At this point, I won't try to repeat what others in the community have already said about the "Strip Safely" [http://www.stripsafely.com/] campaign other than to reiterate some of what I think are their key points, as I have a few points I think are worth noting. The folks at diaTribe have a very well-written summary of what's at stake (see HERE). Also, my friend Riva Greenberg discussed the recent move by Medicare in her Huffington Post column (see http://huff.to/13avkif for details).
Let me take a step back and give you some relevant background which is important for my readers to understand the issues.
Back in 2009, the New York Times reported (see the article at http://nyti.ms/Ddz7L) that the FDA had pressed the international organization, which happens to be the Switzerland-based International Organization for Standardization (ISO) [http://www.iso.org/], which happens to set the standards on accuracy for blood glucose testing supplies that patients use to check their blood sugars. The article noted that the FDA might press ISO to tighten them. The NYT also stated that if ISO refused to act, the FDA suggested it "may instead recognize other (higher) performance standards" on its own, according to a June 2009 letter from Dr. Margaret A. Hamburg, the agency commissioner. Indeed, I personally helped lead the charge that we push our regulators to adopt the tighter standards (catch my post at http://goo.gl/uRPhG for details), something the FDA has not yet done.
What Are Current Accuracy Standards?
The FDA currently uses the 2003 ISO Standard, which requires that 95% of all measurements be within (+/-) 20% of the lab value for values over 75 mg/dl or within (+/-) and 15 mg/dl of the lab value for values under 75 mg/dl.
However, as I've already noted, several years ago, the FDA pressed for tighter standards from ISO, and in April 2013, ISO finally got around to adopting new, stricter accuracy standards.
The new ISO standards require 95% of all measurements to be within (+/-) 15% of the lab value for blood glucose measurements over 100 mg/dl and within (+/-) 15 mg/dl for values under 100 mg/dl. The new standards also require that 99% of blood glucose values must fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes. The CEG defines different "zones" of error and how much that error could cause the person to make a treatment decision that could be dangerous.
In other words, ISO went from a standard of +/- 20% on high readings to +/- 15% on all other readings, and it now requires those standards to be met 99% of the time (rather than 95% of the time). However, right now, the FDA is still using the older, looser ISO standards from 2003. I believe the FDA will eventually adopt the newer standards (after all, they pushed for them in the first place), but like any government entity, they'll have to open the new rules up for public comment.
Beyond the FDA's slowness to tighten the very standards it had pushed ISO to implement several years ago, there is also a growing consensus that the FDA isn't even effectively policing adherence to those standards, but is instead relying on the integrity of manufacturers to ensure those standards are being met. The big players (J&J, Roche, Bayer, Abbott, Sanofi and Nipro) generally do a good job, but FDA needs to crack down on some of the marginal players which sell their products at very low prices (using a lowest-possible-cost business model); their accuracy is presumed to be under the regulatory scrutiny of the FDA, but we know that's not happening right now.
That's where things get messy.
At a recent public meeting, the FDA acknowledged that there are indeed a number of 510(k)-cleared blood glucose (BG) meters and test strips that do not even meet the accuracy standards for which they were originally approved, nor is there a clear course of action to ensure that people with diabetes are using blood glucose strips that even meet current regulatory requirements. Its basically an honor system, but some low-cost players are cheating, and the FDA isn't able do much to make them play by the expected rules of the game.
On May 21, 2013, the Diabetes Technology Society's (DTS) held a conference entitled "Do currently available blood glucose meters (BGM) meet regulatory standards". Diabetes industry reporters from Close Concerns, which publish an industry newsletter called "Closer Look" (in addition to the patient-centered newsletter diaTribe) said of that meeting, "Representatives from academia and industry consistently identified low-cost meters as the source of device inaccuracies on the market."
diaTribe's Adam Brown had this to say (see http://diatribe.us/issues/56/new-now-next/2):
"... the recent 68% price cut in the amount Medicare will pay for glucose strips. In our view, this change will hurt patients in the long run. First, it could mean that unproven and potentially lower-quality manufacturers will become the primary suppliers of test strips for people with diabetes on Medicare. Private insurance providers could follow in Medicare's footsteps and adopt these changes, which could mean limited choices for all patients. Second, the dramatic price cuts stand to reduce the ability of companies to develop next-generation, advanced glucose testing products. We hope the decision is a not permanent, as we also do not see it significantly benefiting healthcare expenditures in the long term (i.e., most healthcare expenditures on diabetes in the US go to hospital visits and services, not to technologies like glucose meters and strips)."
