LifeAfterDx--Diabetes Uncensored

A internet journal from one of the first T1 Diabetics to use continuous glucose monitoring. Copyright 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014

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Location: New Mexico, United States

Hi! I’m William “Lee” Dubois (called either Wil or Lee, depending what part of the internet you’re on). I’m a diabetes columnist and the author of four books about diabetes that have collectively won 16 national and international book awards. (Hey, if you can’t brag about yourself on your own blog, where can you??) I have the great good fortune to pen the edgy Dear Abby-style advice column every Saturday at Diabetes Mine; write the Diabetes Simplified column for dLife; and am one of the ShareCare diabetes experts. My work also appears in Diabetic Living and Diabetes Self-Management magazines. In addition to writing, I’ve spent the last half-dozen years running the diabetes education program for a rural non-profit clinic in the mountains of New Mexico. Don’t worry, I’ll get some rest after the cure. LifeAfterDx is my personal home base, where I get to say what and how I feel about diabetes and… you know… life, free from the red pens of editors (all of whom I adore, of course!).

Thursday, April 14, 2011

Test strip wars

A quick note about this story: Amy T, over and D’Mine asked me a few weeks ago to look into the “test strip thing” in Washington state, and to write up an investigative piece on it.

So I did.

But it ended up being a lot more complicated than either of us ever imagined.

And the story ended up being just a little teensy, tiny bit longer than she wanted. Oh, like maybe almost ten times longer. Assistant Editor Allison Blass asked me, “didn’t it ever occur to you to, I don’t know, STOP at some point??!!!”

Well, I stopped when I had told the story. Some stories are just longer than others and take more time to tell, that’s all.

Anyway, a briefer version of what I discovered posted at diabetes mine, and here for those of you who want to know the full story, with all the details is the “epic” version. Long. Sure. A story worth reading? I hope so.

Let me know in comments—both here and over at D’Mine.


To the best I can tell, it started with a Wall Street Journal Article, but it’s hard to know for sure. News spreads like a virus in the modern world, traveling wirelessly across the landscape of twitter and cell phones, to social media sites accessed in coffee shops, through emails from work computers.

Our interconnected lives put Paul Revere to shame. But it wasn’t the British that were coming this time. It was a little known program in the state of Washington called the Health Technology Assessment Program, or HTA. And apparently they had the power to limit the availably of test strips for diabetic children.

The diabetes social media space exploded overnight in outrage, fear, and pure confusion. But even with a light-speed Paul Revere, by the time the call to arms came, the battle was over. And before any of us could fire a shot, we’d actually won the battle.

But the war itself has just begun.

So what happened? What is this program? How and why do they have the power to leave kids without enough test strips? And why did they choose not to exercise that power?

As it turns out, none of those questions are simple. And the matter is far from dead because the HTA is being considered by many states and at the federal level as a model for reigning in spiraling health care costs nationwide. As panicked politicians struggle to balance budgets, the cost burden from those of us with chronic illnesses will increasingly come under the microscope. And while you might justifiably wonder what politician in his right mind would even consider limiting care for children, the next round of the fight will likely effect us all.

So what the heck is this HTA in the first place?

The HTA was created by the Washington state legislature back in 2006. It’s job is to evaluate cutting edge medical technology by looking at the clinical evidence surrounding its use, and decide if it’s worth paying for or not. It uses a very formal and remarkably transparent process to accomplish its controversial mission. More on that process in a bit, but in a nut shell the HTA embraces the new science of “evidence based medicine” to decide what the state should pay for, health wise, and what it should not.

On the surface, the approach is logical. I’m sure most of us wouldn’t want our tax dollars to go towards paying for overpriced snake oil that may do no good at all, or worse yet, actually hurt someone. The problem, of course, is that as we get into high-tech medicine, separating the snake oil from the medical breakthroughs becomes increasingly more difficult. Looking at a list of technology reviewed by the HTA over the last few years I see they looked at the issues of Computed Tomographic Colonography, Discography, and Hyaluronic Acid Viscosupplementation.

OK.

I have no frickin’ idea whatsoever what any of those things are.

At a glance I’d say I’m not sure I’d want someone tomographing my colon, I thought we all agreed that disco was dead, and maybe my visco needs supplementation, but I really don’t know for sure.

