Confirmation Number:272542 Event Started: 10/18/2004 8:28:24 PM Event Ended: 10/18/2004 5:38:00 PM

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PLEASE STAND BY, THE CONFERENCE WILL BEGIN AT 8:30 A.M. EASTERN TIME. PLEASE STAND BY. THE CONDITION CONFERENCE WILL GIN MOMENTARILY. THE CONFERENCE WILL BEGIN MOMENTARILY.

GET FOLKS FROM OUTSIDE OR OUT IN THE HALL A MINUTE OR SO TO COME IN. MY NAME IS RAYNARD KINGTON. INL' THE DEPUTY DIRECTOR OF NIH. GOOD MORNING. AND WELCOME. IT IS A LE PLEASURE TO BE HERE REPRESENTING SECRETARY THOMPSON IN OPING THE FIFTH MEETING OF THE SECRETARY'S ADVISORY COMMITTEE ON GENETICS, HEALTH AND SOCIETY. THIS COMMITTEE WORK IS INCREASINGLY IMPORTANT IN LIGHT OF ONGOING DEVELOPMENT IN GENETIC AND GENOMES. YOUR SERVICE ON THE COMMITTEE HELPS THE DEPARTMENT AS WELL AS OTHER AGENCIES REPRESENTED AROUND THE TABLE TO STRAY ABREAST OF THE BROAD ARRAY OF CON FLEX MEDICAL, ETHICAL, SCIENTIFIC AND LEGAL USED BY GENETIC AND GENOME TECHNOLOGY. WE GREATLY APPRECIATE YOUR COMMITMENT TO THIS WORK. I'M HERE TO MARK SEVERAL IMPORTANT CHANGES THIS IN THE COMMITTEE LEADERSHIP AND MEMBERSHIP AND HONOR THE SERVICE OF THREE EXCEPTIONAL PEOPLE ONLY TWO OF WHICH I BELIEVE ARE HERE. I WOULD LIKE TO BEGIN BY RECOGNIZING DOCTOR ED EDWARD MCCABE. HE WAS APPOINT FORD EXPERTISE AND KNOWLEDGE IN THE FIELD AND EXCEPTIONAL LEADERSHIP QUALITIES AND HE DID NOT DISAPPOINT. HE WAS ALSO APPOINTED TO PROVIDE A SMOOTH TRANSITION BETWEEN THE SECRETARY ADVISORY COMMITTEE ON GENETIC TESTING AND THIS COMMITTEE WHICH DR. MCCABE CHAIRED FOR THREE YEARS. LET ME THANK YOU FOR YOUR SERVICE FOR THE MISSION TO IMPROVE HEALTH AND FOR YOUR DEDICATION AS CHAIR OF THE COMMITTEE. YOU HAVE ABLY GUIDED THE COMMITTEE THROUGH ITS FIRST YEAR OF LIFE, THROUGH A SYSTEMATIC REVIEW AND PRIORITY SETTING PROCESS THAT LED TO THE COMMITTEE STUDY PRIORITIES AND THROUGH THE DEVELOPMENT OF CONSENSUS RECOMMENDATIONS TO THE SECRETARY ON GENETIC DISCRIMINATION GENETICS EDUCATION FOR HEALTH PROFESSIONS AND DIRECTED CONSUMER MARKETING OF GENETIC TESTS. YOUR LEADERSHIP PROVIDED THE COMMITTEE WITH A FOUNDATION. WE WANT TO ACKNOWLEDGE YOUR LEADERSHIP DEMONSTRATED IN THE TRANSITION OF THE PREVIOUS COMMITTEE TO THE CURRENT COMMITTEE AND AS A TOKEN OF OUR APPRECIATION IT IS A PLEASURE TO GIVE YOU THIS CERTIFICATE FROM THE SECRETARY RECOGNIZING YOUR SERVICE TO THE COMMITTEE. [ APPLAUSE ] ANOTHER PLAQUE, I'M SURE. ( LAUGHTER )

WE WOULD ALSO LIKE TO THANK TWO MEMBERS OF THE COMMITTEE WHOSE SERVICE IS ENDING. KIM ZELLMER AND BRAD MAR GIS WERE APPOINTED FOR THEIR OWN CONSUMER ISSUES. THEY EACH DEVOTED AN EXTRAORDINARY AMOUNT OF TIME TO THE WORK COMMITTEE DURING AND BETWEEN MEETINGS AND CONTRIBUTED IN MANY WAYS TO ADVANCING OUR UNDER STANDING OF THE IMPACT OF GENETIC AND GENOME IMPACT ON FAMILIES AND INDIVIDUAL SOCIETY. MS. ZELLMER LET ME THANK YOU FOR YOUR WORK AND COMMITMENT. I KNOW THAT YOUR PERSONAL COMMITMENT PROVIDED YOU WITH INSIGHT IMPORTANT TO THE COMMITTEE DELIBERATIONS. YOUR CONSIDERATIONS HAVE BEEN ESPECIALLY VALUABLE AND WE APPRECIATED YOUR SERVICE EFORM MUSTILY. WE KNOW THAT THESE ARE INCREDIBLY TIME CONSUMING APPOINTMENTS TO COMMITTEES LIKE THIS AND WE APPRECIATE YOUR TIME. IF YOU COULD COME FORWARD, ANOTHER PLAQUE.

THANK YOU. [ APPLAUSE ]

MR. MARGIS IS NOT HERE. LET ME THANK HIM FOR HIS WORK AND COMMITMENT TO THE COMMITTEE. HE, TOO, HAS PRAT PERSPECTIVES AND INSIGHT, PERSONAL AND PROFESSIONAL TO THE COMMITTEE PARTICULARLY IN THE AREA OF THE WORK ON DIRECT TO CONSUMER MARKETING HAS BEEN PARTICULARLY INVALUABLE AND WE HAVE A PLAQUE THAT WE WILL DELIVER TO MILLIMETER WHEN HE ARRIVES. BOTH OF YOU CAN CONSIDER YOURSELVES EMERITUS MEMBERS WHICH MEANS THAT YOU CAN BE CALLED UPON ANY TIME TO WORK MORE. THE CHALLENGES POSED BY GENETIC AND GENOME TECHNOLOGIES ARE IN MANY WAYS JUST BEGINNING AND THIS COMMITTEE IS GOING TO BE INCREDIBLY VALUABLE FOR THE FORESEEABLE FUTURE AND AS WE LOOK FORWARD WE ARE PLEASED THAT WE WERE ABLE TO IDENTIFY AN EXTRAORDINARY PERSON TO FOLLOW AS CHAIR. AS I WAS DRIVING OVER FROM THE NIH I REALIZED THAT I KNEW DR. REED TUCKSON FOR ALMOST 20 YEARS. DR. TUCK SOP WAS TWO YEARS AHEAD OF ME IN THE TRAINING PROGRAM AT THE UNIVERSITY OF PENNSYLVANIA AND WHEN I ARRIVED FRESH FROM MY MEDICINE RESIDENCECY ALL OF THE CO-HARDT OF PEOPLE WHO BEGAN WHEN I BEGAN WERE TOLD THAT THE BAR HAD BEEN RAISED CONSIDERABLE IN THIS TERMS OF OUR PERFORMANCE AND THAT REED IN PARTICULAR WAS GOING TO BE A TOUGH ACT TO FOLLOW. FOR THE LAST 20 OR ALMOST 20 YEARS, 19, I HAVE COUNTED ON REED AS A COLLEAGUE AND FRIEND AND MENTOR AND HAVE NOT HESITATED TO CALL UPON HIM WHENEVER NECESSARY. WE HAVE CROSSED PATHS REPEATEDLY WHEN HE WAS PRESIDENT OF THE CHARLES DREW UNIVERSITY IN LOS ANGELES AND I OF AT THE RAND CORPORATION AND THEN LATER MOST RECENTLY HE AGREED TO REALLY SERVE ON ONE OF THE MOST DIFFICULT COMMITTEES WE HAVE HAD RECENTLY AND THAT IS THE NIH BLUE RIBBON TASK FORCE ON CONFLICT OF INTEREST POLICIES WHICH REQUIRED AN EXTRAORDINARY AMOUNT OF TIME INVESTMENT OVER A VERY SHORT PERIOD OF TIME IN ADVISING US HOW TO DEAL WITH ISSUES THAT IS OF GREAT IMPORTANT TO THE FUTURE OF THE AGENCY. CLEARLY DOCTOR TUCKSON HAS A TOUGH ACT TO FOLLOW AS WELL HERE BUT WE KNOW THAT YOU ARE UP TO THE TASK AND WE HAVE EVERY CONFIDENCE THAT YOU WILL AS YOU ALWAYS DO PERFORM ADMIRABLY AND MAKE US ALL FEEL THAT WE SHOULD WORK HARDER. WELCOME AND I'LL PASS IT OFF TO YOU, REED.

THANK YOU VERY MUCH. WELL, THANK YOU FOR THAT. AND OBVIOUSLY I JUST WANT TO GIVE A COUPLE OF SECONDS TO SEE IF EVEN THOUGH HE IS GOING TO BE WITH US IN DELIBERATIONS FOR QUITE AWHILE, BUT ED DID JUST A TERRIFIC JOB AND AS SOMEBODY WHO WAS ON THE FIRST COMMITTEE AND WATCHED THIS TRANSITION, I'M JUST -- I JUST MARVEL AT WHAT HE WAS ABLE TO ACHIEVE AS OUR LEADER BOTH ON THE FIRST AND NOW THIS COMMITTEE. BUT ED, WOULD YOU LIKE TO SAY A COUPLE OF COMMENTS, PLEASE?

WELL, THANK YOU. IT HAS BEEN TRULY AN HONOR TO SERVE ON THE SECRETARY ADVISORY COMMITTEE ON GENETIC TESTING AND THEN THE SECRETARY ADVISORY COMMITTEE ON GENETIC HEALTH AND SOCIETY. ONE OF THE THINGS YOU WILL FIND, REED, IS THAT YOU HAVE FANTASTIC STAFF WITH SARA IN CHARGE AND YOU WILL BE WISE TO LISTEN SO WHAT SARA TELLS YOU. IF YOU FOLLOW SARA'S DIRECTIONS YOU WILL LOOK EXTREMELY GOOD, IF I HAVE HAD ANY SUCCESS THAT IS THE SECRET TO IT. BUT ALSO THE COMMITTEE MEMBERS ARE JUST FANTASTIC ON BOTH OF THOSE COMMITTEES AND FROM SOME EXPERIENCES ON THE FIRST COMMITTEE I LEARND THAT YOU ALWAYS HAD MY BACK AND I HOPE THAT I CAN DO EQUALLY AS WELL FOR YOU. THANK YOU.

TERRIFIC. [ APPLAUSE ]

WE HAVE A LOT TO DO AND THANK GOD FOR EACH ONE OF YOU AND IT KB'SING IS GOING TO BE VERY INTERESTING TO WATCH AS SO MANY OF YOU ARE GOING TO HAVE A CHANCE TO PRODUCE AND SHOWCASE THE WORK THAT YOU HAVE BEEN DOING AS COMMITTEE CHAIRS OF THE SUBCOMMITTEES AND SO FORTH AND INL' AMAZED AS I READ THROUGH ALL THIS MATERIAL IS HOW HARD EACH ONE OF YOU ARE WORKING ON THIS COMMITTEE'S BEHALF AND WE OWE YOU A THANKS. THE PUBLIC WAS MADE AWARE OF THE MEETING THROUGH NOTICES IN THE FEDERAL REGISTRY AS WELL AS ANNOUNCEMENTS ON THE SACGHS WEBSITE AND LIST SERVE. I WILL TELL YOU THAT AS I HAVE COME TO REVIEW A LITTLE BIT ABOUT HOW DO YOU EVALUATE THE QUALITY OF ADVISORY COMMITTEES TO THE GOVERNMENT I AM REMINDED AS I HAVE LOOKED THROUGH SOME OF THOSE CRITERIA THAT THE NUMBER ONE WAY IN WHICH THESE COMMITTEES DEMONSTRATE THEIR VALUE TO THE NATION IS THROUGH ITS ABILITY TO REACH OUT TO THE PUBLIC AND SO I'M VERY PLEASED AND I THINK WE'RE GOING TO EVEN TRY TO DO SOME OTHER THINGS IF WE CAN TALK LATER ABOUT IN TERMS OF REDOUBLING OUR EFFORTS TO HAVE ALL OF OUR WORK INTO THE HANDS OF THE PUBLIC THAT IS MOST INTERESTED IN THIS AND THOSE WHO OUGHT TO BE MORE INTERESTED IN WHAT WE ARE DOING. AND SO THIS MEETING WAS MADE AVAILABLE THROUGH THOSE NOTICES. WE WERE RECHARTERED AGAIN THROUGH AUGUST OF 2006 SO YOU'RE STUCK. THE FOLLOWING EX OFFICIOS, AGENCY REPRESENTATIVES, WE WANT TO THANK ALL OF THEM THAT ARE HERE BUT I WANT TO MAKE PARTICULAR NOTE WE ARE JOINED TODAY ALSO BY CARRY DOMINGUS, CHAIR OF THE EQUAL EMPLOYMENT OPPORTUNITY COMMISSION. SHE WILL BE SERVING AS THE MEMBER. WE APPRECIATE YOU ARE TAKING THE TIME AND THE WE KNOW HOW IMPORTANT IT IS TO OUR COUNTRY. MR. RICHARD CAM PA NELLY DIRECTOR OF THE HSS OFFICE FOR CIVIL RIGHTS IS ALSO WITH US TODAY AND THAT IS WORTHY OF NOTE. DOCTOR FRANCES CHESNEY DIRECTOR OF ARC OFFICE OF RESEARCH AND PRIORITIES OCCUPATION HAS BEEN APPOINTED TO SEVEN AS THE NEW EX-OEX OFFICIO AND THANK YOU FOR JOINING AND SERVING AND WE ARE GLAD FOR ALL OF OUR OTHER EX OFFICIOS WHO HAVE BEEN MAINTAINING COMMITMENT TO THE COMMITTEE. CHRIS HOOK AND JOAN REEDE WILL NOT BE ATTENDING. HUNT WILL BE JOINING US TOMORROW AND SO WE THANK THEM FOR THAT. ONE OF THE MOST IMPORTANT THINGS AT LEAST TO ME COMING ON AND I'M SURE TO YOU WAS THAT GIVEN THAT WE ARE ADVISORY TO THE SECRETARY OF HEALTH, DOES THE SECRETARY OF HEALTH AND DOES HIS OFFICE CARE ABOUT WHAT WE ARE DOING? AND I WANTED YOU KNOW THAT I DID PUT IN A CALL TO THAT OFFICE AND SPOKE WITH, YOU KNOW, AS THE NEWS WOULD SAY AN UNNAMED SENIOR OFFICIAL. ( LAUGHTER )

AND I WAS ENCOURAGED THAT THE UNNAMED SENIOR OFFICIAL WAS WELL AWARE OF WHAT WE ARE DOING. I WAS INSISTENT AND ASSURED THAT WITHIN A COUPLE OF DAYS OF MY CONVERSATION THAT THE SECRETARY WOULD BE BRIEFED ABOUT THE FACT THAT THE NEW INCOMING CHAIRMAN OF THE COMMITTEE WANTED TO BE SURE THAT THAT WAS IMPORTANT TO HIM AND THAT HE WAS PAYING ATTENTION TO WHAT WE ARE DOING SO I WILL JUST SIMPLY LEAVE IT THERE AND SAY THAT I THINK IT IS IMPORTANT BECAUSE HOW -- YOU ALL ARE WORKING SO HARD ON THIS COMMITTEE THAT YOU HAVE GOT TO KNOW THAT IT IS NOT JUST BEING FILED ON A SHELF SOME WHERE. THAT THIS IS IMPORTANT. IT IS GETTING DONE. AROUND I'M GOING TO TAKE MY RESPONSIBILITY AS ED HANDS THE BATON OFF TO ME TO REALLY ENSURE THAT THAT IS HAPPENING AND SO I WILL GIVE YOU AN UPDATE ON THAT ON THE SECRETARY CONVERSATION IN THE NEXT TIME THAT WE MEET. LET ME SAY THAT THE STATUS OF THE COMMITTEE'S WORK PRODUCT SINCE JUNE WHAT HAS BEEN GOING ON. WE HAVE THE RESOLUTION ON GENETIC EDUCATION AND TRAINING OF HEALTH PROFESSIONALS. THAT COPY IS AVAILABLE AT THE DESK. IT WAS TRANSMITTED TO THE SECRETARY IN AUGUST. THE ROADMAP FOR THE INTEGRATION OF GENETICS AND GENOMES IN SOCIETY, THE STUDY PRIORITIES OF THE SECRETARY ADVISORY COMMITTEE WILL BE TRANSMITTED TO THE SECRETARY VERY SHORTLY. AND THAT WILL HAPPEN REALLY IN THE NEXT MATTER OF DAYS AND WEEKS. THE LETTER TO THE SECRETARY ON DIRECT TO CON CONSUMER MARKETING OF GENETIC TESTS IS IN THE FINAL STAGES OF REVIEW BY THE COMMITTEE AND WILL BE TRANSMITTED TO THE SECRETARY SOON. IT IS IN THE TABLE FOLDER AND THERE ARE STILL TIME IF YOU HAVE ANY LAST LAST LAST MINUTE SHORT, BRIEF, NONCONTROVERSIAL COMMENTS. SARA IS KICKING ME UNDER THE TABLE SO. FINALLY, A VERY BRIEF OVERVIEW OF THE AGENDA. OF COURSE, FIRST WE WILL START OUT WITH LEARNING ABOUT IMPORTANT HHS INITIATIVES TO PROMOTE FAMILY HISTORY TAKING. WE WILL THEN DIVE VERY DEEPLY INTO THE ISSUE OF A GENETIC DISCRIMINATION AND INFORMATION ABOUT THE NATURE, MAGNITUDE AND SCOPE OF THE DISCRIMINATION PROBLEM IN SOCIETY. WE WILL MOVE TO COMPLETING OUR DELIBERATIONS AND FINALIZING OUR RECOMMENDATIONS ON COVER AND AND REIMBURSEMENT AND THEN FINALLY BEGIN PLANNING FUTURE WORK ON TWO HIGH PRIORITY ISSUES. LARGE POPULATION STUDIES AND PHARMACOGENOMES. PUBLIC DISCUSSIONS ARE SCHEDULED FOR TODAY AND TOMORROW. WE HAVE 7 OR SO WHO REGISTERED TO PROVIDE COMMENTS. ANY OTHERS WHO MAY BE INTERESTED SHOULD SIGN UP AT THE RENAL REGISTRATION DESK AND THEN THIS IS A RELENTLESSLY PUBLIC EXPERIENCE SO IF YOU HAVE COMMENTS WE WELCOME YOU TO DO THAT. LET ME TURN IT OVER TO THE CZAR, THE GENERAL, SARA CAR WHO WILL TAKE CARE OF IMPORTANT TECHNICAL STUFF.

AS YOU KNOW, THE MEMBERS OF THIS COMMITTEE ARE APPOINTED AS SPECIAL GOVERNMENT EMPLOYEES IN ORDER TO SERVE AND EACH AT EACH MEETING I ALWAYS REMIND YOU ABOUT THE RULES OF CONDUCT THAT APPLY TOO GOVERNMENT EMPLOYEES AND TO YOU. THESE RULES ARE IN A DOCUMENT CALLED STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE EXECUTIVE BRANCH AND EACH ONE OF YOU GOT A COPY OF THIS DOCUMENT AND I KNOW YOU HAVE REVIEWED IT VERY CAREFULLY. I'M GOING TO HIGHLIGHT TWO OF THE RULES TODAY. ONE IS ABOUT CONFLICTS OF INTEREST AND THE OTHER IS ABOUT LOBBYING. CONFLICTS OF INTEREST. BEFORE EVERY MEETING YOU PROVIDE US WITH INFORMATION ABOUT YOUR PERSONAL PROFESSIONAL AND FINANCIAL INTERESTS AND THIS IS INFORMATION THAT WE USE TO DETERMINE WHETHER YOU HAVE ANY REAL, POTENTIAL, OR APPARENT CONFLICTS OF INTEREST THAT COULD COMPROMISE YOUR YOUR ABILITY TO BE OBJECTIVE IN GIVING ADVICE DURING THE COMMITTEE MEETINGS. WHILE WE WAIVE CONFLICTS OF INTEREST FOR GENERAL HIGH TEMPERATURERS BECAUSE WE BELIEVE WE ALSO RELY TO A GREAT DEGREE ON YOU TO BE A-10TIVE DURING OUR MEETINGS TO THE POSSIBILITY THAT AN ISSUE WITH ARISE THAT COULD AFFECT OUR APPEAR TO AFFECT YOUR INTERESTS IN A SPECIFIC WAY. IN ADDITION, WE HAVE PROVIDED EACH OF YOU WITH A LIST OF YOUR FINANCIAL INTERESTS AND COVERED RELATIONSHIPS THAT WOULD POSE A CONFLICT FOR YOU IF THEY BECAME A FOCAL POINT OF THE COMMITTEE DLIB RAIS AND IF -- DELIBERATIONS AND IF THIS HAPPENS WE ASK YOU TO REDUCE YOURSELF AND LEAVE THE ROOM. GOVERNMENT EMPLOYEES ARE PROHIBITED FROM LOBBYING. WE MAY NOT LOBBY NOT AS INDIVIDUALS OR AS A COMMITTEE. IF YOU LOBBY IN YOUR PROFESSIONAL CAPACITY OR AS A PRIVATE CITIZEN IT IS IMPORTANT THAT YOU KEEP THAT ACTIVITY SEM RATE FROM YOUR ACTIVITIES ASSOCIATED WITH THIS COMMITTEE. KEEP IN MIND THAT WE ARE ADVISORY TO THE SECRETARY OF HEALTH AND HUMAN SERVICES. WE DON'T ADVISE CONGRESS. THANK YOU FOR BEING SO ATTENTIVE TO THE RULES OF CONDUCT. WE APPRECIATE IT VERY MUCH.

TERRIFIC. TO KICK US OFF ON THE FIRST SESSION ON THE IMPORTANCE OF FAMILY HISTORY IN HEALTH TO GET THAT STARTED I'M GOING TO INTRODUCE FRANCIS COLLINS. WE HAVE TO BE CONCERND THAT FRANCIS FLEW ON THE RED EYE ALL NIGHT SO WE ARE IN GREAT DANGER THAT HE WILL FALL OFF AT ANY MOMENT. SO ELLEN AND DANIEL IF YOU WILL KEEP AN EYE ON HIM, WE WOULD ALL APPRECIATE IT. LFER.

THANKS FOR TELLING JUST ABOUT EVERYBODY ABOUT THAT, REED. THAT'S MUCH APPRECIATED. I PROBABLY WILL NEED THE SUPPORT. WELL, MY PLEASURE TO INTRODUCE ALLEN GUTTMACHER WHO IS GOING TO GIVE THIS PRESENTATION ON THE IMPORTANCE OF FAMILY HISTORY IN HEALTH. ALLEN HAS A DISTINGUISHED CAREER AS A PHYSICIAN IN THE AREA OF MEDICAL GENETICS AND PEDIATRICS FOR SOME TIME. HE WAS THE ONLY BOARD CERTIFIED MEDICAL GENETICIST IN THE STATE OF VERMONT AND RAN THE FIRST NEWBORN IN TNSIVE CARE UNIT IN THE STATE OF VERMONT. THE STATE OF VERMONT WENT INTO SEVERE MOURNING WHEN I RECRUITED HIM TO COME TO NIH BECAUSE AS YOU CAN IMAGINE THE CENSUS DROPPED RATHER DRAMATICALLY IN TERMS OF THESE KINDS OF CAPABILITIES. HE HAS BECOME AN ESSENTIAL PART OF WHAT WE'RE TRYING TO DO IN THE GENOME ARENA AND RUNS OUR OFFICE OF POLYEDUCATION, COMMUNICATION AS WELL AS A HOST OF OTHER ISSUES AND HE HAS BEEN THE POINT PERSON IN OUR DISCUSSIONS WITH THE SURGEON GENERAL ABOUT A PARTICULAR INITIATIVE ON FAMILY HISTORY THAT I THINK HE IS GOING TO TELL YOU SOMETHING ABOUT. I WOULD ALSO JUST LIKE TO SAY BECAUSE IT HAPPENS TO BE THE VERY DAY WHERE THIS IS BEING ANNOUNCED THAT ALLAN HAS BEEN ELECTED TO THE INSTITUTE OF MEDICINE AS OF TODAY. CONGRATULATIONS, ALLAN. [ APPLAUSE ]

WHEN FRANCIS SAID HE WANTED TO INTRODUCE ME I KNEW THAT THERE WAS SOME WAY THAT HE WAS GOING TO TRY TO EMBARRASS ME. SINCE I RECENTLY INTRODUCED HIM I THOUGHT IT MIGHT BE WORSE THAN THAT. THANK YOU. THIS IS AN IMPORTANT ISSUE AND IN FACT THE SURGEON GENERAL HAD HOPED TO BE HERE TO BE ABLE TO GIVE THIS TALK. HE IS SORRY THAT BECAUSE OF ANOTHER COMMIT NT HE COULDN'T BE MERE. I'M VERY SORRY THAT HE COULDN'T BE HERE. I HOPE YOU WON'T BE TOO SORRY THAT BECAUSE OF ANOTHER COMMITMENT HE COULDN'T BE HERE TO TALK ABOUT A TRANSDEPARTMENTAL INITIATIVE THAT THE SURGEON GENERAL IS SPEAR HEADING AND THAT HAS TO DO WITH FAMILY HISTORY. SO FIRST I THOUGHT I WOULD TALK A LITTLE BIT ABOUT THE IMPORTANCE IN FAMILY HISTORY AND HET HEALTH. I REALIZE THAT THIS WILL BE LARGELY PREACHING TO THE CHOIR BUT I WILL END THAR IS MONAR IS SERMON. IF IN IS THE AGE OF GENOMES AS WE TRUMPET IT WHY SHOULD FAMILY HISTORY BE IMPORTANT. IT SEEMS SORT OF OLD FASHIONED. THE KIND OF THING YOU MUST JUST HEAVEN FOR BID USE A PENCIL AND PIECE OF PAPER ABOUT AND NOT THAT SOPHISTICATED GENOMIC TOOL, SET RATE.

WOO WE KNOW IN THE AGE OF GENOMES MOST DISEASES ARE DUE TO MULTIPLE GENES AND VAI.AL FACTORS. WE KNOW THAT BUT WHAT DO WE DO WITH IT? REMIND OURSELVES THAT TODAY EVERY PATIENT THAT IS SEEN HAS AVAILABLE I A FREE, I WOULD UNDERSCORE FREE SINCE THAT IS UNUSUAL MEDICINE PERSONALIZED TOOL THAT CAPTURES MANY OF THOSE ENVIRONMENTAL AND GENETIC INTERACTIONs AND CAN SERVE AS A TOOL FOR INDIVIDUALIZED DISEASE PREVENTION. THAT TOOL, OF COURSE, WHICH HAS STOOD THE TEST OF TIME IS THE OTHER THING TO BE SAID FOR IT IS THE FAMILY HISTORY. NOW, EVEN THOUGH WE WILL, OF COURSE, CONTINUE TO GAIN IMPORTANT NEW GENOME TOOLS IN THE YEARS AHEAD AND THOSE ARE THE KINDS OF THINGS THAT THIS COMMITTEE HAS BEEN THINKING ABOUT AND THEIR IMPACT ON HEALTHCARE FAMILY HISTORY IS GOING TO REMAIN RELEVANT FOR MANY YEARS TO COME AND IN FACT IT WILL BECOME MORE USEFUL BECAUSE IT HAS TO DO WITH SUCH VARIED HEALTH CONCERNS AS YOU SEE HERE, HEART DISEASE, BREAST CANCER, OH VAIVIAN CANCER. OSTEOPOROSIS. ASTHMA, TYPE TWO TIE DIABETES. YOU CAN GO ON AND ON MOST OF THE CAUSES OF MORED MORBIDITY AND MORTALITY THAT WE HAVE FAMILY HISTORY CAN CONTRIBUTE TO OUR UNDER STANDING OF THEM AND OUR APPROACH TO INDIVIDUAL PATIENTS. YET, NONETHELESS, MOST PEOPLE, MANY PEOPLE CERTAINLY ANYWAY ARE UNAWARE OF RELATIVE HISTORIES AND MANY OF US UNDERUTILIZE THIS INFORMATION ADVISING PATIENTS ABOUT HOW TO MAINTAIN GOOD HEALTH. FOR INSTANCE, YOU CAN USE FAMILY HISTORY INFORMATION TO EAFFECT THE WAY THAT YOU DO POPULATION SCREENING FOR ALL OF THESE DIFFERENT KINDS OF CONDITIONS. A LARGE ARRAY OF CONDITIONS TO WHICH FAMILY HISTORY IS PERTINENT. AND THEN BEYOND SCREENING IN TERMS OF OUR MANAGEMENT OF VARIOUS CONDITIONS AGAIN A LARGE SLOUGH OF CONDITIONS FOR WHICH WE HAVE GOOD DATA TO SHOW THAT FAMILY HEALTH HISTORY CAN, IN FACT, MAKE A DIFFERENCE IN MANAGEMENT. SO IF THIS IS SO USEFUL, WHY AREN'T HEALTH PROFESSIONALS USING A MORE CONSISTENTLY AND MORE EFFECTIVELY AND ALL OF US WHO HAVE A CLINICAL BACKGROUND WOULD BE EMBARRASSED TO TALK ABOUT THE WAY WE INDIVIDUALLY USED THE FAMILY HISTORY BUT WOULD CERTAINLY BE EMBARRASSED TO TALK ABOUT HOW ALL HEALTHCARE PROVIDERS IN GENERAL OUR PROFESSIONS TEND TO DO THAT. I THINK ONE BAR IS THAT CLINICIANS TEND TO UNDERESTIMATE THE ACTUAL UTILITY OF THE FAMILY HISTORY. THE WAY THAT WE CAN GET PAST THAT HUMP I THINK IS BETTER TEACHING AND MORE PERVASIVE ROLE MODELING OF THE USE OF THE FAMILY HISTORY. THOSE OF US WHO HAVE PARTICULAR BACKGROUND IN THINKING ABOUT FAMILY HISTORY AND USING IT IN HEALTHCARE OR CAN DEMONSTRATE TO OTHERS HOW IT WOULD BE HELP E. HELPFUL I THINK THE MESSAGE WOULD SPREAD MORE EFFECTIVELY. ANOTHER SIGNIFICANT FACTOR AND, OF COURSE, BECOMES MORE SIGNIFICANT WITH EACH YEAR'S HEALTHCARE CHANGES IS THE INSUFFICIENT TIME REALLY IN THE CLINICAL SET SETTING AFTER OFTEN OBTAIN, ORGANIZE AND AND LIES THE FAMILY HISTORY. IT IS ONE THING TO SAY FAMILY HISTORY CAN BE PERTINENT BUT IT TAKES A LOT OF TIME TO ACTUALLY COLLECT THE INFORMATION THEN TO BE ABLE TO SET IT DOWN IN SOME WAY THAT IS AVAILABLE IN THE FUTURE AND TO REALLY ANALYZE AND DO SOMETHING WITH IT. NOW, HOW DO WE GET PAST THAT HURDLE? WELL, THERE IS CREATIVE APPROACHES OUT THERE THAT PEOPLE HAVE BEEN WORKING NONE RECENT YEARS THAT I THINK ARE BEGINNING TO COME TO TRUE FRUITION THAT WILL HELP PACK TICKSERS WHO ARE -- PRACTITIONERS DO THIS. IF WE DO THAT IN FACT DO THE PATIENTS CARE ABOUT THIS. THERE ARE SOON TO BE PUBLISHED DATA THAT COME FROM THE CDC. THEY ARE NOT PUBLISHED YET SO I'M NOT GOING TO TELL YOU ABOUT THEM BUT YOU CAN LOOK FORWARD TO THEM SOON THAT SHOW THAT THE AMERICAN PUBLIC ACTUALLY IS WELL AWARE THAT FAMILY HISTORY IS IMPORTANT TO HEALTH. BUT DESPITE THAT, THAT RELATIVELY FEW PEOPLE IN THE GENERAL PUBLIC HAVE ACTUALLY EVER COLLECTED HEALTH INFORMATION FROM RELATIVES TO OBTAIN A FAMILY HEALTH HISTORY WHICH SUGGESTS THAT THERE, TOO, IS A BAR, AN OBSTACLE THAT NEEDS TO BE OVERCOME AND THAT IS THAT EVEN THOUGH PEOPLE ARE CONVINCED THAT FAMILY HISTORY CAN BE PERT FEND AND IMPORTANT FOR THEIR O -- PERTINENT AND IMPORTANT FOR THEIR OWN HEALTH THEY HAVEN'T ACTED ON THAT WHICH MEANS AGAIN THERE ARE EMPEDMENTS FOR THIS BEING DIFFICULT FOR FAMILIES TO DO.

WHAT CAN WE DO ABOUT THAT? SOMETHING THAT A NUMBER OF AGENCIES WITHIN THE DEPARTMENT HAVE BEEN TRYING TO DEAL WITH OVER THE LAST FEW YEARS AND THOSE INCLUDE THE SURGEON GENERAL'S OFFICE, HERSA, ARC. VERY IMPORTANTLY THE CDC AND VARIOUS PARTS OF THE NIH AS WELL.

WE HAVE COME TOGETHER TO -- THE SURGEON GENERAL AMERICAN FAMILY HEALTH INITIATIVE SO LET ME TELL YOU A LITTLE BIT ABOUT THIS INITIATIVE. THE GOALS OF THE INITIATIVE ARE, FIRST OF ALL, TO INCREASE THE AMERICAN PUBLIC'S AWARENESS OF THE IMPORTANCE OF FAMILY HISTORY AND HEALTH THOUGH WE AGAIN HAVE DATA THAT THEY ARE FAIRLY AWARE OF THIS ALREADY. BUT NOT SO TRUE IS TO GIVE THE AMERICAN PUBLIC TOOLS TO GATHER, UNDERSTAND EVALUATE AND USE FAMILY HISTORY TO IMPROVE HEALTH, TO INCREASE THE AWARENESS OF HEALTH PROFESSIONALS ABOUT THE IMPORTANCE OF FAMILY HISTORY. GIVE THE HEALTH PROFESSIONALS TOOLS TO BE ABLE TO GATHER, EVALUATE AND USE FAMILY HEALTH INFORMATION AND TOOLS TO COMMUNICATE WITH THEIR PATIENTS ABOUT FAMILY HISTORY.

GENETIC.

AS THEY BECOME MORE AVAILABLE, GENETIC TESTING IT WOULD BE A GOOD IDEA TO HAVE FOLKS BECOME FAMILIAR WITH SOME OF THOSE CONCEPTS BY USING THE OLD TRIED AND TRUE FAMILY HISTORY AND PREPARING BOTH THE AMERICAN PUBLIC AND HEALTH PROFESSIONALS IN WHICH WE BELIEVE THAT WOULD BE AN INTEGRAL PART OF REGULAR HEALTHCARE.

PLEASE PRESSING CALLED MY FAMILY HEALTH PORTRAIT. YOU SEE THIS IS THE BANNER FOR IT. AND THIS IS A DUMMY -- SOME WHAT WHAT IT WILL LOOK LIKE IF YOU LOOK CAREFULLY IT YOU WILL SEE IT SAYS MY FAMILY HEALTH PORTRAIT. THIS IS SUCH A A DUMMY IT HASN'T BEEN UPDATED TO REFLECT THE OFFICIAL NAME MY FAMILY HEALTH PORTRAIT. THIS IS GOING TO BE A WEB BASED TOOL. WHERE INDIVIDUALS AND FAMILIES WILL BE ABLE TO DOWNLOAD DIRECTLY TO THEIR COMPUTERS SO THAT THIS INFORMATION LIVES M ON THEIR COMPUTERS AND NOT ON SOME GOVERNMENT SITE WHICH WOULD BE ILLEGAL AMONGST OTHER THINGS AND ALLOW PEOPLE, NOT JUST ALLOW PEOPLE BUT GIVE PEOPLE A WE BELIEVE EASY INTERACTIVE KIND OF WAY TO GATHER THEIR FAMILY HEALTH INFORMATION. AND THEN ONCE ANY HAVE GATHERED IN FACT GIVE THEM GUIDANCE ABOUT WHAT THEY MIGHT DO WITH THAT INFORMATION. SO NOVEMBER THE 8th, MONDAY IN A FEW WEEKS THERE WILL BE A FORMAL ANNOUNCEMENT OF THE INITIATIVE AND THERE WILL BE THE RELEASE OF THE MY FAMILY HEALTH PORTRAITS WEBSITE AND THERE WILL BE A BIG EVENT DOWNTOWN AND SEVERAL AGENCIES WITHIN THE DEPARTMENT WILL BE COOPERATING IN THAT. WE ARE GOING TO HAVE SOME OTHER MEDIA AROUND THAT DATE SO WE ARE HOPING THAT YOU WILL HEAR A FAIR BIT ABOUT IT IN YOUR LOCAL MEDIA AT THAT TIME AS WELL AS NATIONAL MEDIA. THIS IS THE OFFICIAL LOGO OF THE THING. THERE WILL BE THE PRESS CONFERENCE AT THE NATIONAL PRESS CLUB ON NOVEMBER 8th TO ANNOUNCE THIS. ON THANKSGIVING DAY THIS IS THE FOCUS AND WHAT WILL BE TALKED ABOUT AT THIS PRESS CONFERENCE. THE IDEA IS TO MAKE THANKSGIVING DAY THE DAY WHEN FAMILIES GATHER TOGETHER TO EAT A LOT, TO WATCH THE PACKERS ON TV AND DO OTHER KINDS OF THINGS TORTION USE THAT FAMILY EVENT TO ACTUALLY TALK ABOUT FAMILY HISTORY AND TO GATHER FAMILY HISTORY INFORMATION. THE IDEA THAT THEY COULD USE IT THAT DAY AND GATHER IT BEFORE OR AFTERWARDS BUT THE TIME WHEN THE FAMILY IS REALLY TOGETHER WHEN YOU HAVE, YOU KNOW, AUNT GLADYS AROUND THAT CAN ACTUALLY TELL YOU ABOUT WHAT YOU THOUGHT YOU HEARD ABOUT UNCLE JOE TO GET MORE ACCURATE INFORMATION. THAT IS ANOTHER PROBLEM WITH DOING THIS IN THE OFFICE IT IS THAT OFTEN YOU HAVE THE PERSON THAT COMES IN HAS IMPRECISE INFORMATION. ALL THE CLINICIANS ARE NODDING THEIR HEADS, THAT IS THE EXPERIENCE OF ALL OF US AND WHEN YOU HAVE THE FAMILY GEARED AROUND IS THE BEST TIME TO GET MORE ACCURATE INFORMATION AND TO BE ABLE TO BUILD THAT OVER THE COURSE OF TIME WE ARE HOPING TO MAKE THIS AN AMERICAN ANNUAL EVENT THAT THANKSGIVING WOULD BE THAT DAY. WE HAVE ALL SEEN THAT PICTURE OF THE TRADITIONAL NORMAN ROCKWELL FREEDOM FROM WONT IS WHAT IT USED TO BE CALLED. THE WAY THAT I THINK OF IS NOW IS THAT NOW THAT WE FINISHED THE FAMILY HISTORILET EAT. THANKSGIVING IS THE DAY THAT BEFORE YOU SIT DOWN TO RAISE YOUR CHOLESTEROL LEVELS THAT YOU TALK ABOUT FAMILY HITS TORE R HISTORYAND GATHER THAT INFORMATION. THE INITIATIVE WILL CONTINUE THAT YEAR PAST THANKSGIVING. WE ARE INTERESTED TO HAVE OTHER INTERESTED PARTIES FEDERAL AGENAGENCIES AND NONFEDERAL AGENCIES. OTHER ORGANIZATIONS THAT WE HAD THAT WE ARE ALLOWED TO DO THAT. WE ARE HOPING IT THIS WILL BE SOMETHING THAT NOT JUST THE GENETICS COMMUNITY BUT OTHER COMMUNITIES AS WELL WILL PARTICIPATE IN AND SEE AS AN IMPORTANT KIND OF IDEA TO BRING THIS TOOL THAT WE REAL KNOW KNOW CAN MAKE A DIFFERENCE IN HEALTHCARE AND CAN BE FAIRLY EASILY ACCOMPLISHD THAT WE BE ABLE TO DO THAT IN A MUCH BETTER WAY. SO WITH THAT I'M GOING TO STOP. MR. CHAIRMAN, I DON'T KNOW IF THERE ARE TIME FOR ANY QUESTIONS OR COMMENTS IF FOLKS HAVE THEM. I WOULD BE HAPPY TO TAKE ANY.

WE ACTUALLY DO HAVE JUST A SECOND, THIS IS AN IMPORTANT PRESENTATION. LET ME TURN TO ED. I THINK HE HAS A COMMENT FIRST.

I WANTED TO COMMENT, I TEACH THE MEDICAL STUDENTS. I HAD THREE HOURS LAST WEEK WITH THEM AND I TOLD THEM THAT THIS WAS THE CHEAPEST BUT PERHAPS THE BEST GENETIC TEST THAT WE HAD TODAY. AND THE OTHER THING AS I WAS SHAKING MY HEAD BECAUSE I RECALLED THAT AS A GENETICIST, AS A BOARD CERTIFIED MEDICAL GENETICIST I WAS ALWAYS ASKING MY PATIENTS FOR THEIR FAMILY HISTORY AND I WAS REALIZING THAT I WAS ASKING THEM MORE THAN I COULD PROVIDE MYSELF AND SAT DOWN WITH MY MOTHER AND WENT OVER THE FAMILY HISTORY AND LEARNED QUITE A BIT ABOUT MYSELF THAT I HAD NOT KNOWN. AND TOO SOON THEREAFTER SHE DEVELOPED ALZHEIMER'S DISEASE SO IT WAS VERY IMPORTANT THAT WE WERE ABLE TO RECORD THAT INFORMATION AND STORED IN AWAY IN THE FAMILY BIBLE TO THEN BE UTILIZED BY GENERATIONS TO COME. DH IS AN EXTREMELY IMPORTANT TOOL I THINK TOO FEW OF US TAKE THE TIME TO REALLY GET THAT INFORMATION AND I WOULD ENCOURAGE EVERYONE HERE TODAY TO BE SURE THAT YOU CAN DO FOR YOUR FAMILIES WHAT WE AS GENETICISTS ASK YOUR PATIENTS TO DO FOR US.

ANY OTHER QUICK QUESTIONS OR COMMENTS?

ALAN, THANK YOU SO MUCH. LET ME ASK TWO FOLLOW-UPS BECAUSE YOU HAVE GOT TWO THINGS THAT I THINK WE NEED TO SORT OF GET SOME MORE INFORMATION ABOUT. FIRST IS THE WHATEVER IS GOING TO GO OUT ON THIS IN TERMS OF GENETICS AND LITERACY WHICH IS PART OF THIS, THE WHOLE IDEA OF WHY IS THIS IMPORTANT IN A GENOMIC AGE TO THE PUBLIC AND HOW DO YOU USE THIS INFORMATION WE SURE WOULD LIKE TO SEE THAT AND BENEFIT FROM WHATEVER IS BEING SENT OUT BECAUSE THAT MAY HELP US THROUGH SOME OF OUR EFFORTS TO IMPROVE THE PUBLIC LITERACY AROUND THE ISSUES OF GENETICS AND SO I THINK IT WOULD BE A GREAT FYI FOR US. SECONDLY, IF THERE IS ANY PART OF THIS TOOL IT IS THAT IS GOING TO BE USED AS PART OF ANY OF THE AGENCY'S EFFORTS AROUND INFORMATION TECHNOLOGY OR TECHNICAL MEDICAL RECORDS I THINK IT WOULD BE HELPFUL TO HAVE THAT AS A FYI FOLLOW-UP BECAUSE WE WILL WIND UP HAVING TO DEAL WITH THOSE ISSUES DOWNSTREAM SO IF THIS IS GOING TO BE INTEGRATED IN ANYWAY INTO THE NEW HEALTH INFORMATION TECHNOLOGY EFFORT THAT ARE COMING OUT OF THE GOVERNMENT IT WILL BE INTERESTING TO SEE.

CERTAINLY, WE WELCOME THE OPPORTUNITY TO KEEP THE COMMITTEE AWARE OF THIS AND ALSO TO ASK INPUT FROM THE COMMITTEE AND THROUGH THE COMMITTEE OF THE VARIOUS FOLKS AT THE COMMITTEE IS CONNECTED TO BECAUSE AGAIN THIS IS THE FIRST STAGE OF WHAT WE HOPE WILL BE A LONG-TERM KIND OF INITIATIVE SO WE WOULD BE VERY HAPPY, FOR INSTANCE, WE ARE DEVELOPING NOT JUST COMPUTER-BASED BUT ALSO FAMILIAR NETS AND THOSE KINDS -- PAM PAMPHLETS THAT WE WOULD LIKE ORGANIZATION DISTRIBUTING THOSE. WE ARE DEVELOPING MANY OF THESE THINGS FOR INSTANCE THE COMPUTER BASED TOO I SHOULD TELL YOU WILL BE AVAILABLE NOT JUST IN ENGLISH BUT ALSO IN SPANISH BEFORE THANKSGIVING SO WE WOULD LOVE THE OPPORTUNITY TO INTERACT WITH THE COMMITTEE AS THIS GOES FORWARD.

TO BRING THIS TO CLOSURE, LET ME OFFER THREE QUICK BOTHS THAT WE MIGHT BE ABLE TO DO IF WE CAN DO THIS WITHOUT UNLESS THERE IS MAJOR CONTROVERSY WE MIGHT TRY TO GET AN ENDORSEMENT FIRST THAT WE ENDORSE THE IMPORTANCE OF FAMILY HISTORY AS A TOOL OF FAMILY MEDICINE APROPOS ED'S COMMENTS. THAT WE REPORT TO THE SECRETARY THAT WE ARE ENCOURAGED TO SEE HHS AGENCIES WORKING TOGETHER TO BRING THIS TO FRUITION AND THIRD THAT WE WOULD ENCOURAGE THOSE AGENCIES THAT ARE NOT PART THIS OF TO GET INVOLVED SO THAT WE WOULD THE AT AT LEAST BE SUPPORT IB OF THIS WITH THOSE THREE RECOMMENDATIONS. IS THERE ANY DISCUSSION ABOUT THOSE THREE? EMILY?

I JUST WANTED TO ASK A QUESTION. ARE YOU GOING TO PROVIDE SOME KIND OF LIKE A MAILOUT SO YOU COULD TAKE A PAM NET OR SOMETHING AND MAIL IT TO YOUR ELDERLY RELATIVES AND ASK THEM AT THEIR LEISURE FOR THOSE THAT AREN'T COMPUTER LIT RATE AND ABLE TO DEAL WITH THAT TO SEND INFORMATION BACK?

THERE WILL BE A FAMILIAR PAMPHLET TO EXPLAIN FAMILY HISTORY AND HAS A TEMPLATE THAT YOU CAN RECORD INFORMATION THAT WE MADE AVAILABLE.

WITH THAT BY A SHOW OF HANDS, WOULD YOU SUPPORT ENDORSING THE IMPORTANCE OF FAMILY HISTORY AS A TOOL IN MEDICINE, THAT WE REPORT TO THE SECRETARY THAT WE'RE ENCOURAGED TO SEE HHS AGENT IS WORKING TOGETHER TO GET THIS DONE AND THIRD THAT WE WOULD ENCOURAGE OTHER AGENCIES TO GET INVOLVED AND SUPPORT THIS INITIATIVE? ALL THOSE IN FAVOR AYE. ANYBODY OPPOSED. IN TERRIFIC. FOR A FOLLOW-UP I HOPE WE DO GET THE TWO FOLLOW-UPS SO WE CAN SORT OF SEE WHAT ACTUALLY DOES GO OUT.

VERY GOOD.

THANK YOU.

THANK YOU, APPRECIATE IT.

