[Code of Federal Regulations] [Title 42, Volume 2] [Revised as of October 1, 2002] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR422.152] [Page 859-861] TITLE 42--PUBLIC HEALTH HUMAN SERVICES PART 422--MEDICARE+CHOICE PROGRAM--Table of Contents Subpart D--Quality Assurance Sec. 422.152 Quality assessment and performance improvement program. Source: 63 FR 35082, June 26, 1998, unless otherwise noted. (a) General rule. Each M+C organization that offers one or more M+C plans must have, for each of those plans, an ongoing quality assessment and performance improvement program that meets the applicable requirements of this section for the services it furnishes to its M+C enrollees. (b) Requirements for network M+C MSA plans and M+C coordinated care plans other than PPO plans. An organization offering a network M+C MSA plan or M+C coordinated care plan other than a PPO plan must do the following: (1) Meet the requirements in paragraph (c)(1) of this section concerning performance measurement and reporting. With respect to an M+C coordinated care plan, an organization must also meet the requirements of paragraph (c)(2) of this section concerning the achievement of minimum performance levels. The requirements of paragraph (c)(2) of this section do not apply with respect to an M+C MSA plan. (2) Conduct performance improvement projects as described in paragraph (d) of this section. These projects must achieve, through ongoing measurement and intervention, demonstrable and sustained improvement in significant aspects of clinical care and nonclinical care areas that can be expected to have a favorable effect on health outcomes and enrollee satisfaction. (3) In processing requests for initial or continued authorization of services, follow written policies and procedures that reflect current standards of medical practice. (4) Have in effect mechanisms to detect both underutilization and overutilization of services. (5) Make available to CMS information on quality and outcomes measures that will enable beneficiaries to compare health coverage options and select among them, as provided in Sec. 422.64(c)(10). (c) Performance measurement and reporting. The organization offering the plan must do the following: (1) Measure performance under the plan, using standard measures required by CMS, and report its performance to CMS. The standard measures may be specified in uniform data collection and reporting instruments required by CMS, and will relate to-- [[Page 860]] (i) Clinical areas including effectiveness of care, enrollee perception of care, and use of services; and (ii) Nonclinical areas including access to and availability of services, appeals and grievances, and organizational characteristics. (2) Achieve any minimum performance levels that CMS establishes locally, regionally, or nationally with respect to the standard measures. (i) In establishing minimum performance levels, CMS considers historical plan and original Medicare performance data and trends. (ii) CMS establishes the minimum performance levels prospectively upon contract initiation and renewal. (iii) The organization must meet the minimum performance levels by the end of the contract year. (iv) In accordance with Sec. 422.506, CMS may decline to renew the organization's contract in the year that CMS determines that it did not meet the minimum performance levels. (d) Performance improvement projects. (1) Performance improvement projects are organization initiatives that focus on specified clinical and nonclinical areas and that involve the following: (i) Measurement of performance. (ii) System interventions, including the establishment or alteration of practice guidelines. (iii) Improving performance. (iv) Systematic follow-up on the effect of the interventions. (2) Each project must address the entire population to which the measurement specified in paragraph (d)(1)(i) of this section is relevant. (3) CMS establishes M+C organization and M+C plan-specific obligations for the number and distribution of projects among the required clinical and nonclinical areas, in accordance with paragraphs (d)(4) and (d)(5) of this section, to ensure that the projects are representative of the entire spectrum of clinical and nonclinical care areas associated with a plan. (4) The required clinical areas include: (i) Prevention and care of acute and chronic conditions. (ii) High-volume services. (iii) High-risk services. (iv) Continuity and coordination of care. (5) The required nonclinical areas include: (i) Appeals, grievances, and other complaints. (ii) Access to, and availability of, services. (6) In addition to requiring that the organization initiate its own performance improvement projects, CMS may require that the organization- - (i) Conduct particular performance improvement projects that are specific to the organization; and (ii) Participate in national or statewide performance improvement projects. (7) For each project, the organization must assess performance under the plan using quality indicators that are-- (i) Objective, clearly and unambiguously defined, and based on current clinical knowledge or health services research; and (ii) Capable of measuring outcomes such as changes in health status, functional status and enrollee satisfaction, or valid proxies of those outcomes. (8) Performance assessment on the selected indicators must be based on systematic ongoing collection and analysis of valid and reliable data. (9) Interventions must achieve improvement that is significant and sustained over time. (10) The organization must report the status and results of each project to CMS as requested. (e) Requirements for M+C PPO plans, non-network MSA plans, and M+C private fee-for-service plans. An organization offering an M+C plan, non-network MSA plan, or private fee-for-service plan must do the following: (1) Measure performance under the plan using standard measures required by CMS and report its performance to CMS. The standard measures may be specified in uniform data collection and reporting instruments required by CMS and will relate to-- (i) Clinical areas including effectiveness of care, enrollee perception of care, and use of services; and (ii) Nonclinical areas including access to and availability of services, appeals and grievances, and organizational characteristics. [[Page 861]] (2) Evaluate the continuity and coordination of care furnished to enrollees. (3) If the organization uses written protocols for utilization review, the organization must-- (i) Base those protocols on current standards of medical practice; and (ii) Have mechanisms to evaluate utilization of services and to inform enrollees and providers of services of the results of the evaluation. (f) Requirements for all types of plans--(1) Health information. For all types of plans that it offers, an organization must-- (i) Maintain a health information system that collects, analyzes, and integrates the data necessary to implement its quality assessment and performance improvement program; (ii) Ensure that the information it receives from providers of services is reliable and complete; and (iii) Make all collected information available to CMS. (2) Program review. For each plan, there must be in effect a process for formal evaluation, at least annually, of the impact and effectiveness of its quality assessment and performance improvement program. (3) Remedial action. For each plan, the organization must correct all problems that come to its attention through internal surveillance, complaints, or other mechanisms. [63 FR 35082, June 26, 1998, as amended at 65 FR 40323, June 29, 2000]