[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2901 Introduced in Senate (IS)]
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116th CONGRESS
1st Session
S. 2901
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
November 19, 2019
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 2019''.
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, 2020.
(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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