ALL RIGHT, FOR THE NEXT PART OF OUR EFFORT WE ARE GOING TO DEVOTE FROM NOW UNTIL 12:45 ON A PRETTY SERIOUS DISCUSSION ON GENETIC DISCRIMINATION. YOU WILL REMEMBER THAT THIS IS A TOP PRIORITY FOR OUR COMMITTEE. WE HAVE WRITTEN TWO LETTERS TO THE SECRETARY URGING SUPPORT FOR THE ENACTMENT OF NED FEDERAL NONDISCRIMINATION LEGISLATION. AT OUR MARCH AND JUNE MEETINGS WE DISCUSSED THE QUESTION OF WHETHER THERE WERE ADDITIONAL EFFORTS THAT WE COULD TAKE TO INFORM THE DEBATE REGARDING FEDERAL LEGISLATION IN THIS AREA. THE UNITED STATES SENATE HAS SUBSEQUENTLY YOU NAN M UNANIMOUSLY PASSED A FIREARM DEEGENETICNONDISCRIMINATION BILL BUT THE HOUSE SUB COMMITTEE ON IMPLOWER RELATION HELD A HEARING ON IN THIS JULY WITHOUT FURTHER ACTION THAT WE ARE AWARE OF. THERE IS A SUMMARY OF THOSE HEARINGS IN THE TAB NO. FOUR. THE PURPOSE OF THIS SESSION IS TO GATHER ADDITIONAL PUBLIC PERSPECTIVES ON GENETIC DISCRIMINATION AND INFORMATION ABOUT THE NATURE, MAGNITUDE AND SCOPE OF THIS PROBLEM IN SOCIETY. THE SESSION WAS PLANNED AND ORIGINAORGANIZED BY OUR TASK FORCE. AGNES MASNY TERRIFIC AS CHAIR AND BARBRA HAS LAND AND EVELYN LEONARD AND ROBINSUE FREE FROHBOESE AND JOANNE BOFFMAN ALL WERE EXTRAORDINARILY INVOLVED IN THIS AND WE THANK THEM FOR IT. AMANDA, THANK YOU FOR YOUR LEAD STAFF WORK ON THIS. AND I ALSO WANT TO THANK THE MEMBERS OF THE PANEL FOR PARTICIPATING AND TAKING NOTE OF THE WRITTEN COMMENTS THAT HAVE BEEN SUBMITTED. THEY HAVE BEEN COME COMPILED IN A SEPARATE BINDER WHICH I HOPE YOU ALL HAVE. A COPY IS AVAILABLE FOR REVIEW AT THE VEG STRAIKS DESKS. DRK REGISTRATION DESKS. TO LEAD US THROUGH THIS, LET ME ININTRODUCE AGNES.

I WOULD ALSO LIKE TO THANK DOCTOR TUCKSON WHO IS GOING TO HELP COFFA SILL FATE AND THANK THEM FOR HELPING COORDINATE AND FOR AMANDA WHO HAS BEEN WORKING BY MY SIDE IN HELPING TO PULL ALL THIS TOGETHER AND MOST ESPECIALLY TO THANK ALL OF THE SPEAKERS WHO HAVE COME FROM FAR AND WIDE TODAY TO BE ABLE TO GIVE TESTIMONY TODAY SO THAT WE WILL BE ABLE TO DOCUMENT FOR THE RECORD THE EXPERIENCE OF THE PUBLIC HEALTH PROFESSIONALS AND OTHERS REGARDING THIS VERY IMPORTANT ISSUE OF HEALTH DISCRIMINATION, GENETIC DISCRIMINATION. SO AS DR. REED MENTIONED, WHAT LED UP TO FORMING THIS PARTICULAR TASK FORCE AND THE MEMBERS THAT HE ALREADY INDICATED HAVE BEEN PRESENTED AND THEN THE AS WAS MENTIONED IS THAT ONE OF THE REASONS WHY WE HAVE ACTUALRYLY ACTUALLY ESTABLISHED HAVING A PUBLIC HEARING TODAY IS THAT BOTS FROM THE PAST WE RECOGNIZED THAT THE EVIDENCE ABOUT GENETIC DISCRIMINATION AND PARTICULARLY THE FEAR OF GENETIC DISCRIMINATION HAS BEEN VERY HARD TO DOCUMENT AND THERE ARE VERY MANY REASONS THAT HAVE BEEN BROUGHT FORTH TO THE COMMITTEE REGARDING THE PUBLIC'S CONCERN ABOUT GENETIC PRIVACY AND PRESENTING THEIR INFORMATION IN LEGAL CASES IS STRE HARD TO DO. -- IS VERY HARD TO DO. THAT IS ONE OF THE REASONS WHY WE WANTED TO HAVE THIS HEARING AND ALSO BECAUSE TO DATE THERE HAS BEEN LACK OF SUFFICIENT EVIDENCE AND THIS LACK OF EVIDENCE HAS BEEN ACTUALLY BROUGHT UP AS ONE OF THE REASONS AS A BARRIER TO GOING AHEAD WITH LEGISLATION FOR ANTIDISCRIMINATION. SO AT THE 2004 JUNE MEETING WE DID DECIDE TO UNDERTAKE THIS PUBLIC HEARING IN ORDER TO PROVIDE THE SECRETARY WITH ADDITIONAL INFORMATION THAT MIGHT BE USEFUL IN ADDRESSING THE POTENTIAL OBSTACLES REGARDING GENETIC DISCRIMINATION AND MOVING IT FORWARD FOR LEGISLATION. SO THE PURPOSE OF THIS SESSION AS REED HAS ALREADY MENTIONED IS TO LEARN MORE ABOUT THE MAGNITUDE AND SCOPE AND NATURE OF THE GENETIC DISCRIMINATION THROUGHOUT SOCIETY AND TO PROVIDE ALL OF US WITH THIS PUBLIC FORUM TO BE ABLE TO BOTH HEAR THE TESTIMONY AND THEN TO BE ABLE TO DISCUSS THE ISSUES THAT WILL COME FORTH FROM THIS HEARING. AND THEN THE LAST STEP WILL BE FOR US AS A COMMITTEE TO THEN TO LOOK AT WHAT ARE THE NEXT STEPS THAT WE HAVE TO TAKE TO HOPEFULLY MOVE THE LEGISLATION FORWARD. SO WHAT WE ARE GOING TO BE DOING TODAY IS WE ARE ACTUALLY GOING TO HEAR FROM THREE PANELS. MEMBERS OF THE PUBLIC, HEALTH CARE PROVIDERS AND THEN ADDITIONAL STAKE HOLDERS AND THE PATIENT PANEL WILL CONSIST OF MEMBERS OF THE PUBLIC WHO HAVE EXPERIENCED GENETIC DISCRIMINATION OR WHO HAVE ALTERED THEIR HEALTHCARE BECAUSE THEY HAVE A CONCERN ABOUT GENETIC DISCRIMINATION EITHER FROM INSURANCE OR FROM EMPLOYMENT OR THOSE WHO HAVE HAD TO PAY OUT OF POCKET IN ORDER TO -- BECAUSE OF THEIR CONCERN FOR GENETIC DISCRIMINATION. WE ALSO TOOK TIME TO LOOK AT AS A TASK FORCE IN LOOKING ATGETING MEMBERS OF THE HEALTHCARE COMMUNITY PROVIDERS WHO HAVE THAT FIRST-HAND EXPERIENCE WITH THE PATIENTS HEARING THEIR CONCERNS ABOUT GENETIC DISCRIMINATION TO ALSO BE ABLE TO COME AND TESTIFY. SO AGAIN, HERE, WE HOPE TO HEAR FROM THE PROVIDERS ABOUT SOME OF THEIR PATIENTS WHO MAY HAVE ALTERED THEIR HEALTHCARE DECISIONS OR WHO HAVE NOT PARTICIPATED IN GENETIC RESEARCH BECAUSE OF GENETIC DISCRIMINATION AND OTHER CONCERNS THAT THEY HAVE REGARDING DISCRIMINATION. AND THEN THE THIRD PANEL WILL BE ADDITIONAL STAKE HOLDERS THAT WILL HOPEFULLY GIVE US AN ADDITIONAL PERSPECTIVE IN THIS FROM EMPLOYERS, FROM THE HEALTH INSURANCE PERSPECTIVE AND FROM THE SOCIETY AT LARGE AND THIS PRIMARILY THROUGH A REPRESENTATIVE FROM THE CENTER FOR GENETICS AND PUBLIC POLICY WHO OVER THE PAST SEVERAL MONTHS HAVE HELD TOWN MEETINGS ACROSS THE COUNTRY ON THE ISSUES OF GENETICS AND GENETIC DISCRIMINATION WAS ONE OF THE ISSUES. SO WE WILL BE HEARING THAT PARTICULAR PERSPECTIVE AS WELL. THE COMMITTEE AND THE SACGHS HAD REQUESTED WRITTEN PUBLIC COMMENTS THROUGH THE FEDERAL REGISTER NOTICE, THROUGH THE SACGHS WEBSITE, THROUGH THE MAJOR DISTRIBUTION LIST OF SACGHS AND THEN WE ALSO TARGETED SPECIFIC MEDICAL GROUPS LIKE THE AMERICAN COLLEGE OF OB VET SET IT RICKS AND GYNECOLOGY TO GO DIRECTLY TO THEIR MEMBERSHIP TO ASK ABOUT THIS PARTICULAR ISSUE WHETHER THEY AS PROVIDERS HAVE COME IN CONTACT WITH GENETIC DISCRIMINATION OR THE FEAR OF DISCRIMINATION FROM THEIR PATIENTS AND THEN ALSO VARIOUS LIST SERVES FROM HEALTH PROFESSIONALS, PHYSICIANS, NURSES AND GENETIC COUNSELORS TO REQUEST PUBLIC COMMENTS. SO FROM -- WE DID RECEIVE 43 PUBLIC COMMENTS. # 22 WERE FROM THE PUBLIC. 11 WERE FROM HEALTHCARE PROVIDERS. FROM PROFESSIONAL ORGANIZATIONS. AND ONE VERY NICE THOUGHTFUL TESTIMONY FROM DR.-- FROM REPRESENTATIVE LOUISE SLAUGHTER WHO HAS COSPONSORED THE HOUSE VERSION OF THE BILL 1910. SO WE GOING TO BEGIN THEN WITH THE MOST IMPORTANT PART IS ACTUALLY TO HEAR FROM THE PUBLIC AND WE ARE GOING TO START FIRST WITH THE PATIENT PANEL. AND WE ARE REALLY VERY FORTUNATE TO HAVE WITH US TODAY A PANEL OF 7 MEMBERS OF THE PUBLIC WHO WOULD LIKE TO SHARE THEIR PERSONAL STORIES AND EXPERIENCES AND THEIR OWN PERSPECTIVE ON GENETIC DISCRIMINATION. THEY COME TO US FROM ACROSS THE COUNTRY. AND WHAT I DOLL IS I WILL DO IS I WILL INTRODUCE THE WHOLE PANEL AS A WHOLE AND NOT INTRODUCE YOU AS YOU CAN JUST KIND OF GO IN ORDER ACROSS FROM THE TABLE. WE WILL ASK THE SPEAKERS THAT THEY WILL HAVE TEN MINUTES TO PRESENT THEIR PUBLIC TESTIMONY. WE WILL TRY TO KEEP TRACK OF THE TIME FOR YOU. AND THEN AFTER EVERYONE HAS HAD THE OPPORTUNITY TO PRESENT THEN WE WILL OPEN IT UP FOR QUESTIONS FROM THE ADVISORY GROUP AND THE EX OFFICIOS WILL HAVE AN OPPORTUNITY TO ASK ANY ADDITIONAL QUESTIONS AFTER THE END OF ALL OF THE TESTIMONY. OKAY? SO AGAIN, WE WOULD LIKE TO THANK AND WELCOME OUR FIRST PANEL WE HAVE HEIDI WILLIAMS IS FROM IS A CECELIA KENTUCKY. PHAEDRA MALATEK AND HERE WITH HER TWO SONS FROM CHICAGO, ILLINOIS. AREBECCA FISHER FROM OAKTON VIRGINIA. TONIA PHILLIPS FROM ROANOKE, VIRGINIA. PAULA FUNK FROM LITTLE ROCK, ARKANSAS. MARIA CAROLINA HEINSTROSA FROM WASHINGTON, D.C. AND PHIL HARDT FROM PHOENIX ARIZONA. SO WE ARE GOING TO TURN IT OVER TO YOU. SO, FAY TRA, PHAEDRA WOULD YOU BE WILLING TO START US OFF? HEIDI, YOU WANT TO START AND WE WILL GO DOWN THE LINE?

THANK YOU. MR. CHAIR MAN, MEMBERS OF THE COMMITTEE, MY NAME IS HIGH DEWILLIAMS AND MY CHILDREN JAIME 8 AND JESSE 10 WERE RECENTLY VICTIMS OF GENETIC DISCRIMINATION. IN AUGUST OF 2003, I SAW A COMMERCIAL ON TELEVISION ADVERTISING AFFORDABLE HEALTHCARE INSURANCE FOR INDIVIDUALS THROUGH HUMANA INCORPORATED. I CALLED THE TOLL FREE NUMBER AND TALKED WITH THE YOUNG WOMAN WHO QUOTE IMMEDIATE A PRICE FOR A POLICY THAT WOULD COVER BOFTH MY CHILDREN. I WAS TOLD THAT THE MONTHLY COST TO INSURANCE MY CHILDREN WOULD BE APPROXIMATELY $105 AND I IMMEDIATELY TOLD THE YOUNG WOMAN I WOULD LIKE TO COMPLETE AN APPLICATION SO THAT THE COVERAGE WOULD BEGIN AS SOON AS POSSIBLE. I WAS ASKED A SERIES OF QUESTIONS ABOUT MY CHILDREN INCLUDING WHETHER OR NOT THEY HAD A PREEXISTING CONDITION. HE RELAYED TO THE YOUNG WOMAN UNDER THE THREAT OF A FINE AND INCARCERATION FOR FALSIFYING INFORMATION THE FACT THAT MY CHILDREN WERE CARRIERS OF THE GENETIC DISORDER CALLED ALPHA ONE ANNA TRIP SEEN DEFICIENCY OR AAT. A LIVER DEFICIENCY THAT CAN PROGRESSIVELY AFFECT THE LUNGS OR LIVER OR BOTH BUT THAT MY CHILDREN UNLIKE THEIR MOTHER WHO IS LUNG SYMPTOMATIC WOULD NEVER SUFFER FROM ANY ASPECT OF THE DISORDER. THE YOUNG WOMAN WHO WASN'T QUITE SURE WHAT TO DO WITH THIS INFORMATION ASK NEED HOLD ON THE LINE WHILE SHE CONTACTED HER SUPERVISOR. AS I SPOKE WITH HER SUPERVISOR I AGAIN EXPLAINED HOW MY CHILDREN WERE ONLY CARRIERS OF THE AAT GENE AND THIS MY CHILDREN THEMSELVES WOULD NEVER SUFFER FROM ANY ASPECT OF THE DISORDER AS I AM SUFFERING AND THEY ARE EXCEPTIONAL AACTIVE AND HEALTHY CHILDREN. AGAIN I WAS TOLD TO HOLD THE LINE BECAUSE AS THIS GENTLEMAN WAS UNCOMFORTABLE WITH THE INFORMATION I IMPORTED HE NEEDED TO CONTACT HIS SUPERVISOR. I, ONCE AGAIN, RELAYED THE INFORMATION ABOUT ALPHA ONE AND HOW NYE CHILDREN WERE ONLY CARRIERS. TO BE BORN WHAT IS CONSIDERED SYMPTOMATIC YOU MUST HAVE TWO PAIR RENS WHO ARE AT LEAST CARRIERS OF THE AAT GENE AND BE OF A CERTAIN FINE QUO FINE FOE PHENOTYPE. MY CHILDREN CAN ONLY BE CARRIERS AND AS RESEARCH SU SPORTS WILL NEVER BE SUSCEPTIBLE TO THE VARIOUS PROBLEMS SYMPTOMATIC AAT SPACE INCLUDING LUNG AND LIVE FAILURE. ONCE THE SENIOR SUPERVISOR AND I FINISHED SPEAKING I WAS GIVEN BACK TO THE YOUNG WOMAN WHO INITIALLY TALKED TO ME AND I WAS TOLD THAT I WOULD RECEIVE A REPLY TO MY CHILDREN'S APPLICATION FOR HEALTH INSURANCE WITHIN 24 HOURS. AFTER FIVE DAYS OF WAITING I KNEW IN STINGTIVELY THAT THERE HAD BEEN A PROBLEM WITH MY CHILDREN'S APPLICATION. I RECEIVED A LETTER TWO DAYS LATER EXACTLY ONE WEEK AFTER THE PHONE APPLICATION STATING THAT MY CHILDREN WERE BEING REJECTED FOR THEIR HEALTHCARE INSURANCE FOR HUMANA INCORPORATED DUE TO THEIR AAT STATUS AND FOR MO OTHER REASON. AFTER MUCH SELF-RECRIMINATION I SHARED MY WOES WITH THE ALPHA ONE INTERNET COMMUNITY THAT IS EXTREMELY CONCERNED ABOUT GENETIC GENETIC DISCRIMINATION. LEADING MY FEARS FROM MY CHILDREN HAVING ABOUT BEEN TISE REJECTED FROM HEALTHCARE COVER ANDAGE. NANCY BI ELO HEARD ABOUT MY PROBLEMS WITH HUGH HAN MA INCORPORATED AND APPROACHED ME ABOUT PUBLICLY COMING FORWARD WITH MY STORY THROUGH THE AUSSIES OF THE PUBLIC A-- AUSPICES OF THE PUBLIC ALLIANCE. A WONDERFUL AND KNOWLEDGEABLE AAT DOCTOR AN APPEAL TO THE AUGUST 2003 LETTER A LETTER WHICH REJECTED MY CHILDREN FOR HEALTH INSURANCE COVERAGE ON THE BASIS OF THEIR GENETIC STAT US WAS DRAFTED AND SENT TO HUMANA INCORPORATED. ENCLOSED WITH THE LETTER WAS RESEARCH NAVTION FROM THE NATIONAL INSTITUTE OF HEALTH AND THE ALPHA ONE FOUNDATION SUPPORTING MY ARGUMENT THAT JESSE AND JAMIE AS CARRIERS WOULD NOT BECOME CARRIERS OF ALPHA ONE AND BOTH WOULD REMAIN FREE OF THE AAT DEBILITATING DESTRUCTIVENESS THROUGHOUT THEIR LIFETIME. IN FEBRUARY OF THIS YEAR I RECEIVED MY RESPONSE AFS WAS ONCE AGAIN, SHOCKED TO REED THAT MY CHILDREN WERE WHERING REJECTED FOR HEALTH HEALTHCARE COVERAGE ONLY ON THE BASIS OF THEIR AAT AND NOTHING MORE. IT WAS ONLY AFTER THEY WERE APPROACHED BY A WELL KNOWN NEWSPAPER THAT THEY OFFERED MY CHILDREN FULL COVERAGE UNDER THEIR COMPANY PRO VATTED PRO RATED FROM AUGUST 2003 AND PAID IN FULL THROUGH 2004 BY HUMANA INCORPORATED THEMSELVES. FORTUNATELY FOR ME, A COMPANY THAT DECIDED EVERYBODY IS ENTITLED TO AFFORDABLE HEALTH INSURANCE COVERAGE AND NOT HUMANA COVERS MY CHILDREN. NO ONE SHOULD HAVE TO FORCE AN INSURANCE COMPANY TO COVER PERFECTLY HEALTHY CHILDREN. IN FACT, I DON'T BELIEVE IT SHOULD HAVE MATTERED WHAT THEIR GENETIC STAT US WAS TO BEGIN WITH. WE ARE ALL VIABLE MEMBERS OF A COMMUNITY WITH CONTRIBUTIONS TO MAKE AND SHOULDN'T HAVE TO BE AFRAID THAT OUR GENETIC ANOMALIES IN WHATEVER WERE FORM THEY ARISE WILL BE HELD AGAINST US. I SHOULD NOT HAVE HAD TO SPEND THE BETTER PART OF 6 MONTHS WONDERING IF THE DECISION TO HAVE THE GENETIC STATUS VERIFIED BY THEIR PEDIATRICIAN WAS A HUGE MISTAKE. I SHOULD NOT HAVE TO WONDER IF MY CHILDRENS IF GENETIC STAT US IS GOING TO FOLLOW THEM INTO THE WORK FORCE AND AWN MAKE THEM UNABLE TO BE PLOYED IN THEIR CHOSEN FIELDS. HUMANA INCORPORATED MID ME FEEL GUILTY AND ASHAMED FOR HAVING TO KNOW MY CHILDREN'S AT THAT TIME TUS. FURTHER MORE THEY MADE ME FE GUILTY FOR NEEDING A PARENT'S PEACE OF MIND. THERE IS A CURRENT FEAR REVERB RATING THROUGHOUT THE GENETIC COMMUNITY. IT IS A FEAR THAT FORCES MANY WITHIN THE PARTICULAR COMMUNITY TO ACCEPT WHICH SHOULD BE UNACCEPTABLE. DISCRIMINATION BY GENETIC STATUS. MANY PEOPLE ARE AFRAID TO COME FORWARD AND FIGHT FOR RIGHTS TO EMPLOYMENT AND HEALTH INSURANCE COVERAGE BECAUSE THEY ARE AFRAID OF THE REST DISTRIBUTION THAT MIGHT NOT ONLY BE TAKEN AGAINST THEM BUT TAKEN AGAINST THEIR FAMILIES AS WELL. THEREFORE IT IS BECAUSE OF THE CALLOUS TREATMENT OF M CHILDREN AND THE COUNTLESS OTHERS BEFORE THEM THAT I WANT TO MAKE SURE THAT THIS SORT OF POLICY PRACTICE NEVER HAPPENS TO ANY ONE AGAIN. I WANT TO NEVER AGAIN EXCHANGE E-MAILS WITH SOMEONE PHASED OUT OF A POSITION DUE TO HER GENETIC STATUS. I NEVER AGAIN WANT TO HEAR THE STORY OF SOMEONE WHO HAS BEEN DENIED HEALTHCARE COVERAGE, HAD THE HEALTH INSURANCE COVERAGE CANCELLED AND THEN PASSED EVER FOR PRO MOTION, DEMOTED, FIRED OR SIMPLY NOT HIRED DUE TO GENETIC STATUS. NATIONAL LEGISLATION THAT WOULD MAKE IT ILLEGAL FOR INSURANCE COMPANIES AND EMPLOYERS TO USE ONSOMEONE'S GENETIC AGAINST THEM HAS BEEN INTRODUCE. ONE YEAR LATER THIS IMPORTANT PIECE OF LEGISLATION THAT WOULD PROTECT MANY AMERICANS IS STILL STRANDED IN THE HOUSE OF REPRESENTATIVES IS. AS EACH DAY PASSES AND THE GENETIC COMMUNITY WAITS FOR THE HOUSE TO BRING THIS FOIL A BILL TO A VOTE SCORES OF PEOPLE ARE BEING PERCENPERSECUTED ON THE BASIS OF THEIR GENETIC STATUS CONTRIBUTION IT IS REPRESENT REHENCIBLE THAT ANY TYPE OF DISYIP NATION EXISTS AND MUST BE LEGISLATE THE AGAINST. IT MUST BE ERADICATED IN ANY FORM THAT THIS IS FOUND BEFORE ITS DESTRUCTIVE FORCE HAS HAD THE CHANCE TO HARM ANYBODY ELSE. FINALLY, MY FAMILY AND I WERE EXTREMELY LUCKY. WE HAD THE BACKING OF SEVEN RAL PEOPLE AND ORGANIZATIONS TO HELP US FIGHT OUR BATTLE IN THE WAR AGAINST GENETIC DISCRIMINATION THAT VERY FEW PEOPLE IN THE GENETIC COMMUNITY WIN. ONLY THROUGH LEGISLATION AND EDUCATION WILL GENETIC DISCRIMINATION LOOSEN ITS HOLD ON A COMMUNITY OF PEOPLE WHO ARE SUFFERING FROM ITS DEVASTATEING EFFECTS. THANK YOU.

THANK YOU, MS. WILLIAMS FOR YOUR VERY POWERFUL TESTIMONY. NOW, WE WILL HEAR FROM PHAEDRA MALATEK.

GOOD MORNING. THANK YOU FOR GIVING ME THE OPPORTUNITY TO SFEEK WITH YOU TODAY. MY NAME IS PHAEDRA MALATEK. A WIFE, MOTHER, SISTER, DAUGHTER AND FRIEND OF PEOPLE WHO CARE VERY DEEPLY ABOUT WHAT WE ARE DOING HERE TODAY. I LIVE IN AURORA, ILLINOIS, WITH MY HUSBAND AND TWO SONS. MY PRY PERIOCCUPATION ISED A NCT FACULTY AT TWO LOCAL COMMUNITY COLLEGES. I'M HERE TODAY TO TALK TO YOU ABOUT THE HOPE THAT LIES IN GENETIC TESTING MORE SPECIFICALLY THE GENETIC INFORMATION NONDISCRIMINATION ACT AS 1053 AND I TALK ABOUT HOPE BECAUSE AS RALPH WALDO EMERSON SAYS WE JUDGE OF A MAN'S WISDOM BY HIS HOPE AND TODAY I'M FEELING PRETTY WISE. FOR ME, GENETIC TESTING AND THE PROTECTION OFFERED BY S1053 CAN BE COMPARED IN AN ANALOGY TO WEATHER TRACING OR STORM PREDICTION. EMERGENCY IF YOU WILL THAT WE HAD NO KNOWLEDGE OF THE STORMS THATHAT RECENTLY SWEPT THROUGH THE MORCAKCAKE CINCINNATI. NOW, IMAGINE NEVER HAVING ANY INFORMATION ABOUT ANY STORM EVER. WELL, I THINK THAT IS -- THAT OUR UNDERSTANDING AND CONSIDERATION OF GENETIC TESTING CAN BE COMPARED TO THOSE WHAT IFS. WHAT IF PEOPLE WERE GIVEN THE KNOWLEDGE OF THE POTENTIAL STORMS IN THEIR LIVES? HOW WOULD BE THEY ABLE TO PROTECT THEMSELVES? WHAT WOULD SERVE AS THE PLYWOOD FOR THE WINDOWS AND WHAT EVACUATION ROUTES WOULD BE MADE AVAILABLE TO THEM AND MORE IMPORTANTLY HOW MANY LIVES WOULD BE SAVED? THAT REALLY IS THE QUESTION, ISN'T IT? HOW MANY LIVES CAN BE SAVED THROUGH WHAT WE ARE DOING HERE AND THROUGH THE ENACTMENT OF S1053. CONTINUING THE STORM ANALOGY, CONSIDER A SITUATION WHERE YOU KNOW THAT IS STORM IS COMING OR MAY COME AND YOU TAKE THE PRECAUTIONS SUCH AS BOARDING UP YOUR WINDOWS AND PUTTING THE LAWN FURYK FUHR IN FURNITURE IN THE POOL BUT YOU ARE UNABLE TO GET INSURANCE BECAUSE A STORM MAY COME. YOUR NEIGHBOR HAS NO KNOWLEDGE OF THE STORM AND DOESN'T TAKE THE NECESSARY PLEA PRECAUTIONS. IF THE STORM DOESN'T HIT, EVERYBODY WINS. IF THE STORM DOES HIT THE INSURANCE COMPANY PROVIDES FULL FINANCIAL REIMBURSTMENT FOR THE NEIGHBOR'S SEVERELY DAMAGED OR LOST PROPERTY BUT THERE IS NO COVERAGE FOR YOUR PROPERTY NO MATTER HOW SMALL OR LARGE THE LOSS. IT SEEMS TO ME THAT THAT IS WHAT WE ARE TALKING ABOUT WIT GENETIC DISCRIMINATION. A SITUATION IN WHICH NO ONE WINS AND EVERYONE LOSES. THOSE WITH ADVANCE WARNING ARE ACTUALLY HARMED RATHER THAN HELPED BY THE KNOWLEDGE THEY POSSESS. AN WERE INSURANCE COMPANIES AND THOSE WITHOUT ADVANCED KNOWLEDGE SUFFER EVEN LARGER LOSSES BECAUSE THEY HAVE BEEN GIVEN THE KNOWLEDGE TO PROTECT THEMSELVES. IF FAIR WARNING IS GIVE GIVEN TO ALL PARTIES THE PEOPLE ABLE TO PROTECT THEMSELVES AND THE INSURANCE COMPANIES AGREE TO BE AT RISK FOR ANY LOSS SUFFERED ALL HAVE A LARGER MEASURE OF PROTECTION. THOSE INFORMED CAN BE PROACTIVE AND TAKE PROPHYLACTIC MEASURES OR BE MONITORED MORE CLOSELY INCREASING THE ABILITY TO AVOID HAVING A DISEASE OR HAVE A DETECTED IN THE MOST EARLIEST TREATABLE AND SURVIVABLE STAGES. AS WE ALL KNOW THAT NOT ONLY SAVES LIVES BUT DRAMATICALLY DECREASES THE COSTS TO EMPLOYERS, INSURERS AND THE INDIVIDUALS. A STORM SUCH AS THIS HIT MY LIFE A NUMBER OF YEARS AGO. IN 1991 MY FARE 1991 FATHER GATHERED TOGETHER CHILDREN, NIECES, SIBLING LINGS, COUSINS TO DISCUSS A DISEASE HE HAD BEEN ZING DIAGNOSED WITH. IS IT IS REFERRED TO AS IRON OVERLOAD. MY FATHER HAD BEEN EXHIBITING SYMPTOMS PRIOR TO DIAGNOSIS INCLUDING ARTHRITIS, HEART ARITH MARRHYTHMIA AND CHANGE A SKIN TONE. AT THE SAME TIME THE PHYSICIANS CONJECTURED THAT MY GRANDFATHER AND GREAT GRANDFATHER MAY HAVE ALSO CARRIED AND SUFFERED THE EFFECTS OF THE DISEASE. WITHIN A YEAR OF THE MEETING MY FATHER SUFFERED A HEART ATTACK AND WITHIN TEN YEARS HAD DIED FROM THE DISEASE. SINCE MY FATHER'S DIAGNOSIS, TWO OF MY SIBLINGS DEVELOPED COMPLICATIONS OF THE DISEASE. NONE OF THEM, MY FATHER OR MY SISIBLINGS HAVE HAD GENETIC TESTS FOR HEMOCROW MATOSIS. BECAUSE OF MY FAMILY H S HISTORY AND THE FACT THAT IS IT IS THE MOST COMMON INHERITED DISEASE IN THE UNITED STATES. MY HUSBAND AND I ARE CONCERNED FOR THE HEALTH OF MY TWO CHILDREN. MITCHELL AND TREVOR THROUGHOUT THEIR LIVES WE RECEIVED CONFLICTING INFORMATION ON HOW TO APPROACH THEIR RISK FOR HEMOCROW MOHEMOCROW MA MOW SIS. WE WERE TOLD TO CONSTANTLY MONITOR THEIR DIET. ALL OF THIS MAY HAVE BEEN GOODED A VIS, NONE OF IT REPLACES KNOWING THEY CARRIED THE MUTATION FOR THE DISEASE THAT CONTRIBUTED TO MY FATHER'S DEATH. WITH THAT KNOWLEDGE WE COULD HAVE TAKEN PROVEN MEASURES TO LESSON THE IMPACT, THE PREDISPOSITION FOR THIS DISEASE MIGHT HAVE ON THEIR LIVES. LIKE STORM PREDICTING AND TRACKING CAPABILITIES GENETIC TESTING SEEMS TO OFFER AN OPPORTUNITY TO LEARN MORE ABOUT THE CONSTITUTION OF DISEASES AND THEIR POTENTIAL SERIOUS DAMAGE. IT CAN HELP US TRACK THE PROGRESSION OF THE DISEASE AS WELL AS DETERMINE OR EVEN DETERMINE TREATMENT OR EVEN PROTECTIVE MEASURES TO AVOID THE STORM THAT MAY RESULT FROM A GENETIC MUTATION. FOR MY CHILDREN THIS COULD BE LIFE ALTERING INFORMATION. ALTERING IN THAT IT WILL DECREASE THE LIKELIHOOD THAT THEY WILL BE INCAPACITATED BY HEMOC HROMATOSIS. IT CAN MEAN THE DIFFERENCE BETWEEN FOE FA LACTIC TREATMENT AND THE STARK CONTRAST OF THE OFTEN FEW TILE AND VERY PAINFUL DEATH PROLONGING TREATMENTS. THROUGHOUT THE RECORDED HISTORY OF HURRICANES EXPERIENCES HAVE GONE FROM STORMS THAT CAME OUT OF NO WHERE AS RECENTLY AS A HUNDRED YEARS AGO TO THOSE WE WERE ABLE TO TRACK MINUTE BY MINUTE 100 DAYS AGO. THE DRAMATIC CHANGE IS NOT THE RESULT MUCH THE DECREASE IN THE POWER OF THE STORM BUT RATHER AN INCREASE IN THE TECHNOLOGY AND OUR UNDERSTANDING OF HURRICANES. ALONG THE SAME LINES TECHNOLOGY AND ADVANCES IN THE AREA OF GENETIC TESTING CAN SIMILARLY PROVIDPROVIDE PREDICTABILITY AND GREATER LEVEL OF PROTECTION FOR THOSE AT RISK. THAT RISK OR EVEN THE KNOWLEDGE MUCH THE POTENTIAL RISK CAN BE PROTECTED THROUGH S105 # 3. WHILE THE TECHNOLOGY SEEMS TO BE IN PLACE OR AT LEAST ADVANCING AT A RELATIVELY RAPID CLIP, THE SOCIAL AND ECONOMIC PROTECTIONS ARE NOT. AS IT STANDS RIGHT NOW, IF NYE CHILDREN UNDERGO GENETIC TESTING FOR HEMOCHROMEATOSIS THEY RISK NOT BEING ABLE TO OBTAIN HEALTH INSURANCE AND POSSIBLE DISCRIMINATION WHEN THEY RECEIVE PLOYMENT. WE ARE GIV GIVE AND CHOICE TO PROTECT THEIR HEALTH OR PROTECT THEIR LIVELIHOOD. IT TROUBLES ME THAT S1053 OFFERS PROTECTION THAT WOULD ELIMINATE THE NEED FOR MY HUSBAND AND I DO DECIDE SUCH A DIFFICULT THING AND IT HAS NOT BEEN BROUGHT TO A VOTE IN THE HOUSE OF REPRESENTATIVES. ALL OF THIS IS REMINISCE SENT OF THE SERIES OF CHOICES THAT WERE BEING MADE 40 YEARS AGO. IN THE LATE 50s AND EARLY 60s MY PARENTS FOUGHT DILIGENTLY FOR THE RIGHTS OF PEOPLE WHO WERE GENETICALLY DIFFERENT THAN THEM. THEY WERE NOT DIFFERENT IN THAT THEY WERE A HIGHER RISK OF ARE OBTAINING HEMOAGAIN TOE TESS SKWR S. THE CIVIL RIGHTS ACT ARE THERE TO PROTECT PEOPLE FROM DISYIP NATION BASED ON GENETIC MAKEUP THAT WE CAN SEE. A PERSON'S GENETIC MAKEUP THAT ISN'T VISIBLE SHOULD BE EQUALLY PROTECTED UNDER THE SAME TERMS AND CAN BE THROUGH S1053. IT IS REMARKABLE FOR ME TO REALIZE THAT THE WORK MY PAY NTS DID FOR THE CIVIL RIGHTS IN THE 1960s WERE NOT COMPLETE. HERE I AM WORKING ON THE SAME ISSUE EQUAL RIGHTS AND PROTECTION UNDER THE LAW NO MATTER THE GENETIC MAKEUP OF A PERSON. THE FACT THAT WE CAN LOOK INSIDE A DNA OF A PERSON TO KNOW MORE ABOUT THEM SHOULD NOT PRECLUDE THEM FROM THE PROTECTION THAT WAS FOUGHT FOR SO VALIANTLY. AS I SEE IT, GENETIC TESTING IS THE WEATHER TRACKING DEVICE OF HEALTH. JUST AS WE RELY ON WEATHER TRACKING TECHNOLOGIES TO PREDICT AND ALOUSE ALLOW US TO PROTECT OURSELVES FROM HURRICANES OR OTHER WEATHER RELATED WERE TOES I URGE YOU TO ALLOW US -- I URGE YOU TO ALLOW US TO DO THE SAME FOR GENETIC DISEASES. WE MUST MOVE FORWARD IN PROTECTING PEOPLE FROM THE POTENTIAL STORMS IN THEIR LIVES. YOU CAN DO THIS BY URGING SECRETARY THOMPSON AND MY REPRESENTATIVE SPEAKER HASTERT TO BRING IN BILL TO A VOTE IN THE HOUSE OF REPRESENTATIVES. I'M SURE YOU WILL AGREE WITH ME WHY I SAY THAT PROTECTING LIVES IS EQUALLY OR MORE IMPORTANT THAN PROTECTING PROPERTY. IF WE CAN, WE SHOULD AND S1053 WILL.

THANK YOU, MS. MALATEK. THAT WAS A BEAUTIFUL ANALOGY BETWEEN THE GENETICS AND STORM. WE WILL HEAR NEXT FROM REBECCA FISHER.

UI DON'T THINK I HAVE ANYTHING TO ADD TO THAT. IT SEEMS ALMOST LIKE PREACHING TO THE CHOIR BUT I WOULD LIKE TO THANK THE COMMITTEE FOR EVERYTHING THAT THE COMMITTEE MEMBERS HAVE DONE IN THE PAST TO ADDRESS ADDRESS GENETIC DISCRIMINATION CONCERNS. AND I HOPE THAT OUR REMARKS WILL HELP TO INFORM YOUR ACTIONS GOING FORWARD. IN A PROVOCATIVE OCTOBER EDITORIAL IN THE JURISDICTION DOWNAL OF SIGHNESS NOBEL LAWYER RATE WONDERS WHAT THE HEALTHCARE WILL BE LIKE IN 195 PERHAPS THE KEY YAITION OF A NEW PUBLIC HEALTH PARADIGM IN WHICH THOSE WHO HAVE A GENETIC PREDISPOSITION TO DISEASE WILL LEARN HOW TO TAKE EXTRA CARE. DOCTOR BRENNER NEED NT WAIT 50 MORE YEARS TO SEE THE PREDICTION REAPREDICTION REALIZED. THOSE THAT POSSESS THE RK1 ARE ALREADY TAKING EXTRA CARE. A RECENT STUDY ESTABLISHED THAT 67% OF WOMEN WITH THIS MUTATION ARE DIAGNOSED WITH BREAST CANCER BY THE TIME THEY ARE 50 YEARS OLD. BUT I HAVE A COUSIN WHO DIED OF IT WHEN SHE WAS 28. I HAVE A ANOTHER WHO IS BATTLING STAGE FOUR OH OVARIAN CANCER. HEY HAS A 4-YEAR-OLD. MY MOTHER HAD BREAST CANCER AT 35. HER MOTHER DIED OF OVARIAN CANCER AT 41. HER SISTER HAD BREAST CANCER AT 32. I WAS 31 WHEN I WAS DIAGNOSED WITH STAGE THREE BREAST CANCER. MY DAUGHTER A 21-YEAR-OLD IS IN THIS LINE, TOO. SHE TESTED POSITIVE FOR BRCA1 AND WILL HAVE TO LEARN HOW TO TAKE EXTRA CARE. THE CARE THAT KATIE WILL HAVE TO LEARN HOW TO TAKE INCLUDES NOT ONLY THE LOW FAT DIET SHE IS ALREADY EATING AND THE DAILY EXERCISE RIDGE REGIMEN IT INCLUDES MORE THAN THE BREAST SELF-CM SHE IS REQUIRED TO PERFORM MONTHLY AND BELIEVE ME I DO REMIND HER. IT GEESE BEYOND THE M RIS THAT SHE WILL RECEIVE AT AGE 25. DEMANDS THAT SHE LIKE ME AND LIKE EVERYONE IN OUR FAMILY WHO HAS THIS MUTATION HIDE, THAT IS HIDE, H-I-D-E HER ATHENS INFORMATION EVEN AND EPECS SPECIALLY FROM THOSE LIFE CARE PROVIDERS LIKELY TO HELP HERMAN NAG HER LIFE LONG PREDISPOSITION TO DISEASE ZWLA IS WHAT WE ARE REDUCED TO. HIDING INTEGRAL HEALTH INFORMATION IS THE ONLY FAILSAFE WAY TO AVOID DISCRIM THAT TORRE PRACTICES SUCH AS THE LOSS OF INSURANCE OR LOSS OR DENIAL OF EMPLOYMENT BECAUSE THERE IS NO COMPREHENSIVE FEDERAL LEGISLATION THAT PATENTLY FOR BIDS INSURANCE OR IMPLOWMENT INFORMATION ON THE BABASIS OF GENETIC DISCRIMINATION. SEEKING TO BAN DNA DISCRIMINATION ISN'T REALLY NECESSARY BECAUSE DISCRIMINATION SIMPLY DOESN'T EXIST. ACTUALLY, IT DOES EXIST. BUT THE FACT THAT IT EXISTS ONLY SPORADICALLY AND AND EX-DOATALLY IS THE FUNCTION OF THE NEWNESS OF THE TECH LOGY AND THE FACT THAT USEFUL GENETIC INFORMATION LIKE OURS IS NOT YET YOU YOU BIG WHAT TUS. AND OUT OF THE KIND PS OF THEIR HEARTS REMAIN DISINTERESTED IN THIS INFORMATION IN THE SAME WAY THAT THEY ARE LEGALLY OBLIGED TO REMAIN DISINTERESTED IN INFORMATION SUCH AS RACE, GENDER, CREED OR SEXUAL PREF RENCE. I KNOW FROM EXPERIENCE THAT INSURANCE COMPANIES DON'T WORK THIS WAY. WHEN I WAS SICK, I WORKED AS A MEDICAL LIE LIBRARIAN FOR A SMALL COMMUNITY HOSPITAL IN SOUTH, FLORIDA. THE HOSPITAL WAS SELF-INSURED. PAY ATEX ATTENTION TO THIS PART. THE HOSPITAL WAS SELF-INSURED AND A THIRD-PARTY ADMINISTRATOR MANAGED OUR INSURANCE PLAN. ABOUT A YEAR AFTER MY LAST TREATMENT I WAS SITTING AT MY TEVCEVDESKWHEN THE PHONE RANG. THE PERSON TOLD ME I WAS THE FOURTH PERSON SHE HAD BEEN TRANSFERRED TO AND SOMEONE SUGGESTD THAT PERHAPS I COULD GIVE HER THE INFORMATION SHE NEEDED. PERHAPS I CAN, I OFFERED. WELL, SHE BEGAN, I AM CALLING ABOUT REBECCA FIBBER. HER BONE MARROW TRANSPLANT EXCEEDED THE CALENDAR YEAR CAP LAST YEAR AND I'M CALLING TO FIND OUT IF THAT THE' GOING TO HAPPEN NEXT YEAR. I'M REBECCA FISHER I SAID AND I REALLY HOPE NOT. THIS EXPERIENCE TAUGHT ME SOMETHING. IT TAUGHT ME THAT THERE ARE PEOPLE WHO ARE PAID TO LOOK AT ME AND SEE NOT MY ABILITY TO CONTRIBUTE TO A COMMUNITY, NOT MY HONESTY, MY INTEGRITY AND MY FACE, NOT MY EDUCATION, HARD WORK AND SOCIAL CONSCIENCE, NOT BY FAMILY MEMBERS AND THE WAYS IN WHICH I HAVE HELPED EACH OF THEM SUCCEED, BUT DOLLAR SIGNS, COSTS, INCREASED LIABILITY, AND THE ODDS OF MY DYING AN EXPENSIVE DEATH. LET US FACE THE FACT THAT FINANCIAL INCENTIVES TO USE GENETIC INFORMATION ARE ALREADY PRESENT. THE WASHINGTON POST REPORTED LAST MONTH THAT PLOYER SPONSORED HEALTH INSURANCE PREMIUMS ROSE 11.2% THIS YEAR AND EXPECTED TO RISE 13% WITH THIS YEAR. WITH THESE INCREASES IN MIND AND NO ENJOINEDER AGAINST USING GENETIC INFORMATION TO PREDICT PHYT TYRE LOSSES IT IS FUTURE LOSSES IT AS FAILURE OF SEWARDSHIP SAND I FEEL TERRIBLE THIS THIS COMMITTEE HAS SENT LETTERS T SECRETARY THOMPSON REPEATEDLY WITHOUT ANY ACTION. IT IS A FAILURE OF STEWARDSHIP TO EXPECT K PS AND EMPLOYERS TO DO THE RIGHT THING AND WHEN THEY DON'T LAUGH IRK PRECIOUS MAN HOURS HEALTHCARE DOLLARS AND HIT GAGES COSTS TO UNDO THE DAMAGE. I FEAR FOR MY CHILDREN ESPECIALLY FOR MY DAUGHTER WHO MUST LIVE NOT ONLY WITH AN EXPONENTALLY HIGHER RISK OF DEVELOPING A TERMINAL DISEASE BUT ALSO WITH THE BURDEN OF NEVER KNOWING WHEN SHE WILL BE ASKED TO TAKE A GENETIC TEST FOR A CONDITION OF EMPLOY MMENT OR BE FIRED FROM A JOB BECAUSE SHE IS LIKELY GET BREAST CANCER OR BE DENIED HEALTH INSURANCE ON HER PREDISPOSITION TO DISEASE. WE LIVE IN A WORLD THAT HAS NO SAFETY NET FOR US. HPA IS NO PAN SEIA FOR ALL THAT AILS HEALTH PRIVACY. HPA ADDRESSES NONE OF THE WORK PLACE CONCERNS AND ERISA RULES EXEMPT PLOYER BASED HEALTH PLANS LIKE THE ONE AT THE SMALL HOSPITAL WHERE I WORKED FROM HAN DMANDATORY DOM COMPLYIANCE. IF MY BRICK BRCA1 HAD BEEN KNOWN AND HPA CONDITIONS HAD BEEN IN PLACE THE YOUNG WOMAN WOULD KO HAVE RECOMMENDED FROM HER SUPERIORS AND PROBABLY GOTTEN A HHBONUS HAD SHE DONE IT THAT I NOT BE EXTENDED FURTHER HEALTHCARE COVERAGE. A WHOPPING 45% OF AMERICANS WITH HEALTH INSURANCE THIS IS FROM STEVE DO YOU HUGH AT THE DEPARTMENT OF LABOR,, A WHOPPING 45%, FALL INTO IT. THE GENETIC INFORMATION OF EACH ONE OF THESE INDIVIDUALS TOGETHER WITH THE INFORMATION OF EVERY UNINSURED AMERICAN THAT'S ANOTHER 45 MILLION PEOPLE IS FAIR GAME. IN MY OPINION, GENETIC INFORMATION IS NO DIFFERENT FROM ANY OTHER ESSENTIAL DISTINGUISHING INFORMATION ABOUT ANY HUMAN BEING, ALL OF WHICH, ALL OF WHICH IS BY LAW KEPT OFF THE BARGAINING TABLE THAT BEARS UP THIS HUMAN RIGHTS BASED SOCIETY. BUT IF THIS ARGUMENT IS TRULY DIFFERENT, OKAY, I'M GIVE YOU THIS, IF THIS ARGUMENT IS TRULY DIFFERENT, IF BECAUSE OF ITS FISCAL COMPONENT AS THE UNITED STATES CHAMBER OF COMMERCE MIGHT ARGUE, WE MUST LOCATE THIS DEBATE WITHIN THE FRAMEWORK OF AN IMPLICIT YOU TIL TARIANISM I WOULD POINT TO IMPORTANT CONTRIBUTIONS I AND OTHER GENETICALLY VULNERABLE PEOPLE HAVE BEEN ABLE TO MAKE BECAUSE WE HAVE BEEN LUCKY ENOUGH TO REMAIN CONSIDERED EMPLOYABLE. I WILL POINT TO THE CONTRIBUTIONS MY DAUGHTER 21 YEARS OLD HOPES TO MAKE WITH HER TWO DEGREES IN PUBLIC POLICY AND ECONOMICS FROM DUKE UNIVERSITY. I WOULD POINT TO THE WAY IN WHICH OUR FAMILIES COMPLETION OF INNEWMAN RABBLE SILO. I WOULD ARGUE THAT WE ARE IN FACT MAKING A DIFFERENCE FOR THE HEALTH OF ALL PEOPLE, EVERYONE IN THIS ROOM. THAT WE HAVE LIVED UP TO OUR END OF THE SOCIAL CONTRACT AND DESERVE THE SAME FUNDAMENTAL LEGAL PROTECTIONS THAT ARE EXTENDED TO ALL AMERICANS. LAST SUMMER ATTORNEY LAWRENCE LOR BA REPRESENTING THE U.S. CHAMBER OF COMMERCE, THE LOUDEST VOICE SPEAKING AGAINST FEDERAL GENETIC INFORMATION PROTECTIONS HOLD A HOUSE EDUCATION AND WORK FORCE COMMITTEE THAT THE POSSIBILITY OF MANY PLOYERS BEING ACCUSED OF ENGAGING IN GENETIC GENETIC NATION WOULD BE DISASTEROUS FOR THEM FROM A LEGAL AND PUBLIC RELATIONS PERSPECTIVE. HE OFFERD THAT AS PROOF THAT GENETIC DISCRIMINATION LEGISLATION IS UNNECESSARY. I WOULD LIKE MR. LOR BETTER TO TELL THAT TO MY FRIEND SUSAN. A 38-YEAR-OLD WOMAN HOSPICE TER IS BEING TREATED FOR BREAST CANCER. MOTHER HAD BREAST CANCER AND AUNT DIED OF IT. WE SAT TOGETHER AT ONE OF OUR SON'SIZE ICE HOCKEY GAMES AND SHE SHARED HER STORY. I GENTLY ASKED HER WHETHER SHE CONSIDERED SPEAKING WITH A GENETIC COUNSELOR. OH, KNOW, SHE EX-CHAINED, I WOULD NEVER DRK EXCLAIMED. I WOULD NEVER WANT TO RISK LOSING MY INSURANCE. A MASTERS PREPARED PERSON WHO WATCHES CNN AND READS THE PAPER. PEOPLE ARE AFRAID. THE FEAR KEEPS THEM FROM BEING TESTED EVEN WHEN THIS TEST MIGHT MAKE THE DIFFERENCE BETWEEN WHETHER THEY LIVE OR DIE. AND AT THE RISK OF SOUNDING PARANOID, I WOULD GO ON TO STUG THAT NONE OF US -- SUGGEST THAT NONE OF US PRESENT TODAY CAN AFFORD THE LUXURY OF WRITING OFF THIS PROBLEM TO HIGH RISK INDIVIDUALS LIKE ME. THE STAGE IS ALREADY SET FOR A PROBLEM OF CAT CATASTROPHIC PROPORTIONS. GUTHRIE SPOT PROGRAMS WHERE BY EVERY NEW BORN INFANT ABOUT'S BLOOD IS COLLECTED SCREENED AND STORED ARE FOUND IN ALL THE STATES AND TERRITORIES OF THE U.S. AND PROVIDE WHAT IS POTENTIALLY THE LARGEST AND MOST COMPLETE GENETIC BANK AND LIBRARY AVAILABLE IN THE COUNTRY. CONTINUED NONUSE OF OF GENETIC INFORMATION IMPLIED BY INSURANCE COMPANIES AND EMPLOYERS LACK OF INTEREST TO DATE DOES NOT PROVIDE SAFE UARDS FOR ANY OF US HIGH RISK OR NO.

