OFFICE OF fi/@- ASPE HEALTH POLICY RESEARCH 55';2RT -Inflation Reduction Act Research Series- Medicare Part D Enrollee Out-Of-Pocket Spending: Recent Trends and Projected Impacts of the Inflation Reduction Act The Inflation Reduction Act's redesign of Medicare Part D will reduce enrollee out- of-pocket spending by about $7.4 billion annually among more than 18.7 million enrollees (36 percent of Part D enrollees) in 2025 - nearly $400 per person among enrollees who have savings in out-of-pocket costs under the IRA. Bisma A. Sayed, Kenneth Finegold, T. Anders Olsen, Kaavya Ashok, Sarah Schutz, Steven Sheingold, Nancy De Lew, and Benjamin D. Sommers KEY POINTS e The Inflation Reduction Act (IRA) will make key changesto improve drug affordability for seniors and people with disabilities who have Medicare. e PriortotheIRA, enrollees who enteredthe Part D catastrophic coverage phase of the Part D benefit and did not receive the Low-Income Subsidy (LIS)* paid the most in out-of-pocket costs for their prescriptions. About four percent of non-LIS Part D enrollees, or 1.5 million enrollees, reachedthe catastrophic coverage phase, paying about $3,093 on average in out-of-pocket costs for their Part D medicationsacross all Part D payment phases.® e Qut-of-pocket spending for Part D drugs was highest for enrollees with certain health conditions and who take certain types of medications. For example, the average out-of-pocket drug spending was highest for enrollees with cystic fibrosis (59,522 per enrollee). e Startingin 2025, the IRA will add an out-of-pocket capin Medicare Part D, $2,000 in 2025 and indexed annually for inflation thereafter. The IRA also includes other provisions designed to decrease spending for Part D enrollees and taxpayers. * *For eligible enrollees whose income and resources are limited, the Medicare Prescription Drug, Improvement and Modernization Act of 2003 established extra help (a subsidy) with for prescription drugs. Subsidies are paid by the Federal government to drug plans and provide assistance with premiums, deductibles, and co-payments. Under the IRA, beginningin 2024, the LIS program is expanded to individuals with limited financial resources and incomes up to 150 percent of the Federal Poverty Limit(FPL), which is about $21,870 perindividual in 2023. For more information, please see here. * Enrollee out-of-pocket costs are based on actual payments made by enrollees. Thisvalue excludes manufacturer gap discount payments that count towards the true out-of-pocket limit (TrOOP). TrOOP refers to incurred costs that count towards an enrollee's Medicare Part D drug plan out-of-pocket threshold ($7,400 for 2023). TrOOP determines entry into the catastrophic coverage phase of the Part D benefit and consists of both payments paid by the enrollee (e.g., annual deductible, out-of-pocket costs, and others) as well as other payments not paid by the enrollee (e.g., manufacturer gap discounts for brand drugs). aspe.hhs.gov 1 e QOur analysis estimatesthe combined effect of the IRA provisions modeled in this Report.** When these IRA provisions are all in effect in 2025, it will lead to about a $7.4 billion reductionin annual out-of-pocket spending for 18.7 million enrollees (LIS and non-LIS) in 2025. e ASPE modeling projectsthat about 36 percent or 18.7 million of LIS and non-LIS Medicare Part D enrollees will have savings under the IRA provisions in 2025, with their out-of-pocket costs expectedto be reduced by about $400 per enrollee. Among this population, 8.4 million enrollees are non-LIS enrollees. Theyare expectedto have anestimated $759 average reduction in out-of-pocket spending in 2025. e Among the population of enrolleeswho are expectedtosave in out-of-pocket costs for Part D medications, there's a subset of enrollees who are projected to save at least $1,000. Our modeling estimatesthat nearly 1.9 million enrollees, which consists mostly of non-LIS enrollees, will save at least $1,000 under the IRA provisions; the average annual out-of-pocket savings for this population in 2025 is projectedto be about $2,500 per enrollee, a 66 percent decline relative to baseline. e Otherfeaturesof the IRA not included in these estimates-including drug price negotiationand inflation rebatesfor drug price increases - are expectedto produce additional savings for enrollees and taxpayers. BACKGROUND High prescriptiondrug costs are a challenge for many people enrolled in Medicare, with one report estimating that more than five million Medicare enrollees experience difficulties with drug affordability.* On August 16, 2022, President Biden signed the Inflation Reduction Act (IRA) into law. The IRAincludes provisions that redesign the Medicare Part D prescription drug payment structure and benefits, with the goal of making prescription drugs more affordable and accessible for enrollees.? Prior to the IRA, there was no cap on out-of- pocket spending in Medicare Part D, a provision which goes into effect in 2025 when a $2,000 cap will apply. For Medicare enrollees who require high-priced medications or those who need many different types of medications, the out-of-pocket costs can be substantial. Since it was createdin 2006, Medicare's Part D benefit has grown to provide prescription drug coverage for 51 million of the 65 million Medicare enrollees in 2022. 34 Some Medicare enrollees have drug coverage from a former employer and do not elect to enroll in Part D, while about nine percent of enrollees have no drug coverage atall.5 Under Part D, Medicare subsidizes premium costs for all enrollees through direct subsidy payments made to Part D plans and provides additional premium and cost sharing subsidies for low-income enrollees. The benefit's original design- which included a coverage gap and some enrollee responsibility during a catastrophic phase -left some enrollees with exceedingly high out-of-pocket expenses. The Affordable Care Act (ACA)and the Bipartisan Budget Act of 2018 phased out the coverage gap,* and the coverage gap phase of the Medicare Part D benefit will be eliminated under the IRA. Nonetheless, factors such * IRA provisions modeled in this Report include provisions that institute a $35 out-of-pocket cost sharing cap on a month's supply of each covered insulin and eliminate deductibles for covered insulin in Part D, eliminate out-of-pocket costs for Advisory Committee on Immunization Practices {ACIP)-recommended adult vaccines under Part D, impose a maximum out-of-pocket cap of $2,000 startingin 2025 and indexed to inflation annually thereafter, and eliminate the coverage gap phase and replace the coverage gap discount program with the manufacturer discount program. A complete list of provisions modeled are presented in Table 1. * Out-of-pocket spendingincludes only the amount paid by the enrollee as cost sharing for their prescription drugs covered under Medicare Part D. It does not include premium payments for health insurance. * The coverage gap was phased out through the Coverage Gap Discount Program. This program will be replaced by the Manufacturer Discount Program, starting in 2025, as part of the IRA. Note that the coverage gap phase still exists and will be eliminated in 2024 under the IRA. July 2023 RESEARCH REPORT 2 as rising prices for drugs and the increasing availability of high-cost specialty drugs have resultedin many enrollees being exposed to high out-of-pocket costs. 6 Enrollees with chronic health conditions may be especially at risk for high drug costs in Part D. Among Medicare enrollees over the age of 65, existing researchfinds that about 11 percent with asthma or chronic obstructive pulmonary disease (COPD)report having affordability challenges, 10 percent with diabetes report affordability challenges, and 7 percent with hypertension report affordability challenges.? Affordability challenges are higher for Black and Latino enrollees (about 10 percent each) relative to White enrollees (about 6 percent).® Among Medicare enrollees who are under the age of 65, nearly a quarter report drug affordability problems.® Additionally, some health conditions are particularly expensive to treat, and prescriptiondrugs arean added cost for enrollees beyond other health care costs. The cost of long-term medications for conditions such as diabetes and heart disease, for example, can be expensive as therapies are long-term. %11 Moreover, conditions that require treatment with biologic immunosuppressant therapies, such as medications for rheumatoid arthritis and other inflammatory conditions, can be particularly expensive, with some studies finding that drug costs alone can average over $10,000 per year.12 For Medicare enrollees on fixed incomes, treating such conditions with prescription drugs can represent a substantial expense. When people cannot afford medications, they may not take their medication as directed, skip doses, or ration in other ways, all of which can have serious healthand cost-related consequences. Researchshows that nearly 30 percent of adults report not taking their prescription drugs as prescribed for cost-related reasons. 3 The IRAincludes several provisions designed toimprove affordability of the Part D benefit design. In this Research Report, we analyze utilization and out-of-pocket spending of prescription drugs that are covered under Part D and project impacts of the IRA's drug-related provisions on Part D out-of-pocket spending. First, we examine Part D enrollment and spending from 2007 to 2022 to understand how much enrollees have been paying out-of-pocket for prescription drugs over time. Then, we estimate the impact of IRA Part D drug- related provisions that we expect to have the most direct impact on out-of-pocket spending for prescription drugs. The provisions analyzed here include the following: e 535 out-of-pocket cap on each month's supply of covered insulin and elimination of deductibles for covered insulin, effective January 2023; ¢ elimination of out-of-pocket costs for Advisory Committee on Immunization Practices (ACIP)- recommended adult vaccines covered under Part D, effective January 2023; elimination of five percent coinsurance in the catastrophic coverage phase, effective January 2024; elimination of the coverage gap phase and replacement of the Coverage Gap Discount Program with the new Manufacturer Discount Program, effective in 2025; e and a maximum out-of-pocket cap of $2,000, effective 2025, and indexed annually to inflation thereafter. Medicare Part D Benefit Structure under the IRA The IRA's drug related provisions change the Medicare Part D standard benefit structure, which originally consisted of four phases of prescription drug coverage. Enrollees move through the phases depending on their drug spending and plan policies. Figure 1 shows the coverage phases pre-IRAand under the IRA, beginning with the deductible phase, for Part D enrollees who do not receive the Low-Income Subsidy (LIS), which is financial assistance offered to enrollees who meet certainincome and asset requirements. Non-LISenrollees represent about 72 percent of the program's enrollment and have higher out-of-pocket spending for Part D drugs than their counterparts who receive LIS.'# Figure 1 also shows how, in general, the Medicare Part D standard structure changes withthe IRAredesign in 2025. July 2023 RESEARCH REPORT 3 Figure 1. IRA Changes to the Part D Benefit for Non-LIS Enrollees in 2025 I:I Beneficiary I:I Plan . Manufacturer discount Reinsurance Pre-IRA Post-IRA Catastrophic ) %///// ) Catastrophic Coverage Phase Catastrophic 30% Catastrophic Coverage Phase Coverage / ° Coverage 00P threshold 15% 5% Coverage Gap Phase (67,400) - = 4 Beneficiary Generic |l 75% zrand Generic drugs rugs drugs Zrand 5% Plan rugs Initial Coverage ' 25% Initial Coverage Phase Limit ($4,660) POFThiEHold Initial Coverage Phase (52,000) 10% Manufacturer : . Discount* Deductible Phase Deductible Deductible ($550) ($550) Deductible Phase Notes: Figure 1 represents Part D payment benefit structure before and afterthe IRA redesignin 2025 for non-LIS enrollees. Pre-RA and Post-IRA benefit are scaled to $10,000 of total liability in 2023. *|RA Manufacturer Discount phased in during the initial coverage phase from 2025 through 2029 and in the catastrophic phase from 2025 through 2031. Full details of the IRA changes are available at: Inflation Reduction Actand Medicare | CMS Source: Centers for Medicare and Medicaid Services IRA = Inflation ReductionAct Under the IRA, in 2024, enrollees will no longer pay five percent coinsurancein the catastrophic coverage phase. In 2025, the coverage gap phase will be eliminated and the Coverage Gap Discount Program will be replaced with the new Manufacturer Discount Program. Enrollees will transition from the initial coverage phase to the catastrophic coverage phase when they have incurred $2,000in out-of-pocket costs in 2025 and indexed annually for inflation thereafter. When this provision goes into effect in 2025, Part D enrollees will no longer be responsible for out-of-pocket spending above the annual threshold. This is expectedto have a considerable impact on out-of-pocket spending. Existing research shows thatin 2019, out-of-pocket drug spending for about 1.5 million Part D enrollees exceeded the 2019 annual catastrophic coverage threshold ($5,100) for total out-of-pocket drug spending.15 Non-LIS enrollees who reach the catastrophic coverage phase have more chronic conditions and use more specialty care drugs relative to enrollees who do not enter the catastrophic coverage phase. 