By IDS intern, Douglas L. James
https://integrateddiabetes.com/wp-content/uploads/2025/05/fingerstick.jpg
“Buy-Buy” Test Strips for CGM Users
Years ago, a diabetes healthcare provider told me T1 is a numbers game. Run out of numbers, and the game is over. Diabetes, by its very nature, is an ever-changing condition, honed through experimentation – much like parachuting. Jumping with a failed main chute and no functional reserve chute is unlikely to produce anything good.
Starting January 1, 2025, CMS (the organization that administers Medicare and Medicaid) ruled that all users of FDA-approved CGM devices classified as “non-adjunctive” (not requiring fingerstick confirmation) were not eligible for coverage of fingerstick BG monitors and test strips.
Non-adjunctive CGM usage was for in-hospital sites, allowing BG levels to be monitored from a central nurses’ station backed up with ancillary resources. Out-of-hospital sites usually lack ancillary resources except EMT vehicles. Ancillary resources represent “proven workarounds”.
There are articles published in February 2025 by medical doctors stating the need for occasional fingersticks. This ruling most likely will be promulgated to all health plans.
The 6-year landmark NIH/NIDDK-funded Diabetes Control and Complications Trial (DCCT) study showed that participants with type 1 diabetes who kept their blood glucose levels close to normal greatly lowered their chances of developing eye, kidney, and nerve disease.
This CMS ruling did not contemplate that FDA-approved non-adjunctive CGMs all have an approval DECISION SUMMARY document that contains statements on limitations for non-adjunctive CGM use.
A non-adjunctive CGM is intended to replace fingerstick BG testing for diabetes treatment decisions (using insulin or carbohydrates) except under situations when fingerstick is required to confirm CGM sensor reading (adjunctive use) otherwise inappropriate treatment decisions may result in increased risk of severe dysglycemia when blood glucose values are acutely low or high.
Pediatric populations have an increased risk due to poorer or different CGM performance.
Clinical decisions based on inaccurate, falsely high or falsely low CGM glucose values or inaccurate alerts may lead to inappropriate treatment actions. Fingerstick situations for undetected low or high blood sugar may occur when:
- The user is unfamiliar with the CGM and should consult their healthcare practitioner and user guide to have confidence in making treatment decisions
- A sensor in the warm-up period, the user should use a blood glucose meter for treatment decisions
- The user’s symptoms do not match the glucose value displayed by the device (adjunctive use)
- No glucose value or trend arrow is displayed by the device, or the value is rising or falling rapidly (compression low)
- GCM glucose values are unavailable due to sensor signal drop-out or loss of communication
Who this ruling affects
These insulin-dependent PWD are ‘in the wild’, making treatment decisions. Of PWD, most affected are the 12% dependent T1 (includes other specific types) users of bolus insulin, plus a portion of T2 with worrisome hypo events. T1s with well-controlled A1C near or within the normal range having BG falling into the low 70’s are far less likely to be detected by a CGM unless it is fingerstick calibrated to about ±10 mg/dL. T1 PWD with an active lifestyle are handicapped from the fear of rapidly falling glucose values.
What can be done about it
Consider how much savings and lifestyle benefits from the projected costs of in the billions of dollars per year in the next few years via optimally lowering A1C while avoiding hypoglycemic events are in reach. Please immediately contact your Congressman and both Senators to withdraw the policy issue, cancel, correct, revise, or burn this CMS ruling 1738-r to restore BGM coverage and test strips when using a non-adjunctive CGM for out-of-hospital settings so we rest easier at 03:00 AM.
REFERENCES:
CMS Ruling 13-May-2022: https://www.cms.gov/files/document/cms-1738-r.pdf
Abbott Libre II & III DECISION SUMMARY: https://www.accessdata.fda.gov/cdrh_docs/reviews/K222447.pdf
Dexcom G6 DECISION SUMMARY: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170088.pdf
Dexcom G7 DECISION SUMMARY: https://www.accessdata.fda.gov/cdrh_docs/reviews/K213919.pdf
Fingerstick required: https://www.uptodate.com/contents/glucose-monitoring-in-diabetes-beyond-the-basics
Back to May 2025 NewsletterSign Up For The IDS Monthly Newsletter!
