[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2146 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 2146

  To establish within the Office of the Secretary of Health and Human 
 Services a special task force on ensuring Medicare beneficiary access 
           to innovative diabetes technologies and services.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 21, 2021

  Ms. Collins (for herself and Mrs. Shaheen) introduced the following 
  bill; which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
  To establish within the Office of the Secretary of Health and Human 
 Services a special task force on ensuring Medicare beneficiary access 
           to innovative diabetes technologies and services.

    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 ``Improving Medicare Beneficiary 
Access to Innovative Diabetes Technologies Act of 2021''.

SEC. 2. ESTABLISHMENT OF HHS TASK FORCE ON COVERAGE AND PAYMENT FOR 
              INNOVATIVE DIABETES TECHNOLOGIES AND SERVICES.

    (a) Definitions.--In this section:
            (1) CMS.--The term ``CMS'' means the Centers for Medicare & 
        Medicaid Services.
            (2) FDA.--The term ``FDA'' means the Food and Drug 
        Administration.
            (3) Innovative diabetes technologies and services.--The 
        term ``innovative diabetes technologies and services'' means 
        medical technologies and services for the treatment and 
        management of diabetes for which coverage is not available 
        under the Medicare fee-for-service program.
            (4) Medicare.--The term ``Medicare'' means the program of 
        health insurance for the aged and disabled established under 
        title XVIII of the Social Security Act.
            (5) Medicare beneficiary.--The term ``Medicare 
        beneficiary'' means an individual who is entitled to benefits 
        under part A of title XVIII of the Social Security Act, or 
        enrolled under part B of such title, or both.
            (6) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
    (b) Establishment; Mission.--
            (1) Establishment.--There is established within the Office 
        of the Secretary the Task Force on Innovative Diabetes 
        Technologies and Services (in this section referred to as the 
        ``Task Force'').
            (2) Mission.--The mission of the Task Force is to--
                    (A) advise the Secretary with respect to 
                accessibility to innovative diabetes technologies and 
                services under Medicare;
                    (B) make recommendations to support current and 
                future access to innovative diabetes technologies and 
                services under Medicare; and
                    (C) recommend changes to Medicare to ensure 
                appropriate access by Medicare beneficiaries to such 
                innovative diabetes technologies and services.
    (c) Membership.--
            (1) Appointment.--The Secretary shall appoint individuals 
        with relevant expertise to the Task Force, which shall include 
        the following voting members:
                    (A) CMS officials.--
                            (i) The Director of the Center for 
                        Medicare.
                            (ii) Not more than 2 additional officials 
                        or senior staff of CMS as the Secretary may 
                        specify.
                    (B) Beneficiary ombudsman.--The Medicare 
                Beneficiary Ombudsman.
                    (C) Pharmaceutical and technology ombudsman.--The 
                Medicare Pharmaceutical and Technology Ombudsman.
                    (D) FDA officials.--Not more than 2 officials or 
                senior staff from the Diabetes Branch of the Center for 
                Devices and Radiological Health of FDA as the 
                Commissioner of Food and Drugs may specify.
                    (E) Patient groups.--Representatives of--
                            (i) Medicare beneficiaries;
                            (ii) individuals enrolled under a State 
                        plan under title XIX of the Social Security Act 
                        (or a waiver of such a plan); and
                            (iii) individuals not described in clause 
                        (i) or (ii) who have a diagnosis of diabetes.
                    (F) Health care providers.--Representatives of 
                providers of services, physicians, and practitioners 
                who treat individuals with a diagnosis of diabetes.
                    (G) Manufacturers.--Representatives of 
                manufacturers of diabetes technologies, including 
                innovative diabetes technologies and services.
            (2) Co-chairs.--
                    (A) In general.--Of the members of the Task Force--
                            (i) one co-chair shall be the Director of 
                        the Center for Medicare; and
                            (ii) one co-chair shall be designated by 
                        the Secretary from among voting members 
                        appointed under subparagraph (E), (F), or (G) 
                        of paragraph (1).
                    (B) Rotation of non-government co-chair.--The 
                Secretary shall rotate designations of co-chairs under 
                subparagraph (A)(ii) from among voting members 
                appointed under subparagraph (E), (F), or (G) of 
                paragraph (1).
                    (C) Term of service for non-government co-chair.--
                Each co-chair designated under subparagraph (A)(ii) 
                shall serve a term of 2 years.
            (3) Compensation.--
                    (A) In general.--Except as provided in subparagraph 
                (B), members of the Task Force shall serve without 
                compensation.
                    (B) Travel expenses.--A member of the Task Force 
                may be allowed travel expenses, including per diem in 
                lieu of subsistence, at rates authorized for an 
                employee of an agency under subchapter I of chapter 57 
                of title 5, United States Code, while away from the 
                home or regular place of business of the member in the 
                performance of the duties of the Task Force.
    (d) Meetings.--The Secretary shall convene the Task Force not less 
frequently than 4 times each year. The Secretary shall convene the 
first meeting of the Task Force no later than July 1, 2022.
    (e) Duties.--The Task Force shall carry out the following duties:
            (1) Identification of innovative diabetes technologies and 
        services.--The Task Force shall--
                    (A) identify innovative diabetes technologies and 
                services for the treatment of type I diabetes, type II 
                diabetes, or both, that are in development or that have 
                been cleared or approved by FDA and that are wholly or 
                partially inaccessible to Medicare beneficiaries with 
                diabetes under Medicare;
