Medicare Prescription Drug Benefit: Estimates of Beneficiaries Who Fall Below Countable Income Thresholds, by State

Order Code RS21675 Updated February 17, 2005 CRS Report for Congress Received through the CRS Web Medicare Prescription Drug Benefit: Estimates of Beneficiaries Who Fall Below Countable Income Thresholds, by State Chris L. Peterson Analyst in Social Legislation Domestic Social Policy Division Summary The Medicare Prescription Drug Improvement and Modernization Act of 2003 (P.L. 108-173) establishes a prescription drug benefit that begins in 2006. The costsharing for prescription drugs is reduced for certain beneficiaries, depending on their income-to-poverty ratio and other factors. Using the most recent data, this report provides state-by-state estimates of the percentage and number of beneficiaries who fall below various low-income thresholds, using the definition of income specified in the law. The asset (or “resource”) limits were not factored into the analysis. This report will be updated to reflect new legislation or data. The Medicare Prescription Drug Improvement and Modernization Act of 2003 (P.L. 108-173) establishes a prescription drug benefit, under Medicare Part D, that begins in 2006. The cost-sharing (for example, deductibles and coinsurance) for prescription drugs is reduced for certain beneficiaries, depending on their income-to-poverty ratio and other factors. Table 1 shows estimates of the percentage and number of noninstitutionalized aged (age 65 or older) Medicare beneficiaries who fall below income thresholds relevant to the Part D cost-sharing. Table 2 shows the same estimates except it is for all noninstitutionalized beneficiaries, not just the aged. Even if one qualifies for cost-sharing assistance based on income, that assistance may be precluded by the beneficiary’s countable assets, or resources. This was not accounted for in the estimates. Table 3 summarizes the low-income provisions under Part D and is from CRS Report RL31525, Beneficiary Cost-Sharing Under the Medicare Prescription Drug Benefit (which has a full discussion of these low-income provisions). For additional information, see also CRS Report RL31966, Overview of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, and CRS Report RS21583, Medicare Prescription Drug Plans: Comparison of Actuarial Values. Congressional Research Service ˜ The Library of Congress CRS-2 Table 1. Average Percentage and Number of Aged (65 and Older), Noninstitutionalized Medicare Beneficiaries with Countable Incomes Below Specified Levels, by State, 2001-2003 State Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware DC Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Below 100% of Poverty Percentage 18.7% ± 2.6% 18.3% ± 3.4% 9.7% ± 2.1% 19.5% ± 2.6% 14.6% ± 1.3% 13.1% ± 2.2% 9.9% ± 1.6% 9.9% ± 2.1% 23.3% ± 3.4% 17% ± 1.3% 18.8% ± 3% 20% ± 2.6% 8.2% ± 2% 13.3% ± 1.5% 11.8% ± 1.8% 12% ± 1.9% 12.6% ± 2.1% 15% ± 2.3% 17.8% ± 2.8% 15.3% ± 1.9% 13.8% ± 2.2% 18.3% ± 2.1% 12.7% ± 1.6% 12.1% ± 2.2% 25.7% ± 3.4% 11.3% ± 1.9% 13.4% ± 2.4% 12.8% ± 2.2% 12.8% ± 2.2% 9.9% ± 1.8% 14.1% ± 1.7% 18.5% ± 3% 19% ± 1.3% 19% ± 2.2% 13.4% ± 2.1% 12.6% ± 1.5% 15.4% ± 2.3% 9.1% ± 2% 12.3% ± 1.3% 16.4% ± 2% 20.5% ± 2.5% 13.4% ± 2% 15.9% ± 2.7% 21.7% ± 1.8% 11.8% ± 2.7% 13.3% ± 2.1% 14.4% ± 2.3% 12.2% ± 2.3% 15.7% ± 2% ** * ** * * ** ** ** ** * * * * * ** * * ** * * * * ** ** ** * * * ** ** * * Number 