The Trump Administration’s Failures in Contract Management and Inept Negotiation by Senior White House Officials Denied Americans Ventilators During the Coronavirus Pandemic and Squandered Up to $504 Million in Taxpayer Funds Staff Report Subcommittee on Economic and Consumer Policy Committee on Oversight and Reform U.S. House of Representatives July 31, 2020 oversight.house.gov EXECUTIVE SUMMARY The Subcommittee on Economic and Consumer Policy conducted an investigation to determine why the country was without adequate numbers of ventilators during the initial critical months of the coronavirus pandemic. On April 15, 2020, the Subcommittee sent a letter requesting documents and information from Philips Respironics (Philips), a leading manufacturer of ventilators that reportedly negotiated contracts with the Trump Administration.1 Philips has substantially complied with the Subcommittee’s requests. This staff report is based on a review of thousands of pages of previously non-public documents, including:    Emails and communications between Philips and the Administration regarding ventilators the country would need during a pandemic; Philips’ original September 15, 2014 contract with the Department of Health and Human Services (HHS) for the development and purchase of 10,000 Trilogy Evo Universal ventilators for $3,280 apiece, and the ten modifications to that contract; and Philips’ April 7, 2020 contract for the purchase of 43,000 Trilogy EV300 ventilators for $15,000 apiece. These documents indicate that before and during the pandemic, inept contract management and incompetent negotiating by the Trump Administration denied the country the ventilators it needed. The Administration effectively disabled an Obama-era contract with Philips for ventilators and then struck a second contract with the company in which the Administration overpaid for nearly identical ventilators by as much as $500 million. These are funds that could have been used for personal protective equipment (PPE) and critical medical supplies that were in short supply across the country. FINDINGS  In 2014, the Obama Administration entered into a contract with Philips Respironics, a leading global manufacturer, that would have supplied the nation with 10,000 ventilators by June 2019 in case of a pandemic. Development was initially delayed, and before leaving office, the Obama Administration gave Philips an extension that would have required the company to provide all of the ventilators by November 2019—in time to be deployed for this pandemic.  Philips’ delays continued through 2017 and 2018, but the Trump Administration mismanaged Philips’ repeated failures to meet contractual requirements. It gave Philips three additional extensions, the last of which allowed for final delivery of   1 Letter from Chairman Raja Krishnamoorthi, Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform, to Vitor Rocha, Chief Executive Officer, Philips North America Corporation (Apr. 15, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2020-0415.RK%20to%20Rocha%20Philips%20re%20Triology%20Evo.pdf). 2 the ventilators to be delayed until June 2021. Had the Trump Administration held Philips to the terms of the Obama-era contract, the country would have had 10,000 ventilators that it needed when the coronavirus crisis struck.  On January 21, 2020, when the first coronavirus case was reported in the United States, Philips approached the Trump Administration about accelerating the delivery of ventilators under its existing contract. The Trump Administration ignored this opportunity. For six weeks, it did not respond to Philips’ offer.  Finally, in March 2020, the Trump Administration responded, but rather than demand that Philips meet the deadlines required by its existing contract, or move them up to address the pressing need, the Trump Administration agreed on March 11, 2020, to another extension, removing all delivery deadlines until September 2022. Philips secured the extension by suggesting it would actually help move up delivery. The Trump Administration failed to question Philips and granted the modification, which made the Obama-era contract useless for aiding the country during this pandemic. The Administration never asked Philips to produce more ventilators under the existing contract.  Instead, the Trump Administration, represented by Peter Navarro and other senior officials in the White House, negotiated a new contract with Philips. It agreed to pay Philips almost five times the price than under the previous contract. The ventilators purchased under the new contract (called Trilogy EV300s) were functionally identical to those required under the previous contract (called Trilogy Evo Universals), but the Trump negotiators appeared gullible and conceded to Philips on all significant matters, including price. The documents show that the Administration accepted Philips’ first offer without even trying to negotiate a lower price.  As a result, the federal government overpaid for ventilators—no American purchaser paid more than the U.S. government. Between December 2019 and May 2020, Philips took orders for 5,339 other Trilogy EV300 ventilators from 92 different purchasers in the United States. While the Trump Administration paid $15,000 per ventilator, some small purchasers, buying as few as one unit, were able to negotiate prices as low as $9,327 per unit.  The waste of taxpayer funds caused by the Trump Administration’s incompetent procurement efforts for ventilators could be as much as $500 million or more. By taking advantage of the Trump Administration’s incompetence, Philips was able to secure a financial windfall to which it clearly is not entitled, and these funds should have been dedicated to obtaining desperately needed PPE and other critical medical supplies during this pandemic. To remedy this apparent profiteering, the Trump Administration now should engage competent contracting officers at federal agencies to determine whether any of these funds can be clawed back under the provisions of the contract signed during the Obama Administration or the modifications entered into by the Trump Administration. 3 I. IN 2014, THE OBAMA ADMINISTRATION ENTERED INTO A CONTRACT WITH PHILIPS THAT WOULD HAVE SUPPLIED THE NATION WITH 10,000 VENTILATORS BY JUNE 2019 IN CASE OF A PANDEMIC. BUT DEVELOPMENT WAS DELAYED, AND BEFORE LEAVING OFFICE, THE OBAMA ADMINISTRATION GAVE PHILIPS AN EXTENSION THAT WOULD HAVE REQUIRED THE COMPANY TO PROVIDE ALL OF THE VENTILATORS BY NOVEMBER 2019—IN TIME TO RESPOND TO THIS PANDEMIC. The Obama Administration anticipated the need for ventilators during a pandemic like the one the nation faces today. In 2011, it requested proposals for a contract to develop a “new or improved ventilator to provide life support in clinical and non-clinical environments for severe respiratory conditions resulting from influenza infections or all-hazards events.”2 Philips, a global manufacturer of medical equipment, agreed to produce those ventilators. On September 15, 2014, it entered into a contract with HHS to develop a ventilator for the Strategic National Stockpile (SNS) over the course of 36 months.3 Under that contract, Philips was to receive $13,820,069 for the development of the ventilator.4 That amount was later increased to $14,366,815 by amendment.5 Under the 2014 contract, Philips agreed to complete the development of the ventilator by September 14, 2017. The contract gave HHS the option to purchase 10,000 ventilators at a set price of $3,280 per unit once the design obtained clearance from the Food and Drug Administration (FDA).6 The contract contemplated the following ventilator delivery schedule from the date the purchase option was exercised: 2,500 ventilators were due within nine months (by June 15, 2018), 2,500 more due four months later (by October 14, 2018), 2,500 more due four months later (by February 14, 2019), and the final 2,500 due four months later (by June 15, 2019).7   2 Biomedical Advanced Research and Development Authority, Department of Health and Human Services, BAA-11-100-SOL-00021, BARDA Broad Agency Announcement for Advanced Research and Development of Personal Protective Equipment, Ventilators, and Diagnostics (June 20, 2011) (online at https://govtribe.com/opportunity/federal-contract-opportunity/barda-broad-agency-announcement-baa-for-advancedresearch-and-development-of-personal-protective-equipment-ventilators-and-diagnostics-baa11100sol00021). 