Diabetes Health Type 1: The Good and the Bad in Our Diabetes Advocacy World

And What You Can Do About It

by Scott Strumello; Editor Scott King


Let’s look at some recent examples of activism that have largely been driven by patients with diabetes and why these accomplishments are so exciting.  There are three notable examples, which are as follows:


  1. Gaining Medicare Coverage of CGM’s

Getting CMS Medicare coverage for CGM’s was once seen as unlikely.  We can thank patient advocacy for this 2017’s decision by the Centers for Medicare & Medicaid Services (CMS) for Medicare/Medicaid coverage of Dexcom G5 continuous glucose monitoring systems for people with diabetes.

Dexcom CGM’s were previously labeled by the U.S. Food and Drug Administration (FDA), as an “adjunctive” device, meant to complement but not replace, the information obtained from more traditional fingerstick blood glucose monitoring systems.  Essentially, the FDA previously determined CGM readings could not be used to make therapeutic treatment decisions (such as insulin dosages).

Dexcom concluded that the best way to attain Medicare coverage of CGM’s was to work within the confines of CMS, and in September 2015, it took the first step by requesting that the FDA re-label the G5 device as a “therapeutic CGM” which could technically be used as a replacement of fingerstick blood glucose testing for diabetes treatment decisions.

Diabetes patient voices played a critical role in persuading the FDA to approve the new labeling request for the Dexcom G5 system.  For example, in early July 2016, the diaTribe Foundation (see http://ow.ly/2hCa30gG7nP for the recommended letter text) began seeking signers for a letter it had drafted in support of the new label indication Dexcom was seeking, and it aimed to get at least 1,000 signers to the letter.  Its letter was actually signed by over 10,000 people with diabetes and their families; see http://ow.ly/M69L3085eZb for details.  

diaTribe was joined by advocacy efforts by other diabetes patient advocacy organizations and efforts, including TuDiabetes (now part of Beyond Type 1), the Diabetes Patient Advocacy Coalition (DPAC) [http://diabetespac.org/], the JDRF and many others, all played an important role in getting their members to submit patient letters to the then-open FDA docket.  Perhaps more important, many patients (or parent caregivers) wrote to the FDA and participated in the meetings, telling their personal stories to the FDA about how CGM’s helped improve their lives and diabetes decision-making.

At a hearing held on July 22, 2016, the FDA’s clinical chemistry and clinical toxicology advisory panel voted 8 to 2 in favor of safety, 9 to 1 for efficacy, and 8 to 2 that the benefits of the proposed new label indication would outweigh the risks (see https://www.accessdata.fda.gov/cdrh_docs/pdf12/P120005S041a.pdf for the December 20, 2016 FDA approval letter and http://www.prnewswire.com/news-releases/fda-advisory-committee-votes-in-favor-of-non-adjunctive-label-for-dexcom-g5-mobile-cgm-system-300302609.html for the Dexcom company press release on the decision).

Dexcom was the first  CGM manufacturer to request their system to be re-labeled by the FDA as “therapeutic CGM” and then classified by CMS as durable medical equipment eligible for coverage.  But in doing so, it opened a viable path for rival CGM systems to potentially do the same. Indeed, as of January 4, 2018, Abbott announced that its new Freestyle Libre system was also now available to Medicare patients, having met the codes for therapeutic CGM systems used for coverage by Medicare, which leaves only Medtronic’s CGM as still uncovered by Medicare.  But Medtronic has told shareholders it intends to introduce a standalone Guardian Connect CGM system at some point, but a CGM sensor shortage slowed new shipments. It is pending FDA approval, so it’s likely to launch in the U.S. sometime in foreseeable the future.


  1. Preservation of Protections in the Affordable Care Act

The Patient Protection and Affordable Care Act (a.k.a. the Affordable Care Act, the ACA or Obamacare) was passed into law in 2010.  The basic plan was hatched at the conservative Heritage Foundation in 1989 in a document entitled “The Heritage Consumer Choice Health Plan” authored by Stuart M. Butler.  But it remained an untested idea until Massachusetts successfully passed it into law in 2006. Before the ACA’s passage, it was virtually impossible for people with diabetes to buy healthcare insurance at any price, although most were covered under group plans offered as employee benefits.

The late Jennifer C. Jaff, founder and director of Advocacy for Patients With Chronic Illness, argued the ACA was a civil rights issue for people with all chronic illnesses, including diabetes.  Following the 2015 U.S. Supreme Court decision upholding the ACA, she told the Hartford Courant “I live and breathe chronic-illness law, and in my estimation this is the most important civil rights advance for people with chronic illnesses ever. There can never be equality if we can’t get health insurance.”

