§ 488.330 Certification of compliance or noncompliance. ( a ) *General rules* — ( 1 ) *Responsibility for certification.* ( i ) The State survey agency surveys all facilities for compliance or noncompliance with requirements for long term care facilities. The survey by the State survey agency may be followed by a Federal validation survey. ( A ) The State certifies the compliance or noncompliance of non-State operated NFs. Regardless of the State entity doing the certification, it is final, except in the case of a complaint or validation survey conducted by CMS, or CMS review of the State's findings.
( B ) CMS certifies the compliance or noncompliance of all State-operated facilities.
( C ) The State survey agency certifies the compliance or noncompliance of a non-State operated SNF, subject to the approval of CMS.
( D ) The State survey agency certifies compliance or noncompliance for a dually participating SNF/NF. In the case of a disagreement between CMS and the State survey agency, a finding of noncompliance takes precedence over that of compliance.
( ii ) In the case of a validation survey, the Secretary's determination as to the facility's noncompliance is binding, and takes precedence over a certification of compliance resulting from the State survey.
( 2 ) *Basis for certification.* ( i ) Certification by the State is based on the survey agency findings.
( ii ) Certification by CMS is based on either the survey agency findings (in the case of State-operated facilities), or, in the case of a validation survey, on CMS's own survey findings.
( b ) *Effect of certification* — ( 1 ) *Certification of compliance.* A certification of compliance constitutes a determination that the facility is in substantial compliance and is eligible to participate in Medicaid as a NF, or in Medicare as a SNF, or in Medicare and Medicaid as a dually participating facility.
( 2 ) *Certification of noncompliance.* A certification of noncompliance requires denial of participation for prospective providers and enforcement action for current providers in accordance with subpart F of this part. Enforcement action must include one of the following: ( i ) Termination of any Medicare or Medicaid provider agreements that are in effect.
( ii ) Application of alternative remedies instead of, or in addition to, termination procedures.
( c ) *Notice of certification of noncompliance and resulting action.* The notice of certification of noncompliance is sent in accordance with the timeframes specified in § 488.402(f), and resulting action is issued by CMS, except when the State is taking the action for a non-State operated NF.
( d ) *Content of notice of certification of noncompliance.* The notice of certification of noncompliance is sent in accordance with the timeframes specified in § 488.402(f) and includes information on all of the following: ( 1 ) Nature of noncompliance.
( 2 ) Any alternative remedies to be imposed under subpart F of this part.
( 3 ) Any termination or denial of participation action to be taken under this part.
( 4 ) The appeal rights available to the facility under this part.
( 5 ) Timeframes to be met by the provider and certifying agency with regard to each of the enforcement actions or appeal procedures addressed in the notice.
( e ) *Appeals.* ( 1 ) Notwithstanding any provision of State law, the State must impose remedies promptly on any provider of services participating in the Medicaid program— ( i ) After promptly notifying the facility of the deficiencies and impending remedy or remedies; and
( ii ) Except for civil money penalties, during any pending hearing that may be requested by the provider of services.
( 2 ) CMS imposes remedies promptly on any provider of services participating in the Medicare or Medicaid program or any provider of services participating in both the Medicare and Medicaid programs— ( i ) After promptly notifying the facility of the deficiencies and impending remedy or remedies; and
( ii ) Except for civil money penalties imposed on NFs-only by the State, during any pending hearing that may be requested by the provider of services.
( 3 ) The provisions of part 498 of this chapter apply when the following providers request a hearing on a denial of participation, or certification of noncompliance leading to an enforcement remedy (including termination of the provider agreement), except State monitoring: ( i ) All State-operated facilities;
( ii ) SNFs and dually participating SNF/NFs; and
( iii ) Any other facilities subject to a CMS validation survey or CMS review of the State's findings.
( 4 ) The provisions of part 431 of this chapter apply when a non-State operated Medicaid NF, which has not received a CMS validation survey or CMS review of the State's findings, requests a hearing on the State's denial of participation, termination of provider agreement, or certification of noncompliance leading to an alternative remedy, except State monitoring.
( f ) *Provider agreements.* CMS or the Medicaid agency may execute a provider agreement when a prospective provider is in substantial compliance with all the requirements for participation for a SNF or NF, respectively.
( g ) *Special rules for Federal validation surveys.* ( 1 ) CMS may make independent certifications of a NF's, SNF's, or dually participating facility's noncompliance based on a CMS validation survey.
( 2 ) CMS issues the notice of actions affecting facilities for which CMS did validation surveys.
( 3 ) For non-State-operated NFs and non-State-operated dually participating facilities, any disagreement between CMS and the State regarding the timing and choice of remedies is resolved in accordance with § 488.452.
( 4 ) Either CMS or the survey agency, at CMS's option, may revisit the facility to ensure that corrections are made.
[59 FR 56238, Nov. 10, 1994; 60 FR 50118, Sept. 28, 1995; 76 FR 15126, Mar. 18, 2011]