16 These Part D benefit structure changes are phasedin over time, alongside other key provisions." Figure 2 presents the implementation timeline of IRA Part D provisions from 2023 to 2025 that are modeled in this Report to understand theirimpacts on out-of-pocket spending. These program changes, along with other IRA * This reportdoesnotinclude IRA provisions related to Medicare Part B. For acompletelist of changes related to the IRA for both Parts B and D, please see here: Inflation Reduction Act Timeline (cms.gov). July 2023 RESEARCH REPORT 4 Part D changes, aimto decrease prescription drug costs for Medicare enrollees and taxpayers while improving enrollee access to prescription drugs. Figure 2. Implementation Timeline of IRA Part D Provisions Modeled in This Report, 2023 - 2025 2023 * Medicare Part D enrollees will not pay more than $35 for a month's supply of each covered insulin product. Deductibles for covered insulin products will be eliminated. * Part D enrollees will not pay anything out-of-pocket for adult vaccines covered by Part D and recommended by the Advisory Committee on Immunization Practices. 2024 * Individuals with Medicare Part D who have low incomes will benefit from expanded financial help with prescription drug cost-sharing and premiums. The low-income subsidy program (LIS or "Extra Help") under Medicare Part D will be fully available to certain people with Medicare with limited resources who earn less than 150% of the federal poverty level starting in 2024. * Elimination of 5% enrollee cost sharing in the catastrophic coverage phase, which means people will not have to pay anything out-of-pocket for covered drugs obtained while in this phase 2025 * The coverage gap phase is eliminated and the Manufacturer Discount Program in Medicare Part D will replace the Medicare coverage gap discount program. The new Manufacturer Discount Program will require manufacturer discounts for applicable drugs both in the initial coverage phase and in the catastrophic phase. * People with Medicare Part D won't pay more than $2,000 out-of-pocket annually for prescription drugs. * Government reinsurance in the catastrophic phase of Part D will decrease from 80% to 20% for brand-name drugs, biologicals, and biosimilars and will decrease from 80% to 40% for ¥ generics. Notes: This figure presents Inflation Reduction Act {IRA) provisionsthatimpact prescriptiondrugs covered under Medicare Part D thatare modeled in this Report. Provisions go into effect at different points in the year. Thisfigure does notpresentacomplete list of all IRA drug-related provisions. Complete details of all drug-related provisions of the IRA are available here: Inflation Reduction Act Timeline {(cms.gov).? METHODS This Report consists of a two-part study: 1) examination of Part D enrollment and spending over time and 2) identification of impacts of select IRA drug-related provisions on Part D out-of-pocket spending. Methods to Identify Trends in Enroliment and Spending Over Time We used the Prescription Drug Event (PDE) data and Part D enrollment data, from 2007 through 2022 to examine trends in Medicare Part D enrollment overall and by LIS status. We alsoexamined trends in average out-of-pocket spending for non-LIS enrollees by payment coverage phase for the same time period. We defined out-of-pocket spending as the amount paid by enrollees and reported in the Medicare PDE data." We alsoexamined trends in total Part D costs to understand how the share of drug spending that is paid out-of- * We considered using the CMS's True out-of-pocket (TrOOP) cost, less gap discount, to define out-of-pocket spending. However, we only present findings from payment paid by enrollees as it represents the actual copayment paid by enrollees and may play an important role in drug affordability and an enrollee's decision to purchase the medicationor forgo it. Spendingtrendswere similar when we used enrollee payments and the TrOOP less gap discount definition. July 2023 RESEARCH REPORT 5 pocket has changed over time. Our estimates include all Part D enrollees, including those in fee-for-service Medicare and Medicare Advantage, as well as enrollees in Employer Group Waiver Plans (EGWPs)." Although we present estimates for all enrollees, we focused specifically on non-LIS enrollees because these enrollees have higher out-of-pocket costs than LIS enrollees who receive financial assistance to help pay for prescription drug costs and premiums in Part D. Additionally, we highlight findings for non-LIS enrollees who reach the catastrophic coverage phase because these enrollees have the highest out-of-pocket spending, and the IRA Part D benefit redesign aims to reduce financial burden for enrollees who reach this phase. We also examined demographic characteristics of enrollees to identify any group differences and identified medical conditions with the highest average out-of-pocket Part D drug spending among enrollees in the catastrophic coverage phase using PDE data in 2021 or 2022, depending on the latest year for which dataon enrollees' medical conditions was available. In addition, we examined Part D out-of-pocket drug spending by state of residencein 2022, Methods to Estimate the Impacts of the IRA's Drug-related Provisions We used Medicare PDE data for Part D enrollees in 2021 to develop a simulation model to understandthe overall and state-specificimpacts on Part D out-of-pocket spending for IRA drug-related provisions that we expect to have direct impacts on out-of-pocket drug spending. PDE data from 2021 was used because atthe time the simulation model was being developed, this was the latest year of complete Part D data that was available. We developed two specifications of our simulation model, which allowed us to identify impacts of IRA-drug related provisions depending on whether the provisions arein effectin 2024 or 2025 (Table 1). Note that some provisions go into effect earlier than 2024 or 2025, but we only model the combined effect of provisions in effect in 2024 and 2025. Although we report results from both specifications, we focus primarily on specification B representing the more comprehensive set of IRA policies in effect in 2025 and beyond. Table 1. IRA Part D Drug Related Provisions Included in the Simulation Model Specification A: Provisions that are Modeled in Specification B: Full set of Provisions Modeled that combination and in effect in Calendar Year 2024 are in effect in Calendar Year 2025 e Enrollee cost sharing (i.e., out-of-pocket e Enrollee cost sharing is limited to $35 for a spending) is limited to $35 for a month's month's supply of each covered insulin supply of each covered insulin product product and deductibles for covered insulin and deductibles for covered insulin products are eliminated products are eliminated e Enrollee cost sharing for ACIP-recommended e Enrollee cost sharing for ACIP- adult vaccines is eliminated recommended adult vaccines is eliminated e Full LIS assistance is expanded to people with e Full LIS assistance is expanded to people limited resources who earn less than 150 with limited resources who earn less than percent of the federal poverty level 150 percent of the federal poverty level e Reduction of enrollee coinsurancein the e Reduction of enrollee coinsurancein the catastrophic coverage phase from five to zero catastrophic coverage phase from five to percent zero percent * EGWPs are a type of health plan that employers can choose to offer their employees that include prescription drug coverage. EGWPs are required to meet CMS Part D plan standards but their plans can be more generousthan the standard benefit. For more information on EGWPs, please see here: Employer Group Waiver Plans (EGWPs) | CMS. July 2023 RESEARCH REPORT 6 e 52,000 maximum annual out-of-pocket capfor enrollees, beginning in 2025, and indexed to inflation thereafter o Elimination of the coverage gap phase and replacement of the coverage gap discount program with the Manufacturer Discount Program; the new Manufacturer Discount Programrequires a 10 percent manufacturer discount on brand drugs in the initial coverage phase and 20 percent in the catastrophic coverage phase e Government reinsurance decreases inthe catastrophic coverage phase-from 80 percent to 20 percent for brand-name drugs, biologicals, and biosimilars, and from 80 percent to 40 percent for generics Notes: Estimates do notinclude non-IRAregulations that may impact drug spending (e.g., Part D regulations requiring that pharmacy price concessions be reflected at the point of sale beginningin January 2024). There will be changes to the Part D benefitbetween calendaryears 2024 and 2025. For example, the accumulation of costs for TrOOPis different pre-IRA and in 2025, which is taken into accountin our modeling. ACIP = AdvisoryCommittee on Immunization Practices We focused on these provisions because they are expected to have a direct impact on out-of-pocket drug spending and there is sufficient information available on how these provisions will be implemented to allow for the development of a simulation model to identify impacts. Our simulation model estimated what will happen to Medicare enrollees' Part D out-of-pocket drug spending in 2024 and 2025, when all of the IRA provisions in Table 1 for each calendar year are in effect, while holding enrollment to 2021 levels. We beganwith actual drug costs from the PDE data, matched with Part D enrollment data, inflated to projected 2024 or 2025 values, depending on the model specification and appropriate statutory formulas, and calculated cost sharing (i.e., out-of-pocket spending) based on the pre-IRA benefit." We then calculated cost sharing on the sameinflated 2021 claims, assuming no change in enrollment or the mix of drugs that are used, but with out-of-pocket costs based on the IRA provisions that go into effect by 2024 for Specification A {in 2024 dollars) and by 2025 for Specification B {in 2025 dollars). Our modeling alsotakes into account changes in true out-of-pocket (TrOOP) accumulation, beginning in 2025 under the IRA. TrOOP refers to incurred costs that count towards an enrollee's Medicare Part D drug plan out- of-pocket threshold. TrOOP consists of both payments paid by the enrollee (e.g., annual deductible, out-of- pocket costs, and others) as well as other payments not paid by the enrollee (e.g., manufacturer gap discounts for brand drugs). In2025, payments that count towards TrOOP change and our modeling takes these changes into account.' There are a number of assumptions in our model. We did not adjust 2021 enrollment to projected 2024 and 2025 levels and instead assumed enroliment remains at 2021 levels. Although our simulation model adjusts for utilization changes, it does not adjust for how the mix of prescriptiondrug use may change over time, * Thisinformation was obtained from the Medicare Trustee's Report. Please see here for more details: 2022 Medicare Trustees Report {cms.gov). For example, under the IRA, the manufacturer payments under the discount program will not count towards TrOOP beginningin 2025 and plan supplemental benefits (including EGWP benefits) will count towards TrOOP. July 2023 RESEARCH REPORT 7 changes in utilization that may occur due to the IRA's out-of-pocket cap on spending, or changes in drug formulary preferences. We projected copay adjustments from the enhanced plans based on existing information on how enhanced plans have deviated from the standard benefit in 2021. Additionally, our model does not account for all Part D drug-related provisions in the IRA. For example, the simulation model does not account for the IRA's requirement for Part D sponsors, starting January1, 2025, to provide their plan enrollees with the option to pay out-of-pocket costs under the plan in monthly amounts that are spread throughout the year. The simulation model also does not include any potential impacts associated with negotiation of Part D drugs, which may impact out-of-pocket spending once implemented. Nor does it account for the increasein access todrugs and new drugs that will come out in future years. Italsodoes not account for the Part D inflation rebates nor for spillover effects that may occur if, for example, the inflation rebate provisions in the IRAlead to changes in the prices of drugs covered by private insurance. Our model also does not include changes in plan behavior resulting from the redesign of the Part D benefit. Finally, our model does not take into account other federal or state programs that may reduce spending on Part D drugs.* Additional details about the model are presentedin the Appendix. Our savings estimates are conservative because they do not fully capture policy changes that are designed to reduce the cost of prescription drugs to the Medicare program and taxpayers. FINDINGS Trends in Medicare Part D Enroliment, Total Spending, and Out-Of-Pocket Spending Medicare Part D enrollment more than doubled from 26 million in 2007 to 53 million in 2022 (Figure 3). The majority of enrollment growth was driven by increases in enrollment among non-LIS enrollees, which grew from about 15 million in 2007 to 38 million in 2022. Figure 3. Medicare Part D Enroliment (Millions of Enrollees), 2007 - 2022 53.1 51.6 a5, 46.8 184 >0-1 43.6 45 31.5 29.8 26.2 27.5 28-7 41.9 37.8 40.0 33.8 R 24.6126.4)27.8 29.2]30.5|31.8 EEW) EZWA ELEY 15.2§16.3J17.3|17.8 19.1]21.0]° ™ 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 B All non-LIS Enrollees ~ m AII LIS Enrollees Source: Enrollment calculated using the 2007-2022 Medicare Part D Prescription Drug Event data and Part D enroliment data. * For example, the impacts of the Part D Senior Savings Model (PDSS), which is a voluntary model that tested alternative Part D plan options that offer lower out-of-pocket costs for insulin as supplemental benefits, are not separately accounted in the modeling. Reductionsin out-of-pocket spending are included onlyin so far as the information is presentin the 2021 PDEdata. PDSS began January 1, 2021 and will end in December 31, 2023. Please see here: Part D Senior Savings Model | CMS Innovation Center. July 2023 RESEARCH REPORT 8 Table 2 presents Part D annual total spending per enrollee, out-of-pocket spending per enrollee, and out-of- pocket spending as a share of total spending over time for both non-LIS and LISenrollees. Total spending is based on gross drug costs, which represent total spending for the prescription claim, including Medicare, plan, and beneficiary payments." For non-LIS enrollees, total spending per enrollee grew from about $1,748 per enrollee in 2007 to $3,293 per enrollee in 2022, an increase of about 88 percent." For LISenrollees, total spending per enrollee grew from about $3,214in 2007 to $7,658in 2022, an increase of 138 percent. This is consistent with researchthat shows Medicare Part D costs have increased over time. 18 Existing researchfinds these increases have been driven partly by shifts towards use of newer high-priced brand-name drugs relative to drugs that have been on the market.?