Medicare Prescription Drug Research Articles

Factors associated with new-onset of mental health disorders in Bell's palsy patients: A MarketScan database study

ObjectiveLimited research exists on mental health disorders (MHDs) in Bell's palsy patients. This study investigates risk factors associated with the development of MHDs in these patients. MethodsMarketScan commercial and Medicare outpatient and prescription drug claims data were utilized to conduct this study on adults with Bell's palsy. Patients were identified using International Classification of Diseases, Ninth or Tenth Revision, Clinical Modification diagnosis codes from 2014 to 2020 data. A one-year washout period was applied where patients did not have any diagnosis of MHD before Bell's palsy diagnosis. Patients were included if they were continuously enrolled for at least two years. The primary outcome was new-onset of any MHDs within one year of diagnosis of Bell's palsy. Descriptive statistics and logistic regression model explored risk factors associated with the development of any MHDs. ResultsOut of 37,166 Bell's palsy patients (mean age 49; 50.4 % female), 8.27 % experienced new-onset MHDs, with anxiety being the most prevalent (3.88 %). Female sex [Adjusted odds ratio (AOR) 1.40, 95 % CI 1.30–1.51, p < 0.0001], increasing Charlson comorbidity index (AOR 1.11, 95 % CI 1.04–1.176, p = 0.001), and symptoms like headache (AOR 1.16, 95 % CI 1.34–1.81, p < 0.0001) and facial pain (AOR 1.71, 95 % CI 1.15–2.52, p = 0.007) were associated with increased odds of new-onset of MHDs. ConclusionBell's palsy patients can develop MHDs within first year of diagnosis, although the incidence of MHDs in this cohort is lower than that of the general population. Several factors are associated with the development of MHDs. These findings underscore the significance of addressing mental health in Bell's palsy patients, offering valuable considerations for clinical care and future research.

Herpes zoster vaccination among Medicare beneficiaries with and without prescription drug coverage

IntroductionThe Inflation Reduction Act (IRA) eliminated cost sharing for Medicare Part D-covered vaccines but did not address the cost burden faced by Medicare beneficiaries who did not have prescription drug coverage. This study aimed to determine the characteristics of beneficiaries without prescription drug coverage and to assess the association between the receipt of a herpes zoster vaccine and prescription drug coverage status. MethodsWe used the 2019–2023 National Health Interview Survey and included Medicare beneficiaries aged 65 years and older who enrolled in both Parts A and B or a Medicare Advantage plan. Descriptive statistics were used to examine beneficiaries' characteristics. Logistic regressions were used to examine the associations between the receipt of a herpes zoster vaccine and Medicare prescription drug coverage. ResultsThe study included 33,578 beneficiaries and 93.5 % of beneficiaries had prescription drug coverage. The prevalence of lacking prescription drug coverage was higher among beneficiaries who did not have a college degree, had family income below the poverty level, had no flu shot and well visit within the past year, and had no usual place for care. The probability of receiving a herpes zoster vaccine was higher among beneficiaries with prescription drug coverage than those without prescription coverage (45.2 % versus 25.3 %). ConclusionsHerpes zoster vaccination disparities between beneficiaries with and without prescription drug coverage existed before the IRA. Because the IRA only addresses the cost barrier facing by beneficiaries with prescription drug coverage, vaccination disparities was greater after the IRA implementation.

Assessing the utilization of Current Procedural Terminology codes in pharmacists' services using MarketScan data.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. The Medicare Prescription Drug, Improvement, and Modernization Act and Centers for Medicare and Medicaid Services affirmation enabled pharmacists to use Current Procedural Terminology (CPT) codes for documentation and billing of clinical services. Despite legislative support and potential availability of pharmacists' clinical services, a gap may exist between the reported availability and actual prevalence of these services in real-world settings. The objective was to assess the prevalence of selected CPT codes (99605-99607, 98966-989968, and 99211-99215) in documenting and billing potential pharmacists' clinical services using recent available data. This retrospective study utilized the Merative MarketScan Medicare database from the period January 1, 2016, to December 31, 2020. The dataset included deidentified patient information and CPT codes. Patients with CPT codes for face-to-face medication therapy management (MTM) services (99605-99607), codes for telephonic assessment and management (A/M) services (98966-98968), and/or codes for evaluation and management (E/M) services (99211-99215) were identified from outpatient claims. Descriptive statistics, including prevalence rates, were calculated. This study was approved by an institutional review board and followed STROBE guidelines. There were claims data for 2,784,629 enrollees from 2016 through 2020. Prevalence rates varied during this period, with lower rates for MTM face-to-face CPT codes (0.06%) and telephonic A/M codes (0.58%), while E/M CPT codes showed higher prevalence rates (87%). Study findings exhibited a limited adoption rate for MTM CPT codes for billing pharmacists' clinical services. Future research may focus on assessing pharmacists' perceptions and identifying facilitators and barriers to using CPT codes in billing clinical services.

