Life Science Compliance Update

34 posts categorized "Medical Societies"

October 28, 2014

Physician Payments Sunshine Act: Medical Societies Express Strong Support for H.R. 5539 To Exclude Education Materials From Reporting

Actos

Last month we wrote about a bipartisan effort in Congress to exempt medical textbooks and journals, as well as indirect payments that pharmaceutical and device manufacturers offer to CME providers, from Sunshine Act reporting requirements. Click here for the text of H.R. 5539. Now, the AMA and dozens of physician organizations representing both national specialty societies and state medical societies have expressed their support of the bill. "H.R. is needed to ensure patients benefit from the most up-to-date and relevant medical knowledge," the letter states.

View the medical societies' letter to Representative Michael Burgess (R-TX), who introduced the bill. Allyson Schwartz (D-PA) co-sponsored. 

Congress outlined 12 specific exclusions from Sunshine Act reporting, including “[e]ducational materials that directly benefit patients or are intended for patient use.” In its interpretation of the statute, CMS concluded that medical textbooks, reprints of peer reviewed scientific clinical journal articles, and abstracts of these articles are not directly beneficial to patients, nor are they intended for patient use. "This conclusion is inconsistent with the statutory language on its face, congressional intent, and the reality of clinical practice where patients benefit directly from improved physician medical knowledge," states the letter.

The American Medical Association and other physician organizations have repeatedly stressed the importance of up-to-date, peer reviewed scientific medical information as the foundation for patient care. "Scientific peer-reviewed journal reprints, supplements, and medical text books have long been considered essential tools for clinicians to remain informed about the latest in medical practice and patient care," the letter states. "Independent, peer reviewed medical textbooks and journal article supplements and reprints represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients because better informed clinicians render better care to their patients."

Furthermore, the letter states that FDA's reprint guidance underscores the “important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications.” H.R. 5539 clarifies that the Sunshine Act was designed to support the dissemination of this type of educational material.

The letter also addresses the Centers for Medicare and Medicaid Services (CMS) proposal to eliminate the continuing medical education exemption from the Act. "[This] proposal is inconsistent with the legislative history of the Sunshine Act and will further erode support of independent medical education," the societies note. "There is widespread consensus that the agency’s proposal will harm the dissemination of clinically relevant and critical medical knowledge that improves and enhances patient care. We strongly support the provisions in H.R. 5539 which would clarify that CME that meets the standard for independence must be exempt from Sunshine Act reporting." 

Click here for our article on the outpouring of support in favor of keeping the CME exemption. 

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H.R. 5539 revises the Sunshine Act in the following way: 

Transparency Reports and Reporting of Physician Ownership or Investment Interests, Sec. 1128G. [42 U.S.C. 1320a-7h]

(B) Exclusions.—An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:

(iii) Educational materials that directly benefit patients or are intended for patient use, including peer-reviewed journals, journal reprints, journal supplements, and medical textbooks;

(xiii) A transfer of anything of value to a covered recipient who is a physician if the thing of value is intended solely for purposes of providing continuing medical education to the physician.

 

November 04, 2013

AAFP Postpones NP and PA Membership

The American Academy of Family Physicians (AAFP) recently announced its intent to study whether nurse practitioners (NPs) and physician assistants (PAs) should -- or would want to -- become nonvoting members. AAFP's Congress of Delegates decided not to create a new dues-paying membership category for NPs and PAs.

According to Medpage Today, AAFP's Reference Committee on Organization and Finance believed the number of allied health professionals that belong to other primary care physician organizations is small and that "the implementation cost would be significant for the small number of members that join the AAFP." The Committee also expressed concern "about the divisiveness of the issue for the physician-based organization, and noted the difficulty of tracking NPs and PAs to ensure they are working with an active AAFP member," Medpage reported.

Ultimately, the reference committee recommend the resolutions be referred to the AAFP Board of Directors for further study. The Congress of Delegates agreed.

Outgoing AAFP President Jeffrey Cain, MD, told MedPage Today the NP/PA-membership issue has come up previously.

Thomas Weida, MD, of Hershey, Pa., the delegate who introduced the resolutions on NPs and PAs, said he wanted to provide the allied health professionals access to AAFP's continuing medical education (CME) opportunities. "The academy has been founded on CME, and I think our CME is a high quality," Weida told MedPage Today. "We can then start working together on developing solutions to the challenges that face patients in care delivery and patient-centered medical homes."

This idea is increasingly important as many of the pillars of healthcare reform include team-based care, collaboration, and integration among healthcare providers—whether through the patient centered medical home (PCMH) or Accountable Care Organizations.

Moreover, the significant increase and influx of patients that will have health insurance over the next few years coupled with an unaddressed physician shortage leaves the possibility that NPs and PAs will fill those gaps—making interprofessional CME even more appealing.

Interprofessional CME is already a reality on the CME stakeholder side, with several CME providers receiving dual accreditation for physicians, nurses and/or pharmacists. Thus, the framework to offer interdisciplinary CME is already in place and can only be enhanced and improved as physicians, NPs and PAs work closely together to use the skills and knowledge they can gain from such education. Moreover, interprofessional CME may also offer unique opportunities for these healthcare providers to interact and exchange ideas and best practices for managing patient care.

The head of the American Academy of Physician Assistants strongly supported the measure, Weida said. He added that he was pleased with the result of Tuesday's action. Weida said that he did expect the resolution "to be accepted this first time around" but "the pendulum will swing as we realize the value of working together." Despite the resolution not being adopted, the AAFP maintained that NPs and PAs must work in teams with physicians and not independently.

Incoming AAFP President Reid Blackwelder, MD, told the Congress of Delegates in an address Monday that family physicians must work together -- not against -- NPs and PAs to meet patients' needs.

"Perhaps one of the most important aspects of this discussion is to recognize that ultimately the scope-of-practice issue is not a battle, it's not us against them, it's not good or bad, it's not right or wrong, even though this is often how the discussion is framed," Blackwelder said. "The truth is that each member of the team is critical and has important roles to play, but we are not interchangeable."

 

October 11, 2013

Electronic Health Records: Physician Organizations Requesting One Year Delay in Meaningful Use Stage 2 Requirements and Penalties

As both congressional chambers debate reopening of the goverment, budgets and whether to defund all or pieces of the Affordable Care Act (ACA), healthcare reform continues to be implemented in various areas, such as electronic health records (EHRs) and the meaningful use program. Over the last several weeks, various healthcare stakeholders and groups have expressed their concerns over the implementation deadlines of the Meaningful Use stages as well as other aspects of the program that may be burdensome to physicians and their staff.

As a brief refresher: Under the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act (part of the Recovery Act), hospitals and healthcare providers must be able to demonstrate by 2015 that their EHR systems are capable of certain tasks that constitute "meaningful use."

Currently, to receive a payment, providers must meet 19 of 24 "meaningful use" objectives that include electronically tracking patients' medications and allergies, sending reminders, sharing lab test results and producing summaries of a patient's office visit. The Centers for Medicare& Medicaid Services (CMS) oversees the incentive program.

More than 3,750 hospitals have received a total of $8.8 billion in "meaningful use" incentive payments as of July, according to the CMS website.

Concerns About Meaningful Use

For example, FierceEMR reported that the American College of Physicians recently sent a letter addressed to federal health officials saying that the "very aggressive" timeline and "overly ambitious" objectives of Meaningful Use Stage 2 threaten to limit the success of the overall program.

In the letter—sent to U.S. Department of Health & Human Services (HHS) Secretary Kathleen Sebelius, Centers for Medicare& Medicaid Services (CM) Administrator Marilyn Tavenner and National Coordinator for Health IT Farzad Mostashari—ACP Medical Informatics Committee Chair Peter Basch added that relying on "evolving and draft standards" and untested technology could create "unintended consequences" and "additional costs" for physicians.

