Newsletter Contents
Latest News Updates
-
AdvaMedDx Advocates for Expanded Access to COVID-19 Testing:
- AdvaMedDx Seeking Improvements to Broaden Patient Access to Testing in Next Stimulus Package
- AdvaMed and AdvaMedDx Respond to Senate HELP Chairman White Paper, “Preparing for the Next Pandemic”
- Bucshon and DeGette Introduce Diagnostic Testing Bills
-
AdvaMedDx COVID-19 Testing Advocacy and Education:
- AdvaMedDx Capitol Hill Education Efforts: Value of Diagnostics in COVID-19 and Beyond
- Coverage Advocacy: AdvaMedDx Pressing for Coverage of COVID-19 Serology Testing
-
Payment: CMS Establishes New Payment Rates for COVID-19 Antibody Tests and CPT Panel Issues Code for Antigen Tests
-
AdvaMed and AdvaMedDx Respond to Administration’s Initiatives Focused on the Medical Supply Chain
-
HHS’ Report to Congress on COVID-19 Testing; $11 Billion in Testing Funds to States
-
HHS Issues New Laboratory Data Reporting Guidance for COVID-19
-
Reminder: AdvaMedDx COVID-19 Resources and List of AdvaMed COVID-19 Work Groups
-
Featured Event: July 15, 2020 - Medical Device Virtual Partnering Forum
-
Upcoming Meetings and Events in 2020
1. AdvaMedDx Advocates for Expanded Access to COVID-19 Testing
AdvaMedDx Seeking Improvements to Broaden Patient Access to Testing in Next Stimulus Package
Deliberations on the 5th COVID-19 relief package are under way on Capitol Hill. On May 15, the House passed the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act to respond to the COVID-19 outbreak and its impact to the economy public health by providing emergency supplemental appropriations to federal agencies, assistance to states, and many other provisions to provide relief to businesses and families. Negotiations in the Senate on the 5th package are expected later this month with the Majority Leader having today reaffirmed in public remarks the need for such a package.
AdvaMedDx, in close coordination with our members, has developed two sets of policy proposals that we are advancing for consideration in this upcoming package. The first is designed to broaden timely and efficient access to COVID-19 testing by simplifying the process for ordering a test and strengthening coverage and reimbursement (including federal funding) for COVID-19 testing, among others. AdvaMedDx proposals to expand access to testing can be viewed here. The second set of proposals that would apply to all AdvaMed members focuses on improvements to support the development and delivery of emergency diagnostics, and includes proposals to streamline access to viral samples for test development, permit the use of real world data collected during the emergency for product advancement, and clarification of CLIA-waiver status for emergency diagnostics. See AdvaMed’s response to Senator Alexander’s pandemic white paper for details.
Contact: Susan Van Meter
AdvaMed and AdvaMedDx Respond to Senate HELP Chairman White Paper, “Preparing for the Next Pandemic”
On June 9, Senate HELP Chairman, Lamar Alexander (R-TN) published a white paper titled, “Preparing for the Next Pandemic,” that requests feedback from stakeholders, experts, and members of Congress to inform developing legislation. The white paper can be accessed here.
AdvaMed and AdvaMedDx provided a comprehensive set of recommendations including numerous diagnostics-related recommendations to strengthen access to testing, embrace innovation and put in place our proposed public-private partnership for COVID-19 testing. Please see our complete set of AdvaMed and AdvaMedDx recommendations here.
Contact: Susan Van Meter
Reps. Bucshon and DeGette Introduce Diagnostic Testing Bills
Recently, Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) introduced two bills to increase diagnostic testing capabilities at public health laboratories, in hospitals, and by physicians and other health service providers. AdvaMedDx supports these important bills.
- Diagnostic Testing for Public Health Labs Act (Sponsor: Bucshon, Cosponsor: DeGette): The bill directs the Secretary of the Department of Health and Human Services to award grants to assist eligible public health labs in acquiring high-throughput testing platforms and associated testing supplies through CDC’s ELC Cooperative Agreement. Priority would be given to underserved areas. This bill would provide $250 million in grants with a $2 million cap for any individual lab. A copy of the bill is available here.
- Rapid Testing for Communities Act of 2020 (Sponsor: DeGette, Cosponsor: Bucshon): The bill directs the Secretary through the CDC to award grants to eligible entities including: hospitals, primary care facilities, clinics, physicians, or other health care providers, to purchase rapid testing equipment and materials, including diagnostic and serological testing for use in point-of-care settings. Priority would be given to underserved areas. This bill includes $500 million in grants with up to $20k per entity. A copy of the bill is available here.
