U.S. Department of Health and Human Services Office of Inspector General Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 Suzanne Murrin Deputy Inspector General for Evaluation and Inspections June 2020, OEI-05-20-00190 U.S. Department of Health and Human Services Office of Inspector General Report in Brief June 2020, OEI-05-20-00190 Why OIG Did This Review Part D Plans Generally Include Drugs The ACA requires OIG to conduct a study of the extent to which Commonly Used by Dual Eligibles: 2020 formularies used by Medicare Part What OIG Found D plans include drugs commonly Key Takeaway Overall, we found that the rate of Part D plan used by full-benefit dual eligible Overall, we found that formularies’ inclusion of the 195 drugs commonly individuals (i.e., individuals who are the rate of Part D plan used by dual eligibles (i.e., individuals who are eligible for both Medicare and full formularies’ inclusion eligible for both Medicare and Medicaid) is high, Medicaid benefits). These of the drugs commonly with some variation. On average, Part D plan individuals generally get drug used by dual eligibles is formularies include 97 percent of the coverage through Medicare Part D. high, with some 195 commonly used drugs. In addition, 75 percent Pursuant to the ACA, OIG must variation. Because of the commonly used drugs are included by all annually issue a report with some variation exists in Part D plan formularies. These results are largely recommendations as appropriate. formularies’ inclusion unchanged from the Office of Inspector General’s This is the tenth report OIG has and utilization (OIG’s) findings for formularies reported in the produced to meet this mandate. management of these drugs, some dual mandated annual report from 2019, as well as How OIG Did This Review eligibles may need to from the findings in our reports from make additional efforts 2011 through 2018. For this report, we determined whether the 448 unique formularies (e.g., appeal coverage decisions) to access the We also found that the percentage of drugs to used by the 4,610 Part D plans which plan formularies applied utilization drugs they take. operating in 2020 cover the 200 management tools increased slightly between drugs most commonly used by 2019 and 2020. On average, formularies applied utilization management dual eligibles. We also determined tools to 29 percent of the unique drugs we reviewed in 2020, an increase of the extent to which plan 1 percentage point from 2019. formularies applied utilization management tools to those What OIG Concludes commonly used drugs. To create Inclusion rates for the 195 drugs commonly used by dual eligibles are largely the list of the 200 drugs most unchanged from the inclusion rates listed in our previous reports. Part D commonly used by dual eligibles, formularies include roughly the same high percentage of these commonly we used data from the 2017 used drugs in 2020 as they did in 2019. Medicare Current Beneficiary Survey—the most recent data As mandated by the Patient Protection and Affordable Care Act (ACA), OIG available at the time of our study. will continue to monitor and produce annual reports on the extent to which Of the top 200 drugs, 195 are Part D plan formularies cover drugs that dual eligibles commonly use. In eligible for Part D prescription drug addition, OIG will continue to monitor Part D plan formularies’ application of coverage, 2 are excluded from utilization management tools to these drugs. OIG has no recommendations coverage, 1 is no longer offered as at this time. a prescription, and 1 is a medical supply item covered by Part D. One additional drug is eligible for Part D prescription drug coverage. However, we did not include it in our analysis because we could not confidently project the use of this drug to the entire dual eligible population. TABLE OF CONTENTS BACKGROUND 1 Methodology 7 FINDINGS 12 Part D plan formularies include between 89 and 100 percent of the drugs commonly used by 12 dual eligibles Seventy-five percent of the drugs commonly used by dual eligibles are included in all Part D 14 plan formularies The percentage of commonly used drugs to which plan formularies applied utilization 16 management tools increased slightly between 2019 and 2020 CONCLUSION 19 APPENDICES 21 A. Section 3313 of the Patient Protection and Affordable Care Act of 2010 21 B. List of mandated OIG reports examining dual eligibles’ access to drugs under Part D 22 C. Commonly used drugs and rates of inclusion by formularies 23 D. Five drugs commonly used by dual eligibles were excluded from this analysis 30 E. Rates at which prescription drug plan formularies associated with stand-alone or Medicare 31 Advantage plans include commonly used drugs, by region ACKNOWLEDGMENTS AND CONTACT 33 ABOUT THE OFFICE OF INSPECTOR GENERAL 34 BACKGROUND Objectives 1. To determine the extent to which Part D plan formularies cover the drugs commonly used by dual eligibles. 2. To determine the extent to which Part D plan formularies applied utilization management tools to the drugs commonly used by dual eligibles. Pursuant to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), comprehensive prescription drug coverage under Medicare Part D is available to all Medicare beneficiaries through prescription drug plans (PDPs) and Medicare Advantage prescription drug plans (MA-PDs), hereinafter referred to collectively as Part D plans. 1 For beneficiaries who are eligible for both Medicare and Medicaid (hereinafter referred to as dual eligibles), Medicare subsidizes Part D plan premiums, deductibles, and other cost sharing up to a determined premium benchmark that varies by region. If dual eligibles enroll in Part D plans with premiums higher than the regional benchmark, the dual eligibles are responsible for paying the premium amounts above that benchmark. To control costs and ensure the safe use of drugs, Part D plans are allowed to establish formularies from which they may omit certain drugs from prescription coverage and are allowed to control drug utilization through utilization management tools. 2 These tools include prior authorization, quantity limits, and step therapy. 3 In addition, Centers for Medicare & Medicaid Services (CMS) authorized Part D plans to _____________________________________________________________________________________________________________________________ 1 MMA, P.L. No. 108-173 (enacted Dec. 8, 2003), § 101, Social Security Act § 1860D-1(a). 2 A formulary is a list of drugs covered by a Part D plan. Part D plans can exclude certain drugs from their formularies and can control utilization for formulary-included drugs within certain parameters. Social Security Act § 1860D-4(b) and (c). 3 Priorauthorization—often required for very expensive drugs—requires that physicians obtain approval from Part D plans to prescribe a specific drug. Quantity limits are intended to ensure that beneficiaries receive the proper dose and recommended duration of drug therapy. Step therapy is the practice of beginning drug therapy for a medical condition with the drug therapy that is the most cost-effective or safest and progressing if necessary to more costly or riskier drug therapy. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Background | 1 use indication-based formulary design beginning in contract year 2020 to further control drug utilization. 4 CMS annually reviews Part D plan formularies to ensure that they include a range of drugs in a broad distribution of therapeutic categories or classes. CMS also assesses the utilization management tools present in each formulary. The Medicare Prescription Drug Benefit Beginning in 2006, the MMA made comprehensive prescription drug coverage under Medicare Part D available to all Medicare beneficiaries. 5 Medicare beneficiaries generally have the option to enroll in a PDP and receive all other Medicare benefits on a fee-for-service basis, or to enroll in an MA-PD and receive all of their Medicare benefits, including prescription drug coverage, through managed care. 6 As of January 2020, approximately 47 million of the 62.2 million Medicare beneficiaries were enrolled in a Part D plan. Part D plans are administered by private companies—known as “plan sponsors”—that contract with CMS to offer prescription drug coverage in one or more PDP or MA-PD regions. CMS has designated 34 PDP regions and 26 MA-PD regions. In 2020, plan sponsors offer 4,610 unique Part D plans, with many plan sponsors offering multiple Part D plans. Dual Eligibles Under Medicare Part D Approximately 12.2 million Medicare beneficiaries are dual eligibles. For about 8.7 million dual eligibles, referred to as “full-benefit dual eligibles,” Medicaid provides full Medicaid benefits, including Medicaid-covered services, and may also assist beneficiaries with premiums and cost sharing for Medicare fee-for-service or Medicare managed care. For other dual eligibles, Medicaid does not provide Medicaid-covered services, but provides assistance with beneficiaries’ Medicare premiums or cost sharing, depending on their level of income and assets. 7 Dual eligibles are a particularly vulnerable population. Overall, most dual eligibles have very low incomes—86 percent have annual incomes below 150 percent of the _____________________________________________________________________________________________________________________________ 4 Indication-based formulary design allows Part D plans to limit certain drugs to specific indications. However, if a plan limits coverage of a drug to a specific indication, the plan must ensure that there is a therapeutically similar drug for other indications. 