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18 October 2005 | Volume 143 Issue 8 | Pages 600-608
Background: Low-income Medicare beneficiaries without prescription benefits have high out-of-pocket medication expenses that can discourage adherence to treatment regimens. The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 created a temporary drug discount card program and a prescription benefit with low-income provisions to assist with medication expenditures for eligible seniors.
Objective: To determine the impact of the new drug discount card and prescription benefit on medication expenditures by low-income Medicare recipients who require pharmaceutical company assistance for obtaining medications.
Design: Retrospective, nonrandomized evaluation.
Setting: Family practice physicians' office in northern Virginia.
Patients: 137 Medicare recipients without prescription coverage who received assistance from pharmaceutical companies for medications.
Measurements: Patients were stratified into 3 categories according to income, household size, and the federal poverty line (FPL), as defined by the new Medicare act. Participants' long-term oral and inhaled medications, dosages, and instructions for use were obtained. The MMA criteria for low-income provisions were applied for the drug discount program and for the prescription benefit. Medication costs under the new Medicare benefits were compared with those incurred without assistance and with the use of pharmaceutical company programs for the cohort and FPL categories.
Results: In all income categories, medication costs were lower after enrollment in all programs than those of patients without assistance. Compared with pharmaceutical company assistance, Medicare drug discount cards resulted in less savings for all income groups. For the prescription benefit, persons with incomes less than 135% of FPL had the greatest benefit because of low-income subsidies. Persons ineligible for low-income subsidies receiving the standard benefit had a smaller reduction in out-of-pocket costs and variable monthly expenditures; they realized a superior savings with pharmaceutical company assistance programs.
Limitations: The generalizability of these findings is limited because the authors used a discount pharmacy to determine drug costs for persons receiving no assistance, could not determine asset criteria for the MMA drug benefit low-income subsidy, and used a selected Medicare population.
Conclusions: In a low-income Medicare population without prescription coverage, pharmaceutical company programs offered considerable savings and were superior to the Medicare drug discount cards. For the Medicare prescription plan, the greatest savings was among those eligible for low-income subsidies. Month-to-month medication costs may vary substantially for persons ineligible for such subsidies, and pharmaceutical company assistance may be a better alternative.
On 8 December 2003, President George W. Bush signed the Medicare Prescription Drug, Improvement and Modernization Act (MMA) into law (6). The MMA adds prescription coverage to the Medicare benefits with the goal of alleviating the cost of medications, particularly for persons with low annual incomes or high out-of-pocket medication costs. The details of the plan's eligibility requirements and covered expenses can be found in Table 1 and Table 2. To assist low-income seniors, the program includes provisions for subsidies to provide drug coverage to eligible persons with modest assets and incomes of 150% of the federal poverty line (FPL) or less (7). The MMA also includes a provision for private companies to offer approved drug discount cards to provide temporary assistance for prescription costs until the MMA drug benefit begins on 1 January 2006 (7). Participation in the program is voluntary and is limited to the selection of 1 card. Beneficiaries began to enroll in May 2004, with the goal of selecting the card that would offer the greatest discount on their current medications. MEDICINE AND PUBLIC ISSUES
Impact of the Medicare Modernization Act on Low-Income Persons
Lack of prescription drug benefits is a problem that plagues many Medicare beneficiaries; in 2003, 31% of these individuals had no coverage (1). Not only does this void lead to increased out-of-pocket spending for medications, it also increases the likelihood of deliberate nonadherence to medication and less spending on basic necessities (1, 2). The cost of medication is particularly burdensome for low-income seniors who spend a greater proportion of their income on these expenses (1, 2). Low-income Medicare beneficiaries without drug coverage have limited options if they are not eligible for Medicaid drug assistance. Individual states can pursue alternatives for their residents, including Pharmacy Plus demonstrations (waivers to expand the eligibility for Medicaid drug coverage) and State Pharmacy Assistance Programs. Only 4 states, however, have approved waivers and only 25 states provide pharmacy assistance programs; therefore, they are not a solution for all seniors (3, 4). An option available for all low-income individuals is pharmaceutical company assistance programs and discount cards for covered medications. If resources are available to encourage participation in these programs, persons without drug coverage and with incomes meeting program guidelines can receive eligible medications at reduced cost or free of charge. However, these programs are often underutilized because patients and health care professionals are unaware of their existence (and their qualification requirements) and because of the time and complexity of the applications (5).
