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