Disparities in the utilization of supportive care medications among older adults with metastatic pancreatic ductal adenocarcinoma.

51 Background: Inequities in cancer care delivery can profoundly affect access to high-quality treatments and patient outcomes. Supportive care medication use is important for preserving quality of life in older adults with metastatic pancreatic ductal adenocarcinoma (PDAC). Whether there are differences in supportive care medication use by race and sex is unknown. Our objectives were to assess the racial/ethnic and biological sex inequities in use of treatments for pain, depression, and pancreatic insufficiency-related treatments (PERT) among older adults with PDAC. Methods: We used the Surveillance, Epidemiology, and End Results-Medicare linked database, to identify Medicare beneficiaries aged 65 and older diagnosed with metastatic PDAC from January 2008 to December 2019. We included those continuously enrolled in Medicare prescription drug benefits in the 6 months before and month of diagnosis. Any use of opioid pain medications, antidepressants, and PERT was identified from diagnosis to the end of the study period (at death, disenrollment, or 12 months). Multivariable regression was used to compare supportive care medications use by racial/ethnic and biological sex groups. Results: There were 29,509 individuals in our sample, with12.9% Black patients, 3.9% Hispanic patients, and 83.2% White patients. The mean age was 76.5 (SD: 7.4) years. Mean follow-up time was 135.4 (SD:117.7) days overall, with the shortest follow-up among Black patients 124 (SD:111.1) days and longest for White patients 137.5 (SD: 118.8) days. Antidepressants were used by 23.8%, opioids by 60.3%, and PERT by 12.4% overall. Within race groups there were limited differences in medication use by sex. However, we observed differences in supportive care treatment use by race and ethnicity. Specifically, relative to White individuals, those who identified as Black were 20% less likely (adjusted risk ratio [aRR]: 0.8, 95% CI:0.74-0.85) to receive antidepressants, 14% less likely to receive opioids (aRR: 0.86, 95% CI:0.84-0.89), and 41% less likely to receive PERT (aRR: 0.59, 95% CI:0.53-0.65). Similar patterns were observed for patients of Hispanic ethnicity, with those individuals being 12% less likely (adjusted risk ratio[aRR]: 0.88, 95% CI:0.89-0.98) to receive antidepressants, 9% less likely to receive opioids (aRR: 0.91, 95% CI:0.87-0.96), and 42% less likely to receive PERT (aRR: 0.58, 95% CI:0.47-0.70). Conclusions: Our preliminary data showed differences in the uptake of supportive care drugs among Black and Hispanic patients relative to White patients. Specifically, these individuals were less likely to start opioid pain medications, antidepressants, and pancreatic enzyme replacement therapy compared to their White counterparts. These findings highlight potential gaps in treatment use that may better support patients facing life-limiting illnesses.

Adherence and persistence to tafamidis treatment among Medicare beneficiaries in the presence of a patient assistance program

