Newsletter Contents
Latest News Updates
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AdvaMedDx Testifies Before the U.S. International Trade Commission COVID Investigation
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AdvaMed COVID-19 Test Supply Registry Data Shows Continued Increase in COVID-19 Test Shipments
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Dx Regulatory Reform: AdvaMedDx VALID Act “Redlines” Go to the Hill
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HHS LDT Rescission Policy Update: House E&C Democrats Send Letter to HHS Seeking Clarification on LDT Policy Change; FDA Announces it Will No Longer Review COVID-19 LDTs
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AdvaMedDx Board Approves Policy and Advocacy Agenda for 2021
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Regulatory: FDA Releases Significantly Improved Final Blood Glucose Monitoring Guidances
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Coverage: AdvaMedDx Seeking Clarification on CMS Proposed Rule on Medicare Coverage of 'Breakthrough' Technologies
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Payment: CMS Issues CY2021 CLFS Preliminary Payment Determinations
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Coding: AMA Continues to Approve New Codes for COVID-19 Testing
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Antimicrobial Resistance: Senators Bennet, Young Introduce the PASTEUR Act to Stimulate Innovation and Strengthen Antibiotic Stewardship
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Global: AdvaMed and MedTech Europe Advocate for Improved European Union IVDR Implementation
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2020 MedTech Conference is Now Open
1. AdvaMedDx Testifies Before the U.S. International Trade Commission COVID Investigation
Last month, at the direction of the Senate Finance and House Ways and Means Committees, the U.S. International Trade Commission (ITC) launched an investigation focused on COVID-related medical products, including ventilators, personal protective equipment and IVD test kits, formally referred to as Investigation No. 332-580, COVID-19 Related Goods: The U.S. Industry, Market, Trade, and Supply Chain Challenges, that will culminate into a formal report to be submitted to Congress by December 15. Recognized as an independent and influential organization, the association anticipates the report will be as leveraged by policy makers in the Administration and in Congress, many of whom on both sides of the aisle are interested in the potential pursuit of “Buy American” and other “on-shoring” initiatives.
AdvaMed and AdvaMedDx provided formal testimony for a public hearing on September 23 to ensure the ITC understands the complexity of the medical technology industry and the global nature of the supply chains. Susan Van Meter representing AdvaMedDx testified, along with Ralph Ives and Abby Pratt, EVP and VP, respectively of AdvaMed’s Global Strategy and Analysis division. With the guidance of AdvaMedDx Board member companies, AdvaMedDx’s pre- and post-hearing briefs and testimony describes the IVD industry’s nimble and massive ramp-up during the COVID-19 response and highlights information from the AdvaMed COVID-19 Testing Supply Registry along with other key testing supply chain considerations. The complex and intricate nature of the global supply chain that enables the IVD industry’s mobilization to support the nation’s COVID response was emphasized with key examples in the critical areas of swab and transport media, extraction reagent, and platforms/instruments.
Thank you to the many member companies that provided input into the development of the association’s testimony.
Contact: Susan Van Meter
2. AdvaMed COVID-19 Test Supply Registry Data Shows Continued Increase in COVID-19 Test Shipments
Weekly data from the AdvaMed COVID-19 Testing Supply Registry continues to demonstrate the IVD’s industry’s remarkable response during the COVID-19 pandemic. Since the beginning of the pandemic, over 190 million molecular COVID-19 tests have been shipped to laboratories across the country with manufacturers increasing molecular test production from ~600,000 shipments per day at the start of May to over 1.4 Million shipments per day in early October. These shipments facilitate the roughly ~900,000 tests laboratories across the country run each day.
Additionally, high-quality serology testing that is authorized by FDA remains available at scale with industry capacity to manufacture 100 million tests per month. New antigen testing offerings continue to be introduced to the market with overall capacity expanding each week.
The Registry was developed 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 ~90-95% 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. Dx Regulatory Reform: AdvaMedDx VALID Act “Redlines” Go to the Hill
Since the March 5 introduction of the first bipartisan, bicameral, comprehensive diagnostics regulatory reform legislation, the Verifying Accurate Leading-Edge IVCT Development (VALID) Act, AdvaMedDx and regulatory experts from member companies have performed a complete analysis of the bill finalizing detailed policy recommendations that would improve the legislation’s goals of advancing innovation and provide confidence to patients in the performance of all diagnostics, LDTs and IVDs alike. House and Senate bill sponsors are encouraging other stakeholder to provide comments and recommendations as they work to incorporate stakeholder feedback readying the bill for reintroduction in the next Congress, early in 2021.
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, October 27 at 3:00pm ET.
For more information about the bi-weekly calls or AdvaMedDx's VALID activities, please contact Sarah Killeen.
