Newsletter Contents
Latest News Updates
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AdvaMed and AdvaMedDx Respond to HHS Rescission of Policies on Laboratory Developed Tests
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AdvaMed COVID-19 Test Supply Registry Data Shows Steady Increase in COVID-19 Test Shipments
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AdvaMedDx Webinar: COVID-19 Testing Overview for House Energy and Commerce Committee Staff (September 4, 1pm ET)
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CMS Issues Proposed Rule on Medicare Coverage of Innovative Technology – Provides Immediate, National, 4-Year Coverage for Breakthrough Devices
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AdvaMedDx Policy and Advocacy Agenda Development for FY 2021: Join the Discussions
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AdvaMed Undertakes Initiative to Respond to Racial Disparities in Health
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Registration is Open for AdvaMed’s 2020 MedTech Conference Featuring Timely Diagnostics Programming
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Upcoming Meetings and Events in 2020
1. AdvaMed and AdvaMedDx Respond to HHS Rescission of Policies on Laboratory Developed Tests
On August 19, the U.S. Department of Health and Human Services announced the cancellation of FDA guidances requiring Emergency Use Authorization (EUA) for laboratory developed tests (LDTs) during the COVID-19 pandemic and additional LDT oversight policies beyond the current public health emergency. In response, AdvaMed issued a statement urging the Administration “to ensure all diagnostic test developers, of both IVDs and LDTs, are subject to the same standard of test validation during the pandemic and beyond to protect patients and public health.” We also state our commitment to working with laboratories, providers and patient organizations and bipartisan cosponsors of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act in both chambers of Congress – pressing the need for a modernized, risk-based, scientifically rigorous, and efficient regulation framework for all diagnostic tests to ensure quality and patient safety.
A copy of the HHS “Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests,” is available here.
Contact: Susan Van Meter
2. AdvaMed COVID-19 Test Supply Registry Data Shows Continued Increase in Test Shipments
The AdvaMed COVID-19 Testing Supply Registry real-time data demonstrate that since the beginning of the pandemic, nearly 140 million molecular COVID-19 tests have been shipped since March to laboratories across the country. Manufacturers have increased molecular test production from just shy of 1 million shipments per day at the start of July to over 1.3 Million shipments per day through August 22. These shipments facilitate the roughly 770M of tests laboratories across the country run each day. High-quality serology testing, authorized by FDA, remains available at scale with industry capacity to manufacture 100 million tests per month. Additional antigen testing offerings continue to be introduced to the market with overall capacity expanding each week.
The Registry was developed in partnership with 13 commercial diagnostics manufacturers: Abbott, BD, bioMérieux, Bio-Rad, Beckman Coulter, Cepheid, Hologic, Ortho Clinical Diagnostics, QIAGEN, Roche Diagnostics, Sekisui Diagnostics, Siemens Healthineers, and Thermo Fisher Scientific. These companies represent ~95% of COVID-19 tests shipped in the U.S.
Learn more about the Registry and view public, weekly Registry reports here.
Contact: Susan Van Meter
3. AdvaMedDx Webinar: COVID-19 Testing Overview for House Energy and Commerce Committee (September 4, 1pm ET)
As part of an ongoing series of educational webinars for members of Congress and key congressional Committee staff, on Friday, September 4, AdvaMedDx will host a webinar briefing and discussion with House Energy and Commerce Committee Democratic staff and personal office staff, entitled “In Vitro Diagnostics (IVD) COVID-19 Testing: Supporting Patient Care and Protecting Public Health.” The webinar will focus on the importance of broadly leveraging all molecular, antigen, serology, and NGS COVID-19 testing to support patient care and protect public health as essential to getting us through the pandemic. We will highlight the IVD industry’s massive mobilization and continued commitment to innovate and manufacture quality COVID-19 testing at scale in support of patient care and protecting public health, including through the AdvaMed COVID Testing Supply Registry report made available to government officials to support our nation’s COVID response.
Panelists for the program:
- Maurice Exner, Ph.D., Vice President, Research and Development and Clinical Affairs, Hologic
- Steven Henn, Vice President of Commercial Operations, US Infectious Disease, Abbott
- Chockalingam “Palani” Palaniappan, Ph.D., Chief Innovation Officer, Ortho Clinical Diagnostics
- Susan Van Meter, Executive Director, AdvaMedDx
- Sarah Killeen, VP Government Affairs, AdvaMed
Contact: Susan Van Meter
4. CMS Issues Proposed Rule on Medicare Coverage of Innovative Technology – Provides Immediate, National, 4-Year Coverage for Breakthrough Devices
On August 31, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited proposed rule on "Medicare Coverage of Innovative Technologies." The proposed rule, which is the result of many years of hard work and advocacy on the part of AdvaMed and its member companies, would make significant changes to streamline Medicare coverage for FDA-designated breakthrough technologies that have market authorization. Some key provisions in the proposed rule include:
Automatic Coverage for Breakthrough Technologies
The proposed rule would create a new, voluntary Medicare Coverage of Innovative Technologies (MCIT) pathway that would provide immediate, national Medicare coverage of any FDA-market authorized breakthrough device if the device meets certain criteria. This automatic coverage would begin on the date of FDA-market authorization and would last for four years, after which time coverage would be determined through existing processes (national or local coverage determinations, or claim-by-claim adjudication).
