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ACS Views on Legislative, Regulatory, and Other Issues
Ambulatory Surgical Centers—
January 25, 2005
The Honorable Mark McClellan, M.D., PhD
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Room 445-G
Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, DC 20201
RE: CMS-1478-P; Medicare Program; Update of Ambulatory Surgical Center List of Covered Procedures
Dear Dr. McClellan:
On behalf of the 66,000 Fellows of the American College of Surgeons, I am pleased to submit the following comments in response to the rule that proposes updates to the list of Medicare covered procedures that may be performed in an ambulatory surgical center (ASC) published in the November 26, 2004 Federal Register. The College appreciates the Centers for Medicare and Medicaid Services (CMS) efforts in updating the list of covered services provided in Medicare-certified ASCs.
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) requires that CMS implement a revised payment system for surgical services furnished in an ASC sometime between January 1, 2006 and January 1, 2008, subject to recommendations of a mandated General Accountability Office (GAO) study. The GAO study is to consider the appropriateness of using the groups of covered services and relative weights established under the outpatient prospective payment system (OPPS) as the basis of payment for ambulatory surgical centers. It also must assess whether the payment rates for ASCs should be based on a uniform percentage of the payments, should vary, or should be revised based on specific procedures or types of services. Finally, the study is to determine whether a geographic adjustment should be made.
In implementing a new payment system for ASCs, the College urges CMS to address the issues we discuss in these comments in a comprehensive manner. Specifically, we hope that CMS will re-evaluate its method for approving procedures for Medicare reimbursement in the ASC setting and payment rates for individual procedures. We urge CMS to work closely with the ambulatory surgical community during this process to develop a system in 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.
In the meantime, we believe CMS needs to immediately address several major issues related to the ASC list. The primary concern of all of our Fellows is assuring safe, high-quality patient care in all settings. Therefore, we reviewed this proposed rule with utmost attention to the question of whether procedures can be safely and satisfactorily performed in the ambulatory surgical setting. We have also solicited comments from other surgical specialty organizations and have briefly provided their views on the appropriateness of specific procedures being added or deleted to the Medicare-approved ASC list and the assignment of procedures to ASC payment categories.
Criteria for Covered Surgical Procedures
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 added to 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.
In the proposed ASC rule published in the June 12, 1998 Federal Register, CMS proposed amending the criteria to more accurately reflect current practice and the capabilities of modern ASCs. The College supported these proposed changes, which included removing the time limits on operating, anesthesia and recovery time and discontinuing the use of site-of-service as the principal determinant of which procedures to add to or delete from the list. Although CMS proposed to supplement or replace the quantitative thresholds with qualitative considerations, these changes were never adopted. As a result, procedures that can be safely, satisfactorily and often more efficiently performed in an ASC are currently excluded from the list or are being proposed for deletion.
A key example in general surgery that illustrates the problem with CMS' criteria is CPT code 47562, Laparoscopy, surgical; cholecystectomy. The existing requirement that a procedure cannot exceed 90 minutes of operative time excludes from the ASC list CPT code 47562, which has 118 minutes of intra-operative time recorded in the AMA/Specialty Society Relative Value Update Committee database. In the past, the College agreed that laparoscopic cholecystectomies should only be performed in the hospital setting. However, advances in laparoscopic technology, dissemination of advanced laparoscopic skills among surgeons and availability of safer short-acting anesthetic agents obviate the mandates pertaining to operation and recovery times for laparoscopic cholecystectomy and many other procedures. Some, but not all of these patients, depending upon age, health status, and status of their bilary systems, are now having these procedures performed in the hospital outpatient department and the patient can be safely discharged the same day to recuperate at home. Diagnostic tests such as ultrasound and magnetic resonance imaging of the common bile duct allow surgeons to effectively determine which patients need to be operated upon in a hospital setting and which can safely be operated upon in an ASC.
Relatedly, surgeons are performing procedures now that never were performed on hospital inpatients. The ASC standard that requires an allowed procedure to be performed in a hospital inpatient department 20 percent of the time therefore seems somewhat outdated. The CMS requirement that an ASC allowed procedure be performed in a physician's office 50 percent or less of the time seems similarly out of touch with current safe ambulatory surgical care. The need for ASC rather than office performance of many procedures is quite often determined by the anesthetic needs of the patient as well as patient age and comorbidities rather than the nature of the operation per se. For example, CMS is proposing to delete a number of skin excision codes from the list, based primarily on the 50 percent site-of-service threshold. Although these procedures can often be performed safely in a physician's office, it is inappropriate for CMS to assume that an office setting provides the optimal safe environment for every patient undergoing skin lesion excision. Many of these procedures are performed on elderly patients with multiple skin excisions which may necessitate the use of both local and monitored anesthesia care. CMS should allow payment for ASC services for procedures when the responsible operating surgeon, after evaluating the patient's anesthesia needs and comorbidities, determines that an ASC rather than the office is the best and safest setting for the care of his/her patient.
