Dear AMP Member Colleagues,
When I began as Chair of the PRC Patient Engagement Subcommittee, a group charged with engaging and informing patients about the role our work plays in their care, I knew we had some lofty goals. In an interview in this publication, I laid out my hopes for future projects, including the launch of a COVID-19 resource page on the “Molecular Medicine for Patients” website, the continuation of our “Lunch and Learn” series, and the creation of new resources for inherited disorders testing for the website.
Well, I am happy to say that not only did we meet our goals; we exceeded them. The COVID-19 resource page was very well-received and was visited 1,300 times in 2022. We held two virtual Lunch and Learn events in the past year (with one of the events having our best-attended event yet), welcoming over 130 attendees from patient advocacy groups, health care professional organizations, academic centers and training programs, in vitro diagnostic manufacturing companies, and more. We also released the Spanish version of our “Inside a Clinical Molecular Diagnostics Laboratory” infographic, which is just the first of many planned translation projects. Finally, I am proud to announce that we launched the Inherited Disorders section of the patient website in April, and it has already been visited 1,314 times. Please read on to learn more about these exciting projects and feel free to share them widely in your community.
I would like to thank the committee members and AMP administrative staff for their passionate work on these efforts. I am extremely proud of all that we have accomplished. I look forward to seeing what this committee works on next to engage with the patient and advocacy community, as well as what tools we can create to help patients take charge of their health and feel confident about the tests and treatments they are receiving.
Jill Murrell, PhD
Chair, Patient Engagement Subcommittee,
AMP Professional Relations Committee
In 2020, to help inform patients and advocates about diagnostic testing's role in patient care, AMP created a website with free infographics, descriptions of testing types, answers to frequently asked questions, and regularly updated educational resources. The website launched with a section focused on cancer-specific resources and in 2021 expanded to include a section on COVID-19 testing.
On April 17th, 2023, AMP launched the third section of the website focused on inherited disorders. This is AMP’s most comprehensive patient-centered online resource yet, and aims to answer questions patients, or a lay audience, may have regarding inherited disorders. This section includes information on inherited disorders, variants of uncertain significance, different types of available screening and diagnostics tests, and more. The new resource also allows viewers to skim the information or take a deeper dive in inherited disorders via a brand-new corresponding glossary that defines over 80 molecular pathology terms. Furthermore, this latest addition boasts brand new graphics created to add visual impact to a patient’s understanding of inherited disorders.
This project has been worked on tirelessly by the Patient Engagement Subcommittee, Chaired by Jill Murrell, PhD. AMP Advocacy would like to thank all the members of the subcommittee for their hard work.
AMP looks forward to future projects from the Subcommittee to update and grow our patient facing materials to expand access to genetic testing for all patients.
AMP is excited to announce that we launched our first Spanish graphic in 2022, “Una Mirada a Un Laboratorio Clinico de Diagnostico Molecular”, which is a translation of our “Inside a Clinical Molecular Diagnostics Laboratory” graphic. To help with this effort, AMP’s policy and advocacy team created the Translation Content Editing Working Group to help to edit our translated materials. In addition to Spanish, the group’s volunteers have been working on translations to Mandarin, Romanian, and Farsi and other languages. If you are interested in participating in this working group, or have questions about our efforts, please contact the Policy and Advocacy Department at firstname.lastname@example.org.
AMP is excited to announce that our 3rd Annual Molecular Pathology Economics Summit will held on September 13th, 2023 at the Omni Shoreham Hotel in Washington, DC.
After being delayed for two years due to COVID-19, AMP held its second Annual Molecular Pathology Economics Summit on July 15, 2022. The event brought together 67 attendees representing patient advocacy groups, pharmaceutical companies, diagnostic manufacturers, clinical laboratories, as well as trade and professional associations. Robust, candid discussions between stakeholders explored the unique challenges they face, barriers to patient access to molecular diagnostic testing, as well as potential solutions and/or novel approaches to overcoming these barriers with the goal of identifying shared policy agendas for the participating stakeholders. At the Summit, AMP held its first ever Innovation Lab where stakeholders presented projects and proposals to expand patient access to molecular diagnostics. This provided opportunities to build partnerships amongst attendees to collaborate on action items to improve patient access in the future.
