Palmetto: AMP responded to a new policy by Palmetto entitled “Analytical Performance Specifications for Comprehensive Genomic Profiling”.
AMP expressed numerous serious concerns including circumvention of the local coverage determination (LCD) process, strict testing limitations, and a prohibition against PhD scientists, which is in direct violation of the Social Security Act and CMS’ regulations in both CLIA and the PFS. AMP’s letter to Palmetto is available here: http://amp.org/publications_resources/position_statements_letters/documents/AMPResponsetoM00118-V1_FINAL.pdf
AMP continues to advocate with CMS regarding actions taken by Medicare Administrative Contractors (MACs). It is important that all AMP members be aware of draft LCDs, articles, and other policies in their jurisdictions that could restrict patient access to testing. Communicate your concerns directly to your MAC Medical Director, contact information may be found at: https://www.cms.gov/medicare-coverage-database/indexes/contacts-part-b-medicare-administrative-contractor-index.aspx?bc=AgAAAAAAAAAA&
In collaboration with CAP, AMP recently responded to numerous draft LCDs issued by various MACs. To view our recent responses please visit: http://amp.org/publications_resources/position_statements_letters/AMP2015PositionStatements.cfm
Clinical Lab Fee Schedule (CLFS) Meeting: Aaron Bossler represented AMP at the annual CLFS meeting at CMS on July 16, 2015. He presented crosswalk recommendations for the 2016 CLFS molecular pathology procedures, 2015 molecular pathology and genomic sequencing procedure reconsiderations, and the new 2016 genomic sequencing procedures. AMP’s recommendations were very well received and endorsed by other organizations such as AACC and CAP. AMP’s CLFS crosswalk recommendations are available here: http://amp.org/publications_resources/position_statements_letters/documents/AMPCommentsonCLFS-CY2016-FINAL.pdf
Preliminary Gapfill Determinations: AMP provided comments to CMS on the preliminary gapfill determinations of several molecular pathology and genomic sequencing procedures. AMP’s comments are available here: http://amp.org/publications_resources/position_statements_letters/documents/AMPCommentsonPreliminaryGapfill2015-FINAL.pdf
Next Generation Sequencing (NGS) Reimbursement: AMP officially released the micro-cost and health economic models in March 2015. With almost 400 downloads thus far, we hope members are utilizing these models to accurately calculate the cost of their NGS services and, therefore, effectively communicate value and cost to payers. Hampering the success of pricing efforts is emerging non-coverage decisions for multi-gene sequencing assays, this continues to be a major advocacy focus in 2015. AMP is currently conducting a survey on downloaders to gather information on how laboratories are using these models. The models and supporting materials are available here: http://amp.org/committees/economics/NGSPricingProject.cfm
Jill Hagenkord submitted CPT code change proposals to AMA for cardiac channelopathies and inherited cardiomyopathy on behalf of AMP on July 8, 2015.
Proposals for Oversight of Laboratory-Developed Procedures (LDPs): To assist in discussion efforts about the various proposals circulating in Congress, AMP created a “Principles for Oversight of Laboratory Developed Procedures” which serves a checklist for any proposals or legislation that address regulation of LDPs. The checklist is available here:
In June, AMP provided comments to the House Energy & Commerce Committee on Draft Legislation on the Regulation of In Vitro Clinical Tests. AMP does not support this legislation and the comments summarize our concerns. AMP maintains that Laboratory Developed Procedures (LDPs) are professional services and thus are very distinct from distributed tests. Additional concerns include inappropriate risk classification, inadequate updates to CLIA regulations, and increased regulatory burden on and product liability to laboratories and medical professionals. AMP’s comments are available here: http://www.amp.org/publications_resources/position_statements_letters/documents/AMPcommentsonECDiagnosticDraftBill-FINAL.pdf
On June 22, AMP met with Senate Health, Education, Labor, and Pensions (HELP) Committee staffers comprised of the LDT working group to discuss the oversight of diagnostics. The working group formed in order to begin the process of drafting legislation focused on regulating LDPs. Drs. Janina Longtine, Roger Klein, Eric Konnick, and Cindy Vnancak-Jones participated in the meeting. AMP members answered questions and helped educate staffers on many aspects of laboratory practice such as where labs get their samples, how testing procedures are developed, and how many testing procedures are performed each year.
AMP continues to provide expertise to assist Hill staff as they tackle this complex issue. On August 4, AMP met with Senate HELP Committee staffers and presented AMP’s Proposal for Modernization of CLIA Regulations for Laboratory Developed Testing Procedures (LDPs). The proposal is a product of the CLIA Modernization Workgroup of the Professional Relations Committee (PRC). In developing this proposal, AMP reached out to other professional associations and received very useful comments, and were able to incorporate most of them. AMP continues to dialogue with the larger community of policymakers and stakeholders. The proposal is available here: http://amp.org/advocacy/documents/AMPCLIAmodernizationproposalFINAL.pdf
Genetic Information Nondiscrimination Act (GINA): AMP joined over 60 other organizations in a letter to the Equal Employment Opportunity Commission (EEOC) on the EEOC Proposed Rule expressing concern that the Proposed Rule regarding the Americans with Disabilities Act (ADA) would erode long-standing and important protections afforded to employees under the ADA and would pave the way for weakening the GINA. The letter is available here: http://amp.org/publications_resources/position_statements_letters/documents/AdvocateSign-onletterreEEOCNPRMonwellnessprogramsandtheADA.pdf
“The evolving role of the laboratory professional in the age of genome sequencing: A vision of the Association for Molecular Pathology” by Iris Schrijver et al. was published in the July issue of JMD. The AMP paper describes the current and future roles of the laboratory professional as genomic sequencing analysis becomes an ever more increasingly important tool in diagnostic medicine. The paper is available here: http://jmd.amjpathol.org/article/S1525-1578%2815%2900071-9/abstract