The HTA has also been bold in reviewing things that tend to get accepted on the surface like lumbar fusion, knee joint replacement, breast MRIs, and cardiac stents. And they’ve not been afraid of controversy either. One of the first issues they took on back in ’07 was pediatric bariatric surgery, whether or not to pay for lap-band type procedures on grossly overweight kids. (They ruled against paying for this in the end.)

The HTA’s Vision Statement is to “achieve better health care outcomes for enrollees and beneficiaries of state programs by paying for proven health technologies that work.” It’s mission statement is to “base coverage on evidence that a medical procedure, device, or test is safe, effective, and provides value.” A secondary goal for the HTA is uniformity and consistency of coverage between the various state agencies in Washington state that pay for health care.

Of course what it really is doing is trying to save the state money. The HTA claims, with no citation, that “as much as one-third of the nation’s total health care spending currently goes toward treatments that do not work.” According to a recent HTA press release, since its inception, the HTA has trimmed $31 million dollars per year off of the state’s medical spending.

The way the HTA goes about this is by following a yearlong process that starts with someone saying “hey what about the cost of test strips, are we getting our money’s worth?” and the technology actually being reviewed and ultimately ruled on. And we’re going to follow that process from inception to bitter end.

Welcome to the collision of science, medicine, and money.

How the HTA works

So I don’t want this article to become a dull lecture in public policy, but to understand how taking test strips away from children was seriously considered, could actually have happened, who stood up for the children (and who didn’t), and why that course of action was ultimately rejected, ya gotta understand the process.

And I think the process might surprise you with its thoughtfulness, openness, and balance.

The HTA’s mandate is to investigate health technology, which it defines as “medical procedures, tests, and devices,” which can be either therapeutic or diagnostic in nature. If a HTA investigation shows the tech in question is “proven to be safe, to work, and to add value” then the HTA essentially forces Washington state health programs to pay for it. If the HTA finds against a technology, it will no longer be considered a covered benefit for any for the state’s health programs.

The first step in the process deciding what technology to review. Apparently anyone can “nominate” a technology to be reviewed. Not exactly the same prestige as being nominated for Golden Globe award. Most commonly, the insurance programs themselves, the so called “payors,” nominate technology, presumably technologies that they do not wish to pay for. Of course, the HTA gets more nominations than time allows for, so the program prioritizes their list and selects about ten technologies per year to dig into. Additionally, a tech that was reviewed in the past can be looked at again.

Once a technology is selected for review, the HTA identifies a set of research questions to ask about it. These questions drive the rest of the process forward. The questions form the basis for discovering what is known, from a clinical research perspective, about the technology. In an approach that is repeated throughout the year-long process, both the draft and the final questions are published online before the process moves forward, giving time for public, professional and stakeholder comment.

Once these “key” questions are finalized, a clinical research organization, called an “evidence vendor” is contracted to create an evidence report, which serves as the backbone of the review process. The vendor searches medical literature and summarizes the findings. Again both a draft and later a final report are pubic record, and are open for comment.

Ultimately, the report and feedback is reviewed at one of the quarterly meetings of the HTA Coverage Decision Committee. The committee is made up of eleven independent practicing clinicians. They are not HTA staff. Not politicians. They are practicing medicine men and women. People in the trenches. It’s their word that is final, not the bureaucrats.

Well, not quite final. The HTA revisits its decisions “at least every 18 months,” according to the HTA’s website. Apparently nothing is carved in stone.

The HTA’s mandate is actually fairly narrow, at least in terms of how they look at a medical technology. They have both primary and secondary criteria, which serve as the framework for the questions they ask and how they make their decisions about covering a medical technology. They are:

    Primary Criteria
1)     Is it safe?
2)     It is effective or accurate, and how does it compare to alternatives?
3)     How much does it cost?
    Secondary Criteria
1)     How many people are effected per year?
2)      How severe is the health condition?
3)      How urgent is the review?
4)      How variable is coverage now?
5)      Are there unique ethical concerns? The impact on women, children, elderly or ethnic groups must be considered.

Given the criteria stated above, it amazes me that test strips for diabetic children were even considered at all. Test strips are safe, and they are accurate with no realistic alternative. The population of T1s is small, the condition is severe, and were talking about children for Christ’s sake. But still, the HTA did review test strips for kids.

