Newsletter Contents
Latest News Updates
- AdvaMedDx Proposal to Extend the Reach of COVID-19 Testing in Support of Patient and Public Health
- COVID Regulatory: FDA Update on Pooled Screening Claims for Use in Serial Testing Programs
- COVID Regulatory: AdvaMedDx Comments on FDA Guidance on COVID Variants
- COVID: AdvaMed COVID Supply Registry – Molecular Shipments reach ~433 Million
- Coverage: Updates on Medicare Coverage of Innovative Technology (MCIT)
- PAMA: MedPAC Discusses Potential Revisions to Data Reporting for CLFS
- Dx Regulatory Reform: AdvaMedDx-ACLA to Cohost Stakeholder Session with VALID Act Sponsors, May 10
- Antimicrobial Resistance: CDC Analysis of Inpatient Antibiotic Prescribing Practices & AdvaMedDx Diagnostics Stewardship Recommendations
- Antimicrobial Resistance: New CDC Global Detection and Response Funding Opportunity
- Global Regulatory: WHO Prequalification White Paper Under Development
- Global: AdvaMedDx and World Health Organization Briefing on Influenza Pandemic Preparedness and Response
- Events: May 6: AdvaMed’s Digital MedTech Conference
- Events: August 24-26: CHI’s 13th Annual Next Generation Dx Summit
- Events: Upcoming AdvaMedDx Member Events
Extending the Reach of COVID-19 Testing in Support of Patient and Public Health
In our nation’s continued response to COVID-19, testing remains a critical tool for diagnosis and screening. AdvaMedDx recently provided policy proposals to the Administration recommending strategic mechanisms to extend the reach of quality COVID-19 testing to support patient and public health. These proposals recognize the Administration’s existing K-12 testing plans and other identified priority groups.
The association offered practical public-private mechanisms to leverage the robust laboratory-based and point-of-care testing supply and manufacturing capacity to protect priority groups, particularly in vulnerable settings and underserved communities. Further, the proposals suggest intensified collection and study of serology and T-cell data to accelerate understanding of protective immunity, vaccine efficacy, and the risks of breakthrough infection.
AdvaMedDx members can access these proposals here.
Contact: Susan Van Meter
COVID Regulatory: FDA Update on Pooled Screening Claims for Use in Serial Testing Programs
As part of the agency’s continued updates to COVID EUA templates, the Food and Drug Administration (FDA) announced on April 20th a streamlined pathway for diagnostic test developers with molecular SARS-CoV-2 tests that have received an emergency use authorization (EUA) to securing a claim for serial screening. Per the FDA, the new amendment allows certain authorized molecular diagnostic SARS-CoV-2 tests for “emergency use on pooled specimens for testing individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week as part of a serial testing program without prospective FDA review.” The amendment applies only to the pooling of nasal respiratory specimens and requires that developers submit a complete notification to FDA with information such as validation data and pooling procedure.
Contact: Susan Van Meter
COVID Regulatory: AdvaMedDx Submits Comments on FDA Guidance on COVID Variants
AdvaMedDx has submitted comments to the Food and Drug Administration (FDA) in response to “Guidance for Test Developers and Food and Drug Administration Staff: Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests.” The guidance went into effect upon issuance. Comments submitted may assist in its implementation. AdvaMedDx’s comments note our members’ focus on variants. AdvaMedDx members strive to design their tests in a manner that can withstand variants and are committed to monitoring the impact of virus variants on their COVID-19 tests. AdvaMedDx member companies with diagnostics tests for viruses, including COVID-19, routinely and frequently assess the impact of “variants of concern” on the effectiveness of their tests.
The AdvaMedDx comments include overall recommendations applicable to all testing modalities, including FDA/industry partnership, considering level of clinical concern in determining variants necessitating additional evaluation, utilization of in silico analysis, transparency and flexibility for protocols and reporting results. In addition to these general recommendations, AdvaMedDx provides recommendations specific to molecular, antigen, serology and T-Cell testing.
Contact: Jamie Wolszon
COVID: AdvaMed COVID-19 Supply Registry–Molecular Shipments reach ~433 Million
The latest AdvaMed COVID-19 Testing Supply Registry report demonstrates that participating companies have collectively shipped 433 million molecular tests for COVID-19 nationwide to date for the week ending on April 30th .
The Registry participants 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 comprise around 80% of the COVID-19 Molecular IVD tests on the market in the U.S. The Registry also gathers data on both serology/antibody and antigen testing in which it has been shown that the industry has significant manufacturing capacity for both serology/antibody and antigen testing.
View all public releases of the COVID-19 Supply Registry to date here.
