Title: PPE in America Act
Policy area: Health

Summary:
Protecting Providers Everywhere in America Act or the PPE in America Act
This bill makes temporary changes to the management of the inventory of diagnostic testing supplies and personal protective equipment in the Strategic National Stockpile.
Through FY2026, the Department of Health and Human Services (HHS) must source a certain amount of those products from domestic manufacturers.
Additionally, HHS must periodically assess and take steps to manage the inventory of those products. This includes, as appropriate, transfers or sales to federal agencies and health care facilities.
The bill also provides HHS with additional authorities to manage the inventory. For example, HHS may enter into arrangements with manufacturers to establish revolving stockpiles to mitigate the risk of products expiring.
HHS must report on its efforts to maintain the stockpile's inventory of testing supplies and personal protective equipment.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 308 Introduced in Senate (IS)]

<DOC>






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, 
                     Education, 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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protecting Providers Everywhere in 
America Act'' or the ``PPE in America Act''.

SEC. 2. DOMESTIC PPE PROCUREMENT PILOT PROGRAM.

    (a) In General.--Section 319F-2(a) of the Public Health Service Act 
(42 U.S.C. 247d-6b(a)) is amended by adding at the end the following:
            ``(6) Domestic procurement pilot program.--
                    ``(A) In general.--
                            ``(i) Requirement to purchase domestic end 
                        products.--For the period of fiscal years 2022 
                        through 2026, subject to clause (ii), the 
                        Secretary shall ensure--
                                    ``(I) that not less than 40 percent 
                                of amounts made available under this 
                                section for purposes of procuring 
                                covered testing equipment and personal 
                                protective equipment for the stockpile 
                                under paragraph (1) are allocated to 
                                procurement of such equipment that is a 
                                domestic end product (as defined in 
                                part 25.003 of the Federal Acquisition 
                                Regulations maintained under section 
                                1303(a)(1) of title 41, United States 
                                Code (or any successor regulations)) 
                                manufactured by an entity or entities 
                                that enter into a contract with the 
                                Secretary to sell such equipment to the 
                                Secretary for such purpose; and
                                    ``(II) that additional amounts made 
                                available under this section for the 
                                purposes described in subclause (I), up 
                                to 100 percent of such amounts, are 
                                allocated to procurement of domestic 
                                end products as described in subclause 
                                (I), provided that, with respect to any 
                                such procurement of domestic end 
                                products in excess of the amount 
                                required under subclause (I), domestic 
                                supply exists and the costs of 
                                procuring equipment that is a domestic 
                                end product are not unreasonably high 
                                compared to other equipment that is not 
                                a domestic end product.
                            ``(ii) Exception.--In the event that there 
                        is insufficient domestic end product available 
                        for procurement to meet the needs for certain 
                        covered testing equipment and personal 
                        protective equipment for the stockpile under 
                        paragraph (1) while satisfying the requirement 
                        of clause (i)(I), or that the cost of procuring 
                        equipment that is a domestic end product in 
                        quantities required under clause (i)(I) would 
                        be unreasonably high compared to other 
                        equipment that is not a domestic end product, 
                        clause (i)(I) shall apply with respect to the 
                        applicable equipment only to the extent that 
                        such equipment that is a domestic end product 
                        is available and to the extent that the cost is 
                        not unreasonable, as applicable.
                    ``(B) Sale or transfer of ppe.--
                            ``(i) In general.--With respect to any 
                        covered testing equipment and personal 
                        protective equipment in the stockpile under 
                        paragraph (1), the Secretary--
                                    ``(I) shall assess the stock of 
                                such equipment on a regular basis, and 
                                not less frequently than--
                                            ``(aa) twice per year, 
                                        other than during periods 
                                        described in item (bb); or
                                            ``(bb) monthly, during any 
                                        period in which the Secretary 
                                        determines it likely that such 
                                        equipment will be deployed, 
                                        such as during a public health 
                                        emergency;
                                    ``(II) shall communicate to 
                                manufacturers and suppliers of such 
                                equipment to the stockpile under 
                                paragraph (1) if an assessment under 
                                subclause (I) indicates that there will 
                                be an increased need for such 
                                equipment;
                                    ``(III) may, at appropriate 
                                intervals and with respect to any such 
                                equipment in such stockpile--
                                            ``(aa) transfer such 
                                        equipment to other agencies or 
                                        operating divisions within the 
                                        Department of Health and Human 
                                        Services, or to the Department 
                                        of Defense, the Department of 
                                        Homeland Security, the 
                                        Department of Veterans Affairs, 
                                        or any other Federal agency or 
                                        department, in accordance with 
                                        the needs of such agencies, 
                                        divisions, or departments; or
                                            ``(bb) sell such equipment 
                                        to health care facilities at a 
