Newsletter Contents
Latest News and Updates:
- Biden-Harris COVID Relief and Response Plan Testing Provisions
- AdvaMedDx 2021 Priorities - Member Update Call Feb. 4
- AdvaMed COVID-19 Test Supply Registry: Molecular Test Shipments Reach ~350 Million
- Coverage: CMS Issues AdvaMedDx-Supported Medicare Coverage of Innovative Technology Final Rule
- Coverage: CMS Issues Final NCD for Blood-based Biomarker Tests for Colorectal Cancer Screening
- Regulatory: FDA-CDC Launch Assessment of Antigen Tests for COVID-19
- Regulatory: Personalized Medicine and Molecular Diagnostics Call Feb. 5
- Regulatory: Diagnostics Regulatory Reform – Join Our Bi-Weekly Update Calls
- Antimicrobial Resistance: AdvaMedDx Stewardship Advocacy & Feb.10-11 PACCARB Meeting
- Global: AdvaMedDx Global Update: WHO publishes 3rd Essential Diagnostics List, Urges Country Investment in Diagnostics
- Global: AdvaMedDx-MedTech Europe Joint Survey on IVDR Implementation
- Get Involved with AdvaMedDx’s Policy Work in 2021
- Upcoming Member Events
1. Biden-Harris COVID Relief and Response Plan Testing Provisions
AdvaMedDx appreciates the opportunities to have met with the Biden-Harris Transition, prior to the Inauguration and since with Administration officials, discussing the importance of leveraging all types of COVID-19 tests – both laboratory-based and point-of-care – to extend the reach of testing in health care settings, for K-12 students and teachers, employers and other populations, and for all other appropriate use cases. We have described the full scope and scale of industry mobilization to meet unprecedented demand for quality testing since the beginning of the pandemic, including through sharing data from the AdvaMed COVID-19 Testing Supply Registry. Various public-private engagements over the last several months have aided in accelerating the development of testing and augmenting test manufacturing to help achieve the hundreds of millions of quality molecular, antigen and serology tests made available to hospitals, laboratories, retail pharmacy, schools and other sites since last March. We encourage the Administration to continue to leverage these discrete public-private engagements, including through BARDA and RADx, as opposed to more aggressive tools like the Defense Production Act (DPA) that can inadvertently disrupt supply chains and restrict manufacturing of testing. AdvaMedDx has also encouraged a strong and clear federal education program on the value and utility of testing as a critical tool in our collective ongoing response.
The Biden-Harris Administration’s plan on testing continues to take shape. The Administration has included test provisions in both its $1.9 trillion legislative relief package shared with Congress and in its 200-page National Response Plan. Key details of each are provided below.
American Rescue Plan: Prior to the Inauguration, President Biden announced a $1.9 trillion COVID relief package titled the “American Rescue Plan.” The plan recognizes the important role testing serves now and will continue to serve in our recovery. It includes a proposed $50 billion investment in testing for the expansion of laboratory capacity and the purchase of rapid tests. As we have anticipated, there are provisions aimed at expanding testing specifically to bring back in-person schooling for grades K-12. Further, the plan includes a proposed $30 billion Disaster Relief Fund to address shortages in supplies, including extraction reagent, personal protective equipment, and other supplies, with an additional $10 billion in expanding domestic manufacturing of pandemic supplies. The DPA is cited as a mechanism that could be used to achieve increased production of these supplies.
Discussions on the Hill and with the Administration on a potential relief plan are underway, yet in early stages and not uncomplicated. Democrats may consider use of the Budget Reconciliation tool to pass such legislative in the Senate. Reconciliation requires a simple majority vote, whereas typical procedures require a filibuster proof 61. AdvaMed will keep members updated on deliberations on relief legislation.
National Strategy for COVID-19 Response and Pandemic Preparedness Plan: On January 21, the Biden Administration released their National Strategy for COVID-19 Response and Pandemic Preparedness. The full plan can be accessed here. Various Executive Orders signed by the President underpin the plan and are included in the Plan document as an addendum.
