```

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5502 Introduced in Senate (IS)]

<DOC>

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Diabetes Interventions Addressing 
Barriers to Enrollment, Technology, and Education Services (DIABETES) 
Act'' or the ``Diabetes Act''.

SEC. 2. FINDINGS; SENSE OF CONGRESS.

    (a) Findings.--Congress finds the following:
            (1) According to the Centers for Disease Control and 
        Prevention, in 2021, an estimated 38,400,000 Americans, or 11.6 
        percent of the entire United States population, have diabetes.
            (2) The total number of individuals with diabetes is 
        projected to increase to an estimated 54,900,000 individuals by 
        2030.
            (3) Diabetes disproportionately impacts the Medicare 
        population, as the Centers for Medicare & Medicaid Services 
        found in 2022, and 26 percent of Medicare beneficiaries have 
        diabetes.
            (4) Both type 1 and 2 diabetes can significantly harm long-
        term health and is associated with numerous comorbidities such 
        as cancer, heart disease, chronic kidney disease, blindness, 
        and amputations.
            (5) The direct and indirect cost of diabetes is significant 
        as the American Diabetes Association found that the total 
        annual cost of diabetes in 2022 was $412,900,000,000, 
        $306,600,000,000 of which is attributable to direct medical 
        costs.
            (6) The American Diabetes Association and the American 
        Association of Clinical Endocrinology have set forth clinical 
        guidelines that include the use of continuous glucose monitors, 
        insulin pumps, automated insulin delivery systems, and diabetes 
        self-management training for individuals with diabetes.
            (7) An automated insulin delivery system consists of a 
        continuous glucose monitor, an insulin pump, and an algorithm 
        or software.
            (8) The algorithm or software is a critical component of an 
        automated insulin delivery system as it continuously learns the 
        user's behavior and physiological responses and automatically 
        administers the appropriate amount of insulin.
            (9) 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.
            (10) 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.
    (b) Sense of Congress.--It is the sense of Congress that the 
Secretary of Health and Human Services should commit to take 
administrative action to--
            (1) 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 under 
        section 1862(a)(1)(A) of the Social Security Act;
            (2) ensure the algorithm or software in an automated 
        insulin delivery system is treated as a separately payable 
        supply to durable medical equipment; and
            (3) when applicable, recognize the algorithm or software in 
        an automated insulin delivery system as ``medical supplies 
        associated with the injection of insulin'' consistent with 
        section 1860D-2(e)(1) of the Social Security Act.

SEC. 3. CONTINUED ACCESS TO DIABETES RELATED TECHNOLOGIES.

    (a) In General.--Section 1861(ww) of the Social Security Act (42 
U.S.C. 1395x(ww)) is amended--
            (1) in paragraph (1)--
                    (A) by striking ``and'' after ``upon the agreement 
                with the individual,''; and
                    (B) by inserting ``and ensuring care continuity for 
                individuals using diabetes technology covered under 
                part B as described in paragraph (5),'' after ``(as 
                defined in paragraph (4)),''; and
            (2) by adding at the end the following new paragraph:
    ``(5)(A) Subject to subparagraphs (B) and (C) of this paragraph, 
during the first 12 months of an individual's enrollment for benefits 
under part B, a provider (as defined in subparagraph (E)) may certify 
to the Secretary that an individual is using 1 or multiple diabetes 
technologies covered under part B (as defined in subparagraph (D)).
    ``(B) During the initial preventive physical examination or other 
covered service as determined appropriate by the Secretary during the 
period described in subparagraph (A), the provider may make a 
determination of the individual's use of diabetes technology covered 
under part B. In the case where the provider makes such determination, 
the provider shall submit a certification to the Secretary as required 
under subparagraph (C).
    ``(C) Not later than January 1, 2026, the Secretary shall--
            ``(i) issue a finalized certification form, developed 
        pursuant to public notice and opportunity for comment, for use 
        under this paragraph;
            ``(ii) issue guidance and instructions to medicare 
        administrative contractors (as defined in section 1874A(3)), 
        that require the relevant medicare administrative contractors 
        to only assess whether the certification form is included in 
        the individual's medical records when making a determination of 
        whether coverage of the diabetes technology covered under part 
        B is reasonable and necessary as described in section 
        1862(a)(1)(A);
            ``(iii) develop a process through notice and comment 
        rulemaking for considering whether an individual's diabetes 
        technology that is not covered under part B at the time of the 
        certification described in subparagraph (A) should be a covered 
        benefit under existing statutory authority; and
            ``(iv) issue appropriate guidance to relevant audit and 
        oversight entities to ensure those entities do not 
        inappropriately cause disruptions in access to diabetes 
        technology covered under part B.
    ``(D) For purposes of this paragraph, the term `diabetes technology 
covered under part B' means, with respect to an individual, any device, 
related supplies, and software or algorithm that, at the time the 
certification described in subparagraph (C) is made with respect to the 
individual, is covered under part B for an individual that has diabetes 
under the applicable ICD-10 code list as determined by the Secretary.
    ``(E) For purposes of this paragraph, the term `provider' means a 
physician (as defined in section 1861(r)), nurse practitioner, clinical 
nurse specialist, physician assistant, (as those terms are defined in 
section 1861(aa)(5)), or certified nurse-midwife (as defined in section 
1861(gg)(2)), or other provider of services or supplier as determined 
appropriate by the Secretary.''.
