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Financial Relationships between Urologists and Industry: An Analysis of Open Payments Data
Author's Accepted Manuscript Financial Relationships between Urologists and Industry: an Analysis of Open Payments Data Mahir Maruf, Abhinav Sidana, William Fleischman, Sam J. Brancato, Stephanie Purnell, Shantanu Agrawal, Piyush K. Agarwal
PII: DOI: Reference:
S2352-0779(17)30086-9 10.1016/j.urpr.2017.03.012 URPR 289
To appear in: Urology Practice Accepted Date: 21 March 2017 Please cite this article as: Maruf M, Sidana A, Fleischman W, Brancato SJ, Purnell S, Agrawal S, Agarwal PK, Financial Relationships between Urologists and Industry: an Analysis of Open Payments Data, Urology Practice (2017), doi: 10.1016/j.urpr.2017.03.012. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.
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Financial relationships between Urologists and industry: an analysis of Open Payments data
*AS and MM contributed equally to the article 1
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Mahir Maruf*1, Abhinav Sidana*1, William Fleischman2,3, Sam J Brancato1, Stephanie Purnell1, Shantanu Agrawal3, and Piyush K. Agarwal1
Word Count: Abstract/Manuscript: 255/2700
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National Cancer Institute, National Institutes of Health, Urologic Oncology Branch, Bethesda, MD 2 Robert Wood Johnson Foundation Clinical Scholars Program, Yale School of Medicine, New Haven, CT 3 Centers for Medicare and Medicaid Services, Washington, DC
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Key Words: Sunshine Act; Urology; Conflict of interest; Pharmaceutical Industry; Financial Relationships
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Disclosures: Dr. Fleischman serves as a volunteer researcher at the Center for Medicare and Medicaid Services which administers the Open Payments program. All other authors have no disclosures.
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Corresponding Author: Abhinav Sidana Urologic Oncology Branch Center for Cancer Research National Cancer Institute Building 10 - Hatfield CRC, Room 1-5940 Bethesda, MD 20892 Ph: 301-496-6353
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Methods: A descriptive analysis of Open Payments data released by the Centers for Medicare & Medicaid Services (CMS) for 2014 was performed. Total payment amounts associated with various urologic drug and device categories were calculated. We then examined for correlations between payments and prescribing at the national level using Medicare Part D prescribing data.
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Results: There were 232,207 payments totaling $32,418,618 made to 8618 urologists (73.6% of practicing urologists in the US) during calendar year 2014. The median payment was $15 (interquartile range 11-24). While the majority of the individual payments (68%) were ≤$20, 82% of the urologists in the database received >$100 from industry during 2014. The frequency of industry payments was positively correlated with Medicare Part D prescribing frequency, as well as the sum of claims (r = 0.726, p = 0.005, and r = 0.755, p = 0.003, respectively). Conclusions: Nearly 75% of urologists in US received non-research payments from industry in 2014. Most individual payments were for less than $20, but the majority of urologists received more than 100 dollars in aggregate during the study year, with most of the money going toward speaker fees. Payments were positively correlated with Part D prescribing, yet confounding variables make it difficult to establish a cause and effect relationship.
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Introduction: The Open Payments program was enacted to increase transparency of the financial relationships between physicians and the medical device and pharmaceutical industry. We sought to examine the non-research related financial relationships between urologists and industry in the US using the latest Open Payments data.
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ABSTRACT
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INTRODUCTION: Physician-industry financial relationships may impact prescribing practices and 1-6
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professional behavior.
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Affordable Care Act, created the Open Payments program to increase transparency of financial
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relationships between physicians, and the medical device and pharmaceutical industries. Industry
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began collecting and reporting payments to physicians to the Centers for Medicare & Medicaid
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Services (CMS) in August 2013.
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$100 in aggregate over a year are reportable, while drug samples or devices intended for use
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with, or by patients, are exempt from reporting.
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Payments worth more than $10, or several payments worth
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The Physician Payment Sunshine Act, enacted in 2010 as part of the
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Prior to Open Payments, data collected by Massachusetts demonstrated that up to 61% of
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the state’s urologists received some payment, the highest percentage among all specialties.9 With
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Open Payments data, previous analyses have described the national scope of payments in
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orthopedic surgery
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specialty’s payments to payments in urology.
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categorized payments per urologic subspecialty, however, it did not describe the drugs associated
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with payments, nor whether there were correlations to prescribing patterns.
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evaluate the non-research payments made to urologists by describing the types of payments, their
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geographic distribution by American Urological Association (AUA) section, the key products
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and manufacturers making the payments, and to evaluate for correlation between payments and
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prescribing.
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, and ophthalmology
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and compared the given
A recent urology specific payments study
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We sought to
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, otolaryngology
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METHODS:
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Data Sources Open Payments data is collected by industry, and includes details on the company
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making the payment, payment recipient, payment amount, reason for the payment (e.g. speaker
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fees, food and beverages), and the names of drugs or devices associated with the financial ties.
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Publically available data covers payments made from August 2013 to December 2014. This
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publically available database was accessed on January 15, 2016 via the Centers for Medicare &
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Medicaid Services (CMS) website (www.openpaymentsdata.com). 8 We limited our study to the
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2014 calendar year, and to non-research payments, as these are most commonly associated with
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industry marketing. Physician specialty and geographic information was obtained from the Open
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Payments physician profile database. Urology workforce data was obtained from the 2014
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American Urological Association’s (AUA) annual census.
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was obtained from the Part D Prescriber Public Use File. This is publically available data
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collected by CMS for the 2014 calendar year, and was accessed August 22, 2016 from the CMS
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website (www.cms.gov).
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providers for beneficiaries enrolled in the Medicare Part D prescription drug program. The Yale
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University Institutional Review Board approved the study.