WOO ASK YOU TO AT ONE MINUTE TO WRAP UP.

I'M ALMOST DONE.

WE WITH STRONG FAMILY HISTORY OF DISEASE IN WHICH THE TONE OF ILLNESS HAS BEEN PASSED FROM AGAINATION TO GENERATION ARE SIMPLY THE FIRST LINE OF DEFENSE AGAINST A STAGGERING SPECSPECTRUM OF POSSIBLE ABUSES. WE WANT TO BE HEARD. WE WANT TO BE PROTECTED AND WE DON'T WANT TO SIT IN THE BACK OF THE BUS ANY MORE. THANK YOU.

THANK YOU VERY MUCH. I THINK I DISAGREE WITH YOUR OPENING STATEMENT THAT YOU DIDN'T HAVE ANYTHING MORE TO ADD BECAUSE YOU DEFINITELY HAD A LOT MORE TO ADD. THANK YOU FOR YOUR VERY POWERFUL TESTIMONY. NOW, WE WILL HEAR FROM TONIA PHILLIPS.

GOOD MORNING, LADIES AND GENTLEMEN OF THE COMMITTEE. MY NAME IS TONIA PHILLIPS AND I'M HERE TO TELL MY STORY. IT IS SHORT AND SWEET. I WORK FOR A SMALL COMPANY OF ABOUT 4 PEOPLE INCLUDING MY TWO LOSSES THE OWNERS. WE ARE A TIGHT KNIT FAMILY. THEY HAVE BEEN WITH ME THROUGH MY MOTHER DAIING DIE ARLE OVARIAN CANCER AND MY GENETIC TETING FOR BRCA2 MUTATIONS. I WAS OPEN WITH MY EXPERIENCE JUST BECAUSE WE ARE A SMALL COMPANY AND THERE WAS NO WAY TO HIDE IT. AFTER FINDING OUT I WAS POSITIVE FOR THE BRCA1 MUTATION IN MARCH OF 2003, WHICH MEANS I HAVE AN 80% LIFETIME CHANCE OF GETTING OVARIAN CANCER AND A 45% LIFETIME CHANCE OF GETTING BREAST CANCER, I BEGAN PREVENTATIVE. I HAD A HIS TER HYSTERECTOMY IN OCTOBER OF 2003 AND A PRO FILL PROPHYLACTIC MA SECTTOMY. OUR GROUP HEALTH INSURANCE CAME IN THE MAIL AND IT HAD GONE UP $13,000 A YEAR FOR FOUR PEOPLE. MY BOSS GOT THE BILL AND YELLED THROUGH THE OFFICE NEWS THAT SHE WAS DIRECTING THAT TOWARDS ME I WAS IMMEDIATELY ASKED TO SWITCH TO MY HUSBAND'S HEALTH INSURANCE POLICY BECAUSE MY SITUATION WAS THE REASON THE INSURANCE PREMIUM WENT UP SO MUCH AND THEY SAID THAT I WAS -- IF I WAS TAKEN OFF THE POLICY IT WOULD NOT GO UP. I WAS EVEN TOLD THAT THEY WOULD RAISE NYMY HOURLY RATE IF I SWITCHED. I TOLD HER I WAS NOT COME COMFORTABLE WITH SWITCHING INSURANCE COMPANIES AT THE TIME BECAUSE I WAS STILL IN THE RECONSTRUCTION PROCESS. IT WAS LIKE PULLING TEETH TO GET THE INSURANCE COMPANY TO PAY FOR THESE PROCEDURES AND SWITCHING WOULD CONFUSE AND COMPLICATE EVERYTHING. I DIDN'T THINK IT WAS IN MY BEST INTEREST TO SWITCH WHILE I STILL NEEDED MORE SURGERY. MY FEELING IS THAT ANY ONE IN THE COMPANY COULD BE DIAGNOSED WITH ANYTHING TOMORROW AND THAT IT IS NOT FAIR THAT I BE ASKED TO DROP INSURANCE THAT IS IMPORTANT TO ME. I WAS DOING SOMETHING THAT WOULD PREVENT ME FROM GOING THROUGH A HORRIBLE DISEASE THAT WOULD COST MUCH MORE THAN THE PREVENTATIVE SURGERIES I WAS HAVING. WE FINALLY CAME TO AN AGREEMENT THAT EMPLOYEES WOULD HAVE TO START PAYING HALF OF THEIR PREMIUM WHICH IS FINE AND FAIR WITH ME BUT I'M SHIRR THE OTHER EMPLOYEES WEREN'T TOO HAPPY TO ME. IT SEEMS UNFAIR TO ME THAT I'M TAKING STEPS TO KEEP MYSELF HEALTHY AND PREVENT CANCER IN THE FUTURE AND I'M BEING SINGLED OUT AND MADE TO FEEL I AM A LIABILITY. I ALSO DON'T SMOKE. I WORK OUT. I EAT RIGHT MOST OF THE TIME. IF SOMEONE IN THE COMPANY WERE DIAGNOSED WITH CANCER OR SOME OTHER DISEASE THEY WOULD NOT HAVE BEEN ASKED TO SWITCH INSURANCE COMPANIES AS I WAS ASKED. I HOPE THAT ME COMING HERE AND TELLING MY STORY WILL HELP WITH DEFINING THE PROBLEM AND PASSING LAWS AGAINST GENETIC DISCRIMINATION OF ANY KIND. INARCHINGTHANK YOU.

THANK YOU, MS. FILL MS. PHILLIPS. YOU DEFINITE ANY DO HELP TO DEFINE THE PROBLEM. NOW, WE WILL HERE FROM PAULA FUNK.

GOOD MORNING. THANK YOU SO MUCH FOR INVITING ME TO COME AND TALK ABOUT MY STORY. WHEN YOU ARE GOING THROUGH THE PROCESS OF FINDING OUT YOUR GENETIC PREDISPOSITION SOMETIMES YOU FEEL ALONE AND LAST NIGHT I WAS THINKING THIS ISN'T ANYTHING I SHOULD BE NERVOUS ABOUT BECAUSE YOU ARE HERE TO HELP ME AND I APPRECIATE THAT INVITATION. MY NAME IS PAULA FUNK. I'M A MOTHER OF TWIN THREE-YEAR-OLD DAUGHTERS AND I HAVE A HUSBAND THAT IS HERE WITH ME TO SUPPORT ME TODAY. AND MY FAMILY HAS A STRONG HISTORY OF BREAST AND OH IAN CANCER. I'M GOING TO TELL YOU A LITTLE BIT ABOUT MY FAMILY. MY DAD IS ONE OF TEN CHILDREN AND HE HAS FIVE SISTERS. ALL FIVE OF HIS SISTERS HAVE HAD BREAST CANCER AND THE CURRENT COUNT RIGHT NOW IS THAT 8 OF MY CUE SINS HAVE HAD -- COUSINS HAVE HAD BREAST CANCER AS WELL. THE NUMBER BREAKDOWN THERE, THAT IS 13 WOMEN OUT OF 24 THAT HAVE HAD BREAST CANCER. THIS DISEASE IS SOMETHING THAT THE WOMEN OF MY FAMILY HAVE TO CONSTANTLY THINK ABOUT. THERE IS A CONSTANT THREAT. MY FIRST MEMORY IN LIFE IS TAKING MY AUNT DOROTHY TO HER WEEKLY TREATMENTS TO FIGHT BREAST CANCER. IF IS A SKETCHYY MEMORY BUT I REMEMBER CLEARLY HER LAYING DOWN IN THE BACK OF MY MOM'S STATION WAGON IN A PINK NIGHT GOWN AND WE TOOK HER TO TREATMENT EVERY WEEK AND THAT WAS THE BEGINNING OF MY UNDERSTANDING OF WHAT MY FUTURE HAD FOR ME. MY SWEET AUNT DOROTHY SURVIVED BREAST CANCER TWICE AND IS NOW FIGHTING OH OVARIAN. SHE HAS TO HAVE A SURGERY TO REPAIR TISSUE. THEY HAVE TO DO TREATMENT JUST TO PATCH THE AREA. THIS MAKES ME REALLY SAD. IT MAKES ME FEEL LIKE I HAVE TO AGGRESSIVELY FIGHT MY POSSIBILITY OF OF CANCER. TEN YEARS AGO, I STARTED REAL ZING THIS AND I DECIDED TO PURSUE GENS TESTING. AT THAT -- GENETIC TESTING. AT THAT TIME GENETIC TESTING REQUIRED SEVERAL WOMEN FROM ONE FAMILY TO GIVE A BLOOD SAMPLE TO DETERMINE IF THERE WAS IN FACT A GENETIC MUTATION. I APPROACHED MY AUNTS AND COUSINS ABOUT THIS AND THEY TALKED TO THEIR PHYSICIANS AND THEIR PHYSICIANS RECOMMENDED THAT THEY NOT PURSUE GENETIC TESTING BECAUSE AT THE TIME PEOPLE COULD DENY INSURANCE AND THE DISCRIMINATION COULD BE EVEN WORSE IN THE FUTURE AS MORE WAS LEARNED ABOUT BEING GENETICALLY POSITIVE. BECAUSE OF THIS, I CHOSE NOT TO HAVE THE TEST AT THE TIME. I WAS 23 AND 30 SEEMED LIKE A LONG WAYS AWAY. WELL, I'M 33 NOW AND I'M IN THE MIDDLE OF WHERE MOST OF THE WOMEN IN MY FAMILY BEGIN TO GET BREAST CANCER. TWO OF THE WOMEN WERE 30 WHEN THEY WERE DIAGNOSED. BECAUSE I AM IN THE MIDDLE OF THAT STAGE WHERE MOST OF THE WOMEN GET BREAST CANCER, IN MAY OF 2003 I DECIDED TO CONSIDER BEING GENETICALLY TESTED AGAIN. I TALKED WITH THE GENETIC COUNSELOR AND SHE ASKED ME A LOT OF QUESTIONS ABOUT INSURANCE. IT WAS AN UNFORTUNATE TIME FOR ME TO WANT TO PURSUE IT. MY HUSBAND AND I JUST OPENED OUR OWN SMALL BUSINESS. WE WERE THE TWO PEOPLE IN THE BUSINESS. AS I RESEARCHED ABOUT INDIVIDUAL INSURANCE, I LEARNED THAT EVEN WITH THE GAPS THAT HPA PROVIDES IT IS A BIGGER PROTECTION THAN WHAT INDIVIDUAL INSURANCE PROVIDES. THERE IS NO PROTECTION. IT IS CONSIDERED FREE MARKET AND THEY CAN DENY YOU FOR ANYTHING. AS A MATTER OF FACT, I WAS DENIED FROM INDIVIDUAL INSURANCE BECAUSE I HAD HAD A C SECTION. BECAUSE OF THIS, WE BEGAN LOOKING TO SEE IF WE COULD FIND A GROUP INSURANCE POLICY FOR TWO PEOPLE. ALMOST ALL OF THE INSURANCE COMPANIES REQUIRED THREE TO FIVE PEOPLE TO QUALIFY AS A SMALL GROUP. I FINALLY TALKED TO UNITED HEALTHCARE WHICH ALLOWED THE TWO PERSON COMPANY TO BE CONSIDERED A GROUP IF THEY HAD NOT ACCEPTED THIS MY HUSBAND AND I WERE GOING TO HAVE TO CLOSE OUR SMALL BUSINESS AND HE WAS GOING TO GO TO WORK FOR A LARGE COMPANY SO WE COULD HAVE PROTECTION IN A LARGE GROUP. I'M THANKFUL THAT THEY ACCEPTED ME AS A SMALL GROUP. BUT I LIVE WITH THE FEAR EVERY DAY THAT I COULD BE REJECTED. DURING THE TIME THAT I WAS TRYING TO FIND INSURANCE I ASKED MY FATHER IF HE WOULD BE TESTED FIRST BECAUSE THE GENETIC DISORDER WAS GOING THROUGH HIS SIDE OF THE FAMILY, NOT MY MOTHER'S, WHICH IS WHAT WE USUALLY HEAR. HE TOOK THE GENETIC TEST AND CAME BACK POSITIVE. I KNEW FROM MY RESEARCH THAT I HAD A 50/50% CHANCE OF CARRYING THIS MUTATION AS WELL. IT WAS TORTUROUS WAITING THE THREE MONTHS TO FIND OUT IF I COULD HAVE INSURANCE BUT I FINALLY WAS ABLE TO TAKE THE TEST AND I, TOO, CAME BACK RCA STRAND 1 POSITIVE. THIS MEANS THAT MY TWIN DAUGHTERS HAVE A 50% CHANCE OF HAVING THE MUTATION AS WELL AND I HAVE UP TO AN 88% RISK OF BREAST CAN TER IN MY LIFETIME AND UP TO A 44 RISK OF OVARIAN CANCER AS WELL AND OVARIAN IS PARTICULARLY ALARMING TO ME BECAUSE I HEARD THAT THERE IS A 50% MORTALITY RATE ONCE YOU ARE ABLE TO BE DIAGNOSED WITH IT. I'M SO GRATEFUL THAT I HAVE AN OPPORTUNITY TO SAVE MY OWN LIFE, THOUGH. I HOPE TO HAVE A PROPHYLACTIC MMASMA SECTTOMY THIS FALL. I PLAN ON HAVING MY OVARIES REMOVED AS WELL AFTER I FINISH HAVING CHILDREN. THAT WILL GIVE GIVE ME A 95% CHANCE THAT I WILL NO HAVE OVARIAN CANCER. I PUSHED THROUGH WITH BEING GENETICALLY TESTED IN SPITE OF MY FEARS. I HAVE HAD SEVERAL PROBLEMS ALONG THE WAY BECAUSE I WAS TESTED GENETICALLY. THE FIRST ONE I MENTIONED EARLIER, WE PUT OFF BEING TESTED FOR TEN YEARS BECAUSE OF WHAT THE PHYSICIANS RECOMMENDED BECAUSE OF THE POTENTIAL DISCRIMINATION. COUNTLESS WOMEN IN MY FAMILY DURING THE LAST TEN YEARS HAVE BEEN DIAGNOSED WITH BREAST CANCER AND WE HAVE, AND SEVERAL OF THEM HAVE LOST THEIR BATTLE TO BREAST CANCER ZWLA COULD HAVE ALL BEEN PREVENTED IF WE HAD PURSUED TESTING THEN. THAT GRIEVES ME THINKING ABOUT THE LOSS OF LIFE THERE THAT COULD HAVE BEEN AVOIDED. I HAVE DECIDED THAT KNOWLEDGE ABOUT MY HEALTH IS A GIFT. I WANT EVERYONE TO FEEL THE FREEDOM TO HAVE THAT GIFT. MY DAD AND I PAID FOR OUR OWN TESTS BECAUSE OF OUR FEAR AND R AND THEN MY DOCTORS AFTER I WAS DIAGNOSED BRCA STRAND 1 POSITIVE CHACED MY DIAGNOSIS R CHANGE THE MY DIAGNOSIS CODE FOR EACH PROCEDURE THAT THEY REQUESTED. FOR THE BREAST MRI THEY DIDN'T WRITE THAT I'M BRCA STRAND ONE POSITIVE. THEY SIMPLY WROTE THAT I HAD A STRONG FAMILY HISTORY. AND I KNOW THAT THAT MEANS THAT THERE IS DISCRIMINATION OUT THERE OR THEY WOULDN'T DO THAT BEING BRCA STRAND ONE POSITIVE IS A STRONGER CASE THAN HAVING A STRONG FAMILY HISTORY. I AM IN THE PROCESS OF SENDING OUT INFORMATION PACKETS TO 86 DIFFERENT ADDRESSES OF MY DIRECT RELATIVES AND THINKING ABOUT THE FACT IF THERE IS 86 DIFFERENT ADDRESSES HOW MANY DIFFERENT PEOPLE LIVE THERE BECAUSE THIS IS A DISEASE THAT AFFECTS MEN AND WOMEN. MEN HAVE THE SAME CHANCES CARRYING THIS STRAND AS WOMEN DO. AS I TALKED TO MY FAMILY MEMBERS, THE AMAZING THING TO ME IS THEY HAVE MORE QUESTIONS ABOUT GENETIC DISCRIMINATION THAN THEY DO ABOUT HOW IT AFFECTS THEIR HEALTH. THAT IS SO SAD TO ME. AND MOST OF THE RELATIVES THAT I HAVE TALKED TO HAVE REFUSED TO TAKE THE TESTS BECAUSE OF THAT FEAR. AND I CAN'T HELP BUT THINK JUST IN MY FAMILY IF WE COULD ALL BAND TOGETHER HOW MUCH WE COULD DO FOR THE RESEARCH OF GENETICS IF THEY FELT THE FREEDOM TO BE TESTED. I HAVE ONE COUSIN THAT DESPERATELY WANTS TO TAKE THE TEST BUT HER HUSBAND IS A PREACHER AT A SMALL CHURCH AND THEY HAVE AN INDIVIDUAL INSURANCE POLICY SO SHE CAN'T TAKE THE TEST. THERE IS NO PROTECTION AT ALL FOR HER. AND SHE IS 35. SHE IS TWO YEARS OLDER THAN ME AND IF THE 13 WOMEN IN MY FAMILY THAT HAVE HAD BREAST CANCER MOST OF THEM HAVE BEEN IN THEIR 30s. IF MAKES ME SO SAD THAT SHE HAS TO WAIT UNTIL SHE HAS CANCER UNTIL INSURANCE WILL PAY FOR A PROCEDURE. ONE LAST AREA OF CONCERN IS THE PROBLEM THAT I'M HAVING WITH INSURANCE CURRENTLY. I HAVE HAD MY INSURANCE FOR LESS THAN A YEAR. OTHERS IN THE BASIC SCREENING TESTS THAT -- OTHER THAN THE BASIC SCREENING TESTS THAT I HAD TO DETERMINE WHETHER I CURRENTLY HAVE CANCER OR NOT SUCH AS CA125 COUNTS, ULTRASOUNDS, MA'AM MOW GLAMS AND A BREAST -- MAMMOGRAMS AND A BREAST MRI AND A NEEDLE BIOPSY THERE HAVE BEEN NO OTHER EXPENSES AND I WAS INFORMED THAT MY HEALTH INSURANCE WAS RAISED $100 A MONTH WITH NO EXPLAINABLE REASON. I TALKED TO SEVERAL MEDICAL PEOPLE AND THEY SAY THAT THIS IS UNUSUAL AND LOOKS SUSPICIOUS. INAND ANOTHER PROBLEM THAT I'M HAVING CURRENTLY IS THAT PROPHYLACTIC MEASURES ARE NOT SOMETHING THAT THAT THEY AUTOMATICALLY COVER. OH TWO MONTHS AGO I REQUESTED FOR THEM TO AGREE TO COVER A PROPHYLACTIC MA MASTECTOMY FOR ME. MY FATHER HAD BYPASS SURGERY FIVE YEARS AGO AND THERE WAS NO BOARD OF REVIEW THAT HE HAD TO GO TO FOR THAT SURGERY AND I DON'T UNDERSTAND WHY I HAVE TO SIT AND WAIT DURING THAT TWO MONTHS. ONE THING THAT I WOULD LIKE TO LEAVE YOU WITH, IT I IS I SO APPRECIATE YOU LISTENING. MY MEDICAL MANAGEMENT AND MEDICAL MANAGEMENT OF MANY OF MY FAMILY HAVE GREATLY BEEN AFFECTED BOTH BY GENETIC DISCRIMINATION AND THE FEAR AND POSSIBILITY OF IT. AVOIDING DISCRIMINATION HAS BECOME A MAJOR PART OF MY TAYLY E AND DISCRIMINATION WORRIES ME SO MUCH FOR THE FUTURE AS WELL. LAST SATURDAY, MY HUSBAND JONATHAN AND MY TWO DAUGHTERS AUDREY AND ANNA AND I WALKED IN THE RACE FOR THE CURE. MY 4-YEAR-OLD DAUGHTERS HAD SO MANY QUESTIONS ABOUT WHAT WAS GOING ON AND WHAT WAS IT ABOUT AND MY ANSWERS HAD TO BE SIMPLE BECAUSE THEY WERE SO YOUNG. BUT I COULDN'T HELP BUT THINK WHAT A COMPLEX ISSUE THIS HAS BEEN FOR ME AND MY PRAYER IS THAT WHEN THEY ARE OLD ENOUGH TO DECIDE WHETHER THEY SHOULD BE TESTED GENETICALLY THAT DISCRIMINATION ISN'T EVEN A PART OF THEIR DECISION PROCESS. FINDING OUT YOUR GENETIC STATUS IS PERMANENT. YOU CAN'T TAKE IT BACK. AND IT ISN'T SOMETHING THAT YOU CAN CHANGE YOUR MIND ON AND WHAT I REALLY NEED AND WHAT WE ALL NEED IS A LAW THAT CLEARLY DEFINES THE SAFETY AND THE FACT THAT YOU CANNOT BE DISCRIMINATED AGAINST GENETICALLY. WE DON'T KNOW WHAT THE FUTURE HOLDS OR HOW SOCIETY HAS CHANGED SO AT THIS POINT I'M VERY VULNERABLE DEPENDING ON THE DIRECTION THAT THAT GOES. THANK YOU SO MUCH FOR YOUR TIME AND THANK YOU FOR INVITING ME TO TELL MY STORY.

THANK YOU, MS. FUNK. WE WILL NOW HEAR FROM MS. HEIN STROSA.

GOOD MORNING. MY NAME IS CARE LENA MINE LEE MINE STROH IS A. I AM A TEN YEAR TWO TIME BEST CANCER SURVIVOR. I'M A MOTHER OF A 13-YEAR-OLD DAUGHTER AND THE EXECUTIVE VICE PRESIDENT FOR PROGRAMS PLANNING IN THE NATIONAL BREAST CANCER COALITION. MY FIRST DIAGNOSIS WITH BREAST CANCER WAS AFTER THE AGE OF 35 THE SECOND WAS AT AGE OF 40. MY YOUNGEST SISTER WAS ALSO DIAGNOSED TWICE. FIRST AT AGE 29 AND THEN AT 34. OVER CHRISTMAS LAST YEAR TWO OF MY COUSINS AND AN AUNT WERE DIAGNOSED WITH BREAST CANCER AS WELL. OF COURSE, WE SUSPECT THIS IS A GENETIC MUTATION THAT PREDISPOSES MEMBERS OF MY FAMILY TO BREAST CANCER. APARTMENT CAREFULLY WEIGHING THE POTENTIAL BENEFITS AND HARMS OF GENETIC TESTING I DECIDED NOT TO UNDERGO TESTING FOR FEAR OF POTENTIAL CONSEQUENCES TO MY DAUGHTER. MY FEARS ARE TWO FOLD. FIRST, THAT THE INFORMATION MAY NOT BE PRO DEBTED AND MIGHT -- PROTECTED AND MIGHT EVEN BE MISUSED. I ALSO WORRY THAT IF I TEST POSITIVE MY DAUGHTER MIGHT BE OBLIGATED TO DISCLOSE THE PRESENCE OF A 21ST GENETIC MUTATION AND MIGHT SUFFER DITS CRIM ION AND IN HEALTH INSURANCE AND EMPLIMENT IN THE FEATURE. YET NONE OF US IS SAFE ENOUGH TO UNDERGO AGAINST TESTING. MY FAMILY EXPERIENC ILLUSTRATES WHY OUR FAMILY NEEDS STRONG GENETIC NONDISYIP NATION DISCRIMINATION LAWS. SINCE ITS FOUNDING IN 1991 THE NATIONAL BREAST CANCER COALITION WHICH I AM A MEMBER AND EXECUTIVE VICE PRESIDENT HAS CHANGED THE WORLD OF BREAST CANCER IN PUBLIC POLICY, SCIENCE, INDUSTRY AND ADVOCACY BY EMPOWERING OR FAMILIAR FAMILIES AND FRIENDS AND CREATING RESEARCH AVENUES FOR QUALITY ACCESS TO HEALTHCARE. THE NATIONAL BREAST CANCER COALITION IS NOW OVER 600 STRONG IN TERMS OF ORGANIZATIONS WHO ARE MEMBERS AND WE REPRESENT SEVERAL MILLION PATIENTS, PROFESSIONALS, WOMEN, OUR FAMILIES AND FRIENDS. COALITION MEMBERS INCLUDE CANCER SUPPORT INFORMATION AND SERVICE GROUPS AS WELL AS WOMEN'S HEALTH AND PROVIDER. THE MAPPING OF THE HUMAN GENOME HAS BROUGHT WITH IT THE PROMISE OF REDUCING HUMAN SUFFERING BY TARGEB TARGETING INTERVENTION. THE NATIONAL BRAEFT BREAST CAN SORE LIEVES THAT STRONG LEGISLATION.

IMPORTANT. IT IS INFORMATION THAT SHOULD NOT BE DISCLOTESED WITHOUT THOR ZAIAUTHORIZATION BY THE INDIVIDUAL. IT COULD LEAD TO HARM IN THE AREA OF EMPLOYMENT, EDUCATION, HEALTHCARE AND INSURANCE. THE 1996 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT TOOK STEPS TOWARDS EXTENDING PRO TEBUCKY TO INDIVIDUALS FROM GENETIC DISCRIMINATION IN THE HEALTH INSURANCE ARENA BY CREATING PRIVACY STANDARDS BUT THE LAW DOES NOT GO FAR ENOUGH. IT IS TIME TO EXTEND PROTECTIONS AGAINST GENETIC DISCRIMINATION TO EVERYONE. THE DEVELOPMENT OF NEW GENETIC TESTS NECESSARYIATES LEGISLATIVE ENACT. FEAR OF POTENTIAL DISCRIMINATION THREATENS A WOMAN'S DECISION TO USE NEW GENETIC TECHNOLOGIES AND TO SEEK THE BEST MEDICAL CARE. WOMEN ARE ALSO AFRAID TO ENROLL IN RESEARCH AND CLINICAL TRIALS THAT INVOLVE GENETIC STUDIES AND THIS IN TURN THREATENS THE ABILITY OF THE SIGH SCIENTIFIC COMMUNITY TO CONDUCT THE RESEARCH NECESSARY TO UNDERSTAND THE CAUSE AND FIND A CURE FOR BREAST CANCER. MANY OF THE WOMEN TESTIFYING AND PRESENT IN THE AUDIENCE COULD HAVE EXPERIENCED EXACTLY THOSE CONCERNS. NBCC STRONGLY SU SPORTS THE ENACTMENT OF LEGISLATION THAT WOULD PROTECT MILLIONS OF INDIVIDUALS NOT ONLY IN HEALTH INSURANCE BUT ALSO IN THE WORK PLACE AND THAT WOULD PROVIDE STRONG ENFORCE ENFORCEMENT MONTREAL EXPOMONTREAMECHANISMS.N CAN BCC SUPPORTS SR1910. THIS LEGISLATION PROHIBITS HEALTH PLANS FROM REQUESTING, REQUIRING, COLLECTING OR DISCLOSING GENETIC INFORMATION WITHOUT PRIOR SPECIFIC WRITTEN AUTHORIZATION OF THE INDIVIDUAL. AN INDIVIDUAL'S REQUEST FOR GENETIC SERVICES TO DENY OR LIMIT ANY COVERAGE TO ESTABLISH ELIGIBILITY, EDUCATION, ENROLLMENT OR CONTRIBUTION REQUIRE OPINIONS OR FROM ESTABLISHING PREMIUM RATES BASED ON GENETIC INFORMATION OR AN INDIVIDUAL REQUEST FOR GENETIC SERVICES. THIS LEGISLATION ALSO PROVIDES EMPLOYERS FROM USING GENETIC INFORMATION TO AFFECT THE HIRING OF AN INDIVIDUAL OR TO AFFECT THE TERMS, CONDITIONS, PRIVILEGES, BENEFITS OR TERMINATION OF EMPLOYMENT UNLESS THE EMPLOYMENT ORGANIZATION CAN PROVE THE INFORMATION IS JOB RELATED AND CONSISTENT TO BUSINESS NECESSITY. ALSO FROM REQUESTING, REQUIRING, COLLECTING OR DISCLOSING GENETIC INFORMATION PRIOR TO A CONDITIONAL OF OF EMPLOYMENT OR UNDER ALL OTHER CIRCUMSTANCES REQUESTING OR REQUIRING COLLECTION OF DISCLOW SUR OR DISCLOSURE OF GENETIC INFORMATION UNLESS THE EMPLOYMENT ORGANIZATION CAN PROVE THIS INFORMATION IS JOB RELATED AND CONSISTENT WITH BUSINESS NECESSITY. IT ALSO PROHIBITS FROM ACCESSING GENETIC INFORMATION CONTAINED IN MEDICAL RECORDS RELEASED BY INDIVIDUALS AS CONDITION OF EMPLOYMENT IN CLAIMS FILED FOR REIMBURSEMENT, HEALTHCARE COSTS AND OTHER SERVICES. IT PROHIBITS RELEASING GENETIC INFORMATION WITHOUT THE ORIGINAL THOR AUTHORIZATION OF THE INDIVIDUAL. MOST IMPORTANTLY, HR1910 HAS STRONG ENFORCEMENT LANGUAGE AND PROVIDES INDIVIDUALS WITH A PRIVATE RIGHT OF ACTION TO GO TO COURT FOR LEGAL AND EQUITABLE RELIEF IF THEY ARE A VICTIM OF GENETIC DISCRIMINATION WHETHER SUBJECT TO DISCRIMINATION BY THE HEALTH PLAN OR THE IMPLOWER. NBCC DOES NOT SUPPORT S1053 PASSED BY THE SENATE ON OCTOBER OF TWIEW 2003 BECAUSE IT DOES NOT CONTAIN SUFFICIENT ENFORCEMENT PROVISIONS. UNLIKE HR1910, S1053 DOES NOT PROVIDE INDIVIDUALS WITH A PRIVATE RIGHT OF ACTION SHOULD THEY BECOME A VICTIM OF ENETIC DISCRIMINATION. NBCC LEAVE BELIEVES THAT A RIGHT WITHOUT NO ENFORCEMENT IS REALLY NOT A RIGHT AS OUGHT AT ALL. NO MATTER HOW MUCH IS INCLUDED IN PUTTING PROTECTIONS THAT THE BREAST CANCER PATIENTS NEED IF THE BILL DOES NOT HAVE A STRONG ENFORCEMENT MECHANISM THEN NBCC WILL NOT SUPPORT IT. AS WE CLEARLY CAN SEE FROM THE WITNESSES MERE TODAY GENETIC DISCRIMINATION IS A REAL AND GROWING PROBLEM THAT NEEDS IMMEDIATE SOLUTION. NOT ONE THAT SHOULD WAIT UNTIL WE HAVE FURTHER CASES OF WOMEN AND MEN WHO EXPERIENCED THIS TYPE OF DISCRIMINATION THAT IS SO DETRIMENTAL TO THE ABILITY TO SEEK QUALITY HEALTHCARE. THANK YOU FOR THE OPPORTUNITY TO SHARE THE VIEWS OF THE NATIONAL BREAST CANCER COALITION.

THANK YOU VERY MUCH FOR YOUR OWN PERSONAL EXPERIENCE AS WELL AS FOR THE VIEWS OF THE NATIONAL BREAST CARE COALITION. AND NOW LASTLY WE WILL HEAR FROM PHIL HARDT.

GOOD MORNING. IT IS A PRIVILEGE TO BE HERE TODAY AND I WANT TO THANK THE COMMITEE FOR INVITING ME TO SHARE NYE THOUGHTS AND PERSONAL -- MY THOUSANDS THOUGHTS AND PERSONAL EXPERIENCES. I HAVE HEMOPHILIA B A BLEEDING DISORDER AND ALSO HUNGINGTON ABOUTS DISEASE, A DEGENERATIVE BRAIN DISORDER WHICH I INHERITED FROM MY FATHER. MY TWO BIOLOGICAL DAUGHTERS AND GRAND DAUGHTERS ARE CARRIERS OF HEMOPHILIA B AND AS A RESULT I NOW HAVE TWO HANDSOME GRANDSONS WHO MUST INFUSE WITH CLAW DEAN FACTOR EACH TIME THEY GET HURT. ALL NYE CHIN WERE AT RISK FOR HUNTINGTON'S DISEASE BUT NONE OF THEM CARRY THE DESTRUCTIVE GENE AND CANNOT PASS IT ON TO SCBEPT GENT GENERATIONS. I MENTION BIOLOGICAL BECAUSE I HAVE FIVE ADOPTED CHILDREN FOUR OF HOW MANY HAVE SEVERE HANDICAPS. NEVERTHELESS, OUR STORERY IS ONE OF CONTINUING GENETIC DISCRIMINATION EVEN THOUGH WE HAVE LAWS THAT ARE SUPPOSED TO PROTECT ME, MY CHILDREN AND MY GRAND CHILDREN. IT WAS THE BEST OF TIMES, IT WAS THE WORST OF OF TIMES AS DICKENS SAID IN A TALE OF TWO CITIES. BECAUSE OF ADVANCEMENTS WITH THE HUMAN GENOME PROJECT WE STAND ON THE BRINK OF HAVING MORE USEFUL INFORMATION THAT HAS THE POTENTIAL OF HELPING LITERALLY MILLIONS OF INDIVIDUALS PREPARE EARLY FOR VARIOUS DISEASES. HOWEVER, THE REALITY IS THE KNOWLEDGE THAT YOU ARE CARRYING ANY PARTICULAR GENETIC DISORDER IN MY CASE HEMOPHILIA AND HD IS JUST AS DEVASTATING TO YOU, YOUR CHILDREN, AND YOUR GRAND CHILDREN AS THE DISEASE WILL BE LATER. THIS IS FURTHER EX-AS BETTER RATED IN HUNTINGTON'S DISEASE BECAUSE OF THE SEVERE ILT OF THE SIM AND THE NECESSITY FOR THOSE THAT FACE THE 50/50 CHANCE OF INHERITING IT TO PREPARE EARLY AND THOROUGHLY IN ORDER TO MINIMIZE ITS OVERALL DESTRUCTION. TENS OF THOUSANDS OF INDIVIDUALS WITH HUNTINGTONS DISEASE HAVE LIVED AND DIED AND ARE ALREADY IN THE INSURANCE COMPANY'S PROFITABILITY CALCULATIONS. HOWEVER, IT WASN'T NOTED ON THEIR DEATH CERTIFICATES BECAUSE OF GENETIC DISCRIMINATION FEARS. IT IS LUDICROUS NOW TO BELIEVE THAT BECAUSE YOU CAN KNOW EARLY THAT YOU MIGHT INHERIT A GENETIC DISORDER THAT ALL OF A SUDDEN WE ARE GOING TO CREATE HIGHER MEDICAL COSTS. THIS IS NOT THE CASE. WE ARE LIVING EXAMPLES OF THE TERACISA COMPLEX. IF YOU ARE A MEMBER, HE CONFRONTED EDIFICE WITH THE DA LEMMA. IT IS BUT SORROW TO BE WISE WE WISDOM PROFITS NOT. HUNTINGTON'S DISEASE IS AN IN HAIR AT THIS TIMED PROGRESSIVE BRAIN DISORDER THAT RESULTS IN LOSS OF MENTAL FACULTIES AND PHYSICAL CONTROL. IT CAUSES BRAIN CELLS TO DIE PREMATURELY AND CAUSES SPECIFIC IMPAIRMENT AND EVENT LALLY DEATH. EVERY CHILD OF AN AFFECTED PARENT HAS A 50% CHANCE OF INHERITING THE GENE AND SELL THE DISORDER THEMSELVES. EACH GENE POSITIVE CHILD BECOMING SYMPTOMATIC EVEN AS EARLY AS A YOUNG INFANT OR EVEN IN THE TEENAGE YEARS. HD HIM SYMPTOMS DEBILITATE A PERSON WHEN THEY LEAST EXPECT IT. USUALLY IN THE PRIME OF THEIR LIVES AROUND 40 YEARS OF AGE WHEN THEY STILL HAVE CHILDREN AT HOME AND ARE ACTIVELY PURSUING CAREERS. LIVING WITH HD IS LIKE LIVING WITH ALZHEIMER'S, PARKINSON'S, MS, AND GOING INSANE ALL AT THE SAME TIME. GENETIC TESTING HAS BEEN AVAILABLE FOR HUNTINGTON'S DISEASE FOR LONGER THAN ANY OTHER ADULT ONSET DISORDER SINCE 1993. THE DISCOVERY OF THE GENETIC MUTATION MADE POSSIBLE THE USE OF PREDICTIVE TESTING TO IDENTIFY CURRENT UNAFFECTED CARRIERS. IN 2000 COLLIN SAID GENETIC TESTING IS INTENDED TO GIVE FAMILIES WITH THE FAMILY HISTORY OF HD THE OPPORTUNITY TO ASSESS THEIR OWN RISK FOR DEVELOPING THE DISEASE MORE SPECIFICALLY, MONITOR THE HEALTH STATUS CLOSELY AND IF A PREDICTED MUTATION IS PRESENT MAKE INFORMED CHOICES ABOUT REPRODUCTION AND LIFESTYLE. IT IS INTERESTING TO NOTE HERE THAT BEFORE 1993 THE ALMOST QUARTER OF A MILLION INDIVIDUALS WHO ARE AT RISK FOR HD IN THE UNITED STATES WERE POLLED AND OVER WHELMINGLY ABOUT 90% OF THEM SAID THAT THEY WOULD TAKE ADVANTAGE OF THE TEST TO FIND OUT IF THEY WERE CARRYING THE DESTRUCTIVE HD GENE. HOWEVER, SINCE THE DEFINITIVE TEST BECAME AVAILABLE FEWER THAN 10% HAVE TESTED AS A DIRECT RESULT OF GENETIC DISCRIMINATION. I WOULD LIKE TO NOW TELL A LITTLE BIT ABOUT MY FAMILY HISTORY. IN 1971 I WAS DIAGNOSED WITH HEMOPHILIA B. IN 1989 I WAS HIRED BY ALLEY SIGNAL AUTOMOTIVE AND TOLD BY THE HR MANAGER THERE NOT TO TELL MY BOSS ABOUT MY HEMOTEALIHEYHEMOFILLIA OR I WOULD NEVER BE PROMOTED OR TRAINED BECAUSE HE WANTED TO GET THE BIGGEST RETURN ON INVESTMENT FOR HIS BUCKS AND IF HE KNEW I MIGHT HAVE A DISABILITY I WOULD NEVER GO ANYWHERE IN THE COMPANY. CONSEQUENTLY, ALL FUTURE PLEADING EPISODES HAD TO BE HIDDEN FROM HIM. IN 1996 A CLAIM I FILED ON CREDIT INSURANCE FOR A CAR I PURCHASED ON MY DAUGHTER WAS DENIED BECAUSE I HAD RECENTLY SEEN A NEUROLOGIST ARTING ROVE REGARDING PROBLEMS I WAS HAVING. IN 1997 I WAS DIAGNOSED AS HAVING HAUNTINGTONS HUNTINGTONS IT DISEASE. MY OLD EFTD DAUGHTER WAS TURNED DOWN FOR MORTGAGE INSURANCE BECAUSE OF HUNTINGTON'S DISEASE. COPIES OF SEVERAL REJECTION LETTERS ARE INCLUDED IN YOUR PACKETS AND NOTE THAT THE INSURANCE COMPANIES DON'T HAVE FEAR OF PUTTING THEIR REJECTIONS IN WRITE JG, EACH OF HER RE, CORRECTION LETTERS STATE THAT THEY WILL NOT INSURANCE HER UNTIL SHE TESTED FOR HUNTINGTON'S DISEASE AND TWO, THAT SHE IS FOUND TO BE NEGATIVE.

THEN THE INSURANCE AGENT ON ONE OF THE LETTERS WHERE THEY INSURANCE HER HUSBAND WRITES A NOTE AT THE BOTTOM THAT SAYS WHEN YOU FIND OUT YOUR STATUS FOR HD, THEN WE CAN INSURANCE YOUR CHILDREN. -- ENSURE YOUR CHILDREN SHOWING THAT THE DISCRIMINATION IS DOWN TO THE THIRD GENERATION NOW. IN 2002, MY GRANDSON ENICK MAXIMILIAN IS DENIED HEALTH INSURANCE COVERAGE BECAUSE OF HEMOPHILIA THAT HE INHERITED FROM ME AND A COPY OF IT DENIAL IS ALSO INCLUDED IN YOUR HANDOUTS. THEY MUST NOW EARN LESS THAN THEY ARE CAPABLE OF TO CALL QUALIFY FOR STATE WELFARE IN ORDER TO GET COVERAGE. NOW, IN 2002 MY DAUGHTER MICHELLE ANDERSON PHILLIP TESTED ANONYMOUSLY FOR HD TO PROTECT THEM IN CASE EITHER OF THEM TESTED POSITIVE AND I AM SEW VER THE HUNTINGTON'S DISEASE SOCIETY OF AMERICA AFFILIATE IN THE STATE OF ARIZONA AND IN 2001 A GENETICIST AND I ESTABLISHED ANONYMOUS GENETIC TESTING TO PROTECT INDIVIDUALS SO THAT THEY CAN USE A BOGUS NAME AND SOCIAL SECURITY NUMBER AND ADDRESS AND ALL OTHER INFORMATION AND PAY CASH BUT THE PROBLEM IS IT IS VERY EXPENSIVE. IT IS AROUND $900 OUT OF POCKET TO FIND OUT. BUT IT IS COMPLETELY CONCEALED. BUT IT IS A SHAME THAT WE HAVE TO DO THIS. AND LAST YEAR I PLIED FOR LONG-TERM I APPLIED FOR LONG-TERM CARE INSURANCE AND WAS REJECTED ON THE BASIS OF MY HD AFTER BECOMING DIVORCED AND REALIZED THAT I WOULD PROBABLY NEED SOMEONE TO TAKE CARE OF ME LATER. NOW, HERE IS THE LIST OF WAYS THAT OPEN GENETIC DISCRIMINATION ADVERSELY AFFECTS THOSE WITH HD OVER AND ABOVE THE NEGATIVE EFFECTS OF THE DISEASE ITSELF. THOSE WHO ARE AT RISK ARE RELUCRELUCTANT TO PARTICIPATE IN RESEARCH EVEN ANONYMOUS RESEARCH BECAUSE THEY FEAR OF BEING FOUND OUT. FOR EXAMPLE, THE FARRELL STUDY FOR HT COULD HAVE ALMOST A QUARTER OF A MILLION GAT AT-RISK INDIVIDUALS IN THIS BUT THEY HAVE ONLY BEEN ABLE TO RECRUIT ABOUT 1,000. IMAGINE THE DECREASE IN NUMBER NUMBERS. OTHER IMPORTANT RESEARCH TESTS ARE NO DIFFERENT. BECAUSE OF OUR SMALL NUMBERS UNFORTUNATELY WE NEED EVERY BIT OF DATA POSSIBLE TO MAKE THINGS SIGNIFICANT. PROPER MEDICAL AND MENTAL HEALTHCARE ARE NOT SOUGHT ON A TIMELY BASIS THAT COULD HAVE -- THAT WOULD HELP REDUCE SUFFERING AND RACE EVERYONE'S RAISE Q1S IF QUALITY OF LIFE. OPEN COMMUNECATION IS ALMOST NONEXISTENT BETWEEN PARENTS AND THEIR AT-RISK CHILDREN. HD MUST BE SHEPT SHROUDED IN -- KEPT SHROUDED IN SECRECY TO PROTECT EVERYONE. FOR THE SAME REASON, AT-RISK CHILDREN ARE NOT ENCOURAGED TO SEEK GOOD EDUCATION, COLLEGE EDUCATIONS, CAREERS WITH P COMPANIES THAT OFFER GROUP BENEFITS, MARRIAGE AND CHILD BEARING OPTIONS INCLUDING ADOPT. MISDIAGNOSIS OCCUR BECAUSE ONE DOESN'T KNOW OR KNOWS BUT CAN'T BE ON WITH THEIR DOCTORS AND OTHER HEALTHCARE PROVIDERS FOR FEAR OF BEING DISCOVERED. HEALTHY LIVING HABITS AREN'T ADOPTED EITHER EARLY ON O POSTPONE ONSET. NOW, USING OUR NEGATIVE EXPERIENCES WITH BEING WISE, AND OUR WISDOM, NOT ONLY DOESN'T PROFIT US BUT IS EVEN USED AGAINST US. HOW MANY OTHER FUTURE DISCOVERIES THAT HAVE THE POTENTIAL TO BLESS THE LIVES OF MILLIONS OF OTHERS BY PREDICTING OTHER DISEASES SOON ENOUGH FOR INDIVIDUALS TO TAKE POSITIVE AXPOPOSITIVE ACTION AGAINST THEM WILL BE THWARTED BECAUSE OF FLAGRANT GENETIC DISCRIMINATION? THANK YOU VERY MUCH.

THANK YOU, MR. HARDT. AND THANK ALL OF YOU FOR YOUR VERY PRO FOUND TESTIMONY. NOW, WE ARE GOING TO OPEN UP TO THE COMMITTEE A QUESTION AND ANSWER PERIOD TO BE ABLE TO DIRECT QUESTIONS TO OUR PANELISTS IF ANY MEMBERS OF THE COMMITTEE WOULD LIKE TO TREK ANDIRECTANY QUESTIONS TO THEM.

I JUST WANT TO JUST AS WE GET INTO THAT JUST SAY TO EVE OF YOU THAT ON BEHALF OF -- EACH OF YOU THAT ON BEHALF OF ALL OF US ON THE COMMITTEE WE APPRECIATE YOUR TAKING THE TIME TO COME AND TALK TO US. I CAN IMAGINE THAT IT IS NOT EASY TO DO WHAT YOU ALL JUST DID AND I WILL ASSURE YOU AS THE -- FROM THE CHAIR'S DESK HERE THAT AS WE GO FORWARD IN OUR WORK WE ARE GOING TO MAKE SURE WE DO EVERYTHING IN OUR POWER TO MAKE IT WORTH YOUR WHILE AND THAT SOMETHING H COME OF THIS. I KNOW YOU GO HOME AND PEOPLE SAY WHAT HAPPENED. WE WILL TRY TO MAKE SURE THAT SOMETHING HAPPENS AS A RESULT OF YOU DOING THIS. BEFORE MY COLLEAGUES GET INTO THE SPECIFICS, A REAL BIG THANK YOU TO YOU ALL.

