TY - JOUR AU - Wynia, Matthew, K. AB - The earliest forms of prescription drug benefit management generally entailed only processing claims between plan sponsors and network pharmacies. Not much emphasis was put on creating coverage policies, and little effort was put toward lowering costs. Basically, most prescriptions filled in outpatient pharmacies were covered, with the exception of a few common exclusions, such as oral contraceptives and drugs used to enhance normal health, function, or physical appearance. But this approach to prescription drug benefits began to change rapidly in the early to mid-1990s. Since that time, the number of people covered by prescription drug benefits has increased dramatically through employee-sponsored programs and the recently implemented Medicare prescription drug programs. The number of people using prescription drugs has also increased significantly. In addition, the introduction of expensive new drugs has shifted use away from less-expensive products (e.g., generic drugs). These trends produced year-to-year increases of approximately 10–17% in the costs of prescription drug benefits between 1993 and 2003.1 Although prescription drug costs represented a small percentage of overall health care costs, sponsors of prescription drug plans became interested in addressing these rising costs, fearing that they were unsustainable and would interfere with meeting other organizational objectives. Plan sponsors today know they need to limit drug coverage and use administrative processes to control costs. But doing this is no trivial matter. As health professionals have long recognized, establishing the conditions that determine which plan members will receive the health care resources they need for their well-being confers a certain degree of moral responsibility on the decision-maker. Thus, the challenge to organizations providing prescription drug benefits is to allocate a limited health care resource in a way that is considered fair by those who are affected, and to do it in such a way that the decision-making process is legitimate.2 This challenge has been accentuated by a Medicare prescription drug benefit that relies on private organizations to administer a social health and welfare program. How something ought to be done—in this case, for the purposes of fairness and legitimacy—is an ethical question. As plan sponsors began to face the ethical challenge of setting limits to coverage and implementing administrative practices to lower costs in ways that are morally justifiable, they had little to consult for guidance, particularly to apply as an organization, i.e., from a set of established organizational ethics.3 What is available is rather recent and not always presented in the media most frequently accessed by those who make coverage policy and administration decisions.4,–7 The result has been variability in the approaches used, and some of the methods used do not meet bioethics standards, the pharmaceutical care doctrine, or organizational representations (e.g., mission statements, promotional messages).8 Prescription drug plan sponsors were not the only organizations facing these challenges. The entire health care system was grappling with the issue of coverage policy and administration. To provide the needed guidance to organizations across the health care system, the oversight body of the American Medical Association (AMA) Ethical Force Program produced a consensus report on ensuring fairness in coverage decisions.9,10 This article describes the core elements of the report10 and how they can be applied to managed care pharmacy. Ethical Force Program The Ethical Force Program is led by the AMA’s ethics research group, the Institute for Ethics. The program was established in 1997 “to improve health care by advancing ethical behavior among all participants.”10 Motivating the program are the beliefs that (1) ethics are fundamental to health care systems that are effective and trusted, (2) all stakeholders in health care should be accountable for their ethics, and (3) all stakeholders should work together to ensure that shared ethical standards are widely promoted, understood, and followed. The program functions as a quality improvement organization for ethics and, as such, produces an array of reports and tools that all stakeholders in health care can use. The oversight body of the program determines the topic areas for development and then provides guidance on all the necessary activities. The oversight body comprises a diverse group of leaders from all aspects of health care delivery, including clinicians, researchers, ethicists, managed care executives, public health and patient advocates, business owners, and union representatives.11 During its initial deliberations on potential content areas, the oversight body identified health care coverage decisions as an area that might benefit from a set of shared ethical expectations. Thus, in 2000, work began “to create a workable frame-work for organizations to use to improve ethical quality and promote trust through fostering fair coverage decisions.”9 Consensus report on ensuring fairness in coverage decisions Types of coverage decisions Fairness of coverage decisions can be partitioned into three basic areas: (1) access to care, (2) benefits design, and (3) benefits administration.10 Access to health care is defined as the degree to which individuals and populations obtain health care despite financial, cultural, geographic, and other barriers. Benefits design is the decision-making process that determines what assortment of health care services will be covered by an insurance package, including issues regarding copayments, deductibles, and provider reimbursement. Benefits administration is the decision-making process that determines the insurance coverage of specific services for specific individuals within the scope and limitations of the policy design, including individualized coverage decisions and adjudication of appeals. The report considers only benefits design and administration. Access to health care was not included because it poses unique and important ethical and social challenges that are better addressed