The 2023 program will build on the work accomplished at the past two Summits and incorporate recent developments in the field. Contact the AMP Policy and Advocacy Department (email@example.com) if you have specific topics that you would like addressed at the AMP 2023 Molecular Pathology Economics Summit and we hope that you will plan to join us in Washington, DC.
If you would like to be notified as more information becomes available, please complete this form.
The European Union's (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on May 5th, 2017, and fully implemented on May 22, 2022, sets forth new requirements for medical devices and in vitro diagnostic manufacturers that distribute products in the EU. The IVDR will replace the current In Vitro Medical Devices Directive (IVDD) and places Laboratory Developed Testing Procedures (LDPs) under each countries’ regulatory body to ensure quality assessment. Many challenges have delayed the implementation of the IVDR, including the difficulty in bringing Notified Bodies (NB) online in a timely manner. While the industry as a whole has expressed concern with the new regulation, it is unclear how clinical diagnostic laboratories and the molecular professionals in particular are being affected by the implementation of the IVDR.
In April 2023, AMP circulated a survey to molecular professionals around the implementation of the EU IVDR legislation and the impact it had on their practices. This survey probed professionals within our membership (US and International) and beyond to try to identify successes, failures, and other impacts on laboratories as they worked to come in compliance with these new regulations. AMP engaged its international membership to better understand the global scope and impact of the EU IVDR on clinical laboratories and patient access. In addition to providing us with an opportunity to gather insights on any questions our members still have regarding this new regulation, we will use this information to understand the larger impact this regulation is having on the molecular diagnostic laboratory community workforce.
We would like to thank all of those who participated in the survey process. AMP is currently analyzing the data to understand the impact on laboratories offering molecular diagnostic tests and downstream patient access to these tests in the EU. This data will be used to inform future advocacy by AMP and we will publish this data and summarize these results on AMP’s advocacy website. The results from the survey will help guide conversation during a session focused on the IVDR at our AMP Europe 2023 Congress. This project was generously supported by Loxo@Lilly.
On March 15th, 2023, AMP released the results of the Protecting Access to Medicare Act (PAMA) Impact Survey. Thank you again to all the volunteers that participated.
The Protecting Access to Medicare Act (PAMA) of 2014 has resulted in inappropriately priced tests due to a flawed data reporting system. PAMA led to steep cuts to pricing such that reimbursement no longer reflects the effort or expertise required to perform the procedure. Through this survey, AMP sought to gain more insight into the financial and logistical impacts of this legislation. Fortunately, Congress once again delayed PAMA’s reporting requirements and subsequent cuts to payments rates for another year and the Saving Access to Laboratory Services Act (SALSA) was recently introduced as a way to permanently reform PAMA. Read more here in the Winter 2023 ChAMPion.
AMP intends to use these survey results to support its advocacy for appropriate payment rates and effective PAMA reform, ultimately benefiting your patients’ access to care. The results of this assessment are critical to inform discussions with payers, federal agencies, and members of Congress. AMP will continue to actively work with many professional organizations as part of its ongoing commitment to support public policies that ensure fair and reasonable reimbursement solutions.
To read the full PAMA Impact report please visit: www.amp.org/PAMASurvey
AMP Sign-On Workforce Shortage Response - April 25, 2023
AMP Response to Senate HELP Committee Workforce Shortage RFI - March 20, 2023
AMP response to NGS on Molecular Pathology Procedures - March 18, 2023
AMP response to Prior Authorization Proposed Rule - March 13, 2023
AMP sign on to the Reducing Herditary Cancer Act - March 1, 2023
The AMP EAC and PRC work diligently to provide input to Congress and relevant agencies on all issues affecting regulation and reimbursement of molecular procedures. You can peruse all recent comment letters here.