Definition of Serious and Complex Medical Conditions (1999)

Throughout the course of this study, the committee has been extremely aware of the fact that the topic addressed by this report concerns one of the most critical issues confronting HCFA, health care plans and providers, and patients today. The Medicare+Choice regulations focus on the most vulnerable populations in need of medical care and other services—those with serious or complex medical conditions. Caring for these highly vulnerable populations poses a number of challenges.

In the absence of a fully developed research and clinical knowledge base, combined with the time and resource constraints of this study, the committee chose what it believes is the most prudent and thoughtful approach to its charge. Specifically, the committee has chosen to provide guidance to HCFA and health care plans to support initial steps to address the major issues confronting health care plans and their beneficiaries with serious and complex medical conditions. This guidance is supported by presentation of possible strategies that might be used to screen enrollees for the presence of serious and complex medical conditions. Health care plans are encouraged to be innovative in their initial efforts to develop case-screening methodologies. As plans develop experience with different screening modalities, information can be shared nationally. It is the committee's intent that this will lead to the identification of best practices and subsequent standardized methods for ongoing screening of beneficiaries for serious and complex conditions. The committee also recommends strategies to ensure that the care offered to persons with serious and complex conditions is responsive to the diverse, multidisciplinary needs for services to address a full spectrum of medical, social, and mental health issues. Finally, the committee feels strongly that evaluation and research efforts must occur simultaneously with the

implementation of the guidance and recommendations concerning screening and care of patients with serious and complex medical conditions. As HCFA and health care plans develop the necessary expertise and resources to provide comprehensive, multidisciplinary care to patients with serious and complex conditions, this knowledge can be generalized to address the needs of patients with serious but not complex and complex but not serious medical conditions. The following conclusions and recommendations are based on consideration of these diverse issues.

Recommendation 1: The establishment of an administrative definition for serious and complex medical conditions by the Health Care Financing Administration would be premature at this time.

It is the opinion of the committee that the current state of clinical and research literature does not support development of an operational definition for serious and complex medical conditions. There are a large number of potential ways to screen and identify patients with serious and complex medical conditions, although each has its own set of limitations. Disease classification systems such as diagnosis-related groups, diagnostic cost groups, and the International Classification of Diseases—Ninth Edition lack the sensitivity and specificity required to effectively distinguish between patients with acute care needs and those who need more extensive treatment and service arrays. The validity of patient classifications systems (e.g., diagnosis-related groups) and functional status definitions (e.g., Karnofsky and SF-36 scales) has not yet been determined. Efforts to develop case-mix-adjusted reimbursement systems to ensure cost-effectiveness and high-quality interventions for patients with serious and complex conditions are still in the early stages or are limited to only a single disease category. Similarly, efforts to develop standardized protocols for care coordination, continuity of care, care management strategies, and service reimbursement plans have met with varying degrees of success.

Clinical research relevant to defining patient populations as having serious and complex conditions and developing the most effective care protocols to respond to patient needs is evolving rapidly, but only preliminary results are available. For example, research in correlating patient volume with patient outcomes, differentiating access to services as a function of health plan benefits, and addressing variations in quality of care has just begun to yield meaningful results about particular groups of patients. The committee anticipates that this research will continue to evolve and will provide more definitive conclusions to guide the efforts of health plans to identify patients with serious and complex medical conditions and ensure appropriate levels of treatment and care management. As the science base is strengthened, so too will be the ability of HCFA and health plans to correctly identify patients with serious and complex medical conditions who would benefit from broad strategies of care management.

Recognizing these limitations, the committee recommends that plans first focus their attentions on patient populations with conditions that are serious

AND complex. These conditions are described as persistent, substantially disabling or life threatening that require treatments and interventions across a broad scope of medical, social, and mental health services. Plans will require time to develop expertise and resources to develop methods of case finding and provision of an integrated care management approach for these patients. As such expertise is developed and resources are allocated, plans can then expand their efforts to include patients with serious but not complex conditions and those with complex but not serious conditions.