Who’s effected by HTA decisions

The HTA’s decisions to accept or reject coverage of a medical technology have a vast scope, setting the guidelines for the state’s Medicaid, Labor, Industries, and state Health Care Authority (more on this agency in a moment); as well as providing “voluntary” guidance to the state’s Department of Corrections and the Veterans affairs.

This is worth expanding on a little further. The HTA’s decisions don’t just affect the public assistance populations, the 1.3 million low income adults and children on Medicaid in the state. For instance, the state’s Health Care Authority, the HCA, oversees seven major programs beyond the HTA itself.

1)   The Basic Health program subsidizes private insurance for folks who’s gross family income is at 200% of federal poverty level or below—$44,700 this year for a family of four. So basically people who make too much to get Medicaid but too little to afford private insurance. This program currently has a waiting list in the state of Washington.

2)  The Community Health Services program uses grant funds to help support 36 nonprofit organizations who operate 175 clinics throughout the state, providing medical and dental services. A whopping 273,000 Washingtonians get their health care through this network alone.

3)  The Prescription Drug Program, a state run discount card that helps citizens afford the cost of prescription medications. I noticed that the state provides info on this program in English, Spanish, Russian, Chinese, Korean, Vietnamese, Tagalog, and Punjab—which I think says a lot about the diversity of the Pacific northwest.

4)  The Public Employees Benefits Board. Yep, the HCA overseas health insurance for state workers, retirees, and their dependants. It’s also on point for worker’s compensation coverage for on-the-job injuries.

5)  The Uniform Medical Plan—the actual insurance plan for state employees. The plan covers more than 335,000 public employees, retirees, and family members.

6)   The Washington Health Program, an “affordable” basic health plan geared to provide no-cost coverage for basic health services with an eye to reducing hospital ER visits. This program also serves as a safety net for those on the waiting lists for other programs.

7)   The Washington Wellness Program, an education site and portal for other health and wellness programs in the state, such as exercise, nutrition,  smoking cessation programs and the like.

So HTA decisions affect more than just public assistance patients, for all practical purposes they set the stage for what is covered or not covered for pretty much everyone in the state of Washington.

Since 2007 the HTA has finalized 21coverage decisions, shit-canning 10 technologies and continuing to cover 11 others, at least under conditions where evidence demonstrated benefit.

Among the technologies that were kept are lumbar fusion, bone growth stimulators, and routine ultrasounds for pregnancy. In the trash heap went upright MRIs, implanted infusion pumps for chronic pain, and TENS units (Transdermal Electrical Nerve Stimulators). I was sorta bummed to hear that, as I personally use a TENS unit and find it very helpful for my back pain from degenerative spinal disease. Still, when I researched TENS units for myself, I recall the clinical evidence showed that they only work in about half of people who use them, so presumably the HTA decided half the money spent would be wasted.

The HTA’s look at test strips and CGMs for kiddos

Once a review process starts, all the steps along the way are well documented, amazingly
transparent, and generally posted on the HTA or HCA web sites. The one thing I couldn’t find, or fathom, was why on earth they took on a subject like this in the first place.

Looking at the key questions that are generally reviewed—is it safe, is it effective, how severe is the condition, does it impact children—it seems like the outcome is a foregone conclusion. Why waste the time and money looking at it in the first place?

So I wrote to the HTA and asked, not expecting to get much of an answer. To my surprise, like everything else surrounding the HTA, they were open and brutally honest. Huh. They must have their staff chained to lie detectors attached to electro-shock machines.

Supervisor: Are you using your work computer to post to Facebook?
Employee: No sir, of course no— ZAAAAAAAAAP!

I started with their media contact, Sharon Michael in the HCA public affairs office. She replied within hours and got answers to all my questions by day’s end. Interestingly, at the end of her email was this little note: “FYI: Our offices will be closed on Monday for a state-mandated furlough day.” I found it poignant that even the folks who are tasked with deciding where to stop spending money in health care are furloughed.

A sign of the times.

Her email to me stated that the answers to my questions were “prepared by the HTA program staff,” so we can’t be exactly sure who is speaking, but the staff states that the review of blood glucose monitoring started off  as a request from “state agencies” and goes on to say: 

“Agencies believe that glucose monitoring is an important component of diabetes management; however there are important questions about optimization, frequency, outcomes, and methods for SMBG (author note: Self Monitoring of Blood Glucose) and those questions bear directly on creating a policy that best supports diabetic beneficiaries’ total needs while being the highest and most efficient use of our shared state resources.”

