ASC Adviser

CMS: Rewriting the Rules

After 25 years, agency proposes new ASC conditions for coverage.

By Michael A. Romansky, JD

First, the Centers for Medicare and Medicaid Services (CMS) overhauls the payment system under which ASCs are paid. Then, weeks before the payment rule's Jan. 1 effective date, the agency issued a proposed rule to revise the requirements that ASCs must meet in order to bill the program for services furnished to beneficiaries. These requirements, known as Conditions for Coverage (CfC), have not been modified since the inception of the Medicare ASC program in 1982.

To implement the CfCs, CMS determines facility compliance by contracting with state survey agencies (typically state health departments) that conduct onsite inspections applying these standards. In the alternative, ASCs may elect to meet Medicare standards by being certified by one of the CMS-approved national accrediting organizations whose standards meet or exceed the CfCs, such as the Joint Commission or the Accreditation Association for Ambulatory Health Care.

While this regulation doesn't represent an overhaul of the current ASC certification system, there are a number of key changes in current policy. These provisions, as well as responsive comments submitted by the Outpatient Ophthalmic Surgery Society (OOSS) and the American Society for Cataract and Refractive Surgery (ASCRS), are described below.

Governing Body and Management

The proposal clearly expands the ASC governing body's responsibility and accountability with respect to developing and implementing the facility's quality-assessment program. The leadership of the facility would also be required to ensure that the ASC "coordinate" its disaster preparedness plans with state and local officials. OOSS and ASCRS emphasized that, as limited-service providers, ASCs are neither equipped nor staffed to provide emergency care beyond the facility's own patients and that, as evidenced during Hurricane Katrina, ASCs can make a valuable contribution to relief efforts by making their staff available onsite or at local hospitals.

Quality Assessment and Performance Improvement

CMS appears to have adopted OOSS/ASCRS's longstanding recommendation that CMS utilize a less proscriptive and more proactive facility-specific approach to quality assessment and performance improvement. The proposal would provide each ASC with the flexibility to select its own quality indicators and performance measures, to establish its own priorities for program activities, and to develop performance improvement projects that reflect the scope and complexity of its services and operations.

The Outpatient Ophthalmic Surgery Society (OOSS) is a professional medical organization that provides advocacy, education and practice management support to the nation' ophthalmic ASCs. For more information about OOSS, contact Claudia A. McDougal, executive director, at 866-892-1001 or visit www.ooss.org.

Patient Rights

The proposed regulation mandates that all patients receive written notice of their rights in a language they understand. Citing the impracticability of providing such notice in urban areas where a facility might be treating patient populations encompassing literally dozens of languages, OOSS and ASCRS recommended that ASCs be afforded the flexibility to develop their own processes, e.g., offering meaningful translations or written summaries, for ensuring that patients are fully apprised of their rights. The proposal also mandates that information regarding physician ownership of an ASC be furnished to patients prior to the first visit to the ASC. OOSS and ASCRS emphasized that the duty to disclose should rest with the surgeon, as many states require, not the physician; in fact, prior notice may not be practicable because surgery may be scheduled on short notice or on an urgent basis.

Infection Control

Recognizing the ASC industry's commitment to state-of-the-art infection prevention measures and training and exemplary record of infection control, CMS appears to be delegating to the individual ASC the responsibility to develop and implement its own facility-specific infection-control program.

Patient Admission, Assessment and Discharge

The proposal mandates the conduct of a comprehensive history and physical assessment no more than 30 days prior to surgery. OOSS and ASCRS commented: "If, for example, repetitive or bilateral procedures, such as cataract extraction for both eyes, are scheduled, a comprehensive exam may be appropriate prior to the first procedure, while a more limited update of the first exam may typically be sufficient prior to the second procedure to determine whether there have been any significant changes in the patient's physical condition. Under the proposal, if the bilateral procedures are separated by several weeks — or if the original surgery needed to be rescheduled — the patient would be required to undergo additional and unnecessary comprehensive exams."

CMS' proposal to modify the quarter-century-old ASC conditions of coverage represents a positive step towards balancing the need to optimize quality of care and patient safety, while reflecting the needs and circumstances of an array of surgical providers that are diverse as to size, specialty and type of patient. A final rule is expected to be published within the next several months. OM

Michael Romansky is headlining the OOSS Day Summit, a gathering of ophthalmic ASC owner/physicians, administrators and nurse administrators, in Chicago on April 6, 2008.

Visit www.ooss.org for full program and online registration.

Michael A. Romansky, J.D., is Washington Counsel and Senior Lobbyist for OOSS. He has practiced exclusively in the area of health law for 30 years, representing healthcare providers, companies and organizations before Congress and all federal agencies with jurisdiction over health programs. He has served as Washington counsel to many medical specialty and health trade associations, including the Outpatient Ophthalmic Surgery Society (OOSS), the American Association of Ambulatory Surgery Centers (AAASC), and the American Gastroenterological Association.