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.

CPT-New and Improved?

In response to my recent CPT article, CPT: A Primer, in The Carlat Report, I received an email from Joel Shield, MD. I don't know Dr. Shield, but I want to share some of the content, and I have his permission to do so.

Dr. Shield writes about the real CPT coding, as opposed to what's being presented as CPT coding, which is really the Center for Medicare Services' (CMS) version, the version I've researched and written about because I didn't realize there was a difference.

What is the difference? Basically, the CMS version is a checklist, with, for example, 1-3 elements of HPI, at least 6 elements on exam, and 1 pertinent ROS for a 99213 (see my post).

But the version from the CPT 2013 manual is much more descriptive. You have to meet the same standard-providing enough information to qualify your coding, but it's much less of a checklist.

I'm not getting into too much detail because that might involve purchasing the manual so I could figure out what goes into it. Dr. Shield forwarded two articles he wrote up about the coding, and I'd like to include them, but I haven't figured out how to attach a pdf to a post. If anyone knows, by the way, please comment and tell me how.

However, a nice summary was included with the email I received:


In summary, the CPT manual and the CMS guidelines use the same categories for coding E&M services (the four levels of history, examination, and medical decision making), but differ significantly in some of the details of those categories (for example, the CMS guidelines specifying psychiatric, constitutional, and musculoskeletal parts of the psychiatric examination) and, most importantly, in adding a sub-basement level of very detailed requirements for what defines the levels of history, examination, and medical decision making. While the descriptions of the levels in the CPT manual are, in general terms, the same as those of CMS, because they are more descriptive they can be satisfied more flexibly and more easily. 

Now here's the rub: If you document more descriptively, you can be less freaked out about what goes into your documentation. You might even be able to write the kind of note you're accustomed to, one that has something to do with patient care. But, if you ever get audited, or need to justify your services to someone who may or may not have graduated from high school, someone who is simply going to count the number of bullet points you did or didn't include in your documentation, then you're better off having bullet points to be counted.

To be honest, I'm bugging out a little over all the recent changes. You need to bill differently, and learn how to bill differently. You need to diagnose differently, and learn how to diagnose differently. It's too much. I'd really like to get back to my day job.

Dr. Tele-Love, or, How I learned to Stop Worrying and Love Skype

In the process of learning all about the new CPT coding, I also learned that phone and Skype sessions are not covered by insurance. The reasoning seems to be that they are considered substandard care. And apparently you can't cut a deal with your patient in which he will pay you for a phone or Skype session, regardless of his coverage, because a patient cannot legally agree to substandard care. Well, I guess you CAN make that agreement with your patient, but if he ever decides to sue you, you're buggered.

Furthermore, the point was made by the lawyer who gave the talk I attended that if you call your doctor to ask about something, say, at night, you don't get a bill for it. So, by extension, you can't bill for a full session that takes place on the phone.

True. Only lawyers can bill for phone exchanges. By the minute.

Personally, I don't like phone sessions. Maybe because I don't like talking on the phone, in general. I find it difficult to lose that sense you get of a patient who's in the room with you, not to mention the facial expressions and other visual cues (admittedly, these are lacking in analysis, as well).

That said, sometimes, it's necessary. A patient who needs to move suddenly, but hasn't transitioned to another psychiatrist yet. Or maybe doesn't want to. A patient who's laid up at home because of illness. Or maybe because of maternity or paternity leave. A patient who has to fly to a distant city due to a family emergency or a death.

It seems to me there are a lot of good reasons to rely on phone or Skype sessions, especially when the patient would suffer without any session at all. Are we, as psychiatrists, really supposed to spend 45 minutes on the phone with a patient, making the same comments and interpretations we would make in person, working just as hard as we would in person, and then not charge for the session?

This is a topic for another time, but why do people think it's immoral, or somehow distasteful, for doctors to want to make a living? Are we really supposed to work for free?

So what's the deal, here? Why is tele-medicine considered substandard? Is it just an excuse to limit coverage, or is it based on some factual data?

As it turns out, prison systems routinely use tele-psychiatry. I hope it isn't the case that prisoners are getting substandard care.

And you can use telepsychiatry in some states, but not others. Additionally, the use of telepsychiatry varies based on type of insurance.

For instance, medicaid covers telepsychiatry in NY.

Private insurance varies by insurer. My guess is, if there's any excuse not to cover, they won't cover.

Medicare covers telepsychiatry with some provisos. First, the consumer must be located in a "non-metropolitan statistical area", which may or may not be the same thing as a Health Professional Shortage Areas (HPSA) .

From what I can tell the consumer also has to have the session in a qualified facility, which I guess means that he or she needs to show up at a clinic or hospital, and have a qualified staff person with him or her. During the actual session? I can't figure that out.

The clinician, on the other hand, can be anywhere, even at home, but has to be licensed in the appropriate state. I assume that's the state where the patient is located.

Now, back to that "substandard care" business. If it's good enough for prisoners and people in rural, underserved areas, it should be good enough for anyone. Alternatively, it's not really good enough for anyone, but it's the best anyone can do under certain circumstances.

The next question is, "What does the literature say about how telepsychiatry compares to in-person treatment?"

Stay tuned.