Sunday, August 31, 2014

Clinical Practice Guidelines, Autism, and Ordering of Tests

I just returned recently from giving a presentation to the Institute of Medicine (IOM) on the topic of emerging technology in medical education (more specifically, on graduate and continuing education in the health professions).  The overall theme of the IOM Roundtable discussion was to examine practical approaches to improving genetics education in these groups.  I am a primary care physician, and by no means an expert in genetics or genomics.  My involvement in the meeting centered around using emerging technology within education of health care professionals. 

It was a fantastic one-day conference, and I had the opportunity to meet some very wonderful people; not only fellow educators but also true experts in the field of genetics and genomics education.  The discussions included how genetic providers can best partner with primary care physicians on ordering of tests that will help patients.  We also talked about primary care physicians referring appropriate patients to geneticists for further evaluation.  One of my take home points was that I should be considering genetic conditions more often than I am.  Consider that objective achieved, IOM!

So I recently received this advertisement card in the mail, by Quest Diagnostics.  On one side “Their future is in your hands.”  On the other, a pitch to use the ClariSure brand of chromosomal microarray analysis. 

I have never ordered one of these tests.  I probably need to refer more patients to a genetics clinic, for sure, and not just for patients in whom I am entertaining a diagnosis of autism.

But this phrase right on the pretty glossy paper caught my attention: “Chromosomal Microarray Analysis is recommended as a first tier test for autism spectrum disorders and developmental delay by ACMG” (the American College of Medical Genetics).  Wow, I thought!  That could be considered a pretty bold statement.  Remember, this was sent to me, a primary care doctor, who sees patients with autism, screens pediatric patients at well child visits for it, and refers where appropriate.  The statement above does NOT say “for diagnosis”, “when/if referring to genetics”, or anything like that.  It says “recommended as a first tier test for autism …”.  How should a pediatrician reading this pamphlet sent directly to them interpret that?

I pulled the ACMG guidelines, entitled “Clinical genetics evaluation in identifying the etiology of autism spectrum disorders: 2013 guideline revisions”. In that guideline, Table 4 is titled the following: “Template for the clinical genetic diagnostic evaluation of autism spectrum disorder”.  Indeed, chromosomal microarray is listed as a first-tier test.  But let’s go back to the title of Table 4 and read it more carefully: “… for the clinical genetic diagnostic evaluation of autism spectrum disorder”.  It does NOT say “for pediatricians and primary care providers” anywhere in this table.  I don’t really know too many primary care pediatricians who are ordering this test, but maybe I am insulated.  I am not a clinical geneticist.  So why is this pamphlet being sent to me, a pediatrician?

When I am not sure about something, I like to “go to the literature”.  So I looked for guidelines or a policy by the group with which I affiliate as a pediatrician: the American Academy of Pediatrics (AAP).  I do not recall the AAP recommending chromosomal microarray testing the last time I looked.  The AAP does indeed recommend Screening for Autism, in a guideline from 2007: “Identification and evaluation of children with autism spectrum disorders”, with a simplified algorithm found here, on page 2).  Basically, routine screening in EVERY PATIENT at 18 months for autism spectrum disorders is what pediatricians should be doing.  There is even a code for screening (it’s 96110, for anyone interested!)  I know this algorithm well. 

We are actively working to improve screening for autism in the state of Indiana, and colleagues at my institution have some preliminary data that demonstrate a lowering of the mean age of diagnosis of autism in certain communities by quite a bit (the lower the age, the earlier the patient can be referred to an autism specialist).  Maybe in the future, ordering of a chromosomal microarray analysis will be part of a general pediatrician’s armamentarium, but I’m not sure it is right now.

Is it just me, or should I be bothered by this pamphlet which I received from Quest Diagnostics?  Again, the wording on the pamphlet sent to me, a primary care doctor, at my home address, recommends “chromosomal microarray analysis is recommended as a first-tier test …”.  I struggle with the wording, which omits “by clinical genetics”.  I am not saying that geneticists should not order this test; they probably should.  I am saying that sending this pamphlet to pediatricians, who see scores of patients who may have positive screening tests for autism, seems a bit bold.

Pediatricians should refer patients they are concerned may have autism spectrum disorders to a specialist.  Their concern may arise from a gestalt, or from a formal screening test, such as the M-CHAT-Revised. If this screening test (which costs only time to complete) is positive, a referral to a specialist and a community early intervention service resource is indicated.  One such specialist is a clinical geneticist; another might be a behavioral/developmental pediatrician or a child neurologist.  In addition, each state has its own individual process for early intervention service referral.

People wonder why the costs of health care are so ridiculously high.  I agree with this sentiment: costs are too high!  I do believe that we should be referring patients and interacting more with our genetics colleagues about patients with whom we might be considering certain diagnoses, such as autism spectrum disorders.  But I wonder if general pediatricians are the right audience for such an advertisement for a specific diagnostic test.  I certainly can see this pamphlet sent to the offices of clinical geneticists.

