Department of Health and Human Services OFFICE OF INSPECTOR GENERAL PART D PLANS GENERALLY INCLUDE DRUGS COMMONLY USED BY DUAL ELIGIBLES: 2018 (INITIAL CAPS, SMALL CAPS) Suzanne Murrin Deputy Inspector General For Evaluation and Inspections June 2018 OEI-05-18-00240 Report in Brief June 2018 OEI-05-18-00240 Why OIG Did This Review Part D Plans Generally Include Drugs The Patient Protection and Affordable Commonly Used by Dual Eligibles: 2018 Care Act (ACA) requires OIG to conduct a study of the extent to which Key Takeaway What OIG Found formularies used by Medicare Part D Overall, we found that the rate of Part D Overall, we found that the rate of plans include drugs commonly used by plan formularies’ inclusion of the Part D plan formularies’ inclusion full-benefit dual-eligible individuals 197 drugs commonly used by dual of the drugs commonly used by (i.e., individuals who are eligible for eligibles is high, with some variation. On dual eligibles is high, with some both Medicare and full Medicaid variation. Because some average, Part D plan formularies include benefits). These individuals generally variation exists in formularies’ 96 percent of the 197 commonly used inclusion and utilization get drug coverage through Medicare drugs. In addition, 68 percent of the management of these drugs, Part D. Pursuant to the ACA, OIG must commonly used drugs are included by all some dual eligibles may need to annually issue a report with Part D plan formularies. These results are make additional efforts to access recommendations as appropriate. This largely unchanged from OIG’s findings for the drugs they take. For instance, is the eighth report OIG has produced formularies reported in the mandated they may chose to appeal to meet this mandate. annual report from 2017, as well as our prescription drug coverage findings from 2011 through 2016. decisions, switch prescription How OIG Did This Review drugs, or switch Part D plans. For this report, we determined whether We also found that the percentage of Because these scenarios require the 386 unique formularies used by the drugs to which plan formularies applied additional effort by dual eligibles, 3,476 Part D plans operating in 2018 utilization management tools increased they may result in administrative cover the 200 drugs most commonly slightly between 2017 and 2018. On barriers to accessing certain used by dual eligibles. We also average, formularies applied utilization prescription drugs. determined the extent to which plan management tools to 29 percent of the formularies applied utilization unique drugs we reviewed in 2018, an increase of 1 percentage management tools to those commonly point from 2017. used drugs. To create the list of the 200 drugs most commonly used by dual What OIG Concludes eligibles, we used data from the 2013 Inclusion rates for the 197 drugs commonly used by dual Medicare Current Beneficiary Survey— eligibles are largely unchanged compared with the inclusion the most recent data available at the rates listed in our previous reports. Part D formularies include time of our study. Of the top 200 roughly the same high percentage of these commonly used drugs, 197 are eligible for Part D drugs in 2018 as they did in 2017. prescription drug coverage, 2 are As mandated by the ACA, OIG will continue to monitor and excluded from coverage, and 1 is a Part produce annual reports on the extent to which Part D plan D covered medical supply item. formularies cover drugs that dual eligibles commonly use. In addition, OIG will continue to monitor Part D plan formularies’ application of utilization management tools to these drugs. OIG has no recommendations at this time. TABLE OF CONTENTS Objectives ....................................................................................................1 Background ..................................................................................................1 Methodology ................................................................................................6 Findings......................................................................................................12 Part D Plan Formularies Include Between 85 and 100 Percent of the Drugs Commonly Used by Dual Eligibles ...............................12 Sixty-Eight Percent of the Drugs Commonly Used by Dual Eligibles Are Included in All Part D Plan Formularies ..................14 The Percentage of Commonly Used Drugs To Which Plan Formularies Applied Utilization Management Tools Increased Slightly Between 2017 and 2018 ...................................................17 Conclusion .................................................................................................20 Appendixes ................................................................................................21 A: Section 3313 of the Patient Protection and Affordable Care Act of 2010 ....................................................................................21 B: List of Mandated OIG Reports Examining Dual Eligible Access to Drugs Under Part D ...................................................................22 C: Commonly Used Drugs and Rates of Inclusion by Formularies ....................................................................................23 D: Two Drugs Commonly Used by Dual Eligibles and Not Covered Under Part D ....................................................................29 E: Formulary Inclusion of Stand-Alone Prescription Drug Plans and Medicare Advantage Prescription Drug Plans, by Region ......30 Acknowledgments......................................................................................32 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. BACKGROUND 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 covers 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, they 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 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 The Centers for Medicare & Medicaid Services (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. 1 MMA, P.L. No. 108-173 § 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 drugs from their formularies and can control utilization for formulary-included drugs within certain parameters. Social Security Act § 1860D-4(b) and (c). 3 Prior authorization—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 risky drug therapy. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 1 The Medicare Prescription Drug Benefit Beginning in 2006, the MMA made comprehensive prescription drug coverage under Medicare Part D available to all Medicare beneficiaries.4 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.5 As of January 2018, approximately 43.8 million of the 59.2 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 2018, plan sponsors offer 3,476 unique Part D plans, with many plan sponsors offering multiple Part D plans. Dual Eligibles Under Medicare Part D Approximately 10.9 million Medicare beneficiaries are dual eligibles. For about 8 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.6 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. 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 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.7 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 4 MMA, P.L. No. 108-173 § 101, Social Security Act, § 1860D-1(a). 5 CMS, PDBM, ch. 1, § 10.1. 6 Kaiser Family Foundation, Medicare’s Role for Dual Eligible Beneficiaries. Accessed at http://www.kff.org/medicare/upload/8138-02.pdf on April 13, 2017. 7 Ibid. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 2 covering outpatient prescription drugs for dual eligibles through Part D plans.8 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.9, 10 If dual eligibles enroll in Part D plans with premiums higher than the regional benchmark, they are responsible for paying the premium amounts above that benchmark.11 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.12 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).13 Basic prescription drug coverage is defined in terms of benefit structure (initial coverage, coverage gap, and catastrophic coverage) and costs (initial deductible and coinsurance). Some dual eligibles may be randomly assigned to PDPs that do not cover the specific drugs they use. However, unlike the general Medicare population, dual eligibles can switch Part D plans at any time to find plans that cover the prescription drugs they require.14 When dual eligibles change plans, their 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 their current PDPs will have premiums above the regional benchmark premium for the 8 MMA, P.L. No. 108-173 § 101, Social Security Act, § 1860D-1(a). 9 Social Security Act, § 1860D-14(b); 42 CFR § 423.780(b)(2)(i) 10 Dual eligibles residing in territories are not eligible to receive cost-sharing assistance from Medicare. With this being the case, there are no benchmarks for Part D plans offered in the territories. Social Security Act, § 1860D-14(a)(3)(F). 11 The ACA established a “de minimis” 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 minimis amount. Patient Protection and Affordable Care Act (ACA), P.L. No. 111-148 § 3303, Social Security Act, § 1860D-14(a)(5). For 2018, CMS set the de minimis amount at $2 above the regional benchmark. 12 CMS, PDBM, ch. 3, § 40.1.4. 13 Ibid. 14 Ibid., § 30.3.2. In general, Medicare beneficiaries can switch Part D plans only once a year during a defined enrollment period. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 3 following year. 15 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.16 For dual eligibles who elected their current Part D plans, CMS notifies them that their plans will have premiums above the regional benchmark premium. For 2018, CMS reported reassigning approximately 351,000 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.17, 18 In addition, Part D plans must include Part D-covered drugs in certain categories and classes.19 Part D plans may also control drug utilization by applying utilization management tools. These tools include 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.20 For example, prescription vitamins, prescription mineral products, and nonprescription drugs are excluded from Part D prescription drug coverage.21 Until 2013, barbiturates and benzodiazepines were excluded from Part D prescription drug coverage. However, the ACA reversed this exclusion, 15 Ibid., § 40.1.5. 16 CMS, PDBM, § 40.1.5. 17 Ibid., ch. 6, § 30.2.1. 18 Therapeutic 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. 19 Social Security Act, § 1860D-4(b)(3)(G). 20 MMA, P.L. No. 108-173 § 101, Social Security Act, § 1860D-2(e). 21 Social Security Act § 1860D-2(e)(2), 1927(d)(2). Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 4 removing these two drug types from the list of drug classes ineligible for such coverage.22, 23 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.24 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 category or class), for the most common conditions. CMS uses Part D prescription drug data to identify the most commonly prescribed classes of drugs.25 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.26, 27, 28 Exceptions and appeals process. CMS has implemented an exceptions and appeals process whereby beneficiaries can request coverage of nonformulary drugs or an exception to a utilization management tool that applies to a formulary drug. 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.29 If the beneficiary’s plan makes an adverse determination, the beneficiary has the right to appeal.30 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 22 ACA, P.L. No. 111-148 § 2502, Social Security Act, § 1927(d). 23 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 April 13, 2017. 24 CMS, PDBM, ch. 6, § 30.2.7. 25 Ibid. 26 Ibid., § 30.2.2. 27 Ibid., § 30.2.7. 28 CMS looks to appropriate guidelines from expert organizations such as the National Committee for Quality Assurance, the Academy of Managed Care Pharmacy, and the National Association of Insurance Commissioners. 29 CMS, PDBM, ch. 18, §§ 30.1 and 30.2. 30 Ibid., § 60.1. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 5 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 beneficiaries request 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.31 The temporary fill accommodates beneficiaries’ immediate drug needs the first time they attempt to fill a prescription. The transition period also allows beneficiaries time to work with their prescribing physicians to obtain prescriptions for therapeutically alternative drugs or to request formulary exceptions from Part D plans. Related OIG Work In 2006, 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.32 In 2011, OIG issued the first annual mandated report examining dual eligibles’ access to drugs under Medicare Part D. See Appendix A for statutory mandate. We have released an annual mandated report each year since then. See Appendix B for list of reports. The current report is the eighth report released. METHODOLOGY Scope 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 2018. As part of our assessment, we included dual eligibles’ enrollment data from January 2018, the most recent enrollment data 31 CMS, PDBM, ch. 6, § 30.4.4. OIG, Dual Eligibles’ Transition: Part D Formularies’ Inclusion of Commonly Used 32 Drugs, OEI-05-06-00090, January 2006. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 6 available from CMS at the time of our study. We also compared the results of our 2018 study with those of our 2017 study. 33 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 2013 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, 197 are eligible for coverage under Part D. In this report, we refer to these 197 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. We also went beyond the ACA’s mandate in the 2013 to 2017 reports by examining the utilization management tools that Part D plan formularies apply to the drugs commonly used by dual eligibles. These tools may affect dual eligibles’ access even in cases where 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 2013 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, and prescription drug costs and utilization. The 2013 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 between one year and the next. The list for 2018 overlapped by 91 percent with the list for 2017, which in turn overlapped by 91 percent with the list for 2015.34 33 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2016, OEI-05-16-00090, June 2016. 34 In 2018, we used the 2013 data and in 2017 and 2016, we used the 2012 data. In 2015, we used 2011 data. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 7 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 2013, the MCBS surveyed 11,049 Medicare beneficiaries, of whom 2,456 were dual eligibles who had used prescription drugs during the year (out of 2,718 dual-eligible survey respondents). First DataBank National Drug Data File. We used the March 2013 First DataBank National Drug Data File to identify the drug product information for the 200 drugs with the highest utilization by dual eligibles.35 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 February 2018, we collected from CMS the formulary data and the plan data for Part D plans operating in 2018. The formulary data includes Part D plans’ formularies and utilization management tools for plans operating in 2018. In 2018, there are 386 unique formularies offered by 3,476 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 2018 enrollment data for Part D plans. These data provide the number of dual eligibles enrolled in each Part D plan as of January 2018. 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 2013 MCBS. We excluded respondents from territories because they are not eligible to receive cost-sharing assistance 35 The Mach 2013 First Databank National Drug Data File would have been in effect when the MCBS survey was being conducted 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: 2018 (OEI-05-18-00240) 8 under Part D. The MCBS listed 188,685 drug events for 2,456 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 188,685 drug events associated with 871 drugs. 3. We ranked the 871 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, 197 are eligible under Part D. One fell into a drug category excluded under Part D, and one is no longer prescribed in the form taken by beneficiaries surveyed in the 2013 MCBS. One additional drug is eligible for Part D prescription drug coverage. However, we did not include it in our analysis because the drug represents a medical supply item that is covered under Part D. For details on the two drugs excluded under Part D, see Appendix D. Formulary Analysis We analyzed the 386 unique Part D plan formularies to determine their rates of inclusion of the 197 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. When a drug included multiple ingredients that could be dispensed separately and combined by the patient to the same effect as the combined drug, we treated the drug as included if the ingredients were included in the formulary either separately or in combination. 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 2013. For example, 1 MCBS survey respondent reported taking rosuvastatin calcium (Crestor) 12 times in 2012. We counted this beneficiary/drug combination as 12 drug events. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 9 Low rates of inclusion by formularies. We determined which of the 197 commonly used drugs had low rates of inclusion by formularies by counting how many of the 386 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 197 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 197 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 197 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 197 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 2018 to Part D plans available in 2018. 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 relied on a sample of dual eligibles responding to the MCBS to develop our list of commonly used drugs, a particular dual eligible might not use any of the drugs on our list. However, the drugs most commonly used by dual-eligible MCBS survey participants in 2013 account for 88 percent of Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 10 all prescriptions dispensed to the dual-eligible respondents in the 2013 MCBS. Standards This study was conducted 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: 2018 (OEI-05-18-00240) 11 FINDINGS Part D Plan Formularies Include Between 85 and 100 Percent of the Drugs Commonly Used by Dual Eligibles On average, Part D plan formularies include 96 percent of the drugs commonly used by dual eligibles. Of the 386 unique formularies used by Part D plans in 2018, 12 formularies include 100 percent of the commonly used drugs. At the other end of the inclusion range, two formularies include 85 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 they do not include all of the drugs we identified as commonly used by dual eligibles. Exhibit 1: Nearly two-thirds of Part D plan formularies cover at least 96 percent of the drugs commonly used by dual eligibles. Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2018. Part D plan formularies’ rate of inclusion of the drugs commonly used by dual eligibles in 2018 is similar to that of 2017. The average rate of inclusion decreased slightly between 2017 and 2018, from 97 percent to 96 percent. The range of inclusion rates in 2017 and 2018 differ slightly with 85 to 100 percent of drugs commonly used by dual eligibles in 2018 compared with 88 to 100 percent in 2017. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 12 Nationally, PDP and MA-PD formularies have similar rates of inclusion of the drugs commonly used by dual eligibles, averaging 95 percent and 97 percent, respectively. For PDP formularies, the rates of inclusion ranged from 85 to 99 percent. For MA-PD formularies, the rates of inclusion ranged from 85 to 100 percent. Seven formularies—2 percent of the 386 unique formularies used by Part D plans in 2018—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, and every MA-PD region has a plan that includes at least 98 percent of these 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 96 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 85 percent to 100 percent. Approximately 86 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 10.8 million dual eligibles enrolled in Part D plans, approximately 93 percent are enrolled in Part D plans that use formularies that include at least 90 percent of the commonly used drugs. Seven 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. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 13 Exhibit 2: Enrollment of Dual Eligibles in Part D Plans, by Formularies’ Inclusion of Commonly Used Drugs Part D Plans With Formularies That Number of Dual Percentage of Dual Include: Eligibles Enrolled Eligibles Enrolled 100% of commonly used drugs 222,880 2% 95% to 99% of commonly used drugs 3,631,810 34% 90% to 94% of commonly used drugs 6,133,779 57% 85% to 89% of commonly used drugs 766,106 7% Total 10.754,575 100% Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles and dual eligibles’ enrollment, 2018. The percentage of dual eligibles enrolled in Part D plans that include at least 90 percent of the drugs commonly used by dual eligibles decreased from 96 percent in 2017 to 93 percent in 2018. Sixty-Eight 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 43 percent to 100 percent. At one end of the range, there is a drug that is included in 43 percent of Part D plan formularies, and at the other end, 134 drugs are included in all plan formularies. The average rate of inclusion in formularies is 96 percent. Exhibit 3 shows the rates at which formularies include the 197 drugs. Appendix C lists the 197 drugs and the rates at which formularies include them. Exhibit 3: Formularies’ Rates of Inclusion of Commonly Used Drugs Percentage of the 197 Commonly Percentage of the 386 Formularies Used Drugs Included in Formularies 68% 100% (134 drugs) 22% 85% to 99% (44 drugs) 4% 76% to 84% (7 drugs) 6% 43% to 75% (12 drugs) 100% Total (197 drugs) Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2018. The rates at which formularies include the drugs commonly used by dual eligibles in 2018 are similar to those in 2017. The percentage of Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 14 commonly used drugs included in all formularies decreased slightly between 2017 and 2018, from 70 percent to 68 percent. Part D plan formularies include certain drugs less frequently than others Of the commonly used drugs, 6 percent (12 drugs) are included by 75 percent or less of Part D plan formularies. Exhibit 4 provides the percentage of formularies covering each of these 12 drugs. The drugs that make up this group include both brand-name and generic drugs and are used to treat a variety of primary indications. Six of the 12 drugs are brand-name drugs, which are typically more costly than generic drugs. As for the primary indications, 4 of the 12 drugs are used for diabetes therapy, 2 are muscle relaxants, 2 are used for gastrointestinal conditions, and the remaining drugs treat a variety of conditions. Exhibit 4: Drugs Included by 75 Percent or Less of Part D Plan Formularies Rate of Generic Name of Drug Primary Indication(s) Inclusion by Formularies Solifenacin succinate Overactive bladder, incontinence 74% Hydroxyzine Pamoate Anxiety, Allergy Treatment 73% Insulin aspart Diabetes 72% Nebivolo Hcl Hypertension 71% Tiotropium Bromide Chronic Obstructive Pulmonary Disease 70% Esomeprazole magnesium Dyspepsia, peptic ulcer disease, gastroesophageal reflux 64% disease, Zollinger-Ellison syndrome Methocarbamol Musculoskeletal pain 59% Insulin lispro Diabetes 53% Dexlansoprazole Gastroesophageal reflux disease 52% Glyburide Diabetes 48% Carisoprodol Musculoskeletal pain 45% Glyburide/Metformin Hcl Diabetes 43% Source: OIG analysis of formularies’ inclusion of drugs commonly used by dual eligibles, 2018. The drugs in the shaded rows also had low rates of inclusion by formularies in 2017. Although Part D formularies frequently omit these 12 drugs, they all cover other drugs in the same respective therapeutic classes. For each of these 12 drugs, 100 percent of formularies cover at least 1 drug in the same therapeutic class that is also on the list of 197 drugs commonly used by dual eligibles. The number of drugs included by 75 percent or less of formularies increased from 10 in 2017 to 12 in 2018. There are eight drugs with low inclusion rates in 2018 that were also on the list of commonly used drugs with low inclusion rates in our 2017 report; we note these eight drugs Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 15 above in Exhibit 4. Seven of these eight drugs were also on the list of drugs with low inclusion rates in our 2016 report. There are multiple potential reasons why a commonly used drug might be included by 75 percent or less of formularies:  Two of these drugs—carisoprodol and methocarbamol—are on CMS’s list of Part D medications that are high-risk for the elderly.38  The two drugs above and a third drug—glyburide—are listed by the American Geriatrics Society as being potentially inappropriate for older adults.39  The American Geriatrics Society also cautions against certain uses of proton pump inhibitor drugs (PPIs) and drugs with strong anticholinergic properties. Dexlansoprazole and esomeprazole magnesium are PPIs, and solifenacin succinate has strong anticholinergic properties.40 Dual eligibles can use three options to obtain a nonformulary drug if a formulary does not include a particular drug. All three options require dual eligibles to take additional action. For instance, if dual eligibles wish to obtain therapeutically equivalent alternative drugs that are included by their plans’ formularies, they would need to get new prescriptions from their doctors. Dual eligibles may also go through an appeals process to obtain coverage of nonformulary drugs by submitting statements of medical necessity from their physicians.41 Finally, dual eligibles may