Sunday, November 24, 2013

"Low T Syndrome" and the Fountain of Youth

Psychiatrists are seeing increasing numbers of male patients who are being treated for low testosterone.  The symptoms of "Low T" are being promoted as a reason to get assessed and treated with testosterone.  Not surprisingly, "Low T" is a highly successful pharmaceutical company promotion.  So successful that testosterone seems to have disappeared from the vernacular, replaced by "T".  I have had the opportunity to follow this controversy for the last 30 years.  Back in the days when there were a subgroup of psychiatrists who considered themselves to be "microendocrinologists" testosterone, LH, FSH, and GnRH were studied along with the components of the hypothalamic-pituitary-adrenal and hypothalamic-pituitary-thyroid axes,  particularly in depressives.  Despite a lengthy but low intensity research effort on gonadal steroids in both men and women the data on baseline neuroendocrine correlates and results of supplemental treatments are equivocal.  That said, most psychiatrists have encountered women who have often had a significant response to treatment with gonadal steroids.  Seeing a consistent treatment effect is difficult.

As a clinical psychiatrist, I have found that the clearest information on drugs is available in the FDA approved package insert.  In the case of the product being marketed by the "Low T" ads is a form of testosterone gel that is available in two different strengths.  The only indication for the the product according to that package insert is primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congential or acquired).  Any use for treating depression or augmenting antidepressants is off label use.  If testosterone was effective as an augmenting agent it would join the ranks of most antidepressant augmenting agents as being an off label prescription.  There are three related issues.

The first is the diagnosis of primary or hypogonadotropic hypogonadism.  In most cases, my speculation would be that a middle aged man sees or hears about the "Low T" ad and goes in to see their primary care physician and a testosterone level is ordered.  Most authoritative sources like UpToDate state that testosterone replacement should only occur in men who are hypogonadal.  Making that determination generally requires two low testosterone levels or in the indeterminant cases some expertise in the hypothalamic-pituitary-gonadal axis (HPG), as well as access to a laboratory with some specialized endocrine capabilities.  This is the level where most assessments seem to break down.  The range I am used to seeing is total testosterone levels ranging from about 300-1,000 ng/ml.  Scattergrams of testosterone versus behavioral parameters of interest like libido, aggression, and energy usually show low levels of correlation.  Many men are getting treated for (like the commercial suggests) low testosterone, or a level in the low normal range but not in the deficient range.  That takes treatment into the realm of off label indications because they do not have a diagnosis of hypogonadism.  A definitive algorithm (1) from endocrinologists is available including when to refer to an endocrinologist.

The second issue is whether there is any evidence testosterone either treats depression or is an effective agent to augment the effects of antidepressants.  That would conceivably move testosterone to the level of the augmenting agents used in the STAR*D study of depression.  The best guidance in the literature comes from Pope, et al (2) article on testosterone replacement in men 65 years of age or younger taking serotonergic antidepressants, a total testosterone level of less than or equal to 350 ng/ml, a PSA less than 4.0 ng/ml and an incomplete response to the antidepressant.  The author's conclude that there were no significant differences in response to testosterone or placebo gel.  Their conclusion is that the current practice of testosterone supplementation of antidepressants is not supported, but that there may be identifiable subgroups in larger studies.

Pope's observations are also critical in that he is an expert in anabolic androgenic steroid (AAS) abuse and has observed a euphorigenic hypomanic response to both AAS and prescription testosterone.  In his article he cites this response occurring in about 4.8% of 105 volunteers taking the equivalent of 500 mg/week of testosterone or an equivalent.  These observations are critical because they factor in addictive behaviors associated with substance use and Pope's group has proposed criteria for anabolic-androgenic steroid dependence.  The criteria highlight that fact that there are a number of associated mood symptoms including depression during the withdrawal phase.  Screening for an AAS use disorder and associated comorbidity like muscle dysmorphia

The third issue is the risk benefit analysis and that makes testosterone as an augmenting agent more unique than the other STAR*D agents.  Testosterone has unique medical risks beyond any risk of an additive effect with an antidepressant.  The main risk with other augmenting agents is usually rare cases of serotonin syndrome or side effects specific to the agent.  They are essentially being prescribed for the same indication.  With testosterone, there is no professional body advocating for supplementation in men with a eugonadal state and the risks may be significant starting with the contraindications (breast cancer, known or suspected prostate cancer) and warnings (benign prostatic hypertrophy, exposure to women and children, edema, sleep apnea, and the need to monitor a number of biochemical parameters).  There have also been recent articles showing a possible correlation with a number concerns about increased myocardial infarction, ischemic stroke, and other mortality (3,4,5).

