Few would argue that millions of elderly and disabled Americans with chronic illness have improved quality of life, reduced risk of acute illness and hospitalization, and lower mortality rates because of access to new and effective pharmaceutical agents.1–4 Ironically, however, while the United States is the world leader in pharmaceutical research and development, it is the “world loser” among industrialized nations in its failure to provide insurance coverage for outpatient prescription drugs for disabled and senior citizens. Such coverage is not included in Medicare. Over a third of U.S. Medicare enrollees have no outpatient drug coverage; among the remaining two thirds, almost half have discontinuous or limited coverage.5 The costs of supplemental private drug coverage are so high that only a small minority of elders can afford the high premiums and coinsurance.6 Certainly, some new medications are over-promoted or inappropriately prescribed by physicians. But anecdotal and scientific evidence is mounting that the lack of economic access to new and effective pharmaceuticals is having serious adverse impacts on the health and quality of life of our nation's senior citizens.7,8
Many commentators point to rapidly rising drug expenditures as the culprit in declining access. Between 1993 and 1999, outpatient drug expenditures in the United States increased from $51 billion to $100 billion.9 Yet, only 9.4% of total personal health expenditures in 1999 were for outpatient drugs.9 From a societal perspective, this seems a small price to pay given that medications represent the most effective technologies for controlling the rapidly rising costs of chronic illness. For 5.7% of elderly, however, the costs of prescribed medications exceeded $2,000 in 1995, representing over 17.0% of the typical (median) senior citizen's income of $14,42510,11 or almost all of discretionary income.12 Drug coverage that protects against the high costs of medications is not distributed equally to all elderly Americans. Despite the existence of Medicaid, poor elders who need coverage the most have the least access to it; about a third of those with incomes less than $10,000 have coverage as compared to over 70% of those with incomes above $50,000.13 Disparities in coverage extend to those with poor health status as well: those in poor health are almost half as likely to have drug coverage as those in excellent health.13
What are the clinical consequences of this failure to provide economic access to medications among the elderly? In this issue of the Journal of General Internal Medicine, Steinman et al.14 demonstrate a strong link between lack of prescription drug coverage and underuse of prescribed medications due to costs. Using 2 years of data (1995–1996) and a large sample of elderly participants in the Survey of Asset and Health Dynamics Among the Oldest Old, the researchers provide important and disconcerting data that go beyond anecdotal evidence of cost-related non-adherence. Further, by using self-reports of the cause of reduced drug use (i.e., cost), this study weakens the argument that lower rates of drug use among those without coverage could be due to a lesser need for medication rather than a lack of coverage.
Another notable contribution of the Steinman et al. study is its attention to underuse among high-risk groups without drug coverage. The authors find that among people without drug coverage, minorities are 4 times more likely to report underuse due to cost compared to whites; people with low incomes (i.e., income <$10,000) are 3 times more likely to report underuse for this reason; and those in poor health are 3 times more likely to report underuse due to cost compared to those in very good or excellent health.
While the Steinman et al. study is cross-sectional and relies on self-reports of medication adherence, its findings are consistent with previous studies showing a strong association between drug coverage and use of effective medication. In our recent review of the literature on prescription drug coverage and drug use in the Medicare population, the strongest evidence indicated considerable unmet needs for prescription drug coverage in this population.16 Importantly, lack of coverage for prescription drugs was associated with lower use of clinically essential drugs.15–17 In a study of Medicare beneficiaries with hypertension, we found public drug coverage (e.g., state-supported pharmacy benefit programs) to be associated with almost twice the rate of use of antihypertensives compared with Medicare beneficiaries having only fee-for-service coverage after controlling for health and socioeconomic status ($302 vs $191; P < .05).16 In addition, evidence from well-controlled studies demonstrated that limiting coverage for frail low-income elderly and disabled resulted in: a dramatic reduction (35%) in the use of clinically essential drugs such as insulin, particularly among those with mental health problems and chronic pain; increased exacerbation of chronic illness (both somatic and psychiatric); and a 200% increase in the use of more expensive services (e.g., nursing homes and emergency mental health services) that outweighed the costs of the drugs.6,7,18,19 Previous studies have also identified lower rates of drug use by vulnerable populations (e.g., African-American race, low-income) without drug coverage.15,16 Despite variations in the quality of the existing evidence, the preponderance of the literature supports Steinman et al.'s finding of underuse of medications due to cost, a preventable condition that results in needless and widespread suffering.
Despite bipartisan agreement regarding the seriousness of this national public health issue, the continuing influence of special interests and Congressional gridlock have led to several missed opportunities to address this problem: the demise of the Medicare Catastrophic Coverage Act of 1988 and the 1993 Clinton Health Security Act, as well as the failure to act during the last 3 years when numerous front-page articles describing senior citizens rationing food for medicine8,20 helped to galvanize widespread public support for a solution. Clearly, the details of proposed legislation are highly controversial. Democrats have generally preferred a universal public benefit within Medicare, while Republican proposals tend to emphasize private-sector solutions and targeting of low-income and uncovered individuals. But providing adequate coverage to all elderly is estimated to cost well over $15 billion per year,21 a difficult proposition given the suddenly vanished surplus.
Unfortunately, current legislative proposals22 do not protect many vulnerable, low-income (<200% of poverty), sick and uncovered elders. Most proposals incorporate high cost-sharing (about 50% of drug costs), a cost-containment feature that has been found to reduce use of essential medications, increase hospitalization and nursing home admissions, and increase mortality in a recent well-controlled study.23 Furthermore, in most proposals catastrophic coverage does not kick in until elders expend $4,000 to $6,000 in out-of-pocket drug costs.22
Rather than pass inadequate coverage for all that pales in comparison to typical employer plans, we recommend an approach that recognizes the urgent need of low-income beneficiaries for an unlimited benefit with low copayments.20 We estimate that a substantial portion of the costs of providing coverage to this group, whose lack of economic access to drugs results in low utilization and undertreatment of important chronic illnesses, would be offset by reduced use of institutional services.24 In addition, no one should become impoverished by the need for essential medications. The second priority should be to provide universal protection against very high drug costs (e.g., after $3,000 in out-of-pocket costs). Such an approach will have a larger impact on health than thin coverage for everyone, including those who do not currently need any public assistance.
The urgent need for passage of Medicare drug coverage is recognized by millions of Americans whose votes for future Congressional and presidential candidates may depend on whether promises for a prescription drug program are kept or broken. Unfortunately, the deteriorating economy and the urgency and costs of a response to terrorism make Congressional inaction on the universal provision of drug coverage all too plausible. We urge an affordable compromise that would allow immediate comprehensive drug coverage for high-risk, low-income elderly and catastrophic coverage for all Medicare beneficiaries. Our failure to act yet again would be inexcusable. —