D is for Dilemma

There's an Obama administration proposal to limit coverage for certain classes of drugs (See NYTimes) in Medicare Part D. Since Part D took effect in 2006, there have been 6 protected medication classes:

Anti-retrovirals
Immunosuppressants when used for organ rejection
Anti-depressants
Anti-psychotics
Anti-convulsant agents
Anti-neoplastics

Protected means a part D plan is required to cover all or substantially all drugs in the class. "Moreover, Part D plans may not impose step therapy or prior authorization requirements for these drugs for beneficiaries who are currently taking the drug: both beneficiaries who are currently enrolled in the plan, as well as beneficiaries taking a protected class drug that are newly enrolled in the plan (source, also the following)."

In 2008, the new Medicare Improvements for Patients and Providers Act (MIPPA) law established 2 criteria for what constitutes a protected class:

1. Where restrictions on that class would have major or life threatening consequences

2. Where there is a significant need for individuals with a disease or disorder treated by the drugs in the class to have access to multiple drugs within that class.

Okay, let's stop here for a minute. I'm thinking that there must be a lot of drug classes that meet these two criteria, so it can't be that simple. Moving on.

MIPPA, as it turns out, did not specifically reference the 6 protected drug classes that already existed. So in 2009, CMS announced its intention to review the necessity of the 6 classes, but it allowed that, at least for 2010, those classes would not be messed with. And in 2010, Congress reaffirmed that the 6 classes would remain protected until, basically, somebody figured out that they shouldn't be.

Then, on January 6th of this year, CMS comes along and says, Here's the thing: The 6 protected classes have driven up the costs of Part D. After all, if drug companies know you'll pay for any drug, then you've lost all power to negotiate prices.

We estimate that this change could save the 
Part D program (includes the Part D portion 
of MA–PD plans) approximately $30 million 
in 2016, increasing to $420 million in 2019 
(total of $720* million over this period). 

CMS also claims that there's over-utilization of protected drugs, and that beneficiaries already have adequate protection to ensure they aren't simply switched off their meds. Specifically, "...there are five beneficiary protection provisions in Part D and...only where these patient protections do not adequately protect beneficiaries should the protected class policy apply. [The 5] beneficiary protections [are]: formulary transparency; formulary requirements; reassignment formulary coverage notices; the transition supply policy; and the beneficiary appeals process.

Another editorial break, here. I don't think CMS should be patting itself on the back because they send you a letter and give you some severance meds before they make you switch to something else.

This is the language from the proposal:

Instead of mandating coverage of all 
drug products in a particular class on all 
Part D formularies, we can save costs by 
identifying more efficient formulary 
requirements or other beneficiary 
protections in most cases


So here's the bottom line, all done under the auspices of the affordable care act. There are two criteria:

"First, unrestricted access to all drugs in a category or class of a drug is necessary where a beneficiary initiating access to a drug class would need to receive that access within seven days and, if they did not receive access within seven days, the lack of access would be expected to result in the patient’s death, hospitalization, incapacity, or disability. Second, unrestricted access is necessary where CMS is unable to establish that a formulary that includes less than all drugs in a category or class has sufficient drugs to treat the diseases or conditions treated by those drugs."

There's always going to be some outlier patient who only responds to an expensive medication, so how're they planning to figure that one out?

And here come the exceptions, even for the protected classes:

1. Where there are two or more chemically identical or therapeutically equivalent drugs in a category or class, the requirement to cover all drugs in the category or class would be waived
2. The exceptions policy permits a plan to conduct prior authorization to ensure that a drug is being dispensed for a medically-accepted indication.

1. So if paxil is therapeutically equivalent to zoloft, they don't need to cover wellbutrin?
2. Um...even if the drug is being dispensed for recreational purposes, like you need your adriomycin and haldol for a rave, do they think whoever's dispensing it wouldn't rubber stamp a suitable diagnosis?

Well, The Oscars are coming up, so let's open the envelope and find out which three classes win the "no longer protected" award:

Immunosuppressants when used for organ rejection
Anti-depressants
Anti-psychotics

I'm trying to understand the reasoning whereby not putting a patient on a suitable antipsychotic isn't likely to lead to bad things happening, and where CMS is certain that not all the drugs in these 3 classes are needed, but they are in the other 3.

The implications of this policy change are making my head spin. Why were those six classes chosen to begin with? Does anyone know? That wasn't rhetorical.

And what about the approach? Many more people suffer from hypertension than seizures. And multi-drug regimens for hypertension are not uncommon, with patients sometimes switching meds, depending on effects, or side effects. And doesn't hypertension cause a lot of morbidity? Expensive morbidity? and wouldn't it be cheaper to spend a little more to control blood pressure, than on the consequences of hypertension?