3 Contract between Philips Respironics and the Department of Health and Human Services (Sept. 15, 2014) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1-49_Redacted.pdf). 4 Id. 5 Modification 0005 of Contract between Philips Respironics and the Department of Health and Human Services (Sept. 6, 2017) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/192216_Redacted.pdf). 6 Contract between Philips Respironics and the Department of Health and Human Services (Sept. 15, 2014) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1-49_Redacted.pdf). 7 Id. 4 When Philips initially fell behind in development, the Obama Administration granted one five-month extension to complete development, moving that date from September 14, 2017, to February 19, 2018.8 Had development been completed by that date, the contract contemplated 2,500 ventilators being due by November 19, 2018, the next 2,500 due by March 19, 2019, the next 2,500 due by July 19, 2019, and the final 2,500 due by November 19, 2019. Had the Trump Administration required Philips to fulfill this contract, all 10,000 ventilators would have been in the SNS prior to the pandemic hitting the country. II. PHILIPS’ DELAYS CONTINUED THROUGH 2017 AND 2018, BUT THE TRUMP ADMINISTRATION MISMANAGED PHILIPS’ REPEATED FAILURES TO MEET CONTRACTUAL REQUIREMENTS. IT GAVE PHILIPS THREE ADDITIONAL EXTENSIONS, THE LAST OF WHICH ALLOWED PHILIPS UNTIL JUNE 2021 TO DELIVER VENTILATORS. HAD THE TRUMP ADMINISTRATION HELD PHILIPS TO THE TERMS OF THE OBAMA-ERA CONTRACT, THE COUNTRY WOULD HAVE HAD 10,000 VENTILATORS THAT IT NEEDED WHEN THE CORONAVIRUS CRISIS STRUCK. The documents show that the Trump Administration allowed Philips’ delay to become perpetual and unquestioningly granted Philips three more extensions to the development completion deadline:  First to June 29, 2018;9   8 Modification 0004 of Contract between Philips Respironics and the Department of Health and Human Services (Aug. 19, 2016) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/150191_Redacted.pdf). 9 Modification 0005 of Contract between Philips Respironics and the Department of Health and Human Services (Sept. 6, 2017) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/192216_Redacted.pdf). 5   Then to November 30, 2018;10 and Then to September 30, 2019.11 On September 19, 2019, HHS finally exercised the purchase option from the last Administration’s 2014 contract.12 From the date of exercise, the contract contemplated 21 months to complete delivery of the 10,000 units. By the time the Trump Administration finally exercised the option, 2,500 ventilators should have been due within nine months (by June 19, 2020), 2,500 more due four months later (by October 19, 2020), 2,500 more due four months later (by February 19, 2021), and the final 2,500 due four months later (by June 19, 2021).13 The Administration’s inept management of this crucial contract deprived the country of any ventilators from Philips before the pandemic hit. III. ON JANUARY 21, 2020, WHEN THE FIRST CORONAVIRUS CASE WAS REPORTED IN THE UNITED STATES, PHILIPS APPROACHED THE TRUMP ADMINISTRATION TO ACCELERATE DELIVERY OF VENTILATORS UNDER ITS EXISTING CONTRACT. THE TRUMP ADMINISTRATION IGNORED THIS OPPORTUNITY. FOR SIX WEEKS, IT DID NOT RESPOND. On January 21, 2020, the Centers for Disease Control and Prevention (CDC) issued a press release alerting the nation to the first reported coronavirus case in the U.S.14 That same day, Philips sent an email to HHS and offered to move up delivery of the Trilogy Evo Universal ventilators.15   10 Modification 0006 of Contract between Philips Respironics and the Department of Health and Human Services (June 12, 2018) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/218224_Redacted.pdf). 11 Modification 008 of Contract between Philips Respironics and the Department of Health and Human Services (Apr. 26, 2019) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/228230_Redacted.pdf). 12 Modification 009 of Contract between Philips Respironics and the Department of Health and Human Services (Sept. 19, 2019) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/231232_Redacted.pdf). 13 Contract between Philips Respironics and the Department of Health and Human Services (Sept. 15, 2014) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1-49_Redacted.pdf). 14 Centers for Disease Control and Prevention, Press Release: First Travel-Related Case of 2019 Novel Coronavirus Detected in United States (Jan. 21, 2020) (online at www.cdc.gov/media/releases/2020/p0121-novelcoronavirus-travel-case.html). 15 Email from Charles Mutschler, Senior Project Manager, Sleep and Respiratory Care, Philips, to Anthony Nanes, Logistics Management Specialist, Division of Strategic National Stockpile, Office of the Assistant Secretary for Preparedness and Response (Jan. 21, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2220_Redacted.pdf). 6 Instead of seizing the opportunity to obtain the long-delayed ventilators in a time of great need, HHS did not respond. It took no actions in January or February to respond to Philips’ offer to “accelerate any shipments.” In fact, the Administration ignored this offer for six weeks, until March 4, 2020, when HHS finally asked Philips about expediting production of the Trilogy Evo Universal ventilators.16 IV. RATHER THAN INSIST THAT PHILIPS MEET THE TERMS OF ITS CONTRACT, OR NEGOTIATE AN ACCELERATED SCHEDULE TO ADDRESS THE PRESSING NEED, THE TRUMP ADMINISTRATION AGREED TO A FOURTH EXTENSION, REMOVING ALL DELIVERY DEADLINES UNTIL SEPTEMBER 2022. PHILIPS SECURED THE EXTENSION BY SUGGESTING IT WOULD ACTUALLY HELP MOVE UP DELIVERY. THE TRUMP ADMINISTRATION FAILED TO QUESTION PHILIPS WHEN THE COMPANY REQUESTED MODIFICATIONS TO THE EXISTING CONTRACT, WHICH MADE THE OBAMA-ERA CONTRACT USELESS FOR AIDING THE COUNTRY DURING THIS PANDEMIC. THE ADMINISTRATION NEVER ASKED PHILIPS TO PRODUCE MORE VENTILATORS UNDER THE EXISTING CONTRACT.   16 Emails between Charity Branscum, Project Manager, Philips, Charles Mutschler, Senior Project Manager, Sleep and Respiratory Care, Philips, and Anthony Nanes, Logistics Management Specialist, Division of Strategic National Stockpile, Office of the Assistant Secretary for Preparedness and Response (Mar. 4-10, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/435-437_Redacted.pdf). 