Department of Health and Human Services OFFICE OF INSPECTOR GENERAL PART D PLANS GENERALLY INCLUDE DRUGS COMMONLY USED BY DUAL ELIGIBLES: 2017 (INITIAL CAPS, SMALL CAPS) Suzanne Murrin Deputy Inspector General For Evaluation and Inspections June 2017 OEI-05-17-00160 Report in Brief June 2017 OEI-05-17-00160 Why OIG Did This Review Part D Plans Generally Include Drugs This report fulfills for 2017 the annual Commonly Used by Dual Eligibles: 2017 reporting mandate from the Patient Protection and Affordable Care Act Key Takeaway What OIG Found (ACA). The ACA requires OIG to Overall, we found that the rate of Part D Overall, we found that the rate of conduct a study of the extent to which plan formularies’ inclusion of the Part D plan formularies’ inclusion formularies used by Medicare Part D 197 drugs commonly used by dual of the drugs commonly used by plans include drugs commonly used by eligibles is high, with some variation. On dual eligibles is high, with some full-benefit dual-eligible individuals variation. Because some average, Part D plan formularies include (i.e., individuals who are eligible for variation exists in formularies’ 97 percent of the 197 commonly used inclusion of these drugs and in both Medicare and full Medicaid drugs. In addition, 70 percent of the their application of utilization benefits). These individuals generally commonly used drugs are included by all management tools to the drugs, get drug coverage through Medicare Part D plan formularies. These results are some dual eligibles may need to Part D. Pursuant to the ACA, OIG must largely unchanged from OIG’s findings for make additional efforts to access annually issue a report with formularies reported in the mandated the drugs they take. They could recommendations as appropriate. This annual report from 2016, as well as our appeal prescription drug coverage is the seventh report OIG has produced findings from 2011 through 2015. decisions, switch prescription to meet this mandate. drugs, or switch Part D plans. We also found that the percentage of Because these scenarios require How OIG Did This Review drugs to which plan formularies applied additional effort by dual eligibles, For this report, we determined whether utilization management tools remained they may result in administrative the 369 unique formularies used by the the same from 2016 to 2017. On barriers to accessing certain 3,014 Part D plans operating in 2017 average, formularies applied utilization prescription drugs. cover the 200 drugs most commonly management tools to 28 percent of the used by dual eligibles. We also unique drugs we reviewed in 2017, the same percentage as in determined the extent to which plan 2016. formularies applied utilization management tools to those commonly What OIG Concludes used drugs. To create the list of the Inclusion rates for the 197 drugs commonly used by dual 200 drugs most commonly used by dual eligibles are largely unchanged compared with the inclusion eligibles, we used data from the 2012 rates listed in our previous reports. Part D formularies include Medicare Current Beneficiary Survey— roughly the same percentage of these commonly used drugs in the most recent data available at the 2017 as they did in 2016. time of our study. Of the top 200 As mandated by the ACA, OIG will continue to monitor and drugs, 197 are eligible for Part D produce annual reports on the extent to which Part D plan prescription drug coverage, 1 is formularies cover drugs that dual eligibles commonly use. In excluded from coverage, and 1 is no addition, OIG will continue to monitor Part D plan formularies’ longer prescribed in the form taken by application of utilization management tools to these drugs. OIG beneficiaries. One additional drug is has no recommendations at this time. 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 Objectives ....................................................................................................1 Background ..................................................................................................1 Methodology ................................................................................................6 Findings......................................................................................................12 Part D Plan Formularies Include Between 88 and 100 Percent of the Drugs Commonly Used by Dual Eligibles ...............................12 Seventy 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 Stayed the Same Between 2016 and 2017 .......................................................17 Conclusion .................................................................................................19 Appendixes ................................................................................................20 A: Section 3313 of the Patient Protection and Affordable Care Act of 2010 ....................................................................................20 B: Commonly Used Drugs and Rates of Inclusion by Formularies ....................................................................................21 C: Two Drugs Commonly Used by Dual Eligibles and Not Covered Under Part D ....................................................................27 D: Formulary Inclusion of Stand-Alone Prescription Drug Plans and Medicare Advantage Prescription Drug Plans, by Region ......28 Acknowledgments......................................................................................30 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: 2017 (OEI-05-17-00160) 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 2017, approximately 42.3 million of the 57.7 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 2017, plan sponsors offer 3,014 unique Part D plans, with many plan sponsors offering multiple Part D plans. Dual Eligibles Under Medicare Part D Approximately 11.4 million Medicare beneficiaries are dual eligibles. For about 8.2 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: 2017 (OEI-05-17-00160) 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 following year.15 For dual eligibles who were randomly assigned to their 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 2017, 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. 15 Ibid., § 40.1.5. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 3 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 2017, CMS reported reassigning approximately 277,000 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, 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: 2017 (OEI-05-17-00160) 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: 2017 (OEI-05-17-00160) 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 refill 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.33 We have released an annual mandated report each year since then.34, 35, 36, 37, 38 The current report is the seventh report released. 31 CMS, PDBM, ch. 6, § 30.4.4. 32 OIG, Dual Eligibles’ Transition: Part D Formularies’ Inclusion of Commonly Used Drugs, OEI-05-06-00090, January 2006. 33 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2011, OEI-05-10-00390, April 2011. 34 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2012, OEI-05-12-00060, June 2012. 35 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2013, OEI-15-13-00090, June 2013. 36 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2014, OEI-05-14-00170, June 2014. 37 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2015, OEI-05-15-00120, June 2015. 38 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2016, OEI-05-16-00090, June 2016. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 6 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 2017. As part of our assessment, we included dual eligibles’ enrollment data from March 2017, the most recent enrollment data available from CMS at the time of our study. We also compared the results of our 2017 study with those of our 2016 study.39 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 2012 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.” The list of 200 drugs with the highest utilization by dual eligibles referenced in this 2017 report is the same list of drugs referenced in the 2016 report. 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, 2014, 2015, 2016, and 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. 39 OIG, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2016, OEI-05-16-00090, June 2016. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 7 Data Sources MCBS. We used the 2012 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 2012 MCBS Cost and Use data were the most recent data available at the time of our study and were also used for this analysis in the 2016 report. 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 2016 overlapped by 91 percent with the list for 2015, which in turn overlapped by 93 percent with the list for 2014.40 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 2012, the MCBS surveyed 11,299 Medicare beneficiaries, of whom 2,244 were dual eligibles who had used prescription drugs during the year (out of 2,484 dual-eligible survey respondents). First DataBank National Drug Data File. We used the April 2017 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).41 Part D plan data. In March 2017, we collected from CMS the formulary data and the plan data for Part D plans operating in 2017. The formulary data includes Part D plans’ formularies and utilization management tools for plans operating in 2017. In 2017, there are 369 unique formularies offered by 3,014 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. 