Diabetes Act

Bill Number

S. 4037

Origin Chamber

Senate

Congress

119th Congress, Session 2

Status

Introduced

Latest Action

2026-03-10: Read twice and referred to the Committee on Finance.

Last Updated

2026-03-24T05:18:34Z

AI-Generated Summary

Purpose

The DIABETES Act aims to improve access to diabetes management technologies and education services for Medicare beneficiaries, particularly those newly enrolling in Medicare Part B. It addresses coverage gaps in devices like continuous glucose monitors (CGMs), insulin pumps, and automated insulin delivery (AID) systems, while expanding training options to reduce health complications and costs associated with diabetes.

Key Provisions

• Continued Access to Diabetes Technologies (Section 3): Allows healthcare providers to certify a patient's ongoing use of Medicare-covered diabetes devices (e.g., CGMs, insulin pumps, related software/algorithms) during the first 12 months of Part B enrollment. The Secretary of Health and Human Services (HHS) must create a certification form, issue guidance to contractors, and develop processes for potential coverage expansions by January 1, 2027.
• Expanded Diabetes Self-Management Training (DSMT) and Medical Nutrition Therapy (MNT) (Section 4): Increases initial DSMT hours to 10 (available until used) plus 2 additional hours annually after completion; removes limits if deemed medically necessary. Eliminates patient cost-sharing (deductibles and coinsurance) for these services. Applies to services ordered by physicians or qualified non-physician practitioners (e.g., nurse practitioners, physician assistants).
• Virtual DSMT Testing Model (Section 5): Directs the Centers for Medicare & Medicaid Services (CMS) Innovation Center to test coverage of virtual (web-based, synchronous or asynchronous) DSMT services starting January 1, 2027, evaluating impacts on health outcomes (e.g., reduced A1c levels, fewer hospitalizations), medication adherence, and costs. Includes consultation with stakeholders like clinicians and patient groups.
• Insulin Pump Training Codes (Section 6): Requires HHS to establish new billing codes under the Medicare physician fee schedule for insulin pump setup, calibration, and patient education by January 1, 2027, with outreach to healthcare professionals.
• National Coverage Determination (NCD) for Insulin Pumps (Section 7): Mandates a proposed NCD for insulin pumps and continuous subcutaneous insulin infusion within 180 days of enactment.
• GAO Report on Access Barriers (Section 8): Requires the Government Accountability Office (GAO), in collaboration with HHS, to report within one year on barriers (e.g., prior authorizations, formularies) to diabetes technologies and education in federal health programs, assessing alignment with care standards.
• Exclusion from Competitive Bidding (Section 9): Delays inclusion of CGMs and insulin pumps in Medicare's competitive bidding program until January 1, 2031, to maintain access and innovation.
• Congressional Findings and Sense (Section 2): Highlights diabetes prevalence (affecting 11.6% of Americans, projected to rise), costs ($413 billion annually), and Medicare gaps (e.g., non-reimbursement for AID software). Urges HHS to treat AID algorithms as separately payable under Medicare's durable medical equipment benefit.

Significant Changes to Existing Law

• Amends the Social Security Act (SSA) Section 1861(ww) to add care continuity requirements for diabetes technologies during initial Part B enrollment, including provider certification and streamlined contractor reviews.
• Revises SSA Section 1861(qq) to expand DSMT availability, remove quantity limits, and broaden ordering providers; aligns MNT services with DSMT changes.
• Eliminates cost-sharing for DSMT under SSA Section 1833, making it fully covered like preventive services.
• Adds a mandatory virtual DSMT model to SSA Section 1115A, expanding CMS's innovation testing authority.
• Introduces new HCPCS billing codes and delays competitive bidding under SSA Section 1847, overriding aspects of the 2025 CMS final rule on durable medical equipment.
• Requires a specific NCD process under SSA Section 1869, accelerating coverage decisions for insulin pumps.

Potential Impacts

• On Citizens: Medicare beneficiaries with diabetes (about 26% of enrollees) gain easier access to life-saving technologies and unlimited medically necessary training, potentially reducing complications like heart disease, kidney failure, or amputations. Virtual options could improve access in rural or underserved areas, lowering out-of-pocket costs and encouraging adherence to care.
• On Government Agencies: CMS and HHS face implementation burdens, including form development, guidance issuance, model testing, and a proposed NCD, with deadlines starting in 2027. The GAO report may inform future policy. Could reduce long-term Medicare expenditures by preventing costly hospitalizations, though initial expansions might increase short-term spending.
• On International Relations: No direct impacts, as the bill focuses on U.S. domestic Medicare policy.

Main Stakeholders Affected

• Medicare Beneficiaries with Diabetes: Primary beneficiaries, especially new enrollees, gaining continued device access and free training.
• Healthcare Providers and Suppliers: Physicians, nurse practitioners, and others can certify devices and bill for expanded training; device manufacturers (e.g., CGM/insulin pump makers) benefit from delayed bidding and software recognition.
• CMS and HHS: Responsible for rulemaking, oversight, and innovation models; Medicare Administrative Contractors handle certifications.
• Federal Health Programs: Broader implications for Medicaid, VA, and other programs via the GAO report on access barriers.
• Patient and Professional Groups: Organizations like the American Diabetes Association influence design through consultations; rural/underserved communities may see improved equity.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens Medicare coverage under SSA Section 1862(a)(1)(A) by deeming diabetes technologies "reasonable and necessary," potentially reducing denials and audits. The certification process limits contractor discretion, promoting consistency, while the virtual model tests expansions within CMS's existing authority (no new entitlements created).
• Constitutional: Aligns with equal protection principles by addressing disparities in Medicare access for older adults with chronic conditions; no apparent First Amendment or due process issues.
• Political: Bipartisan (introduced by Sens. Shaheen and Collins), reflects priorities on chronic disease management amid rising diabetes rates. Could set precedents for tech reimbursement (e.g., software as durable equipment) and virtual care post-COVID, influencing future health innovation funding. Budgetary effects may spark debates on Medicare solvency, but emphasis on cost-saving outcomes (e.g., reduced complications) supports fiscal neutrality.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Sen. Shaheen, Jeanne [D-NH]

Cosponsors (1)

Sen. Collins, Susan M. [R-ME]

Recent Actions

• 2026-03-10: Read twice and referred to the Committee on Finance.
• 2026-03-10: Introduced in Senate

Bill Versions

• Diabetes Interventions Addressing Barriers to Enrollment, Technology, and Education Services (DIABETES) Act — issued 2026-03-10 — PDF (18 pages)