Researchers identify steep decline in angioplasties at investigated hospitals.
Under the False Claims Act, the U. S. Department of Justice has investigated hospitals and cardiologists for performing unnecessary percutaneous coronary interventions (PCIs), commonly known as coronary angioplasty or angioplasty. In research results reported today in JAMA Internal Medicine, David Howard, Ph.D., of Emory University in Atlanta, and Nihar Desai, M.D., M.P.H., of Yale identified 16 hospitals that were investigated by the Justice Department, 14 of which have resulted in a settlement and three that resulted in prison sentences for cardiologists. Howard and Desai identified the hospitals by combing through department press releases with search terms such as angioplasty.
Here is their list:
|Lawnwood Regional Medical Center & Heart Institute/Regional Medical Center Bayonet Point||Case pending|
|Fairview Park Hospital||Settled for $2 million|
|Joseph P. Galichia/Galichia Medical Group||Settled for $5.8 million|
|St. Joseph Health System||Settled for $16.5 million; physician sentenced to serve 30 months|
|King's Daughter Medical Center||Settled for $40.9 million; physician sentenced to serve 5 years|
|Peninsula Regional Medical Center||Settled for $1.8 million; physician sentenced to serve 8 years|
|MedStar Health Inc.||Settled for $35 million|
|St. Joseph Medical Center||Settled for $22 million|
|Detroit Medical Center||Case pending|
|St. Michael's Medical Center||Settled for $450,000|
|EMH Regional Medical Center||Settled for $3,863,857|
|North Ohio Heart Center Inc/||Settled for $541,870|
|University of Penn. Health System; physician settled for $126,617||Settled after voluntary disclosure for $845,000|
|Aria Heath Systems||Settled after voluntary disclosure for $564,700|
|Medicor Associates/Hamot Medical Center (now UPMC Hamot)||Claims withdrawn (but $20.75 million settled over alleged violations of anti-kickback and self-referral laws)|
|Jackson-Madison County General Hospital||Seltted for $1,328,465; physician settled for $1.5 million|
These False Claims investigations took place in the context of a growing body of evidence that angioplasty is an effective treatment for a smaller group of patients than was previously thought.
The evidence base for PCI as an effective treatment for people with ST-elevation myocardial infarction is considered quite solid, but several large studies have shown that PCI does not reduce heart attack risk or mortality among patients with stable angina. For example, the COURAGE trial, which compared optimal medical therapy (aspirin or clopidogrel) to PCI in addition to optimal medical therapy among patients with stable angina, didn’t find a difference between the two groups in heart attacks and mortality.
Howard and Desai’s Research Letter in JAMA Internal Medicine examined the effect of the investigations on PCI volume. They compared eight hospitals that were investigated by the Justice Department to matched, noninvestigated hospitals in the same state. From 2006 to 2017, the PCI volume in patients without an acute myocardial infarction at the investigated hospitals decreased by about 81% (from an average volume 1,440 of PCIs in 2006 to 271 procedures in 2017). At the matched hospitals, the volume fell by about 68% (1,168 in 2006 to 369 in 2017).
An accompanying opinion piece by James Salazar, M.D., M.A.S., and Rita F. Redberg, M.D., M.Sc., the editor of JAMA Internal Medicine discussed the Less is More series in the journal and closing the gap between “evidence and practice to reduce low-value care.”
“Although the substantial decrease seen in PCI seen in all hospitals suggests an overall movement to a more evidence-based use of PCI, the differential decrease in hospitals that underwent investigations of false claims suggest that there is a role for the enforcement of accurate reporting of indications for PCI,” wrote Salazar and Redberg.
Another article in this issue of JAMA Internal found that if findings from ISCHEMIA trial were incorporated into the appropriateness criteria for PCI, the number of patients in the “rarely appropriate” category would increase from 7,148 to 52,590.