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?

The Gene Genie

In response to my recent post, In the Genes?, I got the following email message:

Dear PsychPractice,
I am a genetic counselor for Assurex Health, the company behind GeneSight. We read your recent blog post comparing Genesight, the Genecept Assay, and Genelex with interest, and I wanted to reach out to you concerning a couple items that you may not have run across in your search of GeneSight.  While much of what you wrote about GeneSight is accurate, some of it is outdated. For example, GeneSight Psychotropic now includes 12 genes, not 5.  Based on the images of the report in your blog, I wonder if perhaps you pulled the images from our Pine Rest (Winner et al, 2013) study?  This study was published in 2013, at a time when GeneSight had 5 genes.  GeneSight has since been updated and currently includes 12 genes.  Additionally, 4 other studies on GeneSight have been published, as well as 2 meta-analyses of these data, all of which were statistically significant. 

If you are interested in receiving any of these studies, please let me know and I will send them to you.  You may also be interested in white papers on GeneSight genes that outline all current research in the context of psychiatric pharmacogenomics.  We have also created white papers on genes we choose not to add to GeneSight due to lack of clinical utility. 

Somehow, I thought I had gotten the image I used, with the list of genes, from the Genesight site. So I went there to look for it again, and I couldn't find it. So then I tracked down where I found the image, by scrolling through my browser history, and it was here:

Winner, Joel G; A prospective, Randomized, Double-Blind Study Assessing the Clinical Impact of Integrated Pharmacogenomic Testing for Major Depressive Disorder; Discovery Medicine; ISSN: 1539-6509; Discov Med 16(89):219-227, November 2013.

I guess it was from the Pine Rest study, and yes, I suppose it is outdated. And I'm pretty sure I looked up the paper because I couldn't find much information about which genes Genesight uses on their site.

I checked again just now, and it took a while for me to find it, but they do have a description of all the genes they're testing, including four new ones.

Pharmacokinetic:

UGT2B15
CYP2D6
CYP2C19
CYP2C9
UGT1A4
CYP3A4
CYP2B6
CYP1A2

Pharmacodynamic:

HLA-A*3101
HLA-B*1502
HTR2A
SLC6A4

The UGTs and HLAs are the new ones.

So now we've got that straightened out. My apologies to Genesight for propagating outdated information.

That said, since publishing that last post, I have used Genesight. Yes, I have. I chose it partially for reasons having to do with insurance coverage.

I had to meet with a rep. I tried to tell him, via email, that all I needed was a test kit. He insisted that we had to meet in person, and that it would only take 15 minutes. We scheduled and rescheduled, mostly because I was annoyed about the waste of my time so I didn't prioritize the time slot. Maybe that sounds obnoxious, but I felt I was giving up my time, and therefore money, so he and his company could make more money. I was paying to make him money.

He asked if he should just bring along a lunch. I flat out said no. When he got to my office, he had a bag with lunch, from Panera. I refused it, and I'm really proud of this fact because I was super hungry.

The meeting took closer to 40 minutes, with most of my time spent sitting quietly and waiting while the rep talked on the phone to his IT people, to figure out the new tablet system they were using. When the rep did talk to me, there was emphasis on the fact that the tests are covered by medicare. Maybe that makes them more respectable. I don't know. I was also told I'd be receiving 10 more kits in the mail shortly. I was encouraged to use them on new patients, and asked about when I do my chart review, in the mornings or evenings. I tried to explain that I don't have a high volume practice, and it doesn't work that way. He also mentioned something about my EMR, and looked a bit nonplussed when I nodded towards my file cabinet and said, "I don't use one."

I did the test on a Monday. You do two buccal swabs-1 per cheek, 10 seconds each. Then you put the swabs in an envelope and seal it. You add a consent form and the swab envelope to a larger envelope, seal that, and send it out via Fedex-it's already labeled and paid for overnight shipment. This sounded easy, but I wanted it sent off that day, my doorman wasn't sure when or whether Fedex would be in the building, and the closest Fedex drop box had been shut down some time ago. So I wandered around a bit til I found a place. More lost time and money. I had tried to contact Fedex to come pick it up, but their site didn't work properly, so I had to wander.

Also, it was a little confusing, because you don't include an order form. Instead, you login to your Genesight account and order the test there (You can print out and use an order form, but only if you don't use the online system). They give you an order number, but there's nowhere to record it on anything you mail in. I wrote it on the swab envelope, anyway.

The results came in at 10pm on Wednesday night, which is probably within the 36 hour turnover time. I can't get into the clinical details, but the test results were about as helpful as I expected. The pharmacokinetic stuff was fair. They suggested some dose adjustments that might be helpful. They also yellow-boxed, meaning use, but with caution, a couple meds that have caused serious side effects in this patient, in the past.

The pharmacodynamic stuff was not particularly good. Meds were recommended that have been of little or no use in the past, or have actually had deleterious effects. I didn't expect much of this aspect, so I wasn't too disappointed. I already knew that genetic testing that's supposed to predict which drugs will be helpful is not ready for prime time, yet.

The best I can say for Genesight, so far, is that it made one potentially useful suggestion, and it seems to be covered by insurance, or if it isn't, it has a decent financial assistance plan, with patients who make less than $50K per year paying $20 for testing. Will I use it again? Hard to say.

David Bowie: The Jean Genie

Keeping Mum

Hippocrates

This post was prompted by an article written by Ben Goldacre in The Guardian, Care.Data is in Chaos. It Breaks My Heart. The article is about the Health and Social Care Information Centre (HSCIC, in the UK), which, "admitted giving the insurance industry the coded hospital records of millions of patients." These records, according to Goldacre, were line for line, and could be decoded by anyone with an inclination to do so. The purpose of this "gift", by the way, was for the insurance companies' actuaries to figure out premiums, based on likelihood of death (or illness, I assume).

