April 5, 2016

#SuspendBidding


First, there was a poster at ADA last June. Then a white paper and now a peer-reviewed article in Diabetes Care, ADA's journal. 

The evidence is clear. Medicare's program to save money on test diabetes strips cost more in hospital care than it saved and increased mortality. 
  


Previously on YDMV:




March 18, 2016

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. 


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. 


February 29, 2016

HELP I Need Somebody. (In the Next Ten Days)


https://en.wikipedia.org/wiki/Help!_(film)

In HELP, the Beatles protect Ringo from an evil cult. 

Solid plan. 

People with diabetes could use some protecting.

I am not, exactly, suggesting the Senate are an evil cult, but people with diabetes could use the Senate's HELP

Can you find two minutes, in the next ten days, to ask the Senate HELP Committee (Health, Education, Labor, and Pensions) to consider diabetes?

Maybe even ACT NOW.

 

On March 9th, the Committee is going to consider health bills. Ask them to bring S. 586 to the table.

  • Click the picture.
  • Fill in your name and address.
  • DPAC drafts letters for your Senators*. 
  • Feel free to ad you diabetes story to the letters.
  • Push submit to send. 
*DPAC customizes your letters to your Senators. We know who is on the committee, who has cosponsor S586, and who need to support it. All you need to do is click and ask Senators to work with their colleagues bring S 586 to the table. 

After sending the letter, maybe Tweet too. Find you Congress members here and some ready to fire Tweets. #DiabetesCommission



S. 586 creates a commission that will help better address diabetes, in a fiscally responsible manner. The act is budget neutral, and prior experience suggests this commission can have a significant positive impact on care. A generation ago a National Diabetes Advisory Board created the pivotal Diabetes Control and Complications Trial (DCCT) that has defined modern diabetes care.

A new generation of innovative medications and devices are coming to market that can revolutionize how Americans live well with diabetes. Doing so will require the government to change the status quo of federal bureaus working alone, to a coordinated national response, driven by research experts, physicians, educators and people living with diabetes, to keep those agencies with interfering with the doctor-patient relationship.


(HELP may not ACT NOW.  If not, Later, Rinse, Repeat - the Committee meets in April too.)

February 1, 2016

Spare A Rose - Opening Days Deal: Help Kids AND Make Me Look Silly.



The fourth annual Spare a Rose campaign starts today. 

Spare a Rose helps fund IDF's Life for a Child program bringing insulin and support to children in developing nations who may otherwise go without. Spare a Rose is easy, give one less rose this valentine's day and donate the value of that rose to IDF or give a dozen.  

Spare A Rose is a fun way we, people with diabetes, can join philanthropists, industry and other who support these kids. 

Type 1 requires ongoing insulin. Through Spare a Rose you make an ongoing monthly gift to IDF. With the Monthly Donation section of the Spare A Rose giving form your can set ongoing giving. The funds flow straight from you, through PayPal, to IDF and kids in need.

Spare A Rose is a community effort.  It is fun to be a part of something so useful, needed and simple. Now add to that the opportunity of publicly embarrassing your truly

I would love to see Spare A Rose start quickly with ongoing donations. So I'll wear these Disney World map tights to the Friends for Life banquet this summer if we can raise three dozen ongoing gifts in the first three days of Spare A Rose.

Help kids and make me look silly in public at the same time. What could be better? 




#SpareARose

January 29, 2016

Recall on Clinical Glucose Test Strips - Do Consumers Get The Same Attention?

FDA announced a recall of glucose test strip used in clinical settings. The recall in part says,"..because they may report falsely low blood glucose levels. Because the test strips are reporting falsely low blood glucose when the true levels are above 265 mg/dL, there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) including Diabetic Ketoacidosis and Hyperosmolar Hyperglycemic Syndrome in a timely manner and fail to treat elevated blood glucose levels."

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm483792.htm

So if you own a clinical machine, you should take precautions and check you test strip lots.

