II 

118TH CONGRESS 

2D SESSION S. 5502 

To ensure continued access to diabetes technology upon Medicare enrollment, 

and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 12, 2024 

Mrs. SHAHEEN (for herself and Ms. COLLINS) introduced the following bill; 

which was read twice and referred to the Committee on Finance 

A BILL 

To ensure continued access to diabetes technology upon 

Medicare enrollment, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Diabetes Interventions 

5 Addressing Barriers to Enrollment, Technology, and Edu6 cation Services (DIABETES) Act’’ or the ‘‘Diabetes Act’’. 

7 SEC. 2. FINDINGS; SENSE OF CONGRESS. 

8 (a) FINDINGS.—Congress finds the following: 

9 (1) According to the Centers for Disease Con10 trol and Prevention, in 2021, an estimated 


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1 38,400,000 Americans, or 11.6 percent of the entire 

2 United States population, have diabetes. 

3 (2) The total number of individuals with diabe4 tes is projected to increase to an estimated 

5 54,900,000 individuals by 2030. 

6 (3) Diabetes disproportionately impacts the 

7 Medicare population, as the Centers for Medicare & 

8 Medicaid Services found in 2022, and 26 percent of 

9 Medicare beneficiaries have diabetes. 

10 (4) Both type 1 and 2 diabetes can significantly 

11 harm long-term health and is associated with numer12 ous comorbidities such as cancer, heart disease, 

13 chronic kidney disease, blindness, and amputations. 

14 (5) The direct and indirect cost of diabetes is 

15 significant as the American Diabetes Association 

16 found that the total annual cost of diabetes in 2022 

17 was $412,900,000,000, $306,600,000,000 of which 

18 is attributable to direct medical costs. 

19 (6) The American Diabetes Association and the 

20 American Association of Clinical Endocrinology have 

21 set forth clinical guidelines that include the use of 

22 continuous glucose monitors, insulin pumps, auto23 mated insulin delivery systems, and diabetes self24 management training for individuals with diabetes. 


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1 (7) An automated insulin delivery system con2 sists of a continuous glucose monitor, an insulin 

3 pump, and an algorithm or software. 

4 (8) The algorithm or software is a critical com5 ponent of an automated insulin delivery system as it 

6 continuously learns the user’s behavior and physio7 logical responses and automatically administers the 

8 appropriate amount of insulin. 

9 (9) Medicare currently fails to separately reim10 burse for the essential algorithms and software that 

11 drive automated insulin delivery (AID) systems, 

12 which may stifle future innovation and maintenance, 

13 and impede beneficiary access. 

14 (10) Medicare has an existing pathway to sepa15 rately reimburse for the algorithm or software in an 

16 automated insulin delivery system, the Medicare du17 rable medical equipment benefit. 

18 (b) SENSE OF CONGRESS.—It is the sense of Con19 gress that the Secretary of Health and Human Services 

20 should commit to take administrative action to— 

21 (1) recognize that the algorithm or software in 

22 an automated insulin delivery system is a ‘‘reason23 able and necessary’’ item ‘‘for the diagnosis or treat24 ment of illness or injury or to improve the func25 tioning of a malformed body member’’ consistent 


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1 with Medicare coverage requirements under section 

2 1862(a)(1)(A) of the Social Security Act; 

3 (2) ensure the algorithm or software in an auto4 mated insulin delivery system is treated as a sepa5 rately payable supply to durable medical equipment; 

6 and 

7 (3) when applicable, recognize the algorithm or 

8 software in an automated insulin delivery system as 

9 ‘‘medical supplies associated with the injection of in10 sulin’’ consistent with section 1860D–2(e)(1) of the 

11 Social Security Act. 

12 SEC. 3. CONTINUED ACCESS TO DIABETES RELATED TECH13 NOLOGIES. 

14 (a) IN GENERAL.—Section 1861(ww) of the Social 

15 Security Act (42 U.S.C. 1395x(ww)) is amended— 

16 (1) in paragraph (1)— 

17 (A) by striking ‘‘and’’ after ‘‘upon the 

18 agreement with the individual,’’; and 

19 (B) by inserting ‘‘and ensuring care con20 tinuity for individuals using diabetes technology 

21 covered under part B as described in paragraph 

22 (5),’’ after ‘‘(as defined in paragraph (4)),’’; 

23 and 

24 (2) by adding at the end the following new 

25 paragraph: 


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1 ‘‘(5)(A) Subject to subparagraphs (B) and (C) of this 

2 paragraph, during the first 12 months of an individual’s 

3 enrollment for benefits under part B, a provider (as de4 fined in subparagraph (E)) may certify to the Secretary 

5 that an individual is using 1 or multiple diabetes tech6 nologies covered under part B (as defined in subparagraph 

7 (D)). 

