Die deutsche Medizintechnik-Industrie / SPECTARIS Jahrbuch 2022/2023

36 Gastbeitrag Internationale Märkte | Participating in US Public Procurement Markets Participating in US Public Procurement Markets T he public procurement market in the United States is over $2 trillion. The US federal government procures around $575 billion annually in products and services and operates a centralized procurement system called the System for Award Management (SAM). State and local gov- ernments procure on the order of $1.5 trillion annually in products and services. There is no centralized record-keep- ing system for state and local government procurement. The 50 states and 90,000 local governments operate their own procurement processes and keep their own records. » Rules for Public Tender in the United States US public procurement law requires contracts to be awarded under full and open competition. In the US, tenders are called solicitations and advertised contract solicitations usually contain contract re- quirements, instructions on how to prepare and submit a propos- al, the evaluation criteria that will be applied to an offer, applicable regulations for the contract, and contract terms and conditions. For larger solicitations, a bidders’ conference is usually held to brief potential offerors on the buying agency, the goals for the contract, and to answer questions from potential bidders. Even if a bidders’ conference is not held, potential offerors will have an opportunity to submit written questions about the solicitation and these questions often result in modifications to the solicita- tion documents. There are limited exceptions to the full and open competition contracting requirement. Sole source contracting may be allowed when there is only one source that meets the product or service requirements. Contracts may be set aside for small and disad- vantaged businesses if there are enough competitors in the mar- ket to justify a set-aside action. Finally, competition requirements may be suspended in case of an emergency such as a natural disaster or pandemic. At the onset of the pandemic in 2020, tests, personal protective equipment (PPE), and ventilators were all purchased under emergency contracting authority. » Federal Procurement: Medical Devices At the federal level, the Department of Veterans Affairs (VA) and the Department of Defense (DoD) are attractive markets for med- ical device and supply providers. The VA healthcare system, the Veterans Health Administration (VHA), services 9 million enrolled veterans and some of their dependents. Most care is delivered via Veteran Integrated Service Networks (VISNs), which include 150 major medical centers; 1,200 community-based clinics; 50 rehabilitation centers; and 135 nursing homes. The DoD provides care to 9.5 million active military personnel, retirees, and their family members. Most care is provided via the community TRICARE program, with the remaining care provided via the integrated healthcare network. This network includes 55 military treatment facilities (MTF), 375 military medical clinics, and 250 military dental clinics. Federal medical research laboratories can also be attractive mar- kets for certain medical device and supply providers. These lab- oratories include the National Institutes of Health (NIH), Centers for Disease Control (CDC), and Food and Drug Administration (FDA). All federal government solicitations are advertised on the System for Award Management (SAM), the federal government’s cen- tralized procurement system. SAM also serves as the federal government’s vendor registration system. » State and Local Procurement: Medical Devices According to a 2019 government survey, state and local govern- ments spent $322 billion or just under 10 percent of their budg- ets on health and hospitals. 65 percent of this amount or $210 billion was spent on hospital services, including university med- ical centers, state-owned hospitals, and public hospitals. 35 per- cent of this amount or $122 billion was spent on health programs, including mental health and substance abuse, water and air quality, and health inspections. State government markets for medical devices and supplies in- clude state university medical centers, state-owned hospitals, state laboratories, and corrections departments, which often provide medical services to prisoners. Local government markets include departments of health, public hospitals, clinics, labora- tories, and public safety/county sheriffs. Nils Gerber Managing Director Gerber International Consulting and Advisory Services

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