July 7, 2014 – About 240 pages into the 600-page physician fee schedule proposed rule, which is due to be published July 11, the Centers for Medicare & Medicaid Services (CMS) proposed the elimination of the exemption from Sunshine Act reporting for continuing medical education (CME) supported by industry.
“When so many other issues need to be addressed – especially the needed exemption from Sunshine Act reporting for reference texts and journal reprints – it’s startling and disappointing that the CMS would chose to reopen the CME exemption,” said Coalition for Healthcare Communication Executive Director John Kamp. “It’s high time that CMS limit and simplify these rules, not extend and complicate them.”
Specifically, CMS proposes deleting the CME Sunshine Act exemption in its entirety. “Eliminating the exemption for payments to speakers at certain accredited or certifying [CME] events will create a more consistent reporting requirement,” CMS states in a July 3 fact sheet about the proposed changes.
CMS explains in the proposed rule that the changes are in response to stakeholder comments raising concerns “that the reporting requirements are inconsistent because certain continuing education payments are reportable, while others are not.”
Moreover, the proposal would further complicate the enforcement of the statutory exclusion of “indirect” payments that appears unaffected by the new proposal. According to CMS, the indirect payment “ provision excludes indirect payments or other transfers of value where the applicable manufacturer is ‘unaware’ of, that is, ‘does not know,’ the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.”
Under this provision, if an applicable manufacturer conditions its financial sponsorship of a continuing education event on the participation of particular covered recipients, or pays a covered recipient directly for speaking at such an event, those payments are subject to disclosure.
In addition to eliminating the CME exemption, CMS also is proposing three related changes:
- Deleting the definition of “covered device” as it is duplicative of the definition of “covered drug, device, biological or medical supply” which is already defined in regulation.
- Requiring the reporting of the marketed name of the related covered and non-covered drugs, devices, biologicals, or medical supplies, unless the payment or other transfer of value is not related to a particular covered or non-covered drug, device, biological or medical supply.
- Requiring applicable manufacturers to report stocks, stock options or any other ownership interest as distinct categories, to enable CMS to collect more specific data regarding the forms of payment made by applicable manufacturers.
CMS will be accepting comments on its July 11 proposed rule until Sept. 2
The Coalition for Healthcare Communication is working with industry and lobbying partners, including the CME Coalition and the Alliance for CME in the Health Professions, to develop a sharp and effective defense of the CME exemption. All members interested in being part of these discussions should contact John Kamp at: firstname.lastname@example.org
Dec. 20, 2013 – CME Coalition Senior Advisor Andrew Rosenberg stated that a Dec. 18 Journal of the American Medical Association (JAMA) report on the financial relationships between “medical communication companies” and industry contains “many inaccuracies and examples of unfounded innuendo,” according to a recent article in Policy and Medicine.
The article states that JAMA, which did not make its report available to the public but did issue an editorial on the report, “erroneously interchanges medical communications companies with medical education companies,” uses inaccurate data, misunderstands and/or distorts a 2007 Senate Finance Committee Report, criticizes the data policy of medical education companies despite using the same policy, and employs “blatant hypocrisy.”
“JAMA should recognize that not only has the Sunshine Act become the law of the land, but significant strides have been made to ensure that medical professionals know who helps fund CME and other educational programs,” said Coalition for Healthcare Communication Executive Director John Kamp. “PhRMA, AdvaMed, and BIO have all developed significant self-regulatory codes. Moreover, these organizations and communication companies have worked diligently with the ACCME to strengthen the standards for commercial support, increased transparency, and management of potential bias in education,” he continued.“JAMA should know that many of the practices directly or indirectly criticized, such as meeting in Maui, and med ed companies also doing promotion, are practices that have been abandoned for years,” according to Kamp. Indeed, “JAMA mixes up medical education companies with medical communication companies as if they were the same, a distinction that any learned journal should well understand,” he said.