5 MMA, P.L. No. 108-173 (enacted Dec. 8, 2003), § 101, Social Security Act § 1860D-1(a). 6 CMS, Prescription Drug Benefit Manual (PDBM), ch. 1, § 10.1. 7Medicare Payment Advisory Commission and Medicaid and CHIP Payment and Access Commission, Data Book: Beneficiaries Dually Eligible for Medicare and Medicaid—January 2018. Accessed at https://www.macpac.gov/wp-content/uploads/2017/01/January-2018-Beneficiaries-Dually-Eligible-for- Medicare-and-Medicaid-Data-Book.pdf on April 9, 2019. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Background | 2 Federal poverty level, compared with 22 percent of all other Medicare beneficiaries. Additionally, dual eligibles are in worse health than the average Medicare beneficiary—half are in fair or poor health, more than twice the rate of others in Medicare. 8 Because of their self-reported health needs, dual eligibles may use more prescription drugs and health care services in general than other Medicare beneficiaries. Until December 31, 2005, dual eligibles received outpatient prescription drug benefits through Medicaid. In January 2006, Medicare began covering outpatient prescription drugs for dual eligibles through Part D plans. 9 Medicare covers Part D plan premiums for dual eligibles up to a set benchmark. The benchmark is a statutorily defined amount that is based on the average premium amounts for Part D plans for each region. 10, 11 If dual eligibles enroll in Part D plans with premiums higher than the regional benchmark, the dual eligibles are responsible for paying the premium amounts above that benchmark. 12 Dual eligibles’ assignment to Part D plans When individuals become eligible for both Medicare and Medicaid, CMS randomly assigns those individuals to PDPs unless they have elected a specific Part D plan or have opted out of Part D prescription drug coverage. 13 The PDPs to which CMS assigns dual eligibles must meet certain requirements, such as having a premium at or below the regional benchmark amount and offering basic prescription drug coverage (or equivalent). 14 Basic prescription drug coverage is defined in terms of benefit structure (initial coverage, coverage gap, and catastrophic coverage) and costs (initial deductible and coinsurance). Given that assignment is done on a random basis, dual eligibles may be enrolled in PDPs that do not cover the specific drugs the dual eligibles use, or that only cover the _____________________________________________________________________________________________________________________________ 8Kaiser Family Foundation, Medicare’s Role for Dual Eligible Beneficiaries. Accessed at http://www.kff.org/medicare/upload/8138-02.pdf on March 19, 2019. 9 MMA, P.L. No. 108-173 (enacted Dec. 8, 2003), § 101, Social Security Act § 1860D-1(a). 10 Social Security Act § 1860D-14(b); 42 CFR § 423.780(b)(2)(i). 11 Dual eligibles residing in territories are not eligible to receive cost sharing assistance from Medicare. Consequently, there are no benchmarks for Part D plans offered in the territories. Social Security Act § 1860D-14(a)(3)(F). 12 The ACA established a “de minimus” premium policy whereby a Part D plan may elect to charge dual eligibles the benchmark premium amount if the Part D plan’s basic premium exceeds the regional benchmark by a de minimus amount. ACA, P.L. No. 111-148 (enacted Mar. 23, 2010), § 3303, Social Security Act § 1860D 14(a)(5). For 2019, CMS set the de minimis amount at $2 above the regional benchmark. 13 CMS, PDBM, ch. 3, § 40.1.4. 14 Ibid. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Background | 3 specific drugs the dual eligibles use for a limited set of indications. However, unlike the general Medicare population, dual eligibles have up to three special election periods during the first 9 months of the year to find plans that cover the prescription drugs the dual eligibles require and switch plans if needed. 15 When they use a special election period to change plans, dual eligibles’ prescription drug coverage under the new Part D plan becomes effective at the beginning of the following month. CMS annually reassigns some dual eligibles to new PDPs if the dual eligibles’ current PDPs will have premiums above the regional benchmark premium for the following year. 16 For dual eligibles who were randomly assigned to their current PDPs, CMS chooses new PDPs that will have premiums at or below the regional benchmark premium. 17 For 2020, CMS reported reassigning approximately 433,473 Medicare beneficiaries—including, but not exclusively, dual eligibles—because of premium increases. Part D Prescription Drug Coverage Under Part D, plans can establish formularies from which they may exclude drugs and control drug utilization within certain parameters. These parameters are intended to balance Medicare beneficiaries’ needs for adequate prescription drug coverage with Part D plan sponsors’ needs to contain costs. Generally, a formulary must include at least two drugs in each therapeutic category or class. 18, 19 In addition, Part D plans must include drugs covered by Part D in certain categories and classes. 20 Starting in 2020, Part D plans are permitted to use indication-based formulary design. Plans that use this type of design limit formulary coverage of drugs to certain indications, or uses approved by the Food and Drug Administration (FDA). However, for each drug limited to certain indications, these plans must ensure that their _____________________________________________________________________________________________________________________________ 1583 Fed. Reg. 16440, 16514–19 (Apr. 16, 2018). In general, Medicare beneficiaries can switch Part D plans only once a year during a defined enrollment period. In previous years, dual eligibles could switch Part D plans monthly to find plans that covered the drugs they required. 16CMS, PDBM, ch. 3, § 40.1.5. CMS also reassigns beneficiaries who were assigned to plans that were terminated and will not be offered in the following year. For 2020, no beneficiaries were reassigned because of terminated plans. 17 Ibid. 18 CMS, PDBM, ch. 6, § 30.2.1. 19Therapeutic categories or classes classify drugs according to their most common intended uses. For example, cardiovascular agents compose a therapeutic class intended to affect the rate or intensity of cardiac contraction, blood vessel diameter, or blood volume. 20Social Security Act § 1860D-4(b)(3)(G). Current Part D policy requires sponsors to include in their formularies all drugs in six categories or classes, except in limited circumstances: (1) antidepressants; (2) antipsychotics; (3) anticonvulsants; (4) immunosuppressants for treatment of transplant rejection; (5) antiretrovirals; and (6) antineoplastics. CMS, PDBM, ch. 6, § 30.2.5. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Background | 4 formularies also cover at least one therapeutically similar drug for the nonformulary indications. 21 Part D plans may also control drug utilization by applying utilization management tools. These tools include the following: requiring prior authorization to obtain drugs that are on plan formularies; establishing quantity limits; and requiring step therapy. Utilization management tools can help Part D plans and the Part D program limit the cost of prescription drug coverage by placing restrictions on the use of certain drugs. In addition to these drug coverage decisions that Part D plans make regarding individual formularies, certain categories of drugs are excluded from Medicare Part D prescription drug coverage as mandated by the MMA. 22 For example, prescription vitamins, prescription mineral products, and nonprescription drugs are excluded from Part D prescription drug coverage. 23 Until 2013, barbiturates and benzodiazepines were excluded from Part D prescription drug coverage. However, the Patient Protection and Affordable Care Act (ACA) reversed this exclusion, removing these two drug types from the list of drug classes ineligible for such coverage. 24, 25 CMS Efforts To Ensure Prescription Drug Coverage Formulary review CMS annually reviews Part D plan formularies to ensure that they include a range of drugs in a broad distribution of therapeutic categories or classes, as well as all drugs in specified therapeutic categories or classes. 26 During this review, CMS analyzes formularies’ coverage of the drug classes most commonly prescribed for the Medicare population. CMS intends for Part D plans to cover the most widely used medications, or therapeutically alternative medications (i.e., drugs from the same therapeutic _____________________________________________________________________________________________________________________________ 21CMS, Indication-Based Formulary Design Beginning in Contract Year (CY) 2020. Accessed at https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and- Systems/HPMS/Downloads/HPMS-Memos/Weekly/SysHPMS-Memo-2018-Aug-29th.pdf on March 22, 2019. 22 MMA, P.L. No. 108-173 (enacted Dec. 8, 2003), § 101, Social Security Act § 1860D-2(e). 23 Social Security Act § 1860D-2(e)(2), 1927(d)(2). 24 ACA, P.L. No. 111-148 (enacted Mar. 23, 2010), § 2502, Social Security Act § 1927(d). 25 CMS, Transition to Part D Coverage of Benzodiazepines and Barbiturates Beginning in 2013. Accessed at http://www.cms.gov/Medicare/Prescription-Drug- Coverage/PrescriptionDrugCovContra/Downloads/BenzoandBarbituratesin2013.pdf on March 20, 2019. 