Patient Out-of-Pocket Costs for Type 2 Diabetes Medications When Aging Into Medicare.

Importance: For people with type 2 diabetes (T2D), out-of-pocket medication costs may influence medication choice, adherence, and overall diabetes management and progression. Little is known about how these costs change as insured people enter Medicare at age 65 years, when coinsurance in the coverage gap and catastrophic phases of Part D coverage can be increased greatly by use of insulin and newer, branded medications (eg, dipeptidyl peptidase 4 inhibitors, glucagon-like peptide 1 agonists, and sodium-glucose cotransporter 2 inhibitors). Objective: To identify whether reaching age 65 years is associated with T2D medication out-of-pocket costs and utilization. Design, Setting, and Participants: This retrospective cohort study (2012-2020) featuring 7 years of follow-up used prescription drug claims data from the TriNetX Diamond Network. Participants included people in the US with diagnosed T2D, and claims for T2D medications were observed both before and after age 65 years. Data analysis was performed from October 2022 to September 2023. Exposure: Reaching age 65 years, according to participants' year of birth. Main Outcomes and Measures: The primary outcome was patient out-of-pocket costs for T2D drugs per quarter (inflation adjusted to 2020 dollars). Utilization, measured as binary utilization of specific classes, and the number of claims for mutually exclusive classes and combinations of classes were also examined. All outcomes were examined using regression discontinuity design. Results: In claims data for 129 997 individuals with T2D diagnosed at ages 58 to 72 years (mean [SD] age, 65.50 [2.95] years; 801 235 female [50.9%]), reaching age 65 years was associated with an increase of $23.04 (95% CI, $19.86-$26.22) in mean quarterly out-of-pocket costs for T2D drugs, and an increase of $56.36 (95% CI, $51.48-$61.23) at the 95th percentile of spending, after utilization adjustment. Utilization decreased by 5.3% at age 65 years, from 3.40 claims per quarter (95% CI, 3.38-3.42 claims per quarter) to 3.22 claims per quarter (95% CI, 3.21-3.24 claims per quarter), but a shift in composition of utilization, including increased insulin use, was associated with additional increases in patient costs. Conclusions and Relevance: In this cohort study of individuals with T2D, the increase in spending upon reaching age 65 years (when most people enroll in Medicare) was associated with patient coinsurance in the coverage gap and catastrophic coverage phases of Medicare Part D. The increased patient cost burden at age 65 years and a modest reduction in overall T2D drug utilization suggest that as people with T2D age into Medicare, there is potentially an increase in nonadherence and diabetes complications.

Affordability and adherence gains for Medicare Part D low-income subsidy recipients when low-income subsidy benefits expanded in 2024.

BACKGROUND: The lowest-income beneficiaries enrolled in the Medicare Part D prescription drug program receive "full subsidies" that waive the premium and deductible and impose minimal copayments. Those with slightly higher incomes and assets may be eligible for "partial subsidies." Prior to 2024, individuals receiving partial subsidies faced reduced Part D premiums and deductibles and paid 15% coinsurance. Under provisions of the Inflation Reduction Act, recipients of partial subsidies were upgraded to full subsidies beginning in 2024. The objective of this pilot study was to assess whether the new policy is likely to reduce cost-related nonadherence to prescribed medications- a common problem faced by older adults even among those receiving subsidies. OBJECTIVE: To compare cost-related nonadherence among partial- vs full-subsidy recipients with similar characteristics. METHODS: We used 2019 Medicare Current Beneficiary Survey data for the study. The Medicare Current Beneficiary Survey is uniquely suited for this work because it contains administrative data on low-income subsidy enrollment plus extensive survey-based information on financial resources necessary to establish program eligibility and rates of cost-related nonadherence. Explanatory variables included sociodemographic characteristics, economic resources, work status, and health variables. RESULTS: We found that the partial-subsidy group reported significantly more cost-related nonadherence (39% vs 22%; P = 0.01) arising both from a lower propensity to fill some prescriptions (23% vs 12%; P = 0.03) and to more delays in filling others (29% vs 8%; P = 0.03). The differences were more pronounced for women and racial and ethnic minority groups in contrast to men and majority populations, respectively. Because the study samples were small, we could not conduct a detailed regression analysis. CONCLUSIONS: The magnitude of cost-related nonadherence effects associated with partial-subsidy cost sharing suggests that the Inflation Reduction Act policy to expand low-income subsidies may boost medication adherence, most notably among women and racial and ethnic minority groups.

