The Industry Alliance for Continuing Education’s (IACE) Benchmark Work Group (BWG) have shared their 2013 study of the pharmaceutical industry’s best practices related to commercial support of independent medical education (IME). The BWG has surveyed industry since 2010, and their current study incorporates trends over the past four years for a number of important categories, including: IME budgets, company communication with providers, patient education, and monitoring inaccuracies in the activities companies support. The BWG surveyed 32 companies, including pharmaceutical, biotechnology, and, for the first time, two device companies. Almost three quarters of the companies that responded to this year’s survey were organizations with greater than a billion dollars in revenue derived from their US business; there was also an increase from 2012 in the number of organizations falling into the highest revenue categories of $5-10 billion and greater than $10 billion.
This article discusses the findings of the study in depth, but three points are of particular note.
- Benchmarking Survey data suggests that the size of the company does not necessarily correspond with the size of the grant budget;
- Patient education is an increasing component of accredited medical education. As more emphasis is placed on shared decision making between providers, patients and their caregivers, it is likely that the demand for patient education will increase;
- The majority of IME departments believe they need to improve their monitoring of supported activities, but report being stymied by budget constraints. The BWG challenges companies to consider monitoring more online programs as a way of increasing the number of total programs audited without adding personnel and budget.
IME Budget
Is there a correlation with the IME grant budget with corporate revenue?
Generally, yes. Smaller companies, defined as those with US revenue under $1 billion, in all but one case had an IME budget of less than $5 million. At the other end of the spectrum, companies with the greatest amount of US revenue (greater than $10 billion) had the highest IME budget, ranging from $10-50 million. No company indicated a budget of more than $50 million.
However, correlation fell apart with companies that fell in the revenue categories in between ($1 billion to less than $5 billion). The BWG interprets this data to suggest that the size of the company does not necessarily correspond with the size of the grant budget because companies weigh many factors in determining their IME grant budget: “organizational culture and the value placed on IME, the number and types of therapeutic areas of focus, disease state(s)/indications for developed products, product portfolio, product lifecycle, funding landscape, size of learner audience, and numerous other factors.”
Compared with 2012, 25 percent of companies report a higher IME grant budget, 34 percent a lower IME budget, and 41 percent of companies report their budgets as relatively unchanged. IME budget data included all activities that fell within the scope of the IME department, for example, non-accredited programs and patient education.
Projecting ahead to the next funding cycle, 40 percent anticipated the same level of funding in 2014 as they had in the current year, while 25 percent expect an increased budget. Only 9 percent expected less funding; 25 responded that they were unsure.
Budget Comparison with ACCME Data on Commercial Funding
The BWG also contrasted their survey to the 2012 Annual Report released by the Accreditation Council for Continuing Medical Education (ACCME) on July 24, 2013, which allowed the BWG to compare trends in IME budgets with ACCME’s data on commercial funding. According to ACCME, in 2012 commercial support accounted for 28 percent of income, down from 32 percent in 2011 (about a $78 million dollar decrease). However, while the amount of funding declined, the percentage of CME activities that receive commercial support (18 percent in 2012) has remained stable since ACCME started collecting data in 2010. The gap in income appears to be covered primarily by increased revenue from registration fees, plus in-kind funding from the provider, says the BWG, who cautions against direct comparison of the two studies. “The ACCME report captures 2012 income related only to CME, and the scope of self-reported IME budgets includes additional types of support.”
Sole-Funding or Multi-Funded
What percentage of grants were funded solely by one company?
The survey asked organizations about the percentage of funded grants that were sole versus multi supported in the previous year. Twenty-five percent stated that they were the sole funders for the majority of their grants. Seventy-five percent indicating they provide partial support for the majority of their funded activities in 2010.
IME Department Scope and Responsibilities
Consistent with past surveys, 97 percent of responding Pharmaceutical and Biotech companies report that their IME department resides within Medical Affairs and/or Scientific Affairs functions. The responding two device companies reported that their IME function resides within the marketing/commercial units of their organization. The report stated that in some device companies, personnel may be responsible for both IME and external required company product training and education.