I think the point of the IOM meeting recently was to improve the education of primary care physicians.  IOM: consider your goal achieved, with this primary care doc (me), at least.  I wonder how many of my primary care colleagues are now ordering this chromosomal microarray test in patients who have a positive (abnormal) screening test, versus just referring.  Something tells me that chromosomal microarray analysis is not a cheap test either.  But that’s a discussion for a future blog.

Saturday, August 23, 2014

Residency, Success, Team Sports and Being a Member of a Team

In a recent medical education twitter chat, other medical educators and I were discussing success being tied to previous experience playing a team sport.  It stemmed from this article, which suggested that success in residency (otolaryngology) may be more likely if one played a team sport earlier.  This is a fascinating observation, and one that I hadn’t thought of when interviewing applicants.  Others commented that there may be bias since in early schooling, boys are more likely to be members of team sports than girls.

It is interesting that residency program directors really struggle with trying to find the magic bullet that will determine success.  What does “success” really mean?  For program directors, I suppose it could mean having a resident who performed very well clinically, who was not a rabble rouser and thus “caused no trouble”, and who received excellent evaluations throughout training.  It could mean impeccable surgical outcomes for procedurally-related fields (although there are other factors besides a resident involvement in surgery that might affect surgical outcomes).  It could also mean getting a job and starting a practice after residency, or securing a fellowship after residency training.  I really don’t think there is ONE thing that defines this success. 

There may be success on a test (such as passing a board examination): that has been studied.  The old adage: “past performance predicts future performance” is true with regards to tests, in my opinion.  How this translates for programs directors is that those students who performed well on USMLE Step 1 and/or Step 2 are more likely to pass the board examinations after residency.  While this is only one aspect of “being a doctor” (using competency language, it would be the competency of medical knowledge), residency programs are indeed being evaluated on this measure of board pass rate.

There may be success regarding professionalism. Some might take the reverse approach.  When one is unprofessional, what factors predict that unprofessional behavior? This has been studied by Dr. M Papadakis, and basically, past “unprofessional” behavior in medical school predicts future disciplinary action by state medical boards. 

There may be success in securing a match position.  Many educators have published on this, such as this from plastic surgery

I have heard many references over the years that medicine is a “team sport”.  No one takes care of a patient by only herself/himself.  We really need a team to help patients optimize their health.  I believe that the field of geriatrics models this very well, and has described training on working in multidisciplinary teams.  The importance of teams in medicine has also been outlined for patient-centered medical homes, such that teamwork competencies need to be defined.

One of my mentors (a female) has mentioned “I love seeing applicants who were Eagle Scouts”.  I have heard others who get excited seeing certain extracurricular activities, such as volunteerism, on a written application.  Like others, I certainly enjoy reading some things on an application more than others, but I really haven’t found any one thing that predicts success. 

To me, it is not just the application that is important. The application gets you in the door [for the job interview], but the interview gets you the job.  As for defining success: well, we in medical education have a long way to go before we are able to pinpoint that one down.

Sunday, August 17, 2014

Tweeting the (Medical) Meeting

I am currently in the airport on the last leg of a brief trip to present to the Institute of Medicine about using emerging technology in medical education. I am very pleased that the IOM has agreed to use a second screen to showcase a live Twitter feed during the meeting.  I have used this “second screen” option for several presentations over the past few years; it is done as an attempt to demonstrate live the content that is being highlighted: an opportunity for communication and discussion within medical education in a unique format.
I have written about this in the past.  However, this piece from a few days ago cautioned folks who do tweet the meetings.  Dr. Bryan Vartabedian wrote this phenomenal piece on “tweeting the meeting” earlier today.  I concur 100% with his eloquent, succinct statements that really get into “what it is all about” at such meetings.

I hope the demonstration tomorrow goes well.  If interested, please follow the hashtag highlighting this meeting: #IOMgenomics.  My part is “Innovative Models of Education: Using Technology Appropriately in Medical Education” and starts around 9:45 am EST on 8/18/14.  As always, feel free to follow the #meded chat as well.

Friday, August 15, 2014

Open Payments: Impact on the Noble Profession of Medicine

This blog is a follow up to my previous post dated August 4, 2014 on the Open Payments website related to the Sunshine Act.  In that post, I mentioned the opportunity for physicians to review their own data (as submitted by industry manufacturers) and, if said data were not correct, to formally dispute that data.  However, the website went down after errors were discovered in the submitted data.
Since that time, physicians have been very frustrated that the site was down.  I have had very intelligent faculty members (including a chair of a department) contact me to help with figuring out the process.  Fortunately, the site just opened up yesterday, 8/14/14, and again, physicians could review their own data.  