                    (B) develop and consider possible alternative 
                approaches to enable Medicare beneficiaries to access 
                innovative diabetes technologies and services; and
                    (C) determine whether the existing administrative 
                systems, benefit categories, and coverage, coding and 
                payment policies under Medicare would provide or impede 
                access to, and appropriate payment for, innovative 
                diabetes technologies and services.
            (2) Analysis of access disparities.--
                    (A) Private payor policies.--The Task Force shall 
                review coverage policies developed by private payors 
                for innovative diabetes technologies and services and 
                determine whether disparities exist between patients 
                with diabetes insured by private payors as compared to 
                Medicare beneficiaries with diabetes.
                    (B) Case studies.--The Task Force shall recommend 
                to the Secretary the development of real-world patient 
                case studies and health care provider case studies that 
                identify barriers to access, and access disparities, 
                under Medicare with respect to innovative diabetes 
                technologies and services.
            (3) Identification of changes in relevant fda approval and 
        cms coverage policies.--
                    (A) CMS regulatory barriers to coverage.--The Task 
                Force shall--
                            (i) identify all the categories of items 
                        and services for which coverage is available 
                        under Medicare whether established by title 
                        XVIII of the Social Security Act or otherwise 
                        (in this section referred to as benefit 
                        categories) that may be used to provide for 
                        coverage of diabetes technologies and services, 
                        including innovative diabetes technologies and 
                        services;
                            (ii) review regulations and subregulatory 
                        guidance for the benefit categories identified 
                        under clause (i) to identify policies that 
                        limit coverage of, and payment for, diabetes 
                        technologies and services under Medicare, 
                        especially innovative diabetes technologies and 
                        services; and
                            (iii) recommend specific changes to such 
                        regulations and subregulatory guidance to 
                        provide for coverage of, and payment for, 
                        innovative diabetes technologies and services 
                        under Medicare.
                    (B) Interagency collaboration.--The Task Force 
                shall identify strategies to improve collaboration 
                between FDA and CMS that facilitate expeditious 
                clearance or approval of innovative diabetes 
                technologies and services by FDA and expeditious 
                coverage of innovative diabetes technologies and 
                services under Medicare.
            (4) Identification of strategies to support coverage of 
        innovative diabetes technologies and services.--The Task Force 
        shall identify strategies not otherwise described in this 
        subsection to facilitate access to innovative diabetes 
        technologies and services by Medicare beneficiaries as well as 
        by other patients and their health care providers.
    (f) Recommendations.--Not less frequently than annually, the Task 
Force shall make recommendations to the Secretary with respect to--
            (1) existing benefit categories under which innovative 
        diabetes technologies and services should be covered;
            (2) legislative changes to title XVIII of the Social 
        Security Act and administrative changes to regulations 
        promulgated and subregulatory guidance issued with respect to 
        existing benefit categories that are necessary to provide for 
        coverage of, and payment for, innovative diabetes technologies 
        and services;
            (3) elimination of other unnecessary burdens that impede 
        coverage of, and payment for, innovative diabetes technologies 
        and services under Medicare;
            (4) proposals for a new Medicare benefit category to 
        provide for coverage of innovative diabetes technologies and 
        services that cannot otherwise be covered through 
        administrative changes to regulations and subregulatory 
        guidance for existing benefit categories, and specifications 
        for any new benefit category; and
            (5) proposals to streamline interagency administrative 
        processes through greater collaboration between FDA and CMS to 
        facilitate prompt approval or clearance and coverage under 
        Medicare of innovative diabetes technologies and services for 
        Medicare beneficiaries with diabetes.
    (g) Response.--
            (1) In general.--With respect to each recommendation made 
        by the Task Force under subsection (f), not later than 90 days 
        after the date of receipt of each such recommendation, the 
        Secretary shall make a determination whether to implement or 
        reject the recommendation.
            (2) Implementation.--In the case of a determination by the 
        Secretary to implement a recommendation under paragraph (1), 
        the Secretary shall provide the Task Force with a plan for such 
        implementation, including specific details about and a 
        timetable for the implementation.
            (3) Rejection.--In the case of a determination by the 
        Secretary to reject a recommendation under paragraph (1), the 
        Secretary shall provide the Task Force with--
                    (A) a detailed explanation of the rationale for the 
                determination; and
                    (B) recommendations for alternative policies for 
                consideration by the Task Force.
    (h) Report.--The Secretary shall submit an annual report to 
Congress that describes the activities of the Task Force for the year 
involved. Each such report shall include such recommendations for 
improving access to innovative diabetes technologies and services as 
the Task Force determines appropriate.
    (i) Application of FACA.--The Federal Advisory Committee Act (5 
U.S.C. App.), other than section 14 of such Act, shall apply to the 
Task Force.
    (j) Rule of Construction.--The deliberations of the Task Force 
shall not be construed as interfering with or impeding any decision, 
determination, rulemaking, or issuance of subregulatory guidance by the 
Secretary that provides for coverage of, and payment for, innovative 
diabetes technologies and services.
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