8 ‘‘(B) During the initial preventive physical examina9 tion or other covered service as determined appropriate by 

10 the Secretary during the period described in subparagraph 

11 (A), the provider may make a determination of the individ12 ual’s use of diabetes technology covered under part B. In 

13 the case where the provider makes such determination, the 

14 provider shall submit a certification to the Secretary as 

15 required under subparagraph (C). 

16 ‘‘(C) Not later than January 1, 2026, the Secretary 

17 shall— 

18 ‘‘(i) issue a finalized certification form, devel19 oped pursuant to public notice and opportunity for 

20 comment, for use under this paragraph; 

21 ‘‘(ii) issue guidance and instructions to medi22 care administrative contractors (as defined in section 

23 1874A(3)), that require the relevant medicare ad24 ministrative contractors to only assess whether the 

25 certification form is included in the individual’s medVerDate Sep 11 2014 04:24 Jan 17, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S5502.IS S5502

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1 ical records when making a determination of wheth2 er coverage of the diabetes technology covered under 

3 part B is reasonable and necessary as described in 

4 section 1862(a)(1)(A); 

5 ‘‘(iii) develop a process through notice and com6 ment rulemaking for considering whether an individ7 ual’s diabetes technology that is not covered under 

8 part B at the time of the certification described in 

9 subparagraph (A) should be a covered benefit under 

10 existing statutory authority; and 

11 ‘‘(iv) issue appropriate guidance to relevant 

12 audit and oversight entities to ensure those entities 

13 do not inappropriately cause disruptions in access to 

14 diabetes technology covered under part B. 

15 ‘‘(D) For purposes of this paragraph, the term ‘dia16 betes technology covered under part B’ means, with re17 spect to an individual, any device, related supplies, and 

18 software or algorithm that, at the time the certification 

19 described in subparagraph (C) is made with respect to the 

20 individual, is covered under part B for an individual that 

21 has diabetes under the applicable ICD–10 code list as de22 termined by the Secretary. 

23 ‘‘(E) For purposes of this paragraph, the term ‘pro24 vider’ means a physician (as defined in section 1861(r)), 

25 nurse practitioner, clinical nurse specialist, physician asVerDate Sep 11 2014 04:24 Jan 17, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S5502.IS S5502

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1 sistant, (as those terms are defined in section 

2 1861(aa)(5)), or certified nurse-midwife (as defined in sec3 tion 1861(gg)(2)), or other provider of services or supplier 

4 as determined appropriate by the Secretary.’’. 

5 (b) EFFECTIVE DATE.—The amendments made by 

6 this section shall apply to items and services furnished on 

7 or after January 1, 2026. 

8 SEC. 4. EXPANDING ACCESS TO DIABETES OUTPATIENT 

9 SELF-MANAGEMENT TRAINING SERVICES. 

10 (a) IN GENERAL.—Section 1861(qq) of the Social Se11 curity Act (42 U.S.C. 1395x(qq)) is amended— 

12 (1) in paragraph (1)— 

13 (A) by inserting ‘‘and consistent with para14 graph (2)(C)’’ after ‘‘as the Secretary deter15 mines appropriate’’; 

16 (B) by inserting ‘‘or qualified non-physi17 cian practitioner’’ after ‘‘only if the physician’’; 

18 and 

19 (C) by inserting ‘‘(or other physician or 

20 qualified non-physician practitioner furnishing 

21 items or services to such individual, in coordina22 tion with the physician or qualified non-physi23 cian practitioner managing such individual’s di24 abetic condition)’’ after ‘‘managing the individ25 ual’s diabetic condition’’; and 


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1 (2) in paragraph (2)— 

2 (A) in subparagraph (A), by striking 

3 ‘‘and’’ at the end; 

4 (B) in subparagraph (B)— 

5 (i) by striking ‘‘paragraph’’ and in6 serting ‘‘subparagraph’’; and 

7 (ii) by striking the period at the end 

8 and inserting ‘‘; and’’; and 

9 (C) by adding the following new subpara10 graph: 

11 ‘‘(C) the times determined appropriate by the 

12 Secretary shall in no way limit the quantity or dura13 tion of educational and training services furnished 

14 by a certified provider to an individual with diabetes 

15 if such service is deemed medically necessary by a 

16 physician or qualified non-physician practitioner.’’. 

17 (b) EFFECTIVE DATE.—The amendments made by 

18 this section shall apply to items and services furnished on 

19 or after January 1, 2026. 

