Memorandum

US Senate and House of Representatives re-introduce bi-partisan legislation that would establish Medicare coverage of CGM – April 13, 2015

The US Senate and House of Representatives have re-introduced bi-partisan legislation that would establish Medicare coverage of CGM: the Medicare CGM Access Act of 2015. Co-chairs of the Senate Diabetes Caucus – Susan Collins (R-ME) and Jeanne Shaheen (D-NH) – introduced the Senate bill (S. 804), while leadership of the Congressional Diabetes Caucus – Tom Reed (R-NY), Diana DeGette (D-CO) and Ed Whitfield (R-KY) – introduced the House bill (HR. 1427). As we understand it, the legislation is nearly identical to the respective Senate (S.2689) and House (HR. 5644) bills submitted in 2014 that sought to create a Medicare benefit category for CGM and establish a payment and coding structure to go along with it. The bills have also been drafted to pave the way for reimbursing future artificial pancreas technologies, a platform that is mentioned twice in both documents. As we discussed in our detailed coverage from July, we think it is shameful that Medicare does not currently cover CGM given the technology’s ability to significantly reduce hypoglycemia, a major concern (and cost) in the elderly population. JDRF has been working hard on the advocacy front (with many others, led by them) for the past year and is still providing form letters to contact Representatives and Senators, as well as a petition that now numbers over 90,000 signatures: Tell Medicare to Cover Continuous Glucose Monitors for People with Diabetes. The political solution to this problem is unquestionably challenging, and we salute JDRF and its collaborators for continuing to drive awareness in Washington. In parallel, Dexcom’s 4Q14 call said that discussions were still ongoing with the FDA to obtain an insulin-dosing claim for CGM – as a reminder, Medicare’s objection to covering CGM has centered on the technology’s adjunctive labeling (i.e., fingersticks are still needed), which in the payer’s view, means it is precautionary and not medically necessary – obviously we disagree with this though we also realize not so many people over 65 were probably in recent trials. Dexcom expects more clarity by August.