Eligibility for the Clinical Informatics Subspecialty, 2014 Update

One of the posts in this blog with the most page views ever is my January, 2013 description on eligibility for the clinical informatics subspecialty for physicians. No doubt part of the reason for its popularity was my using the post as a starting point for replying to those emailing or otherwise contacting me with questions about their own eligibility.

A year later, I still get such emails and inquiries. While the advice in the 2013 post is largely still correct, we have had the ensuing experience of the first year of the board exam, who qualified to sit for it, and what proportion of those taking the test passed. We can also put various educational offerings in context, not only for their content, but also for how the two boards qualifying physicians for the exam, the American Board of Preventive Medicine (ABPM) and the American Board of Pathology (ABP), viewed them in terms of eligibility to sit for the exam.

The official eligibility statement for the subspecialty is unchanged from last year and is documented in the same PDF file posted then from the ABPM (and summarized by the ABP). One must be a physician who has board certification in one of the primary 23 subspecialties. They must have an active and unrestricted medical license in one US state. For the first five years of the subspecialty (through 2018), the "practice pathway" or completing a "non-traditional fellowship" (i.e. one not accredited by the Accreditation Council for Graduate Medical Education, or ACGME) will allow physicians to "grandfather" the training requirements, i.e., take the exam without completing a formal fellowship accredited by the ACGME.

I have some observations about who was deemed eligible for the exam, although as always, let me give the standard disclaimer that ABPM and ABP are the ultimate arbiters of eligibility, and anyone who has questions should contact ABPM (for physicians in any specialty except pathology) and ABP (for physicians in pathology). I am only interpreting their rules.

One concern many had was the "nontraditional fellowship" for eligibility, in particular whether a master's degree in informatics would allow one to qualify. I argued that a master's degree alone should have qualified someone, since if nothing else, it (at least ours at OHSU) might meet the practice pathway time requirement, with educational time being "worth" one-half of the time of practice, and a master's degree being equivalent to at least 1-1/2 years of full-time study (i.e., 0.5 FTE over three years). (I also asserted last year that anyone education from OHSU would have the background to pass the exam. Experience bore me out, as at least 40 OHSU informatics alumni and current students - some qualifying by additional practice time in the practice pathway - passed the exam, and I am not aware of anyone from our program who did not pass it.)

We have also learned from the experience of having the first exam offered. It was exciting to see 456 diplomates newly certified in the subspecialty, including myself. However, I (and a number of others) were somewhat surprised at the pass rate of 91% for the exam being so high, given the vast body of knowledge covered by the exam and the lack of formal training, especially "book" training, of many who took the exam. It is not uncommon for pass rates for those grandfathering training requirements into a new subspecialty to be much lower. We do not know how the exam or its pass rate may change this year or beyond.

This challenges my statement in last year's posting that a single course, such as 10x10 ("ten by ten") or the American Medical Informatics Association (AMIA) Clinical Informatics Board Review Course, may not be enough. But perhaps with the experience brought to the table by qualifying via the practice pathway, a large amount of additional education is not necessary.

One bit of advice I can certainly give to any physician who meets the practice pathway qualifications (or can do so before 2018) is to sit for the exam before the end of grandfathering period. After that time, the only way to become certified in the subspecialty will be to complete a two-year, on-site, ACGME-accredited fellowship. While we are excited to be developing such a fellowship at OHSU, it will be a challenge for those who are mid-career, with jobs, family, and/or geographical roots, to up and move to become board-certified.

There are actually a number of categories of individuals for whom getting certified in the subspecialty after the grandfathering period will be a challenge:

• Those who are mid-career - I have written in the past that the age range of OHSU online informatics students, including physicians, is spread almost evenly across all ages up to 65.
• Those pursuing research training in informatics, such as an NLM fellowship or, in the case of some of our current students, in an MD/PhD program (and will not finish their residency until after the grandfathering period ends). Why must these individuals also need to pursue a clinical fellowship?
• Those who already have had long medical training experiences, such as subspecialists with six or more years of training - Would such individuals want to do two additional years of informatics when, as I recently pointed out, it might be an ideal experience for them to overlay informatics and their subspecialty training?

Fortunately one option for physicians who do want some sort of certification will be the Advanced Interprofessional Informatics Certification being developed by AMIA. These physicians can and will still apply informatics to make important contributions to healthcare. I am pleased to report that AMIA has revamped its efforts to create this certification, not only for these physicians but also other practitioners of informatics.

National Library of Medicine: Past, Present, and Future

This week I am off to a meeting I look forward to every year, the annual meeting for trainees funded by the National Library of Medicine (NLM) biomedical informatics research training grant program. This meeting has been valuable for its content and networking back to the time I first attended it as a trainee in 1988. I wrote about it in the past in this blog.

The NLM is truly an exemplar not only for the United States (which funds it via Congress), but also the rest of the world as well as many people individually, including myself. The NLM is unparalleled in providing access to biomedical and health knowledge. It not only provides operational systems used around the world daily but also has a robust research and development program that develops, implements, and evaluates the next generation of biomedical and health knowledge tools. The NLM provides access not only to clinical information, but also biological, consumer-oriented, and public health data and information. As one of the institutes of the National Institutes of Health (NIH), it adds value to the research missions of all the other institutes in an integrative manner.

