Improving Medicare Beneficiary Access to Innovative Diabetes Technologies Act of 2019

II 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 tech- nologies and services. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Improving Medicare 4 Beneficiary Access to Innovative Diabetes Technologies 5 Act of 2019’’. 6 VerDate Sep 11 2014 03:17 Nov 26, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2901.IS S2901 kjohnson on DSK79L0C42 with BILLS 2 •S 2901 IS SEC. 2. ESTABLISHMENT OF HHS TASK FORCE ON COV- 1 ERAGE AND PAYMENT FOR INNOVATIVE DIA- 2 BETES TECHNOLOGIES AND SERVICES. 3 (a) DEFINITIONS.—In this section: 4 (1) CMS.—The term ‘‘CMS’’ means the Cen- 5 ters for Medicare & Medicaid Services. 6 (2) FDA.—The term ‘‘FDA’’ means the Food 7 and Drug Administration. 8 (3) INNOVATIVE DIABETES TECHNOLOGIES AND 9 SERVICES.—The term ‘‘innovative diabetes tech- 10 nologies and services’’ means medical technologies 11 and services for the treatment and management of 12 diabetes for which coverage is not available under 13 the Medicare fee-for-service program. 14 (4) MEDICARE.—The term ‘‘Medicare’’ means 15 the program of health insurance for the aged and 16 disabled established under title XVIII of the Social 17 Security Act. 18 (5) MEDICARE BENEFICIARY.—The term 19 ‘‘Medicare beneficiary’’ means an individual who is 20 entitled to benefits under part A of title XVIII of 21 the Social Security Act, or enrolled under part B of 22 such title, or both. 23 (6) SECRETARY.—The term ‘‘Secretary’’ means 24 the Secretary of Health and Human Services. 25 (b) ESTABLISHMENT; MISSION.— 26 VerDate Sep 11 2014 03:17 Nov 26, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2901.IS S2901 kjohnson on DSK79L0C42 with BILLS 3 •S 2901 IS (1) ESTABLISHMENT.—There is established 1 within the Office of the Secretary the Task Force on 2 Innovative Diabetes Technologies and Services (in 3 this section referred to as the ‘‘Task Force’’). 4 (2) MISSION.—The mission of the Task Force 5 is to— 6 (A) advise the Secretary with respect to 7 accessibility to innovative diabetes technologies 8 and services under Medicare; 9 (B) make recommendations to support cur- 10 rent and future access to innovative diabetes 11 technologies and services under Medicare; and 12 (C) recommend changes to Medicare to en- 13 sure appropriate access by Medicare bene- 14 ficiaries to such innovative diabetes technologies 15 and services. 16 (c) MEMBERSHIP.— 17 (1) APPOINTMENT.—The Secretary shall ap- 18 point individuals with relevant expertise to the Task 19 Force, which shall include the following voting mem- 20 bers: 21 (A) CMS OFFICIALS.— 22 (i) The Director of the Center for 23 Medicare. 24 VerDate Sep 11 2014 03:17 Nov 26, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2901.IS S2901 kjohnson on DSK79L0C42 with BILLS 4 •S 2901 IS (ii) Not more than 2 additional offi- 1 cials or senior staff of CMS as the Sec- 2 retary may specify. 3 (B) BENEFICIARY OMBUDSMAN.—The 4 Medicare Beneficiary Ombudsman. 5 (C) PHARMACEUTICAL AND TECHNOLOGY 6 OMBUDSMAN.—The Medicare Pharmaceutical 7 and Technology Ombudsman. 8 (D) FDA OFFICIALS.—Not more than 2 9 officials or senior staff from the Diabetes 10 Branch of the Center for Devices and Radio- 11 logical Health of FDA as the Commissioner of 12 Food and Drugs may specify. 13 (E) PATIENT GROUPS.—Representatives 14 of— 15 (i) Medicare beneficiaries; 16 (ii) individuals enrolled under a State 17 plan under title XIX of the Social Security 18 Act (or a waiver of such a plan); and 19 (iii) individuals not described in clause 20 (i) or (ii) who have a diagnosis of diabetes. 21 (F) HEALTH CARE PROVIDERS.—Rep- 22 resentatives of providers of services, physicians, 23 and practitioners who treat individuals with a 24 diagnosis of diabetes. 25 VerDate Sep 11 2014 03:17 Nov 26, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2901.IS S2901 kjohnson on DSK79L0C42 with BILLS 5 •S 2901 IS (G) MANUFACTURERS.—Representatives of 1 manufacturers of diabetes technologies, includ- 2 ing innovative diabetes technologies and serv- 3 ices. 4 (2) CO-CHAIRS.— 5 (A) IN GENERAL.—Of the members of the 6 Task Force— 7 (i) one co-chair shall be the Director 8 of the Center for Medicare; and 9 (ii) one co-chair shall be designated by 10 the Secretary from among voting members 11 appointed under subparagraph (E), (F), or 12 (G) of paragraph (1). 