Thursday, August 6, 2015

CMS Announces Members of Lab Advisory Panel; First Meeting 8/26/2015

CMS has announced the experts it has selected for a fifteen-member expert advisory panel on laboratory policy.   The panel will hold its first public meeting on August 26, 2015.

The panel will specifically give CMS an opportunity to reopen and revisit issues about molecular test crosswalking and issues on drugs of abuse testing that were discussed at a prior July 26, 2015 public meeting (here).  Details after the break.  Updated August 20, 2015 with additional information about each panelist.

CMS released a public announcement that it has selected the members of an expert advisory committee on laboratory policy.   Authorization for this new federal advisory panel was created by PAMA - the Protecting Access to Medicare Act of April 2014, which also created a new and evolving payment system for lab tests based on market prices of commercial payers.

The charter for the panel is:

Section 1834A(f)(1) of the Act directs the Secretary of the Department of Health and Human Services (Secretary) to consult with an expert outside advisory panel, established by the Secretary, composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests.   
Such individuals may include representatives of clinical laboratories, molecular pathologists, clinical laboratory researchers, and individuals with expertise in laboratory science or health economics. 
The Panel will provide input and recommendations to the Secretary and the
Administrator, Centers for Medicare & Medicaid Services (CMS), on the following:
●  The establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test;
●  The factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests; and
●  Other aspects of the new payment system under section 1834A of the Act.
Specifically for THIS meeting, the August 26 panel will focus on crosswalk issues for new tests and policy and pricing for drugs of abuse testing.

Members of the panel are:

The Panel will consist of the following members and a Chair:

●    Steve Phurrough M.D., Panel Chair, CMS Medical Officer

●    Geoffrey Baird, M.D., Ph.D.
●    Vickie Baselski, Ph.D. 
●    Stephen N. Bauer, M.D. 
●    William Clarke, Ph.D., M.B.A., DABCC, FACB 
●    Judith Davis, M.S. 
●    Stanley R. Hamilton, M.D. 
●    Curtis A. Hanson, M.D. 
●    Kandice Kottke-Marchant, M.D., Ph.D. 
●    Raju Kucherlapati, Ph.D. 
●    Bryan A. Loy, M.D., M.B.A. 
●    Gail Marcus, M.S.E., M.B.A.
●    Carl Morrison, M.D., D.V.M. 
●    Victoria M. Pratt, Ph.D., FACMG 
●    Michele M. Schoonmaker, Ph.D. 
●    Rebecca Sutphen, M.D.

Further information, including the chance to register for the public workshop in Baltimore on August 26, is here on the CMS website.  (Registration open August 7-14).

For my April, 2014 discussion of the panel as proposed in legislation, here.

The CMS announcement provides only names; below are title and internet links where these were clearly available from the name alone:

Geoffrey Baird, MD PhD (here)
Assistant Professor,  Laboratory Medicine, University of Washington
   Research: Novel methods for clinical laboratory tests (Luminex platform, oligo aptamers)

Vickie Baselski, PhD (here, here)
Professor, Pathology, University of Tennessee Health Science Center
   Research: Molecular microbiology

Stephen N. Bauer, MD (here, here)
Pathologist, Path Logic (division of Neogenomics)
   Served on federal boards for Negotiated Rulemaking and Lab Competitive Bidding

William Clarke, PhD MBA (here)
Associate Professor, Pathology, Johns Hopkins
  Director for hospital’s Point of Care Testing and Clinical Toxicology

Judith Davis, MS
  May be: Director of Laboratory Quality Management, Vanderbilt University Medical Center

Stanley R. Hamilton MD (here)
Head, Pathology and Laboratory Medicine, MD Anderson Cancer Center
   Research: Molecular tumor profiling

Curtis A. Hanson MD (here)
Hematopathologist, Mayo Clinic
   Research: Flow cytometry for minimal residual disease; myeloproliferative neoplasm classification

Kandice Kottke-Marchant MD PhD (here)
Institute Chair, Pathology and Laboratory Medicine, Cleveland Clinic
   Research:  Hematology (e.g. textbook, here)

Raju Kuperchalati PhD (here)
Department of Genetics, Harvard Medicine School
Presidential Commission for the Study of Bioethical Issues (here)
   Research: Human genetic disorders, genomic animal models

Bryan A. Loy MD (here)
Medical Officer, Humana
   Lead, Oncology, Laboratory, Personalized Medicine

Gail Marcus MSE MBA
   May be: CEO Calloway Labs (here)

Carl Morrison MD DVM (here)
    Executive Director, Personalized Medicine, Roswell Park Cancer Institute

Victoria M. Pratt PhD FACMG (here)
Associate Professor, Clinical Medical and Molecular Genetics, Indiana University
Director, Pharmacogenomics Laboratory
   Served on the Secretary’s Advisory Committee for Genetics, Health and Socieity
   Former Chief Director, Molecular Genetics, Quest
   Associate Editor, Journal of Molecular Pathology

Michele M. Schoonmaker PhD (here)
Vice President, Government Affairs, Cepheid

Rebeccca Sutphen MD (here, here)
President and Chief Medical Officer, InformedDNA
Professor, Morsani College of Medicine at USF