The Industry Alliance for Continuing Education’s (IACE) Benchmark Work Group (BWG) have shared their 2014 study of the life science industry’s best practices related to commercial support of independent medical education (IME). The BWG has surveyed industry for several years now, and their current study incorporates trends in a number of important categories, including: IME budgets, departmental involvement in grant review committees, interactions with providers, patient education, and monitoring the activities companies support. This year, the survey also highlights the Sunshine Act (Open Payments) and its potential effect on education grants.
View the full report here.
The BWG surveyed 27 organizations, including 19 pharmaceutical, 6 biotechnology, and 3 device companies. Almost two-thirds of the companies that responded to this year’s survey were organizations with greater than one billion dollars in revenue derived from U.S. business.
Company IME Budgets
2014 Budget Estimates
Companies’ estimated grant budget for 2014 generally mirrored the company size: companies with larger revenues had larger IME budgets. Five companies with U.S. revenue over $10 billion had a total U.S. grant budget of $25-$50 million. The report noted that no surveyed company indicated a budget over $50 million. Five companies with revenue between $1-5 billion had IME budgets of between $2.5 and $5 million. There was some interesting variation in the mid-size companies. Some spent in the $10 million range, while others spent less than $2.5 million.
IME Budget Comparison with 2012 and 2013
In 2014, the Benchmarking Insights report identified that 31% of companies reported slightly higher IME budget compared with the previous years, with the majority of companies reporting stable budgets. The report indicates that 17 out of the 27 respondents anticipate stable or increased budgets in 2015.
Interestingly, the report noted that funding for non-accredited education decreased (from 91% to 79%). “In the future, it will be important to examine whether the decrease in funding was due to unintentional consequences of the launch of Open Payments,” states the BWG. The report also indicated that society and membership sponsorships increased (from 25% in 2013 to 46% in 2014).
Grant Review Committees
The report broke down the core members of grant review committees (GRC). Members were primarily medical directors, IME, legal, and compliance in pharmaceutical companies. While a majority of biotechnology and device companies required that all grants were routed to full GRC review, 65% of pharmaceutical companies required full GRC review based on specific criteria. For example, nearly half of respondents noted that only grants that exceeded a certain funding threshold were routed to GRC, and a quarter of responding pharmaceutical companies indicated that only “approvable” grants were routed to GRC.
The report notes that “[t]here appeared to be a trend towards greater autonomy in decision making amongst IME staff at pharmaceutical companies, where the volume of grants was likely to be higher.”
Grant Process
Unsurprisngly, companies with the largest revenues (over $10 billion) had the most grant submissions this past year (ranging between 1,500-2,500). Almost half of the respondents indicated that they approved between 10-25% of grant submissions, and 40% approved between 25-50% of grant submissions. “One explanation for these results may be that larger companies may have more therapeutic areas and larger departments,” notes the report.
The report also looked at the increasing trend toward companies issuing request for proposals. According to the survey, RFPs often included therapeutic areas, target audiences, specified formats, and expected outcomes levels.
Patient Education
Of the 28 respondents, 18 included patient education in their IME department’s scope of responsibility. Half of the respondents stated that between 10-20% of their department budgets were dedicated to patient education. These activities include education both for HCPs including education for patients as well as stand alone patient education. “As patients, their caregivers and family members become more involved in healthcare decision making,” the report notes “it is likely that the demand for patient education will increase. Further, as the healthcare system moves towards increasing patient engagement, it will become more important to educate patients as well as HCPs.”
Monitoring
The survey asked companies to answer questions on their monitoring processes, which the report defined as where company medical or scientific personnel attend live activities or complete enduring activities to assess whether the supported activity was accurate, evidence-based, unbiased, and aligned with the approved application. The primary reason for monitoring IME activities was to ensure that activities were unbiased and consistent with the ACCME Standards for Commercial Support, which 24 out of 26 companies reported.
All companies indicated that they monitored some of their funded activities. A small number of companies monitored more than 75% of funded activities, while the majority monitored less than 25%.
The top reasons that were cited regarding how activities were selected for monitoring included: new provider (65%), new format or educational design (61%), and funded amount (54%). This year, the percentage of companies that believed they were monitoring a sufficient number of grants increased from 16% in 2013 to 30%. Companies cited limited personnel, resources, and budgetary constraints as the main barriers to monitoring more activities.
The report states that “[m]onitoring of CME adds the responsibility of reporting on safety or individual Adverse Events (AEs) discussed and/or mentioned during the activity.” Thus, 80% of surveyed companies had a formal process in place for communicating or reporting general content or safety related inaccuracies that were found during monitoring. Companies reported they may take more than one action, including notifying their legal/compliance/safety departments (53%) and/or notifying the provider either in writing or verbally (about 50%). Six of the 26 companies have a process where they may notify ACCME (or other applicable accrediting organizations) when safety-related errors are identified.
