Macular Degeneration Drug Prescribing Patterns After Step Therapy Introduction in Medicare Advantage.

Importance: In Medicare Advantage (MA), step therapy for physician-administered drugs is an approach to lowering drug spending. The impact of step therapy in MA on prescribing behavior and the magnitude of any changes has not been analyzed. Objective: To evaluate the impact of step therapy on macular degeneration drug prescribing patterns for 3 large MA insurers. Design, Setting, and Participants: This was a retrospective encounter-based analysis using 20% nationally representative MA outpatient and carrier encounter records for 2017 to 2019. Participants were MA beneficiaries who were 65 years or older and had received a macular degeneration drug administration. Macular degeneration drug administrations for beneficiaries of MA Aetna, Humana, and UnitedHealthcare (UHC) insurers were assessed. Humana implemented macular degeneration step therapy in 2019, setting bevacizumab as the plan-preferred drug, and aflibercept and ranibizumab as the plan-nonpreferred drugs. Aetna and UHC, which did not implement macular degeneration step therapy, served as the control group. Data analyses were performed from May 2024 to December 2024. Exposures: A macular degeneration drug administration subject to a step therapy policy. Main Outcome and Measures: A binary indicator of whether the drug administered was bevacizumab. Linear probability models and a difference-in-differences framework were used to quantify changes in prescribing patterns before and after the introduction of step therapy for MA insurers that did and did not implement step therapy. To empirically measure the impact of step therapy, the first administration of a treatment episode was assessed, followed by switching patterns. Results: A total of 18 331 MA beneficiaries, 21 683 treatment episodes, and 171 985 drug administrations were included across the control and treatment groups. The difference-in-differences regressions found a 7.8% (95% CI, 4.9%-10.7%; P < .001) greater probability of being prescribed bevacizumab for the first administration due to step therapy. The predicted probabilities of preferred-drug administration in the treatment group increased from 0.61 to 0.70 between the periods before and after step therapy implementation for the first administration. Step therapy was not significantly associated with an increased rate of medication switching (hazard ratio, 0.86; 95% CI, 0.71-1.06; P = .15). Conclusions and Relevance: The findings of this retrospective encounter-based analysis indicate that step therapy is associated with a greater probability of prescribing the plan-preferred drug for the first administration. The analysis failed to find a statistically significant greater rate of medication switching within a treatment episode. Step therapy changed macular degeneration prescribing patterns, but step therapy alone did not transition all administrations to the plan-preferred drug.

Adjusting starting points for initial price offers: the example of ibrutinib.

The Inflation Reduction Act of 2022 (IRA) allows the Medicare program to negotiate drug prices beginning in 2024. Based on the guidance in the statute, CMS has selected specific data items to use to adjust initial price offers for 10 drugs in the decision-making process. Although much of the data are publicly available, some of these data items will need to be collected directly from drug companies. A 2019 US House of Representatives Committee on Oversight and Accountability investigative report collected a wide range of data from manufacturers of 12 high-revenue drugs that show what is available from the drug companies, including development costs, marketing, pricing, competition, and patent status. This article focuses on the data obtained for ibrutinib, an oral medication for treating hematologic malignancies, which is one of the only drugs reviewed by the committee that also has been selected for Medicare price negotiation. We examine data that can be obtained only from the drug manufacturer that the IRA has explicitly identified as being used to determine the price and suggest potential negotiation strategies for CMS in response.

Sociodemographic and spending characteristics of Medicare beneficiaries taking prescription drugs subject to price negotiations.