So for all of you psychiatrists out there who are being referred men who are being treated for "Low T" or being sent to you with a question about testosterone there are a couple of necessary steps at this point.  Make sure that a diagnosis of hypogonadism has been established.  Let your patient know that testosterone supplementation of antidepressants in eugonadal men at this time is experimental and carries risks.  I would also inquire about a past history of anabolic androgenic steroid use, their conscious experience of that use ranging from mood changes to body image concerns and any prior psychiatric history including a history of addictions or using performance enhancing drugs.  For men considering an evaluation and treatment for "Low T" it is much more complex than filling out an online questionnaire on pharmaceutical company website.  Have realistic expectations about what you can expect, especially if someone is suggesting that testosterone supplementation is a treatment for depression.  Take a good look at the risk and consider that there will probably never be a major study that takes a good look at this issue with a large population of men.  The prospective studies will probably be similar to Pope, et al of about 100 men followed for a short period of time and the retrospective studies will have some innovative designs but they will also be limited by selection factors and significant stratification factors.  That generally means that additional information about risk may only be available in the form of FDA warnings from post marketing surveillance or their own analysis of data that may not be publicly available.

George Dawson, MD, DFAPA

References:

1.  Dandona P, Rosenberg MT. A practical guide to male hypogonadism in the primary care setting. Int J Clin Pract. 2010 May;64(6):682-96. doi: 10.1111/j.1742-1241.2010.02355.x. Review. PubMed PMID: 20518947; PubMed Central PMCID: PMC2948422

2.  Pope HG Jr, Amiaz R, Brennan BP, Orr G, Weiser M, Kelly JF, Kanayama G, Siegel A, Hudson JI, Seidman SN. Parallel-group placebo-controlled trial of testosterone gel in men with major depressive disorder displaying an incomplete response to standard antidepressant treatment. J Clin Psychopharmacol. 2010 Apr;30(2):126-34. doi: 10.1097/JCP.0b013e3181d207ca. PubMed PMID: 20520285

3.  Vigen R, O’Donnell CI, BarĂ³n AE, et al. (2013) Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA 310:1829-1836.

4.  Basaria S, Coviello AD, Travison TG, et al.  Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22. doi: 10.1056/NEJMoa1000485. Epub 2010 Jun 30. PubMed PMID: 20592293; PubMed Central PMCID: PMC3440621.

5. Cappola AR. Testosterone therapy and risk of cardiovascular disease in men.  JAMA. 2013 Nov 6;310(17):1805-6. doi: 10.1001/jama.2013.280387. PubMed PMID: 24193077.

Tip:  Follow the lead authors of these references on Medline and you will have a comprehensive look at the literature in this area.


Monday, November 18, 2013

Evidence based Maintenance of Certification – A Reply to ABMS

The politics of regulating physicians is no different than politics in general and that typically has nothing to do with scientific evidence.  From the outset it was apparent that some people had the idea that general standardized exams with high pass rates and patient report exercises would somehow keep all of the specialists in a particular field up to speed.  That assumes they were not up to speed in the first place.

As a member of a professional organization embroiled in this controversy it has give me a front row seat to the problems with physician regulation and how things are never quite what they seem to be.  From the outset there was scant evidence that recertification exams were necessary and with the exams no evidence that I am aware of that they have accomplished anything.  The American Board of Medical Specialties (ABMS) actually has a page on their web site devoted to what evidence exists and I encourage anyone to go there and find any scientific evidence that supports current MOC much less the approaching freight train of Maintenance of Licensure or linking MOC to annual relicensing by state medical boards.  Feel free to add that evidence to the comments section for this post.
Prior to this idea there were several specialty organizations that had their own programs consisting of educational materials that were self study courses that could be completed on specific topics relevant to the specialist every year.  A formal proctored examination and all of the examination fees that involves was not necessary.  The course topics were developed by consensus of the specialists in the field.  A couple of years ago I watched a CME course presentation by a member of the ABMS who pointed out that three specialty boards (of a total of 24) wanted to continue to use this method for relicensing and recertification.  They were denied that ability to do that because the ABMS has a rule that all of the Boards have to use the same procedure that the majority vote on.  The problem was that very few of the physicians regulated by these Boards were aware of the options or even the fact that there would be a move by the ABMS for a complicated recertification scheme and that they would also eventually push for it to become part of relicensing in many states.
If the ABMS is really interested in evidence based practice, the options to me are very clear.  They currently have no proof that their recertification process is much more than a public relations initiative.  Here is my proposal.  Do an experiment where one half of the specialists to be examined that year complete a self study course in the relevant topics for that year.  That can be designated the experimental group.  The other half of the specialists receive no intervention other than self study on their own for whatever they think might be relevant.  Test them all on the topics selected for the self study group and then compare their test scores.   See who does better on the test.  Secondary endpoints could be developed to review the practices of each group and determine whether there are any substantial differences on secondary measures that are thought to be relevant in the tested areas.
Until this straightforward experiment is done, the current plan and policies of the ABMS are all speculative and appear to be based upon what has been called conventional wisdom.  Conventional wisdom appears to be right because all of the contrary evidence is ignored.  There is no scientific basis for conventional wisdom and it falls apart under scrutiny.  Physicians in America are currently the most overregulated workers in the world.  The rationale for these regulations is frequently based on needing to weed out the few who are incompetent, unethical, or physically or mentally unable to practice medicine.  Many regulatory authorities grapple with that task and maintaining the public safety.  In many cases it is a delicate balance.  But we are far past the point that every physician in the country should be overregulated and overtaxed based on conventional wisdom because regulatory bodies are uncomfortable about their ability to identify or discipline the few.   If the ABMS or any other medical authority wants evidence based safeguards for the public based on examination performance – it is time to run the experiment and stop running a public relations campaign to support the speculative ideas of a few.
George Dawson, MD, DFAPA    