13 (B) ROTATION OF NON-GOVERNMENT CO- 14 CHAIR.—The Secretary shall rotate designations 15 of co-chairs under subparagraph (A)(ii) from 16 among voting members appointed under sub- 17 paragraph (E), (F), or (G) of paragraph (1). 18 (C) TERM OF SERVICE FOR NON-GOVERN- 19 MENT CO-CHAIR.—Each co-chair designated 20 under subparagraph (A)(ii) shall serve a term 21 of 2 years. 22 (3) COMPENSATION.— 23 VerDate Sep 11 2014 03:17 Nov 26, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2901.IS S2901 kjohnson on DSK79L0C42 with BILLS 6 •S 2901 IS (A) IN GENERAL.—Except as provided in 1 subparagraph (B), members of the Task Force 2 shall serve without compensation. 3 (B) TRAVEL EXPENSES.—A member of the 4 Task Force may be allowed travel expenses, in- 5 cluding per diem in lieu of subsistence, at rates 6 authorized for an employee of an agency under 7 subchapter I of chapter 57 of title 5, United 8 States Code, while away from the home or reg- 9 ular place of business of the member in the per- 10 formance of the duties of the Task Force. 11 (d) MEETINGS.—The Secretary shall convene the 12 Task Force not less frequently than 4 times each year. 13 The Secretary shall convene the first meeting of the Task 14 Force no later than July 1, 2020. 15 (e) DUTIES.—The Task Force shall carry out the fol- 16 lowing duties: 17 (1) IDENTIFICATION OF INNOVATIVE DIABETES 18 TECHNOLOGIES AND SERVICES.—The Task Force 19 shall— 20 (A) identify innovative diabetes tech- 21 nologies and services for the treatment of type 22 I diabetes, type II diabetes, or both, that are in 23 development or that have been cleared or ap- 24 proved by FDA and that are wholly or partially 25 VerDate Sep 11 2014 03:17 Nov 26, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2901.IS S2901 kjohnson on DSK79L0C42 with BILLS 7 •S 2901 IS inaccessible to Medicare beneficiaries with dia- 1 betes under Medicare; 2 (B) develop and consider possible alter- 3 native approaches to enable Medicare bene- 4 ficiaries to access innovative diabetes tech- 5 nologies and services; and 6 (C) determine whether the existing admin- 7 istrative systems, benefit categories, and cov- 8 erage, coding and payment policies under Medi- 9 care would provide or impede access to, and ap- 10 propriate payment for, innovative diabetes tech- 11 nologies and services. 12 (2) ANALYSIS OF ACCESS DISPARITIES.— 13 (A) PRIVATE PAYOR POLICIES.—The Task 14 Force shall review coverage policies developed 15 by private payors for innovative diabetes tech- 16 nologies and services and determine whether 17 disparities exist between patients with diabetes 18 insured by private payors as compared to Medi- 19 care beneficiaries with diabetes. 20 (B) CASE STUDIES.—The Task Force shall 21 recommend to the Secretary the development of 22 real-world patient case studies and health care 23 provider case studies that identify barriers to 24 access, and access disparities, under Medicare 25 VerDate Sep 11 2014 03:17 Nov 26, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2901.IS S2901 kjohnson on DSK79L0C42 with BILLS 8 •S 2901 IS with respect to innovative diabetes technologies 1 and services. 2 (3) IDENTIFICATION OF CHANGES IN RELEVANT 3 FDA APPROVAL AND CMS COVERAGE POLICIES.— 4 (A) CMS REGULATORY BARRIERS TO COV- 5 ERAGE.—The Task Force shall— 6 (i) identify all the categories of items 7 and services for which coverage is available 8 under Medicare whether established by 9 title XVIII of the Social Security Act or 10 otherwise (in this section referred to as 11 benefit categories) that may be used to 12 provide for coverage of diabetes tech- 13 nologies and services, including innovative 14 diabetes technologies and services; 15 (ii) review regulations and subregu- 16 latory guidance for the benefit categories 17 identified under clause (i) to identify poli- 18 cies that limit coverage of, and payment 19 for, diabetes technologies and services 20 under Medicare, especially innovative dia- 21 betes technologies and services; and 22 (iii) recommend specific changes to 23 such regulations and subregulatory guid- 24 ance to provide for coverage of, and pay- 25 VerDate Sep 11 2014 03:17 Nov 26, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2901.IS S2901 kjohnson on DSK79L0C42 with BILLS 9 •S 2901 IS ment for, innovative diabetes technologies 1 and services under Medicare. 2 (B) INTERAGENCY COLLABORATION.