Diabetes advocates rally for Medicare reform on insulin pump access

SAN DIEGO – Diabetes stakeholders will meet with CMS in October to urge the agency to update its National Coverage Determination (NCD) guidance on who qualifies for an insulin pump to better reflect current clinical practice. 

CMS currently requires a low C-peptide level for insulin pump coverage, which excludes many people with Type 2 diabetes from obtaining an automated insulin delivery (AID) system, even if they were already been benefiting from the technology prior to moving to Medicare, says Chris Dawson, senior director of government affairs at Tandem Diabetes Care.  

“The NCD for insulin pump therapy was set about 22 years ago when the technology was fairly new,” he said. “Back then, C-peptide levels were one of the few things they had to determine who was Type 1 and Type 2. If you were below a certain level, (you qualified for a pump). Clinicians have since thrown that out the door and commercial payers dropped the C-peptide requirement (nearly a decade ago).” 

Tandem recently published a peer-reviewed study in the American Diabetes Association journal Diabetes Care that shows that the manufacturer’s Control-IQ+ automated insulin delivery system can lower HbA1c’s in adults with insulin-treated Type 2 diabetes. 

Based on the current criteria, patients who have been successfully using insulin pump therapy for years and have aged into Medicare must re-certify that they have diabetes, including taking a C-peptide test. If they “fail” the test – a likely outcome, Dawson says – they are no longer eligible for the pumps. 

“Most Type 2s are not going to pass that test,” he said. “I’ve talked to many a patient over the years – it’s very frustrating for them, and you can imagine the anger and concern that evolves from that. I think the study is going to help us push forward.” 

Efforts to get CMS to update the NCD began gaining steam about four years ago, with the formation of the Diabetes Technology Access Coalition, which is comprised of manufacturers and patient advocacy groups that have been pressing CMS and lawmakers on the issue, says Dawson. 

"Language was recently included in the Health and Human Services budget bill on both the House and Senate side that is encouraging CMS to respond within 180 days with an answer as to why the NCD has not been updated and what they are going to do about it,” he said.

There’s greater momentum in Washington, D.C., these days to take a hard look at changing policy – there have been several meetings in the last month on the NCD process, in general – and embracing technology, says Dawson.  

“This particular issue could be solved very quickly if (HHS Secretary) Robert F. Kennedy or (CMS Administrator) Dr. Mehmet Oz simply said, ‘We’re not going to enforce the C-peptide requirement any longer,’” he said. “They have the ability to do that. So, that’s kind of what we’re going for as a community to get this done quickly.”