Medicare Prescription Drug Plan Research Articles

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.

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.

The Inflation Reduction Act: Recasting the Medicare Prescription Drug Plans

The Inflation Reduction Act: Recasting the Medicare Prescription Drug Plans

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.

Real-World Treatment Patterns of Glucose-Lowering Agents Among Patients with Type 2 Diabetes Mellitus and Cardiovascular Disease or At Risk for Cardiovascular Disease: An Observational, Cross-Sectional, Retrospective Study.

There is limited published literature on longitudinal utilization of glucose-lowering agents (GLAs) among patients with type 2 diabetes (T2D) and cardiovascular disease (CVD or risk of CVD). This retrospective, observational study aimed to provide updated evidence on patient characteristics and utilization of GLAs among patients with T2D and CVD or risk of CVD in the United States. This was a cross-sectional evaluation of patients with T2D aged 50-89years with annual continuous enrolment in a Medicare Advantage and Prescription Drug plan, identified from administrative claims data (Humana Research Database). Patients with T2D and atherosclerotic cardiovascular disease (ASCVD) or heart failure (HF) (CVD cohort), or T2D and an additional CVD risk factor without pre-existing CVD (CVD risk cohort) were identified from 2015 to 2019. Patients were followed from their first observed ASCVD/HF diagnosis or CVD risk factor for each year they were continuously enrolled or until occurrence of a CVD diagnosis (CVD risk cohort only). Use of GLA classes were reported by year, cohort, and age groups (50-64years and ≥ 65years). The percentage of patients on sodium-glucose co-transporter-2 inhibitors (SGLT-2is), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), and GLP-1 RAs with proven cardiovascular benefit, respectively, increased from 2015 to 2019 among ≥ 65 years (CVD cohort: 1.1-3.4%, 1.6-4.0%, and 1.2-3.8%; CVD risk cohort: 1.4-3.7%, 2.0-4.3%, and 1.5-4.1%); and among 50-64years (CVD cohort: 2.6-7.3%, 4.3-10.1%, and 3.4-9.4%; CVD risk cohort: 3.3-6.8%, 4.6-9.6%, and 3.5-8.9%). Although use of SGLT-2is and GLP-1 RAs increased over time, overall utilization of these agents in patients with T2D and ASCVD/HF or at risk for ASCVD/HF remained low, especially for those aged ≥ 65years.

Activation, physical activity, and outcomes among individuals with T2D.

To explore the associations among activation, physical activity, hemoglobin A1c (HbA1c), and healthy days in older adults with type 2 diabetes (T2D) who participated in wellness programs. Observational, longitudinal cohort study utilizing survey, claims, and wellness program data. From January to May 2018, individuals enrolled in a commercial or Medicare Advantage and prescription drug plan with T2D (aged 55-89 years) and SilverSneakers or step count data were eligible. Three waves of surveys were mailed (n = 5000) to collect information on activation (Consumer Health Activation Index; Influence, Motivation, and Patient Activation for Diabetes) and health-related quality of life (Healthy Days). Generalized linear models and predictive models evaluated the associations of unhealthy days and HbA1c with physical activity and activation factors. Additional models tested the relationship between physical activity and future acute care visits, accounting for potential confounders via inverse probability of treatment weighting. Respondents to all 3 waves (n = 1147) had higher comorbidity indices but lower HbA1c than individuals with T2D without physical activity data (P < .0001). Individuals with moderate and high activation levels had 67.4% to 74.0% and 71.6% to 85.6% fewer unhealthy days, respectively, than those with lower activation (P < .01). Individuals with high (> 8000/day) step counts at baseline were predicted to have 2.04 fewer unhealthy days/month at follow-up (P < .05) and 0.19% (P < .02) lower HbA1c units, respectively, compared with those with less than 4000 steps per day. High SilverSneakers activity (> 2 activities per week) reduced subsequent acute care visits by 49%. Increasing patient activation levels encourages physical activity, which can help improve glycemic control and health-related quality of life, especially among older adults.