Starting with my postdoctoral fellowship from 1987-1990, the NLM has certainly enabled success in my career. It also funded my first research grant, one of the old First Independent Research Support and Transition (FIRST) or R29 awards, and then numerous other research as well as training grants. The NLM also funded the initial program and the building where my office resides under the Integrated Advanced Information Management Systems (IAIMS) initiative at Oregon Health & Science University. Like many in the informatics field, I owe a great deal to the NLM for my accomplishments.

At this time, the NLM is preparing for its next round of its long-term planning. This process is slated to begin in 2015 and will result in a publication of its next long-term plan in 2016. This new plan will supersede the last long-term plan that was published in 2006.

In preparation for the next round of long-term planning, the NLM recently held a symposium to reflect over the 30 years of leadership of its current director, Dr. Donald AB Lindberg. The Web site for the symposium allows visitors to leave comments about the past, present, and future of the NLM. The latter comments will be used among the information-gathering efforts to launch the next long-range planning process next year. What an opportunity for the Informatics Professor to share his thoughts on the future of the NLM, which I will put in the rest of this posting and then paste into the future comments portion of the NLM symposium site.

In light of the NLM's success, what recommendations do I suggest for moving into the future?

One of the big challenges for the NLM is its name. I am not one of those people who believes that "libraries" are something of the past. I have a whole chapter in my book on information retrieval (search) devoted to "digital libraries" and their importance [1]. Libraries are certainly changed in the 21st century, but still remain repositories of data, information, and knowledge, even if much of it is now digital. It is still important to have libraries and librarians who collect, curate, make accessible, archive, and preserve data, information, and knowledge. The fact that its materials are mostly digital now does not eliminate the need for these other functions.

However, the NLM always has been more than a library and will likely continue to be so. The NLM funds intramural (within in NLM) and extramural (outside NLM, mainly in universities) research, mostly in informatics. It also provides and funds education, mainly to librarians and future informatics researchers, but also many others. What the NLM really does then, in the big picture, is biomedical and health informatics.

Since the NLM is one of the institutes of the NIH, we may ask then, why is the NLM not called something like (my preferred name) the National Institute for Biomedical and Health Informatics? This would not only reflect its larger activities beyond being a library, but also make its role more clear, especially for those to whom NIH research funding is important (such as Promotion and Tenure Committees at universities). If this name change were made, the library function of NLM could be one of its major divisions, synergizing with its other informatics functions.

Another important recommendation for the future is to expand informatics research funding. If for no other reason, this should be done to give informatics research a fairer share of NIH research funding. Is informatics research really only deserving one-tenth or one-hundreth the funding of the major disease-based institutes? I know that substantial expansion of overall funding is unlikely to come to the NIH any time soon, but consideration should be given to re-prioritizing the role of information systems and technology in achieving the "triple aim" of healthcare (better health, better care, and lower cost) [2].

In teaching to various audiences, I have noted an analysis by Woolf and Benson comparing the overall health benefit of more people having access to a treatment versus the incremental improvement in treatment efficacy [3]. This analysis is mainly used to make the case for investments in universal healthcare (something with which I agree), but can also be applied to the notion that informatics research helps us understand how to provide better access to patient data, along with information and knowledge to deliver more effective care.

I also would advocate that the NLM (or this new institute) should expand its research explicitly in clinical informatics. I argued recently in this blog that the NIH informatics research agenda needed to expand its focus on the role that data, information, and knowledge play in complex clinical settings. I also expressed concern that data science not taking into account the context of health and healthcare might not achieve its potential.

In fact, this newly renamed institute could also be the home of other current activities, such as data science, which is so dependent on informatics and would also synergize with its library function. At a time when many organizations are developing matrixed organizations where the different entities perform integrative functions, NLM can and should take on that role within NIH, with its core function centered around informatics.

References

1. Hersh, WR (2009). Information Retrieval: A Health and Biomedical Perspective (3rd Edition). New York, NY, Springer.
2. Berwick, DM, Nolan, TW, et al. (2008). The triple aim: care, health, and cost. Health Affairs. 27: 759-769.
3. Woolf, SH and Johnson, RE (2005). The break-even point: when medical advances are less important than improving the fidelity with which they are delivered. Annals of Family Medicine. 3: 545-552.

What is the Right Amount of Profit in Healthcare?

I have written in the past that while free markets and capitalism work well in most industries, their value in healthcare is less clear. Other industries set prices that balance cost of production and how much consumers are willing and able to pay. I can, for example, decide when my budget allows me to buy a new car or a new computer. However, I do not believe I could ever put a price on a treatment that would save my life.

A new situation has come to the fore that reinforces this view, which is the release of the drug Sovaldi (sofosbuvir). This drug is curative of Hepatitis C in 90% of patients with the infection and has modest side effects [1]. Hepatitis C is a widespread, devastating disease that is mostly symptomatic yet can insidiously cause cirrhosis and liver failure. This drug is truly miraculous for those with this infection.