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Medicare Part D prescriber data
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This file details the prescriptions, including refills, written by U.S
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Statistical Analysis
We grouped the payments according to the eight AUA regional sections using the
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recipient physician state and zip code. Each payment could be associated with up to five drugs,
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and five devices. We reviewed drug and device names for duplicates or misspellings. If more
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than one product was associated with a payment, it was assumed that equal proportion of the
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payment amount was associated with each item. The number of products associated with each
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payment was used to calculate the average payment per item, and to estimate the total value of
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payments associated with each marketed product. Medications were manually categorized into six broad categories according to their Food
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and Drug Administration’s approved indication of use, or the most commonly used indication for
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drugs with multiple indications: urologic cancer drugs (includes drugs for androgen deprivation
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therapy and drugs commonly used in urologic cancers), drugs used for erectile dysfunction,
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drugs used for overactive bladder and urge incontinence, drugs used for hypogonadism, drugs
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used for benign prostatic hyperplasia, and miscellaneous drugs (includes urologic drugs not
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fitting into above categories, non-urologic cancer drugs and drugs used for non-urologic
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indications). Since payments were not normally distributed, we report medians with interquartile
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ranges (IQR).
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To determine a correlation between industry relationships and prescribing habits, we first
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compared the frequency of industry payments to the number of claims made to Medicare Part D
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for the medications most commonly associated with industry ties. We then compared the
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frequency of industry payments to the aggregate payment amount made by Medicare Part D for
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the same drugs. A Pearson’s correlation coefficient was calculated for each comparison.
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Data management and statistical analysis were performed using Microsoft Excel (version
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2010, Seattle, WA) and Stata (version 13.0, StataCorp LP, College Station, TX).
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RESULTS:
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General description There were 232,207 payments to 8,618 urologists, totaling $32,418,618 during the 2014
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calendar year. The median payment amount was $15 (IQR 11-24). A majority of the individual
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payments (68%) were for $20 or less, and only 11% were for more than $100. Approximately
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74% of practicing urologists in United States received some form of payment from industry.
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The median number of payments per urologist was 16 (IQR 4-40), and median total payment per
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urologist in 2014 was $512 (IQR 159-1302). The number of urologists receiving less than $20,
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$20-$100, $100-$1,000, $1,000-$5,000, and greater than $5,000 in 2014 were 386 (4.5%), 1,145
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(13.3%), 4,393 (51.0%), 1,726 (20.0%), and 968 (11.2%), respectively. Payments to the top 10%
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of the urologists with financial relationships (n=862) amounted to $26 M, or 81% of the total
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payments. The median payment amount to these urologists was $13,674 (IQR 8,872-29,918).
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Out of a total of 232,207 payments, 73.1% (169,638) were associated with drugs only, 23.6%
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(54,878) were associated with devices only, 0.1% (264) were associated with at least one
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medication and one device, and 3.2% (7,427) of payments were missing information on the
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associated device and drug. Payments associated with drugs and devices comprised 38.8%
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($12.6M) and 48.3% ($15.7 M) of total payment amount, respectively. Table 1a and Table 1b
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report the 10 most common drugs and devices associated with financial ties. Myrbetriq
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(mirabegron) and Vesicare (solifenacin), used for treatment of overactive bladder (OAB), were
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the most common drugs, and were associated with nearly 30% of all payments. Sacral
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neuromodulation, a device used in the management of OAB and urinary retention, was the most
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common payment-associated device. We investigated these agents to see what proportion of
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Medicare Part D claims these drugs constituted within their own drug class (Supplemental Figure
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1).
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178 Drugs by category
Urologic cancer drugs (14.4% of total payment amount), and drugs used for OAB and
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urge incontinence (11.3% of total payment amount) were the two most common drug categories
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associated with industry payments (Table 2). The average amount attributed to each drug in the
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urologic cancer drug category was $105, while the same for OAB drug category was only $38.
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Medicare Part D claims
During the 2014 calendar year, 11,877,497 claims to the Medicare Part D prescription
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drug plan were attributed to United States urologists, resulting in $977,110,682.80 paid for
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claims. Table 1a shows the number of Medicare Part D claims and aggregate cost paid for drug
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claims. A significant correlation was observed between the frequency of industry payments and
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the number of claims for that drug (r =0.726, p=0.005). Additionally, a significant correlation
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between the frequency of industry payments and the aggregate payment for claims (r =0.755,
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p=0.003) was observed for the same drugs. There was no correlation between the sum of
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industry payments associated with a medication, and prescribing frequency for the same drug (r
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= -0.122, p=0.755).
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Most common device manufacturers
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Financial relationships were reported by 372 manufacturers and Group Purchasing
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Organizations (GPOs). Table 3 lists the top 5 manufacturers/GPOs with the largest number of
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payments reported. American Medical Systems, now Boston Scientific, reported the highest total
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payment amount of $3.8 M, constituting 11.8% of total amount paid to urologists.
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Geographical distribution
Figure 1 summarizes the total amount, number of receiving physicians, and the median
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payment received by the urologists in the eight AUA sections. The Southeastern section received
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the most payments (63,856 payments, 27.5%), accounting for 26.5% ($8.6 M) of the total value
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of payments. The Southeastern section also had the highest proportion of practicing urologists
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with financial ties to industry (2,062 out of 2,491 per AUA census, 82.8%), and the highest
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median annual payment per physician of $622 (IQR 211-1569). Urologists in the Northeastern
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section received the smallest total value of payment ($0.6M, 1.8%), and ranked second lowest in
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the number of payments (8,559 payments, 3.69%, Supplemental Table 1a). Since speaker fees
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resulted in the largest amount of payment sum, and food and beverage resulted in the largest
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number of payments, these two payment types were explored for their respective geographic
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distribution (Supplemental Table 1b).
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Most common payment type
Food and beverages were the most common reported payment type, representing 88% of
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all payments, but constituting only 14.5% ($4.7 M) of the total payment amount. On the other
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hand, speaker fees represented only 1.5% of all payments, but accounted for 24.3% ($7.8M) of
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the total payment amount (Figure 2).
