Life Science Compliance Update

January 30, 2017

Education at ACC Chapter Meetings Positively Impacts Management of Severe or Resistant Hypercholesterolemia: Preliminary Results


Despite guideline-directed statin therapy, the majority of patients with severe hypercholesterolemia and other high-risk populations continue to have a substantial residual risk of cardiovascular disease (CVD). In patients with severe or resistant hypercholesterolemia, new and emerging treatments to reduce low-density lipoprotein cholesterol (LDL-C) offer additional options to control CVD risk.

To address the gap in care of patients with severe or resistant hypercholesterolemia and enhance awareness about emerging agents, an educational series comprised of five 1-hour lectures was developed by a steering committee of two expert faculty. The content was developed to provide guideline-driven information and clinical trial data on reducing LDL-C levels in patients with severe or resistant hypercholesterolemia who are at high risk for CVD. The activities were held in conjunction with regional chapter meetings of the American College of Cardiology (ACC).

To date, three lectures have taken place, with a total of 186 participants attending. Nearly three-quarters of attendees were MDs/DOs, 62% of whom specialized in cardiology. The majority of participants (60%) reported seeing more than 60 patients with hypercholesterolemia each month. The activity content was found to be highly relevant to the participating clinicians, with 99% agreeing it prepared them to better care for patients and gave them tools/knowledge to change practices to improve care. Interestingly, even in this highly-experienced group of cardiologists, as many as 69% of participants indicated that at least half of the content was new to them.

Preliminary outcome findings demonstrate that participation increased attendee confidence regarding their management of patients with severe/resistant hypercholesterolemia who are at risk for major adverse cardiovascular events. At baseline, 60% of participants felt “confident,” “very confident,” or “expert,” which rose to 90% post activity. After the activity, 78% of participants reported that they will increase monitoring of patient LDL-C levels to assess compliance and response to therapy after participating in this activity, indicating that the education has the potential to positively impact the care of patients with severe or resistant hypercholesterolemia who are at risk of CVD.

Early results also suggested improved knowledge regarding the degree of reduction in the risk of major adverse CVD events with LDL-C reduction to 50 mg/dL (pre-test, 25%; post-test, 73%; P<0.005); the impact of statins on CVD risk (pre-test, 23%; post-test, 56%; P<0.005); and the beneficial impact of LDL-C reduction on the rates of adverse clinical events (pre-test, 42%; post-test, 71%; P<0.005). Improved post-test knowledge was also observed regarding agents for lipid reduction, including CTEP inhibitors, which are still in development (pre-test, 20%; post-test, 80%; P<0.005); identifying the drug class for PCSK9 inhibitors (pre-test, 77%; post-test, 97%; P<0.005); and the indication of a microsomal triglyceride transfer protein inhibitor and an oligonucleotide inhibitor of apo B-100 synthesis (pre-test, 48%; post-test, 90%; P<0.005).

Based on the calculation of the effect size, it is estimated that the cardiologists who attended the activity are 55.4% more likely to deliver evidence-based care to the 83,000 patients seen each year with severe/resistant hypercholesterolemia who are at risk for major adverse cardiovascular events.

In conclusion, while additional data are needed, these preliminary observations support the concept that this regional lecture series has a positive impact on cardiologists’ knowledge, confidence, and practice in managing patients with severe or resistant hypercholesterolemia. In addition to collecting more data from participants at the remaining two venues, we will collect insights into their practice changes during a follow-up survey sent approximately 6 weeks after each live activity.

The initiative, “Managing Severe or Resistant Hypercholesterolemia: The Next Generation of LDL-C Lowering Agents,” is jointly provided by the Potomac Center for Medical Education and Rockpointe and supported by an educational grant from Amgen. The Potomac Center for Medical Education is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.


Carole Drexel, PhD, CHCP, Rockpointe Corporation and Potomac Center for Medical Education, Columbia, MD

Kathy Merlo, CHCP, Rockpointe Corporation and Potomac Center for Medical Education, Columbia, MD

Leanne Berger, Rockpointe Corporation and Potomac Center for Medical Education, Columbia, MD

Thomas Sullivan, Rockpointe Corporation and Potomac Center for Medical Education, Columbia, MD

December 09, 2016

AMA Calls for End to Manditory Secured Exam for MOC


In June 2016, at the AMA House of Delegates meeting in Chicago, one of the topics discussed was Maintenance of Certification. However, what was not mentioned in the AMA press (or really, any other press) was the fact that the AMA officially opposes mandatory ABMS recertification exams.

Interestingly, the position took place with little fanfare: it wasn’t listed in the Top 10 Stories from the AMA 2016 Meeting, nor was it listed in the coverage of the MOC resolutions that passed. It was only mentioned in tweets by attendees. AMA only focused on publicizing the following MOC resolutions:

  • Examining the activities that medical specialty organizations have underway to review alternative pathways for board recertification
  • Determining whether there is a need to establish criteria and construct a tool to evaluate whether alternative methods for board recertification are equivalent to established pathways
  • Asking the American Board of Medical Specialties to encourage its member boards to review their MOC policies regarding the requirements for maintaining underlying primary or initial specialty board certification in addition to subspecialty board certification to allow physicians the option to focus on MOC activities most relevant to their practice.

