42 C.F.R. Subpart D—Quality Improvement
Title 42 - Public Health
Source: 63 FR 35082, June 26, 1998, unless otherwise noted.
(a) General rule. Each MA organization (other than MA private-fee-for-service and MSA plans) that offers one or more MA plans must have, for each of those plans, an ongoing quality improvement program that meets the applicable requirements of this section for the services it furnishes to its MA enrollees. As part of its ongoing quality improvement program, a plan must— (1) Have a chronic care improvement program that meets the requirements of paragraph (c) of this section concerning elements of a chronic care program; (2) Conduct quality improvement projects that can be expected to have a favorable effect on health outcomes and enrollee satisfaction, and meet the requirements of paragraph (d) of this section; and (3) Encourage its providers to participate in CMS and HHS quality improvement initiatives. (b) Requirements for MA coordinated care plans (except for regional MA plans) and including local PPO plans that are offered by organizations that are licensed or organized under State law as HMOs. An MA coordinated care plan's (except for regional PPO plans and local PPO plans as defined in paragraph (e) of this section) quality improvement program must— (1) In processing requests for initial or continued authorization of services, follow written policies and procedures that reflect current standards of medical practice. (2) Have in effect mechanisms to detect both underutilization and overutilization of services. (3) Measure and report performance. The organization offering the plan must do the following: (i) Measure performance under the plan, using the measurement tools 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. (ii) 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 §422.64. (4) Special rule for MA local PPO-type plans that are offered by an organization that is licensed or organized under State law as a health maintenance organization must meet the requirements specified in paragraphs (b)(1) through (b)(3) of this section. (c) Chronic care improvement program requirements. Develop criteria for a chronic care improvement program. These criteria must include— (1) Methods for identifying MA enrollees with multiple or sufficiently severe chronic conditions that would benefit from participating in a chronic care improvement program; and (2) Mechanisms for monitoring MA enrollees that are participating in the chronic care improvement program. (d) Quality improvement projects. (1) Quality improvement projects are an organization's 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 and periodic follow-up on the effect of the interventions. (2) 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. (3) Performance assessment on the selected indicators must be based on systematic ongoing collection and analysis of valid and reliable data. (4) Interventions must achieve demonstrable improvement. (5) The organization must report the status and results of each project to CMS as requested. (e) Requirements for MA regional plans and MA local plans that are PPO plans as defined in this section—(1) Definition of local preferred provider organization plan. For purposes of this section, the term local preferred provider organization (PPO) plan means an MA plan that— (i) Has a network of providers that have agreed to a contractually specified reimbursement for covered benefits with the organization offering the plan; (ii) Provides for reimbursement for all covered benefits regardless of whether the benefits are provided within the network of providers; and (iii) Is offered by an organization that is not licensed or organized under State law as a health maintenance organization. (2) MA organizations offering an MA regional plan or local PPO plan as defined in this section must: (i) 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. (ii) Evaluate the continuity and coordination of care furnished to enrollees. (iii) If the organization uses written protocols for utilization review, the organization must— (A) Base those protocols on current standards of medical practice; and (B) 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 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 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. [70 FR 4723, Jan. 28, 2005, as amended at 70 FR 52026, Sept. 1, 2005] (a) General rule. An MA organization is deemed to meet all of the requirements of any of the areas described in paragraph (b) of this section if— (1) The MA organization 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 used the standards approved by CMS for the purposes of assessing the MA organization's compliance with Medicare requirements. (b) Deemable requirements. The requirements relating to the following areas are deemable: (1) Quality improvement. (2) Antidiscrimination. (3) Access to services. (4) Confidentiality and accuracy of enrollee records. (5) Information on advance directives. (6) Provider participation rules. (7) Part D prescription drug benefit programs that are offered by MA programs. (c) Effective date of deemed status. The date on which the organization is deemed to meet the applicable requirements is the later of the following: (1) The date on which the accreditation organization is approved by CMS. (2) The date the MA organization is accredited by the accreditation organization. (d) Obligations of deemed MA organizations. An MA organization 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 an MA organization's deemed status for any of the following reasons: (1) CMS determines, on the basis of its own investigation, that the MA organization does not meet the Medicare requirements for which deemed status was granted. (2) CMS withdraws its approval of the accreditation organization that accredited the MA organization. (3) The MA organization fails to meet the requirements of paragraph (d) of this section. (f) Enforcement authority. CMS retains the authority to initiate enforcement action against any MA organization that it determines, on the basis of its own survey or the results of an accreditation survey, no longer meets the Medicare requirements for which deemed status was granted. [63 FR 35082, June 26, 1998, as amended at 