The problem with this situation is that the cost of the drug has been set by its manufacturer at $1000 per pill, meaning that the standard 12-week course costs $84,000. The drug manufacturer, Gilead Pharmaceuticals, counters that the drug saves the cost of complications and treatment of the disease, up through the use of liver transplantation that costs 3-4 fold ($300,000) the cost of the drug course along with a lifetime of expensive anti-rejection medicine ($40,000 per year) [2].

This really gets to the crux of the dilemma: What is the right amount of profit due to the innovation developed by a pharmaceutical company like Gilead? And when companies carry out less innovative activities, such as development of "me too" drugs [3], should we penalize them?

Sovaldi is not the first drug for which this dilemma has arisen. The cost of cancer chemotherapy, even when there are some competing alternatives, is extraordinarily expensive. Can the market really put a price on drugs that save or extend lives, for which there are few or no alternatives? A number of leading cancer researchers, including OHSU's Dr. Brian Druker, have raised alarms about the prices of cancer drugs [4, 5]. A Forbes Magazine contributor has discussed these issues in the context of both Sovaldi and cancer drugs [6].

This scenario has also played out with drugs for AIDS in Africa, which was documented in the movie, Fire in the Blood. Fortunately in this situation, funding from the US government came to the rescue, with the President's Emergency Plan for AIDS Relief (PEPFAR) initiative by former President George W. Bush credited with success [7]. But there are still many other challenges for high-cost drugs in developing countries.

Asking whether drug companies are greedy or innovative is probably the wrong question. If one accepts that innovation in medicine is risky and should be rewarded when it is successful, and that the cost of drug development is extraordinarily high, with a serious cost for failures (that must be spread across successes for a company's bottom line), then companies such as Gilead should indeed be rewarded. The right question is, how much should they be rewarded?

The answer gets back to the crux of medicine not adhering to the principles of a free market. When someone has a disease, especially a life-threatening but highly treatable one, he or she does not really have "choice" to choose whether or not to treat their disease? If there is just a single drug treatment, then that person is at the total mercy of the company selling the drug. The same holds for any other aspect of treatment, including the cost of physicians [8].

One possible solution to this problem is to adapt a program that has been proposed for drug development in the developing world and reward those who take the risks to develop new treatments by a measure of their health impact. One organization has proposed a plan that creates a fund to reward innovations based on their health impact globally [9, 10]. This is an intriguing idea, even if there are many challenges in the details of implementing such a model.

There are probably other solutions, but clearly society must develop a mechanism to reward true innovation and health benefits while not allowing those who have made the discovery to engage in predatory pricing. Unless solutions are developed, the current situation is only likely to exacerbate, as new discoveries in personalized [11] and precision [12] medicine emerge, which are unlikely to be developed without substantial cost.

References

1. Sulkowski, MS, Gardiner, DF, et al. (2014). Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. New England Journal of Medicine. 370: 1879-1888.
2. LaMattina, J (2014). What Price Innovation? The Sovaldi Saga. Forbes, May 29, 2014. http://www.forbes.com/sites/johnlamattina/2014/05/29/what-price-innovation-the-sovaldi-saga/
3. Gagne, JJ and Choudhry, NK (2011). How many “me-too” drugs is too many? Journal of the American Medical Association. 305: 711-712.
4. Pollack, A (2013). Doctors Denounce Cancer Drug Prices of $100,000 a Year. New York Times. April 25, 2013. http://www.nytimes.com/2013/04/26/business/cancer-physicians-attack-high-drug-costs.html
5. Experts in Chronic Myeloid Leukemia (2013). The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood. 121: 4439-4442.
6. Munos, B (2014). Sovaldi Vs. Cancer Drugs: Price And Value In The Pharmaceutical Industry. Forbes, June 2, 2014. http://www.forbes.com/sites/bernardmunos/2014/06/02/sovaldi-vs-cancer-drugs-price-and-value-in-the-pharmaceutical-industry/
7. Anonymous (2009). How a Bush Administration Initiative to Combat HIV/AIDS Is Saving Lives. Washington Post. April 9, 2009. http://www.washingtonpost.com/wp-dyn/content/article/2009/04/08/AR2009040803706.html
8. Rosenthal, E (2014). Patients’ Costs Skyrocket; Specialists’ Incomes Soar. New York Times. January 18, 2014. http://www.nytimes.com/2014/01/19/health/patients-costs-skyrocket-specialists-incomes-soar.html
9. Banerjee A, Hollis A, Pogge T. The Health Impact Fund: incentives for improving access to medicines. Lancet. 2010; 375: 166-9.
10. Hollis, A and Pogge, T (2008). The Health Impact Fund: Making New Medicines Accessible for All. New Haven, CT, Incentives for Global Health. http://healthimpactfund.org/wp-content/uploads/2012/11/hif_book.pdf
11. Hamburg, MA and Collins, FS (2010). The path to personalized medicine. New England Journal of Medicine. 363: 301-304.
12. Anonymous (2011). Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease. Washington, DC, National Academies Press.