To read the full Policy and Medicine article, go to: http://www.policymed.com/2013/12/continuing-medical-education-cme-flawed-jama-report-blurs-line-between-medical-communication-companies-and-accredit.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+policymed+%28Policy+and+Medicine%29
Nov. 18, 2013 — Congressman Robert E. Andrews (D-NJ) has asked the Center for Medicare & Medicaid Services (CMS) to exempt from Sunshine Act reporting all food served at qualifying continuing medical education (CME) events, largely because the Sunshine Act final rule provision regarding meals is unclear and confusing, according to a recent article in Policy and Medicine. Specifically, Andrews requested that CMS “exempt from individual reporting the cost of all food served at CME events for CME speakers/faculty and for CME attendees,” the article states. Andrews’ letter to CMS explains that “If the honoraria and expenses of the CME faculty are exempt … the meal that accompanies the presentation for the attendees should be exempt as well,” according to Policy and Medicine.To read the full article, go to: http://www.policymed.com/2013/11/physician-payment-sunshine-act-congressman-calls-for-meals-exemption-for-accredited-cme.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+policymed+%28Policy+and+Medicine%29
July 15, 2013 — When medical professionals participate in continuing medical education (CME), that training saves the healthcare system money, according to a recent article in Medical Marketing & Media (MMM).
The article states that a study conducted by CMEology “shows that CME can trim substantial costs from the healthcare system … even if just a few doctors change their practice as a result of an activity.” The study focused on surgical outcomes and “predicted that for every bleeding-related complication or botched surgery cardiologists were able to avoid after taking an educational activity, healthcare costs should be cut by a mean of $1.5-$2.7 million,” the MMM article noted.
“This study demonstrates what CME experts have known forever: Great medical education leads to better patient care,” said Coalition for Healthcare Communication Executive Director John Kamp.
To read the full article, go to: http://www.mmm-online.com/study-says-cme-leads-to-million-dollar-savings/article/302051/
Dec. 10, 2012 – As the debate continues regarding the pros and cons of industry/physician collaboration, a British-born surgeon has suggested in an article that the recent push to curtail and constrain this important interaction fails to recognize the benefits it can provide to the public health, according to a recent post in Policy and Medicine.
“This article supports the Coalition’s view that when
industry and physicians work together, their relationships often lead to new treatments and procedures that improve care and the quality of life for U.S. patients,”
said John Kamp, Executive Director of the Coalition for Healthcare Communication. “Certainly the system needs to have safeguards, but to continue to thwart these collaborations would do much more harm than good.”
Indeed, the majority of doctors act solely with their patients’ welfare in mind, Dr. Jonathan Mark Sackier states in Human Events. “Recent legislation and hyperbole decreeing that physicians should have no dialogue with life science companies, should not receive royalties for inventions or fees for running clinical trials or delivering speeches and such activities due to concerns of ‘conflict of interest’ are blatantly absurd – in what other branch of human enterprise is effort not rewarded?” Sackier wrote.
Throughout the article, Sackier asserts that major medical breakthroughs in the treatment of many conditions, including cancer and diabetes, were the result of “Clinicians spotting an unmet clinical need, scientists who collaborated to solve a problem, financiers who took a chance, companies who invested time, money and resources.”
He wonders “why, exactly” anyone wants “to throw all of this away,” just because “certain individuals think certain physicians might use undue influence to pervert medical therapies.” He concludes that “doctors need to viagra price be allowed to have free discourse with their industry colleagues, the free speech guaranteed to all in our Constitution.”
To read Sackier’s article in Human Events, go to: http://www.humanevents.com/2012/11/17/doctors-should-be-free-to-collaborate-in-medical-technology-development/
To read the Policy and Medicine post, go to: http://www.policymed.com/2012/12/surgeon-asks-not-throw-the-baby-of-innovation-out-with-the-bathwater-of-coi-regulations.htmlcheap viagra online
Nov. 19, 2012 – At its recent Interim Meeting, the American Medical Association’s (AMA’s) House of Delegates voted to clarify the AMA’s ethical guidance on continuing medical education (CME), according to a Nov. 16 posting on Policy and Medicine. The AMA’s Council on Ethical and Judicial Affairs (CEJA) made revisions that are consistent with many industry standards – such as codes established by AdvaMed and the Pharmaceutical Research and Manufacturers of America (PhRMA) – as well as the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support.
