Global Market Access and Reimbursement Models

Introduction to Global Market Access and Reimbursement Models for Continuous Glucose Monitors

Whether a continuous glucose monitor (CGM) gets paid for depends mostly on who the payer is. A CGM is a small wearable sensor that reads glucose in the fluid under the skin every few minutes. In the United States, Medicare pays for CGMs as durable medical equipment (DME), an item covered under Medicare Part B [1][4]. The UK and Australia work through national programs instead [6][7]. Here is how each model worked as of October 2026, and where the rules are about to change.

Regulatory Framework and Reimbursement Drivers

Each region has its own gatekeeper, and each one asks a slightly different question:

• United States: Medicare's CGM rules sit in a local coverage determination (LCD), a policy written by the contractors that process equipment claims. The one that matters here is LCD L33822, Glucose Monitors [1]. Two changes stand out. Its April 16, 2023 revision dropped the requirement for three or more daily insulin injections or an insulin pump, so a person treated with any insulin, including basal insulin alone, can qualify. The same revision added a second route for people with a documented history of problematic hypoglycemia, whether or not they use insulin [1]. CGMs did not move to a pharmacy channel. On February 28, 2022, CMS determined that both adjunctive CGMs (which need a fingerstick check before treatment decisions) and non-adjunctive CGMs (which don't) can be classified as DME, and the current LCD still treats them that way [1].
• United States, payment: The next change is about payment. In its CY 2026 home health final rule (CMS-1828-F), issued November 28, 2025, CMS said it will pay for all CGMs and insulin pumps on a monthly rental basis, starting on the date they are furnished under the DMEPOS competitive bidding program [5]. CMS's target is for that bidding round to begin no later than January 1, 2028, with CGMs and insulin pumps bid together in a nationwide remote item delivery program [4]. Supplies come with the rental. People who already own their CGM can keep using it until it needs replacing [4].
• Europe: Health technology assessment (HTA) bodies, which judge whether a treatment is worth public funding, shape coverage in much of Europe. The UK's National Institute for Health and Care Excellence (NICE) updated its CGM guidance for adults and children with diabetes in 2022; its guideline for adults with type 1 diabetes is NG17 [2][6]. In Germany, the Federal Joint Committee (G-BA) plays a similar role for statutory health insurance.
• Asia-Pacific: Australia subsidizes CGMs through the National Diabetes Services Scheme (NDSS) [3]. The national subsidy started with people with type 1 diabetes under 21 [7]. Here's what surprised us: in that group, CGM use rose from 5% before the subsidy to 79% two years later, and the odds of meeting the study's HbA1c goal (HbA1c is a lab measure of average glucose over about three months) more than doubled at 12 months [7]. The NDSS page lists who qualifies now [3].

Strategic Implications for Manufacturers

For a public payer, the case for funding a CGM is partly economic. A 2022 Diabetes Care analysis put Australia's youth subsidy at AUD 39,518 per quality-adjusted life-year (QALY, one year of life in full health) gained, below the AUD 50,000 threshold commonly used there [8]. The authors also found the result depended heavily on what the devices cost, and they estimated AUD 34,890 per QALY if the subsidy were extended into adulthood [8].

In the US, the coming bidding round is built around price. Under the program, CMS now sets each single payment amount at the 75th percentile of winning bids rather than the highest winning bid [4]. Using 2025 fee schedule amounts, a bid for a month of class II CGM rental can't exceed $272.69 [4]. CMS expects about ten national contract suppliers for the CGM and insulin pump category, and those suppliers must furnish the brand the physician ordered [4]. Suppliers compete on price. The prescriber still picks the maker, such as Abbott, Dexcom or MiniMed [4]. MiniMed is Medtronic's former diabetes business; as of September 2026 it trades on Nasdaq, and Medtronic is completing its separation through an exchange offer [9]. Our overview of major US manufacturers and product lines covers their current sensors.

We also looked for evidence that the cost of trials proving time-in-range benefits keeps new sensor makers out of these markets. We found no primary source that measures it, so we treat it as an open question.

Conclusion

Coverage for a CGM still depends on where you live. In Australia, the clearest evidence we found links public funding to measured gains in uptake and to a cost-effectiveness result [7][8]. In the US, the question for 2027 and 2028 is how monthly rental and nationwide bidding will change which suppliers people can use; CMS has said the prescriber still chooses the brand [4]. Whether you qualify under a given program, and which device fits you, are questions for your plan and your care team.

References

Each footnote above points to an entry in this page's citation list.