And the staff goes on to say that:

“After the initial selection of the topic, it became clear that insulin dependence and age are key different population.  For adults (mostly non-insulin dependent) a recent well conducted evidence review provided evidence to formulate a policy, but there was no such information on 18 and under group. It did not seem reasonable or optimal to have a limitless supply without any review.” 

The Report itself

In the case of the test strip report, the contracted evidence vendor, Spectrum Research, was given five key questions to research. Paraphrasing the questions and translating them into English they were:

1)    Is there evidence that test strips work?
2)    If so, and if you test more, do you get better outcomes?
3)    Are the damn things safe?
4)     If so, are they equally safe for everyone?
5)    Are they cost effective?

Of course each question has up to eight sub-questions. For instance under the “do the frickin’ things work” question are sub-questions like “what about A1C?” “what about for reducing hospitalizations?” “what about reducing mortality?” and “how does it affect quality of life?”

Oh, yes. And I forgot to mention two further complications. Spectrum was instructed to investigate these questions only for people under the age of 18, and they were instructed to look at both test strips and continuous glucose monitoring (CGM).

On top of all of that, HTA evidence vendors are only allowed to look at specific kinds of medical research, in particular they seek out evidence from randomized controlled trials, or RCTs.

RCTs are considered the gold standard for clinical research. They work by taking a group of similar people (such as age, health, ethnicity) and dividing them into two groups, randomly assigning each person to one group or the other. The first group gets a medication or treatment and the other group, called the “control group” gets diddly-squat. Actually, in medical research, the control group often gets a fake med so they don’t know if they are in a control or study group. Then you wait a little while, or a long while, and then compare the health outcomes of the two groups to see if your therapy worked. Scientifically, it gives you slam dunk results.

The test strip report for the HTA was drafted by seven Spectrum employees with a mix of advanced degrees including two MDs and three PhDs. This report is no small thing. There are four documents totaling 505 pages.

The report used a method called PICO as the lens with which to view and sort the data. PICO stands for Patients-Intervention-Comparators-Outcomes. Say that five times really fast. It’s the inclusion/exclusion criteria for the report. In other words, PICO guided Spectrum in choosing what studies to include in their analysis and what studies to ignore.

P is for Patient. So to be included,  a study had to look at folks under 18 who are insulin dependent. If the study wasn’t 80% or more kiddos, or didn’t have the data separated by age group, it wasn’t included. Some of the stakeholder feedback made a big deal of studies that were left out, but again, the report (and the HTA’s review) was only concerned about the test strip utilization of kids. The adult strip usage in the state of Washington has already been strangled down to the Centers for Medicare & Medicaid guidelines of 100 strips a quarter for pill poppers and 100 strips a month for shooters.

I is for Intervention. They kicked out studies of retrospective CGM use. They only wanted to look at studies on real-time patient use of data.

C is for Comparators. They wanted to find studies that compared how folks did with, say 8 strips per day compared to how they did with 5 strips per day. They also were looking for how folks compared using test strips as a stand-alone therapy vs. those using strips as part of a package of “education, feedback, and support.”

O is for Outcomes. I’m not sure what kind of study wouldn’t report an outcome, but ones that didn’t were not included. Spectrum was instructed to look for outcome data on getting A1C in target and keeping it there (yeah, riiiiiiight), hospitalizations, high and low blood sugars, DKA, microvascular and macrovascular complications, effect on medication or nutritional management, quality of life, length of life, and—of course—cost.

The effort was massive. Spectrum found 240 unique citations. Of these 170 were reviewed by abstract (the reader’s digest version that serves as an “executive summary” of a clinical research paper) and 70 were reviewed in full text. In the end only 20 of the 240 studies that were located in the literature were included in the report. The rest failed the inclusion/exclusion criteria. It doesn’t mean they were bad studies necessarily. It just means they couldn’t help answer the question about strips for kids. Another 23 studies were located in the bibliographies of the reviewed reports and included.

It would seem then, that the primary literature search missed just over half of the relevant clinical evidence.

So what did they find? The report states that “There are no randomized controlled trials or observational studies that evaluate SMBG testing as an independent component of management.” At least none were found. And they looked pretty hard.