separately. Benefits design and administration are highly relevant to managed care pharmacy. Prescription drug benefits have become increasingly complex and involve coverage limits that are discernible by and important to plan members. Indeed, prescription drugs are important enough to convey obligations on those making benefits design decisions to take ethical dimensions into consideration (e.g., what is the ethical basis for excluding certain services from people who may need or want them?). Those involved in benefits administration have the ethical obligation to ensure that requirements and processes are not created in ways that produce unnecessary burdens or risks. Developing the content of the report The oversight body appointed an expert advisory panel on benefits determination to review existing ethical norms and standards relevant to health care coverage decisions and to recommend potential content areas for this topic area. The proposed content areas were evaluated by the oversight body to ensure that all relevant considerations were included and that all aspects included were relevant. The content validity of the output was ensured through an iterative process using numerical rating scales to assess each content area on overall importance and relevance to coverage decisions. Content areas were reassessed, revised, or eliminated by the oversight body. For each of the content areas selected, the expert advisory panel proposed potential expectations for actions that could be measurable by organizations. The expert advisory panel and oversight body reviewed the proposed expectations and used an iterative process to assess the importance, universality, feasibility, and measurability of each expectation. Expectations were then reviewed, revised, or eliminated. The assessment processes involved three iterations over a two-year period. The resulting draft report was then sent to 800 health care leaders and posted on the program’s Web site as ways to solicit additional feedback. The oversight body produced the final report, taking the solicited feedback into consideration. Content areas and expectations The consensus report was completed in three years and contained five content areas, each with a set of measurable performance expectations for health care organizations. In short, ethical organizational processes for making coverage decisions are expected to be transparent, participatory, equitable and consistent, sensitive to value, and compassionate (Table 11). For each content area, there are several measurable expectations for both benefits design and administration. The content areas and their applications to managed care pharmacy are briefly summarized below; the reader is referred to the report itself for the detailed expectations of each content area. Table 1. Report Content Areas10 Content Area Description Transparency Processes for designing and administering health benefits should be fully transparent to those responsible for and affected by these processes. Participation Purposefully and meaningfully involve all stakeholders in creating and overseeing the processes for designing and administering health benefits. Equity and consistency Processes for designing and administering health benefits should result in similar decisions under similar circumstances. Sensitivity to value Processes for designing and administering health benefits should take into account the net health outcomes of services or technologies under consideration and the resources required to achieve these outcomes. Compassion The design and administration of health benefits should be flexible, responsive to individual values and priorities, and attentive to those with critical needs and special vulnerabilities. Content Area Description Transparency Processes for designing and administering health benefits should be fully transparent to those responsible for and affected by these processes. Participation Purposefully and meaningfully involve all stakeholders in creating and overseeing the processes for designing and administering health benefits. Equity and consistency Processes for designing and administering health benefits should result in similar decisions under similar circumstances. Sensitivity to value Processes for designing and administering health benefits should take into account the net health outcomes of services or technologies under consideration and the resources required to achieve these outcomes. Compassion The design and administration of health benefits should be flexible, responsive to individual values and priorities, and attentive to those with critical needs and special vulnerabilities. Open in new tab Table 1. Report Content Areas10 Content Area Description Transparency Processes for designing and administering health benefits should be fully transparent to those responsible for and affected by these processes. Participation Purposefully and meaningfully involve all stakeholders in creating and overseeing the processes for designing and administering health benefits. Equity and consistency Processes for designing and administering health benefits should result in similar decisions under similar circumstances. Sensitivity to value Processes for designing and administering health benefits should take into account the net health outcomes of services or technologies under consideration and the resources required to achieve these outcomes. Compassion The design and administration of health benefits should be flexible, responsive to individual values and priorities, and attentive to those with critical needs and special vulnerabilities. Content Area Description Transparency Processes for designing and administering health benefits should be fully transparent to those responsible for and affected by these processes. Participation Purposefully and meaningfully involve all stakeholders in creating and overseeing the processes for designing and administering health benefits. Equity and consistency Processes for designing and administering health benefits should result in similar decisions under similar circumstances. Sensitivity to value Processes for designing and administering health benefits should take