The plan is broad in scope and details of many policies continue to be developed. Among the many testing related policies, the plan:
- Establishes the Coordinator of the COVID-19 Response and COVID-19 Response Supply Coordinator positions, now filled by Jeff Zients and Tim Manning, respectively.
- Sets-up a COVID-19 Pandemic Testing Board of public sector leaders that will be chaired by Carole Johnson (p. 58). AdvaMedDx has long advocated for a public-private sector testing board to improve our collective response efforts.
- Closes Gaps in Coverage for COVID Testing, (p. 135). AdvaMedDx has encouraged closing de facto gaps in coverage – particularly restricting access to serology/antibody testing as well as repeat diagnostic testing.
- Seeks to Expand Laboratory Capacity (p. 58). The association has encouraged meaningful augmentation of laboratory capacity to meet COVID testing demands, reducing disparities in testing access.
- Aims to Ramp-up Testing Supply for both laboratory-based and point-of care testing, including self-collection, self-testing in the home setting.
- Investment in onshoring manufacturing of test kits and related supplies over a 5-year period. (p. 58). AdvaMedDx members should note a subsequent “Buy America” executive order was signed by the President. The AdvaMed Supply Chain Task Force and International Policy Group have met to examine the order. Notice and comment rule will be required to implement the order.
- Support School Reopening (p. 58-59, 77-81). The federal government will support COVID-19 testing by working with state and local leaders to support the purchase of rapid tests and any necessary expansions in lab capacity, and by providing COVID-19 Testing Support Teams at CDC that help schools develop plans for regular COVID-19 testing, including navigating federal and state requirements, consent, sample collection, and contact tracing. AdvaMedDx has encouraged flexibility in design of testing for schools, leveraging point-of-care and laboratory-based testing for all appropriate use cases.
- Strengthen testing supply chain by promoting predictable and robust federal purchasing of testing supplies (p. 59) AdvaMedDx has emphasized the importance of predictability for IVD companies as the National Plan continues to be fleshed out.
- Standardize State Data Reporting (p. 66). AdvaMedDx has recommended standardization in state reporting of tests run to improve existing variable reports.
AdvaMedDx Engagement with Biden Administration Testing Lead, Carole Johnson: AdvaMedDx is pleased to have met with Carole Johnson, the new National COVID-19 Testing Coordinator, to express our collective and full commitment to continuing to support our nation’s COVID response and our eagerness to work with the new administration. Ms. Johnson communicated her interest in working with the association and our members in her new role. We look forward to continued discussion as details of the Plan continue to be developed.
AdvaMed/AdvaMedDx Engagement with Biden Administration Supply Chain Lead, Tim Manning: Earlier this month, AdvaMed/AdvaMedDx joined a small group of trade associations representing manufacturers producing COVID-related products in a meeting with Tim Manning, the White House COVID-19 Supply Coordinator. Mr. Manning provided an overview of the immediate steps the Administration plans for an all of government assessment of COVID related activities and contracts. He described the powerful tool that is the DPA and how leveraging it would only be done cautiously and in collaboration with industry, explaining the negative ripple effects that can result from its use. Further, as the National Plan identifies shortfalls in twelve categories of critical supplies, the Administration will seek to take swift action to increase the availability of these supplies that include swabs, test reagents, pipette tips, laboratory analysis machines for PCR tests, swabs, nitrocellulose material for rapid antigen tests, and rapid test kits. AdvaMedDx will keep members updated on next steps from the Administration on supply chain matters.