26 CMS, PDBM, ch. 6, § 30.2.7. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Background | 5 category or class), for the most common conditions. CMS uses Part D prescription drug data to identify the most commonly prescribed classes of drugs.27 CMS also assesses each formulary’s utilization management tools to ensure consistency with current industry standards and with standards that are widely used with drugs for the elderly and people with disabilities. 28, 29 Exceptions and appeals process CMS has implemented an exceptions and appeals process whereby beneficiaries can request coverage of nonformulary drugs or exceptions to utilization management tools that apply to formulary drugs. When a Part D plan receives a prescriber’s statement supporting an exception request, the plan must notify the beneficiary of its determination within 72 hours or, for expedited requests, within 24 hours. 30 If the beneficiary’s plan makes an adverse determination, the beneficiary has the right to appeal. 31 If the plan continues to deny the beneficiary’s request, the beneficiary has additional appeal rights and may continue to appeal until those rights are exhausted. Alternatively, the beneficiary can work with his or her prescriber to determine whether there is an appropriate, therapeutically equivalent alternative drug on the plan’s formulary. Transitioning new enrollees to Part D CMS requires that Part D plans establish a transition process for new enrollees (including dual eligibles) who are transitioning to their respective Part D plans either from different Part D plans or from other prescription drug coverage. During Medicare beneficiaries’ first 90 days under a new Part D plan, the new plan must provide one temporary fill of a prescription when the beneficiary requests either a drug that is not in the plan’s formulary or a drug that requires prior authorization or step therapy under the formulary’s utilization management tools. 32 The temporary fill accommodates beneficiaries’ immediate drug needs the first time the beneficiary attempts to fill a prescription. The transition period also allows the beneficiary time to work with his or her prescribing physician(s) to obtain prescriptions for therapeutically alternative drugs or to request a formulary exception from the Part D plan. _____________________________________________________________________________________________________________________________ 27 Ibid. 28 CMS, PDBM, ch. 6, § 30.2.2. 29 CMS, PDBM, ch, 6, § 30.2.7. 30 CMS, Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance, § 40.5.3. 31 CMS, Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance, § 50. 32 CMS, PDBM, ch. 6, § 30.4.4. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Background | 6 Related OIG Work In 2006, the Office of Inspector General (OIG) published a report assessing the extent to which PDP formularies included drugs commonly used by dual eligibles under Medicaid. The study found that PDP formularies included between 76 and 100 percent of the 178 drugs commonly used by dual eligibles under Medicaid prior to the implementation of Part D. Approximately half of the 178 commonly used drugs were covered by all formularies. 33 In 2011, OIG issued the first annual mandated report examining dual eligibles’ access to drugs under Medicare Part D. (See Appendix A for the statutory mandate.) We have released an annual mandated report each year since then. (See Appendix B for a list of these reports.) The current report is the tenth report released. Methodology As mandated in the ACA, this study assessed the extent to which drugs commonly used by dual eligibles are included by Part D plan formularies. To make this assessment, we evaluated formularies for Part D plans operating in 2020. As part of our assessment, we included dual eligibles’ enrollment data from January 2020, the most recent enrollment data available from CMS at the time of our study. We also compared the results of our 2020 study with those of our 2019 study. 34 The ACA did not define which drugs commonly used by dual eligibles we should review. We defined drugs commonly used by dual eligibles as the 200 drugs with the highest utilization by dual eligibles as reported in the Medicare Current Beneficiary Survey (MCBS)—i.e., the 2017 MCBS. We used the MCBS because it contains drugs that dual eligibles received through multiple sources (e.g., Part D, Medicaid, and the Department of Veterans Affairs), and, as such, it provides a comprehensive picture of drug utilization. Of the 200 highest-utilization drugs that we identified using the MCBS, 195 are eligible for coverage under Part D. In this report, we refer to these 195 Part D-eligible, high-utilization drugs as “commonly used drugs.” For each study, OIG went beyond the ACA’s mandate by reviewing drug coverage for all dual eligibles under Medicare Part D, rather than only for full-benefit dual eligibles. With the data available for this study, we could not confidently identify and segregate full-benefit dual eligibles—and, thus, the drugs they used—from the total population of dual eligibles. In the current (2020) report and the previous seven reports, we have also gone beyond the ACA’s mandate by examining the utilization management tools that Part D plan formularies apply to the drugs commonly used by dual eligibles. These tools _____________________________________________________________________________________________________________________________ OIG, Dual Eligibles’ Transition: Part D Formularies’ Inclusion of Commonly Used Drugs, 33 OEI-05-06-00090, January 2006. 34OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2019, OEI-05-19-00220, June 2019. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Background | 7 may affect dual eligibles’ access, even in cases in which formularies include the commonly used drugs. Analyzing the extent to which Part D plan formularies apply these tools to drugs commonly used by dual eligibles allows us to provide a comprehensive picture of Part D plan formularies’ coverage of, and dual eligibles’ access to, those drugs. Data sources MCBS. We used the 2017 MCBS Cost and Use data to create a list of the 200 drugs with the highest utilization by dual eligibles. The MCBS Cost and Use data contain information on hospitals, physicians, prescription drug costs, and prescription drug utilization. The 2017 MCBS Cost and Use data were the most recent data available at the time of our study. Historically, the list of the 200 drugs with the highest utilization by dual eligibles has remained largely unchanged from year to year. The list for 2020 overlapped by 91 percent with the list for 2019, which in turn overlapped by 88 percent with the list for 2018. 35 The MCBS is a continuous, multipurpose survey that CMS conducts of a representative national sample of the Medicare population, including dual eligibles. Sampled Medicare beneficiaries were interviewed three times per year and asked what drugs they were taking and whether they had started taking any new drugs since the previous interview. The MCBS also includes Part D prescription drug events for surveyed Medicare beneficiaries. In 2016, the MCBS surveyed 15,207 Medicare beneficiaries, of whom 2,224 were dual eligibles who had used prescription drugs during the year (out of 3,790 dual eligible survey respondents). First DataBank National Drug Data File. We used the February 2020 First DataBank National Drug Data File to identify the drug product information for the 200 drugs with the highest utilization by dual eligibles. The National Drug Data File is a database that contains information—such as drug name, therapeutic category or class, and the unique combination of active ingredients—for each drug as defined by a National Drug Code (NDC). 36 Part D plan data. In January 2020, we collected from CMS the formulary data and the plan data for Part D plans operating in 2020. The formulary data includes Part D plans’ formularies and utilization management tools for plans operating in 2020. In 2020, there are 448 unique formularies offered by 4,610 Part D plans. The plan data provides information such as the State in which a Part D plan is offered, whether the Part D plan is a PDP or an MA-PD, and whether the Part D plan premium is below the regional benchmark. We also collected 2020 enrollment data for Part D plans. These data provide the number of dual eligibles enrolled in each Part D plan as of January 2020. _____________________________________________________________________________________________________________________________ 35 In 2019, we used 2016 data. In 2018, we used 2013 data. In 2017, we used 2012 data. 36 An NDC is a three-part universal identifier that specifies the drug manufacturer’s name, the drug form and strength, and the package size. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Background | 8 Determining the most commonly used drugs To determine the drugs most commonly used by dual eligibles, we took the following steps: 1. We created a list of all drugs reported by dual eligibles surveyed in the 2017 MCBS. We excluded respondents from territories because they are not eligible to receive cost sharing assistance under Part D. The MCBS listed 150,560 drug events for 2,224 dual eligibles who did not reside in territories. 