“The AMA did the right thing here by encouraging physicians to participate in continuing education programs
that meet existing ACCME and PhRMA guidelines,” said Coalition for Healthcare Communication Executive Director John Kamp. He indicated that the AMA should have gone a step further to recognize the value of other industry-supported education, including REMS and other education sessions regulated by the FDA. “But it”s still a good step forward,” Kamp remarked.
Policy and Medicine”s Thomas Sullivan, who is president and founder of the medical education company Rockpointe Corp., told the buy cheap generic viagra Coalition that “physicians and patients have greatly benefited from educational programs supported by industry. This ethical opinion shows AMA’s continued commitment to companies contributing back
to medicine by supporting accredited CME.”
Sullivan added that “it is helpful for physicians to not have confusion between the ACCME and AMA, and these changes by CEJA bring the AMA ethical opinions in line with the ACCME Standards for Commercial Support.”
To view the full Policy and Medicine article, go to: http://www.policymed.com/2012/11/ama-ceja-ama-house-of-delegates-passes-clarification-to-align-with-accme-standards-for-commercial-su.html
Nov. 6, 2012 – The Association of Clinical Researchers and Educators (ACRE) recently published a statement to assist physicians
as they navigate how to become involved appropriately in research, education or other
collaborations with industry. This statement calls for careful consideration of collaborations, but also notes that these collaborations “have added considerably to patient care and have been conducted with integrity and commitment.”
ACRE wrote the guidelines “because we were getting concerned about the number of conflicting statements and comments being made about involvement by physicians in collaborations with industry,” said Michael Weber, M.D., Chair of the ACRE Writing Committee. “We wanted to give clinicians some basic ideas that they could use in making up their own minds about how to work on projects with companies.”
“All sectors should applaud these common-sense ideas because they enable doctors, educators and scientists to effectively collaborate with industry,” according to John Kamp, Executive Director, Coalition for Healthcare Communication.
ACRE states in its code of conduct guidelines that “the active and continuing collaboration of clinicians and industry is vital to patient care. … Many of the major therapeutic advances across the spectrum of medical practice during recent years have been linked to these collaborations.” The ACRE document includes recommendations for eight types of physician interaction with industry:
- Clinical and scientific research
- Consulting and advisory activities
- Continuing medical education (CME)
- Product-specific education
- Expert witness activities
- Professional medical societies.
The ACRE Code of Conduct Guidelines span 25 pages (the document can be viewed in its entirety by clicking on the document name) and differ from the more stringent rules and bans established by the federal Sunshine Act, medical school deans and other organizations because they are based “on the premise that collaborations with industry [can] create medical progress that adds to the well-being of patients,” Dr. Weber told the Coalition.
Several of ACRE’s key recommendations, which are designed to ensure that physicians do not enter into industry relationships blindly and point out ethical issues that physicians must address, are listed here:
- Physicians should be clear regarding the reasons underlying their research commitments and roles (Research);
- Physicians should be clear about the distribution of funding to be provided by the outside source (Research);
- When asked by industry to serve as public spokespeople, it is generally appropriate for faculty experts to explain scientific and clinical data arising from collaborative work in which they took part (Consulting);
- Faculty members are strongly encouraged to participate in the planning of CME events, and in particular to ensure that they have control over the content of their presentations and are comfortable with their educational and scientific value (CME);
- In deciding whether to join product-specific education programs, physicians should ask whether participation by faculty members provide teaching that ultimately contributes to patient care and should assert their independence and avoid the appearance of selling the product (Product-specific Education);
- Physicians should ensure – before a study begins – that the decision to publish study findings will be made by them (Publishing);
- Overall, it is appropriate to take the position that physicians should not accept money from industry for authorship (Publishing);
- Physicians should ensure that travel support is used samples of viagra for legitimate reasons and that acceptance of travel support is not linked in any way to prescribing performance or other perceived endorsement of a sponsor’s product (Travel); and
- There is a strong obligation for the leaders of medical societies to create internal operational procedures to ensure that their much-needed corporate support does not create inappropriate endorsements of industry products or give the appearance of doing so (Medical Societies).