Naturally. Because who on earth is going to create a RCT where you have one group of kids test and another group not test and then see what happens?

Spectrum went on to say that the best indirect evidence for the value of test strips comes from the famous Diabetes Control and Complications Trial (DCCT) back in the ‘90s that set the stage for the modern treatment of diabetes. Editorializing here, but this is really old news, people. This study happened when many D-folk were still doing urine testing for blood sugar. Meters were new. And primitive.

So why has no one looked at this issue since then?

Because it’s too fucking dangerous to do so, that’s why. Even the DCCT shut down its control arm half-way though. The benefit of testing was so great that it would not have been ethical to keep going. It would have resulted in the death or maiming of study subjects.

So yeah. Testing is that big a deal.

Testing has since become so entrenched in diabetes treatment that it is carved in stone.

But what is not known, what maybe should be studied is More vs. Lots More. I think that would be safe. Not more vs. less. But I would love to see a study looking at whether T1s who test 12 times a day do better than ones who test 8 times a day.

But moving on…..

When it comes to test strips he bottom line of the report, which looks at the bottom line, is “There is no evidence available to assess the cost effectiveness of SMBG or CMG in persons with diabetes ≤18 years old who require insulin. No full economic studies which focused on the cost effectiveness of CGM or the frequency of SMBG were found.”

In short, more than 500 pages to say, “we really don’t know squat.”

All righty then.

What about CGM effectiveness? The report’s bottom line on CGM is “There are a number of questions that remain with regard to rt-CMG use in particular. It is not clear from the evidence available what precise role these devices may play in those 18 years old or younger or which individuals may most benefit from this technology. It is not clear to what extent improvements in overall glycemic control within CMG groups is clinically meaningful or how they may translate long-term into other health outcomes. The short follow-up time in the trials to date preclude making conclusions about the long-term benefits of CGM.”

English translation: we don’t know squat about CGM either.

The response to the report

The Spectrum report got a lot of heat for saying the evidence is weak. In their defense, if you read the report carefully they are not saying the technology is weak, they are merely saying that the evidence—as defined by the search criteria—is weak.

Once the draft report hit the HTA’s web site the public and the stakeholders weighed in. Reponses were filed by American Diabetes Association, The Endocrine Society, and the Pediatric Endocrine Society. So now you know who your friends are. Industry came to bat with Abbott, Beyer, and Roche for the fingerstick team, and Medtronic and Dexcom for the CGM part of the equation. The enemy of my enemy is my friend, right?

Of course, patients, type 3s, and docs weighed in as well.

But painfully missing from the advocacy was the Juvenile Diabetes Research Foundation.

The ADA was able to pull a nice rabbit out of their hat by finding another Washington state study from ‘06 that found the cost of treating “uncomplicated diabetes” –sign me up for that please—is $1,600 per year while a single DKA costs the state $7,000. In fact, the ADA points out in their response, diabetes-related hospitalizations were racking up $1.27 billion per year; suggesting that saving a few pennies now would not be in the best interests of the Washington state tax payers in the long run. Of course they also included the whole little-Susie-will-die pluck the heart strings thing too.

The Endocrine Society letter stated “Although there may be disagreement about whether or not SMBG is useful in patients with type 2 diabetes on oral agents, there is little controversy among endocrinologists about the effectiveness of its use in pediatric, adolescent and adult patients on multiple daily insulin regimens.”

I thought the Pediatric Endocrine Society’s response was both medical and lyrical. A sample: “The DCCT had to be discontinued in 1993 when an interim analysis revealed that the benefits of intensive management of diabetes were so great and unequivocal that it was no longer ethical to continue to conventionally manage patients with diabetes. Since then, it has been justifiably considered unethical to deny any group of children frequent SMBG as to do so would preclude intensive insulin management. Therefore, it is not reasonable or ethical to assume that a dearth of randomized studies of SMBG indicates such monitoring to be ineffective; in fact, the dearth of studies actually results from the fact that intensive insulin management based on frequent SMBG is effective.”