BACKGROUND: The 2022 Inflation Reduction Act authorizes Medicare to negotiate the prices of 10 drugs in 2026 and additional drugs thereafter. Understanding the sociodemographic and spending characteristics of beneficiaries taking these specific drugs could be important describing the impact of the legislation. OBJECTIVE: To describe sociodemographic and spending characteristics of Medicare beneficiaries who use the 10 prescription drugs ("negotiated drugs") that will face Medicare drug price negotiations in 2026. METHODS: A 20% sample of Medicare Part D beneficiaries from 2020 (n = 10,224,642) was used. Sociodemographic and spending characteristics were descriptively reported for beneficiaries taking the negotiated drugs, including subgroups by low-income subsidy (LIS) status and by drug, and for Part D beneficiaries not taking negotiated drugs. RESULTS: Part D beneficiaries taking a negotiated drug compared with Part D beneficiaries not taking a negotiated drug overall had similar sociodemographic characteristics, more comorbidities (3.9 vs 2.2) and higher mean [median] Medicare ($33,882 [$18,251] vs $12,366 [$3,429]) and out-of-pocket (OOP) spending ($813 [$307] vs $441 [$160]). There was variation in characteristics by LIS status. The mean age was highest among non-LIS beneficiaries taking a negotiated drug compared with LIS beneficiaries taking a negotiated drug and beneficiaries not taking a negotiated drug (76.2 vs 69.9 vs 71.4). Among beneficiaries using negotiated drugs, a higher percentage of LIS beneficiaries compared with non-LIS was female (59.7% vs 48.0%), was Black (20.9% vs 6.6%), and resided in lower-income areas (39.1% vs 20.3%). Mean [median] annual Part D OOP spending for negotiated drugs was $115 [$59] for beneficiaries with LIS and $1,475 [$1,204] for beneficiaries without LIS. There were also differences depending on which negotiated drug was used. Drugs for cancer and blood clots had the highest proportions of White users, whereas type 2 diabetes and heart failure drugs had the highest proportions of Black users and beneficiaries residing in lower-income areas. Annual Part D OOP costs were lowest for sitagliptin (LIS: $104 [$60], non-LIS: $1,391 [$1,153]) and highest for ibrutinib (LIS: $649 [$649], non-LIS: $6,449 [$6,867]). Among non-LIS beneficiaries, 24% (22% to 76%) had more than $2,000 in OOP costs. CONCLUSIONS: Inflation Reduction Act OOP spending caps and LIS expansion will lower prescription drug costs for beneficiaries with OOP costs exceeding $2,000 who are mostly White and live in higher-income areas, insulin users who are disproportionately Black with multiple chronic conditions, and beneficiaries with low incomes. However, these provisions will not impact the 76% of non-LIS beneficiaries using negotiated drugs who have OOP costs that are still substantial but below $2,000. Negotiations could reduce OOP costs through reduced coinsurance payments for this group, which is older and has more chronic conditions compared with beneficiaries not taking negotiated drugs. Part D plan design, spending, and utilization changes should be monitored after negotiation to determine if further solutions are needed to lower OOP costs for this group.

Facility Fees for Colonoscopy Procedures at Hospitals and Ambulatory Surgery Centers.

This cross-sectional study investigates commercial facility fee differences for colonoscopy procedures between US hospitals and ambulatory surgery centers located within the same county and contracting with the same insurers.

Hospital Prices For Commercial Plans Are Twice Those For Medicare Advantage Plans When Negotiated By The Same Insurer.

Most major insurers operate in both the commercial health insurance and Medicare Advantage (MA) markets. We investigated the ratio of commercial-to-MA prices negotiated by the same insurer, in the same hospital and for the same services, using 2022 price information disclosed by hospitals in compliance with the hospital price transparency rule. Insurers negotiated median hospital prices for commercial plans that were two to three times higher than their MA prices in the same hospital for the same service. The median commercial-to-MA price ratio in the same hospital varied, from 1.8 for surgery and medicine services to 2.2 for laboratory tests and emergency department visits and 2.4 for imaging services. In multivariable Poisson regression analysis, higher ratios were associated with system-affiliated, nonprofit, and teaching hospitals, as well as with large national insurers. These findings reflect the differences in financial incentives and regulatory policies in the commercial and MA markets. Because insurers respond to differing incentives by obtaining different negotiated prices across markets, policy and practice efforts that alter incentives for insurers may have the potential to lower commercial prices.