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The Congressional Budget Office estimates that 87% of Medicare beneficiaries will enroll in the prescription benefit in 2006; the Centers for Medicare & Medicaid Services (CMS) approximates that 11 million seniors will be eligible for low-income subsidies (10, 11). We sought to determine how the MMA drug discount card and prescription drug benefit would affect low-income persons who require pharmaceutical company assistance for obtaining and affording medications.
Methods
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Our purpose was to determine the out-of-pocket expenditures of low-income senior citizens who obtained medications with the aid of pharmaceutical company assistance programs, the Medicare drug discount card, and the Medicare prescription benefit. Approximately 41% of patients at Amherst Family Practice have Medicare. The practice has 7 physicians and is located in Winchester, Virginia. Winchester is in Frederick County, which has an estimated population of 66 611 and contains a level II, 405-bed medical center that serves the tri-state region of northwestern Virginia, West Virginia, and western Maryland.
After our study received approval from the Human Subjects Review Board of Shenandoah University, participants were identified through a database search of patients at Amherst Family Practice who had received assistance from pharmaceutical companies in the preceding 7 months. The database included patients without prescription insurance who could not afford their medications and relied heavily on medication samples and were referred by physicians or office personnel. Participants with Medicare Part A and Part B coverage were identified from the database and were considered for inclusion. To be eligible, persons had to have obtained at least 1 oral or inhaled medication with pharmaceutical company assistance. Patients were excluded if they were not receiving an oral or inhaled medication, had provided incomplete information for the analysis, had a change in eligibility for pharmaceutical company assistance, or were no longer seen in the practice.
The records of all eligible patients were reviewed for the following: total yearly income; household size; current long-term oral and inhaled medications, dosage, and directions; and the current means for acquiring medications. Topical medications, including creams, ointments, and ophthalmic drops, were excluded because we could not accurately assess a day's supply and because the medications were often prescribed by a physician outside our practice. For each person, total medication costs for various scenarios were evaluated: projected monthly and yearly medication costs without assistance, current monthly and yearly medication costs with pharmaceutical company assistance programs, projected monthly and yearly medication costs with the Medicare drug discount program, and projected monthly and yearly medication costs with the Medicare prescription benefit.
Eligibility criteria for transitional assistance with the Medicare drug discount program and low-income subsidies with the prescription benefit were obtained from review of the MMA (7). Cash prices for 30-day supplies of medications were obtained from http://www.drugstore.com to estimate costs paid by persons receiving no assistance. To determine the discount received with the Medicare drug discount program, the interactive tool on http://www.medicare.gov was used; the card program providing the greatest total discount (lowest monthly cost) for all medications was selected. Medication prices were obtained in June 2004. The Appendix provides details on how drug costs were calculated.
Statistical Analysis
Statistical analyses were completed with SPSS software, version 12.0 for Windows (SPSS, Inc., Chicago, Illinois). Patients were stratified according to 2004 federal poverty guidelines (8). Income categories were defined according to the MMA (7) as less than 135% of FPL, 135% to 150% of FPL, and greater than 150% of FPL. We determined a patient's FPL income category by calculating total yearly income from all sources and by household size. Descriptive statistics were used to calculate demographic data for the entire cohort and within FPL categories. Differences in total monthly and yearly cost of obtaining medications without assistance, with pharmaceutical company assistance, and with the Medicare drug discount program and prescription benefit were examined for the entire sample and within different FPL categories.
