Introduction and Organization of Sections

9000 – Introduction and Organization of Sections (Rev. 24, Issued: 02-12-16, Effective: 03-14-16, Implementation: 03-14-16) This section provides a comprehensive description of the Sanction Review process and procedures to be followed by a Beneficiary and Family-Centered Care – Medicare Quality Improvement Organization (QIO). In addition, the chapter provides a clear understanding of the process the Office of Inspector General (OIG) must follow if a violation of an obligation is confirmed. The process involves a coordinated effort between the QIO, Centers for Medicare & Medicaid Services (CMS), Office of Inspector General (OIG), and the practitioner or other persons involved. Sanction means an exclusion or monetary penalty that the Secretary of the Department of Health & Human Services (HHS) may impose on a practitioner or other person as a result of a recommendation from a QIO. In accordance with §1156(a) of the Social Security Act (Act), it is the obligation of any health care practitioner and any other person (including a hospital or other health care facility, organization, or agency) who provides health care services for which payment may be made (in whole or in part) under this Act to assure, to the extent of his/her authority, that services or items ordered or provided by such practitioner or person to beneficiaries and recipients meet certain criteria. The following three statutory obligations of practitioners and other persons, if not met, may form the basis for the initiation of a sanction action: 1. Services or items ordered or furnished to Medicare patients are to be provided economically and only when, and to the extent, medically necessary; 2. Services or items ordered or furnished are supported by evidence of medical necessity and quality in the form and fashion (and at such time) that the QIO may reasonably require for review (including copies) in exercising QIO duties and responsibilities; and 3. Services or items ordered or furnished are to be of a quality that meets professionally recognized standards of care. In addition: • When identifying a violation (see 42 CFR §1004.40), the QIO must indicate whether the violation is a gross and flagrant violation or is a substantial violation in a substantial number of cases (three or more instances involving a separate admission). (See §9010 – Definitions Related to Sanctions.) • When considering the sanction process, the QIO must consider the degree that the practitioner’s actions were inconsistent with the professional knowledge at the time care was provided and the degree of harm that occurred to the patient. The QIO plays a key role in identifying quality of care issues that warrant a referral for sanction activity, preparing the case for CMS and OIG, and coordinating and communicating with the practitioner or other persons of concern. Best practices for QIO operations in this area are that the QIO Sanction Committee and QIO Sanction Panel should oversee and monitor the process to ensure that timelines are met, processes are followed, and regulatory requirements are met. Upon a finding of a violation and failure of the health care provider to resolve the matter, the QIO initiates the sanction process by notifying the practitioner or other persons and submitting a detailed report to OIG for review and consideration for sanction. The remainder of this section is organized in accordance with the review process flow from the QIO’s identification, notification, and reporting of a violation through the detailed process that OIG follows in the imposition of a sanction through the appeal process.