37 2. We collapsed this list to a list of drugs based on their active ingredients using the Ingredient List Identifier located in First DataBank’s National Drug Data File. For example, a multiple source drug such as fluoxetine hydrochloride (the active ingredient for the brand-name drug Prozac) has only one entry on our list, covering all strengths of both the brand-name drug Prozac and the available generic versions of fluoxetine hydrochloride. From this point forward, unless otherwise stated, we will use the term “drug” to refer to any drug in the same Ingredient List Identifier category, and the term “unique drug” to refer to an NDC corresponding to a drug, as a given drug can have multiple NDCs. This process left 150,560 drug events associated with 858 drugs. 3. We ranked the 858 drugs by frequency of utilization, weighting the drug-event information from MCBS by sample weight. 4. We selected the 200 drugs with the highest utilization by dual eligibles. For a full list of the top 200 drugs, see Appendix C. 5. We removed all drugs not covered under Part D. Of the 200 drugs with the highest utilization, 195 are eligible under Part D. Two fall into a drug category excluded under Part D. (For details on the two drugs excluded under Part D, see Appendix D.) One drug is no longer offered as a prescription. An additional drug is eligible for Part D prescription drug coverage. However, we did not include it in our analysis because—although it is eligible under Part D—Medicare considers it to be a medical supply item. We did not include another drug in our analysis because we could not confidently project the use of this drug to the entire dual eligible population. Formulary analysis We analyzed the 448 unique Part D plan formularies to determine their rates of inclusion of the 195 drugs commonly used by dual eligibles. We counted a drug as included in a Part D plan’s formulary if the formulary included the active ingredient. _____________________________________________________________________________________________________________________________ 37 For the purposes of this report, a drug event is an MCBS survey response indicating that the responding beneficiary took a specific drug at least once in 2017. For example, one MCBS survey respondent reported taking alprazolam 11 times in 2017. We counted this beneficiary/drug combination as 11 drug events. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Background | 9 Low rates of inclusion by formularies. We determined which of the 195 commonly used drugs had low rates of inclusion by formularies by counting how many of the 448 formularies covered each drug. We considered a drug to have a low rate of inclusion if it was included by 75 percent or less of formularies. For such drugs, we counted the number of drugs (if any) that each formulary covered in the same therapeutic category or class. We conducted this analysis to ensure that dual eligibles have access to therapeutically similar drugs. We also conducted additional research to identify potential reasons why some of the 195 commonly used drugs were included by 75 percent or less of formularies. Utilization management tools. We determined the extent to which Part D plans apply utilization management tools to the 195 drugs that we reviewed. The tools that we reviewed are prior authorization, quantity limits, and step therapy. To determine the extent to which Part D plan formularies applied utilization management tools to the 195 commonly used drugs, we conducted an analysis of the NDCs that correspond to the commonly used drugs. Part D plan formularies do not apply utilization management tools at the active ingredient level. Rather, Part D plan formularies apply utilization management tools at a more specific level that identifies whether a drug is brand-name or generic and its dosage form, strength, and route of administration, irrespective of package size. To conduct this analysis, we determined the NDCs (unique drugs) associated with each of the 195 commonly used drugs that are on each Part D formulary. We then calculated the percentage of unique drugs to which each Part D plan formulary applies utilization management tools. Enrollment analysis We weighted the formulary analysis by dual eligible enrollment and weighted the analysis of utilization management tools by both dual eligible enrollment and Medicare enrollment. To do this, we applied enrollment data from January 2020 to Part D plans available in 2020. Data limitations We did not assess individual dual eligibles’ prescription drug use or whether individual dual eligibles are enrolled in Part D plans that include the specific drugs that each individual uses. Because we developed our list of commonly used drugs by using a sample of dual eligibles who responded to the MCBS, a particular dual eligible might not use any of the drugs on our list. However, the drugs most commonly used by dual eligible participants in the 2017 MCBS survey account for 89 percent of all prescriptions dispensed to the dual eligible respondents in the 2017 MCBS. We also did not assess the impact of indication-based formulary design on dual eligibles’ access to prescription drugs. The formulary data we used for this analysis does not include sufficient details for us to determine which drugs were covered for Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Background | 10 only a limited number of indications. As a result, some beneficiaries included in our analysis may not be able to access all commonly used drugs covered by their Part D plans because certain drugs are not available for all indications. Standards We conducted this study in accordance with the Quality Standards for Inspection and Evaluation issued by the Council of the Inspectors General on Integrity and Efficiency. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Background | 11 FINDINGS Part D plan formularies include between 89 and 100 percent of the drugs commonly used by dual eligibles On average, Part D plan formularies include 97 percent of the drugs commonly used by dual eligibles. Of the 448 unique formularies used by Part D plans in 2020, 7 formularies include 100 percent of the commonly used drugs. At the other end of the inclusion range, one formulary includes 89 percent of the commonly used drugs. Exhibit 1 provides a breakdown of the formularies’ inclusion rates for the drugs most commonly used by dual eligibles. CMS generally requires Part D plan formularies to include at least two drugs—rather than all drugs—in each therapeutic category or class. Therefore, Part D plan formularies may still meet CMS’s formulary requirements, even if the formularies do not include all of the drugs we identified as commonly used by dual eligibles. Exhibit 1: About 80 percent of the 448 Part D plan formularies cover at least 97 percent of the drugs commonly used by dual eligibles. Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2020. Part D plan formularies’ rates of inclusion of the drugs commonly used by dual eligibles in 2020 did not change from the rates in 2019. The average rate of inclusion remained at 97 percent between 2019 and 2020. The range of inclusion rates also remained the same between 2019 and 2020; rate of inclusion ranged from 89 to 100 percent in both 2019 and 2020. Nationally, PDP and MA-PD formularies have similar rates of inclusion of the drugs commonly used by dual eligibles, averaging 96 percent and 97 percent, respectively. For PDP formularies, the rates of inclusion range from 89 to 100 percent. For MA-PD formularies, the rates of inclusion range from 90 to 100 percent. Eight formularies— Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Findings | 12 2 percent of the 448 unique formularies used by Part D plans in 2020—are offered by both PDPs and MA-PDs. Regionally, all dual eligibles have the choice of a Part D plan that includes at least 98 percent of the commonly used drugs. Every PDP region has a plan that includes at least 99 percent of the commonly used drugs, while every MA-PD region has a plan that includes at least 98 percent of the commonly used drugs. Appendix E provides a breakdown of formularies’ rates of inclusion of the drugs by PDP and MA-PD region. On average, formularies for Part D plans with premiums below the regional benchmark include 97 percent of the drugs commonly used by dual eligibles The percentage of drugs included by Part D plans with premiums below the regional benchmark is important because dual eligibles are automatically enrolled in, or annually reassigned to, such plans. For drugs commonly used by dual eligibles, formularies for such plans have rates of inclusion that range from 89 percent to 100 percent. Approximately 82 percent of dual eligibles are enrolled in Part D plans with premiums below the regional benchmark. Most dual eligibles are enrolled in Part D plans that include at least 90 percent of the drugs commonly used by dual eligibles Of the approximately 11 million dual eligibles enrolled in Part D plans, approximately 95 percent are enrolled in Part D plans that use formularies that include at least 90 percent of the commonly used drugs. Five percent of dual eligibles are enrolled in Part D plans that use formularies that include less than 90 percent of these drugs. Exhibit 2 provides a breakdown of dual eligibles’ enrollment in Part D plans by the rates at which the plans’ formularies include the commonly used drugs. Exhibit 2: Most dual eligibles are enrolled in Part D plans that include at least 90 percent of the drugs commonly used by dual eligibles. Part D Plans With Formularies That Include: Number of Dual Percentage of Dual Eligibles Enrolled Eligibles Enrolled 100% of commonly used drugs 8,850 0.1% 95% to 99% of commonly used drugs 9,493,260 86.7% 90% to 94% of commonly used drugs 883,689 8.1% 86% to 89% of commonly used drugs 568,034 5.2% Total 10,953,833 100%* Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles and dual eligibles’ enrollment, 2020. *Percentages do not add up to 100 percent due to rounding. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Findings | 13 The percentage of dual eligibles enrolled in Part D plans that include at least 90 percent of the drugs commonly used by dual eligibles increased slightly from 94 percent in 2019 to 95 percent in 2020. Seventy-five percent of the drugs commonly used by dual eligibles are included in all Part D plan formularies Because most of the commonly used drugs are included in a large percentage of formularies, dual eligibles can be confident that regardless of the Part D plan in which they are enrolled, the plan’s formulary will include many of these drugs. By drug, inclusion in formularies ranges from 46 percent to 100 percent. At one end of the range, there is a drug that is included in 46 percent of Part D plan formularies, and, at the other end, 146 drugs are included in all plan formularies. The average rate of inclusion in formularies is 97 percent. Exhibit 3 shows the rates at which formularies include the 195 drugs. Appendix C lists the 195 drugs and the rates at which formularies include them. Exhibit 3: Nearly three quarters of the drugs most commonly used by dual eligibles are included in all Part D plan formularies. Percentage Percentage of the 195 Commonly of the 448 Used Drugs Included in Formularies Formularies 100% 75% (146 drugs) 85% to 99% 17% (34 drugs) 76% to 84% 4% (7 drugs) 46% to 75% 4% (8 drugs) Total 100% (195 drugs) Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2020. The rates at which formularies include the drugs commonly used by dual eligibles increased in 2020. Formularies included 75 percent of the commonly used drugs in 2020, compared to 72 percent in 2019. Part D plan formularies include certain drugs less frequently than others Of the commonly used drugs, 4 percent (eight drugs) are included by less than 75 percent of Part D plan formularies. Exhibit 4 provides the percentage of formularies covering each of these eight drugs. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Findings | 14 The drugs that make up this group include both brand-name and generic drugs and are used to treat a variety of primary indications. Seven of the eight drugs are brand-name drugs, which are typically more costly than generic drugs. As for the primary indications, four of the eight drugs are used for diabetes therapy, and the remaining four drugs treat a variety of conditions, including asthma and chronic obstructive pulmonary disorder. Exhibit 4: Drugs included by less than 75 percent of Part D plan formularies were most frequently used for diabetes therapy. Generic Name of Drug Primary Rate of Inclusion by Indication(s) Formularies Insulin detemir Diabetes 74% Tiotropium bromide* Chronic 72% obstructive pulmonary disease Insulin aspart* Diabetes 71% Budesonide/formoterol Asthma 70% fumarate Canagliflozin* Diabetes 58% Solifenacin succinate* Overactive 54% bladder, incontinence Dexlansoprazole* Gastroesophageal 53% reflux disease Insulin lispro* Diabetes 46% Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2020. * These drugs also had low rates of formulary inclusion in 2019. Although Part D formularies frequently omit these eight drugs, they all cover other drugs in the same respective therapeutic classes. For each of these 8 drugs, 100 percent of formularies cover at least 1 drug in the same therapeutic class that is also on the list of 195 drugs commonly used by dual eligibles. The number of drugs included by less than 75 percent of formularies remained the same in 2019 and 2020—with eight drugs both years. There are six drugs with low inclusion rates in 2020 that were also on the list of commonly used drugs with low inclusion rates in our 2019 report; we note these six drugs with asterisks in Exhibit 4 (above). Five of these six drugs were also on the list of drugs with low inclusion rates in our 2018 report. There are multiple potential reasons why a commonly used drug might be included by less than 75 percent of formularies: Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Findings | 15 • In the case of two of the eight drugs—insulin lispro and insulin aspart—FDA has issued MedWatch Safety Alerts because of the drugs’ delivery systems, which can vary and sometimes result in situations in which patients do not get the insulin they think they injected. 38, 39 • The American Geriatrics Society cautions against certain uses of proton pump inhibitor drugs and drugs with strong anticholinergic properties. Dexlansoprazole is a proton pump inhibitor drug, and solifenacin succinate has strong anticholinergic properties. 40 If a formulary does not include a particular drug, a dual eligible has three options, all of which require taking additional action: • Obtaining a therapeutically equivalent alternative drug that is included by the plan’s formulary. (This option necessitates getting a new prescription from the dual eligible’s doctor.) • Going through an appeals process to obtain coverage of a nonformulary drug by submitting a statement of medical necessity from the dual eligible’s physician. 41 • Switching to a Part D plan with a formulary that does include the drug. Dual eligibles can make such a switch once per calendar quarter during the first 9 months of the year, with the new coverage becoming effective the following month. 42 The percentage of commonly used drugs to which plan formularies applied utilization management tools increased slightly between 2019 and 2020 For the unique drugs that compose the list of commonly used drugs, the percentage to which Part D plan formularies applied utilization management tools increased slightly from 28 percent in 2019 to 29 percent in 2020. Plans with premiums below the regional benchmarks used utilization management tools less frequently than all plans; formularies of these plans used utilization management tools for 24 percent of their drugs. See Exhibit 5 for a breakdown of the 2019 percentage of unique drugs to _____________________________________________________________________________________________________________________________ 38FDA, Caution When Using Pen Needles To Inject Medicines: FDA Safety Communication. Accessed at https://www.drugs.com/fda-alerts/1341-0.html on April 2, 2019. 39 Ibid. 40American Geriatrics Society, American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. 41CMS, Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance, ch. 18, § 40.5. 42 83 Fed. Reg. 16440, 16519 (Apr. 16, 2018). Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Findings | 16 which Part D plan formularies applied utilization management tools as well as the 2020 percentage. Exhibit 5: Part D plan formularies’ application of utilization management tools increased slightly between 2019 and 2020 for commonly used drugs. Percentage of Unique Number of 2019 Percentage of Number of 2020 Percentage of Drugs to Which Plan Part D Plan 2019 Part D Plan Part D Plan 2020 Part D Plan Formularies Applied Formularies Formularies Formularies Formularies Utilization Management Tools Greater than 40% 68 17% 72 16% 30% to 39% 94 23% 118 26% 20% to 29% 137 34% 151 34% 10% to 19% 82 21% 100 22% Less than 10% 20 5% 7 2% Totals 401 100% 448 100% Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2020. Although utilization management tools can restrict beneficiaries’ access to drugs, they are important tools for managing costs in Medicare and ensuring the appropriate utilization of drugs. For example, in 2013, CMS set forth expectations for reviews of opioid overutilization to help ensure that opioids are appropriately prescribed and used. 43 The percentage of unique drugs for which formularies applied the utilization management tools of quantity limits, prior authorization, or step therapy 44 changed slightly between 2019 and 2020. Formularies applied quantity limits to 26 percent of drugs in 2020, an increase of 1 percentage point from 2019; require prior authorization for 4 percent of drugs; and require step therapy for 1 percent of unique drugs. The rate at which plan formularies applied specific utilization management tools varies widely. In 2020, some formularies applied utilization management tools to very few of the unique drugs, whereas at the other end of the range, some formularies applied tools to 48 percent of the unique drugs. More specifically, formularies applied quantity limits to between 0 and 44 percent of unique drugs; require prior authorization for between less than 1 percent and 10 percent of unique drugs; and require step therapy for between 0 and 7 percent of unique drugs. _____________________________________________________________________________________________________________________________ 43CMS, Improving Drug Utilization Review Controls in Part D (Excerpt from Final 2013 Call Letter 04-02-2012). Accessed at https://www.cms.gov/medicare/prescription-drug- coverage/prescriptiondrugcovcontra/downloads/improving-dur-controls-in-part-d.pdf on April 8, 2019. 44 See footnote 3 for explanations of quantity limits, prior authorization, and step therapy. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Findings | 17 Looking at enrollment across plans provides a slightly different picture than looking only at plans themselves. On average, plan formularies in 2020 applied utilization management tools to 29 percent of unique drugs. However, dual eligibles tend to be enrolled in plans with formularies that applied these tools at a slightly higher rate. In 2020, the median plan weighted by dual eligible enrollment applied such tools to 31 percent of unique drugs; in 2019, the figure was 32 percent. Similarly, the median plan weighted by overall Medicare enrollment applied these tools to 32 percent of unique drugs in 2020; in 2019, the figure was also 32 percent. Both dual eligibles and Medicare beneficiaries overall tend to be enrolled in plans with formularies that applied utilization management tools to between 20 and 39 percent of unique drugs. In 2020, 77 percent of dual eligibles and 71 percent of Medicare beneficiaries overall were enrolled in plans with formularies in this range. In 2020, there was an increase in the percentage of Medicare beneficiaries who were enrolled in plans that applied utilization management tools to more than 40 percent of unique drugs. In 2019, 11 percent of dual eligibles and 14 percent of Medicare beneficiaries overall were enrolled in plans that applied utilization management tools to more than 40 percent of unique drugs. These figures increased to 17 percent and 22 percent, respectively, in 2020. Exhibit 6 shows enrollment in Part D plans by dual eligibles and Medicare beneficiaries, as broken down by the percentages at which the plans’ formularies applied utilization management tools. Exhibit 6: The number of beneficiaries who were enrolled in plans that applied utilization management tools to more than 40 percent of unique drugs increased from 2019 to 2020. Percentage of Unique Drugs Percentage of Percentage of Percentage of Percentage of to Which Plan Formularies Dual Eligibles Medicare Dual Eligibles Medicare Applied Utilization Enrolled, 2019 Beneficiaries Enrolled, 2020 Beneficiaries Management Tools Enrolled, 2019 Enrolled, 2020 Greater than 40% 11% 14% 17% 22% 30% to 39% 49% 51% 40% 44% 20% to 29% 34% 28% 37% 27% 10% to 19% 4% 4% 4% 4% Less than 10% 2% 3% 2% 3% Totals 100% 100% 100% 100% Source: OIG analysis of formulary inclusion of drugs commonly used by Medicare beneficiaries and dual eligibles, 2020. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Findings | 18 CONCLUSION When establishing formularies and applying utilization management tools, Part D plans need to balance Medicare beneficiaries’ needs for adequate prescription drug coverage with the need to contain costs for plan sponsors and for the Part D program. By law and under CMS policy, Part D plan formularies do not generally have to include every available drug. Rather, to meet CMS’s formulary requirements, they must include at least two drugs in each therapeutic category or class. For example, for each of the eight drugs that this report identifies as being included by less than 75 percent of Part D plan formularies, all Part D plan formularies cover at least one therapeutically equivalent alternative drug. Additionally, starting in 2020, Part D plans are authorized to limit access to some drugs to only certain indications, provided that they also include a therapeutically similar drug that covers nonformulary indications as well. Part D plan formularies may also institute utilization management tools to ensure appropriate utilization, as well as to control costs. For the drugs commonly used by dual eligibles, we found that the rate of formulary inclusion is high, with some variation. On average, Part D plan formularies include 97 percent of the commonly used drugs. Part D plan formularies’ inclusion of the commonly used drugs ranges from 89 percent to 100 percent. Formulary inclusion rates are similar for PDPs and MA-PDs. Further, formularies for Part D plans with premiums below the regional benchmark include the commonly used drugs at a rate similar to that of Part D plan formularies overall. However, some dual eligibles may be unable to access all drugs covered by their plans’ formularies to the extent that Part D sponsors implement indication-based formulary designs, beginning this year. Inclusion rates for the 195 drugs commonly used by dual eligibles are largely unchanged from those listed in OIG’s 2019 report. Part D plan formularies include roughly the same percentage of these commonly used drugs in 2020 as they did in 2019. Enrollment in plans that cover at least 90 percent of unique drugs increased slightly, with 95 percent of dual eligibles enrolled in such plans in 2020, compared to 94 percent of dual eligibles in 2019. Because some variation exists in the inclusion by Part D plan formularies of the commonly used drugs and in Part D plan formularies’ application of utilization management tools to these drugs, some dual eligibles may need to make additional efforts to access the drugs they take. These dual eligibles could appeal prescription drug coverage decisions, switch prescription drugs, or switch Part D plans. Because these scenarios require additional effort by dual eligibles, they may result in administrative barriers to accessing certain prescription drugs. As mandated by the ACA, OIG will continue to monitor and produce annual reports on the extent to which Part D plan formularies cover drugs that dual eligibles commonly use. In addition, OIG will continue to monitor Part D plan formularies’ Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Conclusion / Recommendations | 19 application of utilization management tools to these drugs. OIG has no recommendations at this time. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Conclusion / Recommendations | 20 APPENDIX A Section 3313 of the Patient Protection and Affordable Care Act of 2010 SEC. 3313. OFFICE OF THE INSPECTOR GENERAL STUDIES AND REPORTS. (a) STUDY AND ANNUAL REPORT ON PART D FORMULARIES’ INCLUSION OF DRUGS COMMONLY USED BY DUAL ELIGIBLES.— (1) STUDY.—The Inspector General of the Department of Health and Human Services shall conduct a study of the extent to which formularies used by prescription drug plans and MA-PD plans under Part D include drugs commonly used by full-benefit dual eligible individuals (as defined in section 1935(c)(6) of the Social Security Act (42 U.S.C. 1396u–5(c)(6)). (2) ANNUAL REPORTS.—Not later than July 1 of each year (beginning with 2011), the Inspector General shall submit to Congress a report on the study conducted under paragraph (1), together with such recommendations as the Inspector General determines appropriate. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Appendix A | 21 APPENDIX B List of mandated OIG reports examining dual eligibles’ access to drugs under Part D OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2011, OEI 05-10-00390, April 2011 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2012, OEI 05-12-00060, June 2012 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2013, OEI 15-13-00090, June 2013 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2014, OEI 05-14-00170, June 2014 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2015, OEI 05-15-00120, June 2015 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2016, OEI 05-16-00090, June 2016 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017, OEI-05-17-00016, June 2017 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018, OEI-05-18-00240, June 2018 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2019, OEI-05-19-00220, June 2019 Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Appendix B | 22 APPENDIX C Commonly used drugs and rates of inclusion by formularies The 200 drugs with the highest utilization by dual eligibles. *Sample is from the 2017 MCBS. Projections and confidence intervals are derived from its survey methodology. Generic Name Sample Projected 95-Percent Confidence Interval* Number of Percentage Size* Drug Formularies of Events* Including Formularies Drug Including Lower Bound Upper Bound Drug Atorvastatin Calcium 3,506 26,514,761 23,033,296 29,996,226 448 100% Lisinopril 3,399 24,917,840 21,021,953 28,813,726 448 100% Amlodipine Besylate 3,292 23,984,655 20,528,125 27,441,185 448 100% Levothyroxine Sodium 4,649 23,948,599 20,854,803 27,042,395 448 100% Omeprazole 3,406 22,249,989 19,516,288 24,983,689 448 100% Metformin Hcl 2,567 21,366,050 18,296,220 24,435,879 448 100% Furosemide 4,107 18,523,601 16,142,689 20,904,514 448 100% Gabapentin 3,293 18,267,640 15,450,285 21,084,994 448 100% Metoprolol Tartrate 2,082 14,241,702 12,095,195 16,388,208 448 100% Simvastatin 1,828 14,228,468 11,645,305 16,811,630 448 100% Hydrocodone/Acetaminophen 2,647 14,094,248 11,761,058 16,427,438 448 100% Losartan Potassium 1,732 12,764,473 10,547,181 14,981,766 448 100% Potassium Chloride 2,628 12,023,377 9,989,348 14,057,406 448 100% Nystatin 2,768 11,830,879 7,823,249 15,838,510 448 100% Albuterol Sulfate 1,741 11,626,113 9,587,105 13,665,121 448 100% Hydrochlorothiazide 1,417 9,884,529 7,988,837 11,780,220 448 100% Metoprolol Succinate 1,600 9,533,225 7,982,869 11,083,581 448 100% Clopidogrel Bisulfate 1,329 9,147,802 7,443,727 10,851,878 448 100% Sertraline Hcl 1,621 8,472,094 6,834,658 10,109,530 448 100% Pravastatin Sodium 931 8,431,469 6,603,696 10,259,242 448 100% Insulin 1,034 8,167,922 6,313,173 10,022,671 447 100% Glargine,hum.Rec.Anlog Carvedilol 1,261 8,147,860 6,778,897 9,516,822 