Contact: Susan Van Meter and Sarah Killeen
2. AdvaMedDx 2021 Priorities - Member Update Call February 4
All AdvaMedDx members are invited to join us Thursday, February 4, 1:30 – 3:00PM (ET) for an overview and strategy discussion on AdvaMedDx’s 2021 advocacy and policy priorities. A copy of the association’s priorities is available here. The priorities, including those focused on payment & coverage as well as FDA regulatory matters, were developed by AdvaMedDx member working groups and finalized by the AdvaMedDx Board of Directors last fall. Geared principally for government affairs professionals, the discussion will provide for an overview of the priorities, consideration of update/modifications to priorities given a changing political landscape, and a focus on our strategy to move our priorities forward in Q1 and Q2.
Contact: Susan Van Meter
3. AdvaMed COVID-19 Test Supply Registry: Molecular Test Shipments Reach ~350 Million
The latest AdvaMed COVID-19 Testing Supply Registry report demonstrates that participating companies have collectively shipped ~355 million molecular tests for COVID-19 nationwide to date with ~1.4 million tests shipped per day, on average for the week ending on January 22nd. 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 produce ~80-85% of the COVID-19 Molecular IVD tests on the market in the U.S. The Registry also reports serology test shipments and will soon report antigen test shipments as well.
Contact: Susan Van Meter
4. CMS Issues Medicare Coverage of Innovative Technology Final Rule
On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) issued its final rule on "Medicare Coverage of Innovative Technology" (MCIT). Under the final rule, CMS has created a new, voluntary Medicare coverage pathway that will provide immediate, national Medicare coverage of devices and diagnostic technologies that are designated as breakthroughs and cleared or approved by the FDA. The rule reflects many years of AdvaMedDx advocacy for more streamlined coverage of innovative technologies to speed access to patients. The automatic coverage will begin on the date of FDA market authorization and last for four years, after which time, coverage will be determined through existing processes (national or local coverage determinations or claim-by-claim adjudication). The MCIT program will apply to breakthrough technologies that received FDA market authorization up to two years prior to the effective date of the final rule.
During the four-year coverage period, additional data development is not required; however, CMS encourages manufacturers to develop clinical evidence that may be needed for one of the other coverage pathways, or to better inform the clinical and patient communities about the new technology. In order to be eligible for the MCIT program, a breakthrough technology must fit into an existing Medicare benefit category, which creates uncertainty for certain digital or wearable technologies, as well as certain screening tests.
The final rule also defines in regulation what it means for an item or service to be considered "reasonable and necessary" for Medicare coverage. This definition goes beyond FDA-designated breakthrough technologies and applies to any item or service that is covered by Medicare. While the rule draws on factors that CMS has historically used in making "reasonable and necessary" decisions, the Agency included a modification to determine whether coverage is appropriate for Medicare beneficiaries, based in some instances on commercial insurer coverage. This is a departure from CMS' traditional approach, particularly given differences between Medicare patients and those covered in the commercial market. CMS expects to release additional guidance on the use of commercial policies to determine Medicare coverage within a year of the rule's effective date.
The rule is currently set to take effect on March 15, 2021. As is often the practice in reviewing regulations finalized at the end of a prior administration, the Biden Administration could delay the effective date pending a review. At this point, we are not aware of action to delay the effective date, but we are monitoring the situation closely and have advocated that CMS implement the new rule as planned.
Contact: Chandra Branham
5. CMS Issues Final NCD for Blood-based Biomarker Tests for Colorectal Cancer Screening
On January 19, 2021, CMS released a final National Coverage Decision (NCD) that will cover future tests for colorectal cancer screening when those tests are approved by the FDA and have met specific sensitivity and specificity criteria. The final NCD can be found here.
CMS will cover blood-based liquid biopsy colorectal cancer screening tests once every three years for patients who are between the ages of 50-85, are asymptomatic and are at average risk of developing colorectal cancer. The test must be approved by the FDA for colorectal cancer screening and must meet the following criteria:
- Sensitivity equal to or greater than 74% and specificity equal to or greater than 90% as compared to colonoscopy.
The proposed NCD included a requirement that tests must be included in clinical guidelines, in addition to the FDA approval, but this requirement was removed in the final version. This is a major development in Medicare coverage, as qualified tests will be covered upon FDA approval.