Association Between Drug Characteristics and Manufacturer Spending on Direct-to-Consumer Advertising.

Importance: Some drugs are heavily marketed through direct-to-consumer advertising. Objective: To identify drug characteristics associated with a greater share of promotional spending on advertising directly to consumers. Design, Setting, and Participants: Exploratory cross-sectional analysis of drug characteristics and promotional spending for the 150 top-selling branded prescription drugs in the US in 2020 as identified from IQVIA National Sales Perspectives data. Promotional spending data were provided by IQVIA ChannelDynamics. Exposures: Drug characteristics (total 2020 sales; total 2020 promotional spending; clinical benefit ratings; number of indications, off-label use; molecule type; nature of condition treated; administration type; generic availability; US Food and Drug Administration [FDA] approval year, World Health Organization anatomical therapeutic chemical classification; Medicare annual mean spending per beneficiary; percent sales attributable to the drug; market size; market competitiveness) assessed from health technology assessment agencies (France's Haute Autorité de Santé and Canada's Patented Medicine Prices Review Board) and drug data sources (Drugs@FDA, the FDA Purple Book, Lexicomp, Merative Marketscan Research Databases, and Medicare Spending by Drug data). Main Outcomes and Measures: Proportion of total promotional spending allocated to direct-to-consumer-advertising for each drug. Results: The 2020 median proportion of promotional spending allocated to direct-to-consumer advertising was 13.5% (IQR, 1.96%-36.6%); median promotional spending, $20.9 million (IQR, $2.72-$131 million); and median total sales, $1.51 billion (IQR, $0.97-$2.26 billion). Of the 150 best-selling drugs, 16 were missing data and key covariates; therefore, the primary study sample comprised 134 drugs. After adjustment for multiple drug characteristics, the mean proportion of total promotional spending allocated to direct-to-consumer advertising for the remaining 134 drugs was an absolute 14.3% (95% CI, 1.43%-27.2%; P = .03) higher for those with low added clinical benefit than for those with high added clinical benefit and an absolute 1.5% (95% CI, 0.44%-2.56%; P = .005) higher for each 10% increase in total sales. Conclusions and Relevance: Among top-selling US drugs in 2020, a rating of lower added benefit and higher total drug sales were associated with a higher proportion of manufacturer total promotional spending allocated to direct-to-consumer advertising. Further research is needed to understand the implications of these findings.

Association Between Open Payments-Reported Industry Transfers of Value and Prostaglandin Analog Prescribing in the US.

Importance: Reported transfers of value (TOV) from pharmaceutical companies have been associated with greater use of branded anti-vascular endothelial growth factor agents by ophthalmologists, but payment under the Medicare Part B buy-and-bill model includes a financial incentive to choose costlier agents, potentially confounding analyses of pharmaceutical TOV and prescribing patterns. How these reported TOV are associated with prescribing patterns for prescription eye drops, not subject to the incentives created by Part B payments, should be considered. Objective: To assess the association between prostaglandin analog (PGA) eye drop prescribing and reported nonresearch TOV by makers of branded PGAs to US vision care professionals. Design, Setting, and Participants: This retrospective cohort analysis used a 20% nationally representative sample of 2018 Medicare Part D claims and industry TOV reported to the Open Payments program. Optometrists and ophthalmologists who had more than 10 claims for PGA drops in the 20% sample were analyzed. Analysis took place from June 2021 to February 2022. Main Outcomes and Measures: Multivariable logistic regression assessing the association between membership in strata of reported TOV and branded PGA prescribing rate, controlling for prescriber demographic factors, local area practices, total PGA prescribing volume, and plan formularies involved. Results: A total of 20 612 ophthalmologists and 5426 optometrists (7449 [29%] female and 18 589 [71%] male) prescribed PGA eye drops. Of these, 9685 (37%) were reported to have received TOV from manufacturers of branded PGAs in 2018, totaling $5 060 346. The median (IQR) reported TOV was $65 ($24-$147). Multivariable logistic regression showed that the predicted probability of primarily prescribing branded PGAs among prescribers who reported receiving no TOV was 12.9% (95% CI, 12.4%-13.4%). This figure increased to 19.6% (95% CI, 18.8%-20.4%) among prescribers receiving TOV, a 50% increase. There was a dose-response association, such that the top 10% of TOV recipients had a 29.2% probability (95% CI, 26.4%-31.9%) of preferential branded use. Conclusions and Relevance: While the median reported TOV to a PGA prescriber was relatively low in this study, there was a positive association between amount of reported nonresearch TOV received from PGA makers and the frequency of branded PGA use. This shows that small reported TOV were associated with differences in prescribing. High rates of branded PGA prescribing may pose a cost burden to patients that affects adherence. Clinicians and policy makers should be aware of these associations.