7 On March 4, 2020, HHS finally asked Philips about expediting production of the ventilators.17 Philips responded the same day, indicating support, and suggesting a contractual modification that it said would help the company accomplish that goal.18 HHS agreed to the modification the next day, on March 5, 2020.19 HHS committed a significant error, however, when it agreed to the modification without posing any questions to the company about how the modification would accelerate shipments or why the company was seeking modification. It was only after agreeing to the modification, five days later, on March 10, 2020, that HHS finally asked Philips how much time the modifications would save.20   17 Id. 18 Id. 19 Id. 20 Emails between Charity Branscum, Project Manager, Philips, Charles Mutschler, Senior Project Manager, Sleep and Respiratory Care, Philips, and Anthony Nanes, Logistics Management Specialist, Division of Strategic National Stockpile, Office of the Assistant Secretary for Preparedness and Response (Mar. 10-11, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/426-428_Redacted.pdf). 8 Philips’ response should have raised alarm bells for HHS—it couldn’t commit to moving up delivery at all.21 Despite that lack of assurance, HHS still executed the contractual modification the next day, on March 11, 2020. The modification cancelled the scheduled delivery obligations which had required benchmarks to be hit, and partial fulfillments to be delivered, throughout the contract. The Administration relieved Philips of any obligation to deliver even a single ventilator before September 29, 2022, when all 10,000 would come due.22 Philips appears to have duped the Administration into thinking that this amendment, which permits a lengthy delay, was necessary for it to expedite production. When questioned about the deal, an HHS spokesman indicated that Philips would be making the ventilators “as soon as possible.”23 However, Philips dispelled that notion by stating that “the company has no plan to even begin production anytime this year.”24 Philips also touted the fact that it was free to sell its ventilators abroad instead of delivering the ventilators to HHS because “its contract with HHS gave the company until 2022 to produce the cheaper stockpile version.”25   21 Id. 22 Modification 00010 of Contract between Philips Respironics and the Department of Health and Human Services (Mar. 10, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/432434_Redacted.pdf). 23 Taxpayers Paid Millions to Design a Low-Cost Ventilator for a Pandemic. Instead, the Company is Selling Versions of it Overseas., ProPublica (Mar. 30, 2020) (online at www.propublica.org/article/taxpayers-paidmillions-to-design-a-low-cost-ventilator-for-a-pandemic-instead-the-company-is-selling-versions-of-it-overseas-). 24 Id. 25 A Company Promised Cheap Ventilators to the Government, Never Delivered, and is Now Charging Quadruple the Price for New Ones, ProPublica (Apr. 8, 2020) (online at www.propublica.org/article/a-companypromised-cheap-ventilators-to-the-government-never-delivered-and-is-now-charging-quadruple-the-price-for-thenew-ones). 9 The pressure of this Subcommittee’s investigation may have encouraged Philips to deliver some ventilators to the U.S., even though the Trump Administration’s contract did not. Philips reported to the Subcommittee that it delivered 200 Trilogy Evo Universal ventilators to HHS in June, about six weeks after the Subcommittee had formally intitiated its probe.26 However, had the Trump Administration not suspended the contract’s partial fulfillment obligation, Philips would have been required to deliver at least 2,500 ventilators by June 19, 2020. In a response to the Subcommittee, Philips reiterated that it is not obligated to complete delivery of the ventilators until Sepember 2022, but it also claimed that it is “working with the SNS to accelerate delivery of the 10,000 unit production by the end of 2021.”27 Even if true, that is more than six months later than the June 19, 2021 deadline to complete delivery prior to the ill-conceived contractual modification. The Trump Administration’s agreement to suspend contractual obligations required by the Obama-era contract ensured that Philips is not obligated to provide ventilators to help Americans in the throes of this pandemic. A. The Administration Never Asked Philips to Make More Ventilators Under the Existing Contract The Obama-era contract provides that the “Government reserves the right to modify the milestones, progress, schedule, budget, or product to add or delete products, process, or schedule as need may arise.”28 The need for more of these ventilators arose when the pandemic was overwhelming American hospitals, which were running short of ventilators.29 HHS knew that the original contract gives it the power to increase its order in times of need. When HHS exercised the option to purchase 10,000 ventilators under the Obama-era contract on September 19, 2019, HHS conducted a site visit of Philips’ manufacturing facility. The minutes of that September visit made clear the purpose of the contract was to be able to quickly make the ventilators available in the case of a pandemic:30   26 Email from Counsel to Philips North America Corporation to Staff, Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform (July 10, 2020). 27 Letter from Counsel to Philips North America Corporation to Chairman Raja Krishnamoorthi, Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform (June 26, 2020). 28 Contract between Philips Respironics and the Department of Health and Human Services (Sept. 15, 2014) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1-49_Redacted.pdf). 29 There Aren’t Enough Ventilators to Cope with the Coronavirus Crisis, New York Times (Mar. 18, 2020) (online at www.nytimes.com/2020/03/18/business/coronavirus-ventilator-shortage.html). 30 Email from Charles Mutschler, Senior Project Manager, Sleep and Respiratory Care, Philips, to Anthony Nanes, Logistics Management Specialist, Division of Strategic National Stockpile, Office of the Assistant Secretary for Preparedness and Response (Nov. 5, 2019) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/485-489_Redacted.pdf). 10 Indeed, on March 19, 2020, in one of Philips’ first communications with White House negotiators about acquiring more ventilators, Philips brought up the $3,280 Trilogy Evo Universal, attaching the following spec sheet to an email about an upcoming sales meeting:31 On March 23, 2020, Philips’ Chief Executive Officer (CEO) touted in an email to HHS Secretary Alex Azar and HHS Assistant Secretary for Preparedness and Response Robert Kadlec that through “co-development with BARDA, Philips has developed the best solution to confront exactly the pandemic we are facing.”32 However, the point escaped the White House negotiators. The Administration did not exercise this option, and the documents show no evidence that it even discussed the possibility of Philips producing more ventilators under the Obama-era contract. As a result, the Trump Administration squandered the ability to buy more of the “best solution to confront exactly the pandemic that we are facing.” Instead, it negotiated a new contract to purchase a much pricier option.   31 Emails between Nick Padula, Vice President, Health and Human Services, Philips, and Christopher Abbott, Associate Director, Office of Trade and Manufacturing Policy, The White House (Mar. 18-19, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/857-862_Redacted.pdf). 