Contact: Chandra Branham
6. FDA-CDC Launch Assessment of Antigen Tests for COVID-19 Confirming Effectiveness Given Variants
On January 25, Office of Health Technology 7/Office of In Vitro Diagnostics and Radiological Health Director Tim Stenzel discussed with AdvaMedDx members FDA efforts to evaluate the potential impact of emerging COVID-19 variants on all modalities of COVID-19 tests. Most immediately, the FDA plans to collaborate with the Centers for Disease Control and Prevention (CDC) to evaluate COVID-19 antigen tests that have secured Emergency Use Authorization (EUA) given the emergence of the variant known as the U.K. variant. This evaluation of the impact of variants on testing will likely expand to other variants and go beyond antigen tests to include additional test types such as molecular and serology. This initiative is still in the early stages of development and AdvaMedDx has the opportunity to provide recommendations for an efficient process. We will be discussing this further during a special call of the Diagnostics Task Force meeting on February 3.
As a reminder, we encourage interested members to participate in opportunities to engage with the CDC during the Clinical Laboratory COVID-19 Response Calls that take place every other Monday at 3:00 PM Eastern and with the FDA during the weekly Virtual Town Hall for Test Developers Wednesdays at 12:15 PM ET.
Contact: Anita Nosratieh
7. Personalized Medicine and Molecular Diagnostics Call
All AdvaMedDx member regulatory experts are invited to join the next call of the AdvaMedDx Personalized Medicine and Molecular Diagnostics Work Group on Friday, February 5 at 2:00 PM ET.
Contact: Anita Nosratieh
8. Diagnostics Regulatory Reform – Join Our Bi-Weekly Update Calls
AdvaMedDx, in collaboration with member companies, is weighing-in with the bipartisan-bicameral sponsors of the Verifying Accurate Leading-edge IVCT Development Act, or VALID Act, as they improve and ready the bill for reintroduction in this new Congress. Reintroduction is anticipated early in Q2.
To guide our advocacy and hear the latest updates, AdvaMedDx members are encouraged to join our bi-weekly diagnostics regulatory reform strategy calls. The next call is scheduled for Tuesday, February 16 at 3:00pm ET.
For more information about the bi-weekly calls or AdvaMedDx's VALID activities, please contact Sarah Killeen.
9. Antimicrobial Resistance: AdvaMedDx Stewardship Advocacy & PACCARB Meeting
AdvaMedDx continues to actively advocate for the importance of diagnostic stewardship in addressing the threat of antimicrobial resistance, both on the Hill and with the Administration.
PASTEUR Act: AdvaMedDx is working in coalition with stakeholder colleagues from professionals' societies and the pharmaceutical industry to support improvement and reintroduction of the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. At the end of last year, AdvaMedDx submitted a letter to the co-sponsors of the PASTEUR Act (H.R. 8920/ S. 4760) expressing support for the objectives of the bill and encouraging the inclusion of more robust diagnostic stewardship elements to emphasize the importance of laboratory and point-of-care diagnostic testing in antimicrobial stewardship. AdvaMedDx’s Diagnostic Stewardship Recommendations were attached to the letter.
Upcoming PACCARB Meeting: The next public meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) will be held on February 10-11, 2021. We are pleased that at the request of the association, PACCARB has invited an AdvaMedDx member company to present on the importance of leveraging diagnostics to improve antimicrobial stewardship during the Innovation Spotlight session of the PACCARB meeting.
