BGM and CGM in the Medicare Ecosystem

Blood glucose monitoring sits at the intersection of three distinct policy currents that are reshaping Medicare simultaneously. The 2023 CGM coverage expansion brought continuous glucose monitoring within reach of a far larger Medicare population than any prior coverage determination. The BALANCE model, announced in late 2025, creates metabolic monitoring demand as a byproduct of GLP-1 drug coverage. And the ACCESS model’s cardio-kidney-metabolic tracks make glucose monitoring integral to the clinical infrastructure for diabetes and CKD management in Original Medicare. For device companies and monitoring vendors, these three currents are not independent. They compound each other, and the organizations positioned at their intersection will find a Medicare market that looks meaningfully different in 2026 than it did in 2022.

CGM Coverage: What Changed and What Remains Constrained

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Medicare coverage of continuous glucose monitors began in 2017 when CMS issued CMS Ruling 1682R, defining therapeutic (non-adjunctive) CGMs as covered under Part B as durable medical equipment. The distinction between adjunctive and non-adjunctive CGMs was operationally significant: a non-adjunctive CGM could be used to make treatment decisions without a standalone blood glucose meter for confirmation, while an adjunctive CGM required finger-stick verification before acting on the reading. In February 2022, CMS resolved this ambiguity by ruling that both adjunctive and non-adjunctive CGMs qualify as DME, expanding the covered device universe.

The April 2023 coverage expansion was more consequential. Before that update, Medicare CGM coverage was largely restricted to beneficiaries on multiple daily insulin injections. After it, coverage extended to any insulin-treated beneficiary and to beneficiaries with documented histories of problematic hypoglycemia regardless of insulin regimen. CMS also dropped the requirement for frequent fingerstick glucose testing as a precondition, aligning Medicare coverage criteria closely with the American Diabetes Association’s 2023 Standards of Care. The practical effect was a substantial increase in the eligible population, though a 2024 quality improvement study found that only about 50 percent of newly eligible Medicare patients were actually using CGMs, pointing to persistent prescribing and access barriers even after coverage expansion.

The eligibility architecture as it stands in 2026 has four criteria. The patient must have diabetes mellitus, must have received sufficient training on CGM use (evidenced by a prescription), must have a CGM prescribed in accordance with FDA indications, and must be either insulin-treated or have a documented history of problematic hypoglycemia including recurrent Level 2 events below 54 mg/dL or a Level 3 event requiring third-party assistance. A treating practitioner visit within six months prior to ordering the CGM is also required.

The DME classification has a structural limitation that technology companies should understand. Coverage under the DME benefit requires a standalone receiver. CGMs that display data exclusively on a smartphone, without a durable receiver component, do not meet the definition of DME and are denied as non-covered. This is not an oversight in coverage policy; it reflects CMS’s longstanding interpretation that a device primarily useful to any person in the absence of illness does not qualify as DME. For companies whose product design routes sensor data only to a patient’s existing smartphone, the coverage path under current policy runs into this constraint. Companies have addressed it through hardware design: the Dexcom G7, FreeStyle Libre 2 and 3, and similar systems include standalone receivers that satisfy the DME requirement.

Medicare Part B pays 80 percent of the approved amount for CGMs and associated supplies after the annual deductible, which in 2025 is $257. The cost to beneficiaries without supplemental coverage runs between $100 and $300 per month depending on the specific system and supplier. An Office of Inspector General report published in December 2025 found that Medicare payments for CGMs and supplies grew from $109 million in 2018 to $1.3 billion in 2023, and that those payments exceeded supplier acquisition costs by $377 million, or 69 percent, in a single year. CMS’s July 2025 proposed rule moved to apply competitive bidding and inherent reasonableness authority to CGM payment rates in response. For device manufacturers and suppliers, this proposed rule signals that the current payment premium that has made Medicare CGM supply profitable is under active regulatory pressure.

The branded competitive landscape in Medicare CGM includes Dexcom (G6, G7), Abbott (FreeStyle Libre 2 and 3), Medtronic (Guardian systems), and Senseonics (Eversense E3, which received expanded Medicare coverage in February 2024 as an implantable system with 180-day sensor life). Ascensia’s Eversense partnership added an alternative for insulin-pump users and patients seeking extended wear. CMS’s public directory approach to ACCESS model participants, combined with the outcomes transparency it is building into that model, may eventually create preference data around which CGM platforms generate better clinical results in the Medicare population, which would feed back into coverage and contracting dynamics.

The BALANCE Intersection

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The BALANCE model, which CMS announced in 2025, tests GLP-1 receptor agonist coverage in Original Medicare as a comprehensive metabolic intervention. GLP-1 drugs reduce weight, improve glycemic control, and generate cardiovascular risk reduction in clinical trial data. The model’s design requires concurrent lifestyle support and, depending on clinical track, metabolic monitoring.

