OIG calls for more extensive evaluation of ASCs

Oversight of ambulatory surgery centers is called “a system in neglect” in a report from the OIG.

Issue: April 15, 2002

WASHINGTON – Accreditation of ambulatory surgery centers is “a system in neglect” according to a scathing government report released in March. Oversight of the surgical facilities is more important than ever, the report said, because of the growing number of centers and the increase in the number of procedures performed in them.

The report, prepared by the Office of Inspector General of the Department of Health and Human Services, takes the Centers for Medicare & Medicaid Services (CMS) to task for not effectively evaluating the oversight of ambulatory surgery centers (ASCs) by state agencies and accreditors.

The CMS pays out more than $1.6 billion for procedures performed in more than 3,000 ASCs, according to the report, “Quality Oversight of Ambulatory Surgical Centers: A System in Neglect.” The number of ASCs has more than doubled during the past decade. At the same time the number of procedures performed in them has increased 730%, from 12,000 to more than 101,000 annually.

The types of procedures permitted in ASCs has grown as well, from 1,500 in 1990 to 2,300 in 2000. Many of the added procedures are complex, involving anesthesia and invasive surgery. CMS has proposed expanding the list even further, to include almost 2,500 procedures.

“We chose to evaluate the oversight of ASCs first because they are one of the fastest growing settings for ambulatory surgery in Medicare,” the report says.

Ophthalmology’s heavy concentration of procedures performed in ASCs is not ignored by the report. The opening page cites a case in which cardiac arrest and death occurred in an ASC during “one of the most common procedures in Medicare,” a cataract removal.

But as the number of ASCs has increased, the report says, oversight by accreditors and state agencies has decreased. Some centers have not been evaluated in more than 5 years, the report says.

“From 1990 to 2000, the elapsed time between re-certification surveys for ASCs already in the program more than doubled, from 1.8 years to 4.4 years,” the report says. “ASCs certified by State agencies are going so long between surveys because the level of re-certification surveys has failed to match ASC growth.”

The OIG oversees all healthcare entities that receive Medicare reimbursement. This report, accompanied by two supplememntal reports, focuses on the overall system of ASC evaluation: the roles of state credentialing agencies and accreditation organizations and how the CMS holds those agencies accountable for ASC compliance with Medicare standards.

The reports are intended to be a warning signal for CMS to increase compliance requirements for ASCs receiving Medicare reimbursement. The report says that ASCs are not being evaluated frequently or thoroughly enough by state agencies and accreditors to assure compliance. Likewise, in the two supplemental reports, the OIG indicates that CMS exercises too little of oversight of state and accreditation organizations over ASCs. State agencies and accreditors directly oversee ASCs and approve their compliance with Medicare’s Conditions of Coverage.

Accreditation agencies that oversee ASCs include the Accreditation Association for Ambulatory Health Care (AAAHC), the Joint Commission for Accreditation of Healthcare Organizations and the American Association for Accreditation for Ambulatory Surgical Facilities (ASF).

Weak systems

The OIG report claims that the CMS has a weak system for surveying, requesting complaints from the public and posting performance reviews, and poor standards for evaluating ASCs. The report also recommends state agencies and accreditation organizations need to develop these types of feedback mechanisms.

As part of its investigation, the OIG reviewed budgets and regional and state operations manuals. It also monitored and validated state and accreditation agency surveys. In its report, the OIG found fault with the evaluation processes for both state agencies and accreditors, and they attributed several complications and deaths at ASCs during routine procedures to a decrease in oversight.

The OIG also said that CMS, state agencies and accreditation organizations do not follow through with patient complaints or compliance failures.

They did find, however, that accreditation organizations have adjusted their standards accordingly over time, but the CMS has not changed its standards since 1982.

The situation is not as bad as the report makes it sound, according to a health lawyer familiar with ASC issues.

“They certainly identify explosive growth of the industry. CMS oversight has not kept up with it,” said Jeffrey Peters, JD, an attorney for Arent Fox, a firm that practices health law. “But the danger of the report is that it’s misleading and not a report about quality. To support their case, they threw in outlier horror stories that could happen in any setting. The report is not intended to single out the ASC industry but rather CMS oversight.”

Recommendations

The OIG report recommends that CMS should establish a closer relationship with both state agencies and accreditors. Other recommendations include the following:

The CMS should determine an appropriate minimum cycle for surveying ASCs certified by state agencies. It should “move away from the one-size-fits-all model” and consider a more adjustable approach that would enable surveyors to tailor Medicare standards to individual ASCs. CMS should use an electronic data system to track surveys and compliance performance.

Reaction

The report also listed comments from some of the regulatory agencies affected by the report.

In its comments, the CMS said it agreed that certain improvements are necessary, but noted that their resources are limited.

Thomas Scully, administrator for CMS, said, “We recognize that the current ASC Conditions for Coverage do not adequately address the many changes that have taken place in the ASC community in recent years.” He noted that “CMS is already involved in designing the new Quality Improvement Evaluation System for survey data.”

Mr. Scully said no organizations have developed reliable quality indicators for surgical procedures.

“For us to develop a validation process with statistical significance is close to impossible at this point in time, given the small number of accredited ASCs,” Mr. Scully wrote.

In its response, the AAAHC acknowledged the need to improve but said that several OIG allegations were incorrect. They noted that numbers of complications occurring in ASCs are small and that the performance of highly invasive procedures in ASCs is prohibited by the CMS.

In its response, the Joint Commission on Accreditation of Healthcare Organizations agreed with the OIG report but said that several faults noted by the CMS did not accurately reflect their evaluation process. The ASF also said that it currently has an extensive review process.

For Your Information:

The Office of Inspector General, author of the reports, can be reached at Office of Public Affairs, Department of Health and Human Services, Room 5541 Cohen Building, 330 Independence Ave. SW, Washington, DC 20201; (202) 619-1343; fax: (202) 260-8512; e-mail: eaffairs@os.dhhs.gov; Web site: http://oig.hhs.gov.

Jeffrey Peters, JD, is an attorney for Arent Fox. He can be reached at 1050 Connecticut Ave. NW, Washington, DC 20036; (202) 857-6295; fax: (202) 857-6395; e-mail: petersj@arentfox.com. Web site: www.arentfox.com.

Thomas Scully, can be reached at the Centers for Medicare Medicaid Services, 7500 Security Blvd., Baltimore, MD 21244-4850; (410) 786-3000; Web site: www.hcfa.gov.

Accreditation Association for Ambulatory Health Care can be reached at 3201 Old Glenview Rd., Ste. 300, Wilmette, IL 60091; (847) 853-6060; fax: (847) 853-9028; Web site: www.aaahc.org.

Joint Commission on Accreditation of Healthcare Organizations can be reached at One Renaissance Blvd., Oakbrook Terrace, IL 60181; (630) 792-5000; fax: (630) 792-5005; Web site: www.jcaho.org.

American Association for Accreditation of Ambulatory Surgery Facilities can be reached at 1202 Allanson Rd., Mundelein, IL 60060; (888) 545-5222; fax: (847) 566-4580; Web site: www.aaaasf.org.

Reference:

Full text of the reports can be accessed at the following Web sites:

Rehnquist J. Quality of Oversight of Ambulatory Surgery Centers: A System in Negelct; Web site: http://oig.hhs.gov/oei/reports/oei-01-00-00450.pdf.

Rehnquist J. Quality of Oversight of Ambulatory Surgery Centers: The Role of Certification and Accreditation. Supplemental Report 1; Web site: http://oig.hhs.gov/oei/reports/oei-01-00-00451.pdf.