Medicare Part D Coverage Restrictions and Patient Cost-Sharing for Opioids Commonly Used for Cancer Pain, 2015-2021.

Nation-wide rapid declines in prescription opioid dispensing gave rise to concerns regarding restricted access to effective pain management for patients with cancer-related pain. One important mechanism for such restrictions could be through more restrictive insurance coverage for opioids. This study aims to assess recent changes in Medicare Part D formulary designs for opioids commonly used for cancer-related pain. We used data from the 2015-2021 Medicare Prescription Drug Plan (PDP) Formulary Files to assess formulary changes for six opioid-dose combinations commonly used for cancer-related pain. We estimated % of PDPs adopting prior authorization, quantity limits (and limits adopted), and a higher cost-sharing tier for each opioid-dose combination. We further estimated median and mean out-of-pocket (OOP) costs across all PDPs for a 30-day supply of the drug. Trends in proportions were tested using the Cochrane-Armitage test; trends in continuous measures were tested using the Jonckheere-Terpstra test. Proportion of PDPs adopting prior authorization increased from close to 0% to about 50% for two long-acting opioids (P < .001). Distribution of quantity limits across PDPs shifted over time to being more restrictive for all opioids considered (P < .001). For four of the six opioids, the proportion of PDPs adopting tier 3 or above increased from below or about 50% to well over 70% (P < .001). For the same four opioids, median OOP costs doubled to quadrupled (P < .001). Medicare PDP coverage has become increasingly restrictive for opioids commonly used for cancer-related pain, with multifold increases in patient OOP costs over the past 7 years. These changes pose concerns for patients with cancer needing opioid therapies for pain control and call for strategies to effectively exempt cancer-related pain from insurance and pharmacy rules intended to apply to opioids for noncancer chronic pain.

Medicare Coverage and Out-of-Pocket Costs of Quadruple Drug Therapy for Heart Failure

BackgroundBeta-blockers, angiotensin receptor-neprilysin inhibitor (ARNI), mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 inhibitors (SGLT2i), known as quadruple therapy, are recommended for patients with heart failure with reduced ejection fraction (HFrEF). ObjectivesThis study sought to determine Medicare coverage and out-of-pocket (OOP) costs of quadruple therapy and regimens excluding ARNI or SGLT2i. MethodsThis study assessed cost sharing, prior authorization, and step therapy in all 4,068 Medicare prescription drug plans in 2020. OOP costs were determined during the standard coverage period and annually based on the Medicare Part D standard benefit, inclusive of deductible, standard coverage, coverage gap, and catastrophic coverage. ResultsTier ≥3 cost sharing was required by 99.1% of plans for ARNI and 98.5% for at least 1 SGLT2i. Only ARNI required prior authorization (24.3% of plans), and step therapy was required only for SGLT2is (5.4%) and eplerenone (0.8%). The median 30-day standard coverage OOP cost of quadruple therapy was $94 (IQR: $84-$100), including $47 (IQR: $40-$47) for ARNI and $45 (IQR: $40-$47) for SGLT2i. The median annual OOP cost of quadruple therapy was $2,217 (IQR: $1,956-$2,579) compared with $1,319 (IQR: $1,067-$1,675) when excluding SGLT2i and $1,322 (IQR: $1,025-$1,588) when including SGLT2i and substituting an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for ARNI. The median 30-day OOP cost of generic regimens was $3 (IQR: $0-$9). ConclusionsMedicare drug plans restrict coverage of quadruple therapy through cost sharing, with OOP costs that are substantially higher than generic regimens. Quadruple therapy may be unaffordable for many Medicare patients with HFrEF unless medication prices and cost sharing are reduced.

Assessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019

Most adults 65 years or older have multiple chronic conditions. Managing these conditions with prescription drugs can be costly, particularly for older adults with limited incomes. To estimate hypothetical out-of-pocket costs associated with guideline-recommended outpatient medications for the initial treatment of 8 common chronic diseases among older adults with Medicare prescription drug plans (PDPs). This retrospective cross-sectional study used 2009 and 2019 Medicare prescription drug plan formulary files to estimate annual out-of-pocket costs among hypothetical patients enrolled in Medicare Advantage or stand-alone Medicare Part D plans. A total of 3599 PDPs in 2009 and 3618 PDPs in 2019 were included after inclusion and exclusion criteria were applied. Costs associated with guideline-recommended medications for 8 of the most common chronic diseases (atrial fibrillation, chronic obstructive pulmonary disease [COPD], heart failure with reduced ejection fraction, hypercholesterolemia, hypertension, osteoarthritis, osteoporosis, and type 2 diabetes), alone and in 2 clusters of commonly comorbid conditions, were examined. Annual out-of-pocket costs for each chronic condition, inflation adjusted to 2019 dollars. Among 3599 Medicare PDPs in 2009, 1998 were Medicare Advantage plans and 1601 were stand-alone plans; among 3618 Medicare PDPs in 2019, 2719 were Medicare Advantage plans and 899 were stand-alone plans. For an older adult enrolled in any Medicare PDP in 2019, the median annual out-of-pocket costs for individual conditions varied, from a minimum of $32 (IQR, $6-$48) for guideline-recommended management of osteoporosis (a decrease from $128 [IQR, $102-$183] in 2009) to a maximum of $1579 (IQR, $1524-$2229) for guideline-recommended management of atrial fibrillation (an increase from $91 [IQR, $73-$124] in 2009). For an older adult with a cluster of 5 commonly comorbid conditions (COPD, hypertension, osteoarthritis, osteoporosis, and type 2 diabetes) enrolled in any PDP, the median out-of-pocket cost in 2019 was $1999 (IQR, $1630-$2564), a 12% decrease from $2284 (IQR, $1920-$3107) in 2009. For an older adult with all 8 chronic conditions (atrial fibrillation, COPD, diabetes, hypercholesterolemia, heart failure, hypertension, osteoarthritis, and osteoporosis) enrolled in any PDP, the median out-of-pocket cost in 2019 was $3630 (IQR, $3234-$5197), a 41% increase from $2571 (IQR, $2185-$3719) in 2009. In this cross-sectional study, out-of-pocket costs for guideline-recommended outpatient medications for the initial treatment of 8 common chronic diseases varied by condition. Although costs generally decreased between 2009 and 2019, particularly with regard to conditions for which generic drugs were available, out-of-pocket costs remained high and may have presented a substantial financial burden for Medicare beneficiaries, especially older adults with conditions for which brand-name drugs were guideline recommended.

Patient and Payer Incentives to Use Patented Brand-Name Drugs vs Authorized Generic Drugs in Medicare Part D

In response to scrutiny over high drug prices, manufacturers of insulin and direct-acting antiviral agents for treating hepatitis C have recently introduced authorized generic alternatives to their patented brand-name products. These authorized generic drugs have list prices at least 50% lower than the list price of the brand-name drugs, which should result in savings to patients. However, it is unclear whether these authorized generic drugs are offered on Medicare Part D formularies because they may not provide savings to plans or Medicare. To assess Medicare Part D formulary coverage for 4 brand-name formulations of insulin and direct-acting antiviral agents and their authorized generic formulations. This cross-sectional study used Medicare Prescription Drug Plan Formulary and Pricing Information Files from quarter 3 of 2020 and Medicare Part D plan enrollment for September 2020. Four patented brand-name drugs (sofosbuvir and velpatasvir fixed-dose combination tablets [Epclusa], ledipasvir and sofosbuvir tablets [Harvoni], insulin lispro [Humalog], and insulin aspart [Novolog]) and their authorized generic formulations for all Part D stand-alone prescription drug plans (n = 959) and Medicare Advantage prescription drug plans (n = 3148) were studied. Beneficiary-weighted formulary coverage of brand-name and authorized generic products; beneficiary out-of-pocket costs; and prerebate plan, manufacturer, and Medicare spending on brand-name and authorized generic products. In quarter 3 of 2020, 97% of beneficiaries were in plans that covered brand-name drugs only or both brand-name and authorized generic drugs; approximately 3% were in plans that covered authorized generic drugs only. Observed authorized generic drug list prices were 67%, 62%, and 50% lower than list prices for Epclusa, Harvoni, and each brand-name insulin product, respectively. Medicare beneficiaries using authorized generic drugs could save $270 per year for 12 vials of Humalog and $2974 for a full course of Harvoni. Plans, however, have limited incentives to encourage authorized generic drug use because rebates for brands likely exceed savings available with authorized generic drugs, particularly for beneficiaries with spending that reaches the Medicare Part D coverage gap. The results of this cross-sectional study suggest that authorized generic drugs for insulin and direct-acting antiviral agents may lower out-of-pocket spending for patients but are unlikely to provide savings for Part D plans or Medicare. Instead, these drugs allow manufacturers to offer products at a lower list price without materially lowering net prices or profits.

