Coverage with Evidence Development
September 4, 2006 1:04 PM   Subscribe

Coverage with Evidence Development. Never heard of it? Me neither, until today. It's what they call this idea: if you want to be covered by Medicare, you're forced to participate in medical research. The AMA approves (article abstract only). So much for informed consent.
posted by ikkyu2 (26 comments total)
Man, how crazy can things get down there?
posted by five fresh fish at 1:32 PM on September 4, 2006

OMG teh Constant Gardener!
posted by Artw at 1:43 PM on September 4, 2006

I am shocked that a group of people would be in favour of something that is in their own interest whilst imposing the costs on others. I've never heard the like but that could be because I was born yesterday.
posted by srboisvert at 2:14 PM on September 4, 2006 [1 favorite]

What I'm getting from it is that treatments that for which coverage would have formerly denied might now be covered if it's determined there's a research benefit. That can't be all bad -- it sounds like that could give some patients options for treatment which might not have been available for them previously. But I can see where linking insurance coverage to participation in research could be a bad precedent.
posted by weston at 2:15 PM on September 4, 2006

IANAD, but this sounds like if the patient is "too old", treatment will not be wasted on him:
"The goal of the evidence-based review is to make an informed decision about whether the item or service is “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,” the standard set by law for Medicare coverage."
Can the MeFi doctors and lawyers reassure me that this is not thinly veiled euthanasia?
posted by Cranberry at 2:52 PM on September 4, 2006

IANADOL, but CMS's "coverage with evidence development" policy doesn't withhold care that would otherwise be given. Instead it seems to be their attempt to gather objective data before deciding to add coverage for new, uncovered services.

Ikkyu2, I don't understand your "so much for informed consent" comment, but would like to. Please elaborate?
posted by Snerd at 3:04 PM on September 4, 2006

This isn't sinister at all. They are proposing to cover stuff that wouldn't otherwise be covered by researching it while they cover it.

Think of it this way: I'm insured, I want access to a treatment that isn't yet approved or fully studied (ie, it's *already* experimental). I get it for free for being in the trial.

This is simply systematizing coverage of stuff rather than denying it based on lack of evidence.

I don't see the problem.

In fact, do you know why children's cancer treatment has advanced far faster than cancer treatment for adults and why many childhood cancers are now curable? Because the pediatric oncologists got together and made sure virtually every child treated was in some way or another involved in a clinical trial (given that no one really knew what worked, at first). Something like 90% of kids in treatment had their data captured this way and treatment improved rapidly.

With adults, it's only like 10 percent or something who are in trials and at least in part as a result, treatment has progressed far more slowly.

The point is, we can systematize data collection and learn quickly, or pretend that stuff works before we know that it does and not collect the data and still be at the same level of understanding 10 years from now.
posted by Maias at 3:49 PM on September 4, 2006

So much for informed consent.

It's extremely sinister if a person isn't informed they are being experimented on. What's the deal?
posted by chance at 5:46 PM on September 4, 2006

The deal is that we are *all* being experimented on because much of medicine is not at all based on evidence.

What they are talking about here, I'd imagine, are things like bone marrow transplants for certain conditions which have preliminary data and are expensive, but there isn't enough data to justify covering yet for everyone.

I don't see why it would be a big deal for people to get these treatments on an experimental basis in return for helping provide the data-- and the informed consent would be obvious, given that if you didn't agree to participate in the study, you wouldn't get the treatment paid for.

This is currently the case with clinical trials: if you don't agree to participate in the study, you don't get the treatment (let alone have it for free), so it isn't any more sinister than what we currently have.
posted by Maias at 6:06 PM on September 4, 2006

The way this is currently worded, it covers more than just expanding services, it covers evaluation of existing services. There is a lot of potential for misuse. For expanded services you can have the government being an agent that acts with the pharmaceutical or medical device companies to recruit patients, even to impel their recruitment into novel protocols. Also, because testing medicines and devices against other existing services, that can be practically everyone else. I don't see where the control group (in this case not placebo but standard of care) are not required to be in a study. And for that matter since database is considered part of this, that's virtually everyone in need of health care. This is a slippery slope.
posted by dances_with_sneetches at 6:42 PM on September 4, 2006

The trial is in compliance with Federal regulations relating to the protection of human subjects.

All aspects of the trial are conducted according to the appropriate standards of scientific integrity.

Sounds like they are following the same HIPAA regulations they have before.

Further, they want to control increasing Medicare expenditures by collecting data on what procedures are being performed.

I'm all for patient rights and national health coverage, but I think this scaremongering does this pursuit a serious disservice.

Controlling spiralling healthcare costs will be necessary to provide everyone with an across-the-board fair level of healthcare, which requires knowing where and making hard decisions about where the money goes.
posted by Blazecock Pileon at 10:00 PM on September 4, 2006

I don't understand your "so much for informed consent" comment, but would like to. Please elaborate?

