Welcome!

Welcome to my blog, a place to explore and learn about the experience of running a psychiatric practice. I post about things that I find useful to know or think about. So, enjoy, and let me know what you think.


Tuesday, October 18, 2016

Finally! Building a Website-The Website

I know, I know, I started writing about building my practice website months ago, and I've completely dropped the ball. But only the blog ball. I've actually been working very hard on my own website, as well as that of my analytic institute, and on other tech-y advances we're adopting. More on that later.

For now, I have finally chosen SquareSpace as my site host, and I'm diligently shoveling away at everything I need to do to get the site up and running.

Why SquareSpace? I know that in my last post on this matter, it looked like I was going to go with Duda. Since then, I've traveled further along the convoluted paths of website-building research, and one of the things I discovered is that SquareSpace is a solid company in many ways, including staying power. I really wasn't sure I could say that about Duda-that a couple years from now, they'll still be around.

In the end, it was a competition between Squarespace, and a hosted site using Wordpress. I'll tell you a little bit about that.

I like Instagram. My interests fall into a few main categories: dogs, crochet/yarn, design, food, and museums. They have targeted ads, which I sometimes look at. One day, an ad came up for SkillShare, where you can take mini-courses taught by whoever. Some are free. Some require a premium subscription. I found a premium class called, Mastering Wordpress: Build the Ultimate Professional Website. So I paid the 99 cent three month trial fee, and started taking the class. It was pretty bad. It was boring, and the guy was describing how to make his EXACT site. But it did make it clear to me that I could do this.

Then I found another course, How to Properly Make a Website with Wordpress-Beginner's Tutorial. This one was helpful. You can check it out on SkillShare, but the guy has his own site called, Websites Made Easy.

Basically, you use HostGator.com to host your site. You can also buy a domain name through them.

To review briefly, the domain name is the name of your site, i.e. its address, like alfredeneumanmd.com. (I actually got a .org domain name). The hosting site is where your site "lives" online. Hosting sites usually have several pricing plans that vary by what's offered.

Once you buy your domain name and pick your hosting plan, you hook up Wordpress to it, and you build your Wordpress site.  Wordpress has a ton of plugins, which are little extra functions that someone else wrote the code for, and which do great things for your site.

I didn't go this route because I actually tried to go this route, and something happened with the billing, and then it somehow got canceled. The problem wasn't on my end, so I started reading reviews of HostGator, and apparently they used to be pretty good, but not so much anymore. So I gave up on it.

It's also not clear to me why this is a better way to go than simply hosting your site through Wordpress.

But here's what it came down to with SquareSpace. It's a one-stop shop. You can buy a domain name through them, and host on their site, and use their software to build your site.

The domain name has an annual fee (no matter where you get it), and SquareSpace charges $20/year, which is more than many of the other hosting sites. But they lock you in at your initial rate. Other sites don't tell you what they'll charge after the first year.

SquareSpace also doesn't give you a hard time about transferring your domain name, if you decide you don't want them to host anymore, as long as you've had your site for at least two months. According to reviews, other hosting sites do give you a hard time. I think it's indicative of SquareSpace's trust that you'll like their product, and want to continue with them.

The pricing is middle of the road. I got the "personal" plan, as opposed to the business plan. It boasts:


and costs $16/month, or $12/month if I pay annually. It includes Domain Privacy, which removes your personal contact information from the public WhoIs internet record of your domain name, which can be crawled by spam marketers for your email address.

The business plan has a few more items that I don't need right now. But you can switch between plans whenever you like. They also require  a 14 day free trial, so you're sure SquareSpace is what you want.

The design software took a little getting used to, but it's powerful, and really quite beautiful. They have excellent online tutorials, and lots of them.

In case you're interested, I chose the Keene template:



I changed the font and ditched the toothbrush, and I really like it. It's clean, uncluttered, and attractive.

The new font looks like this:



Finally, SquareSpace has exceptional customer service, which I came to realize is very important when you're DIY'ing your own site. Every review I read about SquareSpace was impressed by the customer service. I've already made use of it, and the turnaround time was faster than I expected, and they were genuinely helpful.

Next up, the ACTUAL building of the site, or, "How do I introduce myself to the world and describe what I do? What DO I do? Why do I do it that way?" I never realized how philosophical building a website can be.




