CMS 'conditions-for-coverage' update
Generally welcomed by ASC groups

The proposed revisions in the conditions for coverage include a sweeping overhaul of quality-of-care assurance standards. According to CMS, the new focus will be on "a patient-centered, outcome-oriented process that promotes patient care foremost, rather than a prescriptive, inflexible approach that penalizes providers of substandard care." That historical focus on enforcing prescriptive health and safety standards has resulted in CMS' "expending many of our resources on working with marginal providers, rather than stimulating broad-based improvements in quality of care," the agency explained.

During the last decade, "the healthcare industry has moved beyond the problem-oriented approach of monitoring quality assurance to an approach that addresses quality improvement prospectively through focused projects designed to reduce errors and address omissions of care before patients are adversely affected," CMS said.

It proposed requiring each ASC to develop, implement and maintain a Quality Assessment and Performance-Improvement (QAPI) program. Each ASC's governing body would be responsible for ensuring:

• That the QAPI program is "defined, implemented and maintained,"
• That it addresses priorities and evaluates the effectiveness of improvements,
• That "QAPI data-collection methods, frequency and details are appropriate,"
• That "safety expectations are established" and
• That "adequate resources are allocated for implementing the facility's QAPI program."

Beverly A. Kirchner, RN, BSN, CNOR, CASC, a member of AORN's board of directors and co-owner and president of ASC development firm Genesee Associates, Inc., said the proposal to update Medicare's conditions for coverage was "long overdue." She noted that the ASC industry—through a collaboration including professional associations such as AORN, ASC trade groups such as the American Association of Ambulatory Surgery Centers (AAASC) and FASA, and major ASC accrediting organizations—currently is developing a set of ASC quality measures for CMS to consider for inclusion as "pay-for-performance" benchmarks, beginning in 2009.

"The industry already has been taking steps to go beyond these proposed requirements," Kirchner said. "We're looking forward to the new (Medicare) standards because things have changed so dramatically since the current ones were adopted over 20 years ago."

AAASC Executive Director Craig Jeffries said his organization was "delighted that CMS has proposed improvements in the Medicare conditions for coverage that reflect standards of practice that most ambulatory surgery centers already address."

FASA President Kathy Bryant sounded the same theme, noting that "ASCs routinely go well beyond the current Medicare requirements and, in fact, are already doing more than would be required if the proposed standards were adopted."

Although FASA executives still were analyzing the proposals when contacted by AORN Management Connections, Bryant said it was disappointing "that CMS missed the opportunity to remove outdated and onerous requirements in its existing conditions for coverage, such as one that requires ASCs to have a separate waiting room from any other provider."

Announcing the proposed rules Aug. 24, CMS said the changes would update ASC conditions for coverage "to reflect contemporary standards of practice in the ASC community, as well as recommendations from the (Department of Health and Human Services) Inspector General. A February 2002 IG report cited explosive growth in the ASC industry and faulted Medicare's system of quality oversight.

The 2002 IG report noted that almost one-third of ASCs certified by state agencies hadn't been recertified for five or more years and that the every-three-years survey process for ASCs that qualified under accreditation programs devoted too little attention to verifying compliance.

In its proposed rules, CMS noted that the ASC conditions for coverage have remained unchanged since they first were adopted in August 1982, while the number of ASCs participating in Medicare increased at a rate of about 175 facilities a year during the decade from 1990 to 2000. During the period, the total number of ASCs increased from 1,197 to 2,966, and the annual volume of surgical procedures performed by ASCs increased from 1.3 million to 4.3 million, CMS said. Currently, more than 4,600 ASCs participate in the Medicare program.

In addition to requiring QAPI programs, CMS proposed the following new requirements or changes:

• Developing a written disaster-preparedness plan, covering preparedness within the facility and its interaction with local and state officials, to ensure the safety of patients and staff. Annual drills, with follow-up written evaluations and immediate implementation of needed corrections, would be required.
• Expanding responsibility for patient transfers, when needed. New language would require not just transferring a patient to the nearest hospital but to a hospital that would be best equipped to meet the patient's needs.
• Changing the overnight stay rule to require that ASC patients must be discharged by 11:59 p.m. of the day of their surgeries for the procedure to be eligible for Medicare reimbursement.
• Defining a reasonable amount of time (15 to 30 minutes) for a patient to leave an ASC facility after a discharge order is signed.
• Developing and implementing new "patients' rights" policies—a requirement proposed in the 2002 IG report.
  (1) ASCs would have to provide patients with verbal and written notice of their rights, "in a language and manner the patient understands," before furnishing care.
  (2) ASCs would have to establish clear procedures for documenting "the existence, submission, investigation and disposition" of patient grievances, including but not limited to, mistreatment, neglect, verbal, mental, sexual or physical abuse and theft of personal property. The grievance process would have to specify time frames for reviewing and responding to grievances.
  (3) Any applicable physician financial interests or ownership in the ASC would have to be disclosed in writing and furnished to the patient before the first visit.
  (4) ASCs would be responsible for providing patients information on their policies related to advance directives, including applicable state legal requirements. Even if patients hadn't executed an advanced directive, they would have to be informed of their right to make informed decisions about their care.
  (5) Patients would have a right to personal privacy and safety, free from all forms of abuse or harassment, and privacy standards for clinical records would have to conform to HIPAA (Health Insurance Portability and Accountability Act) standards.
• Revising the radiologic services standard to impose requirements that parallel those of the current standard for furnishing laboratory services. CMS would require that portable/contract radiology services used by an ASC be Medicare-certified.
• Separating the current infection-control requirement from the physical environment standard of the environment condition for coverage and introducing a new infection-control condition for coverage. CMS proposes to make ASCs accountable to "prevent, control and investigate infections and communicable diseases, and take actions that result in improvements for those problematic areas identified and monitored as part of the proposed QAPI program." ASCs would be required to "designate a qualified professional, such as a Registered Nurse, as the infection-control officer." ASCs would be "strongly encouraged" to adhere to guidelines published by the federal Centers for Disease Control and Prevention, the Association of Practitioners in Infection Control and The Joint Commission. Policies would have to be established governing both hand hygiene and procedures for proper instrument cleaning and maintenance of sterilization equipment.
• Expanding current regulations requiring evaluations of patients for anesthesia risk before surgery and proper recovery from anesthesia before discharge. The aim is to ensure "that accurate and thorough assessments would be conducted to (en)sure appropriate and safe surgery, and that patients would be able to tolerate a scheduled surgical procedure."
  Each patient would have to have "a comprehensive medical history and physical assessment completed not more than 30 days before" the scheduled date of surgery. The ASC would have to place the medical history and physical assessment in the patient's medical record before starting surgery. Specific documentation of the patient's physical and mental capacity to undergo the planned procedure, and any patient allergies, would have to be documented.
  (2) Thorough postsurgical assessments of the patient's condition would have to be documented in the medical record, and any postsurgical needs would have to be addressed and included in discharge notes.
  (3) ASCs would have to provide written discharge instructions to each patient and "ensure that all patients have the best possible transition to home and that all postsurgical needs would be met."
  (4) Each patient would have to be given a discharge order "signed by the physician or the qualified practitioner who performed the surgery or procedure."
  (5) The physician or qualified practitioner who performed the procedure would have to "be available to provide assistance in the ASC if needed, until all patients have been given a signed discharge order by the aforementioned practitioner." Physicians would not specifically be required to remain on premises while there are patients remaining in the ASC. But "professional standards of practice dictate the ASC should include physician coverage information in the written discharge instructions regarding emergency care in the event of any postoperative adverse effects," CMS said.

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