ACS Views on Legislative, Regulatory, and Other Issues
Ambulatory Surgical Centers—
staff contact: Barbara Peck, bpeck@facs.org
May 27, 2003
Thomas A. Scully, Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Room 445-G
Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, DC 20201
Attention: CMS-1885-FC
RE: CMS-1885-FC; Medicare Program; Update of Ambulatory Surgical Center List of Covered Procedures Effective July 1, 2003
Dear Mr. Scully:
On behalf of the 64,000 Fellows of the American College of Surgeons, we are pleased to submit the following comments in response to the final rule for the Medicare program update of ambulatory surgical center list of covered procedures. The College appreciates the Centers for Medicare and Medicaid Services' (CMS) efforts in updating the list of covered services provided in Medicare-certified ambulatory surgery centers (ASCs).
The College has reviewed the list of the Current Procedural Terminology (CPT) codes for which CMS is soliciting comments and we have briefly provided our view of the appropriateness of those specific procedures being added to the Medicare-approved ASC list. While we recognize that the final rule does not call for expanded comments on the codes that were proposed for addition or deletion in the 1998 proposed rule (HCFA-1885-P Medicare Program: Update of Ratesetting Methodology, Payment Rates, Payment Policies, and the List of Covered Procedures for Ambulatory Surgical Centers Effective October 1, 1998), we have included in our comments a discussion of a few of the issues previously raised by the College in our earlier comments to the proposed rule.
The primary concern of all of our Fellows is assuring high-quality patient care. Therefore, we reviewed both this final rule and the 1998 proposed rule with utmost attention to the question of whether the procedures that are listed can be safely performed in the ambulatory surgical setting.
Furthermore, we recommend to CMS that, following implementation of this phase of the final rule, it work in consultation with providers of ambulatory surgical care to develop an improved method for maintaining a current system of Medicare reimbursement for services that can be safely provided by an ASC. Although of great importance, we touch only briefly on the need for CMS to address the ratesetting methodology for ASCs, as we understand this is to be the subject of a separate final rule.
New CPT Codes Added to the ASC List
The College has reviewed the list of services that are typically performed by our member surgeons that have been introduced into CPT since the 1998 proposed rule and subsequently added to the updated ASC list. We agree that these services can be safely performed in an ASC and are appropriate additions to the ASC list. We appreciate CMS' work in reviewing new codes developed by CPT in order to update the Medicare-approved ASC list.
Comprehensive Review of ASC Medicare-Approved Codes Needed
We recognize that CMS is soliciting comments for only those codes newly added to CPT since the release of the 1998 proposed rule. However, we would be remiss in not speaking to the entire updated list and referencing some of the issues that we raised in the 1998 proposal that CMS has not addressed in this final rule. The College appreciates CMS' response to some of the comments that we, and other surgical specialty organizations, submitted in response to the 1998 proposed rule. It is clear that your agency has carefully reviewed these comments and, in some instances, has agreed to either remove CPT codes from or add codes to the ASC list in response to those comments. Nevertheless, codes remain on the list that the surgical specialties performing these services do not deem appropriate for the ASC setting.
We have included as an attachment a list of services and comments that are representative of the current issues that some of the surgical specialty organizations have in regards to the appropriateness of the ASC list. We believe that these comments clearly illustrate the need for CMS to redress the ASC list, once this phase of the update set forth in the final rule is implemented.
Furthermore, this update finalizes only proposals that were included in the 1998 rule and adds some codes that were newly introduced by CPT since then. CMS did not consider many other procedures that the College and surgical specialty organizations previously identified as appropriate for an ASC. We continue to believe there are services not included on this list that can safely be provided in the ASC setting, some of which were noted in our comments to the 1998 proposed rule.
The College urges CMS to work on developing an approach that will expedite Medicare approval of procedures for purposes of obtaining ASC facility reimbursement. Clearly, the approach currently used is not working, evidenced by the fact that the last comprehensive review of the ASC list was conducted in 1998, rendering the latest list already outdated.
Criteria for Covered Surgical Procedures
In the College's comments in response to the 1998 proposed rule, we expressed support for CMS' plans to amend the criteria used to determine whether a procedure should be added to the ASC list. We agreed that the current criteria were outmoded given the advances that are taking place in surgery and in anesthesiology. The College is disappointed that CMS did not include any changes previously proposed to the criteria for coverage in this final rule.
Currently, the criteria CMS uses to determine whether a procedure should be added to the ASC list require that the procedure not: exceed 90 minutes of operating time; exceed four hours of recovery or convalescent time; result in extensive blood loss; require major or prolonged invasion of body cavities; or directly involve major blood vessels. The existing guidelines also state that a procedure that is on the list must generally be performed in a physician's office 50 percent or less of the time and in a hospital inpatient department at least 20 percent of the time.
