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Technology assessment: Relationship to coverage issues—A case for temporary coverage decisions
Technology Assessment: Relationship to Coverage Issues—A Case for Temporary Coverage Decisions Louis H. Diamond, MBChB, FACP, FCP(SA) ● Making appropriate coverage decisions has the potential of impacting patient outcomes. In both the public and private sectors, great diversity exists in the methodology and process used to make coverage decisions. Because definitional issues are important, they are described in this article. The underpinning of coverage decisions are a commitment to certain methodological principles, including embracing evidence-based medicine. The role of the federal government and local entities in regard to evidence production and process as well as methodology used to formulate policy decisions is complex and requires resolution. A temporary coverage decision can be a helpful tool when no consensus exists. 娀 1999 by the National Kidney Foundation, Inc. iNEX WORDS: Coverage decisions; evidence-based medicine; methodology.
T
HERE IS currently great diversity in both the public and private sector in the process and methodologies used for making coverage decisions. These issues are of growing importance in the face of increasing costs and efforts to implement cost containment programs while at the same time providing access to medical care services (including new technologies) equitably and assuring quality. One of the major decisions includes whether coverage decisions should be made at the local level. If at a local level, what is the role of national organizations and especially the federal government? How do we establish priorities for providing services and developing the ‘‘evidence’’ to support coverage decisions? What are the processes we should use for making coverage decisions? What is the role for the public sector and how do the public and private sectors interact and coordinate their activities? What types of information should be provided to consumers? What types of appeal proceedings should be established and how should they be strengthened? What is the role of the courts? Some of the basic elements of coverage decisions require assessment of the safety and efficacy of the diagnostic or therapeutic intervention under consideration. A careful assessment of the potential harms and benefits needs to be under-
From The MEDSTAT Group, Washington, DC. Received September 11, 1998; accepted as submitted September 14, 1998. Address reprint requests to Louis H. Diamond, MBChB, FACP, FCP(SA), The MEDSTAT Group, 4401 Connecticut Ave NW, Suite 400, Washington, DC 20008. E-mail: [email protected]
娀 1999 by the National Kidney Foundation, Inc. 0272-6386/99/3301-0037$3.00/0 208
taken. Importantly, but controversially, the incorporation of cost-effectiveness evaluations of various therapies needs to be assessed. Finally, the values and interests of all parties need to be accounted for. BENEFIT LANGUAGE AND COVERAGE
Benefit language describes the contract between the entity organizing and responsible for the provision of health care coverage and the parties potentially receiving the benefits. Benefit language is usually described in broad categories, such as the provision of hospital services and emergency services. Such language does and should include a description of cost-sharing arrangements and utilization limits. The description of medical necessity and appropriateness as reasonable and necessary remains controversial, as does the definition of experimental therapy for exclusion from a benefits package. Coverage criteria are essentially legal mechanisms to reach agreement on how to spend the members’ money and hopefully how to maximize the health of the covered patient population.1 The purpose of coverage decisions should be to improve quality, to avoid unnecessary practice, and to control costs. A coverage decision statement should stress the following: ● Coverage applies to a health treatment intervention for a medical condition. ● Sufficient evidence of value exists to indicate that the intervention has a positive effect on health outcomes and will have the intended effect in this case. ● The benefits of the intervention are clear. ● The therapeutic intervention can be delivered cost effectively.1
American Journal of Kidney Diseases, Vol 33, No 1 (January), 1999: pp 208-210
TECHNOLOGY ASSESSMENT
209
BACKGROUND
This sections provides a brief description of some of the major elements that need to be considered when making a coverage decision and discusses an approach to dealing with situations when sufficient evidence does not exist to make full and permanent coverage decisions. A fundamental element to the coverage decision should be to embrace a model of evidence-based decision making. A definition of evidence-based medicine is the conscientious and judicious use of current best evidence from clinical care research in the management of individual patients2 and populations. It is important to recognize that evidence is not ‘‘perfect’’ and is almost never as precise as, for example, the sun rising at 5:15 and 46 seconds. ‘‘Even’’ randomized trials can be flawed.3 In addition to the fundamental limitations of evidence, we need to consider patient preference, physician judgment, and, in the case of coverage decisions, the public interest. These value judgments need to be accounted for, not only when using evidence-based evaluation as a basis for clinical decisions at the bedside, but also when making policy decisions, such as coverage determinations (Fig 1). Additionally, other significant caveats, such as patient factors, require consideration (Fig 2). The relationships of coverage decision to practice guidelines, clinical performance measures, and quality improvements are important (Fig 3), as are the linkages with research initiatives designed to create the evidence and background
Not available online due to copyright restrictions. please see print version.