Recommendation 2: The committee recommends that the Health Care Financing Administration should provide guidance to health plans to assist their efforts to identify patients with serious and complex medical conditions. Specifically, the committee recommends the following language be used to facilitate efforts of plans to identify their enrollees with ''serious and complex conditions": "A serious and complex condition is one that is persistent and substantially disabling or life threatening that requires treatments and services across a variety of domains of care to ensure the best possible outcomes for each unique patient of member."

The committee recognizes the importance at this time of providing health plans with guidance to facilitate operationalization of their own definitions of serious and complex medical conditions. This guidance includes a description of a serious and complex medical condition as one that is persistent and substantially disabling or life threatening that requires treatments and services across a variety of domains of care. The committee reviewed a number of possible categories of conditions that might be considered serious and complex. These are discussed in Chapter 1 of this report and include, but are not limited to, life-threatening conditions, conditions that cause serious disability without necessarily being life threatening, conditions associated with severe consequences, conditions affecting multiple organ systems, conditions requiring coordination of management by multiple specialties, and conditions requiring treatments that carry a risk of serious complications.

Clinical research to identify patient populations with serious and complex medical conditions and develop the most effective care management strategies to respond to patient needs is evolving rapidly, with only preliminary results available. The current state of clinical and research literature does not adequately address all of the challenges and issues relevant to the identification and care of these patients. These issues include, but are not limited to, identification of methods and criteria that can be applied to screen enrollees for the presence of serious and complex conditions; development of strategies for proper care and management of the complex array of medical, social, and mental health problems confronting these patients; development of strategies to evaluate the effectiveness, efficacy, and efficiency of different strategies of care management; and ongoing research to ensure continuous improvements in the care of

patients. Health care service research is only beginning to emerge with initial findings relevant to these issues.

The committee anticipates that this research will continue to evolve and provide more definitive conclusions to guide the efforts of health plans to identify patients with serious and complex medical conditions and help plans to provide appropriate levels of treatment and care management. The committee urges health care plans, in collaboration with federal agencies and research institutions, to support this ongoing research and facilitate a synthesis of emerging results. As the science base is strengthened, so too will be the ability of HCFA and health plans to correctly identify patients who would benefit from a broad care management strategy including those with serious but not complex or complex but not serious conditions.

Recommendation 3: The committee recommends that health plans develop a broad strategy for care management to enable patients and providers to achieve the best possible outcomes for each unique patient or member with a serious or complex medical condition.

This care management strategy should include, but not necessarily be limited to, case finding; screening and selection; problem assessment and identification of strengths; development of treatment or care plans; implementation of care plans with an emphasis on proactive interventions; and monitoring of care plan implementation and outcomes.

The treatments for individuals with serious and complex medical conditions will inevitably vary due to many factors, including characteristics of the individual patient and the patient's social situation, characteristics of individual providers, provider organizations, health plans, resources in the community, health plan benefits, and so forth. Although these factors will vary for all patients, they have less impact on preventive care (e.g., immunizations) and acute care (e.g., setting a broken arm) interventions. Successful outcomes for persons with serious and complex medical conditions will rely on a diverse mix of medical, social, functional, financial, and psychological factors, as well as on how these factors mesh with a community's health and social services resources. There is no single guideline that can prescribe the care or treatments for persons with serious and complex medical conditions.

The committee's recommendations concerning elements of the care management strategy have been derived, in part, from existing publications (Case Management Society of America, 1996; HMO Workgroup on Care Management, 1999). A brief explanation for each of the recommended steps in the care process is provided below.

Case finding refers to methods for identifying persons who may have a serious and complex medical condition. Utilization of the committee's recommended description for serious and complex conditions can facilitate efforts by health plans and providers to identify possible categories of patients for whom case finding should be conducted. Depending on the organization of a health

plan and its provider group(s), case finding methods may include electronic searching of administrative databases; phone screening of new or existing members; referral by patient or family member; referral by a clinician or other professional; or notification by an emergency room, hospital, nursing home, or other provider organization.

Case screening and selection outline a process for deciding exactly which patients meet a plan's criteria for serious and complex medical conditions. These criteria should be established by each health plan with review by HCFA. Examples of selection criteria might include factors such as diagnostic codes, patient age, presence of comorbidities, severity of illness or disability, duration of a disability, and so forth. It is expected that patients meeting these criteria would benefit from coordinated care management.

