technology (transcatheter aortic valve replacement [TAVR]), government,
industry and medicine will need to work in harmony.”
- David R. Holmes, Jr., MD, FACC
President, American College of Cardiology
Today, Edwards Lifesciences’ will request pre-market approval of its SAPIEN Transcatheter Heart Valve from the FDA's Circulatory Systems Devices Panel of the Medical Devices Advisory Committee. And for the first time, the groundwork for our complicated new era of health care rationing will be exposed.
To win an expensive technology on behalf of patients these days, there will have be "harmony" between doctors and their professional organizations and government regulators. If not, patients lose.
At issue is a transformative technology - another milestone forwarding medical innovation on behalf of some of our oldest and sickest patients: those with critical aortic stenosis who are too sick to undergo open heart surgery. Aortic stenosis tends to be a disease of the elderly that carries at least a 2-year 50% mortality when accompanied by a weakened heart muscle. Yet thanks to the wonders of careful engineering and some daring researchers that paired their expertise and lessons learned from a variety of disciples (cardiothoracic and peripheral vascular surgery, cardiology, and even cardiac electrophysiology), technigues and technology have combined to offer a percutaneous option for aortic valve replacement.
Everyone involved in this research (and even those who have watched from afar) knows this therapy works. Most believe in the long run, it will prove to be a safer option than open heart surgery in these patients.
But that's about where the harmony ends.
The new valve is expensive and so is the procedure to implant it. Although rumor, the valve itself might cost $20,000 US. Medicare (the insurer of the elderly) pays only 80% of the costs, typically, and has an arcane coding system that pays more for the code for aortic valve "replacement" than it does for aortic valve "insertion." (For goodness sakes, doctors, stop calling it TAVI and stick with TAVR, okay?!?) Will hospitals and insurers be able to afford a run on these devices? And what about Medicare that's already struggling with a huge unfunded liability?
And then there's the whole issue that doctors can't be trusted to do what's right for their patients anymore. They are uniformly greedy, at least in the eyes of the media and the regulators. They care about themselves more than their patients and thanks to a few unscrupulous doctors (and the fee-for-service system in which they work) ample evidence exists to contribute to this perception handsomely. Marcus Welby, MD: rest in peace.
But doctors still hold sway with their patients. For regulators, this is the biggest problem. Doctors, you see, get to stare directly into the eyes of the patients (and their families) as they discuss their principle problem: their narrowed aortic valve. We have to explain the options for treatment available: (1) doing nothing (and what will happen), (2) having open heart surgery (and what will happen), or (3)
Guess which option the patient is most likely to choose?
The fear with this new technology unleashed on the public, of course, is that the implant rate will reach a fever pitch as hospitals, ever hungry for the latest technology to tout, splash their cardiologists faces over billboards and national TV promoting
But if you really want to see all hell break loose, splash the images of a frail minority patient that was denied the option to receive a percutaneous valve on the basis of their age that turns to the media to expose their story.
Katie bar the door.
So we must be polite. We must demonstrate harmony. We must have databases. We must have panels of doctors and regulators and professional bodies assembled that sing Kum-By-Yah by their campfire is a great display of good will and uniform conviction to diffuse responsibility.
After all, rationing's a bitch.
-Wes
I simply couldn't agree more, Wes. It's even more complex in my world of eye surgery where patients are allowed to opt for "upgraded" implants with payment out of pocket. In truth, the upgrades are not medically necessary as they simply relieve the patient of the need to wear glasses, but the option for the patient to pay has opened Pandora's box, and interestingly given device makers an "easy out" rather than fighting to have newer technology covered.
ReplyDeleteThe best example is "laser cataract surgery", a technology that would make surgery performed by the average surgeon safer with more predictable outcomes, but which is being marketed to and by generally superior surgeons (who don't need the technology) as a patient-paid "upgrade".
http://blog.skyvisioncenters.com/?p=576
Thanks for a good read.
No offense, Wes, but this is karma for cardiology. No other specialty has pushed technology adoption in the name of turf expansion and revenue generation remotely as aggressively. If the government didn't step in to do something (in it's typically heavy handed, incompetent way) in another decade 100% of health care money would probably be going to cardiologists stenting appendixes or something. Evidence of patient improvement after the new techniques being optional, of course.
ReplyDeleteI look forward to an adult conversation about rationing. This isn't it.
ReplyDeleteAnony 07:53 pm:
ReplyDeleteFrom Merrium Webster's Dictionary:
"Definition of RATION
(transitive verb)
1: to supply with or put on rations
2a : to distribute as rations —often used with out
b : to distribute equitably
c : to use sparingly"
Americans will never accept the notion that "rationing" is occurring here, even though there is clear evidence (like it or not) that it is. Dr. Rich has coined a term for the manner by which rationing happens currently in America (along with its toxic effects to our health care system): calling it "covert rationing". He has devoted his entire blog to the topic and I encourage you to explore his perspective.
Now, about that adult conversation concerning rationing...
Thanks for the definition, Dr., and the followup serious and thoughtful examination of rationing of healthcare. That Merriam Webster's...it cleared up ANY questions I had.
ReplyDeleteThanks again for setting me straight!
Option #4 (for those who can afford it): American patients travel to a foreign country to get necessary minimally invasive procedures [rationed] not yet approved by the FDA here in America.
ReplyDeleteAs for the "adult conversation on rationing..." Rationing is inevitable...but...as long as a third party is making decisions that result in rationing (covert or overt) it will be viewed as an injustice -- regardless of whether the resultant rationing is actually medically appropriate. It's a no win situation. The only way people will accept "rationing" is to empower patients with the aid of their personal physicians to come to their own conclusions about what medical care is appropriate for them. Anything else will always and forever be viewed as the feared "death panels," and rightly so. This, of course, requires a nation of adults who actually desire the responsibility for their own lives and health care. So far, the majority of individuals have, for whatever reason, been extremely eager to abdicate that responsibility, with government and other so-called authority figures only too happy to snap up that power for themselves. Until people demand power over their own lives, their needs and desires WILL be rationed by others. You can't have it both ways.
ReplyDeletePluripotent:
ReplyDeleteYou are correct, and one added benefit of self-rationing is that prices come down since without third-party payment, effective demand necessarily comes down (doctors and hospitals will have to reduce their fees...if the regulators will let them or will not needlessly increase their cost of doing business and force them out of business).