REGULATORY REVIEW


  BY KARA NEWBURY


Almost a year has passed since the Centers for Medi- care & Medicaid Services (CMS) released a final rule, but the guidance for


implementing the changes in the rule are still pending.


On September 25, 2019, CMS announced a Burden Reduction final rule, aimed at “removing unnecessary, obsolete or excessively burdensome Medicare compliance requirements for healthcare providers and suppliers.” CMS estimated that these changes would collectively save healthcare providers approximately $843 million in the first year and slightly more in future years. Two changes were spe- cific to ASCs and a third—regard- ing emergency preparedness require- ments—impacted many providers, including ASCs.


While the Conditions for Cov- erage (CfCs) themselves have been updated, CMS has not yet issued addi- tional guidance and, instead, promises only “Guidance pending and will be updated in future release.” In addition, the world looks very


different now than it did one year ago when this rule was being finalized. It is unclear how long clarification will take on some outstanding points of confu- sion, and whether COVID-19 might impact these regulations—particularly those dealing with emergency pre- paredness—moving forward.


 Background


In response to Hurricane Katrina in 2005, CMS implemented disaster pre- paredness requirements for ASCs back in 2009. In December 2013, CMS proposed expanded emergency pre-


Burden Reduction Rule Emergency Preparedness Updates While it is critical for ASCs to be pre- pared in case of an emergency, ASCA and many of its members consider the rule that went into effect in 2017 to be overly burdensome for outpatient, pri- marily elective, facilities. In Septem- ber 2018, less than 10 months after implementation of those emergency preparedness requirements, CMS pro- posed several changes to them in the Burden Reduction Rule it finalized in November 2019. The following changes, applicable


to ASCs, were included in the final Burden Reduction Rule: 


paredness requirements for Medi- care providers and suppliers. Require- ments included annual review of an emergency plan, annual training and increased emergency preparedness testing. It took until September 2016 for a final rule to be released. That rule expanded upon existing disaster pre- paredness requirements in a separate new Emergency Preparedness Condi- tion for Coverage, §416.54. This new set of requirements became effective November 15, 2017, nearly four years after the announcement of the pro- posed rule. CMS also announced a new section to the State Operations Man- ual, Appendix Z—originally released in June 2017—which included emer- gency preparedness requirements for all provider and supplier types, includ- ing ASCs. CMS argued it would be too difficult to add the specific emergency plan (EP) guidance to each appendix that corresponded with specific facili- ties and suppliers—Appendix L in the case of ASCs.


20 ASC FOCUS SEPTEMBER 2020 | ascfocus.org 


review of emergency plan (EP) every two years (instead of annu- ally, as previously required);


elimination of a requirement that facilities document efforts to con- tact local, tribal, regional, state and federal emergency planning officials. ASCs still need to try to coordinate with them, but facili- ties no longer need to document their efforts;


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training requirement changed from every year to every two years (or when EP is significantly updated);


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outpatient providers need only one testing exercise per year instead of two: 


providers must either participate in a community-based, full-scale exercise (if available) or conduct an individual facility-based func- tional exercise every other year, and


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in the opposite years, providers may conduct a testing exercise of their choice, which may include: a community-based full-scale exer- cise (if available), an individual


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