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AMPlifications
Vol.20, No. 1, July 2014
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Congratulations to the newly elected AMP leadership!

We thank them for their service and thank you for voting.

See the list of newly elected AMP 2015 leadership at: www.amp.org/AMP2014electionresults.cfm

 

ADVOCACY

Molecular pathology CPT codes; payment and coverage problems:
Representatives from AMP, CAP, AMA, ACMG, ASCLS, ASCP, ASHI, NFXF, and WDA have been meeting with CMS to outline problems with the MolDX program, the way CMS is proceeding with the molecular pathology CPT codes, and to make recommendations. This is a large and broad stakeholder group that is working very hard to protect patient access to necessary testing and health care professionals' ability to provide that care. Per request from Tamara Syrek-Jensen during a March meeting with the CMS coverage group, the multi-society coalition provided a plan that included Key Recommendations for Medicare Coverage of MolDx and NGS Services. Currently, ACMG is taking the lead on advocating with Medicaid for coverage and payment. Most of the tests with Medicaid coverage problems are for inherited conditions. ACMG is gathering coverage and payment info from their membership and AMP members are welcome to participate.


In its final Physician Fee Schedule (PFS) rule, CMS did not apply Outpatient Prospective Payment System and Ambulatory Surgical Center rates to set the practice expense relative value units for the PFS, which would have cut pay an average of 25 percent. AMP joined the other pathology and laboratory associations to voice strong opposition. AMP members answered a Call to Action and contacted their re
presentatives in Congress. Responding to intense lobbying efforts and constituent requests, many members of Congress co-signed letters to CMS Administrator Marilyn Tavenner that were instrumental in stalling this devastating proposed policy.

 

From July 2013 through May 2014, AMP has drafted and/or submitted comments in response to 14 DLCDs by MACs. To date 26% of requests have resulted in changes in the final LCD. Based on the positive impact of the comments the Economic Affairs Committee expects to continue to respond to DLCDs.

Federal agencies, governmental panels, and policy related committees:
In April, Congress passed a law (http://www.gpo.gov/fdsys/pkg/BILLS-113hr4302ih/pdf/BILLS-113hr4302ih.pdf) that provides a 12-month patch to the correction to the Sustainable Growth Rate (SGR) formula that would have implemented substantial cuts in physician payments. The “SGR patch” contains reforms to the Clinical Laboratory Fee Schedule (CLFS). AMP issued a letter to Senate Majority Leader Harry Reid ahead of the Senate vote outlining concerns with Section 216, “Improving Medicare Policies for Clinical Diagnostic Laboratories” of H.R. 4302, the “Protecting Access to Medicare Act of 2014” (PAMA). The letter noted that the section disadvantages hospital-based laboratories, disregards the CPT code process, conflicts with existing law, and creates confusion among stakeholders. The entire letter can be read here: http://bit.ly/1pI84AP.

During the public meeting for the new CLFS services on July 14, AMP will comment regarding pricing for the new Gene Sequencing Assay (GSA, aka NGS) CPT codes and CLFS reform provision in the PAMA bill.


Despite displeasure with much of Section 216, several of AMP’s requests over the past year have been included in the law. Most significantly, molecular pathologists are referenced specifically in the language. In fact, we are the only medical specialty group identified. This this is a direct reflection of AMP’s lobbying to ensure that molecular pathologists are included in all federal advisory panels focused on laboratory testing. This makes it likely that AMP will have a voice on the newly created advisory panel advising CMS on future coverage and payment determinations for laboratory tests.


Chairman Fred Upton and Representative Diana DeGette are hosting roundtables to identify opportunities to help spur innovation as part of the 21st Century Cures initiative. AMP responded to the request for comments to the white paper entitled “21st Century Cures: A Call to Action” and will continue to follow initiatives of the roundtables.

Capitol Hill:
AMP has met with numerous offices on Capitol Hill regarding restrictions on federal employee travel, coverage and reimbursement of molecular diagnostics, and the oversight and regulation of diagnostics. Specifically, AMP has met with staff for Senators Carper, Coburn, and Reid, and also met with staff working for Representatives Upton, DeGette, Price, Schock, Paulsen, and Burgess. Additionally, after the passage of PAMA, AMP invited Dan Todd, Professional Staff on the Senate Finance Committee to participate in the EAC call to discuss and clarify provisions in the legislation.

There is still time to register to participate in AMP Advocacy Day on November 12, 2014. To learn more and to register, please visit www.amp.org/meetings/2014/ampadvocacyday.cfm.

 

AMP AT WORK FOR YOU

The International Affairs Working Group (IAWG) is growing and now has representation from 13 countries! The IAWG and AMP celebrate the one year anniversary of AMP's first three International Affiliate Organizations: the Hong Kong Society for Molecular Diagnostic Sciences, the Korean Society for Laboratory Medicine, and the Molecular Pathology Association of India.

 

The Membership Affairs Committee (MAC) looks forward to hosting two events during this year's Annual Meeting. One is a session designed for attendees who are early in their career and the other is a luncheon to welcome first-time meeting attendees. Look for a CHAMP posting from the MAC Chair, Nirali Patel, requesting your input on these sessions.

 

The Publication and Communication Committee is busy reviewing the recent submissions for AMP Case Reports for CAP TODAY. View prior reports online now at: http://www.amp.org/publications_resources/AMPCaseReviews.cfm.

 

AMP staff welcomed  AMP member Robyn Temple-Smolkin in January 2014 as a project manager to support the Innovation & Improved Patient Care area of the AMP Strategic Plan. Since moving to independent management, AMP welcomed Rhonda Jenkins as office manager.




EDUCATION

The AMP 2014 Annual Meeting and 20th Anniversary Celebration will be held November 12-15 at the Gaylord National Resort & Convention Center, just outside of Washington, DC.  View the preliminary program, register, and book your hotel online now at: www.amp.org/2014.