They go on to point out that insulin has also come a long way since the DCCT, and more testing is needed now than what was done back then—both for effectiveness and for safety. They further point out that testing does not stand alone. It’s a link in the chain of insulin delivery, and that trying to look at testing in an isolated way is moronic. (OK, I probably paraphrased that a little bit). In their slightly stuffier way they say that testing blood sugar is not merely “a method to improve glycemic control – it is instead a necessary means for adjusting insulin doses…”

Abbott, who presumably sells test strips to the state of Washington, and therefore has the most to lose in dollars, hired United BioSource Corporation to write a counter-report to the Spectrum report. It’s sort of machine-gun science, trying to poke holes in the other guys’ work. Assassination by science, if you will. BioSource’s job was to try and dismantle the Spectrum report. To be fair, they were not playing by the same rules of HTA. Abbott filed BioSource’s 39-page report plus a 14-page appendix that is a copy of the federal statute that governs the protection of human subjects in clinical research as part of their feedback. Their argument was RCTs on kids under 18 would be a violation of federal law.

The BioSource report states “The stated focus of the HTA report is on the efficacy, safety and cost effectiveness related to SMBG, however, the report neglects to address the indirect long-term impact of not maintaining glycemic control. Overwhelming evidence and an established standard of care in support of glucose monitoring to maintain glycemic control has been widely accepted and practiced for at least several decades.”

Spectrum was given the chance to defend their report and respond to feedback. To their credit they did incorporate some evidence provided by the feedback process. But Spectrum defended their decision to give test strips a  low “overall strength of evidence” score simply because they could find precious little if any studies that fit their criteria. The criteria mandated by the HTA.

They point out that doesn’t mean BGL testing at high volume for kids doesn’t work, it just simply hasn’t been studied. They also point out it’s not their job to make a recommendation to the committee.

The decision of the committee
According to the New York Times, the committee, who is currently made up of seven doctors, a nurse, a speech pathologist, a chiropractor, and a naturopathic physician voted unanimously to leave the test strips the hell alone with no daily limit.

CGM wasn’t as well loved by the committee, but it wasn’t kicked to the curb either. The committee advised coverage for “trial settings” and in cases of severe hypoglycemia.

The decision will not be final until May 2011 to allow for further public comment.

At the same meeting the committee shit-canned injections of pain meds around nerves in the spine. They stated that the clinical evidence did not support the practice.

But I don’t live in Washington state, why should I care?

According to the Wall Street Journal, the HTA’s director, Leah Hole-Curry, JD, has been appointed to the federal Patient-Centered Outcomes Research Institute. Yep. The HTA is going nationwide as part of the lumbering rollout of health care reform. Balancing outcomes, evidence, and money is going to be tomorrow’s health care.

Following the money—a LifeAfterDx analysis

A recent “policy brief” posted at the website of Washington state Governor Chris Gregoire states, “in the past decade, the amount Washington state pays annually for health care has doubled to more than $5 billion — a rate of increase that dwarfs any other part of the state budget.”

The Governor is quoted as saying “spending on health care substantially hinders our ability to invest in such essential services as education and public safety — each dollar spent on health care is a dollar not available for anything else. And it’s not just critical public services that are being squeezed. Individuals, families and businesses are also overwhelmed by health care costs.”

For what’s worth, nationally, health care in America costs us as a society 16% of GDP. That means that 16 cents out of every dollar our economy produces disappears into the gaping maw of health care.

Ours is the most expensive health care “system” on the planet. And we are not getting our money’s worth. It costs 2.3 trillion a year, around $7,600 a head on average, but this average is deceptive as it ignores the fact that many American simply can’t afford to participate in the so-called system in the first place. And by far, Americans do not have the best standard of health. The World Health Organization rates us at # 39 amongst nations behind such enlightened nations as Malta, Oman, Luxemburg, Cyprus, and Columbia. Next on the list below us is Slovenia, followed by Cuba and Brunei.

But back to the Pacific Northwest, just how big a deal is the cost of test strips for T1 kiddos for the state of Washington in the first place? Over the last four years Washington state shelled out close to two million dollars to keep between 700 and 900 kids in strips. The dollar amount has been shooting up, with 2009 spending close to double what it cost in 2006. Of course, that’s just the strips that the state is directly picking up the tab for. The cost of strips also influences the cost of the private insurance programs that the state subsidizes for folks caught between total poverty and the ability to keep their heads above water.