"As Meaningful Use has become more prescriptive of certain workflows, it has become less relevant to internal medicine subspecialists," Basch writes. "We are concerned that subspecialists may not adopt and fully realize the potential of certified [electronic health record] products if the requirements of the program do not allow for the unique workflows required by some subspecialists." The letter outlines five areas of concern for ACP members, including:

  • The Stage 2 timeline: ACP recommends an extension of at least one year or "perhaps even longer" for Meaningful Use Stage 2. "The implementation of software by a practice does not mean that the practice is prepared to use it appropriately or to make the care process changes needed to accomplish the objectives," Basch says.
  • Clinical quality measures: ACP believes that the clinical quality measures reporting process won't be ready in time for Stage 2. According to Basch, there hasn't been "sufficient time either for the new e-measures to be tested and validated, or for a determination if the output of the EHR systems is an accurate representation of the performance of the [eligible providers]."
  • ICD-10 and physician quality reporting systems: The implementation of the former means that physicians will need new or updated EHR systems on Jan. 1, 2014, to comply with data collection requirements for the latter.
  • Scoring Meaningful Use measures: ACP calls the "pass-fail" requirements "counter-productive." Basch says that a "partial scoring" or "tiered" system would be more fair and representative of what providers can realistically accomplish. "Not every measure is absolutely appropriate and of equal value to every practice situation," he adds.
  • Planning for Stage 3: ACP believes that "deeming" should be the "preferred pathway" for most providers in achieving Stage 3 of Meaningful Use. "There are better ways for EPs to prepare for and to deliver better outcomes than logging activities that may or may not have direct impact on the quality, safety or value of care," Basch says.

In addition to the ACP's latter, the Medical Group Management Association (MGMA) asked HHS last month to extend reporting for Stage 2 by at least one year and delay the penalties to be imposed on providers who are not meeting the Meaningful Use requirements, as reported by FierceEMR. The CEO of MGMA, Susan Turney, told Secretary Sebelius that while there are more than 2,200 products and almost 1,400 "complete EHRs certified under the 2011 criteria for ambulatory eligible providers, there are only 75 products and 21 complete EHRs for Stage 2 criteria."

"This lack of vendor readiness has significant implications for EPs," and "without the appropriate software upgrades and timely vendor support, EPs will be unable to meet the Stage 2 requirements and thus will be unfairly penalized starting in 2015," Turney wrote. MGMA also called for an extension for providers on the reporting period for Stage 2 incentives from 90 days to one year, as well as an extended reporting period for Stage 1 incentives for providers whose EHR has not been re-certified by January 2015 for the Stage 2 criteria.

The American Academy of Family Physicians (AAFP), also asked federal health officials for a one-year extension to the time frame for compliance with Meaningful Use Stage 2, saying that the current time frame "will outstrip the capacity" of both vendors and family doctors. AAFP Board Chair Glen Stream, M.D., said that such an extension would create "three distinct cohorts:"

  • Cohort 1, which would include eligible professionals attesting to Meaningful Use in 2014 as their first payment year;
  • Cohort 2, which would include EPs attesting to Meaningful Use in 2014 as their second payment year, and;
  • Cohort 3, which would comprise EPs attesting to Meaningful Use as their third or fourth payment year

As reported by FierceEMR, EPs in each of the cohorts under AAFP's proposal would be required to follow specific but distinct timelines for Meaningful Use reporting to receive their bonus payments.

"This modified timeline would allow exemplar practices to implement Meaningful Use Stage 2 requirements early in 2014 and for their experience and learnings to be leveraged by vendors, implementers and other providers to optimize subsequent transitions," Stream said. "Pressure would be kept on vendors to be ready for Meaningful Use Stage 2 by Jan. 1, 2014, while distributing the strain of conversion of vendor product and physician workflow over a 21-month period rather than a nine-month period."

In addition to these letters, Seventeen Republican senators urged HHS to extend the deadline Stage 2 of the Meaningful Use Incentive Program.

The senators—led by John Thune (S.D.), chair of the Senate Republican Conference, and Lamar Alexander (Tenn.), ranking member of the Health, Education, Labor and Pensions Committee--sent a letter Sept. 24, to Secretary Sebelius, asking for a one-year extension "for providers who need extra time to meet the new requirements." The senators expressed three key concerns with the current timeline:

  • Significant timeline pressure
  • A widening of the "digital divide" for small and rural providers 
  • Serious unintended consequences of the rush, such as stifling innovation and increasing medical errors

The senators asked Sebelius to respond by October 8th.

Back in July 2013, Sen. Orrin Hatch (R-Utah) in called for HHS to pause and reassess the program. Hatch's statement came during a Senate Finance Committee hearing, which focused on health IT. National Coordinator for Health IT Farzad Mostashari, who attended the hearing, defended the program, testifying that the Meaningful Use objectives are "strongly aligned with other policy drivers to help" the healthcare system to become safer and more efficient. When asked by Hatch if a break from the program would be a good idea, Mostashari responded that doing so would interrupt momentum being built, reported FierceEMR.

Patrick Conway, chief medical officer at CMS, agreed with Mostashari, testifying that increased EHR adoption will improve the quality of care for CMS beneficiaries. "EHR data can be used to display information in ways that are beneficial for providers and their patients. … By providing tools and incentives for EHR adoption, quality reporting, e-prescribing and patient engagement in their healthcare, CMS is encouraging clinicians, hospitals and beneficiaries to use HIT as a platform for improved healthcare quality and better health outcomes at lower cost."

In addition to this testimony, four hospital Chief Information Officers (CIOs) representing the College of Healthcare Information Management Executives (CHIME) expressed their concern, about increasingly rigorous demands and shorter deadlines in Meaningful Use Stage 2. The CIOs called for a one year extension for Meaningful Use Stage 2.

FierceEMR noted that a majority of hospital CIOs recently polled by healthsystemCIO.com in late May called the Meaningful Use program flawed, agreeing with CHIME's request for a one-year extension. CHIME's proposal came in response to a call in April from six GOP senators to reboot the Meaningful Use incentive program.

"The biggest issue … is that we just don't have enough time to implement and exercise the 2014 certified software," said Pamela McNutt, CIO of Dallas-based Methodist Health System.  "All of the objectives listed as challenges require significant work to implement after upgrading … For example, after delivery of the patient portal we will have to map data elements from the patient record and clinical staff will need to ensure that the data is representing accurately."

Others expressed concern about funding, noting that small and rural hospitals already make ends meet on "razor-thin margins." In fact, Reuters reported on a recent study, which found that small and rural U.S. hospitals are most at risk of not satisfying certain federal requirements for using electronic health record systems.

In this new study, lead author Catherine DesRoches, from Mathematica Policy Research, collaborated with the American Hospital Association (AHA) and analyzed Medicare data to see which types of hospitals were receiving incentive payments indicating progress toward the meaningful use goals.

Between 2011 and 2012, the researchers found, the percentage of hospitals nationwide receiving incentive payments more than doubled from about 17 percent to about 37 percent.

But considerable disparities among hospital types and regions have emerged, the researchers report in the journal Health Affairs. Hospitals in the Northeast were most likely to receive incentive payments, compared to those in other parts of the country, with the West trailing. In 2012, 47 percent of Northeast hospitals got the payments, followed by 41 percent of hospitals in the South, 32 percent in the Midwest and just under 29 percent in the West.

Teaching hospitals were more likely to receive federal incentive payments than nonteaching hospitals, and for-profit hospitals more likely to receive the payments than not-for-profits. Less than 30 percent of government-owned hospitals got the incentives in 2012.

In all categories, as the number of beds at facilities got smaller, the percentage of hospitals receiving payments dropped.

More than half of the hospitals with 200 or more beds received incentive payments, compared to just about 27 percent of hospitals with fewer than 100 beds. And just 10 percent of critical-access hospitals received the incentives in 2012.

These smaller hospitals may have difficulty coming up with the financial resources to implement an EHR system meeting the requirements, they may have trouble attracting the proper support staff to manage the EHRs and they may also have trouble competing with larger clinics for the systems, the study authors point out.

There have been "infrastructure issues" when it comes to smaller and critical-access hospitals, according to Kimberly Lynch, director of the Regional Extension Center (REC) Programs at the Office of the National Coordinator for Health IT in Washington, DC.