 

The AMP 2014 Molecular Pathology Outreach Course, AMPlicons: A Practical Molecular Toolkit and Case Studies, will be offered on Wednesday, November 12 at the Gaylord National Resort & Convention Center at the National Harbor, MD (just outside of Washington, DC). Pathologists, residents, laboratory directors and technologists who have little experience with molecular diagnostic testing are encouraged to attend. The course will provide an overview of techniques and instrumentation used in molecular testing from the framework of the “Molecular Pathology/Molecular Diagnostic Toolkit.” Space is limited, so register today at: www.amp.org/mpoc.


The Training & Education (T&E) Committee is presenting a new series of webinars with the theme of “Next Generation Sequencing 101.” The first webinar, “NGS 101 for the Clinic,” will be presented by Birgit Funke on July 23 at 1:00pm (ET). Registration is free and online at: https://www2.gotomeeting.com/register/432160738. For a list of other upcoming webinars, visit: www.amp.org/Webinars/future_webinars.cfm


AMP continues to collaborate with other organizations by providing endorsement and/or AMP members to present educational sessions or courses in molecular diagnostics, including:
The Association for Pathology Informatics (API) Summit 2014 in May, a session on “Clinical Informatics in the Era of Genomic Medicine – Opportunities and Challenges,” presented by Alexis Carter, Mark Routbort, and Federico Monzon.
The Korean Society of Genomics and Molecular Diagnostics (KSGMD) Conference in June, a session on “Harmonization and Standardization” presented by Lisa Kalman. The KGSMD’s parent organization, the Korean Society for Laboratory Medicine (KSLM) is an official Affiliate Organization of AMP.
AACC 2014 Annual Meeting & Clinical Lab Expo in July, a short course on “Navigating Coding and Reimbursement for Molecular Diagnostic Services” presented by Aaron Bossler and Elaine Lyon. Visit AMP in booth 1834!
Cambridge Health Institute (CHI)’s Next Generation Dx Summit in August with a plenary session, “Next-Generation Sequencing in Clinical Practice: Case Reports of Clinical Utility and Reimbursement,” moderated by President Elaine Lyon and presented by Andrea Ferreira-Gonzalez and Madhuri Hegde.

The Beaumont Annual Symposium on Molecular Pathology (Michigan) in September, sessions presented by Jennifer Hunt, Laura Tafe, and Glenn Palomaki.
CAP’ 14 in September, a plenary session on “Molecular Medicine - Can We Afford It?” that will discuss the economics of diagnostics, co-organized with Jordan Laser for AMP.

ASCP 2014 in October, a “Molecular Diagnostics Primer” course taught by Giovanni Insuasti, Ted Schutzbank, and Jane Gibson.

The T&E Committee has appointed Gregory Tsongalis to be AMP’s representative to the PhD Task Force of the Pathology Workforce Summit that met in December 2013. The task force, comprised of multiple pathology-related organizations, is charged with identifying and tracking the population of PhD scientists being trained for careers in pathology and laboratory medicine.

A Report of the T&E Committee, “Molecular Pathology Curriculum for Medical Laboratory Scientists,” was published in JMD. The report was prepared by the Medical Laboratory Scientist Curriculum Task Force of the T&E Committee (Sara Taylor, Katie Bennett, Josh Deignan, Ericka Hendrix, Susan Orton, Shalini Verma, and Ted Schutzbank). Read the full text article at http://dx.doi.org/10.1016/j.jmoldx.2014.02.003 and the associated press release at: http://www.amp.org/about/press_releases/documents/042214_CurriculumforLabScientists.pdf

 

INNOVATION & IMPROVED PATIENT CARE

AMP continues to work collaboratively with other organizations to improve clinical practice and patient care:
Kojo Elenitoba-Johnson and Loren Joseph co-moderated a two-day Genomics Roundtable in April 2014 co-sponsored by the American Society of Clinical Oncology, AMP, and the College of American Pathologists to discuss issues related to oncology clinical practice and genomic laboratory medicine. AMP members Annette Kim and John Pfeifer presented and AMP was represented by Marilyn Li and Ron Przygodzki. AMP looks forward to potential collaborative efforts with both ASCO and CAP in this area.

Monica Basehore was appointed AMP liaison to the National Institute of Standards and Technology (NIST) Genome in a Bottle Consortium Workshop Steering Committee: http://genomeinabottle.org/.
Sue Richards was appointed AMP liaison to the American College of Medical Genetics Incidental Findings in Inherited Diseases Update Workgroup.
Anna Berry was appointed AMP liaison to the American Society of Cytopathology and Papanicolau Society of Cytology Joint Task Force for recommending the best use of cytology samples for molecular analyses.

In addition, AMP became a member of the Cancer Leadership Council earlier this year.

Members of the ASCP/CAP/AMP Clinical Practice Guidelines Development Group for the Evaluation of Molecular Markers for Colorectal Cancer are currently in the literature review phase of the project. The representatives for AMP are Antonia Sepulveda (Co-Chair), Federico Monzon, Noralane Lindor, and William Funkhouser. Join us at their AMP 2014 Annual Meeting session to hear more about the guidelines currently in progress.

AMP is a member of the FDA Network of Experts program: Ron Przygodzki represented AMP at their recent Open House in May. The Network of Experts program is an interface between FDA and AMP to assist in quickly providing subject matter experts to FDA work groups. AMP serves as the conduit for these announcements to AMP members, providing our members the opportunity to volunteer their expertise for these panels. Watch for CHAMP announcements of opportunities to volunteer!

Bryan Krock was appointed to a two-year term as Junior Member to AMP’s Clinical Practice Committee. Welcome to CPC Bryan!

 

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