Therein lies several problems, which are listed below:
Problem #1: In 2009, the FDA pushed ISO for tighter standards, and in the spring of 2013, ISO responded with tighter standards. Since then, the FDA has not (yet) followed suit. They need to do so.
Problem #2: Although manufacturers must meet accuracy and good manufacturing practices standards at the time they are seeking approval, there is little (if any) enforcement from the FDA on suppliers outside North America, Europe and Japan to ensure those standards are even being met. Right now, only the risk that the FDA could march in, unannounced, and inspect a facility, keeps manufacturers in-line. But once cheap Chinese suppliers have 510(k) approval, they can do pretty much whatever they want, including not adhering to the very standards which got them an approval in the first place.
The FDA notes that for manufacturers outside of the countries they have worked to "harmonize" regulations with (meaning the NAFTA countries including Canada, Mexico and certain other markets in Latin America and Caribbean basin, Western Europe, Japan, Australia and New Zealand and a few others, although China is absolutely NOT on that list), the FDA cannot simply walk in and inspect a facility without pre-arranging the visit. In some cases (China, most notably), the government must arrange for the inspection to take place, and there are countless stories of how manufacturers routinely "dress up" for the regulatory visits, only to revert back to their regular sloppy conditions after the FDA inspectors leave.
Problem #3: The FDA has no post-marketing auditing authority outside of the aforementioned markets to ensure that low-cost suppliers are even meeting FDA standards, nor is there an independent governing or auditing body (or required membership in such a body) to self-police. But, the FDA could mandate there be one … IF they had one they could require membership in. Right now, no such organization exists.
There is a public meeting of the Diabetes Technology Society (DTS) in just a few weeks, on September 9, 2013. The name of that meeting is "Verifying the Performance of Blood Glucose Monitors following FDA Clearance", (see also http://1.usa.gov/35qB5F) and the FDA will be attending this meeting. If patients can unify behind this cause, we have potential to change this for the better.
We need our elected officials and FDA regulators to do several things. But let's start with what Federal lawmakers have encouraged Medicare to do.
Medicare Slashes Mail-Order Prices, But Taxpayers Likely Won't Realize Much Savings
Beginning on July 1, 2013, a new, nationwide mail-order system for Medicare patients supposedly based on competitive bidding went into effect. (see http://nyti.ms/12J2SWV for an article which outlines the change, note that this was not the best-researched article on this subject, but it was widely-read). Its being called the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program, and was based on a tiny trial in just nine areas of the country. The program aims to limit Medicare's expenditures on various supplies, among them blood glucose (self monitoring) testing supplies. Medicare has a sheet describing the change which can be viewed online at http://go.cms.gov/19Xmwi1. I understand the reasons; lawmakers have been avoiding the fact that demographic reality means 10,000 new people become eligible for Medicare every day for the next 20 years. The Baby Boomers are headed into retirement en masse, so lawmakers want them to save money.
According to Medicare, suppliers are currently paid based on fee schedule amounts that averages $77.90 per month for mail-order diabetic testing supplies (100 lancets and test strips) of which the beneficiary pays 20% (approximately $15.58 per month on average). The new program DMEPOS will reduce the average Medicare allowed monthly payment amount for these mail-order supplies from $77.90 to a new national rate of $22.47, which amounts to a reduction of approximately about 70%. However, and this is a HUGE deal, right now, the change applies to Medicare beneficiaries who order diabetes supplies by mail-order, which the New York Times indicates only accounts for about half (maybe 60% at most) of all purchases anyway. However, the remainder can still go to any local pharmacy that's enrolled with Medicare and buy their testing supplies from there, and Medicare will likely end up paying more through that channel.