65 FR 40323, June 29, 2000; 65 FR 59749, Oct. 6, 2000; 70 FR 4724, Jan. 28, 2005] (a) Conditions for approval. CMS may approve an accreditation organization with respect to a given standard under this part if it meets the following conditions: (1) In accrediting MA organizations, it applies and enforces standards that are at least as stringent as Medicare requirements with respect to the standard or standards in question. (2) It complies with the application and reapplication procedures set forth in §422.158. (3) It ensures that: (i) Any individual associated with it, who is also associated with an entity it accredits, does not influence the accreditation decision concerning that entity. (ii) The majority of the membership of its governing body is not comprised of managed care organizations or their representatives. (iii) Its governing body has a broad and balanced representation of interests and acts without bias. (b) Notice and comment—(1) Proposed notice. CMS publishes a notice in the (i) Announces CMS's receipt of the accreditation organization's application for approval; (ii) Describes the criteria CMS will use in evaluating the application; and (iii) Provides at least a 30-day comment period. (2) Final notice. (i) After reviewing public comments, CMS publishes a final (ii) If CMS grants the request, the final notice specifies the effective date and the term of the approval, which may not exceed 6 years. (c) Ongoing responsibilities of an approved accreditation organization. An accreditation organization approved by CMS must undertake the following activities on an ongoing basis: (1) Provide to CMS in written form and on a monthly basis all of the following: (i) Copies of all accreditation surveys, together with any survey-related information that CMS may require (including corrective action plans and summaries of unmet CMS requirements). (ii) Notice of all accreditation decisions. (iii) Notice of all complaints related to deemed MA organizations. (iv) Information about any MA organization against which the accrediting organization has taken remedial or adverse action, including revocation, withdrawal or revision of the MA organization's accreditation. (The accreditation organization must provide this information within 30 days of taking the remedial or adverse action.) (v) Notice of any proposed changes in its accreditation standards or requirements or survey process. If the organization implements the changes before or without CMS approval, CMS may withdraw its approval of the accreditation organization. (2) Within 30 days of a change in CMS requirements, submit to CMS— (i) An acknowledgment of CMS's notification of the change; (ii) A revised cross-walk reflecting the new requirements; and (iii) An explanation of how the accreditation organization plans to alter its standards to conform to CMS's new requirements, within the time-frames specified in the notification of change it receives from CMS. (3) Permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings. (4) Within 3 days of identifying, in an accredited MA organization, a deficiency that poses immediate jeopardy to the organization's enrollees or to the general public, give CMS written notice of the deficiency. (5) Within 10 days of CMS's notice of withdrawal of approval, give written notice of the withdrawal to all accredited MA organizations. (6) Provide, on an annual basis, summary data specified by CMS that relate to the past year's accreditation activities and trends. (d) Continuing Federal oversight of approved accreditation organizations. This paragraph establishes specific criteria and procedures for continuing oversight and for withdrawing approval of an accreditation organization. (1) Equivalency review. CMS compares the accreditation organization's standards and its application and enforcement of those standards to the comparable CMS requirements and processes when— (i) CMS imposes new requirements or changes its survey process; (ii) An accreditation organization proposes to adopt new standards or changes in its survey process; or (iii) The term of an accreditation organization's approval expires. (2) Validation review. CMS or its agent may conduct a survey of an accredited organization, examine the results of the accreditation organization's own survey, or attend the accreditation organization's survey, in order to validate the organization's accreditation process. At the conclusion of the review, CMS identifies any accreditation programs for which validation survey results— (i) Indicate a 20 percent rate of disparity between certification by the accreditation organization and certification by CMS or its agent on standards that do not constitute immediate jeopardy to patient health and safety if unmet; (ii) Indicate any disparity between certification by the accreditation organization and certification by CMS or its agent on standards that constitute immediate jeopardy to patient health and safety if unmet; or (iii) Indicate that, irrespective of the rate of disparity, there are widespread or systematic problems in an organization's accreditation process such that accreditation no longer provides assurance that the Medicare requirements are met or exceeded. (3) Onsite observation. CMS may conduct an onsite inspection of the accreditation organization's operations and offices to verify the organization's representations and assess the organization's compliance with its own policies and procedures. The onsite inspection may include, but is not limited to, reviewing documents, auditing meetings concerning the accreditation process, evaluating survey results or the accreditation status decision making process, and interviewing the organization's staff. (4) Notice of intent to withdraw approval. If an equivalency review, validation review, onsite observation, or CMS's daily experience with the accreditation organization suggests that the accreditation organization is not meeting the requirements of this subpart, CMS gives the organization written notice of its intent to withdraw approval. (5) Withdrawal of approval. CMS may withdraw its approval of an accreditation organization at any time if CMS determines that— (i) Deeming based on accreditation no longer guarantees that the MA organization meets the MA