What we don't know is are the machines and strips used by millions every day working as approved. Who know? How would we know? Ther is no proactive, ongoing post-market process that acquires test strips the way PWD do; you know from retail channels and test them.

The vast majority of comments to FDA on the proposed glucose meter guidance in 2014 called for robust post-market processes. Procedures have been written but when will they be used?

People living work a day lives run the same risk of falsely low or high glucose levels that clinical machines present. More so if the number of blood checks done on retail machines vs. clinical ones is factored in.

Shouldn we be safe with home use devices?

December 14, 2015

Throw the Red Flag. Bidding Strips in No Touchdown

I have written about test strips, bidding, and harm. This week there is an opportunity to look into the details. But it is football season so I thought I would put the reasons to take that opportunity in football terms:

Throw the Red Flag.




Medicare instituted a program to bid test strips. It looked like a great play. They certainly are celebrating in the end zone.

The replay doesn't look good. Instead of tracking patients over time they started with a new group each quarter, in essence starting the game at zero every quarter. They counted the savings yards gained and said the scored but didn't factor in the yardage lost as increased hospitalization cost and increased mortality.

Want the details from all the cameras?  Join the webinar.

November 25, 2015

Thanks NY Times, Please Consider Diabetes Testing too.

The New York Time has a Piece titled,  "F.D.A. Targets Inaccurate Medical Tests, Citing Dangers and Costs" up this week. It is a good bit about the accuracy of medical lab tests.

I am thankful for attention to patient safety driven by quality testing. That applies at home as well as the lab. So I sen this to the reporter. Fee free to join me in asking for equal attention to the test people with diabetes do at home.


Thank you Mr. Pear for your article on lab test it certainly worrying and starting a conversation on the quality and safety of lab tests.
 
An equally concerning issue is the accuracy of home testing devices regulated by FDA. Diabetes test systems are currently required to be accurate to +/- 20%. Level lower than much of the rest of the world. 
 
While FDA has suggested new, more accurate standards, many devices fail to preform to the existing regulatory standard for which they were approved.* FDA has acknowledged this problem. However there is no process to remove underperforming systems form the market. 

Worse Medicare bidding has disputed the market, driving price, not safety or quality. Research shared at the American Diabetes Association scientific sessions showed that the ‘savings’ Medicare achieved were more than offset by increased hospitalizations and mortality.# 
 
I look forward to reading more of the dialog on medical testing you have started and hopefully it will expand to help the 30 million Americans with diabetes stay safe. 
 
*“Blood Glucose Meter Accuracy Problems Acknowledged By FDA, Industry And Clinicians.” ‘Medical Devices Today’ Medicaldevicestoday.com, 27 May 2013. Web. 8 June 2013.

#“CMS Competitive Bidding Hurts Medicare Beneficiaries With Diabetes,” ‘EndocrinologyAdvisor’ 18 June 2015. http://www.endocrinologyadvisor.com/ada-75th-scientific-sessions-2015/competitive-bidding-diabetes-medicare/article/421388/

November 12, 2015

FitBit for Diabetes.



The American Diabetes Association® is one of three charities competing in Fitbit®’s FitForGood challenge. This means YOUR steps could help us win big to help Stop Diabetes®.

You can join in 3 easy steps!


1) Please visit www.fitbit.com/fitforgood. Sign up. Select the American Diabetes Association as your cause.

2) Put on your Fitbit Activity Tracker or use Mobile Track in the Fitbit app on your phone.

3) Start walking. You can walk anywhere, anytime—and every step you take between Nov. 9 and Nov. 20 will be in support of the Association.

In addition to logging your physical steps, you can earn an additional 1,000 steps per day by sharing from the campaign dashboard to social media. So, share away on Facebook and Twitter

October 28, 2015

Of Test Strips, Bidding, and Harm



I have been thinking about test strips. Again - Still. Some of you may know this is a reccuring topic with me. It is, because.., well..., strips matter. 

Test strips are the foundation of good diabetes self-care. People with diabetes, particularly those who use insulin, need to test frequently to manage their blood glucose and make care adjustments, particularly with the insulin. As simple as it sounds test strips are vital to avoiding dangerous low blood sugars from insulin. 