103,000 7,000 63,000 73,000 475,000 53,000 46,000 9,000 14,000 449,000 135,000 31,000 12,000 187,000 88,000 46,000 43,000 77,000 87,000 30,000 81,000 145,000 141,000 60,000 77,000 79,000 16,000 25,000 29,000 15,000 151,000 43,000 438,000 179,000 11,000 168,000 68,000 35,000 215,000 24,000 106,000 13,000 96,000 428,000 20,000 10,000 113,000 75,000 43,000 Below 135% ofPpoverty Percentage 32.9% ± 3.1% 31.1% ± 4% 23.3% ± 3% 34.6% ± 3.2% 31.7% ± 1.7% 25.6% ± 2.9% 19.9% ± 2.2% 20.1% ± 2.8% 37.2% ± 3.8% 29.4% ± 1.5% 33.8% ± 3.7% 33.5% ± 3.1% 19.9% ± 3% 25.2% ± 2% 28.1% ± 2.6% 23.6% ± 2.5% 27.7% ± 2.7% 28.9% ± 2.9% 35.4% ± 3.5% 31.5% ± 2.4% 25.8% ± 2.8% 31.6% ± 2.6% 22.8% ± 2% 22.8% ± 2.8% 43% ± 3.9% 22.4% ± 2.5% 27.7% ± 3.2% 23.7% ± 2.9% 24.7% ± 2.8% 21.2% ± 2.5% 25.3% ± 2.1% 30.5% ± 3.6% 31.5% ± 1.6% 34.9% ± 2.6% 27.5% ± 2.8% 24.7% ± 2% 28% ± 2.9% 22.7% ± 2.9% 24.9% ± 1.7% 32.1% ± 2.5% 34.6% ± 3% 31.6% ± 2.7% 32.3% ± 3.5% 35.3% ± 2.1% 20.9% ± 3.4% 28.8% ± 2.8% 25.5% ± 2.9% 21.1% ± 2.9% 31.5% ± 2.6% ** * ** ** * * ** ** ** * * * ** ** ** * * ** * * * * * ** ** * * * ** ** ** ** ** * * * ** Number 181,000 13,000 150,000 129,000 1,030,000 104,000 92,000 19,000 22,000 778,000 242,000 51,000 29,000 354,000 208,000 91,000 94,000 149,000 173,000 62,000 151,000 251,000 254,000 113,000 129,000 155,000 34,000 47,000 57,000 32,000 272,000 70,000 725,000 329,000 23,000 329,000 124,000 87,000 432,000 47,000 179,000 32,000 195,000 697,000 35,000 21,000 201,000 130,000 87,000 Below 150% of Poverty Percentage 38.3% ± 3.2% 36.8% ± 4.2% 29% ± 3.3% 40.6% ± 3.3% 38.7% ± 1.8% 30.9% ± 3.1% 25.4% ± 2.4% 24.3% ± 3% 41.8% ± 3.9% 36.3% ± 1.6% 38.6% ± 3.8% 38.2% ± 3.2% 26.4% ± 3.2% 31.7% ± 2.1% 35.6% ± 2.7% 29.1% ± 2.7% 32.5% ± 2.9% 37% ± 3.1% 41.1% ± 3.6% 38.4% ± 2.5% 30.8% ± 2.9% 38.4% ± 2.7% 28.2% ± 2.2% 28.7% ± 3% 48.9% ± 3.9% 27.8% ± 2.7% 34.3% ± 3.4% 31.5% ± 3.1% 30.8% ± 3% 29.2% ± 2.8% 31.7% ± 2.2% 35.4% ± 3.7% 37.8% ± 1.7% 40.5% ± 2.7% 34.7% ± 3% 30% ± 2.1% 33.3% ± 3% 27.2% ± 3% 31.8% ± 1.8% 38.9% ± 2.6% 39.9% ± 3.1% 36.2% ± 2.8% 39% ± 3.6% 41.1% ± 2.2% 26.5% ± 3.7% 35% ± 3% 31.2% ± 3% 26.4% ± 3.1% 37.1% ± 2.7% ** * ** ** * * * ** ** ** * * * ** ** * ** * * ** * * * * ** ** * * * ** ** ** ** * * * Number 210,000 15,000 187,000 151,000 1,259,000 126,000 118,000 23,000 24,000 962,000 277,000 58,000 38,000 444,000 264,000 113,000 111,000 191,000 201,000 75,000 181,000 305,000 313,000 141,000 147,000 193,000 42,000 62,000 71,000 44,000 340,000 81,000 870,000 382,000 29,000 398,000 147,000 105,000 553,000 57,000 207,000 36,000 235,000 813,000 45,000 25,000 245,000 163,000 103,000 Total Avg Number of Beneficiaries 549,000 41,000 645,000 373,000 3,251,000 406,000 463,000 94,000 58,000 2,646,000 717,000 153,000 144,000 1,401,000 741,000 387,000 341,000 515,000 488,000 196,000 586,000 794,000 1,111,000 493,000 301,000 694,000 122,000 198,000 229,000 152,000 1,075,000 230,000 2,301,000 943,000 82,000 1,330,000 444,000 385,000 1,738,000 145,000 517,000 100,000 604,000 1,975,000 169,000 72,000 786,000 617,000 277,000 CRS-3 State Wisconsin Wyoming United States Below 100% of Poverty Percentage 11.2% ± 1.8% 11% ± 2.1% 15.3% ± 0.3% Below 135% ofPpoverty Below 150% of Poverty Number Percentage Number Percentage Number * 72,000 20.4% ± 2.4% * 132,000 26.4% ± 2.6% * 170,000 * 6,000 25.5% ± 3% * 14,000 34% ± 3.2% 19,000 5,012,000 28.5% ± 0.4% 9,354,000 34.7% ± 0.4% 11,369,000 Total Avg Number of Beneficiaries 645,000 