Getting Off the Harm Merrygoround

Here we go again. I have written about harm from bidding before. It just got kicked up a notch. 

Today the Journal Diabetes Care has an article on Medicare Bidding in the online preview of the April edition. What 8 months ago was a poster has been peer-reviewed and published in a premier diabetes medical journal. 

A press release on the paper is titled: Medicare's Competitive Bidding Program Puts Beneficiaries' Lives at Risk. 

The paper builds on the Government Accountability Office (GAO) concerns on the safety monitoring of the Competitive Bidding Program.

Meanwhile, Medicare says the program is great, no harm, no foul, and they don't hear any complaints. Oh yeah, and they are going to put beneficiaries through a new round of disruption starting in July.  

Let's NOT do that. 

Surveillance Success!

Good News!

The Diabetes Technology Society (DTS) this week announced the launch of the DTS Surveillance Program for Cleared Blood Glucose Monitors. This surveillance program will provide independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance against accepted standards, and generate information that can assist patients, healthcare providers, and payers in making the right product selection.

For details please see: http://diabetestechnology.org/surveillance.html

Initially the program is being supported by Abbott but DTS says that other BG Monitor manufacturers are currently looking into coming on board.  They (and I think all of us in the community) would welcome funding from other sources that recognize the importance of and wish to lend their support to surveillance of cleared BG Monitoring systems to obtain information about the performance of these products.

The announcement says there will be patient advocates involved. I asked DTS who that would be and they replied, "Patient advocacy groups will be selected based on recommendations by the Steering Committee and the Board of DTS." I may have thoughts on the matter too. 

Finally I asked, what do we need to do to make surveillance mandatory, because, I assume it will start as voluntary?

DTS's reply was, the program can be made mandatory if a special rule is developed by FDA or if a law is passed by Congress.

So there is still advocacy work to accomplish.  

Yo DOC! How do ya feel about 400?

Comments that is.

We are at 342.

If posts to the FDA docket on personal use glucose meters were held to the 2003 ISO standards for glucose meters, I could claim we have 400 comments and consider that an accurate reflection of 342.   342+20%=410.

That's bogus. Let's get a real 400. Commenting is easy. It takes two minutes.

The docket is open to May 7.
That's one place where a 400 is something to feel good about:

Please:

Comment on the Guidance

Add a Second Comment on Generic Strips

Watch the #DOCasksFDA Chat.

Yes, Who is accountable? FDA Notice on Generic Strips

StripSafely asked Who is Accountable for generic test strips.  Apparently it is not a academic question. FDA today release a warning titled, "FDA Safety Communication: Shasta Technologies GenStrip Blood Glucose Test Strips May Report False Results"

From that release:

Recommendations:
Identify whether you are using GenStrips glucose test strips. The strips may be packaged in green and white packaging with the GenStrip name on top, similar to those shown below.


For People with Diabetes:

• Discontinue use of GenStrip Blood Glucose Test Strips.
• Obtain alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters.
• Ask your pharmacist or contact your diabetes care provider if you need help determining which test strips to use with your glucose meter.
• As always, be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). If you experience symptoms of either high or low blood sugar, contact your diabetes care provider for advice on treatment.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm395180.htm

4/30 Update: Please see this MarketWatch report on the issue. GenStrip's Acquiring company states they will replace strips.  http://www.marketwatch.com/story/decision-diagnostics-responds-to-shasta-technologies-fda-safety-warning-letter-2014-04-30

Help FDA understand how generic strips can be part of their new guidance structure. Comment to the dockets and ask for clear rules to protect PWD. Copy and paste the draft comments from StripSafely below to the FDA docket HERE.

Progress

I find many encouraging ideas in the FDA’s draft guidance. Its tighter accuracy standards (particularly in the hypo range) are a big step forward. The new emphasis on test strip lot release criteria will lead to better quality control, and the requirement for front-of-package accuracy information will make clear that the quality of blood glucose meters varies – and allow users to make informed choices.