ACRE also states in the document’s final notes that does not wish to continue the “disturbing trend” of using the terms “conflict of
interest” or “competing interests” when describing relationships between physicians and industry because they are “pejorative.” “Conflict of interest implies that a physician is being rewarded for an action that may not be in the best interests of science or medical progress,” Dr. Weber explained. ACRE prefers the term “acknowledgements of support” when making disclosures, according to the document.
A more balanced approach to monitoring physician-industry relationships appears to be warranted. A Policy and Medicine article discussing ACRE’s recommendations notes that “the absence of bias in CMA programs has been documented in three large studies and several surveys” (to view this article, go to: http://www.policymed.com/2012/11/association-of-clinical-researchers-and-educators-releases-statement-on-relationships-between-physicians-and-industry.html). Dr. Weber remarked that “there is no real evidence of [problems] with CME. The unfortunate fact is that critics assume that the involvement of industry, by definition, is a bad thing.”
Authors of the ACRE guidelines disagree with this characterization. “We believe, if done right, everyone – patients, physicians and industry – benefit from the process,” Dr. Weber stated. “It is important, however, to follow the rules carefully, and we stress this in our guidelines.”
The ACRE guidelines are certainly a step in the right direction, according to the Coalition’s Kamp. “Creating reasonable standards for dealing with the relationship issues that does not call for relationship bans – or extensive paperwork having the effect of a ban – supports both the necessary transparency these relationships require and the value they bring to patients,” Kamp said.
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2012 – Pharmaceutical and medical device companies may be allowed to provide “modest meals and refreshments” at non-continuing medical education (CME) events in Massachusetts if proposed “emergency amendments” to the state’s law covering codes of conduct for these industries are adopted. An Oct. 19 hearing is planned to discuss the amendments.
In July, state legislators passed revisions to the 2008 Pharmaceutical and Device Manufacturer Code of Conduct (PCOC) as part of the 2013 state budget.
The Massachusetts Public Health Council last week set forth an exception to the 2008 gift ban that would allow meals to be offered at non-CME presentations for healthcare professionals outside of the office or hospital setting.
The amendments set forth the following definition: “Modest Meals and Refreshments, food and/or drinks provided by or paid for by a pharmaceutical or medical device manufacturing company or agent to a health care practitioner that, as judged
by local standards, are similar to what a health care practitioner might purchase when dining at his or her own expense.”
The amendments also include the following provisions:
- Pharmaceutical or medical device manufacturing companies and agents may provide or provide payment for modest meals and refreshments to health care practitioners outside of the health care practitioner’s office or hospital setting for the purpose of educating and informing health care practitioners about the benefits, risks and appropriate uses of prescription drugs or medical devices, disease states or other scientific information, provided that such presentations occur in a venue and manner conducive to informational communication. For the purposes of 105 CMR 970.006(3), “appropriate uses” may not include the promotion of off-label uses of prescription drugs or medical devices.
- No pharmaceutical or medical device manufacturing company may provide or provide payment for such meals and refreshments permitted under 105 CMR 970.006(3) unless such pharmaceutical or medical device manufacturing company files quarterly reports detailing all non-CME educational presentations at which such meals or refreshments are provided. Reports shall include:
- the location of the non-CME presentation;
- a description of any pharmaceutical products, medical devices or other products discussed at such presentation;
- the total amount expended on such presentation; and
- an estimate of the amount expended per participant, factoring any meals, refreshments or other items of economic value provided at such presentation.
The amendments, which the Council has asked to be adopted on an emergency basis, also allow “for transparency through federal disclosures published in a searchable database by the DPH allowing monitoring of manufacturer conduct.”
The proposed amendments do not change the code of conduct regarding meals related to CME. The current provision stipulates that pharmaceutical or medical device manufacturing companies may not provide “payment for meals directly to a health care practitioner at any CME event, third-party scientific or educational conferences, or professional meetings, although a CME provider or conference or meeting organizer may, at its own discretion, apply any financial support provided by a pharmaceutical or medical device manufacturing company for the event to provide meals for all participants.”
According to the Massachusetts Public Health Council, the proposed amendments for non-CME events:
- Are consistent with nationally recognized standards included in industry codes of conduct;
- Promote educational and training opportunities;
- Implement legislative intent to balance consumer protection, the legitimate interests of pharmaceutical and medical device manufacturers, and promoting the education of health professionals; and
- Include a definition of modest meals and refreshments that does not include a specific dollar limit.
