It was supposed to be the greatest thing since sliced bread: the first new oral anticoagulant in 50 years that did not require INR testing in the majority of patients. It's time to effective anticoagulation was measured in hours instead of days. There were even some data that suggested a possible propensity to lower intracranial bleeding rates compared its older counterpart, warfarin.
But the world changed for dabigatran (marketed by Boehringer-Ingelheim Pharmaceuticals as Pradaxa®) yesterday. That was the day the new proposed rule for structuring Accountable Care Organizations (ACOs) was proposed by CMS and published online with its addendum of 65 quality measures.
Sadly, dabigatran (and probably most of the other direct thrombin inhibitors being developed) will no longer represent "quality care" for patients with heart failure and atrial fibrillation. Quality measure #51 requires the use of warfarin, not dabigatran, for atrial fibrillation in patients with heart failure.
I am not a dabigatran drug representative, nor economist, but it is clear that innovative medications that have the potential to improve our patients' quality of living by unshackling them from the constant blood testing and phone tag with doctors required by warfarin have been officially deemed expensive and bad medicine.
Sadly, this new ACO rule is already outdated and permits the perpetuation of the status quo. The rule steps backward to tie our patients to warfarin instead of newer anticoagulant agents in the name of an "important quality measure." Once in place, this rule will tie our heart failure patients to our overburdened health care system by requiring all of those with atrial fibrillation to get their at-least-monthly prothrombin times (blood thinning levels) and then contacting their ACO for instructions for warfarin dosage adjustments.
Even more concerning, it will take legislative action (and probably expensive additional "Comparative Effectiveness Research" trials) to change these rules once they become law, and then only after a non-elected body decides it should do so. Never mind that such a study has been done.
This, my friends, is life with an ACO in the years ahead. It is for your own good and the good of our country. I'm sorry I will no longer be able to use my clinical judgment on your behalf soon to select the anticoagulant that's best for you. (Pradaxa, it's been fun.) But rest reassured: my quality scorecard, tied to my salary, will look impeccable. After all, I'll soon be practicing nothing but "quality" and "cost effective" medicine in our new Accoutable Care Organizational structure.