In the medical ethics classes I attended, we were instructed that it was ethically wrong to make someone's receipt of care conditional on their consent for research. We were also taught that when we were doing research on someone, we were to make the subjects informed about all aspects of the research, and we were to obtain their consent after that informing process.

This proposal does none of those things. It proposes to link reimbursement for care to enrollment in research studies. Informed consent is presumed waived.

I think the most surprising thing to me is that the AMA ethics review of the proposal only covered one side of the argument, the 'in favor' side. Usually they either cover the pros and cons in one article, or they get two people to write, one on each side.
posted by ikkyu2 at 10:06 PM on September 4, 2006

umm...well, this was my favorite part of the abstract:

In this article, we argue that CED should not be viewed as coercive because Medicare . . .

what a cliffhanger there, considering that i'm not going to buy a subscription for the opportunity to get a glimpse of what compelling argument Pearson et. al. might have...

that i missing something, or is the conclusion in the original FPP here completely off base? the other (readable) links here point to a recommendation that Medicare pay for treatments that might be considered experimental, if such treatments are taking place within the realm of a legitimate research study and if such treatments are for legitimate medical reasons (and not, say, an elective tummy tuck); and that in covering these services, Medicare would like to please know how the patient did after the procedure (the additional data they are requesting) so that they can use that information to decide whether they should continue to cover the cost of that treatment.

i see nothing here that says that the patient is being forced to participate in such clinical trials or face non-coverage of treatment; in fact, the clinical trials themselves would not enroll a patient who was in any way being forced to accept that treatment--it would violate their own protocols, not to mention that it would be illegal... other words 'coverage with evidence development' doesn't mean 'we won't cover your if you don't participate in clinical trials' means 'hey, if you want, we might be able to cover treatment that is part of a clinical trial, if we think the clinial trial is decent'...
posted by troybob at 10:13 PM on September 4, 2006

We were also taught that when we were doing research on someone, we were to make the subjects informed about all aspects of the research, and we were to obtain their consent after that informing process.

Can you provide examples of specific aspects of research — beyond, say, collecting anonymous statistical data on procedures — which are being collected without the patient's consent, which violate existing HIPAA privacy statutes?
posted by Blazecock Pileon at 10:15 PM on September 4, 2006

Which is not to say I discount your argument, but I would like to see specific examples to define or otherwise qualify the extent and nature of "coercion" hinted at in your FPP's editorial view.
posted by Blazecock Pileon at 10:18 PM on September 4, 2006

...and i think medicare is basically catching up with insurance companies companies have been known to cover the cost of a procedure that it in clinical trials, if they determine the procedure to having some potential (particular it it saves them money)...

...and it can certinaly be the patient asking the insurance company to cover it (because a clinical trial can offer a course of treatment potentially better than or less risky than an approved existing treatment) fact, in one study i know of, patients are begging for insurance coverage under the clinical trial, because the treatment is so promising...the policy being discussed here is basically allowing medicare patients get that coverage and participate as well--but ONLY if they want to...
posted by troybob at 10:22 PM on September 4, 2006

I think the aim here is to look at some "new" therapies or new indications (uses) of existing therapies, but I really hope that we'll have a chance to evaluate some glaring over-prescription issues. A federally-controlled registry is what we're talking about here, and it is something we should applaud, because right now, the drug companies control medical research in this country.

Let's talk about stroke and heart attacks- who has 'em in the US? Old people mostly. But if you go look at the research (industry-funded, natch), you see that the patients tend to be 60-ish, male, and white. The problem is, this population is significantly younger than most of the MI and stroke patients you actually see in the clinics. In general, in research, you'So we're studying the wrong patients! Who knows if our procedures and drugs provide any net benefit to most patients? Nobody knows. This registry idea means we'll be studying the right patients. Read this from the first link:

A recent decision involving CED under the first circumstance described above is the implantable cardioverter defibrillators (ICDs) final decision... The registry... will help provide evidence on the use and course of disease in particular types of Medicare beneficiaries who receive ICDs. This includes many patient groups and settings of care that were not studied in substantial numbers in the clinical trials and some groups in which the clinical evidence of net benefits is less well established.

So now we can track patients over time, and see how they do in the "real world", ie not a controlled double-blind study in a prestigious teaching hospital. MOst importantly, we can monitor the effects of treatment in the real world population, rather than a research population that is almost always pre-selected to show some benefit of the treatment. Participation in this research is minimal - in most cases, the aim is to create a system to follow the patients over time, see if they have any additional problems related to their treatment or disease, which makes perfect sense. This can help our doctors make informed decisions (they cannot currently do so because Pharma controls research), cut costs, and save lives. Still think it's a bad idea?
posted by Mister_A at 7:12 AM on September 5, 2006

Ikkyu2, in what you've posted this really looks like it's saying that Medicare will pay for some experimental treatments that it wouldn't otherwise pay for if you're enrolled in the experiment.