Sunday, October 2, 2016

Rosh Hashanah 5777

Tonight is the start of the year 5777, on the Jewish calendar. Regardless of when you mark the beginning of the year, whether it's tonight, or January 1st, or some other day, the new year is a time for reflection on the past, and hope for the future. May it be a year of happiness, health, and peace.



(It's traditional to celebrate Rosh Hashanah by eating an apple dipped in honey, to symbolize a sweet new year). 

Saturday, October 1, 2016

There IS Something You Can Do



On September 16th, The Department of Health and Human Services (HHS) released a final regulation about clinical trials submitted to the FDA, and the National Institute of Health (NIH)issued a new policy regarding the same subject. These are the basics:


The HHS regulation, also called the "Final Rule", states that a responsible party, such as a pharmaceutical company submitting a phase 2, 3, or 4 clinical trial for review by the FDA, with the purpose of getting a new drug approved, or a new indication for an existing drug, must register the trial at clinicaltrials.gov within 21 days of enrolling the first participant. Registration involves providing, "1) descriptive information, 2) recruitment information, 3) location and contact information, and 4) administrative information."

In addition, "The Final Rule requires a responsible party to submit summary results information to ClinicalTrials.gov for any applicable clinical trial that is required to be registered, regardless of whether the drug, biological, or device products under study have been approved, licensed, or cleared for marketing by the FDA."

The, "...results information must be submitted no later than one year after...the date that the final subject was examined or received an intervention for the purpose of collecting the data for the primary outcome measure. Results information submission may be delayed for as long as two additional years...," for a few complicated reasons we won't get into here.

Results need to include, "1) participant flow information, 2) demographics and baseline characteristics of the enrolled participants, 3) primary and secondary outcomes, including results of any scientifically appropriate statistical tests, and 4) adverse events."

Importantly, "The Final Rule also adds a requirement to submit the clinical trial protocol and statistical analysis plan at the time of results information submission."

Information needs to be updated on clinicaltrials.gov at least once a year. And any errors, deficiencies, or inconsistencies that the NIH (which runs clinicaltrials.gov) identifies need to be addressed by the responsible party.

That's the HHS final rule. Trials need to be registered on clinicaltrials.gov, information needs to be kept relatively current, and results have to be posted.

The NIH policy broadens the scope of which trials they consider subject to these requirements.

These are good things for trial transparency and honesty. We'll get to the catches in a bit.

Let me backtrack and try to explain why I'm writing about this. Currently, pharmaceutical companies submit drug trials to the FDA, to get approval. They're supposed to register these trials on clincialtrials.gov, but they often don't, it's not policed, and the data they do submit isn't checked. Note that clincialtrials.gov is run by the NIH, not the FDA, so there's a built in disconnect right from the start.

While a study is being reviewed by the FDA, the pharmaceutical company can publish anything they want about that study in peer reviewed journals. They can do this even if the drug ends up not being approved. They often mis-report data and results. And there is no way of knowing if they are staying true to their original study protocol, or if they're messing around with the stats in ways that benefit them. The journals have no way of knowing what's true and what isn't. The whole "peer review" part is also a sham, because the "peers" are given whatever information the pharmaceutical company feels like giving them.

And the FDA does nothing to prevent any of this from happening.

This is not me being paranoid. Here's an article that describes a disturbing example:

The citalopram CIT-MD-18 pediatric
depression trial: Deconstruction of medical
ghostwriting, data mischaracterisation and
academic malfeasance

 Jureidini, et al.

Abstract.
OBJECTIVE: Deconstruction of a ghostwritten report of a randomized, double-blind, placebo-controlled efficacy and safety trial of citalopram in depressed children and adolescents conducted in the United States.
METHODS: Approximately 750 documents from the Celexa and Lexapro Marketing and Sales Practices Litigation: Master Docket 09-MD-2067-(NMG) were deconstructed.
RESULTS: The published article contained efficacy and safety data inconsistent with the protocol criteria. Procedural deviations went unreported imparting statistical significance to the primary outcome, and an implausible effect size was claimed; positive post hoc measures were introduced and negative secondary outcomes were not reported; and adverse events were misleadingly analysed. Manuscript drafts were prepared by company employees and outside ghostwriters with academic
researchers solicited as ‘authors’.
CONCLUSION: Deconstruction of court documents revealed that protocol-specified outcome measures showed no statistically significant difference between citalopram and placebo. However, the published article concluded that citalopram wassafe and significantly more efficacious than placebo for children and adolescents, with possible adverse effects on patient safety.