Application to Devices and Diagnostics
CMS states in the preamble that MCIT coverage would be limited to devices only, and exclude diagnostics, biologics and drugs. However, elsewhere in the proposed rule, CMS states that automatic coverage under the MCIT pathway would apply to breakthrough technologies, which are defined as providing for “more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions,” and for which “no approved or cleared alternatives exist or which offers significant advantages over existing approved or cleared alternatives.” Additionally, CMS specifically call out breakthrough diagnostic tests in their press release and factsheet. CMS is seeking comments on whether the MCIT pathway should apply to diagnostics and AdvaMed will urge CMS to clarify that diagnostic breakthrough products are eligible for MCIT.
Coverage with Evidence Development
The proposed rule does not require additional data development or clinical studies during the four-year coverage period. However, CMS is soliciting comment on whether it should require manufacturers to provide data about outcomes or to enter into clinical studies, similar to CMS’s Coverage with Evidence Development (CED) paradigm. The proposed rule would not impact FDA-required post-market data collection, and manufacturers would be encouraged to develop clinical evidence that may be needed for one of the other coverage pathways after the MCIT pathway ends, or evidence to better inform the clinical community about the new technology.
AdvaMedDx is closely examining the proposed rule and its implications for diagnostics.
More information on the proposed rule: CMS press release, factsheet, full text
See AdvaMed’s statement commending CMS’ issuance of the proposed rule here. For additional information or questions, please contact Chandra Branham.
Contact: Chandra Branham
5. AdvaMedDx Policy and Advocacy Agenda Development for FY 2021: Join the Discussions
AdvaMedDx and member companies are well into the process of establishing the association's policy and advocacy agenda for FY 2021. All AdvaMedDx members are encouraged to participate in ongoing work group sessions focused on agenda development in the key areas of: payment & coverage, regulatory, external affairs and antimicrobial resistance. (Note: AdvaMedDx and AdvaMed global priorities are set on a June-to-June basis.) The work groups' recommendations will be presented to the AdvaMedDx Board of Directors for consideration during the board’s next meeting on October 1.
For more information on this ongoing work and to join upcoming sessions focused on agenda development, please reach out to the AdvaMedDx and AdvaMed staff leading this effort:
- Payment and Coverage Priorities: Member companies participating in the Diagnostics Payment Work Group (DPWG) are leading this effort. Please contact Chandra Branham for more information.
- Regulatory Priorities: For these FDA related regulatory issues, member company discussions take place within the Dx Task Force. Please contact Jamie Wolszon for more information.
- External Affairs: Government and public affairs priorities are under development in collaboration with Dx Washington Representatives group. Please contact Sarah Killeen for more information.
- Antimicrobial Resistance: Member companies participating in the Antimicrobial Resistance Work Group (ARWG) are setting forward priorities for 2021. Please contact Phi Vu for more information.
Contact: Phi Vu
6. AdvaMed Undertakes Initiative to Respond to Racial Disparities in Health
AdvaMed leadership and the AdvaMed Board of Directors have recently established a group, comprised of Executive Committee and AdvaMed and member company staff, to actively engage in efforts to address the adverse impacts of racial disparities in health care. Our industry has an important role to play in this effort as developers of technologies and tests that result in the accurate diagnosis of disease and in improved patient outcomes. Over the next several months, the initiative will focus on the development and execution of a workplan that will include engaging public and private sector stakeholders, including health care providers, to address these inequities.
If you are interested in joining the Core Team of the Responding to Racial Disparities in Health initiative or wish to learn more about this important work, please contact DeChane Dorsey.
Contact: DeChane Dorsey
7. Registration is Open for AdvaMed’s 2020 MedTech Conference Featuring Timely Diagnostics Programming
Registration is now open for AdvaMed’s Virtual MedTech Conference. The Virtual MedTech Conference will bring together the world's top medtech executives and innovators to network, conduct business, gain access to capital and share insights in an engaging digital environment. Despite the challenges we are all facing right now – and perhaps because of them – it is important for our community to come together. It is also important that we gather safely and responsibly. That is why AdvaMed has made the decision to hold an all-virtual conference this year.
Beginning in early September, registrants will have access to on-demand sessions via a virtual conference platform, with new sessions released every week through October 7. In addition, several simulcast sessions will be available for viewing from October 5-7, with sessions available on-demand through late October. The conference’s MedTech Connect partnering platform will be open in August so participants can view other users and begin requesting networking meetings.
We are committed to offering the same invaluable content and opportunities as always and continue to be a uniting force for our industry. The conference will include an online Exhibitor Marketplace. Featuring over 100 companies and specialized pavilions, the Exhibitor Marketplace will be a convenient place to explore new partnerships and conduct business in a virtual setting.
