“A bill to ensure continued access to diabetes technology upon Medicare enrollment, and for other purposes.”
No CRS summary available for this bill.
This section states congressional findings regarding diabetes prevalence (38.4 million Americans, or 11.6% of the population, in 2021, projected to rise to 54.9 million by 2030), its disproportionate impact on Medicare beneficiaries (26% affected), associated comorbidities and costs ($412.9 billion total annually in 2022, including $306.6 billion in direct medical costs), clinical guidelines supporting continuous glucose monitors, insulin pumps, automated insulin delivery systems, and self-management training, and Medicare coverage gaps for automated insulin delivery algorithms and software as well as competitive bidding effects on these devices. It expresses the sense of Congress that the Secretary of Health and Human Services should (1) recognize automated insulin delivery algorithms or software as reasonable and necessary for Medicare coverage; (2) treat such algorithms or software as separately payable supplies to durable medical equipment; and (3) when applicable, recognize them as medical supplies associated with insulin injection.
This section amends the personalized prevention plan services provided as part of Medicare's Initial Preventive Physical Examination (IPPE, i.e., "Welcome to Medicare" visit under Part B) to include ensuring care continuity for individuals using diabetes technology covered under Part B (i.e., devices, related supplies, software, or algorithms covered for diabetes via applicable ICD-10 codes). It establishes a certification process whereby, during an individual's first 12 months of Part B enrollment, a physician, nurse practitioner, clinical nurse specialist, physician assistant, certified nurse-midwife, or other designated provider may certify the individual's use of such technology during the IPPE or another covered service; directs the Secretary, by January 1, 2027, to issue a finalized certification form (via notice and comment), guidance requiring Medicare Administrative Contractors to base "reasonable and necessary" coverage determinations solely on the form's presence in medical records, a rulemaking process to consider adding non-covered diabetes technologies, and guidance to audit entities to prevent access disruptions; and applies to items and services furnished on or after January 1, 2027.
This section eliminates Medicare Part B coinsurance and deductible for diabetes outpatient self-management training services (DSMTS) (i.e., education and training for individuals with diabetes or renal disease to improve self-management) furnished on or after January 1, 2027 (previously, Part B paid 80 percent of reasonable charges after the annual deductible, with beneficiaries liable for 20 percent coinsurance). It further revises DSMTS coverage requirements by (1) expanding the ordering practitioner to a physician or qualified nonphysician practitioner (from the physician managing the diabetic condition), (2) specifying an initial 10 hours of individual or group services available until used and an additional 2 hours annually thereafter (from times the Secretary determines appropriate), and (3) prohibiting limits on quantity or duration if deemed medically necessary by an ordering practitioner. The section also makes conforming amendments to medical nutrition therapy services for diabetes by striking a coverage limit clause and requiring services to be consistent with an ordering practitioner's plan (previously, after consideration of such a plan).
This section requires the Center for Medicare and Medicaid Innovation (CMI) to include, among models selected for testing under existing criteria, a new model testing Medicare (title XVIII) coverage of virtual diabetes outpatient self-management training services furnished via qualified web-based programs to applicable beneficiaries with diabetes (as defined in SSA §1861(qq)), with implementation by January 1, 2027. (As background, the CMI tests innovative payment and service delivery models to reduce Medicare and Medicaid expenditures while preserving or enhancing care quality.) The model evaluates participant demographics and effects on health outcomes (e.g., reduced A1c levels and diabetes-related hospitalizations), service utilization (e.g., beneficiary participation and hours, especially in rural and underserved areas), medication adherence, and Medicare expenditures; and requires the Secretary to consult diabetes care stakeholders, primary care clinicians, digital health experts, and beneficiary groups within three months of enactment.
This section directs the Secretary of Health and Human Services, not later than January 1, 2027, to establish new Healthcare Common Procedure Coding System (HCPCS) codes under the Medicare physician fee schedule (SSA §1848(b)) that describe insulin pump hook-up, calibration, patient training and education, and placement services (similar to Current Procedural Terminology codes 95249 and 95250), applicable to insulin pumps covered as durable medical equipment under SSA §1834 and under Medicare Part D. The section further requires the Secretary to conduct education and outreach to stakeholders on billing these new codes using existing communications mechanisms.
This section directs the Secretary of Health and Human Services to issue a proposed national coverage determination (NCD)—a Medicare decision on whether an item or service is reasonable and necessary under SSA section 1869(f)(1)(B)—for infusion pumps and continuous subcutaneous insulin infusion (CSII), item number 280.14, pursuant to SSA section 1862(l), not later than 180 days after enactment.
This section directs the Comptroller General of the United States, in collaboration with the Secretary of Health and Human Services, to submit to the Senate Committees on Finance and Health, Education, Labor, and Pensions and the House Committees on Energy and Commerce and Ways and Means, not later than one year after enactment, a report assessing barriers enrollees face in accessing diabetes technologies (i.e., glucose monitors, insulin delivery technologies, related supplies, and software or algorithms) and diabetes self-management education and support services across federal health care programs (i.e., any U.S. government-funded health benefits plan, including Medicare and the Federal Employees Health Benefits program). The report specifically reviews barriers such as prior authorization practices, preferred formularies, coverage intensity limitations, and other utilization management techniques, and examines whether any federal law, regulation, or policy adversely affects access to such services or limits enrollees' ability to receive care aligning with standards of care.
This section includes continuous glucose monitors and insulin pumps—covered as durable medical equipment under Medicare Part B—among the items and services subject to the competitive acquisition program on or after January 1, 2031. (As background, the program awards contracts through competitive bidding to suppliers of durable medical equipment, prosthetics, orthotics, and supplies in designated areas to reduce Medicare costs.)