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The Elections Are Over: What Does It Mean for Healthcare?

Oct. 28, 2014 — Join us for a Webinar on Nov. 12! John Kamp, Executive Director of the Coalition for ... read more

FDA Response to MIWG Shows Willingness to Revisit Off-label Speech Policies

Oct. 27, 2014 – As members of Congress prepare legislation that may establish the conditions under which companies can share ... read more

House Legislation to Tackle Thorny Off-label Issues

Oct. 20, 2014 – It is looking like Congress may attempt to settle whether companies can speak truthfully about their ... read more

Bipartisan Bill Seeks Fix to Formalize Textbook/Reprint Sunshine Act Exclusions

Oct. 14, 2014 – After multiple efforts failed to convince the Centers for Medicare & Medicaid Services (CMS) that peer-reviewed ... read more

PhRMA, BIO, AdvaMed Tell FDA Social Media Guidance Is Lacking, Violates First Amendment

Oct. 6, 2104 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) recently reopened the comment period for its ... read more

Social Media Master Class Helps Companies Navigate Compliance

Sept. 30, 2014 – Companies striving to use social media marketing both effectively and appropriately likely will benefit from a ... read more

Coalition Panel: Data Regulation Focus Shifting from Privacy to Security

Sept. 29, 2014 – The federal government’s efforts to severely limit the ability of industry to gather and use online ... read more

In Amicus Brief, PhRMA Says Off-label Case “Raises Serious First Amendment Concerns”

Sept. 19, 2014 – Stating that a whistleblower’s interpretation of the False Claims Act has “a critical flaw” because it ... read more

Pfizer’s Susman to Talk Public/Private Partnerships at Nov. 10 Coalition Briefing

Sept. 19, 2014 – Sally Susman, EVP, Corporate Affairs, Pfizer, will share her insights on the importance of public and ... read more

CMS Bombarded with Comments Calling for CME Exemption to Remain

Sept. 9, 2014 – An overwhelming majority of comments sent to the Centers for Medicare & Medicaid Services (CMS) by ... read more

Coalition Comment to CMS: Keep CME Exemption Under Sunshine Act

Sept. 2, 2014 – The Coalition for Healthcare Communication’s comment to the Centers for Medicare & Medicaid Services (CMS) asks ... read more

Open Payments Website Reopened, Dispute Period Extended and One-third of Records Withheld

Aug. 18, 2014 – The Centers for Medicare & Medicaid Services (CMS) recently announced that it had reopened its Open ... read more

Medical Groups Ask CMS to Make Changes to Sunshine Act Implementation

Doctors Recommend Fixes to CME Exemption Elimination, Educational Materials Provision Aug. 6, 2014 – More than 100 medical associations and ... read more

Doctor Tells Congress That Communication Is Hampered by FDA, CMS Practices

July 28, 2014 – FDA and Centers for Medicare & Medicaid Services (CMS) policies are barriers to ongoing evidence development ... read more

FDA Plans to Study Effect of DTC Ads on Adolescents

July 24, 2014 – A better understanding of how adolescents weigh risks and benefits in direct-to-consumer (DTC) ads is needed ... read more

Bruce Grant Urges Pharma Communicators to Recognize Their Role in Health Advances

July 23, 2014 – Although the pharmaceuticals industry has come under fire in recent years, it is important to remember ... read more

FDA Social Media Draft Guidances Answer Some Questions, Raise Others

July 21, 2014 – Although the FDA has attempted to provide some clarity on its position regarding certain social media ... read more

Kamp to Washington Post: Companies Should Be Able to Speak Truthfully About Drugs

July 14, 2014 – Drug companies should be allowed to share truthful information about the off-label uses of their drugs, ... read more

FDA Device Document Revises Mobile Medical Apps Guidance

July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the ... read more

New FDA Social Media Guidances Address Space-limited Media, Correcting Online Misinformation

June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) ... read more

AMA House of Delegates: Revise Sunshine Act Rules on Textbook/Reprints and TOV Amount

June 12, 2014 – The American Medical Association’s (AMA’s) House of Delegates is attempting to bring some common sense to ... read more

House Committee Seeks Patient Input on Availability of Treatments

June 3, 2014 – The House Energy and Commerce Committee is seeking public comments from patients, providers and other stakeholders ... read more

FDA To Study Viewers’ Responses to DTC Ad Risk Information

May 29, 2014 – The FDA announced May 28 in the Federal Register that it plans to conduct an eye ... read more

WLF: FDA’s Revised Reprint Draft Guidance Violates Injunction and First Amendment

May 19, 2014 – In May 15 comments to the FDA regarding its draft guidance on reprint practices for articles ... read more

CHC Comment to FDA: Less Is More in DTC TV Ads

May 2, 2014 – The Coalition for Healthcare Communication believes that “shorter, simpler disclosures are most likely to lead to ... read more

FDA Willing to “Re-examine” Off-label Policies in Light of First Amendment Rulings

April 28, 2014 – The FDA is not taking lightly industry’s concerns that its existing off-label policies are not in ... read more

New Tax Reform Legislation Includes Limit on Ad Tax Deductions

Feb. 27, 2014 – As expected, tax reform legislation introduced yesterday by Senate Ways and Means Committee Chairman Dave Camp ... read more

FDA Is Considering Shorter List of Risks in DTC TV Ad Major Statement

Feb. 17, 2014 – In recognition that the stream of risks currently disclosed on direct-to-consumer (DTC) television ads may be ... read more

Caronia Decision One Year Later: Off-label Change May Be Slow, But It’s Brewing

Jan. 27, 2014 – Although FDA officials have treated the U.S. Court of Appeals for the Second Circuit decision in ... read more

Coalition Calls on Senators to Reject Tax on Advertising

Dec. 16, 2013 – Today the Coalition for Healthcare Communication sent a letter to U.S. Senators and Members of the ... read more

OPDP Sends Warning Letter Based on Statements Made on Fast Money TV Show

Nov. 11, 2013 – The FDA Office of Prescription Drug Promotion’s (OPDP’s) recent enforcement actions – four Untitled Letters and ... read more

Physician Organizations, Medical Societies Implore HHS to Reverse Policy on Reprints and Textbooks

Oct. 28, 2013 – On Monday, 33 physician organizations and 41 national and state medical societies sent a letter to ... read more

MIWG Asks FDA to Clarify Position Regarding Manufacturer Dissemination of New Use Information

Sept. 16, 2013 – The Medical Information Working Group (MIWG), a coalition of medical product manufacturers seeking to improve the ... read more

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CMS Bombarded with Comments Calling for CME Exemption to Remain

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)

“Awareness” Standard

  • “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)

Recommendation Highlights

  • “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

CMS Proposes Eliminating CME Sunshine Act Exemption

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: jkamp@cohealthcom.org

CME Coalition Calls Out JAMA Report Inaccuracies

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

Congressman Requests CME Meal Exemption Under Sunshine Act

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

Study Correlates CME with Healthcare Cost Savings

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/

Surgeon: Physician/Industry Collaboration More Likely To Advance Care than To Create Conflict of Interest

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

AMA To Align CME Guidance with ACCME Standards

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

ACRE Code of Conduct Statement Respects Value of Physician/Industry Relationship

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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
  • Publishing
  • Expert witness activities
  • Travel
  • 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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Massachusetts to Hold Oct. 19 Public Hearing to Discuss “Modest Meal” Exception

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 canadian pharmacy viagra generic from our members in Massachusetts.”

Although Several Sunshine Act Rules Remain Unsettled, Senate Roundtable Participants Largely Agree with Coalition on Major Issues

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.

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