Federal Requirements Governing ASCs

ASCs are subject to a rigorous set of survey and certification standards designed to ensure patient safety. The requirements for achieving and maintaining CMS certification were increased in 2008 with the overhaul of the ASC Conditions for Coverage (CfCs) and further safeguards have since been implemented to enhance patient safety and quality of care in ASCs. Technological advances increasingly drive procedures to the outpatient setting and research confirms that outcomes are very similar, even adjusting for risk, between hospital outpatient departments (HOPDs) and ASCs.

ASC vs HOPD Health and Safety Standards

Outcomes are similar between ASCs and HOPDs in large part because the federal regulations are similar. The ASC CfCs are essentially the same as the hospital Conditions of Participation (CoPs) that apply to HOPDs, and the Code of Federal Regulations sections for each are cited in the Table below.

The hospital CoPs that apply to HOPDs are found in three condition categories: Administration, Basic Hospital Functions and Optional Hospital Services. Optional Hospital Services include surgical services, anesthesia services and outpatient services.

Both sites of service have similar language for quality assessment and performance improvement (QAPI). Regarding physical environment, both ASCs and HOPDs must meet the Life Safety Code provisions applicable to Ambulatory Health Care Occupancies. Both require similar information in medical records and allow for the same flexibilities to the facility to determine when a medical history and physical assessment (H&P) is required.

There are a few slight variations, but nothing that would negatively impact patient safety.

Nursing Services

ASCs are required to have a “registered nurse available for emergency treatment whenever there is a patient in the ASC.” Although inpatient hospitals must provide 24/7 nursing services, the hospital CoP for nursing services found at 42 CFR §482.23 (7) states, “The hospital must have policies and procedures in place establishing which outpatient departments, if any, are not required under hospital policy to have a registered nurse present.” This allows flexibility for those HOPDs that are not open 24/7 to only have nursing staff present when patients are there, just like the requirement for ASCs.

Laboratory and Radiologic Services

Not all ASCs may offer laboratory and radiologic services but if they do, they must meet the same requirements as hospitals.

Patient Rights

There is a lot of language in the hospital patient’s rights CoP, found under the Administration section of the conditions, regarding use of restraint or seclusion. This is, once again, because hospitals are responsible for a broader patient population than just outpatient surgical patients. For ASCs, there are two sections that address patient respect and safety that clearly provide protections to any patients in the ASC: (e) Standard: Exercise of rights and respect for property and person; and (f) Standard: Privacy and safety, which includes the right to receive care in a safe setting, and be free from all forms of abuse or harassment.

Infection Control

The primary difference is that in the CoPs there is an antibiotic stewardship program requirement. ASCs do not routinely prescribe antimicrobial medications, so this requirement would not make sense for the ASC setting. This also is in line with The Joint Commission’s decision to exempt ASCs from requirements on antimicrobial stewardship.

Patient Admission, Assessment and Discharge

There is no specific hospital CoP for admission or assessment. Much of the admission and assessment language is found under §482.24 (CoP: Medical record services).

Emergency Equipment

The language in the ASC CfCs contains more information on what to do in case of an emergency, in general. This is especially true with who can operate emergency equipment, as the ASC CfCs have specific information on emergency personnel. There is no similar language in the Optional Hospital Services CoPs that relate to surgical services, anesthesia services and outpatient services.

Emergency Preparedness

There are slight variations here between the CfCs and the CoPs, simply because the hospital requirements are broadly applicable to every department in the hospital. Presumably, the hospital would determine how to involve off-campus departments in emergency preparedness efforts and work those variations into their policies. For instance, ASCs are not required to have subsistence available in case of an emergency. For the hospital subsistence requirement, it states, “Facilities have flexibility in identifying their individual subsistence needs that would be required during an emergency.”

There also are three CoPs found under Basic Hospital Functions that do not apply to ASCs and are not found in the ASC CfCs.

Food and Dietetic Services

The food and dietetic services CoP, §482.28 under Basic Hospital Functions, states that hospitals “must have organized dietary services that are directed and staffed by adequate qualified personnel.” This makes sense for a setting where patients routinely stay multiple days. As ASCs look to continue to expand services and potentially advocate to keep patients for longer periods of time in their facilities, this might be an area where an ASC CfC would need to develop in the future.

Utilization Review

The only other CoP that is not found in the ASC CfCs is one for utilization review (UR), found at §482.30 under Basic Hospital Functions. The UR plan must provide for review for Medicare and Medicaid patients with respect to the medical necessity of (i) admissions to the institution; (ii) the duration of stays; and (iii) professional services furnished, including drugs and biologicals. While there is no official UR plan in the CfC for ASCs, the Medicare Claims Processing Manual includes language reminding facilities that the “general coverage rules requiring that any procedure be reasonable and necessary for the beneficiary are applicable to ASC services in the same manner as all other covered services.” ASCs also are subject to review by Recovery Audit Contractors (RACs) that review claims on a post-payment basis and “detect and correct past improper payments.”

Organ, Tissue and Eye Procurement

This CoP addresses a hospital’s responsibilities regarding organ procurement and transplantation. Neither of these apply to ASCs.

Please contact Kara Newbury at knewbury@ascassociation.org with any questions.