When you are asked to make a significant change in your practice patterns based on a new idea, you ask for proof that the new idea is better than the old idea. Proof is what the Blue Shield Medical Policy Committee on Quality and Technology was looking for when it considered covering carotid and cerebral angioplasty and stenting for atherosclerosis, stroke, and vasospasm. But proof is not what Nelene Fox was looking for when she lobbied insurers to pay for a bone marrow transplant that accompanied high-dose chemotherapy treatment for breast cancer.1 She was already a believer.
Coverage of carotid and cerebral artery angioplasty and stenting was the first item on the agenda at the Blue Shield Medical Policy Committee meeting held on June 12 in a Los Angeles International Airport hotel ballroom. The panel that reviewed the evidence was comprised mainly of physicians, and money was not on the agenda. The section in the 3-inch-thick agenda book pertaining to angioplasty and stenting referenced 178 articles and contained 11 as attachments. Blue Shield Medical Policy currently provides coverage for carotid endarterectomy surgery for carotid atherosclerosis, and for tissue plasminogen activator for acute stroke.
Before the committee presented its decision, it reviewed the five technology assessment criteria used to determine whether a technology improves health outcomes, is safe and effective, and has established long-term results. Then it presented the facts: In the United States, cerebrovascular disease is currently the third leading cause of death with more than 150,000 stroke-related fatalities annually. There are more than 500,000 strokes annually and more than 2 million stroke survivors with varying degrees of disability. In patients with acute stroke, angiography studies done within 6 hours of symptom onset have demonstrated that 75-80% of patients with an acute ischemic stroke have angiographically visible occlusion of an extracranial and/or intracranial artery as its cause. Atherosclerotic stenosis of the carotid artery close to the carotid bifurcation in the neck causes about 20% of all ischemic strokes and transient ischemic attacks.2
Based on the evidence reviewed, the policy committee determined that carotid and cerebral angioplasty and stenting for atherosclerosis and stroke did not meet all criteria and so will not be covered, but it will cover intracerebral artery angioplasty for vasospasm? induced by subarachnoid hemorrhage. But after hearing the petitions of several attending neurologists and interventional radiologists (the Society of Interventional Radiology was represented), who maintained that significant progress in technology and technique has been made since the seminal studies were done, the committee recommended that carotid stenting be considered for coverage on a case-by-case basis only in centers with a large enough patient volume to ensure physician expertise in selected patients for whom endarterectomy is not an option. Any change in policy is unlikely pending the results of new trials, such as the ongoing Carotid Revascularization Endarterectomy vs Stent Trial.
The aforementioned breast cancer patient did not receive the treatment and died before she could convince her insurer to pay for it. But then again, so did most of the estimated 30,000 recipients of high-dose chemotherapy, 4,000 to 9,000 of whom died from the treatments alone, treatments that cost close to $3 billion.1 Her brother brought a suit against her insurer, Health Net, and a jury awarded the family $89 million. Health Net appealed and then settled out of court for an undisclosed sum. Today, few oncologists believe that high-dose chemotherapy is an effective treatment for breast cancer.
With a Patient Bill of Rights on the horizon, medical costs increasing, and funding for clinical research on the decline, proof that a prodedure or treatment is effective is more important than ever, as are the cost-effectiveness studies on which responsible policy must be based. Clearly, the beneficiary of a health care policy hammered out in the courts is not the patient, nor is it the physician. It is the lawyers. n
- Brownlee S. Bad science and breast cancer. Discover. 2002;23(8):73-78.
- Medical Policy Committee on Quality and Technology Agenda. Blue Shield of California; Los Angeles: 2002; Section A.