Outcomes Measures
The survey also sought to understand how commercial supporters collected outcomes measures from educational providers. The majority of companies reported that upon receiving outcomes measures, they did not aggregate or standardize data. Instead, unique individual outcomes reports are submitted by providers. Organizations that reported standardizing and aggregating outcomes data did so internally or outsourced it to an external vendor.
Outcomes measures from supported educational activities continued to play an important role. The majority of supported educational activities reported level 3 (declarative and procedural learning), level 4 (competence) outcomes with a small percentage who reported level 5 (performance), and level 6 (change in patient outcomes) outcomes. “In the future, companies may choose to support fewer and more impactful educational activities with more complex designs, which may lead to measuring and reporting of higher level outcomes,” states the report.
Publication Plan
The past two year’s surveys asked questions related to sharing outcomes findings more broadly via publication or other public sharing. Over half of the respondents from pharmaceutical companies, including the majority of large pharma companies, and 80% of respondents from biotechnology companies reported that they would be more likely to fund a grant application if it included a publication plan. The remaining companies indicated that publication plans did not have a role in grant decision making process.
The report also notes that over the last 3 surveys “there was a shift in the perception of whether the commercial supporter or the educational provider should be responsible for publication costs.” Here, there appeared to be a trend for larger companies (5/7) that indicated the commercial supporter should pay for publication costs, and for small to midsize companies (7/8) that the provider should pay.
Interactions with Providers
Most commercial supporters indicated that they engaged in discussions with providers, either through face-to-face meetings or via teleconferences. The topics that were most often discussed included status updates for supported grants, new and innovative educational formats, close-out meetings for supported activities, and new and innovative educational outcomes methodologies and technology platforms.
According to the report, less than one-third of companies indicated that they shared their strategic plans for the upcoming year with educational providers.
Open Payments
In last year’s survey, commercial supporters were asked about the potential impact of the Sunshine Act on grant application or operations processes. At that time, 13 out of 31 respondents believed that the ruling would impact their processes; 11 were uncertain as to how the rule would impact their organization. This year, the survey focused on “Open Payments preparedness as companies were nearing the first CMS submission deadline in March 2014.” The report states that the intent “was to gain an understanding of how prepared IME staff felt they were in terms of actual training, technical needs, processes, and reporting tools.”
At the time of the 2014 survey, about two-thirds of responding commercial supporters indicated that they had established sufficient personnel and SOPs, completed internal training, and had received clear consistent communication about Open Payment reporting criteria from their company. Interestingly, one-third of companies reported they did not receive consistent communication internally regarding what was reportable. Interpretation of the law has been a hotly contested issue over the past year and a half.
Respondents were less certain that educational providers were prepared to capture data, with only 5 out of 26 answering that they felt grant recipients were prepared to provide reportable data. Importantly, no company with a revenue >$5 billion answered yes to this question.
The results illustrated that if educational providers were unable to collect and provide required data, 50% of commercial supporters would exclude, seek a refund, or otherwise take action against the educational provider. “Concern regarding the ability to receive accurate data from third party organizations, such as education providers, may be a contributor to new trends in commercial supporters limiting the use of funds to reportable expenses such as plated meals,” states the report.
As the graph below shows, most companies have taken steps to communicate information about Open Payments to the provider community. A majority of commercial supporters now include reporting requirements in their Letter of Agreement (LOA) and about 60% have communicated broadly to the provider community regarding company requirements (e.g., email, website updates, system updates). Most companies reported having a tool, such as a spreadsheet, that educational providers can use to submit data. “It is likely that for many companies this is a manual process as 50% of respondents indicated that their grants system could not yet capture or report these data,” notes the report. “Interestingly, most companies did not list reportable expenses in grant approval letters even though information about reporting requirements was included in the LOA. It may be that specific information regarding reporting for a particular grant is not available until the time of reconciliation when the details of the use of funds are known.”
Trends that could impact 2015
The report notes a number of trends to look for in the coming year. First, the authors posit that they anticipate increases in focus on patient education, and highlight the need to improve measuring the impact of patient education initiatives. Second, the report notes that quality improvement activities will increase in the coming year. Third, the report questions whether progress has been made in measuring outcomes, including aggregating data, measuring impact, and closing the identified care gaps. Finally, the report indicates that Open Payments remains a vital piece of the IME discussion. It will be interesting to see how the industry reacts after the first year of Sunshine data has been published. It will also be important to track how companies resolve the revised CME-exemption language in the new Rule.