Medicare Advantage-pharmacy partnership improves influenza and pneumococcal vaccination rates.

To evaluate the impact of a collaborative effort of a Medicare Advantage and prescription drug (MAPD) plan and community pharmacies to improve vaccination rates for pneumonia and influenza. This quasiexperimental, cluster-randomized intervention study used MAPD data to assess the impact of community pharmacists on vaccination rates. Pharmacies in specific regions (districts) were randomly assigned to intervention or control groups. Intervention pharmacies received reports of patients with a gap in influenza (aged 19-89 years) and/or pneumococcal (aged 65-89 years) vaccinations based on medical and pharmacy claims history. Vaccine-naïve patients were offered vaccinations. The vaccination rates for the previously vaccine-naïve patients utilizing intervention and control pharmacies were compared 6 months post randomization. Inverse probability weighted hierarchical generalized linear models determined the odds of receiving pneumonia and influenza vaccinations for intervention and control groups, controlling for baseline clinical and demographic characteristics. Intervention and control groups had similar ages in the pneumococcal older-adult cohort (mean age, 73.0 vs 73.4 years, respectively; P = .1255). The intervention group was older than the control group in the influenza cohort (mean age, 67.7 vs 66.4 years, respectively; P = .0006). Slightly more than half of each cohort were women, and the proportion of women was not significantly different between the intervention and control groups in each cohort. In multivariable analyses, intervention pharmacies were associated with higher odds of delivering pneumococcal (odds ratio [OR], 1.91; 95% CI, 1.26-2.87) and influenza (OR, 2.18; 95% CI, 1.37-3.46) vaccinations than control pharmacies. A health plan-enabled, pharmacist-led intervention was effective in increasing the number of older adults receiving pneumococcal vaccination and individuals receiving influenza vaccination.

POS-344 ASSOCIATION BETWEEN RELATIVE ESTIMATED GLOMERULAR FILTRATION RATE CHANGES AND CLINICAL OUTCOMES IN PATIENTS WITH TYPE 2 DIABETES

