Considerable confusion remains in the radiology community surrounding what constitutes a valid order for a diagnostic test and who must generate that order. The confusion stems from the fact that there are two sets of rules. The Ordering of Diagnostic Tests Rule covers imaging tests performed in a testing facility, and the Conditions of Participation: Radiology Service Rules covers hospital inpatients and outpatients.

The Centers for Medicare and Medicaid Services defines a testing facility as a physician, group of physicians, or independent diagnostic testing facility (IDTF) that furnishes diagnostic tests to Medicare patients. CMS and the American College of Radiology have clarified the issue in the past, but many facilities still operate in a gray area.

When first issued, the Ordering of Diagnostic Tests Rule defined the treating physician/practitioner and indicated that all diagnostic tests must be ordered by persons in this category. This policy was "intended to prevent the practice of some testing facilities routinely applying protocols which require performance of sequential tests." It did not specifically differentiate, however, between services performed in the hospital versus nonhospital setting. This lack of clarification caused widespread confusion in the industry. The ACR was successful in lobbying CMS to obtain clarification that this rule does not apply to hospital inpatients or outpatients.

The treating physician/practitioner must order all diagnostic tests furnished to a patient who is not a hospital inpatient or outpatient. CMS defines a treating physician as a "physician who furnishes a consultation or treats a patient for a specific medical problem, and who uses the results of a diagnostic test in the management of the patient's specific medical problem," and a treating practitioner as a "nurse practitioner, clinical nurse specialist, or physician assistant, pursuant to state law, who furnishes a consultation or treats a patient for a specific medical problem, and who uses the results of a diagnostic test in the management of the patient's specific medical problem."

The rules clarify that a radiologist performing a therapeutic interventional procedure is considered a treating physician and thus can order tests related to the condition for which the intervention is being performed. A radiologist performing a diagnostic or interventional procedure, however, is not considered a treating physician.

CMS defines an order as a written communication (hand delivered or faxed), telephone call, or e-mail to the testing facility by the treating physician/practitioner or his or her staff. If an order is communicated via telephone, both the treating physician and the testing site must document the telephone call in their respective copies of the patient's medical record.

TESTING FACILITY

When working in a testing facility, a radiologist can set the protocol for a given diagnostic, interventional, or therapeutic procedure ordered (e.g., number of views obtained, thickness of tomographic sections acquired, use or nonuse of contrast media), modify an order with clear and obvious errors (e.g., x-ray of the wrong foot ordered), or cancel an order because the patient's physical condition at the time of the diagnostic testing will not permit performance of the test (any medically necessary preliminary or scout studies performed prior to the canceled order should be coded). A diagnostic testing facility may not change the diagnostic test ordered without a new order from the requesting physician.

CMS does not allow radiologists to change the originally ordered test. It reasons that the radiologist may not know the true intent of the order or of previous studies performed on the patient prior to this request. In this case, written or verbal communication must occur prior to the change in order to obtain a new or revised order.

The radiologist may perform additional testing prior to or without contacting the referring physician only if the radiologist determines that, based on the result of an ordered examination or procedure, an additional examination or procedure should be performed and he or she is unable to reach the referring physician. All of the following criteria must be met:

• The diagnostic test ordered by the treating physician/practitioner is performed.
• The radiologist determines that an additional diagnostic test is medically necessary due to abnormal results of the diagnostic test performed.
• A delay in additional testing would have an adverse effect on the patient.
• The treating physician is notified of the results of the test and uses the results in the treatment of the patient.
• The radiologist documents in the report why additional testing was necessary. (It is critical to document the reason in reports of the original test and the added test.)

CMS has approved the use of conditional orders as long as they are limited to a specific patient. For example, if a patient-specific order reads "diagnostic mammogram of right breast with ultrasound if mass identified," the radiologist may add the ultrasound to characterize the mass. Not acceptable is a standing order for all patients of a given requesting physician, such as "if gallbladder ultrasound for Dr. Smith is negative, do UGI."

The regulation allows for use of computer-aided detection in conjunction with mammography without a written order from the referring (treating) physician. Since there is no medical necessity prerequisite for the use of CAD with mammography procedures, and if all aspects of CAD are performed in conjunction with mammography, the radiologist may determine whether CAD should be performed. The use of CAD in conjunction with mammography is covered under the Radiologist Exception.

HOSPITAL SERVICES

For services performed in a hospital, the CMS Conditions of Participation: Radiology Service Rules (42 CFR 482.26) apply. These rules state only that "Radiologic services must be provided only on the order of practitioners with clinical privileges or, consistent with state law, of other practitioners authorized by the medical staff and the governing body to order the services." Since radiologists generally meet these qualifications, no effort has been made to exclude them from rights and privileges granted others.

Accordingly, a single radiology group can have two sets of rules to follow if its practice encompasses both hospital-based and freestanding imaging. Department managers and imaging center managers should make sure that those who receive orders are knowledgeable as to what documentation is required. Radiologists and managers should be conscious of the two sets of rules and develop policies that are clear and that apply consistently to all radiology technical and medical staff members.

Mr. Reinitz is president of Comprehensive Medical Data Management, based in Powell, OH. He can be reached at kirk_reinitz@cmpminc.com.