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REGULATORY REVIEW


an ASC.” As the rule indicated, the Emergency Medical Treatment & Labor Act (EMTALA) emergency response regulations would continue to address the emergency transfer of a patient from an ASC to a nearby hospital. CMS indi- cated in the final rule that it received split feedback in favor of and opposed to this proposed change. ASCA sup- ported the change but acknowledged that, to ensure continuity of care, it pre- fers that ASCs continue to have a writ- ten transfer agreement in place with hospitals that are willing to develop those agreements.


Final Rule: CMS finalized the removal of the hospital transfer agreement or admitting privileges requirement. In an apparent effort to address concerns from the hospitals, CMS did maintain § 416.41(b)(3), however, 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. For exam- ple, the notice would include details such as hours of operation and the pro- cedures 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 Operations Manual Appendix L—Guidance for Surveyors: Ambulatory Surgical Cen- ters (“Appendix L”), CMS recommends a reappraisal at least every 24 months. According to CMS, providing writ- ten notice, rather than securing a trans- fer agreement, will alleviate the admin- istrative burden of negotiating or being denied negotiating opportunities associ- ated with the written transfer agreement between the ASC and hospital. As CMS indicates in the final rule, “this change does not preclude those ASCs and hos- pitals with functional working relation- ships to continue to have written transfer agreements, which we encourage, and prior preparations in place for patient transfers in the event of an emergency.”


It is important to note that many states and accrediting organizations require either a hospital transfer agree- ment, admitting privileges or both.


Requirements for Comprehensive Medical History and Physical Assessment Background While this specific change was not ini- tiated by ASCA, we have long raised concerns with CMS regarding the bur- den imposed by requiring the medical history and physical assessment (H&P) to be current within 30 days. We also have raised concerns with the use of the word “comprehensive,” as the meaning of this term is unclear.


Proposed Rule: Citing many research studies and “feedback from stakehold- ers,” CMS proposed to “remove the current requirements at §416.52(a) and replace them with requirements that defer, to a certain extent, to the ASC pol- icy and operating physician’s clinical judgment to ensure that patients receive the appropriate pre-surgical assess- ments tailored to the patient and the type of surgery being performed.” The oper- ating physician would still have to doc- ument any pre-existing medical condi- tions and appropriate test results in the


TRACK THE LATEST REGULATORY AND LEGISLATIVE NEWS FOR ASCs


Visit ASCA’s website every week to stay up to date on the latest government affairs news affecting the ASC industry. Every week, ASCA’s Government Affairs Update newsletter is posted online for ASCA members to read. The weekly newsletter tracks and analyzes the latest legislative and regulatory developments concerning ASCs.


ascassociation.org/ GovtAffairsUpdate


medical record, which would have to be considered before, during and after surgery. In addition, all pre-surgical assessments would still be required to include documentation regarding any allergies to drugs and biologicals. The H&P, if completed, would be placed in the patient’s medical record prior to the surgical procedure.


Final Rule: CMS finalized the proposal to revise the requirement at § 416.47(b) (2) to state “Significant medical his- tory and results of physical examina- tion, as applicable.” It finalized the proposal to eliminate the requirement at § 416.52(a) for each patient to have a medical history and physical assess- ment 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 a medical history and physical examination prior to sur- gery. The facility’s policy must include the timeframe for the H&P to be com- pleted prior to surgery. The policy also must address, but not be limited to, the following factors: patient age, diagno- sis, the type and number of procedures scheduled to be performed on the same surgery date, known comorbidities and the planned anesthesia level. Upon admission, each patient must have a pre-surgical assessment completed by a physician or other qualified practi- tioner, in accordance with applicable state health and safety laws, who will be performing the surgery. CMS also is revising § 416.52(a)(1) (iii) to clarify that the ASC policy must be based on nationally recognized stan- dards of practice and guidelines, and applicable state and local health and safety laws. It is important to review state laws before making significant changes to your H&P policies and pro- cedures. Many states still require an H&P, although some might not include a set 30-day timeframe, so some flex- ibility might be afforded there. Most


ASC FOCUS JANUARY 2020 | ascfocus.org 27


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