Newsletter Contents
Latest News Updates
- Diagnostic Testing Provisions in the Coronavirus Response and Relief Supplemental Appropriations Act of 2021
- U.S. International Trade Commission Submits Report to Congress on Production of COVID-19 Related Goods
- AdvaMed COVID-19 Test Supply Registry: Molecular Test Shipments Reach ~300 Million
- AdvaMedDx 2021 Policy and Advocacy Priorities
- FDA CDRH 2021 Priorities: AdvaMedDx Submits Comments on FDA CDRH’s Fiscal Year 2021 Proposed Guidance Development
- Get Involved with AdvaMedDx’s Policy Work in 2021
1. Diagnostic Testing Provisions in the Coronavirus Response and Relief Supplemental Appropriations Act of 2021
The Coronavirus Response and Relief Supplemental Appropriations Act, 2021, now signed into law, combines $900 billion in coronavirus relief and $1.4 trillion in annual government funding. The Act includes AdvaMedDx-supported policies including and provisions allocating significant funding for diagnostic testing and supporting health care providers.
Of interest to AdvaMedDx members, the bill provides $73 billion to the Department of Health and Human Services (HHS) for a broad set of public health priorities that include research, development, manufacturing, procurement, and distribution of vaccines and therapeutics; diagnostic testing and contact tracing; mental health and substance abuse prevention and treatment services; childcare support; and other activities related to coronavirus.
More specifically, of the funds provided to HHS, $22.4 billion is set aside for state, localities, territories, and tribes for testing, contact tracing, and other activities necessary to effectively monitor and suppress COVID-19. This funding can be used for expenses for COVID-19 testing including tests for both active infection and prior exposure, including molecular, antigen, and serological tests, the manufacturing, procurement, and distribution of tests, as well as the development and validation of rapid, molecular point-of-care tests, and other tests. Further, funding provided to states and other governments can be used to scale-up testing to support employers, schools, childcare facilities, and long-term care facilities.
Importantly, $2.5 billion is targeted to improve testing capabilities and contact tracing in high-risk and underserved populations, including racial and ethnic minority populations and rural communities.
The National Institutes of Health will be allocated $1.25 billion to support research and clinical trials related to the long-term effects of COVID-19, as well as continued support for Rapid Acceleration of Diagnostics for COVID-19 (RADx).
HHS’s Assistant Secretary for Preparedness and Response will receive a total of $22.945 billion to respond to coronavirus, including $19.695 billion for the Biomedical Advanced Research and Development Authority (BARDA) for manufacturing and procurement of vaccines and therapeutics, as well as ancillary supplies necessary for the administration of vaccines and therapeutics; and $3.25 billion for the Strategic National Stockpile, whereby “. . . may be used for the construction, alteration, or renovation of non-federally owned facilities for the production of vaccines, therapeutics, diagnostics, and ancillary medical supplies where the Secretary determines that such a contract is necessary to secure sufficient amounts of such supplies.”
Additionally, the new law includes funds to support hospitals and health care providers cover healthcare related expenses related to the pandemic, while also providing relief from several scheduled reductions to Medicare and Medicaid payments to hospitals, among other provisions. Full text of the Coronavirus Response and Relief Supplemental Appropriations Act, 2021 can be accessed here. (testing related provisions begin on page 1836.)
Contact: Susan Van Meter and Sarah Killeen
2. U.S. International Trade Commission Submits Report on Production of COVID-19 Related Goods – Includes Diagnostic Tests
Last week, at the request of the House Ways and Means and Senate Finance Committees, the United States International Trade Commission (USITC) submitted to Congress a report on U.S. industries producing COVID-19 related goods, including diagnostic test kits and components, and any supply-chain challenges and constraints that restricted the availability of such goods, particularly early in the pandemic. The report also reflects on factors affecting domestic production, complexities of global supply chains, imports of finished goods and key inputs.
In the section on COVID-19 testing, the report acknowledges the IVD industry ramp-up to meet an unprecedented demand. Individual IVD company examples are used to illustrate the mobilization as are numerous references to AdvaMedDx’s testimony. Association testimony, leveraging figures from the AdvaMed COVID-19 Test Supply Registry, described the IVD industry’s robust and ongoing response to the pandemic, while outlining the complex and intricate nature of the highly=specialized IVD global supply chain.
The report points to several areas where some constraints in global IVD supply chains have surfaced, including precision plastics, extraction reagent, sample collection materials, and transport media – noting the global supply chains for each component.
Notably, the report does not offer specific recommendations to address the challenges described in report. On IVDs, the report offers the following findings:
- Demand remains high for test kits and related supplies and, “certain materials and laboratory supplies are not interchangeable across manufacturers.”
