July 10, 2015 — The House of Representatives today passed H.R. 6, also known as the 21st Century Cures Act, by an overwhelming majority of 344-77. The legislation, which includes three provisions that are important to healthcare marketers, now heads to the Senate.
The bill’s authors, House Energy and Commerce Committee Chairman Fred Upton (R-Mich.), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-Colo.), Health Subcommittee Chairman Joe Pitts (R-Pa.), full committee Ranking Member Frank Pallone, Jr., (D-N.J.), and Health Subcommittee Ranking Member Gene Green (D-Texas) commented: “Today, we took a big leap on the path to cures, but we still have much work left to do. The 344 votes today should be a springboard for action. On to the Senate.”
In the House, the bill had 230 co-sponsors and the support of more than 700 groups, including the Coalition for Healthcare Communication, which has praised the legislation’s inclusion of provisions that would: (1) exempt CME, reprints and reference texts from reporting under the Sunshine Act; (2) expand authority for biopharmaceutical companies to provide economic information to payers; and (3) direct the FDA to provide further guidance on off-label marketing.
“The Coalition for Healthcare Communication is pleased that so many members of our industry, the public and Congress have embraced this legislation, which will forward innovation and improve the care of patients across the country,” said Coalition Executive Director John Kamp. “It’s nice to see legislation this important move forward.”
Sept. 9, 2014 – An overwhelming majority of comments sent to the Centers for Medicare & Medicaid Services (CMS) by last week’s deadline stated that the agency should either retain the continuing medical education (CME) exemption it recently proposed eliminating or revise its proposed reliance on the “indirect payment” provision under the Physician Payment Sunshine Act.
According to the CME Coalition, the total number of comments supporting maintenance or expansion of the CME exemption was 820, with only 20 comments opposing the exemption. Listed below are excerpts of various comments – organized by subject matter – that joined the comment of the Coalition for Healthcare Communication in recommending that CMS change its proposed position (see related article, http://www.cohealthcom.org/?p=2846).
Possible Consequences of Eliminating CME Exemption
- “Absent that specific exemption, attendees may be less willing to participate in those programs – even if the industry support for the program was completely independent and conflict-free – if they believe their identity and attendance may become known to the commercial supporters and the value of the CME may thus be reported against them.” (American Academy of Family Physicians)
- “The proposed rule will link applicable manufacturers and speakers at independent CME in a manner that is antithetical to the notion of ‘independent’ CME and inconsistent with current guidance from FDA and accrediting organizations regarding the conduct of these programs. PhRMA is concerned that this proposal will harm independent CME programs by diminishing speaker and attendee participation at independent CME and by chilling manufacturer funding of these programs.” (Pharmaceutical Research and Manufacturers of America)
- “Pfizer believes that CMS’ proposal will allow reported CME events to be misperceived as subject to industry control, when in fact none existed. … CMS’ alternatives also are not viable options.” (Pfizer)
- “The unintended consequence … may dissuade participation in valuable CME activities and hinder the adoption and spread of important medical education intended to keep the public safe and enable optimal care and outcomes for patients.” (American College of Radiology)
- “Physicians may decline CME faculty positions to avoid the misperception that they are receiving payments or transfers of value from manufacturers for influential purposes, when in fact these funds are determined without knowing the identity of the CME faculty, and without influence on the faculty or content of the program.” (Biotechnology Industry Organization)
- “We are concerned that removing the exemption for CME from the text of the rule itself will create legal ambiguity as to whether such payments continue to be reportable, leaving manufacturers to rely on CMS’s statements in the preamble to the proposed rule, which carry less weight than the regulation itself under the law.” (Medical Device Manufacturers Association)
- “The creation of new products will produce enduring social gains only if physicians are properly trained and educated about these advances. … Patients count on doctors to be up to date with these latest medical breakthroughs, and CME provides doctors with that knowledge.” (CME Coalition)
Redundancy of Provisions
- “The current proposal by CMS to delete 42 CFR 403.904(g) … is seriously flawed. While there may be overlap between the two sections, they are not the same. … Removing Section 403.904(g) in favor of Section 403.904(i)(1) would be replacing the more certain provision with a more problematic and confusing one.” (American College of Radiology)
- “We are concerned, however, that the indirect payment exclusion, as reflected in the regulatory text itself, is not, in fact, redundant with the CME-specific exclusion that CMS proposes to eliminate. Reliance on the indirect payments exclusion could therefore achieve the opposite result from what CMS intends, as it likely would require the reporting of most applicable manufacturer provision of funds to a CME provider.” (Biotechnology Industry Organization)
- “It would be difficult for funders to claim that they are not ‘willfully ignorant’ about this information during or after the program. Indeed, this information is often freely available well before a CME or CE activity takes place through marketing materials for the activity.” (The Alliance for Continuing Education in the Health Professions)
- “Physician faculty and attendees at accredited CME events are not reportable under the Open Payments program because of the firewall created through their strict adherence to the Standards for Commercial Support (SCS), not by the timing of when an applicable manufacturer may discover their identity.” (American College of Radiology)
- “It is not realistic, nor would it be perceived as transparent, if faculty names were hidden until the day of the program, nor would physicians attend such programs. … Therefore, establishing a policy whereby an arbitrary determination of the presence of a relationship based on the timing of learning of the faculty names is unworkable – the names of faculty at CME programming cannot and should not be hidden.” (American Academy of Pediatrics)
- “AdvaMed member companies have advised that they often come to ‘know’ the identity of a faculty speaker at a program for which they have provided independent support … For example, the manufacturer may have booth space at the same conference, may schedule its own meetings before or after such conferences, or may be part of a presentation panel at the conference. Importantly, in these situations, a company does not know how much – if any – of the grant funding it paid to a third-party conference provider is in turn paid by the third-party conference provider to a physician faculty member.” (AdvaMed)
- “To avoid the appearance of endorsing particular accrediting organizations, CMS could eliminate the requirement in [403.904(g)(1)(i)] that the accredited CME program be accredited by one of the listed organizations and, instead, require that the CME event be recognized by a state or the federal government as accredited or certified.” (Pharmaceutical Research and Manufacturers of America)
- “We are proposing that CMS maintain an explicit definition in the Final Rule of ‘accredited or certified CME’ in the definition section of the Final Rule. … Second, understanding that the ‘awareness’ standard becomes nearly impossible for accredited CME speakers, faculty and attendees to comply with, instead of removing Section 403.904(g), we would recommend revising it…” (CME Coalition)
- “We urge CME to stay its hand at this early stage in the implementation of Open Payments and to avoid hastily discarding the CME exemption, which was carefully considered before it was enacted and which remains critical to the education of our health care providers and consequently to the health of the public.” (American Academy of Family Physicians)
For additional coverage of comments submitted to CMS regarding the proposed CME exemption elimination, go to Policy and Medicine at http://www.policymed.com/2014/09/physician-payment-sunshine-organizations-respond-to-cms.html?utm_source=feedblitz&utm_medium=FeedBlitzRss&utm_campaign=FeedBlitzRss&utm_content=Physician+Payments+Sunshine+Act%3a+Organizations+Respond+to+CMS
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: email@example.com
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 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.html
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 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 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.
Sept. 28, 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 from our members in Massachusetts.”