Useless Fun Fact: Years ago, in another professional trajectory, I passed the first of the however many actuarial exams.

Anyway, then the HSCIC said it couldn't share documentation on this release of information, presumably because it's more important to protect insurance company privacy than patient privacy.

Summarily, in Goldacre's words, "...a government body handed over parts of my medical records to people I've never met, outside the NHS and medical research community, but it is refusing to tell me what it handed over, or who it gave it to, and the minister is now incorrectly claiming that it never happened anyway."

So I started to think about patient privacy, including a long-ago post, What, Exactly, Is HIPAA?, where I wrote that I would follow-up with more information about privacy, and I never did. Incidentally, I've looked, and I still haven't found any contradictory information about what constitutes a HIPAA covered entity, and I'm still convinced that I'm not one, because I don't bill patients electronically.

So I was wondering, what is the difference between privacy and confidentiality, as they relate to patients? And I found this article (Prater), which was helpful.

Basically, confidentiality is the, "...obligation of professionals who have access to patient records or communication to hold that information in confidence," while privacy is the, "...right of the individual client or patient to be let alone and to make decisions about how personal information is shared."

In other words, confidentiality is my professional, or at least ethical obligation to my patients, while privacy is a patient right I need to respect. From this I infer that technically, my patients do not have a right to confidentiality, and I don't have an obligation to protect patient privacy.

Here are some more details.

Confidentiality

Confidentiality goes back, at least, to the Hippocratic Oath:

And whatsoever I shall see or hear in the course of my profession, as well as outside my profession in my intercourse with men, if it be what should not be published abroad, I will never divulge, holding such things to be holy secrets.

It is a cornerstone of professional association codes of ethics. The AMA's code of Ethics, Opinion 5.05, states:

The information disclosed to a physician by a patient should be held in confidence. The patient should feel free to make a full disclosure of information to the physician in order that the physician may most effectively provide needed services. The patient should be able to make this disclosure with the knowledge that the physician will respect the confidential nature of the communication. The physician should not reveal confidential information without the express consent of the patient, subject to certain exceptions which are ethically justified because of overriding considerations.

And don't forget about postmortem confidentiality:

All medically related confidences disclosed by a patient to a physician and information contained within a deceased patient’s medical record, including information entered postmortem, should be kept confidential to the greatest possible degree...At their strongest, confidentiality protections after death would be equal to those in force during a patient’s life. Thus, if information about a patient may be ethically disclosed during life, it likewise may be disclosed after the patient has died.

In reading this stuff, I also found that the AMA has a slightly different slant on the definitions of privacy and confidentiality:

In the context of health care, emphasis has been given to confidentiality, which is defined as information told in confidence or imparted in secret. However, physicians also should be mindful of patient privacy, which encompasses information that is concealed from others outside of the patient-physician relationship.


An example of support for the legal status of confidentiality, as the privileged communication between patient and doctor, can be found in Jaffee v. Redmond, where the, "...U.S. Supreme Court upheld a therapist’s refusal to disclose sensitive client information during trial." (Prater)


Effective psychotherapy...depends upon an atmosphere of confidence and trust in which the patient is willing to make a frank and complete disclosure of facts, emotions, memories, and fears. Because of the sensitive nature of the problems for which individuals consult psychotherapists, disclosure of confidential communications made during counseling sessions may cause embarrassment or disgrace. For this reason, the mere possibility of disclosure may impede development of the confidential relationship necessary for successful treatment. (p.10, Jaffee v. Redmond)


Privacy

There is no constitutional right to medical privacy. Rather, healthcare privacy rights, "...have been outlined in court decisions, in federal and state statutes, accrediting organization guidelines and professional codes of ethics." (Prater)

The big example is HIPAA. Subject to HIPAA, "Individuals are provided some elements of control, such as the right to access their own health information in most cases and the right to request amendment of inaccurate health information...However, in [the] attempt to strike a balance, the Rule provides numerous exceptions to use and disclosure of protected health information without patient authorization, including for treatment, payment, health organization operations and for certain public health activities..."(Prater)

I've been trying to read through the relevant parts of this ponderous document about HIPAA, and on pages 757 and following, in part Squiggle164.512, Uses or Disclosures for which an Authorization or Opportunity to Agree or Object is not Required, I found what appear to be a number of these exceptions to the "privacy" provided by HIPAA. I think. I'm not a lawyer. Such as:

a) required by law
b) public health activities
c) victims of abuse, neglect, or domestic violence
d) health oversight activities
e) judicial and administrative proceedings
f) law enforcement purposes
g) about decedents, i.e. coroners, ME's, funeral directors
h) cadaveric organ, eye, or tissue donation purposes
i) research purposes
j) aversion to serious threat to health or safety
k) specialized government functions
j) worker's compensation

There are many specifics, including disclosing information to a patient's employer, but I'll leave those as an exercise for the reader.

Point being, HIPAA does little to protect patient privacy. I think the value of HIPAA is that it attempts to delineate what patient privacy rights are, and that it has succeeded in making people aware that the privacy of their medical information is vulnerable. It does not solve this difficulty, which becomes hugely magnified by the use of electronic health records. This leads to consideration of one more important term, security, or the means by which patient information is protected, such as a locked filing cabinet, or encrypted data.

What I glean from all this is that there is at least a notion of a patient's right to privacy, which I should try to respect. But that my standards for protecting patient information are much higher than anything HIPAA has to say.