Each year, Sandra Harwood, CMP, vice president of meetings and education for the Infectious Diseases Society of America (IDSA), organizes a Clinical Fellows Meeting, a continuing medical education (CME) event for medical fellows heading into private practice that has helped train more than 1,300 physicians.
In years past, Harwood had no difficulty securing financial support for the meeting. A single proposal might have netted a $350,000 medical education grant from a pharmaceutical company. But those days are gone.
“Today, I hear, ‘We don’t have that kind of money. Maybe you could submit a proposal for $20,000 or $30,000,’” Harwood said. “We’re committed to having the meeting, but this is going to be tough.”
Working Harder for Fewer Dollars
Pharmaceutical and medical-device companies provide support for CME activities through medical education grants, with CME providers — such as hospitals, medical schools, medical associations and societies, and medical education/ communication companies (MECCs) — submitting grant proposals to a company’s medical education group.
Over the past few years, federal regulators and industry watchdogs have turned an increasingly watchful — and skeptical —eye on this grant-making activity. Their concern has been that companies were using CME grants to influence physicians and increase their market share. Calls for increased transparency and accountability in CME funding changed how companies review and award grants, putting increased pressure on CME providers to demonstrate the need for the activity and the expected result.
Not only is it more work to prepare a grant proposal today, there are also fewer grants to go around. Fines for violating rules governing industry-physician relations have tallied in the billions of dollars. That, combined with the threat of jail time and negative public perception hanging in the air, has caused a number of pharmaceutical and medical device companies to reduce their CME programming. Most have shrunk their medical education budgets, and many are accepting fewer grant proposals or putting strict parameters on the types of proposals they’ll accept.
What that means is today’s medical-meeting professionals are working harder for fewer industry dollars. “There’s more competition for a finite number of dollars,” said Harwood, who this year is tasked with putting on essentially the same Clinical Fellows Meeting as in years past, but with a budget that’s $100,000 less. To obtain the necessary revenue, Harwood and her staff are submitting multiple grant proposals. It’s time-consuming and laborious, and Harwood and other planners say their small staffs are struggling under the workload.
At the same time, Harwood said she can’t risk becoming consumed by the grants process, because she has to keep one eye on the horizon. Revenue streams are shifting and a new generation of learners is entering the ranks of CME attendees. The CME of tomorrow will not be the CME of yesterday, or even today. To remain relevant, planners must make strategic choices today that will help them navigate the current system and also prepare them for a new paradigm for CME funding. “We should all care about this,” Harwood said, “because those of us who do not adjust and figure out how to deal with this will be out of a job.”
The Shrinking Pool
Drug and medical-device makers have long been key sources of revenue for CME providers. In 1998, the first year the Accreditation Council for Continuing Medical Education (ACCME) began publishing data on accredited CME program revenue, industry support was nearly $302 million, or 33 percent of total revenue. By 2007, industry support had increased by 300 percent, to $1.2 billion — 47 percent of total revenue.
For backers of industry support, this is all as it should be. Industry involvement in CME, they say, is a natural outgrowth of scientific collaboration, and vital to the advancement of medicine and best-practice health care. Even the American Medical Association’s Council on Judicial and Ethical Affairs, which suggests industry grants be avoided whenever possible, admitted in a 2011 report: “Relationships between medicine and industry have … provided significant resources for professional education, to the ultimate benefits of patients and the public.”
But $1.2 billion is a lot of money — and all those industry dollars raised suspicions about the integrity of the medical education they were paying for. (See the timeline below.) Whether or not bias truly existed, the pressure of a multi-year congressional investigation into industry support of CME (spearheaded by U.S. Sen. Charles Grassley, R-IA, a ranking member of the Senate Finance Committee, and occurring from 2005 to 2007) and negative media attention took a toll, and drug and device makers began to pull back from CME. In 2010, accredited CME providers received $830 million — 37 percent of total income — in commercial support. That’s a drop of 3 percent from the previous year and 31 percent from 2007. While the economic downturn that played out over the same time surely also played a part, most within the industry agree that the increased scrutiny led to at least some of the withdrawal.