Suggestions:

Third Party Strips – Who is Accountable?

In the introduction to its proposed guidance on blood glucose meters, FDA speaks of self-monitoring blood glucose test SYSTEMS (SMBGs – caps mine.) This terminology is important because of its clearly implied meaning:  a meter and its strips are a complete system, designed to be used together.

Why is this important?

There are several reasons:

One is liability. When a third-party manufacturer makes test strips for a meter it is unclear who should be responsible for maintaining the system’s integrity and who would be held accountable in the case that something goes wrong:  the meter company, the strip company, caregiver or the patient.

Generic strips are approved for use with meters sold before specific dates. The data a meter is sold is not always clear. Patients need clarity.

FDA draft guidance speaks of third-party strips starting at line 990 of the over the counter draft guidance (1050 of POC) saying. “We strongly recommend that agreements between the third-party strip manufacturer and the meter manufacturer are in place to ensure that the third-party strip manufacturer is made aware of any design changes to the meter. In cases where this is not possible, the third-party strip manufacturers should sufficiently address, in their submission, how they will mitigate the risk of incorrect results due to meter design changes.”

That is not an academic issue. Insulin is a very dangerous drug that puts over 97,000 American in the emergency room each year.  A recommendation is not enough.  The FDA’s final guidance on blood glucose meters and strips should require formal agreements (and plans) between meter manufacturers and third-party strip manufacturers as part of the criteria used for clearance. Until these standards are in place, third-party strips should not be considered part of a system. Without bing part of a system the should not be cleared for sale. Patient lives are at stake.

Additional third party strip considerations

RESPONSIBILITY – I hope FDA clearly defines who is responsible/liable when an adverse event occurs as a result of the use of a third-party strip.

ACCURACY – Third-party strips should be be held to the same standards of accuracy as all blood glucose test strips. Accuracy should advance. Strips that fail to meet new accuracy standards set by this guidance should be rapidly phased out of the market.

POSST MARKET SURVEILLANCE  - There should be a program in place to ensure the quality and accuracy of all meters and strips, including third-party, after the meters and strips have been cleared for sale

RECALL – Recalls of all strips and meters are an important post market protection. Options to recall must stay open and include third-party strips. In the case of a recall communication to users of a SYSTEM are important. Clear guidance should be in place to ensure that the safety of patients using systems that include third-party strips is not compromised.

MDR – The FDA should require all strip and meter manufacturers to establish clear procedures for Medical Device Reporting in the event of adverse events related to these meters or strips. Third-party strips will add complexity to the submission process; before they are allowed to enter the market, third-party strip manufacturers must establish a clear, robust and simple process for tracking and submitting MDR.

DME – The FDA should make clear in its guidance documents that systems of meters and strips (including third-party) that do not meet the FDA’s stated accuracy requirements cannot be considered durable medical equipment (DME) and thus should not be eligible for reimbursement by CMS or other payers.

THERAPY ADJUSTMENTS Therapy Adjustments: the FDA should also make clear that if a meter and strips cannot be used to “make therapy adjustments” — meaning to dose insulin or calibrate a CGM — then they are, by definition, not a blood glucose meter  (or strip) and cannot be considered DME (and thus cannot be reimbursed as such).

LABELING: Who is going to be responsible for keeping an accurate and up-to-date list of which third-party strips work with which meters? Until this issue is clarified, third-party strips should not be cleared for sale.

Until all of these issues are addressed, third-party strips cannot be considered parts of a self-monitoring blood glucose test system, and should not be cleared for sale.

Moo II / Moo Too. Keep Meters in the ER.

Will there be a blood glucose meter in the Emergency Room? 

I have borrowed ideas from Christel’s blog post on posting comments to the FDA open meter docket. The one with this great picture: 

Articles published last week are timely and relevant to the the professional / in hospital use FDA Meter guidance. Some of the stuff last week was rather startling. What's got me worrying is the remote possibility there will be no blood glucose meter in the ER. 

