Medically-Based Enterprise Risk Management
Expert Consulting
International Skin Care Laboratories — Drug / Cosmetic Approval Process
Challenge:
A manufacturer of a formulated product wanted to get a placental cell-containing ointment that had been approved for use in Europe to be accepted by the USFDA as a therapeutic agent. The CEO of the manufacturing company believed that testimonials by respected European professors should suffice for USFDA approval.
Solution:
We explored the value of performing controlled clinical trials in Europe. Considering expense and time required for clinical trials, we and colleagues suggested reformulating the ointment and packaging the product as a cosmetic. The manufacturer followed our recommendations, and became the now hugely-successful La Prairie brand.
Reflection:
Sometimes an entirely new way of thinking can create a major new financial opportunity for a client. We were able to provide a fresh look at presenting circumstances and suggest an alternative approach to enable our client to accomplish a desired goal.
Stress-Related Symptoms
Challenge:
An executive vice president of the largest telecom company on the East Coast believed that his building, in which certain renovations were taking place, was an indoor air disaster making him sick. Furthermore, he had transmitted his concerns to the 4,000 employees who reported to him. He was complaining of difficulty traveling because hotels were beginning to bother him. The company's most critical project was now in jeopardy. We were contacted by the president of the company to assist in dealing with the situation.
Solution:
Our physician met with the president, executive vice president and medical director of the company. The executive vice president was very driven and severely-overworked. His symptoms were clearly job-stress related, having developed immediately after he drank a cup of coffee which he considered "bad." A highly-motivated individual, he wanted to solve the problem and was receptive to reasonable, medically-based input. He agreed to get psychological help, not to go to an "alternative practitioner" who would likely have contributed to long term disability. He improved, calmed his staff and continued his project successfully.
Reflection:
Most companies in this situation would be reluctant to get this involved with an employee, but without this action, the employee most likely would have become reclusive and permanently dysfunctional. With strong motivation and proper counseling, that course can be interrupted.
Automated Casualty Claims Review System
Challenge:
Automobile casualty claims for medical services were frequently accompanied by excessive medical billing for common injury diagnoses. The insurers knew this was occurring, but had limited ability to challenge the care and charges.
Solution:
We convened panels of respected clinical and academic experts in trauma-related fields, including internists, family practitioners, pediatricians, neurologists, orthopedists, physical medicine and rehabilitation physicians, neurosurgeons, trauma surgeons, physical therapists, chiropractors. Conditions commonly seen following automobile accidents were identified, medical and scientific literature was reviewed, and a set of criteria were developed that described the type of care usually necessitated by the diagnosed injury. We developed a computer program that permitted a comparison of the care rendered by a provider(s) for a given diagnosis to the criteria agreed upon by the expert panel.
Reflection:
The criteria assembled by our expert panels were the precedent for the current evidence-based practice guidelines now promulgated by every medical specialty for a vast array of medical and surgical conditions. Ours was the first automated program which incorporated care criteria and permitted their comparison with medical provider billing by condition. This kind of evaluation is routine today.
Standards of Care and Malpractice Claims
Challenge:
One of the largest medical malpractice insurers in the nation was spending many millions of dollars each year on cases involving alleged obstetrical negligence with the claimed result of neonatal injuries.
Approach:
We performed a comprehensive search of the literature of the day to determine customary standards of practice and how one could tell (proximate cause) whether an obstetrical error was the cause of an injury. We published a 250-page manual that was distributed to all of the national insurer's defense counsel and conducted a series of seminars describing the science and medical facts of the issue.
Reflection:
Claims payouts by this insurer fell dramatically for these kinds of cases. This was an example, early in our company's history, of enterprise risk management. We used standardized, scientifically-supportable information, properly disseminated, to insure uniform application of sound science to defend improperly-supported claims.
Other Case Studies