® Part D out-of-pocket spending declined about 27 percent for non-LIS enrollees between 2007 - 2022, going from about $639 per enrollee in 2007 to $464 per enrollee in 2022, Out-of-pocket spending representeda considerable portion of total spending, ranging from a high of nearly 36.5 percent of total spending in 2007 and then declining over time to a low of about 14 percent of total spending in 2022, The decline in out-of- pocket spending over this period may have been driven by multiple factors, including closing of the Part D coverage gap, which began under the ACAin 2010, and the Bipartisan Budget Act of 2018.20 For LIS enrollees, as expected, out-of-pocket spending made up a smaller portion of total spending compared to non-LIS enrollees across all years. Out-of-pocket spending represented less than one percent of total Part D spending for LIS enrollees in 2022. Table 2. Part D Annual Total Drug Spending and Out-Of-Pocket Spending, By LIS Status and Year Non-LIS Enrollees LIS Enrollees Out-Of- Average AverageTotal AverageOut- Pocket TotalDrug AverageOut- Out-Of-Pocket Drug Of-Pocket Spendingasa Spending Of-Pocket Spendingasa SpendingPer SpendingPer ShareofTotal Per SpendingPer ShareofTotal Year Enrollee?($) Enrollee ($) Spending Enrollee®($) Enrollee ($) Spending 2007 $1,748 $639 36.5% $3,214 $109 3.4% 2008 $1,796 $619 34.5% $3,463 $109 3.1% 2009 $1,843 $627 34.0% $3,634 $114 3.1% 2010 $1,847 $626 33.9% $3,726 $117 3.1% 2011 $1,901 $538 28.3% $3,897 $109 2.8% 2012 $1,894 $507 26.8% $3,889 $97 2.5% 2013 $2,034 $484 23.8% $4,030 $99 2.5% 2014 $2,230 $492 22.1% $4,561 $94 2.1% 2015 $2,401 $493 20.6% $4,983 $93 1.9% 2016 $2,448 $492 20.1% $5,141 $95 1.8% 2017 $2,482 $481 19.4% $5,337 $94 1.8% 2018 $2,617 $482 18.4% $5,642 $93 1.7% * The Part D spending measures do not reflect any manufacturers' rebates or other price concessions. Please see here for more detail: Medicare Part D Spending by Drug - Centers for Medicare & Medicaid Services Data (cms.gov). T Spending estimates are not adjusted for inflation over time July 2023 RESEARCH REPORT 9 Non-LIS Enrollees LIS Enrollees Out-Of- Average AverageTotal AverageOut- Pocket TotalDrug AverageOut- Out-Of-Pocket Drug Of-Pocket Spendingasa Spending Of-Pocket Spendingasa SpendingPer SpendingPer ShareofTotal Per SpendingPer Share ofTotal Year Enrollee®(S) Enrollee ($) Spending Enrollee®($) Enrollee ($) Spending 2019 $2,778 $462 16.6% $5,968 $89 1.5% 2020 $2,937 $461 15.7% $6,258 $93 1.5% 2021 $3,087 $457 14.8% $6,680 $89 1.3% 2022 $3,293 $464 14.1% $7,659 $52 0.7% Source: 2007 - 2022 Medicare Prescription Drug Event data and Part D Enroliment data Notes: Out-Of-Pocket spending is based on the actualenrollee payment as it represents the amount paid by enrollees and may play an importantrole in drug affordability and an enrollee's decisionto purchasethe medication or forgoit. Costs paid on behalf of an enrollee by a plan throughenhanced coverage or certainotherentities (e.g., the Indian Health Service) count toward the out-of-pocket cost limit but are notreflected in the enrollee payment. Spendingestimatesare notadjusted for inflation. 2 Total spendingis based on grossdrug costs, which represent total spending for the prescription claim, including Medicare, plan, and beneficiary payments. Trends in Out-Of-Pocket Spending for Enrollees Reaching the Catastrophic Coverage Phase The share of enrollees reaching the catastrophic coverage phase increased over time. In 2022, about 8.1 percent of all Part D enrollees, or almost 4.3 million people, reached the catastrophic About 8 percent of all Part coverage phase. Among non-LIS enrollees, about 4 percent of D enrollees, or almost 4.3 enrollees, or about 1.5 million people, reached the catastrophic million people, reached coverage phase. the catastrophic coverage Figure 4 shows the share of non-LIS enrollees who reached the phase in 2022. catastrophic coverage phase and the average out-of-pocket drug spending per such enrollee from 2007 - 2022. Out-of-pocket spending includes spending in all coverage phases. These enrollees paid substantially more out-of-pocket for Part D covered drugs than their counterparts who did not reach the catastrophic coverage phase. Average out-of-pocket Part D drug spending in the catastrophic phase declined in years immediately following enactment of the ACA, likely because the ACA beganto close the coverage gap after enactment." In 2022, average annual out-of-pocket spending was $3,093 for non-LIS enrollees who ended the year in the catastrophic coverage phase. Existing research shows that the medianincome of Medicare enrollees is about $29,650 per person, which means that spending about $3,100annually in out-of-pocket costs for prescription drugs In 2022, average annual out-of- represents more than 10 percent of income for a typical pocket spending was $3,093 for Medicare Part D enrollee. 2! non-LIS enrollees who ended the year in the catastrophic coverage Among LIS enrollees, 18 percent of enrollees, or 2.7 million phase, which represents more people, reached the catastrophic coverage phasein 2022. A larger proportion of LIS enrollees reach the catastrophic coverage phase compared to non-LIS enrollees because this than 10 percent of income for a typical Medicare Part D enrollee. * The Bipartisan Budget Act of 2018 closed the Part D coverage gap in 2019. July 2023 RESEARCH REPORT 10 population tends to be sicker and requires greater use of prescription drugs than non-LIS enrollees. 22 However, because LIS enrollees receive assistance with out-of-pocket costs, their copays are limited and the out-of-pocket costs for LIS enrollees who reached the catastrophic coverage phase averaged $87in 2022." Figure 4. Share of Non-LIS Medicare Part D Enrollees Reaching Catastrophic Coverage Phase and Average Annual Out-Of-Pocket Drug Spending for Such Enrollees, 2007 - 2022 5.0% ACA $5,000 4.5% | $4,500 4.0% | $4,000 3.5% 0 $3,500 3.0% | $3,000 2.5% $2,500 2.0% | $2,000 1.5% | $1,500 1.0% | $1,000 0.5% | $500 0.0% | 0 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Percent of Beneficiaries in Catastrophic Phase (%) Average Out-of-Pocket Spending (S) wn I Average Out-of-Pocket (S) == Percent of Enrollees in Catastrophic Phase Source: Out-of-pocket spending calculated using the 2007 -2022 Medicare Prescription Drug Event data and PartD Enrollmentdata. Notes: ACA = "Affordable Care Act", whichbeganto close the Part D coverage gap whenit was enacted, startingin 2010. The gap closed in 2019, ayear earlier than ACA legislated, as aresult of the Bipartisan Budget Act of 2018. The average out-of-pocket spending includes spending for all Part D benefit phases for enrolleeswho reach the catastrophiccoverage phase. Spending estimates are not adjusted forinflation. Medicare Part D Out-Of-Pocket Drug Spending by Demographic Characteristics Table 3 shows the number of non-LIS enrollees by demographic characteristics that reached each coverage phasein 2022 and Table 4 shows average out-of-pocket costs for non-LIS enrollees by their end of year coverage phase. For example, of all women that were non-LIS enrollees, 3.4 percent (or 714,000 out of 21.2 million women), reached the catastrophic coverage phase (Table 3). These women paid an average of $3,048 out-of-pocket in 2022 for Part D prescription drugs (Table 4) across all coverage phases. Generally similar proportions of enrollees across demographic groups reachedthe catastrophic coverage phase, though there were some exceptions. A greater share of men (5 percent) than women (3 percent) reachedthe catastrophic coverage phase. Additionally, a greater share of Medicare enrollees betweenthe ages of 65 - 84 reached the catastrophic coverage phase relative to those under the age of 65 and those ages 85 and over. There are also higher proportions of American Indian/Alaskan Native (Al/AN) enrollees who * The LIS subsidy prior to 2024 can be a full or partial subsidy. For more details, please see: Limited Income and Resources | CMS and https://secure.ssa.gov/poms.nsf/Inx/0603001005. July 2023 RESEARCH REPORT 11 reachedthe catastrophic coverage phase (9 percent). Asian Americans had the lowest share of enrollees reaching the catastrophic coverage phase (3 percent) relative to otherracial and ethnic groups. The absolute number of Part D enrollees in these groups are low relative to White non-Latinos compared to the general population. A similarshare of enrollees from urban or rural areas reached the catastrophic coverage phase. Table 3. Demographic Characteristics of Medicare Part D Non-LIS Enrollees by Coverage Phase in 2022 All Deductible Initial Coverage Coverage Catastrophic Enrollee Characteristics (millions) Phase Phase Gap Phase Coverage Phase Total (Nin Millions) 38.1 6.2 25.2 5.2 1.5 Gender Women 21.2 15.9% 67.8% 12.9% 3.4% Men 16.9 16.7% 63.8% 14.6% 4.9% Age <65 4.0 63.8% 27.9% 5.7% 2.6% 65-69 8.9 11.2% 74.2% 10.8% 3.9% 70-74 9.4 11.1% 71.1% 13.3% 4.5% 75-79 7.2 10.7% 68.6% 16.1% 4.7% 80-84 4.6 9.5% 67.8% 18.4% 4.4% 85+ 4.1 10.3% 67.3% 19.1% 3.3% Race & Ethnicity White non-Latino 323 15.8% 66.0% 14.1% 4.1% Black non-Latino 2.7 18.8% 65.0% 12.6% 3.6% Latino 0.6 17.4% 70.8% 9.0% 2.9% Asian American 0.7 19.4% 69.3% 8.7% 2.6% American Indian / Alaska Native 0.07 15.5% 58.5% 17.0% 8.9% Other or Unknown 1.7 19.3% 65.1% 11.6% 4.1% Geographic Characteristics Urban 34.4 15.6% 66.2% 14.0% 4.1% Rural 2.5 15.5% 67.0% 13.6% 4.0% Source: Demographic descriptive statistics calculated using the 2022 Medicare Part D Prescription DrugEventdata and PartD Enrolimentdata. Notes: Percentagesare calculatedfor each demographic group by row using the total enrollees in each group as the denominator. Table 4 presents average out-of-pocket drug spending in 2022 for non-LIS enrollees by demographic characteristics. Among enrollees who reached the catastrophic coverage phase, Part D out-of-pocket drug spending was highest for those younger thanage 65 ($3,318) relative to other age groups, which ranged from $3,046 for ages 65- 69 to $3,107 for those ages 85 and older. This is expected because these enrollees qualify for Medicare based on certain illnesses or disability. * Among those who reached the catastrophic coverage phase, White non-Latino and Other or Unknown race enrollees had the highest out-of-pocket spending ($3,113) in 2022, followed by Black non-Latino enrollees ($3,007), though differences were fairly modest. Out-of-pocket spending was slightly higher for enrollees in rural enrollees ($3,175) than in urban areas ($3,085). * Individuals can qualify for Medicare at any age based on receipt of Social Security Disability benefits for 24 months or certain health condition, including end-stage renal disease (ESRD) and Amyotrophic Lateral Sclerosis (ALS). For more information, please see: Medicare (ssa.gov). July 2023 RESEARCH REPORT 12 Table 4. Average Annual Out-Of-Pocket Part D Drug Spending Among Non-LIS Medicare Enrollees by Demographic Characteristics and Coverage Phase by End of Year (2022) ] . Deductible InitialCoverage Coverage Catastrophic DemographicCharacteristics All Phase Phase Gap Phase Coverage Phase Total $464 $70 $259 $1,147 $3,093 Gender Women $449 $75 $272 $1,155 $3,048 Men $483 $65 $241 $1,138 $3,131 Age <65 $239 s3 $309 $1,107 $3,318 65-69 $407 $96 $214 $1,114 $3,046 70-74 $478 $118 $247 $1,149 $3,059 75-79 $527 $126 $272 $1,146 $3,073 80-84 $560 $131 $291 $1,157 $3,150 85+ $553 $129 $316 $1,184 $3,107 Race & Ethnicity White non-Latino $482 $73 $269 $1,174 $3,113 Black non-Latino $375 $61 $215 $911 $3,007 Latino $222 $27 $130 $698 $2,164 Asian $286 $49 $163 $1980 $2,993 American Indian/Alaska Native $696 $57 $334 $1,323 $2,977 Other or Unknown $408 S$63 $218 $1,107 $3,113 Geographic Characteristics Urban $471 574 $259 $1,141 $3,087 Rural $517 $80 $308 $1,267 $3,175 Source: Out-of-pocket spending calculated using the 2022 Medicare Part D PrescriptionDrugEvent dataand PartD Enrollmentdata. Estimates are based on the last coverage phasereachedby enrollees by the end of 2022 and theirtotal out-of-pocket spending across all Part D benefit phases in 2022. Estimates for LIS enrollees are available in the Appendix (Tables B1 and B2). Although LIS enrollees proceed through the coverage phases, theyreceive financial assistance with premiums, deductibles, and copayments so their out-of-pocket spending, even for enrollees who reach the catastrophic coverage phase, is much lower than non-LIS enrollees. Medical Conditions for Enrollees Who Reach the Catastrophic Coverage Phase Table 5 presents the top five medical conditions that had the highest share of enrollees who reached the catastrophic coverage phase in 2021 and their average out-of-pocket spending. The average out-of-pocket spending was highest for enrollees with cystic fibrosis ($9,522 per enrollee), which is a genetically inherited disorder that primarily affects lung function. About 34 percent of enrollees with cystic fibrosis reached the catastrophic coverage phase. Enrollees with HIV had the highest share reaching the catastrophic coverage phase (79 percent). Through the year, enrollees with