I ALSO WANT TO THANK ALL OF YOU FOR VERY POWERFUL AND MOVING STORIES THAT YOU HAVE TOLD WHICH CERTAINLY UNDERLINE IN STARK AND COME COMPELLING TERMS THE NEED TO DO SOMETHING ABOUT A SITUATION WHICH GROWS WORSE EVERY DAY. IT IS, I'M SURE, A GREAT DISAPPOINTMENT FOR ALL OF YOU THAT WE HAVEN'T FIXED THIS BY NOW, WHEN THE ARGUMENTS ARE COMPELLING AND WHEN YOU CAN SEE THAT THE LIKELIHOOD OF MORE AND MORE GENETIC TESTING BEING OFFERED IS IN EVERYBODY VISITABLE AND THEREFORE THE LIKELIHOOD OF MORE AND MORE PEOPLE FACING UP TO THE DA DILEMMAS THAT ALL OF YOU HAVE FACED ALMOST BECOMES INEVITABLE. IT SEEMED AS IN THIS WAS GOING TO GET SOLVED AT YET HERE WE ARE. BECKY, FISHER, I KNOW YOU HAVE BEEN AN EFFECTIVE VOICE IN TERMS OF CARRYING THIS PES MESSAGE ON THE HILL. WHAT DO YOU HERE HEAR WHEN YOU SPEAK TO PEOPLE ON THE HOUSE SIDE ABOUT THE IMPORTANCE DOFFING DOING THIS? WHAT IS THE ROAD BLOCK GETTING IN THE WAY NOW? WHAT DO YOU SEE AS THE REASON WHY THIS HASN'T BEEN SOLVED AND WHAT DO YOU SEE AS THE WAY AROUND THAT?

THANK YOU FOR ASKING ME THAT, DOCTOR COLLINS. SOMEONE ELSE ASKED ME THAT ACTUALLY AT THE D.C. CITY COUNCIL. THEY WERE CONSIDERED THE LEGISLATION FOR THE CITY OF WASHINGTON AND MY RESPONSE WASN'T EXACTLY POLITICALLY CORRECT BUT IT IS WHAT I BELIEVE. THE UNITED STATES CHAMBER OF COMMERCE IS THE STRONGEST LOUDEST VOICE SPEAKING OUT AGAINST THIS LEGISLATION. WITHOUT GOING INTO TOO MUCH DETAIL THEY HAVE A LOT MORE MONEY AND THAN MEDICAL LIBRARY AND HEALTH LIFE LIVING IN NORTHERN VIRGINIA AND THIS HE HAVE A LOT MORE CLOUT THAN WE DO. THE ONLY PROBLEM IS THEY DON'T HAVE ANY MORAL AUTHORITY. I STILL GLEEV WE WILL GET IT DONE. WITH ALL DUE RESPECT THE NATIONAL BREAST CANCER COALITION, I THINK THAT THEIR SUPPORT OF THE SENATE BILL WOULD BE A HUGE, HUGE HELP FOR US BECAUSE MOST OF US DON'T REALLY WANT PRIVATE RIGHT OF ACTION. WE JUST WANT THE PROTECTION. SO I WOULD LIKE TO GO ON THE RECORD AS EXPRESSING THAT FOR MYSELF AND FOR LITERALLY HUNDREDS OF PEOPLE THAT I KNOW WHO ARE IN THE SAME BOAT.

THIS IS REALLY TWO PARTS AND IT AGAIN I WISH TO SHARE WHAT HAS BEEN SAID BEFORE. THESE ARE POWERFUL, STRE MPORTANT STATEMENTS THAT ALL OF YOU HAVE MADE AND I APPRECIATE ALL OF THE SACRIFICES THAT YOU HAVE GONE THROUGH BEFORE, YOU AND YOUR FAMILIES AND THE SACRIFICES THAT YOU MAKE JUST TO APPEAR BEFORE US TODAY. SO THANK YOU VERY MUCH. WE AS A GENETICS COMMUNITY AND ALSO AS MEMBERS OF THE PUBLIC HAVE BEEN TOLD THAT GENETIC DISCRIMINATION DOES NOT EXIST E HAVE BEEN TOLD THAT OVER AND OVER. IN FACT, SCHOLARLY ARTICLES HAVE BEEN WRITTEN AND ARE REVENUE RENED IN THE GENETIC LITERATURE WHERE THE AAH THOORS MADE INQUIRIES TO INSURANCE COMPANIES AND GUESS WHAT, THEY SAID THERE IS NO GENETIC DISCRIMINATION. AND YET ALL OF US KNOW THAT IT IS EXISTS AND THAT IS WHY THIS IS SO IMPORTANT TODAY. I WOULD ASK PERHAPS MR. CHAIRMAN, THAT THE NATIONAL CHAMBERS OF COMMERCE BE INVITED AT SOME FUTURE MEETING TO APPEAR BEFORE US SO THAT THEY COULD EXPLAIN WHY IT IS THAT THEY VALUE INDIVIDUALS AS COMMODITIES MORE THAN THEY VALUE THEM AS INDIVIDUALS. BECAUSE I AM, I'M VERY CONCERNED THAT THESE MEMBERS OF OUR COMMUNITIES HAVE THIS AS -- AS SUCH PRO PROFOUND POLICY POSITION TO PROFOUND THAT THEY HAVE PROTECTED THIS BILL FROM LEAVING THE DESK IN THE HOUSE OF REPRESENTATIVES. I DON'T KNOW IF IT HAS LEFT YET. BUT IT -- I MEAN TO BE ABLE TO FREEZE A BILL THAT PASSED UNANIMOUSLY IN THE SENATE WITHOUT LEAVING THE DESK, WE HEARD AT A PREVIOUS MEETING FROM A HOUSE OF REPRESENTATIVES STAFF PERSON THAT THE HOUSE AS TO HAVE SEPARATE HEARINGS, THEY CAN'T SIMPLY RIDE ON THE COATTAILS OF THE SENATE. THERE HAVE BEEN NO HEARINGS BECAUSE IT DID NOT LEAVE THE DESK. AND I WOULD LIKE TO HEAR FROM THE MOST POWERFUL GROUP THAT HAS PROTECTED THAT. WE HAVE ALSO BEEN TOLD IN PREVIOUS MEETINGS AND PIECES IN LITERATURE THAT THERE IS NO NEED FOR LEGISLATION BECAUSE WE ARE ALREADY PROTECTED BY LEGISLATION AND THERE IS THE LITANY OF LAWS THAT ARE CITED INCLUDING THE ADA TO PROTECT INDIVIDUALS AGAINST GENETIC DISCRIMINATION. AND I WAS ASKED AND I SORRY TO PUT YOU ON THE SPOT, DR. MA GEATTY BUT I WOULD ASK HAS THE DEPARTMENT OF JUSTICE EVER GONE THROUGH A SYSTEMATIC REVIEW OF THE CURRENT LEGISLATION TO DOCUMENT THAT IN FACT AS CITIZENS THIS OF COUNTRY WE ARE PROTECTED BY THE EXISTING LAWS?

I'M AFRAID WE HAVEN'T BEEN QUITE EYE APPROACHED TO DO THAT REVIE YET SO I DON'T HAVE ANY SPECIFIC INFORMATION FOR YOU.

WHO WOULD NEED TO APPROACH YOU TO DO THAT REVIEW?

BASICRY THE SECRETARY FOR HEALTH AND HUMAN SERVICES WOULD BE A GOOD STARTING POINT.

WELL, GIVEN THAT WE HAVE BEEN AND THAT I UNTIL RECENTLY HAVE BEEN WRITING LAWS TO TWO SECRETARIES OF HEALTH AND HUMAN SERVICES, IF ANOTHER LETTER FROM THIS COMMITTEE COULD MOVE THAT AGENDA FORWARD AND DETERMINE WHETHER IN FACT WE ARE PROTECTED OR NOT PROTECTED, I WOULD ASK THE COMMITTEE TO GIVE CONSIDERATION TO YET ANOTHER LETTER.

YES, THAT WE WILL TAKE INTO, ONSIDERATION. ALSO FOR THE RECORD JUST TO MENTION THAT THE CHAMBER OF COMMERCE WAS INVITED TO THIS MEETING WITH THE SPECIFIC INVITATION TODAY BUT ACTUALLY REFERRED US TO ANOTHER GROUP WHWHO WE WILL BEHEARING FROM IN THE STAKE HOLDER PANEL.

WHAT IS THE NAME OF THAT GROUP, PLEASE?

THE SEW SOCIETY FOR HUMAN RESOURCE MANAGEMENT.

AND WE HAVE A DOCUMENT FROM THEM ALSO DOCUMENTING THE LAWS THAT EXIST WHICH WAS PART OF THE WHAT PRECIPITATED MY -- MY QUESTION. I WOULD ASK IF THE SOCIETY OF HUMAN RESOURCE MANAGEMENT CONSIDER IS THEMSELVES A SPOKES ERSON FOR THE NATIONAL CHAMBERS OF COMMERCE SO PERHAPS THEY CAN BE PREPARED BECAUSE I WILL BE ASKING THAT QUESTION WHEN THEY SPEAK.

GOOD MORNING. I JOINED MY COLLEAGUES ON THE COMMITTEE IN THANKING EACH AND EVERY ONE OF YOU FOR YOUR COURAGE AND IMPORTANT ADVOCACY IN THIS IMPORTANT AREA. FOLLOWING UP ON DR. MCCABE'S QUESTION ABOUT VARIOUS LAWS AND THEIR COVERAGE, I KNOW SEVERAL OF YOU, I BELIEVE, MS. FISHER AND MS. HIN HEINSTROSA MENTIONED A HPPA GAP AND I WONDERED IF YOU COULD ADDRESS THAT A BIT MORE FROM YOUR PERSPECTIVE? , A I'M PARTICULARLY CURIOUS AS TO WHETHER IT HAS TO DO WITH THE PRIVACY RULE WHICH MY OFFICE WITHIN HHS OFFICE FOR CIVIL RIGHTS IS RESPONSIBLE FOR ENFORCING OR IF IT HAS TO DO WITH OTHER ASPECTS OF HPPA?

WELL, THE PROTECTIONS THAT HEPA BRINGS ABOUT REALLY ARE FOR PEOPLE WHO ARE MEMBERS OF A GROUP PLAN AND DON'T EXTEND TO PEOPLE IN THE INDIVIDUAL MARKETS SO THAT IS AN IMPORTANT GROUP OF OF PEOPLE WHO ARE NOT WELL PROTECTED BY HEPA.

I WOULD JUST LIKE TO ADD TO THAT THAT MY UNDERSTANDING OF THE HEPA GAP IS THAT WELL THE BIGGEST PROBLEM IS IT DOESN'T ADDRESS ANY WORK PLACE CONCERNS AT ALL. BIGGEST PROBLEM. IT ONLY DEALS WITH INSURANCE AND IF YOU ARE JUST CONSIDERING THE INSURANCE PIE THEN THAT PIE IS SLICED UP AGAIN INTO PEOPLE O WHO ARE PROTECTED AND WHO AREN'T PROTECTED. THOSE PROTECTED ARE PROTECTED UNDER GROUP HEALTH INSURANCE PLANS. THIS IS IMPORTANT BECAUSE MOST PEOPLE DON'T UNDERSTAND THIS. HEPA DOES NOT EXTEND TO ERISA ENGERISAEXEMPTED STATE PLANS. 77% OF EMPLOYERS OFFER AT LEAST ONE STATE SELF-FUNDED INSURANCE MAN TO THAT MEANS THAT IF MY HUSBAND WORKS FOR BANK OF AMERICA, WHICH HE DOES, WE HAVE THE CHOICE EVERY NOVEMBER OF GETTING, YOU KNOW, TEN DIFFERENT CHOICES OF PLAN THAT WE COULD SUBSCRIBE TO. WE COULD GO WITH A BLUE CROSS OR AETNA AND BE IN A GROUP HEALTH PLAN OR WE COULD GO WITH BANK OF AMERICA SELF-INSURANCE PLAN. THAT IS BANK OF AMERICA BETTING THAT THEY WILL DO BETTER THAN BLEW CROSS IS WITH THAT MONEY. BLUE CROSS HAPPENS TO ADMINISTER THAT PLAN TO I DON'T REALLY HAVE A CLUE THAT I'M NOT PROTECTED UNDER HEPA. THIS IS A BIG PROBLEM. THERE ARE A HUNDRED MILLION PEOPLE IN THIS COUNTRY WHO ARE HAVING THE SAME PROBLEM AND THEY DON'T EVEN KNOW IT. SO I THINK THIS IS A REALLY IMPORTANT PIECE OF INFORMATION TO GET OUT THERE. DR. COLLINS ASKED EARLIER WHAT WAS THE PUSHBACK ON THE HILL? THE PUSHBACK IS NO PROBLEM, WE DID HEPA. WELL, GUESS WHAT, 2 IT DOESN'T WORK FOR LAST US AND I'M GLAD TO HAVE THE OPPORTUNITY TO TELL YOU ALL THIS BECAUSE MY GUESS IS THAT IT HAS NEVER GOT THAN GRANULAR WITH ANY OF YOU EITHER. THOSE OF US WHO KNOW WHAT WE ARE UP AGAINST KNOW THIS. THANKS FOR ASKING THAT.

ONCE AGAIN, WE WOULD LIKE TO REITERATE WHAT WE HAVE HEARD FROM EVERY ONE OF THE MEMBERS HERE TO THANK YOU VERY MUCH FOR YOUR TESTIMONY. IT CERTAINLY D WE HAVE HEARD YOU AND WE ALREADY HAVE ACTIONS THAT WE WILL BE READY TO TAKE AS WE DISCUSS FURTHER. YES, MS. WILLIAMS?

I WOULD LIKE TO REITERATE, THE FACT THAT A LOT OF PIECE PEOPLE COME FORWARD AND TAKE A CHANCE THAT WHEN THEY GO BACK TO WHEREEVER THEY HAVE COME FROM THAT THEY COULD BE SUMMARILY FIRED, THAT THEY COULD HAVE THEIR INSURANCE POLICIES PULLED FROM THEM. I COME HERE WITH NOTHING TO LOSE, OKAY. THE BA TAKES CARE OF ME ANDISM' ON DISABILITY. I HAVE NOTHING TO LOSE BUT THESE PEOPLE WHO SIT TO MY LEFT HAVE A LOT TO LOSE WHEN THEY GO HOME. AND THEY KNOW THAT. AND THEY COME HERE AT GREAT RISK TO THEMSELVES AND THEIR FAMILIES. AND I WANT EVERYONE TO UNDERSTAND THIS. I WANT THE HOUSE TO UNDERAND IT HIS THAT THERE ARE PEOPLE HERE AT RISK. MY CHILDREN WHO ARE HERE TODAY ARE STILL AT RISK THAT AS THEY GET OLDER AND CHOOSE THEIR CAREERS MY DAUGHTER IS A COMPETITIVE GYMNAST. SHE WANTS TO GLOW UP AND BE A GYMNAST BUT THERE IS A CHANCE THAT SHE COULD BE DISCRIMINATED AGAINST BECAUSE SHE IS A CARRIER OF ALPHA ONE. MY SON WANTS TO BE A RESEARCH SCIENTISTS. HE WANTS TO BUILD HABITATS ON THE MOON. HE IS 10 YEARS OLD. THERE IS A CHANCE THAT WHEN HE GETS TO THAT POINT HE MAY NOT BE HIRED IN HIS CHOSEN FIELD. HE MAY HAVE TO GOD FOR BID FLIP BURGERS AT MCDONALDS THAN LET HIS AT THIS AGELET SEE AT AGE 9 HE WAS CONSIDERED TO HAVE AN ESTIMATED 138IQ, OKAY. AND IT IS A LOT MORE THAN THAT NOW. HE MAY HAVE TO LET HIS CONSIDERABLE IQ GO TO WASTE. AND NOTHING AGAINST MCDONALDS THEY FUND COLLEGE EDUCATIONS ALL OVER THE NATION. BUT MY SON HAS THE POTENTIAL DO GREAT THINGS AND THAT MAY NOT HAPPEN BUT I'M WORE CONCERNED -- I'M MORE CONCERNED WITH THE PEOPLE TO MY LEFT BECAUSE I KNOW WHAT HAPPENS AND I KNOW AND I HAVE SEEN IT AND THAT IS WHAT I WANT EVERYONE TO UNDERSTAND.

WE WILL WORK TODAY NOT TO LET ANY OF YOUR OWN EXPERIENCES GO TO WASTE. THANK YOU. WHAT WE'RE GOING TO DO IS TAKE A BREAK NOW AND THAT WILL BE FOR UNTIL 10:45 AND THEN RECONVENE FOR THE PANEL TWO WHICH WILL BE THE HEALTHCARE PROVIDERS. [ APPLAUSE ]

PLEASE STAKE YOUR TAKE YOUR SEATS SO THAT WE CAN START WITH OUR NEXT PANEL OF PRESENTERS.

OUR SECOND PANEL THEN IS OF HEALTHCARE PROVIDERS AND THE COMMITTEE THEN WILL BE HEARING FROM THEM REGARDING THEIR OWN PATIENTS' EXPERIENCES THAT THEY HAVE BEEN IN CONTACT WITH AND THEY WILL BE TELLING US ABOUT THEIR PATIENTS' CONCERNS ABOUT THE IMPACT OF GENETIC DISCRIMINATION. OUR PANEL THEN WILL BE THREE AND AGAIN THEY WILL EACH HAVE TEN MINUTES TO PRESENT AND WE WILL HAVE TEN MINUTES FOR QUESTIONS AFTER THEIR PRESENTATIONS SO WE WILL BE HEARING FROM JEFF SHAW WHO IS AN ONCOLOGY GENETIC COUNSELOR FROM PENROSE CANCER CENTER IN COLORADO. THEN WE WILL BE HEARING FROM DON HADLEY. A RESEARCHER AT THE NATIONAL IN SISUIT OF HEALTH IN BE THESE DA MARYLAND AND MARK BRANTLY WHO IS A PROFESS OFFER OF MEDICINE AT UNIVERSITY OF FLORIDA. WE BEGIN WITH JEFF SHAW.

MY NAME IS JEFF SHAW AND I'M THE DIRECTOR AND COUNSELOR FOR THE HER HA TARE HEREDITARY CANCER SERVICE IN COLORADO. I DON'T QUITE KNOW WHAT TO DO WITH THIS MUCH OXYGEN. I WOULD LIKE TO THANK YOU FOR GIVING THE OPPORTUNITY TO PRESENT INFORMATION FROM OUR PROGRAM THAT TO THIS COMMITTEE. THE CLINICIANS FEEL THAT YOU WERE A DIFFICULT GROUP TO FOLLOW BUT ONE THING WE HAVE GOT IS NUMBERS SO I HAVE PROVIDED COUNSELING FOR INDIVIDUALS AND FAMILIES IN EVERY AREA OF MEDICAL GENETICS FROM PRENATAL TO ADULT ONSET CONDITIONS. FOR THE LAST SEVEN YEARS I HAVE WORKED EXCLUSIVELY WITH PATIENTS CONCERNED ABOUT HEREDITARY CANCER PREDISPOSITIONS MUCH LIKE THE WOMEN WHO PRESENTED HERE TODAY. THE PURPOSE OF OUR PROGRAM IS TWO-FOLD. ONE, TO PROVIDE THE BEST ESTIMATE OF CANCER RISK SO THAT SCREENING CAN BE APPROPRIATELY MODIFIED SO THAT IF IS CANCER OCCURS IT CAN BE CAUGHT AS SOON AS PROVE POSSIBLE WHEN SURVIVAL IS THE HIGHEST AND TREATMENT TO GO THROUGH. TO REDUCE THE RISK OF CANCER RESPECIALLY IN THOSE WITH AN INHERITED PREDISPOSITION. OW PROGRAM IS CLINICALLY BASED AND BRIDGES THE GAP BETWEEN RESEARCH-BASED PROGRAMS AND THE IMPLEMENTATION OF GENETIC TESTING INTO GENERAL MEDICAL PACK TIGS. ALTHOUGH WE ARE CLINIC ANY BASED AT THE OUTSET WE CREATED A LARGE DATABASE TO COLLECT INFORMATION WE FELT WOULD BE HELPFUL TO THE PROVISION OF OUR SERVICE. THE DATA PRESENTED TODAY COVERS 7 YEARS OF CLINICAL SERVICE TO 00 INDIVIDUALS FOR HA RED TARE I CANCER -- HEREDITARY CANCER PREDISPOSITION. I WILL START WITH THE FEAR OF GENETIC DISCRIMINATION. COUNSELING IS COMPLEX AND TIME CONSUMING. IT INVOLVES, OF COURSE, THE DETAILED FAMILY HISTORY THAT WE TRY AND CONFIRM WITH MEDICAL RECORDS. EDUCATION REGARDING THE DIFFERENCES BETWEEN SPORE RAD DICK, FAMILIAL AND INHERITED CANCER PREDISPOSITIONS AND ALSO THE PSYCHOSOCIAL ISSUES AND FAMILY ISSUES INVOLVED WITH THIS TYPE OF TESTING. AS YOU HEARD, IF YOU TEST ONE INDIVIDUAL THAT INFORMATION IS GOING BE APPLICABLE TO THE ENTIRE EXTENDED FAMILY. IF YOU LOOK AT THE ENTIRE PEOPLE THAT WE SEE 61% OF PATIENTS HAVE A FAMILY HISTORY STRONG ENOUGH TO INDICATE THE POSSIBILITY OF GENETIC TESTING. IF AN INDIVIDUAL IS OFFERED THE POSSIBILITY OF 21ST CENTURY G WE GO THROUGH A LENGTHY -- GENETIC TESTING WE GO THROUGH A LENGTHY PROCESS AND HOW IT ILL APPLY TO THEIR MEDICAL CARE. THE BULK OF THIS DECISION OR THIS DISCUSSION I FEEL I NEED TO BE ALAWYER, UNFORTUNATELY, BECAUSE IT IS STRONG LISTEN TERED AROUND THE CONCERNS OUR PATIENTS HAVE REGARDING GENETIC DISCRIMINATION. NOT ONLY FOR THEMSELVES, BUT FOR THEIR SIBLINGS AND I FIND MOST IMPORTANTLY FOR THEIR CHILDREN. IN OUR PROGRAM'S EXISTENCES, EXPERIENCE, 20% OF THOSE INDIVIDUALS FOR -- WHO ARE ELIGIBLE FOR GENETIC TESTING FOR PRESYMPTOMATIC CANCER PREDICTION DECLINE HAVING THE TESTS. OF THOSE INDIVIDUALS 22% DID SO BECAUSE OF A FEAR OF DISCRIM FAKES. YOU MUST REALIZE THAT THE PEOPLE WHO SEE ME ARE MOTIVATED TO LEARN MORE ABOUT THEIR FAMILY HISTORY. OF INTEREST, THE PATIENTS THAT DID DECLINE BASED ON A FEAR OF DISCRIMINATION 90% OF THOSE HAD A SIGNIFICANT INCREASED RISK FOR OR INCREASED CHANCE FOR TESTING POSITIVE FOR A MUTATION THAT WOULD INCREASE THEIR RISK FOR CANCER. THEREFORE, THE PEOPLE WHO WOULD EXPERIENCE -- EXPERIENCED THE GREATEST POSSIBLE BENEFIT FROM THIS TESTING ARE THE MOST LIKELY NOT TO PURSUE IT. I WOULD LIKE TO GIVE A FEW PATIENT EXPERIENCES BECAUSE SH THESE NUMBERS TAKE ON A PERSONAL TONE IN THE CON CONTEXT OF REAL PEOPLE. I RECENTLY SAW A WOMAN WITH A STRONG FAMILY HISTORY OF CANCER MUCH LIKE THE WOMEN WHO HAVE TALKED EARLIER TODAY. SHE HAD BEEN DIAGNOSED WITH A STAGE ONE BREAST CANCER AT THE AGE OF 46. HER MOTHER DIED OF OVARIAN CANCER AT THE AGE OF 52. TWO MATERNAL AUNTS HAD BREAST CANCER IN THE EARLY 40s AND PASSED AWAY AND HER MATERNAL GRAND MOTHER DIED FROM BEST CANCER AT THE AGE OF 41. WE DETERMINED THAT SHE HAD AT LEAST A 43% CHANCE OF CARRYING AN INHERITED MUTATION THAT WOULD INCREASE HER RISK FOR SECOND PRY PERICANCERS. IF SHE PURSUED THE TESTING AND WAS TERMED TO CARRY ONE OF THE FAULTY GENES SHE WOULD HAVE A 60% RISK FOR A SECONDARY WRES BREAST CANCER. PROPHYLACTIC SURGICAL IN INTERVENTION COULD REDUCE THE RISK FOR THE CANCERS 90% FOR GREATER. IF SHE TESTED POSITIVE EACH OF OTHER FOUR DAWT DAUGHTERS WOULD HAVE A 50% CHANCE TO INHERIT THE FAULTY GENE THAT WOULD INCREASE THE RISK FOR CANCER. SHE HAS DECLINED TESTING AND THIS HAS BEEN VERY EMOTIONAL AND DIFFICULT FOR HER BUT SHE HAS DONE SO BECAUSE SHE IS CONCERNED AS TO HOW THIS INFORMATION COULD AFFECT HER CHILDREN'S CHANCES OF GETTING HEALTH INSURANCE. SHE DOESN'T KNOW WHAT PROFESSION THEY GOING TO GO INTO. SHE DOESN'T KNOW IF THEY WILL BE GROUP OR SELF-INSURED OR WHAT STATE THEY WILL END UP LIVING IN. BECAUSE OF THAT, WITHOUT THE GENETIC TESTING IT IS UNCLEAR HOW TO PROCEED WITH HER MEDICAL CARE, ESPECIALLY THE SURGICAL ONES THAT COULD REDUCE HER RISK FOR CANCER DEVELOPING AGAIN. HOWEVER, WITHOUT DOCUMENTATION OF A MUTATION THAT SHE WOULD CARRY, HER INSURANCE COMPANY WILL NOT PAY FOR ANY OF THESE SURGICAL INTERVENTIONS. THEREFORE, SHE REMAINS IN A STATE OF ANXIETY USING IMPERFECT BREAST AND OVARIAN CANCER SCREENING METHODS AND SIMPLY HOPING THAT ANOTHER CANCER DOES NOT OCCUR. DUE TO HER CURRENT EMPLOYMENT SITUATION SHE MIGHT HAVE TO CHANGE INSURANCE COMPANIES AND IS AFRAID THAT SHE COULD BE DENIED AND WITH THE CURRENT DIAGNOSIS SHE CANNOT AFFORD TO BE WITHOUT HEALTH INSURANCE. ANOTHER PATIENT WE HAD HAD A STRONG FAMILY HISTORY OF FAP. A DOMINANTLY INHERITED CO-RU CO-RUN -- COLON CANCER PREDISPOSITION CHARACTERIZED BY COLOCOLON POLYPS THAT CAN BEGIN AS EARLY AS THE AGE OF 10. INDIVIDUALS WITH THIS CONDITION BASICALLY HAVE UP TO 100% CHANCE OF DEVELOPING COLON CANCER SOMETIME IN THEIR LIFE. HE WORKED HIS WOLE LIFE AT A RELATIVELY -- HIS WHOLE LIFE AT A RELATIVELY SMALL COMPANY WITH A SMALL SELF-DIRECTED GROUP INSURANCE PLAN. HE HAS BEEN WARNED BY HIS DOCTOR NOT TO HAVE GENETIC TESTING FOR FAP AS HE WOULD LOSE HIS JOB OR HEALTH INSURANCE IF THEY WERE TO FIND OUT ABOUT THE CONDITION IN THE FAMILY. AT THE AGE OF 42, HE HAD SIGNIFICANT RECTAL BLEEDING AND FINALLY WENT IN FOR EVALUATION. HE WAS FOUND TO HAVE OVER 400 POLYPS IN HIS COLON. HE WAS SO EXTENSIVE HE NEEDED TO HAVE HIS ENTIRE COLON REMOVED. A DRAS DRASTIC BUT LIVE SAVING TECHNIQUE FOR THESE INDIVIDUALS. LUCKILY, HE DID NOT HAVEIN' INVASIVE COLON CANCER. OTHER FAMILY MEMBERS WERE NOT AS LUCKY. MOST OF THOSE AFFECTED WITH FAP IN HIS FAMILY DIED OF COLON CANCER IN THE LATE 20s. AT THE AGE OF 46 HE CAME TO ME FOR GENETIC COUNSELING. HE HAS TWO CHILDREN, AGES 22 AND 24 AND HE HAD NOT NFORMED THEM OF THE CONDITION PRIOR TO THIS TIME AS HE DID NOT WANT THE FAMILY HISTORY IN THEIR MEDICAL RECORDS DIE TO A FEAR OF GENETIC DISCRIMINATION. UNFORTUNATELY, THIS MEANT THAT THESE EARLY 20-YEAR-OLD CHILDREN WERE NOT HAVING APPROPRIATE SCREENING WITH SEVERAL GENETIC COUNSELING SESSIONS WITH HIM AND HE FINALLY DECIDED THAT HE WOULD DO THE TESTING EVEN WITH HIS FEAR OF THE DISCRIMINATION IN ORDER TO HAVE APPROPRIATE MEDICAL CARE FOR HIS KIDS. HE WAS TESTED AND THE GENETIC MUTATION IN THE APC GENE THAT WAS CAUSING FAP IN HIS FAMILY WAS IDENTIFIED. HIS CHILDREN DECIDED TO HAVE TESTING. ONE CHILD HAS TESTED POSITIVE AND ONE CHILD HAS TESTED NEGATIVE. THE 22-YEAR-OLD THAT TESTED POSITIVE IS NOW HAVING APPROPRIATE SCREENING BUT ALSO LIVES IN FEAR THAT AT SOME POINT SHE COULD LOSE MER MEDICAL INSURANCE. THE FEAR OF GENETIC DISCRIMINATION IN THIS FAMILY COULD HAVE CAUSED THE SAME EARLY DEATHS IN HIS IMMEDIATE FAMILY AS IT DID IN HIS EXTENDED FAMILY. I JUST SAW A 24-YEAR-OLD PATIENT WHOSE MOTHER TESTED POSITIVE FOR A MUTATION IN ONE OF THE BREAST OVARIAN CANCER SUPPRESSOR GENES. SHE DID NOT HAVE TESTING BASED ON A FEAR OF DISCRIMINATION. SHE WAS DIAGNOSED WITH A STAGE THREE BREAST CANCER AND DIED IN JUNE. SHE FINALLY HAD THE TESTING DONE AND A MUTATION WAS IDENTIFIED. THEREFORE WE COULD KEEPLY TEST HER THREE CHILDREN TO SEE IF THEY, INDEED, INHERITED THIS MUTATION OR NOT. ALL THREE CHILDREN DECIDED THEY DID WANT TO BE TESTED BECAUSE THEY FELT IT WAS UPON TORE THEIR CARE. ALL THREE CHILDREN PAID FOR THIS TEST OUT OF POCKET TO KEEP THIS INFORMATION AS CONFIDENTIAL AS POSSIBLE. IN FACT, WHEN WE LOOK AT INDIVIDUALS WHEN THE CHEAPER TESTS CAN BE PERFORMED THIS IS ABOUT $350 WHEN A MUTATION HAS BEEN IDENTIFIED IN A FAMILY. 74% OF THOSE INDIVIDUALS WILL PAY OUT OF POCKET BECAUSE OF THEIR FEAR OF GENETIC DISCRIMINATION. UNFORTUNATELY, IF YOU ARE THE FIRST PERSON BEING TESTED IN THE FAMILY THE TEST COSTS ABOUT $3,000, MAKE THAT REALLY NOT AN OPTION FOR THE BULK OF INDIVIDUALS THAT WE SEE. ALTHOUGH SHE HAS INFORMED HER FAMILY ABOUT THIS MUTATION WELL OVER 50% HAVE DECIDED NOT TO BE TESTED BASED ON A FEAR OF DISCRIMINATION. ALTHOUGH ANECDOTAL MY EXPERIENCE WITH HUNDREDS OF FAMILIES SHOWS ME THAT THAT IS THE CASE FOR MANY OF THESE FAMILY MEMBERS. WHAT ABOUT AFTER TESTING? WE CONDUCT ONE YEAR FOLLOW-UP SURVEY IS OF ALL PAY SHENS SEEN BY OUR PROGRAM. WE ARE HAPPY WE HAVE A 72% RESPONSE RATE TO THE SURVEYS. OF THOSE PATIENTS WHO TESTED POSITIVE FOR AN INHERITED CANCER PREDISPOSITION, 70% REPORT HAVING CONTINUED SIGNIFICANT ANXIETY THAT THEY WOULD EXPERIENCE GENETIC DISCRIMINATION AT SOME POINT IN THE FUTURE. FEAR OF FUTURE GENETIC DISCRIMINATION REMAINS A REAL CONCERN FOR OUR PATIENTS, ESPECIALLY THOSE WHO HAVE TESTED POSITIVE. THEN WE ARE WONDERING ABOUT THOSE PEOPLE WHO DON'T EVEN MAKE IT FOR GENETIC COUNSELING. DHE DON'T EVEN GET -- THEY DON'T EVEN GET TO THE POINT OF BEING OFFERED TESTING. IN ADDITION TO A FEAR OF GENETIC DISCRIMINATION THERE IS ALSO FEAR OF DISCRIM DISCRIMINATION SIMPLE FROM FROM PARTICIPATING IN A GENETIC COUNSELING SESSION. IN 2001 STUDIED FACTORS THAT WOULD INFLUENCE AN INDIVIDUAL'S DIVISION NOT TO COME IN FOR -- DECISION NOT TO COME IN FOR GENETIC COUNSELING. THE BIGGEST REASON OF THE FEAR OF GENETIC DISCRIMINATION, ACCOUNTING FOR 46% OF THOSE INDIVIDUALS SURVEYED. OUR PROGRAM HAD A SIGNIFICANT NUMBER OF PHYSICIAN REFERRED INDIVIDUALS WHO DID NOT SHOW UP FOR THE APPOINTMENTS. WE WANTED TO SEE INFORMALLY IF THIS WAS A CONCERN FOR THE PEOPLE REFERRED TO OUR PROGRAM. WE CONDUCTED AN INFORMAL 6 MONTH SURVEY OF THOSE PATIENTS. IN THE TIME FRAME WE HAD 60 PAY ENTS THAT DID D. SHOT SHOW. IS A% WOULD NOT RETURN THE CALLS 15% WOULD NOT RETURN THE CALLS AND 40% SAID THEY WERE TOLD THEY SHOULD NOT HAVE THIS DOCUMENTED IN THE MEDICAL CHART BECAUSE OF GENETIC DISCRIMINATION. I WAS UNABLE TO GET THE BULK OF THE PEOPLE IN FOR AN APPOINTMENT. THIS SUSUPPORTS THE DATA SEEN IN A GREER STUDY AND A FEAR OF GENETIC DISCRIMINATION IS A BARRIER FOR INDIVIDUALS THAT COULD BENEFIT GREATLY FROM GENETIC COUNSELING AND TESTING FOR HA HA RAID TERRI CANCER PREDISPOSITIONS.

WHEN I BRAD GRADUATED THERE WERE A HANDFUL OF TESTS AVAIL BLE. IN 2004 THERE ARE OVER 1,000 GENETIC TESTS AVAILABLE ON A CLINICAL AND RESEARCH BASIS. THE NUMBER OF GENETIC TESTS THAT WILL BECOME AVAILABLE FOR SINGLE GENE AND COMPLEX DISORDERS IS EXPECTED TO INCREASE EXPONENTIALLY OVER THE NEXT DECADE. I FEEL THAT WITHOUT STRONG FEDERAL PROTECTION TH APPROPRIATENESS OF THESE TESTS WILL BE UNDERUTILIZED. NONE OF US ARE GENETICALLY PERFECT. LEARNING WHAT GENETIC IMPER FEXZIMPERFECTIONS WE HAVE INHERITED AND IS DIFFICULT SOMETIMES FRIGHTENING AND A LIFE CHANGING EXPERIENCE. THE DECISION TO HAVE PRESYMPTOMATIC GENETIC TESTING IS MULTIFACETED. ISSUES REGARDING ONE'S SENSE OF SELF, FAMILY RELATIONSHIPS, ANXIETY, DEPRESSION AND COMPLEX DECISIONS REGARD GED FUTURE MEDICAL CARE. THE CITIZENS OF OUR COUNTRY NEED TO BE ASSURED WHEN DECIDING WHETHER OR NOT TO PURSUE GENETIC TESTING A FEAR OF DIVIDENDS IS NOT -- GENETIC DISCRIMINATION IS NOT A FACTOR. THANK YOU NOR YOUR KIND ATTENTION AND I LOOK FORWARD TO YOUR QUESTIONS.

THANK YOU PL SHAW. HE WILL HEAR NEXT FROM CON DONALD HADLEY.

THANK YOU. I'M AN SOTSIATE INVESTIGATOR AND GENETIC COUNSELOR AT THE NATIONAL GENOME INSTITUTE AT THE NIH. MY PROFESSIONAL EXPERIENCE AND WORK HAS FOCUSED PRIMARILY ON PROVIDING EDUCATION AND COUNSELING TO FAMILIES WHO ARE THREATENED WITH GENETIC AND INHERITED DISEASES. I HAD THE PRESIDENT CLINTON PRIVILEGE OF WORKING WITH THESE FAMILIES FOR THE LAST 23 YEARS. GSH PRESIDENT PRIVILEGE OF WORKING WITH THESE FAMILIES. WAR GOAL WAS TO DEVELOP RESEARCH THAT FOCUSED ON IDENTIFYING FACTORS THAT IN FLEW WENED THE INTERESTS IN AND UPTAKE OF GENETIC COUNSELING AND TESTING AND THE ASSOCIATED PSYCHOLOGICAL, SOCIAL AND BEHAVIORIALOUT COMES. THE RESEARCH AGENDA WAS INSPIRE BY THE EYE IDENTIFICATION OF A RAPIDLY GROWING NUMBER OF GENES THAT PREDISPOSE OR INCREASE CERUS SEPTEMBERIBILITY TO DISEASE. MY RESEARCH SP EUF SPECIFICALLY FOCUSED ON FAMILIES DIAGNOSED WITH HNPCC AND FAMILIES WHO SPECIFICALLY HAVE DILL TEAROUS MUTATIONS IDENTIFIED. THE IDENTIFICATION OF FAMILIES WITH AHNPCC MUTATION ALLOWED THE OPPORTUNITY TO LEARN FROM THEM' AFTER AND DURING THE GENETIC COUNSELING AND THE OFFER OF GENETIC TEST. WE FELT IT WAS YES, NECESSARY TO PLAN FOR A FUTURE WHEN GENETIC TESTING WILL BE MORE ROUTINELY USED TO REPRESIDENT PREDICT FOR RARE AS WELL AS COMMON DISEASES IN THE GENERAL POPULATION. WITHIN THE STUDY ONCE A FAMILY IS IDENTIFIED TO CARRY A MUTATION WE SEQUENTIALLY OFFER PARTICIPATION TO FIRST-DEGREE ADULT RELATIVES AT 50% RISK OF INHERITING THE MUTATION. IT INCLUDES THE PROVISION OF COME PREHEN SIV GENETIC EDUCATION AND COUNSELING ABOUT HNPCC AND THE OPTION OF GENETIC TESTING. FOR THOSE ELECTING TO PURSUE THE TESTING THE CLINICAL CENTER PAYS FOR THE GENETIC STUDIES REMOVING THE ISSUES OF COST AND INSURANCE COVERAGE FROM THE DECISION-MAKING PROCESS. HOWEVER, PRIOR TO THE EDUCATION AND COUNSELING SESSIONS WE ASK PARTICIPANTS TO COMPLETE A QUESTIONNAIRE THAT COLLECTS DEM GRAPHIC INFORMATION, INFORMATION ABOUT THEIR KNOWLEDGE OF GENETICS AND GENETIC TESTING AND PERCEIVED CANCER RICKS AND STANDARDIZED SCALES ASSESSING MOOD, COPING STYLE, SPIRITUALITY AND THEIR PERCEPTION OF THEIR OWN CONTROL OVER HEALTH ISSUES AND FAMILY RELATIONSHIPS. ADDITIONALLY WE ALSO ASK THEM TO SPECIFICALLY IDENTIFY WHAT FACTORS MOTIVATE THEM TO CONSIDER GENETIC TESTING SUCH AS THE DESIRE TO CLARIFY THEIR RICK OR CHILDREN'S RISK FOR CANCER OR GUIDE THE CANCER SCREENING. LIKE WISE, WE ALSO ASKED THEM TO IDENTIFY FACTORS THAT CONCERN THEM ABOUT UNDERGOING GENETIC TESTING SUCH AS EMOTIONAEMOTIONAL CONCERNS ABOUT HANDLING THE RESULTS FOR THEM ELVES OR FOR OTHER FAMILY MEMBERS. THEIR LEVEL OF CONFIDENCE IN THE PREVENTION STRATEGIES THAT EXIST AND THEIR CONCERNS ABOUT TEST RESULTS AFFECTING INSURABILITY. THESE QUESTIONS ARE ASKED INDIVIDUALLY SO WE MIGHT OBTAIN A LEVEL OF SIGNIFICANCE FOR EACH ISSUE. IN ADDITION WE ASK THE PARTICIPANTS TO IDENTIFY THE MOST IMPORTANT REASON FOR THEM TO CONSIDER TESTING AND LIKE WISE THE GREATEST CONCERN THEY HAVE IN CONSIDERING TESTING. ALL THE QUESTIONS ARE VALLEY MEASURES -- VAL DATED MEASURES ELDEVELOPED AND USED BY THE CANCER CONSORTIUM OF THE ETHICAL LEGAL AND SOCIAL IMPLICATIONS PROGRAM. AS WE BEGAN TO TALK INDIVIDUALLY WITH EACH PARTICIPANT DESCRIBING THE INTENT OF THE STUDY AND PROCESS INVOLVED ONE KEY ISSUE WAS CONSISTENTLY IDENTIFIED AND THAT WAS POSED IN THE FORM OF A QUESTION. HOW MIGHT PARTICIPATION IN THIS STUDY AFFECT MY INSURANCE OR THAT OF MY FAMILY. THE QUESTION SAME UNSOLICITED IN THE BEGINNING OF THE INFORMED CONSENT PROCESS. THIS QUESTION AND ASSOCIATED WORRY SEEMED TO PERSIST EVEN AFTER WE PROVIDED EACH PAR PARTICIPANT OF INFORMATION THAT REASSURED THEM OF THE CONFIDENTIAL NATURE OF THE STUDY THAT THE STUDY HAD A CERTIFICATE OF CONFIDENTIALITY ISSUED BY THE NATIONAL INSTITUTE OF HEALTH, ALL ARE EYE SIGNED STUDY ID CODES THAT REMOVES INFORMATION FROM THE DATA AND THE TEST RESULTS AND THE COSTS ARE PAID FOR BY THE STUDY SO INSURERS ARE NOT INVOLVED AND RECORDS ARE PROTECTED AND ARE ONLY RELEASED IF INFORMATION IS RETAINED BY THE PARTICIPANTS. NEVERTHELESS, IT WAS CLEAR THERE WAS AN OVERWHELMING CONCERN SNED IN SOME CASES A PALPABLE ANXIETY ABOUT THE IMPACT OF GENETIC TESTING ON HEALTH INSURANCE. THESE CONCERNS DOMINATE THE INFORMED CONSENT PROCESS AND OCCUR SESSION AFTER HE IS' SESSION. I SPECIFICALLY FERREL ONE YOUNG WOMAN AND HER MOTHER BOTH OF WHOM EXPERIENCED UTERINE AND COLON CANCERS AT YOUNG AGES WITH A FAMILY RIDDLED WITH HNPCC CANCERS. EVEN THOUGH THE YOUNG WOMAN EXPERIENCED CANCER TWICE AND FELT THERE WAS LITTLE RESIDUAL DISCRIM THAT TORRE RISKS TO HER SHE WAS IMMOWMOBILIZED ABOUT THE POTENTIAL GENETIC TEST RESULTS BRANDING HER FAMILY AS UNINSURABLE. SHE OPTED TO WAIT ON TESTING BUT WOULD PERIODICALLY CALL TO DISCUSS THE SAFEGUARDS. SHEAF WASED SHE WASED ADMITTEDLY TORTURED ABOUT THE CONCERNS. SHE YOUR HONOR ARED TO PURSUE -- HEY RETURN THE TO TESTING KNOWING THAT THE RESULTS MAY WELL PREVENT OTHERS FROM EXPERIENCING WHAT SO MANY IN HER FAMILY HAD ALREADY ENDURED. SEQUENCING EFFORTS IDENTIFIED A MUTATION PROVIDING A MEANS TO IDENTIFY THE CANCER RISK AND FOCUS THE CANCER SCREENING AND CONSIDER PREVENTATIVE STEPS SUCH AS FOE FA LACTIC SURGERY. WE ANTICIPATED WE WOULD BE HEARING FROM A FEW OF THE FAMILY MEMBERS. THERE WERE NO CALLS, NO E-MAILS AND NO LETTERS. THROUGH FOLLOW-UP WE LEARND THAT SHE HAD SAIRED THE SHARED THE RESULTS WITH THE FOUR SISTERS AND THEY EXPRESSD THAT THEIR CONCERNS REGARDING DISCRIMINATION WERE TOO GREAT TO SAFELY ALLOW THEM TO PARTICIPATE IN A GENETIC COUNSELING STUDY WITH THE OPTION OF GENETIC TESTING. THEY WERE WORRIED ABOUT WE BEING IN SMALL COMPANIES WITH LIMITED INSURANCE OPTIONS AND THE ASSOCIATED RISKS THAT GENETIC TESTING POSED FOR THEM AS WELL AS THEIR CHILDREN. WE STEP BACK FROM THAT EXPERIENCE AND WONDERED HOW PERVASIVE IS THE THREAT OF GENETIC DISCRIMINATION? IN 2003 WE PUBLISHED A PAPER IN THE ARCHIVES OF INTERNAL MEDICINE WHICH I BROUGHT ALONG FOR YOUR CONSIDERATION. IN THE PAPER WE REPORTED ON ATTITUDES, INTENTIONS AND UPTAKE OF GENETIC TESTING OF INDIVIDUALS WITHIN THESE FAMILIES. OF PARTICULAR RELEVANCE TO THIS GROUP WERE OUR FINDINGS REGARDING THE LEVEL OF CONCERN THAT EXISTS WITHIN THESE FAMILIES ABOUT PARTICIPATING IN A GENETIC COUNSELING AND TESTING RESEARCH STUDY. THE QUESTIONS THAT WE USED TO IDENTIFY THE CONCERNS REGARDING GENETIC TESTING ARE ALSO INCLUDED IN THE PACKET BEFORE YOU. IN LOOKING SPECIFICALLY AT WHAT FACTORS INFLUENCE DECISIONS WE IDENTIFIED AND PUBLISHED THAT 39D% OF PARTICIPANTS REPORTED THAT THE MOST PRESSING CONCERN WAS THE WORRY ABOUT THE POTENTIAL OF A GENETIC TEST RESULT AFFECTING THEIR OR THEIR FAMILY'S INSURABILITY. I LOOKED AT THE DATA TO SEE IF THE LEVEL OF CONCERN HAS HELD TRUE FROM THE EARLIER ANALYSIS SINCE WE ADDED 80 ADDITIONAL PARTICIPANTS. I FOUND THAT THE CURRENT DATA SUGGESTS THE NUMBER IS SLIGHTLY HIGHER THAN ORIGINALLY PUBLISHED. NOW, ABOUT 43% IDENTIFYING THAT THE GREATEST CONCERN REGARDING TESTING PERTAINS TO THE CONCERNS ABOUT DISCRIMINATION. ON FOLLOW-UP AT 6 AND 12 MONTHS A GREATER PROPORTION OF THEM IDENTIFIED DISCRIMINATION AS A SINGLE MOST WORRISOME FACTOR, SPECIFICALLY AT 6 AND 12 MONTHS, 48 AND 54% RESPECTIVEL IDENTIFIED CONCERNS ABOUT GENETIC DISCRIMINATION BY THEIR INSURER AS THEIR PRINCIPAL CONCERN. OBVIOUSLY THIS CONCERN IS NOT GOING AWAY WITH TIME AND ADJUSTMENT TO THE JUT COME OF TESTING. THIS SEEMS SURPRISING SINCE RESEARCH FROM OTHER STUDIES FOCUSED ON PRESYMPTOMATIC AND CERUSUSCEPTIBLE TESTING DEMONSTRATE THAT OTHERS SEEM TO RETURN TOO PRETEST LEVEL FROM A YEAR OUT OF TESTING. WHAT IS DIFFERENT ABOUT THE CONCERNS REGARDING INSURANCE? IF PEOPLE HAVE NOT ACHIEVED WHAT THEY PERCEIVE AS DISCRIM NATION WHAT ARE THERE CONCERNS? PARTICIPANTS Z HAS ANY ONE IN THE STUDY EVER REPORTED DISYIP NATION ON THE PART PART OF THE INSURANCE COMPANY OR EMPLI PLOYER. APPARENTLY JUST REASSURING THEM THAT THE DISCRIMINATION IN GENERAL AND WIN OUR STUDY IS NOT THE NORM DOESN'T HELP. THERE IS A PERVASIVE MISTRUST THAT SEEMINGLY WORSENS WITH TIME. IN SUMMARY, THE PRE VAU VALENCE OF GENETIC DISCRIMINATION BY INSURANCE COMPANIES DOES NOT APPEAR TO BE THE KEY ISSUE. THE ISSUE IS THE PUBLIC PERCEIVES THAT THE GENETIC DISCRIMINATION IS AN OVERWHELMING RISK AND IN MY PERNEXPERIENCE THIS PROVIDES A BARRIER TO GENETIC RESEARCH AND CLINICAL CARE AND IT LIMITS POE TEMPERATURES FOR -- POTENTIAL FOR RESEARCH. THE GREATEST TRAGEDY, HOWEVER IS THE MISSED OPPORTUNITY TO PREVENT CANCER OR DIAGNOSE IT EARLY IF PERSONS AT HIGH RISK WHO ARE UNWILLING TO RISK THE POTENTIAL OF DISCRIMINATION. PROVIDING FEDERAL LEGISLATION PROHIBITING GENETIC DISCRIMINATION WILL REASSURE THE PUBLIC THAT GENETIC DISCRIMINATION IS NOT A RISK, PROVIDE AN INCREASED OPPORTUNITY TORE RESEARCH TO ADDRESS OTHER SIGNIFICANT ISSUES AND REDUCE MORTALITY AND MORMORED BIDITY. THANK YOU FOR THE OPPORTUNITY TO PRESENT OUR WORK.