40 In 2015, we used the 2011 data and in 2014, we used the 2010 data. 41 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: 2017 (OEI-05-17-00160) 8 We also collected 2017 enrollment data for Part D plans. These data provide the number of dual eligibles enrolled in each Part D plan as of March 2017. 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 2012 MCBS. We excluded respondents from territories because they are not eligible to receive cost-sharing assistance under Part D. The MCBS listed 167,848 drug events for 2,244 dual eligibles who did not reside in territories.42 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 167,848 drug events associated with 868 drugs. 3. We ranked the 868 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 B. 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 2012 MCBS. 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. For details on the two drugs excluded under Part D, see Appendix C. 42 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 2012. 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: 2017 (OEI-05-17-00160) 9 Formulary Analysis We analyzed the 369 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. 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 369 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 Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 10 dual-eligible enrollment and Medicare enrollment. To do this, we applied enrollment data from March 2017 to Part D plans available in 2017. 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 2012 account for 88 percent of all prescriptions dispensed to the dual-eligible respondents in the 2012 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: 2017 (OEI-05-17-00160) 11 FINDINGS Part D Plan Formularies Include Between 88 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 369 unique formularies used by Part D plans in 2017, 14 formularies include 100 percent of the commonly used drugs. At the other end of the inclusion range, four formularies include 88 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 97 percent of the drugs commonly used by dual eligibles. Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2017. Part D plan formularies’ rate of inclusion of the drugs commonly used by dual eligibles in 2017 is similar to that of 2016. The average rate of inclusion increased slightly between 2016 and 2017, from 96 percent to 97 percent. The range of inclusion rates in 2016 and 2017 are the same— 88 to 100 percent of the drugs commonly used by dual eligibles. Nationally, PDP and MA-PD formularies have similar rates of inclusion of the drugs commonly used by dual eligibles, averaging 95 percent and Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 12 97 percent, respectively. For PDP and MA-PD formularies, the rates of inclusion ranged from 88 to 100 percent. Eleven formularies—3 percent of the 369 unique formularies used by Part D plans in 2017—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 D 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 88 percent to 100 percent. Approximately 85 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 9.9 million dual eligibles enrolled in Part D plans, approximately 96 percent are enrolled in Part D plans that use formularies that include at least 90 percent of the commonly used drugs. Four 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: 2017 (OEI-05-17-00160) 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 249,598 3% 95% to 99% of commonly used drugs 5,340,291 54% 90% to 94% of commonly used drugs 3,891,989 39% 85% to 89% of commonly used drugs 405,474 4% Total 9,887,352 100% Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles and dual eligibles’ enrollment, 2017. 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 nearly 100 percent in 2016 to 96 percent in 2017. Seventy 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, 138 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 197 drugs. Appendix B 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 369 Formularies Used Drugs Included in Formularies 70% 100% (138 drugs) 22% 85% to 99% (43 drugs) 3% 76% to 84% (6 drugs) 5% 46% to 75% (10 drugs) 100% Total (197 drugs) Source: OIG analysis of State Medicaid claims data, 2007 . The rates at which formularies include the drugs commonly used by dual eligibles in 2017 are similar to those in 2016. The percentage of commonly used drugs included in all formularies increased slightly between 2016 and 2017, from 68 percent to 70 percent. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 14 Part D plan formularies include certain drugs less frequently than others Of the commonly used drugs, 5 percent (10 drugs) are included by 75 percent or less of Part D plan formularies. Exhibit 4 provides the percentage of formularies covering each of these 10 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. Five of the 10 drugs are brand-name drugs, which are typically more costly than generic drugs. As for the primary indications, 3 of the 10 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 Risedronate sodium Osteoporosis, Paget's disease of bone 75% Insulin aspart Diabetes 74% Budesonide/formoterol fumarate Inflammation, bronchodilator 73% Solifenacin succinate Overactive bladder, incontinence 73% Esomeprazole magnesium Dyspepsia, peptic ulcer disease, gastroesophageal reflux 63% disease, Zollinger-Ellison syndrome Methocarbamol Musculoskeletal pain 60% Insulin lispro Diabetes 59% Dexlansoprazole Gastroesophageal reflux disease 51% Glyburide Diabetes 48% Carisoprodol Musculoskeletal pain 46% Source: OIG analysis of formularies’ inclusion of drugs commonly used by dual eligibles, 2017. The drugs in the shaded rows also had low rates of inclusion by formularies in 2016. Although Part D formularies frequently omit these 10 drugs, they all cover other drugs in the same respective therapeutic classes. For each of these 10 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 9 in 2016 to 10 in 2017. There are seven drugs with low inclusion rates in 2017 that were also on the list of commonly used drugs with low inclusion rates in our 2016 report; we note these seven drugs above in Exhibit 4. Five of these seven drugs were also on the list of drugs with low inclusion rates in our 2015 report. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 15 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.43  The two drugs above and a third drug—glyburide—are listed by the American Geriatrics Society as being potentially inappropriate for older adults.44  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.45 If a particular drug has a low rate of inclusion by formularies, a dual eligible may need to obtain a nonformulary drug. There are several means by which dual eligibles can obtain a nonformulary drug, all of which require them to take additional action. 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.46 Finally, dual eligibles may switch to Part D plans with formularies that include their drugs, with the new coverage becoming effective the following month.47 43 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 April 13, 2017. 44 The American Geriatrics Society, American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults, 2015. 45 Ibid. 46 CMS, PDBM, ch. 18, § 30.2.2. 47 Ibid., ch. 3, § 30.3.2. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 16 The Percentage of Commonly Used Drugs To Which Plan Formularies Applied Utilization Management Tools Stayed the Same Between 2016 and 2017 For the unique drugs that compose the list of commonly used drugs, the percentage to which Part D plan formularies applied utilization management tools remained unchanged, at an average of 28 percent in 2016 and 2017. 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 25 percent and 29 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 2016 and 2017. Exhibit 5: Part D Plan Formularies’ Application of Utilization Management Tools to Commonly Used Drugs, 2016 and 2017 Percentage of Unique Drugs Number of Number of Percentage of Percentage of to Which Utilization 2016 Part D 2017 Part D 2016 Part D Plan 2017 Part D Plan Management Tools Are Plan Plan Formularies Formularies Applied Formularies Formularies Greater than 40% 22 6% 60 16% 30% to 39% 189 50% 85 23% 20% to 29% 59 16% 140 38% 10% to 19% 74 20% 66 18% Less than 10% 30 8% 18 5% Totals 374 100% 369 100% Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2017. 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 2013.48 The percentage of drugs for which formularies applied the utilization management tools of quantity limits, prior authorization, or step therapy49 stayed the same from 2016 to 2017. Formularies applied quantity limits to 24 percent of drugs, required prior authorization for 4 percent of drugs, and required step therapy for 1 percent of unique drugs. 48 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 April 13, 2017. 49 See footnote 3 for explanations of quantity limits, prior authorization, and step therapy. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 17 The rate at which plan formularies apply specific utilization management tools varies widely. In 2017, some formularies applied utilization management tools to none of the unique drugs, whereas at the other end of the range, some applied tools to 44 percent of the unique drugs. More specifically, formularies apply quantity limits to between 0 and 42 percent of unique drugs, require prior authorization for between 0 and 14 percent, and require step therapy for between 0 and 8 percent. Looking at enrollment across plans provides a slightly different picture than looking only at plans themselves. On average, plan formularies in 2017 apply utilization management tools to 28 percent of unique drugs. However, dual eligibles tend to be enrolled in plans with formularies that apply these tools at a slightly higher rate. In 2017, the median plan weighted by dual-eligible enrollment applies such tools to 29 percent of unique drugs; in 2016, the figure was 32 percent. Similarly, the median plan weighted by overall Medicare enrollment applies these tools to 30 percent of unique drugs in 2017; in 2016, the figure was 31 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 2017, 87 percent of dual eligibles and 79 percent of Medicare beneficiaries overall were enrolled in plans with formularies in this range. 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. Exhibit 6: Beneficiary Enrollment in Part D Plans by Application of Utilization Management Tools to Commonly Used Drugs, 2016 and 2017 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 2016 2016 2017 2017 Greater than 40% 1% 1% 8% 13% 30% to 39% 79% 72% 37% 39% 20% to 29% 14% 18% 50% 40% 10% to 19% 3% 5% 3% 4% Less than 10% 2% 4% 2% 3% Totals 100%* 100% 100% 100%* Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2017. * Percentages do not add to 100 percent because of rounding. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 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, 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 10 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 97 percent of the commonly used drugs. Part D plan formularies’ inclusion of the commonly used drugs ranges from 88 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 2016 report. Part D plan formularies include roughly the same percentage of these commonly used drugs in 2017 as they did in 2016. Enrollment in plans that cover at least 90 percent of unique drugs decreased, with 96 percent of dual eligibles enrolled in such plans in 2017 compared to nearly 100 percent of dual eligibles in 2016. 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: 2017 (OEI-05-17-00160) 19 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: 2017 (OEI-05-17-00160) 20 APPENDIX B 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 Simvastatin 4,085 20,275,845 18,246,788–22,304,903 369 100% Lisinopril 4,146 20,105,037 17,883,005–22,327,069 369 100% Omeprazole 4,277 17,651,028 15,907,564–19,394,492 369 100% Levothyroxine Sodium 3,875 16,391,504 14,506,699–18,276,310 369 100% Hydrocodone/Acetaminophen 4,335 15,724,258 13,700,633–17,747,884 369 100% Furosemide 3,594 15,682,269 13,969,198–17,395,341 369 100% Metformin HCl 3,053 15,402,973 13,342,093–17,463,852 369 100% Amlodipine Besylate 3,084 14,334,829 12,552,775–16,116,883 369 100% Potassium Chloride 2,535 9,847,651 8,425,381–11,269,921 369 100% Gabapentin 2,195 9,659,579 7,744,867–11,574,290 369 100% Atorvastatin Calcium 1,892 9,469,703 8,032,978–10,906,428 369 100% Metoprolol Tartrate 2,161 9,465,474 8,198,827–10,732,121 369 100% Hydrochlorothiazide 1,684 8,538,793 7,204,227–9,873,358 369 100% Warfarin Sodium 2,143 8,176,792 6,782,635–9,570,949 369 100% Albuterol Sulfate 1,809 8,051,430 6,601,089–9,501,772 369 100% Esomeprazole Magnesium 1,623 7,345,547 5,669,748–9,021,345 233 63% Tramadol HCl 1,814 7,033,265 5,908,206–8,158,324 369 100% Citalopram Hydrobromide 1,743 7,028,557 5,999,840–8,057,274 369 100% Clopidogrel Bisulfate 1,420 6,884,688 5,592,048–8,177,329 369 100% Atenolol 1,341 6,622,365 5,452,738–7,791,992 369 100% Zolpidem Tartrate 1,479 6,486,938 5,054,325–7,919,552 357 97% Carvedilol 1,354 6,189,667 5,070,687–7,308,647 369 100% Insulin 1,299 5,924,792 4,861,244–6,988,340 362 98% Glargine,hum.Rec.Anlog Promethazine HCl 2,023 5,868,471 4,226,080–7,510,861 367 99% Glipizide 1,064 5,847,097 4,635,210–7,058,983 369 100% Fluticasone/Salmeterol 1,111 5,800,120 4,224,983–7,375,257 350 95% Oxycodone HCl/ 1,474 5,676,415 4,586,569–6,766,261 369 100% Acetaminophen Metoprolol Succinate 1,120 5,665,210 4,616,324–6,714,096 368 100% Ranitidine HCl 1,409 5,482,639 4,145,862–6,819,416 369 100% Losartan Potassium 1,153 5,482,241 4,424,476–6,540,005 369 100% Trazodone HCl 1,285 5,420,884 4,236,837–6,604,931 369 100% Clobetasol Propionate 1,232 5,343,963 3,259,867–7,428,059 305 83% Sertraline HCl 1,329 5,328,104 4,285,112–6,371,097 369 100% continued on next page Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 