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Clinical Research and Healthcare Insurance
By Stephen W. Crawford, MD, CPHRM, Medical Director, CIGNA LIFESOURCE Transplant Network, Bloomfield, CT, is Associate Editor for Critical Care Alert.
Dr. Crawford reports no financial relationship to this field of study.
Many of the recent advances in intensive care have been the product of large clinical trials. Over the years, randomized studies have demonstrated agents and modalities that impact survival of our sickest patients. Some examples of clinical trials that have influenced our care in the ICU include the use of erythropoietin to prevent anemia, prophylaxis of gastric stress ulcers, treatment of severe sepsis with corticosteroids and drotrecogin alfa, prevention of ventilator-associated pneumonia with elevation of the head of the bed, and decreasing ventilator-associated lung injury with low-tidal-volume, lung-protective ventilation, among others.
If the past is any predictor of the future, further advances in the ICU will rely on continued performance of clinical trials. While few critics will argue the value of clinical trials in intensive care, there are important questions about how these are funded. There are many discussions occurring at the national level about increased access to health insurance. What is the role of private healthcare insurance in clinical trials in the intensive care unit?
Clinical trials in the ICU have many benefits. The goal remains the improvement in care and improved survival rates. Other end points that are important in these studies are decreasing length of stay and, possibly, decreasing costs.
This issue of cost raises the concern that clinical trials are significantly more expensive to conduct than is routine clinical care. This question has been addressed in cancer clinical trials. Most assessments conclude that cancer clinical trials are either no more expensive, or minimally so, compared to standard treatments.1,2 This finding may be viewed as somewhat surprising. Clinical trials are associated with additional expenses. These trials require additional testing, supplies, and personnel for data management.
Society and future patients may benefit from clinical trials. It is possible that reduced overall costs of care may result from the advances. These costs savings could result from decreased complications and length of stay. For third party payers, such as insurance companies, this should be a valid reason to consider supporting clinical trials. However, for most health plans, clinical trials in the ICU are not covered benefits.
Changing Nature of Healthcare Insurance
Many of the traditional healthcare insurance companies are increasingly less and less involved in insuring the health of the members of their plans. They are increasingly becoming providers of healthcare-related services. Many citizens continue to think of the familiar companies, like CIGNA, Aetna, United Resource Network and Blue Cross, as insurance companies. However, for some of these companies up to 70% of members are covered by self-funded employer plans. Employer groups have adopted a strategy of funding healthcare for their own employees in an effort to control costs. The traditional insurance companies provide the administrative services needed to operate these plans. These administrative services include case management, claims processing, medical director reviews, policy development, and appeal determinations, to name a few.
For these self-funded plans, although the member identifies the large healthcare insurance company as their insurer, in fact, the financial risk of the costs of care are retained by their employer. In an effort to control potential expenses, the employer groups are often actively involved in dictating the specific details of the benefit plan. It is this plan language that determines what medical procedures, supplies and services are benefits covered under the plan.
In many cases, clinical trial participation of any kind is excluded from coverage. It is considered to represent experimental, investigational or unproven care and not a benefit of a plan designed to provide for the standard healthcare needs of the employees. When clinical trials are covered, invariably these are limited to trials of cancer treatments, and only those performed according to specific rigorous safeguards and oversight.
Impact of Re-Insurance
Most of the self-funded employer groups have limited financial reserves to back the healthcare costs of the employees. In order to minimize the financial risk of a catastrophic case that could bankrupt the plan, they purchase insurance against such events. This re-insurance acts as a stop-loss against costs above a predetermined fixed cost.
For obvious financial reasons, the carriers that provide this re-insurance exert tight controls over the administration of this stop-loss coverage. Failure of the benefit coverage being provided strictly according to the language of the benefit plan results in a denial of coverage by the re-insurer for outlier costs above the stop-loss mark. In such cases, the catastrophic costs are borne by the employer group, or depending on the contractual arrangements, by the healthcare company administering the plan.
In either case, there is strong incentive on the part of everyone involved to be certain that procedures not covered in the plan are not authorized. Healthcare insurance company medical directors and administrators have limited latitude in the interpretation of benefit plan language as a result.
Is It Right?
Clinical trials benefit society and lead to advances in healthcare. Is it ethical to have participation in clinical trials limited by third-party payers? One question is: right for whom?
For the groups who are actually financing the healthcare services, they have an interest in seeing that their monies are spent for the healthcare needs of their employers. It can be argued that they do not have a financial obligation to fund research that does not directly benefit their company. These companies have financial and moral obligations to limit coverage to essential, basic healthcare needs of their beneficiaries.
As a result of the changes in the costs and funding mechanisms for healthcare in this country, to an increasing degree, the employers are dictating what medical care is paid for. As a result, clinical research funding in the private sector is being impacted by a form of rationing. Interestingly, this rationing is not being driven by the government or by large insurance companies. It is not the product of coordinated, thoughtfully considered, national policy. Rather, it is driven by employer groups, and driven by the "bottom-line," by money considerations.
The ICU represents a microcosm of the financial impact of changes in private healthcare insurance, in general. A shift to self-funded healthcare plans probably makes it increasingly unlikely that clinical trials will be considered benefits covered by insurance. This leaves private industry and government funding as the major sources of support for clinical trials in the ICU. Perhaps it is time for a national discussion about the value and need for clinical trials in medicine.
NOTE: The views expressed are those of the author and do not necessarily reflect the views of CIGNA Healthcare.