Fig 2. Factors that enter into clinical decisions. Reprinted with permission from Haynes R, Sackett D, Muir Gray F: Transferring evidence from research into practice. I. The role of clinical care research evidence into clinical decisions. ACP J Club 125:A14-A16, 1996
necessary for the appropriate development and use of clinical practice guidelines and performance measures. The use of clinical practice guideline, clinical performance measures, and policy decisions (eg, coverage determinations) needs to be carefully integrated, taking into account the complex relationships within the health care delivery systems, the local circumstances, and the needs of both individual patients and populations. The distinction between coverage decisions and clinical practice guideline is shown in Table 1. There are definitional differences. Both are based on evidence and both incorporate professional judgment, but at different levels. For cov-
Not available online due to copyright restrictions. Please see print verison. Fig 1. Clinical expertise. Reprinted with permission from Haynes R, Sackett D, Muir Gray F: Transferring evidence from research into practice. I. The role of clinical care research evidence into clinical decisions. ACP J Club 125:A14-A16, 1996
Fig 3. Applying clinical tools.
210
LOUIS H. DIAMOND
Table 1. Relationship: Coverage Decision Versus Clinical Practice Guidelines (1 of 2)
Based on evidence Incorporated professional judgment at Individual level Group level Takes into account Public perspective Patient perspective Decision Level/specificity
CD ⫹
CPG ⫹
⫺ ⫹
⫹ ⫺
⫹ ⫺
⫺ ⫹
⫹
⫹⫹⫹
erage decisions the focus is at the group level; for clinical practice guidelines, the individual patient level. Both take into account values and preferences, one at the public level and the other at the individual level. The public perspective is more visible and important for coverage decisions, whereas individual patient preference is more important when clinical practice guidelines are used at the bedside. Finally, the specificity of the decisions, based on evidence and all of the other considerations, is at a more detailed level for clinical practice guidelines, as compared with coverage decisions. COVERAGE DECISIONS
Models for the roles of federal and local entities in creating evidence-based reports and actually making coverage decisions are complex (Table 2). The issue of making a covering decision when the issues and or the evidence are unclear is fraught with conflict. This situation is especially
so for services already being covered and provided. The options available at the two ends of the spectrum are (1) covering all treatments only when pressure from the public or various interest groups is sufficient enough or (2) doing nothing, (eg, not making a coverage decision or reversing an existing coverage determination). The alternative is to pursue a policy of temporary coverage decision making. Under such an option, the circumstances of the temporary coverage decision would be clearly and precisely described, as outlined by the Physician Payment Review Commission in its 1995 Annual Report.4 The therapy or intervention under consideration would be covered on a temporary basis only and with the following provisions: (1) The coverage would be temporary and time limited; (2) Facilities and providers authorized to provide the services would commit to participating in structured data collection and analysis to accumulate evidence supporting intervention; (3) Agreement on a funding mechanisms for the data collection and analysis would be reached, hopefully funded by the payers, the developers of the technologies, and other interest groups; (4) An agreed methodology and process for ongoing evaluation of the data would be reached; and (5) A mechanism to reach a final coverage decision, at a time certain in the future, would be established. SUMMARY
Using a temporary coverage decision vehicle in the face of unreasonable uncertainty is a reasonable alternative to the status quo. REFERENCES
Table 2. Models for Coverage Decisions
● Federal government Local level ● National public/private sector partnership
Construct Evidence Reports
Make Coverage Decisions
x ⫺
x x
x
x
1. Eddy D: Benefit language. JAMA 275:650-657, 1996 2. Haynes R, Sackett D, Muir Gray F: Transferring evidence from research into practice: 1. The role of clinical care research evidence into clinical decisions. ACP J, 125:A14A15, 1996 3. Jadad A, Rennie D: The randomized controlled trial gets a middle-aged checkup. JAMA 279:319-320, 1998 4. Physician Payment Review Commission. Chapter 6. Improving Medicare Coverage Decisions. 1995 Annual Report to Congress.