The next step in the care process should involve an assessment of the patient's problems and strengths. This is a tool for gathering information about the patient's medical, social, functional, and financial status that will be used to further determine his or her need for care management and the resources available to access the necessary services.

Treatment or care planning is also recommended by the committee as an essential element of a care management strategy for patients with serious and complex medical conditions. Such planning supports the development of individualized, goal-focused care plans (based on assessment findings and drawing on evidence-based treatments when available) to provide a guide for delineating patient, provider, and plan responsibilities for accessing and coordinating needed services.

The care management strategy also demands that steps be taken to ensure the implementation of care plans. Execution of the care management plan includes strategies and tactics for providing or purchasing needed services, or for linking patients to covered services, services available in the community, or those for which the patient will have to pay. It also includes advocating for the provision of informal services by family, friends, and neighbors.

The final step of the care process is monitoring implementation and outcomes of the care management strategy. This can be based upon periodic reviews of a patient's status and treatments to determine whether goals are being achieved, whether interventions and treatments continue to be appropriate, whether there is a medical need for continued services, or whether proactive care is required to address potential or emerging new problems. This type of monitoring can also include measurements to assess the impact of care management and treatment on clinical, functional, cost, and satisfaction outcomes.

Throughout the entire care management strategy for persons with serious and complex medical conditions, three principles should be evident. First, the care management strategy should reflect a commitment to continuity and coordination of care, as described among the requirements for National Committee for Quality Assurance accreditation. This entails monitoring continuity and coordination activities, analyzing data to identify opportunities for improvement, and taking actions to bring about improvements, as indicated. Second, the care

process should include multidisciplinary perspectives and treatments, as appropriate. The care of persons with serious and complex medical conditions may require the assessment and treatment expertise of primary care providers; medical and surgical specialists; nurses and nurse specialists; social workers; pharmacists; occupational, speech, and physical therapists; behavioral and mental health professionals; and community-based service providers and resources. Access to expertise from these various disciplines should be available as needed. Third, and perhaps most important, patients and their family members should be involved at every step so that the care process incorporates the patient's expectations and preferences and documents the patient's role in achieving treatment goals.

The committee's recommendations concerning the care management process for patients with serious and complex conditions assumes patient willingness to collaborate with a multidisciplinary team of providers in the development and implementation of that plan. In those instances where a patient or family member declines such participation, appropriate documentation should be entered into the patient record. The presence of such documentation should be considered by HCFA as evidence that a good faith effort has been made by the plan to involve the patient and family in the development of the case management plan.

Recommendation 4: The committee recommends that health plans design and implement strategies for routine screening and selection to identify those beneficiaries with serious and complex medical conditions. These strategies should be consistent with the guidance outlined in Recommendation 2 to determine which patients meet a plan's threshold for serious and complex medical conditions and would benefit from a coordinated care management strategy.

The committee recommends that health plans identify specific categories of patients or health conditions for which screening for the presence of serious and complex conditions should occur on a routine basis. Examples of such categories are provided in Chapter 1. The committee is of the opinion that screening a health care plan's entire population of enrollees is not a feasible, cost-effective, or efficient method of identifying subpopulations with serious and complex medical conditions. The committee feels strongly, however, that early efforts to develop case-screening methodologies should not be prescriptive; rather, innovation should be encouraged. Documentation of locally derived methods by plans will result in extensive nationwide experience that can be assessed and can lead to the identification of best practices and subsequent standardized methods for ongoing routine screening of patient populations.

The appropriate application of resources by a health plan to patients with serious and complex medical conditions requires the identification of those individuals whose health outcomes would benefit by such designation. For the purposes of this report, the committee has not included patients suffering from acute conditions that might require coordinated delivery of sophisticated medi-

cal services to treat complications of acute decompensation. On the other hand, many patients who have endured prolonged hospitalization for an acute medical condition may subsequently need coordinated long-term care to maximize their rehabilitation potential; to treat persistent sequelae of the disease processes that resulted from the acute, severe illness; and to ensure that they receive proactive care to prevent further exacerbation of the illness or disability.