 

September 17, 2013

ASCO Policy for Relationships with Companies and How European Associations Will Benefit

Over the last ten years, European conferences have exploded with increased attendance while US conferences have shriveled. One potential reason could be the restrictions that US associations are placing on abstract presenters to prevent potential conflicts of interest. There is one association that may be one to watch if we see that trend continue.

The American Society of Clinical Oncology (ASCO) released its "Policy for Relationships With Companies". The policy puts in place a ban on submitting abstracts to their meeting from authors of journal articles who have given a promotional talk in the last two years for the supporting company, were employed by that company, or have ownership or significant investment interest.

The policy describes ASCO's comprehensive approach to addressing financial relationships held by ASCO, its key leaders and volunteers, and anyone who seeks to publish or present in an ASCO forum. However, as we will illustrate, the new policy can be overly restrictive, which may diminish the policy's usefulness.

Some highlighted parts of the policy:

DISCLOSURE OF FINANCIAL RELATIONSHIPS

A. Institutional Relationships

The ASCO and Conquer Cancer Foundation (CCF) publicly disclose external support of programmatic activities, including charitable contributions, educational grants, and sponsorships. In addition, the ASCO and CCF publicly disclose financial relationships with Companies held by their directors and officers and by the editors of the Journal of Clinical Oncology (JCO) and the Journal of Oncology Practice (JOP).

B. Individual Relationships

Many volunteers and other individuals take part in the planning, authorship, peer review, or presentation of programs or content through ASCO channels. ASCO considers it important to understand individuals' financial relationships with Companies and to make relevant information available to colleagues, learners, readers, and other affected parties. This Policy requires disclosure of certain financial and other relationships held by all individuals who:

1. are ASCO directors, officers, or senior staff;

2. serve on ASCO committees, task forces, clinical practice guideline panels, and the like, as spokespersons, or in any other volunteer activity or official capacity for ASCO;

3. submit abstracts or make presentations in ASCO educational or scientific programs;

4. submit manuscripts to JCO, JOP, and other ASCO publications;

5. have other roles for which disclosure is required by ASCO; or

6. are immediate family members of individuals who hold relationships 1 through 5 described here.

C. Information to Be Disclosed

Disclosure under this Policy generally includes but may not be limited to the following financial relationships: compensation received for employment, leadership positions, consulting activities, speaking engagements, and expert testimony; as well as ownership interests, research funding (to the individual or the institution), and licensing fees and royalties associated with intellectual property interests.

RESTRICTIONS ON CERTAIN RELATIONSHIPS

A. Original Research in ASCO Educational or Scientific Programs

Abstracts and articles concerning original research are not eligible for inclusion in an ASCO educational or scientific program if the first, last, or corresponding author has:

Participated in a speakers' bureau (on any subject) on behalf of the Company sponsor of that original research at any time during the 2 years before submission of the abstract;

 Held an employment relationship with the Company sponsorof that original research at any time during the 2 years before submission of the abstract; or

 Held a significant ownership interest in the Company sponsor of that original research at any time during the 2 years before submission of the abstract.

B. Original Research in ASCO Journals

Manuscripts (including articles and abstracts) concerning original research are not eligible for publication in JCO or JOP if the first, last, or corresponding author has:

Participated in a speakers' bureau (on any subject) on behalf of the Company sponsor of that research at any time during the 2 years before submission of the manuscript;

Held an employment relationship with the Company sponsor of that research at any time during the 2 years before submission of the manuscript; or

Held a significant ownership interest in the Company sponsor of that research at any time during the 2 years before submission of the manuscript.

The policy was released on April 22, 2013 and effective on that date. To our knowledge no prior notification was sent to ASCO members.

DISCUSSION

This policy eliminates all investors, anyone who has participated in a speaker's bureau, or any company employee(s) from submitting original research at ASCO. This will eliminate a significant number of quality abstracts based. These limits are burdensome and discriminate against many well qualified people who would otherwise be eager to submit their research to ASCO.

The draconian rules will only hurt the transfer of scientific knowledge and their benefits for the public health. Researchers want to publish, just like any other scientist, and all researchers have biases that can impact their methods. This policy implies that somehow company supported research and scientists are not quite as honest as their academic counterparts.

Fortunately there are many additional outlets for presenting and publications at the disposal of oncology researchers. In the future many of these scientists will submit their abstracts and posters elsewhere.

One can expect a significant drop in the quality of abstracts and the number of attendees at ASCO conferences. We are now in a global scientific economy--European and smaller societies are much more open to company science. American associations who have adopted similar policies have seen 30 – 40% reductions in attendance for US meetings where their European counterparts have exploded with corresponding increases in attendance.

The concern for US patients is that science presented and published in Europe can take years before US physicians know about their results. For cancer patients this is a real concern in that they may miss out on breakthroughs in treatment simply because their oncologist is "unaware" of the science.

We will see if in ten years one reminisces, "I remember ASCO when….

August 22, 2013

The Biggest Challenges Facing Medical Meetings 2013

The Professional Convention Management Association (PCMA) recently posted a story in Convene, which discussed "The Biggest Challenges Medical Meeting Planners Face Today." This topic is of particular interest given all of the new obligations that medical meeting planners must abide by to ensure compliance with the Sunshine Act, now that reporting has officially begun.

The article was adapted from an exclusive roundtable of senior-level medical meeting planners, which included:

  • Felix Niespodziewanski, Director of Convention and Meetings, American College of Surgeons (ACS)
  • Barbara Smith, CAE, Executive Director, American Thyroid Association (ATA)
  • isa Astorga, CMP, Director of Meetings International Society on Thrombosis and Haemostasis (ISTH)
  • Ben Hainsworth, Director, Congresses and Meetings Division, European Society of Cardiology (ESC)

Astroga noted that one of the issues with meetings is the Sunshine Act and "how this is going to impact our corporate partners and how that trickledown effect will impact us as a society. People think about the new Sunshine Act here in the States, but there are many countries that have a Sunshine Act, and again, it's understanding all of those different compliances and how they will impact your meeting. And that's terribly burdensome." Moreover, she noted several questions meeting planners have, such as having U.S. speakers go abroad and reporting attributed to the society or meeting host.

Challenges for Medical Meeting Planners

Felix noted that the biggest challenge facing medical meeting planners now is how to "maintain our exhibitor base," given all the changes taking place in health-care delivery and reimbursement. "We're starting to lose some of our largest exhibitors, because they're feeling that we're too broad of an organization. And some of them have switched their focus to be more visible and active with regional or even smaller chapter state meetings, and also to focus more vertically. While the college is an umbrella organization for all of surgery, the largest contingent of membership are general surgeons, and general surgeons are sort of the steak and not the sizzle, as I say it."

Felix added that one reason exhibitors struggle to gain access to providers is because "so few of them now are independent practices. They're part of a large group, or if not a large group, they're employees of some kind of an institution. And frequently the buying decision now has been moved from their hands to someone in finance procurement, to determine what's going to be purchased for the entire institution. And access to the provider has become more and more difficult for pharmaceutical and device manufacturers."

Barbara Smith cited one of the biggest challenges being the "rigors of continuing medical education (CME)", which she said have "gone overboard … on all fronts." She noted how she is in the process of submitting a meeting for CME credit. "It used to be that we would take our entire program, which has 32 hours of CME credit" and "130 faculty, all of whom volunteer their time;" no one is getting paid honoraria or travel, and the faculty pay their registration to come to the ATA meeting. The speakers are thyroid specialists; not "any special $10,000 or $50,000 speakers."

In comparison, the "CME requirements now — for every hour of presentation, for every 20 minutes of presentation, we have to prove that that has a learning objective, it has a pre and post test, it has a proof that that has an impact on patient health. Which makes sense in the big picture of continuing medical education, but when you're explaining how this one 20-minute talk is going to have a lasting effect — as opposed to the whole meeting, where people are coming for an education that is so exemplary, so without conflict, and so academic — I understand that we do have to have high standards, but it does seem like CME is going overboard."

Lisa Astorga noted that her biggest challenge as a truly international society with international meetings is "compliance issues," and not just complying with ACCME standards, but also PhRMA rules and issues of accreditation with local, state and government entities.