I'm all for trying the cheapest suitable medication on the first go-round, but that doesn't always work. And if doctors are prescribing expensive meds before trying cheaper ones, is it because the expensive meds are better, or because they're on formulary so they're covered, anyway, or because a drug rep stopped by to explain why the off patent meds aren't as good as the shiny new ones?

For now, this is just a proposal, and comments will be accepted until 5pm on March 7th, at http://www.regulations.gov.

Squished

I have one of those free subscriptions to magazines from some credit card points, and I don't even remember if I actually ordered a year of Real Simple, or if it was substituted for something else I ordered. I don't look at it much, but I got the February 2014 issue in the mail today, and as I was flipping through to "Roasted Salmon/Barley/Smoked Paprika/Fennel/Swiss Chard/Chickpeas/Basil/Scallions, which I will never have the time or energy to prepare, I noticed an article entitled, The Patient Will See You Now. It's about deciding whether or not to break up with your doctor. It includes some common sense recommendations-voice your concerns, ask what you can do to be seen on time, and so on. In the sidebar, it lists "5 Common Signs That You Need A Change".

1. You're doctor doesn't tailor recommendations to your life.
2. He's always running late.
3. She rushes you.
4. The office is disorganized.
5. She's arrogant.

And since Real Simple is a pretty mainstream publication, tailored more towards women, admittedly, I'm working on the assumption that it reflects what people want from their doctors-they want to be listened to, they want their doctor to spend enough time with them so they feel understood, they want their individual concerns addressed, they want a thorough exam which they seem to equate with time (in my experience, more related to the doctor's skill, but what do I know), and they want to be treated with respect.

None of this is unreasonable. Except.

The lead article in this month's Carlat Report, An Ethical Perspective on the Affordable Care Act, is about some of the ethical conundrums that will arise, if they haven't already, due to the vastly increased number of insured, as well as the other provisions of the ACA. I know a little something about this article because I wrote it. And I'm going on the record now to state that it was extremely difficult to write, mainly because the more I researched the topic, the more discouraged I got about the whole mess.

Allow me to quote:

Several innovations of the ACA are intended to incentivize doctors not only to provide better quality care, but better quality care at equal or lesser cost—in other words, greater value. However, since a goal of the ACA is universal access to health care, this means that doctors are expected to spend more time with more patients, while providing better care for each patient at a reduced cost.

(Note: I'm not allowed to post or otherwise publish the full article for, I think, six months, but I'm pretty sure one small quote is okay. So.)

See the problem? The ACA is convinced that its provisions will allow people to get better care from and spend more time with their doctors, but these same provisions make it impossible to do so. The American public is in for a serious disappointment.

Also today, I received the January 17, 2014 edition of Psychiatric News, and there, on page 4, is an article entitled, DB Helps Develop Tool Kit to Help Physicians Thrive in ACOs. The tool kit was released by the Toward Accountable Care Consortium of North Carolina, to help doctors organize into ACOs, where doctors and hospitals agree to work together to provide "better value" care, meaning higher quality at less cost, and "share in the savings" they generate. These can involve a collaborative care model, in which patients in a primary care setting are screened by their PCPs for psychiatric problems, and then referred to a care manager, often an MSW, who follows up. Psychiatrists supervise the care, but never see the patients. The quality of care in an ACO needs to be measured, to determine if it is both "quality" and cost efficient. This is done by the soon-to-be-not-officially-mandatory-but-you'll-be-penalized-financially-if-you-don't-do-it PQRS, for example, which involves a mind-boggling process, and "measures" that are just time-consuming and meaningless checkboxes.

Allow me to quote:

“This is the wave of the future,” [Bridges] said. “We are leaving fee for service for some kind of new payment system that rewards value, and I believe we are really on the cusp of a remarkable change in the way psychiatrists are going to be working.”


This is the ACA's definition of spending more time with patients and providing better care. And here we doctors are, trying simultaneously to satisfy the people who read Real Simple, and the provisions of the ACA.

After much consideration, I've come to the conclusion that the solution to all of this is obvious.

I need to stop reading.

A New Low

Just when you thought it was safe to have health insurance... I mean, there's the Affordable Care Act, that at least makes it impossible for insurance companies not to insure you if you have a pre-existing condition, even if there are tons of problems with the Act. And there's the Mental Health Parity thing. You'd think that would provide some protection.

Skeptical by nature, I assumed insurance companies would come up with new and interesting ways to bite. And they have not disappointed.

