Life Science Compliance Update

December 07, 2017

HCEA To Host Webinar on New International Ethics Rules

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On Wednesday, December 13, 2017, the Healthcare Convention & Exhibitors Association (HCEA) will present a webinar entitled: “Preparing for the 2018 Ethical MeDTECH, APACMed and China Codes Impact on International Attendee Participation at US Meetings.”

As we have previously written about, beginning January 1, 2018, medical device companies in various regions of the world will no longer be able to directly sponsor participant’s travel to educational meetings. The Accreditation Council for Continuing Medical Education (ACCME) and other organizations have applauded this effort, as it furthers the independence of education and helps to align international codes with current United States standards.

However, because of financial constraints in many markets around the world, healthcare providers depend on outside support to attend US-based meetings. Therefore, it is possible that your annual meeting may see some changes in 2018 and beyond. This webinar will review the codes and explore some of the concerns expressed by medical meeting planners.

The webinar will be moderated by Policy & Medicine’s editor, Thomas Sullivan, and includes panelists: Aline Lautenberg, General Counsel and Director of Legal and Compliance at Eucomed, EDMA, and MedTech Europe; Matthew E. Wetzel, Vice President and Assistant General Counsel at AdvaMed; and Christine Wooster, Chief Revenue Officer at the Heart Rhythm Society.

Registration for the webinar is free for HCEA members and $50 for non-HCEA members. For additional information, contact Kristen Leikwold at kleikwold@hcea.org or call (703) 935-1961.

To register for the webinar, click here.

December 04, 2017

Can CME Help the Opioid Epidemic?

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Another day, another story in the news about the opioid epidemic that is transcending America. Local, state, and national elected officials are speaking out about it, as are physicians and patient advocates.

Sometimes in life, we are put in a fortunate position to take the lead and to have a life-changing effect on strangers. One of the ways we may be able to turn this epidemic around is to continue to educate all parties involved – from the patient, to the caregiver, and yes, even the physician prescribing the medication.

When President Donald Trump declared opioids a national public health emergency, he stated, “Last year, almost 1 million Americans used heroin, and more than 11 million abused prescription opioids. The United States is by far the largest consumer of these drugs, using more opioid pills per person than any other country by far in the world." Often, the addiction begins with a legal prescription for a patient suffering from debilitating pain.

Stakeholders who participated in a POLITICO working group seemed to agree that the CDC guidelines on safe prescribing (a voluntary tool) had catalyzed change in managing chronic pain, and created a general heightened awareness about using smaller doses for briefer periods for acute pain. While working group participants differed on how much impact the guidelines had, all viewed them in a positive light.

Educate Providers at the Beginning of Their Career

We sometimes hear that med school does not fully equip one to be a practicing doctor, and one piece of that is understanding responsible practices for prescribing medications.

While med schools in the United States have “been very active” incorporating training on pain management, as well as addiction and dependence (which aren’t interchangeable), there is still more than can be done.

However, even if the med schools get it right, participants noted how easily training can go out the window if new physicians are practicing in a setting where opioids are prescribed more indiscriminately than the way they were taught to prescribe. This is where continuing medical education (CME) can come in to play a large role.

Is This a Place for CME?

As noted by one participant, “You can teach all you want in medical school but once they get into the clinical environment, if that clinical environment hasn’t changed, then you’re undermining all those lessons.”

Ongoing professional education can take place through formal continuing medical education or within health care systems. For example, one participant recounted a program in which physicians in a health system received feedback on their prescribing patterns — and were told how they stacked up against colleagues. Competitive instinct and “peer accountability” reduced opioid prescribing, said that participant.

Prescribing is only one piece of the puzzle. Most participants said doctors and nurses don’t know enough about addiction — how to spot it, treat it or connect a patient to resources and supports. This is another avenue for CME to enter the picture to help our physicians and patients alike.

Conclusion

Therefore, POLITICO and the stakeholders made a policy recommendation focused on educating providers. They suggest that education on both pain management and addiction has to start in medical school. However, early education is not enough unless it is supplemented by CME. The medical field should continue the progress it has made increasing education around proper prescribing, but it should increase its efforts by evaluating doctors in some meaningful way such as on licensing exams or through CME.

November 30, 2017

ACCME Introduces Guidance for CME Providers on MEDTECH, APACMed and China Codes

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Recently, MedTech Europe, the Advanced Medical Technology Association (AdvaMed), and the Asia Pacific Medical Technology Association (APACMed) introduced changes to their respective codes of conduct relating to professional development activities, including continuing medical education (CME). As such, the Accreditation Council for Continuing Medical Education (ACCME) has offered guidance for CME providers with respect to the changes.  

Starting in 2018, it is expected that the revised codes will require member manufacturers to discontinue making direct payments to clinicians to fund their attendance at professional development activities. However, the manufacturers may continue to support the engagement of physicians in professional development and CME activities through grants that are given to health systems and employers, and through grants to accredited CME providers.  

Following the longstanding procedure, organizations that are accredited in the ACCME system may accept financial support for their educational activities from commercial entities (I.e., device manufacturers) under the revised codes and maintain independence from industry by following ACCME's Standard 3: Appropriate Use of Commercial Support.  

Standard 3 can be met by an accredited organization following the below criteria when accepting funding from commercial interests: 

  • Make all decisions regarding the use of the support, independent of any company or companies; 
  • Have a signed written agreement with the company that includes the specific terms and conditions of the support; 
  • Use the funds only for the educational activity and to offset the cost of participation to the learners as a whole;  
  • Not pay for travel, lodging, honoraria, or personal expenses for any non-teacher or non-author participants of the supported educational activity; and 
  • Disclose to all learners the source (and if in-kind, the nature) of the commercial support.  

The revised codes and ACCME requirements can be aligned together by ensuring that funds received from companies by organizations accredited in the ACCME system are not used to pay for any travel, lodging, honoraria, or personal expenses for any non-teacher or non-author participants. This ensures the accredited organization does not act as an intermediary to establish a relationship between an ACCME-defined commercial interest and the learners in an accredited activity, as well as helping to ensure clinicians' prescribing or device usage patterns are not inappropriately influenced.  

If an international learner receives funding from his or her hospital or other commercial entity not affiliated with the ACCME-accredited organization to participate in the education, the accredited organization is not prohibited from accepting that learner's registration and participation in the education.  

In a press release announcing the changes and the ACCME guidance, ACCME applauded the change, "since they bring industry standards in closer alignment with those that have existed here in the United States since 1992, and in doing so support greater transparency and independence in global medical education. ACCME also noted that the standards and principles in the revised codes are aligned even with the ACCME's own Standards for Commercial Support, which have been internationally recognized as a benchmark for independent medical education and adopted by other healthcare continuing education accreditors throughout the world.  

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