The relationship between GLP-1 therapy and glucose monitoring is clinically relevant. GLP-1 agonists lower blood glucose, which means patients on these agents can experience hypoglycemia, particularly when combined with insulin or other hypoglycemic agents. For patients in the BALANCE model’s diabetes management track, CGM integration serves both therapeutic monitoring and safety functions. The documented history of problematic hypoglycemia that triggers CGM eligibility under current Medicare policy could be created or exacerbated by GLP-1 therapy, which means BALANCE enrollment could generate CGM eligibility for beneficiaries who did not previously qualify.

The BALANCE lifestyle support requirement is the second connection. The model requires participants to engage in structured lifestyle programming alongside pharmacological treatment. Programs that integrate metabolic monitoring with behavioral support, using CGM data as a feedback mechanism for dietary and activity modification, are positioned to serve as the operational infrastructure for BALANCE lifestyle components. This is not a coverage pathway in itself, but it is a market development pathway for monitoring vendors that build clinical partnerships with BALANCE-participating organizations.

The practical volume impact of BALANCE on CGM demand depends on how many beneficiaries enroll and how many are in tracks where metabolic monitoring is clinically appropriate. CMS has not published enrollment projections for BALANCE, and the drug coverage decision itself remains an evolving regulatory picture given the prior authorization and patient selection constraints in the model design.

ACCESS Clinical Tracks and BGM Integration

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The ACCESS model’s cardio-kidney-metabolic track covers diabetes, CKD, and atherosclerotic cardiovascular disease. Its outcome measures include HbA1c control, eGFR and urine albumin-to-creatinine ratio (UACR) progression, blood pressure, lipids, and weight. For participants in this track, glucose monitoring data is not merely a clinical tool; it is integral to the outcome measurement infrastructure that determines whether the organization receives full outcome-aligned payments.

ACCESS care organizations receive OAPs based on the share of enrolled patients who meet condition-specific targets at the end of a care period. For diabetes patients, meeting an HbA1c target requires sustained glycemic control over months, and CGM provides the continuous data visibility that episodic HbA1c testing does not. An ACCESS organization that integrates CGM into its diabetes care pathway gains an operational advantage in identifying patients who are trending away from target before the reconciliation period closes, allowing clinical intervention while there is still time to affect the outcome measurement.

The RPM billing infrastructure that applies outside of ACCESS connects directly to CGM. Remote patient monitoring codes, specifically CPT 99454 for device supply and data transmission and CPT 99457 for the first 20 minutes of monitoring and treatment management, create a billable encounter structure around continuous monitoring. ACCESS organizations operating in an outcomes-based payment framework will not bill RPM codes for enrolled patients during the model period, since OAPs replace FFS billing. But organizations that serve a hybrid population of ACCESS-enrolled and non-enrolled Medicare patients will maintain parallel billing infrastructures where RPM codes apply to the FFS population.

The encounter data connection matters for risk adjustment. Under the V28 HCC model, diabetes with complications (HCC 18) and CKD stage 3 through 5 (HCC 136 through 138) generate risk scores that affect payment in Medicare Advantage and, in an encounter-based risk adjustment future, in Original Medicare as well. CGM-enabled encounters that document glycemic instability, hypoglycemic episodes, or CKD progression generate clinical documentation that supports HCC capture. For organizations managing a Medicare population under any value-based arrangement, the documentation value of CGM-generated data extends beyond clinical monitoring into the risk adjustment infrastructure that determines plan revenue.

Interoperability and Data Sharing

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CGM data generates a high-volume, high-frequency data stream. A patient wearing a Dexcom G7 produces a glucose reading every five minutes, or approximately 288 readings per day. Aggregating, analyzing, and acting on that data within a clinical workflow requires interoperability infrastructure that most primary care practices do not have natively.

CMS’s interoperability requirements under the 21st Century Cures Act final rule require certified EHR technology to support FHIR-based data access, and ACCESS model participants must use CMS’s FHIR APIs for outcomes reporting and care coordination. The practical challenge is that CGM data flows from sensor to receiver or smartphone app, through the device manufacturer’s proprietary platform (Dexcom Clarity, LibreView, Medtronic CareLink), before it can be exported into an EHR or care management system. The standardization of CGM data exchange is improving through the TIDEPOOL project and similar interoperability initiatives, but vendor-to-EHR data connectivity remains fragmented across platforms.

HIPAA compliance governs how CGM data flows between device companies, care organizations, and CMS. Device manufacturers that are business associates of covered entities must execute business associate agreements and comply with HIPAA Security Rule requirements for data transmission and storage. For companies building CGM data infrastructure for Medicare populations, the compliance overhead is not trivial, particularly for smaller vendors that are not yet operating inside Medicare’s data sharing framework.

The competitive moat for CGM companies in Medicare is increasingly not device hardware. It is the data platform. Abbott’s LibreView and Dexcom’s Clarity platforms aggregate population-level glucose data that can feed clinical decision support, support risk stratification for value-based care contracts, and generate the outcomes documentation that ACCESS organizations need for reconciliation. The companies that build clinical workflow integration on top of their device data will convert device revenue into a recurring data services relationship with Medicare-participating organizations.

Related Reading

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MCR-01_04 ACCESS: Digital Health’s New Medicare Beachhead MCR-02_04 The Encounter-Based Risk Adjustment Future