This year’s conference will feature a series of timely diagnostic-specific programming, including the following sessions:
Diagnostics Industry Mobilization to Meet COVID-19 Testing Needs, Assist Policy Makers with Testing Supply Registry
From early in the pandemic, the diagnostic companies mobilized, practically overnight, to help ensure our country would have the tests necessary to combat COVID-19. Like never before, we are seeing each day how testing serves as a front-line tool in the fight against disease. The AdvaMed COVID Testing Supply Registry, created to assist government officials in our nation’s COVID response, will be a highlight of the discussion.
- Moderator: Vincent A. Forlenza, Executive Chairman of the Board, BD
- Christopher Riley, Danaher Vice President & Group Executive, DH Diagnostics LLC
- Matt Sause, President and CEO, Roche Diagnostics Corporation North America
- Kevin Thornal, President, Diagnostic Solutions, Hologic, Inc.
- Andrea F. Wainer, Executive Vice President, Rapid and Molecular Diagnostics, Abbott
Investing in Diagnostics During COVID-19 and Beyond
Leading medtech investors will reflect on how the investment landscape for the in vitro diagnostics (IVD) industry is currently being impacted by the COVID-19 pandemic and beyond.
- Moderator: Brian Miller, Managing Partner & Co-Founder, Linden Capital Partners
- Tycho Peterson, Managing Director, Global Equities, JP Morgan
- Mark Stevenson, Chief Operating Officer, Thermo Fisher Scientific
- Bob Lavoie, Managing Director and Senior Partner, Boston Consulting Group
- Ben Daverman, Managing Director, GTCR
Is IVD Reform Coming Soon? What it Means for You
The rapidly changing diagnostics market creates a challenge for regulatory oversight to keep pace. COVID-19 has highlighted the critical role that diagnostics play in public health. As the need for diagnostics reform and harmonization of clinical laboratory tests is intensely debated among various stakeholders that represent manufacturers, practitioners, patients and regulators, industry leaders and those entering the market continue to monitor the developments in this space. Panelists will discuss potential legislative and regulatory reforms to IVD regulation, and its impact for large and start-up IVD manufacturers.
- Moderator: Nathan Brown, Partner, Akin Gump Strauss Hauer & Feld LLP
- Pamela Bradley, Director, Policy & Advocacy, Adaptive Biotechnologies
- Elizabeth Hillebrenner, CDRH Chief of Staff, FDA
- Lesley Maloney, Head of US Regulatory Policy and Global Policy Lead, Digital Health, Roche
Navigating the Complexities of Getting from Clearance to Reimbursement for Novel Diagnostics
Novel diagnostics are conceived to improve patient care and clinical outcomes. Nevertheless, many of them do not rapidly reach their potential due to reimbursement challenges. These challenges can be due to numerous factors due to misalignment of incentives, coding issues, competition and limited evidence available at the time of diagnostic test clearance. This session explores ways novel diagnostic test developers and providers can assess whether reimbursement challenges will exist and clinical, commercial and policy approaches address these challenges.
- Moderator: Bruce Quinn, MD, PhD, MBA – Principal, Bruce Quinn Associates
- Stefan Walzer, CEO, President & Founder, MArS Market Access & Pricing Strategy GmbH
- Melina Cimler, PhD, CEO & Founder, PandiaDx LLC
- Ben Eckert, Vice President, Market Access, Adaptive Biotechnologies
- Paul Gerrard, MD, Vice President, McDermott+Consulting
To learn more and register, please click here.
Contact: Phi Vu
8. All Upcoming Meetings and Events
September 10
Diagnostics Task Force Meeting, AdvaMed Office, and via teleconference
9:00am-3:00pm ET (to participate please contact Jamie Wolszon)
September 16
Payment Policy Work Group Meeting, AdvaMed Office and via teleconference
(to participate please contact Chandra Branham)
September 17
Diagnostics Payment Work Group Meeting, AdvaMed Office and via teleconference
(to participate please contact Chandra Branham)
September 18
AdvaMedDx Quarterly Global Issues Update Conference Call, 11:00am ET
(to participate please contact AdvaMedDx)
September 24
AdvaMedDx Monthly Antimicrobial Resistance Work Group Call, 11:00am ET
(to participate please contact Phi Vu)
October 1
AdvaMedDx Board Meeting
October 5-7
The Virtual MedTech Confefence (information and registration)
October 22
AdvaMedDx Monthly Antimicrobial Resistance Work Group Call, 11:00am ET
(to participate please contact Phi Vu)
November 11
Diagnostics Payment Work Group Meeting, San Diego, CA
(to participate please contact Chandra Branham)
November 12
AdvaMedDx Monthly Antimicrobial Resistance Work Group Call, 11:00am ET
(to participate please contact Phi Vu)
November 18
Payment Policy Work Group Meeting, AdvaMed Office
(to participate please contact Chandra Branham)
December 2
AdvaMedDx Quarterly Global Issues Update Conference Call, 11:00am ET
(to participate please contact AdvaMedDx)
December 8
AdvaMedDx Board Meeting, Washington, DC
December 13-17
AACC Annual meeting and Expo, Chicago, IL, AdvaMed’s Dx Leaders Unplugged event date TBA
December 17
AdvaMedDx Monthly Antimicrobial Resistance Work Group Call, 11:00am ET
(to participate please contact Phi Vu)