Conceptually, various methodologies could be applied to administrative databases that could produce relevant lists of patients with serious and complex medical conditions who would be likely to benefit from written care management plans. High-cost patients, for example, might merit designation as having serious and complex conditions. Some of these individuals, however, may have undergone a single event such as bypass surgery that is self-limited and not appropriate for such designation. In contrast, others will have conditions, such as organ transplants, disabling traumatic injury, and HIV/AIDS, that clearly require ongoing medical attention and resources to sustain or improve their health status. Aside from costs, certain diagnostic entities could be identified for designation as serious and complex medical conditions. Examples of such entities could include progressive, degenerative disorders, active collagen vascular disease, and metastatic cancers. The committee does not believe it is feasible at this time to create an all-encompassing list of diagnoses appropriate for designation as serious and complex conditions. Indeed, within any diagnostic label, there exists a continuum of disease and disability that requires varying degrees of medical and other health-related support.

Beneficiary survey tools could supplement the use of administrative data sets to identify appropriate patients. Questionnaires that quantify functional status could assist plans in capturing individuals who need special attention in the outpatient setting to improve or sustain functional capacity or physiological stability. Similarly, home health agencies or medical professionals could identify frail elderly patients who require care management to sustain homeostasis. These agents could refer patients' names to health plans for development of a formal management program for serious and complex medical conditions. Such patients could include those of advanced age (over 85) with several comorbid medical conditions such as congestive heart failure, chronic renal failure, and diabetes. These persistent conditions in concert with reduced cognitive functioning or physical capacity to sustain daily living activities produce a constellation of physiological deficits that require supportive health care services for the patient to maintain independent living in a community setting.

There are several reasons why it is essential to the care of persons with serious and complex medical conditions that screening and selection of a plan's designated patient categories or conditions occur on a routine basis. First, periodic screening allows the multidisciplinary care team to adjust the care management approach as patient needs change over time. Second, routine screening is necessary to identify new patients with serious and complex medical conditions. Third, it ensures that persons who are no longer considered to have a seri-

ous and complex condition will be identified and services adjusted accordingly, which could result in a cost benefit.

The committee believes that over time, the health care system will identify reliable, accurate screening techniques for populations of patients with serious and complex medical conditions. In many cases, timely identification will permit appropriate treatment at the level of the primary care provider. Nevertheless, even with robust methodologies in place, there will be patients and families who believe that they require additional resources or attention to adequately manage a persistent health condition. In instances in which a treatment plan is not mutually agreeable, individuals should be able to appeal to the medical director of the provider group or health plan. The review process should be timely and should allow for both internal and independent external review.

Recommendation 5: The committee recommends that health care plans develop a care management strategy that integrates the participation of all those involved in the care of the patient, including primary care physicians; medical and surgical specialists; nurses and nurse specialists; behavioral and mental health specialists; physical, occupational, and speech therapists; social workers; allied health professionals; and community-based service providers.

The development of a collaborative care management strategy involving all those who participate in providing care to the individual patient is critical to the treatment of patients with serious and complex conditions. The treatment plan serves several important functions within the care management strategy. First, it provides a road map and a guide to indicate direction of and demarcate landmarks in care management, making it easier to ensure that all providers involved in the patient's care share the same goals, and that these goals are accessible to the patient and the patient's family. Second, it provides a way to measure progress and the achievement of care goals, and it serves as a powerful communication and coordination tool among the participants involved in the care of the patient, avoiding overlapping or redundant efforts as well as gaps and inattention to components of care assumed to be the responsibility of others on the care team. Third, a treatment plan offers an opportunity to delineate which provider is taking responsibility for specific aspects of care.

Although there is currently no evidence to support the identification of a single format or model as superior to all others, the committee feels confident in recommending certain key components that should be part of any treatment plan for patients with serious and complex medical conditions. Specifically, the plan should involve the collaborative participation of all those taking part in the care of the patient, including primary care physicians; medical and surgical specialists; nurses and nurse specialists; physical, occupational, and speech therapists; rehabilitation specialists; behavioral and mental health specialists; social workers; allied health professionals; and community-based service providers and resources.

