Leslie V. Norwalk, Esq.
Acting Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

October 11, 2006

Dear Ms. Norwalk,

As members of the genetics consumer community, we are very concerned with the quality of laboratories performing genetics testing in the United States. For this reason, we are joining with Genetic Alliance, the Genetics and Public Policy Center, and Public Citizen’s Health Research Group to encourage you to create a genetics specialty under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

On September 26, 2006, the organizations listed above submitted a petition requesting CMS to initiate rulemaking to create a genetics specialty under CLIA. The petition laid out arguments supported by both qualitative and quantitative data in support of this policy.

We believe that the establishment of a genetic testing specialty under CLIA encourages new technology and ensures safety and accuracy when those technologies are implemented. Today, there are more than 1000 diseases for which genetic tests are clinically available, several hundred used in research, and even more in various stages of development. Without a genetic testing specialty, CLIA cannot adequately ensure that consumers receive genetic testing services that are safe, accurate, and clinically useful.

We urge CMS to act quickly by issuing proposed regulations for a genetic testing specialty under CLIA.

Organizations

The Alpha Pack - Wisconsin’s Alpha-1 Support Group
APS Foundation of America, Inc.
BCCNS Life Support Network
Beckwith-Wiedemann Children's Foundation
Birt Hogg Dube Family Alliance
C3: Colorectal Cancer Coalition
Cancer Information & Support Network
CARES Foundation, Inc.
Claire Altman Heine Foundation, Inc.
The Chromosome 18 Registry & Research Society
Coalition of Heritable Disorders of Connective Tissue
Cornelia de Lange Syndrome Foundation
Cystinosis Research Network (CRN)
GeneDx, Inc.
Genetic Alliance BioBank
Genetics, Ethics, and Policy Consulting
FRAXA Research Foundation
Hadassah, the Womens Zionist Organization of America
Hereditary Hemorrhagic Telangiectasia Foundation International
Hypertrophic Cardiomyopathy Association (HCMA)
International Rett Syndrome Association
Kids With Heart National Assn for Children's Heart Disorders, Inc.
Mathew Forbes Romer Foundation
Moebius Syndrome Foundation
National Tay-Sachs & Allied Diseases Association, Inc. (NTSAD)
Neurofibromatosis, Inc.
Parent Project Muscular Dystrophy (PPMD)
Patient's Best Friend
Personalized Medicine Coalition
PXE International
Spina Bifida Association of Greater Pennsylvania
Trimethylaminuria Foundation
VHL Family Alliance

Individuals

Mary Ahearn
Silver Spring, MD

Fran Berkwits
Jewish Genetic Disease Consortium

Brandi Blaisdell
Genetic Counselor
Washington, DC

David Brenner
Jewish Genetic Disease Consortium

Amy Brower, PhD
Executive Director, Medical Informatics & Genetics
Third Wave Technologies, Inc

Apryl Brown
Coordinator
Detroit Medical Reserve Corps

Jerri Burns
Sarcoma Awareness Foundation, Corp.

Landry Burns
Apopka, FL

Marianne S. Clancy
Executive Director
Hereditary Hemorrhagic Telangiectasia Foundation International

Nancy Coleman
Kill Devil Hill, NC

Rosina Cristalli
Jewish Genetic Disease Consortium

Susan Duhig, Ph.D.
St. Louis, MO

Brian Denger
Parent Project Muscular Dystrophy

David Feldman
Jewish Genetic Disease Consortium

Randy Yudenfriend Glaser
Jewish Genetic Disease Consortium

Sunny Greene
Member of Board of Directors
VHL Family Alliance

Lauren Gross
Jewish Genetic Disease Consortium

Jaydee Hanson
Director for Human Genetics Policy
International Center For Technology Assessment

Katharine B. Harris, MBA
Member
National Organization of Albinism and Hypopigmentation (NOAH)

Jordana Holovach
Jewish Genetic Disease Consortium

Camron King
Member of Board of Directors
VHL Family Alliance

Terri L. Klein
Executive Director
ISMRD, International Society for Mannosidosis & Related Diseases

Karen Litwack
Jewish Genetic Disease Consortium

Michele Manion
Primary Ciliary Dyskinesia (PCD) Foundation

Bonnie McElroy
Executive Director
Pull-thru Network, Inc.

Stanley Michelman
Jewish Genetic Disease Consortium

Tammy Moore
Vice President
Costello Syndrome Family Network

Robert F. Murray Jr., MD, MS
Chief, Division of Medical Genetics
Department of Pediatrics and Child Health

Holly Nee, MS, CGC
Walpole, MA

Lois Neufeld
Jewish Genetic Disease Consortium

Robbin Palmer, Ph.D.
Northern Nevada Genetic Counseling

Darlene Perkins, RN, MSN

Kevin Romer
Jewish Genetic Disease Consortium

Howard M. Saal, M.D.
Director, Clinical Genetics
Cincinnati Children's Hospital Medical Center

M. Priscilla Short, MD
Co-Director of University of Chicago NeuroGenetics Clinic Chicago, IL

Katherine B. Sims, M.D.
Director of the Developmental Neurogenetics Clinic
Massachusetts General Hospital

Judith Tsipis
Brandeis University

John Twomey, RN, PhD

Joan O. Weiss, MSW
Founder of Genetic Alliance

Marion Yanovsky
Jewish Genetic Disease Consortium