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mmglobal 02-28-2006 04:15 PM

CMS, the FDA, a Professor and Civics Lessons
By Walter Eisner | Orthopaedics This Week | Volume 2: Issue 8

To some, he�s the devil. To others, he�s a guardian protecting patients from snake oil and guarding the public purse against wasteful and unnecessary medical spending.

Whatever he is, he was perhaps the most powerful man in the orthopedics community this past month.

Richard A. Deyo, M.D., M.P.H., is Professor of Medicine and Health Services and Co-Director of the University of Washington�s Center for Cost and Outcomes Research.

He�s also the guy who some think is persuading CMS to issue a national non-coverage determination for the only FDA-approved disc arthroplasty product�Charite.

There is a civics lesson for the orthopedics community in there somewhere, and we wanted to know how an FDA-approved device is about to be rejected by CMS and how a professor from the state of Washington was so influential.

Dr. Deyo agreed to have a conversation with Orthopedics This Week (shameless plug: he�s one of our readers) and tell us about his involvement in the CMS decision and what lessons were to be learned from this government process.

As Otto von Bismarck said, �those that love sausages and laws shouldn�t watch either one being made.� We hope you love sausage.

OTW: Dr. Deyo, thanks for agreeing to this interview. We�re interested in the civics lessons that can be learned from the Charite experience and how this will impact the development of new products and devices. What made you decide to file this petition to deny coverage by CMS?

Deyo: I�m happy to do the interview. I was concerned mainly about safety issues in an elderly population. I was under the influence of some of my orthopedic colleagues who had recently returned from the training course and were telling me that the course really emphasized that this procedure was intended for a younger and otherwise healthy patients. They were telling me about the importance of wide retraction of the vessels in front of the spine. I had concerns about the efficacy of this device even from the clinical trials. The combination of concerns about safety, issues related to vascular injury in elderly patients and issues related to osteopenia and osteoporosis, which were contraindications, occurred in about 50% of women over 50. With uncertainty about the efficacy it just seemed like this would be a population where it would be reasonable to say, wait, let�s hold off and see what more we could learn about the device before we commit to coverage.

OTW: How do you think people in the orthopedics industry view you?

Deyo: I have friends and enemies for sure in the orthopedic community. There are those who sort of see me as the devil, and there are others who say, well, gosh, yours is a voice of reason and it�s appropriate for us to be cautious about these things. I think opinion about me in the orthopedic community is divided at least. That�s the way it is.

OTW: How did you become involved in this? Did you follow the applications to the FDA and get involved there?

Deyo: No, I wasn�t involved at all, although I was aware of the announcement when it was approved. At that point I was keeping my eye out closely for the clinical trials and data that underlay the FDA decision. Having reviewed those I felt a little disappointed, and then having heard my colleagues talk about what they had learned at the training courses, I thought this didn�t really add up for the Medicare population given what we know so far.

OTW: Did CMS contact you and ask you to comment on this?

Deyo: No, actually I had concerns about this and had spoken in off-hand conversations with people at CMS and they said, well, would you be willing to write a letter and I said sure.

Civics Lesson #1: Know your bureaucrats.

Frankly I was surprised that I was the only person who wrote a letter and was surprised that my one letter was enough to move them. But maybe that�s the case.

Civics Lesson #2: Show up and speak up.

OTW: This is sheer speculation, but it almost looks like they were waiting for somebody to give them an opportunity to comment on this. Where is all this going to go? How are the FDA and CMS going to learn to play nice together?

Deyo: I don�t think they are opposed to each other in any way. I think CMS would say the FDA just doesn�t go far enough in their evaluation of new drugs or devices. I actually think the FDA should set a higher bar, especially for implantable devices. Obviously I don�t want to see a requirement for randomized trials for rubber gloves and contact lenses every time one of those comes along, but when it comes to surgical implants I think it might be reasonable to require randomized trials routinely. In this case they were required, but of course for most spinal implants, especially those for fusion, no randomized trials were ever required and that�s one of the missing links in the evidence chain here also. Again, we�ve compared the new technology to an old technology that itself was never subject to clinical trials.

