The DIABETES Act intervenes across Medicare rules to reduce disruptions when people with diabetes enroll in Part B and to expand access to outpatient diabetes self‑management training (DSMT). It instructs HHS to adopt an enrollment-period certification to preserve access to diabetes devices, requires new billing rules and codes for insulin pump training, and directs testing of virtual DSMT delivery.
The bill also removes Medicare cost‑sharing for outpatient DSMT, orders a GAO assessment of access barriers across federal programs, and sets a regulatory pathway (including a proposed national coverage determination) for insulin pumps. Together the measures aim to protect beneficiary continuity, encourage device- and software-level coverage, and collect evidence on virtual education — but they also create implementation and fiscal tradeoffs for CMS, contractors, device suppliers, and Medicare budgets.
At a Glance
What It Does
Establishes a 12‑month window after Part B enrollment during which a certified provider can document that a beneficiary is already using diabetes technologies so CMS contractors must treat that documentation as part of the medical record review for reasonable‑and‑necessary decisions. It expands outpatient DSMT access with an initial 10‑hour allotment and 2 additional hours per year thereafter and directs Medicare to pay the full cost of those services and waive the deductible. The bill also orders HHS to create billing codes for insulin pump hook‑up and training, to test virtual DSMT under a Section 1115A model, and to propose a national coverage determination for infusion pumps.
Who It Affects
Directly affects Medicare beneficiaries with diabetes, physicians and non‑physician practitioners who certify device use and order DSMT, certified diabetes educators and web‑based DSMT vendors, durable medical equipment suppliers and insulin pump manufacturers, and Medicare administrative contractors responsible for coverage and audits.
Why It Matters
The bill changes administrative practice as much as statute: it constrains how contractors review beneficiary records during the first year of Part B coverage, removes cost barriers to DSMT, and creates new billing paths and pilot evidence for virtual education — all of which could materially change utilization patterns, vendor business models, and CMS oversight priorities.
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What This Bill Actually Does
The central operational change is a short certification pathway for new Part B enrollees who already use diabetes technologies. Within the first 12 months after an individual enrolls in Part B, an eligible clinician may note in the beneficiary’s medical record that the patient is using one or more covered diabetes technologies.
CMS must produce a finalized certification form through notice‑and‑comment and instruct its Medicare administrative contractors (MACs) to focus their reasonable‑and‑necessary reviews on whether that certification appears in the record rather than re‑running full coverage determinations that would otherwise disrupt access at enrollment.
For diabetes education, the bill fixes an initial block of services (10 hours) that beneficiaries can use at any time and then allows two additional hours per year after the initial block is exhausted. It removes Medicare cost‑sharing for outpatient DSMT and prevents the Part B deductible from applying to those services, and it prohibits CMS from capping the quantity or duration of training when a physician or qualified non‑physician practitioner deems more education medically necessary.To operationalize insulin pump support, the Secretary must create specific HCPCS fee‑schedule codes that describe pump hook‑up, calibration and patient training similar to existing CPT descriptors; HHS must then educate clinicians and suppliers on billing those codes.
Separately, the bill directs HHS to issue a proposed national coverage determination specific to continuous subcutaneous insulin infusion (CSII) infusion pumps within 180 days of enactment, creating a formal, agency‑level review of coverage criteria.The bill also pushes CMS to test virtual delivery of DSMT via a Section 1115A model: the pilot must evaluate clinical outcomes (A1c, hospitalizations), utilization and reach into rural/underserved communities, medication adherence and potential Medicare savings. HHS must consult diabetes clinicians, digital health experts and beneficiary groups in designing that model.
Finally, the legislation orders a GAO report (in collaboration with HHS) that maps prior authorization, formulary, utilization management, and other barriers across federal programs, and it amends competitive‑bidding provisions to list continuous glucose monitors and insulin pumps as DME items for consideration beginning in 2031.
The Five Things You Need to Know
During the first 12 months after a beneficiary enrolls in Medicare Part B, a qualifying provider may certify the beneficiary’s use of diabetes technologies so CMS contractors consider that certification as part of medical‑record review for coverage.
CMS must finalize a certification form and related MAC guidance via notice‑and‑comment no later than January 1, 2027, and publish instructions limiting audit activity that would disrupt covered device access.
Outpatient diabetes self‑management training is structured as an initial 10 hours available until used, plus 2 additional hours per year thereafter, and CMS may not limit medically necessary education determined by an authorized clinician.
Medicare will pay 100% for diabetes outpatient self‑management training (no coinsurance) and the Part B deductible will not apply to these services.
The statute explicitly lists continuous glucose monitors and insulin pumps as DME items subject to the competitive bidding framework when furnished on or after January 1, 2031.
Section-by-Section Breakdown
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Short title
Gives the measure the name Diabetes Interventions Addressing Barriers to Enrollment, Technology, and Education Services (DIABETES) Act. This is purely stylistic but useful when tracking statutory cross‑references and implementing guidance.
Findings and Sense of Congress on AID software
Lists epidemiology, cost, and clinical‑guideline context for diabetes and explicitly urges HHS to treat automated insulin delivery (AID) algorithms and software as reasonable and necessary and separately payable items when appropriate. The findings set the tenor: Congress is signaling that software should be recognized as a distinct component of AID systems, and that CMS should avoid administrative treatment that would block access or stifle maintenance and innovation.