32 Email from David Shoultz, Head of Government Affairs (U.S.), Philips, to Alex M. Azar II, Secretary, Department of Health and Human Services (Mar. 23, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2031-2038_Redacted.pdf). 11 Despite rhetoric from the President about the Defense Production Act—claiming that “if people don’t give us what we need for our people, we’re going to be very tough, and we’ve been very tough”—the Trump Administration never used the Defense Production Act to compel more production of ventilators under the original contract.33 V. THE TRUMP ADMINISTRATION, REPRESENTED BY PETER NAVARRO AND OTHER SENIOR OFFICIALS IN THE WHITE HOUSE, NEGOTIATED A NEW CONTRACT WITH PHILIPS. IT AGREED TO PAY PHILIPS ALMOST FIVE TIMES THE PRICE REQUIRED UNDER THE PREVIOUS CONTRACT. ALTHOUGH THE NEW VENTILATORS WERE FUNCTIONALLY IDENTICAL, THE TRUMP NEGOTIATORS APPARENTLY WERE GULLIBLE AND CONCEDED TO PHILIPS ON ALL SIGNIFICANT MATTERS, INCLUDING PRICE. THE DOCUMENTS SHOW THAT THE ADMINISTRATION ACCEPTED PHILIPS’ FIRST OFFER WITHOUT EVEN TRYING TO NEGOTIATE A LOWER PRICE. A. A New Contract Was Negotiated by High-Level Administration Officials from President Trump’s Inner Circle After the Trump Administration relieved Philips of any obligation to provide ventilators under the Obama-era contract for two more years, top Administration officials negotiated a new contract. Persons involved in the negotiations included:    Peter Navarro, Assistant to the President, Director of Trade and Manufacturing Policy, was chief negotiator; Jared Kushner, Senior Advisor to the President, participated in a telephone call with Philips’ CEO on March 18, and at least two other telephone calls with Philips on March 30 and April 1;34 Adam Boehler, Jared Kushner’s former college roommate and current CEO of the U.S. International Development Finance Corporation, assigned an HHS contract officer to formalize the deal already negotiated by the White House;35   33 The White House, Remarks by President Trump, Vice President Pence, and Members of the Coronavirus Task Force in Press Briefing (Apr. 4, 2020) (www.whitehouse.gov/briefings-statements/remarks-president-trumpvice-president-pence-members-coronavirus-task-force-press-briefing-19/). 34 Emails from Hailey Hart, Associate Director, Office of Public Liaison, The White House, to David Shoultz, Head of Government Affairs (U.S.), Philips (Mar. 18, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2056_Redacted.pdf); Emails between Hailey Hart, Associate Director, Office of Public Liaison, The White House, and David Shoultz, Head of Government Affairs (U.S.), Philips (Mar. 18, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2063_Redacted.pdf); Letter from Counsel to Philips North America Corporation to Chairman Raja Krishnamoorthi, Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform (June 26, 2020). 35 Emails from Nick Padula, Vice President, Health and Human Services, Philips, to Colonel James P. Work, and Adam Boehler, Chief Executive Officer, U.S. International Development Finance Corporation (Mar. 27, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1250_Redacted.pdf); Email from Nick Padula, Vice President, Health and Human Services, Philips, to Christopher Abbott, Associate Director, Office of Trade and Manufacturing Policy, The White House (Mar. 26, 2020) (online at 12    HHS Secretary Alex Azar participated in teleconferences with Philips on March 22 and March 28;36 HHS Assistant Secretary for Preparedness and Response, Robert Kadlec participated in a teleconference with Philips on March 22;37 and Members of the National Security Council and National Economic Council participated in a March 17 teleconference with Philips.38 Philips suggested talking points to be included in President Trump’s announcement of the 39 deal:   (https://oversight.house.gov/sites/democrats.oversight.house.gov/files/285-292_Redacted.pdf); Email from Adam Boehler, Chief Executive Officer, U.S. International Development Finance Corporation, to Nick Padula, Vice President, Health and Human Services, Philips (Mar. 27, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1067-1068%20Redacted.pdf); Email from Nick Padula, Vice President, Health and Human Services, Philips, to Adam Boehler, Chief Executive Officer, U.S. International Development Finance Corporation (Mar. 26, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1211_Redacted.pdf). 36 Email from David Shoultz, Head of Government Affairs (U.S.), Philips, to Alex M. Azar II, Secretary, Department of Health and Human Services (Mar. 23, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2031-2038_Redacted.pdf); Email from John Groetelaars, President and Chief Executive Officer, Hillrom Holdings, Inc., to Arwenthia Ford-Barnes, Executive Assistant, Office of the Secretary, Department of Health and Human Services (Mar. 16, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/787_Redacted.pdf); Email from David Shoultz, Head of Government Affairs (U.S.), Philips, to Alex M. Azar II, Secretary, Department of Health and Human Services (Mar. 23, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2028-2030%20Redacted.pdf); Letter from Counsel to Philips North America Corporation to Chairman Raja Krishnamoorthi, Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform (June 26, 2020). 37 Emails between David Shoultz, Head of Government Affairs (U.S.), Philips, Alex M. Azar II, Secretary, Department of Health and Human Services, and Robert Kadlec, Assistant Secretary for Preparedness and Response, Department of Health and Human Services (Mar. 28, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2010-2022%20Redacted.pdf); Email from David Shoultz, Head of Government Affairs (U.S.), Philips, to Alex M. Azar II, Secretary, Department of Health and Human Services (Mar. 23, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2031-2038_Redacted.pdf); Email from David Shoultz, Head of Government Affairs (U.S.), Philips, to Alex M. Azar II, Secretary, Department of Health and Human Services (Mar. 23, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2028-2030%20Redacted.pdf). 38 Emails from Nick Padula, Vice President, Health and Human Services, Philips, to David Shoultz, Head of Government Affairs (U.S.), Philips, Hailey Hart, Associate Director, Office of Public Liaison, The White House, and Monica Volante, Director, Federal Government Affairs, Philips (Mar. 17-18, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/877-879Redacted.pdf). 39 Email from Nick Padula, Vice President, Health and Human Services, Philips, to Christopher Abbott, Associate Director, Office of Trade and Manufacturing Policy, The White House (Mar. 27, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/383_Redacted.pdf). 