OTW: CMS agreed to cover that old technology. What has changed?

�What�s changed is just that CMS is more broke.�

Deyo: I think what�s changed is just that CMS is more broke. It�s that simple. The public doesn�t have an appetite for increasing their own taxes and everybody expects Medicare to be there and so they�ve got to somehow deal with the flood of new technology. It�s not just this by any means. This and a thousand other new technologies that are wildly expensive, whether it�s drug-coated stents or implanted defibrillators or whatever. What I think has changed is they�re finding it harder and harder to pay the bills

OTW: CMS in its preliminary report didn�t touch on the issue of cost and limited resources.

Deyo: They�re not allowed to. That�s not supposed to be part of their consideration. Though I think they are focused appropriately on efficacy and safety. But, let�s be realistic. If these devices were priced at $1.50 they probably wouldn�t be subject to the same level of scrutiny. But if they�re at $15,000 the level of scrutiny goes up. I suspect that�s true for any purchaser of any product, anywhere. The higher the cost, the more carefully you look at it.

OTW: So what are the civics lessons here?

Civics Lesson #3: Show safety AND cost benefit to CMS.

Deyo: If manufacturers intend to market new products in the Medicare population, they probably need to test them in that population. Older people really are different from younger people, and it may not be safe to generalize from younger populations. Maybe that's obvious, but maybe not.

FDA approval is no longer going to allow companies to market at will. It means that the evidence bar has been raised and is being raised by insurance carriers. It�s not going to be enough to say that this more expensive new product is at least as good. People are going to say if it�s more expensive, prove to me it�s better.

OTW: How do you see the roles of the FDA and CMS?

Deyo: The FDA is charged with not only assessing safety but also efficacy. I think that�s why they insisted on the randomized trial in this case. In my opinion the comparison they chose was an unfortunate one that doesn�t really illuminate how effective the device is, and certainly its safety remains untested in the Medicare population because patients over 60 were excluded from the trial. In essence we have no data on how safe and effective it may be on elderly patients.

OTW: You are saying the FDA should have done some additional things before it went over to CMS?

�We are in a whole new world when it comes to drug and device approval.�

Deyo: Yeah, I think what�s happened is that we are in a whole new world when it comes to drug and device approval. I say that because it used to be the case that a manufacturer would make a new drug or device, get it through the FDA and then pretty much assume they�d be able to market it at will. I think in the new world people are saying that FDA approval only goes so far, and in some cases there is not enough evidence in safety and efficacy for us to want to jump in to fund expensive new treatments. They will say that they are going to adhere to a higher standard. I think that is increasingly what insurance companies are and Medicare is doing. So it�s not enough to please the FDA. You now really have to please the customer, the people who are paying for the procedure.

OTW: Does this mean that manufacturers are going to have to meet the clinical criteria the FDA has established and then also meet another clinical standard set up by CMS? Are we setting up two different clinical criteria?

Civics Lesson #4: Know the New CMS Standards.

Deyo: Perhaps. I think the answer to your question is probably yes. Obviously Medicare or any other insurance company is going to look at what the FDA says first before they go any further. But I think then they are going to go a step further and ask is this new product any better than ones we already have available, often at a lower cost? What actually is the magnitude of the benefit we expect and is there enough information yet, even though it�s FDA approved, to be sure about its safety? This is important because it�s estimated that at least one in five new drugs ends up with a black box warning after it has been marketed and probably 50% of new drugs have complications discovered after they�re marketed. So you don�t know everything you need or want to know at the time these things are approved. Basically I think the people who are paying the bills are saying we want more evidence about what this really does before we commit to paying for it.

OTW: Where is the role of the patient and doctor in this? The doctor in determining whether this is an appropriate procedure or device and the patient in making a decision that they are willing to take the risk.