Role of the Funding Source
No funding was received for this study.
Results
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Total medication expenditures for FPL income groups not receiving assistance were compared with expenditures under the various programs. These data are presented in Table 4. Savings with pharmaceutical company assistance programs were consistent throughout income groups.
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Medicare Drug Discount Cards
Of the 109 persons eligible for transitional assistance with the Medicare drug discount program, 56% would qualify to pay only 5% of drug costs. Over a 12-month period, transitional assistance would last an average of 3.2 months (range, 0.8 to 12 months) and would result in monthly costs ranging from $2.10 to $77.13 (mean, $20.94). With the credit expended, the discount on medications would be similar to that received by the group with incomes greater than 135% of FPL; monthly costs increased 11.4-fold to an average $259.71 (range, $22.85 to $720.69). Ineligibility for transitional assistance led to a 25% increase in yearly out-of-pocket drug costs. Although the Medicare drug discount program resulted in savings for all income categories compared with no assistance, medication costs were 2.2 to 3.3 times higher (depending on eligibility for transitional assistance) than those incurred with pharmaceutical company assistance programs.
Medicare Prescription Drug Benefit
Most participants (85.4%) qualified for low-income subsidies; of the entire cohort, 25 persons (18.2%) had annual out-of-pocket costs that exceeded $3600, the point at which catastrophic coverage begins. All income categories had lower out-of-pocket medication costs with the Medicare prescription benefit than with no assistance; those with lower FPL incomes had greater benefit because of the low-income subsidies.
When out-of-pocket costs with the Medicare prescription benefit are compared with costs with pharmaceutical company assistance, the option offering the best benefit varied by income group. For the group with incomes less than 135% of FPL, the Medicare prescription benefit was the best option for lower medication costs. No advantage was apparent between the 2 options for persons with incomes ranging from 135% to 150% of FPL, and pharmaceutical company assistance resulted in lower medication costs for incomes greater than 150% of FPL (Table 4).
The Figure illustrates the monthly drug expenditures by persons with the Medicare prescription benefit whose incomes were either 135% to 150% of FPL or greater than 150% of FPL. The lower income group had higher drug costs in January because of the $50 deductible, but monthly out-of-pocket costs remained constant thereafter. However, monthly drug expenditures of the higher income group varied throughout the year because of the $250 deductible and a gap in coverage. Within those 12 months, 35% of the higher income group (7 out of 20 participants) had total drug costs less than $2250. Of the remaining individuals in this group, 55% (11 participants) stayed in the gap in coverage, whereas 10% (2 participants) reached catastrophic coverage. When the gap in coverage was reached, drug costs were higher overall; absolute increases ranged from $168.01 to $446.00 over 1 to 2 months.
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With the Medicare prescription benefit, the group with incomes less than 135% of FPL paid 7.8% of their total yearly drug expenditures, whereas the groups with incomes of 135% to 150% and greater than 150% of FPL were responsible for 38.0% and 68.7% of their drug costs, respectively.
Discussion
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Strengths of the Analysis
A strength of our analysis is the examination of a real-life issue for low-income senior citizens who do not have prescription insurance, are struggling to afford medications, and are unsure whether the Medicare prescription program will benefit them in 2006. To evaluate the savings of the Medicare drug discount card, we attempted to mimic real scenarios by finding the discount card program that would offer the lowest price on all of a person's medications. We then examined the savings over 12 months, including the effect after transitional assistance has been exhausted. Although our analysis illustrates the impact of the Medicare prescription plan for seniors eligible for low-income subsidies, it also demonstrates the effect in low-income patients who are ineligible for subsidies. Findings for those individuals revealed variable month-to-month out-of-pocket costs because of the design of the standard benefit. Our analysis found a dramatic reduction in medication costs with pharmaceutical company assistance programs in a population with low, fixed incomes; these programs create a viable alternative to the Medicare prescription benefit for individuals who do not qualify for low-income subsidies.