Tafamidis is the only disease-modifying therapy approved to treat patients in the United States with transthyretin amyloid cardiomyopathy (ATTR-CM), which most commonly affects patients aged ≥ 65 years. The manufacturer operates a patient assistance program (PAP) to support access to tafamidis. This study conducted Privacy Preserving Record Linking (PPRL) using Datavant tokens to match patients across Medicare prescription drug plan (PDP) and PAP databases to evaluate the impact of PAPs on treatment exposure classification, adherence, and persistence determined using Medicare PDP data alone. We found 35% of Medicare PDP patients received tafamidis through the PAP only; 14% through both Medicare PDP and the PAP, and 51% through Medicare PDP only. Adherence and persistence were comparable between these cohorts but underestimated among patients who received ≥ 2 prescriptions through Medicare PDP and ≥ 1 through the PAP when solely using Medicare data versus pooled Medicare and PAP data (modified Medication Possession Ratio: 84% [69% ≥ 80% adherent] vs. 96% [93%]; Proportion of Days Covered: 77% [66% ≥ 80% adherent] vs. 88% [88%]; mean days to discontinuation: 186 vs. 252; total discontinuation: 13% vs. 11%). Cross-database PPRL is a valuable method to build more complete treatment journeys and reduce the risk of exposure misclassification in real-world analyses.

The Health Costs of Cost Sharing.

What happens when patients suddenly stop their medications? We study the health consequences of drug interruptions caused by large, abrupt, and arbitrary changes in price. Medicare's prescription drug benefit as-if-randomly assigns 65-year-olds a drug budget as a function of their birth month, beyond which out-of-pocket costs suddenly increase. Those facing smaller budgets consume fewer drugs and die more: mortality increases 0.0164 percentage points per month (13.9%) for each $100 per month budget decrease (24.4%). This estimate is robust to a range of falsification checks and lies in the 97.8th percentile of 544 placebo estimates from similar populations that lack the same idiosyncratic budget policy. Several facts help make sense of this large effect. First, patients stop taking drugs that are both high value and suspected to cause life-threatening withdrawal syndromes when stopped. Second, using machine learning, we identify patients at the highest risk of drug-preventable adverse events. Contrary to the predictions of standard economic models, high-risk patients (e.g., those most likely to have a heart attack) cut back more than low-risk patients on exactly those drugs that would benefit them the most (e.g., statins). Finally, patients appear unaware of these risks. In a survey of 65-year-olds, only one-third believe that stopping their drugs for up to a month could have any serious consequences. We conclude that far from curbing waste, cost sharing is itself highly inefficient, resulting in missed opportunities to buy health at very low cost ($11,321 per life-year).

Restrictiveness of Medicare Advantage provider networks across physician specialties.

The objective was to measure specialty provider networks in Medicare Advantage (MA) and examine associations with market factors. We relied on traditional Medicare (TM) and MA prescription drug event data from 2011 to 2017 for all Medicare beneficiaries in the United States as well as data from the Area Health Resources File. Relying on a recently developed and validated prediction model, we calculated the provider network restrictiveness of MA contracts for nine high-prescribing specialties. We characterized network restrictiveness through an observed-to-expected ratio, calculated as the number of unique providers seen by MA beneficiaries divided by the number expected based on the prediction model. We assessed the relationship between network restrictiveness and market factors across specialties with multivariable linear regression. Prescription drug event data for a 20% random sample of beneficiaries enrolled in prescription drug coverage from 2011 to 2017. Provider networks in MA varied in restrictiveness. OB-Gynecology was the most restrictive with enrollees seeing 34.5% (95% CI: 34.3%-34.7%) as many providers as they would absent network restrictions; cardiology was the least restrictive with enrollees seeing 58.6% (95% CI: 58.4%-58.8%) as many providers as they otherwise would. Factors associated with less restrictive networks included the county-level TM average hierarchical condition category score (0.06; 95% CI: 0.04-0.07), the county-level number of doctors per 1000 population (0.04; 95% CI: 0.02-0.05), the natural log of local median household income (0.03; 95% CI: 0.007-0.05), and the parent company's market share in the county (0.16; 95% CI: 0.13-0.18). Rurality was a major predictor of more restrictive networks (-0.28; 95% CI: -0.32 to -0.24). Our findings suggest that rural beneficiaries may face disproportionately reduced access in these networks and that efforts to improve access should vary by specialty.

Medicare Part B and Part D drug eligibility for center for Medicare and Medicaid Services price negotiation under the Inflation Reduction Act: estimates using 2016-2019 data.