Since 2010, IME departments have also consistently reported responsibility for a range of activities aside from accredited education and non-accredited IME. More than half of organizations report that their IME department had responsibility for fellowship funding and patient education, and at least one-quarter of respondents are responsible for charitable contributions, travel grants for trainees, educational activities taking place outside of the US, sponsorships, and scientific awards.
For most responding companies, the majority of their department budget was allocated to funding grants for certified continuing education. However, 22 percent of companies reported that less than half of their budgets were used in support of accredited activities. Nearly 40 percent of responding organizations believe the scope of their IME department will grow over the next 12 months, and none report that they will decrease the scope of their IME department.
Physician Payment Sunshine Act
The survey was issued in March 2013, and anyone who follows Policy and Medicine knows that a lot has happened with the Physician Payments Sunshine Act since then. Nonetheless, respondents were asked about the potential impact of the Sunshine Act on their grant processes. At the time of the survey, less than half of the respondents agreed that the ruling would impact their processes, while about one-third of organizations were uncertain how the ruling would affect their operations. BWG reports they will assess the full impact that this ruling has had on participating organizations in the 2014 Benchmarking Survey.
Needs Assessments
Half of the respondent companies allocate funds for needs assessments. In 2013, 88 percent (14/16) did so through a fee for service arrangement. A new choice was added in 2013: the “support of educational plan strategy,” which was selected by nearly all of respondents, demonstrating the importance of this information for planning purposes. Other uses are represented in the chart:
Grant Process– Submissions, Approval, Turnaround Time, Caps for Specific Organization
Survey data from the past few years indicates companies are receiving fewer grant applications per year. The majority of commercial supporters received 1,500 or fewer grant applications in 2012 than 2011. The BWG posits that the trend could reflect that commercial supporters have become more targeted in their grant process, many moving to an established window for receiving grant submissions or accepting submissions only in response to a specific request for proposal (RFP) or call for grant (CGA).
This year’s survey revealed that 9 percent (3/32) of companies approved more than half of submitted applications, while one-third (13/32) approved 25 percent or fewer. Three commercial supporters indicated that they approved less than 10 percent of applications to them.
How long do companies dwell on these applications before making a decision?
Ninety percent of commercial supporters reported their average turnaround time from grant submission to communication of a decision is 60 days or less. Three large pharmaceutical manufacturers indicated their average turnaround time exceeds 60 days.
Do companies consider funding caps for grant support?
While a majority of the responding companies do not have funding caps for grant support, approximately one third have some type of process in place to cap IME funding to specific organizations. Companies may consider multiple ways to identity potential conflict based on financial dependence and there does not appear to be a best practice standard regarding this type of risk assessment.
Satellite Symposia
The majority of responding companies continue to recognize the value in supporting satellite symposia, with 88 percent indicating that they fund these activities.
Why does your organization support satellite symposia?
The top reason cited for supporting satellite symposia is to support scientific exchange. Sixty-nine percent of respondents also stated the “ability to reach a specific audience” and that satellite symposia provide a “visible sign of our company’s commitment to education in relevant diseases industry and medical specialty societies (MSS).”
What percentage of your department’s annual budget was allocated for support of satellite symposia? Overall, most companies are investing between 10 – 25 percent of the IME budget in satellites. Most companies (57 percent) reported similar budgets year to year dedicated to satellite symposia, 25 percent reported lower budgets in 2012, and 18 percent had an increased budget in 2012 compared with 2011.
Request for Proposals/Call for Grants (RFP/CFG’s)
The number of organizations stating that they use an RFP or CGA process was almost 60 percent. Companies use multiple methods of dissemination to notify providers of their interest in receiving grant proposals, but the most common way is for the company to post the announcement on their own grant website. There has also been an increase in the number of organizations publicly posting their announcements on external society web sites.
Which items are included in a RFP/CGA developed by your company?
Patient Education
Healthcare providers are directing their support and funding to patient education. Traditionally, the focus of IME departments has been accredited education for healthcare providers; however, all four of the previous Benchmarking surveys indicate that over half of responding companies include patient education at some level in the scope of the IME department’s responsibilities.
Changes in Scope of the Funded Activity:
The majority of responding organizations have a defined mechanism to communicate to grant recipients the requirements for changes in scope of funded activities. In the past three surveys, most organizations stated they include these details within the Letter of Agreement. This year’s survey indicates that many organizations also include change of scope details in their grant submission instructions.
