MD Hospital Agrees to IRO Oversight of Cath Lab

Following the announcement earlier this month of a $1.8 million False Claims Act settlement with the Department of Justice, Maryland's Peninsula Regional Medical Center said Monday that it will retain an independent review organization to evaluate and analyze the medical necessity of procedures performed in its cardiac catherization lab.

The move is part of a corporate integrity agreement the medical center signed as part of  its deal with DOJ to settle a case in which prosecutors said unnecessary cardiac stent procedures were performed by a Pensinsula cardiologist.

The CIA was signed August 9 but wasn't released to the public until Monday when it was posted on the website of the Office of Inspector General.

The document details the steps officials at the Salisbury, MD medical center will take to ensure that the operation of its cardiac cath lab complies with federal and state regulations.

The IRO will review random catheterization lab procedures to assess the appropriateness of case selection, execution of the procedure, and the response to any problems.

The fraud case involved allegations that officials at PRMC knew about, but failed to act on, unnecessary cardiac stent procedures performed by John R. Mclean, M.D., a cardiologist at the medical center. McLean was convicted of fraud in July 2011 after federal prosecutors showed that he inserted unnecessary cardiac stents into more than 100 patients as part of a scheme to defraud government and private insurers of more than $700,000.

Because of the impact on the quality of patient care, the OIG required that the corporate integrity agreement include independent quality monitoring to review PRMC's delivery of care and to evaluate its ability to prevent, detect, and respond to patient care problems.

PRMC must comply with the terms and scope of the CIA for five years. A material breach of the CIA requirements could result in Peninsula being denied access to federal healthcare programs.

In addition to independent review and quality monitoring the medical center agreed to:

• Appoint from senior management a compliance officer who will report directly to the CEO and be responsible for developing and implementing the policies and procedures needed to meet the CIA requirements.
• Appoint a board-certified cardiologist to serve as the medical director of its cardiac cath lab. The director will be responsible for the clinical management and oversight of the lab and will file a quarterly management report to the physician executives and compliance officer.
• Appoint up to three physician executives who will be responsible for medical staff quality matters
• Appoint a peer review consultant to assess peer review, credentialing and privileging

The policies and procedures developed by the compliance officer must address the management and oversight of the cath lab, including recordkeeping for all procedures performed, tracking the volume of cath procedures performed by each physician, and comparing results to national benchmarks.

"Working with the government and fully cooperating with all reviews has culminated in an agreement that strengthens our compliance program. Our standards of accountability were exhaustively reviewed, enhanced and are now more comprehensive than at any time in our 114 year history," said PRMC President and CEO Dr. Peggy Naleppa in a media statement released Monday. 

See Also:
MD Hospital to Settle Cardiac Stents Fraud Case for $1.8M
MD Cardiologist Convicted in Cardiac Stent Scam
Inside Cardiology's PCI Problem