Additional Requirements, Conditions for Coverage for ASCs in Final 2009 Hospital Outpatient and ASC Prospective Payment Systems Rule

On November 18, 2008, the Centers for Medicare and Medicaid Services (“CMS”) published the final 2009 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System rule.  The final rule addresses several significant changes affecting the operation and oversight of ambulatory surgical centers (“ASCs”). Although the final rules are generally less restrictive than those proposed originally, there are several important things you need to know about the changes affecting ASCs: 

“Overnight Stay” Definition.  CMS has dropped its plans to alter the definition of ambulatory surgical centers to include facilities that perform procedures that do not require active monitoring past 11:59 p.m. on the day the procedure was performed.  In response to industry comments, CMS recognized that numerous ASCs operate on a 24-hour basis, and that the “11:59” cutoff was too restrictive.  Instead, 42 C.F.R. §416.2 now provides that a patient’s stay cannot exceed 24 hours from admission.  This definition also brings Medicare rules into line with the laws in several states.

Conditions for Coverage--Pre- and Post-Surgical Assessments.  CMS has finalized a new regulation (42 C.F.R. §416.52) which further clarifies the responsibilities of ASCs to ensure pre- and post-surgical patient assessments are completed.  The new regulation requires the following:

Pre-Surgery:

• The patient must have a comprehensive medical history and physical assessment by a physician or other qualified practitioner no more than 30 days prior to the surgical procedure.
• A pre-surgical assessment must be conducted upon admission by a physician or other qualified practitioner, including an updated medical history.
• The patient’s medical history and physical assessment must be placed in the patient’s medical record prior to the surgical procedure.

Post-Surgery/Discharge:

• The patient’s condition must be assessed and documented in the medical record post-surgery by a physician, other qualified practitioner, or a registered nurse with post-operative care experience.
• Post-surgical needs must be documented in the discharge notes.
• Patients must be provided with written discharge instructions and overnight supplies.
• When appropriate, the ASC must schedule the patient for a follow-up appointment with the physician who performed the procedure.
• ASCs must ensure patients are informed, either in advance of their surgery or prior to leaving the ASC, of their prescriptions, post-operative instructions and physician contact information for follow-up care.
• There must be a written discharge order signed by the physician who performed the procedure.
• Except where provided otherwise by the attending physician, all patients must be discharged in the company of a responsible adult.

Note that CMS also revised 42 C.F.R. §416.42 to revise the requirement that a physician must examine the patient immediately before surgery to evaluate the risk of anesthesia and the surgical procedure, and to mandate that a physician or an anesthetist must evaluate the patient for anesthesia recovery prior to discharge.

Conditions for Coverage--Patient Rights, Physician Disclosure.  The final rule adds patient rights to the ASC conditions for coverage via a new regulation (42 C.F.R. §416.50).  Among the conditions:

• Patients must be provided notice of their rights in verbal and written form prior to the procedure, and have such rights posted in a place likely to be noticed by the patient. The disclosure must include those items listed below and in the regulation, and include the name, address and telephone number for the state agency responsible for patient complaints, and the website for the Medicare Beneficiary Ombudsman.
• The ASC must disclose in writing and in advance of the date of the procedure any physician financial interests or ownership in the ASC. Commentary to the rule suggests that notice be provided in the pre-operative information packet sent to the patient.
• The patient must be provided notice in advance of the procedure date of the ASC’s advance directive policies and the right to request any applicable official state forms, and the ASC must note in the patient’s medical record whether the patient has executed a directive.
• ASCs must establish a patient grievance procedure, and all substantiated allegations must be reported to state and/or local authorities.

Conditions for Coverage—Governing Body and Management.  The final rule expands the responsibilities of the governing body and management in several areas:

• The governing body has oversight and accountability for the development of a disaster preparedness plan for the ASC that provides for emergency care of patients, staff and patient family members who are present in the ASC when events occur in the ASC or its immediate community that threaten the health of these individuals. The rule requires coordination, where appropriate, with state and local authorities to implement the plan, and requires an annual facility drill with written evaluation of the drill (42 C.F.R. §416.41).
• ASCs are required to meet new “Quality Assessment and Performance Improvement”  (“QAPI”) rules, and the governing body has responsibility for oversight and accountability for the program. The QAPI program requires ASCs to continuously monitor quality improvement through focused projects, identify barriers to improvements, take efforts to measure improvements in patient health outcomes, and work to reduce medical errors. ASCs also are expected to measure, analyze and track quality indicators, including adverse patient events, infection control, and other aspects of performance, including processes of care and services furnished in the ASC. (42 C.F.R. §416.43).

Conditions for Coverage—Infection Control.  The final rule also includes a new regulation (42 C.F.R. §416.51) that mandates a sanitary surgical environment in accordance with professionally accepted standards as well as a documented infection control program that reflects nationally recognized infection control standards.

While the general effective date of the 2009 final rule is January 1, 2009, CMS has set the effective date of the above-described requirements as May 18, 2009.  Accordingly, ASCs should review their practices and, if necessary, update them to assure compliance by such time.