FDA's in hospital guidance proposes very tight variance standards. There are interesting comments about FDA’s in hospital use guidance posted at diaTribe. I liken the comments to something approximating, "Hey theses are so tough that nobody may make the meters, then what are ya gonna do?" That, combined with the article on emergancy room visit for hypos, I wrote about in this post, are the basis for the following additional comments to the "Prescription Point-of-Care Use" guidance docket. 

Please, feel free to copy them, add you 2¢, and post them to the FDA docket here:

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use (this refers to the meters healthcare providers use at the office or in the hospital)

http://www.regulations.gov/#!submitComment;D=FDA-2013-D-1445-0001

[Copy]

I am concerned the proposed standards for "Prescription Point-of-Care Use" blood glucose meter may not be not feasible. If so the the result could be a deterioration of in-hospital care for people with diabetes. 

Dr. David Sacks of NIH, Bethesda, MD is quoted by diaTribe saying, “These are incredibly stringent [standards]…I hope that the FDA listens to the complaints, because clearly there will be lots… I think that it’s going to be very difficult for manufacturers to meet these criteria. If they don't make them more lax, there will be no glucose meters approved in the future.”1 

“No glucose meters approved in the future,” is very concerning. 

I worry that if the standard for in clinic/hospital blood glucose meters use is not reachable there will not be devices for inpatient care. No meters may cause delays in emergancy department treatment for people with diabetes. These delays could stem from the need to use slower draw-blood-and-take-it-to-the-lab processes to meet these "incredibly stringent" requirements, as opposed to reasonably rapid finger stick devices in the treatment of patients needing emergancy care. 

Geller et al in a March 10 2014 JAMA article, National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations, estimate over ninety-seven thousand insulin-related hypoglycemia and errors induced emergancy room visit in the United States annually. Of these 29% result in hospital admission. Additionally "Severe neurologic sequelae were documented in an estimated 60.6% (95% CI, 51.3%-69.9%) of ED visits for IHEs" 2

Time matters, appropriate rapid care is needed to minimize lasting harm from hypos. 

FDA should avoid rules with such possible unintended consequence. Result from this guidance that should be improved accuracy in clinical settings from meters. Maters are a valuable tool in professional care setting just as patients need for accuracy in dosing the very dangerous drug insulin outside the is clinical setting. Both need accurate, economical  and timely devices. 

I agree with diTribe’s conclusion on personal use meters, “We are glad to see the FDA trying to improve glucose meters and look forward to formal adoption of the standards in whatever form they ultimately take... the home use accuracy standards are fairly reasonable and should enhance patient safety.”  I also share their concern that if, “... no meter can meet these new accuracy requirements for healthcare facilities, we will not see any of these innovations make it to the market.”

1 http://diatribe.org/issues/61/new-now-next/3

2 https://archinte.jamanetwork.com/article.aspx?articleid=1835360

[/copy] Go here. [paste]

Moo.

Learn more:
http://theperfectd.com/2014/03/14/moo-moo-moo/
http://www.stripsafely.com/sample-page/guidance/

Yo! DOC - FDA is Listening, Let's Speak Up

Public Policy on Diabetes Needs Our Help, Our Voices.

FDA is listening for our comments about glucose meters 'till April 7. They have two dockets open.

Please comment on FDA’s meter guidance proposals. Open dockets are a very important and rare time that the FDA is explicitly and officially focused on listening. Let’s be heard. Just as important as what we say, is that our community's message is repeated to be clear over voices that may seek to maintain the unacceptable status quo for their proprietary gain.

Through the dockets we can:

• Support FDA’s efforts for higher accuracy.
• Call for the same accuracy in both patient and clinical use.
• Ask that only the new level of accuracy be labeled to dose insulin.
• Suggest that only devices meeting new accuracy levels be considered DME by Medicare.
• Repeat the call for robust post market enforcement.