Medicare Spending on Drugs With Accelerated Approval.

BACKGROUND: The U.S. Food and Drug Administration provides accelerated approval to drugs on the basis of surrogate end points deemed to be "reasonably likely" to predict clinical benefit. To receive full approval, drugs must complete a confirmatory trial. Although most accelerated approved drugs ultimately receive full approval, others remain on the market without full approval for many years, and some are withdrawn before full approval is granted. Until confirmatory trials are completed and full approval is granted, there is uncertainty surrounding each drug's clinical benefits. OBJECTIVE: To estimate fee-for-service Medicare payments on accelerated approved drugs without full approvals. DESIGN: Cross-sectional analysis. SETTING: Fee-for-service Medicare Part B and Part D drug claims in 2019. PARTICIPANTS: Beneficiaries enrolled in Medicare Part B and Part D plans. MEASUREMENTS: Medicare spending for drugs treating accelerated approved indications without full approval, beneficiary spending, and drug characteristics. RESULTS: In 2019, 45 drugs associated with 69 accelerated approved indications lacked full approval. Of those, the fee-for-service Medicare program spent $1.2 billion on 36 drugs across 55 indications. Medicare beneficiaries had $209 million in out-of-pocket spending on these drugs. Oncology drugs represented 82% of these indications and 72% of the Medicare spending. Extrapolating to Medicare Advantage, total Medicare spending on these drugs in 2019 was $1.8 billion. LIMITATIONS: The study drugs may have clinical benefit and may come to receive full approval after this analysis. The algorithm used to identify accelerated approved indications is novel. Generalizability to other years is unclear. CONCLUSION: In 2019, fee-for-service Medicare spent $1.2 billion on accelerated approved drugs without full approval. Medicare should adjust incentives to encourage sponsors to complete confirmatory trials as soon as possible. PRIMARY FUNDING SOURCE: Laura and John Arnold Foundation.

Payment incentives and the use of higher-cost drugs: a retrospective cohort analysis of intravenous iron in the Medicare population.

OBJECTIVES: Medicare Part B payment methods incentivize the use of more expensive injectable and infused drugs. We examined prescribing patterns in the context of intravenous (IV) iron, for which multiple similarly safe and efficacious formulations exist, with wide variations in price. STUDY DESIGN: We conducted a retrospective cohort analysis of IV iron utilization and payment in the Medicare population between 2015 and 2017. METHODS: This analysis used a national, random 20% sample of Medicare fee-for-service beneficiaries with Part B claims for IV iron between January 2015 and December 2017-a period before, during, and after a national shortage of iron dextran. This sample included 66,710 Medicare fee-for-service beneficiaries with at least 1 Part B claim for IV iron. RESULTS: The greatest increase in utilization occurred in the most expensive iron formulation, ferric carboxymaltose; its market share rose from 27.4% of use in 2015 to 47.7% in 2017. The use of a less expensive formulation, iron dextran, decreased from 26.7% to 18.7% over the same period. An alternative payment model in Maryland hospitals was associated with markedly less utilization of ferric carboxymaltose, accounting for 4.7% of IV iron utilization in Maryland hospitals. CONCLUSIONS: There was an increase in the dispensing of a higher-priced IV iron formulation associated with a shortage of a less expensive drug that persisted once the shortage ended. These findings in IV iron have broader implications for Part B drug payment policy because the price of the drug determines the physician and health system payment.