Contact: Duane Wright and Sarah Killeen
2. AdvaMedDx COVID-19 Testing Advocacy and Education
AdvaMedDx Capitol Hill Education Efforts: Value of Diagnostics in COVID-19 and Beyond
AdvaMedDx is actively engaging with House and Senate leadership, health committees and other member offices providing education on the IVD industry and its tremendous efforts to develop, manufacture and ship tens of millions of quality COVID-19 tests to help meet the needs of patients and public health during the pandemic. Discussions with Members of Congress and staff have included an overview of molecular, antigen, serology (antibody), and next-generation sequencing COVID 19 tests – and their varied patient and public health use cases, the diagnostic supply chain, and improvements to coverage and reimbursement that would increase access to testing. In support of these efforts, AdvaMedDx has developed educational resources and materials available for members to access and utilize as part of your advocacy efforts. A recording of our latest session for members of the House Energy and Commerce Committee is available here and the slides here. AdvaMedDx encourages CEOs and CMOs of other member companies to volunteer to serve as expert speakers on additional upcoming sessions.
In addition to regular education sessions, when false information on testing arises on the Hill, AdvaMedDx responds, such as on June 9 when the House Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy held a virtual briefing on serology (antibody) testing that failed to recognize high quality serology testing for patient and public health is now available at scale and a narrow view on the use cases for quality serology testing. In response, AdvaMedDx, via a press release, expressed our support for FDA’s revised policy heightening requirements to only allow quality tests that have been validated and authorized by the Agency to enter the market. AdvaMedDx highlighted the importance of serology testing – along with molecular diagnostics and antigen detection tests – to help clinicians and public health experts prevent, detect, and treat COVID-19, in better understanding this new pathogen, and in protecting public health.
Contact: Susan Van Meter
Coverage Advocacy: AdvaMedDx Pressing for Coverage of COVID-19 Serology Testing
AdvaMedDx is concerned that a number of private insurance providers have issued non-coverage determinations for COVID-19 serology testing in recent weeks. The Families First Coronavirus Response Act – signed into law in March – requires group health plans and health insurance issuers offering group or individual health insurance coverage (including grandfathered plans) to cover tests for “the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19” when furnished with a EUA-authorized test. In letters to these insurers, AdvaMedDx urges the decisions be reversed and emphasize the need for physicians and other qualified healthcare professionals have access to the full array of COVID-19 testing to support patients and the public health. The letters can be accessed here, here, and here. We have provided these letters to the media to amplify our concern. We have also sent a letter to the Department of Labor urging adherence to the spirit of the law. We are, however, disappointed with the Administration’s recent decision to limit coverage to testing (see here for the tri-agency release).
Furthermore, AdvaMedDx is linking with a coalition of stakeholders including laboratories, providers, nurses, health plans, and others to press for increased federal funding for testing.
Contact: Chandra Branham
3. Payment: CMS Establishes New Payment Rates for COVID-19 Antibody and CPT Panel Issues Codes for Antigen Tests
In mid-April, the AMA released two new COVID-19 antibody test codes – one for tests typically performed in a central laboratory and another for point-of-care testing. Importantly, CMS recently announced the payment amounts for these codes would be $42.13 for the central lab test and $45.23 for the POC test – in full alignment with AdvaMedDx's recommendations. AdvaMedDx's recommendation letter can be accessed here.
CPT Editorial Panel - Antigen Test Code: Additionally, you may have seen that AMA-CPT Editorial Panel issued a new code for SARS-COv-2 antigen testing.
87426: Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS-CoV-2 [COVID-19]).
Contact: Chandra Branham
4. AdvaMed and AdvaMedDx Respond to Administration’s Initiatives Focused on the Medical Supply Chain
AdvaMed and AdvaMedDx Respond to FEMA’s draft Voluntary Agreement for the “Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to the Pandemic”
FEMA is developing a Voluntary Agreement for the “Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to the Pandemic” under the Defense Production Act intended to strengthen the nation’s response capabilities and sustain the healthcare supply chain during a pandemic. Specifically, the agreement calls on participants to:
- Share information with agreement participants (with the exception of competitively sensitive information)
- Identify and Prioritize Critical Healthcare Resource Requirements
- Validate Critical Healthcare Resource Requirements
- Project Future Demand for Critical Healthcare Resource Requirements
- Manufacture Critical Healthcare Resources
- Allocate Critical Healthcare Resources
- Distribute Critical Healthcare Resources
AdvaMed and AdvaMedDx submitted general comments to FEMA recommending that AdvaMed serve as the industry representative to the voluntary agreement. (Note: the agreement envisions that companies would serves as parties to the agreement). Additionally, AdvaMed also submitted detailed comments on the agreement, available here. Many thanks to the AdvaMedDx members who provided feedback.
