Reimbursement for molecular pathology tests is
AMP’s primary advocacy issue!
View all of AMP's position statements and comments online at: http://www.amp.org/publications_resources/position_statements_letters/2013AMPPositionStatements.cfm
• Gapfill Pricing: AMP submitted comments to CMS to explain its concerns about the gapfill process for pricing the new codes and to recommend modifications to the preliminary gapfill process part of the official public record regarding the 2013 gapfill payment amounts. CMS is slated to report their final determinations in September. During the 2013 Clinical Laboratory Fee Public Meeting on July 10, Katherine Tynan presented AMP’s crosswalk recommendations for new codes 81161, 812XX, and 876XX. Additionally, AMP is working with a coalition of other professional associations and as a member of the Coalition to Strengthen the Future of Molecular Diagnostics (CSFMD).
• Coverage Issues: Comments were submitted in response to the following Medicare Administrative Contractor (MAC) Draft Local Coverage Determinations (LCD):
WPS - Molecular Diagnostic Testing (PATH-037) (DL33219)
Novitas - Biomarkers Overview (DL33640 and DL33638)
First Coast - Molecular Pathology Procedures for Human Leukocyte Antigen (HLA) Typing (DL33732)
First Coast - Molecular Pathology Procedures (DL33703)
Palmetto - Genetic Testing for Lynch Syndrome (DL33779)
Palmetto - Molecular Diagnostic Tests (MDT) (DL33599)
If you would like to view the letters, please visit: http://www.amp.org/publications_resources/position_statements_letters/2013AMPPositionStatements.cfm
• Many thanks to those who helped to prepare the letters or agreed to be the contacts for the local MAC comments including Kay Jewell, Aaron Bossler, Jan Nowak, Katherine Tynan, Roger Klein, Vivianna Van Deerlin, Dara Aisner, Phillip Ruiz, Gretchen Schaef Johns, Maria Bettinotti and Andrea Ferreira-Gonzalez. A number of members from AMP and other organizations co-signed the letters. Several patient advocacy groups also wrote separate letters in support of broader coverage: Fragile X Foundation, Alpha-1 Foundation, SADS (Long QT). The next phase of advocacy will be at the national CMS.
• The Economic Affairs Committee will soon release a survey to ascertain the extent of payment denials. Please respond to that survey with as much information as possible.
• AMP submitted comments regarding concerns with the CMS CY2014 Proposed Physician Fee
Schedule (PFS) Rule that was announced on July 18, 2013. The comment period for the Proposed Rule closed on September 6, 2013. The Final Rule is expected to be published on or around November 1, 2013, and new rates will be effective beginning January 1, 2014. The Rule includes a provision to bundle tests and cap reimbursement for certain services in the PFS at the Outpatient Prospective Payment System (OPPS) rates for 2013. AMP joined seven other pathology organizations to provide an initial response in August regarding general concerns with the impact this rule could have to patient access to testing. Both letters can be read here: http://www.amp.org/publications_resources/position_statements_letters/2013AMPPositionStatements.cfm
• AMP physician members are again reminded of the importance of using the G0452-26 HCPCS code when you provide a professional interpretation of a molecular pathology test. For more information regarding the specific requirements CMS provided for billing the professional interpretative component for molecular diagnostic testing please review the CHAMP Open Forum post by Mary Williams on August 26.
• The AMA Molecular Pathology Advisory Group is currently developing CPT code proposals based on the AMP proposal for genomic sequencing procedures in time for the next submission deadline (October, 28) to the AMA CPT Editorial Panel. Elaine Lyon, Vicky Pratt, Aaron Bossler, Roger Klein, Maria Bettinotti and David Wilkinson are all serving on the AMA Molecular Pathology Advisory Group.
• AMP continues to provide recommendations to the CAP Pathology Coding Caucus (PCC) for needed new molecular pathology CPT codes. The CAP PCC is the first step in developing new pathology CPT codes. Jan Nowak is AMP’s representative.
• LDT White Paper: AMP continues to work with the FDA to educate officials about clinical laboratory practices and operations, and has emphasized the infeasibility of mandating the use of specific assays with particular drugs because of the multiplicity of potential drugs and assays platforms. Additionally, LDTs offer important benefits to patients through the rapid introduction of assays in response to new medical discoveries, enhanced flexibility in performance due to the ability to continually modify assays, and increased innovation stemming from the relative ease in incorporating new test methods and knowledge. AMP will continue to work diligently with FDA on this issue in order to achieve the best outcomes for our patients. The LDT Working Group white paper that addressed the complexities involved with oversight of LDTs was submitted to JMD and is in the peer review process.
• AMP responded to the Presidential Commission for the Study of Bioethical Issues’ request for public comment on the ethical, legal, and social issues raised by incidental findings that arise from genetic and genomic testing, imaging, and testing of biological specimens conducted in the clinical, research, and direct-to-consumer contexts. AMP offered its expertise to assist in the Commission’s efforts and encouraged the Commission to review guidelines and statements from pathology and genetic professional societies engaged in the practice of genomic medicine. AMP believes genetic testing is best pursued in a medical setting in which pre-test and post-test genetic counseling are available. The likelihood of incidental findings and the reporting dilemmas they entail presents yet another argument in support of this position, and argues against the advisability of direct-to-consumer large-scale genetic testing.
• AMP commented on the New FDA draft guidance for Management of Cybersecurity in Medical Devices indicating that while recognizing the importance of cybersecurity for electronic medical records, diagnostics instrumentation and test systems, standards should not prevent qualified professionals from utilizing, maintaining, and/or repairing the systems.
• AMP submitted comments on the FDA Draft Guidance on Molecular Diagnostic Instruments with Combined Functions. AMP believes this is a step forward in that FDA is formalizing the use of open channels on instruments. View the comments online at:
• The Sunshine Act took effect on August 1st. CMS held a webinar Aug. 8 to review the new rules and you can find the slide deck here: http://www.cms.gov/Outreach-and-Education/Outreach/NPC/Downloads/2013-08-07NPC-OpenPayments.pdf AMP is working with exhibitors to facilitate compliance with the new rules.
• AMP continues to monitor federal restrictions on employee travel, and to advocate for a legislative exemption for conferences, the primary purposes of which are scientific collaboration and medical education.
• Capitol Hill: On July 11, 2013, AMP and ACLU held a briefing to educate members of Congress on the AMP v. Myriad Genetics United States Supreme Court decision. It was very well attended. On the same day, PRC Chair Roger Klein and AMP Government Relations Consultant Jennifer Leib visited with a number of congressional staff members.
• As of September 1, AMP is a sponsoring member of the IOM Roundtable on Translating Genomic-Based Research for Health. Vicky Pratt will represent AMP on the Roundtable.
• AMP became a member of the Federation of American Societies for Experimental Biology (FASEB) on July 1. Greg Tsongalis has been appointed to AMP’s seat on FASEB’s Board of Directors and will serve as AMP’s initial representative on the Science Policy Committee.
• In July, AMP joined 70 other organizations as a founding partner to create a global alliance that will enable responsible sharing of genomic and clinical data.
• AMP continues to participate in a variety of policy discussions with other professional societies, laboratory groups, as well as coalition groups such as the Personalized Medicine Coalition.
• Industry Members: An Industry Member Advisory Group is being formed to assist the Professional Relations Committee to respond to FDA draft guidances to industry and other issues of importance to AMP industry members. Information on how to participate in the Advisory Group will be available soon via CHAMP.