HIV paid about $2,478 in out-of-pocket drug costs. Among enrollees with diabetes who use insulin, about 44 percent {or 186,000 enrollees) reached the catastrophic coverage phase and they paid an average of $2,031in out-of-pocket spending for Part D drugs. The remaining medical conditions presentedin Table 5 are for blood cancers (multiple myeloma including other neoplastic disorders and chronic myeloid leukemia). July 2023 RESEARCH REPORT 13 Table 5. Top 5 Medical Conditions with Highest Share of Enrollees Reaching Catastrophic Coverage Phase and their Out-Of-Pocket Spending, 2021 Average Out-Of- Number of Number of Percentin Pocket Spending Per Enrollees Enrolleesin Catastrophic Enrollee for Enrollees Taking Part D Catastrophic Coverage in Catastrophic Medical Conditions Drugs Coverage Phase Phase Coverage Phase? HIV/AIDS 54,988 43,367 79% $2,478 Diabetes with Insulin Use 425,089 186,428 44% $2,031 Multiple Myeloma* 105,013 36,756 35% $7,565 Cystic Fibrosis 3,257 1,110 34% $9,522 Chronic Myeloid Leukemia 20,474 5,866 29% 54,712 Source: Out-of-pocket spending calculated using the 2021 Medicare Part D Prescription DrugEvent data and PartD Enrolimentdata. *Includes Other Neoplastic Disorders related to bone marrow dysfunction. Notes: 2 Estimates are total Part D average out-of-pocket spending perenrollee for those who reached the catastrophic coverage phasein 2021. These estimates include Part D out-of-pocket spending for all phases. Next, we examined the conditions with the highest average out-of-pocket drug spending among non-LIS Part D enrollees who reached the catastrophic coverage phasein 2021. Figure 5 presents these conditions along with the absolute number and percent of enrollees with the condition who reached the catastrophic coverage phase. For example, about 1,110 enrollees with cystic fibrosis reached the catastrophic coverage phasein 2021, which represents about 34 percent of enrollees with this condition in Part D. The average out-of-pocket drug spending per enrollee ranged from approximately $4,712 for enrollees with chronic myeloid leukemia to $9,552 per enrollee for those with cystic fibrosis. Four of the conditions include various systemic cancers (multiple myeloma, secondary cancers, myelodysplastic syndromes, and chronic myeloid leukemia), while other conditions on the listinclude hereditarydisorders, autoimmune disease, primary pulmonary hypertension, and organ transplantation. July 2023 RESEARCH REPORT 14 Figure 5. Ten Medical Conditions with the Highest Average Annual Out-Of-Pocket Part D Drug Spending among Non-LIS Enrollees Who Reach the Catastrophic Coverage Phase in 2021 Cystic Fibrosis (n=1,110 or 34%) $9,522 Hereditary Metabolic/Immune Disorders (n=3,093 or 20%) $7,900 Multiple Myeloma and Other Neoplastic Disorders (n=36,756 or 35%) $7,565 Major Organ Transplant* (n=17,634 or 23%) $6,323 Primary Pulmonary Hypertension (n=11,389 or 16%) $5,282 Secondary Cancers of Bone, Lung, Brain & Other sites _ $4.975 (n=44,785 or 21%) ' Myelodysplastic Syndromes and Myelofibrosis (n=11,315 or 15%) _ $4,972 Motor Neuron Disease** (n= 8,541 or 10%) _ $4,821 Intellectual Disability/Development Disorders (n= 1,270 or 9%) _ $4,752 Chronic Myeloid Leukemia (n=5,866 or 29%) _ $4,712 Source: Out-of-pocket costs calculated usingthe 2021 Medicare Part D Prescription Drug Event dataand PartD Enrolimentdata. Notes: 'n' refer to the number of enrollees with the conditionand percent refers to the percent of enrollees with the medical condition that reachedthe catastrophiccoverage phasein 2021. Estimates are total average out-of-pocket spending perenrollee forthose who reached the catastrophic coverage phasein 2021. These estimatesinclude spending for all coverage phases. *Major organ transplant excludes lung, kidney, and pancreas transplants. **Motor Neuron Disease includes Myasthenia Gravis, Amyotrophic Lateral Sclerosis, and Other Motor Neuron Disease. We also examined prescription drugs that were used by 10,000 or more enrollees in 2022 and the average out- of-pocket spending specifically for these drugs among enrollees using these medications and who reached the catastrophic coverage phase. Results show that seven of the top 10 drugs taken by 10,000 or more enrollees with the highest average out-of-pocket spending were for oncology, which highlights the cost burden of cancer for Medicare enrollees (Table C1in Appendix). This is consistent with existing research that finds a large share of out-of-pocket financial burden is due to cancer treatment, with oncology drugs making up over half of total Part B drug spending in 2021.23 In addition, we examined average out-of-pocket spending for enrollees with various autoimmune diseases by demographic characteristicsand the percentage of enrollees reaching the catastrophic coverage phase (Table C2in Appendix). Results show that about 17 percent of non-LIS enrollees with diseases that require chronic immunosuppressive therapyreached the catastrophic coverage phasein 2022. Additionally, we examined average out-of-pocket costs specifically for biologics among enrollees who reached the catastrophic coverage phase (Appendix Tables C3 and C4). * Enrollees taking immune suppression treatments for rheumatologic diseases and psoriasis had the highest out-of-pocket spending for these drugs. These findings are also * We only examined biologics taken by 10,000 or more enrolleesin the catastrophic coverage phase and rank ordered by average out- of-pocket spending specifically for each drug. July 2023 RESEARCH REPORT 15 consistent with the results from previous analyses showing that biologic medications have contributed to growthin total Medicare drug spending.2* Collectively, these findings suggest that Part D out-of-pocket prescription drug costs are concentrated among a subset of enrollees with specific medical conditions. Part D Annual Out-Of-Pocket Drug Spending by State in 2022 We examined Part D out-of-pocket spending for each state in 2022 and modeled the distribution of out-of- pocket drug spending for enrollees with and without LIS (Table 6). In 2022, the states with the highest average Part D out-of-pocket spending for non-LIS enrollees were North Dakota (S606 per enrollee), Nebraska ($590 per enrollee), and Oklahoma ($589). For LISenrollees, the states with the highest average Part D out-of- pocket spending were Kentucky ($90), North Dakota (589), and Alabama ($81). The variations in meanand median annual out-of-pocket drug spending by state is driven by a number of factors, including differences in medical conditions and in the proportion of enrollees with LIS status. Table 6. Part D Annual Out-Of-Pocket Spending for Enrollees by State in 2022 Non-LIS LIS Total (Non-LIS and LIS) Mean Mean Mean Numberof | OOP | Median | Numberof [ OOP | Median | Numberof | OOP | Median State Enrollees ($) OOP(S) | Enrollees ($) 00P($) | Enrollees ($) 0O0P ($) Alabama 585,515 | §$523 5250 284,624 581 $30 870,139 | $378 5138 Alaska 53,523 | $316 $57 24,032 $50 $16 77,555 | $233 $37 Arizona 861,325 | $443 $143 297,780 $42 $8 | 1,159,105 | $340 $75 Arkansas 339,687 | $521 $222 181,972 $72 $20 521,659 | $365 $107 California 3,805,184 | $378 $120 | 1,865,506 $37 $16 | 5,670,690 | $266 $57 Colorado 617,814 | $401 $112 177,786 $42 $0 795,600 [ $321 $61 Connecticut 403,946 [ $509 5166 214,672 548 S1 618,618 | $349 569 Delaware 146,341 | $484 $201 41,191 563 $14 187,532 | $392 $127 District of Columbia 24,780 | $511 5174 40,491 525 S0 65,271 [ $209 516 Florida 2,983,100 | $447 $129 | 1,126,576 $40 $0 | 4,109,676 | $336 $60 Georgia 1,024,270 | $529 5206 477,385 574 $24 | 1,501,655 [ $385 5104 Hawaii 168,087 | $328 $136 59,804 532 S0 227,891 | $251 $76 Idaho 226,532 | $447 5140 63,832 561 512 290,364 | $362 $90 lllinois 1,388,504 | $510 $197 528,878 $44 $0 | 1,917,382 | $382 $93 Indiana 836,981 | $505 $187 284,288 $51 S0 | 1,121,269 | $390 $100 lowa 449,847 | $535 $187 113,482 $62 $4 563,329 | $440 $119 Kansas 358,774 | $531 $184 94,222 566 S8 452,996 | $434 5116 Kentucky 554,774 | $523 $240 | 257,806 $90 $32 812,580 | $386 $138 Louisiana 478,784 | $528 5242 289,844 564 $20 768,628 | $353 5101 Maine 198,404 | $417 $144 101,473 543 S3 299,877 | $290 $65 Maryland 537,061 | 5486 5201 212,831 572 $31 749,892 | $369 5118 Massachusetts 795,634 | $490 $208 376,434 $49 $8 | 1,172,068 | $348 $96 July 2023 RESEARCH REPORT 16 Non-LIS LIS Total (Non-LIS and LIS) Mean Mean Mean Numberof | OOP | Median | Numberof [ OOP | Median | Numberof | OOP | Median State Enrollees (S) OOP(S) | Enrollees (S) 00P($) | Enrollees (S) 0O0P ($) Michigan 1,435,443 | $419 $173 447,515 $55 $16 | 1,882,958 [ $333 $102 Minnesota 739,081 | $439 5128 182,919 549 s3 922,000 | $362 $82 Mississippi 300,418 | $590 $249 197,848 S77 $30 498,266 [ 5386 $110 Missouri 814,773 | $487 $170 256,954 $61 $5 | 1,071,727 | $385 $99 Montana 146,277 | $468 5158 41,063 566 $21 187,340 [ $380 5102 Nebraska 239,631 [ $590 $208 56,185 566 sS4 295,816 [ $490 $132 Nevada 339,582 | 5416 5124 105,269 563 $22 444,851 $332 579 New Hampshire 197,424 | $472 5174 49,369 576 $27 246,793 | $393 $120 New lersey 1,055,504 | $499 5194 319,275 549 S4 | 1,374,779 | $395 5113 New Mexico 226,178 | $406 $156 125,908 $50 $16 352,086 | $279 §71 New York 2,004,789 | $460 5164 | 1,193,725 538 $2 | 3,198,514 | $303 $58 North Carolina | 1,283,141 | $496 $197 459,632 $70 $18 | 1,742,773 | $384 $112 North Dakota 89,128 [ $606 5233 21,179 589 $28 110,307 | $506 5156 Ohio 1,599,399 | $475 $169 511,384 $51 S0 [ 2,110,783 | $372 $98 Oklahoma 414,046 [ $589 $263 166,425 $65 $14 580,471 $439 $131 Oregon 560,735 | $429 $156 189,980 556 $15 750,715 | $335 $92 Pennsylvania 1,807,454 | 5477 $182 613,392 S$57 $11 | 2,420,846 | $371 $103 Rhode Island 138,456 | $418 $121 57,774 $45 $0 196,230 | $309 $53 South Carolina 695,691 | $535 $220 240,353 561 512 936,044 | $413 5120 South Dakota 117,219 | $559 $191 26,819 $78 $17 144,038 | $469 $132 Tennessee 837,009 | $512 5193 340,906 $73 $20 | 1,177,915 | $385 $110 Texas 2,594,766 | $491 $193 | 1,024,379 $59 $10 | 3,619,145 [ $369 $101 Utah 285,592 | $441 5141 59,087 552 513 344,679 | $374 594 Vermont 94,600 | $467 5141 33,318 555 $22 127,918 | $360 582 Virginia 863,825 | 5493 5183 292,424 566 $13 | 1,156,249 [ $385 $109 Washington 795,807 | $437 $140 273,502 $44 $0 | 1,069,309 | $337 $73 West Virginia 227,697 | $487 $237 116,423 576 $24 344,120 | $348 $126 Wisconsin 788,856 | $453 $159 221,345 541 S0 | 1,010,201 | $362 $94 Wyoming 69,651 [ $528 $195 15,742 $73 $11 85,393 | $444 $133 Total* 38,279,655 | $462 $164 | 14,784,568 $53 $9 | 53,064223 | $348 $85 Source: State estimates for Part D out-of-pocket spending calculated usingthe 2022 Medicare Part D Prescription Drug Eventdata and PartD Enrollment data. * Totalsinclude Medicare Part D enrolleesresidingin territories or outside the United States, who are notshown separately. OOP = Out-Of-Pocket July 2023 RESEARCH REPORT 17 Projected Impacts of the IRA on Part D Enrollees' Annual Out-Of-Pocket Spending The second part of our study aims to understand the impact of the IRA's Part D redesign and drug-related provisions on enrollee out-of-pocket spending using a simulation model. Our simulation model estimated the impact of the IRA's Part D redesign and other drug-related provisions on enrollee out-of-pocket spending using two specifications: specification A includes the IRA Part D related provisions that are in effect in 2024 and specification B, our main specification, includes additional IRA Part D related provisions that are in effect in 2025, as described in Table 1. Note that not all IRAPart D related provisions were included in the modeling." Specification A: 2024 IRA Part D Impacts Our modeling estimates suggest that the IRA's Part D related provisions that arein effect in 2024 (specification A} are projected to result in an annual reduction of 15 percent in average out-of-pocket Part D spending, declining from $463 per enrollee (without the IRA)to $394 per enrollee under the IRAin 2024. Overall, this results in an approximate $3.6 billion reduction in out-of-pocket costs annually. For the baseline scenario, using 2021 data, we projected spending in 2024 in the absence of the IRA. Under this scenario, about 3.9 million enrollees would have reached the catastrophic coverage phase and therefore met the catastrophic coverage threshold (about $8,000 in 2024). Under the IRA, in 2024, this estimate s expectedto reduce to about 3.65 million enrollees, a decline of about 7 percent. This is likely due to the cost sharing caps on insulin and vaccines. Under the IRA, the average out-of-pocket cost are projected to decline about 42 percent ($611) for enrollees who would have previously reached the catastrophic coverage phase pre-IRA.