The Wall Street Journal detailed a piece yesterday mentioning the site as back up and operational, and that the review period to submit disputes would be extended by the number of days that the site was down.  That would make a quick turnaround time for the correction period to be completed before September 30, 2014, the day that that the site was to be officially open to the public.  CMS itself came out with a statement today describing identification of “the problem”, and instituted a system fix to prevent similar errors.  The WSJ followed up today with an updated post highlighting CMS’ position to stick to the September 30, 2014 deadline.

Here is the kicker: CMS will actually withhold approximately 1/3 of the data from the site, due to “intermingled data”, according to a piece earlier today from Charles Ornstein of ProPublica.  “Intermingled data” translated into the fact that physicians were being linked to medical license numbers of NPI numbers that were not theirs.  I cannot fathom how this is possible, as each physician is provided with a unique NPI number.  CMS itself even has an explanation of the NPI number here:  and anyone can look up an individual physician’s NPI number here or here.

If a physician has received no monies from industry, here is what the site will show (in full disclosure, this is the applicable portion of the screenshot from my own log-in):

So where do we go from here?  First, the word needs to get out to physicians that the site is back up, and they should register and review their own data.  The unfortunate problem is that the process is quite complex, and likely takes at least two hours of time to complete all the necessary steps to be able to view the screen above.  A nice explanation of the old timeline and the revised timeline for the dispute period is found in this post

I am all for disclosure and full transparency, but this registration and review process is overly burdensome for physicians, in my opinion.  We need to spend more of our time with our patients, and less time completing administrative duties (translated as “paperwork”, or in today’s current EMR-heavy environment: “computer work”).  The Open Payments system as it currently stands clearly falls into the burdensome “computer work” bucket, and I hope that the process can be simplified in future iterations.  Physicians and other health care providers need to advocate for what makes the profession a noble one: the patient-physician relationship, not time spent trying to comprehend flawed information from a flawed computer system.

Monday, August 4, 2014

The Sunshine Act and Open Payments

Today was a busy day for news about the Sunshine Act and Open Payments. I was asked to present pertinent information about the Sunshine Act to some of the leadership of the medical school where I work, the Indiana University School of Medicine, about this topic.  Essentially, the Physician Payment Sunshine Act (PPSA, shortened to “Sunshine Act”) came out of the Affordable Care Act, and requires that manufacturers of drugs and medical devices (which I'll call “industry”) collect, track and report all payments and financial relationships with physicians and teaching hospitals.  This system was designed to establish a transparent national disclosure system.

As a result, the Center for Medicare and Medicaid Services, or CMS, was tasked with creating a website that provided information about these relationships so that the public can make informed decisions.  That website is known as “Open Payments”.   

As of the time of this writing, for approximately the next three weeks, the “Dispute” period  is still open, whereby individual physicians can register on the website, and review their own data.  If one feels there is a discrepancy, then s/he can file a dispute that industry companies will need to review, and ultimately reconcile.
For my presentation today, I carefully made detailed slides for the leadership to share with the faculty.  I decided today to add in some screen shots of what the report looks like to an individual doctor.  To my dismay, this was the screen I found.

Intrigued with the word "portlet", I sent a request to the CMS Help Desk.  I was pleased with the response time of just a few hours.  This was the response:

[The] portal is down for maintenance at this time.  There is no ETA at this point, but we are working to get this resolved as soon as possible.  We apologize for any inconvenience and Thank you for your understanding.
For further questions please feel free to contact the open payments help desk at 1-855-326-8366.  We are open Monday - Friday from 7:30 am to 6:30 pm CST, excluding Federal holidays.

Thank you,

Open Payments

I wondered what the issue could be.  It turns out that earlier today, this piece was posted by ProPublica.  
How timely! 

I really do hope for two big fixes.  First, that examples like this one here (which generated the ProPublica story) are rare.  The registration to gain access to one’s Open Payments information is complex and cumbersome (the User Guide is unfortunately not much simpler, at 359 pages in length), which one might assume means that CMS is really trying to make sure that someone who logs in is indeed who s/he said s/he is.  Second, that the website can be opened back up very soon. Time is slowly ticking away in the Dispute period.

I am all for transparency, but if a system is going to be put in place to “provide the public with information to make informed decisions”, the information in that system needs to be a) relatively easy to access, and b) correct first and foremost.  It would make sense to me that at the least, industry use the NPI numbers (each physician is assigned a unique number for ONLY that physician and no one else) to insure that physicians with similar names are not mixed up.

-For information about the Sunshine Act and the Open Payments process, see this from the AAMC. 
 -For a step-by-step process about how to register, review, and potentially dispute one’s data, see this from Stanford, along with this FAQ.
 -For a very recent survey of industry and of physicians (85% of whom stated they would like to review their own data BEFORE its submitted to CMS; 7% actually have reviewed their data, however), see this.

By the way, the presentation went fine.  Faculty leaders had great questions.  The take home discussion from many who have already gone through the process: allot two hours for the entire process of registering, waiting for clearance, and potentially for disputing any data that one feels is incorrect.

Fellow doctors, please take the time to review the process and your own data.  After all, we are curious about the details.