Use of Muscle Relaxants After Surgery in Traditional Medicare Part D Enrollees.

BACKGROUND: Surgeons have come under increased scrutiny for postoperative pain management, particularly for opioid prescribing. To decrease opioid use but still provide pain control, nonopioid medications such as muscle relaxants are being used, which can be harmful in older adults. However, the prevalence of muscle relaxant prescribing, trends in use over time, and risk of prolonged use are unknown. STUDY DESIGN: Using a 20% representative Medicare sample, we conducted a retrospective analysis of muscle relaxant prescribing to patients ≥ 65 years of age. We merged patient data from Medicare Carrier, MedPAR, and Outpatient Files with Medicare Part D for the years 2013-2018. A total of 14 surgical procedures were included to represent a wide range of anatomic regions and specialties. RESULTS: The study cohort included 543,929 patients. Of the cohort, 8111 (1.5%) received a new muscle relaxant prescription at discharge. Spine procedures accounted for 12% of all procedures but 56% of postoperative prescribing. Overall, the rate of prescribing increased over the time period (1.4-2.0%, p < 0.001), with increases in prescribing primarily in the spine (7-9.6%, p < 0.0001) and orthopedic procedure groups (0.9-1.4%, p < 0.0001). Of patients discharged with a new muscle relaxant prescription, 10.7% had prolonged use. CONCLUSIONS: The use of muscle relaxants in the postoperative period for older adults is low, but increasing over time, especially in ortho and spine procedures. While pain control after surgery is crucial, surgeons should carefully consider the risks of muscle relaxant use, especially for older adults who are at higher risk for medication-related problems.

Racial and ethnic disparities related to the Medicare Part D Medication Therapy Management Program.

Medicare's Part D Medication Therapy Management (MTM) programs serve approximately 4.5 million eligible beneficiaries. Prior research suggested that the thresholds to enter Part D MTM programs would disproportionately favor White beneficiaries compared with Black or Hispanic beneficiaries. This article summarizes those initial studies and compares the results with more recent analyses of racial and ethnic differences in MTM program enrollment, which, in general, show higher odds of MTM enrollment for minority beneficiaries compared with White beneficiaries. Disparities in the utilization of comprehensive medication review (CMR), a core MTM service, are also discussed. Although trends vary, disparities exist for various minority groups. For example, Black beneficiaries and Hispanic beneficiaries are less likely to be offered a CMR compared with White beneficiaries. Additionally, minority (Asian, Hispanic, and North American Native) beneficiaries are less likely to receive a CMR after being offered the service compared with White beneficiaries. Black, Hispanic, and Asian beneficiaries are more likely than White beneficiaries to have a longer duration between MTM enrollment and CMR offer. There is also a distinct difference in the type of pharmacist (ie, plan pharmacist, MTM vendor pharmacist, or community pharmacist) completing the CMR for certain racial and ethnic groups. For example, compared with White beneficiaries, Black beneficiaries were less likely to receive a CMR from a community pharmacist, whereas Asian beneficiaries were more likely.

Formulary Coverage of Brand-Name Adalimumab and Biosimilars Across Medicare Part D Plans.

This study examines formulary coverage of brand-name adalimumab and biosimilars across Medicare Part D plans.

Role of Specialty Drugs in Rising Drug Prices for Medicare Part D.

