REGULATORY REVIEW


CMS has explicitly determined the procedure would raise one or more specific safety concerns found at 42 CFR §416.166 and listed below: ■■


Poses a significant safety risk to the beneficiary;


■■ Typically requires active medical


monitoring and care past midnight; ■■ Directly involves major blood vessels; ■■


Requires major or prolonged inva- sion of body cavities;


■■ Generally results in extensive blood loss; ■■ Emergent in nature; ■■ ■■


Life-threatening in nature;


Commonly requires systemic throm- bolytic therapy; or


Can only be reported using an unlisted surgical procedure code Unfortunately, the ASC-payable list lags years behind when procedures are being performed in the ASC setting, mainly due to the exclusionary criteria


■■


listed above. These criteria, which the CMS medical directors use to establish the ASC-payable list, were established long before anyone contemplated per- forming total joint replacements in the ASC setting. Every year during the rulemaking process, CMS evalu- ates the procedures excluded from the ASC-payable list and determines if any additional procedure should be moved to the ASC-payable list based on the criteria above.


One of the criterion that is most problematic for ASCs is if the proce- dure “typically requires active med- ical monitoring and care past mid- night.” CMS uses a broad definition of “monitoring” and “care,” and even if ASCA is successful in removing total joints from the IPO list, CMS believes this will be a barrier for movement to the ASC-payable list.


Many ASCs are equipped for over- night stays, and ASCA will work closely with CMS to come up with a policy that satisfies the medical direc- tors’ safety concerns while allowing ASCs to perform these procedures for Medicare beneficiaries. The fact that CMS is excluding procedures it believes “involve major blood vessels” also will be a hurdle to coverage for total joint replacements on the ASC-payable list. ASCA staff, at the direction of its Government Affairs Committee, will continue to advocate for changes to the exclusion- ary criteria list that would allow sur- geons and their Medicare patients the option of total joint replacement sur- gery in the ASC setting.


Kara Newbury is ASCA’s regulatory counsel. Write her at knewbury@ascassociation.org.


24 ASC FOCUS OCTOBER 2017 |www.ascfocus.org


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