death.
The problem is not limited to ICD overuse.
According to a report published earlier this year by U.S. News & World Report, Medicare data indicates that physicians in rural parts of the United States such as upstate New York perform “catheterization procedures such as diagnostic angiograms and artery-clearing angioplasties at higher rates than doctors working at big city hospitals that serve as major cardiac referral centers.”
These unnecessary procedures add to rising healthcare costs while increasing the medical risks to patients, the report states.
If you have received an ICD or other cardiac procedure which may not have been medically necessary, it is important to take immediate action to protect your rights.
You should seek advice from an attorney who will look out for your best interests. An experienced Albany medical malpractice attorney from Powers & Santola, LLP, can review your case and help determine whether you or a family member has been the victim of ICD overuse or a similar unnecessary medical procedure.
Contact us today to receive a free and confidential consultation.