International Journal of Risk & Safety in Medicine 28 (2016) 33–43
DOI 10.3233/JRS-160671


And this is the abstract from the original article, for comparison:

A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents.

Wagner KD1, Robb AS, Findling RL, Jin J, Gutierrez MM, Heydorn WE.

Abstract
OBJECTIVE:
Open-label trials with the selective serotonin reuptake inhibitor citalopram suggest that this agent is effective and safe for the treatment of depressive symptoms in children and adolescents. The current study investigated the efficacy and safety of citalopram compared with placebo in the treatment of pediatric patients with major depression.
METHOD:
An 8-week, randomized, double-blind, placebo-controlled study compared the safety and efficacy of citalopram with placebo in the treatment of children (ages 7-11) and adolescents (ages 12-17) with major depressive disorder. Diagnosis was established with the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version. Patients (N=174) were treated initially with placebo or 20 mg/day of citalopram, with an option to increase the dose to 40 mg/day at week 4 if clinically indicated. The primary outcome measure was score on the Children's Depression Rating Scale-Revised; the response criterion was defined as a score of < or =28.
RESULTS:
The overall mean citalopram dose was approximately 24 mg/day. Mean Children's Depression Rating Scale-Revised scores decreased significantly more from baseline in the citalopram treatment group than in the placebo treatment group, beginning at week 1 and continuing at every observation point to the end of the study (effect size=2.9). The difference in response rate at week 8 between placebo (24%) and citalopram (36%) also was statistically significant. Citalopram treatment was well tolerated. Rates of discontinuation due to adverse events were comparable in the placebo and citalopram groups (5.9% versus 5.6%, respectively). Rhinitis, nausea, and abdominal pain were the only adverse events to occur with a frequency exceeding 10% in either treatment group.
CONCLUSIONS:
In this population of children and adolescents, treatment with citalopram reduced depressive symptoms to a significantly greater extent than placebo treatment and was well tolerated.

Am J Psych. 2004;161(6):1079-83

In the end, the FDA did not approve citalopram for use in children. But the study has been cited over 160 times, putting it in the top 5% of cited articles in medicine from 2004. Between 2005 and 2010, nearly 160,000 children under age 12 received escitalopram, despite the FDA's lack of approval.  (There was a switch at some point from off-patent citalopram to on-patent escitalopram, in this time period.) It's hard not to conclude that the published study had impact on prescribing practices.

There's a much fuller description of this here, by Bernard Carroll. And a lot more about this whole topic on 1BoringOldMan.com.

Getting back to the Final Rule, there are some problematic loopholes. There are allowances for delays in reporting. There is also the crazy idea that the study protocol doesn't have to be reported until the results are submitted. This leaves room for dinking around with the protocol, changing outcome measures after the trial has started, etc.

Here's what you can do. Take a look at this petition, and if you're on board, sign it. It's entitled, "Stop False Reporting of Drug Benefits & Harms by Making FDA & NIH Work Together". The main point is this:

We now petition Congress to require the FDA and NIH to coordinate their monitoring and sharing of key information through ClinicalTrials.gov. Working together, the two agencies could enable stakeholders to verify whether purported scientific claims are faithful to the a priori protocols and plans of analysis originally registered with the FDA. Publication of analyses for which such fidelity cannot be verified shall be prohibited unless the deviations are positively identified (as in openly declared unplanned, secondary analyses). This prohibition shall include scientific claims for on-label or off-label uses made in medical journals, archival conference abstracts, continuing education materials, brochures distributed by sales representatives, direct-to-consumer advertising, and press releases issued by companies or their academic partners. It shall extend to FDA Phase 2, Phase 3, and Phase 4 clinical trials. By acting on this petition, Congress will create a mechanism for stakeholders independently to verify whether inferences about clinical use suggested by the unregulated corporate statistical analyses can be trusted.

Please think about it. Thanks.

Friday, September 30, 2016

PA Victory?

I know everyone has problems with prior authorizations. The Byzantine bureaucracy and obscure explanations for denials are maddening.

I'm suddenly reminded of the DMV scene in Zootopia, except I think insurance companies do it on purpose.






Today I had a minor and unexpected victory, and I think I might know why it worked, so I thought I'd share it.