448 100% Pantoprazole Sodium 1,308 7,997,279 6,548,332 9,446,227 448 100% Alprazolam 1,431 7,873,074 5,711,557 10,034,591 429 96% Ranitidine Hcl 1,349 7,869,357 6,150,384 9,588,329 448 100% Tramadol Hcl 1,589 7,374,208 6,063,505 8,684,912 448 100% Glipizide 821 7,143,261 5,481,593 8,804,929 448 100% Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Appendix C | 23 The 200 drugs with the highest utilization by dual eligibles, continued. Generic Name Sample Projected 95-Percent Confidence Interval* Number of Percentage Size* Drug Formularies of Events* Including Formularies Drug Including Lower Bound Upper Bound Drug Fluticasone Propionate 1,174 7,069,289 5,674,640 8,463,938 448 100% Warfarin Sodium 1,475 6,974,147 4,675,838 9,272,456 448 100% Tamsulosin Hcl 1,196 6,882,707 5,628,311 8,137,103 448 100% Trazodone Hcl 1,392 6,858,709 5,584,708 8,132,711 448 100% Quetiapine Fumarate 1,527 6,296,582 5,124,931 7,468,232 448 100% Citalopram Hydrobromide 1,187 5,942,838 4,468,612 7,417,065 448 100% Montelukast Sodium 1,008 5,914,073 4,551,247 7,276,899 448 100% Prednisone 999 5,727,417 4,639,144 6,815,690 448 100% Oxycodone 879 5,707,652 4,647,439 6,767,866 448 100% Hcl/Acetaminophen Escitalopram Oxalate 1,131 5,563,743 3,730,479 7,397,007 448 100% Atenolol 659 5,446,245 4,126,705 6,765,785 448 100% Sitagliptin Phosphate 806 5,377,234 4,208,739 6,545,729 429 96% Mirtazapine 1,320 5,366,122 4,161,516 6,570,727 448 100% Bupropion Hcl 755 5,155,729 3,469,359 6,842,098 448 100% Allopurinol 763 5,082,766 4,079,784 6,085,748 448 100% Divalproex Sodium 1,355 5,054,977 3,793,666 6,316,288 448 100% Duloxetine Hcl 1,035 5,029,421 3,971,712 6,087,130 448 100% Rosuvastatin Calcium 610 5,027,684 3,784,042 6,271,326 448 100% Donepezil Hcl 1,361 4,806,567 3,608,052 6,005,083 448 100% Ibuprofen 749 4,772,743 3,851,505 5,693,980 448 100% Clonazepam 915 4,521,679 3,110,574 5,932,783 448 100% Meloxicam 761 4,419,667 3,415,543 5,423,791 448 100% Esomeprazole Magnesium 664 4,317,203 3,218,639 5,415,766 345 77% Venlafaxine Hcl 706 4,219,899 3,292,550 5,147,249 448 100% Oxybutynin Chloride 722 4,205,538 2,896,338 5,514,739 448 100% Latanoprost 770 4,187,300 3,121,852 5,252,748 448 100% Insulin Aspart 630 4,083,231 3,001,193 5,165,270 316 71% Diltiazem Hcl 580 4,041,979 3,123,707 4,960,251 448 100% Isosorbide Mononitrate 675 4,016,792 2,974,421 5,059,162 448 100% Alendronate Sodium 533 3,974,224 3,079,871 4,868,578 448 100% Lisinopril/Hydrochlorothiazide 341 3,971,405 2,701,519 5,241,291 448 100% Hydralazine Hcl 585 3,927,628 3,023,269 4,831,987 448 100% Fluoxetine Hcl 678 3,898,533 2,839,966 4,957,101 448 100% Oxycodone Hcl 736 3,776,828 2,784,364 4,769,291 447 100% Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Appendix C | 24 The 200 drugs with the highest utilization by dual eligibles, continued. Generic Name Sample Projected 95-Percent Confidence Interval* Number of Percentage Size* Drug Formularies of Events* Including Formularies Drug Including Lower Bound Upper Bound Drug Lorazepam 1,042 3,745,369 2,952,179 4,538,560 448 100% Pregabalin 658 3,693,834 2,845,309 4,542,358 448 100% Cyclobenzaprine Hcl 545 3,662,123 2,652,038 4,672,208 447 100% Memantine Hcl 1,088 3,624,505 2,716,486 4,532,523 448 100% Zolpidem Tartrate 490 3,513,758 2,208,838 4,818,679 440 98% Levetiracetam 770 3,496,607 2,450,170 4,543,044 448 100% Famotidine 839 3,428,420 2,569,603 4,287,236 445 99% Diclofenac Sodium 599 3,411,890 2,682,805 4,140,976 448 100% Baclofen 644 3,348,267 2,607,072 4,089,462 448 100% Aripiprazole 741 3,287,230 2,464,984 4,109,475 448 100% Insulin Detemir 608 3,263,891 2,259,060 4,268,722 330 74% Risperidone 912 3,261,673 2,142,436 4,380,909 448 100% Lovastatin 407 3,252,884 2,438,753 4,067,016 447 100% Tizanidine Hcl 551 3,251,194 2,461,005 4,041,382 448 100% Buspirone Hcl 642 3,238,310 2,342,026 4,134,594 448 100% Losartan/Hydrochlorothiazide 335 3,163,313 2,330,813 3,995,813 448 100% Naproxen 493 3,146,415 2,403,633 3,889,197 448 100% Finasteride 480 2,960,782 1,827,731 4,093,833 448 100% Budesonide/Formoterol 448 2,954,173 2,211,854 3,696,491 315 70% Fumarate Alcohol Antiseptic Pads** 274 2,905,342 1,837,210 3,973,474 Supply Item Supply Item Polyethylene Glycol 3350** 908 2,828,333 2,170,778 3,485,888 Excluded Excluded Amitriptyline Hcl 389 2,804,769 1,839,361 3,770,177 448 100% Rivaroxaban 444 2,771,551 2,280,525 3,262,578 442 99% Azithromycin 530 2,771,301 2,333,713 3,208,888 448 100% Spironolactone 470 2,753,760 1,943,293 3,564,227 448 100% Tiotropium Bromide 374 2,750,249 2,096,743 3,403,755 322 72% Valsartan 394 2,711,004 1,873,134 3,548,874 446 100% Paroxetine Hcl 411 2,695,821 1,881,253 3,510,389 448 100% Clonidine Hcl 513 2,572,597 1,901,774 3,243,419 448 100% Lamotrigine 601 2,565,889 1,611,136 3,520,643 448 100% Triamcinolone Acetonide 450 2,424,745 1,787,234 3,062,256 448 100% Glimepiride 332 2,319,173 1,483,930 3,154,417 448 100% Diazepam 370 2,237,272 1,399,880 3,074,664 448 100% Apixaban 522 2,190,255 1,291,509 3,089,002 445 99% Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Appendix C | 25 The 200 drugs with the highest utilization by dual eligibles, continued. Generic Name Sample Projected 95-Percent Confidence Interval* Number of Percentage Size* Drug Formularies of Events* Including Formularies Drug Including Lower Bound Upper Bound Drug Benztropine Mesylate 585 2,181,952 1,524,443 2,839,461 448 100% Cephalexin 462 2,168,923 1,808,636 2,529,210 448 100% Valsartan/Hydrochlorothiazide 208 2,083,648 1,273,641 2,893,655 445 99% Ezetimibe 283 2,080,407 1,434,528 2,726,286 448 100% Topiramate 329 2,060,546 1,203,140 2,917,953 448 100% Carbamazepine 436 2,042,858 1,335,518 2,750,198 448 100% Ciprofloxacin Hcl 440 2,015,783 1,664,815 2,366,751 448 100% Lactulose 411 1,992,207 1,187,329 2,797,084 448 100% Acetaminophen With Codeine 362 1,981,127 1,254,226 2,708,028 448 100% Insulin Lispro 329 1,896,051 1,279,278 2,512,824 205 46% Triamterene/Hydrochlorothiazid 185 1,824,876 1,074,026 2,575,725 448 100% Propranolol Hcl 323 1,791,767 1,097,354 2,486,179 448 100% Fenofibrate 217 1,782,991 1,082,751 2,483,231 447 100% Enalapril Maleate 179 1,769,779 905,593 2,633,964 448 100% Gemfibrozil 113 1,763,947 1,143,080 2,384,814 448 100% Ketoconazole 463 1,760,991 1,353,705 2,168,277 448 100% Lidocaine 294 1,694,796 1,212,579 2,177,014 448 100% Amoxicillin 354 1,668,610 1,403,958 1,933,263 448 100% Pioglitazone Hcl 208 1,667,963 1,269,416 2,066,511 448 100% Brimonidine Tartrate 319 1,639,611 1,127,120 2,152,101 448 100% Ropinirole Hcl 315 1,631,405 965,956 2,296,854 448 100% Chlorthalidone 181 1,604,503 929,770 2,279,237 448 100% Temazepam 277 1,601,283 998,072 2,204,494 420 94% Linagliptin 322 1,592,388 974,706 2,210,070 353 79% Olanzapine 632 1,591,348 1,110,709 2,071,988 448 100% Solifenacin Succinate 234 1,568,041 958,484 2,177,597 242 54% Amoxicillin/Potassium Clav 314 1,559,156 1,287,885 1,830,427 448 100% Digoxin 372 1,557,726 1,113,667 2,001,785 448 100% Sulfamethoxazole/Trimethoprim 376 1,556,394 1,296,981 1,815,806 448 100% Levofloxacin 344 1,537,701 1,287,012 1,788,389 448 100% Dorzolamide Hcl/Timolol Maleat 172 1,422,922 746,389 2,099,456 448 100% Dexlansoprazole 253 1,421,606 1,126,083 1,717,130 235 52% Verapamil Hcl 139 1,407,301 702,478 2,112,124 448 100% Meclizine Hcl 266 1,385,985 1,066,354 1,705,615 448 100% Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Appendix C | 26 The 200 drugs with the highest utilization by dual eligibles, continued. Generic Name Sample Projected 95-Percent Confidence Interval* Number of Percentage Size* Drug Formularies of Events* Including Formularies Drug Including Lower Bound Upper Bound Drug Promethazine Hcl 356 1,374,089 901,853 1,846,325 445 99% Celecoxib 260 1,373,116 1,003,862 1,742,370 424 95% Sucralfate 287 1,338,530 868,210 1,808,851 448 100% Nifedipine 209 1,333,977 866,495 1,801,460 443 99% Cyclosporine 192 1,321,576 829,261 1,813,891 448 100% Nitroglycerin 247 1,311,819 1,007,730 1,615,907 448 100% Olopatadine Hcl 271 1,309,908 846,997 1,772,819 429 96% Carbidopa/Levodopa 376 1,294,425 545,138 2,043,711 448 100% Bimatoprost 190 1,286,227 946,896 1,625,559 427 95% Fluticasone/Vilanterol 225 1,257,029 873,110 1,640,948 420 94% Fenofibrate Nanocrystallized 196 1,251,598 723,275 1,779,920 441 98% Fentanyl 281 1,248,854 627,928 1,869,779 448 100% Bumetanide 203 1,235,654 573,161 1,898,148 448 100% Phenytoin Sodium Extended 201 1,226,893 685,081 1,768,704 448 100% Ondansetron Hcl 297 1,226,258 906,182 1,546,334 448 100% Benazepril Hcl 154 1,211,933 660,106 1,763,760 447 100% Morphine Sulfate 333 1,206,063 751,687 1,660,439 448 100% Methylprednisolone 199 1,203,903 1,018,121 1,389,686 448 100% Doxycycline Hyclate 279 1,201,848 906,926 1,496,770 448 100% Ergocalciferol (Vitamin D2)** 189 1,200,330 596,167 1,804,493 Excluded Excluded Dicyclomine Hcl 168 1,159,216 618,650 1,699,783 448 100% Fluconazole 210 1,153,890 753,047 1,554,733 448 100% Calcitriol 175 1,148,149 612,607 1,683,691 448 100% Doxepin Hcl 181 1,144,832 635,462 1,654,202 448 100% Ramipril 130 1,142,590 584,408 1,700,772 448 100% Ziprasidone Hcl 222 1,123,534 531,199 1,715,869 448 100% Omega-3 Acid Ethyl Esters 139 1,119,997 764,858 1,475,135 344 77% Linaclotide 246 1,090,286 777,467 1,403,104 422 94% Timolol Maleate 184 1,083,472 671,116 1,495,828 448 100% Clozapine 330 1,034,103 382,927 1,685,279 448 100% Lurasidone Hcl 261 1,024,610 570,101 1,479,119 448 100% Ipratropium Bromide 196 1,021,067 570,571 1,471,563 448 100% Torsemide 202 1,015,661 534,031 