THANK YOU, MR. HADLEY. THE LAST OF THE HEALTH CARE PROVIDERS IS MR. MARK BRANTLY.

I WOULD LIKE TO THANK THE COMMITEE FOR INVITING ME TO COME AND SPEAK. MY NAME IS MARK BRANTLY. I'M A PULMONARY PHYSICIAN AND PHYSICIAN SCIENTIST AT THE UNIVERSITY EVER FLORIDA. I HAVE BEEN INVOLVED IN LPHA TESTING SINCE IS THE 83 AND TESTED ABOUT 20,000 INDIVIDUALS AND IDENTIFIED # 2,000 INDIVIDUALS OVER THE LAST 20 YEARS AND IN RECENT YEARS I HAVE BEEN TESTING APPROXIMATELY 5-6,000 PATIENTS FOR YEARS FOR ALPHA DEFICIENCY. AT UNIVERSITY OF FLORIDA AND HAVE FIRST HAND EXPERIENCE REGARDING THE IMPACT OF THIS DIAGNOSIS ON THEM PERSONALLY AND ALSO THEIR FAMILIES. LET ME BEGIN BY GIVING A BRIEF EXPO SAY OF ALPHA IMMUNOTRIP SIN LEVEL AND A PI TYPE OR GENE KNOW TYPE. ONE OF THE MORE COMMON GENETIC DISEASES WITH THE FREQUENCY OF 1 IN 3,000 TO 400. THE FINE FOE PHENOTYPE IS PIE MARELY LIVER DISEASE ANN ASSOCIATED A RAPID DECLINE IN LUNG FUNCTION. IT IS ONE OF THE CLASSIC GENES IN WHICH THERE IS AN ENVIRONMENT AND A GENE INTERACTION THAT IS THAT THE SLIDES LOSE FUNK FUNCTION FASTER WHEN THEY SMOKE CIGARETTES. IMPORTANT MR. N. MY CLINIC POPULATION I HAVE INDIVIDUALS THAT ARE 80 YEARS OLD WITH PRO FOUND THAT ARE LIVING ACTIVE LIVE PS. PREVENTION OF BEHAVIORS AND INTERAXEINTERACTIONS IS CRITICAL ASPECT OF THE DISEASE. IT IS NOT ABOUT HAVETH EXPENSIVE AROUND. PEOPLE CAN LIVE WITHOUT HAVING DISEASE IF THEY WERE IDENTIFIED EARLY AND WE ARE ABLE TO PROTECT THEM. EARLY DIAGNOSIS AND PREVENT ATIFF CARAATIVE CARE ARE CRITICAL. IN THE STATE OF FLORIDA THERE ARE 9,000 INDIVIDUALS WITH COPD AND 9,000 DIAPER YEAR. ALMOST A THOUSAND HAVE AT RISK ALLELES. IN THE STATE OF FLORIDA WE HAD A PROGRAM IN WHICH WE HAVE DONE TARGETED DETECTION. WE FIRST BEGAN BY ESTABLISHING A CONSENSUS AMONG THE COMMUNITY WITH THE HELP OF THE ALPHA ONE FOUNDATION THAT DEFENDANTING EXCEEDED THE RISK OF TESTING WE ESTABLISHED A HIGH THROUGHPUT LANT AND PROVIDED PROFESSIONAL AND LAY EDUCATIONAL MATERIALS TO DEAL WITH SOME OF THE EDUCATIONAL MATERIALS SOS ASSOCIATED WITH THE DIAGNOSIS. WE DEVELOPED AN EASY TESTING SYSTEM WHICH PATIENTS CAN PATRIOTIC THEIR FINGER AND SENT IT TO THE CENTRAL LABORATORY. YET WE STILL HAVE SIGNIFICANT BARRIERS TO TESTING THESE INDIVIDUALS DESPITE MAJOR RECOMMENDATIONS FROM THE MAJOR THORACIC SOCIETIES RIDGING A CATEGORY A RECOMMENDATION FOR TESTING. THESE BARRIERS INCLUDE GENETIC DISCRIMINATION AND PARTICULARLY FEAR OF GENETIC DISCRIMINATION IGNORANCE REGARDING THE DISEASE AMONG THE PHYSICIAN POPULATION. WE ALSO ESTABLISHED TERTIARY CARE REFERRAL SYSTEMS TO MAKE SURE THAT THEY HAVE SOME PLACE TO GO WITH THE PATIENTS. SO WE HAVE YET STILL AN IMPORTANT JOB AND THAT IS TO BE ABLE TO INSTEAD RIGHT NOW WE HAVE 5,000 INDIVIDUALS THAT ARE IDENTIFIED WITH ALPHA IMMUNOATRIP SEEN DEFICIENCY. IF THEY WERE IDENTIFIED EARLY OON THEY PERHAPS COULD BE PROTECTED FROM DEVELOPING DISABILITY. ONE OF THE APPROACHES IS A COATED TESTING TRIAL. FUNDED ENTIRELY BY THE ALPHA ONE FOUNDATION AND A LONGITUDINAL STUDY LOOKING AT THE REASONS WHY PEOPLE DO NOT WISH TO BE TESTED THROUGH THEIR PHYSICIAN. WE HAVE TEST THE NOW MORE THAN 3,300 INDIVIDUALS FOR IN THIS TESTING PROGRAM AND HAVE DONE INITIAL LONGITUDINAL FOLLOW-UP. I PROVIDED YOU WITH A MANUSCRIPT WITH THE RESULTS. I WOULD LIKE TO FOCUS IN ON A COUPLE OF THINGS RECENTLY WE HAVE DONE. THE FIRST ONE IS THE RISK AND BENEFITS OF GENETIC TESTING. 33% SAID THAT THE REASON WHY THEY CHOSE THE TESTING TRIAL WAS BECAUSE OF FEAR FOR LOSING THEIR HEALTH INSURANCE OR HIGHER HEALTH INSURANCE COST TS. THE OTHER THING IS IN THE POST TEST WHO WOULD YOU GIVE YOUR RESULTS TO? NOT SURPRISINGLY THEY WOULD GIVE THE RESULTS TO THE CHILDREN AND SPOUSE AND NOT SURPRISINGLY THEY WOULDN'T GIVE IT TO THE EX-SPOUSE.

( LAUGHTER ).

IN ADDITION, THEY WOULD NOT PROVIDE IN INFORMATION TO THEIR HEALTH INSURANCE COMPANIES OR THEIR LIFE INSURANCE COMPANIES AND, INDEED, ONLY ABOUT 16% WOULD DISCLOSE THAT. SADLY, THOUGH, I HAVE TO SAY THAT ONLY 80% OF THESE INDIVIDUALS THAT WERE PRO FOUNDLY DEFISH SHENT WOULD EVEN THEY WILL THEIR PERSONAL PHYSICIAN AND THAT IS PROBLEMATIC AS AS FAR FAR AS I'M CONCERNED. FINALLY, ONE OF THINGS THAT THIS STUDY I THINK BRINGS UP IN CLOSE CONTRAST IS THAT WHEN PATIENTS WERE DIAGNOSED WITH ALPHA ATRIP SEEN IMMUNODEFICIENCY ONE OF THE THERAPIES IS TO DO SPOKING CESSATION. WHILE THERE WAS A TREND FOR THEM QUITTING SMOKING THIS WAS NOT SIGNIFICANT. IN ACTUALITY, IT WAS HIGHER FOR ALPHA IMMUNOATRIP SEEN DEFICIENCY INDIVIDUALS STILL A LARGE PORTION GREATER THAN 80% DID NOT QUIT SNOW COVERING. Y CLINIC I HAVE A 95% QUIT RATE FOR CIGARETTE SMOKING. THE NATIONAL AVER AVERAGE IS 10%? I HOUND THESE PATIENTS TO DEATH. I SCHEDULE THEM FOR APPOINTMENTS TO SEE ME EVERY MONTH AND THE NUTS HASSLE THEM -- NURSES HASSLE THEM. GETTING THEM TO QUIT SMOKING IS ONE OF THE MOST IMPORTANT THINGS THAT I CAN DO. WE WE HAVE TO RESORT TO CODED TESTING AND WE LEAVE OUT THE PHYSICIAN AND HEALTHCARE PROVIDER IN HELPING THESE INDIVIDUALS COPE WITH AND MAKE THESE CHANGES WE SHORT CHANGE THEM IN A BIG WAY. WE SHORT CHANGE THEM BECAUSE THEY ARE AFRAID BECAUSE THEY CAN'T TEST OUR SYSTEM TO PROTECT THEM AND GIVE THEM THE CORRECT INFORMATION. THERE IS ONLY ONE DIFFERENCE BETWEEN MY PATIENTS AND ME. WE ALL AS COMPLEX GENETIC ORGANISMS HAVE FIVE TO 15 QUOTE UNQUOTE LETHAL MUTATION PS MAY BE ASSOCIATE THE WITH OUR DEMICE OR DISABILITY. THE -- DEMISE OR DISABILITY. THE DIFFERENCE FINE ME AND MY PATIENTS IS I DON'T KNOW ABOUT MINE. MY PAIENTS NO ABOUT THEIRS AND HAVE THE ABILITY TO DO RISK PREVENTION. THANK YOU VERY MUCH.

THANK YOU FOR ALL YOUR TESTIMONY AND IT CONTINUES TO CLARIFY THE THAT GENETIC DISCRIMINATION AND ESPECIALLY THE FEAR OF GENETIC DISCRIMINATION IS VERY REAL. WE ARE GOING TO OPEN IT UP NOW AGAIN TO THE COMMITTEE MEMBERS TO ASK OUR HEALTHCARE PROVIDER PANEL ANY QUESTIONS THAT THEY MAY HAVE. BRAD?

SO IT IS ASTOUNDING HOW PEOPLE'S BEHAVIOR DIDN'T CHANGE IN THE LAST STORY EVEN AFTER THEY HAVE THE GENE OH TYPE AND KNOW THE RISK. DID ANY OF YOU ASK THE PARTICIPANTS WHOSE WEARY OF SHARING THE INFORMATION OR PERSPECTIVES BEING TEST -- PARTICIPANTS BEING TESTED IF THEY WOULD IN FACT DO SO IF THERE WAS A LAW THAT PRO VEKTED THEM? IS IT CLEAR TO YOU THAT TOMORROW WE ANOWRCHS ANNOUNCE THERE IS A SOLID LAW THAT SAYS YOU CAN'T DISCRIMINATE THAT THESE PEOPLE WOULD SUDDENLY THEN ALL TIP AND ALL BE WILLING TO PARTICIPATE AND TAKE THE RISK OR WOULD THERE STILL BE QUITE A BIT WITT F PAIR NOW THAT?

I THINK THIS WILL BE PEOPLE WHO WON'T PARTICIPATE FOR OTHER REASONS. IT IS NOT GOING TO BE 100% OF THE PEOPLE WHO DON'T PARTICIPATE THAT HAVE INSURANCE CONCERNS AS THE MAJOR FOCUS. SOME WILL IS STILL BE OUT THERE NOT ARE PARTICIPATING. NOT GETTING INFORMATION AND NOT CONSIDERING TESTING. IT IS CLEAR FROM BOTH A QUALITATIVE PERSPECTIVE AND FROM TALKING WITH THESE PEOPLE IN THE CLINIC AS WELL AT KWAN TAYTIVE THAT THIS IS A -- QUANTITATIVE THAT THIS IS A FEAR AND IF Q3 COULD SAY THERE ARE FEDERAL LAWS THAT PREVENT DISCRIMINATION BY INSURANCE COMPANIES AND EMPLOYERS THAT THAT WOULD BE REMOVED, THAT THAT CONCERN WOULD BE TAKEN OFF THE TABLE AND THEN WE WOULD HAVE BETTER OPPORTUNITIES TO FOCUS OUR EFFORTS TOWARDS THEM HELPING THEM TAKE BETTER CARE OF THEMSELVES THROUGH SCREEN OR DIETS WHAT WHATEVER EXISTS. IF THERE WAS FEDERAL PROTECTION WE WOULD HAVE BETTER COOPERATION AND BE ABLE TO ATTACK THE PROBLEMS THAT REALLY EXIST WITH SOME OF THESE DYSORDERS.

I WOULD -- SIS ORDERS.

I WOULD -- DISORDERS.

I WOULD SECOND THAT. OUR PROBLEM IN COLORADO WE HAVE A STATE LAW THAT SAYS YOU CANNOT DENY HEALTH INSURANCE OR ADJUST RATES BASED ON GENETIC INFORMATION. THE PROBLEM WITH OUR POPULATION IS THEY ARE HIGHLY MOBILE SO THESE INDIVIDUALS DON'T KNOW IF THEY GOING TO BE IN COLORADO A YEAR FROM NOW. I WOULD BELIEVE IF WE COULD SAY FOR THOSE PATIENTS THAT THEIR BIGGEST CONCERN IS THAT THEY COULD MOVE AND BE IN A PLACE WHERE THEY ARE NOT COVERED. IF WE HAVE FEDERAL LEGISLATION THAT WOULD TAKE CARE OF A LOT OF THAT WORRY.

I KNOW EMAFROM THE PATIENT PANEL BUT I HAVE SOMETHING TO ADD. ARKANSAS HAS A STATE LAW THAT PROTECTS ME AND THAT WAS PART OF THE DECISION PROCESS THAT MADE BEDECIDE TO GO AHEAD AND PURSUE GENETIC TIFTING. ING. WITHOUT THAT STATE LAW I DON'T THINK I WOULD HAVE PURSUED IT. THERE ARE HOLES AND IT DOESN'T HELP WITH INDIVIDUAL INSURANCE AND THERE IS ALWAYS THE POSSIBILITY THAT I COULD MOVE SO ALL ALTHOUGH THE LAW IS INCOMPLETE I AM THANKFUL FOR THE LAW AND IT DID INFLUENCE HOW I CHOSE TO PURSUE MY HEALTH.

THIS IS MARK BRANTLY. I THINK THAT THE LAWS WILL DEFINITELY HELP BUT I THINK THERE THERE NEEDS TO BE A EW IETYIAL CHANGE AND THAT IS THAT WE HAVE TO RECOGNIZE THAT DISABILITY SHOULDN'T BE A SCARLET LETTER OR THE POSSIBILITY OF DISABILITY AND I THINK THAT ONCE WE -- UNTIL WE ELIMINATE THOSE POSSIBILITIES WE ARE NOT GOING TO BE ABLE TO REMOVE FEAR FROM THE INDIVIDUALS REGARDING IT BECAUSE RUST HAS TO BE OUT THERE. IT IS NOT JUST THE AAH, LAW. IT IS ABOUT TRUSTING SYSTEM TO DO-RIGHT BUT YOU. PEOPLE WON'T STAND UP UNTIL THEY CAN SEE THAT OTHER INDIVIDUALS HAVE BEEN ABLE TO GO THROUGH THIS AND NOT HAD PROBLEMS WITH THIS BECAUSE THESE THINGS INDIVIDUALLY AFFECT THEM AND NOT ONLY THEMSELVES BUT ALSO THEIR FAMILIES. AND YOU DON'T WANT TO TAKE CHANCES WITH YOUR KIDS NO MATTER WHAT. YOU WOULD RATHER DIE THAN TAKE THE CHANCE OF YOUR KID BEING ABLE TO BE EMPLOYED PROPERLY OR FULFILL THEIR POE POTENTIALS. I DON'T THINK WE WILL SEE AS MUCH ENTHUSIASM FOR GENETIC TESTING UNTIL WE VEAL TRACK TRACK RECORD.

I WANTED TO FOLLOW UP ON THE COMMENT THAT DOCTOR BRANTLY MADE IN THE CLOSING PART OF HIS STATEMENT AND I THINK IT IS IMPORTANT AND I WANT TO EMPHASIZE THIS THAT WE ALL HAVE GENETIC PREDISPOSITIONS TO DISORDERS. THOSE WHO HAVE COME TO SPEAK TO US TODAY RECOGNIZE WHAT THEIR PROBLEMS ARE AND WHAT THE POTENTIAL PROBLEMS ARE. AND I THINK THAT THIS IS VERY IMPORTANT FOR ALL OF US TO RECOGNIZE. IT IS DISCRIMINATION BECAUSE IT IS ARE ARBITRARY AND CAPRICIOUS. SIMPLY BECAUSE WE CAN IDENTIFY SOMETHING ABOUT INDIVIDUALS BECAUSE THEY ARE FORTUNATE OR UNFORTUNATE TO HAVE THEIR GENES IDENTIFIED EARLY IN THE GENOMIC REVOLUTION WE DISCRIM DISCRIMINATE AGAINST THOSE INDIVIDUALS AND THEN WE SHOULD BE DISCRIMINATING AGAINST ALL OF US AND IF WE DISCRIMINATE AGAINST ALL OF US THEN HOPEFULLY WE ARE DISCRIMINATING AGAINST NONE OF US. PAUL MILLER SAME AND SAID THE ARGUMENT HAS BEEN MADE THE FORMER COMMISSIONER FOR THE EEOC HE WOULD COME AND SAY THAT ONE OF THE ARGUMENTS IS THAT ALL OF THIS IS COVERED UNDER THE ADA. ONCE WE COVER ALL OF US UNDER THE ADA WE COVER NO ONE AND THE AD CASMD WAS A WAS PUT IN PLACE TO PROTECT VULNERABLE INDIVIDUALS IN OUR POPULATION. I'M CONCERNED ABOUT THE ADA WAS EXTENDED. I DON'T THINK IT WOULD BE. I THINK THAT HAPPENS TO BE JUST SMOKE BUT SHOULD IT BE, THEN WOULD -- THEN IT WOULD PROTECT NO ONE AND IT WOULD NOT PROTECT THE VULNERABLE. THE OTHER THING, REED, I JUST WANT TO POINT OUT THAT WE HAVE BEEN CHARGED AS A COMMITTEE WITH IDENTIFYING TOPICS OF IMPORTANCE WITHIN THE AGENCIES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND I THINK WHAT WE HAVE HEARD TODAY IS NOT ONLY IS GENETIC DISCRIMINATION A PROBLEM AND WE HAD RESPONSES FROM THE SECRETARY SAYING THEY UNDERSTAND THIS AND THEY ARE SUPPORT ISUPPORTIVE OF THAT LEGISLATION BUT WHAT WE HEARD IS PERHAPS EVEN MORE TROUBLING AND I APOLOGIZE TO THE PANELISTS BUT I HEARD THE PASSION THAT YOU HAD FOR YOUR CHILDREN. WHAT WE HAVE HEARD IS THAT THIS IS A BARRIER TO RESEARCH. IF IF IS A BARRIER TO RESEARCH THAT CERTAINLY SINCE IT IS HEALTH RESEARCH FALLS WITHIN THE PURVIEW OF THE SECRETARY. AND IF IT IS A BARRIER TO RESEARCH, THAT MEANS THAT WE ARE NOT GOING TO MOVE FORWARD TO PROTECT THE CHILDREN OF OUR PANELISTS, TO PROTECT OUR CHILDREN AND GRAND CHILDREN INTO THE FUTURE AND IN FACT THAT IS EVEN MORE TROUBLING TO ME THAN THE IMMEDIACY OF THE DISCRIMINATION THAT WE HEARD ABOUT TODAY. WE ARE DISCRIMINATING IN WAYS THAT WE CAN'T EVEN UNDERSTAND FOR OUR CHILDREN AND OUR GRAND CHILDREN.

ANY FURTHER QUESTIONS?

ON A DIFFERENT SUBJECT, THE -- THE THING ABOUT DISCRIMINATION IS THAT SOMETIMES IT ALLOWS PEOPLE TO DISCRIMINATE WITHOUT HAVING ANY KIND OF STANDARDS FOR THE INFORMATION AND SO ONE THING THAT STRUCK ME THAT I WANTED TO ASK YOU ABOUT WAS, YOU KNOW, EVEN IF YOU HAVE V. A GENETIC MUTATION OR POLYMORPHISM ASSOCIATED WITH SOME RISK, IS THERE REALLY ALWAYS A CONSENSUS ABOUT WHAT THAT RISK IS? AND MY QUICK PERSONAL STORY AS MANY OF YOU KNOW I'M A CARRIER FOR A MUTATION THAT COMPLETELY WIPES OUT A PROTEIN THAT PLAYS A ROLE IN CELL CYCLE CONTROL AND WHEN YOU MARRY SOMEONE WITH DID I DID WITH ANOTHER MUTATION LIKE THAT WE HAD TWO KIDS WITH A REALLY SERIOUS DISEASE. ALONG THE LINES I NEVER TALK ABOUT PEOPLE LIKE ME WHO THE CARRIERS ARE SUPPOSED TO HAVE THREE TO FOUR FOLD HIGHER RISK OF CANCER BUT THERE IS ACTUALLY A COUPLE OF NEW AND GENERAL MEDICINE ARTICLES THAT SAY THAT IS TRUE AND THEN SUBSEQUENTLY THERE HAVE BEEN NUMEROUS OTHER PAPERS DONE WHERE PEOPLE CHALLENGE THAT AND THERE ISN'T THE CONSENSUS OUT THERE YET AND YET WE ALWAYS READ A COUPLE TIMES IN OUR PAST WHAT WE HAD THE INSURANCE COMPANIES LEARN THAT WE ARE CARRIERS FOR THIS DISEASE ARE THEY GOING TO PULL OUT THAT WHAT WE THINK IS SPURIOUS NEW ENGLAND OURNAL OF MED MEDICINE ARTICLE OR THE ONES THAT LOOKS LIKE THE RISK IS NOT AS GREAT. I'M WONDERING. THAT IS ANOTHER SERIOUS DOWN SIDE TO THE GENETIC DISCRIMINATION OR TESTING WHERE DECISIONS LIKE INSURANCE ARE GOING TO BE MADE IS THAT IT IS BAD ENOUGH THAT THEY ARE GOING TO DISCRIM DISCRIMINATE FOR SOMETHING THAT IS REAL OR THAT THEY DON'T KNOW WHAT THEY ARE TALKING ABOUT. I DON'T KNOW IF MY CASE IS RARE OR IF YOU RUN INTO THAT, TOO BUT IT IS AN IMPORTANT POINT THAT THE EPIDEEMOLOGYICAL DATA, EPIDEMIOLOGISTS DISAGREE ALL THE TIME BUT THIS IT CASE IS IS IMPORTANT AND DO YOU SEE THAT ACROSS A LOT OF YOUR OTHER SITUATIONS?

YEAH, WE SEE IT PRETTY OFTEN IN OUR CLINICS. AND AGAIN THE RICK IS VERY HARD -- I MEAN WHEN YOU SPEAK ABOUT RISK FOR GENETIC DISEASES IS IT JUST SPREAD ACROSS EENL ACROSS THE WHOLE POPULATION OF MZ INDIVIDUALS OR A WHOLE POPULATION OF MZ INDIVIDUALS THAT HAVE A HIGH RISK BECAUSE OF A SECOND GENETIC HIT AND ALL OF THE EVEN EPIDEMIOLOGY STUDIES HAVE THAT TYPE OF RISK SO THE RISK IS X WITH CAVEATS. AND I THINK THAT THE VALUE THAT AGAIN PLAYS AN IMPORTANT ROLE IN SORT OF SETTING ASIDE WHAT IS THE RISK. THE RISKS SHOULD HAVE NOTHING TO DO WITH YOUR INSURANCE. BECAUSE WE CAN'T PRECISELY FIX RISK FOR ANY OF THESE GENETIC DISEASES. WE HAVE A -- THEY ARE PRETTY BROAD CONFIDENCE INTERVALS AND THEY CLEARLY ARE BECAUSE OF OTHER EITHER EAR GENES OR VAI. OR -- OTHER GENES OR ENVIRONMENT OR BOTH.

I THINK IN THAT REGARD WE HAVE THE SAME SITUATION IN FAMILIES WITH HA HA RAID TERRI COLORECTAL CANCER WHERE THE INITIAL STUDIES SAID THE LIFETIME RISK MAY BE AS HIGH AS 80% BUT THAT MAY NOT BE TRUE FOR EACH AND EVERY FAMILY THAT WE ENCOUNTER. SOME MAY HAVE LESS RISK THAN THAT BUT STILL SIGNIFICANTLY ELEVATED OVER THE GENERAL POPULATION. IT IS HARD TO USE THOSE NUMBERS AT THIS POINT IN TIME WHEN WE'RE NOT EXACTLY SURE FOR THE PERSON WHO IS SITTING IN FRONT OF US. BUT YET STILL THOSE -- THAT INFORMATION MAY BE PULLED AND USED TO DISCRIM DISCRIMINATE OR SET INSURANCE RATES.

I THINK IN THE GENETICS COMMUNITY OUR CRYSTAL BALL IS ABOUT AS GOOD AS ANY OTHER MEDICAL FIELD. WHEN YOU -- WHEN YOU ARE TALKING ABOUT INDIVIDUALS ABOUT STATISTICS, AND TRYING TO APPLY TO AN INDIVIDUAL IT IS VERY DIFFICULT. AND THERE IS ALWAYS VARIABLES THAT CAN COME IN TO PLAY ESPECIALLY WITH HEREDITARY CANCER PREDISPOSITIONS. WHEN YOU MEET WITH SOMEONE YOU SAY YOU HAVEIN' INCREASED RISK BUT I CAN'T GUARANTEE YOU WILL EVER GET CANCER AND THERE IS CERTAINLY MANY PEOPLE THAT WON'T AND THEREFORE IT -- IT MAKES THE GENETIC DISCRIMINATION EVEN MORE, YOU KNOW, TROUBLING BECAUSE MANY OF THESE PEOPLE WILL NOT DEVELOP WHAT THEY ARE AT AN INCREASED RISK FOR.

ONE MORE QUESTION. WAYNE?

ACTUALLY I WASN'T GOING TO HAVE A QUESTION BUT MORE OF A COMMENT HERE BECAUSE I HAVE BEEN FOLLOWING THE DISCUSSION AND THINKING ABOUT GENETIC INFORMATION IN A SORT OF A AT THE POPULATION LEVEL. WE ALWAYS SEEM TO BE STUMBLING BETWEEN AS THE DIFFERENCE BETWEEN A GENETIC DISEASE AND THE REST OF THE DISEASES. AND AS A BASICALLY THE PANEL SHOWED US THIS MORNING, EVEN WHEN YOU START WITH THE GENETIC DISEASE WHERE YOU HAVE LET'S SAY A MUTATION THAT YOU NOW HAVE -- HAS AN ABNORMAL PROTEIN PRODUCT WITH THE HIGH PEN TRANSFOR DISEASE IT IS REALLY NEVER A STRAIGHTFORWARD RISKS ESTIMATATION EXCEPT IN A FEW RARE INSTANCES WHEREAS IN MOST SITUATIONS YOU HAVE AN INTERACTION WITH OTHER GENES AND I COME IN SORT OF THE ENVIRONMENT AT LARGE. WE HAVE SEEN IT WITH HEMATOCROW MATOSIS AND WE ALSO SEE IT WITH THE CAREERS OF PEOPLE WITH VARIOUS AUTOSOMAL RECESSIVE DISEASES. WHAT IS THE MOST TROUBLING AND I GUESS WE ALL HAVE LEARNED ABOUT SORT OF OUR LETHAL VARIANCE THAT WE CARRY BETWEEN 5 AND 10 AND IT IS REALLY MUCH MORE THAN BECAUSE WE ALL HAVE GENETIC VARIANTS OF DIFFERENT KINDS LIKE OUR HLA AND OUR BLOOD GROUPS AND OUR ABILITY TO METABOLIZE DIFFERENT THINGS LIKE CARCINOGENS SO WE ARE ALL CARRIERS OF GENETIC INFORMATION AND THAT INFORMATION THAT PRODUCES DIFFERENT GENE PRODUCTS DOESN'T HAVE TO BE ABNORMAL GENE PRODUCTS BUT A VARIANT OF A GENE PRODUCT LIKE A VARIANT HLA SYSTEM. WE ARE ALL AT INCREASED RISK OF DIFFERENT DISEASES EVEN OUTSIDE OF THE SCOPE OF THE LE THAT QUIVALENTS THAT WE LEARNED FOR TRADITIONAL GENETIC DISEASES. IF WE KIND OF ACCEPT THE FACT THAT THERE IS GENETIC VARIATIONS THAT ARE IS GOING TO PUT US AS RISK FOR VARIOUS DISEASES I THINK WE CAN SOLVE THE PUZZLE A BIT MORE. WE SEEM TO ALWAYS COME AT IT FROM THE GENETIC EXCEPTIONALISM ANGLE. I'M NOT TRYING TO NEGATE OR MINIMIZE THE PAIN AND SUFFERING OF PEOPLE THAT HAVE THE LABELS OF GENETIC DISEASES BUT I'M TRYING TO ELEVATE THAT TO SUGGEST THAT WE ALL HAVE GENETICALLY DRIVEN INFORMATION THAT PUTS US AT A DIFFERENT SET OF DISEASES AND IT IS ONLY A SUB SET OF THESE DISEASES WHICH MAY BE 5% OF ALL HUMAN AILMENTS. DOESN'T MEAN THAT THE 95% OF ALL OTHER DISEASES ARE NOT GENETIC DISEASES. SO IT IS A EXPANDING THE SCOPE OF GENETICS BEYOND THE TRADITIONAL PURVIEW OF GENETIC DISEASE AND HAVING TO DEAL WITH THE ISSUE U.S. THAT WILL GET US BEYOND GENETIC DISCRIMINATION.

VERY BRIEFLY I CAN'T HELP BUT POINT OUT THAT IS A NICE CONNECTION WITH THE TOPIC THAT IS GOING TO COME UP TOMORROW AFTERNOON WHICH IS THE NEED TOSTER A PRO SPECTIVE POPULATION BASED CO-HORT STUDY THAT WOULD ENABLE YOU TO GET THE RISK AND HOW THEY REACT WITH THE ENVIRONMENT. CASE CONTROL STUDIES HAVE BEEN THE HORK WORKHORSE WITH THE STUDIES BUT NOT GIVING THE ASSESSMENT OF RICK NOR IDENTIFYING THE ENVIRONMENTAL FACTORS THAT MAY SERVE AND IMPORTANT TRIGGERS AND IF WE ARE TO GET BEYOND THE MAJOR BARRIER OF GENETIC DISCRIMINATION BYPASSING EFFECTIVE LEGISLATION AND I S'S HOPE THAT THAT WILL HAPPEN THE NEXT STEP WILL BE TO TRY TO IMPLEMENT THE INDIVIDUALIZED RISK PREDICTION AND I THINK WE NEED DATABASES THAT CONTAIN UNBIASSED INFORMATION OF THE SORT THAT ARE DIFFICULT TO COME BY FROM CASE CONTROL STUDIES BUT WHICH WOULD DERIVE NICELY FROM A LARGE-SCALE PRO SPECTIVE POPULATION BASED STUDY THAT DOES A THOROUGH JOB OF COLLECTING ENVIRONMENTAL EXPOSURE DATA.

WE DO HAVE TO MOVE ON TO THE THIRD PANEL AND NOW WE GOING TO HEAR FROM THE LAST PANEL THERE WILL BE PRESENTING MORE ADDITIONAL STAKE HOLDER PERSPECTIVES. SO WE WILL BE HEARING FROM KATHY HUDSON WHO COMES TO US FROM THE CENTER FOR GENETIC AND PUBLIC POLICY HERE IN WASHINGTON WAG. AS I MENTIONED EARLIER, IT IS HER ORGANIZATION THAT HAS HELD TOWN MEETINGS ACROSS THE COUNTRY TO DISCUSS GENETIC ISSUES. WE WILL HEAR THEN FROM JANE MASSEY LA CAT THAT AN ATTORNEY AND --LY CAT THAT. A PROFESSOR OF LAW WHO WILL HELP US UNDERSTAND SOME OF THE GAPS OF THE CURRENT LEGISLATION AND POLICY THAT WE CURRENTLY HAVE IN THE COUNTRY, FROM JOANNE ARMSTRONG, A PHYSICIAN WITH AETNA REPRESENTING AMERICA'S HEALTH INSURANCE PLANS AND WE DID INVITE THE UNITED STATES CAME BETTER OF COMMERCE -- CHAMBER OF COMMERCE TO PARTICIPATE. HOWEVER, THEY REFERRED US TO THE SOCIETY FOR HUMAN RESOURCE MANAGEMENT AND WE ARE PLEASED TO HAVE MICHAEL ATKIN, THE DIRECTOR OF GOVERNMENT AFFAIRS WITH US TODAY AND MR. ATKIN BEFORE WE BEGIN I DON'T KNOW IF YOU WERE HERE EARLYIER BUT THERE IS A QUESTION ARE YOU CONSIDERED A SPOKESPERSON FOR THE CHAICLAIM BETTER OF COMMERCE?

WE'RE NOT.

YOU'RE NOT. THANK YOU. WE BEGIN WITH KATHY LUD HUDSON.

THANK YOU NOR VINITYING ME. AMANDA ARE YOU GOING TO BE ABLE TO DO MY SLIDES FOR ME.

I'M CATHY HUDSON THE DIRECTOR OF GENETICS AND PUB LIVE POLICY CENTER WHICH IS A PART OF GOWNS HIGH JOHNS HOPKINS UNIVERSITY. OUR MISSION IS TO PROVIDE INFORMATION ABOUT GENETIC TECHNOLOGIES AND AGAINST POLICIES TO THE PUBLIC, TO THE PRESS AND TO POLYMAKECYMAKERS. OVER THE PAST TWO YEARS WE CAN CONDUCTED FAIRLY EXTENSIVE QUALITATIVE AND QUANTITATIVE RESEARCH TO UNDERSTAND WHAT THE PUBLIC TO DOES NOT KNOW ABOUT THEIR GENETIC RISKS THINKS ABOUT ADVANCES IN GENETIC TECHNOLOGIES. WE SURVEYED OVER 6,000 CITIZENS IN TWO SEPARATE SURVEYS. THE FIRST IN DECEMBER OF 2002 ABOUT 1200 AND A SECOND ONE IN PAST APRIL WITH 4800 SITED ZENS AND DONE FOCUS GROUPS 21 IF FIVE CITIES ACROSS THE COUNTRY AND THIS SUMMER COMPLETED A SERIES OF PUBLIC ENGAGEMENTS CALLED THE GENETIC TOWN HOWL HALLS -- HALLS MAKING EVERY VOICE COUNT. THE RESULTS FROM THE SURVEY IN WHICH WE ASK RESPONDENTS IF A GENETIC TEST SHOWS THAT A PERSON HAS AN INCREASED RISK FOR A GENETIC DISEASE DOES FILL IN THE BLANK HAVE THE RIGHT TO KNOW AND YOU CAN SEE THAT IN 2002, 85% OF THOSE SURVEYED SAID NO, AN EMPLOYER SHOULD NOT HAVE ACCESS AND 68% THOUGHT THAT INSURERS SHOULD NOT HAVE ACCESS TO THE INFORMATION. THE NUMBERS WENT UP IN 2004 TO 2% FOR EMPLOYER AND 80% FOR INSURER. I WOULD NOTE THAT IF YOU LOOK AT THOSE WHO HAVE A HIGHER EDUCATION LEVELS OR PRIOR AWARENESS OF GENETIC TESTING THE PERCENTAGE OF THOSE SAYING NO GOES UP EVEN HIGHER. WE ALSO CONDUCTED 21 FOCUS GROUPS ACROSS THE COUNTRY AND FOCUS GROUP PARTICIPANTS WERE PRESENTED WITH A SERIES OF SCENARIOS INVOLVING GENETIC TESTING IN THE REPRODUCTIVE CON EXT. IN THOSE FOCUS GROUPS AND THE SCENARIOS PRESENTED WE DID NOT SPECIFICALLY ASK BY GENETIC DISCRIMINATION BUT PNTS UPON S SPONTANEOUSLY RACED THIS AS A CONCERN. THEY WENT ON TO SPECULATE ABOUT THE ABILITY OF REPRODUCTIVE GENETIC TESTING AND IF INSURERS HAD THAT INFORMATION THIS PLI BE BE USED TO CO-ERS OR INFLUENCE THE REPRODUCTIVE CHASES -- CHOICES. ONE OF THE CONCERNS ABOUT SURVEY WORK IN PARTICULAR IT THAT YOU ARE ASKING PEOPLE FOR THEIR OFF THE CUFF REACTION TO A QUESTION WITHOUT HAVING A LOT OF THE TIME TO LEARN ABOUT IT, TO GHIRCHG THINK ABOUT IT AND RUMINATE ON THE POSSIBLE IMPLICATIONS AND THAT IS TRUE IF FOCUS GROUPS. WE A I DOPPED A -- ADOPTED A MODEL OF DELIBERATIVE DEMOCRACY. AND TRIED TO DEVELOP A PROGRAM TO FIND OUT WHAT AMERICANS THINK ONCE THEY HAD AN OPPORTUNITY TO LEARN A LITTLE BIT ABOUT GENETIC TECHNOLOGIES, THE ISSUES THEY RAISED AND HAVE AN OPPORTUNITY TO TALK WITH FELLOW CITIZENS ABOUT THESE ISSUES. THE NEXT SLIDE. OVER A THREE WEEK PERIOD WITH OTHER CITIZENS THROUGH THE MIRACLE OF INTERNET TECHNOLOGY. PARTICIPANTS IN BOTH THE ONLINE AND IN PERSON TOWN HALLS WERE ASKED TO CONSIDER THREE MAJOR ISSUES IN REPRODUCTIVE GENETIC TESTING. ACCEPTABLE USES. SAFETY AND ACCURACY AND THE IMPACT ON INDIVIDUAL FAMILIES AND SOCIETY. WE PROVIDED BACKGROUND INFORMATION ABOUT THE TECHNOLOGY AS WELL AS A BROAD RANGE OF VIEWS FROM EXPERTS IN MEDICINE, POLICY, BIOETHICS AND THEOLOGY. PARTICIPANTS WERE QUERIED AT PAIVARIOUS TIMES DURING THE TOWN HALLS ABOUT THEIR OPTIMISM AND CONCERN ABOUT THESE TECHNOLOGIES. TWO OF THE QUESTIONS THAT WERE POSED TO THE TOWN HALL PARTICIPANTS WERE WHAT DO YOU THINK ARE THE FACTORS THAT SHOULD BE CONSIDERED IN SETTING LIMITS FOR THE USE OF REPRODUCTIVE GENETIC TESTING AND WHAT ARE SOME OF THE POSSIBLE BENEFITS AND HARMS FOR INDIVIDUAL FAMILIES AND SOCIETIES. PARTICIPANTS WERE GIVEN AN OPPORTUNITY TO TALK WITH TABLE MATES ABOUT THESE ISSUES AND THEN CALLED OUT THE ISSUE OF MOST CONCERN TO THEM. IF A CONCERN HAD ALREADY BEEN CALLED OUT BY ANOTHER TABLE THAT TABLE WAS ASKED TO MOVE TO THE NEXT CONCERN ON THE LIST. ONCE ALLLE CONCERNS WERE EXPRESSED THEY WERE PROJECTED UP ON TO A SCREEN ANDED ENTIRE GROUP HAD AN OPPORTUNITY TO TALK ABOUT THE AND THEN WITH ELECTRONIC KEYPADS VOTE ON THOSE OF MOST CONCERN TO THEM. PUT UP THE NEXT SLIDE ZLA SHOWS THE PEOPLE ACROSS AMERICA TALKING TO ONE ANOTHER ABOUT GENETICS. THE NEXT SLIDE, PLEASE. ISSUE OF GENETIC DISCRIMINATION BASED ON GENETIC TEST RESULTS CAME UP AS AN ISSUE IN EVERY SINGLE TOWN HALL. IN FACT, IN SACRAMENTO AND NEW YORK GENETIC DISCRIMINATION RANKED A AS THE NUMBER ONE ISSUE OF CONCERN WHEN CONSIDERING POTENTIAL HARM FROM GENETIC TESTING. SEATTLE, FORT WORTH AND NATIONALVILLE IT RANKED AS THE SECOND CONCERN. SACRAMENTO, EVERY TABLE LISTED IT AS A CONCERN. AND SAID AS ONE PAR PARTICIPANT DID IN SACRAMENTO WILL YOU HAVE TROUBLE GETTING A JOB BECAUSE YOU HAVE THIS GENE THAT MAY CAUSE CANCER WHETHER OR NOT YOU HAVE CANCER? LIKE THE FOCUS GROUP PARTICIPANTS THE TOWN HALL PARTICIPANTS FEARED THAT INSURANCE COVERAGE WOULD BE A FACTOR IN GUIDING REPRODUCTIVE CHOICES. AND THE NEXT SLIDE. SO? CONCLUSION OUR RESEARCH SHOWS THAT AN OVERWHELMING MAJORITY OF AMERICANS DO NOT WANT INSURERS OR EMPLOYERS TO HAVE ACCESS TO GENETIC TEST RESULTS AND THERE IS WIDESPREAD CONCERN. FIRST AND MOTHER MOST FOREMOST ON AVERAGE AMERICANS MINDS. THE HIGH LEVEL OF -- FIRST AND MOTHER POST. WHAT WE DOLL WHEN NOT IF WE ENACT LEGISLATIVE PROTECTIONs AND WE HAVE TO PUT FOCUS ON MAKING SURE THAT WE GET PUBLIC INFORMATION OUT TO BOTH PROVIDERS AND PATIENTS TO LET THEM KNOW WHAT THEIR RIGHTS ARE SO THAT THEY DON'T LET CONCERNS ABOUT NEWLY UNLAWFUL PRACTICES INFLUENCE THEIR GENETIC TESTING DECISION MAKING. THANK YOU.

