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.

November 30, 2016

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

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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.

November 29, 2016

21st Century Cures Update - Includes Exemption for Education in Open Payments

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When lawmakers head back to Washington, D.C. this week, one of the votes they have ahead of themselves is the 21st Century Cures bill, legislation that is intended to spur the development of new medical treatments. The bill was updated the Friday after Thanksgiving, leaving many of the provisions of previous versions intact, but also adding language intended to improve America’s mental health system and dedicates $1 billion over the course of two years to help combat the opioid epidemic.  

The updated package directs $4.8 billion in funding over a decade to the National Institutes of Health and includes $1.4 billion for President Obama’s Precision Medicine Initiative, $1.8 billion for Vice President Joe Biden’s cancer “moonshot” program, and $1.6 billion for a program focused on enhanced understanding of brain-related diseases like Alzheimer’s. The bill would be paid for mostly through sales of the U.S. strategic petroleum reserve and a fund created in the 2010 health care overhaul intended to promote disease prevention and public health.

The vehicle for the new bill will be existing legislation (HR 34) related to tsunami warning systems. Since the Senate has already passed an amended version of that bill, the package could be sent from the House back to the upper chamber and acted on relatively quickly. The vote is expected to take place on Wednesday, under suspension of the rules, preventing any amendments.

House Energy and Commerce Chairman Fred Upton of Michigan and Senate Health, Education, Labor and Pensions Chairman Lamar Alexander of Tennessee, the two main sponsors of the package, touted the bill as beneficial to virtually every American family. “What we have in the 21st Century Cures Act is an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead to best match the incredible breakthroughs that are happening by the day,” the lawmakers said in a joint statement. “We look forward to swift and favorable consideration of the 21st Century Cures Act in both the House and Senate.”

Sen. Christopher S. Murphy, D-Conn., a vocal supporter of mental health changes, on Sunday released a statement praising the package. “I'm excited Republicans and Democrats have put politics aside and reached a compromise that will allow a mental health reform bill to pass side by side with major new funding to confront the nation's opioid crisis. Both parties needed to make concessions to get this deal done, but the deal that has been struck is good for patients and families. I hope we get it done,” Murphy said.

Key Provisions of the Bill

Measures related to the FDA largely remain intact from the previous House-passed bill. The biggest change is the addition of language to help speed the development of regenerative medicine, or treatments that are designed to help regrow damaged cells or tissues. Such a provision would give the FDA the ability to put some of these treatments through what’s known as “accelerated approval,” a pathway that allows companies to conduct clinical trials on smaller populations and requires follow-up studies once the drug is on the market.

The $1 billion to curb painkiller abuse would effectively grant President Obama’s budget request from February. Included in the funding is a bid to gather support from Democrats, as well as an acknowledgement that this year’s stalled appropriations process would not be adequate for funding the opioid response envisioned by the backers of an opioid abuse package signed into law this summer.

The bill’s section on mental health would make changes to the leadership structure at the Substance Abuse and Mental Health Services Administration and establish/reauthorize grants for state and community mental health services. It would give HHS tools to enhance compliance with parity laws, which require insurers that cover mental health to offer mental health benefits that are as valuable as other medical coverage.

The most notable additions are aspects of a bill from Sen. John Cornyn (S. 2002). Those provisions would offer grants to law enforcement and the judicial system to improve their capacities to deal with mental health problems. Lawmakers wound up dropping controversial language from Cornyn’s bill that would have restored gun rights to certain individuals who had been committed for mental health treatment.

The legislation also changes policies governing electronic medical records by directing the federal government to issue a voluntary model framework on the sharing of patients' health information, and creates a grant program to help develop a reporting system that would provide the government with more information about the use and security of electronic health records.

Open Payments

Inserted into the legislation is a provision from Congressman Defazio, Burgess, and Senator Barrasso to exempt applicable manufacturers from reporting payments made for continuing medical education sessions, medical journals, or textbooks. We tend to believe that the reporting requirements stifle access to important information and have a detrimental effect on continuing medical education (CME) programming.

This represents a smart tweak to the current regulation.  Unlike the other categories under Open Payments, education represents the free exchange of ideas.

“This is about patient care — doctors need good information fast and this facilitates the process,” said John Kamp, who heads the Coalition for Healthcare Communication, a group of ad agencies and medical publishers. “I want my doctors to have information about whatever the latest science is saying.” He noted that the Food and Drug Administration is currently weighing rules for allowing companies to distribute information to physicians about unapproved uses of medicines.

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