[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR488.330]



[Page 924-925]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 488_SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES--Table of 

 

     Subpart E_Survey and Certification of Long-Term Care Facilities

 

Sec.  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 Sec.  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 Sec.  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, during any pending hearing 

that may



[[Page 925]]



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 Sec.  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]