10-144-109 Me. Code R. § 1.03

Current through 2024-51, December 18, 2024

Section 144-109-1.03 - Quality Management Program

The HMO shall have an ongoing internal Quality Management Program to monitor and evaluate its health care services. The HMO shall have a written description of its Quality Management Program containing all of the required elements described in this section.

1.03-1 Structure and Process

The QMP structure and process must include the following components.

A. The HMO shall establish goals and objectives for its QMP.

B. The HMO shall describe the scope of its QMP. The scope of the QMP shall:

1. be comprehensive, addressing both quality of care and the quality of service; and

2. provide for the review of the entire range of care provided by the HMO and assure that all demographic groups, care settings, and types of services relevant to the HMO's services are included in the scope of review. For purposes of this subsection, "demographic groups" include groups broken down by age, race, ethnicity, gender, geographic region, and urban or rural setting. The provisions of this subsection are not intended to require additional studies by an HMO, but rather that over time the studies conducted by an HMO should address all elements of this subsection.

C. The HMO shall develop annually a work plan for its QMP. The HMO's governing body shall review and approve the work plan. The work plan shall include a detailed set of QMP goals and objectives for the coming year, activities planned for that year, a timetable for implementation and accomplishment, an identified party or parties responsible for accomplishing each goal and objective, and planned monitoring of previously identified issues.

D. The HMO shall ensure that the QMP is subject to the review and approval of the governing body.

E. The HMO shall designate a physician to provide medical direction to the QMP. The physician shall be substantially involved in the implementation of the QMP.

F. The HMO shall establish a Quality Management (QM) committee with clear lines of authority over the Quality Management Programand that is accountable to the governing body.

G. To the extent necessary to meet the standards contained in this rule, the HMO shall devote the necessary and appropriate personnel, data and analytic resources. The HMO shall ensure that QM activities are completed in a timely and competent manner.

1.03-2 Operations

The HMO shall ensure that its QMP is fully operational.

A. The QM committee shall:

1. recommend policy decisions;

2. review and evaluate the results of QM activities;

3. institute needed actions; and

4. ensure follow-up, as appropriate.

The activities of the QM committee shall inform, influence, and improve the performance of quality-related functions performed by other organizational components of the HMO.

B. The HMO shall maintain contemporaneous meeting minutes signed and dated by the chair of the QM committee, recording QMP activities, findings, recommendations, actions, and outcomes.

"Contemporaneous" minutes are minutes produced at the time the activity is conducted by a person present at the meeting and are signed and dated within a reasonable period of time.

C. The HMO shall coordinate QMP activities with information from other performance monitoring activities, including utilization review, credentialing, member services, provider relations, contracting, risk management, and resolution and monitoring of member complaints, appeals, and grievances.

D. The HMO shall ensure that participating physicians and other practitioners acting as primary care practitioners are active in quality management activities, including but not limited to:

1. the development and implementation of specific QM activities, including identifying, measuring, and improving aspects of clinical care and service;

2. the education of participating physicians, other participating practitioners acting as primary care practitioners, and facilities about the HMO's QMP, its specific activities, and the results of these activities; and

3. monitoring and auditing practitioner performance to identify individual instances and patterns of poor quality of care and poor quality of service, and to identify opportunities for improvement.

E. The HMO shall ensure that:

1. its contracts with physicians and other practitioners acting as primary care practitioners explicitly require the physician and other practitioners acting as primary care practitioners to cooperate with and participate in the QMP;

2. its contracts with facilities explicitly require the facility to cooperate with the QMP;

3. its contracts with providers explicitly require providers to allow appropriate access to the medical records of members for purposes of quality management, and quality reviews and complaint investigations conducted by the HMO, the State, or the State's delegate; and

4. its contracts with providers explicitly require provider offices and sites to have policies and procedures for:

a. protecting the confidentiality of member health information;

b. limiting access to health care information on a need-to-know basis, consistent with existing law;

c. holding all health care information confidential and not divulging it without the member's authorization, except as consistent with existing law; and

d. allowing members access to their medical records, consistent with existing law.

