II 

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. 

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 ‘‘Improving Medicare 

5 Beneficiary Access to Innovative Diabetes Technologies 

6 Act of 2021’’. 


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1 SEC. 2. ESTABLISHMENT OF HHS TASK FORCE ON COV2 ERAGE AND PAYMENT FOR INNOVATIVE DIA3 BETES TECHNOLOGIES AND SERVICES. 

4 (a) DEFINITIONS.—In this section: 

5 (1) CMS.—The term ‘‘CMS’’ means the Cen6 ters for Medicare & Medicaid Services. 

7 (2) FDA.—The term ‘‘FDA’’ means the Food 

8 and Drug Administration. 

9 (3) INNOVATIVE DIABETES TECHNOLOGIES AND

10 SERVICES.—The term ‘‘innovative diabetes tech11 nologies and services’’ means medical technologies 

12 and services for the treatment and management of 

13 diabetes for which coverage is not available under 

14 the Medicare fee-for-service program. 

15 (4) MEDICARE.—The term ‘‘Medicare’’ means 

16 the program of health insurance for the aged and 

17 disabled established under title XVIII of the Social 

18 Security Act. 

19 (5) MEDICARE BENEFICIARY.—The term 

20 ‘‘Medicare beneficiary’’ means an individual who is 

21 entitled to benefits under part A of title XVIII of 

22 the Social Security Act, or enrolled under part B of 

23 such title, or both. 

24 (6) SECRETARY.—The term ‘‘Secretary’’ means 

25 the Secretary of Health and Human Services. 

26 (b) ESTABLISHMENT; MISSION.— 


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1 (1) ESTABLISHMENT.—There is established 

2 within the Office of the Secretary the Task Force on 

3 Innovative Diabetes Technologies and Services (in 

4 this section referred to as the ‘‘Task Force’’). 

5 (2) MISSION.—The mission of the Task Force 

6 is to— 

7 (A) advise the Secretary with respect to 

8 accessibility to innovative diabetes technologies 

9 and services under Medicare; 

10 (B) make recommendations to support cur11 rent and future access to innovative diabetes 

12 technologies and services under Medicare; and 

13 (C) recommend changes to Medicare to en14 sure appropriate access by Medicare bene15 ficiaries to such innovative diabetes technologies 

16 and services. 

17 (c) MEMBERSHIP.— 

18 (1) APPOINTMENT.—The Secretary shall ap19 point individuals with relevant expertise to the Task 

20 Force, which shall include the following voting mem21 bers: 

22 (A) CMS OFFICIALS.— 

23 (i) The Director of the Center for 

24 Medicare. 


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1 (ii) Not more than 2 additional offi2 cials or senior staff of CMS as the Sec3 retary may specify. 

4 (B) BENEFICIARY OMBUDSMAN.—The 

5 Medicare Beneficiary Ombudsman. 

6 (C) PHARMACEUTICAL AND TECHNOLOGY

7 OMBUDSMAN.—The Medicare Pharmaceutical 

8 and Technology Ombudsman. 

9 (D) FDA OFFICIALS.—Not more than 2 

10 officials or senior staff from the Diabetes 

11 Branch of the Center for Devices and Radio12 logical Health of FDA as the Commissioner of 

13 Food and Drugs may specify. 

14 (E) PATIENT GROUPS.—Representatives 

15 of— 

16 (i) Medicare beneficiaries; 

17 (ii) individuals enrolled under a State 

18 plan under title XIX of the Social Security 

19 Act (or a waiver of such a plan); and 

20 (iii) individuals not described in clause 

21 (i) or (ii) who have a diagnosis of diabetes. 

22 (F) HEALTH CARE PROVIDERS.—Rep23 resentatives of providers of services, physicians, 

24 and practitioners who treat individuals with a 

25 diagnosis of diabetes. 


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1 (G) MANUFACTURERS.—Representatives of 

2 manufacturers of diabetes technologies, includ3 ing innovative diabetes technologies and serv4 ices. 

