Deeper Than the Headlines: Doctors Blowing the Whistle on Other Doctors

In December of 2016, the U.S. Attorney’s Office for the Southern District of Florida announced a $12 million settlement with South Miami Hospital regarding allegations of medically unnecessary cardiac electrophysiology studies and other procedures allegedly performed by John R. Dylewski, M.D.

It’s especially interesting that the whistleblowers in the case against the hospital and Dr. Dylewski were also doctors, James A. Burks, M.D., a board-certified vascular surgeon, and James D. Davenport, M.D., a board-certified cardiologist. They claimed that they had raised concerns about medically unnecessary cardiology procedures with hospital executives, including the CEO. According to them, their complaints fell on deaf ears because Dr. Dylewski was producing a high volume of procedures resulting in significant reimbursement from payors such as Medicare.

Physician Whistleblowers Aren't Uncommon

It’s not uncommon for physicians to be whistleblowers. It actually makes some sense as physicians are involved in the medical services and they observe and hear how other physicians are practicing.

The types of services that Dr. Dylewski allegedly performed without the requisite medical necessity included: echocardiograms, electrophysiology studies, head upright tilt tests, and treatments of arrhythmia by ablation, cryoablation, or implantation of an electronic device.

Drs. Burks and Davenport claimed to have first-hand knowledge through their direct working relationship with Dr. Dylewski as well as by serving on various hospital peer review committee that investigated complaints of unnecessary procedures that were putting patients at risk, all for the benefit of financial gain.

One of the consistent themes found in court documents is the allegation that Dr. Dylewski was performing implantation and/or replacement of automatic implanted cardioverter defibrillators (AICD) when there was not a clinical indication to do so. And specifically, when the ejection fraction (EF) of the patient’s heart was not less than 35% which was claimed by the whistleblowers to be absolutely necessary in order to implant an AICD for the patients in question.

The complaint included brief summaries of seven separate patients as examples of unnecessary procedures.

Patient 5 is a case in point:

“A 65-year-old male patient with congestive heart failure and a previously implanted pacemaker were evaluated by Defendant, DYLEWSKI. As a result of Defendant, DYLEWSKI’s, evaluation, he replaced the pacemaker with an AICD because allegedly the patient’s EF is 25%. Subsequently, the patient was re-evaluated because the AICD was found to be non-functional for unidentified reasons. The defendant, DYLEWSKI, documented that the device was defective and removed and replaced the AICD and both leads with a new AICD and leads. The removed AICD and leads were returned to the manufacturer for evaluation where it was determined to be completely functional. Upon further review of this patient’s records by the ad hoc committee of the South Miami Heart Center Advisory Board, the patient’s preoperative ECHO which had been read by Defendant, DYLEWSKI, showed an EF between 40% to 50% providing no indication for the initial removal of his existing pacemaker and replacement with the AICD. Further, it was determined that any problems with the first AICD were improper lead placement. However, reimbursement for placement of a new device is significantly higher than for lead adjustment and this financial incentive was identified as the reason for the removal and replacement of the AICD.”

There were also allegations of patient harm because of medically unnecessary procedures.

Patient 2 is such an example:

“An 80-year-old male patient with multiple comorbidities and chronic kidney disease was treated by Defendant, DYLEWSKI, who “upgraded” his pacemaker to a biventricular pacemaker using excessive amounts of iodinated contrast. The patient suffered renal failure, dialysis, and eventual death. A review of pre-procedure medical records failed to reveal any indication for the “upgrade” pacemaker procedure and the patient’s ECHO demonstrated an EF greater than 40%.”

Lack of medical necessity can be a complex allegation for compliance officers to deal with. Since the stakes can be high if such accusations have a hint of truth, it might behoove an organization to engage a third-party with expertise in reviewing these types of situations. Medical societies often have published practice guidelines which can give compliance officers a starting place when reviewing the validity of the claims.

In this case about AICD implantation, the following guidelines from “A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines” might be a good starting point (http://www.onlinejacc.org/content/60/14/1297). Having someone on staff in the compliance department with some clinical experience or background could help in the communication between clinicians and attorneys.

As the OIG has stated in previous guidance for physician practice compliance programs, “The individuals from the physician practice involved in these self-audits would ideally include the person in charge of billing (if the practice has such a person) and a medically trained person (e.g., registered nurse or preferably a physician (physicians can rotate in this position)).”

The need for a “medically trained person” is especially important when the allegations are based on doctors blowing the whistle on other doctors.