The Impact of Adherence to Clinical Practice Guidelines on Medical Costs.

OBJECTIVE: To examine the association between non-adherence to clinical practice guidelines (CPGs) and medical and indemnity spending among back and shoulder injury patients. METHODS: Workers compensation claims data was used from a large, US insurer (1999 to 2010). Least square regression models were created to examine the association between spending and guideline-discordant care. RESULTS: Non-adherence to CPGs was associated with higher medical and indemnity spending for 11 of the 28 CPG indicators. Failure to adhere to the other CPGs did not increase medical or total spending. After covariate adjustment, non-adherence to these 11 CPGs was associated with spending increases that ranged from $16,000 for physical therapy (PT) to $114,000 for surgery. CONCLUSIONS: Our results demonstrate that failure to adhere to a subset of CPG indicators significantly predicts increased medical and indemnity spending for two important occupational injuries.

Comparing patient OOP spending for specialty drugs in Medicare Part D and employer-sponsored insurance.

OBJECTIVES: Per capita spending on specialty drugs increased 55% between 2014 and 2018. Individuals aged 55 to 75 years using specialty drugs make the transition from employer-sponsored insurance (ESI) to Medicare Part D coverage. We compared out-of-pocket (OOP) spending across ESI, Medicare fee-for-service (FFS), and Medicare Advantage (MA) prescription drug plans to examine the impact of benefit design on OOP spending. STUDY DESIGN: Analyses consisted of Truven MarketScan and Medicare Part D prescription drug claims from 2013 to 2017 for individuals enrolled in ESI, FFS, and MA drug plans taking at least 1 drug among the top 4 specialty drug classes: rheumatoid arthritis (RA), multiple sclerosis (MS), cancer, and hepatitis C. METHODS: Multivariate regression analyses with fixed effects were used to assess whether there are differences in OOP spending by insurance type and the impact of benefit design differences. A secondary outcome was drug choice within a therapeutic class. RESULTS: There were small differences in drug choice between Medicare and ESI but significant differences in OOP spending. Monthly OOP spending for ESI relative to FFS was $108 less for RA drugs, $288 less for MS drugs, $504 less for cancer drugs, and $1437 less for hepatitis C drugs. Spending was slightly greater for beneficiaries in MA plans compared with FFS. Higher Medicare spending was driven by gaps in coverage in the Part D benefit phases because beneficiaries pay a percentage of list price. CONCLUSIONS: OOP spending was substantially higher for Medicare enrollees compared with ESI enrollees as a result of the Part D benefit structure.

The likely economic impact of fewer elective surgical procedures on US hospitals during the COVID-19 pandemic.

BACKGROUND: To help control the coronavirus disease 2019 pandemic, elective procedures have been cancelled in most US hospitals by government order. The purpose of this study is to estimate national hospital reimbursement and net income losses owing to elective surgical procedure cancellation during the coronavirus disease 2019 pandemic. METHODS: The National Inpatient Sample and the Nationwide Ambulatory Surgery Sample were used to identify all elective surgical procedures performed in the inpatient setting and in hospital-owned outpatient surgery departments throughout the United States. Total cost, reimbursement, and net income was determined for all elective surgical procedures. RESULTS: The estimated total annual cost of elective inpatient and outpatient surgical procedures in the United States was $147.2 billion, and estimated total hospital reimbursement was $195.4 to $212.2 billion. This resulted in a net income of $48.0 to $64.8 billion per year to the US hospital system. Cancellation of all elective procedures would result in estimated losses of $16.3 to $17.7 billion per month in revenue and $4 to $5.4 billion per month in net income to US hospitals. CONCLUSION: Cancellation of elective procedures during the coronavirus disease 2019 pandemic has a substantial economic impact on the US hospital system.