Limitations of the Analysis
Our analysis is not without limitations. We obtained baseline drug costs from http://www.drugstore.com, which offers discounts off retail prices; therefore, actual savings compared with retail pharmacy prices may be greater than we have estimated. Several pharmaceutical companies have established adjunct plans to the Medicare drug discount card programs to provide additional savings to seniors who have depleted transitional assistance and for seniors with incomes between 135% and 150% of FPL (15, 16). These additional benefits were not incorporated into our analysis and should result in lower drug costs on select medications. A limitation in our analysis of the Medicare prescription benefit was the unavailability of specific asset criteria for eligibility for the low-income subsidies; therefore, eligibility was based solely on income. Because beneficiaries must meet annual income and asset limits to receive low-income subsidies, our results probably overestimated the number of seniors who would receive the subsidies. Last, we evaluated a population of low-income Medicare beneficiaries who had no drug coverage and needed assistance with obtaining medications; therefore, our findings may not apply to Medicare beneficiaries of all income levels or to those with existing prescription coverage.
Other Evaluations of the Medicare Drug Discount Cards
The savings of the Medicare drug discount program and the impact of transitional assistance have been evaluated by the Centers for Medicare & Medicaid Services (CMS), the Lewin Group, and the American Enterprise Institute (9, 16, 17). Compared with our evaluation, most of these analyses examined the discounts on specific medications and the influence of transitional assistance over various time frames. The CMS study evaluated commonly used brand-name and generic medications and reported overall savings of 12% to 21% and 28% to 75%, respectively; savings with transitional assistance were greater over a 4-month period, averaging 44% to 92% (17). The Lewin Group found that total savings averaged 35% over 18 months with the Medicare discount card and 47.3% with transitional assistance versus 19.9% in ineligible seniors (16). Last, the American Enterprise Institute found that ineligibility for transitional assistance (persons with incomes > 200% FPL) led to smaller discounts on brand-name (8% to 13%) and generic drugs (6% to 23%) over 7 months than those received by eligible persons (brand-name, 53% to 69%; generic, 50% to 78%) (9).
We found less benefit for transitional assistance over a 12-month period, regardless of a person's eligibility, than the authors of these previous analyses. Our research suggests that pharmaceutical company assistance programs are a better way for low-income individuals to save money, especially given the increase in costs after the depletion of transitional assistance.
Other Evaluations of the Medicare Prescription Benefit
In 2005, CMS estimated that the Medicare prescription benefit would pay 50.4% of drug costs for beneficiaries ineligible for low-income subsidies in 2006 compared with 96.1% for those who are eligible (18). Regarding low-income subsidies, the Medicare prescription benefit will pay 85% of medication costs for persons with incomes ranging from 135% to 150% of FPL to 98% of costs for persons with full Medicaid benefits and incomes less than 100% of FPL (18).
In another analysis by the Kaiser Family Foundation and the Actuarial Research Corporation, persons without previous drug coverage who qualified for low-income subsidies were estimated to achieve, on average, an 89% reduction in drug costs. In comparison, ineligible persons had a 50% reduction that diminished to 23% when monthly premiums were factored into expenses (19). Persons eligible for low-income subsidies would save across all FPL income categories: 84% savings for incomes less than 100% of FPL, 85% savings for incomes ranging from 100% to 135% of FPL, and 77% savings for incomes ranging from 135% to 150% of FPL. For an estimated 5.7 million persons (41.6% of beneficiaries) who do not apply for low-income subsidies or who have qualifying incomes but excessive assets, drug costs will be 2.5 to 9.5 times higher, depending on their income category.