While the AMA House of Delegates Reference Committee C did try to amend the resolution that called for an “immediate end of any mandatory, recertifying examination by the American Board of Medical Specialties (ABMS) or other certifying organizations as part of the recertification process,” the HOD rejected modifications made by the committee, extracted it to a full vote on the house floor, and restored the language of the resolution. The resolution language, as passed, reads:

RESOLVED, That our American Medical Association call for the immediate end of any mandatory, secured recertifying examination by the American Board of Medical Specialties (ABMS) or other certifying organizations as part of the recertification process for all those specialties that still require a secure, high-stakes recertification examination.

There were several delegates that opposed the house action, saying that it shouldn’t try to do away with secure exams. Donna Sweet, MD, stated, “Secure simply means that it guarantees that you or the person are the person who is taking the test.”

ABMS, of course, opposes the AMA resolution. In a statement released by the Association, they stated:

Consumers, patients, hospitals and other users of the Board Certification credential expect board certified physicians to be up-to-date with the knowledge, judgment and skills of their specialty—both at the point of initial certification and along the physician’s career path – and to verify it through an external assessment. The privilege to self-regulate which physicians enjoy demands that we meet that expectation with more than just continuing medical education.

Continuing medical education is an important component of a physician’s continuous learning and an important part of Maintenance of Certification (MOC), but by itself is not sufficient to verify that a physician is up to date. The other components of MOC—professionalism, external assessment of knowledge, judgment and skills, and improvement in medical practice—are also important.

The AMA also approved a resolution to continue working with ABMS to “encourage the development by and sharing between specialty boards” of alternate ways to assess medical knowledge, other than by a secure exam. The AMA HOD also bolstered its support of using appropriate continuing medical education (CME) courses to maintain quality assessments of physicians.

November 30, 2016

21st Century Cures No Longer Includes Open Payments Exemption for Reprints, Textbooks and Non Promotional Education


We previously wrote about the updated version of the 21st Century Cures bill – one that we, along with many others, thought would pass both the House and the Senate with minimal edits, if any. However, the new bill no longer includes a provision that would have exempted drug makers from disclosing non promotional continuing medical education (CME) payments to physicians, including text books and reprints.

The version of the bill released late last week would have allowed manufacturers to be exempt from reporting industry payments to physicians for textbooks, journal reprints, and for speaking at continual medical education events.

This change follows a speech by Senator Elizabeth Warren on Monday, where she described the exemption as covering up bribery. She relayed her belief, which is that drug companies have opted to “cozy up to enough people in Congress to pass this Cures bill that would let drug companies keep secret any splashy junkets or gifts associated with ‘medical education’ and make it harder for enforcement agencies to trace those bribes.”

The opposition to the exemption even crossed party lines, with Senator Chuck Grassley planning to “object to unanimous consent to take up the 21st Century Cures Bill in the Senate,” unless the reporting exemption was removed. As a reminder, Grassley was a co-author of the Physicians Payment Sunshine Act, which requires drug makers and medical device makers to disclose payments they make to physicians to a public database.

Grassley believes that the “Sunshine Act brings transparency to a big part of the health care system for public benefit. Transparency brings accountability wherever it’s applied. With taxpayers and patients paying billions of dollars for prescription drugs and medical devices, and prices exploding, disclosure of company payments to doctors makes more sense than ever.”

He further went on to say, “a lot of earlier payments to doctors were under the umbrella of Continuing Medical Education. We shouldn’t create a loophole that would let drug and medical device companies mask their payments to doctors under a payment category that’s too broad and could gut the spirit and the letter of the Sunshine Act."

Grassley, Warren, and other critics of the exemption have long complained that CME and textbooks have the ability to influence physicians to prescribe expensive brand-name drugs, and that transparency is undermined if drug and device companies are permitted to avoid reporting the value of such sessions and handouts.”

John Kamp, executive director of the Coalition for Healthcare Communication, however, expressed his disappointment at the removal of such a “reasonable provision that enables doctors to be fully informed about medicines.”

This is a disappointment but the vast majority of accredited CME still falls under an exemption for Open Payments reporting as long as the applicable manufacturer does not select or pay the covered recipient speaker directly, or provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program.   

Interestingly enough, the 21st Century Cures Act is one of the most lobbied healthcare bills in recent history, with almost 1500 lobbyists representing 420 companies, universities, and other organizations looking to influence the bill’s contents..

It was just last summer when more than 100 national and state medical societies backed a Senate bill to create the exemption, complaining of “onerous and burdensome reporting obligations…that have already chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals,” seeking to avoid “a similar negative impact” on CME.

The House is still expected to pass the bill on Wednesday, November 30, but only time will tell if it will pass with this most recent edit, and what other edits may be waiting in the wings.


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