In addition to holding the Oct. 19 hearing, the Massachusetts Department of Public Health will be accepting written comments on the proposal. The regulation will be voted on by the Council at its Nov. 14 meeting and will be filed with the Secretary of the Commonwealth. The final regulation will be effective as published on Dec. 7.
“We are working with PhRMA and other allies on how best to participate in the upcoming Oct. 19 hearing,” said Coalition for Healthcare Communication Executive Director John Kamp. “Indeed, we are looking for input from members in comment form and would particularly like to hear canadian pharmacy viagra generic from our members in Massachusetts.”
Review and Commentary by John Kamp, Executive Director, Coalition for Healthcare Communication
Sept. 17, 2012 – The only absolutely certain news coming out of the Sept. 12 U.S. Senate Special Committee on Aging Roundtable on the Sunshine Act is that final rules are on their way. Within the next few years, all industry payments to physicians and researchers will be available on an Internet registry for the patients, press, policymakers to see and act on. However, the most important question is still unanswered: Will the registry support or hinder medical care and innovation?
The Roundtable participants reached considerable consensus on several of the key issues raised in the Coalition for Healthcare Communication Sunshine Act Comment sent to CMS on Feb. 15. Most importantly, the Coalition stressed the importance of placing Sunshine Act data in context, so that all entities will understand that industry payments are vital and useful to the advancement of innovation and patient care in America.
“Without this context, CHC fears the reports will do more harm than good,” the CHC told CMS. “It would be a tragedy if these reports lead the public to misunderstand the complex interaction between scientific research and communication in both the creation and adoption of medical innovations.”
Although the Centers for Medicare & Medicaid Services (CMS) did not offer a glimpse of the final rules or provide any update regarding implementation dates, the CMS representative at the Roundtable – held to discuss the Sunshine proposed rule – made it clear that timely final rules are a priority and that industry would have additional time to put systems in place before data collection is required.
Niall Brennan, director, Policy and Data Analysis Group, CMS, said that he was “hopeful” that at least “some data collection will begin in 2013,” which sends a clear signal that the collection mandate will extend beyond Jan. 1, 2013.
(A detailed summary of the meeting can be found on the Policy and Medicine blog offered by Thomas Sullivan: http://www.policymed.com/2012/09/physician-payment-sunshine-act-senate-special-committee-on-aging-roundtable-let-the-sunshine-in-implementing-the-physic.html.)
CMS’s flexibility on the deadlines was just one of the many good omens at the Roundtable. Virtually every participant understood the immense challenges facing the government, industry and the medical community to get this rule done right, rather than pushing for a final rule with vague provisions and impossible implementation deadlines.
Many of the stakeholders at the Roundtable agreed that the registry must not be used to discredit all industry relationships. Douglas Peddicord, Ph.D., executive director, Association of Clinical Research Organizations (ACRO), was the most articulate on this point at the Roundtable. Peddicord pointed out that all entities must remember that while payments denote “interest,” interests do not necessarily create conflicts of interest. “We need to remember that those interests need to be protected, because without interest by individual doctors, researchers and academia, there is no progress and innovation in medicine,” Peddicord said.
Peddicord made it clear that his was no theoretical concern, citing an ACRO study where 24 percent of researchers said they were less likely to engage in industry-sponsored research if the CMS proposed rule was put in place. He further warned that the United States could lose as much as half of its clinical research activity if
the final rule did not limit the scope of the required disclosures.
Moreover, many Roundtable participants echoed the concern in the CHC comment that without clear rules to avoid errors, inconsistencies, and duplication – and a better error correction process – the registry often could be wrong and misleading. Elizabeth O’Farrell, senior vice president, Policy and Finance, Eli Lilly & Co., offered the best solution. She said clarity and accuracy would be greatly enhanced if CMS adopted a three-phased approach to implementation, giving industry and doctors at least 180 days to report the most frequent, direct and important payments, then phasing in some of the more difficult research and other payments at later dates.
