AMP 2016 Committee and Subdivision Annual Reports

Clinical Lab Fee Schedule (CLFS) and Gapfill Determinations
During the summer, AMP provided written and oral comments to CMS on the Calendar Year 2017 Clinical Lab
Fee Schedule (CY2017 CLFS) and 2016 Gapfill Determinations. Dr. Aaron Bossler represented AMP at the annual
CLFS meeting at CMS on July 18, 2018. He presented crosswalk recommendations for the new 2017 CLFS
molecular pathology procedures, genomic sequencing procedures (GSPs), and microbiology procedures.
In September, CMS released the CY2017 CLFS Preliminary Determinations and the 2016 Final Gapfill Payment
Determinations. For most of the new 2017 molecular CPT codes, including microbiology procedures and
Genomic Sequencing Procedures (GSP’s), CMS recommended use of crosswalk to existing codes to determine
initial pricing. Many of the preliminary CMS recommendations included changes recommended by AMP. AMP
appreciates that the preliminary CMS determination abandons gapfill for the GSPs and instead recommends
crosswalk for price determination of the new GSP codes in 2017. AMP is in the process of developing comments
to CMS on these values.
For the 2016 gapfill final determinations, AMP had submitted comments to CMS on the preliminary
determinations in August 2016. Since CMS began utilizing the gapfill process to price services on the CLFS, AMP
has expressed concerns about the lack of transparency. It remains difficult to constructively respond to gapfill
values as the lack of transparency leaves no discernible rationale for how MACs determine preliminary gapfill
pricing. AMP hopes that implementation of PAMA will ultimately improve the pricing process for molecular
tests. However, initial price undervaluation remains a significant concern and threatens patient access to care if
laboratories stop being able to provide critical procedures. In late September, CMS released final gapfill
determinations and AMP is in the process of responding to those values.
Educational Initiatives
In an effort to keep the membership informed of economic issues facing molecular diagnostics and to increase
the knowledge base of the often complicated issues, the EAC held various webinars throughout the year. The
first EAC-led webinar of the year provided an overview of the molecular coding, coverage, and reimbursement
processes with a focus on Centers for Medicare and Medicaid Services’ (CMS) methods used by the MACs to
make coverage assessments. Later in the year, upon the release of the PAMA final rule, EAC held another
webinar to inform membership on details contained within the final rule. EAC members also assisted with the
webinar series based on the EAC, PRC, and CPC joint manuscript titled “The Spectrum of Clinical Utilities in
Molecular Pathology Testing Procedures for Inherited Conditions and Cancer.”
Medicare Administrative Contractors’ (MACs) Local Coverage Determinations (LCDs)
AMP continues to advocate with CMS regarding coverage policy actions taken by Medicare Administrative
Contractors (MACs). During 2016, AMP provided responses to various MACs for over 15 draft LCDs. Many of the
coverage policies released contained substantial problems, either denying or narrowing coverage for important
molecular pathology procedures. Currently, AMP is in the process of drafting comments to several additional
draft local coverage determinations (LCDs) which will be submitted to the MACs in late November. Monitoring
emerging policies continued to be a major focus of the committee and was led by Dr. Richard Press. AMP and
the College of American Pathologists (CAP) collaborated to draft joint responses. The EAC is very thankful to the
AMP members who volunteered their time and subject matter expertise to assist in responding to the diverse
coverage policy issues.
In 2016, the MolDx Program announced expansion to WPS (MAC Jurisdictions 5 and 8), which includes the states
of Iowa, Kansas, Missouri, Nebraska, Indiana, and Michigan. AMP is extremely concerned about the rapid
expansion of the MolDx Program. With WPS’ recent adoption of the program, 6 MAC jurisdictions, including 23
states, American Samoa, Guam, and the North Mariana Islands operate under the program; this represents half
of the MAC jurisdictions. The continued expansion of MolDx creates a number of issues for laboratories and the
AMP members who provide molecular diagnostic testing. In September, AMP EAC leaders met with
representatives from the pricing and coverage groups at CMS to again discuss AMP’s concerns.