The perspectives, health beliefs, and values of the patient and the patient's family should be taken into consideration, and the care management plan should be constructed in a culturally appropriate manner. Elements of the care management plan should be appropriate both for the age or life phase of each patient as well as the stage or severity of the health condition. This will ensure selection of treatment options that are responsive to the unique needs of patients of different age groups and with conditions of varying severity. The patient should be involved in the development of the plan and should have access to the plan.

The plan should be linked to relevant clinical practice guidelines and should reflect the process of adapting population-based clinical practice guidelines to the unique care and service needs of the individual. The treatment plan should cross areas of expertise and should address the need for coordination of care across the continuum of care delivery settings. The plan should be longitudinal, with accommodations for proactive interventions to prevent potential problems from arising, and it should also enable longitudinal assessment of outcomes. The treatment plan should be a living document that is periodically reviewed, updated, and tested for continuing relevance to the patient's circumstances (e.g., the life phase) and clinical condition (e.g., the disease stage).

Recommendation 6: The committee recommends that health care plans have programs in place to monitor care management plans for both process and outcomes for patients with serious and complex conditions at the level of population, patient, provider, and best practices of care.

The Health Care Financing Administration should establish a formal mechanism to evaluate a Medicare+Choice provider organization's program to monitor the outcomes of care for patients with serious and complex medical conditions. The committee recognizes that the monitoring and evaluation programs will vary between health plans but recommends that all programs include population-based monitoring of the outcomes of care for patients with serious or complex conditions, as well as individual case monitoring, assessment of provider interventions, and evaluation of best practices of care.

Assessment of population-based measures may include, but not be limited to, review of plan-wide policies and procedures; application of working definitions of serious and complex conditions; adoption of evidence-based clinical guidelines; review of health outcomes survey, patient satisfaction and complaint data; and review of clinical outcomes data for patients with serious or complex medical conditions. Individual case monitoring may include, but not be limited to, analysis of complaint data, patient satisfaction, internal and external appeals of the care plan, and overturned denials. Evaluation and monitoring at the level of providers will include efforts to assess clinical quality of care, timeliness of care, and effectiveness of specific interventions. Best practices of care will be identified by data that describe clinical, functional, and patient satisfaction outcomes.

Recommendation 7: The committee recommends that the Health Care Financing Administration collaborate with federal, private, and voluntary agencies, organizations, and consumers to establish an ongoing process to address policy issues to ensure continuous improvements in the care of populations with serious and complex medical conditions.

Access to providers with the appropriate training and expertise is important, but other issues must be addressed to ensure that beneficiaries with serious and complex conditions achieve the best possible outcomes. The committee recognizes that a number of these issues supersede activities that can be accomplished at the level of individual health plans. Issues that must be addressed include, but are not limited to, the following:

• Payment.

The current Medicare capitated payment mechanisms for health plans are not risk adjusted and are derived from experience in the fee-for-service sector. These payment mechanisms may not provide adequate compensation to some health plans. Furthermore, health plans use a variety of methods to compensate individual providers and hospitals. Greater attention should be focused on the improved alignment of financial incentives at all levels to ensure appropriate payment for serious and complex cases through adequate funding and risk-adjusted payment systems.

• Benefits.

Improving the care of persons with serious and complex medical conditions can be supported by ensuring that Medicare beneficiaries can choose among different health plans. When beneficiaries have multiple affordable options, they can select based upon their own evaluations of quality. Where benefits are provided through multiple payment programs (i.e., Medicare and Medicaid dual eligibles), coordination of benefit packages and eligibility requirements is critical. The movement of patients with serious and complex conditions into managed care holds the promise of greater health for these patients and therefore reduced expenditures for Medicaid programs due to reduced nursing home use. Prescription coverage for these patients would result in a direct reduction in state Medicaid prescription coverage expenses. Medicare requirements for management of patients with serious and complex conditions may also serve as the future basis for Medicaid managed care contracts.

• Medicaid and Medicare Fee-for-Service Programs.

