S. 4037: Diabetes Interventions Addressing Barriers to Enrollment, Technology, and Education Services (DIABETES) Act

This bill, officially titled the Diabetes Interventions Addressing Barriers to Enrollment, Technology, and Education Services (DIABETES) Act, aims to improve access to diabetes care and technology for individuals with diabetes, particularly those enrolled in Medicare. Below are the key provisions outlined in the bill:

1. Findings and Rationale

The legislation begins with findings that highlight the prevalence and cost of diabetes in the United States. It notes that:

• Approximately 38.4 million people in the U.S. have diabetes, with projections of nearly 55 million by 2030.
• 26% of Medicare beneficiaries have diabetes.
• Diabetes contributes significantly to healthcare costs, with the American Diabetes Association estimating the annual cost to be over $412 billion.
• Both type 1 and type 2 diabetes lead to serious health complications, highlighting the need for effective diabetes management technologies.
• Current Medicare regulations do not adequately support access to the necessary diabetes management technologies like continuous glucose monitors and automated insulin delivery systems.

2. Access to Diabetes Technologies

The bill proposes to amend Medicare provisions to ensure continued access to diabetes technology. Key stipulations include:

• During the first year of Medicare enrollment, healthcare providers can certify a patient's use of diabetes technology, allowing for continued access to necessary equipment.
• The bill tasks the Secretary of Health and Human Services (HHS) to develop and issue guidelines that facilitate this certification of technology usage.
• Any new technologies that are deemed medically necessary may be evaluated for coverage under Medicare.

3. Diabetes Self-Management Training

To enhance diabetes education, the bill includes measures to improve access to self-management training services:

• Individuals will have access to a total of 12 hours of diabetes self-management training services, including an initial 10 hours plus 2 additional hours each subsequent year as needed.
• The bill prohibits limiting the quantity or duration of necessary educational services.

4. Virtual Training Services

The act establishes a model to test virtual diabetes outpatient self-management training services, aiming to determine their effectiveness in improving health outcomes and reducing costs associated with diabetes care.

5. Insulin Pump Education

The bill requires HHS to create new procedure codes for the training and education around insulin pump usage. This includes hook-up and calibration of devices to improve accessibility and understanding of such technologies for patients.

6. Coverage Decisions on Insulin Pumps

HHS is mandated to propose a national coverage determination for insulin pumps within 180 days of the bill's enactment.

7. Reporting on Access Barriers

Within one year after implementation, the Comptroller General of the United States, in collaboration with HHS, must report on the barriers faced by individuals accessing diabetes technologies and self-management services within federal healthcare programs.

8. Reinforcing Coverage of Diabetes Technologies

The bill reinforces that certain diabetes-related items, such as continuous glucose monitors and insulin pumps, should continue to be covered by Medicare as durable medical equipment starting January 1, 2031.

Effective Date

Most provisions of this bill are set to take effect for services provided on or after January 1, 2027.

Relevant Companies

• ABBV (AbbVie Inc.): May see an impact due to its products in diabetes management, including insulin medications.
• JNJ (Johnson & Johnson): Involved in diabetes care through medical devices and supplies, likely affected by changes in reimbursement policies.
• MDT (Medtronic plc): A significant player in insulin delivery systems, which may benefit from expanded coverage and training provisions in the bill.
• OMAB (Omarba): Focuses on diabetes technologies, and might experience changes related to reimbursement for new innovations.