THANK YOU, MS. HUDSON. NEXT WE WILL HEAR FROM JANE MASSEY LICATA. AGAIN, THANK YOU VERY MUCH FOR INVITING ME HERE TO TESTIFY TODAY. I HAVE COME AT THIS ISSUE OVER THE PAST DECADE FROM A NUMBER OF DIFFERENT PERSPECTIVES. I'M A BIOTECHNOLOGY PATENT AND FDA LAWYER AND I ALSO TEACH AT RESULT GEARS SCHOOL OF FLAW CAMDEN BOTH PATENT AND FDA LAW. I WAS TRAINED AS A SCIENTIST WITH A BACKGROUND IN BIOLOGY AND BIOCREME I BIOCHEMISTRY AND HOLD A DOCTORIATE A THAT I RECEIVED IN 19D 78. THAT WAS BACK WHEN WE DIDN'T KNOW THAT MUCH ABOUT GENES. OVER THE PAST TWO DECADES I HAVE BEEN BLESSED TO LEARN FROM MOLECULAR BIOLOGY AND GENETICS FROM SOME OF THE GREATEST MINDS AND SCIENTISTS IN THE WORLD. MY INTEREST IS AUK DEM PRESIDEN ACADEMIC ANDPRACTICAL. I SERVED ON ANDED A ADVISED INSTITUTIONAL. I HAVE FILE ODE VER 2,000 PATENT APPLICATIONS CONCERNING BIOTECHNOLOGY IN VEPTIONS MOST INVOLVING THE USE OF GENETIC INFORMATION TO DEVELOP NEW DIAGNOSTICS AND THERAPEUTICS AND NEGOTIATED HUNDREDS OF RESEARCH AGREEMENTS CONCERNING GENETIC RESEARCH AND WORKED IN THE NONPROFIT AND PRIVATE SECTOR. I COME AT THIS FROM A PRACTICAL SENSE IS THAT ONE MESSAGE I HAVE TAKEN FROM ALL OF MY CONSTITUENTS IS THAT THERE IS NEED FOR CERTAINTY IN THE MARK PLACE AND IN THE ACADEMIC RESEARCH COMMUNITY AS TO HOW WE GOING TO DEAL WITH BOTH THE ETHICS AND THE DISSEM NATION OF THIS INFORMATION. NOW, I HAVE BEEN VERY, VERY FORTUNATE, I GUESS, IS THAT I HAVE BEEN ASKED TISE TWICE TO TESTIFY BEFORE CONGRESSAL COMMITS ON THE LEGISLATION. I STARTED WORKING ON THIS ISSUE AS AN ACADEMIC IN THE EARLY 0s AND THE FIRST TEAM I TESTIFIED BEFORE A CONGRESSIONAL COMMITTEE WAS IN SEPTEMBER OF 2001 AND AT THAT TIME IT WAS QUITE A BIT OF HOPE THAT THE LEGISLATION WAS GOING TO BE PASSED. I RECENTLY TESTIFIED BEN GF A CONGRESSIONAL -- AGAIN BEFORE A CONGRESSIONAL COMMITTEE IN AN EFFORT TO TRY TO ENCOURAGE THE HOUSE TO FOLLOW SUIT ON THE COMPROMISED BILL PASSED BY THE SENATE. AND THERE HAS BEEN A LOT OF PROGRESS AND DEFINITION IN THE ISSUES THAT ARE PENDING AND ARE BEING CONSIDERED BY CONGRESS. THERE IS THREE SPECIFIC ISSUES AFTER LISTENING TO THE TESTIMONY TODAY THAT I WOULD LIKE TO ADDRESS BECAUSE IN EACH OF THE CASES WHERE I TESTIFIED BEFORE CONGRESS AS AN OBJECTIVE BASICALLY FRIEND OF CONGRESS WITH A TECHNICAL AND LEGAL BACKGROUND A GENTLEMAN FROM THE CHAMBER OF COMMERCE WAS SITTING ON MY LEFT AND I THINK THERE ARE THREE ISSUES THAT HAVE BEEN RAISED THAT I THINK THAT ARE IMPORTANT TO ADDRESS. THE FIRST IS THERE SEEMS TO BE A MISPERCEPTION IN SOME PARTS, NOT ON THE PART OF CONGRESS IN GENERAL OR THE COUNSEL TO THE CONGRESS BECAUSE THESE PEOPLE ARE INCREDIBLY KNOWLEDGEABLE AND HAVE IN FACT ANALYZED REALLY WHERE WE STAND WITH RESPECT TO ALL OF THE FEDERAL LAWS AND GENETIC NONDISCRIMINATION. BASICALLY THERE IS VERY LITTLE FEDERAL PROTECTION FOR GENETIC INFORMATION. WE HAVE HEARD DISCUSSION TODAY ABOUT HIPAA, THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT THAT WAS PASSED IN 1996 HIPAA DOES GOOD AND IMPORTANT THINGS. IT DOES PROHIBIT GROUP PLANS FROM USING HEALTH STATUS FACTORS INCLUDING GENETIC AS A BASIS FOR DENYING OR LIMITING ELLIDGE INTERFOR COVER COVERAGE OR CHARGING MORE FOR COVERAGE. IN THE GROUP HEALTH SETTING, NOT ALL ARE SO EXPLAINED BY SOME OF THE OTHER PANELISTS BUT IN SOME SITUATIONS IT IS HELPFUL. IT DOES LIMIT EX-CLUE OBJECTIONS FROM GROUP PLANS FOR PREEXISTING CONDITIONS FOR 12 MONTHS AND PROHIBIT EX-CLUE OBJECTIONS FOR PEOPLE PREVIOUSLY COVERED FOR A CONDITION FOR 12 MONTHS AND MORE AND SPECIFICALLY STATES THAT GENETIC INFORMATION IN THE ABSENCE OF A CURRENT DIAGNOSE DOES NOT CONSTITUTE A PREEXISTING EXISTING CONDITION SO A GOOD FIRST STEP. BUT HIPAA DOES NOT PREVENT INSURERS FROM COLLECTING GENETIC INFORMATION OR LIMIT THE DISCLOSURE OF GENETIC INFORMATION. IT DOES NOT PREVENT INSURERS FROM REQUIRING AM CAN'TS APPROXIMATE CAN'TS TO UNDERGO TESTING AND DOESN'T APPLY TO THE INDIVIDUAL MARKET OR MANY GROUP PLANS EXEMPT. ANOTHER FEDERAL LAW IS THE AMERICAN WITH DISABILITIES ACT. THE ADA. THE ADA DOES PROTECT INDIVIDUALS WITH SYMPTOMATIC GENETIC DISABILITIES. IT DOES ALLOW AN EMPLOYER TO OBTAIN EXTENSIVE MEDICAL INFORMATION ABOUT A PERSON THAT IS UNDERA CONDITIONAL OFFER OF EMPLOYMENT INCLUDING OBTAINING AND STORING GENETIC SAMPLES, REQUIRING GENETIC SCREENING AS A CONDITION OF EMPLOYMENT, TO PURCHASE AGAINST INFORMATION A BANK AND ONCE EMPLOYED THE IMPLOWEIMEMPLOYER CAN THE REQUEST JOB RELATED INFORMATION THAT. SO THIS THR IS A POSITIVE AND NEGATIVE HERE IN WHAT ACY LOUED UNDER THE ADA. THE ADA DOES NOT EXPLICITLY ADDRESS GENETIC INFORMATION OR DEAL WITH UNAFFECTED CARRIERS OF A DISEASE WHO MAY NEVER GET THE DISEASE THEMSELVES. INDIVIDUALS WITH LATE ONSET GENETIC DISORDERS WHO MAY BE IDENTIFIED THROUGH GENETIC TESTING AS BEING AT RISK OF DEVELOPING A DISEASE OR OTHERS IDENTIFIED THROUGH FAMILY HISTORY AS BEING AT HIGH RISK FOR DEVELOPING THE DISEASE. THOSE PEOPLE JUST AREN'T COVERED. IT DOES NOT PROTECT WORKERS FROM REQUIREMENTS FOR REQUESTS TO PROVIDE PROVIDE GENETIC INFORMATION TO THEIR EMPLOYERS. ANOTHER FEDERAL LAW THAT HAS BEEN MENTIONED IS TITLE 7 OF THE CIVIL RIGHTS ACT. NOW, THIS IS THE STUFF THAT LAW PROFESSORS LOVE. IT O DOES PROVIDE A BASIS FOR AN ARGUMENT THAT GENETIC DISCRIMINATION BASE THE ON RACIALLY OR ETHNICALLY LINKED GENETIC DISEASES CONSTITUTES UNLAWFUL RACE OR ETHNICITY DISCRIMINATION BUT IT IS AN ARE R ARGUMENT AND THERE IS NOT OF LOT OF CASES WHERE THERE WILL BE THAT LINK, POSSIBLE TO ESTABLISH THAT THAT LINK HAS A DIRECT RELATIONSHIP TO RACE OR ETHNICITY. SO ALTHOUGH IT IS A -- YOU KNOW, IT IS THE STUFF THAT WE LIKE TO TALK ABOUT IN LAW SCHOOL AT A PRACTICAL LEVEL I DON'T THINK IT IS SOMETHING THAT THE AMERICAN PEOPLE CAN RELY ON TO PROTECT THEM. NOW, ANOTHER ISSUE THAT I HAVE HEARD MENTIONED FROM THE BUSINESS COMMUNITY IS A CONCERN THAT IF WE DO PASS THIS LEGISLATION AND WE DO HAVE FEDERAL LAW AND CREATE A NEW RIGHT OF ACTION THAT THIS IS GOING TO CREATE ALL OF THIS NEW LITIGATION AND THIS IS GOING TO BE A HUGE PROBLEM FOR EMPLOYERS AND HEALTH INSURANCE COMPANIES. HUGE COST TO THE COMMUNITY. AND I RESPECTFULLY DISAGREE WITH THAT FOR A COUPLE DIFFERENT REASONS. ONE IS THERE HAS BEEN AN EVOLUTION. WHEN I FIRST STARTED WORKING WORKING WITH THIS LEGISLATION THERE WAS A PRIVATE RIGHT OF ACTION IN THERE FOR THE INDIVIDUAL WHO FELT THAT THEY HAD EXPERIENCED GENETIC DISCRIMINATION BUT EVEN THEN ALL THAT THEY WERE GOING TO GET WAS SOME REASONABLE WORD -- ATTORNEYS FEES AND INCLUDING COSTS OF EXPERT WITNESSES IN CASES IN WHICH A PLANNED SPONSOR, HEALTH INSURER OR ANY THIRD-PARTY ACT ON BEHALF OF THE PLANNER OR INSURER VIOLATED THE LAW AND THE CIVIL PENALTIES WOULD NOT EXCEED $50,000 NOR A FIRST VIOLATION OR $100,000 FOR ANY SUBSEQUENT VIOLATION. SO IT WAS ALWAYS FAIRLY LIMITED RIGHT OF ACTION AND TO BE FAIR, I MEAN I THINK IT HAS BEEN POINTED OUT BY THE PANELISTS SOMETHING HA IS NOT LIKELY TO HAPPEN. FOLKS AREN'T REALLY SO CONCERNED ABOUT BRINGING A PRIVATE RIGHT OF AXE. IT IS A HUGE -- OF ACTION. IT IS A HUGE EMOTIONAL AND PROFESSIONAL IN INVESTMENT. THEY ARE CONCERNED ABOUT KEEPING THE HEALTH INSURANCE AND KEEPING THEIR JOB. THE SENATE COMPROMISE LISTENED TO THE CONCERNS OF BUSINESS AND BASICALLY ESTABLISHED ENFORCEMENT FOR VIOLATIONS OF THE PROVISIONS BUT IN A WAY THAT BUSINESS CAN DEAL WITH BECAUSE WHAT THEY SAID IS THIS IS WHAT IT IS GOING TO COST YOU FOR NOT COMPLYING. THIS IS MA WHAT IT WILL COST YOU IF YOU DON'T RESPECT THIS RIGHT AND PUT IT INTO A WAY TO BUILD IT INTO THE WAY THAT YOU DO BUSINESS LIKE LOTS OF OTHER THINGS THAT YOU DO ON A DAY TO DAY BASIS. THE PENALTIES ARE $100 PER DAY FOR EACH DAY THE GROUP HEALTH PLAN IS S. IN VIOLATION. PAYABLE TO THE PARTICIPANT OR BENEFICIARY WITH A MINIMUM FINE OF $2,500 OR MAXIMUM OF $15,000 AND EVEN IF YOU GO THE WHOLE WAY AND THERE IS BOUND TO BE A WILL -- THERE IS FOUND TO BE A WILLFUL VIOLATION YOU ARE TALKING A CAP OF HALF A MILLION TOLL LARES. . THE BUSINESSES THAT I DEAL WITH. THEY WANT TO KNOW WHAT AM I SUPPOSED TO DO TO COMPLY. THIS IS WHAT THE HEALTH SYSTEM ASKED. EVERYBODY FIGURED OUT HOW TO DEAL WITH HIPAA AND FIGURED OUT TO DO IT IN A COST RERETEXTIVE -- EFFECTIVE RESPECTFUL WAY BECAUSE THEY WERE TOLD WE HAVE TO DO IT. I CAN'T SEE WHEN YOU WORK OUT THE ECONOMICS, PARTICULARLY WHEN THE PENALTIES ARE ENCOURAGING COMPLIANCE BUT NOT OUTRAGEOUS THERE IS NOT IN HUGE SECT SPECTER OF RISK AND COST IT IS NOT TRUE AND NOT IN THE COMPROMISE BILL AND IT IS A RESPECTFUL WAY TO TRY TO BALANCE THE CONCERNS. ONE THING THAT THE COMPROMISE BILL DOES THAT IS AWESOME FOR THE INDIVIDUAL IS IT ALLOWS THEM TO KEEP THE HEALTH INSURANCE WHILE THIS IS GETTING WORKED OUT AND THAT IS THE BIG ISSUE THAT THESE PEOPLE WERE CONCERNED ABOUT IS THAT THEY DON'T WANT TO LOSE THEIR HEALTH INSURANCE. SO THAT WHILE THIS PROCESS IS GOING ON THEY ARE SITTING IN A GAP NOT WONDERING WHAT IS GOING TO HAPPEN TO ME OR MY FAMILY. WHAT HAS BEEN BUILT INTO THE COMPROMISE LEGISLATION IS AN ASSURANCE TO THE INDIVIDUAL THAT THEY WILL BE ABLE TO HAVE THEIR INSURANCE PROTECTED WHILE THIS ISSUE IS BEING EVALUATED. AND I THINK THAT THAT IS ALSO VERY GOOD FOR ALL PARTIES. A FAIRLY MINIMAL COST TO THE BUSINESS COMMUNITY AND IT IS A HUGE BENEFIT TO THE WORKER. NOW, ANOTHER ISSUE THAT I HAVE HEARD AS AN OBJECTION TO THE LEGISLATION IS WE DON'T NEED IT BECAUSE THE STATES ALL PASSED THESE LAWS ANYWAY. SO LET'S JUST LEAVE IT TO THE STATES. NOW, I HAVE GREAT RESPECT FOR HOME RULE, I'M FROM THE STATE OF NEW JERSEY AND WE'RE LIKE REALLY BIG ON THAT THERE AND SO FAR 41 STATES HAVE ENACTED LEGISLATION RELATED TO GENETIC DISCRIMINATION IN HEALTH INSURANCE AND 3 IS STATES 31 STATES ADOPTED LAWS REGARDING GENETIC DISCRIMINATION IN THE WORKPLACE. THE STATES HAVE BEEN ACTIVE AND CREATIVE BUT IT IS A PATCHWORK. PATCHWORK OF LAWS. FOR EXAMPLE IN THE STATE OF FLORIDA IT DOESN'T CONCERN HEALTH INSURANCE AT ALL. THE LAW THAT WAS PASSED IN 1978 PROHIBITS ANY PERSON FIRM CORPORATION UNINCORPORATED ASSOCIATION, STATE AGENCY, UNIT OF LOCAL GOVERNMENT OR ANY PUBLIC OR PRIVATE ENTITY FROM DENYING OR REFUSING EMPLOYMENT TO ANY PERSON OR DISCHARGE ANY PERSON FROM EMPLOYMENT BASE ON SICKLE CELL. THAT IS THE LAW IN FLORIDA. FLORIDA WAS ONE OF THARILIEST ONES TO ACT BUT THAT IS THE ONLY COVERAGE THERE IS IN THE STATE OF FLORIDA FOR GENETIC DISCRIMINATION UNDER STATE LAW. IN NEW JERSEY WE ACTUALLY ENACTED IN 1981 AND THEN BROUGHT IN THE LAW IN 1996 AND WE ACTUALLY HAVE ONE OF THE TOUGHEST GENETIC PRAOIRVEC PRIVACY STATUTES IN THE NATION. UNDER MY STATE BASICALLY SAYS IT COVERS SPACE SITUATIONS OF HEALTH INSURANCE, LIFE INSURANCE, AND EMPLOY MEANT. SO IT KO FRS ALL OFFISH SHIES WHICH IS -- ALL OF THE ISSUES WHICH IS NOT THE CASE, A VERY RARE THING TO HAVE ALL OF THOSE COVERED AND BASICALLY THE PROBLEM IS IS THAT THESE ISSUES AS WE TALKED ABOUT CROSS STATE BOUNDARIES AND AFFECT ALL OF OUR CITIZENS SO IF YOU ARE LUCKY ENOUGH TO LIVE IN NEW JERSEY AND YOU HAVE A PROBLEM IN NEW JERSEY YOU HAVE A LAW THAT IS GOING TO SAY THAT GENETIC INFORMATION IS PERSONAL INFORMATION THAT SHOULD NOT BE COLLECTED, RETAINED OR DISCLOSED WITHOUT THE INDIVIDUAL'S AUTHORIZATION. THE ACT PROHIBITS DISCRIMINATION BY EMPLOYERS AGAINST EMPLOYEES CARRYING GENETIC MARKERS OF DISEASES OR BEHAVIORIAL TRAITS AND UNLAWFUL TO REFUSE TO HIRE OR EMPLOY OR DISCHARGE OR REQUIRE TO RETIRE AN EMPLOYEE BECAUSE OF THE EMPLOYEE GENETIC INFORMATION OR BLOOD TRAIT OR BECAUSE THE EMPLOYEE ERENEWSED TO SUBMIT TO A GENS TET OR MAKE AVALABLE A GENETIC TEST TO AN EMPLOYER. IT BANS THE USE OF GENETIC INFORMATION TO ESTABLISH THE AMOUNT OF INSURANCE PREMIUMS, POMCPOLYFEES OR RATES CHARGED FOR HEALTH INSURANCE COURTS WHETHER AN INDIVIDUAL OR GROUP PLAN. THE PENNALCIESTIES IN THE ACT INCLUDE FINES AND PATRIOTS SON TERMS. DAMAGES INCLUDING ECONOMIC, BODILY OR EMOTIONAL HARM PROXIMATELY CAUSED MAY ALSO BE RECOVER.

YOU HAVE ONE MINUTE.

UNDER NEW JERSEY YOU HAVE A VERY STRONG LAW. NOW, NO CASE HAS EVER BEEN BROUGHT UNDER THIS LAW. BUT PEOPLE DOING BUSINESS IN NEW JERSEY UNDERSTAND WHAT THE RULES ARE. AND WHAT THEY HAVE DONE IT THEY HAVE BUILT IN THEIR WAY OF DOING BUSINESS, THEIR WAY OF MAKING INSURANCE DESIXX, THE WAY OF MAKE -- DECISIONS, THE WAY OF MAKING WORK PLACE DECISIONS CONSISTENT WITH THE LAW BECAUSE THEY KNOW WHAT THE RULES ARE. WHAT IMI'M SUGGESTING WE NEED PREDICTABILITY AND PEOPLE NEED TO UNDERSTAND WHERE THEY STAND AND IF WE HAVE HAD LEAST AER THIATHRESHOLD LEVEL IN IN THIS COUNTRY I THINK IT WOULD BE HELPFUL TO ALL YOUR CITIZENS.

THANK YOU VERY MUCH. NEXT WE ARE GOING TO HEAR FROM JOANNE ARMSTRONG.

THANK YOU FOR INVITING ME. I'M JOANNE ARMSTRONG, A SENIOR MEDICAL TREK DIRECTOR FOR ATE THAT TESTIFY ONLY BEHALF OF THE HEALTH INSURANCE PLANS. AMERICA'S HEALTH INSURANCE PLANS IS A TRADE ASSOCIATION REPRESENTING THE PRIVATE SECTOR IN HEALTHCARE. THEY PROVIDE SERVICES FOR OVER 200 MILLION AMERICANS. ET IN SERVES APPROXIMATELY 14 MILLION HEALTHCARE WORKERS THROUGH NATIONAL NETWORK. INCLUDING OVER 300,000 PRY PERI-CARE PHYSICIANS AND SPECIALIST PHYSICIANS OVER 3,000 HOSPITALS IN THE NATIONAL NETWORK. GENETIC MEDICINE IS NOT NEW. DNA AND NONDNA BASED GENETIC TESTING HAS BEEN IN WIDE CLINICAL USE FOR MANY TECH DECADES. CARE YO TYPE KARYOTYPE AND EARS. A PROMISING NEW AREA FTC GENETICS UTILIZES GENETIC TEST RESULTS TO GUIDE THE CHOICE OR DUROROR DURATION OF PHARMA CO-THERAPIES WHILE AVOIDING SIDE EFFECTS AND COSTS IN OTHERS. SCAM THE. S ARE FUNNED IN BREAST CANCER AND COLON CANCER TREATMENT IN TEMPERATURES OF DURATION OF TARP WE KNOTHERAPY WE KNOW THAT PHARMACOGENETICS ARE APPLIED IN. THE SPEED OF THESE NEW DISCOVERIES IS CHALLENGING OUR HEALTHCARE SYSTEMS ABILITY TO EFFECT LIVELY INTEGRATE THEM INTO CLINICAL PRACTICE AND OPTIMIZE THE BENEFITS TO PREVENT AND CURE DISEASE. BECAUSE BOS OF THE COMPLEXITY OF GENETIC INFORMATION THE OPTIMAL USE OF GENETIC TECHNOLOGY REQUIRES INFORMED PROVIDERS, INFORMED MEMBERS AND COORDINATION OF SERVICES ACROSS THE COMPLEX ARRAY OF DELIVERY SISYSTEMS AND UNFORTUNATELY I THINK WE KNOW THAT MUCH WORK NEEDS TO BE DONE IN ALL OF THESE AREAS TO GET IT RIGHT. WE KNOW THAT 7 # 2% OF PHYSICIANS ARE NOT COMPLETELY PREPARED. 72% OF NONGENETICS PHYSICIANS RATE THEIR KNOWLEDGE OF GNZ AS FAIR TO POOR AND WE HEARD SOME TESTIMONY ABOUT THAT. PATIENTS ARE ALSO NOT ADEQUATELY PREPARED TO NAV GAIT THESE WATERS. FULLY 82% OF CONSUMERS CANNOT ANSWER MOST GENETIC MEDICINE KNOWLEDGE QUESTIONS IN NATIONAL SURVEYS. SO AS WITH THE ADOPTION OF OTHER MEDICAL SERVICES AND TECHNOLOGIES HEALTH PLANS ARE AND WILL CONTINUE TO BE IN TRUMENT IN THE PROCESS OF THE CARE. THE PROCESS OF AGAINST HAS STARTED. HEALTH PLANS HAVE DEMONSTRATED SUCCESS IN PROVING PATIENT COMPLIANCE IN A NUMBER OF PHARMA CO-GENETIC AREAS INCLUDING HEPATITIS C MANAGEMENT. AS A SCIENCE OF GENETIC ADVANCES CONCERNS OVER PROTECTING INFORMATION FROM INAPPROPRIATE USES ESCALATED. THERE IS GROWING HEALTH BENEFITS AND CONCERNS ABOUT THE -- THERE IS CONCERNS ABOUT THE POTENTIAL MISS USE OF THE INFORMATION. WE MUST ENGAGE IN RESPONSIBLE POLICY MAKING ON THE ISSUES AND NOT UNNECESSARILY RESTRICT THE USE OF GENETIC INFORMATION NEED TODAY PROMOTE APPROPRIATE HEALTHCARE DECISION MAKING AND ASSIST IN THE COORDINATION OF THIS CARE WHICH IS ALREADY QUITE FRACTURED. I WOULD LIKE TO ADDRESS THE REAR MARKS LARGELY TO THE CURRENT USE OF GENETIC INFORMATION BY HEALTH INSURANCE PLANS TO GIVING THE IMAGINE AN ANSTANDING OF HOW IT IS USE TODAY AND BRIEFLY ADDRESS SOME OF THE ISSUES REGARDING THE LAW TO FS PROTECT THE INFORMATION. THE FIRST QUESTION IS HOW DO HEALTH PLANS CURRENTLY USE GENETIC INFORMATION. GENETIC INFORMATION IS ONE OF MANY TIME TYPES OF MEDICAL INFORMATION USED IN PLANS OF ACTIVITIES INCLUDING THE RISK ASSESSMENT FOR MEMBERS, PREVENTIVE SCREENING EFFORTS, DISEASE MANAGEMENTION QUALITY ASHORE RANS MANAGEMENT PROGRAMS AND THE LAG EPIUMBRELLA OF THE COORDINATION OF THE CARES ACROSS THE COMPLEX ARRAY OF DELIVERY SYSTEMS. A KEY COMPONENT IS TO MAKE SURE THAT PATIENTS AND HEALTHCARE PROVIDERS HAVE THE INFORMATION THEY NEED TO MAKE INFORMED DECISIONS AND THEY ARE FA FACILITATING THE EXCHANGES OF INFORMATION IN GENETIC TO ENCOURAGE THE APPROPRIATE TESTING AND DECISION MAKE THACK FOLLOWS THAT. HEALTH PLANS HAD AN ACTIVE ROLE IN PROMOTING GENETIC COUNSELLING IN THE REPRODUCTIVE HEALTH ARENA TO ASSURE THE HIGHEST QUALITY COUNSELLING IS PROVIDED TO MEMBERS MEMBERS TO MAKE THE BEST DECISION TO THEMSELVES. THE AMOUNT OF ACTIONABLE AND HIGHER QUALITY INFORMATION THAT KO PLS OUT OF IT IS MUCH HIGHER WHETHAN THAT DELIVER THE BY BINONGENETICS TRAINED PHYSICIANS. AS AN EARLY ADOPTER OF COVERAGE FOR BRCA CERUS BRICK SUSCEPTIBLITY TESTING ATE THAT ENSURED THAT AT RISK INDIVIDUALS RECEIVE ADEQUATE INFORMATION TO SUPPORT SUBSEQUENT DECISION MAKING. HEALTH PLANS USE GENETIC INFORMATION TO HELP ENHANCE PREVENTIVE SCREENING AND HEALTH PRO MOTION EF FORS FOR INDIVIDUALS WHO HAVE A DISEASE. GENETIC DATA IS USED BY PLANS TO CREATE DEVIATIONS IN STANDARD COVERAGE BENEFIT PACK ANDS TO ENHANCE THE TYPES OF SERVICES THAT MEMBERS GET COMPARED TO WHAT IS AVAILABLE FOR THE GENERAL POPULATION. FOR EXAMPLE SCREENING TESTS AVAILABLE FOR HEREDITARY NONPOLYPOE SIS COLON CANCER FOR AFFECTED INDIVIDUALS THEY REQUIRE EARLIER AND INCREASED FREQUENCY OF SCREENING. ACCESS TO THE GENETIC INFORMATION ALLOWS HEALTH PLANS TO CREATE DEVIATIONS TO PROVIDE THE SERVICES TO THE MEMBERS. THIS IS ANED A.ED VALUE. FOR PATIENTS BRCA POSITIVE THE WOMEN NEED INCREASED YOU KNOW MORE FREQUENT SCREENING AT AN EARLIER TIME AND THROUGH DIFFERENT TECHNOLOGIES THAN RECOMMENDED BY THE POPULATION AT LARGE AND IN ORDER TO ADMINISTER THE BENEFIT FOSS MAKE IF HAPPEN AND DELIVER ACROSS THE COMPLETION SYSTEM THIS TYPE OF DATA SHARING TAKES PLACE AND ALREADY DISCUSSED IN THIS MEETING GENETIC DATE IT IS MULTIGENERATIONAL AND IN SOME INSTANCES REQUIRES NEW TESTING PARADIGMS FROM A HEALTH PLAN PERSPECTIVE TO ASSESS RISK AND DELIVER THE MOST APPROPRIATE SERVICES TO PATIENTS IN THE BEST POSSIBLE WAY. THE MOST EFFICIENT BRCA SCREENING IS A NARE IS IS A IS A NARE SCENARIO MAY MOVE THE TESTING OF A FAMILY MEMBER MO IS NOT A COVERED FAMILY MEMBER. ETNA COVERS TO THE PLAN IF. TO ADMINISTER THESE TYPES OF BENEFITS DATA SHARING IS NECESSARY. AND THEN ON A VERY PRACTICAL LEVEL PHYSICIANS AND MEMBERS CALL HEALTH PLANS ON A DAILY BASIS, HUNDREDS OF TIMES A DAY WITH SPECIFIC QUESTIONS ABOUT WHERE DID I GET THIS GENETIC TEST DONE AND WHAT IS MY CONTRACT AT LAB, HOW DO I COSHED NATE THE SERVICES SO THESE ARE BASIC OPERATIONAL ISSUES WHERE GENETIC INFORMATION IS SHARED ON A DAILY BASIS. I SHUTED ALSO ADD THAT WHEN CLAIMS ARE SUBMIED THE CLAIMS COME IN WITH SPECIFIC GENETIC MARKERS ON THEM AND THAT IS THE NECESSARY PART OF GETTING THE SERVICES PAID FOR ACROSS AGAIN A VERY COMPLEX HEALTHCARE SYSTEM AND FINALLY AS SCIENTISTS ACQUIRE A GREATER UNDERSTANDING OF THE ROLE DEANS PLAY IN ALL DISEASE STATES ESPECIALLY CHRONIC DISEASES GENETIC INFORMATION WILL BE IN CORPORATE INSIDE DISEASE MANAGEMENT AND PHARMACY MANAGEMENT PROGRAMS AND SPEAKS TO THE COMMENT MADE EARLIER THAT GENETIC INFORMATION WILL BE PART OF STANDARD MEDICAL PRACTICE AS WE UNDERSTAND THE CONSIDERATIONS TO CRONER HYPE -CHRONIC HYPER TENSIVE AND OTHER DISEASE STATES. THAT TAKE PLACE WITHIN THE HEALTH PLANS TODAY AND DATA SHARING WILL BE IMPORTANT TO THIS SUCCESS OF THESE EFFORTS. LASTLY, I WOULD LIKE TO JUST BRIEFLY TURN AND DISCUSS SOME OF THE ISSUES RELATED TO THE INAPPROPRIATE USE OF GENETIC INFORMATION. AHIP BELIEVES THAT THE IMPORTANCE TO PROTECTING GENETIC INFORMATION FROM ILLEGAL AND INAPPROPRIATE USE IS CRITICAL. ONE OF THE UNFORTUNATE MYTHS ABOUT GENETIC INFORMATION IS THAT HEALTH PLANS USE THE INFORMATION TO DENY INSURANCE AT A GLOBAL LEVEL OR TO DISCLOSE GENETIC INFORMATION INAPPROPRIATELY. IN FACT, HEALTH PLAN HAVE MANY YEARS DECADES OF EXPERIENCE IN SHARING AND USING GENETIC INFORMATION FOR GEMS MEMBER MEMBERS WITH LITTLE EMPIRICAL EFDZ THAT IS BEING MISUSED. AS MATTER OF PACK TIGS HEALTH INSURANCE PLANS DO NOT USE TORE DISCLOSE PERSONAL HEALTH INFORMATION FOR PURPOSES OUTSIDE THEIR COVERAGE ACTIVITY AND FEDERAL AND STATE LAWS IN PLACE DO PROVIDE SOME PROTECTION. AS EARLY AS 2002 AETNA RE COG NIELZED THE HEIGHTENED SENSITIVITY OF GENETIC INFORMATION ABINCORPORATED INTO THE EVERDAY USE WITHIN OUR PLAN. PROTECTING THE CON CONFIDENTIALALITY OF ALL HEALTH INFORMATION IS CRITICAL TO PRESERVING THE OPEN AND HONEST COMMUNICATION BETWEEN PHYSICIANSION CLINICS AND AND PATIENTS AND WE BELIEVE THAT CONSUMERS SHOULD BE ABLE TO BENEFIT FROM COORDINATED INTEGRATED HEALTH DELIVERY SYSTEMS. IN CON CONCLUSION AHIP AND ITS MEMBER COMPANIES BELIEVE THAT GENETIC INFORMATION CAN HELP PROVIDERS AND IF EXPECTATIONS MAKE IMPORTANT DETICKSES AND HEALTH INSURANCE PLANS HAVE A ROLE TO PLAY BY ENCOURAGING EVIDENCE BASED COUNSELING AND TESTING AND SUPPORTING CONSUMER ED CATH'S AND PATIENT AWARENESS AND USING GENETIC TEST RESULTS TO ENHANCE PREVENTATIVE CREEN NG AND DISEASE MANAGEMENT AND HEALTH INSURANCE COMPANIES DEM MON DEMONSTRATED RESPONSIBLE USE AND MANAGEMENT OF THE INSURED GENETIC DATA. HEALTH INSURANCE PLANS STRONGLY SUPPORT PROTECTING ALL PATIENT IDENTIFIABLE HEALTH INFORMATION INCLUDING GENETIC INFORMATION FROM UNAUTHORIZED DISCLOSURES AND OTHER ILLEGAL USES AND AS THE SERVICES OF THE SCIENCE O GENETICS ADVANCE WE ARE COMMITTED TO FA TIL TATEING ACCESS TO GENETIC SERVICES AND THE GUARDING AGAINST MISSEUSS USE OF THE DATA. THANK YOU.

THANK YOU, DOCTOR ARM RONG. THE LAST PRESENTER IS MR. MICHAEL ATKIN.

GOOD AFTERNOON. MY NAME IS MIKE ATKIN. I'M THE DIRECTOR OF GOVERNMENTAL AFFAIRS FOR THE SOCIETY FOR HUMAN RESOURCE MANAGEMENT AND I APPRECIATE THE OPPORTUNITY TO PROVIDE COMMENTARY TO THE COMMITTEE REGARDING GENETIC DISCRIMINATION IN THE EMPLOYMENT CONTEXT. I APPEAR TODAY ON BEHALF OF SHRM. 'S LARGEST ASSOCIATION DEVOTED TO RESOURCE MANAGEMENT. WE REPRESENT MORE THAN 190,000 INDIVIDUAL MEMBERS AND OUR MISSION IS TO SERVE THE NEEDS OF THE HR PROFESSION PROVIDING THE MOST ESSENTIAL AND COMPREHENSIVE RESOURCES AVAILABLE. SHRM BELIEVES THAT AN EMPLOYMENT DECISION SHOULD BE BASED ON AN INDIVIDUAL'S CALL FICATIONs AND ABILITY TO PERFORM A JOB. THEREFORE SHRM STRONGLY OPPOSES EMPLOYMENT DISCRIMINATION ON THE BASIS OF AN INDIVIDUAL'S GENETIC INFORMATION. THE SOCIETY ALSO BELIEVES, HOWEVER, THAT ANY LEGISLATE EASTBOUND REMEDY PRO RECOMMENDIVE REMEDY PROPOSED MUST BE CAREFULLY NOT NONOT TO BE OVERLY BROAD. IN MY COMMENTARY TODAY I WILL TRY AND DISCUSS THE INTERPLAY NATIONAL PROPOSED LEGISLATION THAT HAS BEEN ADVANCED PREVIOUSLY MAY HAVE ON CURRENT FEDERAL AND STATE LAWS AS WELL AS EXISTING NONDISCRIM THAT TORRE EMPLOYER TRACK PRACTICES. DESPITE THE FACT THAT THERE HASN'T BEEN STRONG EVIDENCE TO SUGGEST WIDESPREAD USE OF GENETIC INFORMATION BY EMPLOYERS THERE IS INTEREST IN ENACTING LEGISLATION THAT WOULD CODIFY CURRENT PRO TEXASES AS WELL -- PROTECTIONS AS WELL AS FILL THE GAPS UNADDRESSED BY DRENCURRENT LAW. UNDER THE CURRENT FEDERAL FRAMEWORK THERE ARE FEW STATUES THAT CAN POE POTENTIALLY PROVIDE PROTECTIOPROTECTION AGAINST GENETIC DISCRIMINATION BUT THEY REMAIN LARGELY UNTESTED THEED IN THE COURTS. SOME DISEASES MORE PREV PREVALENT IN RE SHALL AND ETHNIC GROUPS TITLE 7 MAY SERVE TO PREVENT DISCRIMINATION AGAINST THESE GROUPS. AT LEAST ONE COURT SAYS SUPPORTS IT UNDER TITLE 7. THE U.S. COURT OF APPEALS IN THE 9th SIR, EITF IN BLEDSOE VERSUS NORM MAN LABORATORY. THE TESTING PERFORMED WITHOUT CONSENT MAY AMOUNT TO ADVERSE IMPACT IN TITLE 7 SINCE THEY WERE TESTED UNDER GENETIC MARKERS. ALTHOUGH IT DOES NOT SPECIFICALLY ADDRESS THE GENETICS ISSUE ANOTHER FEDERAL STOT TIEWAT THASTATUTE IS THE AMERICANS WITH DISABILITIES ACT OR ADA. ACCORDACCORDING TO THE EEOC IN TERP TATION GENETIC DISCRIMINATION IS PROHIBITED UNDER THE THIRD PART WHICH PROTECTS INDIVIDUALS REGARD AS HAVING IMPAIRMENTS THAT SUBSTANTIALLY LIMIT ONE OR MORE MAJOR LIFE ACTIVITIES. THIS PRONG OF THE ADA REFLECTS RECOGNITIONABLY CONGRESS THAT THE REACTIONS OF OTHERS TO IMPAIRMENT OR PERCEIVED IMPAIRMENT SHOULD BE PRO PROHIBITED IN THE SAME WAY AS DISCRIMINATION BASED ON ACTUAL IMPAIRMENT. THE EEOC IN 2001 FILED A GENETIC DISCRIMINATION SUIT AGAINST BURLINGTON NORTHERN SANTA FE RAILROAD IN ITS GENETIC TESTING. EMPLOYEES FILING CLAIMS FOR WORK RELATED CARPAL TUNNEL SYNDROME. THE CASE WAS NOT DECIDED ON THE APPLICATION TO THE GENETIC ISSUE THE SUIT WAS QUICKLY SETTLED. IT IS ESSENTIAL THAT IT IS DEVELOPED TO REFLECT THE REQUIRE OPINIONS AND PROTECTIONS OF -- REQUIREMENTS AND PROTECTIONS OF EXISTING STATUTES OR THAT IT MAKES ILLEGAL PRACTICES.

IN CURRENT LAW AS WELL AS EMPLOYMENT PRACTICES WHERE THE USE OF MEDICAL AND POTENTIALLY GENETIC INFORMATION IS PRESENT IN THE WORK PLACE. UNDER THE ADA MEDICAL RECORDS MAY BE USED TO HELP DETERMINE IF AN EMPLOYEE HAS HA PB IMPAIRMENT THAT SUBSTANTIALLY LIMITS ONE OR MORE MAJOR LIFE ACTIVITIES OR HAS A RECORD OF SUCH A SUBSTANTIAL LIMIT THE IMPAIR SHNT. WAR OVER MEDICAL INFORMATION AN INTEGRAL PART OF DETERMINING A REASONABLE ACCOMMODATION OF A DISABLED EMPLOYEE. SINCE EMPLOYERS ARE REQUIRED TO DETERMINE IF THEY HAVE A DISABILITY IN THE MEANING OF THE LAW THE MEDICAL INFORMATION IS OF OF OFTEN REQUIRED. EMPLOYERS WOULD FACE AN UNSURMOUNTABLE CHALLENGE IN MAKING PROPER DECISIONS WITHOUT THE INFORMATION. THE TAPLY AND MEDICAL LEAVE ACT KEYIATES A SIMILAR CAL CHALLENGE. THE FMLA ALLOWS THEM TO TAKE UP TO 12 WEEKS FOR UNPAIDED LEAVE OF A SERIOUS HEALTH CONDITION OF THEMSELVES OR A FAMILY MEMBER. TO DETERMINE IF THEY QUALIFY FOR FMLA LEAVE, THAT IS IS WHETHER THE SEAR YES HEALTH CONDITION IS MANIFESTED WHICH BY THE EMPLOYEE OR THE FAMILY MEMBER THEY MUST COLLECT CRITICAL INFORMATION ON THE CONDITION. IT MAY WELL INDICATE A GENETIC BASED HEALTH CONDITION. FOR EXAMPLE, AND MANY OF YOU PROBABLY HAVE HEARD OF THIS BEFORE AN EMPLOYEE MAY REQUEST INTERMITTENT LEAVE TO ASSIST AN AILING MOTHER IN RECEIVING RADIATION TEAM FOR A DIAGNOSED BREAST CANCER A SERIOUS CANCER AND. IN GRANT THE REQUEST THEY HAVE AREQUIRED GENETIC INFORMATION. THE IMPLEMENTATION OF STATE COMPENSATION LAWS WILL CREATE CHALLENGES FOR EMPLOYERS. MEDICAL INFORMATION IS NECESSARY TO FILE A CLAIM AND IS USED TO DETERMINE WHETHER OR NOT THE INJURY IS WORK RELATED. IN 1996 1996 CONGRESS ADDRESSED THE ISSUE OF GENETIC INFORMATION NOR GROUP HEALTH INSURANCE AND HIPAA AND HIPAA IMPLOWER THAT SPONSORS THE PLAN PROVIDED THE INFORMATION IS ONLY USED FOR PLAN ADMINISTRATIVE PURPOSES AND THE EMPLOYERS PUT IN PLACE CERTAIN SPECIFIED SAFEGUARDS ON MEDICAL PRIVACY ON THE DISCLOSURES. EMPLOYER SPONSORED WELLNESS PROGRAMS ARE OTHER INSTANCES WHERE THEY MAY ESTABLISH IMPLEMENTATION. HOUGH, IN CON DICING THE RISK ASEVENTHMENT INFORMATION MAY BE COLLECTD THAT WOULD INCLUDE FAMILY HISTORY, BLOOD TEST RESULTS AND OTHER POTENTIAL GENETIC INFORMATION. SIMILAR TO THAT LAW AND PRACTICE EXAMPLES EMPLOYERS MAY ALSO INADVERTENTLY ACQUIRE POTENTIAL GENETIC INFORMATION THROUGH THE WATER COOLER SCENARIO. IT IS NOT UNCOMMON FOR KOE COLLEAGUES TO SHARE INFORMATION ABOUT THE HEALTH STATUS OF FAMILY MEMBERS IN THE WORK PLACE. IT COULD TURN THAT CASUAL CONVERSATION ABOUT LOVED ONES AROUND THE WATER COOLER THEW A LITANY OF COSTLY LITIGATION AND WORK PLACE DISPUTES. IN EACH OF THESE IN TAN STANCES IT IS NOT THE EMPLOYERS INTENT TO SEEK OUT THE GENETIC INFORMATION OF EMPLOYEES. NEVERTHELESS AN EMPLOYER THAT POSSESSIONS THIS INFORMATION WHETHER OR NOT THE EMPLOYER EVER ACTS ON THE INFORMATION COULD BE EXPOSED TO FUTURE LIABILITY IF LEGISLATIVE PROPOSALS TO PROHIBIT DISYIP NATION FOCUS ONLY ON CONTROLLING THE INFORMATION AND NOT ON THE INTENT OF THE EMPLOYER. WE MAKE THE RECOMMENDATIONS. FIRST, LEGISLATIVE PROPOSALS SHOULD DIFFERENTIATE BETWEEN THE MERE POSSESSION OF GENETIC INFORMATION AND THE USE OF THE INFORMATION FORDYCE FOR DISCRIM STORERY PURPOSES. ANY PROPOSED STATUTE SHOULD BE DIRECTED AT CONTROLLING DISCRIM THAT TORRE CONDUCT. SECOND WOO EPIBELIEVE THAT GENETIC DISCRIMINATION IS WRONG AND IF A COMPANY INTENTIONALLY DISCRIDISCRIMINATES REMEDIES SHOULD BE AVAILABLE. SHRM HOE OPPOSES LEGISLATION THAT TO PROVIDE UNLIMITED. THIRD, LEGISLATIVE PROPOSALS SHOULD NOT IMPEDE OR IMPROCEDURE EFFORTS TO PROTECT THE SAFETY AND WELL BEING OF THE EMPLOYEES THROUGH THE WORK PLACE WELLNESS PROGRAMS AND OTHER SERVICES AVAILABLE UNDER STATE AND FEDERAL LAWS AND FOURFOURTH, DUPLICATIVE EFFORTS TO GUARD AGAINST GENETIC DISCRIMINATION ARE COSTLY AND CONFUSING. ANY LEGISLATIVE PROPOSAL REGARDING GENETIC DISCRIMINATION SHUTED TAKE INTO ACCOUNT THE PRO TEXS AVAILABLE UNDER STATE LAWS. I WOULD LIKE TO THANK THE COMMITTEE FOR THE OPPORTUNITY TO APPEAR BEFORE YOU TODAY AND WOULD BE PLEASE PLEASE TODAY ANSWER ANY QUESTIONS YOU MAY HAVE.

THANK YOU. WE WILL OPEN IT AGAIN FOR QUESTIONS TEN MINUTES AND THEN WE WILL PROCEED WITH THE LARGER ROUND TABLE DISCUSSION SO ANY QUESTIONS FOR THE PANEL. YES?

I WOULD LIKE TO ASK MR. AKIN A NUMBER OF THE ISSUES YOU RAISED ARE CERTAINLY ONES THAT HAVE BEEN DISCUSSED FOR SEVERAL YEARS AS VARIOUS VERSIONS OF LEGISLATION HAVE BEEN DEBATED, DRAFTED, REDRAFTED AND SO ON AND I FRANKLY THINK A NUMBER OF THE POINTS YOU MADE HAVE ALREADY BEEN TAKEN CARE OF SO SPECIFICALLY WHAT WOULD YOUR RECOMMENDATION BE STARTING WITH S105 # 3 AS A TEMPLATE BY AFTER ALL DID PASS THE SENATE 95-0 WHAT ADDITIONAL CHANGES WOULD NEED TO BE MADE IN THAT BILL FOR SHRM AND PRESUMABLY THE CHAMBER OF COMMERCE TO BE COMFORTABLE WITH IT? CAN YOU BE EXPLICIT. THE GENERAL SENSE IS THAT THERE IS A CLOUD OF OBJECTIONS WITHOUT GETTING DOWN TO THE SPES FIESITY THAT WOULD IMPLY AN INTENT TO WORK SOMETHING OUT.

IF I MAY THE EMPLOY EMPLOYER COMMUNITY WORKED WITH THE SENATE AND REPUBLICANS AND DEMOCRATS IN THE HOUSE AS WELL AS OTHER STAKE HOLDERS AND HAVE BEEN CONSISTENT IN WHERE WE RAC ED OUR CONCERNS. I WOULD CONCUR THE SENATE IT A GOOD JOB OF TRYING TO ADDRESS THE ISSUES RACED BY THE EMPLOYMENT COMMUNITY. THERE HAVE BEEN CONTINUING LINGERING CONCERNS AND AND WE HAVE SEEN THIS IN STATE LAW AND JANE MENTIONED AS WELL AS JOANNE DID ABOUT THE STATE LAW EFFORTS. ONE OF THE CONCERNS WITH S1053 IS THAT THERE ISN'T A SUNSET PROVISION. WE HAVE SEEN OUR EXPERIENCE WITH THE 30 SOME STATE LAWS ENACTED THAT THE STATES HAD TO GO BACK AND REVISIT THE STATUTES BECAUSE THEY FOUND PROBLEMS WITH THE THAT I THEY INTERACTED WITH THE HEALTHCARE PLANS OR EMPLOYER STATE LAWS AND IT CAUSED PROBLEMS AND CONFLICTS AND ONE OF THE THINGS THAT HAS BEEN ADVOCATED IT THE SUNSET PROVISION TO GIVE AN OPPORTUNITY TO REVIEW THE IMPLICATIONS AND AS GENETIC ADVANCES ARE MADE AND MORE TIS COVERRIES ARE MADE THAT THERE MAY BE THINGS THAT NEED TO BE DONE TO MODIFY THAT LEGISLATION TO LOOK AT THAT ISSUE. SECOND, THERE IS NO FEDERAL PREEMPTION OF THE -- IN S1053 MEANING THAT THE FEDERAL LAW DOES NOT TRUMP THE VARIOUS DIFFERENT STATE LAWS OUT THERE AND THERE IS A DHEARN YOU COULD HAVE SITUATIONS NOT JUST WITHIN THE EMPLOYMENT SIDE BUT ALSO WITHIN REGARDS TO THE HEALTHCARE PLANS WHERE PLANS MIGHT BE COMPLYING WITH NOT ONLY THE FEDERAL STATUTE AS WELL AS IN A ADDITION TO THE STATE STATUTE AND HAVE CONFLICTTH LAWS WITHIN REGARDS TO THAT AND THAT IS ANOTHER ASPECT THAT HAS BEEN RAISED. IT IS NOT BY AREA OF EXPERTISE BUT IN TALKING WITH OTHERS AS THE DEFINITION OF FAMILY MEMBER. MANY FELT IT IS AN OVERLY BROAD TERM ZEE DESCRIBED IN THE SENATE BILL. THERE IS A CONCERN THAT IT IS INTNOT NARROW ENOUGH AND AGAIN I UNDERSTAND THERE IS DIFFERENT TRAINS OF THOUGHTS OUT THERE WITHIN THE GENETICIST POPULATION BUT THOSE ARE SOME OF THE MAIN CONCERNS RAISED AND I WILL SAY THAT WE RAISED THESE CONCERNS WITH SUPPORTERS OF 1053 AND ASKED THEM TO TRY AND GO BACK AND ADDRESS THOSE AND AS OF YET WE HAVE NOT HEARD BACK. EOC SHEPHERDED THROUGH AN INFORMAL IMMEDIATING WITH MEETING WITH STAKE HOLDERS ON ALL SIDES BACK IN APRIL AND IT WAS ASKED OF THE OTHERS TO COME BACK AND TRY AND ADDRESS MANY SOME OF THE ISSUES AND WE ARE STILL WAITING. THE EMPLOYER COMMUNITY HAS NOT TRIED TO KILL THE GENETIC BILL. WE HAVE WORKED CLOSELY WITH ALL ON THIS.

SO CAN I THEN ASK YOU DIRECTLY IS IT A GOAL OF THE SHRM TO SEE EFFECTIVE FEDERAL LEGISLATION PASSED TO PREVENT GENETIC DISCRIMINATION IN THE WORKPLACE?

I THINK THAT WE WOULD CERTAINLY BE SUPPORT SUPPORTIVE OF THAT. THE CONCERN BECOMES REMEMBER WHO WE REPRESENT AS WELL. WE ARE GIVING OUR EMPLOYERS ANOTHER CAUSE OF ACTION TO HAVE TO DEAL WITH AND YOU ARE NEVER GOING TO HAVE EMPLOYER GROUPS STANDING AROUND THE TABLE SUPPORTING THAT TYPE OF EFFORT. I THINK FRANKLY THAT THE LEAST THAT YOU WOULD SEE IS THAT WE WOULD -- WE WOULDN'T OPPOSE THAT EFFORT AND WE DIDN'T OPPOSE S1053. WE CONTINUED TO WORK WITH THE SENATE IN CRAFTING THAT IN THAT EFFORT.

CINDY AND THEN ED. PERHAPS DOCTOR LICATA CAN HELP WITH THIS. A POINT OF CLARIFICATION BECAUSE I WAS WONDERING ABOUT THE PLANS THAT ARE APPARENTLY EXEMPT FROM HIPAA GI WAS WON G IF YOU COULD HELP US CLARIFY THAT. ARE EREIS A PLANS SUB SUBJECT TO HIPAA OR NOT? I THOUGHT THAT SOME MAY FALL UNDER AN EXEMPTION.

