If you're on Medicare and get your diabetes testing supplies through a mail order pharmacy, you're in luck -- things are about to get a lot better. That is, you'll soon have expanded access to the most accurate devices, and non-generic D-supplies you need and want.

Say thanks to Congress, which weaved into a Feb. 9 budget bill very important language to fix a gap in Medicare coverage -- clarifying and strengthening the rules on the distribution of mainstream-brand glucose testing supplies through mail order. And this has implications beyond Medicare, as private insurers often follow suit.

Woot! A great win for our D-Community!

To learn more about what's happening, we had a thorough chat with our friend Christel Marchand Aprigliano, who co-founded the Diabetes Patient Advocacy Coalition (DPAC) and has been advocating on this issue for years now.


A Talk with Advocate Christel Marchand Aprigliano

DM) Hi Christel, can you boil this down for the layperson: What exactly has happened here?

CMA) People with diabetes who are Medicare beneficiaries can now get access to better quality blood glucose meters and test strips, something that hasn’t been possible since the Competitive Bidding Program started in 2011. That program interfered with PWDs’ ability to get what they wanted, all in the name of “cost” as proclaimed by the Centers for Medicare and Medicaid Services (CMS).

Take us back to the start… what’s this Competitive Bidding Program all about?

It all goes back to 2003. Congress began the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program. Sellers who wished to offer supplies to Medicare beneficiaries would bid for the privilege of being selected, offering a price that would be highly competitive. 

It began with the best of intentions -- to save the government and patients money, cut down on fraud, and ensure that patients would get quality equipment easily. There were wide variations in the cost of certain durable medical equipment items like bedpans and walkers. But bedpans and walkers shouldn’t cost more based on where you live, which was happening before (this change).

Were diabetes supplies handled differently?

No, but we know that diabetes testing supplies are different. Measuring blood glucose levels and getting a number that is accurate is essential for diabetes management. Accuracy matters. Unlike bedpans and walkers, blood glucose meters and strips vary in accuracy, with some failing to provide even the basic FDA standards. Allowing diabetes testing supplies to become part of the Competitive Bidding Program (CBP) was a mistake.

To win the bid, the potential mail order suppliers would offer discounted pricing for diabetes testing supplies, assuming they would make it up in volume. Medicare would take all the bids and pick the least expensive ones, averaging the cost of all of the selected suppliers.

Some suppliers, after running the numbers, realized they would not make a profit and backed out of the program. Other suppliers limited their inventory to the least expensive meters that they could get, rather than the blood glucose meters and strips that patients have been trained on and are trusted by their professionals to give accurate readings.

How did this impact people with diabetes on Medicare?

The results of the National Mail Order program for Medicare beneficiaries have been disastrous and, in some markets, deadly.

First, many patients lost the ability to work with the mail order supplier they had used previously, as the number of suppliers nationwide has drastically dropped from more than 20 to only 9. Then often when they called a new supplier, they would learn that outfit didn’t carry the meters or strips they had been prescribed. Patients were sometimes told they simply didn’t have a choice, and would be sent a meter they were never trained on and didn’t know how to use. 

Many patients unable to receive their trusted glucose meters stopped or severely decreased blood sugar testing, while continuing to administer themselves insulin -- which is quite dangerous! Mortality, inpatient admissions, and inpatient costs increased among the PWDs affected by this decreased access to quality testing supplies.

To compound the issue of dwindling access, the Diabetes Technology Society recently conducted a study revealing that an alarming 12 of 18 testing systems available to Medicare patients provide inaccurate results. This means that even if patients do get one of the limited testing systems, it may not even be accurate.

How have diabetes advocates been tackling this issue?

We’ve been raising our voices as individual advocates and through initiatives for many years about the inaccuracy of certain meters not meeting FDA standards.

Since this program began, AADE (the American Association of Diabetes Educators) has conducted several 'secret shopper' studies proving just how hard it is to access meters that were prescribed and how often patients are being given bad information.