5 (2) CO-CHAIRS.— 

6 (A) IN GENERAL.—Of the members of the 

7 Task Force— 

8 (i) one co-chair shall be the Director 

9 of the Center for Medicare; and 

10 (ii) one co-chair shall be designated by 

11 the Secretary from among voting members 

12 appointed under subparagraph (E), (F), or 

13 (G) of paragraph (1). 

14 (B) ROTATION OF NON-GOVERNMENT CO15 CHAIR.—The Secretary shall rotate designations 

16 of co-chairs under subparagraph (A)(ii) from 

17 among voting members appointed under sub18 paragraph (E), (F), or (G) of paragraph (1). 

19 (C) TERM OF SERVICE FOR NON-GOVERN20 MENT CO-CHAIR.—Each co-chair designated 

21 under subparagraph (A)(ii) shall serve a term 

22 of 2 years. 

23 (3) COMPENSATION.— 


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1 (A) IN GENERAL.—Except as provided in 

2 subparagraph (B), members of the Task Force 

3 shall serve without compensation. 

4 (B) TRAVEL EXPENSES.—A member of the 

5 Task Force may be allowed travel expenses, in6 cluding per diem in lieu of subsistence, at rates 

7 authorized for an employee of an agency under 

8 subchapter I of chapter 57 of title 5, United 

9 States Code, while away from the home or reg10 ular place of business of the member in the per11 formance of the duties of the Task Force. 

12 (d) MEETINGS.—The Secretary shall convene the 

13 Task Force not less frequently than 4 times each year. 

14 The Secretary shall convene the first meeting of the Task 

15 Force no later than July 1, 2022. 

16 (e) DUTIES.—The Task Force shall carry out the fol17 lowing duties: 

18 (1) IDENTIFICATION OF INNOVATIVE DIABETES

19 TECHNOLOGIES AND SERVICES.—The Task Force 

20 shall— 

21 (A) identify innovative diabetes tech22 nologies and services for the treatment of type 

23 I diabetes, type II diabetes, or both, that are in 

24 development or that have been cleared or ap25 proved by FDA and that are wholly or partially 


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1 inaccessible to Medicare beneficiaries with dia2 betes under Medicare; 

3 (B) develop and consider possible alter4 native approaches to enable Medicare bene5 ficiaries to access innovative diabetes tech6 nologies and services; and 

7 (C) determine whether the existing admin8 istrative systems, benefit categories, and cov9 erage, coding and payment policies under Medi10 care would provide or impede access to, and ap11 propriate payment for, innovative diabetes tech12 nologies and services. 

13 (2) ANALYSIS OF ACCESS DISPARITIES.— 

14 (A) PRIVATE PAYOR POLICIES.—The Task 

15 Force shall review coverage policies developed 

16 by private payors for innovative diabetes tech17 nologies and services and determine whether 

18 disparities exist between patients with diabetes 

19 insured by private payors as compared to Medi20 care beneficiaries with diabetes. 

21 (B) CASE STUDIES.—The Task Force shall 

22 recommend to the Secretary the development of 

23 real-world patient case studies and health care 

24 provider case studies that identify barriers to 

25 access, and access disparities, under Medicare 


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1 with respect to innovative diabetes technologies 

2 and services. 

3 (3) IDENTIFICATION OF CHANGES IN RELEVANT

4 FDA APPROVAL AND CMS COVERAGE POLICIES.— 

5 (A) CMS REGULATORY BARRIERS TO COV6 ERAGE.—The Task Force shall— 

7 (i) identify all the categories of items 

8 and services for which coverage is available 

9 under Medicare whether established by 

10 title XVIII of the Social Security Act or 

11 otherwise (in this section referred to as 

12 benefit categories) that may be used to 

13 provide for coverage of diabetes tech14 nologies and services, including innovative 

15 diabetes technologies and services; 

16 (ii) review regulations and subregu17 latory guidance for the benefit categories 

18 identified under clause (i) to identify poli19 cies that limit coverage of, and payment 

20 for, diabetes technologies and services 

21 under Medicare, especially innovative dia22 betes technologies and services; and 

23 (iii) recommend specific changes to 

24 such regulations and subregulatory guid25 ance to provide for coverage of, and payVerDate Sep 11 2014 16:38 Jun 25, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2146.IS S2146

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1 ment for, innovative diabetes technologies 

2 and services under Medicare. 