Early 2017 Republican efforts to fully repeal the law failed largely because of people who would be adversely impacted by its repeal, including people with diabetes, who joined tens of thousands of other patient advocates opposing efforts to repeal but not replace the ACA.  Republicans in the White House and in Congress have instead led efforts to sabotage the law, including a huge cut in advertising and other outreach strategies to encourage people to sign up, while also shortening the open enrollment period, and disabling the healthcare.gov webpage on Sundays when most people would ordinarily try to enroll.

Another sabotage effort is to eliminate the individual mandate.  The new tax bill ends the ACA’s requirement that all individuals buy insurance or pay a fine.  Eliminating the individual mandate for healthcare insurance could jeopardize Obamacare’s already-shaky marketplaces, by reducing the number of healthier people who sign up for insurance, and making it more expensive for those who do sign up.  By shrinking the pool of healthy individuals who are paying into the healthcare system through monthly premiums, the Republican bill will further restrict the amount of money available to care for those with chronic illnesses, including diabetes.

To compensate, insurers will raise premiums for everyone who has insurance.  Indeed, the non-partisan Congressional Budget Office (CBO) estimates [https://www.cbo.gov/system/files/115th-congress-2017-2018/reports/53300-individualmandate.pdf] that 13 million people would be left without healthcare insurance coverage by 2027 if the individual mandate is repealed.  While the market for individual health plans may remain stable in much of the country, the average premiums will likely rise by roughly 10%, the CBO said.

Predictably, health insurers and hospitals both oppose repealing the individual mandate, because doing so would likely increase the number of uninsured and destabilize insurance markets as well as leaving hospitals with unpaid bills from people who get care (often at hospital emergency rooms) without paying for it.

Yet more than 8 years after the ACA’s passage, the law seems more entrenched in American life than ever before.  Data from the Centers for Medicare and Medicaid Services show that 2017 enrollments are stable on the healthcare.gov website, while individual state exchanges in California, New York, Washington, Maryland, Minnesota, Connecticut and Rhode Island all show increased volume into state exchange call centers.

For the time-being, patients’ best defense is to continue putting pressure on their elected lawmakers in Congress.  Phone calls, letters, e-mails, and visits telling them what the protections in the ACA mean to you and your family can cause lawmakers, particularly those with a re-election in 2018, to reconsider their stance on repealing but not replacing the ACA and sabotaging the ACA.


  1. Efforts to Address High Prices for Insulin and other Diabetes Medicines

One of the most perplexing challenges has been sky-high insulin prices in the U.S. (prices for most prescription drugs in the U.S. are higher than in virtually all other developed countries).  According to an article in the Washington Post [https://www.washingtonpost.com/news/wonk/wp/2016/10/31/why-insulin-prices-have-kept-rising-for-95-years/], citing data from IMS Health, Truven Health Analytics, and other independent analysts, a version of insulin that carried a list price of $17 a vial in 1997 is priced at $138 today. Another that launched two decades ago with a sticker price of $21 a vial has been increased to $255.  The most aggressive price increases have been in the past several years. People with diabetes are getting sucker punched on the cost of insulin, and hard, from several different directions.

Not only does insulin cost significantly more in the U.S. than in most other countries, but increasingly, those high costs for insulin are paid for out-of-pocket as insurance plans with deductibles have become more prevalent.  According to the Commonwealth Fund [http://www.commonwealthfund.org/publications/newsletters/washington-health-policy-in-review/2016/sep/september-19-2016/deductibles-rise-in-employer-sponsored-health-plans], in 2016, 29% of U.S. workers used plans with relatively high deductibles, compared to just 20% in 2014, and the incidence is expected to continue rising in the future as employers look to manage their own costs for insurance benefits.

That means that even many people with insurance must contend with the fact that only lower, “negotiated” prices are applied towards any patient deductible amounts.  Also, seniors covered under Medicare struggle with the Medicare Part D donut hole for prescriptions. Samples from doctors’ offices are one option, but do little to address the problem beyond immediate needs.  Indeed, there is a growing number of stories of patients who started GoFundMe [https://www.gofundme.com/] campaigns online to raise money to pay for insulin (medical fundraising is one of the site’s top categories), and unfortunately, some have resulted in patient deaths.

