This week, there was some very good news from the Centers for Medicare & Medicaid Services (CMS) and the JDRF, notably for people with Type 1 diabetes who rely on Dexcom CGM devices. Essentially, CMS has accepted FDA labeling for the system and will no longer prohibit coverage.
JDRF did a press release which can be seen at http://www.prnewswire.com/news-releases/jdrf-encouraged-by-medicare-decision-to-take-first-step-toward-coverage-of-continuous-glucose-monitors-for-people-with-type-1-diabetes-300390684.html.
Dexcom had its own release which can be seen at http://www.businesswire.com/news/home/20170112006146/en/Centers-Medicare-Medicaid-Services-CMS-Classify-Therapeutic.
This really began last year when Dexcom submitted a supplemental application to its existing FDA premarket approval to add a new indication for use of the Dexcom G5 Continuous Glucose Monitoring System, asking that it be officially approved for making insulin dosage decisions.
Previously, the Dexcom G5 was only approved to measure glucose in interstitial fluid as an adjunctive device meant to complement, but not replace, the information obtained from more traditional fingerstick blood glucose monitoring devices. According to an FDA briefing document (see http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ClinicalChemistryandClinicalToxicologyDevicesPanel/UCM511810.pdf for more detail), the level of accuracy of the Dexcom G5 mobile continuous glucose monitoring (CGM) system is "close to, but not as good as, typical self-monitoring blood glucose meters in the U.S. market."
I agree with the FDA briefing document and won't use my Dexcom for dosing decisions, but some do and they find the trending info. CGM's provide to help in their decision-making. But the Dexcom application request raised some questions as to whether the FDA would even agree to re-label the device. At a hearing held on on Friday, 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 (see 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 more detail) of the proposed new label indication would outweigh the risks. Although the FDA is not bound by its advisory panels' votes, it often heeds their advice in making its decisions.
There was some patient activism involved in helping to persuade the FDA to re-label the device. For example, in early July 2016, the diaTribe Foundation (see https://diatribe.org/sign-diatribes-letter-fda-supporting-use-cgm-insulin-dosing for the recommended letter text) began seeking signers for a letter it had drafted in support of the new indication Dexcom was seeking, and it aimed to get at least 1,000 signers to the letter (apparently, their letter was signed by over 10,000 people with diabetes and their families, see http://ow.ly/M69L3085eZb for more). There were also advocacy efforts by the Diabetes Hands Foundation, Diabetes Daily, Diabetes Patient Advocacy Coalition (DPAC), the JDRF and others (Insulin Pumpers, for example). Personally, I liked the diaTribe Foundation's letter, and I used that as the basis for my own comments on why I felt the new label indication was appropriate when I submitted my own comments to what was then an open-docket at FDA. But, I think what was unique (and encouraging) about all of the efforts was the degree of spontaneous organization and collaboration amongst all the parties involved. Instead of contradictions and bickering, most of the initiatives built upon the efforts of one another.
Just before Christmas 2016, we got a decision. FDA agreed to expand the approved use of Dexcom's G5 Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment (insulin dosage) decisions in people 2 years of age and older with diabetes (see the press release at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534056.htm for details). This was definitely something many patients with diabetes wanted to see happen, although maybe not for the reason of avoiding a fingerstick as some writers erroneously presume. Rather, it's the implication the decision might have on securing Medicare coverage of the Dexcom G5 system. Of course, an FDA label is one thing, but getting Medicare to cover these devices was an entirely different matter. Medicare is huge, but is frequently difficult to work with and is sometimes unpredictable.
This week, the Centers for Medicare & Medicaid Services (CMS) re-classified therapeutic Continuous Glucose Monitors (CGM) as "Durable Medical Equipment" under Medicare Part B, which means that for some patients with diabetes who are on Medicare, they actually might be able to get coverage now. It's not a blanket decision, but the direction seems clear. Also, many insurance companies base coverage decisions based upon what Medicare does, so this might help some gain coverage with private insurance, too.
Here's the CMS link to the coverage details: https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/CMS-Rulings-Items/CMS1682R.html.
A downloadable document link to the full CMS Ruling No. CMS-1682-R can be found at https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/Downloads/CMS1682R.pdf.