Contact: Sarah Killeen
4. HHS LDT Rescission Policy Update: House E&C Democrats Send Letter to HHS Seeking Clarification on LDT Policy Change; FDA Announces it Will No Longer Review COVID-19 LDTs
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. The most immediate effect of this announcement is that emergency use authorizations (EUAs) are no longer required for COVID-related LDTs. AdvaMed and AdvaMedDx have strongly urged the Administration reverse the rescission of these policies “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.”
On October 9, in light of the HHS announcement, the FDA updated its LDTs policy, through their FAQs page, stating that to prioritize review resources they will not require premarket review of LDTs and will be declining to review EUA requests for LDTs at this time. Importantly, key considerations such as obtaining liability protection from the PREP Act still requires an EUA. This HHS/FDA policy change also does not affect criteria for coverage and reimbursement of COVID-19 tests as many payers will only cover tests that have an EUA.
On the same day, Democrats on House Energy & Commerce Committee sent a letter to Secretary Azar expressing concern about the implications of this LDT regulatory policy change for public health – not only during the pandemic but beyond as well. Further, the letter raises concerns about how the policy will affect test developers, health care providers, and patients. The letter requests answers to a series of questions surrounding the Secretary’s decision to change the LDT policy by October 21, 2020.
Contact: Susan Van Meter
5. AdvaMedDx Board Approves Policy and Advocacy Agenda for 2021
Days ago, the AdvaMedDx Board approve the AdvaMedDx Policy and Advocacy Agenda for 2021. The agenda is specifically developed by the AdvaMedDx membership to direct 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. The 2021 agenda was developed through an iterative process with AdvaMedDx member work group chairs, and full committees, from July through September.
In the areas of Payment & Coverage, AdvaMedDx’s top priorities for 2021 include focusing on the development of payment reform proposals to improve payment rate setting under the Protecting Access to Medicare Act (PAMA) and improving coverage and payment for COVID-19 testing including through robust implementation of a proposed automatic coverage policy for “breakthrough” products released by HHS weeks ago. For Regulatory Affairs, our top priorities next year remain advancing comprehensive diagnostic regulatory reform on the Hill, the implementation of MDUFA IV, and preparations for MDUFA V. Under External Affairs, AdvaMedDx will continue to prioritize educational briefings for Capitol Hill and other stakeholders.
In the weeks leading up to the new year, AdvaMedDx will host a session open to all members to review the association's full 2021 priorities. Please contact Phi Vu to learn more.
Contact: Phi Vu
6. Regulatory: FDA Releases Significantly Improved Final BGM Guidances
At the end of September, the FDA released two final guidance documents outlining expectations for premarket submissions for blood glucose monitoring devices (BGMs), including those intended for point-of care use and for self-monitoring. These final guidances are the culmination of years of AdvaMedDx advocacy to improve upon previous versions of the guidances issued in October 2016. We are pleased to see significant improvements from the 2016 versions, including the removal or revision of provisions that would have significantly increased costs and burden for manufacturing without corresponding benefit to patients and the elimination of a warning statement that would have inappropriately restricted the use of self-monitoring meters in the professional setting. These and other provisions in prior versions of the guidances would have served as a major disincentive to the development of new or modified BGMs, adversely impacting innovation and patient access.
Contact: Jamie Wolszon
7. Coverage: AdvaMedDx Seeking Clarification on CMS Proposed Rule on Medicare Coverage of 'Breakthrough' Technologies
On September 1, 2020, CMS published the long-awaited proposed rule on "Medicare Coverage of Innovative Technology" (MCIT) in the Federal Register. The proposal rule would create a new, voluntary MCIT pathway that would provide immediate, national Medicare coverage of a new FDA-designated and market-authorized breakthrough technology for four years from the date of FDA market-authorization, after which time coverage would be determined through existing processes (national or local coverage determinations, or claim-by-claim adjudication). Of note, the proposed rule does not require additional data development or clinical studies during the four-year coverage period as a condition for coverage. CMS is seeking public comment on this issue and several others in the proposed rule including a proposed definition for the term “reasonable and necessary”.
AdvaMedDx reached out to CMS last month to confirm the applicability of the MCIT pathway to diagnostics and received confirmation that the new pathway would apply to any breakthrough-designated medical device, which by definition includes diagnostic tests. AdvaMedDx, in collaboration with the association’s Payment Policy and Diagnostic Payment Work Groups, is developing our comments due to CMS on November 2. Therein AdvaMedDx will seek additional clarification on the implications of this proposed rule for diagnostic tests.
Contact: Chandra Branham
8. Payment: CMS Issues CY2021 CLFS Preliminary Payment Determinations
On September 22, 2020, CMS posted the Preliminary Payment Determinations for new and substantially revised test codes that will be paid under the CY2021 Clinical Laboratory Fee Schedule (CLFS). Notably, CMS is proposing to gapfill the new COVID-19 codes U0001, U0002, U0003, U0004, 87635, 86769, and 86328 for the CY 2021 CLFS, which is inconsistent with the broad recommendations of stakeholders, including AdvaMedDx, to use a more appropriate crosswalk methodology instead.