into account the net health outcomes of services or technologies under consideration and the resources required to achieve these outcomes. Compassion The design and administration of health benefits should be flexible, responsive to individual values and priorities, and attentive to those with critical needs and special vulnerabilities. Open in new tab Transparency The central theme of this content area is the ethical obligation to provide people who are asked to accept coverage limits and administrative burdens with the specifics of coverage policies and the rationales for them.9 People need detailed information to make informed choices about their benefits. People cannot be expected to accept benefit-coverage policy designs and administrative requirements as fair without knowing what they are and the rationales for them. Without transparency, suspicion and cynicism directed toward the benefits are likely to take hold, and the processes used to develop them will not be accepted as legitimate. When the expectations of this content area are met, people affected by a particular benefit-coverage policy will know which health care products and services are covered. They will also understand the basis for those decisions. Applying this content area to managed care pharmacy would involve making prescription drug benefit packages, administrative requirements, and their rationales clear to individual plan members. For example, if a policy limits the quantity of triptans covered at one time (unless an exceptional situation exists), the plan could inform members about the limit and explain the rationale for the limit and the administrative procedures to apply for an exception. Plan members could be told that only three of the seven available triptans are covered by the plan because the triptans, as a group, are generally considered interchangeable but vary in cost; therefore, coverage of these drugs is limited to the three least-expensive triptans. If the more expensive triptans are covered, the costs to the plan and its members would increase unnecessarily. But plan members would also be instructed on the administrative procedures necessary to obtain an exception to this policy. Oblique references to a plan sponsor’s “sole discretion” on establishing coverage policies or to “proprietary” aspects of coverage policy and administrative elements would fall far short of meeting the requirements of transparency. Prescription drug benefit plans have a variety of mechanisms available to use to meet the requirement of transparency. Regular communications, such as plan descriptions and updates, can provide the detail needed to adequately address transparency. Letters explaining specific coverage decisions can provide information on the basis and rationales for these decisions. Customer service representatives can be trained to provide all the information plan members need to fully understand the plan’s rules and reasons for them. Managed care pharmacists are in positions to develop these capabilities and often are in positions where they can insist on the development and use of these capabilities for the purpose of transparency. Participation The primary thrust of this content area is that input on benefits design and administration should not be limited to those responsible for creating and maintaining the policies and administrative practices. To meet the requirements of this content area, the input of all stakeholders should be sought and accommodated (e.g., plan sponsors, plan members, network physicians and pharmacists, manufacturers, benefits consultants).9 Patients, physicians, pharmacists, and others cannot easily move among plans when they are dissatisfied. Hence, these and other stakeholders do not have the power to create market-based accountability, which is drawn from the potential to “exit” the plan. Participation, or “voice,” is therefore all the more important in benefits design and administration that meet the ethical requirements posed by the special status of health care.12 With more people involved who can contribute different views and perspectives, the educational and quality improvement opportunities also expand accordingly. When combined with transparency, all activities in which stakeholders participate are known by all stakeholders, which should add to the legitimacy of the process.3,9,12,13 Stakeholder participation can take different forms. Stakeholders can hold formal positions in policymaking functions or be polled for input on various issues. Input can be inferred from various reports or other information sources. In whatever form participation takes, however, its credibility requires that conflicts of interest be minimized. Applying this concept to prescription drug benefits, plan members could serve on committees that make decisions on the prescription drugs that will be covered. When committees like these decide to limit coverage to only three of the seven available triptans, for example, the plan members’ view has been incorporated, and other stakeholders are more likely to consider the decision as legitimate. Evaluations of the percentage of people requesting coverage exceptions for other triptans can be used to determine the acceptability of the benefit (e.g., a large number of requests for triptans that are not covered would indicate that physicians’ and plan members’ preferences were not adequately considered). The participation of various stakeholder groups must often be balanced with organizational management needs. Certain forms of participation could have negative effects on an organization’s ability to make safe, effective, efficient, and financially sound decisions. Thus, organizations may be reticent to provide opportunities for the direct participation of stakeholders for fear of disruption and impasse. Concerns about the loss of management controls and efficiencies stemming from the participation of stakeholders should be managed by the processes used to obtain and use the necessary inputs and not by avoiding or frustrating stakeholder participation.9 Equity and consistency This content area is motivated by concerns about the potential for health care resources to be