therapeutic services can be paid for separately, in addition to the facility fee. In an effort to clarify the distinction, we have revised the regulation, and we propose to adopt the following policy. We assume that when the descriptor for a CPT code includes explicit reference to some kind of imaging, guidance, or other diagnostic test, the cost, and therefore the ASC payment rate that we have derived for that procedure, include the imaging, guidance, or other diagnostic test, and those services are considered to be within the scope of ASC services. An example of such a procedure is CPT code 56362, Laparoscopy with guided transhepatic cholangiography; without biopsy. In the case of a procedure such as this, because the imaging is explicitly integral to and inseparable from the surgical procedure, it is considered within the scope of service and no separate payment is allowed for the imaging.
When the descriptor for a CPT code specifies "with or without" some kind of imaging, guidance, or other diagnostic test, we assume that the cost, and therefore the ASC payment rate that we have derived for that procedure, do not include the imaging, guidance, or other diagnostic hest, and those services are considered to fall outside the scope of ASC facility services. Therefore, the ASC facility fee for the procedure would not include payment for costs incurred to furnish this type of monitoring. There are other procedures, such as CPT code 36533, insertion of implantable venous access port, with or without subcutaneous reservoir, where the physician may or may not elect to use some type of imaging such as a fluoroscope to assist in placing the device. In such cases, we assume that the cost, and therefore the ASC payment rate for procedure, do not include the imaging or guidance. In the case of these procedures, the imaging, guidance, or other diagnostic test is considered to fall outside the scope of ASC facility services, and the ASC facility fee does not include payment for the costs incurred to furnish these services.
Payment for the costs incurred by an ASC to perform any tests granted waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as part of preparing a patient for surgery on the day of surgery is included in the ASC facility fee for the surgical procedure, and no separate payment for these tests is allowed. If an entity that is approved by Medicare as an ASC also wants to be paid by Medicare for diagnostic laboratory services, other than tests granted waived status under CLIA, that entity must meet the laboratory requirements spelled out in 42 CFR Part 493. In this case, the entity would be considered a certified laboratory billing Medicare for certified laboratory services, not as a Medicare approved ASC billing Medicare for ASC facility services. Classification as a certified laboratory or classification as a Medicare approved ASC is, for Medicare billing purposes mutually exclusive.9
F. Multiple Procedures
When more than one procedure is performed on one patient, HCFA rules provide that the second procedure (the lower-priced procedure) is reimbursed at 50% of its rate.
(a) Single and multiple surgical procedures.
(1) If one procedure on the ASC list is performed in a single operative session, payment of the ASC facility fee is based on the prospectively determined rate for that one procedure.
(2) If more than one surgical procedure is furnished in a single operative session, payment is based on:
(i) The full rate for the procedure with the highest prospectively determined rate; and
(ii) One half of the prospectively determined rate for each of the other procedures.10
II.
PROPOSED PAYMENT METHODS
HCFA, as of June 1999, formally proposed an overhaul of the payment methodology for ASCs.11 Here, it proposed adoption of a system based on ambulatory payment
classifications ("APCs"). The APCs effectively expand payment groups from 8 to 105, and include a revised payment amount for lithotripsy. Under the new system, each ASC and hospital-based outpatient department will be paid using the APCs. However, the ASC rates are based on data obtained from a 1999 HCFA study of ASCs. In contrast, the hospital departments are reimbursed using data developed from a 1996 study of hospital data.
Each of the current and proposed ASC rate-setting methodologies consists of four major components: (1) determine a per procedure cost for every reported code at the individual facility level, (2) determine a per procedure cost for ever reported CPT code across all facilities, (3) determine the proper classification for procedures, and (4) determine a standard payment rate that is generally a fair all the procedures within each group. The standard payment rate arrive final step becomes the Medicare ASC facility fee or payment rate.12
Here HCFA comments:
In developing the payment rates proposed in this notice, we have retained the same basic methodology that is explained in the final notice published in the Federal Register on February 8,1990 (52 FR 4526) and outlined above. We have introduced a few refinements that we believe enable us to measure more precisely
10 Id. at 32,327. 11 See generally, Id. 12 Id. at 32,301.
the costs incurred by ASCs individually and collectively to perform procedures on the ASC list.13
The 1994 data used for ASCs and the APCs are summarized as follows