PPE in America Act

II 117TH CONGRESS 1ST SESSION S. 308 To establish a pilot program to address shortages of testing equipment and personal protective equipment through enhanced domestic production, and for other purposes. IN THE SENATE OF THE UNITED STATES FEBRUARY 12, 2021 Mr. DURBIN (for himself and Mr. CASSIDY) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions A BILL To establish a pilot program to address shortages of testing equipment and personal protective equipment through enhanced domestic production, and for other purposes. 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 ‘‘Protecting Providers 4 Everywhere in America Act’’ or the ‘‘PPE in America 5 Act’’. 6 VerDate Sep 11 2014 19:07 Feb 27, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S308.IS S308 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 308 IS SEC. 2. DOMESTIC PPE PROCUREMENT PILOT PROGRAM. 1 (a) IN GENERAL.—Section 319F–2(a) of the Public 2 Health Service Act (42 U.S.C. 247d–6b(a)) is amended 3 by adding at the end the following: 4 ‘‘(6) DOMESTIC PROCUREMENT PILOT PRO- 5 GRAM.— 6 ‘‘(A) IN GENERAL.— 7 ‘‘(i) REQUIREMENT TO PURCHASE DO- 8 MESTIC END PRODUCTS.—For the period 9 of fiscal years 2022 through 2026, subject 10 to clause (ii), the Secretary shall ensure— 11 ‘‘(I) that not less than 40 percent 12 of amounts made available under this 13 section for purposes of procuring cov- 14 ered testing equipment and personal 15 protective equipment for the stockpile 16 under paragraph (1) are allocated to 17 procurement of such equipment that 18 is a domestic end product (as defined 19 in part 25.003 of the Federal Acquisi- 20 tion Regulations maintained under 21 section 1303(a)(1) of title 41, United 22 States Code (or any successor regula- 23 tions)) manufactured by an entity or 24 entities that enter into a contract with 25 VerDate Sep 11 2014 19:07 Feb 27, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S308.IS S308 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 308 IS the Secretary to sell such equipment 1 to the Secretary for such purpose; and 2 ‘‘(II) that additional amounts 3 made available under this section for 4 the purposes described in subclause 5 (I), up to 100 percent of such 6 amounts, are allocated to procurement 7 of domestic end products as described 8 in subclause (I), provided that, with 9 respect to any such procurement of 10 domestic end products in excess of the 11 amount required under subclause (I), 12 domestic supply exists and the costs 13 of procuring equipment that is a do- 14 mestic end product are not unreason- 15 ably high compared to other equip- 16 ment that is not a domestic end prod- 17 uct. 18 ‘‘(ii) EXCEPTION.—In the event that 19 there is insufficient domestic end product 20 available for procurement to meet the 21 needs for certain covered testing equip- 22 ment and personal protective equipment 23 for the stockpile under paragraph (1) while 24 satisfying the requirement of clause (i)(I), 25 VerDate Sep 11 2014 19:07 Feb 27, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S308.IS S308 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 308 IS or that the cost of procuring equipment 1 that is a domestic end product in quan- 2 tities required under clause (i)(I) would be 3 unreasonably high compared to other 4 equipment that is not a domestic end prod- 5 uct, clause (i)(I) shall apply with respect to 6 the applicable equipment only to the extent 7 that such equipment that is a domestic end 8 product is available and to the extent that 9 the cost is not unreasonable, as applicable. 10 ‘‘(B) SALE OR TRANSFER OF PPE.— 11 ‘‘(i) IN GENERAL.—With respect to 12 any covered testing equipment and per- 13 sonal protective equipment in the stockpile 14 under paragraph (1), the Secretary— 15 ‘‘(I) shall assess the stock of 16 such equipment on a regular basis, 17 and not less frequently than— 18 ‘‘(aa) twice per year, other 19 than during periods described in 20 item (bb); or 21 ‘‘(bb) monthly, during any 22 period in which the Secretary de- 23 termines it likely that such equip- 24 ment will be deployed, such as 25 VerDate Sep 11 2014 19:07 Feb 27, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S308.IS S308 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 308 IS during a public health emer- 1 gency; 2 ‘‘(II) shall communicate to man- 3 ufacturers and suppliers of such 4 equipment to the stockpile under 5 paragraph (1) if an assessment under 6 subclause (I) indicates that there will 7 be an increased need for such equip- 8 ment; 9 ‘‘(III) may, at appropriate inter- 10 vals and with respect to any such 11 equipment in such stockpile— 12 ‘‘(aa) transfer such equip- 13 ment to other agencies or oper- 14 ating divisions within the Depart- 15 ment of Health and Human 16 Services, or to the Department of 17 Defense, the Department of 18 Homeland Security, the Depart- 19 ment of Veterans Affairs, or any 20 other Federal agency or depart- 21 ment, in accordance with the 22 needs of such agencies, divisions, 23 or departments; or 24 VerDate Sep 11 2014 19:07 Feb 27, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S308.IS S308 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 308 IS ‘‘(bb) sell such equipment to 1 health care facilities at a com- 2 petitive price, as determined by 3 the Secretary, taking into ac- 4 count the current market pricing 5 for the applicable equipment and 6 the operational budget for the 7 stockpile; and 8 ‘‘(IV) may enter into a contract 9 or cooperative agreement with an enti- 10 ty that has expertise in supply chain 11 logistics and management to carry out 12 the activities described in this sub- 13 paragraph. 