Research supporting the validity of changes in estimated glomerular filtration rate (eGFR) as a surrogate endpoint for end-stage kidney disease (ESKD) or other clinical outcomes in patients with type 2 diabetes mellitus (T2DM) is limited. The primary purpose of this study was to evaluate the association between relative changes in eGFR and clinical outcomes in patients with T2DM. This was a retrospective cohort study using administrative claims data. Patients 65-89 years of age with T2DM, without initial stage V chronic kidney disease (CKD) or ESKD, enrolled in a Medicare Advantage and Prescription Drug Plan, with an index eGFR 25-89 ml/min/1.73m2 in 2008-2017 were identified. Patients with one serum creatinine test result available for calculation of eGFR and a second serum creatinine test result within 3-24 months of the first value were included. The primary exposure of interest was relative decline in eGFR of ≥40% in up to a 2 year period (landmark time). Outcomes included ESKD/kidney failure, all-cause mortality, and a composite cardiovascular (CV) event measure (non-fatal myocardial infarction, stroke, hospitalization for heart failure, or death in-hospital or within 30 days of discharge for a CV-related admission). The associations between relative eGFR change and the clinical outcomes of interest were evaluated with multivariable adjusted survival (Cox) models after a landmark time of 2 years. Age, race, region, low-income subsidy/dual eligibility status, first eGFR, comorbidities, laboratory values (e.g., hemoglobin A1c, cholesterol, urine albumin-to-creatinine ratio), medications, healthcare resource use and costs were included as variables in the models. A total of 288,170 patients were included; 90,990 patients with a first eGFR of 25-59 ml/min/1.73m2 and 197,180 with a first eGFR of 60-89 ml/min/1.73m2. The median age was 72 years, 53.1% were female, and 76.9% were white. A majority (73.9%) of patients were living in the Southern United States, with 67.9% living in urban locations, and 11.2% and 8.1% were low-income subsidy and dual eligible, respectively. Overall, 1.6% (n=4,581) of patients had a relative eGFR decline of ≥40% in the landmark time. The overall adjusted hazard ratio (HR) for ESKD/kidney failure was 4.38 (95% CI: 3.99, 4.81) in patients with a ≥40% decline as compared to those with a <40% decline. The adjusted HR for all-cause mortality was 1.98 (95% confidence interval [CI]: 1.87, 2.10) and the composite CV outcome was 1.67 (95% CI: 1.53, 1.82). The association between a ≥40% relative eGFR decline and ESKD/kidney failure was generally similar in the subgroup of patients with an initial eGFR of 60-89 ml/min/1.73m2 (HR: 4.37 [95% CI: 3.79, 5.04]) and in the subgroup with an initial eGFR of 25-59 ml/min/m2 (HR: 4.60 [95% CI: 4.06, 5.20]). Subgroup analyses by initial eGFR were consistent with the overall analysis for the CV outcome and all-cause mortality. The results for the overall and subgroup analyses are presented in Figure 1. In an older patient population with eGFR 25-89 ml/min/m2 and T2DM, a relative eGFR change of ≥40% was associated with ESKD/kidney failure, as well as with all-cause mortality and CV events, providing further support to the validity of this measure as a proxy for “hard” clinical outcomes.

Medicare Prescription Drug Plan Coverage of Hormone Therapies Used by Transgender Individuals.

Purpose: Although pharmacologic hormone therapy represents one of the mainstays of gender-affirming therapy for transgender individuals, there are many access barriers for these therapies, including insurance coverage of these drugs. The purpose of this study was to examine Medicare coverage of hormone therapies used by transgender individuals. Methods: Using Centers for Medicare and Medicaid Services prescription drug plan formulary files, we determined plan coverage, coverage restrictions, and out-of-pocket (OOP) costs for all 10 drugs recommended in the 2009 and 2017 Endocrine Society treatment guidelines for transgender patients. Results: For masculinizing therapies, the proportion of plans providing unrestricted coverage ranged from 22% to 79% in 2010 and from 5% to 75% in 2018. For feminizing therapies, the proportion providing unrestricted coverage ranged from 24% to 100% in 2010 and from 13% to 100% in 2018. Median annual OOP costs for masculinizing therapies ranged from $232 to $1112 in 2010 and from $180 to $2176 in 2018. For feminizing therapies, OOP costs ranged from $84 to $2716 in 2010 and from $72 to $3792 in 2018. Conclusion: Our findings highlight the variability in access to guideline-recommended hormone therapies for individuals insured through Medicare.

Prostaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017.