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DISCUSSION In this cross-sectional study of Open Payments data, we found 74% of urologists received a payment from industry in 2014. Previously, Bandari et al. summarized the payments data by urologic subspecialty,
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however, the study does not break down payments by specific drugs, devices, manufacturers and
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geographic distribution of these payments. 13 Furthermore, although not indicative of causation,
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our results demonstrate that the frequency of industry relationships correlate with the frequency,
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and aggregate value, of Medicare Part D claims for drugs regularly associated with financial ties.
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Our findings are also consistent with studies prior to Open Payments
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were similarly small, with the most common payment in the category of food and beverages.
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, where most payments
The question then becomes: what effect do these financial relationships have on the
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prescribing behavior of urologists? We believe that physicians prescribe medications based on
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the indication, side effect profile, insurance coverage, and cost to the patient. Still, the effect of
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financial relationships with industry has been well explored, and amid concerns for conflicts of
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interest, there remains a need to elucidate the extent to which physicians may be influenced by
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pharmaceutical companies. We found that the frequency of industry payments for a certain drug
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was associated with a higher frequency of claims for that medication. This may raise a concern
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for a potential conflict of interest, however it is difficult to conclude the cause of such a
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correlation, since all the factors that influence prescribing cannot be controlled for in this
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analysis. For example, Viagra (sildenafil) was the most common erectile dysfunction drug
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associated with payments to urologists, yet it composed only 20% of Medicare Part D claims for
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drugs used to treat ED. Stendra (avanafil), another ED medication commonly associated with
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financial ties, constituted no claims at all. Cialis (tadalafil) may have a significantly higher
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proportion of Medicare Part D claims for ED treatment simply because Cialis (tadalafil) is often
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covered by Medicare Part D plans. As a result, factors outside of industry relationships are likely
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to confound any measurement of the effect of financial ties. A review of 58 studies that
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investigated prescribing behavior of physicians with industry relationships determined that the
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limitations of most studies hindered the ability to conclude the extent that these interactions
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affect prescribing frequency.
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financial relationships and prescribing habits.17,
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unavoidable, but themselves do not indicate a moral or legal infraction.19 Furthermore, the
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correlation of payments with prescribing habits does not indicate directionality since prescribing
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frequency may prompt educational office visits from industry in instances where the
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management of urologic conditions are limited to a few drugs. Still, there is a growing body of
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evidence that points to the influence of pharmaceutical industry, and the commonality is the
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concern for a conflict of interest. 1, 2
Other studies suggest there may be no relationship between
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Financial relationships are quite often
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Some argue that physician-industry relationships often benefit patients by educating
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physicians and fostering the development of new drugs and devices via collaboration with
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physicians.
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allowing for collaboration where it may benefit patients. Efforts to date have largely focused on
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increased transparency, initially via self-disclosures of conflicts, and now on a larger scale with
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the Open Payments program. But beyond ethical professional guidelines, with information
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regarding these relationships now readily available for public access, patients’ views on such
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relationships may reshape physician and industry behavior.
The challenge is mitigating the negative effects of such relationships while
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Several studies have noted that financial ties perceived to influence the level of care a
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physician provides are viewed unfavorably by patients. 21-23 However, compensation specifically
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for speaking is viewed more favorably, with 82% of patients enrolled in a research trial
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considering it permissible for their physician to receive speaker fees from the company of the
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drug trial, as they believed this signified their physician’s expertise.
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more than 55% of payments above $5,000 were associated with speaker and consulting fees, yet
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the proportion of urologists receiving more than $5,000 was relatively low (11.2%). Other forms
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of compensation, such as gifts, are more likely to be viewed as unacceptable due to the
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perception of altered clinical judgment, potentially resulting in poorer quality of care. 25-27
Our results show that
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The AUA has adopted the Council of Medical Specialty Societies’ (CMSS) policy
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regarding interaction with industry. The CMSS develops voluntary codes of conduct for the
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interactions with industry that focus on independence from company influence, and transparency
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of financial interactions. For example, these guidelines deem personal gifts and compensation in
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the form of entertainment as inappropriate, and discourage members from engaging with
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industry in such manner
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impact of physician-industry ties on the practice of urologists.
. There are, to our knowledge, no published studies evaluating the
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As transparency of physician-industry financial relationships increases, it may contribute
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to a decline in these relationships due to reluctances of the donor to give, and the beneficiary to
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receive. Indeed, in Massachusetts where payment reporting has been mandatory since 2009, a
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small but significant decrease in relationship reports was noted in the subsequent years. 9
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Our study has important limitations. First, the Open Payments database consists of
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industry provided data, and questions about data accuracy and completeness have been raised 29.
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Second, the data does not encompass the entire scope of the relationship between urology and
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industry, since payments to nurse practitioners, physician assistants, and resident physicians were
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exempt from reporting. A bill to amend the current law has recently been introduced to require
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reporting of payments to these providers.
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payments, and thus our results only reflect a subset of urology-industry relationships. Fourth, the
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South Central, Southeastern, and Northeastern sections of the AUA include urologists from areas
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outside the United States, however we analyzed only payments made to United States urologists.
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Due to this, we may have underestimated the proportion of urologists receiving payments by
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industry in those sections. Finally, the effect on prescribing behavior may be difficult to
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generalize since the Part D Prescriber Public Use File only contains data on claims related to
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patients on the Medicare part D prescription plan. Thus, there are intrinsic limitations as to which
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specific medications would be covered by the prescription plan and would confound the exact
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influence of industry. Claims to Medicare do not account for all of a urologist’s practice, and
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thus, correlation to prescription data misses a large portion of prescriptions. Additionally, the
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generic medication, compared to the commercial brand, may often be economically justifiable
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for many patients, and this study explored only the effect on claims for the commercial brand
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medication. Exploration into the effect on generic medication prescription frequency would
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certainly be valuable, however, the Open Payments database does not contain data on generic
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medications. Moreover, determining the effect of industry payments on an individual level may
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reveal more consequential results.