Deyo: In the days when there was snake oil, patients and doctors were free to make that decision and it often injured people. You could take a very hands-off approach and say there shouldn�t be any regulation here and it should all be between the doctor and the patient and let them look at the evidence and figure it out for themselves. I don�t want to return to the days of snake oil, which was essentially that situation. I think the public expects that when these new devices are approved they can be pretty confident they�re safe and effective. In fact, I think the public has been disillusioned by recent events�Vioxx, for example.

Civics Lesson #5: Are new FDA Criteria Coming?

OTW: Is that an indictment of the FDA?

Deyo: I think it is to a degree. The FDA itself is at least talking about trying to bolster post-marketing surveillance and make changes in regard to how they evaluate and then monitor drug safety. I think they�ll be considering the same kinds of issues with regard to device safety. I think it�s a reflection on limitations, at least on the FDA process, and a reminder that it�s not the last word.

OTW: Is CMS in effect then becoming a new FDA?

Deyo: I don�t think so. The truth is that CMS is still going to depend on the FDA to do a first screen with regard to basic questions of safety and efficacy. But I think in part because they are holding the purse strings, and they�re going broke, Medicare has to take a more careful look at what they�re getting for their money.

�Medicare has to take a more careful look at what they�re getting for their money.�

OTW: Some would call that rationing.

Deyo: In this case I�m not sure you�re rationing anything. We have a new technology that is fully equivalent to something we had before at a lower price. What are we rationing? It�s not like we�re rationing something that is highly effective that�s being withheld from people. We�re withholding something that is equally effective to what we already have, often at a lower cost. And there are still important questions about safety in the clinical trials that the rate of serious complications was slightly higher for the disc, and certainly in the elderly population its safety is simply untested. It has not been evaluated in people over age 60. Medicare has to consider that. Everybody gets upset because Medicare is seen as the key to other insurance coverage but that�s not their concern. Their concern is for the population they serve.

OTW: If rationing isn�t the right word, they obviously have to establish tougher criteria for what new things they will pay for as they look at what�s available in the marketplace.

Deyo: The FDA, for example, even with drugs, has never required that a new drug prove that it�s any better than other drugs that are on the market. That�s simply not part of the approval process. They have to prove that a new drug is better than a placebo, that�s all. In fact, we have many examples where new wildly expensive drugs were actually less effective than something that was already on the market for less than ten times the cost. Would it make sense for Medicare to cover all of those things just because the FDA has approved them? Doesn�t seem like a reasonable thing to me. It doesn�t seem like good stewardship of public resources, and I think they�re asking the same kind of questions with new devices. What�s the proof that this more expensive new technology is any better than the one we�ve got, and the answer usually is, there�s no evidence.

Civics Lesson #6: Better than placebo is not good enough.

OTW: This seems like a rolling bar that keeps getting put higher and higher as ensuing products and technologies come along.

Deyo: There are good reasons for that. I think the bar keeps moving because the costs keep increasing. We�re now at what � about 2 trillion dollars a year for health care. Two years ago it was a trillion. The cost of health care is going up three, four, five times the rate of inflation. How long can we sustain that? I don�t know. But it�s mostly these new technologies that in an earlier era you could say, yeah we�ll raise taxes a little bit or whatever and manage to absorb the cost. But now something comes along for treating cancer for a hundred thousand dollars a year and pretty soon the people paying the bills are raising their eyebrows.

OTW: It seems like it�s less about the pure clinical evaluations here because, as you said, the FDA may determine it�s safe, but CMS has to determine if they want to pay for it given their financial restraints.

Civics Lesson #7: Know the CMS budget constraints.

Deyo: And also given what bang you get for the buck. How much efficacy there is. And again, I would say in this case the reason I wouldn�t call this an example of rationing is that so far there is no evidence that this treatment is superior to other treatments that are already available. In what sense is that rationing?

OTW: I would say you are rationing a choice. If I were on Medicare, I would be given the choice to take one procedure but I�m not being given the option for another procedure.