- Once authorized, tests were quickly brought to market by industry. Production of test kits and sample collection and transport devices increased substantially.
- Challenges impacting domestic production include, “the time required to design the tests, shortages of key inputs, the time needed to bring new machinery online, and difficulties in recruiting new workers.”
- “The rise in global demand exceeded the global supply of key goods used in diagnostic testing, some of which were only produced by a handful of firms before the pandemic. Further, many supplies can be used only on certain types or brands of laboratory equipment. A decline in air freight capacity also made it harder and more expensive to import products.”
Policy makers on Capitol Hill may consider the report in future deliberations on “Buy American” and other “on-shoring” proposals.
Contact: Susan Van Meter
3. AdvaMed COVID-19 Test Supply Registry: Molecular Test Shipments Reach ~300 Million
To date, Registry participants companies have collectively shipped ~300 million molecular tests nationwide with ~1.8 million tests shipped per day, on average for the week ending on December 19th. During that same period, states have reported ~230M tests run.
The milestone of ~300 million molecular tests shipped is the achievement of the 14 Registry participants companies that came together to build the Registry, providing near-real time data on test supplies to HHS leaders and states. The companies are Abbott, BD, bioMérieux, Bio-Rad, Beckman Coulter, Cepheid, Fujirebio, Hologic, Ortho Clinical Diagnostics, QIAGEN, Roche Diagnostics, Sekisui Diagnostics, Siemens Healthineers, and Thermo Fisher Scientific. Registry participants produce ~80-85% of the COVID-19 Molecular IVD tests on the market in the U.S. The Registry also reports serology test shipments and will soon report antigen test shipments as well.
Contact: Susan Van Meter
4. AdvaMedDx 2021 Policy and Advocacy Agenda
The AdvaMedDx Policy and Advocacy Agenda, developed with the collaboration and guidance of the AdvaMedDx membership directs the association’s work on top priorities of IVD manufacturers in the areas of Payment and Coverage, Regulatory Affairs (FDA matters), External Affairs and Global Advocacy. Policies related to COVID-19 are included among a broad range of policy and advocacy priorities for the New Year.
For 2021, AdvaMedDx’s top Tier I regulatory priority is pursuit of diagnostics regulatory reform legislation, the need for which is underscored by the current pandemic. The goal of reform is the establishment of a single, predictable regulatory framework for all in vitro clinical tests, including laboratory developed tests (LDTs), that would foster innovation in diagnostics development to advance patient and clinician access to quality diagnostics. Additionally, AdvaMed and AdvaMedDx will prioritize the launch of Medical Device User Fee Agreement (MDUFA) V negotiations expected start at the beginning of 2021.
In setting the AdvaMedDx Coverage and Payment Priorities for 2021, the association notes the Families First Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic Security Act (CARES) delayed the Protecting Access to Medicare Act (PAMA) data reporting period, froze CLFS rates for 2021 at 2020 rates and pushed back additional cuts to 2022-2024 (capped at 15%). AdvaMedDx intends to take advantage of this period of delay to focus on development of payment reforms under PAMA, including improving rate-setting methodologies for new tests, in collaboration with our laboratory partners.
For a summary of all AdvaMedDx’s 2021 policy priorities, please click here.
Contact: Susan Van Meter
5. FDA CDRH 2021 Priorities: AdvaMed Submits Comments on FDA CDRH’s Fiscal Year 2021 Proposed Guidance Development
AdvaMed submitted comments to FDA’s Center for Devices and Radiological Health (CDRH) in response to CDRH's priority list of 2021 guidances planned for review or issuance. AdvaMed identified as priorities for Agency action a number of diagnostic-related policy guidances, including seeking finalization of guidance for Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic (IVD) Devices to support innovation of modern instrumentation; and an update to the Antimicrobial Susceptibility Test (“AST”) Systems - Frequently Asked Questions document that reflects recent changes to 510(k) requirements for ASTs and FDA’s current thinking regarding ASTs. AdvaMed’s full comment can be accessed here.
Contact: Anita Nosratieh
6. Get Involved with AdvaMedDx’s Policy Work
AdvaMedDx members drive our association’s policy and advocacy work, in large part through engagement in our work groups. These various work groups serve as forums for member company representatives to stay current on key issues and to guide test association’s efforts. Below is a list of a handful of our many active policy work groups along with the name and contact information for each work group lead. If you are not yet a group member, please contact the individuals below to participate and ensure you are up-to-speed on AdvaMedDx's work and activities in 2021.