Sunday, November 17, 2013

Neuron Perspectives in Neuroscience

Eric Kandel's thought, research, and writing have been a major source of inspiration to me ever since I read his neuroscience text and his classic article Psychotherapy and the Single Synapse in the New England Journal of Medicine nearly 34 years ago.  I was very pleased to see that he wrote the lead article in Neuron's   25th Anniversary edition entitled "The New Science of the Mind and the Future of Knowledge."  I read the article in the same spirit that I read the original NEJM article, guidance from a world class neuroscientist who was also trained as a psychiatrist.  At that level the article is quite exciting because somewhere along the line Dr. Kandel has clearly been following concepts that are far removed from the synapse and does a good job of summarizing the major points and the current deficiencies.  He also comes back to the idea that psychotherapy is a biological treatment as he proposed in the original 1979 article.

One of the most interesting aspects of the article is that Kandel does not apologize for psychoanalysis.  He is also not excessively critical.  I read an article about his residency class at Harvard and psychoanalysis was certainly prominent at the time.  Although it is fashionable these days to throw Freud under the bus, he points out that Freud and subsequent analysts were right about a number of issues that neuroscience has caught up with including:

1.  Unconscious mental processes pervade conscious thought.
2.  The importance of unconscious thought in decision making and adaptability.

The probable link here is that Freud, psychoanalysis, and current neuroscience is focused on the mind rather than descriptive psychiatry.  At some point the majority of the field got sidetracked on the issue of identifying a small number of pathological conditions by objective criteria.  The mind was completely lost in that process and those few psychiatrists who were focused on it were engaged in generating theories.  He criticizes the field for a lack of empiricism but recognizes that has changed with clinical trials of psychodynamic psychotherapy and recent interest in testing psychoanalytical theories with the available neuroscience.  He also points out that Aaron Beck was a psychoanalyst when he developed cognitive behavior therapy focused on conscious thought processes and became a leading proponent for an evidence based therapy.

It was good to see a discussion of the hard problem of consciousness.  I was on the ASSC listserv for many years until it eventually lost a home and was shut down.  Many of the experts in consciousness studies posted on that thread but there was very little neuroscience involved but plenty of discussion of the neural correlates of consciousness.

Information flow through the brain has always been one of my interests.  The idea that information flows through biological systems at both chemical and electrical levels is a relatively recent concept.  At the clinical level behavioral neurologists like Mesulam and Damasio discussed it based on cortical organization and information flow primarily at cortical levels.  I taught a course for many years that talked about the basic information flow through primary sensory cortex, association cortex and then heteromodal cortices.  The model had good explanatory power for any number of syndromes that impacted on this organizational model.  For example, achromatopsia made sense as a lesion in pure sensory cortex and posterior aphasia made sense as a lesion of heteromodal cortex.

Using this model, overall information flow from the sensory to the motor or output side could be conceptualized, but there were plenty of open boxes in the flowchart along the way.  The theory of how consciousness is generated from neural substrates was still a problem.  Social behavior was another.  Despite decades of descriptive psychiatry, the diagnostic criteria for major psychiatric disorders still depended on symptoms.  In many cases aberrant social behavior was a big problem and often a more accurate reflection of why patients were disabled, unable to work and had limited social networks.  Even though there were scales to rate positive and negative symptoms in schizophrenia, aberrant social behavior cut across a number of major psychiatric disorders.  In my first job as a community psychiatrist, we rated social behavior of the people in our community support program and it was a better predictor of disability than diagnosis or ratings of positive symptoms.  The neuroscience of social behavior remained resistant to analysis beyond the work done on cortical lesions and obvious comparisons to those syndromes.  But people with schizophrenia had no obvious frontal lesions.

Dr. Kandel points out the developments in these areas ranging from de novo point mutations affecting circuitry in the frontal cortex to mirror neurons to the neuroendocrinology and genetics of social behavior.  The review of Thomas Insel's work with voles and the extension of that work by Bargmann in C. elegans highlights the importance of specific systems in social behavior and how these systems are preserved across species.

One of the most interesting areas outlined by Dr. Kandel was the issue of art and the neuroscience of its creation and perception.  I have just posted on abstract art and was able to locate a quote from Kandinsky:

"The abstract painter derives his "stimulus" not from some part or other of nature, but from nature as a whole, from its multiplicity of manifestations which accumulate within him and led to the work of art.  This synthetic basis seeks its most appropriate form of expression which is called "nonobjective".  Abstract form is broader, freer, and richer in content than objective [form]." (Kandinsky Complete Writings on Art - p 789)

Kandel develops a narrative based on Viennese art historians and the importance of the aesthetic response to art.  That response is an emotional one based on the life experience of the viewer and the neuroscience of that response can be studied.  He looks at the inverse optics problem, facial recognition, and comes up with a flow diagram of the processes involved in viewing visual art.  I did not realize it until I read this article but he has a new book on the subject and ordered a copy to review at a future date.

