The age of accountability. (Health Care Technology).
* Evidence-based Medicine
* Objective Clinical Data
* Variations in Outcomes
* Verifying New Medical Technologies
* Implementing Evidence-based Coverage Policies
In 1988, Arnold Relman, the editor of the New England Journal of Medicine, coined the term "the age of accountability," to describe the growing emphasis on evidence-based medicine. (1) Small area analysis of practice patterns had revealed widely disparate rates of certain surgeries (such as transurethral resection of the prostate [TURP]) that had no obvious explanation based on the available clinical data. Review of data also suggested that in many cases commonly accepted "standards of care" were not supported by objective clinical data. Accountability and evidence-based medicine set a new standard, suggesting that from that point forward, new medical technologies should require validation of their safety and effectiveness through controlled studies prior to their broad dissemination.
Evidence-based medicine has been endorsed by a wide variety of public and private health related organizations. The federal government, through the Agency for Health Care Policy and Research, has created a network of evidence-based practice centers, which are charged with thoroughly reviewing the large body of literature focusing on certain controversial medical practices. Medical specialty societies, such as the American College of Cardiology, have issued policy guidelines that are carefully documented with the supporting literature, including a discussion of the quality of literature. Given this broad endorsement of evidence-based medicine, payers have also adopted this standard as part of their coverage decision-making process. The contractual definitions of the terms "medically necessary" and "investigational" are often rooted in the concept of evidence-based medicine.
A week in the life of a mythical medical director
Certainly, the concept of evidence-based medicine appears to be rational, objective, and consistent. However, the process can become extremely messy in its application to coverage decisions. After all, the coverage decision is really one of the most basic elements of health care. The following discussion represents a week in the life of a mythical medical director who is attempting to implement his or her company's evidence-based coverage policies.
Your medical policy department has completed an analysis of a new lab test and determines that while it would be considered medically necessary about 75 percent of the time, the rest of the time it would be considered not medically necessary. Therefore, the policy contains multiple patient selection criteria. While the policy is clinically sound and has been approved by the plan's local medical advisory panel, the head of the plan's claims system points out that there is no way this plan can be operationalized without suspending 100 percent of the claims involving this lab test. The claims system area is under heavy pressure to decrease its operational costs and to electronically adjudicate as many claims as possible.
In an appeal letter, a provider points out that the surgery he performed on a prior patient was paid for, while the same surgery on a similar patient was denied as being investigational. A review shows that the first case was covered inadvertently due to the use of nonspecific CPT codes. Both the patient and the provider respond that the coverage discrepancy between the two cases appears arbitrary and capricious, two words that make your legal department jittery. You begin to wonder if all past is precedent.
The head of the medical director's network operations calls and says that the flagship hospital in your network has decided to purchase a new technology that will be used as a screening method for heart disease. Radio ads promoting this technology will begin next month. Your policy states that this technology would be considered investigational, due to lack of long-term data on whether detection and management of this risk factor will lead to improved health outcomes. Although you recognize that final patient outcome data for a screening technique will always be difficult to obtain, you also feel that the widespread use of the technology could lead to unnecessary angioplasties or other revascularization procedures. On the other hand, your marketing efforts have touted your members' access to this academic hospital.
The marketing department calls to let you know that one of your competitors has decided to provide coverage for a new Pap smear screening technology. Your analysis suggests that while the new technique may be associated with increased sensitivity for a single Pap smear, how it compares with a program of regular yearly Pap smears is not entirely known. Therefore, you feel that any increased dollars for cervical cancer screening might be better spent in increasing the percentage of women who undergo regular Pap smear screening. However, your program is largely being upstaged by your competitor, who is running ads saying their new coverage decision reflects their commitment to women's health care.
One of your coverage appeal cases was sent out for external review. The three experts were chosen by an outside vendor and thus were completely independent. These consultants agree with your coverage denial. Despite this independent process, a lawsuit is threatened. You have been somewhat heartened because one of the reviewers is prepared to testify on your behalf in court and you would like to have a trial to validate your coverage decision-making process. However, the legal department has just phoned to say that they have accepted a settlement. They point out that this would have been a jury trial, which is always unpredictable. They cite the award of $90 million in a recent case, and state they cannot assume that kind of risk. You are somewhat satisfied when they tell you that your objective coverage decision-making process may have prompted the plaintiffs to accept the modest settlement that was offered.
A coverage appeal on your desk involves an original denial for a new orthopedic procedure. While it has received FDA approval, the FDA evaluated it on the basis of an intermediate health outcome, rather than a final health outcome of long-term freedom from joint pain or lack of disease progression. The manufacturer points out that the accepted 'standard of care" is not substantiated by final health outcome data, and thus there appears to be a different standard of evidence required for its technology. The manufacturer is not convinced by your explanation of the "age of accountability."
Your medical policies are scheduled for review every two years at the latest. A review of your policy on balloon dilation of the prostate reveals that these devices are no longer marketed. You recall that eight years ago, a good chunk of your time was spent defending your coverage policy on this minimally invasive treatment for benign prostatic hyperplasia. At that time you had been concerned about the lack of data regarding its long-term effects, particularly since balloon dilation did not attempt to remove any of the obstructing prostatic tissue. You wonder how many men underwent this procedure to no avail.
The case sitting on your desk for your decision involves a young woman who had presented with liver metastases from a melanoma; the primary site is unknown and there are no other sites of disease. Her physician has recommended that the patient undergo a course of chemoembolization to the liver, requiring several hospitalizations of several days. The physician agrees that this treatment is investigational. However, the physician points out that standard systemic chemotherapy is known to be ineffective, For the physician, it makes no sense that the payer would cover a therapy that is known to be ineffective, while it would not cover therapy that might have a chance of working.
As you gather your thoughts at the end of the week, you realize how very hard it is to be consistent and that the many compromises that must be made leave the concept of evidence-based medicine battered and somewhat tattered.
The Blue Cross and Blue Shield Association is an association of independent, locally operated Blue Cross and Blue Shield Plans. The information presented in this column does not necessarily represent the policy or views of either the Association or any of the Plans,
(1.) Relman, AS. Assessment and accountability: The third revolution in medical care. N Eng J Med. 1988:319:1220-2.
Elizabeth Brown, MD, is National Medical Consultant for the Blue Cross and Blue Shield Association in Chicago, Illinois. She can be reached by calling 312/297-6186 or via email at Elizabeth.Brown@bcbsa.com.