T
HERE IS currently great diversity in both the public and private sector in the process and methodologies used for making coverage decisions. These issues are of growing importance in the face of increasing costs and efforts to implement cost containment programs while at the same time providing access to medical care services (including new technologies) equitably and assuring quality. One of the major decisions includes whether coverage decisions should be made at the local level. If at a local level, what is the role of national organizations and especially the federal government? How do we establish priorities for providing services and developing the ‘‘evidence’’ to support coverage decisions? What are the processes we should use for making coverage decisions? What is the role for the public sector and how do the public and private sectors interact and coordinate their activities? What types of information should be provided to consumers? What types of appeal proceedings should be established and how should they be strengthened? What is the role of the courts? Some of the basic elements of coverage decisions require assessment of the safety and efficacy of the diagnostic or therapeutic intervention under consideration. A careful assessment of the potential harms and benefits needs to be under-
From The MEDSTAT Group, Washington, DC. Received September 11, 1998; accepted as submitted September 14, 1998. Address reprint requests to Louis H. Diamond, MBChB, FACP, FCP(SA), The MEDSTAT Group, 4401 Connecticut Ave NW, Suite 400, Washington, DC 20008. E-mail: [email protected]
娀 1999 by the National Kidney Foundation, Inc. 0272-6386/99/3301-0037$3.00/0 208
taken. Importantly, but controversially, the incorporation of cost-effectiveness evaluations of various therapies needs to be assessed. Finally, the values and interests of all parties need to be accounted for. BENEFIT LANGUAGE AND COVERAGE
Benefit language describes the contract between the entity organizing and responsible for the provision of health care coverage and the parties potentially receiving the benefits. Benefit language is usually described in broad categories, such as the provision of hospital services and emergency services. Such language does and should include a description of cost-sharing arrangements and utilization limits. The description of medical necessity and appropriateness as reasonable and necessary remains controversial, as does the definition of experimental therapy for exclusion from a benefits package. Coverage criteria are essentially legal mechanisms to reach agreement on how to spend the members’ money and hopefully how to maximize the health of the covered patient population.1 The purpose of coverage decisions should be to improve quality, to avoid unnecessary practice, and to control costs. A coverage decision statement should stress the following: ● Coverage applies to a health treatment intervention for a medical condition. ● Sufficient evidence of value exists to indicate that the intervention has a positive effect on health outcomes and will have the intended effect in this case. ● The benefits of the intervention are clear. ● The therapeutic intervention can be delivered cost effectively.1
American Journal of Kidney Diseases, Vol 33, No 1 (January), 1999: pp 208-210
TECHNOLOGY ASSESSMENT
209
BACKGROUND
This sections provides a brief description of some of the major elements that need to be considered when making a coverage decision and discusses an approach to dealing with situations when sufficient evidence does not exist to make full and permanent coverage decisions. A fundamental element to the coverage decision should be to embrace a model of evidence-based decision making. A definition of evidence-based medicine is the conscientious and judicious use of current best evidence from clinical care research in the management of individual patients2 and populations. It is important to recognize that evidence is not ‘‘perfect’’ and is almost never as precise as, for example, the sun rising at 5:15 and 46 seconds. ‘‘Even’’ randomized trials can be flawed.3 In addition to the fundamental limitations of evidence, we need to consider patient preference, physician judgment, and, in the case of coverage decisions, the public interest. These value judgments need to be accounted for, not only when using evidence-based evaluation as a basis for clinical decisions at the bedside, but also when making policy decisions, such as coverage determinations (Fig 1). Additionally, other significant caveats, such as patient factors, require consideration (Fig 2). The relationships of coverage decision to practice guidelines, clinical performance measures, and quality improvements are important (Fig 3), as are the linkages with research initiatives designed to create the evidence and background
Not available online due to copyright restrictions. please see print version.