Prostaglandin analogs are the most effective treatment for glaucoma, a common condition among older adults. Despite the availability of generic drugs, the costs associated with these prescription drugs are rising. To characterize Medicare prescription drug plan (PDP) formulary coverage and beneficiary out-of-pocket cost for prostaglandin analogs from 2009 to 2017 and Medicare spending on prostaglandin analogs from 2013 to 2017. This study was a retrospective analysis. We used 2009, 2013, and 2017 Medicare PDP formulary, beneficiary cost, and pricing files to determine beneficiary first-prescription out-of-pocket costs and plan coverage (unrestricted, restricted, or not covered) of branded latanoprost 0.005%, travoprost 0.004%, bimatoprost 0.03% and 0.01%, and tafluprost 0.0015% and of generic latanoprost 0.005% and generic bimatoprost 0.03%. We also used Medicare Part D spending data to determine aggregate spend in 2013 and 2017. In 2009, 92% of plans covered branded latanoprost, 83% covered branded bimatoprost; and 49% covered branded travoprost, whereas in 2017, 6% of plans covered branded latanoprost; 95% covered branded bimatoprost; and 96% covered branded travoprost. Although generic latanoprost was universally covered, generic bimatoprost was only covered by 35% of plans in 2017. Median out-of-pocket cost of branded prostaglandins without generic equivalents was $35 (IQR = $29-$40) in 2009, $45 (IQR = $42-$101) in 2013, and $90 (IQR = $45-$159) in 2017. Median out-of-pocket cost of all available generic prostaglandins was $10 (IQR = $5-$33) in 2013 and $10 (IQR = $4-$15) in 2017. In 2013, Medicare spent $733 million on prostaglandin analogs; in 2017, this increased to $1.09 billion, with $943 million (86%) spent on branded prostaglandins and $148 million (14%) spent on generics. Medicare PDP coverage of branded prostaglandins remained stable from 2009 to 2017. While median beneficiary out-of-pocket costs associated with generic prostaglandins remained stable, those associated with branded prostaglandins increased nearly 3-fold. Research reported in this publication was supported by National Heart, Lung and Blood Institute of the National Institutes of Health under Award Number T35HL007649. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health. Shah has received research support through Mayo Clinic from the U.S. Food and Drug Administration (FDA) to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938); the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative (TCPI); the Agency for Healthcare Research and Quality (U19HS024075, R01HS025164, R01HS025402, R03HS025517); and the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R56HL130496, R01HL131535), National Science Foundation, and the Patient Centered Outcomes Research Institute to develop a clinical data research network. Ross has received research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing; Medtronic and the FDA to develop methods for postmarket surveillance of medical devices (U01FD004585); the FDA to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938); the Blue Cross Blue Shield Association to better understand medical technology evaluation; the Centers of Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I); the Agency for Healthcare Research and Quality (R01HS022882); the National Heart, Lung and Blood Institute of the NIH (R01HS025164); and the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and the Collaboration on Research Integrity and Transparency at Yale. The other authors have nothing to disclose.

Impact of an adherence intervention program on patient adherence and star ratings measures in a large community pharmacy chain

ObjectiveThis study aimed to determine the impact of an adherence intervention program on medication adherence rates and performance on the Centers for Medicare and Medicaid Services star ratings measures. SettingThe study was conducted in a large community pharmacy chain comprising more than 2200 pharmacies and 7000 pharmacists across 36 states. Practice descriptionPharmacists conducted adherence interventions with patients with a proportion of days covered (PDC) of less than 80% for hypertension, cholesterol, and diabetes star ratings medications. Practice innovationA longitudinal, pharmacist-led adherence intervention program with automated follow-up interventions was implemented between June 2017 and December 2017. EvaluationThe percentage of patients with a PDC of greater than or equal to 80% and performance on CMS star ratings measures were evaluated for Medicare Part D Prescription Drug Plan (PDP) and Medicare Advantage Prescription Drug (MAPD) Plan populations in 2017 compared with that of 2015 and 2016. Patient-level PDC change, pharmacist intervention completion, and pharmacist recommendation of additional pharmacy services were also measured. ResultsA total of 241,261 interventions were generated in the electronic dispensing systems. Pharmacists enrolled 60,232 patients and completed 75.4% of follow-up interventions, with an average of 1.3 follow-ups per patient. For the Medicare PDP population, improvement in the percentage of adherent patients ranged from 1.1% to 1.2% and 0.9% to 1.8% for 2015-2016 and 2016-2017, respectively, whereas improvement ranged from 2.1% to 2.5% and 2.0% to 3.0% for 2015-2016 and 2016-2017, respectively, for the MAPD Plan population. In 2016 and 2017, performance on cholesterol and diabetes measures achieved the 4-star cut point, and the hypertension measure achieved the 5-star cut point. ConclusionThis study demonstrated the successful implementation and pharmacist participation in an adherence intervention program in a large community pharmacy chain. Compared with the previous year, medication adherence improved for patients attributed to hypertension, cholesterol, and diabetes measures, and performance on CMS star rating measures was maintained, despite an increase in cut points.