To reduce Medicare prescription drug expenditures, the 2022 Inflation Reduction Act (IRA) allows the Centers for Medicare & Medicaid Services (CMS) to directly negotiate with drug manufacturers on Medicare prices of high-expenditure drugs (≥$200m annual spending) which meet certain eligibility criteria. However, it is unclear what proportion of high-expenditure drugs covered by Medicare, and attributable annual drug spending, would typically be eligible for CMS negotiations in a given year. We used historical Medicare drug spending data to determine how many high-expenditure drugs, and attributable drug spending, would have been eligible for CMS negotiations had the IRA been in effect from 2016-2019, while also determining which of the IRA's eligibility criteria is most restrictive. From 2016-2019, approximately one third (33.3% for Part B, 32.4% for Part D) of high-expenditure Medicare drugs would have been eligible for negotiation, with ineligible drugs accounting for 75.2% and 63.8% of spending on high-expenditure drugs in Medicare Part B and D, respectively. Most ineligible high-expenditure drugs were ineligible because they launched too recently. From 2016-2019, between 59 and 74 high-expenditure drugs were eligible per year, indicating that in some years there may not be enough eligible drugs for CMS to negotiate on the maximum number of drugs allowable by law. The IRA's current eligibility criteria may restrict CMS from being able to negotiate drug prices on approximately two-thirds of the high-expenditure drugs covered by Medicare and may not allow CMS to negotiate on the maximum number of drugs allowable by law. Congress could consider relaxing eligibility requirements for price negotiation, such as those pertaining to launch date recency, to ensure there are a sufficient number of high-expenditure drugs eligible for negotiation or make certain ineligible drugs contributing to significant annual Medicare spending eligible for negotiation on a case-by-case basis.

THE IMPACT OF CLOSING MEDICARE PART D COVERAGE GAP ON MENTAL HEALTH OF OLDER ADULTS

Abstract The ACA mandated the gradual elimination of the Medicare prescription drug coverage gap (also called the “Doughnut Hole”) beginning in 2011. This policy change can impact mental health through mechanisms such as reduction in out-of-pocket (OOP) expenses and increased access to prescription medication. However, no previous study has examined its impact on mental health outcomes of older adults on Medicare. Employing data from the Medical Expenditure Panel Survey (from 2006 to 2016), compare the mental health of Medicare beneficiaries (66-70 years; N=7,664) with that of non-Medicare beneficiaries (60-64 years; N=8,079) before versus after policy implementation. We find that the 2011 phasing out of Medicare drug coverage gap was associated with 0.86-point (p&amp;lt; 0.05) improvement in the Mental Component score of the Short-Form 12 Health Survey among beneficiaries. Our analysis was robust to using alternate measures of mental health outcomes (Kessler Index and PHQ-2) as well as to an alternate construction of treatment and control groups (comparing individuals aged 60-70 years on Medicare and private insurance). We find no detectable differences in the mental health of Medicare beneficiaries who already receive subsidies for costs associated with the coverage gap through the Low Income Subsidy (LIS) program. Further, we find that elimination of the doughnut hole reduced OOP expenses by $32.65 among Medicare beneficiaries in our sample. Overall, our results for mental health and OOP expenses are mainly attributable to women. This evidence highlights indirect effects of drug coverage gap elimination on mental health outcomes among Medicare beneficiaries.

Analyzing Access and Costs of Oral Medications for Overactive Bladder: Uncovering Disparities

To report out-of-pocket costs associated with overactive bladder (OAB) medications among Medicare beneficiaries and the uninsured. We performed a cross-sectional analysis of the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary Data (Q1-2022). FDA-approved medications for OAB were identified. We calculated out-of-pocket costs for Medicare beneficiaries in each Part D prescription benefit phase, average retail price, total yearly costs and discounted prices through cash-pay discount coupons (GoodRx) or online pharmacies like Mark Cuban Cost Plus Drug Company (MCCPDC). We also report plan utilization management requirements. We analyzed 5721 plan formularies for 18 medications. Mirabegron was the only beta-3 agonist (B3). Only Vesicare oral solution (14.3% of plans) and Mirabegron (0.1%) required prior authorization. Many plans required step therapy for selective generic anticholinergics (ACH) (12.4%-43.3%), while the B3 rarely required step therapy (0.6%). Monthly costs varied by coverage phase and averaged $59 for ACHs in the initial coverage phase ($14 in catastrophic; $72 in coverage gap). The monthly cost for the B3 averaged $47 in the initial coverage phase ($26 in catastrophic; $129 in coverage gap). The total yearly cost for generic ACHs ranged from $494 (oxybutynin IR) to $1452 (darifenacin) and the yearly cost for brand-name ACHs ranged from $1175 (Toviaz ER) to $2198 (Oxytrol). The total yearly cost for the B3 was $1283. We evaluated coverage, out-of-pocket costs, total yearly costs, and utilization management for OAB medications to make pricing more transparent. While selective medications may be "covered," coverage does not translate into affordable drug prices.