Importance: Prices for brand-name drugs affect both federal spending and out-of-pocket liability for Medicare Part D enrollees. Objective: To examine how prices for brand-name drugs, net of rebates and discounts, have changed from 2010 to 2019 and to examine the role of specialty drugs in those changes. Design, Setting, and Participants: This study involved a descriptive analysis of prescription drug spending and prices between 2010 and 2019. The universe of prescription drug event data from those years were combined with confidential data from the Centers for Medicare & Medicaid Services on rebates and discounts that manufacturers and pharmacies pay to Medicare Part D plans to calculate rebate percentages, net spending, and net prices at the drug level. Specialty drugs were identified using information from IQVIA, allowing for a stratified analysis by specialty status. Data were analyzed from March 2019 to March 2024. Main Outcomes and Measures: Average prices (net of rebates and discounts in 2019 US dollars) and average annual price growth for brand-name prescription drugs, overall and separately for specialty and nonspecialty drugs. Results: Average net prices for brand-name drugs doubled from 2010 to 2019 (from $167 to $370). Growth in specialty drug prices was an underlying factor in those increases: average annual price growth was 13.2% for specialty drugs compared with 2.6% for nonspecialty drugs. Price growth for specialty drugs over the decade was smaller than what the Congressional Budget Office reported for the 2010 to 2015 period (increase of 22.3% per year vs 4.5% per year for nonspecialty drug prices), suggesting that price growth slowed after 2015. Drugs that treat hepatitis C contributed to that difference because prices for those drugs were initially high and then subsequently fell. Absent those drugs, price growth for specialty drugs averaged 18.1% in the first half of the decade and 6.9% in the second half. Conclusions and Relevance: Results of this study show that prices for specialty drugs have continued to increase over time in the Medicare Part D program, which contributes to high out-of-pocket liability for users of those drugs in addition to US federal budgetary expenditures.

Benefit Design And Biosimilar Coverage In Medicare Part D: Evidence And Implications From Recent Reforms.

There is substantial disparity between Medicare Part D and employer-sponsored health insurance plans in the coverage of biosimilars and their reference biologics. These disparities may be due to design elements of Part D plans that encourage the adoption of more expensive biologic drugs. We undertook several analyses to illustrate the dynamics of benefit design incentives over time, compare formulary coverage in Part D plans with that of employer-sponsored plans, and study how the Bipartisan Budget Act of 2018 affected Part D formulary coverage. Using these analyses of Part D reforms enacted through the Bipartisan Budget Act, we discuss the implications of elements of the Inflation Reduction Act of 2022 that will be implemented in 2025. Biosimilar coverage increased by 23 percentage points five quarters after the Bipartisan Budget Act was implemented. We predict that the Inflation Reduction Act will also have a positive effect on biosimilar coverage. Given ample evidence of a relationship between drug coverage and utilization, our results suggest that Medicare patients and the federal government could realize substantial savings if Part D formularies resembled those of employer-sponsored plans.

The national financial burden of guideline directed medical therapy for heart failure patients from 2013 to 2021.

BACKGROUND: Guideline Directed Medical Therapy (GDMT) has been revolutionary in improving outcomes of heart failure patients. However, with the addition of more medication classes, the annual cost of these medications on the US healthcare system needs further evaluation. OBJECTIVES: We aim to evaluate the trend of annual cost of GDMT from 2013 to 2021 using the Medicare-part D Database. METHODS: Using Medicare Part D database (2013-2021), we determined the number of beneficiaries receiving these drugs, the total number of 30-day fills for each medication, and the total annual spending on these medications. Linear regression was used to analyze data using Python Programming Language. P value of less than 0.05 was considered to be statistically significant. RESULTS: The estimated annual Medicare- part D spending on empagliflozin had a 50 % increase in cost between 2020 and 2021, which could be attributed to its FDA approval for heart failure with reduced ejection fraction. Empagliflozin cost Medicare 3.73 billion USD in 2021 alone. In addition, sacubitril-valsartan had a strong trajectory since its introduction to the market in 2015. Since its approval in July 2015, it cost Medicare 4.51 billion USD. The Mineralocorticoid Receptor Antagonist class was the least costly class of GDMT. CONCLUSION: The rise in the cost of GDMT is not proportionate amongst the different classes of GDMT. Newer classes of medications cast a significant cost on Medicare in recent years.

Comprehensive Medication Review Completion Rates and Disparities After Medicare Star Rating Measure.