1.03-3 Clinical Guidelines

A. The HMO shall adopt clinical guidelines. At least two guidelines shall address chronic or acute conditions. At least four guidelines shall address preventive health services. Each guideline shall:

1. be based on reasonable scientific evidence;

2. be developed, adapted, or reviewed by participating practitioners;

3. be disseminated to participating practitioners;

4. address process oroutcomes for quality of care or quality of service issues;

5. be relevant to the HMO's enrolled membership residing in Maine; and

6. be updated as necessary, but no less often than once every two years.

B. For at least two guidelines addressing chronic or acute conditions, the HMO shall:

1. at least annually measure its performance against the two guidelines;

2. ensure that applicable clinical guidelines are consistent with decisionmaking in utilization review, member education, covered benefits, and other areas as appropriate.

1.03-4 Studies

As part of its QMP, the HMO shall conduct studies as governed by this section.

A. Over a three-year period, the HMO shall complete at least:

1. three quality of care studies that relate to chronic or acute conditions; and

2. two quality of service studies.

These study requirements are intended to require no more than the study requirements already imposed by NCQA at the time this rule takes effect. When appropriate, the Department shall coordinate these study requirements with those imposed by the Department approved national accrediting organization.

B. A study is "complete" when, consistent with other provisions under this section, the HMO has:

1. selected a study topic;

2. selected a measure or measures;

3. selected a benchmark and/or a performance goal;

4. identified the affected population;

5. identified the data to be collected;

6. collected and analyzed the data;

7. determined interventions, if the study reveals an opportunity for improvement;

8. implemented strong interventions (as defined in Section 1.03-5(C)), if the study reveals an opportunity for improvement;

9. conducted re-assessment.

C. The HMO shall choose study topics that:

1. are designed to objectively and systematically monitor and evaluate the quality of care and quality of services delivered to its members;

2. are relevant to the population served by the HMO that resides in Mainein terms of such categories as age groups, disease categories, special risk status or geographic distribution. A study to measure the HEDIS Effectiveness of Care Measures is relevant within the meaning of this subsection; and

3. have been selected as a priority area for study based on an appropriate rationale.

D. The QMP shall identify objective measures of quality that measure variables relating to a specific aspect of the quality of care or quality of service issue to be studied. The measures must be based on current knowledge and, where applicable, clinical knowledge. They must measure outcomes or processes when those processes have been significantly related to outcomes.

E. The HMO shall establish benchmarks derived from appropriate sources or reasonable performance goals, or both, against which it shall measure the quality of care or quality of service.

F. The HMO shall assess the HMO's performance on the selected measures based on a systematic, ongoing collection and analysis of valid and reliable data. The HMO shall identify the affected population, as appropriate; collect appropriate data using appropriate sampling; and use a measurement methodology appropriate for the selected measure.

G. The HMO shall quantitatively analyze the data, comparing its results against the selected performance goal and/or benchmark, and against its own past performance, if applicable.

H. The HMO shall analyze the results of its study to identify the reasons for the results, barriers to improvement, and appropriate interventions. As necessary to perform these functions, the HMO shall establish a multidisciplinary team composed of practitioners and personnel who understand the relevant processes of care and potential barriers to improvement. This team shall analyze and address systems issues, barriers to improvement and develop interventions.

1.03-5 Intervention and Assessment

Based on its analysis of its study results and identified interventions, the HMO shall take action to improve quality when it has identified an opportunity for improvement in the quality of care or service. In taking such action, the HMO shall:

A. specify the persons or persons responsible for initiating an intervention;

B. outline the schedule and accountability for implementing appropriate interventions;

C. identify and take an appropriate intervention or interventions. An intervention must be sufficiently strong that it has some likelihood of making a positive impact on the identified problem, be related specifically to the cause of the identified problem, and be timed appropriately to impact the problem;

