Newsletter Contents
Latest News Updates
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AdvaMedDx Launches National COVID-19 Test Supply Registry
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AdvaMed and IVD Industry Representatives Participate in HHS’s New National Testing Implementation Forum
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AdvaMedDx Advocates for Broadened Access to Testing, Other Priorities as Congress Prepares the Next COVID-19 Relief Package
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AdvaMedDx Testing Education Efforts Continue with Briefing for New Democrat Coalition
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AdvaMed’s New MedDeviceNetwork: Connecting MedTech with Competent Suppliers
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Payment: 2021 Physician Fee Schedule Proposed Rule Delays PAMA Reductions
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Payment: CMS Proposes Revisions to the Laboratory Date of Service Policy
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Coding and Payment: CMS Hosts Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
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Antimicrobial Resistance: Diagnostic Testing to be Featured During Next PACCARB Meeting
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Antimicrobial Resistance: House Includes Diagnostic Stewardship Requirements in National Defense Authorization Act
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Regulatory: FDA Issues New Guidance for Non-Laboratory Testing – Including Updates for Home Use, Pooled, Multi-Analyte, and Point-of-Care Testing
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Regulatory: AdvaMedDx Provides Comments on IMDRF IVD Classification Document
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Regulatory: AdvaMedDx Submits Comments to WHO Regarding Use of Reliance in IVD Prequalification Program
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Featured Event: The MedTech Conference to Go Virtual for 2020 – Registration Open
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Upcoming Meetings and Events in 2020
1. AdvaMedDx Launches National COVID-19 Test Supply Registry
On July 21, AdvaMed announced the creation of a comprehensive, national COVID-19 diagnostic supply registry to help state and federal governments in their pandemic responses. The Registry is launched 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 manufacturers represent approximately 95% of the COVID-19 commercial testing market.
The AdvaMed COVID-19 Test Supply Registry provides near real-time aggregated data on COVID-19 molecular, serology, and antigen tests shipped to hospital, public health, and reference laboratories throughout the U.S. These data are analyzed with publicly available information on the number of molecular tests run and the percent of positive results, delivered via weekly reports to federal and state policy makers in furtherance of the IVD industry’s effort to support our nation’s COVID response. Public editions of the weekly Registry reports are available here.
Registry data show that across leading COVID diagnostic manufacturers, roughly 100 million molecular COVID-19 tests have been manufactured and shipped to hospitals, public health, and reference laboratories and other sites since March, including ~75 million commercial tests and ~25 million extraction reagents, a key input into non-commercial laboratory developed tests. Further, manufacturers have increased molecular test production from ~600,000 shipments per day at the start of May to about 1 million shipments per day by July 25th (data based on a four-week rolling average).
AdvaMed and AdvaMedDx welcome additional IVD manufacturers and laboratories to join our Registry efforts.
Contact: Susan Van Meter
2. AdvaMed and IVD Industry Representatives Participate in HHS’s New National Testing Implementation Forum
On July 22, HHS announced the establishment of a National Testing Implementation Forum (“the Forum”) – bringing together key stakeholders in the diagnostics testing ecosystem to address various issues with COVID-19 testing. Specifically, forum members will provide input to address supply chain issues, defining optimum use cases for testing in various settings, increasing public health laboratory capacity, implementing a national surveillance strategy, and identifying barriers to data reporting among many other issues. AdvaMed leadership, along with CEO representatives from the IVD industry, were pleased to join public sector participants from HHS, FDA, CDC, NIH and CMS, along with private sector stakeholders including hospitals, laboratories and others during the Forum’s first meeting on July 30. You can read more about the forum here.
Contact: Susan Van Meter
3. AdvaMedDx Advocates for Broadened Access to Testing, Other Priorities as Congress Prepares the Next COVID-19 Relief Package
In May, the House passed The Health and Economic Recovery Omnibus Emergency Solutions Act or HEROES Act, a $3 trillion stimulus package in response to the COVID-19 pandemic. At the end of July, Senate GOP leaders put forward a set of COVID response bills known collectively as the Health, Economic Assistance, Liability Protection and Schools (HEALS) Act. Negotiations between House and Senate leaders and the White House continue in an effort to find a pathway forward for relief legislation that can clear both chambers and be signed into law. AdvaMedDx has developed and shared with Congressional leadership our industry’s recommendations for inclusion in this developing legislation that would broaden access to COVID-19 diagnostic testing during this public health emergency and strengthen the Strategic National Stockpile. Further, AdvaMedDx joins AdvaMed in advocating for streamlined access to samples to enable test development, leveraging of Emergency Use Authorization (EUA) data to support regulatory approval, and specific improvements to Medicare programs to ensure access to innovative medical technologies during the COVID-19 emergency period, among other recommendations.