What actions do companies take in response to a request for changes in scope for an IME Grant?
Monitoring and Reporting Inaccuracies
In order to monitor supported events, company medical personnel attend live activities, or complete enduring activities to assess whether the activity is accurate, evidence-based, unbiased, and aligned with the approved application. While many organizations state that they monitor supported activities, the percentage of grants monitored has remained low across the past three surveys. The vast majority of commercial supporters monitor less than a quarter of their supported activities. Two companies in 2013 indicated that they did not monitor any of the activities for which they provided support.
The majority of respondents have identified monitoring of activities as an area in need of improvement. The percentage of companies that believe they are monitoring a sufficient number of grants dropped nearly 50 percent from 2012 to 2013, with only 16 percent agreeing with this statement in 2013. The two most frequently cited barriers to monitoring more programs are limited personnel resources and budgetary constraints. The report indicates: “It is interesting to note that while the definition of monitoring over the past three survey years has been inclusive of both live AND enduring activities, the limitation of ‘personnel and budget’ is consistently raised as the driver behind the low number of activities monitored, indicating that respondents may be focusing exclusively on live programs.”
How do companies report inaccuracies they find during program monitoring?
Eighty percent of the companies surveyed have a formal process in place for communicating or reporting general content or safety related inaccuracies that are found during program monitoring. Companies may take more than one action, including notifying their legal/compliance departments (42 percent) and/or notifying the provider in writing or verbally. Five of the 31 companies report notifying ACCME (or other applicable accrediting organizations) when content or safety-related errors are discovered.
Educational Outcomes Measures and Outcomes Publications
This year’s survey found that nearly all companies (90 percent) share insights from outcomes reports received from providers within their organizations. Respondents reported that they use the data for annual planning, internal demonstration of IME value, and for evaluating providers. A majority of respondents also placed a high value on publication—71 percent stated that they would be more likely to fund a high quality grant that had a publication plan over one that did not.
Should costs for publication or public sharing of data be included in the grant budget and paid for by the commercial supporter?
Respondents were pretty even between “yes” and “no” in 2013. In 2012, more than twice as many respondents indicated that this was a responsibility of the provider rather than the commercial supporter. Respondent also texted answers to explain their answers, as displayed below.
Interactions with Providers
Ninety percent of commercial supporters indicated that they engage in discussions with providers, either face-to-face or by teleconference. The topics most often discussed include status updates for supported grants, new and innovative educational formats, close-out meetings for supported activities including review of outcomes reports, and new and innovative educational outcomes methodologies.
Overall, less than one-third of companies indicated that they are discussing their plans for the year with providers. The most common reasons cited for conducting these post-activity discussions included instances where the activity used a complex format, activities where the evaluation/outcomes data is unclear and additional information is required, and grants that exceeded a certain dollar threshold.
Application of Findings
The majority of respondents replied that they would use the report to benchmark process and budget best practices against other companies. Many stated that they used previous surveys to help champion IME internally, while others used it to help develop new processes, to justify resources (both financial and personnel), to negotiate larger IME budgets, to increase monitoring, and to support higher level outcomes assessment requirements.
2014 Survey Will Address Sunshine Act and ACA Implications
The 2014 IACE Benchmarking Survey will incorporate issues related to the Physician Payments Sunshine Act as well as the Affordable Care Act (ACA). The current report anticipates they will ask a number of specific questions next year:
Sunshine Act
- How have new reporting requirements impacted commercial funding for non-certified education and education certified for non-physician healthcare providers?
- How have companies changed allowable use of funds (for example, meals)?
- How are companies communicating reporting requirements to providers and to physicians?
- What’s the perceived readiness of providers to communicate reporting needs and collect/report data?
- Are IME departments receiving feedback from faculty or learners about reporting requirements?
ACA
- How will the ACA impact the type of educational needs the physician and the healthcare team will have and the methods for providing education to them?
- What implications will performance measurement and value based reimbursement have on professional development and specifically CME?
- Will we continue to see an increase in quality improvement measures tied to quality initiatives within healthcare systems and institutions? How will CME support these efforts?
- How will the development of ACO’s or ACO like organizations impact who will be making decisions regarding therapeutic options in the future?
- Will the target audience change as ACO’s evolve?