Gerard F. Anderson's research while affiliated with Johns Hopkins Medicine and other places

Publications (291)

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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 pharm...
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Background Well-functioning competitive markets are key to controlling generic drug prices. This is important since over 90% of all drugs sold in the US are generics. Recently, there have been examples of large price increases in the generic market. Methods This paper examines price trajectories for generic drugs using a group-based trajectory mod...
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Opinions relating to a national coverage determination for aducanumab. See the related article by DiStefano et al., pages 1685–1694.
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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 t...
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Objectives: Three different out-of-pocket (OOP) maximums in Medicare Part D have been proposed: $2000 by the House of Representatives, $3100 by the Senate Finance Committee, and the beginning of catastrophic coverage by the Medicare Payment Advisory Commission. However, little is known about how beneficiaries would be affected. Study design: We...
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Background: Despite controversy among experts regarding aducanumab's approval by the U.S. Food and Drug Administration, little is known about public opinion on this matter. Methods: We conducted a representative survey of U.S. adults ages 35 and older to (1) determine opinions regarding aducanumab's approval, (2) identify any evidence of reputat...
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Background Advanced chronic kidney disease (CKD) patients are at higher risk of sepsis-related mortality following infection and bacteremia. Interestingly, the urate-lowering febuxostat and allopurinol, both xanthine oxidase inhibitors (XOis), have been suggested to influence the sepsis course in animal studies. In this study, we aim to investigate...
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Objective To compare prices paid by commercial insurers for ambulatory services in physician office and hospital outpatient settings. Data Sources MarketScan Commercial Claims and Encounters database obtained from Truven Health Analytics. Study Design We examined ambulatory service claims for a sample of privately insured individuals who were con...
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BACKGROUND: Genetic therapies are a promising treatment for children born with spinal muscular atrophy (SMA); however, their high price tags can evoke coverage restrictions. OBJECTIVE: To assess variation in coverage guidelines across fee-for-service state Medicaid programs for 2 novel genetic therapies, nusinersen and onasemnogene abeparvovec, tha...
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Policy Points Policymakers considering introduction of a health insurance "public option" to lower health spending and reduce the number of uninsured can learn from Washington State, which offered the nation's first public option ("Cascade Care") through its state exchange in 2021. This article examines insurer participation, pricing, and enrollmen...
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Objective To examine non-profit hospitals’ financial and spending allocations when the private sector payment rate is higher than the Medicare's payment rate. Data Sources Hospital financial data for 2014 – 2018 from Center for Medicare and Medicaid Services Hospital Cost Reports, hospital characteristics from the American Hospital Association (AH...
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Nonprofit hospitals provide charity care to financially disadvantaged patients according to their self-designed eligibility policies. The Affordable Care Act may have prompted nonprofit hospitals to adopt more generous eligibility policies, but no prior research has examined the longitudinal trend. The expansion of Medicaid coverage in many states...
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Importance Drug companies offer coupons to lower the out-of-pocket costs for prescription drugs, yet little is known about why they do so for some drugs but not for others. Objective To examine whether the following factors are associated with manufacturer drug coupon use: (1) patient-cost characteristics (mean per-patient cost per drug, mean pati...
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Objectives: Self-insured employers cover more people than Medicare, Medicaid, or direct purchasers of private insurance.This study examined the ability of self-insured employers to negotiate hospital prices and the relationship between hospital prices and employer market power in the United States. Study design: Repeated cross-section analysis o...
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The proliferation of "ultra-expensive" drugs has sparked debate on their sustainability and affordability. Medicare Part D's share of annual spending on these drugs increased by 1,170 percent between 2012 and 2018, largely because the number of beneficiaries receiving them increased during this period.
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Policymakers are using different ways to measure the community benefit provided by non-profit hospitals because different policy makers have different policy objectives. We compare 3 commonly used measures of community benefit; examine the correlation across the 3 measures; examine how the distribution of community benefits varies across non-profit...
