ࡱ> q` bjbjqPqP ::~~~~~~~4h.4pI\n n ( r t t t - I*H$Jh4MhI~ I~~ *I> > > p~ ~ r > r > > ~~> b  p> ^ @I0pI> Mv pM> M~> > II X pI ~~~~~~  10-144 DEPARTMENT OF HUMAN SERVICES Chapter 109 QUALITY OVERSIGHT FOR COMMERCIAL HMOs TABLE OF CONTENTS Page 1.01 INTRODUCTION 1 1.02 DEFINITIONS 1 1.02-1 Accessibility 1 1.02-2 Acute condition 1 1.02-3 Availability 1 1.02-4 Benchmark 1 1.02-5 Chronic Condition 1 1.02-6 Commissioner 1 1.02-7 Continuity of Care 1 1.02-8 Coordination of Care 1 1.02-9 Department 2 1.02-10 Facility 2 1.02-11 Governing Body 2 1.02-12 Guideline 2 1.02-13 Health Care Services 2 1.02-14 Health Maintenance Organization (HMO) 2 1.02-15 HEDIS Effectiveness of Care Measures 2 1.02-16 Intervention 2 1.02-17 Measure 2 1.02-18 Member 2 1.02-19 National Committee for Quality Assurance 2 1.02-20 NCQA Accreditation Survey Report 3 1.02-21 Participating 3 1.02-22 Performance Goal 3 1.02-23 Physician 3 1.02-24 Practitioner 3 1.02-25 Preventive Health Services 3 1.02-26 Primary Care 3 1.02-27 Primary Care Practitioner (PCP) 3 1.02-28 Provider 3 1.02-29 Quality 3 1.02-30 Quality Management Program (QMP) 4 1.02-31 Quality of Care 4 1.02-32 Quality of Service 4 1.02-33 Quality-Related Function 4 1.02-34 Superintendent 4 1.02-35 Utilization Review 4 TABLE OF CONTENTS (cont.) Page 1.03 QUALITY MANAGEMENT PROGRAM 4 1.03-1 Structure and Process 4 1.03-2 Operations 5 1.03-3 Clinical Guidelines 7 1.03-4 Studies 8 1.03-5 Intervention and Assessment 10 1.03-6 Continuity of Care and Utilization 11 1.03-7 Evaluation 11 1.03-8 Improved Quality Through Cooperation 12 1.03-9 Waiver for HMOs with Fewer Than 20,000 Members 13 1.04 CERTIFICATE OF AUTHORITY REVIEW 13 1.04-1 Document Submittal 13 1.04-2 Examination 15 1.04-3 Certification 15 1.05 PERIODIC EXAMINATION 15 1.05-1 Coordinated with Department Approved National Accrediting Organization 16 1.05-2 Review Process and Report 17 1.05-3 Deeming 17 1.05-4 Coordination of Standards 18 1.05-5 Not Coordinated with the Department Approved National Accredited Organization 18 1.05-6 Review Process 18 1.05-7 Document Submittal 19 1.06 ANNUAL STATEMENT 22 1.06-1 Specifications for the Annual Statement 22 1.01 INTRODUCTION These regulations are promulgated by the Department of Human Services pursuant to Title 22 M.R.S.A., Section 42 and establish standards for assuring the quality of care provided by commercial health maintenance organizations pursuant to Chapter 56 of Title 24-A M.R.S.A. Nothing in these regulations may be interpreted to create or enlarge a cause of action in favor of a member or other third party against an HMO or provider. 1.02 DEFINITIONS Unless otherwise indicated, the following terms shall have the following meanings: 1.02-1 Accessibility is the extent to which a member of an HMO can obtain available services at the time they are needed. This refers to telephone access, the ability to schedule an appointment and to physical, language and other barriers to obtaining the service. 1.02-2 Acute Condition is an illness or health problem of a short-term or episodic nature. 1.02-3 Availability is the extent to which the HMO has practitioners of the appropriate type and number distributed geographically to meet the needs of its membership. 1.02-4 Benchmark is the measure of best performance, set externally to the HMO, for a particular indicator or performance goal in the health maintenance organization industry. 1.02-5 Chronic Condition is a disease or condition, usually of slow progress and long continuance, requiring ongoing care. Examples include asthma, hypertension, and diabetes. 1.02-6 Commissioner is the Commissioner of the Department of Human Services. 1.02-7 Continuity of Care is the provision of care by the same set of practitioners to a member over time, or if the same practitioners are not available over time, a mechanism to provide appropriate clinical information in a timely fashion to other practitioners who continue to provide the same type and level of care. 1.02-8 Coordination of Care describes the mechanisms assuring that the member and practitioners have access to, and take into consideration, all the required information on the members conditions and treatments to assure that the member receives appropriate health care services. 1.02-9 Department is the Department of Human Services. 1.02-10 Facility is an institution providing health care services or a health care setting, including but not limited to appropriately licensed or certified hospitals and other inpatient centers, ambulatory surgical or treatment centers, skilled nursing centers, residential treatment centers, diagnostic, laboratory and imaging centers, and rehabilitation and other therapeutic health settings. 1.02-11 Governing Body is the board of directors, or other body, with ultimate authority and responsibility for the overall operations of the HMO, or its designee. 