21 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 Alendronate Sodium 1,134 5,059,020 4,027,978–6,090,062 369 100% Valsartan 999 4,988,907 3,709,041–6,268,773 365 99% Quetiapine Fumarate 1,580 4,695,543 3,580,822–5,810,265 369 100% Pravastatin Sodium 1,055 4,497,382 3,599,813–5,394,952 369 100% Fluticasone Propionate 1,031 4,475,369 3,782,797–5,167,942 369 100% Montelukast Sodium 983 4,241,912 3,276,654–5,207,171 369 100% Prednisone 987 4,140,130 3,299,891–4,980,370 369 100% Rosuvastatin Calcium 862 4,079,698 3,143,992–5,015,404 345 93% Donepezil HCl 1,067 3,945,615 3,220,946–4,670,284 369 100% Risperidone 1,320 3,931,788 3,128,046–4,735,529 369 100% Bupropion HCl 880 3,854,353 2,640,727–5,067,980 369 100% Isosorbide Mononitrate 797 3,805,846 3,135,306–4,476,386 369 100% Clonidine HCl 765 3,747,550 2,494,439–5,000,661 369 100% Tamsulosin HCl 741 3,702,932 2,870,655–4,535,209 369 100% Lovastatin 760 3,603,172 2,680,255–4,526,090 368 100% Aripiprazole 915 3,588,383 2,471,105–4,705,661 369 100% Cyclobenzaprine HCl 884 3,576,109 2,862,722–4,289,496 366 99% Duloxetine HCl 829 3,455,834 2,612,026–4,299,643 369 100% Pantoprazole Sodium 745 3,437,474 2,677,159–4,197,789 369 100% Allopurinol 713 3,403,401 2,647,198–4,159,603 369 100% Escitalopram Oxalate 881 3,387,426 2,551,390–4,223,461 369 100% Ibuprofen 953 3,311,577 2,684,384–3,938,770 369 100% Fluoxetine HCl 793 3,256,783 2,506,927–4,006,640 369 100% Alprazolam 852 3,243,748 2,306,161–4,181,334 322 87% Oxycodone HCl 923 3,211,833 2,344,856–4,078,811 369 100% Diltiazem HCl 804 3,112,978 2,356,110–3,869,845 369 100% Glimepiride 596 3,102,504 2,097,429–4,107,579 369 100% Azithromycin 826 2,990,930 2,651,776–3,330,084 369 100% Divalproex Sodium 1,147 2,956,347 2,371,699–3,540,994 369 100% Memantine HCl 820 2,946,246 2,305,419–3,587,073 369 100% Nystatin 778 2,877,573 1,728,167–4,026,980 369 100% Pregabalin 620 2,874,390 1,945,883–3,802,897 369 100% Olanzapine 826 2,743,691 1,746,975–3,740,406 369 100% Famotidine 598 2,741,416 2,001,603–3,481,230 365 99% Amitriptyline HCl 648 2,732,645 2,025,566–3,439,723 369 100% Sitagliptin Phosphate 563 2,731,020 1,929,937–3,532,103 358 97% Tiotropium Bromide 561 2,700,930 2,048,631–3,353,230 301 82% continued on next page Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 22 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 Meloxicam 641 2,699,758 2,079,860–3,319,656 369 100% Ketoconazole 778 2,678,585 1,642,081–3,715,089 369 100% Mirtazapine 693 2,629,860 1,932,977–3,326,744 369 100% Nifedipine 467 2,620,445 1,841,087–3,399,804 360 98% Lisinopril/Hydrochlorothiazide 561 2,602,432 2,034,129–3,170,735 369 100% Lamotrigine 812 2,568,810 1,524,901–3,612,719 369 100% Levetiracetam 774 2,542,145 1,772,630–3,311,661 369 100% Clonazepam 696 2,474,602 1,754,467–3,194,736 369 100% Enalapril Maleate 551 2,442,608 1,834,260–3,050,956 369 100% Triamterene/ Hydrochlorothiazide 484 2,409,224 1,777,659–3,040,789 369 100% Paroxetine HCl 608 2,399,150 1,706,298–3,092,003 369 100% Celecoxib 482 2,386,463 1,634,429–3,138,497 335 91% Benztropine Mesylate 796 2,344,725 1,666,426–3,023,025 368 100% Carbamazepine 711 2,291,674 1,547,240–3,036,107 369 100% Ciprofloxacin HCl 561 2,201,817 1,879,769–2,523,865 369 100% Spironolactone 530 2,167,379 1,706,024–2,628,734 369 100% Nitroglycerin 489 2,159,899 1,556,844–2,762,953 369 100% Diclofenac Sodium 459 2,071,649 1,535,708–2,607,591 369 100% Valsartan/ Hydrochlorothiazide 411 2,043,602 1,418,412–2,668,792 362 98% Digoxin 563 2,017,627 1,397,347–2,637,908 369 100% Latanoprost 451 1,941,504 1,429,872–2,453,136 369 100% Topiramate 676 1,919,140 1,225,777–2,612,502 369 100% Morphine Sulfate 482 1,917,895 1,323,903–2,511,887 369 100% Fluocinonide 517 1,914,945 984,579–2,845,310 368 100% Polyethylene Glycol 3350 563 1,911,548 1,456,516–2,366,580 369 100% Sulfamethoxazole/ Trimethoprim 575 1,882,925 1,565,574–2,200,276 369 100% Lorazepam 478 1,872,334 1,385,592–2,359,076 369 100% Ipratropium/Albuterol Sulfate 475 1,863,411 1,265,089–2,461,734 362 98% Carbidopa/Levodopa 469 1,847,813 1,150,958–2,544,668 369 100% Fenofibrate Nanocrystallized 393 1,802,940 1,311,234–2,294,646 348 94% Glyburide 333 1,800,905 1,292,057–2,309,754 178 48% Levofloxacin 450 1,776,547 1,439,401–2,113,694 369 100% Oxybutynin Chloride 465 1,772,254 1,130,986–2,413,522 369 100% Venlafaxine HCl 565 1,769,289 1,293,093–2,245,485 369 100% Verapamil HCl 386 1,768,870 1,232,568–2,305,172 369 100% Pioglitazone HCl 350 1,765,584 1,267,958–2,263,210 369 100% continued on next page Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 23 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 481 1,712,919 1,305,637–2,120,202 369 100% Triamcinolone Acetonide 401 1,709,516 1,194,175–2,224,857 369 