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Objective We examined the characteristics of non‐profit hospitals providing more community benefits and charity care than value of their tax exemptions and how this relationship changed between 2011 and 2018. Data sources Primary dataset was schedule H Form IRS 990 data. This data was merged with the American Hospital Association, Medicare Hospita...
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In concentrated labor markets, where workers have fewer employers to choose from, employers may exploit their monopsony power by contributing less to workers' health benefits. This study examined if labor market concentration was associated with higher worker contributions to health plan premiums. We combined publicly available data from the Census...
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Objectives: Stand-alone prescription drug plans (S-PDPs) and Medicare Advantage prescription drug (MA-PD) plans are incentivized to cover outpatient medications differently. This could affect the coverage of inhalers that prevent costly exacerbations of chronic obstructive pulmonary disease (COPD), with impacts for the Medicare program and its ben...
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Objectives: Most Medicaid beneficiaries with hepatitis C virus (HCV) are not treated with direct-acting agents because of budget constraints, but they experience costly complications after becoming Medicare eligible. Maryland's "total coverage" proposal could receive a credit from Medicare to offset Medicaid investments in treatments that could le...
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Importance: Patients may be unaware of which laboratory is processing their clinical tests, limiting their ability to choose an in-network laboratory. Out-of-network laboratory services could increase patients' out-of-pocket costs and their reluctance to obtain necessary tests. Objective: To evaluate the frequency and cost of out-of-network bill...
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The different tax treatment of government, nonprofit, and for-profit hospitals implies different charity care obligations, with the greatest obligation for government hospitals and the least for for-profit hospitals. Prior research has not examined charity care provision among all three ownership types at the national level. Using 2018 Medicare Hos...
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The COVID-19 pandemic has revealed the vulnerability of the US generic drug supply chain to foreign production. Many policies have been proposed to mitigate this vulnerability. In this article, we argue that nonprofit drug manufacturers have the potential to make important contributions.
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Importance Despite ongoing debate regarding the high prices that patients pay for prescription drugs, to our knowledge, little is known regarding the use of coupons, vouchers, and other types of copayment “offsets” that reduce patients’ out-of-pocket drug spending. Although offsets reduce patients’ immediate cost burden, they may encourage the use...
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Importance: Branded products of multisource drugs are frequently dispensed in the Medicare Part D program, increasing costs for the program and patients. Objective: To examine the reasons for dispensing branded multisource drugs in Medicare Part D. Design, setting, and participants: This cross-sectional study examined claims for multisource dr...
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Among the various approaches to address rising prescription drug costs, one option is to allow the federal government to negotiate prices directly with drug manufacturers. Debates over the appropriate negotiating approach have occurred on several dimensions, ¹ including the number of drugs eligible for negotiation, the levers that would be implemen...
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Importance Prior research suggests an association between burden of disease and National Institutes of Health (NIH) funding. The allocation of NIH funding should reflect, to some extent, the health needs of the population, along with other factors. Objective To examine the factors associated with NIH funding in 2019 for 46 diseases. Design, Setti...
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Objectives While the United States does not have a method for assessing the added therapeutic benefit of drugs, France, Canada, and Germany do. We examined the added therapeutic benefit of the most expensive drugs prescribed to Medicare Part D beneficiaries in the United States. Methods We identified ultra-expensive drugs with annual Medicare spen...
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Improving the market availability and penetration of biosimilars, “follow-on” versions of biologic products, will require attention to key legal obstacles. Because biosimilars offer the potential for sizeable cost savings to payors and improved access to biologic drugs for patients, obstacles to the timely licensure and market availability of biosi...
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Purpose Biosimilars can generate competition and provide cost savings over reference biologics for the Medicare program and beneficiaries. The extent to which these benefits can be realized in the Medicare Part D program depends on how biosimilars and biologics are placed in the formulary. We conducted a study to examine Medicare formulary placemen...
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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 o...