Validated prediction of imminent risk of fracture for older adults.

To develop and validate predictive models for imminent fracture risk in a Medicare population. This retrospective administrative claims (Humana Research Database) study assessed imminent risk in Humana's Medicare Advantage and Prescription Drug plan members. Individuals (aged 67-87 years on January 1, 2015 [index]) with 1 year or more of history were followed for 3 months to up to 2 years, with censoring at death/disenrollment. The cohort was split into training and validation samples (1:1). Cox regression models assessed demographics, fracture history, medically significant falls, osteoporosis-related factors, frailty markers, and selected medications and comorbidities for independent predictors (P <.001) of incident nontraumatic clinical fractures in 12 and 24 months. A 6-variable model of 12-month risk used a published method for the risk-scoring point system. Of 1,287,354 individuals (mean age, 74.3 years; 56% female; 84% white), 3.8% had at least 1 fragility fracture at 12-month follow-up; 6.6% experienced fracture at 24 months (women vs men: 12 months, 4.8% vs 2.5%; 24 months, 8.3% vs 4.4%; both P <.01). At 12 months, recent fracture conferred approximately 3-fold-higher fracture risk (vs no recent fracture). Older age, white race, female sex, osteoporosis-related screening/diagnosis/medication, antidepressant/antipsychotic/sedative hypnotic/muscle relaxant medications, history of falls, fracture history, and respiratory conditions also increased risk (all P <.0001). The simplified model (recent fracture, age, sex, race, falls, antidepressant/antipsychotic/sedative hypnotic/muscle relaxant medications) performed well (C statistic = 0.71). Recent fracture, older age, female sex, white race, falls, and antidepressant/antipsychotic/sedative hypnotic/muscle relaxant medications predict imminent fracture risk in an older-adult Medicare Advantage population. Imminent fracture risk can be assessed using 6 easily quantified factors.

Medicare beneficiaries' out-of-pocket costs for commonly used generic drugs, 2009-2017.

To examine differences in the out-of-pocket costs for common generic drugs used to treat chronic conditions when individuals used their Medicare prescription drug plan (PDP) or when purchased through Walmart's generic drug discount programs (GDDPs) from 2009 to 2017. A retrospective analysis of Medicare PDP Formulary files and Walmart's GDDP retail drug lists from 2009 to 2017. We identified all generic drugs used to treat chronic conditions that were on Walmart's GDDP retail drug list from 2009 to 2017. We then determined the out-of-pocket costs for each drug for each Medicare PDP and compared those costs with Walmart's GDDP cash price. There were 62 and 43 generic medications used to treat common chronic diseases available through Walmart's GDDP in 2009 and 2017, respectively. Across all PDPs, the median beneficiary out-of-pocket expenditure for a 30-day supply of the GDDP-available medications for chronic diseases decreased from $5.70 (interquartile range [IQR], $2.55-$7.98) in 2009 to $2.00 (IQR, $0.00-$4.00) in 2017 (P <.001) Approximately three-fifths (60.2%) of PDPs required beneficiaries to pay out-of-pocket costs higher than those of Walmart's GDDP in 2009, but only one-third (33.4%) did so in 2017. Although Medicare beneficiary out-of-pocket costs for commonly used generic drug prescriptions generally decreased over time, Medicare beneficiaries may still be paying more for the same drugs than they would through Walmart's GDDP. Increased generic drug price transparency, including enforcing bans on gag clauses, is needed to ensure that Medicare beneficiaries obtain drugs using the most affordable options.

What you should know about 2020 Medicare prescription drug plans

What you should know about 2020 Medicare prescription drug plans

Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings.