3 (B) INTERAGENCY COLLABORATION.—The 

4 Task Force shall identify strategies to improve 

5 collaboration between FDA and CMS that fa6 cilitate expeditious clearance or approval of in7 novative diabetes technologies and services by 

8 FDA and expeditious coverage of innovative di9 abetes technologies and services under Medi10 care. 

11 (4) IDENTIFICATION OF STRATEGIES TO SUP12 PORT COVERAGE OF INNOVATIVE DIABETES TECH13 NOLOGIES AND SERVICES.—The Task Force shall 

14 identify strategies not otherwise described in this 

15 subsection to facilitate access to innovative diabetes 

16 technologies and services by Medicare beneficiaries 

17 as well as by other patients and their health care 

18 providers. 

19 (f) RECOMMENDATIONS.—Not less frequently than 

20 annually, the Task Force shall make recommendations to 

21 the Secretary with respect to— 

22 (1) existing benefit categories under which in23 novative diabetes technologies and services should be 

24 covered; 


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1 (2) legislative changes to title XVIII of the So2 cial Security Act and administrative changes to reg3 ulations promulgated and subregulatory guidance 

4 issued with respect to existing benefit categories that 

5 are necessary to provide for coverage of, and pay6 ment for, innovative diabetes technologies and serv7 ices; 

8 (3) elimination of other unnecessary burdens 

9 that impede coverage of, and payment for, innova10 tive diabetes technologies and services under Medi11 care; 

12 (4) proposals for a new Medicare benefit cat13 egory to provide for coverage of innovative diabetes 

14 technologies and services that cannot otherwise be 

15 covered through administrative changes to regula16 tions and subregulatory guidance for existing benefit 

17 categories, and specifications for any new benefit 

18 category; and 

19 (5) proposals to streamline interagency admin20 istrative processes through greater collaboration be21 tween FDA and CMS to facilitate prompt approval 

22 or clearance and coverage under Medicare of innova23 tive diabetes technologies and services for Medicare 

24 beneficiaries with diabetes. 

25 (g) RESPONSE.— 


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1 (1) IN GENERAL.—With respect to each rec2 ommendation made by the Task Force under sub3 section (f), not later than 90 days after the date of 

4 receipt of each such recommendation, the Secretary 

5 shall make a determination whether to implement or 

6 reject the recommendation. 

7 (2) IMPLEMENTATION.—In the case of a deter8 mination by the Secretary to implement a rec9 ommendation under paragraph (1), the Secretary 

10 shall provide the Task Force with a plan for such 

11 implementation, including specific details about and 

12 a timetable for the implementation. 

13 (3) REJECTION.—In the case of a determina14 tion by the Secretary to reject a recommendation 

15 under paragraph (1), the Secretary shall provide the 

16 Task Force with— 

17 (A) a detailed explanation of the rationale 

18 for the determination; and 

19 (B) recommendations for alternative poli20 cies for consideration by the Task Force. 

21 (h) REPORT.—The Secretary shall submit an annual 

22 report to Congress that describes the activities of the Task 

23 Force for the year involved. Each such report shall include 

24 such recommendations for improving access to innovative 


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1 diabetes technologies and services as the Task Force de2 termines appropriate. 

3 (i) APPLICATION OF FACA.—The Federal Advisory 

4 Committee Act (5 U.S.C. App.), other than section 14 of 

5 such Act, shall apply to the Task Force. 

6 (j) RULE OF CONSTRUCTION.—The deliberations of 

7 the Task Force shall not be construed as interfering with 

8 or impeding any decision, determination, rulemaking, or 

9 issuance of subregulatory guidance by the Secretary that 

10 provides for coverage of, and payment for, innovative dia11 betes technologies and services. 

Æ 


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