Life Science Compliance Update

December 09, 2016

AMA Calls for End to MOC

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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.

July 14, 2016

AMA, AAFP and Medical Societies Support Senate Bill Promoting CME Exemption in Open Payments

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A long list of over one hundred specialty groups and state medical societies penned a joint letter to Senator John Barrasso expressing their “strong support” for S. 2978, the Senate bill that would exempt certain continuing medical education (CME) from Sunshine Act reporting requirements. Among the lengthy list of groups signing the letter were groups such as the: American Medical Association, American College of Cardiology, American Academy of Family Physicians, and Medical Society of the District of Columbia.

The groups note that the enactment of the senate bill would “protect the dissemination of peer and independent third-party reviewed services and products that improve patient care.” Such legislation is important because evidence-based medicine is facilitated by a practicing physician's ability to look at independent peer-reviewed journals, medical textbooks, and independent continuing medical education.

In the letter, the groups urge Congress to pass the bill because CMS has already "chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals" and appears ready to also stifle access to independent certified and/or accredited CME. The letter also mentions the fact that the bill attempts to clarify that CME which meets the standard for independence must be exempt from Sunshine Act reporting. Such a requirement has become necessary due to contradictory guidance from CMS that required several revisions to subregulatory guidance.

The letter continues on, stating, "[a]dding to the concern, a recent New England Journal of Medicine article, which was co-authored by current and former CMS staff, says that 'payments related to all accredited CME activities must be reported beginning in 2017.' This statement only adds to the confusion surrounding the status of independent CME as it relates to Open Payments reporting.” 

The groups believe that when Congress first enacted the Physician Payments Sunshine Act, it specifically intended to exclude independent sources of clinical information from sunshine reporting requirements. Congress wrote into the law twelve exclusions from the reporting requirements, including an exclusion for "[e]ducational materials that directly benefit patients or are intended for patient use."

However, CMS has decided to interpret the statute to mean that medical textbooks, reprints of peer-reviewed scientific clinical journal articles, and abstracts of these articles are not directly beneficial to patients, nor are they meant to be used by patients. According to the letter, "[t]his conclusion is inconsistent with the reality of clinical practice where patients benefit directly from improved physician medical knowledge and is not supported by the statutory language on its face or congressional intent.”

The letter continues, stating, "[s]cientific peer-reviewed journal reprints, supplements, and medical text books have long been considered essential tools for physicians to remain informed about the latest in medical practice and patient care. Independent, peer-reviewed medical textbooks and journal article supplements and reprints represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients because better informed clinicians render better care to their patients."

The groups also make mention of the 2009 FDA guidance, "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices," stating that the guidance shows that the FDA understands the "important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications."

As one of the participating organizations, the American Academy of Family Physicians issued a statement on the letter, noting that the Academy “seeks to safeguard physicians’ unfettered access to high-quality educational resources and independent certified and/or accredited CME.

May 20, 2016

Senator Durbin Asks Medical Associations to Endorse Mandatory Opioid CME – AMA Shows Interest

Following last month's letter to the Pharmaceutical Research and Manufacturers of America (PhRMA), asking the group to "take financial responsibility for the drug industry's role in curtailing the opioid overdose epidemic," United States Senator Dick Durbin sent a letter to four physician associations asking them to endorse mandatory CME programs.

The letter, which was sent to the American Medical Association (AMA), the American Academy of Family Physicians (AAFP), the American College of Emergency Physicians (ACEP), and the American Dental Association (ADA), noted several steps the Senator feels as though the associations can take to address the opioid epidemic. While the letters all had the same goal and the same roadmap to get there, each one was individually focused on the addressed association, using their mission statements to reach out and personalize his prayer for support.

Sen. Durbin believes that "the increased frequency with which prescription opioids have been prescribed in recent years has played a major factor in our nation's escalating heroin epidemic, including an alarming increase in opioid-related emergency room visits, opioid-related treatment admissions for abuse, and opioid-related overdose deaths." He cited statistics, including the statistics that the United States accounts for almost 100% of the world total consumption of hydrocodone and 81% of the world total consumption of oxycodone.

He believes that the best way to reduce the number of Americans who suffer from opioid addictions is to ensure that patients never become addicted in the first place.

Senator Durbin believes that the associations each can address the opioid and heroin crisis by "supporting evidence-based interventions." In part, he recommended that the AMA could prioritize helping physicians be more judicious in their prescribing patterns, while working to protect access for those who need opioids to manage their pain.

Several of the steps Senator Durbin mentioned in his letters to the associationswere: endorsing mandatory continuing medical education programs for opioid prescribers; supporting initiatives that require physicians to check prescription drug monitoring programs before prescribing painkillers to patients; and supporting increased transparency in physician prescribing practices and proper intervention for those who may be outliers.

Senator Durbin, in his letter, does acknowledge that there are "many patients suffering from acute and chronic pain" and that "doctors face a challenge in evaluating its existence or severity," since pain is always subjective.

Durbin HealthExec Interview

After publishing his letters, Senator Durbin participated in an interview with HealthExec, where he was asked whether or not he had heard from doctors that what he's asking of the associations would actually help. He responded, saying that he has heard from doctors in both directions. He believes that doctors who say it isn't their fault, that they try to keep their patients happy and satisfied, aren't providing a good answer, or doing their job. He believes that they "have to make certain they're doing what's medically necessary, number one, and do no harm to the patient."

In the interview, Senator Durbin did not appreciate the idea of training new professionals to not prescribe opioids en masse, though. He feels as though there should be some responsibility taken by current physicians, and some actions to rectify the current situation.

AMA Response

Following receipt of the letter from Senator Durbin, AMA President Steven Stack, MD, penned an open letter to medical professionals to "play a lead role" in reversing the rise in opioid addiction, but did not endorse the standards that were advocated in Sen. Durbin's letter.

Instead of endorsing mandatory continuing education programs, however, Stack endorsed ideas such as: avoiding prescribing opioids for new patients who have chronic pain unrelated to cancer; to register and use Prescription Drug Monitoring Programs (PDMPs); and work on reducing opioid exposure to patients who are already on chronic opioid therapy when the risks exceed the benefits.

Interestingly, on May 17, 2016, Inside Health Policy reported that the AMA is starting to warm up to the idea of mandatory opioid prescriber education tied to DEA registration. This is a huge change from before, when the AMA tended to focus on an alternative approach because they felt as though mandatory CME was too "one size fits all."

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