Medicare is already promoting this as a big victory for U.S. taxpayers. Laurence Wilson, director of Medicare's chronic care policy group said in an interview "The large mail-order suppliers recognized this was a huge market and they could afford to accept a lower price to reach that volume of customers. The taxpayer wins." However, such exuberance is premature.
That, like other well-publicized government procurement initiatives for the U.S. military back in the 1980s which found that U.S. taxpayers had ended up spending $640 on toilet seats, $7,600 on coffee makers, and $436 on plain old hammers, is probably wishful thinking. Simply put, this particular program has not been very well thought out or tested, and I would argue is unlikely to produce the major cost savings that are now being promoted.
Diabetes Self Management magazine observed (see http://bit.ly/168xxdX):
"According to Peter Cramton, an economics professor, a person who can no longer buy test strips from his preferred mail-order supplier may switch to a local pharmacy, in which case Medicare would end up paying about 260% more. And according to Andrea Bergman, a representative for a coalition of product manufacturers, pharmacies, and other groups that take issue with the new program, the bidding process may lead suppliers to narrow their offerings under the new program, possibly making certain types of test strips unavailable by mail order through Medicare."
However, the biggest problem is that the preferred mail-order suppliers are able to slash their prices by 70% by doing two things.
First, they provide little (if any) customer service, which is no big deal for taxpayers, although Medicare recipients might find it challenging (if not impossible) to check on the status of an order.
Second, and this is perhaps more important, the 18 vendors that were selected could disappear down the road because they aren't making any money (remember, they aren't charities ... that hasn't happened ... yet ... but as the program matures, we could see the number fall from 18 to just a handful, or we could see them try to negotiate better deals with suppliers resulting in the major brands refusing to cut any more deals, leaving only cheap suppliers). However, that may leave only sub-standard providers still in business. Of note: right now, surprisingly few of the major brands are actually manufactured in China because the process is largely automated and can be done domestically or at places like Johnson & Johnson's massive facility in Scotland. But, as diaTribe rightly observed:
"In 2013, as part of a process dubbed "competitive bidding", CMS chose a non-U.S. provider of test strips that resulted in a 72% reduction in the price to be paid for glucose monitoring test strips which won on the basis of price, not quality."
I totally understand the issues Medicare is facing with an onslaught of Baby Boomers threatening to bankrupt a system that U.S. lawmakers have pretty much avoided doing anything to fix for decades (in spite of their knowledge of the demographic reality we now face).
Pound-Wise and Penny-Foolish
Unfortunately, the CMS decision appears to be pound-wise and penny foolish.
CMS is pointing to a big reduction in price and declaring the program a success on that basis alone. However, there is already considerable evidence showing that non-branded glucose test strips do not even meet current accuracy guidelines required by FDA, and the FDA's hands are tied somewhat on the matter. Unlike in the U.S., the FDA cannot simply walk in, unannounced, and inspect a facility based in China to ensure compliance with good manufacturing standards. Instead, inspections must be pre-arranged so that the company being inspected is aware well in advance of the date their facilities will be inspected, and can clean its act up to give the illusion that they are adhering to the FDA's standards, when we know as soon as they leave, they return to the same poor quality control standards and routine adulteration (an FDA term) that existed prior to the inspection.
We may save something today, the longer-term impact may not provide the savings now being promoted. The reason? [Note: I've used Jeff Hitchcock's letter to his own Senator, and build upon his letter as a foundation for my letter, which is below]
Life-and-death medication dosage decisions for insulin in treating diabetes are made several times each day based on the results of blood glucose test readings. The FDA is tasked with outlining the standards manufacturers must meet on such productions. However, if current accuracy standards aren't being met, and the blood glucose readings aren't as accurate as the FDA requires, dosage errors are certain to occur. Unfortunately, those mistakes will prove to be very expensive for us as taxpayers, and a recent move by the new Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program implemented on July 1, 2013 by the Centers for Medicare & Medicaid Services (CMS) is something I believe Medicare really needs to consider BEFORE it promotes the program to taxpayers as delivering big cost savings on its mail-order system. The data is likely to prove otherwise.
