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.