For example, she noted her organization would be going into Amsterdam, and at the very last minute was told that the Netherlands has this law that non-prescribing attendees cannot go into the exhibit hall. Astroga said: "Wow. So, this is a Dutch law. This is an industry-imposed sort of thing, and now what do we do?" And who polices this, and what if somebody sneaks in? Do the police come and shut us down? And how does this work exactly?

Ben Hainsworth, also noted that his organization was going to Amsterdam and noted the same issue. His organization is interpreted this Dutch law to mean that not even nurses (some of whom can prescribe) could attend such meetings as medical professionals.

To comply with the Dutch Law, Astroga noted that her group will be putting a sign outside of the hall that says, "Any non-prescribing attendee is not permitted in the hall." "We've been told that no one ever polices it, there's never been a fine or anything against it. But in addition to that, it's my understanding that the EU is sort of implementing this not from a state governmental law, but as an industry law across Europe. So that'll be interesting to see how this pans out."

Astroga also mentioned the challenge of the sponsorship/ exhibit climate — "is it up, is it down, where are we going? — because the society's funded a great deal by sponsorship. That whole environment seems to change on a dime. Just when you think things are done and over, they come back up."

Hainsworth noted that "the overarching issue that … is uncertainty, because we know that there are compliance issues, we know that there are funding issues, we know that there are demographic shifts. But what we never know is when they're really going to bite in, so to adapt a business model appropriately — not to overreact, not to under-react or to react too late — is really tricky. If we knew that certain things were going to be applied and when, it would be so much easier to deal with. It's just that we don't have that visibility."

This uncertainty creates problems for meeting planners because they do not know "how big a venue to hire." Another uncertainty Hainsworth noted is "traditionally the registration fees are being paid by industry — not necessarily only pharma, but the health-care industry. And as that slowly goes down, we hear some people saying that physicians, or at least let's say half of them, would pay for their own congress attendance if they had to or would find alternative funding. But we also hear that they wouldn't. So the uncertainty as to that gap or the hole that's going to be left by the industry decision not to fund delegates doesn't put us on a firm footing."

Hainsworth explained that this sort of "widespread uncertainty" changes the medical meeting planning process by destabilizing decision-making. If you "lack a certain visibility in what your overall metric is going to be, you don't know whether you can invest in new technology. You're not too sure if you're going to try out that new venue. You're not too sure if you're going to be able to hire those six-month interns or the extra staff that you might need for something. Or you don't know if you're going to be able to adjust your pricing."

Astroga noted that it also makes meeting planners "hesitant to do anything," and "when the funding actually does come through, it's trying to implement things in a much shorter timeline: Okay, so now we can do this. How do we pull it together and have it done right, have it done correctly, and make the attendee experience what it should be in the time that we have to get things done?"

To adapt to this kind of uncertainty, ESC hired a procurement officer, who has the main task of determining the terms, conditions, scalability and the flexibility of what we buy or rent," which is "putting a lot more pressure on our suppliers," Hainsworth noted.

Opportunities for Medical Meeting Planners

With respect to opportunities for meeting planners, Barbara Smith noted that planners still have the ability to provide face-to-face meetings in the digital era. "Incredible synergy and collaborations happen in the halls of hotels outside the meeting room, inside the meeting room. Our thyroidologists already have international collaborations on research, international collaborations on writing guidelines, and what a meeting like this provides is that opportunity for, as we've all experienced, that kind of light bulb going off. That always happens when human beings get together and sit down and talk to each other. I don't think that will ever be replaced."

Astroga pointed to technology and the kind of evolution meeting planners have participated in making meetings more technologically advanced—and how younger people will bring this experience and excitement to meetings in the future. Both Astroga and Hainsworth also pointed to the importance of the content organizations and societies create and provide to healthcare professionals—which "is the most valuable asset of any organization right now."

Another update in meetings is offering translation services for meetings in different languages or offering meetings with simultaneous translation, given the growing global foot print and collaboration involved in health care.

Additionally, attendees expect different and new technologies. Learners want "the mobile app, they want interaction; more people are using their iPads and you're getting audience response." Hainsworth noted that a proper balance of such new technology is needed, however, and it should not alienate certain members of the audience who may not be familiar or up to speed with such technology. Nevertheless, he noted that attendees are becoming more demanding—not "necessarily knowing exactly what they want, but they're becoming a bit more discerning."

Part of the reason attendees are becoming more discerning is that professionals more and more are paying for their participation in meetings. "So it's a lot more individual people who are really deciding on their own to come, and they're obviously, for that reason, much more demanding and harder to satisfy — but without saying what they might be expecting, what they might be demanding, what they're going to be looking for. They simply are more demanding as a group of people. More of them have made the personal decision on their own to sacrifice their time or their holidays and money to go there."

Although new technology and content is increasingly online, including CME, Felix noted that there is still tremendous value in having "live" experience at meetings, including education and networking. "I think the medical industry is such that there needs to be that interchange, that interaction between people to discuss solutions and possible solutions," Felix noted.

Hainsworth added that while medical meetings are also a chance for professionals to "get away from work" that is becoming more demanding, the "live" environment is "a bit more conducive to what they consider to be their specialty." Astroga agreed, and noted that networking and connections are the biggest factors for live meetings. Professionals like "seeing colleagues."

"One thing about medical meetings, you can get a pair of these physicians or researchers that haven't seen each other for a while, and they'll sit down, they'll talk for hours. It's amazing. Just looking at each other's research or looking at each other's way of how they're doing it at their institution or their facility. So the networking is extremely, extremely important for them," Astroga noted. While networking may be for the older base of attendees, Astroga added that younger professionals are "extremely excited about giving these posters and talking about their abstracts. It's a really big deal for them."

Barbara noted that the value of live meetings in her experience has been the "high-quality science [that ATA attendees are interested in], where they're learning cutting edge, they're learning new data that's not just a review of what they already have read in their journals. They're not coming to find out what's happened in the past year. Our attendees come to hear about the absolute current state of thyroid research and discovery."

With respect to international meetings, the panel noted "normal challenges" that attendees may face, such as visa issues. For a U.S.-based society, Astroga also noted issues dealing with foreign funding such as Cuba or Iran, and having to deal with OFAC [the U.S. Office of Foreign Assets Control]. "But generally most of it is just getting folks there — again, the visa issues, and for some of them that have never traveled outside of their area, just being able to make sure that we are accommodating, helpful, and can give them some insight and knowledge to where they're going," Astroga noted.

Lastly, the panel discussed new and exciting developments around medical meetings. Barbara discussed meetings involving patients who hear from scientists and physicians about particular issues and who partner with patients to take them through exhibit halls. The participation of patients to a greater degree in their own healthcare—bringing information to their physicians—will be "the new frontier" to a much greater degree.

Hainsworth said he was excited about medical meetings taking place over the whole course of the year, with mobile, digital, remote and paperless meetings, to engage professionals to participate at various times. This creates more value than just attending a weeklong meeting at a nice venue. "A lot of us that work for associations, we do have the hope that we're actually doing something that shows a higher cause than just share value and so on, and I think that the way that things are evolving means that our work will improve the impact that the professions that we represent have on society," he added.

June 20, 2013

NIH - NHLBI Discontinues Guidelines Program Passes Work off to Associations

Over the years, we have written about the important role clinical practice guidelines play in physician care and treatment of patients. In fact, many continuing medical education (CME) programs have improved physician adherence to certain guidelines, which has led to better diagnosis and treatment of certain diseases (for example antibiotic guidelines in hospitals and hypertension guidelines).

For example, in 1977, the National Heart, Lung, and Blood Institute (NHLBI) issued the first of a number of clinical practice guidelines that would emerge from the National Blood Pressure Education Program, as well as from other similar efforts like the National Cholesterol Education Program. The NHLBI guidelines have covered a variety of topics, including, but not limited to, cholesterol, blood pressure, asthma, and von Willebrand Disease. "Over the years, these groundbreaking health education initiatives have promoted marked increases in the public's awareness of cardiovascular disease risk factors and contributed to the major reductions in coronary heart disease mortality observed during this period."