Some of the conclusory remarks about neuroscience and what it means to society are the most important.  It is easy to be cynical about any scientific endeavor and it is also very easy to be political.  Neuroscience has to endure (although to a much lesser degree) than what psychiatry endures.   There are people out there commenting on neuroscience who don't seem to know much about it.  In many cases they are not scientists.  Even in the case of scientists, it is often easy to forget that the public will probably not hear the most objective and the most scientific.  They will typically hear from the experts who unambiguously support one side of the scientific argument as opposed to the other.  Kandel is cautious in his suggested applications of neuroscience to society.  He does not view it as a panacea or an explanation for behavior necessarily.  An example:

"Attributing love simply to extra blood flow in a particular part of the brain trivializes both love and the brain.  But if we could understand the various aspects of love more fully by seeing how they are manifested in the brain and how they develop over time, then our scientific insights would enrich our understanding of both the brain and love."    

Hopefully you will have time to read this paper.  I have highlighted a few more based on my reading about neuroscience over the past 20 years or so.  I will end with a paragraph on technical expertise.

When I was interviewing for residency positions 30 years ago, one of my questions that drew the strongest emotional reaction was: "Does your program have a reading list for residents?"  That question on average elicited shock or at least irritation from the average residency director.  The only exception was Johns Hopkins.  They handed me a neatly bound list of several hundred references that they considered key references that every psychiatric trainee should read.  I should have taken it as a sign and applied there, but my trajectory in life has been more random and circuitous than studied.  If I was a current residency director, I would have a list with a neuroscience section and the following articles from this volume of Neuron would be on it.  People often recoil when I talk about the technical expertise needed to be a psychiatrist.  Technical seems like too harsh a word for most psychiatrists.  Most of the media debate after all is essentially rhetorically based political discussions  I would say that if you read these articles, you can consider them to be a starting point for what you might need to know about neuroscience and psychiatry in the 21st century.

George Dawson, MD, DFAPA

A reading list for psychiatrists of the future (all available free online at the above link):

Kandel, Eric (2013) The New Science of Mind and the Future of Knowledge.  Neuron 80: 546 – 560
                             
McCarroll Steven A, Hyman Steven E (2013) Progress in the Genetics of Polygenic Brain Disorders: Significant New Challenges for Neurobiology. Neuron 80:578-587.

SĂ¼dhof Thomas C (2013) Neurotransmitter Release: The Last Millisecond in the Life of a Synaptic Vesicle. Neuron 80:675-690.

Huganir Richard L, Nicoll Roger A (2013) AMPARs and Synaptic Plasticity: The Last 25 Years. Neuron 80:704-717.

Dudai Y, Morris Richard GM (2013) Memorable Trends. Neuron 80:742-750.

Shadlen Michael N, Kiani R (2013) Decision Making as a Window on Cognition. Neuron 80:791-806

Buckner Randy L (2013) The Cerebellum and Cognitive Function: 25 Years of Insight from Anatomy and Neuroimaging. Neuron 80:807-815.


Saturday, November 16, 2013

Hyperbole and a Half blogger on NPR

It's Tuesday night and I just finished a lecture at about 7:40 and headed home.  That involves about a 45 minute drive down Minnesota Highway 8.  The last two days in Minnesota have been bitterly cold.  That first bitter cold that feels like it is 35 below, but it is really only there to steel you against 35 below.  It was actually 19 above.  The only consolation to driving down one of the most dangerous roads in Minnesota in the dark and bitter cold is that I get to listen to Terry Gross on NPR.  To make things even more interesting she was interviewing a depressed blogger with huge appeal on the internet.  She writes the popular blog Hyperbole and A Half.  

Terry Gross started out with a lot of questions about the quirky cartoon character that blogger Allie Brosh uses to represent herself on the blog.  The interview proceeds through some introductory excerpts but comes to the author's depression at about the 13:38 mark and goes for about 20 minutes.  As I am listening to her talk about depression, I am thinking of the hundreds of people I have talked with about their depressions.  I am always trying to find out if I missed anything or if there is a different way to view all of these unique presentations of depression.

Ms. Brosh's description of depression and its personal and interpersonal toll is unique among descriptions of depression I have seen in the media.  She talks about the transition from an emotional depression with excessive emotion and self loathing to a state that is totally devoid of emotion.  The "emotional deadening" in some ways is a relief and she later says that it has lead to reduced anxiety.   She has thought of herself as too emotional and thought it was interesting that she no longer had that weakness.  She blogs about it as Adventures in Depression and Depression Part Two and we have already learned that these were very popular posts on her blog.

In one example, she describes an interaction with a friend telling her that her cat has died and she states she is not able to generate enough "organic emotion" that she needs to be concerned about showing an appropriate facial expression to her friend.  Her concern is that she is doomed to live an emotionless state and that rapidly equates to meaninglessness and eventual suicidal thinking.  She talks about needing to manage this information to protect people and also protect herself from their emotional reaction.  She is eventually able to tell her husband and mother, but even during this interview she discloses that her husband may have heard details of her plan that he had never heard before.  This disclosure is clearly painful and she pauses - overcome with emotion.