All participants asked CMS to offer a more practical approach to accounting for incidental items, especially food. .Indeed, calculating the cost of meals and other food provided at educational events – and determining whether specific individuals consumed them – was discussed in some detail at the Roundtable, with the majority of the stakeholders agreeing that administrating and monitoring this provision likely would consume more cost and time than is warranted.
O’Farrell said the meal allocation methodology in the proposed rule is unworkable and inappropriate. Indeed, “nobody really cares about bagels,” said Charles Rosen, M.D., clinical professor of Orthopedic Surgery, University of California, Irvine School of Medicine, the most outspoken industry critic on the Roundtable. He encouraged a more reasonable final rule provision for meals and incidentals.
Mark McClellan, director, Engelberg Center for Health Care Reform at the Brookings Institution and moderator of the Roundtable, focused all participants on the hot-button issue of “indirect” payments, a significant area of concern noted in all industry and medical society comments.
For example, the Coalition encouraged CMS in its comments to reverse its broad inclusion of “indirect payments” despite their exclusion in the Sunshine Act. Speaking about CME, Jeremy Lazarus, M.D., president of the American Medical Association, explained to Rosen and others the difference between certified and promotional education and asserted that certified CME was intended to be excluded under the “indirect” exemption in the Sunshine statute.
In sum, the Roundtable discount cialis without prescription participants agreed that the CMS proposed rule is only a first step toward workable and clear implementation of the Sunshine Act.
Many of the additional steps must be taken by us. CMS will do its best to follow the letter and intent of the statute, and may even help to advance the public understanding of the data.
But most of that burden will have to be carried by industry and, in particular, by industry and its communication partners. We still have a long way to go to do our part after the registry is out to ensure that its data and the underlying importance of industry partnerships is fully understood not only by patients,
but by doctor collaborators, policymakers and the press.
July 30, 2012 – A report released last week by the Accreditation Council for Continuing Medical Education (ACCME) shows that the pharmaceutical industry’s funding of CME programs continued to decline in 2011. This trend is likely to continue if regulations to implement the “Sunshine” provisions of the Affordable Care Act proceed as proposed, and could
put an increasing number of patients at risk.
The 2011 ACCME Annual Report Data show that industry support for CME dropped by 11.4 percent, which equates to almost $94 million less spent on CME in 2011 than in 2010. This decline marks an ongoing shift away from industry as the primary supporters of CME activities. In 2007, industry funding represented 46 percent of total funding, but in 2011, industry funded only 32 percent of CME activities.
“The decline in commercial support for medical education demonstrates the folly of over-regulation. While the covered patient population continues to expand and the effective use of medicines is key to efficient and appropriate delivery of care, public policy makers should be developing rules and policies that encourage, not discourage, commercial support for doctor education,” said John Kamp, Executive Director of the Coalition for Healthcare Communication. “Transparency is a laudable goal, knee jerk journalism and regulatory over reaction have moved us in the wrong direction.”
Although total income from CME was down 1.1 percent in 2011, income from advertising/exhibits at CME events and “other income,” which included registration fees and funds that came from a provider organization, did help the balance sheet. For publisher/medical education companies, income from CME activities was up 2.4 percent in 2011.
Non-physician attendance in CME events increased by 1 percent, while physician bio viagra herbal attendance decreased by .05 percent. Overall, publishing/education companies drew the most physician participants, with medical schools and hospitals/health care delivery systems rounding out the top three, according to the report. ACCME notes that its data for 2011 excludes in-kind support for CME and includes state and regional CME statistics.
This downward trend in industry CME spending is unlikely to be reversed by additional burdens imposed by Sunshine provision proposed regulations, the specter of which already may be dissuading health care providers from participating in
CME. Further, if the proposed regulations – which call for CME providers to report the value of education provided for each certified CME program attendee and would mandate that industry value and report each company-sponsored education and research activity – are published as proposed, they could further suppress both CME funding and participation.
“Regardless, I hope the final rules from HHS on the Sunshine Act will be much more sensible than the draft proposals. The industry, including PhRMA, BIO, AAFP, AMA, the Coalition and others have given them a much more sensible road map to effective but more sensible regulation,” Kamp continued. “Meanwhile, let’s take this week’s decision by Massachusetts regulators to kill the ban on drug coupons as a step in the right direction, and applaud similar steps.”