Economic implications of decreased elective orthopaedic and musculoskeletal surgery volume during the coronavirus disease 2019 pandemic.

PURPOSE: In order to reduce viral spread, elective surgery was cancelled in most US hospitals for an extended period during the COVID-19 pandemic. The purpose of this study was to estimate national hospital reimbursement and net income losses due to elective orthopaedic surgery cancellation during the COVID-19 pandemic. METHODS: The National Inpatient Sample (NIS) and the Nationwide Ambulatory Surgery Sample (NASS) were used to identify all elective orthopaedic and musculoskeletal (MSK) surgery performed in the inpatient setting and in hospital owned outpatient surgery departments throughout the USA. Total cost, reimbursement, and net income were estimated for all elective orthopaedic surgery and were compared with elective operations from other specialties. RESULTS: Elective MSK surgery accounted for $65.6-$71.1 billion in reimbursement and $15.6-$21.1 billion in net income per year to the US hospital system, equivalent to $5.5-$5.9 billion in reimbursement and $1.3-$1.8 billion in net income per month. When compared with elective surgery from all other specialties, elective MSK surgery accounted for 39% of hospital reimbursement and 35% of hospital net income. Compared with all hospital encounters for all specialties, elective MSK surgery accounted for 13% of reimbursement and 23% of net income. Estimated hospital losses from cancellation of elective MSK surgery during 8 weeks of the COVID-19 pandemic were $10.9-$11.9 billion in reimbursement and $2.6-3.5 billion in net income. CONCLUSION: Cancellation of elective MSK surgery for 8 weeks during the COVID-19 pandemic has substantial economic implications on the US hospital system.

Comparative Renoprotective Effect of Febuxostat and Allopurinol in Predialysis Stage 5 Chronic Kidney Disease Patients: A Nationwide Database Analysis.

Hyperuricemia has been associated with chronic kidney disease (CKD) progression. The antihyperuricemic febuxostat's potential renoprotective effect has been demonstrated in stage 1-3 CKD. Large-scale studies comparing the renoprotective potential of febuxostat and allopurinol in advanced CKD are lacking. We exclusively selected 6,057 eligible patients with predialysis stage 5 CKD prescribed either febuxostat or allopurinol using the National Health Insurance Research Database in Taiwan during 2012-2015. There were 69.57% of allopurinol users and 42.01% febuxostat users who required long-term dialysis (P < 0.0001). The adjusted hazard ratio (HR) of 0.65 (95% confidence interval (CI) 0.60-0.70) indicated near 35% lower hazards of long-term dialysis with febuxostat use. The renal benefit of febuxostat was consistent across most patient subgroups and/or using the propensity score-matched cohort. The adjusted HR was 0.66 (95% CI, 0.61-0.70) for long-term dialysis or death. In conclusion, lower risk of progression to dialysis was observed in predialysis stage 5 CKD febuxostat users without compromising survival.

Patient Selection After Mandatory Bundled Payments for Hip and Knee Replacement: Limited Evidence of Lemon-Dropping or Cherry-Picking.

