42 CFR 423.165 - Compliance deemed on the basis of accreditation.

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There are 3 Updates appearing in the Federal Register for 42 CFR 423. View below or at eCFR (GPOAccess)
§ 423.165 Compliance deemed on the basis of accreditation.
(a) General rule. A Part D sponsor is deemed to meet all of the requirements of any of the areas described in paragraph (b) of this section if—
(1) The Part D sponsor is fully accredited (and periodically reaccredited) for the standards related to the applicable area under paragraph (b) of this section by a private, national accreditation organization approved by CMS; and
(2) The accreditation organization uses the standards approved by CMS for the purposes of assessing the Part D sponsor's compliance with Medicare requirements.
(b) Deemable requirements. The requirements relating to the following areas are deemable:
(1) Access to covered drugs, as provided under §§ 423.120 and 423.124.
(2) Drug utilization management programs, quality assurance measures and systems, and MTMPs as provided under § 423.153.
(3) Privacy, confidentiality, and accuracy of enrollee records, as provided under § 423.136.
(c) Effective date of deemed status. The date the Part D sponsor is deemed to meet the applicable requirements is the later of the following:
(1) The date the accreditation organization is approved by CMS.
(2) The date the Part D sponsor is accredited by the accreditation organization.
(d) Obligations of deemed Part D sponsors. A Part D sponsor deemed to meet Medicare requirements must—
(1) Submit to surveys by CMS to validate its accreditation organization's accreditation process; and
(2) Authorize its accreditation organization to release to CMS a copy of its most recent accreditation survey, together with any survey-related information that CMS may require (including corrective action plans and summaries of unmet CMS requirements).
(e) Removal of deemed status. CMS removes part or all of a Part D sponsor's deemed status for any of the following reasons—
(1) CMS determines, on the basis of its own investigation, that the Part D sponsor does not meet the Medicare requirements for which deemed status was granted.
(2) CMS withdraws its approval of the accreditation organization that accredited the Part D sponsor.
(3) The Part D sponsor fails to meet the requirements of paragraph (d) of this section.
(f) Authority. Nothing in this section limits CMS' authority under subparts K and O of this part, including, but not limited to the ability to impose intermediate sanctions, civil money penalties, and terminate a contract with a Part D plan sponsor.
[70 FR 4525, Jan. 28, 2005, as amended at 75 FR 19818, Apr. 15, 2010]

Title 42 published on 2014-10-01

The following are only the Rules published in the Federal Register after the published date of Title 42.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2015-02-24; vol. 80 # 36 - Tuesday, February 24, 2015
    1. 80 FR 9629 - Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Physician-Owned Hospitals: Data Sources for Expansion Exception; Physician Certification of Inpatient Hospital Services; Medicare Advantage Organizations and Part D Sponsors: CMS-Identified Overpayments Associated With Submitted Payment Data; Corrections
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      Correction of final rule.
      Effective Date: This document is effective February 24, 2015. Applicability Date: The corrections noted in this document and posted on the CMS Web site are applicable to payments for services furnished on or after January 1, 2015.
      42 CFR Parts 411, 412, 416, 419, 422, 423, and 424

Title 42 published on 2014-10-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR 423 after this date.

  • 2015-02-24; vol. 80 # 36 - Tuesday, February 24, 2015
    1. 80 FR 9629 - Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Physician-Owned Hospitals: Data Sources for Expansion Exception; Physician Certification of Inpatient Hospital Services; Medicare Advantage Organizations and Part D Sponsors: CMS-Identified Overpayments Associated With Submitted Payment Data; Corrections
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      Correction of final rule.
      Effective Date: This document is effective February 24, 2015. Applicability Date: The corrections noted in this document and posted on the CMS Web site are applicable to payments for services furnished on or after January 1, 2015.
      42 CFR Parts 411, 412, 416, 419, 422, 423, and 424