1.02-12 Guideline is a systematically developed descriptive tool or standardized specification for care to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. 1.02-13 Health Care Services are services for the diagnosis, prevention, treatment, cure or relief of a health condition, illness, injury or disease, including mental illness and alcohol and chemical dependency. 1.02-14 Health Maintenance Organization (HMO) is an entity licensed pursuant to Title 24-A, M.R.S.A. Chapter 56. 1.02-15 HEDIS Effectiveness of Care Measures is that portion of the Health Plan Employer Data and Information Set (HEDIS) that measures the outcomes of care and care processes, as defined by National Committee for Quality Assurance. HEDIS is a set of standardized performance measures designed to allow for reliable comparison of the performance of managed health care plans. 1.02-16 Intervention is an action taken by the HMO to increase the probability that a desired outcome will occur. 1.02-17 Measure is a quantifiable element of performance that can be compared to the same element of other performances, such as a dimension of a function, process, or outcome. Measures can be of activities, events, occurrences, or outcomes for which data can be collected to allow comparison with a threshold, a benchmark, or prior performance. 1.02-18 Member is a policyholder, subscriber, enrollee, or other individual entitled to benefits under an HMO benefit plan. 1.02-19 National Committee for Quality Assurance (NCQA) is a national organization that accredits quality assurance programs in prepaid 1.02 DEFINITIONS (cont.) managed care organizations. 1.02-20 NCQA Accreditation Survey Report is the detailed survey report reported to the HMO by NCQA upon completion of NCQAs survey of the HMO. The NCQA accreditation survey report is not the accreditation summary report that is published by NCQA. 1.02-21 Participating, with respect to a provider, is one who is under contract with the HMO, an intermediary, or with the HMOs contractor or subcontractor, who has agreed to provide health care services to members with an expectation of receiving payment, other than coinsurance, copayments or deductibles, directly or indirectly from the HMO. 1.02-22 Performance Goal is the desired level of achievement set for itself by an HMO. 1.02-23 Physician is a licensed doctor of medicine or osteopathy practicing within the scope of a license. 1.02-24 Practitioner is a physician or other person licensed, accredited or certified to perform specified health care services consistent with state law. This definition applies to individual practitioners, not corporate persons. 1.02-25 Preventive Health Services are health care services designed for the prevention and early detection of illness in asymptomatic people, generally including routine physical examinations, tests, and immunizations. 1.02-26 Primary Care is the level of care that encompasses routine care of individuals with common health problems and chronic illnesses that can be managed on an outpatient basis, traditionally provided by family practice, pediatrics, general practitioners, internal medicine, and obstetricians/ gynecologists. 1.02-27 Primary Care Practitioner (PCP) is a practitioner under contract with an HMO to supervise, coordinate, and provide primary care health care services to members; maintain continuity of member patient care; and initiate member patient referrals for specialist care. 1.02-28 Provider is a practitioner or facility. 1.02-29 Quality is the degree to which a health care service or health care services, or the availability, accessibility, continuity or coordination of care meet established professional or regulatory standards, or 1.02 DEFINITIONS (cont.) judgments of value to the consumer. 1.02-30 Quality Management Program (QMP) is that program prescribed by Section 1.03. 1.02-31 Quality of Care relates to the quality or appropriateness of health care services, including preventive health services. 1.02-32 Quality of Service relates to the availability, accessibility, continuity or coordination of care and to the satisfaction of members with the quality of care, and the availability, accessibility, continuity and coordination of care. 1.02-33 Quality-related Function is a function that is related to the quality of care, the quality of service, quality management program, or any other function that relates to the quality of health care services or health care delivery. 1.02-34 Superintendent is the Superintendent of the Bureau of Insurance. 1.02-35 Utilization Review is any program or practice by which the HMO seeks to review the utilization, clinical necessity, appropriateness, efficacy or efficiency of health care services, procedures, or providers. 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 1.03-1 Structure and Process (cont.) 