PricewaterhouseCooper's evaluation of the Medicare prescription benefit found that beneficiaries without previous drug coverage, regardless of income, would pay 41% of total drug costs on average; senior citizens qualifying for low-income subsidies would pay only 5% to 15% of drug costs, depending on the degree of benefit (20). These researchers performed a separate analysis in low-income beneficiaries (limited to persons with incomes of 
150% of FPL) and found that the proportion of individuals paying less than $250 annually for medications will increase from 40% to 65% with the drug benefit and the low-income subsidies. The out-of-pocket costs for medications will decrease from an average $1495 yearly to $725 (21).
A recent report stated that an estimated 2.37 million Medicare beneficiaries will have qualifying incomes for low-income subsidies but will be ineligible because of excessive assets (22). These individuals will face much higher drug costs with the standard drug benefit. The existing analyses of the prescription benefit fail to illustrate how a gap in coverage will affect people from month to month. The average 2.2-fold increase in out-of-pocket costs that occurs over 1 to 2 months when beneficiaries reach the gap in coverage found in our analysis could create a hardship for fixed-income individuals who are ineligible for low-income subsidies.
In summary, 15% of Medicare beneficiaries will be eligible for transitional assistance with the Medicare drug discount cards (8). We found that the $600 subsidy helps offset drug costs, but recipients face large increases in medication costs when it is exhausted; those individuals who are ineligible for transitional assistance will realize little savings. The use of pharmaceutical company-sponsored assistance programs provided lower out-of-pocket costs and should be considered for all low-income seniors; the Medicare drug discount card and transitional assistance can be used for unmet medication needs. Most pharmaceutical company programs will not limit access for persons with Medicare-approved discount cards.
In addition, 37 million Medicare beneficiaries are projected to enroll in the Medicare drug benefit in 2006 (8). For the estimated 11 million senior citizens eligible for low-income benefits, we found that the program substantially reduced medication costs compared with expenditures by persons receiving no assistance (8). The remaining low-income individuals who do not qualify for the low-income subsidies will receive the standard benefit and face higher out-of-pocket costs and variable monthly drug costs if and when they reach a gap in coverage. In addition, persons with annual medication expenditures less than $810 who enroll in the drug benefit will actually pay more for drugs than if they had no coverage (9). Table 5 illustrates how eligibility for the low-income subsidies can drastically affect out-of-pocket medication costs. Before enrolling in the drug benefit, individuals should consider their eligibility for low-income subsidies and their prescription needs and projected costs. For some seniors, such alternatives as pharmaceutical company assistance programs may provide more cost savings.
Appendix
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Costs for a 30-day supply for all long-term oral and inhaled medications were obtained from http://www.drugstore.com and used to calculate monthly and yearly medication costs. If a brand-name drug was obtained through pharmaceutical company assistance and a generic alternative was available, the price for the generic medication was used.
Determination of Medication Costs with the Use of Pharmaceutical Company Assistance Programs
Medical records and a database of patient assistance records were used to determine how patients currently acquired medication. Baseline costs for 30-day supplies of medications were determined from http://www.drugstore.com, and generic alternative drug prices were obtained if available. Costs for medications obtained through pharmaceutical company assistance programs were assigned as zero; costs for medications obtained with a pharmaceutical company discount card were assigned depending on the card. The discount cards used by persons in the analysis were the Pfizer Share Card (Pfizer Inc., New York, New York) and the LillyAnswers card (Eli Lilly and Co., Indianapolis, Indiana); prices for a 30-day supply of a single medication with these cards were $15 and $12, respectively. From this information, we then calculated total adjusted monthly and yearly medication costs.
Medication Costs with the Medicare Drug Discount Card
We determined the discounted medication costs for the Medicare Drug Discount program by using http://www.medicare.gov and selecting the "Find available Medicare-approved drug discount cards, and compare prices for your prescriptions" link. After we input the requested information, the site provided various Medicare drug discount cards. The card with the lowest monthly cost on all medications was selected, and the discounted cost for a 30-day supply for each medication was recorded. Monthly and yearly medication costs were determined from the prices obtained from http://www.medicare.gov.