AdvaMed and AdvaMedDx Responds to Request for Information on the Strategic National Stockpile
On May 15, the Administration released a request for information (RFI) regarding the Strategic National Stockpile (SNS) to: 1) solicit inputs on the proposed strategy and structure of the SNS and the role of public-private partnerships in achieving this vision; and 2) to understand constraints associated with meeting pandemic demand and determine how the U.S. government can contribute to improving supply availability. The RFI was targeted towards private sector manufacturers, distributors, trade associations, and other organizations who might partner with the U.S. government in executing on this vision.
In AdvaMed and AdvaMedDx’s response to the RFI, the association noted the extraordinary ramping up undertaken by the medical technology industry has proven effective to ensure Americans have the medical supplies and technologies they need to care for COVID-19 patients and support frontline and healthcare workers – urging the Administration to be mindful not to hinder or disrupt existing supply chains and industry efforts to continue to ramp up production and accelerate delivery of critical medical supplies during the pandemic.
Specifically, AdvaMedDx noted the SNS should have adequate supply of diagnostic testing equipment, materials, and supplies. The stockpile should include tests for pathogens like the flu that can help with differential diagnosis; equipment necessary to process IVD tests such as test instruments, analyzers and other capital equipment; and medical supplies used in the collection, transport and processing of IVD tests. AdvaMed’s full comments can be accessed here.
Contact: Abby Pratt
5. HHS’ Report to Congress on COVID-19 Testing; $11 Billion in Testing Funds to States
In case you missed it, on May 24, the Administration delivered a COVID-19 Strategic Testing Plan to Congress, as required by the Paycheck Protection Program and Health Care Enhancement Act, P.L. 116-139 (PPP Act). The report will be updated every 90 days until funds are expended. The contents of the report largely mirror the Administration’s national guidelines for "Opening Up America Again" and a high-level testing blueprint that aims to serve as the foundation for reopening the country, published on April 16, designed to “facilitate State development and implementation of testing plans and rapid response programs.” The full report to Congress can be accessed here.
The report emphasizes the need for a strong partnership with private industry to increase test production and testing capacity, coordination with individual states to develop and implement their own testing plans, and Federal support to state laboratories to facilitate laboratory data sharing. Specifically, $11 billion provided in the Paycheck Protection Program and Health Care Enhancement Act (“PPP Act”) to purchase diagnostic tests, instruments, and laboratory supplies to support increased testing capacity for COVID-19 will be managed and distributed by the CDC. To receive funding, states must submit to HHS COVID-19 testing plans that include testing needs and laboratory and testing capacity estimates.
AdvaMedDx is working with our State MedTech Association partners from across the country, discussing our collective advocacy to broaden access to testing. In particular, the association is providing support to SMTAs actively weighing-in with their states on each state’s plan required to draw down from the $11 billion in funding from the PPP. Final state plans are due to the CDC this Friday, July 10th. AdvaMedDx and SMTAs are encouraging the full scope and scale of COVID-19 testing – molecular, antigen, serology, NGS at the point-of-care and laboratory-based – be leveraged to best support patient care and protect public health including via repeat and parallel testing and statewide epidemiological surveys.
Contact: Susan Van Meter
6. HHS Issues Laboratory Data Reporting Guidance for COVID-19
On June 4, HHS published guidance that specifies what additional data must be reported to HHS by laboratories along with COVID-19 test results. The guidance standardizes reporting to ensure that public health officials have access to comprehensive and nearly real-time data to inform decision making in their response to COVID-19. The data and demographic elements that must be reported under this new guidance include the type of test ordered, test result date, patient age/race/sex/location, provider name/location, and specimen source.
The new reporting requirements will provide information needed to better monitor disease incidence and trends by initiating epidemiologic case investigations, assisting with contact tracing, assessing availability and use of testing resources, and anticipating potential supply chain issues. As the pandemic continues, access to clear and accurate data is essential to communities and leadership for making decisions critical to protecting public health. The guidance can be accessed here and FAQs here.
Contact: Phi Vu
7. Reminder: AdvaMedDx COVID-19 Resources and List of AdvaMed COVID-19 Work Groups
AdvaMedDx COVID-19 Diagnostic Testing Resources Available Online
COVID-19 MedTech Resource Center
AdvaMed, AdvaMedDx and AdvaMed Accel members can find all resources on COVID-19 at the newly revamped COVID-19 MedTech Resource Center on the AdvaMed web site here – including a dedicated page for diagnostic testing. The site includes a wide range of tools and resources to help AdvaMedDx members stay current on state and federal policies, legislation, educational sessions, talking points, including documents specific to diagnostic manufacturers such as fact sheets, Q&As, and background materials on COVID-19 testing, and much more. The site is updated daily.