100% Cephalexin 461 1,708,905 1,354,546–2,063,263 369 100% Insulin Aspart 438 1,697,897 1,236,282–2,159,511 274 74% Meclizine HCl 354 1,694,107 1,166,438–2,221,776 368 100% Cinacalcet HCl 273 1,686,744 228,751–3,144,737 369 100% Benazepril HCl 314 1,662,487 1,061,779–2,263,195 368 100% Amoxicillin 449 1,645,349 1,440,430–1,850,269 369 100% Ezetimibe 315 1,630,531 1,137,372–2,123,691 369 100% Hydralazine HCl 352 1,626,562 1,040,354–2,212,770 369 100% Losartan/Hydrochlorothiazide 323 1,616,723 1,126,209–2,107,237 369 100% Methocarbamol 332 1,604,238 957,852–2,250,624 222 60% Carisoprodol 468 1,569,542 1,069,916–2,069,169 168 46% Lansoprazole 300 1,517,331 937,732–2,096,931 289 78% Lidocaine 392 1,497,702 1,062,229–1,933,176 369 100% Baclofen 432 1,496,342 901,759–2,090,925 369 100% Propranolol HCl 441 1,466,579 989,903–1,943,256 369 100% Tizanidine HCl 465 1,402,405 922,152–1,882,657 369 100% Buspirone HCl 345 1,392,828 771,720–2,013,936 369 100% Lactulose 352 1,376,489 858,083–1,894,894 369 100% Brimonidine Tartrate 270 1,364,643 814,036–1,915,250 369 100% Omega-3 Acid Ethyl Esters 337 1,340,484 863,754–1,817,215 323 88% Methadone HCl 233 1,334,501 668,812–2,000,191 368 100% Metoclopramide HCl 272 1,311,286 790,771–1,831,801 369 100% Ropinirole HCl 318 1,304,881 795,681–1,814,080 369 100% Phenytoin Sodium Extended 414 1,299,826 893,247–1,706,406 369 100% Budesonide/ Formoterol Fumarate 297 1,282,394 897,195–1,667,593 270 73% Timolol Maleate 251 1,278,484 801,832–1,755,136 369 100% Hydrocortisone 279 1,276,518 768,357–1,784,678 369 100% Travoprost 325 1,223,842 898,838–1,548,847 327 89% Olopatadine HCl 288 1,210,924 776,919–1,644,928 353 96% Hydroxyzine HCl 296 1,208,115 813,793–1,602,437 355 96% Bimatoprost 206 1,206,009 747,306–1,664,713 352 95% Insulin Detemir 325 1,203,894 807,216–1,600,572 303 82% Ziprasidone HCl 331 1,183,365 639,947–1,726,783 369 100% Doxazosin Mesylate 253 1,166,572 705,708–1,627,436 369 100% Insulin Lispro 243 1,165,251 612,842–1,717,661 217 59% continued on next page Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 24 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 Diazepam 336 1,163,773 805,788–1,521,758 369 100% Pramipexole Di-HCl 269 1,163,159 716,859–1,609,460 369 100% Dexlansoprazole 255 1,154,307 605,989–1,702,624 189 51% Acetaminophen With Codeine 324 1,146,119 835,514–1,456,724 369 100% Finasteride 193 1,142,207 645,801–1,638,614 369 100% Metronidazole 277 1,082,251 740,294–1,424,207 369 100% Estrogens, Conjugated 207 1,062,210 680,581–1,443,839 305 83% Ramipril 216 1,044,656 618,660–1,470,651 366 99% Mometasone Furoate 273 1,041,955 738,062–1,345,847 368 100% Doxycycline Hyclate 306 1,039,974 803,052–1,276,896 369 100% Gemfibrozil 317 1,002,452 655,398–1,349,505 369 100% Insulin Regular, Human 321 997,047 448,381–1,545,713 369 100% Clozapine 377 996,800 256,796–1,736,805 369 100% Amoxicillin/Potassium Clav 296 992,326 798,742–1,185,910 369 100% Fentanyl 283 950,958 630,440–1,271,475 369 100% Fenofibrate 200 947,241 530,041–1,364,441 368 100% Terazosin HCl 196 944,375 600,107–1,288,642 369 100% Quinapril HCl 176 941,788 521,252–1,362,324 363 98% Amlodipine Besylate/ Benazepril 210 938,298 638,282–1,238,313 352 95% Tolterodine Tartrate 218 934,963 602,658–1,267,269 355 96% Insulin Nph Hum/Reg Insulin Hm 223 926,025 503,322–1,348,729 369 100% Fluconazole 268 906,521 631,479–1,181,562 369 100% Sucralfate 252 899,714 608,736–1,190,692 369 100% Niacin 249 884,662 476,245–1,293,079 364 99% Colchicine 183 874,820 496,096–1,253,544 369 100% Solifenacin Succinate 189 861,786 578,376–1,145,197 268 73% Megestrol Acetate 226 860,045 569,049–1,151,041 369 100% Ciclopirox Olamine 190 846,025 291,480–1,400,570 353 96% Calcitriol 181 844,443 510,574–1,178,312 369 100% Hydroxychloroquine Sulfate 227 843,974 546,086–1,141,862 369 100% Dicyclomine HCl 258 835,905 510,720–1,161,090 369 100% Sevelamer Carbonate 181 834,843 473,155–1,196,532 365 99% Dorzolamide HCl/ Timolol Maleate 183 820,248 535,827–1,104,669 363 98% Raloxifene HCl 170 817,458 404,826–1,230,090 369 100% Ergocalciferol (Vitamin D2) 238 815,762 577,444–1,054,081 0 0%** Dutasteride 175 812,367 421,163–1,203,571 345 93% **See Appendix C. continued on next page Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 25 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 Cyclosporine 206 811,780 542,087–1,081,473 369 100% Ipratropium Bromide 212 809,312 479,306–1,139,318 369 100% Methylprednisolone 208 804,664 635,543–973,784 369 100% Prednisolone Acetate 186 793,727 589,346–998,109 363 98% Clotrimazole/Betamethasone Dip 215 793,462 607,917–979,006 289 78% Estradiol 152 785,815 436,414–1,135,216 369 100% Primidone 200 780,692 193,858–1,367,527 369 100% Torsemide 197 780,054 485,186–1,074,923 