Which sounds a lot like "Medicare won't pay for experimental treatments for people who aren't in the experiments," which seems a well-duh thing to me because I am not a physician. Why would people be receiving experimental treatments outside of an experimental protocol?

And it sounds like the alternative would be "This is an experimental treatment which we don't cover, so tough shit."

Clearly there's something else going on, so what is it?
posted by ROU_Xenophobe at 8:57 AM on September 5, 2006

The full JAMA article is available on google's cache.

In it, they talk about extending treatment options (like bariatric surgery) to Medicare patients who would not otherwise be covered -- but rather than letting them choose non-study options, they would be required to participate in a medical study if they wanted to pursue that course of treatment.

So yes, it seems to be extending coverage. But it sounds like it's extending coverage of medical studies and denying treatment for similar procedures that are not still in trial phases. Which, essentially, is forcing you to participate in clinical trials or receive no treatment, even when that treatment is available to other patients.
posted by occhiblu at 9:36 AM on September 5, 2006

occhiblu your interpretation of that editorial is 180 degrees from mine.

...without CED there would be no coverage at all... seems to be the essential thing here. Now a word about clinical trials: You don't need Medicare or any other coverage to participate in the vast majority of clinical trials. The experimental medical treatment is provided free of charge, as is blood work, etc. In many cases, the trial sponsor will actually pay you to participate. With CED, no one is forcing anyone to undergo medical experimentation, especially when existing treatments are available. With CED, we're talking about registries, by and large.

A registry is a different thing altogether from a clinical trial experiment. In the examples cited in the editorial, registries were created to monitor outcomes in a patient population that was insufficiently represented in controlled clinical trials. Registries in general require the absolute minimum participation from patients, often just signing the consent. The treatments in registries are not experimental per se, they are on the market, but the registry is collecting additional data about "real world" use of the treatment, and/or data on use in a population that is not represented in the original clinical trials.

The bariatric surgery example you cite, occhiblu, is way off base. "Non-study options" for obesity are diet and exercise! And if you have diabetes, you will receive meds thru Medicare; you won't be forced into a trraumatic, potentially lethal operation. The fact is, people over 65 probably shouldn't have bariatric surgery, and the US taxpayers shouldn't be paying for it, because it has a high mortality rate and almost always comes with complications. WHere do you get this idea that people are being "forced" into bariatric surgery? You are making stuff up.

For the knee-jerk reactionists reading this post, this is not a give-away to big pharma, this is a commendable, common sense approach to medical care that may well be resisted by big pharma. They do not control the data, which may show that their products are not appropriate for many patients, or may show that other, older products are equally or more effective, or safer, etc. This is not a case of the government forcing people into medical research. It's easy to be jaded about American medicine, but please, consider things on their merits rather than indulging your visceral urge to bash.
posted by Mister_A at 10:22 AM on September 5, 2006

I work at an academic medical center and I must say I have mixed feelings about this. It sounds like it is intended as a way to expand Medicare's coverage of experimental treatments, but there is definitely an element of coercion that is hard to ignore, as well as the issue of informed consent. Protection for research subjects in the US already leaves something to be desired; a standard clause in most consent forms for research in this country is a clause stating that the patient is responsible for any additional medical care required if there are complications arising from the study. This was discussed extensively in the May 4, 2006 NEJM. Further concerning me is that this comes on the heel of a proposal to ease restrictions on using prisoners in clinical trials. The history of ethical abuse in human experimentation is unfortunately long and this country is no exception. Vigilance is needed to prevent the erosion of the protections in place now that in large part are only a few decades old.
posted by TedW at 10:22 AM on September 5, 2006 [1 favorite]

Blazecock Pileon: So we're clear, the HIPAA laws and the non-coercion regulations are two totally different things. HIPAA only covers access to and privacy of medical information. Nothing more. The idea of "coercion", on the other hand, is regulated in the Belmont Report, a document from which almost all human subject research ethics developed.

Specifically, the Belmont Report States, in the section on "Respect For Persons":
An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.

Unjustifiable pressures usually occur when persons in positions of authority or commanding influence -- especially where possible sanctions are involved -- urge a course of action for a subject. A continuum of such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and undue influence begins. But undue influence would include actions such as manipulating a person's choice through the controlling influence of a close relative and threatening to withdraw health services to which an individual would otherwise be entitled.

So I think ikkyu2 may be leaning more towards the idea that Medicare is causing undue influence, rather than actual coercion. But, note how the report states that the line between what is okay and what is not is unclear. This is why, for example, Institutional Review Boards (the regulating body of a research institution, which reviews studies to make sure that it meets the requirements in the Belmont Report) will say what amount of money is okay to offer to healthy subjects for their time.

