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ASCA Meets with CMS Survey and Certification and Clinical Standards Staff

Meeting focuses on the recent finalization of CMS’ burden reduction rule

BY KARA NEWBURY | NOVEMBER 2019

On November 18, ASCA staff met with representatives from the Centers for Medicare & Medicaid Services (CMS) Survey and Certification Group and Clinical Standards Group. The conversation centered around the recent finalization of CMS’ burden reduction rule that goes into effect on November 29, and how those changes impact ASCs. Specific topics of discussion included:

• Updates to State Operations Manual Appendices: ASCA did receive confirmation that State Operations Manual Appendix L - Ambulatory Surgical Centers, which has not been updated since 2015, should be revised soon to reflect rule changes from the past four years. While exact dates were not given, ASCA is optimistic it will be released by spring 2020. CMS staff indicated that the Infection Control Surveyor Worksheet for ASCs will not be updated at this time. It is important to note that the guidance for emergency preparedness (EP) for all provider types is found in Appendix Z, which will also be updated shortly to reflect the changes finalized in the burden reduction rule. CMS has no plans to include all EP guidance in Appendix L, but it will be updated to remove references to “disaster preparedness” and at the very least include the Emergency Preparedness Condition for Coverage and references to Appendix Z.
• Emergency Preparedness (EP): As follow-up to the meeting, ASCA received the following information and resources to pass along:
• Top EP Citation for ASC (data from 2017-2018): Policy & Procedure (P&P) for 1135 Waivers. The facilities must have policies and procedures which address “The role of the facility under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.” To be compliant with the requirement, facilities need to have a policy and procedure for addressing the facility’s awareness of the 1135 Waiver Process and their role in such a potential event. There is no specific form or document template. Facilities can print out information from CMS’ 1135 Waivers website (see “Downloads” section which would help facilities in having this within their P&Ps, especially Requesting an 1135).
• Resources for ASCs: CMS provides EP resources on its website. CMS is currently working on revisions to Appendix Z and will post the new appendix here when it is finalized. Additionally, CMS also partnered with ASPR’s Technical Resources, Assistance Center, and Information Exchange (TRACIE), which developed resources and checklists created from CMS guidance. Read the overview document combining the EP final rule, the Interpretive Guidelines and CMS revisions for ASCs or visit the TRACIE website. (All checklists are under the Facility-Specific Requirement Overviews.) These checklists can be used by providers and suppliers, as well as the surveyors in order to have a provider-specific checklist, including the Tag Number, CFR and IGs/Survey Protocol. The checklist near the end has the latest changes, but the guidance is old with the caveat. ASPR will update the guidance to mirror CMS when it’s ready.
• The Overview Course will also have ASC and EP changes and the EP Basic Course will hopefully be ready in the Spring. If you have specific ASC EP questions, feel free to also contact QSOG_EmergencyPrep@cms.hhs.gov.

• Hospital Transfer Agreements/Admitting Privileges: This requirement has been removed from the ASC Conditions for Coverage (CfCs) effective November 29, 2019, and is replaced with a requirement that ASCs provide written notice to a local hospital as to their “operation and patient population served.” In the rule, CMS goes on to say, “For example, the notice would include details such as hours of operation and the procedures that are performed in the ASC.” ASCA staff has received questions as to whether a hospital agreement would “count” for this new written notice requirement. CMS staff had not contemplated this idea but agreed with ASCA that if the transfer agreement contains the information required in the written notice (hours of operation and population served in the ASC), it would count. ASCA told CMS there was confusion as to how much detail facilities would need to go into (such as, is a list of specialties sufficient or is a specific procedure list needed). ASCA supported keeping the requirement simple with just a list of specialties served. CMS acknowledged the concerns and further guidance is anticipated in the updated State Operations Manual Appendix L in the future.
• Medical History & Physical Assessment (H&P): Effective November 29, 2019, CMS has eliminated the requirement at § 416.52(a) for each patient to have a medical history and physical assessment completed by a physician not more than 30 days before the scheduled surgery and replaced it with the requirement for ASCs to develop and maintain a policy that identifies those patients who require a medical history and physical examination prior to surgery. This policy must be based on “nationally recognized standards of practice and guidelines, and applicable state and local health and safety laws.” ASCA staff raised concerns with the “nationally recognized standards” language and asked that CMS clarify what may meet this requirement. It is important to note that many states and accrediting organizations still require an H&P for all patients.

As a reminder, accrediting organizations and states can require more than CMS. ASCA’s Government Affairs team has crafted two one-page briefs detailing existing state requirements for both H&Ps and transfer agreements and admitting privileges. These briefs were created through a survey of state administrative rules and statutes across the country and represent the most complete and verifiable information ASCA could obtain on existing state requirements. The briefs include a categorization of state laws and regulations covering each issue, as well as a map graphic visualizing where the states stand on H&Ps and transfer agreements and admitting privileges. ASCA members may access these resources on ASCA’s website. Write Stephen Abresch with any questions regarding these resources, as well as questions regarding specific state requirements.

If you have questions, write Kara Newbury.