Newsletter Contents
Latest News Updates
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HHS COVID-19 Diagnostics Design-A-Thon is Underway: AdvaMed Serving Among Judges
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Air Travel Industry Pressing for Expanded Pre-flight COVID-19 Testing, Consults with AdvaMedDx
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Capitol Hill Steering Committee on Pandemic Preparedness: Diagnostic Testing Session, Nov 17; AdvaMedDx to Participate
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House GOP Leaders Cite AdvaMed COVID Registry Data in Testing Guidance Request to NIH
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COVID Testing Recommendations for K-12 Schools: Ongoing Public, Private Efforts
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Global COVID Updates: Sign Up to Receive AdvaMed’s Weekly Global COVID Update
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Transition: Biden-Harris Update COVID-19 Response Plan, Announce Advisors
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Health Disparities: AdvaMed Issues MedTech Industry Principles to Address Racial Health Disparities
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Regulatory: AdvaMedDx, ACLA, Friends of Cancer Research and American Cancer Society Cancer Action Network Co-host Dx Reg Reform Stakeholders Session
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Diagnostic Tests Included in FDA’s “Buy America” Essential Medical Countermeasures List
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Coverage: AdvaMed Submits Comments on CMS Proposed Rule for Medicare Coverage of Innovative Technology
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Payment: Revised CMS Policy on Medical COVID-19 Test Payment Tied to Result Turn Around Time
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Payment: AdvaMedDx Urging CMS to Set Payment Rates for COVID-19 Test Codes Using Crosswalk
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Regulatory Event: Registration is Open for the Annual FDA-Industry IVD Roundtable
1. HHS COVID-19 Diagnostics Design-A-Thon is Underway: AdvaMed Serving Among Judges
Beginning Monday and running through November 30, HHS Office of the Chief Information Officer (OCIO), HHS Office of the Assistant Secretary for Health (OASH), and the U.S. Food and Drug Administration (FDA) is hosting the COVID-19 At-Anywhere Diagnostics Design-a-thon. Teams of diagnostic tool hardware developers, software developers, designers, and engineering experts are submitting their ideas and designs to improve the standardization and reporting of COVID-19 test data. AdvaMed and AdvaMedDx are pleased to be part of this exciting public-private event, including by serving among a pool of judges that have the great opportunity to take-in pitches from innovators striving to improve our collective COVID-19 response.
Be sure to catch the Design-a-thon kick-off tomorrow, Monday, November 16 at 8:30AM with live opening remarks by Dr. Deborah Birx, U.S. Coronavirus Response Coordinator.
All information about the Design-a-thon, including how to register, is available here.
Contact: Susan Van Meter
2. Air Travel Industry Pressing for Expanded Pre-flight COVID-19 Testing, Consults with AdvaMedDx
Recently, AdvaMedDx provided briefings to Airlines for America (A4A), the association representing the American airline industry, to describe the different types of COVID-19 tests available and emphasize how all tests – molecular (of all types), antigen, serology – should be leveraged across both lab and point of care modalities to address the needs of public health. A4A is part of a larger group of airline and hotel industry associations that have formed the Coalition for Safe Alternatives to Quarantine. The new coalition (along with the U.S. Chamber of Commerce) is urging the U.S. Departments of Health, Transportation, and Homeland Security for the development and application of pre-departure COVID-19 testing protocols to reduce the need for quarantines and travel bans in order to safely reopen travel networks and increase consumer confidence in air travel safety.
The Coalition is asking the Administration to work with state governments and international partners to implement evidence-based risk mitigation strategies for air travel that includes comprehensive, cost-effective, pre-departure testing procedures and contact tracing policies that can eliminate the need for broad restrictions and traveler quarantines. Further, the International Civil Aviation Organization’s Council on Aviation Recovery Task Force has developed a series of guidances for air travel during the pandemic. ICAO CART are considering the development of additional guidance specific to diagnostic testing protocols.