AdvaMedDx Public Resource: COVID-19 IVD Emergency Use Authorizations (EUAs) Landing Page
AdvaMedDx has developed a COVID-19 IVD landing page that serves as a single point of entry for learning more about each COVID-19 IVD EUA test with links to each company’s web site. As IVD manufacturers secure EUAs for COVID-19 tests, AdvaMed and AdvaMedDx are amplifying this progress on various media platforms to recognize each achievement to highlight COVID-19 testing advances across the industry.
Contact: Phi Vu
AdvaMed/AdvaMedDx COVID-19 Work Groups
AdvaMed and AdvaMedDx have established a number of COVID-19 Work Groups to streamline key discussions and workstreams around COVID-19 diagnostic testing, personal protective equipment, supply chains, and others. A list of active work groups is provided below. We encourage members who are interested in any of the activities below to reach out directly to the points of contact provided to receive additional details and to join.
AdvaMedDx COVID-19 Work Group
Mission: Forum to discuss key regulatory, communications, and other issues as an IVD industry to support patient care and public health in this emergency.
Meeting Frequency: Ad hoc
Contact: Michelle Spencer
AdvaMed All-Member Coronavirus Task Force
A platform to share information and industry concerns about COVID-19’s impact, both among the AdvaMed membership and with U.S. government stakeholders (FDA, CDC, and HHS/ASPR). The task force covers an array of topics from a broader level, leveraging the expertise of AdvaMed’s various departments.
Meeting Frequency: Weekly on Fridays at 2:00pm ET
Contact: Kyle Churchman.
AdvaMed General Counsels/Executive Coronavirus Task Force
To ensure efficient, clear communication with member company senior leadership on all coronavirus-related activities as filtered up by AdvaMed's other internal groups that conduct coronavirus-related work and the broader coronavirus coordination task force that provides members information across departments.
Meeting Frequency: Weekly on Wednesdays at 2:00pm ET
Staff lead: Chris White
AdvaMed PPE COVID-19 Task Force:
Discuss relevant issues and develop strategic response relating to personal protective equipment due to the COVID-19 pandemic, including the potential for coordinating with the government.
Meeting Frequency: Weekly on Tuesdays at 2:15pm ET.
Contact: Chandra Branham.
AdvaMed Supply Chain Task Force:
Work with members to identify and resolve domestic and global supply chain challenges associated with the COVID-19 pandemic. Articulate best practices for ensuring robust and stable supply chains and advocate to U.S. and foreign governments policies that will help our member companies get their products to the patients and healthcare workers who need them the most.
Meeting Frequency: Weekly on Thursday at 3:00pm ET.
Contact: Abby Pratt
AdvaMed Accel COVID-19 Town Hall
Share information and benchmarks on issues of common concern to AdvaMed’s small company membership.
Meeting Frequency: Weekly on Tuesdays at 1:00pm ET
Contact: Ashley Wittorf
AdvaMed COVID-19 HCIR Health Care Setting Re-Entry Task Force
Develop and advance best practices recommendations concerning Health Care Industry Representatives (HCIRs) re-entry into health care settings.
Meeting Frequency: Ad hoc
Contact: Terry Chang
8. Featured Event: July 15, 2020 - Medical Device Virtual Partnering Forum
AdvaMed has partnered with AUTM to bring together industry and academic representatives to facilitate a dialogue between both groups surrounding the topic of Sponsored Research. Panelists, including several AdvaMed members, will discuss the latest IP topics, best practices for establishing and maintaining open lines of communication with industry contacts, and the differences between medical technology and other industry models for technology transfer. The event will also feature virtual breakout rooms that enable attendees to meet and interact with medical technology industry execs, share details on available technologies, and gain a better understanding of how to work together.
To learn more about this event and to register, please click here.
Contact: Sophearay Smith
9. All Upcoming Meetings and Events
July 23
AdvaMedDx Monthly Antimicrobial Resistance Work Group Call, 11:00am ET
(to participate please contact Phi Vu)
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 Michelle Spencer)
September 24
AdvaMedDx Monthly Antimicrobial Resistance Work Group Call, 11:00am ET
(to participate please contact Phi Vu)
October 5-7
AdvaMedDx Board Meeting and MedTech Conference
October 22
AdvaMedDx Monthly Antimicrobial Resistance Work Group Call, 11:00am ET
(to participate please contact Phi Vu)
November 10
West Coast Dx Summit, San Diego, CA
(to participate please contact Chandra Branham)
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 Michelle Spencer)
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)
