The Centers for Medicare and Medicaid Services (CMS) today issued detailed interpretive guidelines for ambulatory surgical centers (ASCs) participating in the Medicare program. ASCs nationwide have been taking various actions to address the new Conditions for Coverage (CfCs) which take effect today, including the CfC requirement that patients be notified of defined legal rights "in advance of the date of the procedure." 42 CFR § 416.50(a)(1).

Guidelines Provide Direction on New Notice Provision

The new pronouncement comprehensively revises CMS's State Operations Manual, which will be used to guide the Medicare certification process and will color future ASC regulatory compliance activities. Importantly, the interpretive guidelines provide much-needed guidance on the new CfC notice provision which requires an ASC to communicate with its patients regarding a variety of matters that CMS deems pertinent to the overall informed consent process—including, among other things, physician financial interests in the ASC and the facility's policy on advance directives regarding the provision of health care if a patient becomes incapacitated. The advance notice requirement has been the subject of increasing controversy and concern since it appears to prohibit same-day scheduling of surgery by ASCs participating in Medicare under any circumstances, with an ASC potentially risking the facility's Medicare certification for noncompliance, regardless of the best interests of patient care, in urgent medical circumstances.

The interpretive guidance creates a limited exception to the advance notice requirement that narrowly addresses certain clinical exigencies, but the new provision will not provide the broad regulatory relief which some facilities were seeking. According to CMS (Interpretive Guidelines 416.50(a)(1)):

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.

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 (emphasis in original).

Narrow Regulatory Exception Confirms Heightened Scrutiny by CMS

Surgeons and proceduralists treating sick and injured patients at ASCs may take some comfort from this regulatory exception, so long as the referring physician certification requirements regarding medical necessity and suitability of the site-of-service are properly documented. Nonetheless, the use of the exception is "expected to be rare," so ASCs will generally still need to implement the "prior to the date of surgery" notification requirements as previously expressed. Today's welcome but narrow exception confirms that, as the ASC industry continues to grow and mature, heightened regulatory scrutiny by CMS under the new CfCs and otherwise seems sure to continue and intensify.