Given that 80 percent of accredited CME providers accept at least some commercial support, the decrease in CME grants has had a significant impact on revenue mix. “Five years ago, our funding was one-third from registration, one-third from exhibits, and one-third from industry funding,” Harwood said. “Now it’s two-fifths registration, one-fifth exhibits, one-fifth industry, and one-fifth other.” For IDSA, “other” includes governmental grants and royalties from tape/DVD sales.
At The Endocrine Society, industry support is currently about 26 percent of total CME income. “It used to be higher,” said Wanda Johnson, CMP, CAE, senior director of meetings and education. “It’s definitely a different landscape today.”
MECCs have traditionally been the most dependent on industry support, so it’s no surprise they are feeling the brunt of the decrease. In 2010, accredited MECCs received $93 million less in commercial support than the year before, according to ACCME, while total income for accredited MECCs fell for the third straight year. “We’ve seen a lot of companies go out of business,” said Tom Sullivan, president and founder of Rockpointe Corporation, a Columbia, Md.–based MECC.
Devil’s in the Details
Whether a CME provider accepts a lot or only a little industry support, the competition for the shrinking number of grants has gotten tougher, and pressure to write a successful grant proposal is greater than ever. “We may not have viewed it as a competition in the past, but it most definitely is today,” Johnson said. “And you need to position yourself as best you can.”
In the old days, a grant proposal might have been a one-page explanation of the planned activity. Today it must provide a data-driven needs assessment that explains the practice gap and justifies the need for the programming. It must incorporate adult-learning principles and provide evidence that the activity will result in changed physician behavior and improved patient care. And every CME grant proposal must adhere to stringent industry and federal guidelines designed to ensure that industry-sponsored CME is scientifically rigorous and free from bias.
“It is very time-consuming,” said Lisa Hathaway Stella, CMP, director of industry relations and meetings and education for the Cardiovascular Research Foundation (CRF). “It’s a literature review; it’s interviewing key opinion leaders and establishing the true need for the program. You didn’t used to spend hours doing research to justify the program, and now that’s a requirement.”
Even at MECCs, which typically have more staff dedicated to grant proposals than smaller medical associations and societies, are feeling the strain of the new requirements, according to Sullivan. “To write a good grant,” he said, “you have to have a very robust needs assessment. You have to include outcomes and whether or not it helped change what the physicians believe or what they practice. It takes a lot of time and staff effort.”
Because the purse strings have tightened, CME providers aren’t likely to receive full funding from a single proposal. That means meetings and education staff must repeat the arduous proposal process multiple times for a single event. “For just one program, we submit 10 different proposals,” said Cathy Scheck, vice president of education and meetings for the Heart Rhythm Society (HRS). “In a year, we probably submit 35 to 50.” Hathaway Stella added: “We used to get one commercial supporter for an evening program or a breakfast meeting. Now, even for that, we have to reach out to multiple commercial supporters.”
And while most of the large pharmaceutical and device companies have an online grant-submission process, that doesn’t make the task any easier. There’s no universal application form, so every proposal must be customized. “It is onerous, because each company has a different process and a different schedule,” Scheck said. “A big part of our job is just keeping up with the various schedules.”
To help manage the increasingly complicated grants process, a number of CME providers are staffing up. At ISDA, Harwood is looking to bring on a full-time staff person. At the American Society of Anesthesiologists, Chief Learning Officer Diane Gambill doesn’t rely on grants. But in her previous life, she was chief scientific officer for a MECC, where she expanded her staff of medical writers from three to 12 and her CME group from one to five to support the grant-writing process.
At CRF, Hathaway Stella hired a new project manager to oversee satellite programs so she can spend more time writing grants to fund those programs. She’s also brought on people with more clinical expertise to beef up her grant proposals. “We need to be better versed from a scientific perspective in order to meet the needs assessment and demonstrate the practice gap,” Hathaway Stella said. “My current senior grant associate has a clinical background.”
At HRS, Scheck is looking to her association’s members and leadership for that clinical expertise. She said: “We’re relying more on our physicians to help us with our grant writing and articulate our message.”
Gambill also advises physician organizations to tap into their member knowledge base. “A lot of groups use medical writers who might not have a scientific or medical background,” she said. “That’s okay, as long as you have input from the key thought leaders with regard to what the solutions are to closing the gaps that you identify from your data.”
And don’t just seek input from the members of the academic medical world, she added; it’s important to get input from community physician members, too, because they’re closest to the practice gaps.