BACKGROUND: On April 1, 2016, the Centers for Medicare & Medicaid Services (CMS) introduced bundled-payment programs for hip replacement and knee replacement (HKR) in selected metropolitan statistical areas (MSAs) to decrease the costs and cost variability of HKR and to increase the quality of care. Early program analyses showed cost savings; however, studies also demonstrated a trend toward the selection of healthier patients for HKR performed under the bundled system. We compared the characteristics of patients who underwent HKR before implementation of the bundled-payment system (pre-policy) with those of patients who underwent HKR after implementation (post-policy). METHODS: Patients who underwent HKR from 2015 to 2016 were identified from Medicare inpatient claims files. After matching for MSA characteristics, we used a difference-in-difference design to evaluate changes in patient case mix from pre-policy to post-policy by comparing Medicare beneficiaries receiving HKR in bundled MSAs (bMSAs) with those receiving HKR in non-bundled MSAs (nbMSAs). The main characteristics of interest were race, dual eligibility (for Medicare and Medicaid), tobacco use, obesity, presence of diabetes with or without complications, and Charlson Comorbidity Index (CCI) value. We also evaluated pre-policy to post-policy changes in patient case mix by comparing Medicare beneficiaries in bMSAs who underwent HKR compared with those who underwent hip hemiarthroplasty. Hip hemiarthroplasty was used as a control to determine whether there were changes in access to HKR. RESULTS: We found significant differences in the unadjusted baseline characteristics between the bMSA and nbMSA cohorts, both for unmatched and matched samples. We found no significant post-policy changes in the characteristics of patients undergoing HKR. Patients undergoing hemiarthroplasty had significantly higher CCI values than did those undergoing HKR in bMSAs post-policy, although the difference was small (0.36-point higher CCI value; p < 0.01). Patients undergoing hemiarthroplasty were also 2.4% more likely to have diabetes mellitus without complications compared with those who underwent HRK post-policy (p < 0.01). CONCLUSIONS: In contrast to previous investigators, we found little to no significant change in the characteristics (including race, dual eligibility, tobacco use, obesity, presence of diabetes with or without complications, and CCI value) of Medicare beneficiaries who underwent HKR after the initiation of the CMS mandatory bundled-payment policy.

Financial Eligibility Criteria and Medication Coverage for Independent Charity Patient Assistance Programs.

Importance: Although independent charity patient assistance programs improve patient access to costly prescription drugs, recent federal investigations have raised questions about their potential to increase pharmaceutical spending and to violate the federal Anti-Kickback Statute. Little is known about the design of the programs, patient eligibility, or drug coverage. Objective: To examine the eligibility criteria of the independent charity patient assistance programs and the drugs covered by them. Design, Setting, and Participants: Descriptive cross-sectional study of the 6 largest independent charities offering patient assistance programs for patients including, but not limited to, Medicare beneficiaries in 2018. These charities offered 274 different disease-specific patient assistance programs. Drugs were identified for subgroup analysis that had any use reported on the Medicare Part D spending dashboard and any off-patent brand-name drugs that incurred more than $10 000 in Medicare spending per beneficiary in 2016. Exposures: Support by independent charity patient assistance programs. Main Outcomes and Measures: The primary outcomes were the characteristics of patient assistance programs, including assistance type, insurance coverage (vs uninsured), and income eligibility. The secondary outcomes were the cost of the drugs covered by the patient assistance programs and the coverage of expensive off-patent brand-name drugs vs substitutable generic drugs. Results: Among the 6 independent charity foundations included in the analysis, their total revenue in 2017 ranged from $24 million to $532 million, and expenditures on patient assistance programs ranged from $24 million to $353 million, representing on average, 86% of their revenue. Of the 274 patient assistance programs offered by these organizations, 168 (61%) provided only co-payment assistance, and the most common therapeutic area covered was cancer or cancer treatment-related symptoms (113 patient assistance programs; 41%). A total of 267 programs (97%) required insurance coverage as an eligibility criterion (ie, excluded uninsured patients). The most common income eligibility limit was 500% of the federal poverty level. The median annual cost of the drugs per beneficiary covered by the programs was $1157 (interquartile range, $247-$5609) compared with $367 (interquartile range, $100-$1500) for the noncovered drugs. Off-patent brand-name drugs (cost: >$10 000) were covered by a mean of 3.1 (SD, 2.0) patient assistance programs, whereas their generic equivalents were covered by a mean of 1.2 (SD, 1.0) patient assistance programs. Conclusions and Relevance: In 2018, among 274 patient assistance programs operated by the 6 independent charity foundations, the majority did not provide coverage for uninsured patients. Medications that were covered by the patient assistance programs were generally more expensive than those that were not covered.