* Under the baseline scenario, in 2024, about 36.3 million non-LIS enrollees are projected to pay $3,000 or less in out-of-pocket costs andabout 913,000 non-LIS enrollees are projected to pay more than $3,000. Under the IRA, about 36.8 million enrollees are projected to pay $3,000 or less in out-of-pocket costs and about 507,000 enrollees are projected to pay more than $3,000. Therefore, the percentage of non-LIS Part D beneficiaries spending more than $3,000 out of pocket will drop due to the IRAfrom 2.5% to 1.4%, which represents about 407,000 fewer enrollees paying $3,000 or more in a year. In 2025, as discussed below, all beneficiaries will have their Part D OOP spending capped at $2,000. Detailed average impact estimates per enrollee by LIS status are presentedin Table 7A for specification A. * For example, the potential impacts of the inflation rebate provisions and the impact of Part D drugs that are selected for negotiation are not included in the simulation model. * Thisincludes some enrollees who are in the catastrophic coverage phase in the baseline but would fall below the catastrophic coverage phase under the IRA. July 2023 RESEARCH REPORT 18 Table 7A. Model Specification A: Projected Average Annual Out-Of-Pocket Impact Per Enrollee of 2024 Inflation Reduction Act Medicare Part D Redesign, by Low-income Subsidy (LIS) Status 2024 2024 Annual Out-Of- Baseline Projected IRA Policy Percentage Pocket Spending (withoutIRA) (with IRA) Impact Change Non-LIS $610 $541 -$70 -11.4% LIS $82 $15 -$67 -81.9% All $463 $394 -$69 -14.9% Source: ASPE Part D Simulation Model Notes: Table 7A presents modeling estimates forannual enrollee out-of-pocket drug spending underthe Inflation Reduction Act (IRA) in 2024 dollars. This specificationincludes onlythe IRA drug-related provisions that are modeledin this study that are in effectin 2024 as presented in Table 1. Estimates arebasedon a simulation of what would happen in 2024 without the IRA (baseline)and with the IRA (projected). The simulation modelis based on a 10 percent random sample of PDEdatain 2021. Specification B: 2025 Part D IRA Impacts Our results show that the IRA drug-related provisions modeled in this paper that are in effect in 2025 will reduce average out-of-pocket drug spending by 30 percent, a reduction of about $144 per enrollee. Atthe 90t percentile for savings, this translates to savings of about $298 and at the 95 percentile, this translates tosavings of about $709 per When the IRA Part D drug- enrollee. Overall, this results in about a $7.4 billion reduction in out- related provisions modeled of-pocket costs in 2025. |n specification B, as expected, the impact of are in effect, we project it will the IRAis greater thanin specification A because in 2025, the $2,000 out-of-pocket cap goes into effect, which substantially limits out-of- pocket spending for enrollees. reduce out-of-pocket drug spending by 30 percent, declining from 5486 annually For the baseline scenario, using 2021 data, we estimated spending in per enrollee to $342 under 2025 in the absence of the IRA. Under this scenario, about 3.8 the IRA in 2025 million enrollees are expected to reach the catastrophic coverage phase and therefore meet the catastrophic coverage thresholdin the absence of the IRA, which is estimated tobe about $8,500. Among enrollees who would reach the catastrophic coverage phase in the absence of the IRA, enrollees with high spending (those at the 90 percentile and 95t percentiles of out-of-pocket spending) are projected to have about $4,000 and $5,500in out-of-pocket costs, respectively. Under the IRA, the number of enrollees who reach the catastrophic coverage phase would increase to 9.5 million enrollees, an increase of about 5.6 million enrollees or 147 percent from baseline. This increase in the number of enrollees in the catastrophic coverage phasein 2025 is due to the much lower out-of-pocket limit ($2,000) imposed by the IRA. Under the IRA, the average out-of-pocket costs are projected to decline about 73 percent ($1,126) for enrollees who would have previously reachedthe catastrophic coverage phase pre-IRA. Additionally, in the baseline scenario, about 36.2 million non-LIS enrollees are projected to pay $3,000 or less in out-of-pocket costs andabout 1.1 million non-LIS enrollees are projected to have out-of-pocket spending greaterthan $3,000in 2025. Under the 2025 IRA, this changes sothat enrollees no longer have out-of-pocket payments greater thanthe $2,000 due tothe out-of-pocket cap instituted by the IRA. Detailed average impact estimates per enrollee by LIS status are presented in Table 7B for Specification B. July 2023 RESEARCH REPORT 19 Table 7B. Model Specification B: Projected Enrollee Average Annual Out-Of-Pocket Impact of 2025 Inflation Reduction Act Medicare Part D Redesign, by Low-income Subsidy (LIS) Status (2025 dollars) 2025 2025 Annual Out-Of- Baseline Projected IRA Policy Percentage Pocket Spending (without IRA) (with IRA) Impact Change Non-LIS $640 $468 -$171 -26.8% LIS $86 $13 -$72 -84.3% All 5486 $342 -$144 -29.6% Source: ASPE Part D Simulation Model Notes: Table 7B presents modeling estimates for annual enrollee out-of-pocket drug spending underthe Inflation Reduction Act(IRA)in 2025 dollars. Specification B includes all IRA drug-related provisions modeled in this study thatare in effectin 2025as presented in Table 1. Estimates are based on a simulation of what would happen in 2025 without the IRA (baseline) and with the IRA (projected). The simulation model is based on a 10 percent random sample of PDE data in 2021. The IRAPart D provisions have a greater relative impact on LIS enrollees than non-LIS enrollees (84 percent vs. 27 percent in specification B), but larger absolute impact on non-LIS enrollees ($171 in savings vs. $72 in savings). LISenrollees have higher gross drug costs, onaverage, than non-LIS enrollees, but have lower out-of- pocket spending because much of their cost sharing is covered by federal assistance. The dollar impact of the IRA on out-of-pocket drug spending is thus larger for non-LIS enrollees thanfor LIS enrollees. LISenrollees, however, have a larger percentage impact because they will be more likely to reach the $2,000 limit, toward which low-income cost sharing and third-party payments will all be counted, as they are now before the IRA out-of-pocket limit is implemented. Distribution of Projected Savings We examined the distribution of projected savings to understand how many people would save under the IRA. We began by examining those with the most savings, specifically, the projected population of enrollees who are expected to save at least $1,000 or more in 2024 and 2025. Table 8 presents the average savings distribution only among enrollees with savings of $1,000 or more in 2024 and 2025. Among those who are expected to save $1,000 or more, the average savings are projectedto be about $2,900in 2024 for nearly 636,000 LIS and non-LIS enrollees and $2,500in 2025 for nearly 1.9 million LIS and non-LIS enrollees. Of the nearly 1.8 non-LIS enrollees saving over $1,000in out-of-pocket costs, about 1.1 million (63%) were in the catastrophic coverage phase in the baseline." * Our analysis shows that enrollees do not have to reach the catastrophic coverage phase to save over $1,000, as the baseline TrOOP limit is about $8,500. July 2023 RESEARCH REPORT 20 Table 8. Average Out-Of-Pocket Savings Among Enrollees with Projected Savings of $1,000 or More Policy Impact Average OOP MedianOOP Average OOP Number of Savings Per Percentage Savings Per Savings atthe Enrollees Enrollee Change Enrollee 90t Percentile Specification A: 2024 Non-LIS 579,000 $2,948 56.8% $1,798 $6,607 LIS 56,740 $1,939 88.4% $1,916 $2,594 Total 635,740 $2,858 58.0% $1,806 $6,219 Specification B: 2025 Non-LIS 1,787,390 $2,504 65.7% $1798 $4,265 LIS 69,300 $2,060 86.4% $1,915 $2,857 Total 1,856,690 $2,487 66.2% $1,801 $4,165 Source: ASPE Part D Simulation Model Notes: OOP=0ut-Of-Pocket Table 9 presents demographic and health characteristics for non-LIS enrollees who are expectedto save $1,000 or more. Results show that a larger share of Al/AN enrollees are expected to have out-of-pocket savings of $1,000 or more than other racial/ethnic groups, with average out-of-pocket savings of about $2,460, followed by White enrollees (4.9 percent with average savings of $2,477). Among enrollees with health conditions, a greater share of those with HIV {about 71 percent)and those who are long-term insulin users (51 percent) are expected to have savings of at least $1,000 or more, with enrollees with HIV demonstrating the largest average out-of-pocket savings ($3,181) across the health conditions examined. Table 9. Demographic Characteristics and Average Savings Among Non-LIS Enrollees with Projected Savings of $1,000 or More in 2025 Percentof Average Out-Of- Numberof Enrollees with at Pocket Savings Number of Enrollees with least$1,000in among those with Demographic TotalEnrollees Savings of Out-Of-Pocket $1,0000r morein Characteristics with Savings $1,000 or More Savings savings Age <65 3,437,750 175,600 5.1% $2,892 65-69 10,279,640 460,880 4.5% $2,506 70-74 9,531,160 468,010 4.9% $2,483 75-79 6,498,130 341,350 5.3% $2,480 80-84 3,991,460 200,410 5.0% $2,436 85-89 2,207,650 98,270 4.5% $2,302 90+ 1,313,870 42,870 3.3% $2,085 Gender Women 20,691,770 857,070 4.1% $2,444 Men 16,567,890 930,320 5.6% $2,559 Race White 31,672,420 1,564,800 4.9% $2,477 Black 2,683,950 108,390 4.0% 82,827 July 2023 RESEARCH REPORT 21 Percentof Average Out-Of- Numberof Enrolleeswith at Pocket Savings Number of Enrollees with least$1,000in among those with Demographic Total Enrollees Savings of Out-Of-Pocket $1,0000r morein Characteristics with Savings $1,000 or More Savings savings Latinos 574,580 15,770 2.7% $2,584 Asian 696,370 21,900 3.1% $2,573 American Indian/Alaskan Native 68,680 7,530 11.0% $2,460 Other 1,563,660 69,000 4.4% $2,561 Geography Urban 33,849,090 1,622,660 4.8% $2,508 Rural 2,454,360 119,960 4.9% $2,460 Health Characteristics HIV 68,240 48,380 70.9% $3,181 Non-HIV 37,191,420 1,739,010 4.7% $2,485 Long-term Insulin User 452,080 229,760 50.8% $2,116 Non-long-term Insulin User 36,807,580 1,557,630 4.2% $2,561 Rheumatic Disorders 562,740 80,960 14.4% $2,894 Non-Rheumatic Disorders 36,696,920 1,706,430 4.7% $2,485 Source: ASPE Part D Simulation Model Notes: Savings are in 2025 dollars. Table 10A and Table 10B show savings thresholds and the number of enrollees expectedto save under each threshold across the entire population of enrollees in Part D. Our analyses showthatin 2024, 15.4 million enrollees (or 30 percent) would have savings under the IRA provisions that are in effect that year. In 2025, 18.7 million or 36 percent of enrollees would have savings under the IRA provisions that are in effect that year. July 2023 RESEARCH REPORT 22 Table 10A. Specification A: Distribution of Projected Out-Of-Pocket Savings for 2024 IRA Drug- Related Provisions, by LIS Status Non-LIS LIS All Numberof Percentof | Numberof Percentof | Numberof Percentof Projected IRA Savings Enrollees Enrollees Enrollees Enrollees Enrollees Enrollees Savings <= $0? 32,202,680 86.4% | 4,052,330 28.2% | 36,255,010 70.2% $0 < Savings <= $100 2,007,510 5.4% | 7,328,150 51.0% | 9,335,660 18.1% $100 < Savings <= $200 875,310 2.3% | 1,597,120 11.1% | 2,472,430 4.8% $200 < Savings <= $300 774,740 2.1% 417,360 2.9% [ 1,192,100 2.3% $300 < Savings <= $400 205,430 0.6% 735,860 5.1% 941,290 1.8% $400 < Savings <= $500 173,440 0.5% 103,400 0.7% 276,840 0.5% $500 < Savings <= $600 124,980 0.3% 34,010 0.2% 158,990 0.3% $600 < Savings <= $700 99,870 0.3% 17,870 0.1% 117,740 0.2% $700 < Savings <= $800 83,590 0.2% 11,470 0.1% 95,060 0.2% $800 < Savings <= $900 71,510 0.2% 7,850 0.1% 79,360 0.2% $900 < Savings <= $1,000 61,600 0.2% 5,910 0.0% 67,510 0.1% Savings > $1,000 579,000 1.6% 56,740 0.4% 635,740 1.2% Total 37,259,660 100.0% | 14,368,070 100.0% | 51,627,730 100.0% Source: ASPE Part D Simulation Model Notes: Savings are in 2024 dollars. Enrolimentis based on 2021 levels. aThere are situations where an enrollee may have an increase in out-of-pocket spending under the 2024 IRA drug-related provisions. Table 10B. Specification B: Distribution of Projected Out-Of-Pocket Savings for 2025 IRA Drug- Related Provisions, by LIS Status Non-LIS LIS All Numberof Percentof | Numberof Percentof | Numberof Percentof Projected IRA Savings Enrollees Enrollees | Enrollees Enrollees Enrollees Enrollees Savings <= $0° 28,849,140 77.4% | 4,039,670 28.1% | 32,888,810 63.7% $0 < Savings <= $100 2,056,990 5.5% | 7,287,500 50.7% | 9,344,490 18.1% $100 < Savings <= $200 1,116,020 3.0% | 1,538,980 10.7% | 2,655,000 5.1% $200 < Savings <= $300 1,115,240 3.0% 480,400 3.3% | 1,595,640 3.1% $300 < Savings <= $400 506,700 1.4% 714,390 5.0% | 1,221,090 2.4% $400 < Savings <= $500 443,790 1.2% 139,870 1.0% 583,660 1.1% $500 < Savings <= $600 353,190 0.9% 46,660 0.3% 399,850 0.8% $600 < Savings <= $700 309,930 0.8% 20,790 0.1% 330,720 0.6% $700 < Savings <= $800 275,710 0.7% 13,950 0.1% 289,660 0.6% $800 < Savings <= $900 242,960 0.7% 9,440 0.1% 252,400 0.5% $900 < Savings <= $1,000 202,600 0.5% 7,120 0.0% 209,720 0.4% Savings > $1,000 1,787,390 4.8% 69,300 0.5% | 1,856,690 3.6% Total 37,259,660 100.0% | 14,368,070 100.0% | 51,627,730 100.0% Source: ASPE Part D Simulation Model Notes: Savings are in 2025 dollars. Enrolimentis based on 2021 levels. aThere are situations where an enrollee may have an increase in out-of-pocket spending under the 2024 IRA drug-related provisions. July 2023 RESEARCH REPORT 23 The distribution of savings suggest that a sizable subset of the Medicare Part D enrollee population is expected to save in out-of-pocket costs under the IRA. In 2025, this translates to about 36 percent of all enrollees who are projected to have savings, including 23 percent of LIS enrollees and 72 percent of non-LIS enrollees. Given the subset of enrollees that are expected to save under the IRA's drug related provisions, we examined the average annual out-of-pocket savings per enrollee taking into account only enrollees with savings in 2025. Our results (Table 11) suggest that average out-of-pocket costs will amount to about $396 in savings per enrollee with savings, with greater savings accruing to non-LIS enrollees, who would save about $759 per enrollee, than LIS enrollees. Table 11. Specification B: Projected Average Annual Out-Of-Pocket Savings Per Enrollee Among Enrollees with Savings in 2025 Number of Enrollees Out-Of-Pocket Savings for Each Enrollee LIS Status TotalSavings with Savings (Among Enrollees with Savings) Non-LIS $6,386,000,000 8,410,520 $759 LIS $1,037,000,000 10,328,400 $100 Total $7,422,000,000 18,738,920 $396 Source: ASPE Part D Simulation Model Notes: Savings are shown only for enrollees who had out-of-pocket savingsunder 2025 IRA provisions, which represent about 36 percentof all enrollees. Savingsare in 2025dollars. We also examined savings by demographic groups to understand differences in savings. Appendix Table D2 