The devil is in the details and all politics are local. Cliches, but in the implementation of health care policy and payment in the US, true cliches. Two articles over the weekend bear this out. The AP reports that insurers and pharma companies are fighting over the details of whether therapeutic categories are broadly defined in the details of the the MMA’s new Part D drug benefit (as the insurers want) or more narrowly (as the pharmas want). What’s at stake here is the ability of the insurer or PBM to switch a patient from an expensive branded product to a generic or a cheaper older brand. If they are in the same category, it’ll probably be OK, but if it’s in a different category, it probably won’t be. So should Cox-2 inhibitors be in the same category as ibuprofen? In fact a trial underway is looking at that precise question, and if there’s no real difference perhaps Vioxx and Celebrex will only be available under some kind of step therapy within Medicare Part D. Well you see where this is going.

For those of you really interested, here’s the first draft of the US pharmacopoeia guidelines, which includes a series of steps for meetings and comments. Those of us who prefer to gloss over the details and look at the big picture just need to realize that over the next decade lots of lobbying dollars will be spent to change tiny line items in the resulting final document.

And talking of tiny details in new regulations it appears that the Bush administration is running into trouble by trying to create regional Medicare managed care plans when the nation’s health plans (especially the Blues of course) are actually 51 different plans, all operating under different local statutes, and are not too keen to develop the alliances or infrastructure required to compete regionally when they’re mostly happy with their monopolies infrastructure at home. Now if you want competition, you have to make the market big enough so that you can have a few plans with some scale compete in a region. But of course it makes no sense for any plan to go into, say, a North Dakota and take on the local Blues plan with its 80% market share. How this gets squared away I don’t know, but I suspect that you’ll see an exemption for the share of the population living outside the top 100 metro areas, which after all are the real units that matter in the business of America (think TV markets!).

Frankly the state-based health insurance system is an anachronism. But then the state-based system of electing Senators (and Presidents!) is an anachronism too. (Note that a senator from California represents 15 million people where one from Alaska represents 200,000, but as far as the law’s concerned their votes are equal). It might actually be easier and faster for HHS to abolish the states and come up with 10 regions! On second thoughts, maybe not. But what a great idea.