According to the U.S. Department of Health and Human Services' Medical Expenditure Panel Survey (MEPS), in 2012, the average/mean cost for an Emergency Room (ER) visit was $1,318 and in 2009, and the median cost was $615. In other words, we may have saved a little bit on the cost of blood glucose testing supplies up-front, but a few ER visits due to mistaken medication dosages (on things like insulin for treating diabetes) is likely to erase those savings very quickly. As a point of reference, according to an October 18, 2006 study published in Journal of the American Medical Association (JAMA) [see HERE for complete details], an estimated 56,000 "adverse events" requiring patient emergency room treatment (most due to hypoglycemia) are reported each year, making insulin the medicine with the highest level of adverse effects. No other medicine even matches it!
People like me in the diabetes community are justifiably fearful that the glucose test strips from the winning bidder, as well as other low-cost bidders from outside the United States, some of whom will be new to our marketplace, will not be sufficiently accurate to allow the safe dosing of insulin. Adding to this concern is the absence of any regulatory rule that requires FDA to monitor incoming glucose test strips on a routine basis to ensure that the strips meet the accuracy requirements that were required for marketing approval in the United States.
Finally, I ask you to encourage the FDA to adopt ISO's 2013 accuracy standards for self-monitoring of blood glucose testing supplies. Commissioner Margaret Hamburg pushed ISO to adopt these standards in 2009. Also, as a U.S. lawmaker, I urge YOU to grant the FDA the authority to impose penalties and/or remove inaccurate blood glucose strips from the market. Currently, the FDA does not have a mechanism to make this happen, unless a product is recalled.
That's the letter I'm sending to my U.S. Congressmen/women which deals primarily with the Medicare issue first. My recommendation to my readers is as follows:
1) Write to your letter about CMS' (Medicare's) new mail order program delivering illusory savings to taxpayers. The reality suggests the savings will be a mirage.
2) Separately, you should write to U.S. Food and Drug Administration (FDA) addressed to Margaret Hamburg and ask her to push for the FDA to adopt ISO's 2013 accuracy standards; after all, they pushed for these! Her address is: U.S. Food and Drug Administration, Dr. Margaret A. Hamburg, MD, Commissioner of Food and Drugs, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002.
3) Finally, join in the StripSafely campaign at http://www.stripsafely.com/ (@StripSafely on Twitter) which is advocating that patients with diabetes (and/or their caregivers) to do pretty what I've noted in my letter above (although the Medicare issue was not addressed).
The StripSafely campaign urges the FDA to:
- Perform ongoing tests of blood glucose strips to assure compliance with regulatory accuracy and quality standards. Currently, glucose test strips are only tested before approval, and these tests are done by the manufacturers themselves - it would be great to have an independent body test quality and accuracy on an ongoing basis;
- Tighten blood glucose meter accuracy standards to ensure that strips are more accurate than the current requirements. The International Standards Organization (ISO) just recently adopted a tighter accuracy standard, though the FDA has not yet adopted it. The current US standard is looser than the new ISO Standard* and the field has been waiting for years for tighter standards to be announced.
- Impose penalties and/or remove inaccurate strips from the market. Currently, the FDA does not have a mechanism to make this happen, unless a product is recalled.
Feel free to use my sample letter as the basis for your own letter to Congress about the Medicare issues. Separately, the StripSafely has some letter templates you can use to contact the FDA as well as your lawmakers to move on the issues. To contact your Congressmen/women, please visit http://www.usa.gov/Contact/Elected.shtml where you can find out how to reach your own elected officials.