Contact: Susan Van Meter
Coverage: Updates on Medicare Coverage of Innovative Technology (MCIT)
In March, CMS announced it would delay implementation of its final rule on Medicare Coverage of Innovative Technology (MCIT) by 60 days, until May 15, 2021. The final rule was published in January of 2021, and if implemented, would provide immediate, national coverage for technologies that are designated as “breakthroughs” by the Food and Drug Administration (FDA). In the same notice announcing the implementation delay, CMS opened a new public comment period soliciting feedback on several areas of concern with the MCIT rule. The Agency raised operational issues, concerns regarding the volume of technologies being designated as “breakthrough” by the FDA, concerns about the evidence base and general questions about the adequacy of the rulemaking process. In a comment letter submitted to CMS on April 15th, AdvaMed responded to each of the concerns raised by CMS, and urged the Agency to implement the final rule, which would expedite access to breakthrough devices and diagnostic tests for Medicare beneficiaries with severe or debilitating conditions or illnesses.
The final rule that was issued in January also included provisions that codified what it means for an item or service to be “reasonable and necessary” for purposes of Medicare coverage. In its comment letter, AdvaMed recommended that if CMS felt it needed additional feedback with respect to the definition of “reasonable and necessary” beyond the additional comment period, CMS should sever this distinct provision from the MCIT provisions of the final rule and address the definition of reasonable and necessary separately.
The final MCIT rule’s effective date was delayed until May 15, 2021, which means that unless CMS takes additional action to further delay the rule, the Agency should implement the MCIT program at that time. AdvaMed is working with other stakeholders, including other associations, physician societies and patient groups, to advocate for implementation without further delay.
Contact: Chandra Branham
PAMA: MedPAC Discusses Potential Revisions to Data Reporting for CLFS
On April 2, 2021, the Medicare Payment Advisory Commission (MedPAC) discussed the impact of the Protecting Access to Medicare Act (PAMA) on Medicare’s Clinical Laboratory Fee Schedule (CLFS). Legislation passed at the end of 2019 mandated that MedPAC look at alternative methods for CMS to obtain private payer data for setting payment amounts on the CLFS. The Commission is expected to issue its report in June.
Notably, MedPAC did not find issues relating to access for laboratory tests. Utilization of routine tests was stable but was increasing for high-cost tests. MedPAC staff reported that CMS could use a sampling methodology to survey laboratories (rather than the current requirement for universal reporting by applicable laboratories). Sampling would reduce burden by reducing the number of laboratories required to report private payer data by 70 percent. Rates would then be more representative of the market, because physician office laboratories and hospital laboratories are underrepresented in the current system, while independent laboratories are overrepresented.
MedPAC staff also commented that a more representative survey could increase Medicare spending by 10 - 15%. Any such change would require that Congress change the law. MedPAC staff suggested that rates be based on “efficient laboratories” though it is unclear how efficiency would be measured. Lastly, MedPAC suggested that there may be a need to establish an alternative way to set payment rates for new high-cost tests.
Again, based on the discussion at the meeting and additional staff research, the MedPAC report will be issued in June, and AdvaMedDx will provide additional analysis at that time.
Contact: Chandra Branham
Dx Regulatory Reform: AdvaMedDx-ACLA to Cohost Stakeholder Session with VALID Act Sponsors, May 10
On May 10th, AdvaMedDx and the American Clinical Laboratories Association (ACLA) will cohost a session with the diagnostics regulatory reform stakeholder group comprised of IVD manufacturers, laboratories, patient organizations and hospitals who support comprehensive reform for a discussion with the Verifying Accurate Leading-edge IVCT Development Act (VALID) Act sponsor offices on their ongoing work to prepare the VALID Act for reintroduction in this new session of Congress. Lead staff from the offices of Senators Michael Bennet (D-CO) and Richard Burr (R-NC) and Representatives Diana DeGette (D-CO) and Larry Bucshon, MD (R-IN) will provide an update on their plans to reintroduce the bill and participate in a discussion on how stakeholders can support the legislative process moving forward to secure comprehensive diagnostics regulatory reform.
All AdvaMedDx members are encouraged to join. The meeting will be held from 2:00 – 3:00 PM ET. To join, please RSVP to Sumita Bhattarai.
As a reminder, AdvaMedDx’s Regulatory Reform Strategy Group meets every other Tuesday at 3:00 PM ET. The sessions are geared towards regulatory and government affair member company experts. Please contact Sarah Killeen for more information.
Contact: Sumita Bhattarai
Antimicrobial Resistance: CDC Analysis of Inpatient Antibiotic Prescribing Practices & AdvaMedDx Diagnostics Stewardship Recommendations
Recently, the Centers for Disease Control and Prevention (CDC) published a new analysis that found that over 50% of antibiotics prescribed to patients in U.S. hospitals for several common conditions did not adhere to recommended prescribing practices. Prescribing was considered inappropriate for a number of reasons, including the lack of diagnostic test results confirming the presence of an infection.
These findings highlight the importance of antimicrobial stewardship programs to ensure appropriate antibiotic use and improve patient outcomes. AdvaMedDx has a set of recommendations that emphasize the role and importance of laboratory and point-of-care diagnostic tests in antimicrobial stewardship programs in inpatient hospital settings. These principles can be viewed here.
