CMS evaluates an application on the basis of the following information:

1. (a) Information contained in the application.
2. (b) Information obtained by CMS or the State administering agency through on-site visits or any other means.

3. (c) Use of information from a current or prior PACE program agreement.

   1. (1) If, during the 12 months preceding the deadline established by CMS for the submission of an application or submission of a response to a CMS request for additional information, a PACE organization fails to comply with the requirements of the PACE program under any current or prior PACE program agreement or fails to complete a corrective action plan during the applicable 12-month period, CMS may deny an application based on the applicant's failure to comply with the requirements of the PACE program under any current or prior PACE program agreement even if the applicant currently meets all of the requirements of this part.

      1. (i) An applicant may be considered to have failed to comply with the requirements of the PACE program under a PACE program agreement for purposes of an application denial under paragraph (c)(1) of this section if any of the following conditions apply with respect to the applicant during the applicable 12-month review period:

         1. (A) Was subject to the imposition of an enrollment or payment sanction under § 460.42(a) or (b) for one or more of the violations specified in § 460.40.
         2. (B) Failed to maintain a fiscally sound operation consistent with the requirements of § 460.80(a) after the end of the trial period.
         3. (C) Filed for or is currently in State bankruptcy proceedings.

         4. (D) Met or exceeded 13 points for compliance actions for any one PACE program agreement.

            (1) CMS determines the number of points accumulated during the performance period for compliance actions based on the following point values:

            (i) Each corrective action plan issued under § 460.19(c)(3) during the performance period counts for 6 points. Corrective action requests issued under § 460.194 are not included in the point calculations.

            (ii) Each warning letter issued under § 460.19(c)(2) during the performance period counts for 3 points.

            (iii) Each notice of non-compliance issued under § 460.19(c)(1) during the performance period counts for 1 point.

            (2) CMS adds all the point values for each PACE organization's program agreement to determine if the 13-point threshold described in paragraph (c)(1)(i)(D) of this section has been reached.

      2. (ii) CMS may deny an application submitted by an organization that does not hold a PACE program agreement at the time of the submission if the applicant's parent organization or another subsidiary of the parent organization meets the criteria for denial stated in paragraph (c)(1)(i) of this section. This paragraph does not apply to a parent organization that completed the acquisition of a subsidiary that meets the criteria for denial within the 24 months preceding the application submission deadline.
4. (d) If CMS has terminated a PACE program agreement under § 460.50, or did not renew a PACE program agreement, and that termination or non-renewal took effect within the 38 months preceding the submission of an initial or expansion PACE application from the same organization, CMS may deny the application based on the applicant's substantial failure to comply with the requirements of the PACE program, even if the applicant currently meets all of the requirements of this part.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25671, June 3, 2019; 89 FR 30843, Apr. 23, 2024]