Unfortunately, I have to mask any clinical information, so you'll have to take my word on a number of points. Some things may sound peculiar or not-thought-out, but like most cross-sectional views of a patient's medication regimen, if you knew the full history, it would make sense.

Here's what happened. I needed to get a PA for a new medication, M. The patient had had trials of multiple cheaper covered medications, and had either failed them, or had been unable to tolerate them. The insurance company's criteria seemed to be having failed a 4 week trial of, or been unable to tolerate, two medications.

A number of months ago, I had tried to get a PA for a new med for this patient, and the application was rejected, despite the fact that the criteria were obviously met. I didn't have the energy to pursue it then, and there were one or two more covered meds left to try.

The difference now seems to be that I've since had a Genesight test done on this patient. As I've described in the past, I have my doubts about the whole genetic testing business, but I used the test results as documentation to support my rationale. M was in the "Green Column", and the other meds in that column had already been tried.

It worked! Who knew? I'm only guessing that that's the reason, but I can't think of any other difference. Same patient, same insurance company.

It wasn't a pure victory, though. This medication has a starter pack that's used to titrate gently. THAT wasn't approved. And using a single dose form, starting lower, and then increasing the number of pills per day, well, that wasn't covered, either, because it involved too many pills. What I needed to do was skip the recommended titration, and go straight to the next dose up. Not dangerous, but possibly hard to tolerate.

To me, it feels like a punishment for asking the insurance company to cover the medication.

I guess with insurance companies, you take what you can get.





Tuesday, September 27, 2016

ICD-10 Changes

I know it's been forever. I have actually been super busy. I still am, but since this is timely and important, I thought I'd post something.

There are ICD-10 changes that go into effect on October 1st. These are intended to correspond to recent changes in DSM-5. I suppose it should now be called DSM-5.1.

These are the changes:



I hope this is helpful.

Friday, August 5, 2016

Laziness






I'm very curious about the idea of laziness. "Lazy" is one of those words we throw around as though everyone understands what it means and agrees on its definition. Kind of like, "Love". But I don't think anyone honestly knows what lazy means. I'm not sure it even has a meaning. I think what is really meant by, "He's so lazy," is, "I don't understand why he's not doing the things I think he should be motivated to do, or that I would be doing in his position."

I'm hard pressed to think of an instance in which the word lazy is used in a non-pejorative way. At least in reference to a person or an animal. Rivers and summer days are exempt from this criticism.

I searched Pep-Web to see if the concept is addressed in the analytic literature, and there were a lot of hits for "laziness" (343) and "lazy" (806), but none in a title, and while I didn't go through every one, the ones I did look at all seemed to be either quoting someone speaking about himself or someone else, or describing someone, and all with the assumption that no elaboration was needed as to what was meant by "laziness" or "lazy".

I'll share a multilayered thought I just had. I generally make an effort to write correctly, which means that there's a comma before quotes, and the first word of a quote is capitalized, and the ending punctuation is within the quotes, even though that's weird. Or, "That's weird." Not, "that's weird". But it's not always clear to me what to do when I'm referring to an individual term. Do I place a comma before, "Lazy?" Do I always need to put quotes around, "Lazy?" Do I capitalize , "Lazy," if I use it over and over again? Do I place the punctuation within the quotes if it's just a word I'm defining, like, "Lazy"?

I assume I should do the same thing with "lazy" that I do with longer quotes, but I don't always do so. And my thought was, I'm just too lazy to bother.

Then I thought about Frank McCourt in Angela's Ashes, where he doesn't bother to use quotes, but he manages to write in such a way that you're never confused about who's saying what. Presumably, he's mimicking Joyce. So who cares whether I get the punctuation right or not? The whole purpose of punctuation is to make yourself understood, and if readers know what I mean, what difference does it make?

I'm impressed by how easily I fell into using the catchall term, "Lazy," to explain why I don't always punctuate correctly. But I'll get back to this.

I Googled, "What is Laziness?" and after the definition: the quality of being unwilling to work or use energy; idleness, I linked to an article by Neel Burton, MD, in Psychology Today, The Causes of Laziness.

It's not a bad article, but the explanations are a bit simplistic: We haven't evolved enough past our ancestral need to conserve energy and to assume life will be short so why plan for the future; We prefer immediate gratification to long-term goals; We can't see the purpose of our work; We're afraid of success; We're afraid of failure so we don't try.

