Medicare CGM Access Act Update: sponsorship improving, though 64% of diabetes caucus members have not signed on – September 8, 2015

Bipartisan support of the Medicare CGM Access Act of 2015 continues to grow following the  reintroduction in the Senate and House of Representatives in late March. As of today, 27 Senators and 134 House members have cosponsored the bill, solid progress in just four months. However, there is so much low-hanging fruit – a striking 64% of Congressional Diabetes Caucus members have yet to co-sponsor the bill (see the full list below). This list includes 17 non-sponsoring Senate Diabetes Caucus members out of 28 total members, and 214 non-sponsoring House Diabetes Caucus members out of 330 total - yes, two-thirds of the House is on the Diabetes Caucus! JDRF is obviously working incredibly hard to change this, and its page here makes it easy to send a letter to members of Congress; we just did it and it took fewer than five minutes.

Passing the bill would be a tremendous victory, as it would create a Medicare benefit category for CGM and establish a payment and coding structure to go along with it. The bill has also been strategically drafted to pave the way for reimbursing future artificial pancreas technologies. The 2014 iteration did not secure enough sponsorship before Congress ended, but that has not deterred the type 1 diabetes community. Last month Bob Amato, a type 1 for an impressive 67 years (and a patient of the great Dr. Howard Wolpert), delivered a stirring testimony before the Senate Aging Committee about the need for CGM. He benefited greatly while enrolled in the JDRF CGM trial, but has since been unable to access it. The stirring two pages of remarks are very worth reading here, detailing his battle with hypoglycemia unawareness and a car accident that almost killed him. Joslin has been terrific in helping medalists advocate in front of Congress.

As a reminder, Medicare’s primary objection to covering CGM stems from the adjunctive labeling (i.e., that treatment decisions be based on BGM readings rather than CGM readings). Dexcom seems very close to overcoming this objection, as its 2Q15 call predicted an insulin-dosing claim in the US sometime next year. Such a replacement claim should address the first key hurdle to Medicare coverage of CGM – establishing a benefit category. Medicare will then assess whether there is sufficient evidence to support coverage of CGM for the Medicare population. We assume that is the case but are not positive – are there enough studies of CGM in the elderly population? Of course, there is plenty of compelling data on severe hypoglycemia in the elderly, particularly those with longstanding type 1 diabetes.

Estimates suggest that roughly 25-30% of the type 1 diabetes population is enrolled in Medicare, which translates to ~400,000 patients (assuming ~1.5 million type 1s in the US). In new news to us, JDRF further estimates that roughly one-third of type 1s on Medicare (~133,000 patients) are under 65 years old. We were surprised to hear this and of course that makes the passage of this legislation even more important for the broader type 1 community. We salute the entire coalition working on this bill, which includes AADE, AACE, Endocrine Society, JDRF, Dexcom, J&J, and Medtronic. We just hope Congress sees the ROI – many believe, of course, that the fairly dysfunctional Congress will just say no to anything that costs money.

• Nearly two thirds (59%) of total diabetes-related medical costs are attributed to those 65 years and older. Much of this obviously stems from type 2 diabetes, but we imagine a non-trivial amount comes from type 1. T1D Exchange data suggests that 16% of patients over 65 years with longstanding type 1 diabetes (>40 years) have experienced at least one severe hypoglycemia episode in the past year (seizure or loss of consciousness) – that stat is incredibly striking every single time we hear it.
• No one has terribly accurate numbers on the total annual cost of hypoglycemia-related hospitalizations, but at an estimated $17,500 for each visit, it should theoretically pale in comparison to the cost of CGM. The big question is the number-needed-to-treat – how many patients need to wear CGM 24/7 to avoid one severe hypoglycemia admission? This number is also constantly improving as CGM gets cheaper through work from Abbott and Dexcom/Google.
  
  • At DTM 2014, Dr. Claudia Graham estimated that using CGM would save payers ~$89 million per year (assuming they have 10 million covered lives and a 46% reduction in severe hypoglycemia). The number ranged in sensitivity analyses from $59 million (with $1,200/year higher cost CGM) to $329 million (with a 100% reduction in severe hypoglycemia). The long list of assumptions is noted here. Dr. Graham emphasized that the model is a “starting point,” as there are many research gaps, especially appropriately powered clinical studies to examine reductions in hypoglycemia and severe hypoglycemia with CGM. We would’ve guessed the number would’ve been higher, but $90 million could fund a lot for patients, that’s for sure.
• A striking 64% of Congressional and Senatorial diabetes caucus members have yet to sponsor the Medicare CGM Access Act – these individuals are listed below. This list includes 17 non-sponsoring Senate Diabetes Caucus members out of 28 total members, and 214 non-sponsoring House Diabetes Caucus members out of 330 total. It is unbelievable to us that so many government leaders who support diabetes work (in theory) and could be a member of the Diabetes Caucus could not to support this bill. View the list of current co-sponsors here: S. 804 U.S. Senate and H.R. 1427 U.S. House.

Table 1: Senate Diabetes Caucus Members That Have Not Sponsored S. 804

Table 2: House Diabetes Caucus Members That Have Not Sponsored H.R. 1427