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While pioglitazone reduces insulin resistance and hepatic gluconeogenesis effectively in patients with type 2 diabetes mellitus (T2DM), these benefits remained controversial in patients with end stage renal disease (ESRD). We compared major adverse cardiac cerebrovascular events (MACCEs) and mortality (overall, infection-related, and MACCE-related)...
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Objectives To examine policy options to deny orphan drug exclusivity after drugs exceed a target population of 200 000 across all orphan indications (combined prevalence threshold) or once drugs receive a nonorphan approval (market approval threshold). Methods Retrospective analysis of drugs with 2 or more orphan approvals from 1983 to July 01, 20...
Preprint
While pioglitazone reduces insulin resistance and hepatic gluconeogenesis effectively in patients with T2DM, these benefits remained controversial in patients with ESRD. We compared MACCEs and mortality (overall, infection-related, and MACCE-related) of pioglitazone to that of DPP4-inhibitors in patients with T2DM and ESRD. From Taiwan’s national h...
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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) presc...
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Objectives: It is unclear on what basis Medicare drug plans impose coverage restrictions on orphan drugs. This study aims to investigate the factors associated with utilization controls in Medicare fee-for-service Part D formularies. Study design: Cross-sectional analysis. Methods: We used multivariate logistic regression to assess the associa...
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PurposeIn 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...
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Background In order to help control the COVID-19 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 due to elective surgical procedure cancellation during the COVID-19 pandemic. Methods The National Inpatient Samp...
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State fee-for-service Medicaid programs have traditionally based payments to pharmacies for drugs on a percentage of the drugs' list price. Because list prices have increased more quickly than the prices actually paid by pharmacies, estimating appropriate reimbursements has become challenging. In recent years most states have switched to models whe...
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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, U.S. insurer (1999 to 2010). Least square regression models were created to examine the association between...
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Objectives The Orphan Drug Act extends exclusivity of branded drugs by 7 years for each rare disease approval. By extending market exclusivity, manufacturers can forestall generic competition. We determined the prevalence of drugs with multiple orphan approvals, the duration for which manufacturers are able to maintain exclusivity using this mechan...
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The financial viability of rural hospitals has been a matter of serious concern, with ongoing closures affecting rural residents' access to medical services. We examined the financial viability of 1,004 US rural hospitals that had consistent rural status in 2011-17. The median overall profit margin improved for nonprofit critical access hospitals (...
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Objectives Little is routinely disclosed about the costs of the pivotal clinical trials that provide the key scientific evidence of the treatment benefits of new therapeutic agents. We expand our earlier research to examine why the estimated costs may vary 100-fold. Design A cross-sectional study of the estimated costs of the pivotal clinical tria...
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The Supreme Court ruled in FTC v. Actavis that a delay in generic entry may be anticompetitive when part of a patent settlement includes a large and otherwise unjustified value transfer to the generic company, termed a reverse payment patent settlement, or “pay-for-delay.” Following Actavis, drug companies have limited the size of reverse payments...
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The United States relies primarily on market forces to determine prices for drugs, whereas most other industrialized countries use a variety of approaches to determine drug prices. Branded drug companies have patents and market exclusivity periods in most industrialized countries. During this period, pharmaceutical companies are allowed to set thei...
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Although biosimilars may offer cost savings over their comparable biologics, use of biosimilars in the United States remains relatively low. This study investigates two barriers to uptake of biosimilars in the United States. First, the U.S. Food and Drug Administration requires that four-letter suffixes be added to the nonproprietary names of all b...
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Hospitals are eligible for nonprofit status, which exempts them from income, property, and sales taxes, in exchange for providing charity care and other community services.¹⁻⁵ Importantly, charity care differs fundamentally from uncompensated care or bad debt because there is no expectation that patients will pay for the services.³,4,6 Based on eac...
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Objectives To examine the uptake of filgrastim-sndz (Zarxio), the first biosimilar to launch in the United States, in the Medicare Part B fee-for-service program from its launch in September 2015 to December 2017 and compare characteristics of patients and facilities that used filgrastim-sndz or originator filgrastim (Neupogen). Methods The 20% sa...
