An exception for patient notice as well as new interpretive guidelines for changing conditions of coverage (CfCs) for Medicare-approved ambulatory surgery centers (ASCs) are the latest developments that facilities must digest.
On Nov. 18, 2008, the Centers for Medicare & Medicaid Services (CMS) adopted the Hospital Outpatient Prospective Payment System final rule, which included revisions to the ASC CfCs. However, on May 15, CMS announced that it will allow an exception for the patient notices required in advance of the day of the procedure in certain cases. Specifically, CMS said that it is not acceptable for the ASC to provide the required notice for the first time to a patient on the day that the surgical procedure is scheduled to occur, unless the referral to the ASC for surgery is made on that same date and the referring physician indicates, in writing, that it is medically necessary for the patient to have the surgery on the same day, and that surgery in an ASC setting is suitable for that patient. According to the ASC Association, in such situations, the ASC must provide the required notice prior to obtaining the patient’s informed consent. Cases of surgery occurring on the same day it is scheduled are expected to be rare, since ASCs typically perform elective procedures. Frequent occurrence of such cases may represent noncompliance with the advance notice requirement.
“The new conditions will require ASCs to provide patients with notice of their rights and referring physician ownership in advance of the date of the procedure,” says Joshua M. Kaye of McDermott Will & Emery LLP. “While it is understandable that a patient be fully informed in order to appropriately understand the procedure and whether their physician has a financial interest in the facility, a number of practical concerns arise for an ASC in actually carrying out these new responsibilities that could serve as an impediment to patients receiving timely care, particularly in situations where a procedure must be scheduled on short notice.”
“What people were concerned about was not being able to do cases the same day that they were scheduled,” says Kathy Bryant, president of the ASC Association. “No one was complaining to us about having to comply with that mandate; however, some may have questioned how much patients are really going to read the information ASCs give them. They were not objecting to providing that if that’s what the government wanted them to do. ASCs did feel very strongly about the potential inconvenience to a patient; if a patient is in pain and you can fix him or her today, what sense does it make to send that patient home so they can get this information and come back tomorrow? Many people called us with heart-rendering stories about patients they had helped in the past who they might not be able to help in the future. So we were delighted that we were able to get CMS, with the help of some of our friends like Congressman (John) Larson (D-Conn.), to make a change in that provision. I still don’t think that provision is exactly where we need it to be but certainly CMS made much progress and many of these cases will now be able to be scheduled on the day of surgery.”
One of the most worrisome changes CMS had proposed last year was altering the conditions to prohibit overnight stays; however, CMS reversed its position in the final rule. The new language states, “Ambulatory surgical center or ASC means any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization, and in which the expected duration of services would not exceed 24 hours following an admission. The entity must have has an agreement with CMS to participate in Medicare as an ASC, and must meet meets the conditions set forth in subparts B and C of this part.”
Another significant change is a rigorous focus on demonstrated infection prevention and control knowledge and practice in an ASC. In 416.51 Conditions for coverage — Infection control, an ASC must maintain an infection control program that minimizes infections and communicable diseases. The facility must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice, and the infection prevention program must include documentation that the ASC has considered, selected and implemented nationally recognized infection control guidelines, such as those issued by the Centers for Disease Control and Prevention (CDC). The program must be implemented under the direction of a designated and qualified professional who has training in infection control; it must be an integral part of the ASC’s quality assessment and performance improvement program; and it must contain a plan of action for preventing, identifying and managing infections and communicable diseases, and for immediately implementing corrective and preventive measures that result in improvement.
“No one is objecting to having greater scrutiny on infection control, but what our members are troubled by is some of CMS’ comments about infections in ASCs, even given that every bit of data we can find on infections in ASCs shows them as having an extremely low rate of infection,” Bryant says. “ASCs agree they should comply with the process, and if the way of determining a facility’s compliance with proper infection control practices is through surveys, I don’t think anyone has an objection to that. But they do want to be recognized for the stellar job they have done in infection control.”
Bryant encourages any ASC whose survey does not go according to the new standards to alert the ASC Association. “ We are trying to monitor this closely and will make sure they do apply the new standards appropriately, and if we learn more about how they are applying the new standards with other members, we will share that information. The new interpretive guidelines are extremely detailed and include a number of clarifications on standards that applied even before May 18. In many cases they mirror exactly what we’ve been telling ASCs for some time as to how they should be interpreted. I think there are some areas where they may have gone beyond the regulations a little in their explanations, so I strongly encourage everyone to get these guidelines which are available on our Web site.”
Bryant adds, “No one can deny there have been some media reports of some infection control standards not being followed. In infection control, we should be applying the highest standards and if anyone isn’t, they should be called to task for that. I do think ASCs are just so eager to comply, that if someone says you have to have training, they want to know how much training. As long as CMS hasn’t specified how much training, it means the ASC administrator gets to determine. People are asking what they need to do, and the interpretive guidelines will help answer their questions.” These new interpretive guidelines are available by clicking HERE.
Let’s take a look at other changes in the CfC language:
- In 416.41 Condition for coverage—Governing body and management, an ASC must have a governing body that assumes full legal respon-sibility for determining, implementing and monitoring policies governing the ASC’s operation. Additionally, this governing body is accountable for a quality assessment and performance improvement program that ensures facility policies and programs are administered so as to provide qual-ity healthcare in a safe environment. The CfC also mandates that an ASC have a written disaster preparedness plan that provides for the emer-gency care of patients, staff and others in the facility in the event of fire, natural disaster, functional failure of equipment, or other unexpected events or circumstances that are likely to threaten the health and safety of those in the ASC. The facility must coordinate its plan with state and local authorities, and it must conduct at least one annual drill to test the plan's effectiveness. The ASC must complete a written evaluation of each drill and promptly implement any corrections to the plan.
- In 416.43 Conditions for coverage—Quality assessment and performance improvement, an ASC must develop, implement and maintain an ongoing, data-driven quality assessment and performance improvement (QAPI) program that demonstrates measurable improvement in patient health outcomes and improves patient safety by using quality indicators or performance measures, and by the identification and reduction of medical errors. An ASC must also measure, analyze and track quality indicators, adverse patient events, infection control and other aspects of performance that includes care and services provided by the facility.
- In 416.50 Condition for coverage—Patient rights, an ASC must inform the patient or the patient’s representative of the patient’s rights via verbal and written notices in advance of the surgery, and must protect and promote the exercise of these rights. As part of this CfC, an ASC must also disclose any physician financial interests or ownership in the facility.
- In 416.52 Conditions for coverage—Patient admission, assessment and discharge, an ASC must ensure every patient has the appropriate pre-surgical and post-surgical assessments completed and that all elements of the discharge requirements are completed.