57,000 32,782,000 Source: Table prepared by the Congressional Research Service based on data from the March supplement of the Current Population Survey, 20022004. Notes: Even if one qualifies for cost-sharing assistance based on income, that assistance may be precluded by the beneficiary’s countable assets, or resources, a topic not addressed in this report. Income is determined based on the definition of countable income for Supplemental Security Income, not by total family income. The Department of Health and Human Services’ federal poverty guidelines are used rather than the Census Bureau’s federal poverty threshold. The range given for the percentages reflect the 90% confidence interval. These demonstrate that, because the estimates are based on a portion of the entire aged Medicare population, the estimates are subject to variability. The size of the confidence intervals depends primarily on sample size. A 90% confidence interval means that if all possible samples were surveyed under the same sample design and general conditions, the estimated percentage in each income category would lie within the confidence interval 9 out of 10 times. The number of beneficiaries is based on the corresponding percentage point estimate. The number of beneficiaries is subject to the same kind of variability as the percentage, but the 90% confidence interval is not provided because of space constraints. * Indicates percentage of beneficiaries is statistically lower than the national rate, at the 90% confidence level. ** Indicates the percentage of beneficiaries is statistically higher than the national rate, at the 90% confidence level. Table 2. Average Percentage and Number of Noninstitutionalized Medicare Beneficiaries (Aged and Disabled) with Countable Incomes Below Specified Levels, by State, 2001-2003 State Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware DC Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Below 100% of Poverty Percentage 24.3% ± 4% 23.7% ± 5.4% 12.1% ± 3.5% 25.6% ± 4.2% 17.6% ± 2.1% 17.8% ± 3.9% 13.7% ± 2.9% 13.7% ± 3.5% 29.1% ± 5.4% 19.6% ± 2.1% 23.2% ± 4.7% 24.2% ± 4.3% 11.6% ± 3.6% 18.1% ± 2.6% 16.4% ± 3.2% 15.4% ± 3.2% 16.5% ± 3.5% 19.2% ± 3.7% 20.6% ± 4.4% 19.7% ± 3.1% 18.1% ± 3.7% 20.4% ± 3.4% 18.2% ± 2.8% 14.5% ± 3.6% 31.6% ± 5.2% 16.3% ± 3.4% 16.5% ± 3.9% 15.8% ± 3.7% ** * ** * * ** ** * * * ** Number 171,000 12,000 90,000 120,000 671,000 85,000 72,000 15,000 20,000 590,000 212,000 42,000 19,000 300,000 143,000 68,000 64,000 123,000 122,000 46,000 121,000 180,000 246,000 80,000 123,000 131,000 24,000 36,000 Below 135% of Poverty Percentage 39.7% ± 4.6% 38.5% ± 6.1% 26% ± 4.7% 40.3% ± 4.7% 35.1% ± 2.6% 30.4% ± 4.7% 23.9% ± 3.6% 24.8% ± 4.4% 42.8% ± 5.9% 32.1% ± 2.4% 39% ± 5.5% 37.3% ± 4.8% 23.2% ± 4.8% 30.8% ± 3.1% 32.1% ± 4% 26.8% ± 4% 31.6% ± 4.3% 34.4% ± 4.4% 37.7% ± 5.3% 36.1% ± 3.7% 29.3% ± 4.4% 34% ± 4% 29.1% ± 3.3% 25.8% ± 4.4% 47.7% ± 5.6% 27.4% ± 4.1% 30.5% ± 4.8% 27% ± 4.6% ** * ** * * ** ** * * * * ** * * Number 280,000 20,000 193,000 189,000 1,338,000 145,000 126,000 28,000 30,000 967,000 355,000 65,000 38,000 511,000 280,000 119,000 123,000 220,000 223,000 83,000 196,000 300,000 394,000 143,000 186,000 219,000 45,000 61,000 Below 150% of Poverty Percentage 44.9% ± 4.7% 44.1% ± 6.3% 31.8% ± 5% 46% ± 4.8% 41.8% ± 2.7% 35.8% ± 4.8% 29.6% ± 3.9% 29.6% ± 4.7% 47.5% ± 5.9% 39% ± 2.5% 44% ± 5.5% 41.6% ± 4.9% 29.7% ± 5.1% 36.9% ± 3.3% 