The emotion in the interview is familiar to me.  It is how people really describe severe depressions.  They don't recite symptoms in a diagnostic manual, they talk about what the depression means to them and how it affects them and their relationships.  They talk about how it affects their inner life.  They talk about what seems to help and what strategies are useful and not useful.  In the moment, it can be painful to be around a person with depression.  Any empathic person resonates with the emotion in this interview.  At one point Terry Gross apologizes for putting her through it.  Things are tense.

Ms. Brosh talks about the type of interpersonal interaction that was most useful.  She cautions against advice giving like "try yoga" or be thankful for everything that you have and you will come out of your depression.  What was helpful was somebody taking her seriously and listening to her experience especially her thoughts about suicide.  As you listen to the interview she is clearly changed by the depression and has adapted to it.  Her main deterrent to suicide was the impact it would have on the people she loved, but we also hear how tenuous that connection can be during severe depression.  We learn that one of the thoughts that would keep her going if she got depressed again would be the idea that she knows she will come out the other side.  Terry Gross asks her about treatment and whether "any kind of therapy or medication that alleviates some of it?"  She clarifies that she is about 60% recovered.  Despite some initial concerns about medication she found that it (bupropion) was "very helpful".

I found this to be a powerful piece  about depression.  It describes the feeling and thinking state of the depressed person and the associated problems with relatedness.  At one point Terry Gross comments on the artistic aspects of creativity that flows from the depression and Ms. Brosh appreciates than comment.  With all of the abstract discussion of depression in the popular press and the assembly line treatment approach in health care systems, this interview is a more genuine discussion and rich source of information about what it is really like for the person and the struggle to recover.  I highly recommend listening to the audio file and reading the blog.

George Dawson, MD, DFAPA

Sunday, November 10, 2013

The New York Times Editorial Board on Parity

The New York Times Editorial Board came out with a comment on mental health parity entitled Equal Coverage for the Mentally Ill.  Like most sources with no knowledge of how mental health treatment works in this country - their outlook was very rosy.  I am  sure that is what the authors of the original bill - the late Senator Paul Wellstone and Senator Pete Domenici were hoping for.  Let me tell you why that is not going to happen.  As I followed the link to who is actually on the Editorial Board it is probably significant that there is nobody with health care expertise.  Even if there was the national press has a naive approach to health care and seems to present a distinctly politicized and business friendly viewpoint.  I would generally characterize that as a view that is very short on quality and long on cost effectiveness rhetoric.  The press seems to uncritically accept that "high quality cost effective" health care is the goal of businesses and governments.  Nothing could be farther from the truth.

The actual Rule that was published yesterday is a 205 page document.  It is written in a style that defies comprehension by anyone who is not a Congressional insider or an attorney.  Despite being highly acclaimed by a number of organizations including the American Psychiatric Association (APA) there is a surprising lack of details in why this is some sort of advance.  I go into this with thirty years of experience battling managed care in its various forms and needless to say I am no friend to that approach.  I know that the real goal is for managed care companies to make money and they make money by denying care and providing low quality care.  I also know that governments at all levels are very friendly to the managed care cartel and have bought their theology.  Practically all health care legislation is managed care friendly and the PPACA (Obamacare) facilitates super managed care organizations called Accountable Care Organizations.  With that backdrop and realizing that like most other people, I lack the legal qualifications to read this document, here are a few of my impressions:

1.  Medical necessity - there are 44 references to medical necessity in the document.  There is some concern about transparency.  It is quite easy for a managed care company to tell a person or their physician, pharmacy, or hospital that they are not covering a service because it is not "medically necessary."  This generally means that the company can employ doctors who can arbitrarily deny services.  In Minnesota in the 1990s, several psychiatrists were concerned that these companies were discharging people from hospitals prematurely and they insisted on seeing the actual criteria for these decisions.  They were advised that they were "proprietary" and not available.  The new Rule seems to demand adequate disclosure of these criteria.  Even if it did, the disclosure of this information is irrelevant.  In fact, there are criteria in use right now that are essentially made up on financial information and they have nothing to do with psychiatric treatment.  Unless there is an actual appeal process to a neutral party who has the power to overturn these decisions, managed care companies will continue to do whatever they want.

2.  Utilization review - there is one reference to utilization review (UR), a managed care tactic that is basically designed to harass physicians into discharging patients from a hospital based on the financial demands of the managed care company.  An example would be serial calls to a physician treating a patient with suicidal ideation.  The attending physician who sees the patient every day is concerned that the patient has a significant suicide risk and wants to continue to treat them on an inpatient basis.  The reviewer who is an employee of the managed care company, is sitting in a room several states away, and has never seen the patient and has no professional responsibility to them decides the patient is not at high risk and that they should be discharged from the hospital.  This leads to a series of unproductive conversations and forces the physician working with the patient to call him every day to justify keeping the patient in the hospital.  In many ways dealing with this process is like dealing with a bill collector.  The only difference is that you are paying a penalty for doing  your work and being responsible to a patient.