A patient of mine submitted a claim a while back. A couple months later, when it wasn't reimbursed, the patient followed up, and sure enough, the insurance company had no record of the claim. (I happen to know that the claim was submitted properly). The patient re-submitted the claim, and the insurance company's response was that it was submitted too late, so they wouldn't reimburse. (I think there's a similar joke about a dry cleaner).

The patient appealed. Forms were filled out. Phone calls were made. More forms were filled out.
And now, another form needs to be filled out to "justify" out-of-network services, even though the appeal is about the supposedly late submission of the claim. My job, in this, is to cite two examples in "the literature" explaining why the patient requires out-of-network services.

When I learned this, my first thought was, "How am I supposed to come up with that?" But after some thought, I decided there are a couple arguments to be made, characterized by certain lines of inquiry.

1. Continuity of Care-do patients fare better when they don't switch providers?
2. Therapeutic Alliance-related to continuity of care, but also different, since it is possible to continue care with someone with whom you have a poor therapeutic alliance.

And there's an uncomfortable "3", which is, "Do patients actually have better outcomes with out-of-network providers, and if so, why?"  Related to this is, "Are there discernible differences between providers who accept insurance, and those who don't?"

So I thought I'd make lemonade and post about researching these ideas. I'd prefer sparkling limeade with coconut, but we're talking insurance companies here.

I searched, "continuity of care psychiatry", and got a bunch of links. And then I got more links from those links. Some of the articles were about defining the meaning of continuity of care. Others seemed to just assume that continuity of care was a good thing.
There was a reference to the National Service Framework for Mental Health, which is a 2001 Department of Health document from the UK, too long for me to read in full, but the source I got it from (can't remember) claimed that it recommends continuity of care as essential.

Here's more:

Intensity and Continuity of Services and Functional Outcomes in the Rehabilitation of Persons with Schizophrenia

Clients who...had fewer gaps in service delivery achieved greater rehabilitative improvement in social, work, and independent living domains and had fewer days of hospitalization.

Another article that seems critical is:

Tessler RC. Continuity of care and client outcome. Psychosocial Rehabilitation Journal 1987; 11(1):39-53.

Unfortunately, I couldn't track it down online. Not even the abstract.

There's what looks to be a not-quite-on-my-target paper, Continuity of care in mental health: understanding and measuring a complex phenomenon, but the bibliography is promising.


I found this article in the "continuity of care" search:

Therapeutic Alliance and Psychiatric Severity as Predictors of Completion of Treatment for Opioid Dependence

among patients with moderate to severe psychiatric problems, less than 25 percent with weak therapeutic alliances completed treatment, while more than 75 percent with strong therapeutic alliances completed treatment...In this patient subgroup, a strong therapeutic alliance may be an essential condition for successful treatment.


Next I searched, "therapeutic alliance and treatment outcome."

I found this article in JAMA Psychiatry:

The Role of the Therapeutic Alliance in the Treatment of Schizophrenia
Relationship to Course and Outcome

This study examined the relationship of the therapeutic alliance to the treatment course and outcome of 143 patients with nonchronic schizophrenia... Results showed that patients who formed good alliances with their therapists within the first 6 months of treatment were significantly more likely to remain in psychotherapy, comply with their prescribed medication regimens, and achieve better outcomes after 2 years, with less medication, than patients who did not.

And this one from J consult Clin Psychol:

The relationship between the therapeutic alliance and treatment outcome in two distinct psychotherapies for chronic depression.

This study tested whether the quality of the patient-rated working alliance, measured early in treatment, predicted subsequent symptom reduction in chronically depressed patients...A more positive early working alliance was associated with lower subsequent symptom ratings in both the CBASP (cognitive behavioral analysis system of psychotherapy) and BSP (brief supportive psychotherapy),...p < .001.

Then there's the psychoanalytic literature. There are a ridiculously large number of hits for "therapeutic alliance" and "analytic dyad", but they're mostly about the meaning and development of those elements. It's axiomatic that a good alliance is a necessary part of any treatment.

I also searched "discontinuity in psychiatric care", and mostly I got measurements-e.g. how many new patients in a clinic drop out of treatment. They didn't seem to address the problem of what happens to patients when they stop treatment, or switch treatment providers.

I searched:
"patient outcomes in psychiatric clinics with frequent change in providers"
"Do psychiatric patients get worse when they switch providers"
"Do psychiatric patients drop out of treatment when they switch providers"

Nothing came up that seemed to address what typically happens in an outpatient clinic, where there's resident turnover every year, and what that does to patients, which is what I was hoping to find with those searches.