Another way physician organizations can make use of internal resources is to mine their member data. “The key to success is always to focus on the facts that you have in your hands,” Gambill said. “One of the things that medical societies have is a huge amount of evaluation and outcomes data. The place to invest, in my opinion, is in analysis of that data to create grants based on the gaps that are identified from that data.”
Connected and Collaborative
Whether CME providers look outside or turn inward for help with the grant process, the key is to be strategic with grant submissions. “We used to do a scattershot approach and blanket the landscape with everything we could think of,” Johnson said. “Now we’re more strategic and targeted.”
Another obvious, but too often ignored, piece of advice is to study funders’ clinical goals and interests. Most companies post their educational objectives and priorities online. “If you have a better understanding of their educational goals for the year,” Hathaway Stella said, “you can be more strategic about submitting grant requests.”
Pfizer, for example, recently announced that it was reorganizing its medical education group into two tracks. The majority of grants — 90 percent — will now be allocated through a request-for-proposal (RFP) process and will focus on a narrower group of clinical interests. Even though the company previously listed its clinical areas, said Maureen Doyle-Scharff, senior director of Pfizer’s Medical Education Group, too many proposals were off-target. A majority of those were rejected, and the process was a waste of both parties’ time.
Rather than going it alone, some CME providers are teaming up to go after industry grants —including The Endocrine Society, which has focused on collaboration with other medical societies. Johnson said: “We’re looking for collaborative projects where we can engage in larger initiatives that bigger organizations may be able to help pull together.”
HRS, meanwhile, has partnered successfully with the larger American College of Cardiology (ACC). “We’ve been successful in developing content on cardiac rhythm management and atrial fibrillation to disseminate via ACC,” Scheck said. “We’re basically the content providers, funded by industry, with the money raised collaboratively with ACC.”
Though MECCs are cut off from CME grants by pharma giants Pfizer and GlaxoSmithKline (suspicion of bias has always hung heaviest around MECCs because they don’t have members to answer to), that doesn’t mean they can’t partner with a medical society or other CME provider. “We are looking at collaboration with medical education companies,” Scheck said, “where the Heart Rhythm Society might be the content provider and we’re putting our Good Housekeeping seal on a program they [MECCs] do.”
Likewise, a MECC can help an association reach a broader audience and provide more learning environments (local or web-based, for example) — something that funders look for, Sullivan said. But don’t partner just for the sake of partnering. “You need to find a partner with a complementary skill set,” Sullivan said. “It has to be the right partner.”
Gambill recommends that physician organizations explore collaborations with universities and medical schools, which are appealing to funders. “Collaboration with academic institutions is likely to curry favor with pharmaceutical companies,” she said, “because it broadens the reach of the educational activity and those organizations are favorably perceived by the public.”
But collaboration isn’t a cure-all, Johnson cautioned, and should be approached judiciously. “It’s a time-consuming process,” she said. “It’s not a wave of a magic wand and everybody comes together and everybody agrees to what we’re going to get out of it.”
The Shifting Paradigm
In addition to pursuing collaborations, Johnson and most other planners we interviewed are exploring how to boost other sources of revenue, including industry advertising and sponsorship (which is on the rise), fees, governmental grants and non-traditional sources of funding, such as grants from third-party payers. Planners are also re-examining CME settings, with an eye on both funders and future learners. The Endocrine Society, for example, is looking at more regional education and e-learning opportunities. “I think there will still be a role for the face-to-face interactions,” Johnson said, “but I am very cognizant that the generation coming into the field today has learned in a completely different manner.”
In fact, the days of the “anonymous learner” are gone, Doyle-Scharff said, referring to the large annual conferences and congresses that have been a stronghold of CME programming. With Pfizer’s restructuring and new two-track system, only 10 percent of its CME grants would go toward those types of meetings.
Shifting funding away from those events will enhance the impact of Pfizer’s dollars, Doyle-Scharff said, because while there will always be value in face-to-face interaction at a large, annual meeting, that’s not the best setting for quality education. And it’s not where funders are going to be spending their dollars. “I grew up in CME and I believe in the power of education, but you have to recognize that it’s got to be more than education for education’s sake,” she said. “Everyone has to roll up their sleeves and think about who the learner is and what their true needs are. You can’t rely on the perceived need of the learners anymore; that’s not going to cut it.”