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Third, we limited our analysis to non-research
CONCLUSIONS
More than 70% of practicing urologists received payments from industry in 2014. Most
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payments were small, and paid for food and beverages, but a large amount of compensation went
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to speaker fees. Although Medicare Part D prescription data suggest a possible correlation
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between industry payments and prescription frequency, too many confounding variables exist to
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clearly establish causation between payments and prescribing behavior. Drugs for urologic
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cancer, OAB, and urge incontinence were the most common drugs associated with payments.
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Future studies may reveal trends in these financial relationships and highlight the longitudinal
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effect of the Open Payments program.
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Table 1a. Most common drugs associated with industry payments to urologists. The frequency of claims and aggregate sum of Medicare Part D claims are shown for each drug.
Sum of claims (% of total)
266,258 (2.2)
Vesicare (solifenacin succinate)
28,027 (12.2)
$220,513 (0.7)
$7 (5-9)
503,237 (4.2)
Toviaz (fesoterodine fumarate) Viagra (sildenafil citrate) Stendra (avanafil) Botox (onabotulinumtoxinA) Rapaflo (silodosin) Zytiga (abiraterone acetate) Xtandi (enzalutamide) Firmagon (degarelix)
15,602 (6.8) 14,632 (6.4) 12,850 (5.6) 12,180 (5.3) 11,549 (5.0) 10,539 (4.6) 10,105 (4.4) 7,050 (3.1)
$6 (4-7) $6 (4-7) $15 (11-21) $14 (10-20) $13 (9-18) $14 (10-21) $16 (12-23) $14 (11-19)
165,814 (1.4) 11,545 (0.1) 0 (0) 68 (0) 265,385 (2.2) 6,723 (0.1) 2,028 (0) 492 (0)
Total
163,546 (71.2)
$245,992 (0.8) $87,069 (0.3) $1,140,809 (3.5) $1,057,452 (3.3) $733,301 (2.3) $1,341,044 (4.1) $1,478,923 (4.6) $435,753 (1.3) $8,879,731 (27.4)
$84,341,459.95 (8.6) $151,328,236.4 (15.5) $41,757,819.49 (4.3) $1,514,206.57 (0.2) 0 (0) $55,020.48 (0) $57,534,305.26 (5.9) $49,513,188.87 (5.1) $17,047,312.34 (1.7) $296,093.74 (0) $403,387,643.10 (41.3)
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Drug Name (generic)
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Frequency of claims (% of total)
Myrbetriq (mirabegron)
Pharmaceutical Industry Payments Sum of Median Number of payments payments payment (% of total) (% of total) (IQR) 41,012 (17.8) $2,138,874 (6.6) $8 (6-12)
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Pearson's Correlation Number of payments and frequency of claims: r = 0.726, p = 0.005 Number of payments and sum of claims: r = 0.755, p = 0.003 Sum of payments and frequency of claims: r = -.122, p = 0.755
Medicare Part D claims
1,221,550 (10.3)
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Table 1b. Most common devices associated with payments to urologists. Median payment (IQR) $17 (11-46) $21 (10-68) $355 (97-787) $66 (21-131) $29 (13-100)
3,508 (1.5) 3,496 (1.5) 3,496 (1.5) 2,616 (1.1) 1,721 (0.7) 42,215 (18.2)
$485,812 (1.5) $122,692 (0.4) $122,692 (0.4) $1,008,421 (3.1) $323,169 (1.0) $9,451,275 (29.1)
$17 (7-54) $10 (6-21) $10 (6-21) $63 (23-229) $23 (6-63)
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Sum of payments (% sum of all payments) $677,329 (2.1) $874,130 (2.7) $3,027,878 (9.3) $1,726,287 (5.3) $1,082,866 (3.3)
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Sacral Nerve Stimulation AMS 700 Series Cryo Probe Penile Reconstruction Greenlight Laser Therapy AMS 800 Urinary Control System Macroplastique Urgent PC Da Vinci Surgical System AdVance Male Sling System Total
Number of payments (% of total) 7,831 (3.4) 5,864 (2.5) 4,595 (2.0) 4,557 (2.0) 4,531 (2.0)
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Table 2: Number and amount of payments associated with various drug classes Number of payments (% of total)
Sum of payments (% of sum of all payments)
Drugs for Overactive bladder Urologic cancer drugs Erectile Dysfunction drugs Drugs for Hypogonadism Miscellaneous drugs Drugs for Benign Prostatic Hyperplasia
69,107 (29.8) 44,211 (19.0) 33,952 (14.6) 17,771 (7.7) 16,463 (7.1) 13,361 (5.8)
$3,664,150 (11.3) $4,653,438 (14.4) $1,348,409 (4.2) $878,218 (2.7) $1,275,547 (3.9) $766,504 (2.4)
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Drug class
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Table 3. Most common companies associated with payments to urologists. Number of payments (% of total)
Sum of payments (% of sum of all payments)
Median payment (IQR)
Astellas Pharma Inc. Auxilium Pharmaceuticals Inc. Pfizer Inc. Actavis Pharma Inc. American Medical System Total
48,347 (20.8) 19,985 (8.6) 17,176 (7.4) 14,885 (6.4) 13,975 (6.0) 114,368 (49.2)
$3,520,319 (10.9) $1,701,506 (5.2) $332,292 (1.0) $844,838 (2.6) $3,810,083 (11.8) $10,209,037 (31.3)
$15 (11-20) $15 (11-21) $11 (7-12) $13 (9-18) $29 (14-105)
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Company Name
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Figure 1: Geographical distribution of payments by American Urological Association (AUA) sections. Sum represents the total amount paid to physicians in the AUA section, N represents the number of physicians reporting a financial relationship and Med represents the median
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annual payment per urology. The original map was altered to represent only data from the United States. Puerto Rico, Guam and the Virgin Islands are not shown. United States map obtained
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from Creative Commons, AMK1211.
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Figure 2: Characteristics of payments to the urologists. Left panel: number, total amount and median amount for various payment types. Right panel: Pictorial depiction of proportions of total payment amount by various payment types. (Speaker fees are a combined category of
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Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program, compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing education program, and compensation
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for serving as faculty or as a speaker for an accredited or certified continuing education
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program).