Of interest, the email I received from the HTA answering our questions about why they chose to review test strips in the first place, added this little tidbit at the end, almost as an afterthought: “Later in the process, as agencies reviewed their utilization data, they also discovered that high utilization may reflect mismanagement of diabetes, and be an indicator of overuse of other resources, such as emergency room care due to poorly controlled diabetes. A reasonable restriction on number of strips may do two things – force cases of poorly managed diabetes into the payment review process, where better management/re-education might be part of the solution – and also detect cases of fraud where strips are being purchased under an insurance plan and resold.” 

Overall, however, the glucose monitoring costs work about to about $770 bucks per kid per year on average. Less than two bucks per day per kid. 85% of that cost is strips, the rest being meters, lances, lancing devices and some CGM supplies.

Data on the state’s test strip spending comes from two primary sources. One source is insurance reporting data from the state’s employees, dependents, and retirees; and the other source is data about the folks covered under the various assistance programs. There are some troubling differences between the two sets of statics.

Looking just at 2009, the most recent year for which data is available, the employee plans were shelling out a total of $1,389.31 in testing supplies per kid while the social programs were only paying out $554 per child.

The employee plans were covering 110 T1 kiddos while the social programs had 547 (with another 282 pediatric T2s, a shocking number to me, but not part of the test strip data as the vast majority of those kids are on orals and don’t test often).

The data between the two sets clearly shows that kids on assistance programs generally test one time less per day than kids on employee programs. In ’09 employee covered kids tested on average 4.9 times per day while kids on social programs tested on average 3.8 times per day. That one-strip-less-per-day difference remains consistent over the last four years.

Interestingly, 12% of the T1 kids covered under the state’s worker plans had a hospital visit in 2009 while 56% of the public assistance kids ended up in the hospital the same year.

Could one less strip per day really lead to so many more hospitalizations? Is this, by itself, proof that better testing gives better outcomes?

To be honest, I doubt it. We have to remember that T1 children living in poverty face an entire array of other issues from nutrition, education, social support, to God only knows what else. We need to be careful about making assumptions here.

Still, it is interesting.

But to me, I’m shocked that either 4 or 5 strips a day keeps these kids out of the grave. In my playbook a well controlled T1 needs a minimum seven strips per day. Minimum. Here’s my recipe for control: one test in the morning that doubles as your pre-breakfast test so you can correct your meal bolus as needed for elevated or below target blood sugar. Then one test two hours after b-fast. This is your way to see if you did your morning bolus right, fix it if you need to, and is also your after-meal advanced hypo warning system if something went wrong in the other direction. You need to do the same before and after lunch. And before and after dinner. And of course at bedtime. Many kids also need to check or be checked in the middle of the night. And what if you have a hypo? How many strips will that little adventure use up?

And there are more disparities here. And not all of them make sense. The social service programs shell out a lot more for meters than the employee programs do. It could be that meter companies aren’t supplying sample meters to the nonprofit clinics that most of the poor utilize, while private practices are better supplied. But when you only look at spending on strips per child you see that the kids covered under employee plans get $1,274 per year in strips while kids covered under social programs get $470 per year in strips. Now, we’ve seen that kids on the social programs either get or use fewer strips per day. But not enough fewer to account for the vast difference in dollars. Are the social service kids getting inferior strips? Are the kids of employees getting overpriced strips? I don’t know.

Another troubling disparity is that the employee programs shelled out around $11,000 in CGM stuff, while the social programs didn’t spend a dime on CGM. Apparently, none of the T-1 kids covered by social programs, who we’ve already seen have much higher hospitalization rates, have access to CGM.

But limiting strips to kids wouldn’t have saved the state a half million a year in the first place. Not without paying for a lot of funerals. The best the state could have done is to reduce this amount. After all, there was no talk of eliminating test strip coverage altogether.

It begs the question: why didn’t someone look at this a little more closely before embarking on this adventure? The review was not cheap. The savings wouldn’t have been great. The results pretty much a foregone conclusion. Why waste more money?

How much did this look at test strips cost the state anyway? There is no real way to know, or determine, how much the staff time of various persons at the effected agencies who had to collect and review data cost the state, but there is one price tag that is definitive: how much did the state of Washington pay the evidence vendor, Spectrum Research, for the study?

We asked HTA and they answered. To date, they have paid Spectrum $83,432.70 for the glucose monitoring reports. Nice work if you can get it.

