Study Gives Terminal Patients Option: $18,000 or More Treatment

ASCO--Researchers at Virginia Commonwealth University's MasseyCancer Center have launched what is believed to be the first willingness-to-paystudy done in a real-life setting. Thomas J. Smith, MD, reportedon potential problems created by the innovative study design ata scientific session of the ASCO annual meeting in Philadelphia.

All patients in the study, designed by Dr. Smith and attorneyKaren Swisher, must be insured by the co-sponsor Trigon Blue Cross/BlueShield and must have a terminal cancer with "absolutely nooption of curative therapy," Dr. Smith said.

Patients will be randomized to either stay with their fee-for-serviceinsurance or to cash in their insurance policy for a lump sum"indemnity" payment of approximately $18,000.

Patients randomized to the lump sum payment can do whatever theywant with the money, "save it, buy a boat, give it to theirgrandchildren," Dr. Smith said, but if they want palliativechemotherapy or radiotherapy, then it must be paid for from thelump sum. This is analogous to the proposed "medical IRAs"in which patients would purchase care out of their own funds,he said

As an ethical protection, all patients will receive hospice care.Furthermore, if the lump sum is spent on treatment that is producingpositive results, the patient may continue on standard insuranceto avoid the risk of depleting the indemnity fund. Patients canalso convert back to standard insurance by repaying the indemnity,"but they would have to sell the boat or otherwise raisethe money," Dr. Smith said.

An additional randomization is to standard or advanced patienteducation, to see if such information better informs their decisionmaking. The primary endpoints are quality of life, patient satisfaction,and cost of care.

The researchers plan to enroll 120 patients over the next 3 years,and the study team is now working with primary care physiciansand pulmonary physicians to enhance accrual.

Barriers to the Trial

Dr. Smith described practice issues as the main barrier to thestudy. "This is a disruption of a reimbursement system thatpeople perceive as already stressed," he said, "anda variation in practice style. Our pulmonologists want to sendtheir patients who desire aggressive therapy to their aggressivedoctors and their hospice-desiring patients to hospice doctors."

Other physician barriers include possibly reduced revenue fromgiving less chemotherapy, and a reluctance to discuss terminalillness openly with patients. "Most patients coming to ourward, even for terminal care, don't have DNR orders," hesaid.

From the patient's perspective, getting an indemnity further complicatesclinical decision-making by adding the economic element. A pilotstudy suggested that only about one patient in four may agreeto participate. "However, all of us have had experience withpatients who are paying for their care out-of-pocket where discussionsabout money for value come up, so it can be done," Dr. Smithpointed out.

A final wrinkle to be worked out is the tax consequences of thelump payment. "How does one handle an $18,000 check on yourtax form? No one knows," Dr. Smith said, but Trigon has agreedto cover the additional tax liability, if any.