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 HMOs 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 HMOs 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 Program and 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; 1.03-2 Operations (cont.) 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 HMOs 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 1.03-2 Operations (cont.) 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 States 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 members 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 or outcomes for quality of care or quality of service issues; 1.03-3 Clinical Guidelines (cont.) 5. be relevant to the HMOs enrolled membership residing in fb88; 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; 1.03-4 Studies (cont.) 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 fb88 in 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 HMOs 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 1.03-4 Studies (cont.) 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 providers 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 1.03-5 Intervention and Assessment (cont.) 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 HMOs members residing in fb88, to ensure that the interventions are likely to have a positive impact on that portion of the study population residing in fb88. 1.03-6 Continuity of Care and Utilization A. The HMO shall: 1. have a systematic method, appropriate to the HMOs 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 HMOs 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 1.03-7 Evaluation (cont.) 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 HMOs 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 1.03-8 Improved Quality Through Cooperation (cont.) 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 fb88 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 fb88 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. 1.04 Certificate of Authority Review 1.04-1 Document Submittal An applicant for a Certificate of Authority shall submit documentation consistent with the requirements of Chapter 850(6) or the following documentation: A. A written description of its QMP including: 1. a timeline for implementation; 2. an organizational chart or charts; 1.04-1 Document Submittal (cont.) 3. a job description and the credentials of the senior executive and other principal staff responsible for quality management activities; 4. a job description and the credentials of the applicants medical director; 5. the job description and the credentials of the members of the QMP committee; 6. a description of the QM committee function and plan for ongoing operation; 7. a description of the resources that will be devoted to QM activities; 8. a description of the system for peer review activities; 9. a description of the applicants plan for developing and disseminating clinical guidelines; 10. a description of the applicants plan for conducting quality management studies; 11. a description of the applicants plan for conducting intervention and assessment when the quality management studies identify opportunities for improvement; 12. a description of the applicants plan for monitoring and evaluating the continuity of care and utilization; 13. a description of the applicants plan for evaluating the performance of its QMP; and 14. such other information as may be reasonably required by the Department. B. Documentation describing the applicants credentialing policies and procedures. If the same or similar information pertaining to credentialing is supplied to the Bureau of Insurance, a copy of that information submitted to the Department will satisfy the requirement of this section. C A written description of the applicants proposed QMP work plan for its initial year of operation and a certification from the 1.04-1 Document Submittal (cont.) governing body that it has reviewed and approved the work plan for that year. D. Other information as may be reasonably required by the Department. 1.04-2 Examination. The Department shall conduct an examination of the applicant. The examination may include a desk audit and an onsite review. 1.04-3 Certification. The Department shall certify the applicants compliance with the requirements of Title 24-A M.R.S.A., 4204(2-A)(B), if the following conditions are met: A. The applicant has in place systems, policies and procedures and required written documentation complying with the requirements of this rule and of Title 24-A M.R.S.A., 4204(2-A)(B) B. The Department determines that the applicant has a work plan in place for implementing the systems, policies and procedures identified in Section 1.04-3(A) in satisfaction of the requirements of this rule, within a maximum of three years from the date of the examination conducted under this section; and C. The Department determines that the safeguards are in place to ensure the health care services to be provided by the applicant are rendered under reasonable standards of quality of care consistent with prevailing professionally recognized standards of medical practice. 