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Washington, DC December 9, 2020 – United States Senators Elizabeth Warren (D-Mass.) and Tina Smith (D-Minn.), members of the Senate Health, Education, Labor, and Pensions (HELP) Committee, sent a letter to Alex Azar, Secretary of the Department of Health and Human Services (HHS) summarizing the findings from their investigation into the nation’s testing capacity and the availability of pediatric testing and making recommendations for how the federal government can improve national testing infrastructure.

On August 26, 2020, Senators Warren and Smith wrote to five of the largest COVID-19 testing laboratories regarding each company’s capacity to process COVID-19 diagnostic tests and deliver prompt results. From the responses to these letters, the lawmakers learned that lab companies experienced a large surge in COVID-19 diagnostic testing needs during the summer surge, straining lab company capacity and slowing test turnaround times in some cases. Supply shortages hampered their efforts to develop additional capacity. They also experienced confusion about payment and reimbursement in different scenarios – for instance, whether insurers or the government was responsible for payment when a test was not considered “medically necessary.”

Furthermore, in response to reports that families were having difficulty obtaining COVID-19 testing for their young children, on October 7, 2020, Senators Warren and Smith wrote to the retail providers participating in the HHS Community-Based Testing Sites partnership to ask for information about their policies regarding pediatric testing and their plans to expand testing to more age groups. They found that pediatric testing is becoming more widely available, though most retail providers were not currently offering testing for young children. The responses from the retail providers indicated that the primary barrier to expanding pediatric testing is the providers’ use of “self-swab” test kits, which are difficult for children or their caregivers to use. Additionally, independent pharmacies have had difficulty obtaining the tests needed to participate in the HHS program. Following Senator Warren and Smith’s letters, Walgreens announced that it would begin offering testing for children as young as three years old, and Rite Aid announced that it would offer testing for children as young as 13. 

“Together, our findings reveal significant gaps in COVID-19 testing capacity, exacerbating the ongoing public health threat. Addressing these problems will require aggressive federal government action. We have previously called for dedicated federal funding and a national testing plan to ensure that everyone who needs a COVID-19 test can access one quickly and easily,” wrote the lawmakers. 

The Senators now recommend that the federal government: 

  1.  Invoke the Defense Production Act to ensure that testing labs and providers have adequate access to supplies needed to conduct tests and to ensure that supplies are reaching communities that are most in need;
  2. Clarify rules regarding payments for testing so that patients and providers can more clearly understand when third-party payers, the government, or other responsible parties should provide reimbursement for various types of COVID-19 testing, including for diagnostic, screening, or surveillance purposes;
  3. Provide detailed guidance on appropriate procedures for testing children and education and outreach to retail providers to enable them to offer pediatric testing services more widely; and
  4. Work with independent pharmacies to address supply chain issues and provide greater access to tests so that more independent providers are able to participate in the HHS Community-Based Testing Sites program. 

In April, Senators Warren and Smith led 44 of their colleagues calling on Vice President Mike Pence, Head of the White House Coronavirus Taskforce, and the Federal Emergency Management Agency to conduct a national inventory of the COVID-19 diagnostic testing supply, publicly release data on testing results, and provide a detailed plan and timeline for addressing future shortages and gaps in the testing supply chain. The Trump administration never took these actions.