The boxed warning (also known as "black box warning") is one of the FDA's strongest safety actions for pharmaceuticals. After the FDA issues black box warnings for drugs, prescribing changes have been inconsistent. Formulary management may provide an opportunity to restrict access to drugs with serious safety concerns. To examine Medicare prescription drug plan formulary changes after new FDA postmarket black box warnings and major updates to preexisting black box warnings. In this cohort study, we identified each drug that received a new FDA postmarket black box warning or a major update to a preexisting black box warning from January 2008 through June 2015 and examined its formulary coverage. The main outcome measure was the proportion of Medicare prescription drug plan formularies providing unrestrictive coverage immediately before the black box warning, at least 1 year after the warning and at least 2 years after the warning. Unrestrictive formulary coverage was defined as coverage of a drug without prior authorization or step-therapy requirements. Of 101 new black box warnings and major updates to preexisting warnings affecting 68 unique drug formulations, the mean percentage of formularies providing unrestrictive coverage changed from 65.4% (95% CI = 59.6%-71.2%) prewarning; 62.6% (95% CI = 56.3%-68.9%, P = 0.04) at least 1 year postwarning; and 61.9% (95% CI = 55.4%-68.5%, P = 0.10) at least 2 years postwarning. The mean percentage of Medicare prescription drug plan formularies providing unrestrictive coverage decreased modestly by approximately 3 percentage points after drugs received postmarket FDA black box warnings. Formulary restrictions may present an underused mechanism to reduce use of potentially unsafe medications. This study was supported by a student research grant received by Solotke and provided by the Yale School of Medicine Office of Student Research under National Institutes of Health training grant award T35DK104689. Karaca-Mandic, Shah, and Ross acknowledge support from Agency for Healthcare Research and Quality (AHRQ) grant R01 HS025164, which studies factors associated with de-adoption of drug therapies shown to be ineffective or unsafe. The content of this study is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors assume full responsibility for the accuracy and completeness of the ideas presented. Ross has received support from the following: the U.S. Food and Drug Administration (FDA) as part of the Centers for Excellence in Regulatory Science and Innovation (CERSI) program; Johnson and Johnson through Yale University to develop methods of clinical trial data sharing; Medtronic and the FDA to develop methods for postmarket surveillance of medical devices; the Blue Cross Blue Shield Association to better understand medical technology evaluation; the Centers for Medicare & Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting; the AHRQ to examine community predictors of health care quality; and the Laura and John Arnold Foundation, which established the Collaboration for Research Integrity and Transparency at Yale University. Shah has received support from the FDA as part of the CERSI program. In addition, he has received support through the Mayo Clinic from CMS, AHRQ, National Science Foundation, and Patient-centered Outcomes Research Institute. Karaca-Mandic has provided consulting services to Precision Health Economics and Tactile Medical for work unrelated to this manuscript. Dhruva and Solotke have no conflicts of interest to report.

Psychometric evaluation of the Medicare Advantage and prescription drug plan disenrollment reasons survey.

To develop and assess the reliability and validity of composite measures of reasons for disenrollment from Medicare Advantage (MA) and prescription drug plans (PDPs). Medicare beneficiaries who responded to the Medicare Advantage and Prescription Drug Plan Disenrollment Reasons Survey. Separate multilevel factor analyses of MA and PDP data suggested groupings of survey items to form composite measures, for which internal consistency and interunit reliability were estimated. The association of each composite with an overall plan rating was examined to evaluate criterion validity. Five composites were identified: financial reasons for disenrollment; problems with prescription drug benefits and coverage; problems getting information and help from the plan; problems getting needed care, coverage, and cost information; and problems with coverage of doctors and hospitals. Beneficiary-level internal consistency reliability exceeded 0.70 for all but one composite (financial reasons); plan-level internal consistency reliability exceeded 0.80 for all composites; average interunit reliability for plans with≥30 survey completes exceeded 0.75 for 3 of 5 composites. As expected, greater endorsement of reasons for disenrollment was associated with lower overall plan ratings. The Disenrollment Reasons Survey provides a reliable and valid assessment of beneficiaries' reasons for leaving their plans. Multiple reasons for disenrollment may indicate especially poor experiences.