Importance: Comprehensive medication reviews (CMRs) are offered to qualifying US Medicare beneficiaries annually to optimize medication regimens and therapeutic outcomes. In 2016, Medicare adopted CMR completion as a Star Rating quality measure to encourage the use of CMRs. Objective: To examine trends in CMR completion rates before and after 2016 and whether racial, ethnic, and socioeconomic disparities in CMR completion changed. Design, Setting, and Participants: This observational study using interrupted time-series analysis examined 2013 to 2020 annual cohorts of community-dwelling Medicare beneficiaries aged 66 years and older eligible for a CMR as determined by Part D plans and by objective minimum eligibility criteria. Data analysis was conducted from September 2022 to February 2024. Exposure: Adoption of CMR completion as a Star Rating quality measure in 2016. Main Outcome and Measures: CMR completion modeled via generalized estimating equations. Results: The study included a total of 561 950 eligible beneficiaries, with 253 561 in the 2013 to 2015 cohort (median [IQR] age, 75.8 [70.7-82.1] years; 90 778 male [35.8%]; 6795 Asian [2.7%]; 24 425 Black [9.6%]; 7674 Hispanic [3.0%]; 208 621 White [82.3%]) and 308 389 in the 2016 to 2020 cohort (median [IQR] age, 75.1 [70.4-80.9] years; 126 730 male [41.1%]; 8922 Asian [2.9%]; 27 915 Black [9.1%]; 7635 Hispanic [2.5%]; 252 781 White [82.0%]). The unadjusted CMR completion rate increased from 10.2% (7379 of 72 225 individuals) in 2013 to 15.6% (14 185 of 90 847 individuals) in 2015 and increased further to 35.8% (18 376 of 51 386 individuals) in 2020, in part because the population deemed by Part D plans to be MTM-eligible decreased by nearly half after 2015 (90 487 individuals in 2015 to 51 386 individuals in 2020). Among a simulated cohort based on Medicare minimum eligibility thresholds, the unadjusted CMR completion rate increased but to a lesser extent, from 4.4% in 2013 to 12.6% in 2020. Compared with White beneficiaries, Asian and Hispanic beneficiaries experienced greater increases in likelihood of CMR completion after 2016 but remained less likely to complete a CMR. Dual-Medicaid enrollees also experienced greater increases in likelihood of CMR completion as compared with those without either designation, but still remained less likely to complete CMR. Conclusion and Relevance: This study found that adoption of CMR completion as a Star Rating quality measure was associated with higher CMR completion rates. The increase in CMR completion rates was achieved partly because Part D plans used stricter eligibility criteria to define eligible patients. Reductions in disparities for eligible Asian, Hispanic, and dual-Medicaid enrollees were seen, but not eliminated. These findings suggest that quality measures can inform plan behavior and could be used to help address disparities.

Oncology drug pricing: potential Medicare savings on cancer-directed and supportive care medications through the Mark Cuban cost plus drug model.

Prescription drug costs within oncology remain a challenge for many patients with cancer. The Mark Cuban Cost Plus Drug Company (MCCPDC) launched in 2022, aiming to provide transparently priced medications at reduced costs. In this study, we sought to describe the potential impact of MCCPDC on Medicare Part-D oncology spending related to cancer-directed (n = 7) and supportive care (n = 26) drugs. We extracted data for drug-specific Part-D claims and spending for 2021. Using 90-count purchases from MCCPDC, we found potential Part-D savings of $857.8 million (91% savings) across the 7 cancer-directed drugs and $28.7 million (67% savings) across 21/26 (5/26 did not demonstrate savings) supportive care drugs. Collectively, our findings support that alternative purchasing models like MCCPDC may promote substantial health care savings.

Shingles Vaccination in Medicare Part D After Inflation Reduction Act Elimination of Cost Sharing.

This cross-sectional study uses data from retail pharmacies to examine shingles vaccine uptake among Medicare Part D beneficiaries following an IRA policy to eliminate cost sharing.

Medicaid Eligibility Loss Among Dual-Eligible Beneficiaries Before and During COVID-19 Public Health Emergency.

