But it has a CPT code.

In Spite of ample evidence to the contrary, many health care professionals and others persist in believing that assignment of a CPT code signifies that a procedure is established as safe and effective. The author discusses why a CPT code should be viewed as signifying nothing other than the existence of the procedure. He also suggests that CPT codes should not be assigned until safety and effectiveness are ensured.

An interesting paragraph was added in boldface to the 1991 and 1992 editions of Physicians Current Procedural Terminology[1] of the American Medical Association:

"Inclusion of a descriptor and its associated specific fivedigit identifying code number in CPT is generally based upon the procedure being consistent with contemporary medical practice and being performed by many physicians in clinical practice (not on an investigational basis) in multiple locations. Inclusion in CPT does not represent endorsement by the American Medical Association of any particular diagnostic or therapeutic procedure. InClusion or exclusion of a procedure does not imply any health insurance coverage or reimbursement policy."

The key words in this paragraph are "not on an investigational basis." This paragraph implies that if a particular procedure has been assigned a CPT code, it is no longer investigational and thus can be considered established medical practice. Such an inference has been picked up on and utilized by sponsors of technologies, especially medical device companies, to argue that a procedure is established and should be reimbursed (notwithstanding the disclaimer of the last sentence of the paragraph). Indeed, even some payers have ascribed the same connotation to the assignment of a CPT code for a particular procedure.

The bottom line on all this is that a CPT code reflects and is based on the attainment of some threshold of utilization of a procedure by the practicing medical community. When this threshold is judged to have been achieved, the CPT committee votes to assign a code to that procedure. Assignment of a code is not based on any formal evaluation of the safety and effectiveness of the technology. Rather, the criteria for assignment of a CPT code to a new technology are "consistency with medical practice and being performed by many physicians in clinical practice." The use of such criteria may be appropriate for the assignment of a CPT code, but they should not constitute the basis for explicit or implicit declarations about the investigational or established status of a particular procedure. Gone are the days when widespread acceptance of a particular procedure would be translated into a certification of the safety and effectiveness of a technology. Examples of the fallibility of such a criterion have led many physicians, patients, payers, regulators, etc. to require that cold hard outcome data be available to support the safety and effectiveness of a technology before widespread diffusion occurs.

A clear illustration of this, both in definition and in practice, is provided by another activity of the American Medical Association. The Diagnostic and Therapeutic Technology Assessment (DATTA) program defines "investigational" as "there is no consensus on the safety or effectiveness of this technology to date, there is insufficient evidence to determine its appropriateness, or it warrants further study; use of this technology for the given indication in the specified patient population should be confined largely to research protocols."

There have been examples in the past in which the DATTA program has evaluated a technology and concluded that its safety or effectiveness was investigational and a CPT code had been assigned. This dichotomy of opinion by two important programs of the AMA was not significant until the phrase "not on an investigational basis" was added to the handbook in 1991. A recent example highlights this dichotomy.

A February 1992 DATTA evaluation[2] concluded that the effectiveness of endoscopic balloon dilation of the prostate is investigational. In the 1991 edition of the CPT handbook, a code (521510) for transurethral  balloon dilation of the prostatic urethra (any method) was added, and the same code is present in the 1992 edition. Based on the extensive DATTA evaluation published in JAMA, it is difficult to see how the phrase "not on an investigational basis" could be justified when applied to the application of transurethral balloon catheter dilation of the prostate for benign prostatic hypertrophy.

The CPT handbook should be recognized for what it is: "a listing of descriptive terms and identifying codes for reporting medical services and procedures performed by physicians. The purpose of the terminology is to provide a uniform language that will accurately describe medical, surgical, and diagnostic services...."

The CPT process should not be construed as some form of technology assessment that can develop substantiable conclusions about the safety and effectiveness of procedures. Technology assessment places a high priority on having health outcomes data from recognized peer reviewed journals to form the basis for evaluative conclusions. Actually, it might serve the useful purpose of enhancing appropriate utilization of health care technology if CPT codes were developed with more in-depth consideration of available formal technology assessments. Indeed, the question arises, Should CPT codes be assigned at all without a formal assessment of the safety and effectiveness of a technology? At the very least, the purpose of the CPT codes should be more clearly communicated to the user. Deletion of confounding statements about what the CPT codes imply (e.g., not on an investigational basis) would serve to enhance the clarity of such communication.

References

1. Physicians' Current Procedural Terminology. Chicago, Ill.: American Medical Association, 1992.

2. Miller-Catchpole, R. "Diagnostic and Therapeutic Technology Assessment (DATTA): Endoscopic Balloon Dilation of the Prostate." JAMA 267(8):1123-8, Feb. 26, 1992.

William T. McGIVNEY, PhD, is Head, Technology Assessment and Policy, Aetna Health Plans, Hartford, Conn, The views expressed in this article are those of the author and do not necessarily reflect those of Aetna Health Plans.