39.3% ± 4.2% 32.2% ± 4.2% 36.4% ± 4.5% 41.7% ± 4.6% 43.3% ± 5.4% 42.7% ± 3.8% 34.4% ± 4.6% 40.5% ± 4.2% 34.2% ± 3.4% 31.4% ± 4.7% 54.2% ± 5.6% 32.2% ± 4.3% 37.6% ± 5.1% 34.9% ± 4.9% ** * ** ** * * ** * * * * ** * Number 317,000 23,000 236,000 216,000 1,595,000 170,000 156,000 33,000 33,000 1,174,000 401,000 73,000 49,000 611,000 343,000 143,000 142,000 267,000 256,000 99,000 230,000 357,000 463,000 174,000 212,000 258,000 55,000 79,000 Total Avg Number of Beneficiaries 706,000 52,000 743,000 469,000 3,813,000 476,000 528,000 113,000 70,000 3,011,000 911,000 175,000 164,000 1,658,000 872,000 443,000 390,000 640,000 591,000 231,000 668,000 882,000 1,354,000 553,000 390,000 801,000 147,000 225,000 CRS-4 State Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming United States Below 100% of Poverty Percentage 15.2% ± 3.5% 12.8% ± 3.1% 18.7% ± 2.8% 26.4% ± 5% 22.5% ± 2.2% 25.7% ± 3.5% 15.5% ± 3.5% 16.6% ± 2.6% 19.7% ± 3.9% 14.9% ± 3.6% 16% ± 2.2% 19.9% ± 3.3% 28.3% ± 4.1% 17.3% ± 3.4% 21.6% ± 4.4% 26.1% ± 3% 16.5% ± 4.7% 17.9% ± 3.6% 19.1% ± 3.8% 16.5% ± 3.9% 20.8% ± 3.2% 16.1% ± 3.2% 16.7% ± 3.8% 19.5% ± 0.5% * * ** ** ** * * * * ** ** * Number 40,000 22,000 230,000 76,000 599,000 307,000 14,000 256,000 101,000 69,000 317,000 33,000 188,000 20,000 168,000 601,000 32,000 15,000 181,000 119,000 74,000 122,000 11,000 7,526,000 Below 135% of Poverty Percentage 28.1% ± 4.4% 24.7% ± 4% 30.5% ± 3.3% 38.7% ± 5.5% 35% ± 2.5% 40.8% ± 3.9% 29.8% ± 4.4% 29.1% ± 3.2% 32.8% ± 4.6% 29% ± 4.6% 28.7% ± 2.7% 35.1% ± 3.9% 41.3% ± 4.5% 35% ± 4.3% 38.9% ± 5.2% 39.9% ± 3.3% 25.4% ± 5.6% 33% ± 4.4% 31.2% ± 4.5% 25.1% ± 4.6% 36.5% ± 3.8% 26.1% ± 3.9% 30.7% ± 4.8% 33% ± 0.6% * * ** ** * * ** ** ** * * * Below 150% of Poverty Number Percentage 74,000 33.9% ± 4.7% 42,000 33% ± 4.4% 375,000 36.4% ± 3.5% 111,000 43.2% ± 5.6% 934,000 41.1% ± 2.5% 487,000 46.5% ± 4% 27,000 36.5% ± 4.6% 451,000 34.6% ± 3.3% 169,000 37.8% ± 4.7% 135,000 33.5% ± 4.8% 570,000 35.2% ± 2.8% 58,000 42% ± 4.1% 275,000 46.2% ± 4.5% 39,000 39.3% ± 4.4% 301,000 44.6% ± 5.3% 919,000 45.2% ± 3.4% 50,000 31.4% ± 5.9% 28,000 39.2% ± 4.6% 295,000 37.1% ± 4.7% 182,000 30.2% ± 4.9% 130,000 42% ± 3.9% 198,000 32.1% ± 4.1% 20,000 38.4% ± 5% 12,750,000 38.9% ± 0.7% * * ** * * * ** ** ** * * * Number 90,000 57,000 447,000 125,000 1,096,000 555,000 33,000 535,000 194,000 155,000 698,000 70,000 307,000 44,000 346,000 1,043,000 62,000 34,000 350,000 218,000 150,000 243,000 25,000 15,041,000 Total Avg Number of Beneficiaries 265,000 172,000 1,230,000 288,000 2,668,000 1,193,000 91,000 1,549,000 514,000 465,000 1,982,000 166,000 665,000 113,000 775,000 2,306,000 196,000 86,000 945,000 724,000 357,000 758,000 66,000 38,649,000 Source: Table prepared by the Congressional Research Service based on data from the March supplement of the Current Population Survey, 20022004. Notes: Even if one qualifies for cost-sharing assistance based on income, that assistance may be precluded by the beneficiary’s countable assets, or resources, a topic not addressed in this report. Income is determined based on the definition of countable income for Supplemental Security Income, not by total family income. The Department of Health and Human Services’ federal poverty guidelines are used rather than the Census Bureau’s federal poverty threshold. The range given for the percentages reflect the 90% confidence interval. These demonstrate that, because the estimates