—The 3 Task Force shall identify strategies to improve 4 collaboration between FDA and CMS that fa- 5 cilitate expeditious clearance or approval of in- 6 novative diabetes technologies and services by 7 FDA and expeditious coverage of innovative di- 8 abetes technologies and services under Medi- 9 care. 10 (4) IDENTIFICATION OF STRATEGIES TO SUP- 11 PORT COVERAGE OF INNOVATIVE DIABETES TECH- 12 NOLOGIES AND SERVICES.—The Task Force shall 13 identify strategies not otherwise described in this 14 subsection to facilitate access to innovative diabetes 15 technologies and services by Medicare beneficiaries 16 as well as by other patients and their health care 17 providers. 18 (f) RECOMMENDATIONS.—Not less frequently than 19 annually, the Task Force shall make recommendations to 20 the Secretary with respect to— 21 (1) existing benefit categories under which in- 22 novative diabetes technologies and services should be 23 covered; 24 VerDate Sep 11 2014 03:17 Nov 26, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2901.IS S2901 kjohnson on DSK79L0C42 with BILLS 10 •S 2901 IS (2) legislative changes to title XVIII of the So- 1 cial Security Act and administrative changes to reg- 2 ulations promulgated and subregulatory guidance 3 issued with respect to existing benefit categories that 4 are necessary to provide for coverage of, and pay- 5 ment for, innovative diabetes technologies and serv- 6 ices; 7 (3) elimination of other unnecessary burdens 8 that impede coverage of, and payment for, innova- 9 tive diabetes technologies and services under Medi- 10 care; 11 (4) proposals for a new Medicare benefit cat- 12 egory to provide for coverage of innovative diabetes 13 technologies and services that cannot otherwise be 14 covered through administrative changes to regula- 15 tions and subregulatory guidance for existing benefit 16 categories, and specifications for any new benefit 17 category; and 18 (5) proposals to streamline interagency admin- 19 istrative processes through greater collaboration be- 20 tween FDA and CMS to facilitate prompt approval 21 or clearance and coverage under Medicare of innova- 22 tive diabetes technologies and services for Medicare 23 beneficiaries with diabetes. 24 (g) RESPONSE.— 25 VerDate Sep 11 2014 03:17 Nov 26, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S2901.IS S2901 kjohnson on DSK79L0C42 with BILLS 11 •S 2901 IS (1) IN GENERAL.—With respect to each rec- 1 ommendation made by the Task Force under sub- 2 section (f), not later than 90 days after the date of 3 receipt of each such recommendation, the Secretary 4 shall make a determination whether to implement or 5 reject the recommendation. 6 (2) IMPLEMENTATION.—In the case of a deter- 7 mination by the Secretary to implement a rec- 8 ommendation under paragraph (1), the Secretary 9 shall provide the Task Force with a plan for such 10 implementation, including specific details about and 11 a timetable for the implementation. 12 (3) REJECTION.—In the case of a determina- 13 tion by the Secretary to reject a recommendation 14 under paragraph (1), the Secretary shall provide the 15 Task Force with— 16 (A) a detailed explanation of the rationale 17 for the determination; and 18 (B) recommendations for alternative poli- 19 cies for consideration by the Task Force. 20 (h) REPORT.—The Secretary shall submit an annual 21 report to Congress that describes the activities of the Task 22 Force for the year involved. Each such report shall include 23 such recommendations for improving access to innovative 24 VerDate Sep 11 2014 03:17 Nov 26, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S2901.IS S2901 kjohnson on DSK79L0C42 with BILLS 12 •S 2901 IS diabetes technologies and services as the Task Force de- 1 termines appropriate. 2 (i) APPLICATION OF FACA.—The Federal Advisory 3 Committee Act (5 U.S.C. App.), other than section 14 of 4 such Act, shall apply to the Task Force. 5 (j) RULE OF CONSTRUCTION.—The deliberations of 6 the Task Force shall not be construed as interfering with 7 or impeding any decision, determination, rulemaking, or 8 issuance of subregulatory guidance by the Secretary that 9 provides for coverage of, and payment for, innovative dia- 10 betes technologies and services. 11 Æ VerDate Sep 11 2014 03:17 Nov 26, 2019 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6301 E:\BILLS\S2901.IS S2901 kjohnson on DSK79L0C42 with BILLS