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CMS: Medicare & Medicaid Services AUA: American Urological Association IQR: Interquartile Range OAB: Overactive Bladder GPO: Group Purchasing Organizations CMSS: Council of Medical Specialty Societies
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Key of Definitions for Abbreviations
PII: DOI: Reference:
S2352-0779(17)30086-9 10.1016/j.urpr.2017.03.012 URPR 289
To appear in: Urology Practice Accepted Date: 21 March 2017 Please cite this article as: Maruf M, Sidana A, Fleischman W, Brancato SJ, Purnell S, Agrawal S, Agarwal PK, Financial Relationships between Urologists and Industry: an Analysis of Open Payments Data, Urology Practice (2017), doi: 10.1016/j.urpr.2017.03.012. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.
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Financial relationships between Urologists and industry: an analysis of Open Payments data
*AS and MM contributed equally to the article 1
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Mahir Maruf*1, Abhinav Sidana*1, William Fleischman2,3, Sam J Brancato1, Stephanie Purnell1, Shantanu Agrawal3, and Piyush K. Agarwal1
Word Count: Abstract/Manuscript: 255/2700
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National Cancer Institute, National Institutes of Health, Urologic Oncology Branch, Bethesda, MD 2 Robert Wood Johnson Foundation Clinical Scholars Program, Yale School of Medicine, New Haven, CT 3 Centers for Medicare and Medicaid Services, Washington, DC
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Key Words: Sunshine Act; Urology; Conflict of interest; Pharmaceutical Industry; Financial Relationships
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Disclosures: Dr. Fleischman serves as a volunteer researcher at the Center for Medicare and Medicaid Services which administers the Open Payments program. All other authors have no disclosures.
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Corresponding Author: Abhinav Sidana Urologic Oncology Branch Center for Cancer Research National Cancer Institute Building 10 - Hatfield CRC, Room 1-5940 Bethesda, MD 20892 Ph: 301-496-6353
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Methods: A descriptive analysis of Open Payments data released by the Centers for Medicare & Medicaid Services (CMS) for 2014 was performed. Total payment amounts associated with various urologic drug and device categories were calculated. We then examined for correlations between payments and prescribing at the national level using Medicare Part D prescribing data.
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Results: There were 232,207 payments totaling $32,418,618 made to 8618 urologists (73.6% of practicing urologists in the US) during calendar year 2014. The median payment was $15 (interquartile range 11-24). While the majority of the individual payments (68%) were ≤$20, 82% of the urologists in the database received >$100 from industry during 2014. The frequency of industry payments was positively correlated with Medicare Part D prescribing frequency, as well as the sum of claims (r = 0.726, p = 0.005, and r = 0.755, p = 0.003, respectively). Conclusions: Nearly 75% of urologists in US received non-research payments from industry in 2014. Most individual payments were for less than $20, but the majority of urologists received more than 100 dollars in aggregate during the study year, with most of the money going toward speaker fees. Payments were positively correlated with Part D prescribing, yet confounding variables make it difficult to establish a cause and effect relationship.
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Introduction: The Open Payments program was enacted to increase transparency of the financial relationships between physicians and the medical device and pharmaceutical industry. We sought to examine the non-research related financial relationships between urologists and industry in the US using the latest Open Payments data.
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ABSTRACT
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INTRODUCTION: Physician-industry financial relationships may impact prescribing practices and 1-6
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professional behavior.
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Affordable Care Act, created the Open Payments program to increase transparency of financial
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relationships between physicians, and the medical device and pharmaceutical industries. Industry
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began collecting and reporting payments to physicians to the Centers for Medicare & Medicaid
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Services (CMS) in August 2013.
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$100 in aggregate over a year are reportable, while drug samples or devices intended for use
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with, or by patients, are exempt from reporting.
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Payments worth more than $10, or several payments worth
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The Physician Payment Sunshine Act, enacted in 2010 as part of the
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Prior to Open Payments, data collected by Massachusetts demonstrated that up to 61% of
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the state’s urologists received some payment, the highest percentage among all specialties.9 With
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Open Payments data, previous analyses have described the national scope of payments in
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orthopedic surgery
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specialty’s payments to payments in urology.
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categorized payments per urologic subspecialty, however, it did not describe the drugs associated
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with payments, nor whether there were correlations to prescribing patterns.
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evaluate the non-research payments made to urologists by describing the types of payments, their
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geographic distribution by American Urological Association (AUA) section, the key products
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and manufacturers making the payments, and to evaluate for correlation between payments and
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prescribing.
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, and ophthalmology
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and compared the given
A recent urology specific payments study
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We sought to
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, otolaryngology
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METHODS:
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Data Sources Open Payments data is collected by industry, and includes details on the company
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making the payment, payment recipient, payment amount, reason for the payment (e.g. speaker
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fees, food and beverages), and the names of drugs or devices associated with the financial ties.
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Publically available data covers payments made from August 2013 to December 2014. This
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publically available database was accessed on January 15, 2016 via the Centers for Medicare &
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Medicaid Services (CMS) website (www.openpaymentsdata.com). 8 We limited our study to the
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2014 calendar year, and to non-research payments, as these are most commonly associated with
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industry marketing. Physician specialty and geographic information was obtained from the Open
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Payments physician profile database. Urology workforce data was obtained from the 2014
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American Urological Association’s (AUA) annual census.
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was obtained from the Part D Prescriber Public Use File. This is publically available data
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collected by CMS for the 2014 calendar year, and was accessed August 22, 2016 from the CMS
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website (www.cms.gov).
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providers for beneficiaries enrolled in the Medicare Part D prescription drug program. The Yale
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University Institutional Review Board approved the study.