switch to Part D plans with formularies that include their drugs, with the new coverage becoming effective the following month.42 38 This list—“Use of High-Risk Medications in the Elderly: High-Risk Medications” — is part of the Healthcare Effectiveness and Information Set national drug code measures published by the National Committee for Quality Assurance. A drug that is listed as being high risk for the elderly is one that has a high risk of serious side effects in that population. CMS uses its prescription data and this medication list to calculate the percentage of Medicare beneficiaries who received at least one high-risk medication in the past year. CMS publishes this percentage and other measures of Part D patient safety so that Medicare beneficiaries can make informed decisions in choosing Part D plans for their prescription drug coverage. National Committee on Quality Assurance, HEDIS 2012 NDC List. Accessed at http://www.cms.gov/Medicare/Prescription-Drug-Coverage/ PrescriptionDrugCovContra/Downloads/MemoPatientSafetyMeasures_071610.pdf on May 31, 2018. 39 The American Geriatrics Society, American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults, 2015. 40 Ibid. 41 CMS, PDBM, ch. 18, § 30.2.2. 42 Ibid., ch. 3, § 30.3.2. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 16 The Percentage of Commonly Used Drugs To Which Plan Formularies Applied Utilization Management Tools Increased Slightly Between 2017 and 2018 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 2017 to 29 percent in 2018. There was not much of a difference between plans with premiums below the regional benchmarks and those with premiums above those benchmarks; formularies for the two groups of plans used utilization management tools for 26 percent and 31 percent, respectively, of their drugs. See Exhibit 5 for a breakdown of the percentage of unique drugs to which Part D plan formularies apply utilization management tools in 2017 and 2018. Exhibit 5: Part D Plan Formularies’ Application of Utilization Management Tools to Commonly Used Drugs, 2017 and 2018 Percentage of Unique Drugs Number of Number of Percentage of Percentage of to Which Utilization 2017 Part D 2018 Part D 2017 Part D Plan 2018 Part D Plan Management Tools Are Plan Plan Formularies Formularies Applied Formularies Formularies Greater than 40% 60 16% 78 20% 30% to 39% 85 23% 130 34% 20% to 29% 140 38% 90 23% 10% to 19% 66 18% 66 17% Less than 10% 18 5% 22 6% Totals 369 100% 386 100% Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2018. Although utilization management tools can restrict beneficiaries’ access to drugs, they are important tools for managing costs in Medicare and ensuring 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. As a result, formularies’ application of utilization management controls to oxycodone HCl/ acetaminophen drugs increased by 30 percent in 2013.43 The percentage of drugs for which formularies applied the utilization management tools of quantity limits, prior authorization, or step therapy44 changed slightly between 2017 and 2018. Formularies applied quantity limits to 26 percent of drugs in 2018—a 2 percentage point increase from 43 CMS, Supplemental Guidance Related to Improving Drug Utilization Review Controls in Part D, September 6, 2012. Accessed at https://www.cms.gov/Medicare/Prescription- Drug-Coverage/PrescriptionDrugCovContra/Downloads/HPMSSupplementalGuidance Related-toImprovingDURcontrols.pdf on May 30, 2018. 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: 2018 (OEI-05-18-00240) 17 2017—, required prior authorization for 4 percent of drugs, and required step therapy for 1 percent of unique drugs. The rate at which plan formularies apply specific utilization management tools varies widely. In 2018, some formularies applied utilization management tools to very few of the unique drugs, whereas at the other end of the range, some applied tools to 56 percent of the unique drugs. More specifically, formularies apply quantity limits to between 0 and 53 percent of unique drugs, require prior authorization for between less than 1 and 12 percent, and require step therapy for between 0 and 11 percent. Looking at enrollment across plans provides a slightly different picture than looking only at plans themselves. On average, plan formularies in 2018 apply utilization management tools to 33 percent of unique drugs. However, dual eligibles tend to be enrolled in plans with formularies that apply these tools at a slightly lower rate. In 2018, the median plan weighted by dual-eligible enrollment applies such tools to 31 percent of unique drugs; in 2017, the figure was 29 percent. Similarly, the median plan weighted by overall Medicare enrollment applies these tools to 32 percent of unique drugs in 2018; in 2017, the figure was 30 percent. Both dual eligibles and Medicare beneficiaries overall tend to be enrolled in plans with formularies that apply utilization management tools to between 20 and 39 percent of unique drugs. In 2018, 71 percent of dual eligibles and 66 percent of Medicare beneficiaries overall were enrolled in plans with formularies in this range. The number of Medicare beneficiaries that were enrolled in plans that apply utilization management tools to more than 40 percent of unique drugs increased substantially in 2018. In 2017, 8 percent of dual eligibles and 13 percent of Medicare beneficiaries overall were enrolled in plans that applied utilization management tools to more than 40 percent of unique drugs. This increased to 24 percent and 26 percent respectively in 2018. 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’ apply utilization management tools. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 18 Exhibit 6: Beneficiary Enrollment in Part D Plans by Application of Utilization Management Tools to Commonly Used Drugs, 2017 and 2018 Percentage of Unique Percentage Percentage Percentage Percentage Drugs to Which Plan of Dual of Medicare of Dual of Medicare Formularies Apply Eligibles Beneficiaries Eligibles Beneficiaries Utilization Management Enrolled, Enrolled, Enrolled, Enrolled, Tools 2017 2017 2018 2018 Greater than 40% 8% 13% 24% 26% 30% to 39% 37% 39% 29% 37% 20% to 29% 50% 40% 41% 29% 10% to 19% 3% 4% 3% 4% Less than 10% 2% 3% 2% 3% Totals 100%* 100% 100% 100%* Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2018. * Percentages do not add to 100 percent because of rounding. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 19 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, Part D plan formularies do not 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 12 drugs that this report identifies as being included by 75 percent or less of Part D plan formularies, all Part D plan formularies cover at least 1 therapeutically equivalent alternative drug. 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 96 percent of the commonly used drugs. Part D plan formularies’ inclusion of the commonly used drugs ranges from 85 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. Inclusion rates for the 197 drugs commonly used by dual eligibles are largely unchanged compared with those from OIG’s 2017 report. Part D plan formularies include roughly the same percentage of these commonly used drugs in 2018 as they did in 2017. Enrollment in plans that cover at least 90 percent of unique drugs decreased, with 93 percent of dual eligibles enrolled in such plans in 2018 compared to 96 percent of dual eligibles in 2017. Because some variation exists in Part D plan formularies’ inclusion of the commonly used drugs and in their application of utilization management tools to these drugs, some dual eligibles may need to make additional efforts to access the drugs they take. They 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’ 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: 2018 (OEI-05-18-00240) 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: 2018 (OEI-05-18-00240) 21 APPENDIX B List of Manadated OIG Reports Examining Dual Eligible 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 Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 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 2012 MCBS. Projections and confidence intervals are derived from its survey methodology. Number of Projected Percentage of Sample 95-Percent Confidence Formularies Generic Name Drug Formularies Size* Interval* Including Events* Including Drug Drug Lisinopril 4,038 20,381,310 18,552,913–22,209,708 386 100% Omeprazole 4,425 19,707,133 17,636,412–21,777,854 386 100% Simvastatin 3,677 18,903,811 16,928,645–20,878,978 384 99% Amlodipine Besylate 3,855 18,789,961 16,676,942–20,902,979 386 100% Levothyroxine Sodium 4,242 18,298,908 16,405,768–20,192,048 386 100% Hydrocodone/Acetaminophen 4,494 17,495,817 15,328,947–19,662,688 386 100% Furosemide 4,123 17,425,375 15,574,619–19,276,131 386 100% Metformin Hcl 3,045 15,842,128 14,038,922–17,645,334 386 100% Atorvastatin Calcium 2,305 12,007,784 10,370,261–13,645,307 386 100% Metoprolol Tartrate 2,554 11,989,842 10,506,455–13,473,229 386 100% Potassium Chloride 3,020 11,709,300 10,192,735–13,225,866 386 100% Gabapentin 2,736 11,258,811 9,908,637–12,608,985 386 100% Nystatin 3,276 10,800,847 7,318,942–14,282,752 386 100% Warfarin Sodium 2,512 9,504,416 8,097,300–10,911,531 386 100% Albuterol Sulfate 2,052 9,204,690 7,942,991–10,466,390 386 100% Hydrochlorothiazide 1,585 9,049,481 7,557,151–10,541,811 386 100% Insulin 1,469 7,319,078 5,814,550–8,823,605 381 99% Glargine,hum.Rec.Anlog Metoprolol Succinate 1,403 7,260,928 6,108,639–8,413,218 385 100% Clopidogrel Bisulfate 1,388 7,230,886 6,099,241–8,362,532 386 100% Losartan Potassium 1,341 7,202,477 5,960,029–8,444,926 386 100% Citalopram Hydrobromide 1,725 7,093,303 5,960,073–8,226,533 386 100% Carvedilol 1,486 6,952,455 5,706,949–8,197,960 386 100% Esomeprazole Magnesium 1,582 6,926,582 5,590,920–8,262,244 247 64% Pantoprazole Sodium 1,616 6,892,160 4,604,999–9,179,321 386 100% Tramadol Hcl 1,792 6,807,062 5,819,372–7,794,751 386 100% Alprazolam 1,608 6,597,576 5,415,535–7,779,617 365 95% Trazodone Hcl 1,551 6,511,067 4,727,359–8,294,774 386 100% Glipizide 1,155 6,481,486 5,271,745–7,691,227 386 100% Atenolol 1,323 6,288,611 5,220,203–7,357,019 386 100% Promethazine Hcl 1,730 6,256,116 4,504,615–8,007,618 384 99% Pravastatin Sodium 1,260 6,247,140 4,770,713–7,723,567 385 100% Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 23 Sertraline Hcl 1,543 6,022,241 4,987,710–7,056,771 386 100% Clonazepam 1,590 5,877,149 4,656,463–7,097,835 386 100% Quetiapine Fumarate 1,648 5,801,415 4,446,747–7,156,082 386 100% continued on next page The 200 Drugs With the Highest Utilization by Dual Eligibles, continued Number of Projected Percentage of Sample 95-Percent Confidence Formularies Generic Name Drug Formularies Size* Interval* Including Events* Including Drug Drug Zolpidem Tartrate 1,345 5,607,270 4,429,096–6,785,444 378 98% Ranitidine Hcl 1,412 5,450,546 4,356,459–6,544,634 386 100% Fluticasone/Salmeterol 1,136 5,427,435 4,383,617–6,471,253 372 96% Montelukast Sodium 1,145 5,240,144 3,928,815–6,551,473 386 100% Rosuvastatin Calcium 929 5,137,546 4,054,742–6,220,350 376 97% Oxycodone Hcl/ 1,212 4,957,132 3,982,154–5,932,110 386 100% Acetaminophen Clobetasol Propionate 1,507 4,930,172 2,690,032–7,170,312 302 78% Donepezil Hcl 1,404 4,870,667 4,189,206–5,552,128 384 99% Lorazepam 1,374 4,837,237 3,946,993–5,727,481 386 100% Fluticasone Propionate 1,168 4,776,350 4,033,937–5,518,762 386 100% Oxycodone Hcl 1,188 4,660,197 3,374,303–5,946,091 385 100% Tamsulosin Hcl 879 4,490,524 3,658,245–5,322,803 386 100% Memantine Hcl 1,316 4,209,279 3,461,970–4,956,589 386 100% Prednisone 1,035 4,114,787 3,508,209–4,721,364 386 100% Bupropion Hcl 951 4,038,001 2,740,350–5,335,653 386 100% Alendronate Sodium 824 4,002,546 3,172,023–4,833,070 386 100% Allopurinol 792 3,970,410 3,153,877–4,786,944 386 100% Duloxetine Hcl 1,062 3,965,375 3,018,646–4,912,104 386 100% Valsartan 895 3,950,999 3,159,255–4,742,743 383 99% Divalproex Sodium 1,179 3,864,519 2,625,743–5,103,295 386 100% Risperidone 1,263 3,822,970 2,947,217–4,698,723 386 100% Fluoxetine Hcl 832 3,699,624 2,704,123–4,695,126 386 100% Tiotropium Bromide 718 3,696,364 2,719,547–4,673,181 271 70% Ibuprofen 1,014 3,690,403 3,130,468–4,250,339 386 100% Lisinopril/Hydrochlorothiazide 610 3,672,967 2,948,971–4,396,963 386 100% Isosorbide Mononitrate 781 3,589,706 2,863,637–4,315,775 386 100% Mirtazapine 930 3,588,107 2,763,598–4,412,615 386 100% Cyclobenzaprine Hcl 912 3,572,843 2,872,182–4,273,504 383 99% Aripiprazole 938 3,516,759 2,734,316–4,299,201 386 100% Clonidine Hcl 782 3,328,949 2,503,272–4,154,625 386 100% Paroxetine Hcl 731 3,282,143 2,465,231–4,099,056 386 100% Meloxicam 698 3,220,620 2,481,759–3,959,481 386 100% Fluocinonide 777 3,165,499 852,695–5,478,304 379 98% Escitalopram Oxalate 843 3,163,799 2,577,363–3,750,234 386 100% Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 24 Sitagliptin Phosphate 669 3,145,817 2,351,761–3,939,873 374 97% Levetiracetam 996 3,127,461 2,400,044–3,854,879 386 100% Famotidine 751 3,076,189 2,392,508–3,759,870 382 