REGULATORY REVIEW
facility-based functional exer- cise, a drill, or a tabletop exercise or workshop that includes a group discussion led by a facilitator.
providers are exempt from the next required exercise after an event requiring activation of the EP (i.e., if the facility must deal with an emergency). If an ASC’s state law aligns with
the revised CMS requirements and the ASC is not accredited or its accre- diting organization’s requirements do not conflict, the ASC can now use the regulations above to guide its emer- gency preparedness planning, even though Appendix Z has not yet been updated to reflect these changes. Guidance often takes a long time to be updated during normal times, let alone during a global pandemic. In addition, the hurdles being
faced and lessons being learned dur- ing this public health emergency could impact future emergency pre- paredness requirements.
The removal of the hospital trans- fer agreement or admitting privileges requirement was another significant change to the ASC CfCs included in the 2019 Burden Reduction final rule. However, in an apparent effort to address concerns from hospitals, CMS maintained §416.41(b)(3) and revised the language within to simply require ASCs to periodically provide the local hospital with written notice of its operation and patient population served. So even though one require- ment or “burden” was removed, a new one was added. CMS indicated that the notice should include details such as hours of operation and the proce- dures that are performed in the ASC. CMS indicates that the “periodically” language is similar to that found in § 416.45(b), “Medical staff—Standard: Reappraisal.” Although a timeframe is not specified, in the State Opera- tions Manual Appendix L—Guidance
As with all regulations, states might have more requirements than the federal government. For accredited facilities, if the accrediting organization has not updated its standards to reflect the CMS requirements, the facility must still meet the more stringent requirements.”
—Kara Newbury, ASCA
for Surveyors: Ambulatory Surgical Centers (“Appendix L”), CMS rec- ommends a reappraisal at least every 24 months.
According to CMS, providing written notice, rather than securing a transfer agreement, will alleviate the administrative burden of nego- tiating or being denied negotiating opportunities associated with the written transfer agreement between the ASC and hospital. As CMS indi- cates in the final rule, “this change does not preclude those ASCs and hospitals with functional working relationships to continue to have written transfer agreements, which we encourage, and prior prepara- tions in place for patient transfers in the event of an emergency.”
Assessment
In the Burden Reduction Rule, CMS also finalized its proposal to elimi- nate the requirement at §416.52(a) for each patient to have a medi- cal history and physical assessment (H&P) completed by a physician not more than 30 days before the sched- uled surgery and replace it with the requirement for ASCs to develop
and maintain a policy that identifies those patients who require an H&P prior to surgery. The facility’s policy must include the timeframe for the H&P to be completed prior to sur- gery and also must address, but not be limited to, the following factors: patient age, diagnosis, the type and number of procedures scheduled to be performed on the same surgery date, known comorbidities and the planned anesthesia level. The pre-surgical assessment, com- pleted by a physician or other quali- fied practitioner upon patient admis- sion, is still required.
According to §416.52(a)(1)(iii), the H&P policy must be based on nationally recognized standards of practice and guidelines, and applica- ble state and local health and safety laws. When ASCA staff asked CMS staff what would be considered accept- able “nationally recognized stan- dards,” CMS indicated it would look into the question and include clarifi- cation in the State Operations Manual Appendix L guidance. Unfortunately, we are still waiting on updates to this guidance, and given the current pub- lic health emergency, it is unclear how quickly it will be made available. As with all regulations, states
might have more requirements than the federal government. In addition, for facilities that are accredited, if the accrediting organization has not updated its standards to reflect the CMS requirements, the facility must still meet the more stringent require- ments. For ASCA members, a state- by-state review of hospital transfer, admitting privilege and H&P require- ments is available at https://www.
ascaconnect.org/viewdocument/bur- den-reduction-rule-analysis.
ernment Affairs and regulatory counsel. .
ASC FOCUS SEPTEMBER 2020 |
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