Now on to point "3", patient outcomes with out of network vs. in network psychiatrists. That search came up with things like, "benefits of antidepressants" and "Providers are responsible for the correct submission of claims", under OUTreach...Network.

One thing we do know is that fewer psychiatrists than doctors of other stripes accept private insurance:

The percentage of psychiatrists who accepted private noncapitated insurance in 2009-2010 was significantly lower than the percentage of physicians in other specialties (55.3% ...vs 88.7% ... P < .001) and had declined by 17.0% since 2005-2006.

But what are the differences between shrinks who decide to join an insurance network, and those who don't? And whose patients do better? I wonder if the study's been done. And if it hasn't, someone should do it, because the results are not simply academic.

Pick Two

Many years ago, I watched a Showtime special, with the comedian, Yakov Smirnoff, doing a one man show. He ended with a Q&A session:

Q: Is your name really Yakov Smirnoff?

A: No, it's Jack Daniels.

Q: What's health care like in the (former) Soviet Union?

A: Well, it's free. And you get what you pay for.


C'mon, people. This is where the US is headed. Remember the Design/Engineering adage?

Good, Fast, Cheap. Pick Two

Here are a couple of articles to check out:

Lower Health Insurance Premiums to Come at Cost of Fewer Choices

'Affordable Care' or a Rip-Off?

I've said it before but it bears repeating. Coverage does not equal care. The Affordable Care Act may make it possible for people to buy a plastic card with a number that they can give to doctors and hospitals. This doesn't mean they'll get good care. It doesn't even mean they'll get any care.

'“If a health plan has a narrow network that excludes many doctors, that may shoo away patients with expensive pre-existing conditions who have established relationships with doctors,” said Mark E. Rust, the chairman of the national health care practice at Barnes & Thornburg, a law firm. “Some insurers do not want those patients who, for medical reasons, require a broad network of providers.”'

Good, Fast Cheap. Pick Two.

Get the picture?

Coverage vs. Care

Since I can't seem to get myself to write an all out, well-constructed post while I'm on vacation, I thought I'd point readers to this Op-Ed in the NYTimes.

It's one of those thingys where the Times publishes an Op-Ed piece, and then asks for readers' responses, which it publishes on Sunday, with a response by the original author.

This one is about Obamacare, and the Affordable Care Act, and how the exchanges set up to help people find coverage are wonderful, and how could those evil Republicans oppose this, and there are many examples of this system working, etc. (I'm a registered Democrat, BTW).

Most of it fell out on the side of: the ACA is going to have a rocky start, but in the long run it'll be great because everyone will have access to health insurance.

I really don't know how the ACA is going to play out. Maybe it'll really help people get insurance coverage. What struck me, though, is the way everyone is all excited about health insurance, and no one is talking about health care.

Yay! Everyone will have access to health insurance. Boo! Many doctors won't accept the insurance because of the Byzantine bureaucracy and the paltry reimbursement. Boo! Doctors who do accept insurance will be bombarded by overwhelming numbers of patients with shiny new health plans.

Coverage is not synonymous with Care.

Just As Good

All the hype about healthcare reform and the Affordable Care Act and Obamacare reminds me of an article a friend sent me a couple years ago.

The basic idea is that you can't have more people covered and better quality of care for less money. So concessions need to be made somewhere.

The article, written by David Kent, entitled, Just-as-Good Medicine, and published in American Scientist,  March/April 2010 issue, is not only informative, it's extremely well-written and entertaining. Please read it.

And here's the first paragraph, to whet your appetite:


The rabbi’s eulogy for Sheldon Kravitz solved a minor mystery for my father: what was behind the odd shape of the juice cups he had been drinking from after morning services for the last few years? Adding a bit of levity while praising his thrift and resourcefulness, the rabbi told of how Sheldon purchased, for pennies on the dollar, hundreds of urine specimen cups from Job Lot, that legendary collection of pushcarts in lower Manhattan carrying surplus goods—leftovers, overproduced or discontinued products, unclaimed cargo. At the risk of perpetuating a pernicious cultural stereotype, for men of my father’s generation like Sheldon, raised during the Great Depression, bargain hunting was a contact sport and Job Lot was a beloved arena. My father, too, would respond to the extreme bargains there with ecstatic automatisms of purchasing behavior and come home with all manner of consumer refuse, including, and to my profound dismay, sneakers that bore (at best) a superficial resemblance to the suede Pumas worn and endorsed by my basketball idol, the incomparably smooth Walt “Clyde” Frazier. My father would insist that such items were “just as good” as the name brands. But we, of course, knew what “just as good” really meant.