13 The chief “negotiator” for the White House was Peter Navarro, Assistant to the President and Director of Trade and Manufacturing Policy. In a March 19, 2020, email to Navarro’s staff, Philips’ Vice President of Health and Human Services identified Peter Navarro as “on point, and we are in process now,” while discussing multiple negotiations meetings with Peter Navarro.40 Philips confirmed in a letter to the Subcommittee that “From March 17 until the contract was signed on April 7, Philips participated in several teleconferences, chiefly with Dr. Navarro … to discuss and finalize the terms of the April 2020 contract.”41   40 Email from Nick Padula, Vice President, Health and Human Services, Philips, to Christopher Abbott, Associate Director, Office of Trade and Manufacturing Policy, The White House (Mar. 18, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/857-862_Redacted.pdf) 41 Letter from Counsel to Philips North America Corporation to Chairman Raja Krishnamoorthi, Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform (June 26, 2020); Email from Nick Padula, Vice President, Health and Human Services, Philips, to Christopher Abbott, Associate Director, Office of Trade and Manufacturing Policy, The White House (Mar. 24, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/870_Redacted.pdf); Email from Nick Padula, Vice President, Health and Human Services, Philips, to Christopher Abbott, Associate Director, Office of Trade and Manufacturing Policy, The White House, Mark Sebastiaan Anthony Stoffels, Senior Vice President, Business Leader Connected Care North America, Philips, Trina Eaddy, Senior Counsel and Compliance Officer, Philips, and John Frank, Business Group Leader, Sleep and Respiratory Care, Philips (Mar. 25, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/301_Redacted.pdf). 14      Philips even addressed the invoice for 42,900 of the 43,000 units to Peter Navarro (reflecting the final cost per unit on March 25, 2020—13 days before a final contract was executed):42   42 Invoice for Trilogy EV300 Bundle from Philips Respironics, to Peter Navarro, Assistant to the President and Director of the Office of Trade and Manufacturing Policy, The White House (Mar. 25, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/298-299_Redacted.pdf). 15 HHS professional contract officers were excluded until the last moment. By then, the generous terms of the contract had already been agreed to by the White House. After Peter Navarro agreed to Philips’ terms, Philips sent a “Letter Contract” reflecting those terms (cost, number of ventilators, delivery schedule, and contract clauses) to Jared 16 Kushner’s former college roommate, Adam Boehler, asking at Peter Navarro’s behest, to be assigned an HHS contract officer to “negotiate” the already-agreed-upon contract.43 Adam Boehler did what the Philips official asked. Philips’ email introduction to the HHS contract officer reveals that any negotiation by professional staff would be a mere formality— attached to the introduction email was the Letter Contract reflecting the terms that were already agreed upon with Peter Navarro.44   43 Email from Trina Eaddy, Senior Counsel and Compliance Officer, Philips, to Adam Boehler, Chief Executive Officer, U.S. International Development Finance Corporation (Mar. 27, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/960-989%20Redacted.pdf). 44 Email from Trina Eaddy, Senior Counsel and Compliance Officer, Philips Adam Boehler, Chief Executive Officer, U.S. International Development Finance Corporation (Mar. 27, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/992-1021_Redacted.pdf). 17 After the final contract was in hand, Philips thanked Mr. Navarro.45   B. The Trump Administration Paid Nearly Five Times the Price Per Ventilator Than the Obama Administration Negotiated The ventilator purchased under the Obama-era contract is the Trilogy Evo Universal, at a cost of $3,280 per unit:46   45 Email from Nick Padula, Vice President, Health and Human Services, Philips, to Christopher Abbott, Associate Director, Office of Trade and Manufacturing Policy, The White House, and Peter Navarro, Assistant to the President and Director, Office of Trade and Manufacturing Policy, The White House (Apr. 8, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/393_Redacted.pdf). 46 Modification 008 of Contract between Philips Respironics and the Department of Health and Human Services (Apr. 26, 2019) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/228230_Redacted.pdf). 18 On April 7, 2020, Philips was awarded a second contract to deliver 43,000 Trilogy EV300 ventilators to HHS. Under that contract, HHS agreed to pay Philips $15,000 per ventilator ($645,000,000). The contract also included some component parts, bringing its total value to $646,683,750.47 Philips also sells an identical model to commercial customers, called the Trilogy Evo, at a market list price (not the government price) of $11,167.48 C. Had the White House Negotiators Asked Basic Questions of Philips, They Would Have Discovered that the Ventilators Purchased Under the New Contract Were Functionally Identical to the Ventilators Under the Prior Contract Aside from price, there is no discernable difference in either appearance or functionality between the Trilogy Evo Universal, the Trilogy Evo, and the Trilogy EV300. For a comparison showing that the features and specifications of the three models are the same, see Appendix A. Philips seemed to concede the similarities between models in a March 18, 2020, email to the White House, in which it referred to the Trilogy Evo and the Trilogy EV300 as one ventilator:49   47 Contract between Philips Respironics and the Department of Health and Human Services (Apr. 17, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/236-258_Redacted.pdf). 48 Commercial Market List Prices for Philips Ventilators (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1151.pdf). 49 Emails between Nick Padula, Vice President, Health and Human Services, Philips, and Hailey Hart, Office of Public Liaison, The White House (Mar. 18, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1122-1125_Redacted.pdf). 19 The Trilogy Evo Universal is the name that Philips calls the ventilator it sold to HHS under the Obama-era contract. HHS was intimately familiar with the functionality and appearance of that model since it co-developed it with Philips and drafted the specifications. Further, the purchase option in the first contract was contingent on Philips receiving FDA 510(k) approval to market the ventilator. Philips submitted 510(k) applications for both the Trilogy Evo Universal and the Trilogy Evo at the same time. On the same day, FDA granted both applications and issued nearly identical authorizations, using the same words and specifications to describe both ventilators.50 For a comparison of the Trilogy Evo Universal and Trilogy Evo 510(k) approvals, see Appendix B. D. The White House Negotiators Failed to Discern Differences Between Ventilator Models, and Missed Obvious Signals to Purchase Cheaper Option Philips initially suggested selling the same model to the Trump Administration that the Obama Administration had purchased for $3,280 each: the Trilogy Evo Universal.51 Then Philips suggested that the Administration buy the middle-priced Trilogy Evo.52   50 Food and Drug Administration, Center for Devices and Radiological Health, Trilogy Evo Ventilator (K181166) 510(k) approval letter (Jul. 18, 2019) (online at www.accessdata.fda.gov/cdrh_docs/pdf18/K181166.pdf); Food and Drug Administration, Center for Devices and Radiological Health, Trilogy Evo Universal Ventilator (K181170) 510(k) approval letter (Jul. 18, 2019) (online at www.accessdata.fda.gov/cdrh_docs/pdf18/K181170.pdf). 