Deyo: Those kinds of choices, if the newer choice is more expensive than the other, would be dandy if you were willing to pick up the difference of cost and if we were reasonably certain about the long-term safety and efficacy. Again, I think the public has an expectation that we know how safe and effective these devices are, and for this technology I just don�t think we�re there yet.

OTW: If the industry accepted your notion of outcome-based research would they be better off because they�d be more successful in getting new technologies out into the marketplace?

�The pathway I�m arguing for would be more expensive at the outset.�

Deyo: Perhaps so. On the other hand to be realistic, the pathway I�m arguing for would be more expensive and require more cost for research at the outset. I understand that that�s a significant burden. On the other hand, it probably is true that if we had a better scientific base when new products are introduced, their likelihood of market success would be even greater.

OTW: If the issue here is resources, what will happen? Have we hit the wall? Are we going to be stuck with existing technologies?

Deyo: I don�t think so at all. I don�t think innovation is going to stop, I don�t think creativity is going to end and I don�t think that the drive to improve medical technologies is going to change.

Civics Lesson #8: �New innovations are going to have to prove their value, not just in being equally good to something already available, but really better, more effective, more safe or less costly.�

OTW: Will it get more expensive?

Deyo: It already is. These artificial discs are $15,000 a pop. Implanted defibrillators are $50,000 a pop. This is most people�s annual income for one treatment for one person. You can�t ignore the cost. The reality in today�s environment is you cannot ignore the cost and simply pretend the money available for medical care is infinite. It�s not, and in some sense we are hitting the wall in terms of cost. I don�t think we�re hitting the wall in terms of innovation, but I think what it may mean is that new innovations are going to have to prove their value, not just in being equally good to something already available, but really better, more effective, more safe or less costly. That�s not an impossible bar to meet, but it�s a higher bar.

OTW: We�ve used up our time and we appreciate your willingness to share your thoughts with us on these subjects.

sahuaro 02-28-2006 04:29 PM

Okay, I get the message. Old folks and the disabled aren't worth the money.
Wonder what Dr. Deyo will do if he gets into a car accident...

Kim 02-28-2006 06:47 PM

Hmmm I wonder what happens if he ever needs ADR and cant get coverage for it? Wonder what he would opt for a fusion? I highly doubt it!

Mariaa 02-28-2006 07:38 PM

What irks me is people like Dr.Deyo probably don't have Medicare and gap or supplemental insurance as their primary medical insurance if they have it at all. I'd love to know what his insurance policy is, and that of his older family members...

I think there should be a peer based committee for Medicare legislation and regulations, and these people should be recipients of this type of healthcare and clearly understand and "feel" the impact of the healthcare policy/regulation and issues.

The old,the elderly and the disabled don't deserve $15,000 a pop but this Dr.Deyo probably thinks he and his family members do...that would be my guess at least~

Kim 03-01-2006 03:07 PM

I totally agree with you Maria I am sure he would be on a plane to timbuktoo to get himself or his family members the best care that is known to man and would not bat an eye at $15000 a pop for an aritificial disc if they needed one. What gets me is reading the article he sent a letter to CMS and they read it and took so much stock in it when he had not worked with the disc or had any real evidence to back his claims etc. Sounds to me that they just used him to validate what they wanted to do in the first place.

And lest we forget its not just the elderly that use Medicare. Its the younger disabled people as well what about them? They count as well and deserve adequate medical care. You never see anything about that touted in these articles its just about over 65 and the osteoporosis factors etc.

