Experimental Medical Treatments: Who Should Decide Coverage?

• Publication year: 1996
• Citation: Vol. 20 No. 02

UNIVERSITY OF PUGET SOUND LAW REVIEWVolume 20, No. 2WINTER 1997

Experimental Medical Treatments: Who Should Decide Coverage?

Jody C. Collins(fn*)

Introduction

Imagine you or your wife, your sister, your mother, your aunt, or your best friend, has just been diagnosed with breast cancer. Treatment is expensive. What if you or your loved one does not have medical insurance? Worse yet, what if you or your loved one has medical insurance, but it does not cover the treatment you need to survive?

What are you going to do? Can you pay for the treatment out of pocket? What if it costs anywhere from $100,000-$300,000? If you do not have that kind of money sitting in the bank, can you raise the money? Will friends and family and the community donate their hard earned dollars to save a life? In the case of Nelene Fox, her family and community did just that.(fn1)

Unfortunately, the efforts of family and community were too late. By the time Nelene raised enough money to afford the High Dose Chemotherapy and Bone Marrow Transplant (HDC-ABMT) her doctor recommended, the cancer had advanced and her body had deteriorated to such a degree that the procedure could not help her.(fn2) Nelene Fox had health insurance coverage through her employer, but was denied coverage for the treatment by her health maintenance organization, HealthNet, because HealthNet deemed the coverage to be experimental.

What caused the death of Nelene Fox: the cancer or the inability to get the treatment that she so desperately needed when she needed it? If a treatment can add a few years to someone like Nelene Fox's life, should an HMO be required to pay for the treatment? Does it matter what an insurer should do in those circumstances, or is the only relevant consideration what the insurer must do according to the terms of the insurance policy? As the law stands, coverage decisions with regard to experimental treatment provisions are left to the whim of the insurer or the rushed decision of a trial court. No uniform method exists on which insurers, policyholders, doctors, or courts can rely when determining whether an experimental treatment should be covered. As a result, coverage determinations are erratic and inconsistent.

For example, with regard to HDC-ABMT, some courts have ruled that HDC-ABMT is not experimental.(fn3) Others have ruled the treatment is experimental. (fn4) Still others have declined to decide whether the treatment is experimental and have determined coverage based on other grounds.(fn5) In light of the inconsistent judicial opinions, some state legislatures have taken matters into their own hands. Eleven states have passed legislation that requires health benefit providers to offer or provide autologous bone marrow transplants for breast cancer patients regardless of experimental or investigational contract provisions.(fn6) Unfortunately, the legislation currently written is inconsistent and is not available to all breast cancer patients.

HDC-ABMT for breast cancer patients is not the only controversial procedure to be classified as experimental or investigative. The same concerns arise when dealing with any new or experimental treatment. To illustrate the controversy surrounding experimental treatment provisions in general, this Comment examines the case law and resulting legislation pertaining to HDC-ABMT as a treatment for breast cancer. Part I presents background information on autologous bone marrow transplants generally, and how the treatment relates specifically to breast cancer patients. Part II presents a survey of current law regarding coverage of HDC-ABMT for breast cancer. Part III explores the merits and limits of judicial and legislative determinations of whether a particular treatment is covered under an insurance policy. Part III then concludes that while judicial and legislative intervention may be appropriate, these methods fail to uniformly secure treatment for breast cancer sufferers. Part IV presents alternatives to existing judicial and legislative determinations. Specifically, this Comment recommends more expansive legislation that addresses experimental procedure exclusions generally and proposes a model statute.