A few lawmakers in Congress recognize the severe hardship that high list prices for drugs are causing.  Senator and former Presidential candidate Senator Bernie Sanders of Vermont and Representative Elijah Cummings of Maryland requested [https://www.sanders.senate.gov/insulinprices] that the U.S. Department of Justice and the Federal Trade Commission investigate three main insulin makers for price collusion. [see https://www.statnews.com/pharmalot/2016/11/03/sanders-insulin-investigation/ for more], although like much in the Federal government recently, there has been little action to date.  It’s certainly worth reminding your own lawmakers about that.

But progress is indeed being made by individual states, including in Vermont, Maryland, California, Nevada and most recently, Colorado, with more routinely being proposed across the country.

Not all state efforts have succeeded.  In 2017, the drug industry spent millions to defeat what was known as the Drug Price Relief Act, also known as Ohio ballot Issue 2.  That initiative would have barred Ohio state agencies from buying drugs at prices higher than what’s paid by the Department of Veterans Affairs (the VA), which receives discounts.  Ohio was deluged and pilloried in a dizzying crush of robocalls, direct mail and ads on TV and radio advertising. One reason why the 2017 Ohio ballot initiative drew such unusual attention was because it generated so much spending from outside the state, which is atypical for most Ohio ballot initiatives.  

As of October 27, 2017, campaign finance reports filed with the state of Ohio showed that “Ohioans Against the Deceptive Rx Ballot Issue” had spent a staggering $39.4 million against Issue 2 since July, and it still reportedly had $7.8 million in the bank as election day approached (see https://www.cincinnati.com/story/news/politics/2017/10/27/ohio-issue-2-drug-industry-financed-groups-spending-big-kill-it-finance-reports-show/806421001/ for more detail).  Reports to the state also showed that a majority of that money came directly from a subsidiary of the Pharmaceutical Researchers and Manufacturers of America (better known as PhRMA).

In the end, all the ads and robocalls funded by non-Ohioans mainly succeeded in confusing voters, although that was sufficient for the pharmaceutical industry.  By the time election day came, there were reports of voter confusion on what they were being asked to vote for or against, causing many Ohio voters to simply ignore the issue completely when they voted (see https://www.npr.org/sections/health-shots/2017/11/07/562328211/voters-confused-by-ohio-s-ballot-question-on-drug-prices for more).

But perhaps the most notable for people with diabetes was the passage of Nevada’s law known as SB539, or the Diabetes Drug Transparency law, which was signed by that state’s Republican Governor Brian Sandoval on June 15, 2017 and goes into effect January 1, 2017 (see https://www.leg.state.nv.us/App/NELIS/REL/79th2017/Bill/5822/Overview for more), which is worthy of particular attention to people with diabetes.  Key elements of the Nevada law are as follows:


  • Requires insulin manufacturers including Novo Nordisk, Sanofi, and Eli Lilly to annually disclose information about insulin list prices, profits made on insulin products, and discounts granted to middlemen also known as pharmacy benefit managers or PBM’s (the biggest ones being Express Scripts, CVS’ Caremark unit, UnitedHealthcare’s OptumRx unit, Argus, EnvisionRXOptions, ProCare RX and several smaller PBM’s).  That information is usually considered a “trade secret” by Big Pharma.
  • Manufacturers must also explain to Nevada officials, in writing, any insulin price hikes above the previous year’s inflation rate within 90 days, and will be fined $5,000/day if they fail to comply.
  • A requirement that pharmaceutical sales representatives must register with the State of Nevada and provide details about their interactions with healthcare providers.
  • A stipulation that nonprofit organizations must also disclose when they receive funding from drug companies, PBM’s, and/or health insurers.


The drug industry trade groups PhRMA and BIO immediately sued Nevada, but lost in Court because the trade organizations failed to show they had legal standing or that they could suffer financially if the law went into effect.  Yet pricing transparency is being fought fiercely by the drug industry.

On November 1, 2017, in Novo Nordisk’s Q3 quarterly earnings call for shareholders, Reuters reported (see https://www.reuters.com/article/us-novo-nordisk-results/drugmaker-novo-nordisk-warns-of-u-s-legislation-cautious-on-2018-idUSKBN1D1428 for the article) that CEO Lars Fruergaard Jørgensen warned investors about pricing transparency legislation, particularly in individual U.S. states, as he noted that he felt Federal healthcare policies which could potentially hurt the drug industry had diminished somewhat during the year.  But at the state level, he warned investors that more and more legislation was being prepared to increase clarity around prices, and those carried risks for Novo Nordisk.

“If the transparency bills lead to a disclosure level that is too excessive, it becomes difficult to do business, for instance, if we have to publicly share what is in our contracts,” Mr. Jørgensen said.

