Special Report and Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director
Nov. 30, 2016 – As you may have seen, the language proposed for clarifying the intent of the educational provisions of the Sunshine Act have been stricken from the 21st Century Cures Act, which is scheduled for a vote in the House today and in the Senate early next week.
This means that the distribution of textbooks and journal reprints by industry will continue to be reportable under the Sunshine Act and leaves reporting of company-sponsored continuing medical education (CME) under the direction of the CMS division of HHS. Currently, CMS exempts certified CME activities from such reporting.
Against the pleas of 100 national and state medical societies, as well as legions of other stakeholders in medical education, Senators Grassley and Warren – with a misguided view of the medical industry – have muddied the waters by forcing the stripping of these clarifying provisions from the 21st Century Cures Act.
From the beginning, the goal for the Coalition for Healthcare Communication was to lessen the bureaucratic demands of educating the medical community on the latest developments in the field. No one can deny that obstacles to that process may create a lapse in patient care somewhere along the line. The suggestion that a reprint, to pick an extreme, was a “gift” and should be reported to the American public is representative of how distorted our political process has grown today.
It makes me mad as hell and inspires me to work harder to bring about change in our system. We start with the hope that a new Administration with new players may have a more respectful view of the contributions industry makes to healthcare. We hope that lessening the burdens placed on industry by uninformed bureaucrats lacking any desire to make our systems work more smoothly will prevail.
Clearly, we have to stop and learn lessons from these proceedings. A message has been delivered. But it is certain that as long as our ultimate focus is on improved patient care, we will have a mission that is worthy and contributes to the good of medicine. So we are already on a course to a brighter day tomorrow.
Oct. 6, 2016 – The Centers for Medicare & Medicaid Services (CMS) recently clarified in a revised FAQ that manufacturers that provide a payment or transfer of value to support continuing medical education (CME) but do not specify that the CME provider should offer payment to a specific physician speaker or faculty member would not be subject to reporting under the Sunshine Act Open Payments program.
“Finally, after years of equivocating, CMS is clearly stating that faculty and students at certified CME programs are not subject to Sunshine reporting,” said Coalition for Healthcare Communication Executive Director John Kamp. “Amen to that!”
“The revised FAQ 8165 replaces an earlier FAQ on the same subject by providing greater specificity with regard to the exclusion of certain CME-related payments from Sunshine Act reporting that meet the standards outlined by CMS,” according to an update from Policy and Medicine.
The CME Coalition states that although “this FAQ is fully consistent with its earlier interpretation of the status of independent CME-related payments when CMS revised the regulations in 2014, as well as the interpretation of other leading stakeholders like the American Medical Association, the revised FAQ now provides even greater clarity to stakeholders.”
The CME Coalition also states that because the revised FAQ “does not represent a shift in policy, this FAQ applies to all CME-related transfers of value that have taken place since January 1, 2014.”
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