A number of airports and individual airlines have already partnered with health companies to offer its passengers COVID tests, either at-home or in-person, and returning those results before boarding. In some cases, passengers with a negative test result can bypass quarantine requirements upon arrival at their destination. AdvaMedDx has heard reports of individual airlines generating policies that inadvertently excluded key types of COVID tests from being used by their passengers to demonstrate a negative result. AdvaMedDx will continue to offer educational sessions with the air travel industry stakeholders to ensure that there is proper understanding of the varying roles of different types of diagnostics tests available and the importance of leveraging all types as part of a comprehensive public health strategy.
Contact: Susan Van Meter
3. Capitol Hill Steering Committee on Pandemic Preparedness: Diagnostic Testing Session, Nov 17; AdvaMedDx to Participate
On November 17 at 11AM ET, the Capitol Hill Steering Committee on Pandemic Preparedness & Health Security is hosting a webinar titled, “Navigating a Pandemic: The Strategic Role and Future Development of Diagnostic Technologies”. Panelists will include Amesh Adalja, MD, Senior Scholar, Johns Hopkins Center for Health Security; Michael Mina, MD, PhD, Assistant Professor of Epidemiology, Harvard T. H. Chan School of Public Health; and Susan Van Meter, Executive Director, AdvaMedDx. The discussion will focus on the important role of diagnostic testing both during the COVID-19 pandemic and in preparation for future pandemics.
The Capitol Hill Steering Committee on Pandemic Preparedness & Health Security, sponsored and managed by Johns Hopkins Center for Health Security, is a recently established educational forum to discuss new topics, technologies, and ideas that can improve domestic health security – convening staff from congressional offices, federal agencies, and the public focused on strengthening US health security. Honorary Co-Chairs include Senators Baldwin (D-WI), Burr (R-NC), Casey (D-PA), and Hyde-Smith (R-MS). The Steering Committee hosts monthly events focused on lessons learned from responses to natural, man-made, and other complex health emergencies, such as the COVID-19 pandemic, and how to better mitigate and respond to future health crises.
AdvaMedDx members are invited to attend Steering Committee educational sessions. To learn more and register, please click here.
Contact: Susan Van Meter
4. House GOP Leaders Cite AdvaMed COVID Registry Data in Testing Guidance Request to NIH
On October 29, in recognition of the significant ongoing work of the National Institutes of Health (NIH) to generate evidence to improve recommendations and guidance on testing protocols in schools, workplaces and other settings, GOP leaders on the House Energy & Commerce Committee sent a letter requesting NIH provide information on these studies and how data from them will used to quickly help inform better utilization of national testing capacity to manage the pandemic and reopen the country. Notably, data from the AdvaMed COVID-19 Test Supply Registry was cited by Representatives Walden (R-OR), Burgess (R-TX), and Guthrie (R-KY) to indicate that the U.S. has rapidly increased testing capacity since the start of the pandemic. Specifically, the letter cites ongoing research supported by the NIH Rapid Acceleration of Diagnostics (RADx) initiative that may be helpful in determining the utility of various types of diagnostic tests and seeks to better understand how findings from those efforts can bolster the national COVID-19 testing activities. Several AdvaMedDx member companies have partnered with RADx to boost national COVID-19 testing capacity.
Contact: Susan Van Meter
5. COVID Testing Recommendations for K-12 Schools; Underserved Communities: Ongoing Public, Private Efforts
To assist K-12 school administrators as they contemplate transitioning from remote learning to in-person or hybrid options – or to expand current in-person offerings for students and families, the Duke Margolis Center for Health Policy partnered with the Rockefeller Foundation and the Johns Hopkins Center for Health Security to develop a white paper, “Risk Assessment and Testing Protocols for Reducing SARS-CoV-2 Transmission in K-12 Schools.” The paper includes a set of complementary, evidence-based recommendations to augment existing CDC guidance on school testing. The white paper “can help schools integrate screening tests with other mitigation measures in an effective strategy to protect against spread of the virus at school and in the wider community.” AdvaMedDx appreciates the opportunities to have engaged with authors of the paper.