Estimating the Impact of the Inflation Reduction Act on the Out-of-pocket Costs for Medicare Beneficiaries With Advanced Prostate Cancer.

Combination systemic therapy for advanced prostate cancer has reduced mortality, but high out-of-pocket costs impose financial barriers for patients. The Inflation Reduction Act's $2,000 out-of-pocket spending cap for Medicare's prescription drug benefit (Part D) can potentially lower out-of-pocket spending for beneficiaries starting in 2025. This study aims to compare out-of-pocket spending for commonly prescribed regimens for advanced prostate cancer before and after implementation of the Inflation Reduction Act. Medication regimens constructed to treat metastatic, hormone-sensitive prostate cancer consisted of baseline androgen deprivation therapy with traditional chemotherapy, androgen receptor inhibitors, and androgen biosynthesis inhibitors. Using 2023 Medicare Part B prices and the Medicare Part D plan finder, we estimated annual out-of-pocket costs under current law and under the Inflation Reduction Act's redesigned standard Part D benefit. Under current law, out-of-pocket costs for Part D drugs ranged from $464 to $11,336 per year. Under the Inflation Reduction Act, annual out-of-pocket costs for 2 regimens remained unchanged: androgen deprivation therapy with docetaxel and androgen deprivation therapy with abiraterone and prednisone. However, out-of-pocket costs for regimens using branded novel hormonal therapy were significantly lower under the 2025 law with potential savings estimated to be $9,336 (79.2%) for apalutamide, $9,036 (78.7%) for enzalutamide, and $8,480 (76.5%) for docetaxel and darolutamide. The $2,000 spending cap introduced by the Inflation Reduction Act may significantly decrease out-of-pocket costs and reduce financial toxicity associated with advanced prostate cancer treatment, impacting an estimated 25,000 Medicare beneficiaries.

Insertable Cardiac Monitoring Results in Higher Rates of Atrial Fibrillation Diagnosis and Oral Anticoagulation Prescription after Ischaemic Stroke.

After an ischaemic stroke, atrial fibrillation (AF) detection allows for improved secondary prevention strategies. This study aimed to compare AF detection and oral anticoagulant (OAC) initiation in patients with an insertable cardiac monitor (ICM) versus external cardiac monitor (ECM) after ischaemic stroke. Medicare Fee-for-Service (FFS) insurance claims and Abbott Labs device registration data were used to identify patients hospitalized with an ischaemic stroke in 2017-2019 who received an ICM or ECM within three months. Patients with continuous Medicare FFS insurance and prescription drug enrolment in the prior year were included. Patients with prior AF, atrial flutter, cardiac devices, or OAC were excluded. ICM and ECM patients were propensity score matched 1:4 on demographics, comorbidities, and stroke hospitalization characteristics. The outcomes of interest were AF detection and OAC initiation evaluated with Kaplan-Meier and Cox proportional hazard regression analyses. A total of 5,702 Medicare beneficiaries (ICM, n=444; ECM, n=5,258) met inclusion criteria. The matched cohort consisted of 2,210 Medicare beneficiaries (ICM, n=442; ECM, n=1,768) with 53% female, mean age 75 years, and mean CHA₂DS₂-VASc score 4.6 (1.6). ICM use was associated with a higher probability of AF detection (hazard ratio (HR) 2.88, 95% confidence interval (CI) [2.31, 3.59]) and OAC initiation (HR 2.91, CI [2.28, 3.72]) compared to patients monitored only with ECM. Patients with an ischaemic stroke monitored with an ICM were almost 3 times more likely to be diagnosed with AF and to be prescribed OAC compared to patients who received ECM only.