AdvaMedDx IVD Priorities
AdvaMedDx is urging Congress consider of a number of policy recommendations to expand COVID-19 molecular, antigen, serology and next generation sequencing (NGS) testing by strengthening coverage and reimbursement for all COVID-19 testing, ensuring appropriate federal funding for testing, and freezing future Medicare cuts to the Clinical Laboratory Fee Schedule.
In furtherance of the association’s advocacy efforts, recently AdvaMedDx joined nearly 50 leading stakeholders representing patients, employers, clinical laboratories, health insurance providers and other leaders from across health care community urging Congressional leadership to dedicate federal funding for the critical testing needed to reopen the country. Expanded access to COVID-19 testing for all individuals, regardless of their coverage status or purpose for receiving the test (i.e. diagnostic, public health, or return-to-office), will require additional dedicated and robust federal funding. The full letter can be accessed here.
In addition, AdvaMedDx recommends improvements to the Strategic National Stockpile by allowing the Federal government to work with industry to maintain critical supplies including diagnostic tests. These recommendations have been included in one of the HEALS Act bills, Senate HELP Chairman Alexander’s Preparing for the Next Pandemic Act. The bill also provides funding to states to create and maintain their own stockpiles of critical supplies.
AdvaMedDx's letter to Congress with our association’s full policy recommendations can be accessed here.
AdvaMed and AdvaMedDx Priorities
In addition to the priorities specified above, AdvaMed and AdvaMedDx are advocating for the inclusion of additional policies in the developing legislative package. These include improvements to the FDA’s EUA process by streamlining access to viral samples to ensure diversification of testing development and capacity, and leveraging of EUA data to ensure that product advancements made during this public health emergency can be utilized to support full marketing status. Additionally, we are pursuing improvements to Medicare’s New Technology Add-On Program (NTAP) and Pass-Through Program to ensure access to innovative medical technologies during the COVID-19 emergency period. AdvaMed’s full recommendations can be accessed here.
Contact: Duane Wright and Sarah Killeen
4. AdvaMedDx Testing Education Efforts Continue with Briefing for New Democrat Coalition
On July 16, AdvaMedDx hosted a webinar briefing and discussion with about 50 members of the House New Democrat Coalition, entitled, “In Vitro Diagnostics (IVD) COVID-19 Testing: Supporting Patient Care and Protecting Public Health.” The briefing was part of our ongoing series of educational sessions for Congress, focused 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. The association and member company expert speakers highlighted 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.
Our sincere thanks to the following member company experts who severed as speakers for the program:
- Charles Cooper, MD, Global VP, Medical and Scientific Affairs, Integrated Diagnostic Solutions and Global Health, BD
- Shamiram Feinglass, MD, MPH, Chief Medical Officer, Beckman Coulter
- David Persing, MD, PhD, Executive Vice President, Chief Medical and Technical Officer, Cepheid
A video recording of the session is available here and final slide presentation here.
Contact: Susan Van Meter
5. AdvaMed’s MedDeviceNetwork: Connecting MedTech with Competent Suppliers
This week, AdvaMed announced the expansion of what began as the VentConnect platform this spring and is now expanded to become the MedDeviceNetwork platform. The expanded and rebranded MedDeviceNetwork platform is moving beyond ventilators, designed to connect medical device and diagnostics companies with component suppliers to help quickly boost production and distribution of vital technologies, addressing supply chain needs.
Diagnostics manufacturers can sign up on the MedDeviceNetwork site and create secure spreadsheets identifying parts and components, such as precision plastics, that are in short supply. Suppliers wishing to assist production complete a brief application on their company’s capacity and materials. Manufacturers can review supplier applications and decide whether to share their supply list needs. The manufacturer and supplier can then separately choose whether to enter an agreement to provide the needed materials.
