42 CFR 488.4 - Application and reapplication procedures for accreditation organizations.

§ 488.4 Application and reapplication procedures for accreditation organizations.
(a) A national accreditation organization applying for approval of deeming authority for Medicare requirements under § 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—
(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]
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§ 488.4 General rules for a CMS-approved accreditation program for providers and suppliers.

(a) The following requirements apply when a national accrediting organization has applied for CMS approval of a provider or supplier accreditation program and CMS has found that the program provides reasonable assurance for providers or suppliers accredited under the program:

(1) When a provider or supplier demonstrates full compliance with all of the accreditation program requirements of the accrediting organization's CMS-approved accreditation program, the accrediting organization may recommend that CMS grant deemed status to the provider or supplier.

(2) CMS may deem the provider or supplier, excluding kidney transplant centers within a hospital and ESRD facilities, to be in compliance with the applicable Medicare conditions or requirements. The deemed status provider or supplier is subject to validation surveys as provided at § 488.9.

(b) [Reserved]

[80 FR 29835, May 22, 2015]

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