1,497,290 433 97% Doxazosin Mesylate 119 1,000,405 520,599 1,480,211 448 100% Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Appendix C | 27 The 200 drugs with the highest utilization by dual eligibles, continued. Generic Name Sample Projected 95-Percent Confidence Interval* Number of Percentage Size* Drug Formularies of Events* Including Formularies Drug Including Lower Bound Upper Bound Drug Amiodarone Hcl 212 976,206 463,364 1,489,049 448 100% Haloperidol 205 957,307 472,576 1,442,039 448 100% Canagliflozin 101 949,529 471,952 1,427,107 261 58% Hydrocortisone 239 945,236 676,889 1,213,583 448 100% Dextroamphetamine/Amphetamine 181 943,299 345,815 1,540,783 448 100% elviteg/cob/emtri/tenof alafen** 169 929,383 -188,460 2,047,226 Excluded Excluded Lubiprostone 204 924,910 414,901 1,434,918 347 77% Amlodipine Besylate/Benazepril 160 924,647 523,690 1,325,604 434 97% Tolterodine Tartrate 168 910,574 613,074 1,208,073 433 97% Prednisolone Acetate 136 908,681 672,083 1,145,279 448 100% Folic Acid** 158 908,345 422,315 1,394,376 Excluded Excluded Ipratropium/Albuterol Sulfate 292 907,850 635,783 1,179,918 433 97% Insulin Degludec 97 904,496 157,185 1,651,807 343 77% Valacyclovir Hcl 127 893,860 335,040 1,452,681 448 100% Clobetasol Propionate 216 887,582 407,481 1,367,684 345 77% Umeclidinium Bromide 113 874,194 285,404 1,462,984 342 76% Clindamycin Hcl 145 839,832 684,231 995,434 448 100% Tacrolimus 73 835,964 575,871 1,096,058 448 100% Fluvoxamine Maleate 193 834,436 203,536 1,465,336 448 100% Adalimumab 93 830,593 442,227 1,218,960 448 100% Valproic Acid 53 821,974 616,774 1,027,173 448 100% Mupirocin 212 805,700 576,692 1,034,708 448 100% Lithium Carbonate 200 801,133 247,245 1,355,021 448 100% Brimonidine Tartrate/Timolol 185 797,031 500,453 1,093,609 411 92% Oxcarbazepine 247 795,983 438,599 1,153,368 448 100% Colchicine 118 770,523 369,814 1,171,232 448 100% Metoclopramide Hcl 159 770,150 437,879 1,102,421 448 100% Insulin Regular, Human 132 767,711 405,593 1,129,829 448 100% Ranolazine 107 767,060 262,796 1,271,324 448 100% Metolazone 129 761,836 316,141 1,207,530 406 91% Sitagliptin Phos/Metformin Hcl 113 760,918 327,297 1,194,539 428 96% Fluocinonide 153 756,816 250,866 1,262,766 442 99% Mirabegron 105 746,707 259,499 1,233,916 447 100% Ammonium Lactate 150 740,771 356,666 1,124,875 439 98% Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Appendix C | 28 The 200 drugs with the highest utilization by dual eligibles, continued. Generic Name Sample Projected 95-Percent Confidence Interval* Number of Percentage Size* Drug Formularies of Events* Including Formularies Drug Including Lower Bound Upper Bound Drug Paliperidone 124 733,149 566,608 899,690 448 100% Metronidazole 160 729,510 513,216 945,805 448 100% Travoprost 213 727,589 435,398 1,019,780 397 89% Source: OIG analysis of drugs commonly used by dual eligibles, 2020. **See Appendix D. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Appendix C | 29 APPENDIX D Five drugs commonly used by dual eligibles were excluded from this analysis In 2020, five drugs commonly used by dual eligibles were excluded from this analysis. Generic Name Reason Excluded From Analysis Alcohol antiseptic pads Supply covered by Part D Polyethylene glycol 3350 Nonprescription drug not covered under Part D Ergocalciferol (vitamin D2) Vitamin or mineral product not covered under Part D Elviteg/cob/emtri/tenof alafen Unable to confidently project use to entire dual eligible population Folic acid Vitamin or mineral product not covered under Part D Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2020. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Appendix D | 30 APPENDIX E Rates at which prescription drug plan formularies associated with stand-alone or Medicare Advantage plans include commonly used drugs, by region Inclusion of commonly used drugs by formularies associated with stand-alone plans, by PDP region Across all 34 PDP regions, the rates of formularies’ inclusion of commonly used drugs ranged from 89 percent to 100 percent. The average range of inclusion was 96 percent for all PDP regions, except for the New York region, which averaged 97 percent. Inclusion of commonly used drugs by formularies associated with Medicare Advantage plans, by MA-PD region Exhibit E-1: MA-PD formularies’ inclusion of commonly used drugs, by MA-PD region. MA-PD State(s) Number Average Rate Minimum Maximum Region* of of Drug Rate Rate MA-PDs Inclusion by Formularies 1 Maine, New Hampshire 69 98% 96% 98% 2 Connecticut, Massachusetts, 125 98% 93% 99% Rhode Island, Vermont 3 New York 218 97% 93% 98% 4 New Jersey 64 97% 90% 99% 5 Delaware, the District of 44 98% 97% 99% Columbia, Maryland 6 Pennsylvania, West Virginia 202 98% 93% 100% 7 North Carolina, Virginia 186 98% 94% 99% 8 Georgia, South Carolina 180 98% 96% 99% 9 Florida 448 98% 90% 100% 10 Alabama, Tennessee 148 98% 96% 99% 11 Michigan 94 98% 96% 99% 12 Ohio 154 98% 93% 99% 13 Indiana, Kentucky 147 98% 96% 99% Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Appendix E | 31 MA-PD formularies’ inclusion of commonly used drugs, by MA-PD region, continued. MA-PD State(s) Number Average Rate Minimum Maximum Region* of of Drug Rate Rate MA-PDs Inclusion by Formularies 14 Illinois, Wisconsin 206 98% 90% 100% 15 Arkansas, Missouri 130 98% 96% 99% 16 Louisiana, Mississippi 98 98% 96% 99% 17 Texas 199 98% 93% 99% 18 Kansas, Oklahoma 86 98% 96% 99% 19 Iowa, Minnesota, Montana, 140 98% 90% 99% Nebraska, North Dakota, South Dakota, Wyoming 20 Colorado, New Mexico 89 98% 93% 99% 21 Arizona 99 98% 96% 99% 22 Nevada 45 98% 93% 99% 23 Idaho, Oregon, Utah, 255 98% 93% 99% Washington 24 California 374 98% 94% 99% 25 Hawaii 23 98% 96% 99% Source: OIG analysis of formularies’ inclusion of drugs commonly used by dual eligibles, 2020. * Region 26, which covers Alaska, had no MA-PDs available for 2020. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Appendix E | 32 ACKNOWLEDGMENTS AND CONTACT Acknowledgments Lisa Minich served as the team leader for this study, and Jonathan Carroll served as the lead analyst. Office of Evaluation and Inspections staff who provided support include Joe Chiarenzelli, Kevin Farber, and Frank Rogers. This report was prepared under the direction of Laura Kordish, Regional Inspector General for Evaluation and Inspections in the Chicago regional office, and Kelly Waldhoff and Adam Freeman, Deputy Regional Inspectors General. Contact To obtain additional information concerning this report, contact the Office of Public Affairs at Public.Affairs@oig.hhs.gov. OIG reports and other information can be found on the OIG website at oig.hhs.gov. Office of Inspector General U.S. Department of Health and Human Services 330 Independence Avenue, SW Washington, DC 20201 Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Acknowledgments and Contact | 33 ABOUT THE OFFICE OF INSPECTOR GENERAL The mission of the Office of Inspector General (OIG), as mandated by Public Law 95- 452, as amended, is to protect the integrity of the Department of Health and Human Services (HHS) programs, as well as the health and welfare of beneficiaries served by those programs. This statutory mission is carried out through a nationwide network of audits, investigations, and inspections conducted by the following operating components: The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting audits with its own audit resources or by overseeing audit work done by others. Audits examine the performance of HHS programs and/or its grantees and contractors in carrying out their respective responsibilities and are intended to provide independent assessments of HHS programs and operations. These audits help reduce waste, abuse, and mismanagement and promote economy and efficiency throughout HHS. The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide HHS, Congress, and the public with timely, useful, and reliable information on significant issues. These evaluations focus on preventing fraud, waste, or abuse and promoting economy, efficiency, and effectiveness of departmental programs. To promote impact, OEI reports also present practical recommendations for improving program operations. The Office of Investigations (OI) conducts criminal, civil, and administrative investigations of fraud and misconduct related to HHS programs, operations, and beneficiaries. With investigators working in all 50 States and the District of Columbia, OI utilizes its resources by actively coordinating with the Department of Justice and other Federal, State, and local law enforcement authorities. The investigative efforts of OI often lead to criminal convictions, administrative sanctions, and/or civil monetary penalties. The Office of Counsel to the Inspector General (OCIG) provides general legal services to OIG, rendering advice and opinions on HHS programs and operations and providing all legal support for OIG’s internal operations. OCIG represents OIG in all civil and administrative fraud and abuse cases involving HHS programs, including False Claims Act, program exclusion, and civil monetary penalty cases. In connection with these cases, OCIG also negotiates and monitors corporate integrity agreements. OCIG renders advisory opinions, issues compliance program guidance, publishes fraud alerts, and provides other guidance to the health care industry concerning the anti-kickback statute and other OIG enforcement authorities. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2020 OEI-05-20-00190 Endnotes | 34