The use and creation of guidelines has continued to grow over the years, and more than 2,500 now can be found in the archives of the Agency for Healthcare Research and Quality's (AHRQ) National Guideline Clearinghouse. The last guidelines were published from 1997-2003 with ground breaking reports such as ATP3 and JNC6. In 2007 NHLBI Began the process of convening the panels of experts to revise the guidelines on high blood cholesterol, high blood pressure, and overweight/obesity in adults and develop new reports on cardiovascular risk assessment and lifestyle modification.

However, various concerns were raised about the reliability of certain guidelines and the processes involved in their development.  In response to these concerns, the Institute of Medicine (IOM) issued a new set of standards for clinical practice guidelines in March 2011 intended to enhance the quality of guidelines being produced. 

Consequently, a recent development regarding guidelines creation occurred yesterday, when the NHLBI issued a statement announcing that it will "refocus" its health education agenda to its "core mission of knowledge generation and synthesis by supporting and producing rigorous systematic reviews that can then be used by other collaborating organizations to generate guideline products that serve the public interest."

The NHLBI has decided that "the five integrated cardiovascular guideline products will be published as evidentiary reviews, and that the Institute will subsequently collaborate with other organizations to prepare and issue the related clinical practice guidelines." The decision was made at a public meeting with the NHLBI Advisory Council (NHLBAC).

While the detailed elements of the new NHLBI model remain to be further refined, the Institute said its "overall framework is well aligned with the IOM approach," and outlined "six operating principles" that will govern the new framework:

    1. Before taking on new evidence syntheses, the NHLBI will consult closely with external stakeholders to identify high-priority needs with compelling relevance to the NHLBI mission and the health of the nation.
    2. Once those needs are identified, the NHLBI will work with external stakeholders to determine which critical questions are most crucial for their ability to generate guidelines that are reliable, robust, credible, relatively easy to implement and likely to promote significant improvements in public health.
    3. In supporting and generating evidence syntheses, the NHLBI will pay careful attention to the evolving standards on systematic reviews promulgated by the IOM and other credible sources (citing an IOM report on Standards for Systematic Reviews) (see below for more)

    4. In enabling partner organizations to generate their own guideline products, the NHLBI will continue to abide by the highest standards for developing trustworthy clinical practice guidelines and continue to adapt as best practices and the landscape of stakeholders evolve.(citing an IOM Report on Clinical Practice Guidelines)

    5. The NHLBI will implement a process for internal evaluation and continuous improvement in line with our commitment to results-based accountability and stewardship of public resources.
    6. The syntheses will identify evidence gaps which can guide research investments in areas of importance to public health.

Below is a summary of NHLBI's reasoning for making this decision and some historical background on their previous guideline activities. The Institute noted that while the "time has come for a change in [its] practice of generating clinical guidelines," it will "remain steadfastly committed" to generating "rigorous systematic evidentiary reviews in support of the highest quality clinical practice guidelines worthy of the public trust." They maintained that the "new collaborative partnership model of guideline development will enable the NHLBI to 'recruit knowledge and science in the service of national strength' as envisioned by President Franklin Roosevelt 73 years ago.

Background

For more than sixty-five years, the NHLBI core mission has been, and continues to be, the generation and dissemination of knowledge and science with the goal of securing a healthy nation. On July 26, 1972, Elliot Richardson, the Secretary of the US Department of Health, Education, and Welfare (now HHS), announced the establishment of a "National Hypertension Program." The program planned a four-step approach to include (1) agreement on standards and conditions for treatment, (2) education of health workers, (3) public dissemination of information, and (4) research on the impact of the program on health care delivery.

Richardson appointed two committees: (1), the "Hypertension Information and Education Advisory Committee," which focused on the knowledge of hypertension and the communication of that knowledge, and (2), an "Interagency Working Group" to focus on exchange of information and coordination with the professional community.

After NHLBI created the initial guidelines noted above, "the landscapes surrounding the management of blood pressure and cholesterol disorders, as well as the landscape of clinical practice guidelines," underwent profound changes. "Many more effective strategies are available for clinicians and patients to choose from, and orders of magnitude more clinical evidence information is available. The advent of the internet and the proliferation of mass media outlets provide the lay public with direct-to-consumer access to a plethora of health information."

Clinical research sophistication has grown, as the "mega-trial" has gone from being the exception to the norm. During this period the number and scope of governmental entities engaged in providing guidance on clinical practice has also changed substantially.

NHLBI also noted that "numerous organizations outside government have developed expertise and experience in developing guidelines. Indeed, a special working group of the NHLBAC has noted that nearly all NIH Institutes and Centers have elected to limit engagement in guideline development to efforts involving close collaboration with professional societies or other external groups. "In recent history, the NHLBI has been the lone exception to this general NIH practice," the statement explains.

Discussion

Part of the explanation for NHLBI's discontinuation of guideline making is tied to the fact that the number "of available guidelines provided by a variety of sources has literally exploded." However, "serious questions and controversies have arisen about how guidelines should be developed, implemented, and evaluated," and "[c]ritics have aptly noted that it is not a given that clinical practice guidelines benefit patients."

Frequently, guideline "developers have been criticized for failing to adequately control for conflicts of interest, for issuing guidelines of variable quality, and for issuing contradictory guidelines that leave clinicians feeling confused and vulnerable. Despite these allegations, NHLBI correctly maintained that "the development of clinical practice guidelines leads to invaluable benefits for patients and clinicians:

  • improved outcomes due to better deployment of evidence-based strategies,
  • improved consistency of care,
  • empowering information for patients,
  • improved public policy through attention drawn to areas of importance to public health,
  • assistance to clinicians who aim to keep their practices up-to-date,
  • guidance for quality improvement activities; and
  • help researchers and research funders identify important research gaps and set the stage for the iterative process of new knowledge generation and advances in patient care.

NHLBI also noted the "debate about who should be in the driver's seat." (i.e., writing the guidelines. "Primary care generalists, specialists, and government agencies may each have limitations which impede their effectiveness in leading the development of guidelines." These concerns have led many organizations to actively reach out to many stakeholders, as was the case in a cardiovascular guideline on risk assessment that. NHLBI emphasized that multiple stakeholders working together collaboratively should write guidelines, rather than one entity, because "there is a much greater likelihood of high-quality products, products that reflect diverse perspectives, philosophies, and expertise."

NHLBI then went on to cite the two IOM reports (noted above) addressing clinical guidelines and the recommendations and analysis they helped provide in general and to the Institute. The Institute noted IOM's distinction in creating two reports: one on standards for systematic reviews and the other on development of trustworthy guidelines. With respect to the former, NHLBI noted that standards for systematic reviews, which NHLBI will be continuing, include:

  1. assembling expert teams with the capacity to manage bias, conflicts of interest, and stakeholder input;
  2. identifying pressing clinical needs while developing an optimal analytic framework;
  3. developing and following rigorous protocols that cover the search and assessment of evidence, as well as its synthesis; and
  4. preparing structured, user-friendly peer-reviewed final reports

The Institute noted that the "standards on guidelines include a similar focus on transparency, management of conflict of interest, team composition, effective articulation of recommendations, external review, and updating." IOM stated that, "Clinical Practice Guideline developers should use systematic reviews that meet standards, [and should interact with] the systematic review team regarding the scope, approach, and output of both processes."

Conclusion

NHLBI's decision demonstrates an interesting point: even the most cutting edge scientists who are constantly analyzing new scientific and medical information and data are sometimes not able to keep up with the pace or have enough resources to synthesize this kind of information to create new information that physicians can act on to improve patient care. This point is the very heart of why continuing medical education (CME) is so critical for America's healthcare system.

CME provides an additional resource for physicians who do not have the time or resources to learn about clinical practice guidelines, the systematic reviews that helped shape such guidelines, or the reasoning behind the recommendations. Further, CME can help physicians walk through these guidelines in a way they can explain to their patients and if necessary to other colleagues.

Ultimately, with the NHLBI leaving the guideline writing industry, it will be incumbent upon professional medical associations and physician organizations to continue the research, collaboration, and analysis necessary to inform physicians in all fields and specialties about new treatments, discoveries and breakthroughs through clinical practice guidelines. This task, however, may be difficult for some organizations and groups given the tremendous task this amounts to and the incredible financial and resource burden imposed on groups—particularly if they are going to comply with IOM recommendations.