The committee was unable to address the third point of its charge with any degree of thoroughness. This is primarily due to the fact that the committee lacked sufficient information and time to conduct informed deliberations about the implications of alternative definitions for serious and complex medical conditions for Medicaid and commercial programs, especially when applied to Medicare beneficiaries who are dual eligible. The committee strongly recommends that HCFA, in collaboration with Medicare and Medicaid provider plans, establish this as a research priority. Resources and expertise should be allocated to conduct a study to define the relevant issues and generate possible approaches to address this question.

In the meantime, the committee suggests that the basic guidance provided in this report concerning the description of serious and complex medical conditions and recommendations concerning strategies for care management for this patient population should be extended to include Medicaid beneficiaries and those that are dual eligible. In addition, this guidance should apply to patients enrolled in fee-for-service Medicare programs. This should be a priority area for collaborative research on policy issues to ensure continuous improvements in the care of populations with serious and complex medical conditions covered by Medicaid and fee-for-service Medicare plans.

• Consumer Education and Participation.

Many patients, especially those with persistent and disabling conditions, are ready and able to become more active participants in the care delivery process. Attempts should be made to increase patient participation in clinical decision-making and caregiving processes consistent with improving clinical outcomes and satisfaction.

• Professional Training.

To serve persons with serious and complex medical conditions, an aggressive strategy must be developed to educate and train health professionals to provide appropriate care for this population. There is currently a great undersupply of persons trained in care management processes, multidisciplinary team care, geriatrics, patient education and self-management, and cultural competence.

• Information Technology.

More sophisticated information technology is required to provide high-quality, coordinated care to those with complex or serious medical conditions. More sophisticated information systems are needed to support efforts to monitor, analyze, and improve patient care. Continued development of electronic medical records will be an important factor in ensuring that all health care organizations and providers involved in the care of a patient have timely access to complete information on the patient's clinical conditions, diagnostic and therapeutic test results, and services received. Confidentiality protections must be respected throughout the process of technology development.

• Regulatory Framework.

Developing a regulatory approach for the Medicare+Choice program that affords adequate protections for beneficiaries with serious and complex medical conditions while encouraging innovation in a rapidly changing health care environment will be an ongoing challenge. Periodic evaluation and modification will be essential.

• Applied Research.

Research is needed to further inform the policy process and to identify best practices in the care of patients with serious and complex conditions. Attention should be focused on the following areas: effects of benefits coverage and payment methods on care delivery; determination and dissemination of best practices in the identification of patients with serious and complex conditions; efficacy, effectiveness, and efficiency of multidisciplinary teams; use of information technology to support care coordination and delivery; and development of innovative methods of designing, implementing, and coordinating medical, social, and other services.

These and related issues will require HCFA to actively collaborate with all types of payors, health care plans, providers, research organizations, and consumer and disability groups to develop strategies and solutions that will maximize the quality of health care and other services for patients with serious and complex medical conditions.

The needs of patients with serious and complex medical conditions far exceed the boundaries of a single issue such as access to specialists for care. For health care delivery systems to provide high-quality, effective care for these patients, the systems must be responsive to a diverse array of clinical, social, mental, and functional health issues. The development of a health care delivery system that will provide quality and effective care for these patient populations must be responsive to a diverse group of clinical, social, mental, and functional health issues. The health care delivery system must also be capable of working effectively with other community and social support systems.

The questions raised by HCFA concerning implementation and regulations for the Medicare+Choice program apply broadly to include all health care delivery and payment systems, including fee-for-service care. This study is one of the first to address these complex and extremely important topics. Thus, the committee urges HCFA, health care plans, and consumer groups to view this report, and especially its conclusions and recommendations, as first steps in the effort to address the unique and complicated needs of persons with serious and complex medical conditions and to ensure that they receive the most cost-effective and best-quality care possible. The work of this committee is intended to support and provide direction for future work to be conducted by HCFA, in collaboration with all types of health care plans and consumer organizations, to design innovative strategies to ensure adequate reimbursement, access to broad care management, and the highest possible quality of treatment services required by patients with serious and complex medical conditions.