The Regulatory Definition of an Ambulatory Surgery Center
Ambulatory Surgical Center, or ASC, means any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization, has an agreement with CMS to participate in Medicare as an ASC, and meets the conditions set forth in The State Operations Manual – MEDICARE PROGRAM PART 416 – AMBULATORY SURGICAL SERVICES Subpart A – General Provisions and Definitions and Sec. 416.1 Basis and scope/416.2 Definitions.
“ASC services” means facility services that are furnished in an ASC. “Covered surgical procedures” means those surgical and other medical procedures that meet the criteria specified in §416.65 and are published by CMS in the Federal Register.
The regulatory definition of an ASC does not allow the ASC and another entity to mix functions and operations in a common space during concurrent or overlapping hours of operation. Another entity may share common space only if the space is never used during the scheduled hours of ASC operation. However, the operating and recovery rooms must be used exclusively for surgical procedures. Although an ASC is not required to be in a building separate from other healthcare activities (e.g. hospital, clinic, physician’s office) it must be separated physically by at least semi-permanent walls and doors. An ASC must use its space for ambulatory surgery exclusively. Record keeping and staff must be exclusive to the ASC.
To participate in the Federal ASC program and receive facility fees from government payers, the ASC must meet Medicare criteria and approval, known as Certification. This Certification is also mandatory in order to contract with “other” payers for facility fees.
A prerequisite to Medicare Certification is compliance with State Licensure Law. Although Medicare governs the ASC program, each State Department of Health is their own authority, having jurisdiction over the program. Forty-three states require a state license for ASCs. These states specify the criteria that ASCs must meet for licensure prior to Certification. Information can be found on the individual State Department of Health’s Web site, many of which publish their rules and regulations, such as patient’s rights, incidence reporting and safety programs. This prerequisite of State Licensure, however, may exempt some single-specialty facilities in some states.
The process of Licensure and Certification includes surveys and approval by the Medicare program as a provider of surgical services. Typically, the survey is performed by the individual State Department of Health or by a third party Accrediting Body. In return for making increased payments to ASCs, federal and state governments have specific requirements for the physical environment, as well as a whole host of rules and regulations covering procedures performed, staffing and administrative functions. Specific conditions for coverage can be found on the Federal Register, 42 CFR 416, The State Operation Manual.
Certificate of Need
Some states require a Certificate of Need, (commonly referred to as CON, Certificate of Public Need or Determination of Need) but certainly not all, or even a majority, to establish a new ASC. CON is a state regulatory program intended to balance cost, quality and access issues and ensure that only needed services and facilities are developed in a given region. It may be possible to obtain an exemption in some states for single specialty ASCs, or for just one operating room, or for wholly physician owned ASCs. The process of CON or an exemption varies by state, for example:
- A petition may be filed in some states for exemption.
- Some states have a number of rooms exemption – such as single-operating room facilities.
- Some states have a cost of project threshold for exemption.
Many surgery centers choose to go through voluntary accreditation processes conducted by their peers. This accreditation is sometimes referred to as a “third party survey” and may be mandatory in some states or with some payers. ASCs can seek accreditation from one of three accrediting bodies: Accreditation Association for Ambulatory Health Care (AAAHC), Joint Commission or The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF).
All accredited ASCs must meet specific standards that are evaluated during on-site inspections. These accrediting bodies also have deemed status by CMS to survey for Medicare Certification. Typically this survey is after the facility has been open for six months, however, an early option is available to satisfy state and/or payer requirements. Proof of State License or exemption letter will be needed before they will schedule survey. Medicare Certification survey through an accrediting body is unannounced. Accrediting bodies will typically give a one month window for survey.
All ASCs must meet requirements of the Federal and State Fire Safety Codes: safe, sanitary and appropriate environment for an ASC. It is crucial to determine the individual state regulations prior to any construction, as both the source and year of the requirements need to be considered. Codes used by the individual states can be from the Centers for Medicare & Medicaid Services, the National Fire Protection Association and/or from the American Institute of Architects. Some states have their own individual building codes as well. These codes include specifics on construction type, engineering, electrical and mechanical systems, as well as storage and monitoring and alarm systems. It is vitally important in creating physical environments (the planning and spatial design of your facilities) that you meet regulatory standards while facilitating efficient use of staff (the only truly vital aspect of your cash flow model), maximum procedural volume and patient-centered care.
read more →