requirements, and failure to meet those requirements could jeopardize the health or safety of Medicare enrollees and constitute a significant hazard to the public health; or (ii) The accreditation organization has failed to meet its obligations under this section or under §422.156 or §422.158. (6) Reconsideration of withdrawal of approval. An accreditation organization dissatisfied with a determination to withdraw CMS approval may request a reconsideration of that determination in accordance with subpart D of part 488 of this chapter. [63 FR 35082, June 26, 1998, as amended at 65 FR 40323, June 29, 2000; 65 FR 59749, Oct. 6, 2000] (a) Required information and materials. A private, national accreditation organization applying for approval must furnish to CMS all of the following information and materials. (When reapplying for approval, the organization need furnish only the particular information and materials requested by CMS.) (1) The types of MA plans that it would review as part of its accreditation process. (2) A detailed comparison of the organization's accreditation requirements and standards with the Medicare requirements (for example, a crosswalk). (3) Detailed information about the organization's survey process, including— (i) Frequency of surveys and whether surveys are announced or unannounced. (ii) Copies of survey forms, and guidelines and instructions to surveyors. (iii) Descriptions of— (A) The survey review process and the accreditation status decision making process; (B) The procedures used to notify accredited MA organizations of deficiencies and to monitor the correction of those deficiencies; and (C) The procedures used to enforce compliance with accreditation requirements. (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 plan reviewed as part of the accreditation process; (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) The organization's policies and practice with respect to the participation, in surveys or in the accreditation decision process by an individual who is professionally or financially affiliated with the entity being surveyed. (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) A description of the organization's procedures for responding to and investigating complaints against accredited organizations, including policies and procedures regarding coordination of these activities with appropriate licensing bodies and ombudsmen programs. (7) A description of the organization's policies and procedures with respect to the withholding or removal of accreditation for failure to meet the accreditation organization's standards or requirements, and other actions the organization takes in response to noncompliance with its standards and requirements. (8) A description of all types (for example, full, partial) and categories (for example, provisional, conditional, temporary) of accreditation offered by the organization, the duration of each type and category of accreditation and a statement identifying the types and categories that would serve as a basis for accreditation if CMS approves the accreditation organization. (9) A list of all currently accredited MA organizations and the type, category, and expiration date of the accreditation held by each of them. (10) A list of all full and partial accreditation surveys scheduled to be performed by the accreditation organization as requested by CMS. (11) The name and address of each person with an ownership or control interest in the accreditation organization. (b) Required supporting documentation. A private, national accreditation organization applying or reapplying for approval must also submit the following supporting documentation: (1) A written presentation that demonstrates its ability to furnish CMS with electronic data in CMS compatible format. (2) A resource analysis that demonstrates that its staffing, funding, and other resources are adequate to perform the required surveys and related activities. (3) A statement acknowledging that, as a condition for approval, it agrees to comply with the ongoing responsibility requirements of §422.157(c). (c) Additional information. If CMS determines that it needs additional information for a determination to grant or deny the accreditation organization's request for approval, it notifies the organization and allows time for the organization to provide the additional information. (d) Onsite visit. CMS may visit the accreditation 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) Notice of determination. CMS gives the accreditation organization, within 210 days of receipt of its completed application, a formal notice that— (1) States whether the request for approval has been granted or denied; (2) Gives the rationale for any denial; and (3) Describes the reconsideration and reapplication procedures. (f) Withdrawal. An accreditation organization may withdraw its application for approval at any time before it receives the formal notice specified in paragraph (e) of this section. (g) Reconsideration of adverse determination. An accreditation organization that has received notice of denial of its request for approval may request reconsideration in accordance with subpart D of part 488 of this chapter. (h) Request for approval following denial. (1) Except as provided in paragraph (h)(2) of this section, an accreditation organization that has received notice of denial of its request for approval may submit a new request if it— (i) Has revised its accreditation program to correct the deficiencies on which the denial was based; (ii) Can demonstrate that the MA organizations that it has accredited meet or exceed applicable Medicare requirements; and (iii) Resubmits the application in its entirety. (2) An accreditation organization that has requested reconsideration of CMS's denial of its request for approval may not submit a new request until the reconsideration is administratively final. [63 FR 35082, June 26, 1998, as amended at 65 FR 40324, June 29, 2000]
Title 42: Public Health
PART 422—MEDICARE ADVANTAGE PROGRAM
Subpart D—Quality Improvement
§ 422.152 Quality improvement program.
§ 422.156 Compliance deemed on the basis of accreditation.
§ 422.157 Accreditation organizations.
§ 422.158 Procedures for approval of accreditation as a basis for deeming compliance.