51 Emails between Nick Padula, Vice President, Health and Human Services, Philips, and Christopher Abbott, Associate Director, Office of Trade and Manufacturing Policy, The White House (Mar. 18-19, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/857-862_Redacted.pdf) (In a March 19, 2020, pitch to the White House, Philips presented the $3,280 Trilogy Evo Universal ventilator as an option for the upcoming contract, attaching a Trilogy Evo Universal specification sheet to the email to White House negotiators about an upcoming sales meeting). 52 Email from Nick Padula, Vice President, Health and Human Services, Philips, to Christopher Abbott, Associate Director, Office of Trade and Manufacturing Policy, The White House (Mar. 20, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/780-786_Redacted.pdf). 20 Philips pitched the Trilogy Evo as the best option to Secretary Azar and Assistant Secretary Kadlec on March 23, 2020.53   53 Email from David Shoultz, Head of Government Affairs (U.S.), Philips, to Alex M. Azar II, Secretary, Department of Health and Human Services (Mar. 23, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2031-2038_Redacted.pdf). 21 Yet, the Administration did not buy either of those less expensive models; it purchased the Trilogy EV300. In arriving at that selection, the Administration never requested, and never received, a side-by-side comparison of the three models of ventilators. But it did see a narrative comparison of the Trilogy Evo and the Trilogy EV300. In that comparison, the two ventilators are referred to as a single ventilator:54   54 Emails between Nick Padula, Vice President, Health and Human Services, Philips, and Hailey Hart, Office of Public Liaison, The White House (Mar. 18, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1122-1125_Redacted.pdf). 22 There is no record that the Administration asked if there were differences between the models. The Administration did not request or receive any data on Philips’ cost of production. Philips did provide the Administration with the list of commercial market prices for Philips’ ventilators. That document showed that Philips charged thousands more for a Trilogy EV300 than for a Trilogy Evo.55 Nevertheless, the contract HHS signed on April 7, 2020, committed to purchasing 43,000 ventilators from Philips: 100 Trilogy Evos followed by 42,900 Trilogy EV300s. The Administration agreed to pay as much for the Trilogy Evos as the Trilogy EV300s ($15,000 each), even though the commercial market list price of the Trilogy Evo is only $11,167.56 Philips appears to have duped the Administration, which failed to ask any relevant questions about the differences between ventilator models, into buying the priciest model, the $15,000 Trilogy EV300, and in paying over list price for the middle-level model. E. The White House Negotiators Were Easily Steered into the Priciest Option and Failed to Question the False Reason Philips Gave for It to Be Selected A single email may explain how the Administration was steered into the most expensive option, the Trilogy EV300. On May 25, 2020, Philips sent an email to the White House negotiators, stating:57   55 Commercial Market List Prices for Philips Ventilators (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1151.pdf). 56 Id. 57 Email from Nick Padula, Vice President, Health and Human Services, Philips, to Christopher Abbott, Associate Director, Office of Trade and Manufacturing Policy, The White House (Mar. 25, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/303_Redacted.pdf). 23 There is no evidence that the Administration ever questioned Philips’ assertion that the Trilogy EV300’s screen was “more clinician-friendly” or why that purported feature justified an extra $11,720 per ventilator (the cost difference between the Trilogy Evo Universal and the Trilogy EV300)—over $500 million extra cumulatively. Had the Administration asked how the screen was different, it would have discovered that the screens on the Trilogy EV300 are identical to the screens on the less expensive Trilogy Evo and Trilogy Evo Universal Models: Trilogy Evo Universal58 Trilogy Evo59 Trilogy EV30060   58 Philips Trilogy Evo Universal Instructions for Use Manual--Page 89, ManualsLib (Jan. 26, 2018) (online at www.manualslib.com/manual/1571575/Philips-Trilogy-Evo-Universal.html?page=89#manual). 59 Specification sheets for Trilogy EV300 and Trilogy Evo Ventilators (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1134-1137.pdf). 60 Id. 24 View of the Screens of the Three Ventilators Trilogy Evo Universal61 Trilogy Evo62 Trilogy EV30063   61 Philips Trilogy Evo Universal Instructions for Use Manual—About Trilogy Evo Universal; Parts of Trilogy Evo Universal, ManualsLib (Jan. 26, 2018) (online at www.manualslib.com/manual/1571575/PhilipsTrilogy-Evo-Universal.html?page=12#manual). 62 Trilogy Evo Quick Start Guide for Clinicians, Philips Respironics (Nov. 13, 2019) (online at https://d1oohiyvdehe01.cloudfront.net/phil%2F1%2Ffiles%2F10006%2F19767%2Ffile?Policy=eyJTdGF0ZW1lbn QiOiBbeyJSZXNvdXJjZSI6Imh0dHBzOi8vZDFvb2hpeXZkZWhlMDEuY2xvdWRmcm9udC5uZXQvcGhpbCUy RjElMkZmaWxlcyUyRjEwMDA2JTJGMTk3NjclMkZmaWxlIiwiQ29uZGl0aW9uIjp7IkRhdGVMZXNzVGhhbiI6 eyJBV1M6RXBvY2hUaW1lIjoxNTk0NDEzMDY5fSwiSXBBZGRyZXNzIjp7IkFXUzpTb3VyY2VJcCI6IjAuMC 4wLjAvMCJ9fX1dfQ__&Signature=Wv3qc6arlyMKbOr4NrkAWrLjLytXpgvjfdAsimxUcuSygsmTX6~YcizYAWhaP5vcOpzifmouXYzORfvsev1xmacLxyN6XNGEzIEtmdufPwY8zOZlpfIREQxhtqv6RFVpcCIFKHlq7NRykBVs5HskjyvRqPQoeya2TUK KLvPHM_&Key-Pair-Id=APKAJTOZQY4H2RTLVYOA). 63 Continuum of Care. Simplified Workflow. Introducing Trilogy EV300, Philips Respironics (Jan. 2020) (online at https://philipsproductcontent.blob.core.windows.net/assets/20200214/a05bc42d33834d0e89c9ab61013d781a.pdf). 25 In fact, Philips explained to the White House in a March 18, 2020, email that the user interface was consistent across the platform:64 The Administration’s willingness to spend hundreds of millions of extra dollars for non-existent “more clinician-friendly screens” constitutes waste. F. After the Sale Was Completed, Philips Misleadingly Claimed That the Trilogy EV300 Was Selected Because It Was Available, and Other Models Were Not. That Statement is Inaccurate, Yet the Administration Repeated It There is no evidentiary record that the Administration probed Philips’ production capability for the company’s various models or that it factored that into its selection of the EV300. After the second contract became public, Philips issued a public statement that the $15,000 ventilators were available, and the $3,280 models were not. Philips claimed that it “had only made the stockpile version in small batches and didn’t want to ramp up production on a ventilator that it hadn’t mass produced, a slower process than increasing production of other models.” An HHS statement at the time was lent in support of that assertion: “the agency purchased ‘what was immediately available.’”65 The implication in Philips’ post-hoc justification—that Philips was already selling the Trilogy EV300—is inaccurate. The statement offered by the Trump Administration is also false. The ventilator that the Trump Administration purchased was not on the market. The following chart shows that Philips did not begin rolling out the Trilogy EV300 until March 2020, when the Trump Administration agreed to buy them:66   64 Emails between Nick Padula, Vice President, Health and Human Services, Philips, and Hailey Hart, Office of Public Liaison, The White House (Mar. 18, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1122-1125_Redacted.pdf). 