To reiterate our 1998 comments, these standards are clearly outdated and we were pleased to note that CMS had planned to amend the criteria to more accurately reflect current practice. We found that the proliferation of laparoscopic and endoscopic procedures which involve little blood loss and reduce the need to invade major body cavities make problems of blood loss less pervasive. These advances combined with the development of short-acting, general anesthesia obviate mandates pertaining to operation and recovery times. Similarly, surgeons are performing procedures now that never were performed on inpatients. Hence, the standard that a procedure be performed in a hospital inpatient department 20 percent of the time is archaic. Equally antiquated is CMS' requirement that a procedure be performed in a physician's office 50 percent or less of the time, as the number of procedures that can be performed safely in multiple settings continues to grow. Accordingly, we supported your agency's 1998 proposal to no longer use the criteria based on time limits for operating, anesthesia, and recovery and to discontinue using site of service (20/50 rule) as the principal determinant of which procedures to add or delete from the list.
We also suggested expanding the new criteria to permit the ASC list to include procedures that are ordinarily performed in an office setting but may require the more extensive facilities and services of an ASC to accommodate the special needs of a particular patient. Your agency's proposed change in the 1998 proposed rule would have allowed Medicare beneficiaries who have special the health needs or risks, and for whom an office would not be a safe setting even for a relatively simple operation, to have access to an ASC as an alternative to the hospital.
We believe these criteria need to be reviewed in the context of evaluating what is an effective overall process for determining which procedures can safely be performed in an ASC, as recommended above.
Payment Categories and Overall Ratesetting Methodology
In addition to the question of which services are appropriately provided in an ASC setting, the College has encountered issues of correct payment, based on the categories CMS has established for ASC procedures. For example, in this final rule CMS has elected to place CPT 40761, plastic repair of cleft lip/nasal deformity; with cross lip pedicle flat, into a lower payment category than other cleft lip/nasal procedures. The difference in payment for 40761, compared to other codes in the same immediate family is $485. Plastic surgeons who are Fellows of the College have indicated that the equipment, supplies and clinical resources that an ASC has to provide for this service may well exceed those of the other lip/nasal procedures in the higher payment category.
Similar problems have emerged with urology services that require insertion of penile prostheses. Included in the previously mentioned attachment are comments from urology indicating that the ASC payments for these procedures are not adequate to cover these services due to the high cost of the prostheses used in these procedures that fall outside of the scope of what is included in the ASC facility payment. These two examples from surgical specialties illustrate the need for a revised payment methodology that more accurately captures the cost to ASCs of providing services.
We understand that CMS has encountered many legislative and regulatory obstacles in finalizing the ASC list and establishing a new ratesetting methodology. In fact, part of the delay was probably in response to requests made by providers of ambulatory surgical services to hold off implementation of the ASC rule until efforts to develop a prospective payment system (PPS) for hospital outpatient department services (HOPD) were completed. The College, along with other surgical organizations, made this request in comments to the 1998 proposed rule, reasoning that the ASC regulation and the HOPD rule should be evaluated together so that the agency and the medical specialty societies have the necessary data at hand to effectively evaluate the impact of both plans. We still believe such data are necessary in order to devise a reimbursement system that more accurately captures the cost of providing a service in the ASC setting and one that does not create an inappropriate financial incentive to provide a service in one setting rather than another.
Again, we recognize that this portion of the final rule states that CMS will be addressing the reimbursement methodology separately. The College urges CMS to work with the ambulatory surgical community to develop a process by which ASCs can be fairly reimbursed by Medicare for services that are appropriate in that setting and one which provides for changes in technology and current-day practices. We would be pleased to assist CMS with this effort in any way that your agency might find useful.
Final Thoughts
The College firmly believes that patient safety and patient health status are paramount in determining appropriate site of service. Ultimately, it is the surgeon and the patient who can best determine where a service should be provided. Consideration must be given to the anesthetic risk, age, and general medical condition of the patient; the expected duration and complexity of the operation; the anticipated degree and duration of postoperative pain and discomfort; and the probability of peri- and post-operative complications. An operation should not be performed in an ambulatory setting—irrespective of convenience or cost - if the risk to the patient in undergoing the operation is increased. On the other hand, in certain situations, the ambulatory setting may be appropriate for a patient undergoing a procedure not typically performed in an ASC. We believe CMS can develop a better mechanism than currently exists for evaluation of these factors.
Thank you again for the opportunity to comment on the final rule updating the ASC procedure list. We hope that you have found these comments useful. Please feel free to contact our Washington Office at 202-367-2701 if you have any questions or if we can be of further assistance.
Sincerely,
Thomas R. Russell, MD, FACS
Executive Director
Revised April 11, 2006
ACS Views on Legislative, Regulatory, and Other Issues
Advocacy and Health Policy
This page and all contents are Copyright © 2003-2006
by the American College of Surgeons, Chicago, IL 60611-3211
|