Insulin can be a dangerous drug. An article in the Journal of the AmericanMedical Association estimates that ninety-seven thousand of Americans a year go to the emergency room due to low blood sugars caused by insulin.(1) The journal goes on to says most of those insulin ER visits are seniors, Medicare’s people and that one in three of the ER visits the person is hospitalized. When it is dangerious, it is expensive.



The ninety-seven thousand mentioned cited in that article is MORE than the government estimate of Americans who go to the ER for stimulants including methamphetamines.(2) It is shocking that insulin beats breaking bad as reasons Americans go to the ER. However, the comparison does help put good self-management in perspective. Clearly a goal is the safe use of insulin that helps keep America's, particularly seniors, well while preventing the need for emergency room and avoiding unnecessary hospital admissions cost to Medicare.


We all have heard of medical trials. Trials, because they can impact the participant's health, have strict rules. Some of those rules came about as the result of studies that were unethically done on people without their permission or knowledge.(3) It seems logical that if someone were going to introduce new means of accessing something as critical to maintaining health as test strips that they would follow the trails safety rules.


Unfortunately, that was not the case.


Medicare changed the rules for how beneficiaries get test strips. Medicare tested it in 2011 in nine pilot cities around the country. But they didn’t treat it as a clinical trial or follow safe trail protocols. Maybe because they judged the rules don't apply to them as a government agency. Medicare said it was a huge success, they saved money and there were few complaints and no disruption.

A poster presented at the American Diabetes Association scientific session in June 2015 by skilled academic scientists looked carefully at Medicare’s data. It showed that in the nine pilot cities(4) there was a disruption of patients access to test strips. How and how many strips people with diabetes acquired shifted. In some cases, people on insulin stopped receiving testing supplies. The researchers found an increase in hospitalizations, higher cost, and more mortality in people with diabetes using insulin in the test cities.

I don't know who is right, Medicare, who says there was no harm and extended the program nationwide or the researchers who found statistically significant increase in mortality, hospitalization, and costs in Medicare's data. I am not a scientist, a statistician or a bioethicist. I do want to know if people on Medicare are safe.


Congress is paying the bills. They authorized this experiment. They should find out what the truth and tell us is Medicare program safe? ACT NOW to ask Congress to get to the truth.



(1) Geller AI, Shehab N, Lovegrove MC, et al. National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations. JAMA Intern Med. 2014;174(5):678-686. doi:10.1001/jamainternmed.2014.136. https://archinte.jamanetwork.com/article.aspx?articleid=1835360

(2) National Institute on Drug Abuse. Drug-Related Hospital Emergency Room Visits Retrieved from http://www.drugabuse.gov/publications/drugfacts/drug-related-hospital-emergency-room-visits

(3) https://en.wikipedia.org/wiki/Belmont_Report

(4) Test sites included Charlotte-Gastonia-Concord (North Carolina and South Carolina); Cincinnati-Middletown(Ohio, Kentucky and Indiana); Cleveland-Elyria-Mentor (Ohio); Dallas-Fort Worth-Arlington (Texas); Kansas City(Missouri and Kansas); Miami-Fort Lauderdale-Pompano Beach (Florida); Orlando (Florida); Pittsburgh(Pennsylvania); and Riverside-San Bernardino-Ontario (California)

Help out DHF and the DOC with a two question survey, Especially T2s

This from my friend Corinna

I wanted to let you know about a project we're working on and ask for your help with a short (2-question) survey. We're working on a Tier 1 PCORI Pipeline to Proposal  project aimed at eventaually looking at the efficacy of peer support delivered online. You know, that thing that the DOC does. 

Would you take a couple of minutes to respond? 

You can find the survey on TuDiabetes at: http://www.tudiabetes.org/forum/t/meet-idocr/48282


Spreading the word would also be appreciated. Please point other PWD, especially those living with Type 2, to this survey. Thanks so much.

With warm aloha,
Corinna