65 A Company Promised Cheap Ventilators to the Government, Never Delivered, and is Now Charging Quadruple the Price for New Ones, ProPublica (Apr. 8, 2020) (online at www.propublica.org/article/a-companypromised-cheap-ventilators-to-the-government-never-delivered-and-is-now-charging-quadruple-the-price-for-thenew-ones). 66 Philips Ventilator Sale Chart (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2241.pdf). 26 The Administration knew this. In a March 18, 2020 email to the White House, Philips explained that the Trilogy EV300 was a new product being introduced and that it would take time to build up inventory:67 By selecting the $15,000 model, the Administration demonstrated that it either failed the most basic duty of reading what Philips sent it or that it was not concerned about overpaying. G. The Administration Took Philips’ First Offer—There is No Evidence It Even Tried to Negotiate a Lower Price for the Ventilators Contrary to President Trump’s rhetoric, the Administration’s conduct in negotiations with Philips reveals a complete failure to attempt to secure a better price. On March 18, 2020, President Trump invoked the Defense Production Act (DPA) and issued an Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19.68   67 Emails between Nick Padula, Vice President, Health and Human Services, Philips, and Hailey Hart, Office of Public Liaison, The White House (Mar. 18, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1122-1125_Redacted.pdf). 68 Executive Order 13909, Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19 (Mar. 18, 2020) (online at www.federalregister.gov/documents/2020/03/23/202006161/prioritizing-and-allocating-health-and-medical-resources-to-respond-to-the-spread-of-covid-19). 27 In the negotiations for ventilators, the Administration did not use that leverage to negotiate a better price. Philips’ first proposal to the Administration, dated March 24, 2020, offered to provide 43,000 ventilators for $15,000 per ventilator, and $1,683,750 worth of circuits and filters, for a total contract price of $646,683,750:69   69 Email from Trina Eaddy, Senior Counsel and Compliance Officer, Philips, to Adam Boehler, Chief Executive Officer, U.S. International Development Finance Corporation (Mar. 27, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1251-1280_Redacted.pdf). 28 Two days later, on March 26, 2020, Philips had a letter contract in hand for its requested amount: $646,683,750:70 On March 30, HHS gave Philips a formal authorization to proceed on those terms.71   70 Email from Nick Padula, Vice President, Health and Human Services, Philips, to Christopher Abbott, Associate Director, Office of Trade and Manufacturing Policy, The White House (Mar. 26, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/285-292_Redacted.pdf). 71 Email from Annette Wright, Contracting Officer, Centers for Disease Control and Prevention, to Trina Eaddy, Senior Counsel and Compliance Officer, Philips (Mar. 30, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2163-2166_Redacted.pdf). 29 On April 7, 2020, the final contract was awarded for the purchase of 43,000 ventilators for $15,000 per ventilator and $1,683,750 worth of circuits and filters, for a total contract price of $646,683,750.72 The documents show no attempt by Administration to negotiate a lower price. H. Peter Navarro Promised 50% Prepayment ($323,341,875) Before the Delivery of a Single Ventilator, Which Was Later Reduced to 10% By HHS Professional Staff Peter Navarro failed to discover that he was buying ventilators identical to the Trilogy Evo Universals at almost five times the price, and he accepted without negotiation Philips’ opening offer on cost. Beyond that, he promised Philips a 50% prepayment, which would have amounted to a $323,341,875 prepayment to a company that had not yet delivered a single ventilator on a contract from 2014. His staff told Philips he had done this for other companies as well.73   72 Contract between Philips Respironics and the Department of Health and Human Services (Apr. 17, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/236-258_Redacted.pdf). 73 Emails between Trina Eaddy, Senior Counsel and Compliance Officer, Philips, and Tami Hagberg, Acting Assistant Deputy Associate General Counsel, Department of Health and Human Services (Mar. 31-Apr. 1, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1414-1417_Redacted.pdf). 30 Fortunately, in this instance, Mr. Navarro’s promise was later reduced by HHS professional staff to 10%, which still amounts to $64,668,375:74 VI. THE ADMINISTRATION DRASTICALLY OVERPAID FOR VENTILATORS— NO AMERICAN PURCHASER PAID MORE THAN THE ADMINISTRATION. BETWEEN DECEMBER 2019 AND MAY 2020, PHILIPS TOOK ORDERS FOR 5,339 OTHER TRILOGY EV300 VENTILATORS FROM 92 DIFFERENT PURCHASERS IN THE UNITED STATES. SOME SMALL PURCHASERS, BUYING AS FEW AS ONE UNIT, WERE ABLE TO NEGOTIATE PRICES AS LOW AS $9,327, COMPARED TO $15,000 PAID BY THE TRUMP ADMINISTRATION.   74 Email from Trina Eaddy, Senior Counsel and Compliance Officer, Philips, to Vivian Hubbs, Chief Contracting Officer, Centers for Disease Control and Prevention (Apr. 5, 2020) (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1847_Redacted.pdf). 31 While the Administration failed to attempt to negotiate price, other U.S. purchasers successfully did. Between December 18, 2019, and May 27, 2020, Philips sold 5,339 other Trilogy EV300 ventilators to 92 different purchasers in the United States. None of them paid more per ventilator than HHS. The prices were subject to negotiation. For example, one Missouri purchaser, acquiring just a single Trilogy EV300, secured it for just $9,327. A New Jersey purchaser acquiring only two ventilators was able to purchase them for $10,573 each. A buyer in Florida making a larger purchase of 155, got them for $10,400 each.75   75 Table Listing Sales of All EV300 Ventilators to Purchasers in the United States Between December 19, 2019 and May 27, 2020 (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/22422248.pdf). 32 33 The prices of Trilogy EV300 ventilators were subject to negotiation. It would stand to reason that a purchaser of 43,000 units would be able to negotiate a better deal than a purchaser of a single unit. However, that did not happen—the Trump Administration, with all its purchasing power, paid the highest price among American purchasers. The Subcommittee requested the same information on Philips’ foreign ventilator sales during this time period, but Philips has refused to produce it. 34 VII. THE TRUMP ADMINISTRATION’S INCOMPETENT PROCUREMENT EFFORTS FOR VENTILATORS SQUANDERED UP TO $500 MILLION OR MORE. PHILIPS TOOK ADVANTAGE OF THE TRUMP ADMINISTRATION’S INEPTNESS AND SHOULD RETURN EXCESS TAXPAYER FUNDS. If the Trump Administration had purchased 43,000 Trilogy Evo Universals for the same price that the Obama Administration had negotiated, it would have spent $503,960,000 less in taxpayer dollars. There is no indication that the units the Administration purchased provide any benefit over the Trilogy Evo Universals, which were designed specifically for use in a pandemic. The Trump Administration’s efforts constitute over half-a-billion dollars of waste, fraud, or abuse. Philips should return the excess so that it may aid the nation’s response to the coronavirus pandemic. 