The files can be accessed here. AdvaMedDx is collaborating with several stakeholders including ACLA to address this issue with CMS during the 30-day public comment period, which ends October 21, 2020.
Contact: Chandra Branham
9. Coding: AMA Continues to Approve New Codes for COVID-19 Testing
Since the start of the current public health emergency, the American Medical Association (AMA) has continued to approve new CPT codes related to SARS-CoV-2, the virus that causes COVID-19. A summary of the codes that have been approved to date can be found here. These codes include a new code 99072 for the additional supplies and clinical staff time required to mitigate transmission of respiratory infectious disease while providing evaluation, treatment, or procedural services during a public health emergency, as defined by law. While CMS, and some private payers, have established payment rates for some of these new codes, CMS still has not established national pricing for new CPT codes for antigen test codes. AdvaMedDx will continue to monitor and encourage CMS to establish payment rates for antigen tests.
Contact: Chandra Branham
10. Antimicrobial Resistance: Senators Bennet, Young Introduce the PASTEUR Act to Stimulate Innovation and Strengthen Antibiotic Stewardship
On September 30, Senators Bennett (D-CO) and Young (R-IN) introduced the PASTEUR Act – legislation that would establish a subscription-based reimbursement model for novel antibiotics and establish grants to support antibiotic stewardship programs. Earlier this summer, AdvaMedDx, working with members of our Antimicrobial Resistance Work Group, developed and submitted recommendations to Senator Bennet on a draft version of this legislation to ensure that essential role of diagnostic testing and diagnostic expertise in guiding appropriate use of antibiotics were adequately included in the bill. We are pleased to see that several of our key recommendations are reflected throughout the introduced version of the PASTEUR Act.
Some key diagnostic stewardship-related provisions in the bill include a requirement for participating drug sponsors to submit appropriate use of diagnostics plan for their new antibiotic (in partnership with diagnostic experts as needed), a requirement for the HHS Secretary to ensure that clinical guidelines includes the use of appropriate diagnostic approaches, and the establishment of a grant program under the CDC to support hospital and other inpatient facility efforts to judiciously use antimicrobial drugs, such as by establishing or implementing appropriate use programs and using appropriate diagnostic tools, among others.
The press release from the bill sponsors can be viewed here, including bill text and a one-pager.
Contact: Chandra Branham
11. Global: AdvaMed and MedTech Europe Advocate for Improved European Union IVDR Implementation
Recently, AdvaMed and MedTech Europe jointly held a session for members of the AdvaMedDx Board of Directors on the current status of implementation of the European Union in vitro Diagnostic Medical Devices Regulation 2017/746 (EU IVDR). The new regulation, passed in May 2017, is intended to reform regulation for IVDs by establishing a new risk classification system and strengthening clinical requirements for claims. It is estimated that when implemented the IVDR will increase the volume of IVDs that need to be reviewed by over 780%. AdvaMed and MedTech Europe joint advocacy request the EU swiftly address challenges with the implementation timeline given the inchoate infrastructure and guidance in place to adequately implement the new regulation by May 2022, as required by law.
The COVID-19 pandemic, understandably, has impacted the pace of implementation. MedTech Europe, AdvaMed, and other stakeholders are pressing for an updated implementation plan from regulators, and are urging for the establishment of contingency plans which may include postponing the date of implementation. AdvaMed will continue to work with our MedTech Europe partners to advocate that the new regulations are implemented in a manner that is sustainable in the long-term without compromising patient access to critical medical technologies and diagnostic tests.
For additional information, including presentation materials, please contact Joe Gatewood.
Contact: Joe Gatewood
12. The 2020 Virtual MedTech Conference is Open
The all-virtual 2020 MedTech Conference is now live with on-demand content and partnering available until October 23, 2020. The featured live-streamed event from October 5-7 can now be viewed on-demand and with keynote speakers including FDA Commissioner Dr. Stephen Hahn. Conference registration remains open.
This year’s conference features several timely diagnostic-specific programs. Conference attendees will have access to these sessions and scores of others, including, “Diagnostics Industry Mobilization to Meet COVID-19 Testing Needs, Assist Policy Makers with Testing Supply Registry” will feature IVD executives detailing how diagnostic companies mobilized, practically overnight, to help ensure our country would have the tests necessary to combat COVID-19 and include a discussion on the establishment of the AdvaMed COVID Testing Supply Registry to assist government officials in our nation’s COVID response. Another session, titled, “Investing in Diagnostics During COVID-19 and Beyond” session features leading medtech investors reflecting on how the investment landscape for the in vitro diagnostics (IVD) industry is currently being impacted by the COVID-19 pandemic and beyond. Other diagnostic sessions feature leading experts and discussions on diagnostic regulatory reform and reimbursement for novel diagnostics.
To learn more and register, please click here.
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.