Nevertheless, it is promising to see that NHLBI will continue to focus on creating sound systematic reviews for researchers and groups to use as evidence for guidelines. Hopefully, NHLBI and future guideline writers will include CME stakeholders in this new process because CME may be the ultimate conduit from which physicians learn about such recommendations.

May 02, 2013

American Medical Association: Launches Improving Health Outcomes Initiative

Health Rehab
To bolster ongoing efforts to address the leading causes of suffering and death in our nation and to engage the physician community in improving national health outcomes, the American Medical Association (AMA) recently announced the first phase of its new multi-year, multi-million dollar improving health outcomes (IHO) initiative: preventing cardiovascular disease and type 2 diabetes and improving health outcomes for those with these conditions. 

“Cardiovascular disease accounts for one-third of all deaths in our nation, and one-in-three adults could have diabetes by 2050 if current trends continue,” said AMA President Jeremy Lazarus, M.D. “The toll of these diseases on our nation is staggering – in terms of human suffering and health care costs. T he direct and indirect cost of cardiovascular disease and diabetes is more than $535 billion a year.” 

The AMA’s efforts will include working closely with ongoing national programs, galvanizing America’s physicians and patients to focus on preventing and controlling cardiovascular disease and diabetes and teaming with new partners to address high blood pressure and prediabetes. 

“When America’s physicians work together with patients, communities and other members of the health care team we can have a tremendous impact on health outcomes,” said Dr. Lazarus at the National Summit on Health Disparities hosted by the National Minority Quality Forum.  “We will begin our new initiative with a focus on risk factors for cardiovascular disease and diabetes, aiming for optimal blood pressure, blood sugar and cholesterol levels for all U.S. adults.” 

The AMA chose the National Summit on Health Disparities to launch its effort as rates of diabetes are higher in Native American, African American and Latino communities, and African Americans are more likely to have cardiovascular disease.  

Cardiovascular Disease 

The key to preventing cardiovascular disease is preventing and treating high blood pressure.  One-in-three U.S. adults has high blood pressure, the number one risk factor for disability and death.  The AMA is partnering with the Armstrong Institute for Patient Safety and Quality, a research institute within Johns Hopkins Medicine, to help meet and exceed the goal of the U.S. Department of Health and Human Services’ Million Hearts Initiative to bring the high blood pressure of 10 million more Americans under control by 2017.  

AMA and the Armstrong Institute will work with physicians, care teams, patients and communities to better understand the reasons for uncontrolled blood pressure, find clinically meaningful solutions and share lessons learned. 

Directed by Peter Pronovost, senior vice president for patient safety and quality at Johns Hopkins Medicine, the Armstrong Institute is best known for its successes in dramatically reducing central-line associated bloodstream infections in hospital ICUs. The Armstrong Institute is committed to eliminating preventable harm for patients, optimizing patient outcomes and experience and reducing waste in health care delivery. 

Diabetes 

One-in-three U.S. adults has prediabetes, a condition in which blood sugar is higher than normal but not yet in the diabetic range.  Those with prediabetes are at greatly increased risk of developing type 2 diabetes.  The AMA’s initial efforts to help prevent diabetes will be in support of the Centers for Disease Control and Prevention’s (CDC) National Diabetes Prevention Program.  The CDC encourages physicians to refer patients with prediabetes to an evidence-based lifestyle change program that helps increase physical activity, improve diet and achieve moderate weight loss, which reduces the risk for type 2 diabetes.  

In partnership with the YMCA of the USA, the AMA will work to increase physician referrals of patients with prediabetes to the evidence-based diabetes prevention programs offered by the YMCA. 

“We are excited to work with the AMA on our shared goal of preventing diabetes. Connecting physician practices to the YMCA’s Diabetes Prevention Program will ensure that those at greatest risk have the opportunity to prevent or delay diabetes,” said Jonathan Lever, vice president of health innovation and strategy, YMCA of the USA. “This novel collaboration between medical practices and community-based programs could prove to be a model for promoting health and wellness.”  

“These are the first steps toward the AMA’s ambitious, long-term goal of achieving measurable improvements in health outcomes for patients in the United States,” said Dr. Lazarus. “We look forward to partnering with many individuals and organizations who share these goals.” 

The IHO initiative is one of three parts of the AMA’s new five-year strategic plan, which includes improving patients’ health outcomes, accelerating change in medical education and enhancing practice sustainability and physician professional satisfaction – all critical factors in optimizing the health of our nation.

 

April 25, 2012

Choosing Wisely: Associations Join to Educate Physicians and Pateints on Unnecessary Tests and Treatments

Choosing Wisely

A recent initiative lead by the American Board of Internal Medicine Foundation (ABIM Foundation) and in partnership with Consumer Reports, aims at reducing unnecessary medical treatment, which some estimate constitutes one-third of medical spending in the U.S.  This includes unnecessary hospitalizations and tests, unproven treatments, ineffective new drugs and medical devices, and futile care at the end of life.  Some claim that doctors perform 45 common tests and procedures less often. 

The initiative, called Choosing Wiselyurges patients to question these services if they are offered.  The initiative has garnered 9 professional medical specialty partners with 8 others preparing to follow.  These partners include: 

These specialty societies represent 374,000 physicians.  Each society has developed a list of "Five Things Physicians and Patients Should Question" which patients can access from the choosingwisely.org website.   Additionally, eight new specialty societies have joined the campaign and will be releasing lists in fall 2012: 

A recent article in the Journal of the American Medical Association (JAMA), also discussed the new initiative.  The article explained how the origins of this campaign are from the “Medical Professionalism in the New Millennium: A Physician Charter.”  Authored in 2002 by the ABIM Foundation, American College of Physicians Foundation, and European Federation of Internal Medicine, the charter has as its fundamental principles the primacy of patient welfare, patient autonomy, and social justice. 

It articulates the professional responsibilities of physicians, including a commitment to improving quality and access to care, advocating for a just and cost-effective distribution of finite resources, and maintaining trust by managing conflicts of interest.  The charter's commitment to a just distribution of finite resources specifically calls on physicians to be responsible for the appropriate allocation of resources and to scrupulously avoid superfluous tests and procedures. 

“Overuse is one of the most serious crises in American medicine,” said Dr. Lawrence Smith, physician-in-chief at North Shore-LIJ Health System and dean of the Hofstra North Shore-LIJ School of Medicine, who was not involved in the initiative.  “Many people have thought that the organizations most resistant to this idea would be the specialty organizations, so this is a very powerful message.”

“Many previous attempts to rein in unnecessary care have faltered, but guidance coming from respected physician groups is likely to exert more influence than directives from other quarters.  But their change of heart also reflects recent changes in the health care marketplace.” 

The list of tests and procedures they advise against includes EKGs done routinely during a physical, even when there is no sign of heart trouble, M.R.I.’s ordered whenever a patient complains of back pain, and antibiotics prescribed for mild sinusitis — all quite common.

The American College of Cardiology is urging heart specialists not to perform routine stress cardiac imaging in asymptomatic patients, and the American College of Radiology is telling radiologists not to run imaging scans on patients suffering from simple headaches.  The American Gastroenterological Association is urging its physicians to prescribe the lowest doses of medication needed to control acid reflux disease.

Even oncologists are being urged to cut back on scans for patients with early stage breast and prostate cancers that are not likely to spread, and kidney disease doctors are urged not to start chronic dialysis before having a serious discussion with the patient and family.

Other efforts to limit testing for patients have provoked backlashes.  In November 2009, new mammography guidelines issued by the U.S. Preventive Services Task Force advised women to be screened less frequently for breast cancer, stoking fear among patients about increasing government control over personal health care decisions and the rationing of treatment.

“Any information that can help inform medical decisions is good — the concern is when the information starts to be used not just to inform decisions, but by payers to limit decisions that a patient can make,” said Kathryn Nix, health care policy analyst for the Heritage Foundation a conservative research group. 