are based on a portion of the entire Medicare population, the estimates are subject to variability. The size of the confidence intervals depends primarily on sample size. The number of beneficiaries is subject to the same kind of variability as the percentage, but the 90% confidence interval is not provided because of space constraints. * Indicates percentage of beneficiaries is statistically lower than the national rate, at the 90% confidence level. ** Indicates the percentage of beneficiaries is statistically higher than the national rate, at the 90% confidence level. CRS-5 Source of Data. The state-by-state percentages presented in this report were calculated using the March supplement of the Current Population Survey (CPS). The CPS March supplement is a survey of approximately 99,000 households selected to be demographically representative of the civilian noninstitutionalized population of the United States. The analyses in this report were based on data from the CPS for 2001, 2002 and 2003. The sample sizes available for many states are small, especially when examining a subset of the sample like Medicare beneficiaries over the age of 65. Small sample sizes increase the likelihood that the characteristics of the survey participants differ from the characteristics of the population they are meant to represent, which is known as sampling error. To increase the reliability of state-level estimates, multipleyear estimates were calculated. Income Defined. In P.L. 108-173, income is counted according to Supplemental Security Income (SSI) eligibility guidelines. As a result, appropriately estimating the number of individuals who may be eligible for assistance under the law requires a more in-depth analysis than simply looking at individuals’ or families’ reported total income. The estimates of income used in this report were obtained by taking respondents’ total income as reported in the CPS and subtracting from it the amounts and types of income specified according to SSI eligibility rules as follows. Income was divided into two categories — earned income, which consists of the CPS variables for wages and self-employment earnings, and unearned income. The CPS gathers information on 17 types of unearned income. Two of these are not considered income for SSI purposes: education assistance and child support payments.1 The amount of countable unearned income was reduced by up to $240 per year ($20 per month). If that maximum amount was not reached (that is, if unearned income was less than $240 for the year), then the remainder of the $240 disregard was subtracted from earned income.2 Countable earned income was reduced by an additional $780 per year ($65 per month). Once the remaining countable earned income was calculated, if there was any left, half of it was subtracted, and the amount that remained was counted as earned income. The couple’s or individual’s countable earned and unearned incomes were then added together and compared to the federal poverty guidelines. Poverty Defined. The poverty guidelines are published by the Department of Health and Human Services and are used primarily for determining eligibility for many federal programs, which is why the guidelines are used in this analysis. The poverty thresholds, although more commonly used for poverty-related analyses, are a different measure of poverty updated by the Census Bureau, used primarily for statistical purposes. The 2004 poverty guidelines for an individual living alone in the 48 contiguous states are $9,310; for a family of two, the guideline is $12,490. In Alaska, the guidelines are $11,630 for an individual living alone and $15,610 for a family of two. In Hawaii, the guidelines are $10,700 for an individual living alone and $14,360 for a family of two. 1 Child support payments only count as income under SSI when determining eligibility for a child for whom those payments are received. 