What it sounds like, to me, is that Medicare is now *additionally* covering research studies, whereas before it did not. I seem to recall hearing that this stipulation was included in the recent Medicare Modernization Act, but I can't find any links to back that up. To me, it makes it sound like whereas before any medication given under research was not covered, now it will be. If people don't want to participate in a particular research study, then they need to know that (a)they may not be able to get that particular treatment, but instead would be given the "standard of care", and (b) if they did so, there's a chance that Medicare wouldn't cover it (although Medicare does usually cover the tried-and-true standard of care in most cases). Again, as the Belmont report states, the line between undue influence and coercion is unclear.

Also, if we want to be anal about it, Medicare is only talking about participating in "Data Collection Systems." To me, that doesn't mean that any intervention (treatment) needs to be administered. Or, alternately *any* treatment could be administered, but if the institution had IRB approval to collect observation data on those patients then that would be okay. We'll see, obviously, how this pans out in the future.
posted by sarahnade at 10:30 AM on September 5, 2006

Mister_A wrote: You don't need Medicare or any other coverage to participate in the vast majority of clinical trials. The experimental medical treatment is provided free of charge, as is blood work, etc. In many cases, the trial sponsor will actually pay you to participate.

This isn't true in all cases. Usually, the only time a sponsor would pay a subject in a trial is if they are healthy. And usually, that's a phase I study with not a lot of subjects. In many cancer trials, for example, patients receive no monetary compensation, and any labs or costs that are not specified as part of the protocol are not covered under trial costs, and the patients still rely on insurance to cover that. Moreover, many sponsors *do not* pay for their drugs to be used in the trial. I am coordinating a trial like that right now. In this case, the drug in question had fallen out of favor with the company, since they were working on a new formulation without as many side effects. So they didn't want to spend the money to pay for the old drug to be used in the trial (the expected number of patients to get the drug was ~225, and they would be on the drug for a year, so that would get pretty expensive). I had one patient whose authorization for the drug had lapsed or been forgotten, and the pharmacy told him it would cost $10K for a month's worth. We eventually got it worked out, but I've never heard a grown man so scared in my life.
posted by sarahnade at 11:14 AM on September 5, 2006

"You have a health condition, for which you insurance company will not cover treatment. If you want treatment, the government requires that you must participate in this medical experiment."

That doesn't sound coercive to you? Presumably most people on Medicare do not have regular unlimited access to the opinions of doctors and doctor-wannabes on AskMe, or the free time to research other treatment options and how to pay for them. While it's great that treatment options may now be available to those who want them, the power differential between low-income sick patient and government-insurance-agency is likely to create some huge ethical issues.

And with Medicaid threatening to drop your coverage if you don't conform to its requirements for staying healthy, are we setting up a system in which it seems reasonable to deny all healthcare coverage to individuals who don't consent to being lab rats? After all, it would be in their best interests not to be obese -- it says so in the Medicaid contract! -- so if they don't do everything possible to get thin, then we can assume they're simply not serious about staying healthy and why should taxpayers be funding their healthcare?
posted by occhiblu at 1:51 PM on September 5, 2006 [1 favorite]

If "evidence development" means recording all the data about you, your disease and how we treat you in a big database (presumably encoded and double blinded and good stuff like that) so that after a few years we can look at our database and say "Treatment A is better than treatment B." then I'm all for it and think that's what we ought to be doing all the time anyway.*

If it means, "Hey, I just made this in the lab, let's stick it in someone and see what happens!" I want a second opinion.

*My mother in law got her treatment for adult onset leukemia paid for by a study like this. She's still with us a decade later, so it worked for her.

Note: In the interest of full disclosure work for a big pharma company (rhymes with wiser) and so am probably a man in black or something.
posted by Kid Charlemagne at 2:48 PM on September 5, 2006

This has nothing to do with clinical trials regarding new drugs or new devices. Pharma and device manufacturers pay the costs of these trials, which are astronomical. It can cost hundreds of millions of dollars to get a new class of med to market.

This has to do with accepted, standard-of-care therapies - like implanted cardiac defibrillators (ICDs). These are tested, proven beneficial in properly-conducted trials, and approved.

The ICD registry will be a valuable tool for docs, right? I'm not an idiot. I can see that. I can also see that the same arguments that are made for waiving consent and dismissing privacy concerns are the same arguments that always get made in favor of this. There are a large contingent of docs - I used to be among them - who feel that they are proof against ethical wrongdoing because of their training, their intelligence, the restricted scope of their intent, and their good intentions.

Eventually a bad apple works its way into the system those good docs built. The result is a Tuskeegee or a Nurnburg trial.

Ok, editorial off.
posted by ikkyu2 at 4:08 PM on September 5, 2006

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