allocated in inadequate or irrational ways or in a manner that may discriminate against some plan members. To be equitable, the benefit-coverage policies should provide health care services that take the needs of the entire affected population into account and should be consistent with local norms or with the stated objectives of the sponsoring organization. Benefits design and administration should also be connected to relevant facts and rationales rather than being the product of seemingly arbitrary choices. To be consistent, people affected by particular policies and administrative practices in similar situations must be treated in similar ways.9 Establishing and respecting general principles can be important to meeting the requirements for equity and consistency. General principles can provide guidance on establishing benefit policies that do not discriminate against particular individuals or groups within an affected population. Principles, for example, can establish a requirement that the needs of an entire affected population be accounted for in benefit-coverage policies. Principles can also require that precedents be established and referenced in creating and administering these policies. Referring to precedents will contribute to consistency.13 The triptan examples that have been used above show how this content area can be applied to prescription drug benefits. Limiting coverage to three of the seven triptan agents can be equitable when the necessary assessments have been made to determine that, with few exceptions, the affected population can be served adequately. The consistency requirement is met when the coverage limit is applied equally to all members of a particular plan. It is also met when the exceptions process for triptans that are excluded is equally manageable by all who may be affected. Sensitivity to value Sensitivity to value recognizes that cost and value matter in the allocation of health care resources. A major theme of this content area involves establishing the net benefits of specific products and services and determining when the benefits provided justify coverage within the defined scope of a particular benefits package. Another major theme refers to the importance of how net benefits and value are established. This content area specifies that a particular product or service should be covered when it provides a value consistent with the objectives of the benefits package. However, only those products or services producing the best net effects should be covered among those that offer similar clinical attributes. When a group of products and services provide similar net benefits, only those that provide the best value through lower costs should be covered. Not to be excluded from the evaluation of net benefits are the costs incurred to all people and organizations that can be affected (e.g., hospital costs, employer costs, family costs) and the costs and burdens of administrative procedures that might be required (e.g., prior-authorization programs). This content area clearly applies to pharmaceutical resources.5,6 Organizations determining prescription drug benefits must evaluate the safety and effectiveness of drug categories and individual drugs to ensure that they provide a net benefit that meets their objectives. Sometimes these evaluations must extend to specific diagnoses; that is, a net benefit can be expected from the use of a drug for certain purposes but not for others. For instance, coverage policies that are sensitive to value will be limited to uses that have been established by accepted clinical and scientific methods. Drugs that produce clear net benefits over other available drugs should be covered when they are consistent with the objectives of the benefits package. Moreover, among a group of drugs that produce the same clinical effects, the organization should limit coverage to the leastexpensive options so that the greatest value is achieved. To arrive at the best possible decisions on value, consistent and accepted cost-effectiveness methods are required.9 The example of the triptans used above is also illustrative for this content area. Triptans, as a category of drugs, are generally considered safe and effective for the treatment of migraine headaches. However, the safety and effectiveness of triptans have not been established for the prevention of migraine headaches; therefore, an organization could limit coverage of this group of drugs to just the treatment of migraine headaches in order to achieve the best net benefit.14 Because there are several triptan agents that can deliver the same clinical benefit, the organization can also limit coverage to the least-expensive individual agents. In determining the net value of these coverage decisions, however, the organization should assess the full costs and burdens of the decision. If triptan A were to be more expensive but also more effective than triptan B, then lack of coverage for A might actually lead to increased costs of care elsewhere (such as emergency department, hospital, or home care costs). Furthermore, there are costs associated with establishing administrative processes to adjudicate coverage limits (e.g., prior authorization) and an exceptions process for coverage requests of noncovered triptans when the covered triptans are not viable clinical options. Compassion Compassion differentiates health care services from ordinary consumer products. This content area was created to recognize and establish a set of expectations to consider individuals’ needs in the course of designing and administering benefits packages for populations. By focusing on compassion, organizations are reminded that health and access to health care services can be important determinants in an individual’s opportunity to achieve life plans and objectives. Organizations are also prompted to pay special attention to individuals belonging to vulnerable subpopulations affected by the benefits packages, which can include people with rare diseases or particularly serious illnesses. Meeting the expectations of the other content areas goes a long way toward meeting the requirements for this content area. Organizations that