Indeed, CME providers that are too complacent in today’s evolving marketplace will soon find themselves left behind, Johnson said. “The entire CME paradigm is shifting,” she said. “I think we’re all going to have to be collaborative and creative, and we’re going to have to rethink the type of education we’re delivering.”
Timeline: The Rise and Fall of Industry-Backed CME
A chronology of the regulations, standards, and guidelines that govern, guide, and restrict industry provider relations.
The Pharmaceutical Research and Manufacturers of America (PhRMA), the leading trade association for pharmaceutical and biotech companies, releases its Code on Interaction with Health Care Professionals. The Code is designed to govern relations between industry representatives and health-care providers, and to ensure there is no undue influence to prescribe or recommend certain medications.
The Advanced Medical Technology Association (Adva- Med), the chief trade group for the medical-device industry, follows suit with its own Code of Ethics on Interactions with Health Care Professionals.
The U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) issues “Compliance Program Guidance for Pharmaceutical Manufacturers, ”which recommends that drug and device makers adopt corporate policies to prevent kickbacks to CME providers, and that the companies separate their education-grant activity from their product-marketing activity.
The Accreditation Council for Continuing Medical Education (ACCME) releases updated Standards for Commercial Support, addressing conflicts of interest, transparency, and independence. All CME providers must comply with the standards in order to obtain accreditation.
ACCME releases Accreditation Criteria, which incorporate the 2004 Standards for Commercial Support and shift focus to CME effectiveness. The criteria state that CME programs should be designed to change physicians’ competence or performance, or patient outcomes, and that all accredited providers must evaluate their programs’ effectiveness in achieving those goals.
The U.S. Senate Finance Committee releases a staff report, the culmination of a two-year investigation, claiming that there is evidence that drug and medical-device companies use educational grants as a way to increase market share, and that some CME programs are improperly influenced by commercial sponsors.
Pharmaceutical giant Pfizer announces that it will no longer award grants to medical education/communication companies (MECCs). GlaxoSmithKline follows suit in 2009.
PhRMA and AdvaMed adopt new, more restrictive codes (effective 2009) to govern the pharmaceutical industry’s relationships with physicians and other health-care professionals. Under the new codes, companies can’t provide health-care professionals with pens, pads, mugs, or other non-educational gifts, and can’t directly provide meals or receptions at CME events.
U.S. Sen. Charles Grassley, R-IA, ranking member of the U.S. Senate Finance Committee, contacts leading U.S. medical associations and societies requesting details about industry funding the groups have received since 2003.
Federal regulators reach a $2.3-billion settlement with Pfizer for off-label drug promotion – the largest settlement to date with a single defendant in the Justice Department. The Justice Department had charged Pfizer with making illegal payments and providing entertainment and travel gifts to doctors to induce them to promote and prescribe the company’s drugs.
The nonprofit Institute of Medicine(bold) releases Conflict of Interest in Medical Research, Education, and Practice, a report that calls for an end to educational grants from pharmaceutical and medical-device manufacturers and for a new funding mechanism “free of industry influence.”
Pfizer, as part of the 2009 settlement, begins posting payments made to health-care professionals – for meals, compensation, payments, and “transfers of value” of $25 or more— to its website. In 2011, the value is lowered to $10 or more.
The Physician Payment Sunshine Act is written into the Patient Protection and Affordable Care Act of 2010, requiring industry to report to HHS all payments and transfers of value to physicians and other health-care providers on an annual basis. If passed, the Act will require disclosure of both direct payments, such as speaking and consulting fees, and indirect payments, such as travel, lodging, and participation in CME programs – even if the program is administered by a third-party organization, such as a medical society. The gathering and reporting of the data, therefore, will fall to CME providers.
The American Medical Association’s Council on Judicial and Ethical Affairs releases a report stating that industry funding of CME should be avoided altogether, if possible.
GlaxoSmithKline agrees to pay $3 billion to the U.S. Justice Department for settlement of ongoing criminal and civil investigations into the company’s sales and marketing practices, including funding of CME activities.
The Sunshine Act
Drug and medical-device companies must begin recording all transfers of value to physicians and other providers for 2013 reporting.