The paper notes that the different testing approaches (diagnostic, screening, and surveillance) that leverages lab-based and point-of-care testing serve different purposes and comprehensively outlines various testing approaches and protocols as key considerations to aid school administrators design and customize a testing program for their individual school district based on community priorities, budget, and risk assessment.
To put the recommendations in action, The Rockefeller Foundation in collaboration with the U.S. Department of Health and Human Services, and state and local health departments is deploying ~120,000 Abbott BinaxNOW tests in pilot projects in five areas: Louisville, Los Angeles, New Orleans, Tulsa, and Rhode Island.
Beyond testing in schools, the NIH is actively supporting work to expand COVID-19 testing for underserved and vulnerable populations. This includes establishing multiple clinical research sites across the country to evaluate, in real-time, a variety of testing methods in specific populations, areas, and settings. Similarly, many AdvaMedDx members have entered into partnerships with the NIH, CDC, academic institutions, among others to better understand and alleviate barriers to testing and broaden patient access to testing.
Contact: Susan Van Meter
6. Global COVID Updates: Sign Up to Receive AdvaMed’s Weekly Global COVID Update
Every Friday, AdvaMed’s Global Strategy & Analysis Department provides a round-up report on COVID-19 related activity and policy development in AdvaMed’s priority markets including snapshots of the key statistics and advocacy initiatives. As AdvaMedDx members track COVID-19 related developments around the world, assessing the public health and economic impacts of the pandemic, AdvaMed’s COVID-19 Weekly Global Report is a useful resource. To join the report distribution list, please contact Ralph Ives, Executive Vice President, Global Strategy & Analysis.
Contact: Ralph Ives
7. Transition: Biden-Harris Update COVID-19 Response Plan, Announce Advisors
On November 8, President-elect Biden and Vice President-elect Harris released an updated COVID-19 plan that includes, as a key tenant, the objective of ensuring all American have access to regular, reliable, and free testing. The plan calls for:
- Doubling the number of drive-through testing sites.
- Investing in next-generation testing including at-home and instant tests.
- Establishing a Pandemic Testing Board to guide production and distribution of “tens of millions of tests” – modeled after FDR’s War Production Board.
- Establishing a Public Health Jobs Corps for contact tracing and protection of at-risk populations.
The Biden-Harris team also announced the members of a COVID-19 Advisory Board that includes Dr. Vivek Murthy, former Surgeon General under President Obama, Dr. David Kessler, former FDA commissioner under the George H.W. Bush and Clinton Administrations, and Dr. Marcella Nunez-Smith, Yale University. Further, a group of agency review teams focused on transition matters specific to each federal department, including the Department of Health and Human Services, were also announced. More information on these announcements are available here.
Contact: Susan Van Meter
8. AdvaMed Issues MedTech Industry Principles to Address Racial Health Disparities
AdvaMed, under the leadership of the Board of Directors, earlier this year, launched an effort to identify specific areas where the medtech industry can provide value or unique leadership as we strive collectively to achieve equity in patient care. AdvaMed has released a set of principles to guide the industry in addressing racial health disparities.
“Racial disparities and inequity within the domain of health care and access to care for people of color have persisted for far too long,” the principles read. “AdvaMed is committed to long-term action to reach real solutions. The following principles and considerations are intended as initial steps…as we embrace the long overdue call to address these inequities.”
The principles can be accessed in full here and AdvaMed's statement on the principles can be viewed here. AdvaMed’s Principles revolve around four key considerations: 1) Promoting Inclusion and Equity in Healthcare, 2) Partnering in Education with Stakeholders, 3) All Patients Deserve Access to Innovative Technology, and 4) Promoting Research Equity in the MedTech Industry.