14 ‘‘(ii) GROUP PURCHASING ORGANIZA- 15 TIONS AND MEDICAL PRODUCT DISTRIBU- 16 TORS.—In making sales under clause 17 (i)(II)(bb), the Secretary may transact 18 with group purchasing organizations and 19 medical product distributors to facilitate 20 timeliness, logistical assistance, and appro- 21 priate pricing, and to determine appro- 22 priate amounts of covered testing equip- 23 ment and personal protective equipment 24 for applicable health care facilities. 25 VerDate Sep 11 2014 19:07 Feb 27, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S308.IS S308 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 308 IS ‘‘(iii) COMPENSATION TO HHS.— 1 ‘‘(I) TRANSFERS FROM OTHER 2 AGENCIES.—A Federal agency receiv- 3 ing equipment as described in clause 4 (i)(II)(aa) shall transfer to the Sec- 5 retary such amounts as the Secretary 6 and head of the applicable agency de- 7 termine to be fair compensation for 8 such equipment. 9 ‘‘(II) SALES OF PPE.—There 10 shall be transferred from the Treasury 11 to the Secretary each fiscal year, for 12 purposes of procuring covered testing 13 equipment and personal protective 14 equipment for the stockpile under 15 paragraph (1), an amount equal to 16 the sum of the amount received in the 17 previous fiscal year from sales de- 18 scribed in clause (i)(II)(bb). 19 ‘‘(C) VENDOR-MANAGED INVENTORY.—For 20 purposes of meeting the goals under subpara- 21 graph (A), and to promote efficient and predict- 22 able operations of the stockpile while mitigating 23 the risk of product expiration or shortages, the 24 Secretary may enter into arrangements, 25 VerDate Sep 11 2014 19:07 Feb 27, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S308.IS S308 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 308 IS through a competitive bidding process, with one 1 or more manufacturers of domestic end prod- 2 ucts to establish and utilize revolving stockpiles 3 of covered testing equipment and personal pro- 4 tective equipment managed and operated by 5 such manufacturer. Under such an arrange- 6 ment— 7 ‘‘(i) the manufacturer (or a subcon- 8 tractor or agent of the manufacturer)— 9 ‘‘(I) shall— 10 ‘‘(aa) produce or procure 11 covered testing equipment or per- 12 sonal protective equipment for 13 the stockpile under paragraph 14 (1); 15 ‘‘(bb) maintain constant 16 supply, possession, and re-stock- 17 ing capacity of such equipment in 18 such quantities as the Secretary 19 requires for purposes of the 20 stockpile under paragraph (1); 21 and 22 ‘‘(cc) fulfill or support the 23 deployment, distribution, or dis- 24 pensing functions of the stockpile 25 VerDate Sep 11 2014 19:07 Feb 27, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S308.IS S308 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 308 IS at the State and local levels, con- 1 sistent with paragraph (3); and 2 ‘‘(II) may sell or transfer such 3 equipment for the purposes of the 4 manufacturer’s existing inventory and 5 commercial contracts; and 6 ‘‘(ii) the Secretary shall— 7 ‘‘(I) compensate the manufac- 8 turer for the covered testing equip- 9 ment or personal protective equip- 10 ment; and 11 ‘‘(II) pay a management fee, as 12 appropriate. 13 ‘‘(D) EVALUATION AND REPORT.— 14 ‘‘(i) IN GENERAL.—The Secretary 15 shall— 16 ‘‘(I) conduct an evaluation of the 17 program under this paragraph; 18 ‘‘(II) not later than 2 years after 19 the date of enactment of this para- 20 graph, submit an interim report to 21 Congress on such program; and 22 ‘‘(III) not later than 5 years 23 after the date of enactment of this 24 paragraph, complete such evaluation 25 VerDate Sep 11 2014 19:07 Feb 27, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S308.IS S308 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 308 IS and submit to Congress a final report 1 on the program. 2 ‘‘(ii) CONSIDERATIONS.—The evalua- 3 tion and reports under clause (i) shall con- 4 sider how the program has impacted the 5 continuity of stockpiling and readiness for 6 the stockpile under paragraph (1), implica- 7 tions of the program on the domestic sup- 8 ply chain, cost effectiveness of the pro- 9 gram, and access to covered testing equip- 10 ment and personal protective equipment 11 for the Federal agencies and health care 12 facilities pursuant to subparagraph 13 (B)(i)(II). 14 ‘‘(E) COVERED TESTING EQUIPMENT AND 15 PERSONAL PROTECTIVE EQUIPMENT.—For pur- 16 poses of this paragraph, the term ‘covered test- 17 ing equipment and personal protective equip- 18 ment’ means diagnostic supplies (which may in- 19 clude test kits, reagents, and swabs), res- 20 pirators, masks, gloves, eye and face protection, 21 gowns, and any other appropriate ancillary 22 medical equipment or supplies related to testing 23 or personal protection that meet the Secretary’s 24 VerDate Sep 11 2014 19:07 Feb 27, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S308.IS S308 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 308 IS requirements for inclusion in the stockpile 1 under paragraph (1).’’. 2 Æ VerDate Sep 11 2014 19:07 Feb 27, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6301 E:\BILLS\S308.IS S308 pamtmann on DSKBC07HB2PROD with BILLS