The two forces that have driven the increase in accreditation of outpatient ambulatory surgery centers (ASC’s) in the United States are reimbursement of facility fees by Medicare and commercial insurance companies, which requires either accreditation, Medicare certification, or state licensure, and state laws which mandate one of these three options. Accreditation of ASC’s internationally has been driven by national requirements and by the competitive forces of “medical tourism.” The three American accrediting organizations have all developed international programs to meet this increasing demand outside of the United States.
Key points
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The two forces that have driven the increase in accreditation of outpatient ambulatory surgery centers (ASC’s) in the United States are reimbursement of facility fees by Medicare and commercial insurance companies, which requires either accreditation, Medicare certification, or state licensure, and state laws which mandate one of these three options.
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Accreditation of ASC’s internationally has been driven by national requirements and by the competitive forces of “medical tourism.” The three American accrediting organizations have all developed international programs to meet this increasing demand outside of the United States.
Introduction
Over the past decade, there has been an increasing interest on the part of many aspects of American medicine to become more involved with international colleagues, from the interest of the Accreditation Council on Graduate Medical Education and the American Board of Medical Specialties in exploring opportunities in international residency training and board certification to the development by many medical specialty organizations of increased relationships with international counterparts. Simultaneously, the growth of medical tourism has been driven by commercial insurance payers and corporations as well as by individuals to obtain medical care abroad at cheaper rates or to obtain procedures or drugs not yet available in the United States. This situation has also spurred domestic interest in foreign medicine and surgery.
There is a long history of the international involvement of American physicians in medical missions, medical education, international medical organizations, fellowship study abroad, and rich collegial interactions, but more recently there has been a realization that there is increased quality and sophistication in medicine around the world, as well as a growing desire both in the United States and in many other countries to increase professional interaction for mutually beneficial goals. These newer initiatives have been based on recognition of the similarity of challenges confronting physicians in all parts of the world, and the value of sharing experiences and solutions. In some areas, the United States has had successes in solving problems, or has developed programs that may be of value to our international colleagues; in many other areas, various other countries have had greater successes in dealing with challenges or developed a more innovative approach that we can benefit from in the United States. Unlike many older relationships, in which the United States tended to dominate and control the activities and focus of an international exchange, the more recent approach has been more collegial, more equal, and more focused on mutual benefit.
Introduction
Over the past decade, there has been an increasing interest on the part of many aspects of American medicine to become more involved with international colleagues, from the interest of the Accreditation Council on Graduate Medical Education and the American Board of Medical Specialties in exploring opportunities in international residency training and board certification to the development by many medical specialty organizations of increased relationships with international counterparts. Simultaneously, the growth of medical tourism has been driven by commercial insurance payers and corporations as well as by individuals to obtain medical care abroad at cheaper rates or to obtain procedures or drugs not yet available in the United States. This situation has also spurred domestic interest in foreign medicine and surgery.
There is a long history of the international involvement of American physicians in medical missions, medical education, international medical organizations, fellowship study abroad, and rich collegial interactions, but more recently there has been a realization that there is increased quality and sophistication in medicine around the world, as well as a growing desire both in the United States and in many other countries to increase professional interaction for mutually beneficial goals. These newer initiatives have been based on recognition of the similarity of challenges confronting physicians in all parts of the world, and the value of sharing experiences and solutions. In some areas, the United States has had successes in solving problems, or has developed programs that may be of value to our international colleagues; in many other areas, various other countries have had greater successes in dealing with challenges or developed a more innovative approach that we can benefit from in the United States. Unlike many older relationships, in which the United States tended to dominate and control the activities and focus of an international exchange, the more recent approach has been more collegial, more equal, and more focused on mutual benefit.
The increase of mandatory accreditation of ambulatory surgical centers
In the United States, the accreditation of outpatient surgical facilities, especially those not part of an acute care hospital, has slowly become important, and, in many cases, mandatory, for several reasons.
Federal Medicare Program
The federal Medicare program began to certify out-of-hospital ambulatory surgical centers (ASCs) and reimburse them for facility fees in 1982 after developing and publishing the conditions for coverage (CfCs) in the Federal Register. These requirements form the fundamentals for determining which facilities can participate as a supplier under the Medicare program. These CfCs have undergone numerous revisions and refinements over the ensuing years.
Three National Accrediting Organizations
Beginning in 1996, the Centers for Medicare and Medicaid Services (CMS, then called the Healthcare Financing Authority) began to allow the 3 national accrediting organizations to deem compliance with the CfCs for ASCs by an approved inspection process. This system was separate from the state agency process, which had been the only option to achieve Medicare certification before that time.
The 3 organizations (the American Association for the Accreditation of Ambulatory Surgery Facilities [AAAASF], the Joint Commission, and the Accreditation Association for Ambulatory Health Care [AAAHC]) had to be approved by CMS as a deeming agency by showing that their standards and processes met or exceeded the CfCs for ASCs. That approval must be renewed by CMS every 6 years.