1.05 Periodic examination The Department shall conduct a periodic examination of the HMO as often as the Commissioner deems necessary for the protection of the interests of the people of the State, but not less frequently than once every three years. The periodic examination shall include a desk audit and onsite review. No notice requirements pertaining to a scheduled examination shall be interpreted to preclude the Department from conducting an onsite examination without notice to the HMO. The Department shall not conduct a scheduled periodic examination of an HMO before three years following the date of the issuance of the HMOs first license. As provided in this section, a periodic examination may be coordinated with an accreditation survey by a DHS approved national accrediting organization. An HMO accredited by, or seeking accreditation by, a nationally recognized 1.05 Periodic examination (cont.) accrediting organization may apply for Department approval of the accrediting organization. An application must include a copy of the accrediting organizations standards for the Departments consideration along with a statement identifying with specificity any differences between those standards and the requirements of this rule. Should the Department approve the HMOs application the periodic examination review process will be coordinated with the Department approved nationally recognized accrediting organization as described in this Section. In the event an HMO does not seek approval of a nationally recognized accrediting organization and the HMO is accredited by or seeking accreditation by NCQA, NCQA shall be considered the Department approved national accrediting organization. 1.05-1 Coordination with the Department Approved National Accrediting Organization If an HMO is subject to review by a Department approved national accrediting organization, the Department shall coordinate its periodic examination of the HMO with the Department approved national accrediting organizations accreditation review process. In order for the Department to coordinate the review process, the following provisions shall apply: A. Within ten (10) working days after receiving its Department approved accrediting organization accreditation survey report, the HMO shall submit to the Department the following documentation: 1. the documentation required under Section 1.05-7, or such portion of that documentation as the Department may require; and 2. the final accreditation survey report of the Department approved accrediting organization, as required under Section 1.05-2. B. The Department shall schedule an onsite review of the HMO for a date six weeks from one of the following dates: 1. One hundred (100) calendar days following the last day of NCQAs onsite accreditation review; 2. the HMOs receipt of the NCQA accreditation survey report if receipt is later than one hundred (100) calendar days from the conclusion of NCQAs onsite survey; or 3. such other date to be determined by the Department, if 1.05-1 Coordination with the Department Approved National Accrediting Organization (cont.) the HMO or the Department can show good cause for delay. The onsite review will be limited to only that portion of the periodic examination for which the Department did not deem the HMO in compliance with an equivalent State standard, based on the results of the Department approved national accrediting organizations review and as allowed under Section 1.05-3. 1.05-2 Review Process and Report If an HMO submits to an accreditation review by a Department approved, nationally recognized accrediting organization, the HMO shall: A. Notify the Department of the dates scheduled for the Department approved accrediting organizations onsite survey; B. Contemporaneously with its submittal to the Department approved accrediting organization, furnish the Department with a duplicate copy of all documentation submitted to the accrediting organization unless otherwise directed by the Department; C. Cooperate with the Departments participation as an observer on the Department approved accrediting organizations onsite survey; and D. Submit its full accrediting organization accreditation survey report to the Department as required in Section 1.05-1. The accrediting organization accreditation survey report shall be held confidential by the Department except to the extent that portions of the accreditation survey report are incorporated into the final review findings report or are made available to the general public by the accrediting organization or by the HMO. 1.05-3 Deeming In conducting a periodic examination or any