35 APPENDIX A 36 Front View of Each Ventilator, Showing No Differences Trilogy Evo Universal76 Trilogy Evo77   76 Philips Trilogy Evo Universal Instructions for Use Manual—About Trilogy Evo Universal; Parts Of Trilogy Evo Universal, ManualsLib (Jan. 26, 2018) (online at www.manualslib.com/manual/1571575/PhilipsTrilogy-Evo-Universal.html?page=12#manual). 77 Trilogy Evo Quick Start Guide for clinicians, Philips Respironics (Nov. 13, 2019) (online at https://d1oohiyvdehe01.cloudfront.net/phil%2F1%2Ffiles%2F10006%2F19767%2Ffile?Policy=eyJTdGF0ZW1lbn QiOiBbeyJSZXNvdXJjZSI6Imh0dHBzOi8vZDFvb2hpeXZkZWhlMDEuY2xvdWRmcm9udC5uZXQvcGhpbCUy RjElMkZmaWxlcyUyRjEwMDA2JTJGMTk3NjclMkZmaWxlIiwiQ29uZGl0aW9uIjp7IkRhdGVMZXNzVGhhbiI6 eyJBV1M6RXBvY2hUaW1lIjoxNTk0NDEzMDY5fSwiSXBBZGRyZXNzIjp7IkFXUzpTb3VyY2VJcCI6IjAuMC 4wLjAvMCJ9fX1dfQ__&Signature=Wv3qc6arlyMKbOr4NrkAWrLjLytXpgvjfdAsimxUcuSygsmTX6~YcizYAWhaP5vcOpzifmouXYzORfvsev1xmacLxyN6XNGEzIEtmdufPwY8zOZlpfIREQxhtqv6RFVpcCIFKHlq7NRykBVs5HskjyvRqPQoeya2TUK KLvPHM_&Key-Pair-Id=APKAJTOZQY4H2RTLVYOA). 37 Trilogy EV30078 Utility Panel View of Each Ventilator, Showing No Differences Trilogy Evo Universal79*   78 Introducing Trilogy EV300, Philips Respironics (Jan. 2020) (online at https://philipsproductcontent.blob.core.windows.net/assets/20200214/a05bc42d33834d0e89c9ab61013d781a.pdf). 79 Philips Trilogy Evo Universal Instructions for Use Manual—Page 13, ManualsLib (Jan. 26, 2018) (online at www.manualslib.com/manual/1571575/Philips-Trilogy-Evo-Universal.html?page=13#manual). 38 Trilogy Evo80 Trilogy EV30081 Although it is not pictured in the Trilogy Evo Universal diagram, that model comes equipped with an oxygen blender module—shown in this diagram from an alternate angle:82   80 Trilogy Evo Quick Start Guide for Clinicians, Philips Respironics (Nov. 13, 2019) (online at https://d1oohiyvdehe01.cloudfront.net/phil%2F1%2Ffiles%2F10006%2F19767%2Ffile?Policy=eyJTdGF0ZW1lbn QiOiBbeyJSZXNvdXJjZSI6Imh0dHBzOi8vZDFvb2hpeXZkZWhlMDEuY2xvdWRmcm9udC5uZXQvcGhpbCUy RjElMkZmaWxlcyUyRjEwMDA2JTJGMTk3NjclMkZmaWxlIiwiQ29uZGl0aW9uIjp7IkRhdGVMZXNzVGhhbiI6 eyJBV1M6RXBvY2hUaW1lIjoxNTk0NDEzMDY5fSwiSXBBZGRyZXNzIjp7IkFXUzpTb3VyY2VJcCI6IjAuMC 4wLjAvMCJ9fX1dfQ__&Signature=Wv3qc6arlyMKbOr4NrkAWrLjLytXpgvjfdAsimxUcuSygsmTX6~YcizYAWhaP5vcOpzifmouXYzORfvsev1xmacLxyN6XNGEzIEtmdufPwY8zOZlpfIREQxhtqv6RFVpcCIFKHlq7NRykBVs5HskjyvRqPQoeya2TUK KLvPHM_&Key-Pair-Id=APKAJTOZQY4H2RTLVYOA). 81 Trilogy EV300 Evolution of Care: Simple, Portable, Reliable, Adaptable, Philips Respironics (Feb. 2020) (online at www.usa.philips.com/c-dam/b2bhc/master/landing-pages/experience-catalog/sleep-and-respiratorycare/how-philips-is-globally-addressing-the-coronavirus-covid-19/clinical-resources/trilogy-ev300-clinicalpresentation.pdf). 82 Philips Trilogy Evo Universal Instructions for Use Manual—Page 13, ManualsLib (Jan. 26, 2018) (online at www.manualslib.com/manual/1571575/Philips-Trilogy-Evo-Universal.html?page=13#manual). 39 The Trilogy Evo Universal’s oxygen blender module is also described in a June 26, 2020, letter from Philips to the Subcommittee:83   83 Letter from Counsel to Philips North America Corporation to Chairman Raja Krishnamoorthi, Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform (June 26, 2020). 40 Patient Panel View of Each Ventilator, Showing No Differences Trilogy Evo Universal84 Trilogy Evo85   84 Philips Trilogy Evo Universal Instructions for Use Manual—Page 13, ManualsLib (Jan. 26, 2018) (online at www.manualslib.com/manual/1571575/Philips-Trilogy-Evo-Universal.html?page=13#manual). 85 Trilogy Evo Quick Start Guide for Clinicians, Philips Respironics (Nov. 13, 2019) (online at https://d1oohiyvdehe01.cloudfront.net/phil%2F1%2Ffiles%2F10006%2F19767%2Ffile?Policy=eyJTdGF0ZW1lbn QiOiBbeyJSZXNvdXJjZSI6Imh0dHBzOi8vZDFvb2hpeXZkZWhlMDEuY2xvdWRmcm9udC5uZXQvcGhpbCUy RjElMkZmaWxlcyUyRjEwMDA2JTJGMTk3NjclMkZmaWxlIiwiQ29uZGl0aW9uIjp7IkRhdGVMZXNzVGhhbiI6 eyJBV1M6RXBvY2hUaW1lIjoxNTk0NDEzMDY5fSwiSXBBZGRyZXNzIjp7IkFXUzpTb3VyY2VJcCI6IjAuMC 4wLjAvMCJ9fX1dfQ__&Signature=Wv3qc6arlyMKbOr4NrkAWrLjLytXpgvjfdAsimxUcuSygsmTX6~YcizYAWhaP5vcOpzifmouXYzORfvsev1xmacLxyN6XNGEzIEtmdufPwY8zOZlpfIREQxhtqv6RFVpcCIFKHlq7NRykBVs5HskjyvRqPQoeya2TUK KLvPHM_&Key-Pair-Id=APKAJTOZQY4H2RTLVYOA). 41 Trilogy EV30086 Philips has repeatedly compared the Trilogy Evo and the Trilogy EV300 without demonstrating any difference in the models. And according to Philips’ specification sheets, there is no difference between those models (except that the less expensive Trilogy Evo model actually has two more ventilation modes):87 Trilogy Evo Trilogy EV300   86 Trilogy EV300 Evolution of Care: Simple, Portable, Reliable, Adaptable, Philips Respironics (Feb. 2020) (online at www.usa.philips.com/c-dam/b2bhc/master/landing-pages/experience-catalog/sleep-and-respiratorycare/how-philips-is-globally-addressing-the-coronavirus-covid-19/clinical-resources/trilogy-ev300-clinicalpresentation.pdf). 87 Specification Sheets for Trilogy EV300 and Trilogy Evo Ventilators (online at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/1134-1137.pdf). 42 43 The only reason that Philips appears to charge different prices for identical ventilators appears to be the intended buyer. The following Philips specification sheet highlights the identical functionality between the Trilogy Evo and the Trilogy EV300 but indicates that they are intended to be sold for different intended care settings. In a comparison chart of Philips’ ventilation solutions, the Trilogy EV300 is listed as a hospital-only solution, while the Trilogy Evo is listed for either hospital or home.88   88 Philips Ventilation Solutions Datasheet, Philips Respironics (online at www.philips.com/cdam/b2bhc/master/Products/Category/ventilation/group/philips-ventilation-specifications-comparisonchart.pdf?_ga=2.251455040.772752659.1594060554-879679223.1594060554). 44 In a brochure for the Evo model, Philips emphasized the models’ similarities with the headline: “Different care settings. Same clinical technology.” The functionality of the models is the same; the differences are based entirely on the care environment for which they are being sold.89   89 Trilogy Evo Product Brochure, Philips Respironics (online at https://philipsproductcontent.blob.core.windows.net/assets/20191028/752f8345d10143f380ccaaf400e7d93d.pdf). 45 46 APPENDIX B 47 The FDA’s 510(k) approvals show that the Trilogy Evo Universal and the Trilogy Evo are identical. The Evo and Evo Universal Ventilators were deemed substantially equivalent to legally marketed predicate devices after review of their respective Section 510(k) premarket notifications of intent to market on the same day. The 510(k) summaries for each model are substantially identical:90 Trilogy Evo Universal 510(K) from FDA Trilogy Evo 510(K) from FDA   90 Food and Drug Administration, Center for Devices and Radiological Health, Trilogy Evo Ventilator (K181166) 510(k) Approval Letter (July 18, 2019) (online at www.accessdata.fda.gov/cdrh_docs/pdf18/K181166.pdf); Food and Drug Administration, Center for Devices and Radiological Health, Trilogy Evo Universal Ventilator (K181170) 510(k) Approval Letter (July 18, 2019) (online at www.accessdata.fda.gov/cdrh_docs/pdf18/K181170.pdf). 48 The comparisons of technological characteristics with the predicate device are particularly telling, as both models share a primary predicate device: Trilogy Series Ventilator with Oximetry (K111610):91 Trilogy Evo Universal Trilogy Evo   91 Id. 49