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.

The Seventeenth Annual PCC: Day 1 Highlights

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The Annual Pharmaceutical and Medical Device Compliance Congress is an important opportunity for industry compliance professionals and regulators to exchange information and learn from one another. This year was no exception and this article briefly recaps the highlights from the conference’s first day.

Seventeen years have passed since the Pharmaceutical Compliance Forum held its first Compliance Congress. Now with over 350 attendees, the Congress, held this October in Washington, DC, 1 continues the tradition of being an excellent opportunity for networking, transformational learning, and “effective knowledge exchange.” 2

Following the traditional format, the Day 1 plenary session focused on the “hot topics” the continue to occupy the attention of life science compliance professionals. These sessions included:

• The Chief Compliance Officer Roundtable

• The FCPA Enforcement Panel

• Annual OIG Update

Read Full Article in the December 2016 Issue of Life Science Compliance Update

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December 08, 2016

21st Century Bill Headed to President Obama’s Desk

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Nearly three years after its initial introduction, the 21st Century Cures Act has finally passed both houses of the Congress, and is expected to be signed by President Obama relatively quickly. This bill represents one of the few truly bipartisan efforts undertaken by this Congress.

We have previously written about some of the items included (and excluded) in the bill. The bill gives the health institutes the authority to finance high-risk, high-reward research using special procurement procedures, as opposed to more conventional grants and contracts. It also requires the agency’s director to establish “Eureka prize” competitions to advance biomedical research and improve treatments for serious illnesses. The bill also creates a new assistant secretary for mental health and substance use, to be appointed by the president, thereby raising the status of mental health issues throughout the country.

Further, the bill directs federal agencies to step up their enforcement of laws that require equal insurance coverage for mental and physical illnesses. Federal laws and rules requiring mental health parity have been adopted with bipartisan support over the last twenty years, but a White House task force recently found that compliance with those laws has been lagging.

Political Reactions

The bill includes $500 million a year to help states prevent opioid misuse and get better treatment for addicts. "These additional resources are particularly critical in rural areas, where rates of opioid misuse and overdose are high, access to treatment is limited, and patients who seek treatment are often met with waitlists that can mean the difference between life and death," said Agriculture Secretary Tom Vilsack.

In a statement made by President Obama shortly after passage of the bill, “We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s, and helping people seeking treatment for opioid addiction finally get the help they need.”

Obama also noted, “This is a reminder of what we can do when we look out for one another. Like Joe Biden and so many other Americans, I’ve lost people I love deeply to cancer. I’ve heard often from those whose loved ones are suffering from Alzheimer’s, addiction and other debilitating diseases. Their heartbreak is real, and so we have a responsibility to respond with real solutions. This bill will make a big difference, and I look forward to signing it as soon as it reaches my desk.”

Senator Susan Collins (R-ME) stated, “I doubt that there is a family in America who will not be touched by this important legislation.” Representative Steve Cohen (D-TN) was also pleased with the passage, saying, “I don’t think there is enough money that we can put into the N.I.H., because it is important and affects all Americans independent of political party, race, sexual orientation – you name it.”

Medical and Industry Reactions

"The remarkable bipartisan, bicameral support for the 21st Century Cures Act proves that congressional lawmakers are serious about the need for scientific research, effective care-delivery, and the removal of barriers to scientific progress," said Dr. Daniel Hayes, president of the American Society of Clinical Oncology.

"This legislation will improve the lives and health of countless Americans," said American Psychological Association President Susan McDaniel. "It will increase access to effective, evidence-based care, particularly for those with serious mental illness."

In a Statement from Sharad Lakhanpal, MBBS, MD; President of the American College of Rheumatology, he noted,  "While we are pleased that the 21st Century Cures Act will infuse additional, much-needed funding to the NIH to support medical research across the healthcare spectrum, we also know that more can and should be done to help Americans who are disproportionately impacted by arthritis and other rheumatic diseases. Today, arthritis is the leading cause of disability among U.S. veterans and the second most common reason for medical discharge from the U.S. Army. One in three veterans is diagnosed with arthritis, compared with one in five members of the general U.S. population.

As Congressional leaders turn their attention to budget appropriations for the upcoming fiscal year, we urge them to prioritize the creation of a dedicated $20 million arthritis research program at the Department of Defense so that we can better meet the care needs of the thousands of active duty and veteran members of our Armed Forces who live with arthritis.”

Conclusion

Once the bill is signed by President Obama, it will be up to the Food and Drug Administration (FDA) to implement many portions of the law, which could take years. Funding may be immediate, but the actions the FDA and other federal agencies are responsible for may still be quite a bit away. We will all have to stay tuned as this bill, and its effects, continue to progress.

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