361 98% Nitrofurantoin Monohyd/ M-Cryst 192 773,126 516,975–1,029,278 344 93% Albuterol 176 770,589 478,225–1,062,953 0 0%** Sumatriptan Succinate 146 Excluded Excluded Excluded Excluded Risedronate Sodium 147 763,979 295,176–1,232,781 275 75% 0.9% Sodium Chloride 216 754,836 155,720–1,353,952 369 100% Cilostazol 202 751,130 399,943–1,102,317 369 100% Amiodarone HCl 149 750,614 391,667–1,109,561 369 100% Chlorthalidone 150 735,530 370,480–1,100,580 366 99% Doxepin HCl 202 724,154 404,293–1,044,015 369 100% Mupirocin 204 697,884 520,300–875,469 369 100% Ondansetron HCl 183 663,507 421,480–905,535 369 100% Metolazone 127 657,608 251,543–1,063,674 361 98% Clonidine 114 654,668 234,616–1,074,720 369 100% Source: OIG analysis of drugs commonly used by dual eligibles, 2017. **See Appendix C. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 26 APPENDIX C Two Drugs Commonly Used by Dual Eligibles and Not Covered Under Part D Generic Name Reason Excluded Under Part D No longer prescribed without Albuterol* sulfate Ergocalciferol (vitamin D2)* Vitamin or mineral product Source: OIG analysis of formulary inclusion of drugs commonly used by dual eligibles, 2017. *These drugs were also on the 2016 report’s list of drugs commonly used by dual eligibles and not covered under Part D. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 27 APPENDIX D Formulary Inclusion of Stand-Alone Prescription Drug Plans* and Medicare Advantage Prescription Drug Plans**, by Region Exhibit D-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 21 95% 89% 100% Connecticut, Massachusetts, 2 Rhode Island, Vermont 19 95% 89% 99% 3 New York 17 95% 89% 100% 4 New Jersey 19 95% 89% 99% Delaware, the District of 5 Columbia, Maryland 18 95% 89% 100% 6 Pennsylvania, West Virginia 22 96% 89% 100% 7 Virginia 21 95% 89% 100% 8 North Carolina 20 95% 89% 100% 9 South Carolina 19 95% 89% 99% 10 Georgia 21 95% 89% 100% 11 Florida 18 95% 89% 99% 12 Alabama, Tennessee 22 96% 89% 100% 13 Michigan 21 95% 89% 100% 14 Ohio 20 95% 89% 99% 15 Indiana, Kentucky 21 95% 89% 100% 16 Wisconsin 22 95% 89% 99% 17 Illinois 21 95% 88% 100% 18 Missouri 21 95% 89% 100% 19 Arkansas 20 95% 89% 100% 20 Mississippi 17 95% 89% 99% 21 Louisiana 18 95% 89% 100% 22 Texas 21 95% 88% 100% 23 Oklahoma 20 95% 88% 99% 24 Kansas 20 95% 89% 99% Iowa, Minnesota, Montana, 25 Nebraska, North Dakota, South Dakota, Wyoming 20 95% 89% 100% 26 New Mexico 21 95% 88% 100% 27 Colorado 21 95% 89% 100% 28 Arizona 20 95% 89% 100% 29 Nevada 21 95% 89% 99% 30 Oregon, Washington 19 95% 89% 99% 31 Idaho, Utah 22 95% 89% 100% 32 California 22 95% 89% 99% 33 Hawaii 17 95% 89% 99% 34 Alaska 16 95% 89% 99% Source: OIG analysis of formularies’ inclusion of drugs commonly used by dual eligibles, 2017. *PDP. **MA-PD. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 28 Exhibit D-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 45 97% 95% 99% Connecticut, Massachusetts, 2 Rhode Island, Vermont 93 97% 94% 99% 3 New York 185 97% 94% 100% 4 New Jersey 38 96% 88% 98% Delaware, the District of Columbia, 5 Maryland 28 98% 96% 100% 6 Pennsylvania, West Virginia 148 98% 94% 100% 7 North Carolina, Virginia 112 97% 89% 100% 8 Georgia, South Carolina 89 98% 94% 100% 9 Florida 243 98% 90% 100% 10 Alabama, Tennessee 76 97% 95% 99% 11 Michigan 66 98% 94% 99% 12 Ohio 117 97% 93% 99% 13 Indiana, Kentucky 100 97% 94% 99% 14 Illinois, Wisconsin 140 97% 92% 99% 15 Arkansas, Missouri 69 97% 88% 99% 16 Louisiana, Mississippi 59 98% 95% 100% 17 Texas 142 97% 93% 100% 18 Kansas, Oklahoma 53 97% 95% 99% Iowa, Minnesota, Montana, Nebraska, 19 North Dakota, South Dakota, Wyoming 79 97% 92% 99% 20 Colorado, New Mexico 59 98% 96% 100% 21 Arizona 59 97% 94% 100% 22 Nevada 31 97% 94% 99% 23 Idaho, Oregon, Utah, Washington 168 97% 93% 100% 24 California 259 97% 93% 100% 25 Hawaii 18 98% 95% 100% Source: OIG analysis of formularies’ inclusion of drugs commonly used by dual eligibles, 2017. ***Region 26, which covers Alaska, had no MA-PDs available for 2017. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 29 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. Other Office of Evaluation and Inspections staff from the Chicago regional office who conducted the study include Megan Shade. Central office staff who provided support include Kevin Farber, Meghan Kearns, Christine Moritz, and David Tawes. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (OEI-05-17-00160) 30 Office of Inspector General http://oig.hhs.gov The mission of the Office of Inspector General (OIG), as mandated by Public Law 95452, 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 individuals 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 individuals. 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.