“With health care reform, changes in Medicare and the advent of accountable care organizations, there has been a strong push for using this information to limit patients’ ability to make decisions themselves.” 

Some of the tests being discouraged — like CT scans for someone who fainted but has no other neurological problems — are largely motivated by concerns over a malpractice lawsuits, experts said. Clear, evidence-based guidelines like the ones to be issued Wednesday will go far both to reassure physicians and to shield them from litigation. 

“These all sound reasonable, but don’t forget that every person you’re looking after is unique,” said Dr. Eric Topol, chief academic officer of Scripps Health, a health system based in San Diego, adding that he worried that the group’s advice would make tailoring care to individual patients harder.  “This kind of one-size-fits-all approach can be a real detriment to good care.”

Cancer patients also expressed concern that discouraging the use of experimental treatments could diminish their chances at finding the right drug to quash their disease.


“I was diagnosed with Stage IV breast cancer right out the gate, and I did very well — I was what they call a ‘super responder,’ and now I have no evidence of disease,” said Kristy Larch, a 44-year-old mother of two from Seattle, who was treated with Avastin, a drug that the F.D.A. no longer approves for breast cancer treatment. “Doctors can’t practice good medicine if we tie their hands.” 

“By identifying tests and procedures that might warrant additional conversations between doctors and patients, we are able to help patients receive better care through easy-to-use and accessible information,” said James A. Guest, J.D., president and CEO of Consumer Reports. “We’re looking forward to being a part of this innovative effort working with the ABIM Foundation, the specialty societies, and our eleven consumer communications collaborators to get this important message out to diverse populations of patients.”

April 23, 2012

American Academy of Neurology and Industry Collaboration

Accountability
With the increased scrutiny on physician-industry collaboration and relationships, physicians, academic medical centers, and professional medical associations (PMAs) are beginning to feel the pressure to improve their policies and become more transparent.  A recent article reviewed the confluence of interest policies for the American Academy of Neurology and its affiliated organizations (AAN).  

The article highlights the response of the AAN to the heightened concern about industry COI through an AAN Board of Directors–appointed task force, a review of existing policies, and the implementation of newly revised policies governing AAN relationships with industry. 

Background and Summary  

AAN has relationships with industry, including pharmaceutical and medical device manufacturers and other medically related commercial product and service companies, which have mutual benefits, but can carry the risk of conflicts of interest (COI).  COI may cause unintended harm by creating bias, favoritism, undue influence, and a resulting loss of public and member confidence in the integrity and objectivity of the AAN.  In recognition of these risks, the AAN has longstanding policies to prevent and limit COI and their consequences, including strict enforcement mechanisms to guarantee that the policies are followed. 

The authors of the article reviewed the AAN′s polices governing its interactions with industry, mechanisms for enforcement, and the recent findings of the board-appointed COI task force, in the context of the 2009 David Rothman and colleagues' article in JAMA, the Council of Medical Specialty Societies (CMSS) Code for Interactions with Companies (Code), efforts of the American Medical Association in this area, and increased public and Congressional scrutiny of physician/physician organizations' relationships with industry. 

With respect to continuing medical education (CME), AAN policy and practices are congruent with the principles identified in the CEJA Report 1-A-11, “Financial Relationships with Industry in Continuing Medical Education:” minimizing industry influence on programming, transparency for learners, firewalls between industry and program development. H aving zero industry involvement with CME programming is a sound aspirational goal, as noted by CEJA.  However, the article recognized that,” having industry support does not present a prima facie unethical situation and the integrity of the AAN can be protected with appropriate measures (as outlined in the Principles, CEJA report, and ACCME Standards).” 

The AAN′s Policy on Conflicts of Interest provides four mechanisms for addressing COI: avoidance, separation, disclosure, and regulation.  The authors concluded that, “Complete avoidance of relationships between the AAN and industry is not a reasonable strategy because areas of appropriate mutual gain would be sacrificed unnecessarily and because effective and less radical remedies are available.” 

Rothman and colleagues identified several guiding principles to consider when addressing relationships with industry, which the AAN supports: transparency, diversification of support, and firewalls to prevent inappropriate influence on programs and publications.  However, the AAN disagreed with some of Rothman and colleagues' recommended methods for enacting these principles.  For example, AAN, along with the CMSS Code signatories, believe a complete ban on funding “stifles a mutually beneficial relationship between PMAs and industry in which the two groups share a common interest of supporting patient well-being and medical innovation, with an understanding that these relationships must be highly regulated.” 

The AAN′s Principles Governing Academy Relationships with External Sources of Support, including recent amendments proposed by the COI task force, regulate industry interaction with AAN programming, products, and leadership.  With the Policy, Principles, and other methods of COI prevention, the AAN meets or exceeds all recommendations of the CMSS Code. 

With its adherence to the Principles since 2004, the AAN has been a leader among professional medical associations in appropriately managing COI related to interactions with industry,” the article concluded.  Recent amendments to the Principles maintain the AAN′s position as a leader in a time of increased public scrutiny of physicians' and professional medical associations' relationships with industry.  The AAN is responsive to the recommendations of the COI task force, and has adopted the CMSS Code. 

Study and Review of AAN COI Policies 

AAN promotes the highest quality patient-centered neurologic care and enhances member career satisfaction through providing education, information, policy development, and advocacy for AAN members and patients; by setting and maintaining the highest ethical and professional standards for members, staff, and programs; and by upholding the integrity of the AAN and keeping the interests of patients first. 

Pharmaceutical and medical equipment manufacturers strive to benefit patients by providing products and services that help physicians diagnose, treat, and rehabilitate patients.  To carry out the AAN′s mission, its members prescribe industry-developed treatments that their patients need and use.  Therefore, the article recognized, “relationships between the AAN and industry are natural and mutually beneficial.” 

The principal risk in AAN–industry relationships is the development of COI that jeopardize AAN′s mission.  The article defined COI as “situations in which professional judgment concerning a primary interest such as patient welfare is unduly influenced by a secondary interest such as financial gain.”  COI are a serious problem for physicians if they demote the primacy of the patient's interests and if their presence diminishes the overall confidence that patients and the public have in the medical profession.  For medical societies such as the AAN, COI could diminish the confidence of AAN members, patients, and the public in the AAN′s integrity and could jeopardize the AAN′s core value to keep the interests of patients first.

Relationships with industry can produce COI or the appearance of COI, if AAN members, patients, or the public believe that the AAN has sacrificed its credibility and integrity by promoting the interests of industry for its financial gain.  The use of industry support to offset costs of AAN programs and offerings makes the issue of maintaining our organizational independence, credibility, and integrity a serious ongoing concern. 

This concern is magnified by the national publicity generated by current inquiries by the United States Congress into relationships between physicians and industry, and between medical associations and industry, in which all relationships are suspect, scrutinized, and publicized.  This trend of increasing public scrutiny makes even the appearance of COI a liability for the AAN. 

The AAN Board of Directors and the AAN Ethics, Law and Humanities Committee previously established policies addressing AAN relationships with industry and COI: the Principles Governing AAN Relationships with External Sources of Support, first published in 2004, and the Policy on Conflicts of Interest, substantially amended in 2008.  In response to the article by Rothman et al. and the contemporaneous COI policy formulation by the CMSS, AAN leadership commissioned an ad hoc task force in 2009 to 1) evaluate the extent of AAN-industry relationships; 2) review existing AAN policies that regulate the relationships in the context of policies of other professional medical associations and prevailing ethical standards; and 3) make recommendations to limit COI in such relationships. 

The task force made their recommendations from their findings in the form of proposed amendments to the Principles Governing AAN Relationships with External Sources of Support.  The revised Principles document was approved by the AAN Board of Directors and adopted by the AAN Foundation Board of Trustees in June 2010.

The task force found many of AAN′s existing policies and practices to be proficient in appropriately preventing or managing COI related to AAN relationships with industry and consistent with prevailing codes and standards (including ACCME standards and aspects of the Rothman et al. article and the CMSS Code). 

The article noted that public disclosure of COI is an essential step but only mitigates the COI by making others aware of it.  Regulation is a necessary strategy to promote mutual interests while minimizing the possibility of COI.  Regulation requires the drafting of effective policies and their vigilant enforcement.  The Principles Governing Academy Relationships with External Sources of Support is the AAN′s primary policy in providing such regulation. 