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Objectives. To assess older Americans’ willingness to trade off the possibility of choosing or changing their prescription drug plan for lower drug spending. Methods. We used data from the Kaiser Family Foundation Health Tracking Poll on prescription drugs carried out in February 2019. This nationwide telephone survey oversampled participants aged...
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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; howe...
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Objectives: New federal policies aim to focus Medicare Advantage (MA) plans on the needs of individuals with complex health conditions. Our objective was to examine enrollment patterns of MA beneficiaries with complex needs and the association of enrollment patterns with MA plan performance. Design: Cross-sectional study. Setting: The 2015 Med...
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This paper examines the financial performance of all mergers and acquisitions (M&A) involving publicly traded companies that occurred in the U.S. generic drug industry from 1996 to 2017. The control group was chosen using a nearest neighbor matching procedure. Our empirical strategy controls for unobservable firm‐specific fixed effects as well M&A...
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Hyperuricemia has been associated with chronic kidney disease (CKD) progression. The anti‐hyperuricemic 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 6057 eligible pre‐d...
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Many programs use care managers to improve care coordination for high-need, high-cost patient populations. However, little is known about how programs integrate care managers into care delivery or the attributes shared by successful programs. We used a case study approach to examine the common attributes of 10 programs for high-need, high-cost indi...
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Executive summary: We explore whether nonprofit hospitals report similar amounts of charity care to the Internal Revenue Service (IRS) and Centers for Medicare & Medicaid Services (CMS). We use nonprofit hospitals' financial reports to the IRS and the CMS Medicare costs report for 2011 and 2012. In 2012, hospitals reported spending 7.6% more in ch...
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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...
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Charges for air ambulance services were 4.1-9.5 times higher than what Medicare paid for the same services in 2016. The median charge ratios (the charge divided by the Medicare rate) for the services increased by 46-61 percent in 2012-16. Air ambulance charges varied substantially across the US, and some of the largest providers had among the highe...
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Since the mid-1990s, the differential between what public and private health insurers pay for hospital and physician services has widened considerably. While Medicare establishes rates administratively, private insurers operate within the market to set prices; in part because of increasing consolidation of hospitals, these negotiated private rates...
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Many countries use external reference pricing to help determine drug prices. However, external reference pricing has received little attention in the US-perhaps because the US is often the first adopter of drugs. External reference pricing could be used to set prices for drugs that were already established in the market. We compared the price diffe...
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Objective: As nurse practitioners (NPs) and physician assistants (PAs) become an integral part of delivering emergency medical services, we examined the involvement of NPs and PAs who billed independently in emergency departments (EDs). Methods: We used Medicare provider utilization and payment data from 2012 to 2016 to conduct a retrospective a...
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In public opinion polling, controlling pharmaceutical spending is often at the top of the list of health policy concerns.¹ States have been attempting to lower drug spending for years and have taken a number of different approaches. The Trump Administration proposed multiple reforms to address drug spending,² and Congress is holding hearings on how...
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Transparency has become one of the primary themes in health care reform efforts in the United States and across the world. In the face of exorbitant drug prices, high levels of patient cost-sharing, and pharmaceutical expenditures that consume a growing proportion of public sector budgets, much attention has been drawn to the pharmaceutical industr...
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In the Medicare Part D program, the potential of generic drugs to achieve savings is underused. One reason is that prescription drug plans earn some of their profits through rebates and other price concessions paid by pharmaceutical manufacturers (Medicare calls this direct and indirect remuneration).¹ Although the goal of prescription drug plans i...
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Objectives: To examine whether the share of pharmaceutical industry funds allocated to patient advocacy organizations (PAOs) is disproportionately large in the United States relative to other industrialized countries and to compare pharmaceutical companies' disclosure practices across industrialized countries. Methods: We examined funding of PAO...