I. Understanding HDC-ABMT and Breast Cancer

To understand the numerous variables that are considered when determining whether a procedure is experimental, it is helpful to look at background information about both the disease-breast cancer, and the treatment-HDC-ABMT. Decisionmakers must take into consideration factors such as how common the disease is, whether the treatment is used to treat other diseases, and what kinds of success rates accompany the procedure. Breast cancer is an appropriate example because the disease is common and touches many peoples' lives.(fn7) If you think the disease will not affect your life or your loved ones, the statistics prove you wrong. Each year the number of women in the United States who are diagnosed with breast cancer exceeds 180.000.(fn8) Breast cancer ranks as the most common form of cancer in women, numbering 184,300 new invasive cases in 1996.(fn9) Breast cancer is the second leading cause of cancer death in women, with an estimated 44,300 deaths in 1996.(fn10)

HDC-ABMT has emerged as a last resort treatment for breast cancer patients. Despite the wide use of HDC-ABMT in the treatment of other cancers such as leukemia or Hodgkin's disease,(fn11) insurance coverage for HDC-ABMT treatment of breast cancer has been erratic at best.

HDC-ABMT is a type of systemic treatment for cancer that involves a two-part procedure.(fn12) First, a physician extracts from the patient her own bone marrow cells which are then frozen.(fn13) Next, the patient undergoes high-dose chemotherapy in an attempt to kill the cancer cells.(fn14) The dose of chemotherapy is near lethal, and may be one thousand times more potent than that of standard chemotherapy.(fn15) The patient's remaining bone marrow is destroyed in the chemotherapy process. Once chemotherapy is completed, the patient's own, "autologous," frozen marrow is reinfused intravenously into the patient's bloodstream.(fn16) After the chemotherapy and transplant, the patient's immune system is essentially nonfunctional until the bone marrow begins producing new blood cells. Because of susceptibility to viral infections, great care, including extensive hospitalization, must be taken to prevent the patient from becoming infected.(fn17) The cost of this procedure carries an expensive price tag, ranging from $100,000-$300,000.(fn18)

The HDC-ABMT procedure has been criticized for having an "excessive" mortality rate.(fn19) The high dose chemotherapy used to kill cancerous cells, coupled with the bone marrow transplantation, imposes serious trauma on the body. However, current studies indicate higher response and survival rates from HDC-ABMT treatment as compared to patients treated with standard chemotherapy.(fn20) HDC-ABMT also causes tumor shrinkage, which in turn leads to an increased survival rate.(fn21) Despite research which indicates that HDC-ABMT results in higher response, survival, and tumor shrinkage rates when compared to standard chemotherapy, HDC-ABMT still has a low survival rate overall. Depending on the data analyzed, the survival rates of persons undergoing bone marrow transplants range from five to twenty percent.(fn22)

Because of the low survival rates and the high cost of the procedure, insurance companies are hesitant to pay for HDC-ABMT and physicians do not recommend the procedure unless it is the patient's last hope. Therefore, the recommendation and coverage of this treatment has led to extensive litigation.

II. Survey of Current Law

A. Case Law

The case law surrounding HDC-ABMT reflects the controversial nature of its subject matter. Decisions show that the courts cannot make consistent individual determinations, let alone broad policy statements. The cases described below demonstrate that the courts are an inappropriate forum for coverage determinations regarding experimental treatment provisions.

Judicial interpretation of experimental treatment provisions have been inconsistent. The 3rd, 5th, and 7th Circuits have ruled that HDC-ABMT as a treatment for breast cancer is experimental and not covered.(fn23) In contrast, the 8th Circuit characterized HDC-ABMT as experimental only with regard to treating some forms of cancers such as melanomas, but not with regard to treating advanced cancer.(fn24) Other courts have not addressed the issue of whether the treatment is experimental, but have ruled in favor of requiring insurance companies to pay for the treatment on other grounds.(fn25) Finally, the 4th Circuit skirted the experimental treatment issue by upholding the insurer's decision to deny coverage based on the express policy language.(fn26)

The inconsistent body of precedent allows courts to ignore the issue of the character of the treatment and either deny or provide coverage by relying on contract principles and the language of the insurance policies. The inconsistency also allows courts to order or deny coverage based on expert testimony regarding the utility and efficacy of the treatment. As the case law stands, medical decisions that should be decided on a doctor-patient level, as well as insurance decisions that should be decided on a insurer-insured level, are being decided on a judicial level. Unfortunately, at the judicial...