Contact: Kristina Shultz
10. AdvaMedDx Global Update: WHO publishes 3rd Essential Diagnostics List; Urges Country Investment in Diagnostics
January 29, the World Health Organization (WHO) rolled-out the 3rd edition of the WHO Essential Diagnostics List (EDL) available here. WHO states that the EDL is intended to serve as a reference guide to countries to prioritize diagnostics tests that should be available at each level of the health care system and should be adapted to meet the particular health needs of a country. In its press release on the EDL and a new video, WHO emphasizes the overall value of diagnostics, explaining the cost-effective and foundational nature of diagnostics to the delivery of quality care. Importantly, and most welcome, in rolling out the latest edition, the WHO communicates that the EDL is just one tool and urges countries to prioritize investment in testing.
Key highlights:
Details on the 3rd EDL: WHO has made available a draft, electronic version of the 3rd Edition that comprises 209 recommendations for 154 in vitro diagnostics and can be accessed here. The site is searchable by disease/health condition, setting, assay format, IVD purpose and year of WHO recommendation.
Developing Guide for Implementation: The WHO said that it will soon publish a step-by-step guide to aid countries wanting to develop a national list. So far, WHO has worked with Nigeria, India, Bangladesh, and Pakistan to support the development of their national EDLs, and indicates that it is currently “in discussions with mostly African countries that have requested assistance to boost their diagnostic services.”
Recommendations Against Inclusion in the EDL: There is one novelty in the third edition, compared to prior editions: for the first time, it contains recommendations against the use of certain test categories:
“Do Not Do Recommendations”
In line with the latest WHO guidelines, SAGE IVD issued three Do Not Do
recommendations for inclusion in the EDL, specifically advising countries against
the procurement and use of:
- Western blot assays to diagnose HIV infection
- Line immunoassays to diagnose HIV infection
- Commercial serodiagnostic tests to diagnose TB
Contact: Susan Van Meter
11. AdvaMedDx-MedTech Europe Joint Survey on IVDR Implementation
As part of our continuing, joint advocacy, AdvaMedDx and MedTech Europe have launched a survey of IVD member companies that are or will be certified under IVDR (Regulation (EU) 2017/746) due to take effect May 2022. The survey will collect examples of IVD devices (of all classes – A, B, C, D) being submitted to Notified Bodies, under IVDR requirements. Aggregated survey results will support our advocacy efforts to improve implementation of the European IVDR Regulation.
All AdvaMedDx members with IVD products in the European market are asked to kindly complete the survey by March 5.
To receive the link to the survey, please contact Sumita Bhattarai.
12. Get Involved with AdvaMedDx’s Policy Work
AdvaMedDx members drive our association’s policy and advocacy work, in large part through engagement in our work groups. These various work groups serve as forums for member company representatives to stay current on key issues and to guide test association’s efforts. Below is a list of a handful of our many active policy work groups along with a name and contact information for each work group lead. If you are not yet a group member, please contact the individuals below to participate and ensure you are up to speed on AdvaMedDx's work and activities in 2021.
13. Upcoming Member Events
- February 3: Dx Task Force Call on FDA-CDC COVID-19 antigen assessment to confirm effectiveness given U.K. variant. Regulatory experts interested in joining should please contact: Anita Nosratieh
- February 3: Diagnostics Payment Work Group quarterly meeting. Payment & Coverage experts interested in joining, please contact Chandra Branham
- February 4: AdvaMedDx 2021 Priorities – Member Update call. Government affairs professional interested in joining, please RSVP to Sumita Bhattarai.
- February 5: Personalize Medicine Work Group meeting. Interested regulatory experts should contact: Anita Nosratieh
- February 16: AdvaMedDx Bi-Weekly Regulatory Reform Call. Government affairs and regulatory experts interested in joining should please contact Sarah Killeen
- February 17: AdvaMedDx Antimicrobial Resistance work group call. If interested in joining, please contact Kristina Shultz.
- February 19: Dx Task Force quarter meeting. Regulatory experts interested in joining should please contract Jamie Wolszon.
- February 22: AdvaMedDx Board of Directors meeting
- February 25: Save the date for a Genetic Alliance/AdvaMedDx Hill Briefing: Precision Medicine – Diagnosing with Genetic Sequencing (details to be announced shortly).