include elements of compassion in their benefits packages will benefit by being seen as credible and fair. Physicians and plan members may also feel that it is less necessary to “game the system” within these organizations.15 In applying compassion to managed care pharmacy, the drugs covered in a plan should be fairly representative of the needs of the entire affected population, including vulnerable individuals and those who would be among a very few who need a particular drug (e.g., rare disorders). For example, a prescription drug benefit would cover some number of triptans for the treatment of migraine headaches. Plan members who require noncovered triptans for clinical reasons would have a means to make such a request without suffering undue burden or risk. If a dispute arises between a plan member and the payer organization about coverage for a noncovered triptan, there would be mechanisms manageable by plan members to argue the case further and to ensure that people with the necessary expertise, and without conflicts of interest, are involved in making the final decision. Discussion The rising costs of providing prescription drug benefits over the past several years have resulted in the need to limit covered pharmaceuticals and to implement a variety of administrative practices (e.g., prior-authorization programs, step-therapy protocols) to contain costs. As health care professionals, pharmacists working in the managed care and pharmacy benefits industries want patients to have access to the medications they need to attain good health outcomes. Furthermore, pharmacists do not want their good intentions in controlling the costs of pharmaceuticals to merely result in higher costs elsewhere in the system. Therefore, the pharmacists involved in determining coverage limits and in operating administrative programs can experience ethical tensions and moral distress. The traditional education and training of pharmacists have not prepared them to recognize and manage the ethical tensions and moral distress they can now face in managed care pharmacy environments. They are generally left to their own devices. Many pharmacists have done well by their own moral identity, moral resources, and reliable intuitions; others have not.8 Yet, pharmacists must respond correctly to these ethical challenges because the health of individual patients and groups of people can be affected. Pharmacists accrue this obligation through their status as health care professionals and through the trust placed in them as represented by the awarding of licenses to practice. Conclusion The Ethical Force Program’s consensus report, “Ensuring Fair Coverage Decisions,” provides guidance to pharmacists involved in determining prescription drug benefit-coverage policies and administrative practices. The report states that ethical organizational processes for making coverage decisions should be transparent, participatory, equitable and consistent, sensitive to value, and compassionate. References 1 Heffler S, Smith S, Keehan S et al. U.S. health spending projections for 2004–2014. Project Hope. http://content.healthaffairs.org/cgi/reprint/hlthaff.w5.74v1 (accessed 2005 Apr 29). 2 Daniels N, Sabin J. Limits to health care: fair procedures, democratic deliberation, and the legitimacy problem for insurers. Philos Public Aff . 1997 ; 26 : 303 –50. Crossref Search ADS PubMed 3 Pearson S, Sabin JE, Emanuel E. No margin, no mission: health-care organizations and the quest for ethical excellence. New York: Oxford Univ. Press; 2003 . 4 Emanuel EJ. Justice and managed care: four principles for the just allocation of health care resources. Hastings Cent Rep . 2000 ; 30 (3): 8 –16. Crossref Search ADS PubMed 5 Teagarden JR, Daniels N, Sabin JE. A proposed ethical framework for prescription drug benefit resource allocation policy development. J Am Pharm Assoc . 2003 ; 43 : 69 –74. 6 Daniels N, Teagarden JR, Sabin JE. An ethical template for pharmacy benefits. Health Aff . 2003 ; 22 : 125 –37. Crossref Search ADS 7 Daniels N, Sabin JE. Setting limits fairly: can we learn to share medical resources? New York: Oxford Univ. Press; 2002 . 8 Teagarden JR. Pharmacists, ethics, and pharmacy benefits. Am J Pharm Educ . 2003 ; 67 : 1 –6. 9 Wynia MK, Cummins D, Fleming D et al. Improving fairness in coverage decisions: performance expectations for quality improvement. Am J Bioeth . 2004 ; 4 : 87 –100. Crossref Search ADS PubMed 10 Fleming D, Sabin J, Saphire-Bernstein I. Ensuring fairness in health care coverage decisions: a consensus report on the ethical design and administration of health care benefits packages. Chicago: American Medical Association; 2004 . 11 American Medical Association.The Ethical Force Program. www.ama-assn.org/ama/pub/category/14401.html (accessed 2005 Jan 8). 12 Rodwin M. The neglected remedy: strengthening consumer voice in managed care. www.prospect.org/print/V8/34/rodwin-m.html (accessed 2005 Jan 19). 13 Daniels N, Sabin JE. The ethics of accountability in managed care reform. Health Aff . 1998 ; 17 : 50 –64. Crossref Search ADS 14 Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review). St. Paul, MN: American Academy of Neurology; 2000 . 15 Wynia MK, Cummins DS, VanGeest JB et al. Physician manipulation of reimbursement rules for patients: between a rock and a hard place. JAMA . 2000 ; 283 : 1858 –65. Crossref Search ADS PubMed Author notes The opinions in this report are those of the authors and, where specified, of the oversight body for the Ethical Force Program. They should not be ascribed to Medco Health Solutions, Inc., the American Medical Association, or the other organizations involved in the Ethical Force Program. Copyright © 2006, American Society of Health-System Pharmacists, Inc. All rights reserved. TI - Ensuring fairness in coverage decisions: Applying the American Medical Association Ethical Force Program’s consensus report to managed care pharmacy JF - American Journal of Health-System Pharmacy DO - 10.2146/ajhp050546 DA - 2006-09-15 UR - https://www.deepdyve.com/lp/oxford-university-press/ensuring-fairness-in-coverage-decisions-applying-the-american-medical-RO76SigSH0 SP - 1749 VL - 63 IS - 18 DP - DeepDyve ER -