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Medicare Part D prescriber data
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This file details the prescriptions, including refills, written by U.S
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Statistical Analysis
We grouped the payments according to the eight AUA regional sections using the
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recipient physician state and zip code. Each payment could be associated with up to five drugs,
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and five devices. We reviewed drug and device names for duplicates or misspellings. If more
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than one product was associated with a payment, it was assumed that equal proportion of the
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payment amount was associated with each item. The number of products associated with each
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payment was used to calculate the average payment per item, and to estimate the total value of
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payments associated with each marketed product. Medications were manually categorized into six broad categories according to their Food
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and Drug Administration’s approved indication of use, or the most commonly used indication for
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drugs with multiple indications: urologic cancer drugs (includes drugs for androgen deprivation
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therapy and drugs commonly used in urologic cancers), drugs used for erectile dysfunction,
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drugs used for overactive bladder and urge incontinence, drugs used for hypogonadism, drugs
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used for benign prostatic hyperplasia, and miscellaneous drugs (includes urologic drugs not
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fitting into above categories, non-urologic cancer drugs and drugs used for non-urologic
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indications). Since payments were not normally distributed, we report medians with interquartile
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ranges (IQR).
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To determine a correlation between industry relationships and prescribing habits, we first
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compared the frequency of industry payments to the number of claims made to Medicare Part D
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for the medications most commonly associated with industry ties. We then compared the
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frequency of industry payments to the aggregate payment amount made by Medicare Part D for
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the same drugs. A Pearson’s correlation coefficient was calculated for each comparison.
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Data management and statistical analysis were performed using Microsoft Excel (version
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2010, Seattle, WA) and Stata (version 13.0, StataCorp LP, College Station, TX).
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RESULTS:
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General description There were 232,207 payments to 8,618 urologists, totaling $32,418,618 during the 2014
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calendar year. The median payment amount was $15 (IQR 11-24). A majority of the individual
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payments (68%) were for $20 or less, and only 11% were for more than $100. Approximately
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74% of practicing urologists in United States received some form of payment from industry.
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The median number of payments per urologist was 16 (IQR 4-40), and median total payment per
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urologist in 2014 was $512 (IQR 159-1302). The number of urologists receiving less than $20,
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$20-$100, $100-$1,000, $1,000-$5,000, and greater than $5,000 in 2014 were 386 (4.5%), 1,145
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(13.3%), 4,393 (51.0%), 1,726 (20.0%), and 968 (11.2%), respectively. Payments to the top 10%
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of the urologists with financial relationships (n=862) amounted to $26 M, or 81% of the total
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payments. The median payment amount to these urologists was $13,674 (IQR 8,872-29,918).
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Out of a total of 232,207 payments, 73.1% (169,638) were associated with drugs only, 23.6%
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(54,878) were associated with devices only, 0.1% (264) were associated with at least one
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medication and one device, and 3.2% (7,427) of payments were missing information on the
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associated device and drug. Payments associated with drugs and devices comprised 38.8%
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($12.6M) and 48.3% ($15.7 M) of total payment amount, respectively. Table 1a and Table 1b
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report the 10 most common drugs and devices associated with financial ties. Myrbetriq
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(mirabegron) and Vesicare (solifenacin), used for treatment of overactive bladder (OAB), were
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the most common drugs, and were associated with nearly 30% of all payments. Sacral
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neuromodulation, a device used in the management of OAB and urinary retention, was the most
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common payment-associated device. We investigated these agents to see what proportion of
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Medicare Part D claims these drugs constituted within their own drug class (Supplemental Figure
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1).
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178 Drugs by category
Urologic cancer drugs (14.4% of total payment amount), and drugs used for OAB and
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urge incontinence (11.3% of total payment amount) were the two most common drug categories
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associated with industry payments (Table 2). The average amount attributed to each drug in the
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urologic cancer drug category was $105, while the same for OAB drug category was only $38.
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Medicare Part D claims
During the 2014 calendar year, 11,877,497 claims to the Medicare Part D prescription
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drug plan were attributed to United States urologists, resulting in $977,110,682.80 paid for
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claims. Table 1a shows the number of Medicare Part D claims and aggregate cost paid for drug
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claims. A significant correlation was observed between the frequency of industry payments and
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the number of claims for that drug (r =0.726, p=0.005). Additionally, a significant correlation
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between the frequency of industry payments and the aggregate payment for claims (r =0.755,
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p=0.003) was observed for the same drugs. There was no correlation between the sum of
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industry payments associated with a medication, and prescribing frequency for the same drug (r
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= -0.122, p=0.755).
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Most common device manufacturers
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Financial relationships were reported by 372 manufacturers and Group Purchasing
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Organizations (GPOs). Table 3 lists the top 5 manufacturers/GPOs with the largest number of
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payments reported. American Medical Systems, now Boston Scientific, reported the highest total
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payment amount of $3.8 M, constituting 11.8% of total amount paid to urologists.
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Geographical distribution
Figure 1 summarizes the total amount, number of receiving physicians, and the median
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payment received by the urologists in the eight AUA sections. The Southeastern section received
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the most payments (63,856 payments, 27.5%), accounting for 26.5% ($8.6 M) of the total value
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of payments. The Southeastern section also had the highest proportion of practicing urologists
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with financial ties to industry (2,062 out of 2,491 per AUA census, 82.8%), and the highest
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median annual payment per physician of $622 (IQR 211-1569). Urologists in the Northeastern
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section received the smallest total value of payment ($0.6M, 1.8%), and ranked second lowest in
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the number of payments (8,559 payments, 3.69%, Supplemental Table 1a). Since speaker fees
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resulted in the largest amount of payment sum, and food and beverage resulted in the largest
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number of payments, these two payment types were explored for their respective geographic
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distribution (Supplemental Table 1b).
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Most common payment type
Food and beverages were the most common reported payment type, representing 88% of
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all payments, but constituting only 14.5% ($4.7 M) of the total payment amount. On the other
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hand, speaker fees represented only 1.5% of all payments, but accounted for 24.3% ($7.8M) of
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the total payment amount (Figure 2).
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DISCUSSION In this cross-sectional study of Open Payments data, we found 74% of urologists received a payment from industry in 2014. Previously, Bandari et al. summarized the payments data by urologic subspecialty,
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however, the study does not break down payments by specific drugs, devices, manufacturers and
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geographic distribution of these payments. 13 Furthermore, although not indicative of causation,
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our results demonstrate that the frequency of industry relationships correlate with the frequency,
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and aggregate value, of Medicare Part D claims for drugs regularly associated with financial ties.