other function related to quality oversight, the Department shall consider the HMOs national accrediting organization accreditation survey report to determine whether the HMOs compliance with the national accrediting organizations standards applicable to the same subject matter are equivalent to compliance with certain of the standards imposed by this regulation or Title 24-A, M.R.S.A Chapter 56. Nothing herein 1.05-3 Deeming (cont.) shall be interpreted to require the Department to deem (i.e., treat compliance with an accrediting organization standard as compliance with any State standard). When the Department does not deem the Department will explain how the State standard is different from the national accrediting organizations standard and how the difference is necessary to meet the requirements of Title 24-A M.R.S.A. Chapter 56, Sections 4204 and 4215. In addition, nothing herein shall be interpreted to preclude the Department from considering other information, other than the accreditation survey report, in determining compliance with the requirements of this regulation or Title 24-A, M.R.S.A. Chapter 56. 1.05-4 Coordination of Standards The Department shall revise, where appropriate, its data collection tool to reflect the most recent revisions to the standards of the Department approved accrediting organization. Currently, the Department uses NCQA standards and procedures as its model for HMO quality oversight. 1.05-5 Not Coordinated with the Department Approved National Accreditation Organization If the Departments periodic examination is not coordinated with a national accreditation review, (i.e., when an HMO has not submitted to or is not scheduled to submit to review by a Department approved national accrediting organization within the three-year time period imposed by 24-A M.R.S.A. Chapter 56, Section 4215.), the Department shall give the HMO twenty weeks notice that an onsite review has been scheduled. Six weeks prior to the scheduled onsite review, the HMO shall submit the documentation required under Section 1.05-7. 1.05-6 Review Process The periodic examination, when the examination is not coordinated with the review by a Department approved national accrediting organization, shall be conducted as follows: A. The Department will review the documentation submitted by the HMO; B. The Department will conduct an onsite examination of the HMO to determine the HMOs compliance with the regulatory and statutory requirements; 1.05-6 Review Process (cont.) C. Based on the Departments review of the documentation and its onsite examination the Department will produce preliminary review findings that evaluate the HMOs compliance with the regulatory requirements; D. The Departments preliminary review findings will not be final until: 1. the HMO has had twenty days, or such additional reasonable period as the Commissioner may allow, to review and comment on the findings; and 2. final approval by the Commissioner or Superintendent, as applicable. E. The Departments final review findings are public documents. All other working papers, survey instruments, and preliminary findings are confidential except to the degree that they are incorporated into the final review findings or are made available to the general public by the HMO or as otherwise provided by law. 1.05-7 Document Submittal The HMO shall submit, in a format acceptable to the Department, the following documentation: A. Information relating to the structure and process of the QMP, including: 1. A written description of the QMP for current year (and previous year if substantially different); 2. An organization chart for the QMP; 3. An annual workplan for the current year; 4. An annual workplan for the previous year; 5. QM committee agendas; 6. Reports on QMP activities; 7. List of HMO full-time equivalent staff and consultants dedicated to quality management; 1.05-7 Document Submittal (cont.) 8. Brief description of data available to and used in quality management; and 9. Brief description of personnel, including credentials, (HMO staff and consultants) providing analytical expertise to the quality management function. B. Information relating to the operations of the QMP, including at least one template of the following contracts, representative of a typical contract of that type: 1. a primary care practitioner contract; 2. a specialty care physician contract; 3. a hospital contract; and 4. another facility contract. C. Information relating to the HMOs clinical guidelines, including: 1. date of first dissemination; 2. dates of any updates; 3. whether it is related to preventive health; 4. whether it is related to any issues studied by the HMO. D. For each of two of the HMOs most comprehensive clinical guidelines, information including: 1. its relevance to the enrolled members residing in fb88; 2. primary sources; 3. mechanisms for