AdvaMedDx’s Antimicrobial Resistance Work Group is presently working on a complementary set of principles to encourage the use of diagnostic tests to inform antimicrobial prescribing in ambulatory settings. All AdvaMedDx members are welcome to join the work group.
Contact: Kristina Shultz
Antimicrobial Resistance: New CDC Global Detection and Response Funding Opportunity
On April 27th, CDC announced a new five-year funding opportunity that will support the establishment of two new global CDC networks: the Global Action in Healthcare Network (GAIHN) and Global Antimicrobial Resistance (AR) Laboratory & Response Network.
GAIHN will detect and contain infectious disease threats in the healthcare setting, initially targeting antimicrobial-resistant infections, healthcare-associated infections (HAIs), and COVID-19.
The Global AR Laboratory & Response Network will improve the detection of existing and emerging AR threats and identify the risk factors that drive the emergence and spread of AR across healthcare, the community, and the environment. The new global network will support goals in the U.S. National Action Plan on Combating Antibiotic Resistant Bacteria, 2020-2025.
CDC will host a webinar with more information on May 18th and May 20th. This opportunity is open to all entities with experience in healthcare infection detection and response, and/or antibiotic resistance. More details on this funding opportunity are available here.
Contact: Kristina Shultz
Global Regulatory: WHO Prequalification White Paper Under Development
AdvaMedDx, in collaboration with a subgroup of member regulatory experts is developing a white paper outlining challenges experienced with the World Health Organization (WHO) IVD prequalification program. Challenges discussed to date include lengthy review timeframes, due in part to unwillingness to rely upon authorizations from competent regulatory authorities and insufficient laboratory capacity, and lack of transparency.
Any interested AdvaMedDx member is welcome to join the discussion and white paper development.
Contact: Jamie Wolszon
Global: AdvaMedDx and World Health Organization Briefing on Influenza Pandemic Preparedness and Response
On April 13th, AdvaMedDx hosted a briefing session with the World Health Organization Pandemic Influenza Preparedness (PIP) Secretariat on the PIP Framework, for members of the AdvaMedDx PIP working group. The PIP Framework aims to improve and strengthen the sharing of influenza viruses with human pandemic potential and to increase the access of developing countries to vaccines, therapeutics, and diagnostics. The briefing provided an overview of key facts of the Framework including the Standard Material Transfer Agreements 2 (SMTA2) and Partnership Contribution (PC) Mechanisms, as well as an overview of the Global Influenza Surveillance and Response (GISRIS) and how it is being leveraged during the COVID-19 pandemic.
During the session, the WHO described the broad methodology the Secretariat uses to determine which IVD companies with flu tests are subject to SMTA2 and PC. Full details of this methodology are included in the materials reference above.
Also, during the briefing, two representatives from Halteres Associates provided an overview of the draft reports they have developed for WHO on influenza diagnostics and the IVD industry. The WHO is likely to use those reports to inform any potential policy changes to the PIP Framework in the future. AdvaMedDx PIP Work group members have been given the opportunity to provide feedback on these draft reports.
The AdvaMedDx PIP work group is open to all AdvaMedDx members.
Contact: Susan Van Meter
May 6: AdvaMed’s Digital MedTech Conference
Registration is open for AdvaMed’s Digital MedTech Conference, which is being held virtually this year on May 6th, 2021.
The Digital MedTech Conference is where leading experts, innovators and key decision makers come together to discuss the critical technology and business issues facing the digital health community and explore the trends impacting the industry. The conference will feature a variety of keynotes, panels and spotlight sessions covering a range of topics in digital health including:
- Telehealth in the Wake of COVID-19
- Artificial Intelligence (AI) and Patient Care
- The Evolution of Digital Surgery
- Connected Medication Management
- And more!
Please visit the Digital MedTech Conference website to view the agenda and register.
Contact: AdvaMed Events Team
August 24-26: CHI’s 13th Annual Next Generation Summit
Cambridge Health Institute’s (CHI) 13th Annual Next Generation Dx Summit will take place in-person at the Grand Hyatt Washington, D.C. on August 24-26, 2021 with a virtual option for those who want to participate remotely. As part of this year’s program, AdvaMedDx and CHI are co-organizing a short course: “Navigating the EUA Process for Diagnostics: Practical Advice, Education and POC.”
The Summit brings together international diagnostics professionals and offers unparalleled insights on the latest developments in diagnostics. It also provides ample opportunities for networking with key leaders in the industry. Covered topics span point-of-care diagnostics, advanced diagnostics for infectious diseases, drug-diagnostics co-development, and technologies for liquid biopsy, among many others. Now in its thirteenth year, the Next Generation Dx Summit is a must-attend event with complete coverage of the most timely and important issues for the industry.
For more information on the event program, speakers or to register, visit the Next Generation Dx Website.
Contact: Susan Van Meter
Upcoming Member Events