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Our findings are also consistent with studies prior to Open Payments
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were similarly small, with the most common payment in the category of food and beverages.
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16
, where most payments
The question then becomes: what effect do these financial relationships have on the
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prescribing behavior of urologists? We believe that physicians prescribe medications based on
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the indication, side effect profile, insurance coverage, and cost to the patient. Still, the effect of
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financial relationships with industry has been well explored, and amid concerns for conflicts of
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interest, there remains a need to elucidate the extent to which physicians may be influenced by
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pharmaceutical companies. We found that the frequency of industry payments for a certain drug
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was associated with a higher frequency of claims for that medication. This may raise a concern
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for a potential conflict of interest, however it is difficult to conclude the cause of such a
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correlation, since all the factors that influence prescribing cannot be controlled for in this
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analysis. For example, Viagra (sildenafil) was the most common erectile dysfunction drug
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associated with payments to urologists, yet it composed only 20% of Medicare Part D claims for
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drugs used to treat ED. Stendra (avanafil), another ED medication commonly associated with
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financial ties, constituted no claims at all. Cialis (tadalafil) may have a significantly higher
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proportion of Medicare Part D claims for ED treatment simply because Cialis (tadalafil) is often
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covered by Medicare Part D plans. As a result, factors outside of industry relationships are likely
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to confound any measurement of the effect of financial ties. A review of 58 studies that
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investigated prescribing behavior of physicians with industry relationships determined that the
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limitations of most studies hindered the ability to conclude the extent that these interactions
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affect prescribing frequency.
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financial relationships and prescribing habits.17,
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unavoidable, but themselves do not indicate a moral or legal infraction.19 Furthermore, the
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correlation of payments with prescribing habits does not indicate directionality since prescribing
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frequency may prompt educational office visits from industry in instances where the
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management of urologic conditions are limited to a few drugs. Still, there is a growing body of
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evidence that points to the influence of pharmaceutical industry, and the commonality is the
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concern for a conflict of interest. 1, 2
Other studies suggest there may be no relationship between
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Some argue that physician-industry relationships often benefit patients by educating
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physicians and fostering the development of new drugs and devices via collaboration with
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physicians.
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allowing for collaboration where it may benefit patients. Efforts to date have largely focused on
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increased transparency, initially via self-disclosures of conflicts, and now on a larger scale with
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the Open Payments program. But beyond ethical professional guidelines, with information
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regarding these relationships now readily available for public access, patients’ views on such
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relationships may reshape physician and industry behavior.
The challenge is mitigating the negative effects of such relationships while
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Several studies have noted that financial ties perceived to influence the level of care a
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physician provides are viewed unfavorably by patients. 21-23 However, compensation specifically
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for speaking is viewed more favorably, with 82% of patients enrolled in a research trial
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considering it permissible for their physician to receive speaker fees from the company of the
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drug trial, as they believed this signified their physician’s expertise.
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more than 55% of payments above $5,000 were associated with speaker and consulting fees, yet
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the proportion of urologists receiving more than $5,000 was relatively low (11.2%). Other forms
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of compensation, such as gifts, are more likely to be viewed as unacceptable due to the
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perception of altered clinical judgment, potentially resulting in poorer quality of care. 25-27
Our results show that
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The AUA has adopted the Council of Medical Specialty Societies’ (CMSS) policy
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regarding interaction with industry. The CMSS develops voluntary codes of conduct for the
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interactions with industry that focus on independence from company influence, and transparency
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of financial interactions. For example, these guidelines deem personal gifts and compensation in
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the form of entertainment as inappropriate, and discourage members from engaging with
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industry in such manner
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impact of physician-industry ties on the practice of urologists.
. There are, to our knowledge, no published studies evaluating the
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As transparency of physician-industry financial relationships increases, it may contribute
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to a decline in these relationships due to reluctances of the donor to give, and the beneficiary to
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receive. Indeed, in Massachusetts where payment reporting has been mandatory since 2009, a
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small but significant decrease in relationship reports was noted in the subsequent years. 9
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Our study has important limitations. First, the Open Payments database consists of
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industry provided data, and questions about data accuracy and completeness have been raised 29.
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Second, the data does not encompass the entire scope of the relationship between urology and
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industry, since payments to nurse practitioners, physician assistants, and resident physicians were
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exempt from reporting. A bill to amend the current law has recently been introduced to require
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reporting of payments to these providers.
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payments, and thus our results only reflect a subset of urology-industry relationships. Fourth, the
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South Central, Southeastern, and Northeastern sections of the AUA include urologists from areas
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outside the United States, however we analyzed only payments made to United States urologists.
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Due to this, we may have underestimated the proportion of urologists receiving payments by
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industry in those sections. Finally, the effect on prescribing behavior may be difficult to
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generalize since the Part D Prescriber Public Use File only contains data on claims related to
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patients on the Medicare part D prescription plan. Thus, there are intrinsic limitations as to which
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specific medications would be covered by the prescription plan and would confound the exact
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influence of industry. Claims to Medicare do not account for all of a urologist’s practice, and
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thus, correlation to prescription data misses a large portion of prescriptions. Additionally, the
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generic medication, compared to the commercial brand, may often be economically justifiable
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for many patients, and this study explored only the effect on claims for the commercial brand
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medication. Exploration into the effect on generic medication prescription frequency would
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certainly be valuable, however, the Open Payments database does not contain data on generic
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medications. Moreover, determining the effect of industry payments on an individual level may
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reveal more consequential results.
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Third, we limited our analysis to non-research
CONCLUSIONS
More than 70% of practicing urologists received payments from industry in 2014. Most
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payments were small, and paid for food and beverages, but a large amount of compensation went
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to speaker fees. Although Medicare Part D prescription data suggest a possible correlation
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between industry payments and prescription frequency, too many confounding variables exist to
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clearly establish causation between payments and prescribing behavior. Drugs for urologic
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cancer, OAB, and urge incontinence were the most common drugs associated with payments.