Learn more about the guidance.

http://www.stripsafely.com/sample-page/guidance/about-guidance/

See how to steps to posting on a FDA docket. (It is easy.)

http://www.stripsafely.com/sample-page/comment2fda/

Here's links to the open dockets and one set of sample comments to post to both.

http://www.stripsafely.com/sample-page/guidance/

The current set rules for glucose meters is from 2003. It may be another decade before we get another chance. These dockets are open to April 7. Now is the time to join the community and speak up.

Please help build momentum for the effort by sharing that you posted to the docket through your favorite social media channels with the hashtag #StripSafely.

AADE Research on Meter Accuracy and Choice

From AADE

Research Highlights the Need to Ensure Accuracy And Patient Choice of Diabetes Testing Supplies

Inaccurate Blood Glucose Meters Cause Safety Concerns; Government’s Competitive Bidding Program Limits Access

For Release: January 21, 2014

Two new surveys conducted by the American Association of Diabetes Educators demonstrate once again the need for the healthcare, insurance, and diabetes educator communities to ensure that people with diabetes are using meters that are appropriate for their individual needs – and are accurate.

One survey – conducted online in November by Harris Interactive for the American Association of Diabetes Educators – found that 27 percent of patients with type 1 diabetes had experienced health problems due to inaccurate blood glucose meter readings. Roughly nine percent of those with type 2 diabetes had experienced health problems as a result of inaccurate readings.

While accuracy was ranked by a majority (60%) as one of the top three most important factors in determining which meter to use, more than two-thirds (68%) were not aware that many meters available today do not meet global standards for accuracy.

 

(more)

Act for People with Diabetes.

Hey it is video day! We are joining with Kerri at SixUntilMe and sharing a videos today encouraging actions on diabetes.





Sign the petition: 
http://www.change.org/petitions/us-food-and-drug-administration-sponsor-a-patient-meeting-on-diabetes

Join StripSafely:
http://www.stripsafely.com/join/

Come Play!

My friend Scott Johnson won Insulindependence.org’s Athletic Achievement award and I think that says a lot. Scott is into athletics for all the right reasons; joy, sportsmanship, camaraderie, and health. Scott wants everyone he meets to join the basketball game and play for the simple fun of playing. I hadn’t played basketball since the 70s, Scott made me feel welcome on the court. Same with a young kid who was standing there watching the game, Scott handed him the ball and invited the kid onto the game. That is why, for me, he is a role model. Athletics isn’t about self aggrandizement, it isn’t about winning, to Scott it is about joining with others and playing.

play |plā| verb
1 engage in activity for enjoyment and recreation rather than a serious or practical purpose:
2 take part in (a sport):

I am proud of Scott. 

( I am proud of Kerri the Dancing Check too.)

This is not to say I have anything against serious sports. I was screaming like the lunatic I am, when Charlie Kimball’s team won the Indycar race at Mid Ohio. Team. Racing is a team sport with all kinds of different skills contributing to a common effort to make the team's car get there first.

Today, I would love you to join me in some play. I want you to be part of a team, one that needs a lot of players who are willing to do something a little outside their individual and collective “box.” Join the StripSafely Tweet In.

1. Go to the StripSafely Twitter Page, 
2. Find your Elected officials, Listed by State. (Maybe include the Congressional leadership too)
3. Click the Tweet about Meeting Link.

That will send a Tweet asking the representative asking them to send a staffer to the September 9 Diabetes Technology Society meeting. That is easy and it isn’t asking a lot from Congress, just being aware of our need for accuracy.

Some feel that politics is a dirty partisan game, I know others have felt that way. They found that speaking up from principal was not only empowering but could be fun too. Maybe our voice can help reduce  partisanship by not playing that game. Just be real.

Let's make this fun! Tweet the 'stock' message then improvise some of your own tweets, share why accurate diabetes testing matters to you. Be nice, be a good sport, no trash talking, join with others and play. Maybe as a team we can all win the race to more accurate glucose testing.

Lets make this a team effort about joy, sportsmanship, camaraderie, and health.