practitioner involvement; 4. evidence and date of review; 5. mechanisms for dissemination to practitioners; 6. a description of the last two performance assessments; 7. a description of the HMOs method for ensuring consistency between guidelines and the utilization review 1.05-7 Document Submittal (cont.) function and member and physician education. E. Completed forms, as provided by the Department, describing the HMOs studies meeting the number and specifications of Section 1.03-4; F. Copies of the following communications with members and providers, evidencing communication of guidelines, QM activities, medical record standards, or any other communication required with members or providers under this rule: 1. newsletters; 2. manuals; 3. special mailings; 4. member handbooks; 5. reports. G. Copies of the HMOs policies, procedures, or standards for peer review and credentialing; H. A description of credentialing committee activities related to the HMOs peer review function; I. A copy of the HMOs credentialing application; J. A description of the HMOs study of overutilization and underutilization, including: 1. methods used to identify problems and dates HMO began using method; 2. frequency of analysis; 3. the HMOs standards or thresholds for underutilization; 4. whether the HMO identified problems; and 5. the methods the HMO used to correct or monitor the problem. K. A description of the HMOs study of continuity or coordination of care, including: 1.05-7 Document Submittal (cont.) 1. mechanisms for monitoring the continuity or coordination of care; 2. methods used for analyzing the data; 3. conclusions the HMO drew as a result of its study; and 4. the methods the HMO used to correct or monitor problems. L. Any other documentation that may be reasonably required by the Department in order to properly conduct its examination. 1.06 Annual Statement The HMO shall submit an annual statement to the Commissioner on March 1 of each year, except that an HMO that has been licensed less than six months as of March 1 shall not be required to report until the following year. 1.06-1 Specifications for the Annual Statement The annual statement shall be in a format and meeting specifications acceptable to the Commissioner and shall contain the following information: A. QMP Description. The HMOs most recently approved written description of its QMP; B. Work Plan. The HMOs most recently approved work plan; C. Evaluation. The HMOs most recently approved annual QMP evaluation report; D. HEDIS Effectiveness of Care Measures. The HMOs HEDIS Effectiveness of Care Measures for the most recent NCQA reporting period. Beginning two years after the effective date of this rule or approval of the HMOs certificate of authority application, whichever is later, the Effectiveness of Care Measures shall have been audited by an NCQA-certified auditor or other auditor approved by the Department; and E. Credentialing Activity. For the most recent calendar year, the HMO shall submit the following information relating to practitioner credentialing, broken down by type and specialty: 1. number of practitioners reviewed for credentialing; 1.06-1 Specifications for the Annual Statement (cont.) 2. number of practitioners given credentials; 3. number of practitioners denied credentials and why; 4. number of practitioners given provisional credentials; 5. average duration of provisional credentials prior to full credential decision; 6. identity and number of practitioners given provisional credentials but not given full credentials and why; 7. number of practitioners reviewed for recredentialing; 8. identity and number of practitioners denied recredentialing, and why; and 9. identity and number of practitioners with whom affiliation was terminated outside of periodic recredentialing process, and why. F. Certification Certification by the governing body or a member of senior HMO management that the reports submitted pursuant to this section are accurate, to the knowledge and best ability of that body or person.     10-144 Chapter 109 DEPARTMENT OF HUMAN SERVICES Section 1 QUALITY OVERSIGHT FOR COMMERCIAL HMOs 3/2/01 page ii 10-144 Chapter 109 DEPARTMENT OF HUMAN SERVICES Section 1 QUALITY OVERSIGHT FOR COMMERCIAL HMOs 3/2/01 page 23 j  6 y!!E)u)U*`*--j.p....66VEWEIFJFGGHI2M3MRRWWXX``cciillllppuuhH}6CJaJhH}CJOJQJ^JaJhH}5;CJaJhH}>*CJaJhH}5CJaJhH}CJaJhH}5CJ aJ I,-9:`abcdefghijk}$a$ $hh]h`ha$$ a$}~  6 O n  X ^` X ^` X ^ X ^ X 0^`0 $ !a$$ a$  F x  : X o " Q o $ X ^` X ^` X ^`    < = _ v I X ^` X 0^`0 $ !a$$ a$ X ^`$ X ^`!"Xz9Tst X 0^`0 X ^` X ^` X ^`UV` $^`a$ $h^h`a$$^a$ h^h` X ^``a  CDuvNO#$ ^`$ ^`a$ $^`a$ $^`a$ Y!Z!!!!!""##o$p$$$3%4%&&&&3(4(D) ^` h^h` $^`a$D)E)u)v)M*N*P*i*j*****g+h+Y,Z,H-I---j.k..$a$$$^`a$ h^h`$$^`a$ $^`a$..//////0010}0~0000000?3 $@ ^@ `a$$ $ ^$ `a$$ $ ^$ `a$$^a$ $^`a$ 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