In March 2011, following medical necessity audits of coronary stent procedures performed at Westmoreland Hospital in Westmoreland County Pennsylvania, Excela Health, the owner of the hospital, notified approximately 140 patients that they may have received unnecessary stents as a result of procedures performed by Ehab Morcos, M.D. and Bou Samar, M.D., members of the Medical Staff at Westmoreland Hospital. The hospital also issued a press release regarding the possible unnecessary procedures in which the physicians were named. Drs. Morcos and Samar resigned from the Medical Staff before the results of the audits were made public. No action was taken with respect to their medical staff membership or clinical privileges.
The physicians filed a lawsuit against Excela and others alleging a concerted effort to destroy their practices in retaliation for their complaints regarding poor quality care. They further alleged that the medical necessity audits were conducted outside the normal medical staff peer review process in violation of their rights to have a fair opportunity to be heard and that the audits were conducted inadequately. Excela responded that the actions were warranted under the circumstances and that the outside auditing firm used comprehensive auditing practices.
Approximately 85 patients have since filed medical professional liability actions against the doctors, the hospital and others.
These events were of concern to the Pennsylvania Medical Society. The Society concluded that medical staffs needed further guidance on several of the issues presented, including whether a medical staff should be involved in compliance audits; whether such audits require peer review confidentiality protection; and whether physicians who are the object of such investigation have due process rights.
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Those questions were the subject of a Task Force of the American Medical Association, which has recently issued “Guidelines for Organized Medical Staff Involvement in Hospital Compliance Programs.” The AMA Task Force recommends:
- Hospital compliance programs should be directed by a hospital-designated Chief Compliance Officer who reports to the Chief Executive Officer and Governing Body;
- The hospital should establish a Compliance Committee to operate and monitor the hospital’s compliance program;
- The Compliance Committee should include one or more physician members of the medical staff who are not employed by the hospital and who are selected by the medical staff to represent its interests and serve as a liaison between the Compliance Committee and the medical staff;
- The Compliance Committee should be given broad latitude to independently conduct audits and that the Compliance Committee should be permitted to utilize external reviewers of its choosing;
- Preliminary audit findings should not form the basis of reporting to governmental authorities and private payers, or the imposition of corrective action. Rather, they should trigger further investigation by the Compliance Committee and, where appropriate, the medical staff;
- Preliminary audit finding should not be disclosed to patients and audit findings should never be disclosed to the public;
- The Compliance Committee should determine the nature of the investigation required by preliminary audit findings and the medical staff should be assigned responsibility for conducting all investigations pertaining to suspected non-compliance as it relates to substandard care, including the provision of unnecessary services;
- Physicians under investigation should be notified if preliminary audits uncover evidence of non-compliance;
- If a medical staff determines that the external reviewer is necessary to facilitate its investigation, the external reviewer should be selected in compliance with applicable medical staff bylaws;
- Medical staff investigations should be limited to issues relating to quality of care, including medical necessity issues. Other issues should be referred to the Compliance Committee;
- Compliance Committee investigations should be conducted in accordance with a written compliance plan which should provide for notification to physicians under investigation, including notification that the physician has the right to be represented by legal counsel throughout the process;
- Following completion of the investigation, a physician who is the subject of investigation should be given an opportunity to provide information to the Compliance Committee, including a right to review evidence considered and a sufficient period of time to respond thereto;
- The medical staff should determine whether matters identified in the investigation warrant the initiation of medical staff corrective action and, if so, a fair hearing and due process should be provided in accordance with medical staff bylaws; and
- The final report of the Compliance Committee should be furnished to the CEO and Governing Body, which determines what must be reported to the government, private payers, affected patients and the public.
The American Medical Association Task Force’s recommendations should prompt discussion among hospitals, medical staffs, legal counsel and compliance and audit advisors about how to respond to these issues. As illustrated by the events in Westmoreland County Pennsylvania, addressing these questions and developing responsive policies could be critical to avoiding an onslaught of legal claims and counterclaims.