    (b) Effective Date.--The amendments made by this section shall 
apply to items and services furnished on or after January 1, 2026.

SEC. 4. EXPANDING ACCESS TO DIABETES OUTPATIENT SELF-MANAGEMENT 
              TRAINING SERVICES.

    (a) In General.--Section 1861(qq) of the Social Security Act (42 
U.S.C. 1395x(qq)) is amended--
            (1) in paragraph (1)--
                    (A) by inserting ``and consistent with paragraph 
                (2)(C)'' after ``as the Secretary determines 
                appropriate'';
                    (B) by inserting ``or qualified non-physician 
                practitioner'' after ``only if the physician''; and
                    (C) by inserting ``(or other physician or qualified 
                non-physician practitioner furnishing items or services 
                to such individual, in coordination with the physician 
                or qualified non-physician practitioner managing such 
                individual's diabetic condition)'' after ``managing the 
                individual's diabetic condition''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (A), by striking ``and'' at the 
                end;
                    (B) in subparagraph (B)--
                            (i) by striking ``paragraph'' and inserting 
                        ``subparagraph''; and
                            (ii) by striking the period at the end and 
                        inserting ``; and''; and
                    (C) by adding the following new subparagraph:
            ``(C) the times determined appropriate by the Secretary 
        shall in no way limit the quantity or duration of educational 
        and training services furnished by a certified provider to an 
        individual with diabetes if such service is deemed medically 
        necessary by a physician or qualified non-physician 
        practitioner.''.
    (b) Effective Date.--The amendments made by this section shall 
apply to items and services furnished on or after January 1, 2026.

SEC. 5. PROVIDING INSULIN PUMP TRAINING AND EDUCATION.

    (a) In General.--Not later than January 1, 2026, the Secretary of 
Health and Human Services (in this section referred to as the 
``Secretary'') shall establish new Healthcare Common Procedure Coding 
System codes under the fee schedule established under section 1848(b) 
of the Social Security Act (42 U.S.C. 1395w-4(b)) that describe hook-
up, calibration, and patient training with respect to an insulin pump 
similar to Current Procedural Terminology codes 95249 and 95250 (and 
any succeeding codes). The Secretary shall ensure the newly established 
codes sufficiently describe patient education and training as well as 
insulin pump placement services for technologies covered under section 
1834 of the Social Security Act (42 U.S.C. 1395m) and part D of title 
XVIII of the Social Security Act (42 U.S.C. 1395w-101 et seq.).
    (b) Education and Outreach.--The Secretary shall use existing 
communications and mechanisms to provide education and outreach to 
stakeholders with respect to the ability of health professionals to 
bill the newly established codes described in subsection (a).

SEC. 6. NATIONAL COVERAGE DETERMINATION ON INSULIN PUMPS.

    Not later than 180 days after the date of enactment of this Act, 
the Secretary of Health and Human Services shall issue a proposed 
national coverage determination (as defined in section 1869(f)(1)(B) of 
the Social Security Act (42 U.S.C. 1395ff(f)(1)(B)) for infusion pumps, 
continuous subcutaneous insulin infusion (CSII), number 280.14 pursuant 
to section 1862(l) of the Social Security Act (42 U.S.C. 1395y(l)).

SEC. 7. REPORT ON ENROLLEE ACCESS TO DIABETES-RELATED SERVICES AND 
              TECHNOLOGIES IN FEDERAL HEALTH CARE PROGRAMS.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Comptroller General of the United States, in 
collaboration with the Secretary of Health and Human Services, shall 
submit to the Committee on Finance and the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce and the Committee on Ways and Means of the House of 
Representatives, a report that assesses the barriers individuals face 
in accessing diabetes technologies and diabetes self-management 
education and support services across Federal health care programs. The 
report shall specifically review barriers, which include prior 
authorization practices, the use of preferred formularies, coverage 
intensity limitations, and other utilization management techniques, to 
accessing diabetes technologies and diabetes self-management education 
and support services faced by individuals enrolled in a Federal health 
care program, and whether any Federal law, regulation, or policy 
adversely affects access to those covered services or limits the 
ability of individuals with diabetes to receive services that align 
with standards of care.
    (b) Definitions.--In this section:
            (1) Diabetes technologies.--The term ``diabetes 
        technologies'' means items described in section 1861(ww)(5)(D) 
        of the Social Security Act, as added by section 3, and any 
        device, related supplies, and software or algorithm that 
        monitors or manages an individual's diabetes that is medically 
        necessary for the individual's diagnosis of diabetes, 
        regardless of whether the device, related supplies, and 
        software or algorithm is covered under part B of title XVIII of 
        the Social Security Act. Such term includes glucose monitors, 
        insulin delivery technologies, related supplies, and software 
        or algorithms.
            (2) Diabetes self-management education and support 
        services.--The term ``diabetes self-management education and 
        support services'' means services described in section 1861(qq) 
        of the Social Security Act (42 U.S.C. 1395x(qq)).
            (3) Federal health care program.--The term ``Federal health 
        care program'' means any plan or program that provides health 
        benefits, whether through insurance or otherwise, that is 
        directly funded in whole or in part, by the United States 
        Government, including a Federal health care program (as defined 
        in section 1128B(f) of the Social Security Act (42 U.S.C. 
        1320a-7b(f))) and a health benefits plan under chapter 89 of 
        title 5, United States Code.
                                 <all>
```