The cost for a 30-day medication supply for participants eligible for transitional assistance was determined from prices provided by http://www.drugstore.com. Persons with incomes less than 100% of FPL had a 5% copay, while those participants with incomes ranging from 100% to 135% of FPL had a 10% copay applied. The duration of transitional assistance over 12 months was determined by dividing $600 by the total yearly drug cost without assistance and multiplying by 12. Total medication costs per year with the transitional assistance were determined by taking the monthly cost of all medications with the 5% or 10% copay and multiplying by the time transitional assistance would last. Total medication costs after depletion of transitional assistance were determined by taking the monthly discounted cost of medications from http://www.medicare.gov and multiplying by the number of months remaining in the year after transitional assistance. Total yearly medication costs were determined by adding the yearly amount paid with transitional assistance to the amount paid after transitional assistance.
Medication Costs with the Medicare Prescription Benefit
For persons with incomes less than 135% of FPL who were eligible for low-income subsidies, a monthly $2 copay was assigned to generic medications. If a brand-name drug was obtained through pharmaceutical company assistance and a generic alternative was available, the generic copay was used. A $5 copay was assigned to brand-name medications. Monthly and yearly medication costs were then determined.
For participants whose income ranged from 135% to 150% of FPL and who were eligible for low-income subsidies, monthly medication costs without assistance were calculated first. The $50 deductible was then applied to the January out-of-pocket medication costs. If the month's expenses for January were less than $50, the remainder of the deductible was carried over to February. This strategy continued until the deductible was depleted. In the month that the $50 deductible was met, a 15% copay was applied to all excess monthly medication costs and added to the deductible amount (or remaining deductible amount) when total out-of-pocket expenses were being determined. Yearly medication costs were calculated by adding the monthly medication costs over the 12 months.
For the participants with incomes greater than 150% of FPL and receiving the standard benefit, a premium of $35 was included in each month's out-of-pocket drug costs. The accumulated total drug cost was tallied each month to determine when the gap in coverage and catastrophic coverage began, if applicable. After total medication costs were determined for each month, the $250 deductible was applied to the January out-of-pocket medication costs. If expenses for January were less than the $250 deductible, the remainder of the deductible was carried over to February. We continued to use this formula until the deductible was depleted. In the month that the $250 deductible was met, a 25% copay was applied to the excess monthly medication costs and added to the deductible cost (or remaining deductible amount) when determining total out-of-pocket expenses. If total medication costs exceeded $2250, expenses that month were determined by applying the 25% copay to medication costs up to $2250 and adding 100% of medication costs for those exceeding $2250. Each month thereafter, 100% of monthly "no assistance" medication costs were inputted until $5100 in drug costs was reached (hence, a gap in coverage).
Monthly medication costs during the month that total medication costs exceeded $5100 were determined by taking 100% of medication costs up to $5100. The amount above $5100 was matched to a combination of individual monthly "no assistance" medication costs to find a similar amount; the monthly cost was then determined by applying the $2 copay for generic drugs and the $5 copay for brand-name drugs. These copays were also applied when catastrophic coverage took effect (any month after cumulative medication costs had reached $5100). Yearly medication costs were determined by adding the monthly medication costs over the 12 months.
Author and Article Information
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Acknowledgments: The authors thank Estee Graves, PharmD, and Arthur Harralson, PharmD, BCPS for their substantial contributions.
Grant Support: None.
Potential Financial Conflicts of Interest: None disclosed.
Requests for Reprints: Dawn E. Havrda, PharmD, BCPS, Shenandoah University School of Pharmacy, 1775 North Sector Court, Winchester, VA 22601; e-mail, dhavrda{at}su.edu.
Current Author Addresses: Drs. Havrda and Kirkpatrick: 1775 North Sector Court, Winchester, VA 22601.
Drs. Omundsen and Bender: Amherst Family Practice, 1867 Amherst Street, Winchester, VA 22601.
References
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