The original VentConnect platform was launched in May in conjunction with Google, the Aerospace Industries Association (AIA), and other industry alliances and partners. With the expansion, the platform will be managed solely by AdvaMed.
Contact: Susan Van Meter
6. Payment: 2021 Physician Fee Schedule Proposed Rule Delays PAMA Reductions
On August 3, CMS released the Physician Fee Schedule Proposed Rule for CY2021. The proposed rule includes two proposals related to clinical laboratory test payments. First, the rule proposes to conform existing regulations to statutory changes that were made in the year-end omnibus budget bill for 2020 (the "Further Consolidated Appropriations Act, 2020") and the Coronavirus Aid, Relieve and Economic Security (CARES) Act in 2020. Those changes delay the next data reporting period under PAMA until 2022, freeze payments under the Clinical Laboratory Fee Schedule in 2021 at 2020 rates, and delay application of the 15% cap on payment reductions until 2022-2024. Through the proposed rule, CMS also solicits comments on the payment for specimen collection for COVID-19 diagnostic tests after the conclusion of the Public Health Emergency. Comments are due to CMS by October 3. AdvaMedDx will work with member companies to develop comments through our Payment & Policy Work Groups.
Contact: Chandra Branham
7. Payment: CMS Proposes Revisions to the Laboratory Date of Service Policy
On August 4, CMS released the CY 2021 Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule, which includes a new proposal related to the laboratory date of service (DOS) policy. For background, the DOS policy guides when and how certain laboratory tests can be billed when the specimen is collected during the hospital encounter but the test is performed at a later date.
In the rule, CMS proposes to exclude cancer-related protein-based MAAAs (multianalyte assays with algorithmic analyses) from the OPPS packaging policy and create a new exception to the laboratory DOS rule, similar to the existing exceptions for molecular pathology tests and advanced diagnostic laboratory tests (ADLTs). Under this proposal, Medicare would pay for cancer-related protein-based MAAAs under the Clinical Laboratory Fee Schedule (CLFS) instead of the OPPS and the performing laboratory would bill Medicare directly for the test if the test meets all laboratory DOS requirements. CMS notes in the discussion that these tests should be excluded (i.e., not packaged into the payment for the hospital procedure) because the tests have a different pattern of clinical use, which makes them generally less tied to the primary service in the hospital outpatient setting than more common and routine laboratory tests, and are not used to guide the hospital treatment but rather to determine post-hospital care.
AdvaMedDx will work with member companies to develop comments through our Payment & Policy Work Groups.
Contact: Chandra Branham
8. Coding and Payment: CMS Hosts Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
On July 29-30, CMS held a virtual public meeting of its Advisory Panel on Clinical Diagnostic Laboratory Tests (CDLTs). The purpose of this meeting was to provide an opportunity for the Advisory Panel, which was established by the Protecting Access to Medicare Act (PAMA) of 2014, to convene and make recommendations to CMS regarding the payment basis for new laboratory test codes and codes under reconsideration for the 2021 Clinical Laboratory Fee Schedule (CLFS). CMS will issue preliminary determinations later this year regarding how these codes, which were discussed at the annual CLFS Public Meeting on June 22, 2020, will be priced (i.e., crosswalk to an existing code on the CLFS or use a gapfill methodology to determine payment).
A complete list of CY 2021 new and reconsidered codes can be found on the CLFS Annual Laboratory Meeting website here (select “Test Code Updates”). There will be an opportunity to comment on the preliminary payment determinations, and final payment determinations will be issued later this year.
Contact: Chandra Branham
9. Antimicrobial Resistance: Diagnostic Testing to be Featured During Next PACCARB Meeting
The next Presidential Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB) public meeting will take place virtually on September 9-10. AdvaMedDx successfully encouraged the PACCARB to include a discussion on how the COVID-19 pandemic has impacted antimicrobial resistance diagnostic testing be included at the meeting. Dr. Kalvin Yu, Medical Director, BD, and member of the AdvaMedDx Antimicrobial Resistance Work Group has been invited to offer a presentation entitled, “The Role of Diagnostic Stewardship during a Public Health Emergency.” Dr. Yu will focus on the need for appropriate diagnostics given the rates of coinfections and antibiotic use in COVID-19 patients, as well as challenges faced in using diagnostics at a large scale during a public health emergency. For more information on this upcoming meeting, please click here.