A bargain, I guess. The HTA tell us that clinical evidence reports range from $75,000 to $150,000 each. They further tell us that this is a typical market rate. So that means the glucose report was towards the lower end of the scale. Abbott probably shelled out a similar amount for their anti-report report.

So I can’t help but think that the 667,000 test strips that could have been bought with that money.

Summary

Washington State is trying to base their medical spending decisions on clinical evidence. As a government, they are stating they are willing to pay for medical technologies that work, are safe, and are cost effective. They don’t want to pay for things that don’t work, are dangerous, or expensive approaches that offer no benefit over cheaper alternatives. It’s not a bad system.

No one in their right might would question the goal. If the health care system pays for medical snake oil we all pick up the tab, collectively, as a society—both in dollars lost and in sicker people.

But that said, separating the wheat from the chaff is no easy matter. The HTA relies heavily on searching clinical data to form “evidence based” reports on medical technology effectiveness.
But the well may be poisoned.

Author Carl Elliott in his chilling book “White Coat, Black Hat” claims that as much as 40% of the content of so-called peer reviewed medical journals isn’t real science, but may be material that is actually written by the pharma industry and “edited” by medical academia desperate for publication credits in their vicious publish-or-perish environment.

Of course, if that proves true, we’d expect the side effect to be that stuff which doesn’t work very well might look better on paper than it really is. But still, this illustrates the difficulty of separating commerce, greed, and good science from medicine and health care.

On the other side of the coin, cutting edge approaches may not have a sufficient track record of success under their belts to look good on paper, even if they work, are safe, and are cost effective.

Truly, the Devil is in the details.

And, of course, many more times than once, clinical research has later been proven to be flat-out wrong. Consider the epic drug recalls of medications that seemed safe in clinical trials only to prove dangerous once unleashed on the public. Vioxx comes to mind. Fen Phen comes to mind. A dark cloud hangs over Avandia, once the most prescribed diabetes medication on the planet.

And yet, I’m impressed by something that strikes me as unique and courageous about the HTA approach: cost is openly discussed and considered as part of the coverage review, unlike insurance companies who mainly look at money while pretend to only be interested in science.

I think Washington state deserves kudos for recognizing the inherent weakness in fact finding, and for designing the HTA so that all the stakeholders can be heard and be involved at each step in the process to provide for balance.

But most importantly, in the end, the state has put the final say in the hands of medical professionals who actually work in the trenches. It beats the hell out of the status quo where a Wall Street Suit who’s only looking at a balance sheet decides my health destiny.

And the mere fact that test strips and CGMs for kids weren’t kicked to the curb may be the ultimate testimony that this system actually works.




3 Comments:

Blogger Scott said...

I cannot help but wonder whether the cost issue could be partially addressed by the fact that prices, even those negotiated prices (which are far lower than retail) among pharmacy benefits managers have increased during the same period? We know that spending nearly doubled in the 3 years between 2006 and 2009, and I would have to presume that like the various drug trend reports produced by Medco, Express Scripts and CVS Caremark, the cost excludes higher utilization rates (e.g. more patients using test strips) and is therefore on a cost-per-patient basis (if it's not, then that's a problem). The reality is that for all the complaining healthcare payers do about costs, their analysis is sometimes missing simple alternative solutions: press for bigger discounts from the manufacturers. One of them is bound to cave in and do it because the business is big enough to accept a tighter margin. Still, thanks for an interesting review of the situation. BTW, the net impact of this seems to be limited mainly to employees in the State of Washington, and as you note, doctors can override the guidelines. I remain unconvinced this will have a larger impact on the overall population given the disjointed manner in which healthcare is paid for in the U.S.

9:52 AM  
Blogger George said...

What a great post. I have just learned so much that I need a nap.

I love reading anything you write Wil. You make it so I can actually understand this stuff.

That is not an easy task.

11:40 AM  
Blogger Scott K. Johnson said...

Wil...

1) I'm SO GLAD that you were able to publish this.

2) This was a fantastic ride through a complicated subject. You made it fun to learn. I'm with George here - it's no easy task to break this stuff down into everyday language.

3) It was really interesting to see who all weighed in on the matter once it was open for public review. Gives us all a lot to think about, doesn't it?

4) Did I already say I'm so glad this work got to see the light of day?

11:48 AM  

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