Identifying the impact of health insurance on subgroups with changing rates of diagnosis.

Expanded access to health care often leads to new diagnoses for previously undetected conditions. New diagnoses make it difficult to identify the causal effect of expanding health insurance on individuals with particular diagnoses: the newly diagnosed in the treatment group are likely to differ in unobserved ways from the control group. This paper provides two methods for dealing with this problem depending on the data available to the researcher and diagnosis-specific knowledge. If there is no panel dimension to the data, then the causal effect for the subgroup of interest can be bounded from either above or below depending on the condition in question. If panel data are available, then the newly diagnosed can be identified, and their treated outcomes subtracted from the overall effect of interest. I apply these methods to find that the difference-in-discontinuities estimator underestimates the effect of Medicare prescription drug coverage on the uptake of insulin by first-time users by 20%.

HPR34 Impact of the Inflation Reduction Act on Pricing, Reimbursement, and Market Access in the US

The Inflation Reduction Act (IRA), passed in late 2022, includes several provisions to lower Medicare prescription drug costs and federal government drug spending. The bill is expected to have significant repercussions in the pharmaceutical industry.

CMS Finalizes New Medicare Advantage Prior Authorization Rule

CMS Finalizes New Medicare Advantage Prior Authorization Rule

Examining Opportunities to Increase Savings From Medicare Price Negotiations

Allowing the US Centers for Medicare & Medicaid Services to negotiate prescription drug prices for Medicare may improve drug affordability. To estimate savings from Medicare price negotiation under the Inflation Reduction Act (IRA) and examine opportunities to increase savings. This cross-sectional, population-based study used data from 2020 Medicare prescription drug claims. The study was conducted and data were analyzed in 2022. Eligibility for Medicare price negotiation under the IRA and alternative criteria. Minimum savings under the IRA's eligibility criteria were estimated and compared with savings within alternative scenarios, including (1) selecting drugs for negotiation based on net spending after rebates rather than gross spending; (2) extending eligibility to drugs with biosimilar or generic competitors; (3) reducing the minimum years since US Food and Drug Administration approval for eligibility; and (4) changing 2 or 3 of these factors. Estimated savings were calculated at different levels of scale-up of price negotiation under the IRA, from 10 Part D drugs in 2026 to 60 Part B and D drugs in 2029. Gross spending was calculated using the US Centers for Medicare & Medicaid Services 2020 Medicare drug spending dashboard. Rebates were estimated using SSR Health data. Information on FDA approvals, generics, and biosimilars was obtained from FDA websites. Under IRA rules, estimated minimum savings from price negotiation in 2026 for 10 Part D drugs would be $3.2 billion. For 2029 for 60 Part D and B drugs, estimated savings were $16.0 billion. Selecting drugs for negotiation based on net rather than gross spending would be associated with estimated savings of $4.6 billion (a 45% increase) in 2026 and $18.9 billion (an 18% increase) in 2029. Including drugs with generic competitors or biosimilars would be associated with an estimated savings of $6.6 billion (a 109% increase) in 2026 and $24.9 billion (a 56% increase) in 2029. Making both changes would be associated with savings of $9.5 billion (a 200% increase) in 2026 and $28.3 billion (a 77% increase) in 2029. A sensitivity analysis suggested that reducing the required number of years since marketing approval by 2 years would be associated with increased estimated savings of 4% when 10 Part D drugs are negotiated and 12% when 60 Part D and B drugs are negotiated. Changing all 3 criteria would be associated with the greatest increase in estimated savings in 2029 (119% increase when 10 Part D drugs are negotiated and 93% increase for 60 Part D and B drugs). The results of this cross-sectional study suggest that adjusting the eligibility criteria for Medicare prescription drug price negotiation to permit inclusion of drugs with biosimilar or generic competitors and selecting drugs based on net rather than gross spending may be a promising approach to substantially increase estimated savings.

Statins in Kidney Transplant Recipients: Usage, All-Cause Mortality, and Interactions with Maintenance Immunosuppressive Agents.