12‑month certification to preserve device access at Part B enrollment
Adds a new paragraph enabling a provider to certify that a beneficiary is using diabetes technology during the first 12 months of Part B coverage. CMS must issue a final certification form via notice‑and‑comment by Jan 1, 2027, develop a process for considering non‑Part B technologies for future coverage, and direct MACs and oversight entities to avoid audit activity that disrupts access. Practically, this means that during initial coverage reviews MACs are instructed to check for the certification in the medical record rather than initiating new coverage denials that could interrupt an enrollee’s existing device use.
Restructures outpatient DSMT and eliminates beneficiary cost‑sharing
Specifies an initial 10 hours of DSMT (individual or group) available until used and authorizes 2 additional hours per year after that initial block; expands ordering authority from only the treating physician to include qualified non‑physician practitioners; and bars CMS from limiting quantity or duration when a clinician deems services medically necessary. The bill also changes Medicare payment rules so the program pays the full fee schedule amount for DSMT and the Part B deductible and coinsurance do not apply, shifting the full financial burden to Medicare for those services.
Pilot to test virtual DSMT coverage under Medicare
Requires CMS to create a Section 1115A model to evaluate synchronous and asynchronous web‑based DSMT furnished by qualified web programs, with metrics including A1c reduction, hospitalizations, utilization (including rural reach), medication adherence, and cost impacts. The Secretary must consult stakeholders within three months of enactment when designing the model. Results will generate evidence CMS can use to decide permanent virtual coverage policies.
HCPCS codes and outreach for insulin pump training
Directs HHS to establish Healthcare Common Procedure Coding System (HCPCS) codes by Jan 1, 2027, that capture insulin pump hook‑up, calibration, and patient training (modeled on CPT 95249/95250). The agency must also communicate to providers and suppliers how to bill those codes. This creates a concrete billing pathway for clinical time spent initiating and teaching pump use, which affects provider reimbursement and program accounting.
Proposed national coverage determination for CSII infusion pumps
Requires the Secretary to publish a proposed National Coverage Determination (NCD) for infusion pumps (CSII) — referenced by Medicare local coverage item number 280.14 — within 180 days of enactment under the statutory rulemaking procedure. An NCD will formalize coverage criteria and evidentiary standards for these devices across Medicare jurisdictions, replacing some local inconsistency.
GAO report on access barriers in federal health programs
Mandates a Comptroller General assessment (in collaboration with HHS) within one year that catalogs barriers beneficiaries face obtaining diabetes technologies and DSMT across federal programs. The review must examine prior authorization, preferred formularies, coverage intensity limits, and utilization management, and identify whether federal laws, rules, or policies impede alignment with standards of care.
Competitive bidding listing for CGMs and insulin pumps (effective 2031)
Adds continuous glucose monitors and insulin pumps — when covered as durable medical equipment under the DME definition — to the list of items subject to the DMEPOS competitive bidding program if furnished on or after Jan 1, 2031. This provision shifts how CMS will procure and reimburse these items in the future and could trigger supplier network changes and price competition.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- Medicare beneficiaries already using diabetes devices — the 12‑month certification reduces the risk that enrollment in Part B will interrupt a beneficiary’s existing device access while CMS re‑evaluates coverage.
- Patients who need diabetes self‑management training — the initial 10‑hour allotment, ongoing annual hours, and removal of cost‑sharing lower financial and timing barriers to receiving structured education.
- Certified diabetes educators and web‑based DSMT vendors — clearer payment rules and a Section 1115A pilot for virtual services create billing opportunities and potential market expansion into telehealth delivery.
- Clinicians initiating insulin pumps — the new HCPCS codes create a discrete billing path for pump hook‑up, calibration and training time, improving reimbursement transparency for that clinical work.
Who Bears the Cost
- The Medicare program (and therefore taxpayers) — full payment of DSMT and waived deductibles increase program outlays for education services and may raise utilization.
- DME and device suppliers — listing CGMs and pumps within competitive bidding starting in 2031 could compress margins, alter distribution networks, and force operational changes to qualify for bid contracts.
- CMS administration and MACs — must implement new certification forms, issue MAC guidance, create audit guardrails, design a new 1115A model and publish an NCD within statutory deadlines, all of which require operational resources.
- Small DSMT providers and clinics — while payment is clarified, administrative burdens tied to new codes, documentation of medical necessity waivers, and participation in virtual pilot programs may require investment in billing, training and digital platforms.
Key Issues
The Core Tension
The central dilemma is balancing beneficiary continuity, access, and innovation against program integrity and cost control: the bill lowers administrative barriers and expands paid education (increasing utilization and potential program spending) while also preparing to subject critical diabetes devices to competitive procurement that can reduce prices but may limit supplier options and innovation—there is no policy lever here that simultaneously maximizes access, preserves a broad market of suppliers, and minimizes spending without tradeoffs.
The bill pushes CMS to create administrative safeguards that preserve device access at enrollment, but it does so by instructing contractors to ‘‘only assess whether the certification form is included’’ in the record. That lowers the administrative bar for continuity but leaves open how MACs should adjudicate ambiguous or potentially fraudulent certifications, and how the agency will reconcile certifications with later medical‑necessity reviews.
Mandating separate recognition of algorithms/software and directing CMS to develop HCPCS codes and an NCD are pro‑innovation moves, yet they raise complex classification questions (is software a supply, an accessory, or a service?), valuation challenges, and cybersecurity and post‑market maintenance obligations. Finally, the statute simultaneously signals concern about competitive bidding’s impact on access while statutorily adding CGMs and insulin pumps to the competitive bidding list effective Jan 1, 2031 — a direct policy tension that could produce both cost savings and narrower equipment choice for beneficiaries if CMS proceeds with aggressive bidding rules.
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