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AMPlifications Vol. 20, No. 3, November 2014
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Coming up next week, the AMP 2014 Annual Meeting offers an abundance of educational and networking opportunities. Sessions from committees are mentioned below and the full program is available online now. Also, if you haven't registered but plan to attend, you can still register online in advance. We're excited to have so many special and exciting events at this year's Annual Meeting!

  • Welcome Reception and Special Address by Dr. Francis Collins
  • Specialty Lunches (these are part of your registration but space is limited so show up early!)
  • Early Bird Case Study Sessions: Don’t like to sleep-in while at the Annual Meeting? Early risers have the opportunity to listen and learn as trainees, technologists, and seasoned molecular pathology professionals present interesting case studies at special Early Bird sessions.
  • Trainee Luncheon: Trainees, residents and fellows are invited to meet and mingle with senior and junior faculty members in molecular pathology to explore strategies for getting employed at the annual Trainee Lunch. You won’t want to miss out on the annual text book give-away!
  • Educational Needs Survey: Results of the Training & Education Committee’s annual Educational Needs Survey will be presented at a lunch session. Participate in the discussion on identifying the knowledge gaps in molecular diagnostics and genomics education so that AMP Education can better address those needs in 2015.
  • Innovation & Improved Patient Care: A report on the Evidence Basis and Clinical Utility for Molecular Testing, an update on Practice Guidelines for the Evaluation of Molecular Markers for Colorectal Cancer, and an Informatics special lunch highlight clinical practice efforts.
  • AMP Economic Affairs and Professional Relations Committees are hosting sessions on Oversight of LDPs and the Microcosting and Health Economic Modeling Project.
  • Corporate Workshop Day: this ever-popular day of exhibitor-hosted workshops is free and available to anyone. Located at the Gaylord National (where the Annual Meeting will be held), this event offers more than 70 sessions. Download a PDF of the program now and plan your day in advance.

Want to get involved in AMP? The Annual Meeting is the perfect time to network with your colleagues and investigate potential opportunities to volunteer in AMP projects. Ask your AMP Committee Members, Subdivision Leadership, or AMP staff - all of whom will be wearing identifying ribbons on their badges - about upcoming opportunities.


More than 70 AMP members are expected to participate in AMP Advocacy Day on November 12, 2014! We aim to educate Congressional offices on the following themes:
1. The value of molecular testing and the critical role of the molecular professional to positively impact patient care.
2. Concerns with FDA regulation of LDPs, including asking Congress to direct FDA to engage in the notice and comment rulemaking process, ensuring a response to all comments and performance of cost impact analysis.
3. The potential impact of the reporting system and potential penalties of the "Protecting Access to Medicare Act of 2014" (PAMA).

Elaine Lyon, Nina Longtine, Aaron Bossler, and Roger Klein will speak at the AMP Congressional briefing during Advocacy Day on November 12 on the topic of “Realizing the Dream of Precision Medicine by Preserving Access to Innovative, High Quality Tests.” Elaine, Nina, and Aaron will also be speaking at a related press conference on November 13 to share their current understanding of how the FDA draft framework could impact patient care.


CMS released the 2015 Clinical Laboratory Fee Schedule (CLFS) proposed determinations on October 03, 2014. CMS opted to use gapfill for most of the new Gene Sequencing Assay (GSA, aka NGS) CPT codes, but AMP’s crosswalk recommendations for the microbiology codes were accepted. CMS’ decision to use gapfill for GSA codes makes the data collected from AMP’s Micro-costing and Health Economic Value Analysis project all the more valuable.

AMP responded to new Pharmacogenomics Testing dLCDs issued by Cahaba and Noridian. AMP will also be responding to Palmetto’s billing guidelines that they are not covering CDH1 genetic testing since they are not tests typically performed in the Medicare population.

CPT Code Proposal The EAC CPT Subcommittee advises on AMP’s position on new CPT code proposals submitted to the Pathology Coding Caucus (PCC). The Work Group, consisting of Jill Hagenkord (Chair), Aaron Bossler, Samuel Caughron, Roger Klein, Elaine Lyon, Jan Nowak, and Linda Sabatini, has designed new code proposals for disorder specific multigene panels that were submitted to the AMA CPT Editorial Panel in November 2014.

On October 3, 2014, the Food and Drug Administration’s (FDA) draft guidance document entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Framework Guidance) and an accompanying draft guidance document entitled FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) were published in the Federal Register (FR). The dockets for public comment for these guidances will be open for 120 days from the date of publication of the notices in the FR. The FDA intends to hold a public meeting in early January 2015 to collect additional input during the comment period. AMP intends to provide comments and encourages members to do so as well.

AMP has signed onto a letter prepared by the American Medical Association requesting that the FDA pursue notice and comment rulemaking in relation to the FDA guidance on oversight of LDTs.