20 SEC. 5. PROVIDING INSULIN PUMP TRAINING AND EDU21 CATION. 

22 (a) IN GENERAL.—Not later than January 1, 2026, 

23 the Secretary of Health and Human Services (in this sec24 tion referred to as the ‘‘Secretary’’) shall establish new 

25 Healthcare Common Procedure Coding System codes 


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1 under the fee schedule established under section 1848(b) 

2 of the Social Security Act (42 U.S.C. 1395w–4(b)) that 

3 describe hook-up, calibration, and patient training with re4 spect to an insulin pump similar to Current Procedural 

5 Terminology codes 95249 and 95250 (and any succeeding 

6 codes). The Secretary shall ensure the newly established 

7 codes sufficiently describe patient education and training 

8 as well as insulin pump placement services for technologies 

9 covered under section 1834 of the Social Security Act (42 

10 U.S.C. 1395m) and part D of title XVIII of the Social 

11 Security Act (42 U.S.C. 1395w–101 et seq.). 

12 (b) EDUCATION AND OUTREACH.—The Secretary 

13 shall use existing communications and mechanisms to pro14 vide education and outreach to stakeholders with respect 

15 to the ability of health professionals to bill the newly es16 tablished codes described in subsection (a). 

17 SEC. 6. NATIONAL COVERAGE DETERMINATION ON INSU18 LIN PUMPS. 

19 Not later than 180 days after the date of enactment 

20 of this Act, the Secretary of Health and Human Services 

21 shall issue a proposed national coverage determination (as 

22 defined in section 1869(f)(1)(B) of the Social Security Act 

23 (42 U.S.C. 1395ff(f)(1)(B)) for infusion pumps, contin24 uous subcutaneous insulin infusion (CSII), number 


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1 280.14 pursuant to section 1862(l) of the Social Security 

2 Act (42 U.S.C. 1395y(l)). 

3 SEC. 7. REPORT ON ENROLLEE ACCESS TO DIABETES-RE4 LATED SERVICES AND TECHNOLOGIES IN 

5 FEDERAL HEALTH CARE PROGRAMS. 

6 (a) IN GENERAL.—Not later than 1 year after the 

7 date of enactment of this Act, the Comptroller General 

8 of the United States, in collaboration with the Secretary 

9 of Health and Human Services, shall submit to the Com10 mittee on Finance and the Committee on Health, Edu11 cation, Labor, and Pensions of the Senate and the Com12 mittee on Energy and Commerce and the Committee on 

13 Ways and Means of the House of Representatives, a report 

14 that assesses the barriers individuals face in accessing dia15 betes technologies and diabetes self-management edu16 cation and support services across Federal health care 

17 programs. The report shall specifically review barriers, 

18 which include prior authorization practices, the use of pre19 ferred formularies, coverage intensity limitations, and 

20 other utilization management techniques, to accessing dia21 betes technologies and diabetes self-management edu22 cation and support services faced by individuals enrolled 

23 in a Federal health care program, and whether any Fed24 eral law, regulation, or policy adversely affects access to 

25 those covered services or limits the ability of individuals 


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1 with diabetes to receive services that align with standards 

2 of care. 

3 (b) DEFINITIONS.—In this section: 

4 (1) DIABETES TECHNOLOGIES.—The term ‘‘di5 abetes technologies’’ means items described in sec6 tion 1861(ww)(5)(D) of the Social Security Act, as 

7 added by section 3, and any device, related supplies, 

8 and software or algorithm that monitors or manages 

9 an individual’s diabetes that is medically necessary 

10 for the individual’s diagnosis of diabetes, regardless 

11 of whether the device, related supplies, and software 

12 or algorithm is covered under part B of title XVIII 

13 of the Social Security Act. Such term includes glu14 cose monitors, insulin delivery technologies, related 

15 supplies, and software or algorithms. 

16 (2) DIABETES SELF-MANAGEMENT EDUCATION

17 AND SUPPORT SERVICES.—The term ‘‘diabetes self18 management education and support services’’ means 

19 services described in section 1861(qq) of the Social 

20 Security Act (42 U.S.C. 1395x(qq)). 

21 (3) FEDERAL HEALTH CARE PROGRAM.—The 

22 term ‘‘Federal health care program’’ means any plan 

23 or program that provides health benefits, whether 

24 through insurance or otherwise, that is directly 

25 funded in whole or in part, by the United States 


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1 Government, including a Federal health care pro2 gram (as defined in section 1128B(f) of the Social 

3 Security Act (42 U.S.C. 1320a–7b(f))) and a health 

4 benefits plan under chapter 89 of title 5, United 

5 States Code. 

Æ 


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