The challenge of reining in the rising costs of the Medicare Program is particularly thorny because it confronts a recalcitrant societal tension between the necessity for cost control and the value of open-ended technology use for life extension in the later years. That tension is becoming more deeply entrenched because a growing number of older patients and their families, when faced with life-threatening disease and informed by their doctors that they may benefit from certain treatments, do not often or easily refuse them. To reject therapies that are considered standard care would be to deny the authority of the latest medical knowledge and to deny the value of longevity.

An aging society, a growing array of expensive life-extending interventions, expanding Medicare coverage policy, evidence of effectiveness, and the primacy of individual autonomy together contribute to deepening tension in which the value of new treatments and individual choice is pitted against the sustainability of the Medicare program.

We argue that the debate over the ethics of cost control continues because connections within the organization of U.S. health care delivery have emerged as a broadly-based locus for ethics. Traditionally, ‘ethics’ in health care,  bioethics, has been understood as the content of difficult clinical choices, such as whether to withhold or withdraw treatment.  That conceptual framing ignores the powerful, linked organizational mechanisms connecting biomedical science with health care delivery. Ethical judgment, we contend, is implicit in the organization of the system through which evidence-based medicine influences Medicare reimbursement criteria and standards of care; and in the ways evidence and standards of care emphasize the potential ‘good’ of particular treatment options for ever-expanding patient populations.

‘Ethics’ continues to be thought of as a topic that is outside the linkages forged among scientific outcomes data, Medicare payment criteria, standards, and treatment necessity, rather than as being embedded in that structure of connected health care delivery drivers. Thus, acknowledgement of what constitutes ‘the ethical’ has been displaced from that larger frame of connections onto the tension between cost control and rationing. That limited idea of ethics set the stage for the notion of ‘death panels’ in 2009, the idea that life and death decisions about healthcare would be made by bureaucrats  rather than by knowledgeable healthcare professionals.

The chain of linked mechanisms of health care delivery

Because life-threatening conditions are common among the elderly, Medicare coverage policies play a key role in determining which life-extending therapies become possible and appropriate treatments for older citizens. Centers for Medicare and Medicaid Services (CMS) committees continually review the treatments Medicare will pay for and the diseases and conditions it will consider under its coverage umbrella. The “reasonable and necessary” clause that statutorily establishes the parameters for coverage, while acknowledged to be partly responsible for why cost-effectiveness has not been incorporated into Medicare coverage policy, is one example of language that directs ethical practice, and it illustrates the embedding of ethical reasoning in structural guidelines.

Evidence-based assessments by the CMS of what is “reasonable and necessary” are the key factor in determining reimbursement, though improved outcomes are becoming a CMS priority. Those assessments privilege new technologies and increase the pressure on Medicare and other large payers to cover them. Interventions shown to be effective in clinical trials (though often for younger populations with specific conditions) quickly become ‘best’ treatments and standards of care, despite scant data on the effects on the oldest citizens, especially those with co-morbidities. The trend continues for ever-older patients to receive new technologies, even at the end of life.

Physicians do not and cannot ignore what becomes standard of care, and these standards are deemed to be the right of every patient. With every new intervention shown to be effective for some, “need” is ratcheted up beyond the boundaries of the original study population. More “need” is created through the development of new therapies, through clinical trial and other study results, and through the expansion of Medicare payment for those therapies. Standards and need reinforce one another and contribute to more recommendations and demands for treatment.

Cost-effectiveness and value for individuals and for society are ignored or minimized in this broader conceptualization of implicit ethical judgment. The lack of attention paid by the CMS to cost-effectiveness in general, and the inability to define value in relation to specific interventions and outcomes highlight the fact that the “technological imperative,” rather than value, underlies Medicare policy. The potential for costs to spiral out of control is particularly acute with regard to life-extending interventions for the elderly.

By enabling payment for new treatments, by legitimating potentially life-extending procedures for those in ever-later life through the connections forged between the ‘good’ of those procedures and technological evidence, Medicare coverage decisions proscribe the ‘downstream’ clinical choices faced by physicians, patients and families. Our point is that the ethics of those ‘downstream’ choices is already prefigured by and subsumed within the connections made between ever-emerging evidence, the shaping of standards and need, and the organization of payment. By permitting evidence-based therapeutics to drive coverage policies, Medicare creates both the infrastructure and value for the linkages among scientific rationality and treatment options to occur.

Because acknowledgment of the role of ethical judgment in the three links embedded in the structure of American health care delivery – from evidence to reimbursement, from reimbursement to standards of care, and finally, from standards to therapeutic options debated, offered and accepted in the clinic — is masked by the rationality of the links themselves, that acknowledgment is absent in public debate. It remains unexposed and unanalyzed in discussions of the challenge of using cost effectiveness criteria to influence Medicare policy.