THERE IS AN EXEMPTION AND IT IS BASICALLY THE SMALLER SELF-INSURED PLANS THAT FALL OUT. AND I THINK THIS IS KIND OF RELEVANT TO UNDERSTANDING WHAT EREIERISA DOES HAVE FED FEDERAL PREEMPTION IS THAT IN ADDRESSING THE ISSUE OF THIS CONCERN ABOUT HAVING TO DEAL WITH LOTS OF DIFFERENT STATE RULES OR DIFFERENT RULES EVEN WITHIN FEDERAL GUIDELINES WHAT IS IN INTENDED BY S105 # 3 IS IT CREATES A THRESHOLD. IN YOU HAVE A STATE LAW THAT IS MORE STRICT AND HAS LIKE NEW JERSEY THOSE ARE ENFORCEABLE. BUT EVERYBODY HAS TO COME UP TO AT LEAST ONE CONSISTENT NATIONAL LEVEL AND WHAT THAT NATIONAL LEVEL IS IS THAT THE SAME STANDARDS THAT ARE CURRENTLY APPLYING WOULD GENERALLY NOW APPLY TO ALL INDIVIDUAL PLANS AND TO ALL GROUP PLANS. AND THAT THE THOUGHT IS THAT IF YOU ARE COVERED BY ERISA YOU DO HAVE PREEMPTION AND THIS IS ONE OF THE ISSUES DISCUSSED BEFORE CONGRESS AS WELL. ANOTHER ASPECT OF THIS THAT IS UNDERSTANDING WHO IS COVERED AND WHO IS NOT COVERED. THERE WAS A GREAT DEBATE ABOUT THE CONTEXT OF THE FAMILY MEMBERS AND SO FORTHED AND THE COMPROMISE THAT WAS MADE IN THE SENATE THERE WAS TO FOCUS ON A DEFINITION OF USE OF GENETIC TEST INSTEAD OF GETTING HUNG UP AGAIN ON THE DEFINITION OF GENETIC INFORMATION AND ALSO TO INCLUDE PEOPLE THAT MIGHT NOT NECESSARILY HAVE A BLOOD RELATIONSHIP BECAUSE THEY ARE COVERED BY THE PLAN SUCH AS THE GENTLEMAN WAS EXPLAINING WITH HIS ADOPTED CHILDREN IS THAT WHEN THE CLAIM GETS MADE AGAINST A PLAN OR AGAINST A FIRSPARTICULAR MEMBER'S PLAN IS THAT YOU KNOW THEN YOU HAVE TO GO INTO THE EXPLANATION OF WHETHER THIS IS A RELEVANT RISK TO THIS PERSON OR NOT SO THE BURDEN HAS BEEN SHIFTED AND THAT IS PART OF THE COMPROMISE TO PROTECT THE INDIVIDUAL BENEFICIARY SO THEY CAN MAINTAIN IND INSURANCE AND INTO THE FEEL THREATENED WHILE IT IS BEING SORTED OUT AND THERE IS NOT THE LIMITATION OF THE BLOOD RELATIONSHIP. I THINK EVERYBODY TOOK SERIOUSLY THE CONCERNS OF THE EMPLOYER AND SAID WE WILL DO RISK SHIFTING HERE AND BE CONCERNED ABOUT PROTECTING THE INDIVIDUAL'S RIGHTS BUT GIVE MORE CERTAINTY IN THE BUSINESS KNOWING THAT THEY WILL APPLY TO A GENERALIZED FEDERAL STANDARD THAT IS A A THEREBY THRESHOLD AND WILL CALL ALL INDIVIDUAL PLANS IN.

THANK YOU AROUND THANK YOU FOR APPEARING BEFORE US. I HAVE A COMMENT AND THEN QUESTION. I WANT TO FOLLOW UP ON AGNES' QUESTION TO MR. ACHE AKIN WHERE HE SAID HE WAS NOT A SPOKESPERSON FOR THE NATIONAL CHAMBERS OF COMMERCE. I WOULD LIKE TO POINT OUT THEN THAT THE NATIONAL CHAMBERS OF COMMERCE BASICALLY GAVE THE CMIECOMMITTEE A RESPONSE OF NO COMMENT WHEN ASKED TO APPEAR BEFORE US AND ANY OF US THAT HAD MEDIA TRAINING NO THAT KNOW COMMENT IMPLIES A CONCERN ABOUT GUILT. I WOULD JUST LIKE TO POINT OUT THAT I'M NOT DPSH I'M NOT JUDGE -- I'M NOT JUDGING THE NATIONAL CHAMBERS OF CAN COMMERCE BUT THEY DID RESPOND NO COMMENT TO US. PERHAPS THEY WOULD WISH TO CONTINUE THAT IN THE FUTURE. PERHAPS NOT,. THAT WILL BE THEIR CHOICE. I WOULD BE INSULTED, BY THE WAY, EXCEPT FOR MY IN INTERPRA EXPECTATION OF THEIR RESPONSE. THE OTHER IS A QUESTION FOR MR. AKIN. AND FIRST PERHAPS YOU WERE IN THE AUDIENCE FOR THE INITIAL PANEL. IF NOT, THEN I WOULD ENCOURAGE YOU TO READ THE TESTIMONY OF THOSE INDIVIDUALS WHO APPEARED BEFORE US IN IN THE INITIAL PANEL TODAY BECAUSE IT WAS REALLY QUITE POWERFUL. YOU SAY THAT THERE WAS NO EVIDENCE OF WIDESPREAD USE OF GENETIC INFORMATION IN EMPLOYMENT DISCRIMINATION AND YET IN YOUR PRESENTATION YOU RAISED A NUMBER OF EXAMPLES OF POTENTIALS FOR GENETIC DISCRIMINATION LIKE THE WATER COOLER SCENARIO AND THOSE SORTS OF THINGS AND YOU ALSO SAID OR I HAVE A QUESTION IF THERE IS NO EVIDENCE OF GENETIC DISCRIMINATION THEN WLIE IS HERE THE FEAR OF WIDESPREAD LITIGATION A PBD AN AROUND AN ISSUE THA DOESN'T EXIST. THE TESTIMONY SEEMED IN TENALLY INCONSISTENT TO ME AND I WOULD LIKE YOU TO CLARIFY FOR ME.

I THINK THERE IS A DIFFERENCE BETWEEN THE ACTUALITY OF CASES AND BROUGHT IN FEAR AND I DID NOT HEAR THE FIRST PANEL BUT HEARING MY COLLEAGUES ON THE SECOND PANEL TALK ABOUT WAS THE FEAR OF THE DISCRIMINATION AND I DO NOT DISCOUNT THAT AND NOR DOES THE SHRM AND WE CERTAINLY HEARD THAT BUT WE ARE NOT HEARING FROM EMPLOYERS EVEN WANTING TO HAVE THIS INFORMATION. I WAS -- I KNOW THAT THE EEC HAD VERY FEW CASES BROUGHT UNDER THE ADA IN TERM TERMS OF A DISCRIM THAT TORRE CODISCRIMINATORY CONTENT. THE CONCERN ON THE LITIGATION HAS TO GO BACK TO THE TITLE 7, THE AMERICANS WITH DISABILITIES ACT AND TPA PLLY MEDICAL LEAVE ACT AND OTHER LITANY THAT EMPLOYERS ARE REQUIRED TO COMPLY WITH NOW. WHAT WE HAVE SEEN IS THAT THE LAWS THAT ARE WELL INTENDED. WE DON'T AS DISAGREE TO TRY TO CRAFT LEGISLATION TO PROHIBIT GENETIC DISCRIMINATION. OUR HR DEALS IN THE MURPHY'S LAW AND OFTEN WHAT HAPPENS IS IT IS NOT THE MANY EMPLOYEES -- THE EMPLI PLOYERS GET PLACED WITH FRIVOLOUS LAWSUITS AND IF A LAW IS NOT CAREFULLY CRAFTED TO ADDRESS THE ISSUES THAT WE RAISED THEY END UP IN COURT AND BURDEN SHIFTS TO THE EMPLOYER TO PROVE THAT THEY JUST BECAUSE THEY HAD THE KNOWLEDGE THAT SOMEBODY MAY HAVE A GENETIC MARKER THAT THEY IN FACT DISCRIMINATED AGAINST THAT INDIVIDUAL AND WHAT WE HAVE BEEN CONCERNED ABOUT IT MOST OF THE EARLIER VERSIONS OF THE LEGISLATION FOCUSED PRINCIPALLY ON TRYING TO CONTROL THE INFORMATION AND OUR CONCERN IS THAT IT IS ALREADY OUT THERE AND BEEN REQUIRED TO BE OUT THERE FOR COMPLIANCE WITH A VARIETY OF DIFFERENT FEDERAL AND STATE LAWS. IF DISCRIMINATORY CONTEND CON CONTENT, THAT IS ENTIRELY DIFFERENT AS OPPOSED TO THE INFORMATION ITSELF.

THANK YOU. I REALLY -- WE DO HAVE TO MOVE ON BECAUSE WE ARE ALREADY EBEE ND IN OUR ROUND TABLE DISCUSSION TO THAT I HAVE TO MOVE US ON TO THAT BECAUSE WE HAVE ONLY TO 1:15 FOR THE PARTICULAR DISCUSSION.

SO WHAT WE ACTUALLY NEED TO DO AS A COMMITTEE NOW IS TO LOOK WHERE DO WE WANT TO GO? WHAT STEPS DO WE WANT TO TAKE AFTER HAVING HEARD SOME OF THIS INFORMATION? WE HAVE HEARD ALREADY SOME PARTICULAR THAT HAVE BEEN BROUGHT UP, SOME PARTICULAR RECOMMENDATIONS, ONE-RUN. UNBEING THAT WE HAVE A LETTER FROM THE NEW CHAIR TO THE SECRETARY DESCRIBING SOME OF THE INFORMATION THAT WE HEARD TODAY, BROADENING THE ASPECT OF DISCRIMINATION. THE SECOND IS AGAIN DO WE WANT TO SPECIFICALLY INVITE AGAIN THE CHAMBER OF COMMERCE TO ADDRESS SOME OF THE QUESTIONS THAT OUR COMMITTEE HAS. THE THIRD IS TO MAKE A SPECIFIC REQUEST TO THE DEPARTMENT OF JUSTICE TO REVIEW SOME OF THE GAPS IN THE LEG LEGISLATION AS WE CURRENT HAVE AS TO WHETHER WE NEED TO GO ANY FURTHER WITH THIS WITH NEW LEGISLATION THEN COVER THOSE GAPS. AND THEN THE OTHER THAT WAS ACTUALLY ONE OF THE PURPOSES OF THIS PARTICULAR COMMITEE WAS TO LOOK NOT ONLY AT THE CURRENT GENETIC TESTS AND GENETIC DISEASES AS WE KNOW TODAY BUT THE BROADER ASPECT OF GENETICS AND GENOMICS AS TO WHERE WE ARE GOING TO BE GOING IN TERMS OF RESEARCH AND MED K58 K58 CAL CES. BEGIN WITH FIRST DEBRA AND THEN REED.

I THINK FROM THE PRESENTATIONS TODAY IT IS CLEAR THAT FEAR OF GENETIC DISCRIMINATION IS REAL. AND IT IS PREV PREVALENT. IT IS NOT RARE. AND THIS IS FEAR OF LOSS OF INSURANCE. AS WELL AS EMPLOYMENT. AND NOT ONLY FOR THEMSELVES BUT DOWN TO THE NEXT GENERATIONS. REAL DISCRIMINATION PROBABLY HAS OCCURRED BUT MAY NOT BE REALIZED TO THE FULL EXTENT BECAUSE OF THIS FEAR SO PEOPLE ARE NOT HAVING THE TEST STOG THERE MAY NOT BE AS MUCH ACTUAL DISCRIMINATION OCCURRING AS MIGHT OCCUR IF PEOPLE WERE HAVING THE TESTING. AND THIS FEAR IS COMPROMISING MEDICAL CARE. DIAGNOSIS. DEFINING RISK. TREATMENT AFTERTESTING. AND REALIZING POSSIBLE BENEFITS FOR OTHER FAMILY MEMBERS. IT IS ALSO COMPROMISING RESEARCH PARTICIPATION. AND IT IS MOST DISTURBINGLY COMPROMISING LIFE AND DEATH DECISIONS BY PATIENTS. AND PEOPLE. HEALTH INSURERS LOOK LIKE THEY ARE SUPPORTING LAWS TO PROTECT THE INDIVIDUALS FROM GENETIC DISCRIMINATION AND I GUESS EMPLOYERS ARE NOT GOING TO IMPEDE LAWS FOR GENETIC DISCRIMINATION. BUT I THINK IT IS ALSO CLEAR FROM JANESS IT PRESENTATION THAT FEDERAL LAWS PROTECTING FROM THE GENETIC DISCRIMINATION COULD TKO NOT EXIST. NOT THAT PROVIDE ADEQUATE PROTECTION. I DON'T KNOW THAT ASKING FOR A RITIATION OF THAT FROM THE DEPARTMENT OF JUSTICE IS REALLY WORTH WHILE. SACGHS HAS ALREADY AGREED THAT LEGISLATION IS NEEDED AND I DON'T THINK WE NEED -- WE HAVE SENT TWO LETTERS TO THE SECRETARY AND SO FAR THE HOUSE IS NOT MOVING FORWARD WITH I DON'T KNOW IF THEY ARE DELIBERATING ON BUT THEY ARE CERTAINLY NOT PASSING LEGISLATION. I AM LOATH TO CONTINUE OUR PREVIOUS PATTERN OF SENDING LETTERS TO THE SECRETARY SINCE THIS APPEARS TO HAVE HAD LITTLE IMPACT ON ACHIEVING PASSAGE OF GENETIC DISCRIMINATION PROTECTION LAWS SO MY QUESTION IS WHAT ELSE CAN WE DO? CAN WE SEND INFORMATION FROM THIS PUBLIC FORUM TO MEMBERS OF THE HOUSE OR SO THE SECRETARY TO ASK HIM TO PASS ON? I GUESS THE ONLY THING WE CAN DO IS ADDRESS THE SECRETARY. CAN WE REQUEST MEMBERS OF THE HOUSE TO ADDRESS SACGHS? CHAIRS OF THE COMMITTEES THAT ARE DELIBERATING THIS PROCESS. IS THERE ANYTHING ELSE WE CAN DO OTHER THAN SIMPLY SENDING LETTERS BECAUSE THAT HAS NOT BEEN VERY EFFECTIVE IN MY OPINION TO DATE.

GET A QUICK RESPONSE IN TERMS OF THE TECHNICAL ISSUES THERE. ON THE FIRST PART OF YOUR COMMENT, WE ARE NOT ALLOWED AND I WILL GET CORRECTED I'M SURE HERE IN A SECOND BUT WE ARE NOT ALLOWED TO DIRECTLY WRITE TO THE CONGRESS. WHAT WE CAN DO IS TO ASK THE SECRETARY TO TAKE OUR INFORMATION AND SEND THAT TO CONGRESS. SO THAT WE CAN INSTEAD OF SENDING THE LETTER TO THE SECRETARY YOU CAN ASK THE SECRETARY TO SEND STUFF ON OUR BEHALF TO CONGRESS. AS REGARDS INVITING MEMBERS OF CONGRESS TO COME HERE AND BE A PART OF THAT DISCUSSION, THAT IS ONE I'M NOT SURE ABOUT.

WELL, YOU KNOW, WE HAD INVITED CONGRESSIONAL STAFF IN THE PAST AND I DON'T THINK THERE IS A PROHIBITION INVITING A MEMBER OF CONGRESS TO COME AND TALK TO US. SO WE COULD CERTAINLY, YOU KNOW, CHECK WITH THE SECRETARY'S OFFICE ABOUT THAT AND CONVOY A LETTER OF INVITATION.

MY POINT IN ASKING THE SECRETARY TO COMMUNICATE WITH THE JUSTICE WAS TO BROADEN THE DISCUSSION PERHAPS WITHIN THE ADMINISTRATIVE BRANCH SO THAT WAS REALLY THE INTENT BECAUSE I AGREE WITH YOU, IT HAS BEEN VERY FRUSTRATING. THE EFFORTS THAT WE HAVE MADE AND HAVE NOT MOVED FORWARD. I THINK SO THAT WOULD BE ALSO PERHAPS MY WHEN I ASKED VAHID THE QUESTION BEFORE AND I OI POLL GIES FOR NOT PROVIDING SOME -- APOLOGIZE FOR NOT PROVIDING SOME PRE-QUESTION INFORMATION TO HIM, BUT THAT WAS REALLY THE INTENT SO PERHAPS WE COULD DISCUSS ARE THERE OTHER THINGS THAT WE COULD DO TO INCREASE THE VISIBILITY OF THE ISSUE WITHIN THE ADMINISTRATION. THE PRESIDENT IS ON RECORD AS BEING SUPPORTIVE OF THIS. THE SECRETARY AND BOTH BEFORE AND -- BEFORE HE BECAME PRESIDENT AND DURING HIS PRESIDENCY. SECRETARY THOMPSON SIMILARLY IS ON RECORD BOTH AS THE GOVERNOR AND NOW AS THE SECRETARY OF BEING SUPPORT IB SUPPORTIVE OF THIS AND YET THERE HAS BEEN NO MOVEMENT. PART OF MY REASON TO CHALLENGE THE CHAMBER OF COMMERCE TO COME BEFORE US IS THAT THE SCUTTLEBUTT THAT I HAVE HEARD IS THAT THE CHAMBER HAS BEEN VERY ACTIVE IN HOLDING THIS AT THE DESK. THAT THEY ARE REALLY THE PEOPLE AND I APPRECIATE MR. ATKIN BEING SENT TO REPRESENT THAT SEGMENT OF OUR ECONOMY WHEN THE PEOPLE SENDING HIM DIDN'T HAVE THE GUTS TO COME BEFORE US THEM ELVES. SO I APPRECIATE YOUR WILLINGNESS TO TO THAT, MR. KAY KIN. I THINK YOU SHOULD TAKE BACK THE MESSAGE, THOUGH, THAT WE SEE WHAT WAS DONE. WE ARE NOT STUPID AND YOU WERE SENT HERE SO THAT WE COULD NOT QUESTION THE PEOPLE WHO ARE HOLDING THIS AT THE DESK. THAT IS WHAT WE HAVE TO DO IS FIGURE OUT HOW WE CAN MOBILIZE ALL OF WHAT WE HAVE HEARD TODAY. KATHY, DOCTOR HUDSON SAID THAT THIS IS A MAJOR ISSUE THROUGHOUT THE UNITED STATES. HOW DO WE MOBILIZE THE PEOPLE OF THIS COUNTRY TO COUNTER ACT THE CHAMBER'S EFFORTS TO SUB VERT WHAT IS RIGHT FOR THE AMERICAN PEOPLE?

THIS IS EMILY BUT JUST FOR A FACTUAL INFORMATION MR. AKIN, CAN WE BECLEAR ON -- FROM YOU, WHETHER OR NOT -- YOU REPRESENT THROUGH YOUR ASSOCIATION OR THE COALITION AND I NEED YOU TO CLARIFY WHETHER IT IS AN ASSOCIATION OR A CO-ALIGS OF WHAT WHICH THE CHAMBER IS A PART. GIVE US A SENSE OF SO MANY OTHER ORGANIZATIONS THERE ARE THAT HAVE THE SAME OPINION ORPHA LOSSFY THAT YOU HAVE EXPRESS -- OR P. PHILOSOPHY THAT YOU EXPRESSED SO WE KNOW WHETHER OR NOT AS ED LAYS IT IN ON HERE HOW MUCH IS THE CHAMBER BUT HOW MUCH THERE ARE OTHER INTERESTS HERE?

THE CHAIM SBER A MEMBER CHAMBER IS A MEMBER OF THE GENE COALITION AND SRM IS A MEMBER AND I WOULD GUESS THERE ARE 40 OTHER ASSOCIATIONS MEMBERS OF THE GENE COALITION AND THE PRINCIPLES I LAID OUT HAS BEEN ADOPTED BY THE GENE COALITION. I DON'T RECALL AND I CERTAINLY DON'T WANT TO SPEAK ON BEHALF OF THE CHAMBER SAYING THAT NO, THEY ARE POTHEY OPPOSED. THEY RAISED CONCERNS WITHIN 1053 AND SHARED THE CONCERNS WITH PUBLIC POLYMAKERS ON BOTH SIDES OF THE AISLE. THE COALITION HAS BEEN VERY CONSISTENT ON THE SET OF PRINCIPLES AND THAT IS LOOKING AT ANY LEGISLATION MOVING THROUGH WHETHER ADVANCED IN THE HOUSE OR SENATE.

TURN TO EMILY. MIKE, YOU HAVE BEEN FORTHCOMING HERE AND I KNOW YOU HAVE STAFF SUPPORT HERE AS WELL OR OTHER COLLEAGUES IF WE MIGHT GET A LIST OF THE OTHER 40 AND OUR TEAM CAN TRY TO DURING THE LUNCH BREAK OR SOMETIME TODAY GET THAT BACK SO AT LEAST WE WILL UNDERSTAND THE RANGE AND DEPTH OF THE INTERESTS THAT YOU ARE SO ARTICULATELY REPRESENTING TODAY. EMILY?

SO I GUESS WHEY WOULD LIKE TO UNDERSTAND WHILE WE HAVE YOU ON THE HOT SEE THE HERE RIGHT NOW IS WHEW EXACTLY IT -- WHAT EXACTLY IT IS THAT EMPLOYERS ARE CONCERNED ABOUT? BECAUSE IT SEEMS TOS TO ME THAT FROM AN ADMINISTRATIVE POINT OF VIEW FOR A THAN HAS EMPLOYEES IN MORE THAN ONE STATE THAT HAVING A FEDERAL PIECE OF LEGISLATION COVERING THIS WOULD ACTUALLY SIMPLY FIE THEIR LIVES IN MANY FAYS RATHER THAN -- WAYS RATHER THAN HAVING TO WORRY ABOUT THE SALES REP IN NEW JERSEY HAVING A DIFFERENT SITUATION THAN THE THE SALES REP IN TENNESSEE OR TEXAS OR CALIFORNIA OR WHAT EVER. I MEAN EVEN IF YOU DON'T HAVE MULTIIROMULTIPLE HEAD QUARTERS IN DIFFERENT STATES MANY COMPANIES HAVE EMPLOYEES DISTRIBUTED OVER ALL THE STATES. WHAT IS IT JUST THIS PARTICULAR WORDING OR WHAT IS THE ISSUE WITH HAVING A SORT OF UNIFIED FLOOR. IN.

WELL, S1053 IS NOT A PREEMPTION. IT IS IN ADDITION TO WHATEVER THE STATE LAWS ARE. SO THAT THERE IS A DID I RENS. IF IT WAS A PREEMPTION I DON'T THINK THAT THERE WOULD BE AS BIG OF A CONCERN WITH 1053.

MY UNDERSTANDING IS IF IT WAS IN A STATE WHERE IT WAS A HIGHER LEVEL THAN THE STATE THAT THE FEDERAL LAW WOULD THEN APPLY. THE ONLY PLACES WHERE THE FEDERAL LAW WOULDN'T APPLY WOULD BE IN STATES THAT HAVE HIGHER LEVELS OF PROTECTION ZWLA IS, CORRECT?

RIGHT.

, CORRECT.

BUT THAT COULD BE QUITE A FEW. I DON'T HAVE THE INFORMATION IN FRONT OF ME BUT THERE COULD BE SERVSEVERAL.

DO YOU KNOW HOW MANY -- IF 105 # 3 WENT TO BECOMING LAW HOW MANY STATES WOULD HAVE STRICTER REGULATIONS?

IF YOU GIVE ME ABOUT FIVE MINUTESKY TELL YOU BECAUSE I HAVE A COMPLETE ANALYSIS OF ALL THE STATES SO I WILL WORK ON THAT RIGHT NOW.

HIGHHEY DID I HIGH DEHEID WILLIAMS.

MY CHILDREN ARE THE ULTIMATE IRONY IN HEALTH INSURANCE BECAUSE HUMANA INCORPORATED IS HEAD QUARTERED IN LOUISVILLE, KENTUCKY, AND MY CHILDREN WERE BORN IN THE STATE OF KENTUCKY AND THEY WERE DENIED TWICE IN WRITING AND THE GENETIC ALLIANCE HAS COPIES OF THE LETTERS DUE TO THEIR CARRIER STATUS. THAT WAS THE ONLY REASON THEY WERE DENIED. ALSO, I WANT TO MAKE THIS POINT THAT ALONE IN MY FAMILY HISTORY AND THERE IS A HISTORY OF OBESITY, DIABETES, HEART DISEASE, STROKE, PROSTATE CANCER, BREAST CANCER AND MY PERSONAL FAVORITE, MALE PATTERN BALDNESS. THESE ARE ALL CONSIDERED GENETIC DISORDERS UNDER THE AGAINST DISORDER WEBSITE AT NIH. EVERY SINGLE ONE OF THEM. AND WHAT I AM AFRAID OF IS THAT ONCE EMPLOYERS AND INSURANCE COMPANIES GET TIRED OF PICKING AT THE MORE EX-SO EXOTIC DISORDERS THAT THEY WILL COME AFTER PEOPLE'S FAMILY HISTORIES WHERE THESE THINGS HAVE BEEN SHOWING UP YEAR AFTER YEAR AFTER YEAR GENERATION AFTER GENERATION. I'M ALL FOR EDUCATION, TOO, AS FAR AS THESE DISORDERS ARE CONCERNED. I THINK IT IS MORE IMPORTANT THIS IS JUST AS IMPORTANT AS THE LEGISLATION BECAUSE I KNOW THAT SOME WHERE DOWN THE LINE MY CHILDREN ARE KING TO GOING TO INTEREST TO HAVE THEY'RE SPOUSES GENETICALLY TESTED TO SEE WHETHER OR NOT THEY CARRY THE AHE GENE BECAUSE THIS WILL GO ON TO THEIR CHILDREN, ENDING UP AS A SYMPTOMATIC PATIENT LIKE MYSELF IF THEY ARE NOT GENETICALLY TEST SOD THIS COULD COME DOWN TO EVEN THEIR CHILDREN AS THEY ARE BORN OR EVEN BEFORE THEY ARE BORN IN THE WOMB AND COULD BE PREVENTED FROM EMPLOYMENT AND INSURANCE.

THANK YOU VERY MUCH FOR THAT. THAT'S VERY HELPFUL. WE HAVE DEBRA AND THEN CINDY AND THEN FRANCIS AND LET ME JUST TRY TO CAUTION EVERYBODY AND JUST DO A TIME CHECK HERE YEWE HAVE A TOUGH CHALLENGE OF A 1:05 TIME TO STOP. BREAK 1550 1:05. DID BE CHANGE THE SCHEDULE?

WE HAVE A NEW SCHEDULE. EVEN THERE WE HAVE A TOUGH CHALLENGE ZWLA IS GREAT BETWEEN YESTERDAY AND TODAY. TERRIFIC. 1:15. WE ARE TRYING NOW TO TAKE THIS AND ZERO IN ON WHAT THIS COMMITTEE CAN DO. SO I WANT TO JUST SORT OF KEEP PEOPLE ON POINT SO WHAT CAN WE DO AND WHAT SHOULD WE DO. DEBRA, LET'S GO THERE? JUST A QUICK FOLLOW-UP QUESTION TO MR. AKIN. I MIGHT HAVE MISSED IT WHAT IS THE GENE COALITION? WHAT IS THE MISSION? WHAT ACTIONS HAVE THEY TAKEN TO DATE?

THE GENE COALITION IS A GROUP OF ORGANIZATIONS, PRINCIPALLY EMPLOYER PROVED AND THERE ARE HEALTHCARE ORGANIZATIONS ACTIVE THAT WORKED WITH THE HOUSE AND SENATE ON LEGISLATIVE PROPOSALS DEALING WITH GENETIC DISCRIMINATION.

CYNTHIA AND THEN FRANCIS?

PROBABLY GOES WITHOUT SAYING BUT I WILL SAY IT GENNYWAY, I THINK IT IS -- AGAIN P. ANYWAY, I THINK IT IS UNANIMOUS THAT WE ALL STRONGLY SUPPORT FEDERAL LEGISLATION TO PREVENT GENETIC DISCRIMINATION. I HAVE BEEN IN WASHINGTON ENOUGH TO KNOW THAT SOMETIMES WE A TENDENCY TO SAY TO SOMEONE WELL IF YOU DISAGREE WITH ME OR HAVE A DIFFERENT APPROACH YOU ARE BAD OR EVIL OR HAVE ANY ROUS PUFERPS AND THAT I DON'T THINK THAT IS THE CASE. PEOPLE WERE TELLING US COMPELLING STORIES ABOUT PERSONAL LIVES AND HEALTH AND LIVELIHOOD AND FAMILIES. FOLKS ON THE OTHER SIDE OF THE ISSUES, THOUGH, ARE PROBABLY DOING SIMILAR THINGS AND THEY ARE FOCUSED ON THEIR LIVELIHOOD AND ABILITY TO STAY IN WHICH IS AND I DON'T DON'T BANT TO DEEM DEE MONIZE ONE SIDE OR THE OTHER. SEIZE THE COMMON GROUND AND I KNOW THAT INDIVIDUALS HAVE BEEN TRYING AND WORKING ON THIS ISSUE BUT JUST FOR THE SAKE OF THROWING SOMETHING SOME WHAT CONTROVERSIAL OUT THERE, I HAVEN'T SEEN, MIKE, THE SPECIFIC PROPOSALS THAT THE COALITION MAY BE PUTTING FORWARD OR IS ADVOCATING WITH REGARD TO CHANGES THAT NEED TO BE MADE TO THE SENATE BILL BUT IF YOU HAVE GOT ACTUAL LEGISLATIVE LANGUAGE THAT MIGHT BE HELPFUL FOR US TO LOOK AT THAT. AND TO THROW OUT THE LITTLE CONTROVERSIAL PIECES TO SAY TO THE REST OF THE FOLKS HERE IF AND I'M NOT SAYING I AGREE WITH THEM BECAUSE I HAVEN'T SEEN THE PROPOSALS BUT JUST FOR THE SAKE OF ARGUMENT IF WE HAD THE RECOMMENDATIONS OF THAT COALITION IS A GHAIL ILL THAT INCORPORATED THOSE CHANGESER TTER THAN NO BILL AT ALL? IN OTHER WORDS, IF WE WERE TO SAY TO THE EMPLOYERS EXPRESSING CONCERN OR MAYBE SOME OF THEM EVEN OPPOSED TO THE LEGISLATION IF WE WERE TO ADOPT THAIFER RECOMMENDATIONS IS THE FEELING THAT IT WOULD GUT THE LEGISLATION AND NOT BE WORTH WHILE? IN OTHER WORDS,ER BETTER TO HAVE A BILL THAT IS LESS THAN PERFECT OR FIGHT FOR SOMETHING THAT WE FEEL IS CRITICAL, EACH AND EVERY ONE OF THE PROVISIONS AS CRAFTED BY THE SENATE IS INTEGRAL TO THE ACTUAL LEGISLATION? I THROW THAT OUT THERE AS SORT OF -- AND IT IS HARD FOR YOUR FOLKS TO ANSWER BECAUSE YOU DON'T HAVE THE DRAFT PROPOSALS OR RECOMMENDED CHANGES IN FRONT OF YOU EITHER. I WONDER IF THAT COULD BE A STARTING POINT FOR WHAT WE MIGHT DO AS A COMMITTEE.

EXCELLENT POINT. WE WILL COME BACK AND NAIL THAT ONE, FRANCIS.

A SUGGESTION AND THEN I WANT TO ASK A QUESTION. A SUGGESTION IN TERMS OF TRYING TO INFLUENCE THE POLITICAL PROCESS BEYOND WHAT THE COMMITTEE HAS DONE ALREADY IN TERMS OF WRITING LETTERS TO THE SECRETARY. I LIKE THE IDEA OF ENCOURAGING THE SECRETARY TO FOLLOW UP BY CONTACTING THE RELEVANT MEMBERS OF THE LEGISLATIVE BRANCH THAT ARE IN THE BEST POSITION TO ACTUALLY GET THIS UNSUCK AND THAT WOULD INCLUDE THE -- UNSTUCK. THE WOULD INCLUDE THE SPEAKER AND MAJORITY LEADER TOM DELAY AND JOE BARTON, THE CHAIR PERSON OF THE ENERGY AND COMMERCE COMMITTEE WHICH WOULD HAVE THE PRIMARY JURISDICTION OVER THE BILL AND IF MR. BARTON WERE TO TAKE AN INTEREST IN HOLDING A HEARING ON THIS I'M SURE THAT WOULD BE SOMETHING THAT WOULD HAPPEN. THIS IS THE THREE SORT OF PRESSURE POINTS THAT MIGHT BE INCLUDED. WE COULD PERHAPS PUSH THIS JUST A LITTLE FURTHER BY THAT EXPLICIT SUGGESTION. THE QUESTION I WANTED TO ASK, I DON'T -- I DIDN'T WANT TO LET THE HEALTH INSURANCE SIDE OF THIS COMPLETELY OFF THE HOOK. SOMEBODY A LITTLE BIT AGO SAID WELL THE HEALTH INSURERS ARE IN FAVOR OF A BILL THAT WOULD PREVENT GENETIC DISCRIMINATION. I'M NOT QUITE SURE THAT THAT IS THE WAY I HAVE HEARD IT SO CAN I ASK DOCTOR WERE ARMSTRONG? OBVIOUSLY YOUR ARGUMENTS ARE THAT HEALTH INSURERS HAVE NOT BEEN USING GENETIC INFORMATION AND WILL NOT BE INTERESTED IN USING IT YET WE HEARD AN EXAMPLE FROM HEIDI WILLIAMS WHERE HER CHILDREN ALMOST LOST THEIR HEALTH INSURANCE. I THINK FROM THE SUR SURVEY AND ALL OF THE TRISHED PANELISTS IS THAT THE PUBLIC DOES NOT BELIEVE THAT HEALTH INSURANCE COMPANIES WILL PASS UP THE OPPORTUNITY TO USE THIS INFORMATION IF THEY HAD THE CHANCE TO TO SO. THATSTHAT'S NOT AN ARGUMENT THAT SEEMS TO BE CARRYING THE DAY. IF IT'S TRUE THAT HEALTH INSURANCE COMPANY IS ARE NOT INTERESTED IN USING THE INFORMATION THEN I WOULD SAY THEY PROBABLY SHOULDN'T DARE TOO MUCH IF THERE IS LEGISLATION THAT SAYS THEY CAN'T BECAUSE THEY WEREN'T GOING TO USE IT ANYWAY?

DOES AHIP SUPPORT 1053?

I DON'T KNOW AHI PISMD THINKION. FROM AETNA APARTMENT PERSPECTIVE WOO VERY UPPORTED THE SENATE BILL. OUR PERSPECTIVE IS THAT IT IS ALREADY OCCURRING AND THIS ACTIVITY HAS BEEN HANDLING IN HEALTHCARE FOR DECADES. WE HANDLE HUNDREDS OF THOUSANDS OF CLAIMS A YEAR IN THE HEALTH PLAN. A TREMENDOUS AMOUNT OF MANAGEMENT PROGRAMS THAT WOUL AROUND THAT INVOLVE DISEASE MANAGEMENT AND PHARMACY MANAGEMENT. IT MAY NOT BE IDENTIFIED AT GENOMIC. IT MAY BE A WHOLE HOST OF OTHER MANAGEMENT CONDITIONS BEING ACTIVELY MANAGED PERHAPS NOT UNDER THE RUE RIDGE RUBLE RICK OF GENOMESIC SKWR S, BUT NOT NO USE IN A DISCRIMINATORY MANNER AND I WOULD DEFER THE DECISION OF AHIP ON IT TO AHIP?

CAN THEY COME AND LET US KNOW WHAT THE THINKING IS THINK IT IS IMPORTANT TO UNDERSCORE WHAT JOANNE SAID IN THE SENSE OF THE USE OF THE INFORMATION AND I THINK FOR THE RECORD I WOULD LIKE US TO BE PRECISE AND I THINK IF I I HEARD JOJOANNE USING THE INFORMATION FOR THE PURPOSE OF HER WHOLE TESTIMONY WAS AROUND USING INFORMATION FOR APPROPRIATE COORDINATION OF CARE IS SOMETHING THAT YOU ARE CLEARLY INTERESTED IN. I THINK FRANCIS THE THESIS OF HIS QUESTION IF I UNDERSTOOD IT IS THE USE OF THIS INFORMATION IN WAYS THAT WOULD BE NEGATIVE TO THE INDIVIDUAL FROM AN UNDERWRITING OR INSURING POINT OF VIEW AND I THINK THAT JOANNE'S ANSWER STANDS ON ITS OWN BUT I THINK THIS IS A SUBTLE POINT THAT NEEDS TO BE TRISHED.

I'M TOM WILD GEAR, THE VICE PRESIDENT FOR PRIVATE REGULAR LATHES WITH AMERICA'S HEALTH INSURANCE PLANS. WE DID NOT OPPOSE THE SENATE BILL. WE EXPRESSED TO CONGRESS ON VARIOUS OCCASIONS OUR CONCERNS THAT LEGISLATION BE CAREFULLY DRAFTED FOR SOME OF THE REASONS THAT JOANNE POINTED OUT THAT THERE ARE A NUMBER OF REASONS WHY HEALTH PLANS USE HEALTH INFORMATION AS PART OF DISEASE MANAGEMENT, AS PART OF OTHER PROGRAMS IN COMMUNICATING WITH A PROVIDER AND COMMUNICATING WITH PATIENTS AND WE WANT TO MAKE VERY SHORE SURE THAT IF THERE IS LEGISLATION THAT PASSES CONGRESS THAT IS DOESN'T JEOPARDIZE THOSE FUNCTION GS. WEWE WOULD AGREE YOU SHOULD NOT BE ABLE TO USE GENETIC INFORMATION TO UNFAIRLY DISCRIMINATE BUT MAKE SURE THAT THE INFORMATION THAT THE HEALTH PLAN HAS, THE HEALTH INFORMATION THAT PLANS HAVE BEEN USING FOR DECADES IS NOT JEOPARDIZED.

COULD YOU THEN EXTEND THAT TOWARDS THE REAL ISSUE NOW THEN WHICH IS THE BILL IN THE HOUSE? DO YOU FIND THAT AHIP'S POSITION IS ONE THAT IS STU SUPPORTIVE OF AND AGAIN YOU HAVE PROBABLY GOT A BETTER FILLINGEFINGER ON THIS THAN I WILL, IS AHIP IN SUPPORT OF TRYING TO REACH A CONSENSUS THAT GETS THIS NEW THROUGH OR FIND ITSELF MORE ALIGNED PERHAPS WITH SOME OF THE POSITIONS THAT PEOPLE ARE SORT OF ASSOCIATING WITH THE GENE COALITION?

WE ARE MEMBERS OF THE GENE COALITION. AGAIN, WHAT WE TRIED TO DO IN DEALING WITH THIS ISSUE IS EDUCATE MEMBERS OF CONGRESS ABOUT HOW HEALTH PLANS USE HEALTH INFORMATION. THE BILL THAT IS ON THE HOUSE SIDE THE SLAUGHTER BILL TO BE HONEST WITH YOU I'M NOT FAMILIAR WITH ALL THE DETAILS OF THE BILL. I KNOW IT IS DIFFERENT FROM WHAT CAME OVER FROM THE SENATE IN A NUMBER OF RESPECTS. BUT AGAIN, IF THERE IS GOING TO BE FEDERAL LEGISLATION OUR ONLY CONCERN IS THAT SOME OF THE ISSUES THAT MY MIKE AND OTHERS RAISED ARE ADDRESSED IN THE BILL.

LET ME THEN JUST -- LET ME JUST TAKING THIS AND IF YOU COULD HANG THERE FOR A SECOND. LET ME TURN TO THE OTHER SIDE OF THIS EQUATION FOR A MINUTE. NBCC AND I THINK WE SORT OF HEARD I THINK IN TESTIMONY OR IN THE EARLIER THAT THEY SORT OF DIDN'T LIKE THE SENATE BILL BECAUSE IT WASN'T AND MAYBE THIS IS NOT A FAIR WAY TO SAY IT BUT IT WASN'T TOUGH ENOUGH ON SOME OF THE SANCTIONS AND SO ON ONE END WE HAVE GOT THIS SENATE BILL WHICH IS SORT OF A -- S'S IT IS KIND OF STRANGE TO SAY IT BUT A MIDDLE GROUND KIND OF DEAL. SOME FEEL LIKE THE SENATE BILL HAS TOO MUCH IN TERMS OF RISK ON THE PART OF EMPLOYERS IN TERMS OF LEGISLATIVE SANCTIONS AND UNININTENDED LEGAL EXPOSURE WHICH MAKES THEM NERVOUS AND YOU GOT OTHER FOLKS SAYING IT ISN'T TOUGH ENOUGH AND THEN THE SORT OF MIDDLE GROUND SOME WHERE. DO WE UNDERSTAND ANYTHING OR LEARN ANYTHING RIGHT NOW ON THE POTENTIAL OF FRACTIONIZATION ON THE SIDE OF THE PEOPLE THAT SORT OF WANT IT MORE? YOU KNOW, I MEAN ARE WE GOING TO SEE ANY BRINGING TOGETHER OF THAT PART OF THE COMMUNITY? OR ARE WE GOING TO SEE THE NBCC SORT OF STAYING WAY OUT AND NOT COMING IN TO ANY CHANCE OF A GRAMMAR OF CO-EXISTENCES ON THIS?

CAN I SPEAK TO THAT. NOW SOMETHING ABOUT THE NBCC POSITION AND THEY ARE GENERALLY PEOPLE WHO SAY THAT BREAST CANCER THINGS LIKE BREAST CANCER IS -- WOULD BUT CURED IF IT WERE A MEN'S DISEASE AND I THINK THEY POLITTE SIZED THE ISSUE SO MUCH THAT THEY REALLY ARE OFF TO ONE SIDE. I AGREE THAT THIS SHOULD NOT BE A SITUATION WHERE SOMEONE BECOMES SIN DFLS ISTER. I DO THINK THAT THE STAKE HOLDERS THAT YOU ARE HAVING ABOUT THOSE THAT HAVE A VESTED INTEREST IN GETTING THIS MOVED ALONG ARE NOT CHAMPIONED ANY LONGER BECAUSE THE NATIONAL PARTNERSHIP FOR WOMEN AND FAMILIES HAS BASICALLY LOST THEIR -- OUR CHARGE LEADER. SHE HAS SINCE GONE TO A DIFFERENT ORGANIZATION SO THERE REALLY ISN'T ANY ONE OUT THERE CONSOLIDATING STILL LEADING THE CHARGE FOR THOSE OF US WHO ARE STILL IN IT. I THINK THAT IS A BIG PROBLEM. I ALSO THINK THAT IT IS DIFFICULT FOR YOUR COMMITTEE TO APPROACH CONGRESS BECAUSE OF ENJOINEDERS AGAINST YOUR LOBBYING ACTIVITIES. I WOULD SAY IN ECHOING SOMETHING DOCTOR COLLINS SAID SECRETARY THOMPSONS'S WIFE, HIS MOTHER-IN-LAW AND HIS DAUGHTER HAVE ALL HAD PREMENOPAUSAL BREAST CANCER. I THINK THERE IS BRCA1 AFOOT. I THINK THAT THOSE OF US OUT THERE ARE WAITING FOR HIM TO SPEAK FORMALLY ON THIS ISSUE AND I THINK HE WOULD DO VERY -- GO FORWARD FAR FORWARD GETTING IT DONE.

AS WE TRY THEN TO SEE WHERE WE PUT -- WHERE THE LEVERAGE POINTS ARE FOR US TO BE ABLE TO DO SOMETHING MEANINGFUL, MR. AKIN MENTIONS A MEETING THAT OCCURRED NOT LONG AGO -- A FEW MONTHS AGO WHERE IT SOUNDS LIKE THERE WAS SOME SENSE OF TRYING TO GET A CONSENSUS ON THE PART OF DIFFERING PARTIES AND TO DATE NO RESPONSE. I'M SURE PROBABLY OTHERS MAY HAVE -- THE OTHER FOLLOW FOLKS THAT DIDN'T RESPOND YET MAY HAVE A VIEW ABOUT THAT BUT AT THE END OF THE DAY IS THERE ANYTHING THAT ANY ONE HERE CAN TELL US THAT IS ANOTHER MEETING THAT IS PLANNED? ANY BEHIND THE SCENES SORT OF BROKERING TO TRY TO GET THIS DONE? OR FROM ALL OF AVAILABLE INFORMATION THAT THE POINT IS THIS COMMITTEE LEFT TO ASSUME THAT THERE IS THE -- THAT THIS THING HAVE FRACTIONIATED AND THE PARTY IS ARE IN SEPARATE CAMPS AND THERE IS NO WAY TO PULL ABOUT TOGETHER? CAN WE KNOW ANYTHING ABOUT THE CURRENT STATUS.

II'M NOT OEN THE PANEL BUT I REPRESENT.

PLEASE STATE YOUR NAME AND COME TO THE MIKE. [ INAUDIBLE ]

I REPRESENT --

MY NAME IS JOANNE HOWES. I'M WITH A FIRM DDB BASS ANDHOUSE AND HAVE BEEN WORKING WITH THE COALITION FOR GENETIC FAIRNESS THAT BECKY FISHER REVENUE RENED ON BEHALF OF THE NATIONAL PARTNERSHIP FOR WOMEN AND FAMILIES. I MEAN I THINK THE REALITY THAT MANY OF US FEEL IS A THAT WE WORKED VERY HARD TOGETHER. THE BILL THAT PASSED THE SENATE WE WORKED -- THERE WERE CHANGES MADE THAT YOU KNOW OUTSIDE OF THE NATIONAL BREAST CANCER COALITION GROUPS SAW IT, IT WAS A COMPROMISE. IT WASN'T WHAT EVERYBODY WANTED. BUT WE FELT IN GOOD FAITH THAT WAS THE RIGHT WAY TO GO. WE HAD BEEN ASSURED THAT THE POINT IN TIME THAT IT HAD THE SUPPORT OF THE CHAMBER OF COMMERCE, THAT IT HAD THE SUPPORT OF THE HEALTH INSURANCE INDUSTRY AND THAT THEY HAD BEEN AT THE TABLE FRANKLY MORE THAN WE HAD BEEN AT THE TABLE WHEN THE NEGOTIATIONS GOT MADE TO MOVE S105 # 3 SO WHERE WE ARE NOW IS THAT WE WORKED ALSO VERY HARD TO GET THE ATTENTION OF PHAEDRA IS IN THE SPEAKER'S DISTRICT AND HAS BEEN WORKING HARD TO GET THE ATTENTION OF THE SPEAKER AND WORKING HARD TO GET THE ATTENTION AS DR. COLLINS SAID OF THE PEOPLE IN TEXAS AND I THINK A THAT WE FEEL SOMETIME STYMIED.

THANK YOU FOR THAT. I THINK I CAN TAKE WHAT YOU ARE SAYING HERE. AS OF RIGHT YOU YOUR ANSWER IS THAT WE ARE UNAWARE OF ANY PARTICULAR ACTIVITY THAT IS ON THE DOCKET WHERE EVERYBODY IS SORT OF SITTING DOWN AND TRYING TO WORK THIS OUT, THAT THIS SORT OF SEEMS TO BE A GREAT DEAL OF FRAUS FRUSTRATION.

IT IS ELECTION RELATED. NOTHING IS HAPPENING IN THIS TOWN THAT IS NOT ELECTION RELATE.

THEY SAID -- THE REPUBLICAN LEADERSHIP SAID THEY'RE NOT GOING TO DO IT THIS YEAR.

THANK YOU VERY MUCH. WE WILL START NOW NAILING THIS THROUGH TO SOLUTIONS BUT ED YOU WANTED TO COMMENT.

I JUST WANTED TO COMMENT, FIRST OF ALL, ABOUT THE ELECTION BUT THEN I AM CONCERNED THAT IN THE NEXT SESSION THAT IT WILL STILL BE STUCK AT DESK AND SO THE ISSUE AND MAYBE CINDY I THINK THE ISSUE IS HOW DO WE PRY IT LOOSE SO THAT THERE CAN BE THE DELIBERATION? AS LONG AS IT IS NOT UNDER DELIBERATION THEN THERE IS NO DISCUSSION AND IT BASICALLY DOESN'T! IST. SO THE ISSUE IS HOW DO WE PRY IT LOOSE SO THERE CAN BE PUBLIC DISCUSSION?

WELL, PHAEDRA HAS A COMMENT.

I WANT TO QUICKLY COMMENT ON MY CONVERSATIONS WITH THE SPEAKER'S OFFICE AND THEY HAD A READY ANSWER. IT IS CLEARLY SOMETHING THAT IS ON HIS PLATE AND SOMETHING THAT THEY HAVE REVIEWED AND THIS HAVE WITH THE SENIOR HEALTH POLICY ADVISOR SO I FELT LIKE IT WAS SOMEBODY IN THE SNOW KNOW IN TERMS OF WHERE THE SPEAKER SAT ON THIS. HIS COMMENT WAS THAT WE ARE NOT GOING TO LEGISLATE SOMETHING THAT IS NOT HAPPENING. THEY ARE LOOKING FOR BODIES AND CASUALTIES AND UNTIL THEY HAVE THE CASUALTIES THEY ARE NOT WILLING TO MOVE FORWARD ON IT. WE'RE CASUALTIES. I'M THE ONLY ONE HERE FROM THE SPEAKER'S DISTRICT. PERHAPS IT NEEDS TO COME IN A CON AT THIS TIME WENT LEVEL.

THANK YOU, ED. THAT WAS THE PURPOSE OF TODAY'S PANELS BECAUSE WE HAVE BEEN HEARING THAT IT DOESN'T EXIST BUT I CAN TELL YOU AS A MEDICAL GENETIC PROFESSIONAL IT DOES EXIST A BECAUSE IER THAT OVER AND OVER. WHAT WE DO IS THAT WE PRIME MINISTERPERHAPS AS AWAY OF PREPARING YOURSELF FOR THE NEXT ROUND, I DON'T KNOW IF ANYBODY LOOKED THROUGH THIS BUT THE TESTIMONY WE HEARD THIS MORNING IN THE FIRST PANEL WAS INCREDIBLY POWERFUL. THE DOCUMENTATION THAT WE HAVE IN THE SPIRAL BOUND BOOK IS INCREDIBLY POWERFUL AND SUGGESTS THAT IT IS STILL ANECDOTAL BUT AN ACCUMULATING NUMBER OF ANECDOTES. NOT SOMETHING THAT CAN EASILY CONTINUE TO BE SWEPT UNDER THE RUG. I WOULD PRO PROPOSE, REED, SOME DISCUSSION PERHAPS WITH YOU AND SARA OVER THE LUNCH ABOUT WHAT IT WOULD TAKE AND WHETHER THERE IS STAFF TIME AVAILABLE TO TAKE THIS SPIRAL BOUND NOTEBOOK AND SUMMARIZE IT TO SEND IT FORWARD.