‘The Balance of Revenue Has Shifted’
The bad news for continuing medical education is that financial support from drug and device makers is down for the third consecutive year, and it’s not likely to recover any time soon &emdash or ever. “The bottom line is, budgets have decreased, and they’re not going to increase,” said Maureen Doyle-Scharff, senior director of Pfizer’s Medical Education Group. “I don’t see that happening.”
The good news is it might not matter. Total CME revenue is up, according to the Accreditation Council for Continuing Medical Education (ACCME), and it seems medical meeting organizers are finding other ways to foot the bill for CME. As ACCME stated in its 2010 annual report: “The balance of revenue has shifted.”
In 2010, total income for organizations that offer CME programming increased 3 percent over 2009, while “other income” – which encompasses any income that’s not commercial support or advertising/exhibit money — grew nearly 10 percent. Other income now accounts for more than half of total income for CME providers.
Governmental grants and grants from nonprofits fall under the “other income ”umbrella. A number of meeting planners say they’re more aggressively going after such funds. “We’ve started to look at government grants more than ever,” said Wanda Johnson, CMP, CAE, senior director of meetings and education for The Endocrine Society. “We hired a grant writer whose focus is foundation and government grants.”
Another component of “other income” is registration fees &emdash which many meeting organizers either already have raised or are looking into raising. The Cardiovascular Research Foundation increased attendance fees for all events by about 10 percent this year. At the Infectious Diseases Society of America (IDSA),Vice President of Meetings and Education Sandra Harwood, CMP, hasn’t yet raised fees, but expects to soon. She said: “My outlook is, groups like ours will have increasing pressure to raise registration rates to make up some of the difference of shrinking pharma money.”
At the same time, organizers are hesitant to raise fees too much. “After a while, you reach a curve where you’re too expensive and people stop coming,” said Tom Sullivan, president and founder of Rockpointe Corporation, a medical education company based in Columbia, Md. “I know of one annual meeting that has seen its professional attendees drop from 18,000 to 12,000.” Although he can’t attribute the drop directly to rising registration fees, he believes it’s a contributing factor.
Indeed, research suggests that at least for now, physicians are unwilling to pay more for CME. According to a 2011 study in the Archives of Internal Medicine, a majority of physician respondents said commercial support of CME programs introduces bias — but only 42 percent were willing to pay increased registration fees to decrease or eliminate commercial support.
While some planners struggle with the question of raising fees, others point out that plenty of industry money is still available; it’s just not being distributed via education grants. Instead, a number of planners say that they’re seeing renewed interest in traditional advertising and sponsorship opportunities – space that is not subject to the same standards and requirements as CME grants because it’s purely promotional, and not educational. While advertising and exhibit income remained almost unchanged between 2009 and 2010, it grew 64 percent over the past decade, according to ACCME.
At The Endocrine Society, Johnson said she’s had success securing industry sponsors for communication centers, which are designated spaces in the exhibit hall where attendees can check email or charge phones or laptops. She’s also seeing more interest in banners and stand-alone advertising kiosks. She said: “It’s easier to get approval for sponsorship money than for grants.”
Cathy Scheck, vice president of education and meetings for the Heart Rhythm Society, agrees. “We’re seeing more promotional dollars going to non-CME product talks on our exhibit floor,” she said. “It’s not accredited CME, and it’s clearly noted that it’s not CME, but they have been very well attended.” To ensure these well funded but non-accredited learning events don’t pull attendees away from accredited CME, Scheck says she tries to limit them to evening hours.
At IDSA, Harwood is seeing more advertising at CME events held in convention centers. But such blatant displays of industry dollars don’t always sit well with attendees or the leadership of the medical societies sponsoring an event, meaning you have to maintain a delicate balance between generating revenue and maintaining your organization’s professional reputation. “The perception among our board has been that it’s somehow distasteful to have blatant advertising within the confines of the convention, ”Harwood said. “But we’re looking at those sorts of things very closely now.”
One way to soft-sell sponsorship is to create more palatable sponsorship opportunities. “We’re trying to divert industry dollars away from the traditional advertising, like billboards or airport ads, to awareness campaigns,” Scheck said. “Instead of Company XYZ buying a banner, we might approach them with a consumer focused awareness-building campaign, something that fits our mission and goals but needs their financial support.”