Variations in life expectancy in Organization for Economic Co-operation and Development countries--1985-2010.

AIM: We examined the impact of different behavioral factors of health on the variations in the levels and rate of increase in life expectancy in Organization for Economic Co-operation and Development countries between 1985 and 2010. METHODS: Using the World Health Organization's conceptual framework of socio-economic determinants of health, we incorporated Organization for Economic Co-operation and Development, World Bank and United Nations data to estimate the impact of these variables on life expectancy for 30 Organization for Economic Co-operation and Development countries. We used a random effect model to control the fixed effect of year and each country. RESULTS: Results show that the level of health care spending is the most important factor predicting life expectancy. Other important factors are gross domestic product per capita, labor productivity, years of schooling and percentage of gross domestic product spending allocated for public services. Life expectancy was reduced by smoking and higher daily calorie consumption. Countries that were previously part of the Soviet Union had lower life expectancies. Political factors had only a minor impact on life expectancy. CONCLUSIONS: Life expectancy increased an average of 5.1 years in Organization for Economic Co-operation and Development countries between 1985 and 2010, but there was wide variation. Health spending per capita, economic factors and two behavioral factors - smoking and caloric intake - explained most of the variation and suggest where increased policy attention could have the greatest impact on life expectancy. Policymakers who consider our estimates recognize that they may see greater or less impact depending on the characteristics of their nation.

Geographic variability of adherence to occupational injury treatment guidelines.

OBJECTIVES: To determine the geographic variability and relationship between six occupational injury practice guidelines. METHODS: Guidelines were developed by an expert panel and evaluated using workers' compensation claims data from a large, national insurance company (1999 to 2010). Percentage compliance for each guideline was adjusted for age and sex using linear regression and mapped by hospital referral region. Regions with the lowest compliance were identified, and correlations between guidelines were calculated. RESULTS: Compliance to the unnecessary home care guideline showed the lowest geographic variation (interquartile range: 97.3 to 99.0), and inappropriate shoulder bracing showed the highest variation (interquartile range: 77.7 to 90.8). Correlation between the guidelines was weak and not always positive. CONCLUSIONS: Different guidelines showed different degrees of geographic variation. Lack of correlation between guidelines suggests that these indicators were not associated with a single underlying health care quality or patient severity construct.

Multiple chronic conditions and life expectancy: a life table analysis.

BACKGROUND: The number of people living with multiple chronic conditions is increasing, but we know little about the impact of multimorbidity on life expectancy. OBJECTIVE: We analyze life expectancy in Medicare beneficiaries by number of chronic conditions. RESEARCH DESIGN: A retrospective cohort study using single-decrement period life tables. SUBJECTS: Medicare fee-for-service beneficiaries (N=1,372,272) aged 67 and older as of January 1, 2008. MEASURES: Our primary outcome measure is life expectancy. We categorize study subjects by sex, race, selected chronic conditions (heart disease, cancer, chronic obstructive pulmonary disease, stroke, and Alzheimer disease), and number of comorbid conditions. Comorbidity was measured as a count of conditions collected by Chronic Conditions Warehouse and the Charlson Comorbidity Index. RESULTS: Life expectancy decreases with each additional chronic condition. A 67-year-old individual with no chronic conditions will live on average 22.6 additional years. A 67-year-old individual with 5 chronic conditions and ≥10 chronic conditions will live 7.7 fewer years and 17.6 fewer years, respectively. The average marginal decline in life expectancy is 1.8 years with each additional chronic condition-ranging from 0.4 fewer years with the first condition to 2.6 fewer years with the sixth condition. These results are consistent by sex and race. We observe differences in life expectancy by selected conditions at 67, but these differences diminish with age and increasing numbers of comorbid conditions. CONCLUSIONS: Social Security and Medicare actuaries should account for the growing number of beneficiaries with multiple chronic conditions when determining population projections and trust fund solvency.