Cardiovascular diseases account for 32% of deaths among kidney transplant recipients. Statin therapy is common in this population. However, its effect on mortality prevention remains unclear among kidney transplant recipients, whose clinical risk profile might be unique because of concomitant immunosuppressive therapy. In this national study of 58,264 single-kidney transplant recipients, statin use was associated with a 5% decrease in mortality. More importantly, this protective association was stronger among those who used a mammalian target of rapamycin (mTOR) inhibitor for immunosuppression (27% decrease in mTOR inhibitor users versus 5% in nonusers). Our results suggest that statin therapy may reduce mortality in kidney transplant recipients and that the strength of this protective association may vary by immunosuppression regimen. Cardiovascular diseases are the leading cause of mortality in kidney transplant (KT) recipients, accounting for 32% of deaths. Statins are widely used in KT recipients, but effectiveness for preventing mortality remains unclear in this population, especially because of interaction between statins and immunosuppressive agents. We analyzed a national cohort to assess the real-world effectiveness of statins for reducing all-cause mortality in KT recipients. We studied statin use and mortality among 58,264 adults (18 years or older) who received single kidneys between 2006 and 2016 and had Medicare part A/B/D. Statin use was ascertained from Medicare prescription drug claims and deaths from Center for Medicare and Medicaid Services records. We estimated the association of statin use with mortality using multivariable Cox models, with statin use as a time-varying exposure and immunosuppression regimen as effect modifiers. Statin use increased from 45.5% at KT to 58.2% at 1-year post-KT to 70.9% at 5-year post-KT. We observed 9785 deaths over 236,944 person-years. Overall, statin use was significantly associated with lower mortality (adjusted hazard ratio [aHR], 0.95; 95% confidence interval [CI], 0.90 to 0.99). The strength of this protective association varied by calcineurin inhibitor use (among tacrolimus users, aHR, 0.97; 95% CI, 0.92 to 1.03 versus among calcineurin nonusers, aHR, 0.72; 95% CI, 0.60 to 0.87; interaction P =0.002), mammalian target of rapamycin (mTOR) inhibitor use (among mTOR inhibitor users, aHR, 0.73; 95% CI, 0.57 to 0.92 versus among nonusers, aHR, 0.95; 95% CI, 0.91 to 1.00; interaction P =0.03), and mycophenolate use (among mycophenolate users, aHR, 0.96; 95% CI, 0.91 to 1.02 versus among nonusers, aHR, 0.76; 95% CI, 0.64 to 0.89; interaction P =0.002). Real-world evidence supports statin therapy for reducing all-cause mortality in KT recipients. Effectiveness might be greater when combined with mTOR inhibitor-based immunosuppression.

The Inflation Reduction Act: Recasting the Medicare Prescription Drug Plans

The Inflation Reduction Act: Recasting the Medicare Prescription Drug Plans

Effects of Medicare Part D coverage gap closure on utilization of branded and generic drugs.

The Affordable Care Act included a provision to gradually eliminate the Medicare prescription drug coverage gap between 2011 and 2020, which substantially lower medication costs in the gap. Using 2007-2016 Medicare claims data, we estimate how filling the gap affects individuals' out-of-pocket spending and medication use, separately for branded and generic drugs. One important difficulty in estimating the policy impact is that around the same time, many blockbuster drugs commonly used by the Medicare population experienced patent expiration and began to see generic entry. Because generic entries affected different therapeutic classes at different times, we run difference-in-differences models by therapeutic category at the beneficiary-month level to isolate the effect of the gap closure from that of generic entry. Overall, we find that filling the gap substantially reduced out-of-pocket spending and increased the use of branded drugs, which had larger discount rates during the analysis period. Beneficiaries reaching the gap, at older ages, or with comorbidities experienced larger reduction in out-of-pocket spending. We show that without accounting for generic entry, the effect of filling the coverage gap on medication use is underestimated for branded drugs and overestimated for generic drugs.

Premiums and Out-of-Pocket Spending for Long-acting Insulins Under the Medicare Part D Senior Savings Model

This study uses data from January/Q1 2022 Medicare Prescription Drug Plan Formulary files to compare premiums and total spending for users of long-acting insulin who selected prescription drug plans in 2022 and to estimate potential savings for beneficiaries who selected Senior Savings model-participating plans.