Your agency's proposed change in the 1998 proposed rule would have allowed Medicare beneficiaries who have special 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. As the number of procedures that can be performed competently and safely in multiple settings continues to grow, CMS may be better served by greater flexibility in determining ASC payment eligibility. Procedures performed in the ASC setting often result in shorter patient stays, greater convenience for the patient and financial savings to both the patient and to the Medicare program.
In its 2004 report to Congress, the Medicare Payment Advisory Commission (MedPAC) recommends that CMS use only two criteria to determine which procedures should be allowed Medicare reimbursement when performed in an ASC: 1) the procedure can safely be performed in an ASC, and 2) the procedure can be performed without an overnight stay. MedPAC also recommends that CMS have a list of procedures that cannot be paid by Medicare when performed in an ASC, as opposed to the current list of procedures that can be reimbursed when performed in an ASC, which is similar to the approach used for hospital outpatient departments. The College urges CMS to consider MedPAC's recommendations as it addresses changes to the ASC payment methodology and that it review the criteria in the context of evaluating what is an effective overall process for determining which procedures can safely be performed in an ASC.
Review of ASC List of Medicare-Covered Procedures
The College appreciates CMS' response to some of the comments that surgical specialty organizations submitted in response to the March 28, 2003 final ASC 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. However, many of the changes to the list that CMS is proposing are based on recommendations contained in the January 2003 Office of Inspector General (OIG) report "Payment for Procedures in Outpatient Departments and Ambulatory Surgical Centers." OIG recommends CMS remove 72 codes that do not conform to CMS' established criteria, stating that not doing so has cost Medicare $8 to $14 million more for services performed in ASCs as opposed to outpatient departments or physician offices. The College is troubled with the focus of the OIG report in that it recommends removal of these procedures based purely on financial considerations and on numeric criteria which, as we have discussed in detail above, are outdated and lack clinical significance. The OIG even acknowledges in its report that it "did not evaluate the quality of care provided in these settings nor any concerns about access to care." We disagree with CMS' decision to remove over 100 procedures from the list based on faulty rationale that does not have as its primary consideration patient safety or quality of care.
The College has reviewed the list of general surgery procedures that are typically performed by our members and have identified those that we believe can be safely performed in an ASC. We have provided, as an attachment, comments on services that we believe are appropriate additions or deletions to the ASC list. We have also included as part of the attachment a list of services and accompanying comments from other surgical specialty organizations, whose members are Fellows of the College. We believe that these comments clearly illustrate the need for CMS to revisit the ASC list and we would ask CMS to carefully consider the attached recommendations.
Conclusion
The College firmly believes that patient safety and overall patient health status are paramount in determining the 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 never be performed in an ambulatory setting—irrespective of convenience or cost—if the risk to the patient is increased by the ambulatory surgical setting. Conversely, the ambulatory setting may be safe and appropriate for a patient undergoing a procedure not typically performed in an ASC. We believe CMS must develop a better mechanism than currently exists for evaluation of the factors that determine propriety of ASC performance of procedures.
Thank you again for the opportunity to comment on the proposed rule updating the ASC procedure list. We hope that you have found these comments useful. Please feel free to contact our Washington Office at 202-337-2701 if you have any questions or if we can be of further assistance.
Sincerely,
Cynthia A. Brown
Director, Division of Advocacy and Health Policy
Attachment A: List of Services and Specialty Society Recommendations (80K PDF)
A "Yes" in "Specialty Society Recommendation" column indicates the specialty society recommends that the procedure should be added to the Medicare-approved list or remain on the list.
A "No" in "Specialty Society Recommendation" column indicates the specialty society recommends that the procedure should not be included on the Medicare-approved ASC list.
| Acronym |
Specialty Society |
| AAFPRS |
American Academy of Facial Plastic and Reconstructive Surgery |
| AAO |
American Academy of Ophthalmology |
| ACOG |
American College of Obstetricians and Gynecologists |
| ACS |
American College of Surgeons |
| ASCRS |
American Society of Cataract and Refractive Surgery |
| ASCRS (C & R) |
American Society of Colon and Rectal Surgeons |
| ASGS |
American Society of General Surgery |
| ASMS |
American Society of Maxillofacial Surgeons |
| ASPS |
American Society of Plastic Surgeons |
| ASSH |
American Society for Surgery of the Hand |
| AUA |
American Urological Association |
| OOSS |
Outpatient Ophthalmic Surgery Society |
| SVS |
Society for Vascular Surgery |
Revised September 3, 2008
ACS Views on Legislative, Regulatory, and Other Issues
Advocacy and Health Policy
This page and all contents are Copyright © 2003-2008
by the American College of Surgeons, Chicago, IL 60611-3211
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