presents the policy impact and the percent change in out-of-pocket spending from baseline for each simulation model specification. Our findings show that generally, the share of savings accrue at similar rates across specifications. Enrollees under the age of 65 have savings of about 44 percent in out-of-pocket spending under 2025 IRA provisions. This is consistent with our earlier findings that show this age group has higher out-of-pocket spending than other age groups, likely because they qualify for Medicare based on disability or illness. Men have slightly more savings than women (about 4 percentage point difference in 2025). Among racial and ethnic groups, Al/AN enrollees have the greatest reduction in out-of-pocket savings in 2025, followed by Latinos enrollees. As expected, non-LIS enrollees have greater relative reduction in out- of-pocket spending comparedto LIS enrollees. Enrollees in rural and urban areas have similar reductions in out-of-pocket spending. Results also show that enrollees with HIV are expected to have the largest reductionin out-of-pocket spending (69 percent), followed by enrollees who use insulin long-term (63 percent), and enrollees with rheumatic disorders (44 percent). Savings by State We modeled the impact of the IRAPart D redesign on Part D out-of-pocket spending for enrollees in eachstate (Table 12). Our results show that the states with the largest average savings per enrollee who have savings in out-of-pocket costs are Nebraska ($387) and Wyoming ($375) in 2024 (Specification A) and Nebraska ($630) and Wyoming ($608) in 2025 (Specification B). July 2023 RESEARCH REPORT 24 Table 12. Projected Impact of Inflation Reduction Act Medicare Part D Redesign for Enrollees Expected to Have Out-Of-Pocket Savings, by State, 2024 and 2025 Spedcification A: 2024 Savings (2024 dollars) Specification B: 2025 Savings (2025 dollars) Average Number of Savings Numberof | Average Enrollees per Enrollees | Savings per with Out- Enrollee Total Estimated | withOut- Enrollee Total Estimated Of-Pocket with Out-Of-Pocket Of-Pocket with Out-Of-Pocket State Savings Savings Savings Savings Savings Savings Alabama 306,150 $218.33 $66,840,296 366,890 $359.73 $131,983,143 Alaska 24,400 $161.97 $3,952,168 30,520 $309.38 $9,442,237 Arizona 319,030 $220.77 $70,433,176 388,850 $379.35 $147,508,867 Arkansas 177,740 $210.48 $37,410,810 203,210 $341.84 569,464,876 California 1,914,530 $162.25 $310,630,320 | 2,180,530 $295.51 $644,379,120 Colorado 177,270 $272.37 $48,283,780 220,050 $451.28 $99,304,666 Connecticut 210,880 $209.37 $44,151,087 255,900 $367.55 $94,055,573 Delaware 48,030 $257.14 $12,350,623 63,350 $448.51 528,413,083 District of Columbia 31,270 $120.61 $3,771,380 33,190 $183.87 $6,102,580 Florida 1,212,260 $235.12 $285,027,129 | 1,479,230 $401.15 $593,397,513 Georgia 498,960 $240.82 $120,161,017 589,320 $394.96 $232,756,502 Hawaii 68,180 $140.50 $9,579,566 82,130 $280.75 $23,057,663 Idaho 65,470 $275.83 $18,058,327 82,160 $461.75 $37,937,117 lllinois 470,160 $248.88 $117,015,573 597,880 $432.70 $258,702,317 Indiana 306,360 $278.52 $85,328,914 385,650 $465.07 $179,352,376 lowa 126,560 $327.45 $41,442,197 163,690 $524.51 $85,857,481 Kansas 100,930 $333.43 $33,653,011 129,630 $550.04 571,301,576 Kentucky 280,240 $223.84 $62,727,677 333,560 $359.04 $119,760,791 Louisiana 281,590 $189.77 $53,436,767 327,110 $320.05 $104,692,595 Maine 110,280 $178.66 $19,702,230 126,850 $298.30 $37,839,589 Maryland 232,500 $226.56 $52,675,430 284,990 $387.91 $110,551,046 Massachusetts 406,650 $193.52 $78,694,886 481,730 $333.23 $160,525,210 Michigan 541,020 $208.35 $112,723,226 672,860 $356.00 $239,539,146 Minnesota 184,490 $298.18 $55,012,011 234,800 $483.22 $113,461,163 Mississippi 177,700 $226.86 $40,313,171 203,300 $364.26 574,054,703 Missouri 276,380 $278.65 $77,014,526 348,280 $461.94 $160,886,006 Montana 44,830 $283.96 $12,730,030 54,010 $460.60 $24,877,143 Nebraska 67,170 $387.17 $26,006,108 88,600 $629.59 555,781,343 Nevada 117,370 $266.68 $31,300,207 143,020 $433.81 562,043,947 New Hampshire 56,260 $307.09 $17,276,733 72,960 $490.01 $35,751,168 New Jersey 352,520 $288.27 $101,620,278 473,370 $519.78 $246,047,780 New Mexico 110,150 $167.84 $18,487,579 125,870 $272.72 534,327,699 New York 928,480 $212.17 $196,995,599 | 1,145,400 $389.63 $446,277,061 North Carolina 542,140 $243.55 $132,040,481 662,600 $405.85 $268,914,391 July 2023 RESEARCH REPORT 25 North Dakota 26,380 $298.26 $7,868,054 33,050 $505.87 516,718,953 Ohio 541,670 $271.58 $147,107,228 687,430 $451.18 $310,154,676 Oklahoma 166,080 $262.46 $43,589,795 206,000 $452.25 $93,164,394 Oregon 185,550 $231.55 $42,963,391 224,100 $388.30 587,017,149 Pennsylvania 645,530 $269.94 $174,255,025 829,770 $466.79 $387,330,525 Rhode Island 56,590 $197.75 $11,190,442 68,120 $339.62 $23,134,972 South Carolina 270,890 $251.06 $68,009,386 334,960 $434.55 $145,557,773 South Dakota 31,210 $371.89 $11,606,591 39,710 $586.73 523,299,064 Tennessee 379,460 $255.77 $97,054,529 459,280 $417.36 $191,685,868 Texas 1,098,260 $234.83 $257,901,924 1,323,430 $399.64 $528,899,748 Utah 75,960 $291.68 $22,156,230 95,950 $490.54 547,067,108 Vermont 36,350 $308.85 $11,226,635 44,030 $491.89 $21,658,034 Virginia 314,440 $266.35 $83,749,536 390,400 $440.62 $172,017,610 Washington 288,470 $243.89 $70,355,127 344,470 $412.96 $142,251,405 West Virginia 117,150 $208.41 $24,414,649 140,540 $346.26 548,663,280 Wisconsin 234,150 $283.82 $66,457,248 298,750 $47491 $141,879,088 Wyoming 16,260 $375.37 $6,103,591 21,920 $607.58 513,318,138 Total* 15.4 million $231.19 $3.6 billion | 18.7 million $396.08 $7.4 billion Source: ASPE Part D Simulation Model Notes: *Totals include Medicare Part D enrollees residing in territories or areas outside the United States, who are not shown separately. DISCUSSION Substantial numbers of Medicare enrollees in Part D experience high out-of-pocket spending burdens, but several provisions under the IRAwill produce meaningful savings for more than 18 million people by 2025. Medicare Part D enrollment doubled from 2007 to 2022, and the majority of enroliment growthwas driven by increases in enrollment among non-LIS enrollees, who are alsothe most affected by Part D out-of-pocket costs. Ourfindings show that the share of enrollees reaching the catastrophic coverage phase (the phase under which enrollees have five percent cost sharing responsibilities pre-IRA) has been increasing over time. For some health conditions, the share of enrollees reaching the catastrophic coverage phase is particularly high (e.g., HIV where about 79 percent of enrollees reached the catastrophic coverage phase or enrollees with diabetes who use insulin where about 44 percent of enrollees reached the catastrophic coverage phasein 2021). For enrollees who reach the catastrophic coverage phase, Part D out-of-pocket spending can be substantial. * In 2022, average annual Part D out-of-pocket spending was $3,093 for the 1.5 million non-LIS enrollees who reached the catastrophic coverage phase. For atleast half of Medicare enrollees, this represents about 10 percent of their totalincome on Part D drugs alone. For some health conditions, the out-of-pocket costs are much higher. For example, the average out-of-pocket drug spending per enrollee who reachedthe catastrophic coverage phase ranged from approximately $4,712 for chronic myeloid leukemia, a type of cancer of the blood, to $9,552 per enrollee for cysticfibrosis. These findings suggest that althoughthe Part D coverage gap closed after implementation of the ACA and the Bipartisan Budget Act of 2018, some Medicare Part D enrollees with serious health conditions still face substantial out-of-pocket spending requirements to receive their medications. * Other out-of-pocket medical costsare notincluded in the estimates presented in this Report. July 2023 RESEARCH REPORT 26 Under the previous Part D benefit design, there were no caps to limit these out-of-pocket payments. For all Part D enrollees, and particularly for enrollees prescribed high priced medications or enrollees who take many medications, the absence of limits on out-of-pocket spending creates significant financial burdens. The IRA builds on the ACAand aims to reduce Medicare spending and enrollee out-of-pocket spending for Part D drugs through a series of provisions that change the Medicare Part D benefit structure, such as limiting Part D out-of- pocket spending to $2,000 and indexed to inflation annually thereafter, instituting a $35 monthly cap on each one-month supply of covered insulin products, eliminating cost sharing for Advisory Committee on Immunization Practices (ACIP)-recommended adult vaccines, and expanding the full LIS subsidy to certain people with limited resources who earnless than 150 percent of the federal poverty level. Our analysis shows that when the full implementation of the Part D drug-related provisions of the IRAthat are modeled in this paper are in effect, it will result in an estimated $7.4 billion reduction in annual out-of-pocket spending for enrollees in 2025. This estimate is conservative, since the inflation rebate and negotiation provisions of the IRA are not modeled in this paper. Across the Medicare Part D population who do not receive LIS, this translates to an average annual savings of $171 per non-LIS enrollee in 2025. Our analyses of out-of- pocket spending over time suggests that there is a subset of enrollees who incur significant financial burden due to out-of-pocket costs. When we examine out-of-pocket savings only among the subset of enrollees with savings, this translates to about $759 saved annually per non-LIS enrollee with savings, which would benefit 8.4 million enrollees. We find that nearly 1.9 million enrollees, consisting mostly of non-LIS enrollees, will save atleast $1,000in out-of-pocket costs. Collectively, these findings suggest that the subset of enrollees who had the highest out-of-pocket spending under the pre-IRA Part D benefit structure are expected to benefit the most from the IRA drug-related provisions modeled in this Report. Our estimate for the number of enrollees who would be impacted by reductions in out-of-pocket drug spending is higher than previous studies that did not account for IRA provisions that both reduce enrollee cost sharing from five percent to zero percent after reaching the catastrophic threshold and lower the catastrophic threshold.1213 As noted above, other aspects of the IRAincluding theinflation rebate cap and negotiationare expected to generate additional out of pocket savings for enrollees and taxpayers. Our estimates do not account for the potential increases in Part D drug accessibility. The IRA's provisions may allow enrollees to obtain drugs that were previously unaffordable to them, allowing them to better manage their health conditions. Future researchshould explore the impact of these and other provisions, such as the IRA's inflation caps on drug prices and Medicare price negotiation of select high-cost drugs. July 2023 RESEARCH REPORT 27 APPENDIX Section A: IRA Simulation Model Estimate Methodology and Assumptions Our simulation model estimated what would have happened to Part D out-of-pocket drug spending under the following IRA provisions, depending on whether they arein effectin 2024 or 2025. Table Al. IRA-Part D Drug Related Provisions Included in the Simulation Model Specification A: Provisions that are Modeled in Specification B: Full set of Provisions Modeled that combination and in effect in Calendar Year 2024 are in effect in Calendar Year 2025 e Enrollee cost sharing (i.e., out-of-pocket spending) is limited to $35 for a month's supply of each covered insulin product and deductibles for covered insulin products are eliminated e Enrollee cost sharing for ACIP- recommended adult vaccines is eliminated e Full LIS assistance is expanded to people with limited resources who earn less than 150 percent of the federal poverty level e Reduction of enrollee coinsurancein the catastrophic coverage phase from five to zeropercent Enrollee cost sharing is limited to $35 for a month's supply of each covered insulin product and deductibles for covered insulin products are eliminated Enrollee cost sharing for ACIP-recommended adult vaccines is eliminated Full LIS assistance is expanded to people with limited resources who earn less than 150 percent of the federal poverty level Reduction of enrollee coinsurancein the catastrophic coverage phase from five to zero percent $2,000 maximum annual out-of-pocket cap for enrollees, beginning in 2025, and indexed to inflation thereafter Elimination of the coverage gap phase and replacement of the coverage gap discount program with the Manufacturer Discount Program; the new Manufacturer Discount Programrequires a 10 percent manufacturer discount on brand drugs in the initial coverage phase and 20 percent in the catastrophic coverage phase Government reinsurance decreases inthe catastrophic coverage phase-from 80% to 20% for brand-name drugs, biologicals, and biosimilars, and from 80% to 40% for generics Notes: Estimates do notinclude non-IRA regulations that may impact drug spending (e.g., Part D regulations requiring that pharmacy price concessions be reflectedatthe point of sale beginningin January 2024). There will be changes to the Part D benefitbetween calendaryears 2024 and 2025. For example, the accumulation of costs for TrOOPis different pre-IRA and in 2025, which is taken into accountin our modeling. ACIP = Advisory Committee on Immunization Practices Our model did not include the estimated effects for all Part D drug related provisions in the IRA, which we expect to impact Part D out-of-pocket spending. For example, we did not model the following provisions: e requiring Medicare to negotiate prices for certain high-expenditure, single source drugs, e implementing Part B and Part D inflation rebates, and July 2023 RESEARCH