During the Annual Meeting, AMP will be launching a new communication tool that will allow you to send a message to your members in Congress. Look for future announcements on how you can participate in AMP advocacy online.



A new AMP policy addressing Clinical Practice Guideline development was developed by the CPC and approved by the AMP Board of Directors in September 2014. This guidance document will assist AMP leadership to identify, prioritize, and implement the development of guidelines needed based upon input from the AMP membership. Look for announcements on how to contribute your ideas for practice guideline development in January 2015.

Earlier this fall, AMP members participated in an open comment period on the ACMG Interpretation of Sequence Variants Work Group manuscript draft currently in development and due to be completed in 2015. Elaine Lyon and Julie Gastier-Foster are the AMP liaisons to this project.


AMP’s Whole Genome Analysis group will be retired in 2015, having successfully completed their original charge of assisting the incorporation of this once disruptive technology into clinical practice. WGA’s accomplishments include a JMD article titled, Opportunities and Challenges Associated with Clinical Diagnostic Genome Sequencing. The CPC and Board of Directors would like to recognize WGA Chair Jane Gibson and 2014 WGA Work Group members for a job well done. Future WGA/NGS-related projects will be developed and implemented by the CPC.

The Clinical Practice Committee is will be accepting applications through November for a junior (trainee) member to serve on the committee for a two-year term (2015-2016). Watch for the special CHAMP announcement with more information.


At AMP this year, as you attend sessions, converse with your colleagues, and listen in on the Business Meeting, keep an ear out for important announcements regarding clinical practice guidelines, papers in press, and work group development!



Recruiting Junior (Trainee) and Technologist Committee Members: The T&E Committee will be accepting applications through November for a junior member and technologist member to serve on the committee for a two-year term (2015-2016). Watch for the special CHAMP announcement with more information.

There's still time to register for the JMD 2014 CME Program by logging into AMP Online Services. Earn up to 48 CME credits! PDFs of the six exams are available online as well.

AMP Molecular Genetic Patholo
gy 2015 Review Course: The review course is scheduled for April 30-May 3 in Bethesda, MD. Further planning and details will be announced in December. The Course Director for the MGP 2015 Review Course is Iris Schrijver.

The T&E Committee launched a series of webinars on the basics of next generation sequencing. This successful "NGS 101 Series" are available now via AMP Online Services and include:
“NGS 101 for the Clinic,” presented by Birgit Funke, PhD, FACMG on July 23.
• “Viewing and Interpreting Sequencing Data,” presented by Patrik Vitazka, MD, PhD, on September 11.
• “Nomenclature in the Context of Next Generation Sequencing Bio-Informatics,” presented by Robert Daber, PhD on October 29.

Registration is now open for the upcoming webinar, “The Role of the Pathologist in Reporting & Communicating Accurate and Succinct Results in the Genomic Era”, presented by Colin Pritchard on November 7 at 2:30pm Eastern.

AMP continues to collaborate with other organizations by providing endorsement and/or AMP member expertise to organize or present educational sessions in molecular diagnostics, including:
ASCO/CAP/AMP Molecular Oncology Tumor Boards monthly webinar series in 2015, with Michelle Shiller and Maria Arcila representing AMP on the planning committee.
SLAS 2015, February 7-11 in Washington DC. AMP members Roger Lebo and Reid Robison are presenting.
Cambridge Health Institute (CHI) Molecular Medicine Tri-Conference: February 15-17 in San Francisco. AMP speakers include Elaine Lyon, Loren Joseph, Paul Rothberg, Alexis Carter, Federico Monzon, Mark Routbourt, Vicky Pratt, and Monica Basehore.
USCAP 2015: March 21-27 in Boston. Marina Nikiforova and Eric Duncavage will co-moderate AMP’s Companion Society Meeting on the evening of Sunday, March 22, 2015. An AMP reception for all Trainees is also being scheduled.



Look for more AMP Case Reports that have been published in CAP TODAY. The next report will be in the November issue and available online along with the Q&A. The Publication and Communication Committee reviews case reports submissions as they are received. Consider drafting and submitting one for a future issue.


The International Membership Grant application process will be launching in the coming weeks. The Grant allows for selected International members to receive complimentary AMP membership for one year. Look for details in an upcoming CHAMP announcement.


The International Affairs Working Group (IAWG) continues to help advance education to molecular diagnosticians outside of the U.S. If you are involved in the planning for a molecular pathology-related educational event outside the U.S., consider applying for support from AMP. The IAWG will be reviewing applications in early 2015.


The Membership Affairs Committee will begin developing a survey of AMP members early next year. The goal is to gather information from members to inform future decisions by leadership regarding education, advocacy, and related initiatives.



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