Contact: Phi Vu
10. Antimicrobial Resistance: House Includes Diagnostic Stewardship Requirements in National Defense Authorization Act
On July 21, the House passed the FY21 National Defense Authorization Act (NDAA) that included an AdvaMedDx-supported amendment from Rep. Bera (D-CA) directing the Department of Defense (DoD), in collaboration with the Centers for Disease Control and Prevention (CDC), to develop diagnostic stewardship recommendations to strengthen antimicrobial stewardship at military medical treatment facilities. While the Senate-passed version of the NDAA did not include the diagnostic stewardship language, AdvaMedDx is working in close collaboration with the Infectious Diseases Society (IDSA), the American Society for Microbiology (ASM), and members of the Stakeholder Forum on Antibiotic Resistance (S-FAR) to urge House and Senate negotiators working to reach a compromise version of the NDAA to include this diagnostic stewardship provision in the final package to be cleared by both chambers.
Contact: Phi Vu
11. Regulatory: FDA Issues New Guidance for Non-Laboratory Testing – Including Updates for Home Use, Pooled, Multi-Analyte, and Point-of-Care Testing
On July 29, at the urging of AdvaMedDx and our member companies, the FDA published the long-awaited Emergency Use Authorization (EUA) template for the validation of molecular and antigen tests to be used outside of laboratories for the diagnosis of SARS-CoV-2 infection. The template specifies that non-laboratory use includes settings such as home, schools, offices and sporting events. The new template includes performance and safety recommendations, strategies for validation of assays and any associated smartphone apps, and suggestions for shipping and shelf-life evaluations.
Additionally, the FDA updated the molecular diagnostic EUA templates for commercial manufacturers and for laboratories to now include additional information on recommendations for validation of pooling strategies and multi-analyte respiratory panels. The template for manufacturers also includes new recommendations for validation of point-of-care testing.
Contact: Jamie Wolszon
12. Regulatory: AdvaMedDx Provides Comments on IMDRF IVD Classification Document
On July 23, AdvaMedDx submitted comments in response to the International Medical Device Regulators Forum (IMDRF) IVD Working Group public consultation: "Principles of In Vitro Diagnostic (IVD) Medical Devices Classification." The association’s comments indicate our support of the document noting that significant modifications are not needed at this time given how well-accepted the principles of classification embodied in this document are worldwide. Specifically, AdvaMedDx agreed with maintaining the current risk-based classification approach based on the product’s intended use as outlined in the document. AdvaMedDx’s comments can be accessed here.
Contact: Jamie Wolszon
13. Regulatory: AdvaMedDx Submits Comments to WHO Regarding Use of Reliance in IVD Prequalification Program
On July 14, AdvaMedDx submitted comments to the World Health Organization (WHO) responding to the public consultation: "Collaborative Procedure between the WHO and National Regulatory Authorities (NRAs) in the Assessment and Accelerated National Registration of WHO Prequalified IVDs." While AdvaMedDx supports the concept of the proposed collaborative procedure to allow national regulatory authorities to rely on a WHO IVD prequalification assessment instead of insisting on a separate review, several revisions are needed to ensure the proposed program accomplishes its goals. In addition, the document does not contemplate that WHO would rely upon decisions of regulatory decision makers such of FDA and AdvaMedDx urged WHO to also include this aspect of reliance. A full copy of the comments can be found here.
Contact: Jamie Wolszon
14. Featured Event: The MedTech Conference to Go Virtual for 2020 - Registration Open
Registration is now open for AdvaMed's Virtual MedTech Conference that will feature a mix of live and on-demand content available to all registrants, making it easier than ever for medtech professionals, health care providers, regulators, investors and other stakeholders to participate.
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, a number of 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.
Conference sessions will include a range of topics designed to appeal to all aspects of the medical technology ecosystem, including early stage investment; regulatory, reimbursement and legal/compliance issues; offerings on digital health, AI and cybersecurity; and key overseas markets such as Europe, China and Brazil. In addition, educational programs and networking opportunities will offer insights on how medtech companies have faced the COVID-19 challenge, lessons learned and how the industry and the world will look moving forward.
To learn more and register, please click here.
15. All Upcoming Meetings and Events
August 20
AdvaMedDx Monthly Antimicrobial Resistance Work Group Call, 11:00am ET
(to participate please contact Phi Vu)
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)