The rule seems to suggest that the amount of UR done is not a problem as long as it is equally applied across both mental health and general medical surgical services.  There are major problems with that idea.  The first is a decade long initiative by the managed care industry to internalize utilization review by case managers.  They claim these case managers are part of some kind of imaginary patient care team.   In fact they are there applying business standards to force physicians to discharge patients.  The second problem is that UR is completely unnecessary.  Managed care companies have huge financial leverage.  They reimburse a set amount per admission/discharge diagnosis that is a discounted rate.  The only conceivable uses for UR today are to pressure inpatient physicians and to create an incentive through internal UR to increase profits by managing discounted rates.  That happens when a hospital receives a fixed payment for what is probably a 5 day hospitalization and they now have UR by case managers to get physicians to discharge these patients in 3 days instead of 5.  There is no major psychiatric condition requiring hospitalization that  responds to three days of treatment.

3.  Small employer exemption - the Mental Health Parity And Addiction Equity Act (MHPAEA) does not apply to small employers:

 "MHPAEA and the regulations under it do not apply to employers with 50 or fewer employees (although, separately, the EHB regulations adopt MHPAEA)."   

According to the Census that eliminates about 34 million people or about the same number of uninsured that the PPACA purports to cover for the first time.  It also defeats the concept of parity.  But it turns out there are a lot of exceptions.  So who knows the total number of people who will be not even be covered:

"MHPAEA requirements do not apply to:
  • Non-Federal governmental plans that have 100 or fewer  employees;
  • Small private employers who have 50 or fewer employees;
  • Large group health plans that are exempt from MHPAEA based on their increased cost.  Large group health plan sponsors that make changes to comply with MHPAEA and incur an increased cost of at least two percent in the first year that MHPAEA applies to the plan (the first plan year beginning after October 3, 2009) or at least one percent in any subsequent plan year (generally, plan years beginning after October 3, 2010) may apply for an exemption from MHPAEA based on their increased cost. If such a cost is incurred, the plan is exempt from MHPAEA requirements for the plan year following the year the cost was incurred. Subsequently, the plan sponsors must notify the plan beneficiaries that MHPAEA does not apply to their coverage.  These exemptions last one year. After that, the plan is required to comply again; however, if the plan incurs an increased cost of at least one percent in that plan year, the plan could claim the exemption for the following plan year. The following set of FAQ’s provide additional information related to the application of MHPAEA. In particular, see Q. 11 for a discussion of the processes by which plans may claim a cost exemptionhttp://cms.gov/cciio/resources/factsheets/aca_implementation_faqs5.html); and
  • Self-funded non-Federal governmental employers that opt-out of the requirements of MHPAEA.  Non-Federal governmental employers that provide self-funded group health plan coverage to their employees (coverage that is not provided through an insurer) may elect to exempt their plan (opt-out) from the requirements of MHPAEA by following the Procedures & Requirements for HIPAA Exemption Election posted on the Self-Funded Non-Federal Governmental Plans webpage (Seehttp://cms.gov/cciio/resources/files/hipaa_exemption_election_instructions_04072011.html), then issuing a notice of opt-out to enrollees at the time of enrollment and on an annual basis. Thereafter, the employer must also file the opt-out notification with CMS"

4.  This bill will have no impact on gun violence.  You can't assess and treat potentially violent and aggressive people in a rationed, low quality system of care that is run by case managers bent on getting people out of the hospital.  There are many better suggestions on this blog but they require a system of quality care and professionalism.

5.  The bill will not save any money.  It should be painfully apparent that delegating the management of health care in the United States to a profit motivated middleman is a recipe for health care inflation.  That point is routinely lost on politicians and journalists.  The other point that these folks never seem to get is that managed care companies have in many cases acquired the means of production that they had sought to control.  This creates an additional conflict of interest.  If you now own all of the MRI scanners, you have an interest in seeing them run 24/7 especially when they might be covering a significant part of your hospital costs.  That might explain what an MRI of the C-spine is $1,500 in the US and $150 in Japan.

6.  The rule is doomed if the Editorial Board is serious about it depending on enforcement by state insurance commissioners.  The members of the Board must not have ever filed a complaint with a state insurance commission.  In many states it is difficult to find the state agency responsible for taking complaints against managed care companies.  Unlike Medical Boards, insurance complaints are often a well kept secret.  There are often pro-insurance and pro-managed care statutes in state law and industry insiders on the commission.  In my experience, the only hope state residents have against the managed care industry is an activist Attorney General.  Activist AGs happen about once a decade.    

These are all huge deficiencies in a Rule that is supposed to assure parity between mental health and substance use disorders and general medical surgical treatment.  Combined with pressure for collaborative care in primary care clinics, it is very easy to imagine that this Rule will not make any difference at all.  That is my preliminary take on the Rule with my previously stated qualifiers.

I fully expect a business friendly government to continue to be an obstacle to the provision of quality mental health and addiction services largely due to the conflict of interest it creates when it uses private businesses to make money by denying care at several levels.  But the New York Times won't be telling you that.

George Dawson, MD, DFAPA

Final Rule on Mental Health Parity.  Federal Register.  November 13, 2013.

Saturday, November 9, 2013

Abstract Art

When I was a kid in a small town we had the same art teacher for the first eight years.  There were five elementary schools and Mr. Cooper would travel to all five schools and try to teach us art.  I just recently learned that he also taught art in the same way in elementary schools in the surrounding small towns.  When I went to junior high school I was surprised to see him in the 7th and 8th grade teaching in an old art deco building on the high school campus (my high school was grades 7-12).

