A new bill introduced by Sen. Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.), co-chairs of the Senate diabetes caucus, seeks to keep insulin pumps and continuous glucose monitors (CGMs) out of the Medicare competitive bidding program for five years.
S. 4037, the Diabetes Interventions Addressing Barriers to Enrollment, Technology and Education Services Act, “also expands Medicare coverage of diabetes self-management training sessions, where diabetes educators help train Medicare patients on how to manage the disease and use complex diabetes technologies,” the American Association for Homecare (AAHomecare) said in a March 12 announcement.
The bill noted that 38.4 million Americans — 11.6% of the country’s population — have diabetes. By 2030, the number of Americans with diabetes is expected to jump to 54.9 million.
The percentage of Medicare beneficiaries with diabetes — 26% — is even higher than the national figure.
The bill said the “direct and indirect costs” of diabetes, according to the American Diabetes Association, was estimated at $412.9 billion in 2022, with $306.6 billion going toward “direct medical costs.”
CGMs, insulin pumps, automated insulin delivery systems, and diabetes self management are all included in clinical guidelines from the American Diabetes Association and the American Association of Clinical Endocrinology, the bill added, stating, “Medicare currently fails to separately reimburse for the essential algorithms and software that drive automated insulin delivery (AID) systems, which may stifle future innovation and maintenance, and impede beneficiary access.
“Medicare has an existing pathway to separately reimburse for the algorithm or software in an automated insulin delivery system, the Medicare durable medical equipment benefit.”
Diabetes technology is part of the next competitive bidding round
The Centers for Medicare & Medicaid Services’ (CMS) final home health rule, released in late November, included CGMs and insulin pumps. In the final rule, CMS said those supplies would be in the Remote Item Delivery segment, created for durable medical equipment (DME) typically provided repeatedly through mail order.
Based on 2024 claims data for insulin pumps and CGMs, CMS said, “We believe this would result in approximately 10 national contract suppliers for the CGM/insulin pump product category.”
Competitive bidding program registration and bidding dates are due to be announced this year, in late spring to early summer.
The new Senate bill said reclassifying CGMs and insulin pumps “as items requiring frequent and substantial servicing when they are phased into the competitive bidding program will have numerous unintended consequences that may prevent Medicare beneficiaries from accessing the continuous glucose monitor or durable insulin pump they need to survive.”
Including insulin pumps, CGMs and related supplies in competitive bidding “further limits innovation and access to diabetes technologies,” the bill added.
The bill said the secretary of the U.S. Department of Health & Human Services “should commit to take administrative action to recognize that the algorithm or software in an automated insulin delivery system is a ‘reasonable and necessary’ item ‘for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member’ consistent with Medicare coverage requirements.”
Language in the bill also said the algorithm or software in an automated insulin delivery system is treated as a separately payable supply to durable medical equipment and “when applicable, recognize the algorithm or software in an automated insulin delivery system as ‘medical supplies associated with the injection of insulin.’”
Preserving patient access
A March 11 press release from Shaheen’s office said, “The senators’ bill also includes a provision exempting insulin pumps and continuous glucose monitors from the Medicare competitive bidding process for five years. This comes after Shaheen and Collins urged CMS Administrator Mehmet Oz not to finalize a proposal the lawmakers warned could reduce and complicate patient access to CGMs and durable insulin pumps.”
“Sens. Shaheen and Collins have a long record of standing by the millions of Americans who use diabetes products and working to ensure they can benefit from continuing technological advances for these devices,” said Tom Ryan, AAHomecare president/CEO in the March 12 announcement. “Their new legislation is an important step forward in protecting access to these critically important products and maintaining a robust supplier infrastructure to support patients.
“I know that diabetes stakeholders in our industry are ready to engage their legislators on this issue. That enthusiasm, coupled with the support from leading diabetes advocacy groups who have endorsed this bill, will make a strong impact on Capitol Hill.”