AdvaMedDx members are encouraged to help guide the association’s work to execute on the principles collaborating with health care providers, Congress and the FDA by joining the Responding to Racial Disparities in Health core team. Efforts moving forward will include work to improve diversity in clinical trials, establish medical technology assistance programs, make available accessible educational materials on medical technologies, and use data driven strategies to identify and address inequities in access to medical technology.
Interested members should please reach out to DeChane Dorsey, Vice President, Payment and Health Care Delivery Policy and AdvaMed’s team lead on this important effort.
Contact: DeChane Dorsey
9. Regulatory: AdvaMedDx, ACLA, Friends of Cancer Research and American Cancer Society Cancer Action Network Co-host Dx Reg Reform Stakeholders Session
AdvaMedDx, jointly with the American Clinical Laboratory Association, Friends of Cancer Research, and the American Cancer Society Cancer Action Network, recently co-hosted a session of a broad group of stakeholders who share the goal of comprehensive diagnostics regulatory reform. The stakeholder group, representing industry, labs, providers, and patients, highlighted their top priority areas for improvements to the VALID Act that each have communicated to the bill’s sponsors. The bipartisan, bicameral sponsors of the VALID Act are working this fall to improve the bill in advance of reintroduce early in 2021.
Last month, AdvaMedDx provided detailed policy recommendations to the VALID Act sponsors to improve the legislation’s goals of advancing innovation and providing confidence to patients and providers in the performance of all diagnostic tests. The association’s top priority is striving to ensure the diagnostic-specific regulatory framework proposed by the VALID Act would be a truly modernized and fully risk-based regulatory apparatus designed to embrace innovation for the good of patient care and public health.
As a reminder, AdvaMedDx members are encouraged to join our bi-weekly diagnostics regulatory reform strategy calls as we work collectively to improve and advance the legislation. The next call is scheduled for Tuesday, November 24 at 3:00PM ET.
For more information about the bi-weekly calls or AdvaMedDx's VALID activities, please contact Sarah Killeen.
Contact: Susan Van Meter
10. Diagnostic Tests Included in FDA’s “Buy America” Essential Medical Countermeasures List
As part of the “Buy America” Executive Order 13944 issued on August 6, the FDA recently published information on the implementation of the Executive Order which includes the issuance of a list of essential medicines, medical countermeasures, and critical inputs that are medically necessary to have available at all times in adequate quantities to support future national responses to infectious disease outbreaks, such as COVID-19, as well as chemical, biological, radiological and nuclear threats. The executive order also seeks to ensure sufficient and reliable, long-term domestic production of these products, and to minimize potential shortages by reducing our dependence on foreign manufacturers of these products. On October 30, as directed by the Executive Order, the FDA published a list that comprises 223 essential drug and biological products and 96 essential medical devices which includes diagnostic test kits, reagents, and supplies to support rapid test development and processing.
Inclusion on the list triggers several “Buy America” provisions including, among others, a requirement for federal agencies to limit the procurement of products on the list to those manufactured domestically. There are notable exceptions for that requirement that are tied to increased cost, possibility of shortages, and public health that could have an impact on how the order is implemented. Further, domestic manufacturers of products on the list may also have access to an accelerated FDA regulatory approval process for new products.
The FDA has opened a docket for interested stakeholders to provide comments on the list. AdvaMed and AdvaMedDx, working with member companies’ experts through the association’s Regulatory and Global Work Groups, are carefully reviewing the list and working to generate formal feedback to the FDA.
Contact: Zach Rothstein
11. Coverage: AdvaMed Submits Comments on CMS Proposed Rule for Medicare Coverage of Innovative Technology
On November 2, AdvaMed submitted formal comments on CMS’ proposed rule on "Medicare Coverage of Innovative Technology" (MCIT) and Definition of “Reasonable and Necessary”. AdvaMed and AdvaMedDx commends CMS’ efforts to streamline Medicare coverage of innovative medical devices and diagnostics that improve health outcomes for patients with debilitating or life-threatening illnesses, and we commend CMS for taking this important step.