D. measure whether the interventions have been effective;

E. identify the procedures to be followed if the interventions have not been effective;

F. adhere to identified procedures for intervening with a provider, including the range of activities (e.g., educational feedback, onsite assistance) when the opportunity for improvement relates to a provider's conduct. The HMO shall consider the limitations of small area analysis before implementing an intervention with a specific provider based on practice-level data. Procedures for intervening shall include procedures for terminating the affiliation with, or otherwise sanctioning a provider in the event the HMO identifies serious quality deficiencies associated with that provider that could adversely affect the health or welfare of members; and

G. devote adequate resources, proportional to the HMO's members residing in Maine, to ensure that the interventions are likely to have a positive impact on that portion of the study population residing in Maine.

1.03-6 Continuity of Care and Utilization

A. The HMO shall:

1. have a systematic method, appropriate to the HMO's delivery system, for detecting problems in the continuity and coordination of care that members receive;

2. routinely collect and analyze data to evaluate continuity and coordination of care; and

3. promptly implement interventions, when appropriate, to improve the continuity and coordination of care that members receive. An intervention required under this section shall satisfy the requirements of Section 1.03-5.

B. The HMO shall:

1. have a systematic mechanism, appropriate to the HMO's delivery system, for identifying patterns of underutilization and overutilization;

2. systematically collect and analyze data to detect underutilization and overutilization. The HMO shall have written standards or thresholds for identifying potential underutilization or overutilization; and

3. promptly implement interventions when it identifies underutilization or overutilization. An intervention required under this subsection shall satisfy the requirements of Section 1.03-5.

1.03-7 Evaluation

A. Annually, the HMO shall prepare a written report on the QMP that describes:

1. completed and ongoing QM activities, including all delegated functions;

2. a trending of measures to assess performance in quality of care and quality of service;

3. an analysis of whether there have been any demonstrated improvements in the quality of care or service; and

4. an evaluation of the overall effectiveness of the QMP, including an analysis of barriers to improvement.

The annual evaluation report shall be reviewed and approved by the HMO's governing body.

B. The HMO shall establish a mechanism for periodic reporting of QMP activities to the governing body, practitioners, members and appropriate HMO staff. The HMO shall ensure that the findings, conclusions, recommendations, actions taken, and results of QM activity are documented and reported to appropriate individuals within the organization and through established QM channels.

1.03-8 Improved Quality Through Cooperation

A. Nothing in this section is intended to prevent an HMO from cooperating with other HMOs to minimize duplicative and inconsistent requirements imposed on providers. The Department will work to promote a collaborative relationship between HMOs and providers to address the following factors potentially having a negative impact on the quality of care and services:

1. multiple, uncoordinated, plan-level studies, imposing unnecessary burdens on providers;

2. inconsistent or duplicative practice guidelines promulgated across multiple HMOs;

3. inconsistent and duplicative administrative requirements imposed on providers across multiple HMOs.

B. Nothing in this section is intended to prevent an HMO from cooperating with other HMOs to maximize the value to be gained from conducting quality management activities. The Department will work with HMOs to identify opportunities for maximizing the value of quality management activities through cooperation. The Department will promote the coordination of studies across HMOs to minimize their expense and maximize their value. The Department will work with HMOs to identify study topics of particular value to Maine HMO members.

1.03-9 Waiver for HMOs with Fewer Than 20,000 Members

A. An HMO with fewer than 20,000 members may apply for a waiver from specified requirements of Section 1.03. A waiver request must include:

1. specification of the particular requirements of this section for which a waiver is requested;

2. a proposed alternative plan for meeting the goals of the requirements for which a waiver is requested, including but not limited to assuring and managing the quality of care and service delivered to its members;

3. an explanation of the value to be gained by its members and the citizens of Maine if the waiver request is granted.

B. The Department may grant the waiver application if it is satisfied that adequate safeguards are in place and the alternative plan is sufficient to ensure the health care services delivered by the HMO are rendered under reasonable standards of quality of care consistent with prevailing professionally recognized standards of medical practice.

10-144 C.M.R. ch. 109, § 1.03