Last, but certainly not least on the issue of insulin pricing, are a number of class-action lawsuits challenging the secretive pricing arrangements in several different states.  The Type 1 Diabetes Defense Foundation [also known as T1DF, https://www.t1df.org/] is an Oregon-based 501(c)(3) nonprofit organization which was founded in November 2015 for nationwide equal access to school emergency care with a pilot school accommodation project in Washington State.  Its founders have children with Type 1 diabetes, and it became a public benefit corporation dedicated to advancing equal rights and opportunities for Americans with Type 1 diabetes and other forms of insulin dependent diabetes. T1DF depends on individual donations and accepts no industry funding.  At the heart of its consumer rights program, T1DF’s putative class action lawsuits challenge the overpricing of insulin and other crucial drugs and supplies (including testing supplies and glucagon).

T1DF is not alone in pursuit of a judicial remedy to the current insulin pricing scheme in the United States.  Several other cases have been certified as class-action status, including cases filed in New Jersey and Massachusetts.

Biosimilars (the FDA refers to them as follow-on biopharmaceuticals) are basically like generics for biotech medicines including insulin, and have some potential help to offset U.S. insulin pricing insanity.  Already, a Lantus biosimilar called Basalgar is now on the market (CVS’ Caremark unit recommended its clients go with that instead of Sanofi’s Lantus because Caremark got a bigger rebate from Lilly) in the U.S., and a Humalog biosimilar called Admelog was formally approved by the FDA on December 11, 2017 and is expected to be available in the U.S. during 2018.  

Because presently, every biosimilar insulin being sold in the U.S. is from rival big pharma companies (Lilly/Boehringer Ingelheim is selling Basaglar, while Sanofi is selling Admelog), it’s perhaps not too surprising that the net price discounts seen with these varieties of insulin have only been in the range of 25% to 30% compared to net price discounts of 75% to 80% for many small molecule drugs.  That said, Merck/Samsung Bioepis already has a Lantus biosimilar now pending FDA approval (its awaiting settlement of a lawsuit filed by Sanofi), and we could potentially see a rival like Novartis’ Sandoz unit also introduce some biosimilars in the not-too-distant future, although I’m not aware of any others now pending approval. But typically, when there are several different manufacturers of the same products, the prices are more likely come down a bit further.

Another potential challenge is that Donald J. Trump has nominated as his candidate of choice to be Health and Human Services Secretary none other than Alex Azar (he is the man personally responsible for Lilly’s decision to aggressively raise the list prices on insulin sold in the U.S. from 2007 to 2017).  I am not optimistic that he is the best choice for the role, although I would acknowledge that he has some first-hand knowledge of how drug pricing in the U.S. works (or rather, does NOT work), and he could offer some potential work-arounds for the broken drug pricing system in the U.S., although he may not have any motivation to implement anything.

My recommendation on insulin prices is to continue letting your Federal and State lawmakers know how big of a problem runaway prices on medicines including insulin are for you personally.  The more they hear about the issue, the more likely they are to address it. Persist and continue calling your elected officials regularly on the issue – it’s not too much to write to them once per week on the subject until they do something.  In the interim, some patients (for example, some patients with Type 2 diabetes who use insulin) may find satisfactory results using older insulin varieties like Regular, which are already considerably less expensive than the newest insulin analogues are, although that is not ideal for every person.  Until one of the class-action lawsuits succeeds, or lawmakers (either Federal or in your State) make this a priority to lower prescription drug prices, there aren’t very many viable options (note that I do not even discuss so-called patient assistance programs because there is no uniformity in eligibility criteria for any of those).  GoFundMe campaigns are also limited, and are certainly not a healthcare plan that lawmakers can or should cite as a solution. However, know that if you run for Congress and win a seat, you are guaranteed to have one of the nation’s best healthcare insurance plans for life, so it may indeed be worth running for office! Above all else, be certain to exercise your right to vote in 2018, because the candidates in office indeed have a very real impact on our diabetes lives.


Writers Bio:

Scott Strumello has been a long-time Type 1 diabetes activist since his own diagnosis at age 7 in 1976.  He is one of the first diabetes bloggers at blog.sstrumello.com, with an inaugural post in 2005, although much of his recent activity is on his widely-read Twitter feed at twitter.com/sstrumello.  He has been a fundraiser and benefactor for the JDRF, the Diabetes Research Institute Foundation, and patient-run advocacy organizations including the former Diabetes Hands Foundation (which is now part of Beyond Type 1), the Diabetes Patient Advocacy Coalition (DPAC), and he has assisted the organization now known as the diaTribe Foundation, but his personal patient advocacy activity with the U.S. Food and Drug Administration is perhaps the work he considers most important.


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