Importance: Medicaid coverage loss can substantially compromise access to and affordability of health care for dual-eligible beneficiaries. The extent to which this population lost Medicaid coverage before and during the COVID-19 public health emergency (PHE) and the characteristics of beneficiaries more at risk for coverage loss are currently not well known. Objective: To assess the loss of Medicaid coverage among dual-eligible beneficiaries before and during the first year of the PHE, and to examine beneficiary-level and plan-level factors associated with heightened likelihood of losing Medicaid. Design, Setting, and Participants: This repeated cross-sectional study used national Medicare data to estimate annual rates of Medicaid loss among dual-eligible beneficiaries before (2015 to 2019) and during the PHE (2020). Individuals who were dual eligible for Medicare and Medicaid at the beginning of a given year and who continuously received low-income subsidies for Medicare Part D prescription drug coverage were included in the sample. Multivariable regression models were used to examine beneficiary-level and plan-level factors associated with Medicaid loss. Data analyses were conducted between March 2023 and October 2023. Exposure: Onset of PHE. Main Outcomes and Measures: Loss of Medicaid for at least 1 month within a year. Results: Sample included 56 172 736 dual-eligible beneficiary-years between 2015 and 2020. In 2020, most dual-eligible beneficiaries were aged over 65 years (5 984 420 [61.1%]), female (5 868 866 [59.9%]), non-Hispanic White (4 928 035 [50.3%]), full-benefit eligible (6 837 815 [69.8%]), and enrolled in traditional Medicare (5 343 537 [54.6%]). The adjusted proportion of dual-eligible beneficiaries losing Medicaid for at least 1 month increased from 6.6% in 2015 to 7.3% in 2019 and then dropped to 2.3% in 2020. Between 2015 and 2019, dual-eligible beneficiaries who were older (ages 55-64 years: -1.4%; 95% CI, -1.8% to -1.0%; ages 65-74 years: -2.0%; 95% CI, -2.5% to -1.5%; ages 75 and older: -4.5%; 95% CI, -5.0% to -4.0%), disabled (-0.8%; 95% CI, -1.1% to -0.6%), and in integrated care programs were less likely to lose Medicaid. In 2020, the disparities within each of these demographic groups narrowed significantly. Notably, while Black (0.6%; 95% CI, 0.2% to 0.9%) and Hispanic (0.7%; 95% CI, 0.3% to 1.2%) dual-eligible beneficiaries were more likely to lose Medicaid than their non-Hispanic White counterparts between 2015 and 2019, such gap was eliminated for Black beneficiaries and narrowed for Hispanic beneficiaries in 2020. Conclusions and Relevance: During the PHE, Medicaid coverage loss declined significantly among dual-eligible beneficiaries, and disparities were mitigated across subgroups. As the PHE unwinds, it is crucial for policymakers to implement strategies to minimize Medicaid coverage disruptions and racial and ethnic disparities, especially given that loss of Medicaid was slightly increasing over time before the PHE.

Online Tools to Decrease Out-of-Pocket Prescription Costs for Patients: A Practical Guide for Urologists.

INTRODUCTION: Patients who seek urologic care have recently reported a high degree of financial toxicity from prescription medications, including management for nephrolithiasis, urinary incontinence, and urological oncology. Estimating out-of-pocket costs can be challenging for urologists in the US because of variable insurance coverage, local pharmacy distributions, and complicated prescription pricing schemes. This article discusses resources that urologists can adopt into their practice and share with patients to help lower out-of-pocket spending for prescription medications. METHODS: We identify 4 online tools that are designed to direct patients toward more affordable prescription medication options: the Medicare Part D Plan Finder, GoodRx, Amazon, and the Mark Cuban Cost Plus Drug Company. A brief historical overview and summary for patients and clinicians are provided for each online resource. A patient-centered framework is provided to help navigate these 4 available tools in clinic. RESULTS: Among the 4 tools we identify, there are multiples tradeoffs to consider as financial savings and features can vary. First, patients insured by Medicare should explore the Part D Plan Finder each year to compare drug plans. Second, patients who need to urgently refill a prescription at a local pharmacy should visit GoodRx. Third, patients who are prescribed recurrent generic prescriptions for chronic conditions can utilize the Mark Cuban Cost Plus Drug Company. Finally, patients who are prescribed 3 or more chronic medications can benefit from subscribing to Amazon RxPass. CONCLUSIONS: Prescription medications for urologic conditions can be expensive. This article includes 4 online resources that can help patients access medications at their most affordable costs. Urologists can provide this framework to their patients to help support lowering out-of-pocket drug costs.

Assessing the Trends of Tramadol Utilization in the Medicare Part D Population in Rhode Island.