I would like to see statistics as to what the percentages of Medicare recipients are under 65. I bet there are a lot more than anyone ever stops to think about.
Kim

sahuaro 03-01-2006 10:00 PM

Some further thoughts, venting and more serious:
Since Deyo is objecting to defibrillators, is he going to lobby to recall Cheney's? (had to get that one off my chest, pun intended)
More seriously: Dr. Deyo is pretending to be Dudley Doright but in actuality he belongs to a group which represents private insurance and whose aim is to reduce costs for insurance companies.
Ran the article by my husband who is a physician and although he in no way supports Deyo, he did point out that the clinical trials by definition excluded people over 60 so that there were no data to present to Medicare for that population. I asked him if European data would be acceptable to Medicare and he said no--American patients and American controls. He also said that stents were originally disallowed by Medicare as not being superior to angioplasty but continued research showing less mortality and continued pressure led to Medicare's reversing its decision. He also pointed out--and this is very depressing--that as far as Medicare is concerned there is a big difference between mortality and morbidity (e.g, the improved quality of life for ADR recipients) and that Medicare will not readily agree to put out the money to increase quality of life.

03-01-2006 11:32 PM

I found Dr Deyo's comments to be most troublesome... It's troublesome because

(1) he makes it sound like fusion is acceptable just because we've used it for so long and it's less expensive than ADR. He ignores the reasons and motivations for why ADR is being developed in the first place...to provide a BETTER solution to disc problems that preserves motion! What a joke! There are serious drawbacks to fusion and that's why we are trying to find something better. Now, that we have an option, what...did we forget why we didn't love fusion before?????

Folks we need to find and submit data to CMS to back up the common knowledge that fusion SUCKS! Data to illustrate the numbers of failed fusions that require additional surgeries and how much that costs! Data that details how many fusion patients need a second or third fusion surgery down the road due to stress on adjacent levels. We need medical studies detailing and reminding us of the risks associated with different fusion approaches. Doesn't AILF approach have the same vascular risks as ADR? Isn't PILF less desireable for lumbar fusion because large muscle groups and major nerve roots are in the way, plus less access to disc space? Why aren't our surgeon's reminding CMS of all the downsides to various fusion techniques so that the only critical data being looked at is about ADR? What surgey is perfect??? NONE! Every surgey has risks...I don't believe that for an ideal ADR patient, the risks of ADR is worse than fusion!

Someone with clout needs to remind these people there is a reason why so many surgeons do NOT recommend fusion to younger patients... because of the lack of movement and stress on spines for decades is too much!!!! But now that ADR is an option, younger disabled patients can be fixed! So for some people, including some medicare recipients, the more effective treatment may be withheld!

(2) This is just a political sham...CMS cannot be allowed to ignore disabled young people...if it's illegal to use monetary reasons as a justification to ban ADR, then CMS MUST be forced to acknowledge the younger medicare population.

Isn't it suspicious that Dr. Deyo claims that CMS shouldn't concern itself with how it's decision might influence private insurance coverage. Major insurance companies administer medicare healthcare...there is a very real relationship there! And, if insurance companies look to CMS for leadership (more so than the FDA...as crazy as it sounds, it seems to be the case), then CMS, as a government entity, must consider the ramifications it's decision will have on the general population.

There must be another way for CMS to "protect" certain people in the medicare population (with adr contraindications) without a national ban that hurts everyone whether they are over 60 or not!

Besides if the majority of the patients over 60 are not good canidates due to bone density or other issues...then what's the big deal...surgeons, CMS, the FDA and manufacturers should be working together to make sure these patients are not offered ADR with or with out a CMS ban. But why ban it for everyone...why ban it for those in the medicare population that are not part of Dr. Deyo's "concern?" It's very simple for the manufacuturer to issue a warning listing all contraindications. We also see manufacuturers producing commercials for consumers all the time, why cant the solution be for the FDA to force the manufacturer to educate the public and surgeons about who is and who is not a good candidate for ADR. Wouldn't that slow down the demand for ADR from the older population and those who maybe aren't the best candidates?