99% continued on next page The 200 Drugs With the Highest Utilization by Dual Eligibles, continued Number of Projected Percentage of Sample 95-Percent Confidence Formularies Generic Name Drug Formularies Size* Interval* Including Events* Including Drug Drug Diltiazem Hcl 759 3,034,429 2,389,782–3,679,076 386 100% Pregabalin 647 3,032,962 2,084,114–3,981,811 386 100% Glimepiride 568 3,027,684 2,309,913–3,745,454 386 100% Amitriptyline Hcl 651 3,006,497 2,338,978–3,674,016 386 100% Lovastatin 580 2,905,667 2,303,928–3,507,406 384 99% Enalapril Maleate 554 2,859,600 2,095,511–3,623,689 386 100% Diazepam 683 2,859,179 2,145,764–3,572,593 386 100% Olanzapine 935 2,805,880 2,153,123–3,458,637 386 100% Polyethylene Glycol 3350 791 2,794,905 2,261,081–3,328,728 386 100% Morphine Sulfate 671 2,785,883 2,016,589–3,555,177 386 100% Lamotrigine 792 2,584,433 1,820,559–3,348,306 386 100% Ciprofloxacin Hcl 710 2,572,783 2,250,615–2,894,952 386 100% Nitroglycerin 567 2,516,794 1,989,315–3,044,272 386 100% Digoxin 671 2,499,207 1,849,180–3,149,233 386 100% Topiramate 768 2,497,034 1,765,504–3,228,563 386 100% Oxybutynin Chloride 611 2,496,353 1,865,024–3,127,681 386 100% Insulin Aspart 576 2,457,698 1,734,741–3,180,655 277 72% Latanoprost 570 2,362,248 1,830,307–2,894,189 386 100% Azithromycin 656 2,360,326 2,078,870–2,641,781 386 100% Diclofenac Sodium 564 2,347,071 1,797,777–2,896,364 386 100% Sulfamethoxazole/ Trimethoprim 679 2,316,522 1,948,947–2,684,096 386 100% Benztropine Mesylate 831 2,315,393 1,755,885–2,874,901 385 100% Spironolactone 564 2,309,373 1,714,941–2,903,804 386 100% Celecoxib 536 2,308,905 1,617,011–3,000,799 363 94% Baclofen 640 2,259,728 1,773,860–2,745,596 386 100% Hydrocortisone 355 2,228,990 393,049–4,064,931 386 100% Valsartan/ Hydrochlorothiazide 362 2,148,809 1,446,999–2,850,620 382 99% Ketoconazole 643 2,118,032 1,508,222–2,727,841 386 100% Buspirone Hcl 544 2,117,000 1,566,401–2,667,599 386 100% Venlafaxine Hcl 676 2,086,177 1,603,806–2,568,547 386 100% Ipratropium/Albuterol Sulfate 514 2,071,560 1,613,340–2,529,780 379 98% Nifedipine 399 2,061,785 1,496,922–2,626,648 377 98% Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 25 Triamterene/ Hydrochlorothiazid 434 1,998,788 1,490,958–2,506,617 386 100% Lidocaine 566 1,991,949 1,504,848–2,479,050 386 100% Lactulose 478 1,971,518 1,048,559–2,894,477 386 100% continued on next page The 200 Drugs With the Highest Utilization by Dual Eligibles, continued Number of Projected Percentage of Sample 95-Percent Confidence Formularies Generic Name Drug Formularies Size* Interval* Including Events* Including Drug Drug Naproxen 475 1,935,742 1,514,931–2,356,553 386 100% Carbamazepine 557 1,892,355 1,301,937–2,482,774 386 100% Budesonide/Formoterol 354 1,877,636 1,080,548–2,674,725 306 79% Fumarate Hydralazine Hcl 423 1,870,997 1,381,326–2,360,669 386 100% Cephalexin 576 1,859,516 1,586,809–2,132,222 386 100% Amoxicillin 502 1,859,250 1,639,830–2,078,670 386 100% Carbidopa/Levodopa 524 1,840,512 1,292,455–2,388,569 386 100% Meclizine Hcl 430 1,825,694 1,314,979–2,336,409 386 100% Hydroxyzine Hcl 332 1,816,899 683,133–2,950,664 368 95% Levofloxacin 525 1,815,766 1,491,041–2,140,491 386 100% Insulin Detemir 424 1,804,441 1,267,928–2,340,954 315 82% Phenytoin Sodium Extended 565 1,796,703 1,343,910–2,249,496 386 100% Pioglitazone Hcl 402 1,778,633 1,249,826–2,307,440 386 100% Losartan/Hydrochlorothiazide 323 1,756,708 1,195,562–2,317,854 386 100% Propranolol Hcl 441 1,671,564 1,144,349–2,198,778 386 100% Ropinirole Hcl 342 1,668,001 946,318–2,389,683 386 100% Triamcinolone Acetonide 417 1,636,176 1,228,192–2,044,160 386 100% Verapamil Hcl 347 1,604,821 980,059–2,229,583 386 100% Clozapine 475 1,570,432 374,731–2,766,134 386 100% Temazepam 400 1,555,608 1,137,384–1,973,832 359 93% Fenofibrate Nanocrystallized 400 1,535,334 1,046,334–2,024,334 376 97% Omega-3 Acid Ethyl Esters 342 1,493,157 979,970–2,006,343 364 94% Terazosin Hcl 281 1,492,288 963,820–2,020,756 386 100% Fentanyl 447 1,476,511 927,847–2,025,175 386 100% Tizanidine Hcl 386 1,427,368 969,496–1,885,240 386 100% Benazepril Hcl 299 1,413,392 933,212–1,893,572 385 100% Insulin Lispro 332 1,399,742 956,645–1,842,840 204 53% Finasteride 279 1,368,049 837,874–1,898,225 386 100% Bimatoprost 236 1,364,658 897,674–1,831,642 372 96% Mometasone Furoate 313 1,351,763 984,967–1,718,558 385 100% Ezetimibe 282 1,341,551 937,005–1,746,098 386 100% Fenofibrate 239 1,324,483 859,187–1,789,779 385 100% Amoxicillin/Potassium Clav 324 1,313,164 1,018,028–1,608,301 386 100% Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 26 Acetaminophen With Codeine 334 1,301,414 987,348–1,615,481 386 100% Lansoprazole 298 1,296,387 849,556–1,743,219 302 78% Brimonidine Tartrate 314 1,282,393 892,130–1,672,657 386 100% **See Appendix D. continued on next page The 200 Drugs With the Highest Utilization by Dual Eligibles, continued Number of Projected Percentage of Sample 95-Percent Confidence Formularies Generic Name Drug Formularies Size* Interval* Including Events* Including Drug Drug Solifenacin Succinate 319 1,274,551 822,905–1,726,196 284 74% Carisoprodol 344 1,266,633 832,511–1,700,754 173 45% Estradiol 186 1,237,965 694,043–1,781,887 386 100% Glyburide 210 1,237,276 752,972–1,721,581 187 48% Gemfibrozil 373 1,226,890 843,027–1,610,754 386 100% Metoclopramide Hcl 297 1,220,585 817,332–1,623,838 386 100% Doxycycline Hyclate 367 1,205,416 874,913–1,535,919 386 100% Estrogens, Conjugated 196 1,205,404 718,999–1,691,810 310 80% Fluconazole 352 1,200,530 913,815–1,487,245 386 100% Timolol Maleate 252 1,199,817 791,436–1,608,199 386 100% Dexlansoprazole 232 1,183,857 561,313–1,806,402 201 52% Raloxifene Hcl 235 1,183,587 614,731–1,752,442 386 100% Pramipexole Di-Hcl 263 1,142,484 657,526–1,627,442 386 100% Sucralfate 366 1,139,606 826,665–1,452,547 386 100% Metronidazole 331 1,135,808 843,094–1,428,522 386 100% Bumetanide 278 1,111,267 589,762–1,632,772 386 100% Alcohol Antiseptic Pads* 153 1,029,885 651,603–1,408,167 Supply Supply Doxazosin Mesylate 255 1,029,363 668,462–1,390,263 386 100% Torsemide 192 1,026,453 640,900–1,412,006 378 98% Prednisolone Acetate 223 1,022,524 722,209–1,322,839 374 97% Nph, Human Insulin Isophane 195 1,007,125 587,060–1,427,190 386 100% Olopatadine Hcl 266 1,006,336 643,460–1,369,212 369 96% Colchicine 179 1,005,889 639,022–1,372,756 386 100% Rivastigmine 298 959,298 618,966–1,299,630 378 98% Niacin 219 957,366 521,221–1,393,511 386 100% Folic Acid** 243 957,331 612,086–1,302,575 Excluded Excluded Haloperidol 308 956,071 643,517–1,268,625 386 