REPORT 28 e requiring plans to provide their plan enrollees with the option to pay out-of-pocket costs under the plan in monthly amounts that are spread throughout the year. We used data from the Medicare Prescription Drug Event (PDE)file to estimate the total cost associated with prescription drug use by coverage phase nationally and for each state. PDE data for Medicare enrollees in traditional {also known as fee-for-service) and Medicare Advantage plans were used in the analyses. Specifically, we used data for each enrollee in a 10 percent random sample, thus capturing that enrollee's entire history of prescriptiondrug use within the year. We matched the 2021 PDE data with Part D enrollment data to identify enrollees by LIS status, age, gender, race, ethnicity, and state. We fit our simulatedPart D data to 2021 actuals, attempting to simultaneously match on the per-beneficiary out of pocket amounts by state as well as by demographic categories, while also attempting to matchtotals for covered plan paid amounts, reinsurance, and low-income subsidies. To generate the policy impact of the IRA provisions modeled in this paper, we followed a multistep process: e We calculated enroliment and baseline drug costs using the PDE files for 2021. We identified totaland out-of-pocket costs in each individual enrollee's drug claims history observed in the Part D data and summed across all enrollees to generate overall spending estimates, spending estimates by drug payment phase, and spending estimates separately for each state andyear. We allocated cost liabilities by payer. ¢ We inflated the 2021 out-of-pocket amounts to projected 2024 or 2025 values using the statutoryformula for updating the Part D catastrophic threshold, which will continue to apply to the $2,000threshold after 2025. This formula led us to multiply 2021 average out-of-pocket spending per enrollee by an adjustment ratio of about 1.16 for Specification A, which captures the select IRA Part D-related provisions that arein effect in 2024, and 1.21 for Specification B, which captures the selected IRA Part D-related provisions that arein effectin 2025. This information was obtained from the Medicare Trustee's Report, Table IV.B8.25 ¢ We then used our microsimulation model to identify the impact of select provisions of the IRA. We assumed actual 2021 enrollment, plan design, and total drug cost (adjusted for inflation to 2024 and 2025 as above) as in the baseline but applied IRA provisions to each of the 2021 claims depending on when the provisions arein effect (see Table Al). We used the existing PDE data for each enrollee in 2021 to estimate out-of-pocket costs under the IRA drug-related provisions we modeled. e We subtractedthe difference between actual out-of-pocket spending in 2021 projected to 2024 and 2025 levels and out-of-pocket spending projected under the IRA provisions modeled in this Report. Assumptions and Limitations of Modeling Estimates Our simulation model includes a series of assumptions and limitations. The simulation uses utilization of drugs in 2021 as its source of data, but the drug classes that maybe dominant in 2025 is unknown and may change over time. For 2024 and 2025 simulations, we use hypothetical benefit structures as a baseline, which represent what Part D would have looked like in absence of IRA. The baseline TrOOP threshold in 2024 was $8,000and was set toapproximately $8,500in 2025, which is an estimate of what TrOOP would have been if the IRA had not been passed. For 2024, the phase transitions are already defined, and we modified only the benefit structure to change the catastrophicthreshold, as well as applied insulin and vaccine copay limits. For 2025, we must assume what the benefit structure and phase transitions would look like under the previous Part D payment structure (pre-IRA). We applied standard coinsurance at 25 percent and an enrollee premium share of 25.5 percent. July 2023 RESEARCH REPORT 29 Our model of the Part D redesign under the IRA does not fully take into account how manufacturers may respond to provisions of the IRA. For example, our estimates do not capture the potential increases in drug launch prices that manufacturers mayadopt. However, provisions in the IRA aim to limit the ability of manufacturers and plans to raise costs and premiums. Specifically, provisions requiring manufacturers to pay a rebate if drug price increases outpace inflation, requiring Part D plans to increase their share of costs that are above the out-of-pocket spending cap, allowing Medicare to negotiate prices for select drugs, and requiring drug manufacturers to provide a price discount on brand name drugs above the out-of-pocket spending cap all aim to limit increases in drug costs and premiums. Finally, our model does not take into account other federal or state programs that mayreduce spending on Part D drugs." Nor do we account for changes in enrollee behavior as a result of the IRA Part D provisions. * For example, the impacts of the Part D Senior Savings Model (PDSS), which is a voluntary model that tested alternative Part D plan options that offer lower out-of-pocket costs for insulin as supplemental benefits, are not separately accounted for in our modeling. Reductionsin out-of-pocket spending are included onlyin so far as the information is present in the 2021 PDE data. PDSS began January 1, 2021 under the CMS Innovation Center and will end December 31, 2023. July 2023 RESEARCH REPORT 30 Section B: LIS Enrollees and Out-Of-Pocket Spending We examined LIS enrollees' coverage phase at the end of the year and their average out-of-pocket spending in 2022. Theseresults are presentedin Tables B1 and B2. For LIS enrollees, about 2.7 million enrollees reached the catastrophic coverage phase and their average out-of-pocket spending was about $87. There were some differences by age, race/ethnicity, and geographic location. Table B1. Demographic Characteristics of Medicare Part D LIS Enrollees by Coverage Phase, 2022 All Deductible Initial Coverage Coverage Catastrophic Enrollee Characteristics (millions) Phase Phase Gap Phase Phase Total (Nin Millions) 14.9 3.0 6.7 2.4 2.7 Gender Women 8.7 17.1% 46.8% 17.2% 18.9% Men 6.2 25.0% 42.5% 14.8% 17.7% Age <65 6.0 33.6% 34.4% 12.2% 19.8% 65-69 2.9 13.6% 51.5% 16.5% 18.4% 70-74 2.1 11.4% 50.7% 18.7% 19.2% 75-79 1.5 10.0% 51.4% 20.3% 18.3% 80-84 1.1 9.3% 52.7% 21.4% 16.6% 85+ 1.3 10.4% 56.6% 20.7% 12.3% Race & Ethnicity White non-Latino 8.8 18.9% 44.9% 17.1% 19.1% Black non-Latino 3.1 21.1% 45.5% 15.3% 18.1% Latino 1.3 23.1% 46.4% 14.3% 16.2% Asian American 0.8 21.8% 43.3% 16.1% 18.9% American Indian / Alaska 0.1 25.7% 43.0% 14.4% 16.9% Native Other or Unknown 0.8 27.2% 43.5% 13.7% 15.7% Geographic Characteristics Urban 13.2 19.4% 46.4% 14.3% 16.2% Rural 1.1 18.0% 43.3% 16.1% 18.9% Source: Demographic descriptive statistics calculated using the 2022 Medicare Part D Prescription DrugEvent dataand PartD Enrolimentdata. Notes: Percentagesare calculated for each demographic group by row using the total enrollees in each group as the denominator. July 2023 RESEARCH REPORT 31 Table B2. Average Annual Out-Of-Pocket Part D Drug Spending Among LIS Medicare Enrollees by Demographic Characteristics and Coverage Phase by End of Year (2022) Demographic Characteristics Deductible Initial Coverage Coverage Gap Catastrophic All Phase Phase Phase Phase Total $52 $6 $42 $100 $87 Gender Women $56 S7 S44 $102 $86 Men S48 $5 $39 $97 $89 Age <65 $43 $3 S44 $96 $78 65-69 $54 $12 $38 $99 $91 70-74 $60 $14 $42 $102 $95 75-79 $63 $14 $43 $105 $97 80-84 $64 $14 $44 $107 $97 85+ S56 $13 $41 $100 $91 Race & Ethnicity White non-Latino $62 $7 $49 $116 $99 Black non-Latino S44 $6 $36 $84 $75 Latino $32 $6 $26 $65 S61 Asian $32 $7 $26 $57 $55 American Indian/Alaska S50 S7 $44 $98 $90 Native Other or Unknown $32 $5 $27 566 $64 Geographic Characteristics Urban $52 $6 $41 $98 $86 Rural $74 $10 $61 $133 $110 Source: Out-of-pocket spending calculated using the 2022 Medicare Part D Prescription DrugEventdataand PartD Enrollment data. Notes: Average out-of-pocket spending calculated based on the latest phase the enrolleeisin by the end of the yearand includes out-of-pocket spending across all coverage phases. July 2023 RESEARCH REPORT 32 Section C: Out-Of-Pocket Spending for Part D Prescription Drugs Among Medicare Part D enrollees {LIS and non-LIS), thetop 10 Part D drugs ranked by average out-of-pocket spending for these medications among enrollees who reached the catastrophic coverage phase are presented in Table C1. These drugs are takenby at least 10,000 enrollees. Out-of-pocket spending for these drugs ranges from a high of $5,376 for Revlimid, a drug typically used to treat cancer, toa low of $1,910for Nuplazid, a drug usedto treat psychosis. Table C1. Top 10 Part D Drugs Taken by at least 10,000 Enrolleeswho reach the Catastrophic Coverage Phase with Utilization Ranked by Out-Of-Pocket Spending in 2022 Numberof Average OOP Costsfor Biologic General Enrollees Drug per Enrollee Brand Name (Y/N) Indication Most Common Diagnosis Utilizing Drug Using Drug REVLIMID N Oncology Multiple Myelomaor 44,126 $5,376 myelodysplastic syndrome IMBRUVICA N Oncology CLL and NHLs 21,687 $5,366 POMALYST N Oncology Multiple Myeloma 12,416 $5,195 JAKAFI N Oncology Myelodysplastic 15,820 $4,795 syndromes CALQUENCE N Oncology CLL 10,938 54,388 OFEV N Pulmonary Idiopathic pulmonary 19,834 $3,671 fibrosis* XTANDI N Oncology Metastatic Castrate- 15,535 $2,858 resistant Prostate Cancer VENCLEXTA N Oncology CLL 14,549 $2,849 STELARA Y Rheumatology Psoriatic Arthritisand IBD 19,107 $2,137 NUPLAZID N Psychology Psychosis and Parkinson's 13,291 $1,910 Neurology associated psychosis Source: 2022 Medicare Part D Prescription Drug Event data and Part D Enroliment data. Notes: Scripts are ranked by average out-of-pocket spending for each drug. *|diopathic pulmonary fibrosis is a chronic disease that affects the lungs. CLL = Chroniclymphocyticleukemia NHL = Non-Hodgkin lymphoma IBD = Inflammatory bowel disease OOP = Out-Of-Pocket We examined total Part D out-of-pocket spending for enrollees with various auto-immune diseases giventhe high costs of immunosuppressive treatments and the common immunosuppressive therapyregimens across the different conditions. Specifically, we examined out-of-pocket Part D drug spending for enrollees with systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, ulcerative colitis, Crohn's disease, psoriasis and Graves' disease." For non-LIS enrollees, the average out-of-pocket cost per enrollee wagher for men ($1,092) than women ($949) (Table C2). Average out-of-pocket spending per enrollee was relatively similar across age groups, with * Hashimoto's thyroiditis was also included in this population July 2023 RESEARCH REPORT 33 the exception of enrollees who are younger than age 65 and those who are betweenthe ages of 70 - 74; both of these groups had average out-of-pocket spending of about $1,000. Table C2 also shows that about 17 percent of non-LIS enrollees with diseases that require chronic immunosuppressive therapyreached the catastrophic coverage phasein 2022. Additionally, 82,726 enrollees or about 15 percent of non-LIS enrollees paid more thanthe 2025 out-of-pocket cap under the IRA($1662, which is $2000 deflated to 2022 dollars). Table C2. Part D Out-Of-Pocket Spending for Non-LIS Enrollees on Chronic Immunosuppressive Therapies (2022) Percent of Number of Percent of Number of Average Non- . . " Non-LIS LISOOP Enrollees |n. Enrolle:es with Enrollo.tes with Enrollees Spending ($) Catastrophic Spending > Spending > Demographics Coverage Phase $2,000° $2,000° Total 561,721 - 17.0% 82,726 14.7% Gender Women 407,803 $949 15.5% 56,630 13.9% Men or Unknown 153,918 $1,092 21.1% 26,096 17.0% Age <65 69,361 $1,008 17.9% 10,662 15.4% 65-69 154,508 $999 18.2% 22,970 14.9% 70-74 150,026 $1,006 17.9% 22,407 14.9% 75-79 104,261 $988 16.5% 15,211 14.6% 80-84 54,199 $942 14.1% 7,600 14.0% 85-89 21,934 $890 11.9% 2,935 13.4% 90 and older 7,432 $833 9.5% 941 12.7% Race White Non-Latino 486,456 $1,010 16.9% 73,845 15.2% Black 38,514 $746 14.3% 3,445 8.9% Latino 8,381 $566 19.4% 666 7.9% Asian 6,857 $831 16.2% 834 12.2% Al/AN 1,758 $1,800 32.9% 613 34.9% Other 19,755 $1,084 21.8% 3,323 16.8% Source: Demographic descriptive statistics and out-of-pocket spending calculated usingthe 2022 Medicare Part D Prescription Drug Event data and Part D Enrollment data. Notes: *The $2,000 out-of-pocket cap underthe IRA goes into effectin 2025. We deflated this amountto 2022 dollars, which translatesto $1,662in 2022. Estimates are presented for enrollees who exceeded the $2,000cap in 2025. OOP = Out-Of-Pocket Al/AN= AmericanIndian/Alaska Native Out-Of-Pocket Spending for Biologics Table C3 lists the top 10 highest average out-of-pocket cost for non-insulin biologics that are taken by at least 10,000 Medicare Part D enrollees who reach the catastrophic coverage phase. The highest average OOP spending ($2,137 per enrollee) is for Stelara, which is an immune system suppressant often used to treat inflammatory conditions. Most of these non-insulin biologics in Table C3 are similarly usedto treat rheumatologic and inflammatory disease. July 2023 RESEARCH REPORT 34 Table C3. Top 10 Non-insulin Biologics taken by at least 10,000 Medicare Part D Enrollees with the Highest Average Out-Of-Pocket Spending for Each Drug Among Enrollees in the Catastrophic Coverage Phase, 2022 Brand name Average OOP Costs Number of Indication Most Commonly Associated (Drug vs Drug- for Each Drug Per Enrollees Conditions device) Enrollee Using the Using the Drug Drug Stelara(Drug) $2,137 19,107 Rheumatologic: Immune Inflammatory bowel diseases systemsuppressant and psoriatic arthritis Enbrel (Drug) $1,159 10,383 Rheumatologic: Immune Rheumatoid arthritisand systemsuppressant psoriatic arthritis Enbrel Sureclick $882 30,422 Rheumatologic: Immune Rheumatoid arthritis and (Drug-device) system suppressant psoriatic arthritis HumiraPen $823 14,810 Rheumatologic: Immune Rheumatoid arthritisand (Drug-device) system suppressant inflammatory bowel diseases Humira (CF) Pen $729 53,355 Rheumatologic: Immune Rheumatoid arthritis and (Drug-device) system suppressant inflammatory bowel diseases Humira (CF) $689 11,218 Rheumatologic: Immune Rheumatoid arthritisand (Drug) system suppressant inflammatory bowel diseases Dupixent (Drug) $659 34,212 Rheumatologic: Immune Atopic dermatitis or mod- system suppressant severe eczemaand asthma more specific to atopic pathways Kanjinti (Drug) $584 19,779 Oncology: HER2 Breast cancer most targeted therapy for commonly breastcancers Cosentyx Pen* $562 13,220 Rheumatologic: Immune Psoriatic arthritis (Drug-device) system suppressant Repatha $405 51,153 Cardiovascular: Novel Familial Sureclick (Drug- device) targeted therapy for lowering cholesterol hypercholesterolemia or genetically inherited bad cholesterol syndromes Source: Average out-of-pocket costs calculated using the 2022 Medicare Part D Prescription Drug Event dataand PartD Enrollment data. Notes: * Cosentyx pen represents a two-pen product. OOP = Out-Of-Pocket Table C4 presents a list of the five biologics with the top highest average out-of-pocket spending for enrollees reaching the catastrophic coverage phase. Strensiq, a replacement therapyused to treat people with perinatal/infantile- and juvenile-onset hypophosphatasia,* hadthe highest average out-of-pocket spending * Juvenile-onset hypophosphatasiaisa rare inherited condition that affects the bones and may cause low bone mineral density, joint pain, skeletal issues, and other challenges. See here for complete details: Childhood hypophosphatasia - About the Disease - Genetic and Rare Diseases Information Center (nih.gov) July 2023 RESEARCH REPORT 35 among Medicare Part D enrollees (LIS and non-LIS) who ended the year in the catastrophic phasein 2022, These biologics have high out-of-pocket costs, however the absolute number of enrollees taking these medications is small. Table C4. Biologics with the Highest Average Out-Of-Pocket Spending among Medicare Part D Enrollees in Catastrophic Coverage Phase, 2022 Brand Name Number of Enrollees Average OOP Costs for each Drug per Utilizing Drug Enrollee Usingthe Drug Strensiq 164 $39,681 Naglazyme <10 $21,976 Elelyso <10 $20,884 Kalbitor 42 $11,831 Berinert 58 $11,493 Source: Average out-of-pocket costs calculated using the 2022 Medicare Part D Prescription Drug Event dataand PartD Enrollmentdata. OO0P = Out-Of-Pocket July 2023 RESEARCH REPORT 36 Section D: Demographic Characteristics for Enrollees with Projected Savings Our findings show that generally, the share of savings accrue at similar rates across specifications. Enrollees under the age of 65 have savings of about 44 percent in out-of-pocket spending under 2025 IRA provisions. This is consistent with our earlier findings that show this age group has higher out-of-pocket spending than other age groups, likely because they qualify for Medicare based on disability or iliness. Men have slightly more savings than women (about 4 percentage point difference in 2025). Among racialand ethnic groups, Al/AN enrollees have the greatest reduction in out-of-pocket savings in 2025, followed by Latinos enrollees. As expected, non-LIS enrollees have greater relative reduction in out-of-pocket spending compared to LIS enrollees. Enrollees in rural and urban areas have similar reductions in out-of-pocket spending. Results also show that enrollees with HIV are expected to have the largest reduction in out-of-pocket spending (69 percent), followed by enrollees who use insulin long-term (63 percent), and enrollees with rheumatic disorders (44 percent). Table D1. Projected Annual Average Out-Of-Pocket Savings by Demographic Characteristics, by Specification Specification A: 2024 Specification B: 2025 Demographic Characteristics Policy Impact Percent Change? Policy Impact PercentChange? Age <65 -S81 -31% -$121 -44% 65-69 -569 -16% -$138 -30% 70-74 -$72 -14% -$156 -29% 75-79 571 -13% -$167 -28% 80-84 -562 -11% -$159 -27% 85-89 -548 -9% -$136 -24% 90+ -$27 -6% -595 -20% Gender Women -562 -14% -$128 -28% Men -578 -16% -5165 -32% Race White -$71 -14% -$155 -29% Black -$70 -23% -$112 -36% Latinos -$51 -31% -$70 -40% Asian -$49 -21% -$82 -33% American Indian/Alaskan Native -$90 -24% -$161 -41% Other -$62 -16% -$126 -31% LIS Status Non-LIS -$70 -11% -$171 -27% LIS -$67 -82% -$72 -84% Geography Urban-Rural -S69 -15% -$144 -30% Rural -$74 -16% -$145 -30% Health Care Characteristics HIV -$576 -45% -$925 -69% Non-HIV -567 -14% -$140 -29% July 2023 RESEARCH REPORT 37 Long-term Insulin User Non-long-term Insulin User Rheumatic Disorders Non-Rheumatic Disorder -$533 -561 -$221 -566 -46% -13% -25% -15% -$767 -63% -$133 -28% -$405 -44% -$139 -29% Source: ASPE Part D Simulation Model Notes: 2Percent change is calculated relative to baseline out-of-pocket spending. Specification A presents estimates in 2024 dollars and Specification B presents estimates in 2025 dollars. July 2023 RESEARCH REPORT 38 REFERENCES ! Tarazi, W., Finegold, K., Sheingold, S., De Lew, N., and Sommers, BD. Prescription Drug Affordability among Medicare Beneficiaries (Issue Brief No. HP-2022-03). Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. January 2022. https://aspe.hhs.gov/reports/medicare-prescription-drugs 2 The White House Briefing Room. BY THE NUMBERS: The Inflation Reduction Act (08-2022). The W hite House, August 2022. 3 Tarazi, W., Welch, WP., Nguyen, N., Bosworth, A., Sheingold, S., De Lew, N., and Sommers, BD. Medicare Beneficiary Enrollment Trends and Demographic Characteristics. (Issue BriefNo. HP2022-08). Office of the Assistant Secretaryfor Planning and Evaluation, U.S. Department of Healthand Human Services. March 2022. medicare-beneficiary-enrollment- ib.pdf (hhs.gov) 4 Centers for Medicare and Medicaid Services. (2023). Medicare Monthly Enroliment. Retrieved from: Medicare Monthly Enrollment - Centers for Medicare & Medicaid Services Data (cms.gov). 5 Tarazi, W., Welch, WP., Nguyen, N., Bosworth, A., Sheingold, S., De Lew, N., and Sommers, BD. Medicare Beneficiary Enrollment Trends and Demographic Characteristics. (Issue BriefNo. HP2022-08). Office of the Assistant Secretaryfor Planning and Evaluation, U.S. Department of Healthand Human Services. March 2022. medicare-beneficiary-enrollment- ib.pdf (hhs.gov) 6 Trish, E., Xu, J., & Joyce, G. (2018). Growing number of unsubsidized part D beneficiaries with catastrophic spending suggests need foran out-of-pocket cap. Health Affairs, 37(7), 1048-1056. https://doi.org/10.1377 /hithaff.2018.0006 7 Tarazi, W., Finegold, K., Sheingold, S., De Lew, N., and Sommers, BD. Prescription Drug Affordability among Medicare Beneficiaries (Issue Brief No. HP-2022-03). Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. January 2022. prescription-drug-affordability.pdf(hhs.gov] 8 Tarazi, W., Finegold, K., Sheingold, S., De Lew, N., and Sommers, BD. Prescription Drug Affordability among Medicare Beneficiaries (Issue Brief No. HP-2022-03). Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. January 202 2. prescription-drug-affordability.pdf(hhs.gov 9 Tarazi, W., Finegold, K., Sheingold, S., De Lew, N., and Sommers, BD. Prescription Drug Affordability among Medicare Beneficiaries (Issue Brief No. HP-2022-03). Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. January 2022. prescription-drug-affordability.pdf(hhs.gov) 18 Taylor S. 1. (2020). The High Cost of Diabetes Drugs: Disparate Impact on the Most Vulnerable Patients. Digbetes care, 43(10),2330-2332. https://doi.org/10.2337/dci20-0039 11 Nasir, K. (2019, November 25). High out-of-pocket costs can make lifesaving medications out of reach for millions of Americanswith cardiovascular disease. American Heart Association. https://newsroom.heart.org/news/high-out-of- pocket-costs-can-make-lifesaving-medications-out-of-re ach-for-millions-of-americans-with-cardiovascular-disease 2 Chen, B.K., Yang, Y. T., & Bennett, C.L.(2018). Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court's Recent Rulings do not Solve Fundamental Barriers to Competition. Drugs, 78(17), 1777-1781. https://doi.org/10.1007/s40265-018-1009-0 13 Hamel, L., Lopes, L., Kirzinger, A., Sparks, G., Kearney, A., Stokes, M., Brodie, M. (2022) Public Opinionon Prescription Drugs and Their Prices. KFF. https://www.kff.org/health-costs/poll-finding/public-opinion-on-prescription-drugs-and- their-prices/ 14 Cubanski, J., & Damico, A. (2022, August 17). Key facts about Medicare part D enrollment and costs in 2022. KFF. https: //www.kff.org/medicare/issue-brief/key-facts-about-medicare-part-d-enrollment-and-costs-in- 2022 /#:~text=Nearly%206 %20in%2010%20beneficiaries,Income%20Subsidy%20(LIS) %20 program 15 Cubanski, J.,, Neuman, T., Damico, A.{(2021). Millions of Medicare Part D Enrollees Have Had Out-of-Pocket Drug Spending Above the Catastrophic Threshold Over Time. KFF. https://www.kff.org/medicare fissue-brief/millions-of- medicare-part-d-enrollees-have-had-out-of-pocket-drug-spending-above-the-catastrophic-threshold-over- time/#:~:text=In%202019%20alone%2C%20the%201.5 the%20vear%20(%243.8 %20billion). 16 Sen, A. P., Parasrampuria, S., Anderson, K. E., & Anderson, G. (2020, September 17). Catastrophic coverage in the Medicare Part D drug benefit: Which beneficiaries need itand how much are they spending ?. Commonwealth Fund. July 2023 RESEARCH REPORT 39 https://www.commonwealthfund.or benefit#l 17 Center for Medicare & Medicaid Services. (2022). Inflation Reduction Act: CMS Implementation Timeline. CMS. https://www.cms.gov/files/document/10522-inflation-reduction-act-timeline. pdf 18 Anderson-Cook, A., Jones, E., Noda, A., & Miller, M. E. (2022). What's drivingup Medicare part D costs? High brand- name drug netprices and a shift to high-cost specialty drugs. Health Affairs Forefront. https://doi.org/10.1377/forefront.20220418.919082 19 Anderson-Cook, A., Jones, E., Noda, A., & Miller, M. E. (2022). What's drivingup Medicare part D costs? High brand- name drug net prices and a shift to high-cost specialty drugs. Health Affairs Forefront. https://doi.org/10.1377/forefront.20220418.919082 20 Anderson-Cook, A., Jones, E., Noda, A., Miller, M. (2022). What's Driving Up Medicare Part D Costs? High Brand-Name Drug Net Prices And A Shift To High-Cost Specialty Drugs. Health Affairs Forefront. https: //www healthaffairs. ora/conten t/forefront/s driving-up-medicare-part-d-costs-high-brand-name-drug-net-prices- 2lKoma, W., Neuman, T., Jacobson, G., & Smith, K. (2020, April 24). Medicare beneficiaries flnanCIaIsecurlty before the coronavirus pandemic. Kaiser Family Foundation. Retrieved from: https://www.kff.org/medicare/issue-brief/medicare- beneficiaries-financial-security-before-the-coronavirus-pandemic/ 22 Congressional Budget Office. (2011). Spending Patternsfor Prescription Drugs Under Medicare Part D. Congressional Budget Office Publication42633. https.//www.cbo.qov/publication/42633 2 Nguyen X. Nguyen, T. Anders Olsen, Steven H. Sheingold, and Nancy Delew. Medicare Part B Drugs: Trendsin Spending and Utilization, 2008-2021. Washington, DC: Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and HumanServices. June, 2023. 24 Nguyen X.Nguyen, T. Anders Olsen, Steven H. Sheingold, and Nancy Delew. Medicare Part B Drugs: Trendsin Spending and Utilization, 2008-2021. Washington, DC: Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and HumanServices. June, 2023, 25 The Board of Trustees, Federal Hospital Insurance, and Federal Supplementary Medical Insurance Trust Funds. (2022). Retrievedfrom: 2022 Medicare TrusteesReport (cms.gov). July 2023 RESEARCH REPORT 40 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Assistant Secretaryfor Planning and Evaluation 200 Independence Avenue SW, Mailstop 447D Washington, D.C. 20201 For more ASPE briefs and other publications, visit: aspe.hhs.gov/reports D40 [=] ABOUTTHE AUTHORS Bisma A. Sayed is an Economist in the Office of Health Policy in ASPE. Kenneth Finegold is a Senior Social Science Analystin the Office of Health Policy in ASPE. T. Anders Olsen is an Oak Ridge Institute for Science and Education (ORISE) Fellow in the Office of Health Policy in ASPE. Kaavya Ashok was a graduate internin the Office of Health Policy in ASPE. Sarah Schutz is an Oak Ridge Institute for Science and Education (ORISE) Fellow in the Office of Health Policyin ASPE. Steven Sheingoldis the Director of the Division of Health Care Financing Policyfor the Office of Health Policyin ASPE. Nancy De Lew is the Acting DeputyAssistant Secretary for Health Policyin ASPE. Benjamin D.Sommers is Senior Counselor at ASPE. The authors are grateful for the contributions of Acumen, LLCstaff to the CMS Medicare data analysis and the simulationmodel. The statements expressedin this Issue Brief do not necessarilyreflect the views of Acumen, LLC. SUGGESTED CITATION Sayed, BA, Finegold, K, Olsen, TA, Ashok, K, Schutz, S, Sheingold, S, De Lew, N, Sommers, BD. Inflation Reduction Act Research Series: Medicare Part D Enrollee Out-Of-Pocket Spending: Recent Trends and Projected Impacts of the Inflation Reduction Act. (Issue Brief No. HP-2023-19). Office of the Assistant Secretaryfor Planning and Evaluation, U.S. Department of Healthand Human Services. July 2023 COPYRIGHTINFORMATION All material appearingin thisreportisin the publicdomainand may be reproduced or copied without permission; citationas to source, however, is appreciated. DISCLOSURE This communication was printed, published, or producedand disseminated at U.S. taxpayer expense. Subscribe to ASPE mailing list to receive email updates on new publications: https://list.nih.gov/cgi-bin/wa.exe?SUBED1=ASPE-HEALTH-POLICY&A=1 For general questions or general information about ASPE: aspe.hhs.gov/about July 2023 RESEARCH REPORT 41