Now back to my previous point. I don't think anyone knows much about why she does what she does. Even less about why someone else does what he does. You can get at some unconscious content in analysis, but there will always be mysterious actions and thoughts.

What I do notice is that when I have to make a decision about how to punctuate, it causes a slight twinge of anxiety. Am I doing this right? Is my meaning clear if I don't do it right? Why do I care? Do I care?

Clearly, I do.

I'm reminded of Otto Fenichel's paper, On the Psychology of Boredom. Fenichel describes a particular kind of boredom, a sort of ennui, in which the bored person can never settle into any particular activity. Fenichel's understanding of this is that it reflects a warded off, unacceptable wish. So the bored person wants something, but is unable to allow himself to know what it is he wants, because he's conflicted about it, and it makes him anxious. So instead, he searches for something to satisfy the wish, but of course, nothing does, because he doesn't consciously know what he's wishing for.

Laziness is not directly related to boredom, though obviously it can be, in some instances. The common thread here is anxiety generated by unconscious content-likely conflict. And it's hard to assess motivation when there's all sorts of unconscious fermentation going on.

My final association:  I read a story when I was a kid, and I still don't quite understand it. It was a Chinese fable about a lazy boy who never did anything his mother asked. He never helped out at home. He never did any kind of work. He was just a lazy good-for-nothing. Then one day, there was some kind of threat to his family, and the boy got up and deftly handled the situation, and saved the day.

The End.


Wednesday, July 27, 2016

Good and Bad Ideas

Today, NY State sent a letter to insurance companies, telling them they better comply with parity laws, and that they'll be checking up to make sure the insurers are keeping in line. Specifically, the letter was written to "remind" insurers that

MHPAEA (Mental Health Parity and Addiction Equity Act) prohibits issuers whose
policies or contracts provide medical and surgical benefits and MH/SUD benefits from applying
financial requirements, quantitative treatment limitations (“QTLs”), and NQTLs to MH/SUD
benefits that are more restrictive than the predominant financial requirements or treatment
limitations that are applied to substantially all medical and surgical benefits covered by the plan...

...state regulators [will] further review the processes, strategies, evidentiary standards, or other factors used inapplying the NQTL to both MH/SUD and medical and surgical benefits to determine parity compliance:

• preauthorization and pre-service notice requirements;
• fail-first protocols;
• probability of improvement requirements;
• written treatment plan requirement; and
• other requirements, such as patient non-compliance rules, residential treatment limits,
geographical limitations, and licensure requirements.

Accordingly, issuers are advised that the Department of Financial Services will be reviewing
issuers’ NQTLs and QTLs to ensure that issuers fully comply with MHPAEA and will take
necessary action in the event of any non-compliance.

Some additional NQTLs are:

"...treatment limitations based on geography, facility type, provider specialty, and the criteria limiting the scope or duration of benefits or services."

This is a good idea, enforcing rules for insurance companies.  But I worry about certain bad ideas. In fact, I have a sneaking suspicion that insurance companies pay lawyers or others so inclined large sums of money to sit around all day and come up with new bad ideas by finding ways to comply with parity laws, but still hinder or delay reimbursement.

I've written previously about one of these bad ideas, namely, an insurance company's demand that I provide proof that my patient requires out of network services. I almost fell for this and started researching articles on continuity of treatment, etc., until Dinah from Shrink Rap pointed out that the insurance company doesn't need to cover out of network services, but if they do cover out of network, the patient doesn't need to justify not using in-network care.

Other egregious examples are stalling and finally informing the patient that the claims were never submitted, or that they were lost, and then sometimes even more egregiously, when the claims are resubmitted, the insurance company comes back and says it's too late to submit.

Or prior authorization. I tried to get Brintellix, now Trintellix (because Brintellix sounds too much like some other drug) approved, got rejected, appealed by filling out a long form that met every criterion for approval, got rejected again, and finally decided it's a crappy drug anyway, and not worth the effort.

A recent gem involved asking the patient's spouse, who is the primary insured, to call the insurance company to verify or "prove" that the patient has no other insurance (Doesn't, never did).

And I'm quite convinced that these stalling tactics are effective overall, because some percentage of them will not be pursued by patients. That percentage is a gold mine for insurance companies. And mental health patients are perhaps more susceptible than most to this hindrance, since things like depression, psychosis, and anxiety can get in the way of accomplishing tiresome, long, and frustrating tasks like talking to insurance companies.

Anyone else have insurance horror stories?