                                        competitive price, as 
                                        determined by the Secretary, 
                                        taking into account the current 
                                        market pricing for the 
                                        applicable equipment and the 
                                        operational budget for the 
                                        stockpile; and
                                    ``(IV) may enter into a contract or 
                                cooperative agreement with an entity 
                                that has expertise in supply chain 
                                logistics and management to carry out 
                                the activities described in this 
                                subparagraph.
                            ``(ii) Group purchasing organizations and 
                        medical product distributors.--In making sales 
                        under clause (i)(II)(bb), the Secretary may 
                        transact with group purchasing organizations 
                        and medical product distributors to facilitate 
                        timeliness, logistical assistance, and 
                        appropriate pricing, and to determine 
                        appropriate amounts of covered testing 
                        equipment and personal protective equipment for 
                        applicable health care facilities.
                            ``(iii) Compensation to hhs.--
                                    ``(I) Transfers from other 
                                agencies.--A Federal agency receiving 
                                equipment as described in clause 
                                (i)(II)(aa) shall transfer to the 
                                Secretary such amounts as the Secretary 
                                and head of the applicable agency 
                                determine to be fair compensation for 
                                such equipment.
                                    ``(II) Sales of ppe.--There shall 
                                be transferred from the Treasury to the 
                                Secretary each fiscal year, for 
                                purposes of procuring covered testing 
                                equipment and personal protective 
                                equipment for the stockpile under 
                                paragraph (1), an amount equal to the 
                                sum of the amount received in the 
                                previous fiscal year from sales 
                                described in clause (i)(II)(bb).
                    ``(C) Vendor-managed inventory.--For purposes of 
                meeting the goals under subparagraph (A), and to 
                promote efficient and predictable operations of the 
                stockpile while mitigating the risk of product 
                expiration or shortages, the Secretary may enter into 
                arrangements, through a competitive bidding process, 
                with one or more manufacturers of domestic end products 
                to establish and utilize revolving stockpiles of 
                covered testing equipment and personal protective 
                equipment managed and operated by such manufacturer. 
                Under such an arrangement--
                            ``(i) the manufacturer (or a subcontractor 
                        or agent of the manufacturer)--
                                    ``(I) shall--
                                            ``(aa) produce or procure 
                                        covered testing equipment or 
                                        personal protective equipment 
                                        for the stockpile under 
                                        paragraph (1);
                                            ``(bb) maintain constant 
                                        supply, possession, and re-
                                        stocking capacity of such 
                                        equipment in such quantities as 
                                        the Secretary requires for 
                                        purposes of the stockpile under 
                                        paragraph (1); and
                                            ``(cc) fulfill or support 
                                        the deployment, distribution, 
                                        or dispensing functions of the 
                                        stockpile at the State and 
                                        local levels, consistent with 
                                        paragraph (3); and
                                    ``(II) may sell or transfer such 
                                equipment for the purposes of the 
                                manufacturer's existing inventory and 
                                commercial contracts; and
                            ``(ii) the Secretary shall--
                                    ``(I) compensate the manufacturer 
                                for the covered testing equipment or 
                                personal protective equipment; and
                                    ``(II) pay a management fee, as 
                                appropriate.
                    ``(D) Evaluation and report.--
                            ``(i) In general.--The Secretary shall--
                                    ``(I) conduct an evaluation of the 
                                program under this paragraph;
                                    ``(II) not later than 2 years after 
                                the date of enactment of this 
                                paragraph, submit an interim report to 
                                Congress on such program; and
                                    ``(III) not later than 5 years 
                                after the date of enactment of this 
                                paragraph, complete such evaluation and 
                                submit to Congress a final report on 
                                the program.
                            ``(ii) Considerations.--The evaluation and 
                        reports under clause (i) shall consider how the 
                        program has impacted the continuity of 
                        stockpiling and readiness for the stockpile 
                        under paragraph (1), implications of the 
                        program on the domestic supply chain, cost 
                        effectiveness of the program, and access to 
                        covered testing equipment and personal 
                        protective equipment for the Federal agencies 
                        and health care facilities pursuant to 
                        subparagraph (B)(i)(II).
                    ``(E) Covered testing equipment and personal 
                protective equipment.--For purposes of this paragraph, 
                the term `covered testing equipment and personal 
                protective equipment' means diagnostic supplies (which 
                may include test kits, reagents, and swabs), 
                respirators, masks, gloves, eye and face protection, 
                gowns, and any other appropriate ancillary medical 
                equipment or supplies related to testing or personal 
                protection that meet the Secretary's requirements for 
                inclusion in the stockpile under paragraph (1).''.
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