The format in his classes was generally the same.  He would spend the first 10-15 minutes talking about art - usually a specific artist or groups of artists, or a technique.  A couple of times a year he would bring in a large orthographic projector that would allow him to project pictures from art books onto a movie screen.   He would typically turn us loose for the last 45 minutes using a specific technique.  During that time he would walk around and make comments on what we were doing and make suggestions on how to improve our art.  Mr. Cooper was very serious and talked with us in a serious manner even though we were kids.  He was serious about art.

The most memorable sessions for me involved finger painting.  That day we would all get a blank piece of white paper.  Mr. Cooper would walk around and place a dollop of thinned wheat paste onto the paper and tell us to spread it around.  He would them come around and place red, blue, green, and yellow powdered paint on the corners of the paper - several tablespoons of each.  For a class of 20-30 kids it takes a while to set all of that up.  Before he could get back up in front of the class, 90% of the kids were already smearing the paint around and 98% of them had smeared it all together.  The standard mix resulted in a lavender clay colored product.  When that happens you are limited to geometry - whatever lines or shapes you could put into the surface.  The few people who keep their colors separate - had many options based on the primary color options and combinations of those colors.  I have never thought about it before but this is a science intersection of sorts - more degrees of freedom or combinations from the basic step of not mixing all of your paint together.

I was one of the people who never mixed the colors together.  I liked the boundaries between bright colors and the areas of pure bright colors.  I liked the non geometric shapes stretched across the paper through numerous color zones.  There was something very satisfying about creating a painting from this simple technique.  At the same time, we were presented with art work by the masters.  We saw plenty of meticulous realistic art from the masters of several eras.  Even then it seemed like many had an abstract quality.  I can remember liking Edward Hopper's work at first sight.  This Andrew Wyeth image had the same effect.  Over the past 40 years, I have studied art where I could find it but I always gravitate to the abstract.  If I have a choice it is typically color field artists like Hans Hoffman, but any abstract artist will do.  I used to tell myself that I would start painting again in my spare time, but practicing medicine these days is not conducive to spare time or doing anything creative during it.  My wife and I do have time to appreciate local abstract artists and purchase some of our favorite pieces like the work of Steve Capiz below (click to enlarge):

    
The artist in this case has been painting abstracts for 50 years and he is still going strong.  He is currently painting very large canvasses on the order of 6-10 feet high and wide.  The last time I was in his gallery there were probably 40 - 50 paintings on sale and I honed in on exactly two of them including the one above.  If you walk into my house you will find the above 36" x 36" painting to the right of the entrance and as you look across the room to the left there is a 48" x 48" abstract above a fireplace in your line of sight.  If you look down the stairwell there is a large print - Morris Louis #2703.  There are four other paintings by Steve Capiz throughout the house.



The reaction to abstract art is always interesting.  When I post some of the art on my Facebook page, friends often comment on what the painting looks like.  It seems like a projective test.  My wife takes the interior design approach.  The colors of the painting need to "pull together" the colors in the room.  Our painter wears a T-shirt that says: "Don't buy art to match the furniture."  He encourages my wife to listen to me when it comes to abstract art.  But I am really not aware of why I love abstract art and why I can discriminate enough to select 2/50 paintings from my favorite artist.  Did it have something to do with my fingerpainting experience?  Or is my brain set up to fingerpaint in a certain way and be attracted to abstract art?  My life experience has certainly been broadened by art.  I have no idea how it has affected my thinking.  Some of those details are known for musical performance.  Learning to play the cello and clarinet has probably led to some enduring changes in my brain plasticity.

Experiments aside - I am glad I met Mr. Cooper when I was a kid.  It has been my experience that you never know enough at the time to optimize your experience with good teachers.  That is as true for art as it was for neuroanatomy.

George Dawson, MD, DFAPA

Monday, November 4, 2013

Accountability - The Last Refuge of a Scoundrel

On April 7, 1775, Samuel Johnson said:  "Patriotism is the last refuge of a scoundrel."  His biographer had to clarify that Dr. Johnson was not talking about love of country but "pretend patriotism which so many have made a cloak for self interest".  We see the rhetorical application in American elections where politicians spend more time on discussions of their military records rather than issues relevant to any kind of plan that they have for the nation or solving any real problems.  Nunberg makes the observation that that the term can also mean an irrational bias favoring one's country and that Americans have applied the term indiscriminately at times. He also points out that it can be a word designed to put people on the defensive.  

If I had to pick a word in the medical field that has similar uses - it would be "accountability".  There has probably been no single word more responsible for facilitating managed care and recent government intrusions into the practice of medicine.  If you think about the premise of physicians being "accountable" to politicians and businesses - it is absurd on the face of it.  Taking a professional who has been trained to be accountable to an individual patient and who operates in a professional environment that specifies behavior toward that person and telling them that they are now going to be monitored by businesses with a goal of maximizing profits or politicians with numerous conflicts of interest and a clear interest in getting re-elected - is an ongoing disaster.  So  how has it happened?  I would suggest that most of it has to do with rhetoric.