The growing use of the implantable cardiac defibrillator: one clinical outcome of embedded ethics

The implantable cardiac defibrillator (ICD) illustrates how Medicare policy shapes standards, need, and practice. As physician use and expertise of the device increases, and as direct-to-consumer advertising becomes more common, patient familiarity with it grows and patients are led to expect it to extend life and improve its quality.

The swift movement from technological capability to standard of care and need is reinforced by the politics and economics of cardiac treatment. In the clinic, physicians are paid to insert devices, not to discuss their implications for chronic care and end of life experience. Thus, once new devices are shown to be effective for certain populations under specific circumstances, and are approved for use by insurance mechanisms, specialists feel obliged to offer them widely, and patients consider, want and, most often, accept them, whether appropriate or not.  A recent study shows that 22.5 percent of patients with ICDs in the National Cardiovascular ICD registry between 2006-09 did not meet evidence-based criteria for implantation.

Initially approved by the US Food and Drug Administration in 1985, the ICD was framed by Medicare as “a treatment of last resort…” for patients who had documented episodes of life-threatening arrhythmias or cardiac arrest. Following a series of clinical trials which showed survival benefits for lower risk populations, the ICD has come to be considered as a means of primary prevention of sudden cardiac death. As a result of expanding indications for use, Medicare coverage criteria for the device broadened considerably, and 600,000 more people annually are considered appropriate candidates. As the US population ages, the number of older persons receiving the device will increase and the number of devices going to the very elderly may increase as well. Currently, one-fifth of ICD devices are implanted in persons age 80 and above.

Implications and consequences of expanded ICD use

The use of an ICD can further complicate clinical care because of its implications for end-of-life care and for extending the dying process. Furthermore, because the ICD can correct a lethal heart rhythm, it enables recipients to live on with other cardiac problems, shifting the cause of death from arrhythmias to lengthier periods of heart failure. This in turn causes patients to become candidates for even more complex implantable therapies – such as the left ventricular assist device (LVAD), a mechanical pump that enables a severely weakened heart to pump blood through the body, and which is Medicare-covered for patients who require permanent mechanical cardiac support. The LVAD costs 10 times more than an ICD to implant and monitor. Thus, increased use of the ICD paves the way for treating end-stage heart failure later, with even more powerful and invasive devices.

Advising a patient in the eighth or ninth decade of life to implant an ICD as a preventive strategy carries with it care ramifications that patients and families do not necessarily foresee, as well as cost implications for the Medicare program. Postponing death from a heart attack allows one to live with and suffer from the symptoms of heart failure and a host of other degenerative conditions.

Increased usage of the ICD reinforces the lack of medico-social acceptability of sudden death and extends that lack of acceptability to older persons with advanced heart disease. While opinions diverge about whether the use of the ICD in very old individuals is appropriate therapy, use of this device is increasing because it prevents death, because specialists are trained to use it and thus are inclined to do so and, significantly, because clinical trial evidence and Medicare reimbursement have paved the way for its expanded use.

Reform initiatives to consider cost effectiveness

Two new entities have recently been established under the Obama health care reform package, and are tasked with considering the cost implications of health care decisions. This is an opportunity for new thinking about what drives costs. The Center for Medicare and Medicaid Innovation (CMI), within CMS, is charged with developing new ways to provide and pay for health care, with the dual goals of cost reduction and quality preservation. The independent Patient-Centered Outcomes Research Institute (PCORI) will develop national standards for the conduct of comparative effectiveness research, contract with private and public agencies to conduct and review research, and allow those publicly available study findings to inform health care decision-making. PCORI’s charge includes the identification of “…the effect on national expenditures associated with a health care treatment, strategy, or health condition…”

Thus, both CMI and PCORI are mandated to consider the cost implications of treatments and should, in our opinion, extend their purview to look at the ethical underpinnings of availability and demand for services.  However, because they are required to consider only relative costs of alternatives, the actual cost per unit of benefit will remain unexamined. The key question — what cost is too much? — has not been addressed by legislation or coverage decisions. It can only be addressed in a new approach that understands and considers the links among evidence-based therapeutics, payment criteria, and the making of standards, options and need. And then, a paradigm shift in expectations will need to occur.

Conclusion  and Challenge

The ethical judgments embedded in the connections among evidence-based medicine, Medicare policy, standards of care, need and expectation are not acknowledged and have not been included in discussions of the causes of rising medical care costs. While the technical yardsticks of safety and efficacy have been the basis for coverage decisions, the linkages from government-funded and industry-driven evidence to coverage approval, to standards of care and then to need, all include implicit ethical judgments and choices in and of themselves.

Disregarding the role of Medicare policy in shaping the ‘downstream’ effects of this broad context of ethics will doom health care reform from the outset. The current reform initiatives offer a forum for addressing the relationship of rising costs to the ethical judgment implicit in Medicare policy and in the organizational mechanisms of the U.S. health care delivery system.