So we’d better start taking innovation – of both the incremental and discontinuous creative-destructive varieties – seriously. And that means both spending more on harder developmental R&D (with concomitant higher investment risks). In this regard, the new legislative language on the development of FOBS (follow-on biologics or, if you prefer, biosimilars) is a good thing. (And don’t ever call them generic biologics!)
There’s lip service to the need for more robust comparative effectiveness – although this is a battle yet to be either defined (comparative effectiveness or cost effectiveness or clinical effectiveness?) or fought (do we need a U.S. version of NICE?). And a battle royal it will be. In addition, there’s as yet-to-be reconciled language on a Medicare advisory board that could very well morph into a national formulary body. L’audace, l’audace, toujours l’audace. This isn’t even the end of the beginning.
Of course we bid adieu to the infamous Medicare Part D Doughnut Hole. Pax vobiscum. The Medicare prescription drug benefit is coming in hundreds of millions of dollars under budget already and consistently has 90% + approval ratings by America’s savvy seniors. Medicare Advantage programs? Don’t ask.
It’s terrific that now insurance companies can’t turn anyone down because of a pre-existing condition (bravo!) but no they can’t charge higher premiums for people who have them? Nice if you’ve got ‘em – not so nice for everyone else. This isn’t an elegant solution and will have to change. Otherwise it’s just a slow march to a single-payer system.
We spent a lot of wasted time throwing around terms like “death panels” but, at the end of the day, didn’t even begin to address the elephant-in-the-room issue of how much of our national treasure we spend on end of life care. And you thought the abortion debate was divisive!
The legislation doesn’t do anything really significant about driving young, healthy people into the insurance pool. The anemic penalties (which don’t even kick-in right away – the demographics and politics aren’t too hard to figure out) actually disincentivize youthful participation. After all, why not pay the monthly penalty (which is less than even a very affordable monthly insurance premium) if, when you do face a medical emergency, you can’t be turned down or charged more? Nor does the bill create any sort of national insurance pool – where we can all benefit from a 50-state economy of scare insurance marketplace.
The best things about the bill are what is does not do.
No drug importation. (Sorry Senator Dorgan. Hooray Peggy Hamberg.) And the Non-Interference Clause remains the law of the land. When originally drafted (wisely by then Senators Daschle and Kennedy), we knew then what we need to remember now, that (1) direct government negotiations for Medicare drug prices won’t (according to numerous government studies and leading economists) lower Medicare drug prices and (2) it is the next slippery step towards even broader price controls. And price controls equal choice controls.
So let’s keep our eye on the prize.
No, not the November elections – the real prize: better access to healthcare for all Americans. Innovation that focuses on creating a chronic healthcare culture that embraces prevention and prophylactic care. We will not survive as a nation of obese, hypertensive diabetics. Rather than wasting time on spin, let’s redouble our efforts on innovation. Then, when we succeed through brainpower and teamwork (and, hopefully some civil bipartisanship), the circus surrounding this vote and the past year’s partisan political warfare will be but a footnote in American political history.
Yes we can.
Peter J. Pitts is Partner/Director of Global Regulatory and Health Policy at Porter Novelli. He is also President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.