U.S. Department of Health and Human Services Office of Inspector General Data Snapshot June 2022, OEI-05-22-00230 Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2022 Key Takeaway Why OIG Did This Review Dual eligibles-that is, beneficiaries who are covered by both Medicare and Dual eligibles have access Medicaid-are a vulnerable population whose access to prescription drugs is to the majority of particularly important. Overall, they have very low incomes and-because they are commonly used drugs in more likely to be in poorer health than other Medicare beneficiaries-tend to use 2022 via Part D plans. more Medicare services.1 Because Medicare prescription drug coverage is an This is consistent with important tool for ensuring access to prescription drugs, Congress mandated that OIG's findings from OIG study whether Part D formularies cover prescription drugs commonly used by previous years. Dual dual eligibles.2 eligibles have several options if their plans do What OIG Did not cover specific drugs; however, these options For this report, we determined whether the 449 unique formularies used by the may be burdensome and 5,288 Part D plans operating in 2022 cover 195 of the 200 drugs most commonly do not guarantee access used by dual eligibles. See the methodology for more information about how we to the drugs. determined the most commonly used drugs. This is OIG's twelfth annually mandated report examining dual eligibles' access to drugs under Medicare Part D. Results A majority of the 449 Part D plan formularies Part D plans with premiums below the covered almost all (at least 97 percent) of the regional benchmark also covered almost all drugs most commonly used by dual eligibles. commonly used drugs. Regardless of the plan in which they are enrolled, dual Similarly, among Part D plans with premiums below eligibles can expect to have access to most drugs. the regional benchmark, a majority of formularies (95 of 132) covered at least 97 percent of the drugs commonly used by dual eligibles. Each year, the Centers for Medicare & Medicaid services (CMS) establishes a premium benchmark for Part D plans that varies by region.3 It is particularly important that plans with premiums below the regional benchmark have high inclusion rates for the most commonly used drugs because: • Dual eligibles do not need to pay additional amounts in premiums for these plans.4 • When CMS randomly assigns dual eligibles to Part D plans, it assigns them to plans with premiums below the regional benchmark without considering their specific prescription drug needs.5 Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2022 1 Results (cont'd) A small number of drugs were covered by fewer While beneficiaries have several options if their than 75 percent of formularies. formularies do not cover specific drugs, these options require dual eligibles to take administrative Although formularies frequently omitted eight actions and do not guarantee that they can get the commonly used drugs in 2022, they all covered drugs. alternative drugs in the same respective therapeutic Dual eligibles have up to three chances classes, as CMS requires.6 during the first 9 months of the year to switch to plans that cover the prescription drugs they require.7 Dual eligibles can use an exceptions and appeals process to request coverage of nonformulary drugs by their plans.8 Dual eligibles can work with their prescribers to find an alternative drug covered by their plans. Dual eligibles can pay out of pocket for the noncovered drugs. Conclusion When establishing formularies, Part D plans are permitted to balance Medicare beneficiaries' needs for adequate prescription drug coverage against the need to contain costs for plan sponsors and for the Part D program. Part D plans may omit certain drugs from prescription coverage in order to control costs. However, omitting drugs from coverage can also limit the ability of beneficiaries to access the prescription drugs they need. In general, dual eligibles have access to nearly all of the most commonly used drugs via their Part D plan formularies in 2022. A majority of these formularies covered almost all commonly used drugs, and only a small number of commonly used drugs were not covered by most formularies. These findings are largely unchanged from OIG's findings reported from 2011 through 2021. Dual eligibles have several options if their formularies do not cover specific drugs, but these options may be burdensome and do not guarantee access to the drugs. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2022 2 Top 200 Commonly Used Drugs* Generic Name Percentage Generic Name Percentage Generic Name Percentage of of of Formularies Formularies Formularies Including Including Including Drug Drug Drug Dexlansoprazole 44% Promethazine Hcl 99% Rosuvastatin Calcium 100% Insulin Lispro 45% Valsartan 99% Duloxetine Hcl 100% Umeclidinium Bromide 62% Nifedipine 100% Glipizide 100% Insulin Degludec 64% Lovastatin 100% Tramadol Hcl 100% Insulin Aspart 65% Tizanidine Hcl 100% Divalproex Sodium 100% Insulin Detemir 68% Fenofibrate 100% Tamsulosin Hcl 100% Tiotropium Bromide 69% Benazepril Hcl 100% Insulin Glargine,hum.Rec.Anlog 100% Solifenacin Succinate 75% Irbesartan 100% Prednisone 100% Omega-3 Acid Ethyl Esters 77% Atorvastatin Calcium 100% Mirtazapine 100% Linagliptin 79% Amlodipine Besylate 100% Escitalopram Oxalate 100% Travoprost 82% Lisinopril 100% Warfarin Sodium 100% Nebivolol Hcl 83% Metformin Hcl 100% Allopurinol 100% Sitagliptin Phosphate 85% Levothyroxine Sodium 100% Alendronate Sodium 100% Umeclidinium Brm/Vilanterol Tr 88% Omeprazole 100% Citalopram Hydrobromide 100% Budesonide/Formoterol Fumarate 90% Gabapentin 100% Bupropion Hcl 100% Esomeprazole Magnesium 91% Furosemide 100% Diltiazem Hcl 100% Liraglutide 91% Losartan Potassium 100% Fluoxetine Hcl 100% Linaclotide 92% Metoprolol Succinate 100% Risperidone 100% Temazepam 92% Hydrocodone/Acetaminophen 100% Oxycodone Hcl/Acetaminophen 100% Alprazolam 94% Pantoprazole Sodium 100% Hydralazine Hcl 100% Clobetasol Propionate 94% Nystatin 100% Diclofenac Sodium 100% Fluticasone/Vilanterol 94% Simvastatin 100% Meloxicam 100% Dulaglutide 95% Albuterol Sulfate 100% Ibuprofen 100% Olopatadine Hcl 95% Potassium Chloride 100% Levetiracetam 100% Brimonidine Tartrate/Timolol 96% Hydrochlorothiazide 100% Cyclobenzaprine Hcl 100% Hydroxyzine Hcl 96% Metoprolol Tartrate 100% Lisinopril/Hydrochlorothiazide 100% Bimatoprost 96% Carvedilol 100% Oxybutynin Chloride 100% Torsemide 96% Montelukast Sodium 100% Lorazepam 100% Celecoxib 96% Trazodone Hcl 100% Losartan/Hydrochlorothiazide 100% Tobramycin/Dexamethasone 97% Fluticasone Propionate 100% Famotidine 100% Empagliflozin 98% Quetiapine Fumarate 100% Atenolol 100% Apixaban 99% Sertraline Hcl 100% Pregabalin 100% Rivaroxaban 99% Clopidogrel Bisulfate 100% Isosorbide Mononitrate 100% Fenofibrate Nanocrystallized 99% Pravastatin Sodium 100% Clonazepam 100% * Of the top 200 drugs, we analyzed 195 drugs for this review. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2022 3 Top 200 Commonly Used Drugs (cont'd)* Generic Name Percentage Generic Name Percentage Generic Name Percentage of of of Formularies Formularies Formularies Including Including Including Drug Drug Drug Paroxetine Hcl 100% Hydroxychloroquine Sulfate 100% Colchicine 100% Zolpidem Tartrate 100% Ropinirole Hcl 100% Metronidazole 100% Baclofen 100% Meclizine Hcl 100% Hydrocortisone 100% Spironolactone 100% Digoxin 100% Bumetanide 100% Lamotrigine 100% Levocetirizine Dihydrochloride 100% Prednisolone Acetate 100% Donepezil Hcl 100% Insulin Nph Hum/Reg Insulin Hm 100% Labetalol Hcl 100% Buspirone Hcl 100% Amoxicillin/Potassium Clav 100% Calcitriol 100% Topiramate 100% Propranolol Hcl 100% Fluconazole 100% Latanoprost 100% Ciprofloxacin Hcl 100% Estradiol 100% Aripiprazole 100% Morphine Sulfate 100% Prazosin Hcl 100% Clonidine Hcl 100% Sulfamethoxazole/Trimethoprim 100% Gemfibrozil 100% Memantine Hcl 100% Ipratropium/Albuterol Sulfate 100% Metoclopramide Hcl 100% Glimepiride 100% Methotrexate Sodium 100% Dorzolamide Hcl 100% Benztropine Mesylate 100% Ketoconazole 100% Verapamil Hcl 100% Fluticasone 100% Clozapine 100% Anastrozole 100% Propion/Salmeterol Olanzapine 100% Acetaminophen With Codeine 100% Methylprednisolone 100% Azithromycin 100% Carbidopa/Levodopa 100% Ondansetron 100% Venlafaxine Hcl 100% Ondansetron Hcl 100% Nitrofurantoin Monohyd/M-Cryst 100% Naproxen 100% Lactulose 100% Phenytoin Sodium Extended 100% Carbamazepine 100% Oxcarbazepine 100% Nitroglycerin 100% Amitriptyline Hcl 100% Mirabegron 100% Mupirocin 100% Enalapril Maleate 100% Doxycycline Hyclate 100% Amiodarone Hcl 100% Cephalexin 100% Dorzolamide Hcl/Timolol Maleat 100% Dextroamphetamine/Amphetamine 100% Finasteride 100% Ziprasidone Hcl 100% Isosorbide Dinitrate 100% Triamcinolone Acetonide 100% Brimonidine Tartrate 100% Ammonium Lactate 100% Pioglitazone Hcl 100% Cyclosporine 100% Clindamycin Phosphate 100% Chlorthalidone 100% Doxazosin Mesylate 100% Ramipril 100% Oxycodone Hcl 100% Fentanyl 100% Phenobarbital** Excluded Ezetimibe 100% Triamterene/Hydrochlorothiazid 100% Lacosamide** Excluded Pramipexole Di-Hcl 100% Diazepam 100% Ranitidine Hcl*** Excluded Amoxicillin 100% Dicyclomine Hcl 100% Alcohol Antiseptic Pads*** Excluded Sucralfate 100% Levofloxacin 100% Ergocalciferol (Vitamin D2)*** Excluded Ipratropium Bromide 100% Timolol Maleate 100% Source: OIG analysis of drugs commonly used by dual eligibles, 2022. * Of the top 200 drugs, we analyzed 195 drugs for this review. **Drugs excluded from our analysis because we were unable to confidently project their use to the entire dual-eligible population. ***Drugs excluded from our analysis because they are not covered by Part D. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2022 4 Methodology We determined whether the unique formularies used by Part D plans operating in 2022 cover the prescription drugs mostly commonly used by dual eligibles. • We used the 2019 Medicare Current Beneficiary Survey (MCBS) Cost and Use data to create a list of drugs with the highest utilization by dual eligibles. • We used the February 2022 First DataBank National Drug Data File to identify the drug product information for the drugs with the highest utilization by dual eligibles. • To determine the drugs most commonly used by dual eligibles, we took the following steps: o We created a list of all drugs reported by dual eligibles surveyed in the 2019 MCBS, excluding territories. o We collapsed this list to a list of drugs based on their active ingredients. o We ranked the drugs by frequency of utilization, weighting the drug-event information from MCBS by sample weight. o We selected the 200 drugs with the highest utilization by dual eligibles. • Of the top 200 drugs, we analyzed 195 drugs for this review. We removed three drugs not covered under Part D and two drugs for which we were unable to confidently project use to the entire dual-eligible population. • We collected from CMS the formulary data and the plan data for Part D plans operating in 2022. The formulary data include Part D plans' formularies for plans operating in 2022. • We then analyzed the unique Part D plan formularies to determine their rates of inclusion of the 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. Standards We conducted this study in accordance with the Quality Standards for Inspection and Evaluation issued by the Council of the Inspectors General on Integrity and Efficiency. Acknowledgments Lisa Minich served as the team leader for this study, and Jonathan Carroll served as the lead analyst. Office of Evaluation and Inspections headquarters staff who provided support include Kaliane Davidson, Robert Gibbons, and Christine Moritz. This report was prepared under the direction of Laura Kordish, Regional Inspector General for Evaluation and Inspections in the Chicago regional office; Adam Freeman, Deputy Regional Inspector General; and Hilary Slover, Assistant Regional Inspector General. Sources 1 Kaiser Family Foundation, "What is the role of Medicare for dual-eligible beneficiaries?", A Primer on Medicare: Key Facts About the Medicare Program and the People it Covers. Accessed at https://www.kff.org/report-section/a-primer-on-medicare-what-is-the-role-of- medicare-for-dual-eligible-beneficiaries/ on April 6, 2022. 2 For the mandate, see the Patient Protection and Affordable Care Act, P.L. No. 111-148 § 3313(a). For each study, OIG has reviewed drug coverage under Medicare Part D for all dual eligibles, rather than only for full-benefit dual eligibles as specified by the mandate. (Under Social Security Act § 1935(c)(6), full-benefit dual eligibles are individuals who are eligible for both Medicare and full Medicaid benefits.) With the data available for these studies, we could not confidently identify and separate full-benefit dual eligibles-and thus the drugs they used-from the total population of dual eligibles. 3 Social Security Act § 1860D-14(b); 42 CFR § 423.780(b)(2)(i). 4 Medicare subsidizes dual eligibles' premiums, deductibles, and other cost-sharing obligations up to a determined premium benchmark that varies by region. Medicare Prescription Drug, Improvement, and Modernization Act of 2003, P.L. No. 108-173 (enacted Dec. 8, 2003), § 101, Social Security Act § 1860D-14. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2022 5 Sources (cont'd) 5 CMS randomly assigns dual eligibles to a Part D plan with premiums below the regional benchmark when (1) they become eligible for both Medicare and Medicaid but have not elected a Part D plan, (2) their current Part D plan will have a premium above the regional benchmark for the following year, or (3) the plan to which they were assigned is terminated. CMS, Prescription Drug Benefit Manual (PDBM), ch. 3, § 40.1.4-5. 6 Planformularies do not generally have to include every available drug. Rather, to meet CMS's formulary requirements, they must include at least two drugs in each therapeutic category or class. CMS, PDBM, ch. 6, § 30.2.1. 7 83 Fed. Reg. 16440, 16514–19 (Apr. 16, 2018). 8 CMS, Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance, §§ 40-60. Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2022 6