Outcomes of Compliance Process
This new process of deeming compliance dramatically improved the inspection system for ASCs seeking to participate in the Medicare program and made the requirements more uniform across all the states. The lengthy and variable delays in arranging site inspections under the state programs were virtually eliminated, and the number of certified facilities steadily increased. In 2011, the last year of available data, there were 5368 Medicare-certified ASCs, with continued growth over the last 3 years despite the economic slowdown.
The ASC payment system underwent a substantial revision in 2008, most significantly increasing the number of surgical procedures that would be covered.
More than 3500 surgical procedures are covered by the Medicare system in certified ASCs. However, payments from Medicare are not a substantial source of revenue for most ASCs. A study by the Medical Group Management Association in 2009, for example, showed that only 17% of ASC revenue was from Medicare, on average. Commercial insurance reimbursement was the greatest source of revenue, but in many states Medicare certification is required to collect facility fees from commercial insurers.
Effect of State Laws on Accredited Surgical Facilities
The other factor that has increased the number of accredited surgical facilities has been the gradual increase in state laws requiring that all outpatient surgical centers be accredited by 1 of the 3 national organizations, certified by Medicare, or licensed by the state. This movement began in California in 1995, when the state began to evaluate the need for some oversight of the burgeoning ambulatory surgery industry, which had no requirements for operating until that time.
Unlike the situation in acute care hospitals, which have long had extensive requirements covering all aspects of patient care, including safety, sterility, personnel, physical plant, and so forth, the outpatient center could start caring for patients, administering general anesthesia, and performing major surgery without anyone inspecting the facility or certifying compliance with even basic requirements.
The new law went into effect in July, 1996 in California, and has been followed by laws in 21 states that mandate either state licensure, accreditation by 1 of the 3 national organizations, or certification by Medicare. However, this situation means that there are still no requirements for these outpatient surgical centers in 28 states: no oversight, no inspection process, no standards to comply with, no control over what is performed in these facilities. In several states, laws have been proposed, and rejected by the regulatory agencies as unnecessary because there have been no reported deaths or serious complications as yet from these centers. Although elective surgery on generally healthy patients is inherently safe, as the types of procedures that are performed on an outpatient basis increase, and the health requirements for patients who qualify for surgery in ASCs decrease, it is inevitable that untoward outcomes will occur without some basic standards in place. Numerous studies have shown the safety of even major surgery performed in accredited facilities, but without external oversight, the risks can increase to a dangerous level. The reluctance to act until a crisis occurs has meant that most states still have no protections in place to assure their citizens that basic requirements have been met when they have surgery and anesthesia in an outpatient surgical center.
The 2 major forces that have driven the requirement for accreditation of outpatient ambulatory surgery centers in the United States are:
- 1.
Reimbursement of facility fees by Medicare and commercial insurance companies, which requires either accreditation, Medicare certification, or state licensure
- 2.
State laws that mandate 1 of those 3 options for all centers
Impact of Professional Plastic Surgery Societies on Accredited Surgical Facilities
An additional strong incentive for plastic surgeons to operate only in accredited, Medicare-certified, or state-licensed facilities is the requirement for membership in the 2 largest national plastic surgery societies, the American Society of Plastic Surgeons, and the American Society for Aesthetic Plastic Surgery, that all outpatient surgery other than those performed under just local anesthesia is performed only in such facilities. The American Board of Plastic Surgery (ABPS) now also requires compliance with this requirement as a part of the Maintenance of Certification program, which is mandatory for all diplomates certified after 1995. As a result, virtually all plastic surgeons certified by the ABPS operate only in these inspected surgery centers, whether or not their state requires it, and whether or not Medicare or commercial insurance cover the procedures that they are performing. This situation adds a measure of reassurance to patients considering elective surgery procedures, especially aesthetic surgery, in that they now know that not only is the surgeon performing the procedure appropriately trained and ABPS Board certified to perform it safely but the facility where it is being done is also certified as meeting national standards for patient safety and quality care.
International Facility Accreditation
None of these forces acting to require some degree of external oversight of the functions of an ASC exists internationally. Although some nations have imposed mandatory compliance with national standards, including France, the United Kingdom, Brazil, Australia, and Germany, most nations have no requirements in place. A recent effort to develop an ASC accreditation requirement in the European Union (based largely on the AAAASF model) has yet to materialize, caught up in the political turmoil that limits that group’s efforts in so many areas. With so many more serious issues to confront in most nations, regulating ambulatory surgery centers is not even being considered. The Swiss Society of Plastic, Reconstructive, and Aesthetic Surgery recently mandated that surgery performed by its members outside of licensed hospitals must be done in ambulatory surgical facilities that have been inspected and accredited by the international affiliate of AAAASF, known as AAAASF-I.