Before I point out the medical applications of the accountability rhetoric let me say that I don't consider this to be specifically applied to medicine.  Accountability rhetoric is broadly applied by any person or group seeking some kind of political advantage.  An obvious example is education and teaching.  Politicians everywhere get a lot of mileage out of the idea that they are going to hold teachers accountable usually through standardized test scores.  It has become a pat answer to taxpayers concerns about the money being spent on education and low graduation rates.  In some states, the test scores are marched out every year and used to rank schools and teachers.  Never mind the fact that the school system that produces the top international performance scores does not work that way.  In Finland, a professional teaching culture is by far and away the most significant factor in their academic excellence.  In the book written about this the teachers say they would not tolerate the kinds of intrusions that are common in the United States.  These intrusions are all based on accountability rhetoric.  

In preparing for this post, I searched my e-mails from the past three years and found 1800 e-mails containing the word accountability.  Most of those hits were due to the Health Insurance Portability and Accountability Act (HIPAA).  If you read the long title of this act it was clearly doomed out of the box.  The major impetus for the PPACA (Obamacare) was health insurance portability suggesting that HIPPA was already a failure.  That did not deter legislators from including a Privacy Rule under HIPAA to supposedly crack down on privacy violations.  My read of the bill is that is actually broadens the use of anyone's medical information among all "covered entities" affiliated with your health plan.  In the meantime,  the Privacy Rule was so threatening that it almost immediately made it more difficult for the doctors doing the work to get access to data.  Was it necessary for physicians?  Absolutely not - physicians are trained in medical privacy and all broad breaches of medical privacy have been due to either hacking or business people losing computers with significant amounts of data.  Make no mistake about it - politicians will be there to make the most accountable people accountable and greatly decrease their efficiency.   A great example of the title of this post.

I have recently posted a number of examples of accountability rhetoric being used for political leverage against physicians.   It can be used by medical boards, advocacy organizations, state agencies, federal agencies, and specialty boards in addition to politicians.  I am going to focus on a single example and that is Medicare.  All of the information that follows is public and can be accessed through the Medicare link on the American Psychiatric Association's web site.  I picked it up on my Facebook feed but it disappeared and I had to call APA staff to figure out where it went.  I am very familiar with the history of Medicare quality initiatives because I was one of their quality reviewers for inpatient hospitalizations in Minnesota and Wisconsin in the late 1980s and 1990s.  If you look for inpatient psychiatry measures you will find that many of them (polypharmacy, multiple drugs from the same class, discharge planning) are unchanged from that era, despite the fact that the review organization was disbanded because it did not find enough quality or utilization problems to justify its ongoing existence.

The APA points out that Medicare now has a fee scale that takes into account "quality of care measures instead of just paying a standard fee for every procedure (CPT) code".  They have a Physician Quality Reporting System (PQRS) that requires psychiatrists to report on one measure in order to avoid a 1.5% penalty.  For 2013 that report has to be made on one Medicare patient.  This is described as an "incentive" to report on quality performance measures and of course a "penalty" for those who fail to report.   A managed care company would call it a "holdback" in that it is technically work that has been done, but the no cost way to turn it into an "incentive" is just to take it from the people doing the work and make it seem like they are rewarded with it later.

The document goes on to document "measures identified as pertinent to psychiatrists (along with their designated codes)".  If you are a psychiatrist read through these reporting measures and marvel at the morass of initial codes that I am sure are going to grow as this administrative nightmare continues.  The further problem is that Medicare/CMS clearly has the goal of comparing physicians and holding them accountable based on the fantasy that these measures actually mean something in clinical practice or even the world.  And if this list of measures is not enough, there are also 50+ page guidelines online like: "The American Medical Association-convened Physician Consortium for Performance Improvement - Adult Major Depressive Disorder Performance Measurement Set" that describes an additional set of performance measures.  The AMA is involved and if you click the link 2013 PQRS Quality Measures you can search on Major Depressive Disorder and find the following links.  You can download the 50+ page document from the top link.

Most people realize that physicians currently have some of the highest burnout rates of any group of professionals.  Those burnout rates are directly related to micromanagement even before we get to the level I just described in the above paragraphs.  The paradox that every physician is aware of is that these reportable measures are not valid objective markers and they are being promoted by bureaucrats who not only have no accountability but in the case of the mental health system of care are some of the same people who destroyed it in the first place.  Don't forget that Congress skewed insurance coverage of mental illness and addictions so badly that Senators Wellstone and Domenici had to write legislation in an attempt to correct that.  At this time the final form of their legislation is still pending.

So accountability has become the last refuge of scoundrels.  Be very skeptical of any politician or bureaucrat waving that flag.  It has little to do with reality and more to do with promoting their own self interests while creating a tremendous and unnecessary burden for the doctors they regulate.

George Dawson, MD, DFAPA

Nunberg G.  Going Nucular: language, politics, and culture in confrontational times.  Cambridge: MA Perseus Books Group, 2004.

For a complete analysis of political doublespeak as applied to medicine see:

Robert W. Geist:  Hot Air IndexPolitical/Commercial Double-speak Lexicon for Medicine