[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: 42CFR488.4]



[Page 659-660]

 

                         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 A_General Provisions

 

Sec.  488.4  Application and reapplication procedures for accreditation 



organizations.



    (a) A national accreditation organization applying for approval of 

deeming authority for Medicare requirements under Sec.  488.5 or 488.6 

of this subpart must furnish to CMS the information and materials 

specified in paragraphs (a)(1) through (10) of this section. A national 

accreditation organization reapplying for approval must furnish to CMS 

whatever information and materials from paragraphs (a)(1) through (10) 

of this section that CMS requests. The materials and information are--

    (1) The types of providers and suppliers for which the organization 

is requesting approval;

    (2) A detailed comparison of the organization's accreditation 

requirements and standards with the applicable Medicare requirements 

(for example, a crosswalk);

    (3) A detailed description of the organization's survey process, 

including--

    (i) Frequency of the surveys performed;

    (ii) Copies of the organization's survey forms, guidelines and 

instructions to surveyors;

    (iii) Accreditation survey review process and the accreditation 

status decision-making process;

    (iv) Procedures used to notify accredited facilities of deficiencies 

and the procedures used to monitor the correction of deficiencies in 

accredited facilities; and

    (v) Whether surveys are announced or unannounced;

    (4) Detailed information about the individuals who perform surveys 

for the accreditation organization, including--

    (i) The size and composition of accreditation survey teams for each 

type of provider and supplier accredited;

    (ii) The education and experience requirements surveyors must meet;

    (iii) The content and frequency of the in-service training provided 

to survey personnel;

    (iv) The evaluation systems used to monitor the performance of 

individual surveyors and survey teams; and

    (v) Policies and procedures with respect to an individual's 

participation in the survey or accreditation decision process of any 

facility with which the individual is professionally or financially 

affiliated;

    (5) A description of the organization's data management and analysis 

system with respect to its surveys and accreditation decisions, 

including the kinds of reports, tables, and other displays generated by 

that system;

    (6) The organization's procedures for responding to and for the 

investigation of complaints against accredited facilities, including 

policies and procedures regarding coordination of these activities with 

appropriate licensing bodies and ombudsmen programs;

    (7) The organization's policies and procedures with respect to the 

withholding or removal of accreditation status for facilities that fail 

to meet the accreditation organization's standards or requirements, and 

other actions taken by the organization in response to noncompliance 

with its standards and requirements;

    (8) A description of all types (for example, full, partial, type of 

facility, etc.) and categories (provisional, conditional, temporary, 

etc.) of accreditation offered by the organization, the duration of each 

type and category of accreditation and a statement specifying the types 

and categories of accreditation for which approval of deeming authority 

is sought;

    (9) A list of all currently accredited facilities, the type and 

category of accreditation currently held by each facility, and the 

expiration date of each facility's current accreditation; and

    (10) A list of all full and partial accreditation surveys scheduled 

to be performed by the organization.

    (b) The accreditation organization must also submit the following 

supporting documentation--

    (1) A written presentation that demonstrates the organization's 

ability to furnish CMS with electronic data in ASCII comparable code;

    (2) A resource analysis that demonstrates that the organization's 

staffing, funding and other resources are adequate to perform the 

required surveys and related activities; and

    (3) A statement acknowledging that as a condition for approval of 

deeming authority, the organization will agree to--



[[Page 660]]



    (i) Notify CMS in writing of any facility that has had its 

accreditation revoked, withdrawn, or revised, or that has had any other 

remedial or adverse action taken against it by the accreditation 

organization within 30 days of any such action taken;

    (ii) Notify all accredited facilities within 10 days of CMS's 

withdrawal of the organization's approval of deeming authority;

    (iii) Notify CMS in writing at least 30 days in advance of the 

effective date of any proposed changes in accreditation requirements;

    (iv) Within 30 days of a change in CMS requirements, submit to CMS 

an acknowledgement of CMS's notification of the change as well as a 

revised crosswalk reflecting the new requirements and inform CMS about 

how the organization plans to alter its requirements to conform to CMS's 

new requirements;

    (v) Permit its surveyors to serve as witnesses if CMS takes an 

adverse action based on accreditation findings;

    (vi) [Reserved]

    (vii) Notify CMS in writing within ten days of a deficiency 

identified in any accreditation entity where the deficiency poses an 

immediate jeopardy to the entity's patients or residents or a hazard to 

the general public; and

    (viii) Conform accreditation requirements to changes in Medicare 

requirements.

    (c) If CMS determines that additional information is necessary to 

make a determination for approval or denial of the accreditation 

organization's application for deeming authority, the organization will 

be notified and afforded an opportunity to provide the additional 

information.

    (d) CMS may visit the organization's offices to verify 

representations made by the organization in its application, including, 

but not limited to, review of documents and interviews with the 

organization's staff.

    (e) The accreditation organization will receive a formal notice from 

CMS stating whether the request for deeming authority has been approved 

or denied, the rationale for any denial, and reconsideration and 

reapplication procedures.

    (f) An accreditation organization may withdraw its application for 

approval of deeming authority at any time before the formal notice 

provided for in paragraph (e) of this section is received.

    (g) Except as provided in paragraph (i) of this section, an 

accreditation organization that has been notified that its request for 

deeming authority has been denied may request a reconsideration of that 

determination in accordance with subpart D of this part.

    (h) Except as provided in paragraph (i) of this section, any 

accreditation organization whose request for approval of deeming 

authority has been denied may resubmit its application if the 

organization--

    (1) Has revised its accreditation program to address the rationale 

for denial of its previous request;

    (2) Can demonstrate that it can provide reasonable assurance that 

its accredited facilities meet applicable Medicare requirements; and

    (3) Resubmits the application in its entirety.

    (i) If an accreditation organization has requested, in accordance 

with part 488, subpart D of this chapter, a reconsideration of CMS's 

determination that its request for deeming approval is denied, it may 

not submit a new application for deeming authority for the type of 

provider or supplier that is at issue in the reconsideration until the 

reconsideration is administratively final.



[58 FR 61838, Nov. 23, 1993]