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Future studies may reveal trends in these financial relationships and highlight the longitudinal
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effect of the Open Payments program.
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Table 1a. Most common drugs associated with industry payments to urologists. The frequency of claims and aggregate sum of Medicare Part D claims are shown for each drug.
Sum of claims (% of total)
266,258 (2.2)
Vesicare (solifenacin succinate)
28,027 (12.2)
$220,513 (0.7)
$7 (5-9)
503,237 (4.2)
Toviaz (fesoterodine fumarate) Viagra (sildenafil citrate) Stendra (avanafil) Botox (onabotulinumtoxinA) Rapaflo (silodosin) Zytiga (abiraterone acetate) Xtandi (enzalutamide) Firmagon (degarelix)
15,602 (6.8) 14,632 (6.4) 12,850 (5.6) 12,180 (5.3) 11,549 (5.0) 10,539 (4.6) 10,105 (4.4) 7,050 (3.1)
$6 (4-7) $6 (4-7) $15 (11-21) $14 (10-20) $13 (9-18) $14 (10-21) $16 (12-23) $14 (11-19)
165,814 (1.4) 11,545 (0.1) 0 (0) 68 (0) 265,385 (2.2) 6,723 (0.1) 2,028 (0) 492 (0)
Total
163,546 (71.2)
$245,992 (0.8) $87,069 (0.3) $1,140,809 (3.5) $1,057,452 (3.3) $733,301 (2.3) $1,341,044 (4.1) $1,478,923 (4.6) $435,753 (1.3) $8,879,731 (27.4)
$84,341,459.95 (8.6) $151,328,236.4 (15.5) $41,757,819.49 (4.3) $1,514,206.57 (0.2) 0 (0) $55,020.48 (0) $57,534,305.26 (5.9) $49,513,188.87 (5.1) $17,047,312.34 (1.7) $296,093.74 (0) $403,387,643.10 (41.3)
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Frequency of claims (% of total)
Myrbetriq (mirabegron)
Pharmaceutical Industry Payments Sum of Median Number of payments payments payment (% of total) (% of total) (IQR) 41,012 (17.8) $2,138,874 (6.6) $8 (6-12)
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Pearson's Correlation Number of payments and frequency of claims: r = 0.726, p = 0.005 Number of payments and sum of claims: r = 0.755, p = 0.003 Sum of payments and frequency of claims: r = -.122, p = 0.755
Medicare Part D claims
1,221,550 (10.3)
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Table 1b. Most common devices associated with payments to urologists. Median payment (IQR) $17 (11-46) $21 (10-68) $355 (97-787) $66 (21-131) $29 (13-100)
3,508 (1.5) 3,496 (1.5) 3,496 (1.5) 2,616 (1.1) 1,721 (0.7) 42,215 (18.2)
$485,812 (1.5) $122,692 (0.4) $122,692 (0.4) $1,008,421 (3.1) $323,169 (1.0) $9,451,275 (29.1)
$17 (7-54) $10 (6-21) $10 (6-21) $63 (23-229) $23 (6-63)
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Sum of payments (% sum of all payments) $677,329 (2.1) $874,130 (2.7) $3,027,878 (9.3) $1,726,287 (5.3) $1,082,866 (3.3)
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Sacral Nerve Stimulation AMS 700 Series Cryo Probe Penile Reconstruction Greenlight Laser Therapy AMS 800 Urinary Control System Macroplastique Urgent PC Da Vinci Surgical System AdVance Male Sling System Total
Number of payments (% of total) 7,831 (3.4) 5,864 (2.5) 4,595 (2.0) 4,557 (2.0) 4,531 (2.0)
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Table 2: Number and amount of payments associated with various drug classes Number of payments (% of total)
Sum of payments (% of sum of all payments)
Drugs for Overactive bladder Urologic cancer drugs Erectile Dysfunction drugs Drugs for Hypogonadism Miscellaneous drugs Drugs for Benign Prostatic Hyperplasia
69,107 (29.8) 44,211 (19.0) 33,952 (14.6) 17,771 (7.7) 16,463 (7.1) 13,361 (5.8)
$3,664,150 (11.3) $4,653,438 (14.4) $1,348,409 (4.2) $878,218 (2.7) $1,275,547 (3.9) $766,504 (2.4)
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Table 3. Most common companies associated with payments to urologists. Number of payments (% of total)
Sum of payments (% of sum of all payments)
Median payment (IQR)
Astellas Pharma Inc. Auxilium Pharmaceuticals Inc. Pfizer Inc. Actavis Pharma Inc. American Medical System Total
48,347 (20.8) 19,985 (8.6) 17,176 (7.4) 14,885 (6.4) 13,975 (6.0) 114,368 (49.2)
$3,520,319 (10.9) $1,701,506 (5.2) $332,292 (1.0) $844,838 (2.6) $3,810,083 (11.8) $10,209,037 (31.3)
$15 (11-20) $15 (11-21) $11 (7-12) $13 (9-18) $29 (14-105)
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Figure 1: Geographical distribution of payments by American Urological Association (AUA) sections. Sum represents the total amount paid to physicians in the AUA section, N represents the number of physicians reporting a financial relationship and Med represents the median
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annual payment per urology. The original map was altered to represent only data from the United States. Puerto Rico, Guam and the Virgin Islands are not shown. United States map obtained
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from Creative Commons, AMK1211.
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Figure 2: Characteristics of payments to the urologists. Left panel: number, total amount and median amount for various payment types. Right panel: Pictorial depiction of proportions of total payment amount by various payment types. (Speaker fees are a combined category of
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Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program, compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing education program, and compensation
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program).
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CMS: Medicare & Medicaid Services AUA: American Urological Association IQR: Interquartile Range OAB: Overactive Bladder GPO: Group Purchasing Organizations CMSS: Council of Medical Specialty Societies
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Key of Definitions for Abbreviations