100% Dorzolamide Hcl/Timolol 196 954,636 615,415–1,293,858 380 98% Maleat Olmesartan Medoxomil 162 951,864 475,332–1,428,396 296 77% Cyclosporine 238 924,140 652,810–1,195,471 386 100% Ergocalciferol (Vitamin D2)** 258 915,961 611,911–1,220,011 Excluded Excluded Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 27 Insulin Regular, Human 294 913,137 530,888–1,295,387 386 100% Ipratropium Bromide 262 904,182 563,910–1,244,455 386 100% Tolterodine Tartrate 243 902,139 567,891–1,236,388 370 96% Methocarbamol 202 896,527 592,249–1,200,805 226 59% **See Appendix D. continued on next page The 200 Drugs With the Highest Utilization by Dual Eligibles, continued Number of Projected Percentage of Sample 95-Percent Confidence Formularies Generic Name Drug Formularies Size* Interval* Including Events* Including Drug Drug Lithium Carbonate 310 894,184 460,392–1,327,975 386 100% Nebivolol Hcl 204 888,540 570,909–1,206,171 273 71% Ziprasidone Hcl 280 887,738 486,410–1,289,066 386 100% Phenobarbital 197 878,403 385,109–1,371,696 386 100% Methadone Hcl 218 875,640 436,833–1,314,448 378 98% Methylprednisolone 210 870,654 686,948–1,054,361 386 100% Dicyclomine Hcl 253 869,035 570,356–1,167,714 386 100% Desvenlafaxine Succinate 192 853,705 189,589–1,517,822 381 99% Ciclopirox Olamine 201 844,790 240,577–1,449,004 371 96% Glyburide/Metformin Hcl 191 843,420 311,508–1,375,332 166 43% Travoprost 210 841,574 569,616–1,113,531 359 93% Hydroxyzine Pamoate 240 839,497 585,752–1,093,241 282 73% Methotrexate Sodium 173 829,816 416,386–1,243,246 386 100% Mupirocin 246 828,189 583,299–1,073,078 384 99% Hydroxychloroquine Sulfate 166 819,701 443,539–1,195,863 386 100% Cinacalcet Hcl 215 817,054 330,264–1,303,843 386 100% Amlodipine Besylate/ 216 792,127 436,368–1,147,887 371 96% Benazepril Ramipril 190 784,878 417,990–1,151,766 384 99% Isosorbide Dinitrate 174 753,498 371,545–1,135,451 384 99% Ondansetron Hcl 201 752,416 556,573–948,260 386 100% Dextroamphetamine/ 251 740,436 301,160–1,179,711 386 100% Amphetamine Rivaroxaban 191 736,498 393,445–1,079,550 296 77% Clindamycin Hcl 207 733,660 539,565–927,755 386 100% Source: OIG analysis of drugs commonly used by dual eligibles, 2018. **See Appendix D. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 28 APPENDIX D Two Drugs Commonly Used by Dual Eligibles and Not Covered Under Part D Generic Name Reason Excluded Under Part D No longer prescribed without Folic Acid sulfate Ergocalciferol (vitamin D2)* Vitamin or mineral product Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2018. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 29 APPENDIX E Formulary Inclusion of Stand-Alone Prescription Drug Plans* and Medicare Advantage Prescription Drug Plans**, by Region Exhibit E-1: PDP Formularies’ Inclusion of Commonly Used Drugs, by PDP Region PDP Number of Average Rate of Drug Maximum State(s) Minimum Rate Region PDPs Inclusion by Formularies Rate 1 Maine, New Hampshire 24 95% 88% 99% Connecticut, Massachusetts, 2 Rhode Island, Vermont 22 95% 88% 99% 3 New York 20 95% 88% 99% 4 New Jersey 22 94% 88% 99% Delaware, the District of 5 Columbia, Maryland 21 95% 88% 99% 6 Pennsylvania, West Virginia 26 95% 88% 99% 7 Virginia 24 95% 88% 99% 8 North Carolina 24 94% 88% 99% 9 South Carolina 22 95% 88% 99% 10 Georgia 24 95% 88% 99% 11 Florida 21 95% 88% 99% 12 Alabama, Tennessee 25 95% 88% 99% 13 Michigan 24 95% 88% 99% 14 Ohio 23 95% 88% 99% 15 Indiana, Kentucky 24 95% 88% 99% 16 Wisconsin 25 95% 88% 99% 17 Illinois 24 94% 85% 99% 18 Missouri 24 95% 88% 99% 19 Arkansas 21 95% 88% 99% 20 Mississippi 20 95% 88% 99% 21 Louisiana 21 95% 88% 99% 22 Texas 24 94% 85% 99% 23 Oklahoma 23 94% 85% 99% 24 Kansas 23 95% 88% 99% Iowa, Minnesota, Montana, 25 Nebraska, North Dakota, South Dakota, Wyoming 23 95% 88% 99% 26 New Mexico 24 94% 85% 99% 27 Colorado 24 95% 88% 99% 28 Arizona 23 95% 88% 99% 29 Nevada 24 95% 88% 99% 30 Oregon, Washington 22 95% 88% 99% 31 Idaho, Utah 25 95% 88% 99% 32 California 25 95% 88% 99% 33 Hawaii 20 95% 88% 99% 34 Alaska 19 94% 88% 99% Source: OIG analysis of formularies’ inclusion of drugs commonly used by dual eligibles, 2018. *PDP. **MA-PD. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 30 Exhibit E-2: MA-PD Formularies’ Inclusion of Commonly Used Drugs, by MA-PD Region Average Rate of MA-PD Number of State(s) Drug Inclusion by Minimum Rate Maximum Rate Region*** MA-PDs Formularies 1 Maine, New Hampshire 55 97% 91% 99% Connecticut, Massachusetts, 2 Rhode Island, Vermont 99 96% 92% 99% 3 New York 199 97% 91% 100% 4 New Jersey 42 96% 89% 98% Delaware, the District of Columbia, 5 Maryland 40 97% 95% 100% 6 Pennsylvania, West Virginia 192 97% 91% 100% 7 North Carolina, Virginia 144 97% 89% 100% 8 Georgia, South Carolina 112 97% 91% 100% 9 Florida 283 97% 91% 100% 10 Alabama, Tennessee 91 97% 95% 98% 11 Michigan 69 97% 95% 98% 12 Ohio 127 97% 92% 100% 13 Indiana, Kentucky 112 97% 94% 100% 14 Illinois, Wisconsin 157 97% 85% 99% 15 Arkansas, Missouri 90 97% 91% 100% 16 Louisiana, Mississippi 65 97% 91% 100% 17 Texas 159 97% 94% 100% 18 Kansas, Oklahoma 57 97% 91% 100% Iowa, Minnesota, Montana, Nebraska, 19 North Dakota, South Dakota, Wyoming 97 96% 91% 100% 20 Colorado, New Mexico 62 97% 91% 100% 21 Arizona 68 97% 95% 100% 22 Nevada 34 97% 91% 99% 23 Idaho, Oregon, Utah, Washington 193 97% 92% 100% 24 California 266 97% 93% 100% 25 Hawaii 19 97% 95% 100% Source: OIG analysis of formularies’ inclusion of drugs commonly used by dual eligibles, 2018. ***Region 26, which covers Alaska, had no MA-PDs available for 2018. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 31 ACKNOWLEDGMENTS This report was prepared under the direction of Thomas Komaniecki, Regional Inspector General for Evaluation and Inspections in the Chicago regional office. Hilary Slover served as the team leader for this study. Central office staff who provided support include Kevin Farber, Meghan Riggs, Christine Moritz, and David Tawes. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2018 (OEI-05-18-00240) 32 Office of Inspector General https://oig.hhs.gov 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: Office of Audit Services 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 assessments help reduce waste, abuse, and mismanagement and promote economy and efficiency throughout HHS. Office of Evaluation and Inspections 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. Office of Investigations 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. Office of Counsel to the Inspector General 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.