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CMS Updates ASC Guidance for Surveyors

Distinct entity, H&P, periodic written notice and anesthesia risk assessment requirements undergo revisions

BY KARA NEWBURY | JULY 2022

The Centers for Medicare & Medicaid Services’ (CMS) updates to the State Operations Manual (SOM) Appendix L - Guidance for Surveyors: Ambulatory Surgical Centers make conforming revisions to the regulatory tags and interpretive guidelines, as well as clarifications and technical corrections to other guidance areas based on stakeholder feedback.

CMS released the updated Appendix L on June 17. This came just two weeks after CMS announced an advanced copy of the changes in a surveyor memo on June 3. CMS published multiple final rules over the past several years that amended the ASC Conditions for Coverage (CfC).

Because CMS sent out that advanced copy, ASCA staff had the opportunity to catch an error that was fixed in the June 17 version. The advanced copy inadvertently left in the following sentence about ASC records under the distinct entity guidance: “Furthermore, care must be taken when such an arrangement is in use to ensure that the ASC’s medical and administrative records are physically separate.” This sentence has been problematic for ASCs in the past, as it has been used to cite facilities that share electronic health records with other related entities, such as physicians’ offices. ASCA raised this concern with CMS, arguing that the guidance was written before electronic health records were commonplace and that sharing medical records is necessary for coordinating patient care, and CMS promised to look into the issue. ASCA followed up with CMS staff after the advanced copy was released, and the agency confirmed it was left in by accident and would be removed in the official release of the updated SOM Appendix L.

Other significant changes to Appendix L are highlighted below.

Medical History and Physical (H&P) Assessment

The Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction Final Rule (84 FR 51732), frequently referred to as the 2019 Burden Reduction Rule, changed the H&P requirements for facilities, and the CfC now states: “The ASC must develop and maintain a policy that identifies those patients who require a medical history and physical examination prior to surgery.” While much of Appendix L had been updated to indicate that H&Ps were no longer required by CMS in all cases, a sentence inadvertently left in place stated that surveyors should confirm that medical records include a “comprehensive medical history and physical assessment completed not more than 30 days before the date of the surgery.” The updated Appendix L, on page 19, changes that language to “A medical history and physical assessment, as applicable, if required by the ASC’s policy.”

In addition, beginning on page 142, CMS added interpretive guideline language for the revised H&P requirements. When the requirement was changed in 2019, ASCA asked CMS staff to clarify which “nationally recognized” guidelines would be appropriate for ASCs to follow. While CMS does not provide an exhaustive list, there is guidance in the revised Appendix L: “For example, the American College of Surgeons, the American Society of Anesthesiologists, the American College of Cardiology, and the American Academy of Ophthalmology have best practice guidelines or recommendations for preoperative care.”

As a reminder, the presurgical assessment requirement found at 42 CFR §416.52(a) remains; CMS adds clarifying language as to what is required for this assessment beginning on page 143 of Appendix L.

Periodic Written Notice Requirement

This requirement, also finalized in the 2019 Burden Reduction Rule, states: “The ASC must periodically provide the local hospital with written notice of its operations and patient population served.” ASCA requested CMS to provide facilities with more information on how to comply with this requirement, and the revised Appendix L on pages 44–45 adds further guidance that the ASC provide the notice upon opening of the facility and at least every 24 months “to ensure the ASC keeps the local hospital informed and up-to-date on ASC information and any pertinent patient population changes.”

The revised Appendix L also provides guidance on what the notice must include. The written notice must include information concerning the ASC’s operations, including the ASC’s name, address, hours of operation, administrator’s name and contact information for any follow-up questions. It also must include information about the patient population served by the ASC, which includes, but is not limited to, surgical specialties and whether the ASC sees adult and/or pediatric patients. The written notice can be communicated to the local hospital through the mail or electronically, and CMS advises ASCs to have a current copy on file.

Anesthetic Risk

The Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule (84 FR 62568), included a change to 42 CFR §416.42(a) Standard: Anesthetic Risk and Evaluation. The old language at 42 CFR §416.42(a)(1) stated that “A physician must examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed.” The new language now allows an anesthetist or physician to do the anesthesia risk assessment, stating, “(1) Immediately before surgery - (i) A physician must examine the patient to evaluate the risk of the procedure to be performed; and (ii) A physician or anesthetist as defined at § 410.69(b) of this chapter must examine the patient to evaluate the risk of anesthesia.” Although the revised Appendix L does not provide much guidance, it does include the updated standard and a few changes to the interpretive guidelines for the standard beginning on page 46.

Informed Consent

The revised Appendix L also includes language in the interpretive guidelines for 42 CFR §416.47(b) Standard: Form and Content of Record clarifying that the patient or the patient’s representative must sign informed patient consents. On page 93, it states: “Documentation of a properly executed informed patient consent that is signed by the patient or, if applicable, the patient’s representative.”

Infection Control Worksheet

CMS also updated the Infection Control Surveyor Worksheet on June 21 to clarify that questions H, I and J which address multidose medications/infusates do not apply to multidose eye drop bottles.

Please write Kara Newbury with any questions.