In a June 11 letter to the American Hospital Association, Administrator Thomas Scully of the Centers for Medicare and Medicaid Services confirmed that the "Ordering of Diagnostic Tests" rule (42 CFR 410.32) does not apply to diagnostic tests furnished to hospital outpatients and inpatients. He clarified that the rule applies to tests provided to non-hospital patients, and only to clinical diagnostic lab tests furnished to patients of hospital outpatient departments.
Tests provided to hospital inpatients and outpatients are covered under the hospital conditions of participation (42 CFR 482.26), which state "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." Scully also noted in his letter that there may be separate state requirements and local Medicare policies that apply as well. To ensure that the interpretation of CMS carriers and intermediaries is consistent with policy, Scully noted that CMS might issue further instructions to its contractors or amend the regulation.
As a result of extensive comments on the subject and many meetings with the ACR, CMS issued clarification in Medicare Carrier's Manual, Transmittal #1725. Although CMS clarified under Section 15021 (B) that the ordering of diagnostic tests rule does not apply to the hospital setting, a number of compliance officers and attorneys felt that section 15021 (B) of the Medicare Carriers Manual did apply to hospital inpatients and outpatients, since the transmittal was unclear. Scully's letter of June 11 reaffirmed the CMS position that the "Ordering of Diagnostic Tests" rule does not pertain to hospital patients.
Background of "Ordering of Diagnostic Tests" Rule
First issued in November of 1996, and clarified in the Federal Register of October 31, 1997, the "Ordering of Diagnostic Tests" rule defined the "treating physician" and indicated that all diagnostic tests provided to non-hospital patients must be ordered by the treating physician/practitioner. According to the 1997 Federal Register, this policy was intended to prevent the practice of some testing facilities to routinely apply protocols that require performance of sequential tests.
CMS clarified in Transmittal 1725 that
- the "Ordering of Diagnostic Tests" rule does not apply to hospital inpatients or outpatients;
- an order from the treating physician to the testing facility may be via written communication (hand delivered or faxed), via e-mail or via telephone;
- additional testing may be done by the radiologist prior to or without contacting the referring physician, as long as an attempt has been made, if certain criteria are met (see below for specific criteria); and
- an order may conditionally request an additional diagnostic test for a particular beneficiary if the initial ordered test result yields a certain value (i.e., if test X is inconclusive, then perform test Y to answer the clinical question).
CMS also clarified in this transmittal in section 15021 (E) of the MCM that a radiologist may perform the following without notifying the treating physician:
- Unless specified in the order, the radiologist may set the protocol for a given diagnostic, interventional or therapeutic procedure ordered (e.g., number of radiographic views obtained, thickness of tomographic sections acquired, use or non-use of contrast media).
- The radiologist may modify an order with clear and obvious errors (e.g., X-ray of wrong foot ordered).
The radiologist may cancel an order because the beneficiary'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 cancelled order should be coded. For example, a barium enema cannot be performed because of residual stool in the colon as identified on scout KUB. The scout KUB is payable by Medicare.
Adding Additional Radiology Procedures
If the radiologist determines—based on the result of an ordered examination or procedure—that an additional examination or procedure should be performed, and he or she has made an attempt and is unable to reach the referring physician, additional diagnostic radiology tests may be obtained by the radiologist without obtaining a new order if all of the following criteria are 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 beneficiary;
- the treating physician is notified of the results of the test and uses the results in the treatment of the patient; and
- 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.)
For example, a bone scan reveals a lesion on the femur requiring plain films to make a diagnosis, or the last cut of an abdominal CT scan with contrast shows a mass requiring pelvic CT scan to further delineate the mass.
Changing the Ordered Test to an Entirely Different Test
The transmittal states that a diagnostic testing facility that furnishes a diagnostic test ordered by the treating physician/practitioner may not change the diagnostic test ordered (e.g., CT to MRI) without a new order from the requesting physician.
CMS does not allow radiologist to change the originally ordered test, because 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 (e.g., e-mail, mail or fax) or verbal (e.g., telephone) communication must occur prior to the change in order to obtain a new or revised order.
Definition of an "Order"
CMS defines an order as
- A written communication (hand delivered or faxed);
- a telephone call; or
- an electronic mail to the testing facility by the treating physician/practitioner or his/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.
Who is a "Treating Physician"?
The Social Security Act defines a "treating physician" as a "physician who furnishes a consultation or treats a beneficiary for a specific medical problem, and who uses the results of a diagnostic test in the management of the beneficiary's specific medical problem." The ACR argued that the radiologist "manages" the imaging/interventional components of the patient's medical care and thus should be considered a "treating physician."
The new transmittal clarifies 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. However, a radiologist performing a diagnostic or interventional [solely diagnostic invasive] procedure is not considered a treating physician.
Conditional Test Requests
As described above, CMS has approved the use of conditional orders as long as they are limited to a specific beneficiary. 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. However, a standing order for all patients of a given requesting physician is not acceptable. For example, a standing order for UGI if gallbladder ultrasound is negative for all Dr. Smith's patients.
Thomas Scully's letter