In 2004, the AAN Board of Directors approved the Principles Governing AAN Relationships with External Sources of Support, which outline six principles and eight special guidelines to be observed when establishing and maintaining relationships with external sources of support, including industry supporters.  The task force also added a section to the Principles specifically outlining special guidelines concerning AAN relationships with industry in particular contexts involving industry (e.g., CME programming, advocacy training, guideline development and dissemination, exhibit hall activities). 

The task force identified several goals they felt would be met by their proposed amendments to the Principles.  All AAN policies governing relationships with industry must be transparent to members and the public.  These policies must assure that any financial support of the AAN by industry is not conditional on any real or implied quid pro quo.  Industry monies or representation ought not to influence AAN administration, policies, services, practices, or educational activities.   

AAN policies should address the public relations issue of the appearance of COI or undue influence.  Such influence grows in magnitude in proportion to the extent of AAN financial relationships with industry.  AAN policies governing relationships with industry should be configured to allow appropriate areas of mutual benefit while, most importantly, maintaining the AAN′s high ethical and professional standards and protecting its most valuable and cherished asset, its credibility and integrity as a PMA. 

AAN and CMSS regulate through policies that require society control over education programming, transparency of industry funding for programming and publications, disclosure or recusal by faculty and guideline authors, and overall prevention from over-reliance on industry funding for operations.  Evidence of AAN enforcement of such policies is AAN′s 2011 reaccreditation with commendation by the ACCME—demonstrating AAN′s compliance with ACCME's criteria.  In addition, AAN support from industry was well below that recommended by Rothman et al.: 18% in 2009 and 17% in 2010 (including journal advertising revenues and meeting exhibits—both excluded from the calculations recommended by Rothman et al.). 

The Principles expressly prohibit the AAN from accepting industry funding for development and initial distribution of guidelines.  Since adoption of the CMSS Code, the AAN requires a majority of the guideline development panel members to be free of COI relevant to the subject matter of the guideline.  In addition, the chair of the panel (or at least one of the chairs, if multiple) is required to be free of COI.   

Conclusion 

Ultimately, AAN should be encouraged for their approach to maintaining physician-industry relationships, while promoting transparency.  The concern is that organizations can engage in group think , often ignoring the benefits of collaboration in attempt to appease their critics. 

The statements made in this article reflect their understanding of the important role physician-industry collaboration can have, and the dedication and oversight needed to ensure such relationships continue ethically to benefit patients.  Other PMA’s should look to this article and AAN for guidance on how to continue collaborating with industry through thoughtful, reasonable COI policies. 

December 14, 2011

Specialty Societies and Patient Advocates Contribution to Comparative Effectiveness Research

Comparative Effectiveness
A recently article in Health Affairs explained how, “Specialty societies and patient advocates have critical roles to play to help accelerate the benefits of comparative effectiveness research (CER).” 

Specialty societies are a “trusted intermediary that can convey the views of practicing physicians to those sponsoring and conducting research, disseminate research findings widely and effectively, and foster conversations about the research and its importance between patients and physicians.” 

Patient advocates can explain the importance of CER to their constituents, helping to address fears that some may have that CER is a tool to deny needed care.  They can also disseminate specific findings to educate patients about the sorts of interventions they should (and should not) request. 

The authors of the article suggest ten specific steps that specialty societies and patient advocates can take to promote the use of CER. 

The authors include include Norman Kahn, MD, Executive Vice-president and Chief Executive Officer of the Council of Medical Specialty Societies (CMSS); John Rother, JD President and CEO of the National Coalition on Health Care; Timothy Lynch, JD, Director of Foundation Programs for the ABIM Foundation; David Hoyt, MD, Executive Director of the American College of Surgeons; and Steven Weinberger, MD, Executive Vice President and Chief Executive Officer of the American College of Physicians.

The Research

Specialty societies and patient advocates should urge the Patient-Centered Outcomes Research Institute (PCORI) and other entities sponsoring CER to ensure patients and clinicians play active roles in designing CER studies and identifying the research questions to be studied. 

Studies should be designed to inform the real-world decisions physicians and patients must make, and including clinicians and informed patients in the design process would help.  Societies could help train clinicians to participate effectively in the CER process, and advocates could train patients, who are often concerned about outcomes—such as those related to quality of life—that may not be apparent to researchers or clinicians.

Specialty societies and patient advocates should help ensure that reports produced by the researchers undertaking CER studies are written to maximize their value for physicians and patients

Societies and patient advocates should review those reports and provide feedback to PCORI about their usefulness and suggested improvements.  Similarly, societies and advocates could seek out opportunities to review reports conducted outside of PCORI.

Specialty societies and patient advocates should support complete transparency in CER.  Societies and patient advocates should call for information about research methods, investigators’ affiliations, and funding sources to be detailed explicitly and disseminated with the findings.

Access/Dissemination

Specialty societies should incorporate CER findings as quickly as possible into practice guidelines, patient guides, and other educational and communication tools.  To maximize the usefulness of CER studies for clinicians and patients, specialty societies should respond quickly to new research, disseminating findings through their journals, continuing medical education (CME) offerings, and educational programs that meet the standards of specialty certifying boards for inclusion in maintenance of certification.  Patient advocates should also disseminate evidence-based research findings through their communication channels.

Specialty societies and patient advocates should advocate for decision support tools that incorporate guidelines reflecting CER findings.  Societies and patient advocates should work with the Office of the National Coordinator for Health Information Technology (ONC) and the HIT vendor and policy communities to ensure that systems and templates for electronic health records can accommodate the incorporation of guidelines reflecting CER findings, and can capture and deliver the data and information that are needed.

Physician-Patient Communication

Specialty societies should educate their members about how to talk to their patients about evidence-based medicine, emphasizing the importance of fully disclosing risks and benefits discovered in the research, and describing all viable treatment options.  Physician communication should also elicit patients’ concerns, preferences, and values.  Patient advocates should educate their constituents about the importance and validity of CER, describing how it can help advance more personalized care.  Doctors are uniquely positioned to persuade patients, most of whom have little experience as consumers or users of research or statistical evidence, of the value and integrity of CER findings.  However, many physicians could benefit from advice about how to talk about CER findings and their relevance to patients.  Specialty societies are well-suited to provide that assistance, and they should work collaboratively with patient advocates to develop communications strategies to reinforce the benefits of CER in improving care and address concerns that CER will lead to the denial of needed care.

Specialty societies and patient advocates should promote shared decision-making, including the use of decision aids that incorporate CER findings.  Societies and patient advocates can help promote the use of existing decision aids and  encourage the development of new ones.  Societies can also encourage physicians to welcome dialogue and empower their patients to become genuine partners in their care by encouraging discussion and questions about their care.

Measurement

Specialty societies and patient advocates should encourage measure developers to develop measures that are based on proven evidence.  As producers of guidelines that underlie measures, and as consumers of measures, specialty societies can enhance their quality both through basing guidelines on CER analyses and by urging the prompt development and updating of measures as the research base matures.  Patient advocates can promote patient experience measures and public reporting derived from measures reflecting evidence-based clinical guidelines.

As specialty societies build and expand registries, they should link CER and other evidence bases in order to optimally answer clinical questions.  Specialty societies are increasingly employing registries to identify and close gaps in quality of care, reduce wasteful and inefficient care variations, and implement quality improvement measures.  These registries’ power to shape care will be enhanced if they collect the categories of data that would be most useful to CER researchers.  Specialty societies and patient advocates should seek to support these linkages through future specifications for physician quality reporting system (PQRS) registries, meaningful use criteria, and electronic health record (EHR) certification standards.

Promoting CER

Specialty societies and patient advocates should encourage their constituents to communicate the benefits of CER within the medical and patient communities and among the public.  The practice of medicine and the health of the American people will be improved if CER can deliver on its promise, and physicians and engaged patients can be CER’s most effective ambassadors.  Physicians and patient leaders can publicly embrace CER and explain how it can improve health care quality and advance personalized care.

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