Fig 2. Factors that enter into clinical decisions. Reprinted with permission from Haynes R, Sackett D, Muir Gray F: Transferring evidence from research into practice. I. The role of clinical care research evidence into clinical decisions. ACP J Club 125:A14-A16, 1996
necessary for the appropriate development and use of clinical practice guidelines and performance measures. The use of clinical practice guideline, clinical performance measures, and policy decisions (eg, coverage determinations) needs to be carefully integrated, taking into account the complex relationships within the health care delivery systems, the local circumstances, and the needs of both individual patients and populations. The distinction between coverage decisions and clinical practice guideline is shown in Table 1. There are definitional differences. Both are based on evidence and both incorporate professional judgment, but at different levels. For cov-
Not available online due to copyright restrictions. Please see print verison. Fig 1. Clinical expertise. Reprinted with permission from Haynes R, Sackett D, Muir Gray F: Transferring evidence from research into practice. I. The role of clinical care research evidence into clinical decisions. ACP J Club 125:A14-A16, 1996
Fig 3. Applying clinical tools.
210
LOUIS H. DIAMOND
Table 1. Relationship: Coverage Decision Versus Clinical Practice Guidelines (1 of 2)
Based on evidence Incorporated professional judgment at Individual level Group level Takes into account Public perspective Patient perspective Decision Level/specificity
CD ⫹
CPG ⫹
⫺ ⫹
⫹ ⫺
⫹ ⫺
⫺ ⫹
⫹
⫹⫹⫹
erage decisions the focus is at the group level; for clinical practice guidelines, the individual patient level. Both take into account values and preferences, one at the public level and the other at the individual level. The public perspective is more visible and important for coverage decisions, whereas individual patient preference is more important when clinical practice guidelines are used at the bedside. Finally, the specificity of the decisions, based on evidence and all of the other considerations, is at a more detailed level for clinical practice guidelines, as compared with coverage decisions. COVERAGE DECISIONS
Models for the roles of federal and local entities in creating evidence-based reports and actually making coverage decisions are complex (Table 2). The issue of making a covering decision when the issues and or the evidence are unclear is fraught with conflict. This situation is especially
so for services already being covered and provided. The options available at the two ends of the spectrum are (1) covering all treatments only when pressure from the public or various interest groups is sufficient enough or (2) doing nothing, (eg, not making a coverage decision or reversing an existing coverage determination). The alternative is to pursue a policy of temporary coverage decision making. Under such an option, the circumstances of the temporary coverage decision would be clearly and precisely described, as outlined by the Physician Payment Review Commission in its 1995 Annual Report.4 The therapy or intervention under consideration would be covered on a temporary basis only and with the following provisions: (1) The coverage would be temporary and time limited; (2) Facilities and providers authorized to provide the services would commit to participating in structured data collection and analysis to accumulate evidence supporting intervention; (3) Agreement on a funding mechanisms for the data collection and analysis would be reached, hopefully funded by the payers, the developers of the technologies, and other interest groups; (4) An agreed methodology and process for ongoing evaluation of the data would be reached; and (5) A mechanism to reach a final coverage decision, at a time certain in the future, would be established. SUMMARY
Using a temporary coverage decision vehicle in the face of unreasonable uncertainty is a reasonable alternative to the status quo. REFERENCES
Table 2. Models for Coverage Decisions
● Federal government Local level ● National public/private sector partnership
Construct Evidence Reports
Make Coverage Decisions
x ⫺
x x
x
x
1. Eddy D: Benefit language. JAMA 275:650-657, 1996 2. Haynes R, Sackett D, Muir Gray F: Transferring evidence from research into practice: 1. The role of clinical care research evidence into clinical decisions. ACP J, 125:A14A15, 1996 3. Jadad A, Rennie D: The randomized controlled trial gets a middle-aged checkup. JAMA 279:319-320, 1998 4. Physician Payment Review Commission. Chapter 6. Improving Medicare Coverage Decisions. 1995 Annual Report to Congress.