§ 512.294 Extreme and uncontrollable circumstances. ( a ) *General.* If CMS determines that there is an EUC pursuant to paragraph (b) of this section, CMS may grant RO participants exceptions to the RO Model requirements under paragraph (c) of this section and revise the RO Model's pricing methodology under paragraphs (e) and (f) of this section.
( b ) *Determination factors.* CMS determines whether there is an EUC based on the following factors: ( 1 ) Whether the RO participants are furnishing services within a geographic area considered to be within an “emergency area” during an “emergency period” as defined in section 1135(g) of the Social Security Act;
( 2 ) Whether the geographic area within a county, parish, U.S. territory, or tribal government designated under the Stafford Act served as a condition precedent for the Secretary's exercise of the 1135 waiver authority, or the National Emergencies Act; or
( 3 ) Whether a state of emergency has been declared in the geographic area.
( c ) *Modified requirements.* CMS may grant RO Participants exceptions to the following RO Model requirements: ( 1 ) *Reporting requirements.* CMS may delay or exempt RO participants from one or more of the RO Model's quality measure or clinical data element reporting requirements if an EUC impacts the RO participants' ability to comply with quality measure or clinical data element reporting requirements.
( 2 ) *Other requirements.* CMS may issue a notice on the RO Model website that may waive compliance with or modify the following RO Model requirements: ( i ) The requirement set forth at § 512.220(a)(2)(vii) that RO participants provide Peer Review (audit and feedback on treatment plans).
( ii ) The requirement set forth at § 512.220(a)(3) that RO participants actively engage with an AHRQ-listed patient safety organization (PSO).
( d ) *Model performance period.* If CMS determines that the EUC affects the United States and if CMS determines that the EUC would impact RO participants' ability to implement the requirements of the RO Model prior to the start of the model performance period, CMS may amend the model performance period.
( e ) *Trend factor.* If CMS determines that the EUC affects the entire United States, and if CMS determines that as a result of the EUC, the trend factor (specific to the PC, TC, or both for an included cancer type) for the upcoming PY has increased or decreased by more than 10 percent compared to the corresponding trend factor of the previous CY when FFS payment rates are held constant with the previous CY, CMS may modify the trend factor calculation for the PC, TC, or both the PC and TC of an included cancer type in a manner that ensures the trend factor is consistent with the average utilization from the previous CY.
( f ) *Quality withhold.* In response to a national, regional, or local event, CMS may adjust the quality withhold by choosing to repay the quality withhold during the next reconciliation and award all possible points in the subsequent AQS calculation amount or to not apply the quality withhold to RO Model payments during the EUC if CMS removes the quality measure and clinical data element reporting requirements pursuant to paragraph (c)(1) of this section.
[86 FR 63997, Nov. 16, 2021]