OBJECTIVE: To assess the trends in tramadol dispensing among Medicare Part D patients in Rhode Island. METHODS: An analysis was conducted of the Medicare Part D Provider Utilization and Payment Data Public Use File for the years 2013-2021. Chi squared tests were conducted to assess statistical significance of annual changes in proportions. RESULTS: Following tramadol becoming a controlled substance in 2014, the number of dispensed tramadol prescriptions and patients with a tramadol prescription decreased every subsequent year through 2021 (prescriptions: 42,157 to 33,026; patients: 12,654 to 9,653). The percentage of opioid prescriptions that were tramadol increased from 16.32% in 2013 to 21.19% in 2020. CONCLUSION: Tramadol utilization has been decreasing among the Medicare Part D population in Rhode Island while the percentage of opioid dispensings that were tramadol have been increasing. Future studies are needed to assess whether patients utilizing tramadol are at a higher risk for adverse outcomes.

The association between polypharmacy and health-related quality of life among older adults with prostate cancer.

INTRODUCTION: Older adults with prostate cancer (PC) are at risk of polypharmacy, which further complicates disease management and health-related quality of life (HRQoL). This study evaluated the association between polypharmacy and HRQoL among Medicare beneficiaries with PC. MATERIALS AND METHODS: This observational, retrospective study analyzed data from the Surveillance, Epidemiology, and End Results (SEER) Medicare Health Outcomes Survey (MHOS) data resource. Beneficiaries aged ≥65 and enrolled in Medicare Advantage Organizations were included if they had a PC diagnosis and continuously enrolled in Part D for 12 months prior to the completion of MHOS. Polypharmacy was determined based on the unique number of concurrent Part D prescriptions during 12 months before survey: no polypharmacy (NP, n = 0-4), polypharmacy (PP, n = 5-9), and excessive polypharmacy (EPP, n ≥ 10). HRQoL was assessed using the Physical and Mental Component Summary T-scores (PCS and MCS, respectively) in MHOS. ANOVA and Pearson's Chi-Square tests were performed to assess variances between polypharmacy and continuous/categorical variables. Multivariate linear regression models with generalized estimating equations were used to assess the association between polypharmacy and HRQoL. The severely impaired HRQoL cohort was identified based on normalized z-scores of PCS and MCS. Odds ratios were calculated to prioritize drug-drug and class-class pairs associated with patients with severely impaired HRQoL. RESULTS: Data from 16,573 beneficiaries (24,126 records) showed that 44.4% had PP and 10.1% had EPP. Beneficiaries with PP and EPP had significantly lower mean PCS and MCS scores compared to those without polypharmacy (p < 0.001). After adjusting for covariates, beneficiaries with EPP had clinically significantly lower PCS (adjusted marginal difference: -8.47 [-9.00, -7.94]) and MCS (adjusted marginal difference: -4.32 [-4.89, -3.75]) compared to the NP group. Top-ranked drug-drug pairs like tiotropium bromide and oxycodone/acetaminophen exhibited significant associations with HRQoL decline. Analysis of class-class pairs highlighted (1) corticosteroid hormone receptor agonists and opioid agonists and (2) benzodiazepines and adrenergic beta2-agonists as having significant associations with HRQoL decline. DISCUSSION: Polypharmacy exhibits a significant association with HRQoL declines among older adults with PC.

Medicare Part D Plans Greatly Increased Utilization Restrictions On Prescription Drugs, 2011-20.

Drug utilization management tools can be employed to ensure that medicines are prescribed cost-effectively, but they can also be implemented in ways that reduce adherence and harm patient health. We examined trends in the prevalence of utilization restrictions on non-protected-class compounds in Medicare Part D plans during the period 2011-20, including prior authorization and step therapy requirements as well as formulary exclusions. Part D plans became significantly more restrictive over time, rising from an average of 31.9 percent of compounds restricted in 2011 to 44.4 percent restricted in 2020. The prevalence of formulary exclusions grew particularly fast: By 2020, plan formularies excluded an average of 44.7 percent of brand-name-only compounds. Formulary restrictions were more common among brand-name-only compared with generic-available compounds, among more expensive compounds, and in stand-alone compared with Medicare Advantage prescription drug plans.

The Inflation Reduction Act: Implications for Medicare spending and access to biologic therapies for chronic rhinosinusitis with nasal polyposis and asthma.

KEY POINTS: In 2021, Medicare spending on biologics was $926 million in Part B (FFS) and $1.3 billion in Part D (FFS/MA). Between 2017 and 2021, annual Medicare spending on biologics increased by approximately 200%. Between 2023 and 2025, Medicare Part D OOP costs for biologics will decrease by an estimated 50%-60%.