Advocates through DPAC’s advocacy platform sent thousands of emails to CMS and policymakers asking for the Competitive Bidding Program to be reviewed for diabetes testing supplies and to stop the program based on the studies completed.

And you personally testified before Congress on this very issue?

Yes, I’ve spoken at Congressional staff briefings and scientific meetings alongside reps from AACE (the American Association of Clinical Endocrinologists) and the Diabetes Technology Society. I’ve sat in representatives’ offices, sharing data and more importantly, personal stories about struggles to access supplies from those who contacted me. We’re not talking about a group of nameless, faceless individuals. These are members of our Diabetes Community who were not getting the safe, trusted supplies they needed.

In Summer 2017, I had the honor of providing expert testimony in front of the Energy & Commerce Health Subcommittee, asking them to support a bill that would eliminate loopholes that were allowing suppliers to fudge the original intent of patient protections through the anti-switching rule and the 50% market rule.

Can you please explain those two key rules and how they've been "strengthened"?

Under the 50 Percent Rule, bidders for mail-order diabetes supplies were supposed to demonstrate that their bids cover "at least 50%, by volume, of all types of diabetic testing strips on the market."

However, this “50% of supplies” was only being required in a supplier’s initial bid -- and in fact they were skirting this by offering their customers access to only 50% of what's in their inventory, meaning patients really only had access to a small number of supplies the bidder was getting at its own best financial advantage.

The Anti-Switching Rule was established to make sure beneficiaries could maintain access to their preferred testing meters and strips. It was meant to ensure that mail order outfits couldn't force people to switch.

But until now, they have essentially been doing that via aggressive marketing and by putting customers on automatic shipment programs, that were difficult to opt out of. This policy change means if an individual is sent a meter they didn’t want, they should be able return it and go to a local pharmacy instead to get preferred supplies.

So what happened to change those rules recently?

Two pieces of legislation – the House bill, H.R. 3271, and the matching Senate bill, S. 1914 -- were both gathering bipartisan support for the past six months. A lot of behind-the-scenes work went into these efforts, even as Congress couldn’t settle on a final budget bill and government shutdown scenarios were playing out.

The Congressional Diabetes Caucus Co-Chairs -- Rep. Tom Reed and Rep. Diana DeGette -- as well as their staffers, were able to bring the bill language into the Bipartisan Budget Act of 2018, which was signed into law on Feb. 9. It takes effect at the start of next year.

To say I’m pleased about this is an understatement; I’m giddy that beginning on Jan. 1, 2019, these protections will be in place for our Medicare diabetes community.

Can you clarify again, what exactly will change with this new legislation?

Previously, mail order bidders supplied a list of products they claimed to offer, but often don't keep in inventory, so PWDs were forced to pick from a small number of brands they often didn't even recognize. But now with the more strict interpretation of the 50% Rule, the suppliers will have to make more well-known, mainstream brands available.

And with the Anti-Switching Rule being strengthened, the mail order suppliers won't be able to push people away from the products they've been prescribed, or prevent them from getting needed supplies at a local pharmacy.

Does this go beyond just meters and strips? And beyond Medicare?

Competitive bidding is still part of the Medicare program and insulin pumps were to be included in the next round of bidding. However, the next round of bidding (which was to take effect on January 1, 2019) is currently on a temporary hold, awaiting further review from the current Administration. If it does start again, they stated they will add the insulin pump category. 

Meanwhile, private insurers and PBMs are forcing patients across the country to switch medicines and devices, as they restrict formularies and device choice even more.

As the saying goes: As Medicare goes, insurers typically follow. So these changes to Medicare competitive bidding are good news, as they have implications for all of us.

What’s next as to diabetes advocacy on this topic?

The diabetes policy advocacy community will be ready to fight the Competitive Bidding Program again, if and when needed. For us, it’s a matter of keeping everyone safe. We’ve seen what this win for our community did -- and we’ll continue to work to keep winning for all people with diabetes.


Thanks for this update and all the work you've done on this issue, Christel!