Here's the section of Dr. Deyo's comments that inflames me:

Deyo: In this case I�m not sure you�re rationing anything. We have a new technology that is fully equivalent to something we had before at a lower price. What are we rationing? It�s not like we�re rationing something that is highly effective that�s being withheld from people. [YES THAT IS EXACTLY WHAT THEY ARE DOING!] We�re withholding something that is equally effective to what we already have[FUSION IS NOT EQUALLY EFFECTIVE FOR THOSE PATIENTS WHO ARE IDEAL CANDIDATES FOR ADR], often at a lower cost [NO WAY, FUSION WAS NOT RECOMMENDED FOR ME BECAUSE I AM TOO YOUNG, WHICH MEANS I CANNOT BE A PRODUCTIVE SELF SUPPORTING INCOME PRODUCING CITIZEN...OR I CAN TAKE FUSION AND WILL NEED MORE EXPENSIVE SURGIES DOWN THE ROAD!). And there are still important questions about safety in the clinical trials that the rate of serious complications was slightly higher for the disc[ISN'T THIS DATA RELATED TO THE EXPERIENCE LEVEL OF THE SURGEON AND THE NECESSARY EVILS OF THEIR LEARNING CURVE ON THE PROCEDURE?], and certainly in the elderly population its safety is simply untested. It has not been evaluated in people over age 60. Medicare has to consider that [SO BAN IT JUST FOR PEOPLE WITH CERTAIN MEDICAL CONDITIONS LIKE OSTEOPENIA AND OSTEOPOROSIS???]Everybody gets upset because Medicare is seen as the key to other insurance coverage but that�s not their concern. Their concern is for the population they serve. [THAT INCLUDES PATIENTS UNDER 60 WHO CAN NO LONGER WORK DUE TO DISABLING PAIN...WHY AREN'T THEY ACKNOWLEDGING THIS PART OF THE POPULATION THEY ARE SUPPOSED TO BE SERVING?????]

Mariaa 03-02-2006 12:00 AM

Kim and LBP,
I meant to include the disabled in with "the old and the elderly" which are essentially the same population (so I went back and stuck it in) ~ however I was caught up in a thought.. you see, I am part of the disabled Medicare population~ became this at age 48 so I most definately agree ...

Actually I started with my back injury in 1982 but was able by some miracle to continue working until the year 2000~

I would imagine that AARP will be crawling up this guy's butt in response...

sahuaro 03-02-2006 12:39 AM

LBP and Mariaa:
I am as offended and incensed as you are--my post was meant to indicate that there are some political realities that need to be acknowledged. It is interesting that the interview was structured as a "civics lesson"--the task now is to apply the lesson. AARP may be a valuable ally--as would advocacy groups for the disabled.

Mariaa 03-02-2006 10:33 AM

Sahuaro
Agreed re disabled advocates groups and I really think that the "Grey Panthers" will get moving on something like this and AARP will get involved..

Anyone who is a Medicare recipient may want to communicate/correspond with an advocacy group's representative, as well as contacting local/district political representatives/Congressperson~

There are plenty of healthy Medicare recipients or persons that are in good general health. While the general population of 60 and above may be excluded from clinical trials, that doesn't mean a person of otherwise good health is not a candidate for much of what is tested in clinical trials, in fact, much of what is tested is utilized or prescribed for an over 60 y.o. population re meds, technology on the cardiac and orthopedic front and so forth.

As an RN,NP I worked in many a setting where the patients receiving various implants were considered to be middle aged, or elderly. A good surgical candidate is a requirement for many a surgery, however, with stents, valves, pacemakers and such, often the population is lying in and around 50-70 plus years old..

Now more than ever, insurance issues are at the heart of everything. Reimbursement~ a key issue in healthcare..

However, I'm 52, my WC insurance may pay for ADR (who knows) and I'm in good general health, it really galls me to think that I spent half my life working in healthcare only to become a recipient of an insurance carrier that wouldn't pay for something at my age that might actually prolong my life, allow me to be productive once again, and allow me to benefit from working and maybe not taking 6-8 medications related to whatever condition I might have..

What a system that only allows the rich and well insured to have life sustaining/altering/improving healthcare~

The idea of healthcare for everyone in this society is almost laughable.. but it's not..

I'm going to contact my city's Disabled Resources Center to see if I can speak with someone about this~ also want to put something in writing that will address/respond to what has been stated by Dr.Deyo in this interview.


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