2 SSI, public assistance welfare, disability payments and financial assistance payments are considered unearned income when calculating total income. However, they are excluded when calculating how much of the $240 disregard a beneficiary will receive. The CPS variable for “financial assistance payments” is assumed to be state or nonprofit assistance. CRS-6 Table 3. Summary of Prescription Drug Coverage for Low-Income Individuals in Part D, 2006 Dual Eligibles with Countable Incomec at or below 100% of Poverty Noninstitutionalized Dual Eligibles with Countable Income Above 100% of Poverty; Medicare Beneficiaries with Countable Income Below 135% of Poverty Plus Assets Testd All Other Medicare Beneficiaries with Countable Income Below 150% of Poverty Plus Assets Testd Monthly premiume $0 $0 $0-$35 Cost sharing for first $250 of drug costs (annual deductible) $0 $0 $50 $1/generic or preferred multiple-source drug,f $3 for all others $2/generic or preferred multiplesource drug,f $5 for all others 15% $0 $0 $2/generic or preferred multiple-source drug,f $5 for all others Institutionalizeda Dual Eligiblesb Cost-sharing for drug costs from $250 to $5100 (copayment or coinsurance rate) Cost-sharing for drug costs exceeding $5100 (copayment) No cost-sharing or premium Source: Congressional Research Service (CRS) Report RL31525, Beneficiary Cost-Sharing Under the Medicare Prescription Drug Benefit, by Chris L. Peterson and Jim S. Hahn. a. To be considered “institutionalized,” dual eligibles must be an inpatient in a Medicaid-certified medical institution or nursing facility, according to 1902(q)(1)(B) of the Social Security Act, as amended. b. “Dual eligibles” are those Medicare beneficiaries who are also enrolled to receive the full benefits of their state’s Medicaid program. c. “Countable income” means the amount of income counted for determining eligibility for Supplemental Security Income (SSI), defined in Section 1612 of the Social Security Act, as amended. “Poverty” refers to the federal poverty guidelines published by the Department of Health and Human Services. d. The assets test refers to the amount of assets counted for determining eligibility for SSI, defined in Section 1613 of the Social Security Act, as amended. To qualify in the below 135% of poverty category in 2006, countable assets (resources) are limited to $6,000 for an individual and $9,000 for a married couple. To qualify in the category below 150% of poverty, countable assets are limited to $10,000 for an individual and $20,000 for a couple. e. Additional amounts may be required for prescription drug plans with relatively high premiums. The full $35 premium is an estimate from the Congressional Budget Office (CBO). f. A “multiple-source drug” is a covered outpatient prescription drug for which there are two or more drug products rated as therapeutically and pharmaceutically equivalent by the Food and Drug Administration.