In our letter to CMS, AdvaMed expresses our strong support for the MCIT pathway proposal for FDA-designated breakthrough technologies and urges CMS to finalize the MCIT portion of the proposed rule as quickly as possible. We specifically requested that CMS make clear in the final rule that the MCIT pathway applies to diagnostic tests. The MCIT provisions are critical for Medicare beneficiary access to breakthrough devices and diagnostics.
Additionally, automatic coverage through the MCIT pathway applies to FDA-cleared or approved breakthrough devices and diagnostics “within a Medicare benefit category”. In order to avoid unnecessary access delays to innovative breakthrough devices including diagnostic and screening tests, AdvaMed recommends CMS apply its discretion to determine the appropriate benefit category to cover certain breakthrough technologies, such as diagnostic testing, cancer screening or devices used in asymptomatic and/or at-risk and high-risk populations, given breakthrough technologies likely will not have NCCN, USPSTF or other relevant coverage guidelines at the time of FDA market authorization that support a benefit category.
In regard to CMS’s efforts to clarify its definition of “reasonable and necessary” for Medicare beneficiaries, AdvaMed opposes codification of the proposed definition at this time. We recommend that should CMS wish to proceed, it should initiate a more extensive dialogue using an open and transparent process that includes multiple opportunities for stakeholder input and consideration.
Contact: Chandra Branham
12. Payment: CMS Policy on Medical COVID-19 Test Payment and Result Turn Around Time
On January 1, 2021, CMS will implement a new policy that ties reimbursement for molecular COIVD tests run on high-throughput platform to turnaround time of results. This policy is a revision to their April 14, 2020 Administrative Ruling that authorized payment of $100 for COVID-19 diagnostic tests performed utilizing high-throughput technologies. Under this revised Administrative Ruling, payment for those tests will be reduced to $75, with an additional Medicare payment of $25 (total of $100) to laboratories that complete testing in two calendar days of the specimen being collected. AdvaMedDx continues to confer with our laboratory stakeholder partners to assess potential implementation issues, including review of the appropriateness of the two-day window given potential transport challenges as cases rise around the country.
The revised Administrative Ruling can be found here.
Contact: Chandra Branham
13. Payment: AdvaMedDx Urging CMS to Set Payment Rates for COVID-19 Test Codes Using Crosswalk
AdvaMedDx recently joined a stakeholder consensus letter to CMS to formally submit our recommendations on the COVID-19 on the CY2021 Clinical Laboratory Fee Schedule (CLFS) Preliminary Determinations for COVID-19 codes. Specifically, we urge CMS to assign rates for these codes using the crosswalk method rather than gapfill and offer specific crosswalk recommendations that we believe best reflect the resources required to develop and furnish these tests. Final CMS payment determinations have not been released, but we expect them later this month.
Contact: Chandra Branham
14. Regulatory Event: Registration is Open for the Annual FDA-Industry IVD Roundtable
Registration now open for the FDA-Industry IVD Roundtable meeting scheduled for Thursday, November 19 at 10AM ET. The meeting will be held virtually and will feature interactive discussion sessions on a variety of topics with leadership and staff from the FDA CDRH Office of In Vitro Diagnostics and Radiological Health (OIR) (now known as OHT7). Registration is free and is available until capacity is reached. A final agenda will be available in the coming days. Please click here to register.
Call for Questions for Q&A Session
As in previous years, there will be a formal Q&A session with FDA management as part of the Roundtable event. Please submit any questions of interest (e.g., policies, priorities, guidance, regulatory questions) to Jamie Wolszon. Questions received will be shared with FDA in an aggregate, de-identified manner in advance of the meeting.
Contact: Jamie Wolszon
Want to get more involved? Please contact our key workgroups leads to ensure you are engaged and up-to-speed on AdvaMedDx's work and activities.