THAT IS A TERRIFIC SUGGESTION. LET ME TRY THIS THEN AND LET THE COMMITTEE. LET ME PRO POTES WHAT I PROSE ANDLE MISS SOMETHING. WHEY THINK I HEAR AT LEAST AS NEXT STEPS. NUMBER ONE, THAT THIS IS THE MOST MINIMAL STEP IS THAT WE ASK FOR A MEET MEETING WITH THE SECRETARY OF HEALTH TO TALK TO HIM ABOUT HOW SERIOUS AN ISSUE WE THINK THIS IS. THAT WE WOULD PRESENT TO HIM A SUMMARY WITH DETAIL OF THE TESTIMONY WE HEARD HERE TODAY.



Caller: ARTICULARLY THE OVERWHELMINGLY POWERFUL STATEMENTS FROM THE PUBLIC COMMITTEE AS WELL AT SCIENTIFIC STUDTY STUDIES THAT WE HEARD FROM THE HEALTH PROFESSIONAL COLLEAGUES SO THAT WE BIND THAT SOMEHOW TOGETHER IN A DOCUMENT AS ED I THINK HAS JUST SUGGESTED THAT WE CAN HAND TO HIM AND AT SAME TIME PERHAPS ASK HIM IF HE MIGHT BROKER AT THAT CONVERSATION A MEETING WITH THE SECRETARIES OF LABOR AND OF COMMERCE?

JUSTICE. EXCUSEEXCUSEEXCUSE ME, I FORGOT. JUSTICE. AND ASK THEM ALL TO COME TOGETHER AND OR SENIOR PEOPLE SO WE CAN GIVE IT ALL TO THEM AT ONE TIME WITH ALL OF THEM TO TRY TO EXTEND THE NATURE OF THE CONVERSATION WITHIN THE FEDERAL GOVERNMENT. OF COURSE, ALL THIS DEPENDENT UPON FRANCIS' IMPORTANT REALITY CHECK ABOUT WHAT HAPPENS IN THE NEXT COUPLE OF WEEKS AND SO FORTH AROUND SO ON. SO THAT MEANS BY THE WAY WHATEVER WE COME UP WITH WE WILL WIND UP WITH A CONFERENCE CALL DISCUSSING NEXT STEPS BASED EVEN SOME OF THOSE REALITIES.

I WOULD POINT OUT THAT AN IMPORTANT THING HAS OCCURRED. YOU MENTIONED IT. OUR CHARTER HAS BEEN CONTINUED TO 2006 SO NO MATTER WHAT HAPPENS.

GOOD POINT.

WE CONTINUE.

AND THIS ISSUE WILL CONTINUE.

SO MAYBE THE STRATEGY COULD BE THE SAME.

I MEAN I THINK IT IS IMPORTANT FOR US TO BEGIN THE STRATEGY SO THAT WE CAN ADDRESS THE PROBLEM IN THE NEXT SESSION OF CONGRESS.

NUMBER TWO, THAT IF PART OF OUR ASKING FOR THAT MEETING WITH THE SECRETARY THAT WE WOULD TAKE THE SAME DOCUMENT THAT WE ALREADY GOT BOUND TOGETHER AND WE WILL WORK ON, SARA, THANK YOU, WOULD BE THAT WE WOULD ASK THAT THAT TESTIMONYPY -- TESTIMONY BE TRANSMITTED TO THE CONGRESS AS A FUNCTION OF WHAT WE DO SINCE WE CAN'T DO IT DIRECTLY WE HAVE TO SORT OF SAY THAT WE ARE SO CONCERNED ABOUT THIS THAT WE HAVE ASKED THE CONGRESS, WE WANT TO GET IT TO THEM AND YOU ARE THE ONLY WAY WE CAN DO THAT THAT SO PLEASE SEND IT. NUMBER THREE, FRANCIS INDICATES THAT WHATEVER WE DO WITH CONGRESS SHOULD BE FOCUSED IN ON THREE MAJOR FOCI. NUMBER ONE BEING THE SPEAKER. NUMBER TWO THE MAJORITY LEADER AND NUMBER THREE BEING JOE BART KWRO PB. THAT DMITEE AGAIN?

ENERGY AND COMMERCIAL.

AND EDUCATION IN THE WORK FORCE. I BELIEVE THE BILL HAD BEEN REFERRED TO THREE THREE DIFFERENT COMMITTEES IN.

ENERGY AND THE COMMERCE IS THE ONE THAT SERVE LOOKING AT TO TAKE THE LEAD IF YOU WANT TO MAKE YOUR EFFORT MOST LIKELY TO YIELD FRUIT I WOULD GO FOR ENERGY AND COMMERCE.

YOU DON'T WANT THE OTHER CHAIRMEN TO FEEL LIKE THEY HAVE BEEN IGNORED OR GIVE THEM SO SORT OF EXCUSE FOR SAYING HEY, I WASN'T PART OF THAT DEAL OR DIDN'T GET THAT STUFF. I WOULD SEND IT TO THE CAME AND AND RANKING MEMBER.

FINE BUT PRIORITYIZE FRIENDLY AMENDMENT AND THAT SOUNDS LIKE A WINNER. YOU HAD A COMMENT?

IN LOOKING THROUGH THIS BOOK WHAT I DON'T SEE IS ACTUAL COPIES OF EVERYONE'S TESTIMONY THAT WAS GIVEN TODAY TO.

WE WILL GO BACK AND GET THOSE.

PUT ALL THAT TESTIMONY IN AND ALSO WHERE PEOPLE ARE FROM. WHAT CONGRESSAL CITIES DISTRICT. STAY SNED STATE IS EXTREMELY HELPFUL.

GOOD.

IT PWR EUPBGS HOME THE FACT THAT THIS IS NOT -- IT BRINGS HOME THE FACT THAT THIS IS NOT JUST ONE CONGRESSMAN'S ISSUE. AN ISSUE FOR ALL.

AND I WILL MARCH THROUGH THE NEXT ONE BUT I THINK I SEE ED'S HAND.

I WOULD SAY AS POWERFUL AS THE COMMENTS WERE FROM THE FIRST PANEL I WOULD INCLUDE THE COMMENTS FROM ALL PANELS THIS IMPORTANT MORNING.

YES.

THAT IS TERRIFIC.

THE NEXT THING THAT WE HEAR IS THAT WE WILL SEND A LETTER TO THE GENE COALITION ASKING CYNTHIA'S POINT AND YOU HAVE TO ASK ME WITH THE LANGUAGE, ULTIMATELY IS WOULD YOU PLEASE BE FIF FICK ABOUT WHAT IT - SPECIFIC ABOUT WHAT IT IS THAT IS WRONG ABOUT THIS LEGISLATION THAT YOU OBJECT TO AND WHAT IS THE SOLUTION TO THIS PROBLEM? I THINK IT WAS FRANCIS' POINT AS WELL, WAS PRETTY CLEAR ON IT SO THAT IF YOU GUYS ARE PERCEIVED AS BEING YOU, KNOW, THE HOLDUP HERE THEN HELP US TO SOLVE THE PROBLEM OR DECLARE FOR ONE AND ALL THAT IS HOW YOU FEEL THAT THAT AIN'T IS PROBLEM AND WE ARE GOING TO STICK TO THAT AND AIN'T CHANGING SO WHAT IS IT. TELL US WHAT IT IS. SIMILARLY, AHIP. I THINK HAS A RESPONSIBILITY HERE BECAUSE IT HAS BEEN ASKED SPECIFICALLY IN THE MEETING TO STATE WHERE YOU ARE ON IT AND HOW YOU VIEW IT AND I THINK THAT THE ISSUE SPECIFICALLY FOR AHIP IS TO BE VERY CLEAR ABOUT WHETHER OR NOT IT IS A PROBLEM OF USE OF THE INFORMATION FOR COORDINATING CARE, YOU KNOW, THAT STUFF WHICH IS -- AND I'M GOING BY THE WAY, ASK THE PEOPLE FROM THE ADVOCACY COALITIONS, I THINK THAT OUR THINKING ON THIS WILL BE GREATLY ADVANCED IF YOU HAVE STRONG FEELINGS ABOUT THE USE OF THE INFORMATION FOR COORDINATION OF CARE, YOU KNOW, IF YOU DON'T HAVE -- I MEAN IF YOU HAVE A PROBLEM WITH EVEN THAT THAT PART OF IT WE ALL REALLY NEED TO UNDERSTAND THAT BUT IF YOUR ISSUE IS REALLY THE DISCRIMINATION ISSUE AROUND UNDERWRITING AND INSURANCE AND SO FORTH WE NEED TO -- YOU KNOW, THAT IS ONE THING. BUT IF SOMEBODY IS SAYING HEY, YOU ARE NOT SUPPOSED TO EVEN THOUGH IT TO COORDINATE CARE WHICH IS ALL THE TESTIMONY WE HEARD FROM THE AETNA REPRESENTATIVE AND THAT IS WHAT AHIP'S POINT IS THEN WE NEED TO KNOW WHETHER THAT IS AN ISSUE OR NOT. I THINK IT IS PROBABLY THE OTHER AND MAYBE I'M GENERALIZING TOO MUCH.

I WOULD ASK ALSO AND I DON'T THINK THAT WE CAN APPROACH OR YOU CAN APPROACH THE CHAMBER DIRECTLY. BUT I WOULD ASK THE COLLEAGUES AT THE CHAMBER OF COMMERCE GIVEN THAT I HAVE DEMONIZED THEM HERE TODAY TO RESPOND. BECAUSE AS CINDY SAID PEOPLE IN THE ROOM ALL UNDERSTAND THAT WE HAVE ISSUES BUT NOT BEING IN THE ROOM RAISES SERIOUS QUESTIONS SO I WOULD ASK FRIENDS OF THE CHAMBER TO TAKE BACK THE MESSAGE THAT PERHAPS THEY MIGHT WANT TO RESPOND IN THE PACKET AS WELL.

I THINK THAT WE AND ED YOU HAVE MORE EXPERIENCE AT THE HELM THAN I DO VAR OR EVER HAVE, I HOPE, BUT I THINK WE ARE ABLE TO WRITE A LETTER GIVEN THAT TESTIMONY HAS COME UP AND OFFER THEM THE OPPORTUNITY TO CLARIFY AND I THINK YOU ARE GOOD SO WE WILL ALSO SEND A LETTER TO THE CHAMBER. BUT MR. AKIN, I WOULD PROBABLY SAY THAT GIVING GIVEN THE NUMBER OF ORGANIZATIONS THAT I ASSUME THAT ARE IN THE ORGANIZATION AND THE CLOUT THE CHAMBER MAY BE AN ISSUE BUT SERVE IMPORTANT TO OUR COMMITTEE AND WE WOULD LIKE TO HEAR IT GO. I THINK THAT IS MY LIST AND I'M WONDERING WHAT IT WE MISS?

-- WHAT DID WE MISS?

YES.

I WOULD JUST RECOMMEND YOU TALKING TO DOCTOR MCCABE'S POINT ABOUT WE HAVE CUMULATIVE ANECDOTE AND ALL THE SPEAKERS TESTIMONY AND PUBLICATIONS WITH HARD DATA AND I WOULD STRONGLY RECOMMEND THAT THOSE DATA BE PART OF THE PACKET THAT YOU ARE COMPILING.

I GUESS THE LAST POINT WOULD BE THIS AND THAT IS I WONDER WHETHER -- I THINK WHAT THE COMMITTEE IS CLEAR ABOUT IS THAT THIS ISSUE HAS BEEN PRIORITPRIORITIZED. I WOULD BE SURPRISED IF IT THERE IS ANYTHING ON THIS DMITEDMITECOMMITTEE TODAY THAT FEELS LESS STRONGLY TODAY THAN THEY DID BEFORE. I THINK WE ARE ALL JAZZED UP ABOUT THIS. ASSESS MAYBE AT THE NEXT MEETING, YOU KNOW, CONSIDER BRINGING TOGETHER THOSE PEOPLE THAT ARE DETERMINANT AND IF THERE IS NO NEGOTIATION OR CONVERSATION HAPPENING ODD OF THE ROOM PUT A LITTLE CIRCLE AND INVITE PEOPLE TO IT AND YOU KNOW IF YOU DON'T COME YOU GET ED MCCABEED, YOU NOW ( LAUGHTER )

I MEAN SORT OF STRIKE FEAR IN EVERYBODY'S HEART. SO WE CREATE A CIRCLE AND SAY LOOK, WE'RE GOING TO LOCK THE DOOR AND HAVE EVERYBODY WORK IT OUT. IF THERE IS NOBODY ELSE WORKING IT OUT. THEN MAYBE WE HAVE TO. THAT IS NOT THE KIND OF JOB WE WOULD HAVE BUT IN A VACUUM THAT IS HOW I FEEL. CLEARLY WE NEED TO TALK ABOUT THIS AGAIN AS A COMMITTEE. IT IS CLEAR THAT WE NEED TO PROBABLY HAVE A CONFERENCE CALL ON THIS. IF WE GOING TO GET ANYTHING SO WE WILL SUMMARIZE THIS AND GET IT BACK TO FOLKS AND PROBABLY DO A QUICK CALL AND NOT TAKE A LOT OF Y'ALLS TIME BUT MAKE SURE WE ARE LOCKED IN ON THIS AS WE GO FORWARD.

I WANTED TO OFFER AN ASSISTANCE TO THE DEPARTMENT OF JUSTICE HAVE THE COMMISSION INDEPENDENTLY ANALYZE THE GAPS MAYBE LEGISLATIVELY WE HAVE A LOT OF EXPERIENCE IN THIS AREA SO WE WOULD LIKE TO DO THAT.

THAT WOULD BE A GREAT ADDITION. ONE THING ABOUT THE LUNCH. KWRA L ARE NOTY'ALL ARE NOT GOING TO BE HAPPY EITHER THE MEMBERS OF THE COMMITTEE OR THE GUESTS ABOUT LUNCH. IT IS SHORT. AND IT IS A NO FUN LUNCH BREAK. IT IS NOT BECAUSE WE ARE RUDE AND WE DON'T LOVE YOU OR CARE ABOUT YOU. THERE ARE MORE LAWS AND REGULATIONS THAT TELL US WHETHER OR NOT YOU CAN HAVE FOUR PEOPLE IN A ROOM WITH A SANDWICH AND THAT WILL MAKE YOUR HAIR HURT AND I WILL HAVE TO TELL YOU THAT THERE IS A REASON WHY THIS THING IS SET UP THE WAY IT IS. AND IT IS NOT BECAUSE WE ARE RUDE. SOME OF Y'ALL GOT TO RUN AND FIND A SANDWICH AND BE BACK HERE BY IN 15 MINUTES AND IT AS WORKING LUNCH AND IT IS ALL SCRUNCHED UP LIKE THIS IS THE ONLY WAY WE CAN FEED THESE PEOPLE IS TO MAKE THEM WORK DURING THE TIME THAT THEY ARE ACTUALLY EATING OTHERWISE WE COULDN'T EVEN GIVE THEM A HA HAMBURGER. I APOLL GUIDANCE FOR IT. THAT IS THE WAY THE BUREAUCRACY IS. THANK YOU VERY MUCH. SEE YOU ALL IN FIFTEEN MINUTES. DEFINITION CERTAINLY CAN DO SO BUT IF THERE IS DISCUSSION AMONGST THE COMMITTEE MEMBERS ABOUT WHETHER THEY WANT TO DO THAT I SUPPOSE NOW MIGHT BE A GOOD TIME TO DO SO.

I COULDN'T REMEMBER WHERE IT CAME FROM BUT IT SEEMED THAT IT WAS FROM PRIOR COMMITTEE WORK AND IT WAS A CONSENSUS AND I'M NO EX-CERT IN -- EXPERT IN THE FIELD SO I DEFER TO OTHERS AS TO MODIFICATION OF THE DEFINITION. WE SHOULD BE CONSISTENT AND SHOULDN'T HAVE DIFFERENT DEF NEXES IDEFINITIONS.

IT DOES COME FROM SACGHS.

RIGHT, THE OVERSIGHT REPORT AND THERE WAS A LOT OF DELIBERATION AROUND THERE AT THE TIME.

RIGHT.

CERTAINLY WE WANT FOR THE DIFFERENT REPORTSS TO BE CONSISTENT.

I COULD REFER YOU TO THE OTHER REPORT OR WHO EVER. THERE IS A CLEAR DEFINITION OF GENETIC AND GENOMICS AND SO IF WE ARE REFERRING TO A GENETIC TEST THAT IS A TEST TO LOOK AT GENETIC DISEASES AND THAT GENETIC DEFINITION DOES NOT INCLUDE A CHOIRED. THAT IS IN GENOMICS. IF IF YOU LOOK AND PAGE 19, THE -- THERE IS A DEFINITION FOR GENETICS AND GENOMICS TECHNOLOGY BUT IN DEFINITION OF THE GENOME TEST.

RIGHT.

TO YOU

SO YOU WOULD LIKE CHANGED THE DEFINITION OF THE GENOME TEST.

I WOULD BUT I DON'T KNOW WHAT OTHER COMMITTEE MEMBERS THINK ABOUT THIS AND MAYBE ED AND REED YOU WERE PART OF THE PREVIOUS SACGHS DELIBERATIONS THAT INCLUDED ACQUIRED BUT IT IS CONCERNING THAT LOOK AT THE WHOLE REVIEW DOCUMENT OF OUR DLIB RAIS ON DELIBERATIONS THAT WE DO DEFINE GENETICS WITHOUT INCLUDING ACQUIRED AND THAT IS INCLUDED IN GENOMICS WHICH I AGREE ACQUIRED DOES FALL INTO GENOMGENOMIC TESTING IF YOU WANT TO DEFINE THAT CIENT OF TESTING. -- THAT KIND OF TESTING.

I'M TRYING TO READ THIS THROUGH QUICKLY. SO, I SEE THE SIDE-BAR ON 19. IS THAT CHA YOU ARE REFER.

IS THAT WHAT YOU ARE REFERRING TO.

THE FIRST SENTENCE THAT SAYS THE GENETIC TESTING PERFORMED ON TO DEFECT [ INDISCERNIBLE ]

IT IS THE OR ACQUIRED THAT BOTHERS ME. AND I CAN REFER YOU TO THE OTHER DOCUMENT.

YEAH, SO I THINK IF YOU HEN LOOK DOWN TO WHAT ARE GENETIC AND GENOMIC TECHNOLOGIES, I THINK THAT IS WHERE IT TALKS ABOUT ACQUIRED -- AGAIN, ACQUIRED THERE. SO IT LOOKS LIKE IF WE WENT BACK TO THE VISION REPORT AND JUST BROUGHT THE TWO PAGE 2 OF THE -- A ROAD MAP FOR THE INTEGRATION OF GENETICS AND GENOMICS INTO HEALTH AND SOCIETY. IS THAT WHAT YOU ARE REFERRING TO SGLSMT YEAH, I THINK ONE CAN GO BACK TO THE DEFINITION.

THE ROADMAP IS ON TAB 3 AND WE ARE TALKING PAGE 2.

I THINK IT IS IMPORTANT FOR US TO BE INTERNALLY CONSIST EPT AND I DON'T SEE ANY NEED FOR US TO BE CONSISTENT WITH THE WORK OF A PREVIOUS COMMITTEE RECOGNIZING THE YEARS HAVE ELAPSED SINCE THAT AND THE SACGHS DEFINITION I THINK WAS TAKEN ACTUALLY FROM AN EARLIER COMMITTEE SO THERE HAS BEEN QUITE A BIT OF TIME BETWEEN WHEN THAT WAS CRAFTED. I WOULD SUGGEST THAT WE BRING IT IN TO CONSISTENCY WITH THE ROAD MAP. THAT WOULD SEEM TO MAKE SENSE.

BOTTOM LINE IS WE ARE TALKING ABOUT TRYING TO TAKE THE DEFINITION IN THE REIMBURSEMENT DOCUMENT AND SUBSTITUTE THAT ONE WITH THE BOX ON PAGE 2 WHICH SO THAT WE ARE CONSISTENT IN TERMS OF HOW WE DO THIS.

SIR SARA?

I WON'TED TO POINT OUT THAT WHEN THEY WERE DELIBERATING WE HADN'T PERHAPS IT WAS AN OVERSIGHT ON OUR PART BUT WE HADN'T REALLY -- THE ISSUE ABOUT THE TERM GENOMICS DIDN'T REALLY -- WE DIDN'T HAVE DEEP DELIBERATIONS ABOUT THAT THE WAY WE DID HERE IN THE LAST MEETING. AND SO WE WEREN'T TRYING TO MAKE THAT DISTINCTION. THAT IS WHAT THE DEFINITION IN THE ROADMAP REPORT DOES IS TRIES TO CLARIFY WHAT WE MEAN BY BOTH THOSE TERMS AND THAT THEY ARE BOTH IMPORTANT BUT IF WE WERE GOING TO ADOPT OR USE THAT AS THE BASIS FOR WHAT WE HAVE IN THE COVERAGE AND REIMBURSEMENT PART IT STILL SEEMS LIKE WE NEED TO DO A LITTLE BIT OF WORK TO TRANSLATE THOSE CONCEPTS INTO WHAT A TEST IS AND WHAT A GENETIC TEST IS AND WHAT A GENOMIC TEST IS. I'M NOT SURE IT MIGHT BE HELPFUL TO HAVE MAYBE NOT RIGHT NOW BUT YOU AND EMILY AND OTHERS AND ED INVOLVED IN HELPING US DO THAT BECAUSE I'M NOT SURE IT IS A STRAIGHTFORWARD TANS TRANSLATION.

AS I LOOK AT IT THE DEFINITION ON PAGE 2 IS THE DEFINITION OF GENETIC AND GENOMICS AND DOESN'T TRANSLATE IT INTO THE TESTING.

RIGHT.

IF YOU LOOK AT WHAT OF GENETIC SLASH/GENOMIC TECHNOLOGIES THAT WOULD BE TRANSLATABLE FOR GENOMIC TESTING AND JUST SEPARATE THEM OUT. I THINK IT COULD BE DONE BY A SMALL --

I THINK MAYBE WHAT WE MIGHT ALSO DO. ONE OF THE CHALLENGES AND JOBS THAT WE HAVE AND SARA I WANT TO MAKE SURE HERE IS THAT IS TO EDUCATE THE PUBLIC AND SO WE OUGHT TO TAKE EVERY OPPORTUNITY TO REMIND PEOPLE ABOUT THE FUNDAMENTAL BLOCKING AND TACKLING TERMS AND SO WHAT I THINK WE SHOULD TO DO DO PERHAPS OR CONSIDER AS A SMALL GROUP IS STATE THE DEFINITION FIRST IN THE VISION STATEMENT AND THEN SAY WHAT THIS MEANS IN TERMS OF GENETIC TESTS AND TECHNOLOGIES IS THIS SO YOU CAN SEE THE LOGICAL PROGRESSION OF THE IDEAS. BUT I THINK THAT WE HAVE GOT TO TAKE EVERY CHANCE WE CAN TO EDUCATE.

I KNOW THIS SOUNDS LIKE A SMALL POINT BUT IT IS IN THE MINDSET IT IS NOT BECAUSE GENETICS WHERE IT IS INHERITABLE HAS DIFFERENT ETHICAL LEGAL AND SOCIAL EMPLICATIONS THAN ACQUIRED MUTATIONS AND WHILE THEY ARE DONE USING THE SAME TECHNOLOGIES IN THE LABORATORY THE SURROUNDING ISSUES ARE QUITE DIFFERENT.

YES.

BUT DEBENTURE WRA, FOR COVER -- BUT DEBRA, FOR COVERAGE IN THIS CASE IS THE INTENT TO INCLUDE GENOME AND THE HE IISA HE IISA IS A MAN TICK.

TO INCLUDE.

IT IS CONFUSING TO HAVE A DEF NEX OF DEFINITION OF A GENETIC TEST WHEN WE DEFINED GENETICS ELSEWHERE.

SEEMED TO MAKE IT CONSISTENT BUT INCLUDE IT ALL.

I DEFINITELY WANT GENOMICS INCLUDE.

WE WILL HAVE ED AND DEBRA WILL WORK ON THIS WITH THE -- WITH YOU? SUSAN? ALL RIGHT. SO ED AND DEBRA WILL WORK ON THIS. THANK YOU FOR DOING THAT.

THE NEXT SECTION OF THE REPORT FOCUSES ON HOW COVERAGE DECISIONS ARE MADE IN BOTH THE PUBLIC SECTOR AND THE PRIVATE SECTOR AND OUTLINES THE MEDICARE COVERAGE DECISION-MAKING PROCESS, NATIONAL COVERAGE DECISIONS AS WELL AS LOCAL COVERAGE DECISIONS AND REVIEWS IN GENERAL HOW THESE DECISIONS ARE MADE IN THE PRIVATE SECTOR AND THEN REVIEWS THE STATE OF PLAY IN TERMS OF COVERAGE FOR GENETIC TESTS AND SERVICES IN BOTH THE PUB PUBLIC AND PRIVATE PECKESECTOR AND THE ROLE OF ECONOMIC EVALUATIONS. THEN WE MOVE ON TO PAYMENT DECISIONS. CLINICAL LABORATORY FEE SCHEDULE AND THE EXISTING PAYMENT RATES FOR GENETIC TESTS AND SERVICES. AND THEN, OF COURSE, THE BILLING PROCESS HOW ARE CODES DEVELOPED. HOW ARE THE TESTS AND SERVICES CODED. WHAT ARE THE BILLING PRACTICES IN MEDICARE AS WELL AS IN THE PRIVATE SECTOR.

SO I WILL PROVIDE THOSE CPT CODES BUT QUESTION, DO TKO YOU WANT THEM AS GENETIC CPT AND THERE ARE GENETIC ONES AND GENOMIC? THE SAME C ABOUT PT CODES COVER BOTH.

I THINK WE NEED TO CLARIFY THAT SO THAT THOSE READING ITLE UNDERSTAND.

YES.

HERE IS WHERE WE GET TO THE MEAT. BARRIERS AND RECOMMENDATIONS. THE REPORT OUTLINES SPECIFIC BARRIERS TO COVERAGE AND REEMBURSTMENT IN THE MEDICARE PROGRAM AND OTHER PUBLIC PROGRAMS AS WEM AS IN THE PRIVATE SECTOR AND THEN IN THE BLUE BOXES IN THE REPORT AND IF YOU HAVE A SIMPLY A STEER ROC STEERRED SOXEROXCOPY I SUPPOSE IT IS GREY. WE ADDRESS AOUTLINE SPECIFIC TO ADDRESS FOR THE BARRIERS OR MOST OF THE BARRIERS THAT HAVE BEEN IDENTIFIED. HOW WE PROPOSE GOING THROUGH THIS IS REALLY A SORT OF A SYSTEMATIC ANALYSIS OF THE REPORT AND THAT PART OF THE REPORT CALLED BARRIERS AND RECOMMENDATIONS. WE WANT THE FOCUS ON THAT SECTION. THAT THAT IS PAGES 49-73 OF THE REPORT AND GO THROUGH EACH ONE IN A SYSTEMATIC FASHION AND DISCUSS WHETHER THE PROPOSED -- WHETHER WE SHOULD MAKE A RECOMMENDATION, FIRST OF ALL. IF WE SHOULD, IF THERE IS A RECOMMENDATION OUTLINED IN THE BLUE/GREY BOX WHETHER IT IS SOMETHING THAT THE COMMITTEE WOULD LIKE TO PUT FORWARD AND ARE THERE ALTERNATIVE RECOMMENDATIONS THAT THE COMMITTEE FEELS THAT WE SHOULD INCLUDE IN THE REPORT. AND, OF COURSE, YOUR OBJECTIVE HERE IS TO REACH A CONSENSUS. IF THERE IS NO CON KEN CERUS CON KEN CERUS OR WE CAN'T COME UP WITH A RECOMMENDATION THEN IT WON'T GOO INTO THE REPORT. OUR IDEA IS AT THE END OF THE DAY OR THE END OF TOMORROW PRODUCE SOMETHING CONCRETE THAT CAN BE UTILIZED BY THE SECRETARY AND OARS AS A AND OTHERS AS A USEFUL GUIDE TO IMPROVE POLICY IN THIS AREA.

CINDY, CAN I ASK A QUESTION?

YES, DEBRA.

UNFORTUNATELY, I JUST TOOK A BITE OF BROWNIE. THE QUESTION IS IS THIS GOING TO GO AFTER WE MAKE OUR RECOMMENDATIONS DIRECTLY TO THE SECRETARY OR IS THIS SOMETHING THAT GOES OUT FOR PUBLIC COMMENT FIRST?

PUBLIC COMMENT.

OH, GREAT, OKAY. I MISSED THAT STEP.

TURNING TO MEDICARE ONE OF THE FIRST THINGS IDENTIFIED AND WE TALKED ABOUT IT IN THE LAST MEETING AND IT NS THE REPORT HERE IS THE SCREENING EXCLUSION IN MEDICARE. CMS POLICY IS SUCH THAT TESTS THAT ARE PERFORMED IN THE ABSENCE OF SIGNSION SYMPTOMSION COMPLAINTS OR PERSONAL HISTORY ARE NOT COVERED UNLESS EXPLICITLY AUTHORIZED BY STATUTE SO A PREDICTIVE TEST OR PRESYMPTOMATIC GENETIC TEST IS NOT COVERED BY MEDICARE BECAUSE OF THIS POLICY. PREVENTATIVE SERVICES THAT HAVE BEEN COVERED BY MEDICARE HAVE BEEN SPECIFICALLY AUTHORIZED BY CONGRESS SO WE DON'T HAVE THAT HERE. THIS EXCLUSION IS ONE OF THE CRITICAL BARRIERS TO COVERAGE OF GENETIC TESTS AND SERVICES IN THE MEDICARE PROGRAM. EMILY, YES?

I THINK IT IS IMPORTANT FOR US TO SAY MAJOR BARRIER FOR SOME GENETIC TESTS BECAUSE IN PAIR GRAPH THE WAY IT IS -- PARAGRAPH THE WAY IT IS WRITTEN IMPLIES THAT ALL GENETIC TESTS ARE SCREENING TESTS AND THIS IS A BARRIER FOR EVERYTHING. THIS IS A BARRIER FOR A SUB SET OF TESTS CARRIER SCREENING. WE SHOULD MAKE THAT CLEAR IN THE OPENING SENTENCE PARTICULARLY SINCE FOR WHATEVER REASON THIS WHICH I THINK IS THE SUBSET OF ALL GENETIC TESTS IS THE FIRST THING THAT APPEARS. I MIGHT SUGGEST THAT WE PUT THE ORDER IN A LITTLE DIFFERENT AND DEAL WITH THE THINGS THAT AFFECT ALL GENETIC TESTS FIRST AND THEN SOME OF THE SUB SET THINGS AS LATER JUST IN TERMS OF POINT ORGANIZATION OF THE SECTION.

RIGHT.

ESPECIALLY SINCE IN THE MEDICARE COMMUNITY IT IS LESS LIKELY TO BE A PRESYMPTOMATIC TEST.

RIGHT.

SO FROM A POINT OF VIEW OF PRESYMPTOMATIC SCREENING AND PROBABLY EVEN THE MAJORITY OF SCREENING MEDICARE IS NOT THE CARRIER THAT IS GOING TO BE PAYING FOR THAT SO THIS BECOMES ONE OF THOSE MINOR EXTRA POINTS IINSTEAD OF THE MAJOR PINTS POINTS AND I THINK WE SHOULD START WITH THE MAJOR POINT.

LOOK AT THAT -- YES, SORRY, ED?

YES, JUST BEFORE WE LEAVE THAT I WOULD ALSO POINT OUT ON PAGE 61 IS PREVENTIVE NATURE OF GENETIC SERVICES IT WOULD SEEM LIKE WE ARE RESHUFFLING AND REORGANIZING THIS IS A NICE LEAD-IN TO WHY SCREENING IS IMPORTANT AND WHY IT IS IMPORTANT TO ELIMINATE THE SCREENING EXCLUSION SO I THINK YOU CAN -- AND THERE IS NO RECOMMENDATION THAT GOES WITH THAT SO IT WOULD FIT NICELY TOGETHER.

THE WAY THAT THIS CHAPTER IS ORGANIZED IS THE MEDICARE SPECIFIC BARRIERS ARE LISTED FIRST AND THEN THE PREVENTIVE NATURE OF GENETIC SERVICES SECTION IS LISTED UNDER A BARRIER THAT IS APPLICABLE TO PUBLIC AND PRIVATE INSURERS SO IN COMBINING THE TWO THERE WOULD NEED TO BE SOME REO RE REORGANIZATION OF EACH SECTION. WE TRIED TO KEEP SEPARATE THE BARRIERS SPECIFIC TO MEDICARE AND ONES THAT ARE APPLICABLE ACROSS-THE-BOARD.

AGAIN, YOU MIGHT WANT TO DO IT THE OTHER WAY AROUND. THE ONES DONE ACROSS-THE-BOARD FIRST AND THEN DO THE MEDICARE SPECIFIC THINGS BECAUSE MEDICARE IS THE SUBSET OF ALL INSURANCE.

I THINK PROBABLY THE REASON IT WAS INITIALLY DONE THIS WAY AND IT CERTAINLY ISN'T CRITICAL THAT WE LEAVE IT THIS -- IN THIS ORDER AT ALL BUT I THINK IF I RECALL CORRECTLY THE THINKING WAS THAT MEDICARE OFTEN TIMES IS THE MODEL THAT MANY IN THE PRAO PRIVATE SECTOR FOLLOW SO HOW MEDICARE GOES THE PRIVATE SECTOR GOES AS WELL. NOT ALWAYS, BECAUSE I THINK AS WE DISCOVERED IN MANY CASES THE PRIVATE INSURERS ARE TAKING MORE OF A LEAD AND ARE BEING A LITTLE BIT MORE PROGRESSIVE IN THE AREA OF GENETICS AND GENETIC TESTS AND SERVICES BUT I HAVE NO OBJECTION AT ALL UNLESS ANY ONE ELSE DOES TO REORDERING IT SO THAT WE DO THE BARRIERS AM CBL TO BOTH PUBLIC -- APPROXIMATE CABLE APRESIDENT APPLICABLE TO PUBLIC AND PRIVATE SECTOR FIRST.

DATE IT GOING ON IN MEDICARE IS EASILY AND PUBLICLY AVAILABLE AND WHAT IS ACTUALLY GOING ON IN PRIVATE INSURANCE IS NOT ALWAYS AS EASY TO GET AT EXACTLY WHAT THEY ARE REIMBURSING OR MAKING THEIR DECISIONS SINCE THEY ARE NOT OBLIGATED TO BE PUBLIC ABOUT THAT.

DOES ANY ONE HAVE ANY OBJECTION TO CHANGING THE ORDER?

NO.

WE'LL DO IT. WE WILL STILL GO THROUGH THE REPORT THE WAY IT IS CURRENTLY CONFIGURED BUT WE WILL CHANGE THE ORDER IN THE NEXT DRAFT. THE SCREENING EX-CLUE CLIEWK CLIEWKS -- EXCLUSION BARRIER, THE RECOMMENDATIONS OUTLINED THERE IS SORT OF AN ORDER TO THIS. CMS INFORMED US THAT NUMBER FOUR, WHICH IS FOR THEM TO UNILATERALLY CHANGE THEIR INTERPRA EXPECTATION OF THE LAW TO ALAW THEM TO COVER SCREENI SERVICES WITHOUT ANY LEGISLATIVE ACTION IS UNLIKELY TO OCCUR AND IS NOT FEASIBLE AND I THINK THEY THUT THOUGHT NUMBER ONE WHICH WOULD BE FOR CONGRESS TO CHANGE THE LAW WOULD BE A BETTER APPROACH. HAVING SAID THAT WE ARE ALL AWARE OF HOW DIFFICULT IT TOSS GET CONGRESS TO CHANGE THE MEDICARE STATUTE BY ADDING A PROVISION FOR -- WE DON'T WANT TO GIVE THE IMPRESSION HA WE THINK THAT IS A CAKE WALK AND PUT THAT AS NUMBER ONE AND EVERYBODY LIKES THAT AND BE DONE WITH IT BECAUSE THAT HAS ITS OWN CHALLENGES AS WELL. THESE FOUR RECOMMENDATIONS ARE NOT NECESSARILY MUTUALLY ECK CLUE SUV EXCLUSIVE IN ANY WAY. THE ORIGINAL ORDER WAS WHAT MIGHT BE THE MOST EFFECTIVE RECOMMENDATION NOT NECESSARILY THE EASIEST OR MOST FEASIBLE. I DON'T KNOW IF ANY ONE HAS ANY SUGGESTIONS, ADDITIONAL RECOMMENDATIONS THEY WANT TO PUT UP FOR CONSIDERATION BEFORE WE GO THROUGH EACH ONE? ED?

I'M SORRY. I DON'T HAVE ANY ADDITIONAL ONES BUT I THINK ESPECIALLY, YOU KNOW, GIVEN THE VISIBILITY THAT FAMILY HISTORY IS GOING TO HAVE PERHAPS IT IS IN HERE BUT WE NEED TO MAKE SURE WE TAKE THE INFORMATION THAT ALAN GUTTMACHER PRESENTED WHICH REPRESENTS A COALITION AMONG THE HHS AGENCIES AND REALLY PLAY THAT UP SO SINCE THAT IT SOMETHING THAT THE SECRETARY IS GOING BE QUITE AWARE OF AND I WOULD JUST BUILD THAT IN HERE WITH THE WEBSITE AND ALL OF THAT INFORMATION. I THINK NUMBER ONE IS GOING TO REQUIRE A CULTURE SHIFT IN AMERICAN MEDICINE REALLY AND CULTURE IS ALWAYS HARD TO CHANGE. BUT IT IS ESSENTIAL THAT THIS CHANGE. SO WHILE IT MAY BE, YOU KNOW, IT MAY NOT HAPPEN OVERNIGHT PERHAPS AT LEAST WE CAN BEGIN HAMMERING THAT WE NEED TO MOVE FROM ACUTE INTERVENTION TO PREVENTION.

HOW DIFFICULT IS NUMBER TWO TO DO, THOUGH, IN THE CONTEXT OF THIS FAMILY HISTORY TOOL THAT IS BEING ROLLED OUT? IT WOULD BE A NICE THING TO COORDINATE THAT NOW FAMILY HISTORY THAT WE ARE EMPHASIZING CONSTITUTES MEDICAL JUSTIFICATION FOR TESTS BEING DONE SO HOW DOES TWO HAPPEN? CAN SOMEBODY INFORM US?

THIS IT TERENCE KAY FROM CMS. ACTUALLY FOR NUMBER TWO WE HAVE, YOU KNOW, A FAIRLY STRAIGHTFORWARD PROCESS WE HAVE IT ON OUR WEB PAGE OF HOW YOU -- ANY ONE THE COMMITTEE OR ANY ONE CAN ASK FOR A NATIONAL COVERAGE DECISION AND WHAT KIND OF INFORMATION WE WOULD LOOK FOR. SO SORT OF PROCESS WISE I THINK, YOU KNOW, IT IS FAIRLY STRAIGHTFORWARD. I THINK THE MAJOR ISSUE IS GOING TO BE SORT OF, YOU KNOW, I MEAN IN GENERAL AS I HAVE LISTENED TO THE DISCUSSIONS TODAY WHETHER THE ISSUES ARE LEGISLATIVE OR REGULATORY I THINK FOR COMMUNICATION PURPOSES FOR EXAMPLE I HEARD TODAY THAT THERE IS OVER A THOUSAND GENETIC TESTS. AND SO I WOULD THINK, YOU KNOW, OBVIOUSLY I COULDN'T SPEAK FOR CONGRESS BUT I WOULD THINK BOTH CONGRESS AND THE AGENCY WOULD BE WONDERING GHEE, WHAT REALLY -- GE, WHAT REALLY IS GOING ON HERE AND WHAT ARE WE WALKING INTO AND IT ALMOST SEEMS LIKE IF YOU LOOK AT THE HISTORY OF PREVENTIVE SERVICES AS ADD TO THE MEDICARE BENEFIT WHETHER MAMMOGRAMS OR COLON CANCER SCREENING OR WHATEVER THAT THERE WAS A CASE MADE -- A SPECIFIC CASE MADE FOR THOSE SERVICES AND IN A WAY THAT, YOU KNOW, EVERYONE COULD UNDERSTAND. AND FOR RIGHT NOW FOR GENETIC TESTS SORT OF LISTENING TO THE CONVERSATION OR REVIEWING THE MATERIAL I THINK A LOT OF FOLKS FRANKLY WOULD BE LIKE ME. I'M NOT A CLINICIAN. IT WOULD BE SORT OF HARD TO UNDERSTAND THE IMPLICATIONS AND WE EARLIER TODAY WE WERE TALKING ABOUT THOUSANDS IN THE TESTS AND WOULD WE WANT TO COVER ALL OF THOSE, WHICH ONES ARE REALLY MOST BENEFICIAL FOR MEDICARE? SO IT AS LONG ANSWER TO YOUR QUESTION. THE PROCESS TO DO NUMBER TWO IS STRAIGHTFORWARD BUT I THINK THE COMMENT THAT SOMEBODY MADE HERE A LITTLE WHILE AGO THAT CMS HAD INDICATED THAT, YOU KNOW, IT MIGHT BE UNLIKELY THAT WE WOULD DO NUMBER TWO. ALL I WOULD SAY IS THAT, YOU KNOW, WE TAKE THE COMMITTEE VERY SERIOUSLY AND WE ARE HAVE INTERESTED IN YOUR RECOMMENDATIONS AND WE HAVE TRIED TO ATTEND ALL OF THE MEETINGS AND I ALSO WOULD PUT IN, YOU KNOW, A PLUG FOR A LOT OF APPRECIATION FOR THE INVOLVEMENT OF THE STAFF AND THIS COMMITTEE AND HOW COOPERATIVE AND RESPONSIVE THEY HAVE BEEN TO COMMENTS WE MADE THAT HAVE BEEN REFLECTED IN THE DRAFT REPORT. I THINK IT HAS BEEN A VERY PRODUCTIVE RELATIONSHIP WHERE WE UNDERSTAND A LOT MORE THAN WHEN WE STARTED AND HOPEFULLY OUR CONCERNS LIKE WISE THAT YOU KNOW YOU GAINED APPRECIATION FOR THAT. WE CAN DO NUMBER TWO. WE WILL CERTAINLY GIVE IT, YOU KNOW, SEAR WITH SERIOUS CONSIDERATION. BUT, WE ARE VERY MUCH LOOKING FOR SORT OF EASTBOUND DENSE E BAY -- EVIDENCE BASIS FOR DECISION-MAKING ON NATIONAL COVERAGE AND FAIR CONSIDERATION WOULD BE GIVEN ON HOW BEST TO CRAFT THE ARGUMENT SO THAT THE AGENCY WOULD BE PERSUADED TO MAKE A CHANGE LIKE THAT.

IF I'M UNDERSTANDING YOU CORRECTLY. I DON'T UNDERSTAND HOW NATIONAL COVERAGE KEY DECISIONS ARE MADE, I HAVEN'T READ THE WEBSITE. YOU ARE IMPLYING THAT SOMEONE HAS TO BRING THIS TO YOU AS A PROPOSAL. NOT SOMETHING THAT CMS DOES THEMSELVES. AND WOULD HO WOULD BRING THE NATIONAL -- AND WHO WOULD BRING THE NATIONAL COVERAGE DECISION PROPOSAL TO WHATEVER COMMITTEE THERE IS THAT WOULD SAY YES OR NO?

AGAIN, BECAUSE THERE IS THE SECRETARY COMMITTEE, I WOULD HAVE TO DEFER TO WHAT YOUR PROCESS IN S. IN. IN GENERAL, OUR PROCESS IS THAT ANY ONE CAN KA SK FOR -- CAN CAN ASK FOR A NATIONAL COVERAGE DECISION AND WE AS THE AGENCY HAVE IN OUR OFFICE OF CLINICAL STAN AND QUALITY WE HAVE A COVERAGE ANALYSIS GROUP, DOCTOR STEVE FUR ROW WHO HAS ATTENDED A NUMBER OF THE MEETINGS IN THE PAST HEADS UP THAT GROUP. AND WE WOULD BE HAPPY TO PROVIDE FURTHER DETAILS ON EXACTLY HOW ONE WOULD DO THIS BUT BASICALLY IF YOU LOOK AT SOME OF THE EXAMPLES AND THEY ARE WIDE RANGING, BASICALLY FOLKS COMMENT AND PROVIDE, YOU KNOW, THE SPECIFIC REQUEST AND WHY THEY THINK WE SHOULD MAKE THE REQUEST AND WHAT DATA, STUDIES ARE AVILLABLE AVAILABLE TO SUPPORT THAT REQUEST.

JUST SOME QUICK COMMENTS ABOUT FAMILY HISTORY. TWO YEARS AGO WE HAD AN EXPERT PANEL AT CDC TO TALK ABOUT FAMILY HISTORY AS A GENETIC TEST. AND AT THAT TIME THE THINKING WAS AND IT IS SORT OF PROPELLED US IN THE NEXT PHASE WAS THAT IF YOU APPROACH FAMILY HISTORY LIKE A GENETIC TEST THAT DESERVES ITS OWN EVALUATION FOR ITS UTILITY AND WHETHER OR NOT THERE IS A GENETIC TEST THAT GOES ALONG WITH IT. IN OTHER WORDS, HOW GOOD IS IT ANALYTICALLY AND SORT OF THE WHOLE ACE PARADIGM AND IT IS VERY OBVIOUS THAT FAMILY HISTORY PER SE IS SORT OF A MIXED BAG. I MEAN WHEN YOU TAKE FAMILY HISTORY SOMETIMES EVEN IF IT IS RELIABLE SOMETIMES IT LEADS YOU TO AGAIN TESTING AND SOMETIMES IT DOESN'T AND I THINK TO ELABORATE ON THE EVIDENCE BASED PROCESS I THINK FAMILY HISTORY DESERVES ITS OWN EVIDENCE BASED PROCESS. WE ALL THINK THAT FAMILY HISTORY IS GOOD BUT WE NEED TO COLLECT IT BUT IN TERMS OF WHETHER OR NOT IT WILL BE ASSOCIATED WITH GENETIC TESTING, IT IS NOT ALWAYS OBVIOUS. I MEAN A SIMPLE CASE IN POINT WOULD BE BRCA1 TESTING. THERE IS A LOT MORE WOMEN THAT HAVE A FAMILY HISTORY OF BREAST CANCER MAYBE TEN TO ONE AS OPPOSED TO THE SMALL FRACTION OF WOMEN THAT ARE IN THE RANGE OF EVEN BEING CONSIDERED FOR BRCA1 TESTING. I THINK WE CAN USE FAMILY HISTORY AS A LAUNCHING PAD FOR COVERAGE DECISIONS BUT I MEAN I GUESS FOLLOWING THE SAME RULES OF ENGAGEMENT AS GENETIC TESTS AND I'M NOT SUGGESTING ANY CHANGE TO THE WORDING HERE BUT U I MEAN AT LEAST THE GOOD THING IS THAT YOU PUT FAMILY HISTORY AS SOME WHAT UP THERE FOR THE DECISION-MAKING PROCESS.

I SHOULD POINT OUT AS WELL THAT THE FIRST RECOMMENDATION TALKING ABOUT LEGISLATIVE CHANGE, WE HAD DISCUSSED A BILL, THE MEDICARE PREVENTATIVE SERVICES COVERAGE ACT, 1678D 2535HR4898 AND THAT LEGISLATION WOULD ADD PREVENTATIVE SERVICES AS AS A MEDICARE BENEFIT CATEGORY AND ENABLE CM STOSMD DETERMINE AND AFTER ASSESSING THE EVIDENCE SO THIS HE COULD DETERMINE WHETHER AN ITEM OR SERVICE IS REASONABLE OR NECESSARY. SO EVEN WITH THE CONGRESSIONAL AUTHORIZATION OPTION, THERE STILL WOULD HAVE TO BE AN ASSESSMENT OF THE EVIDENCE IN ORDER TO LEAD TO A NATIONAL COR COVERAGE TEE SITION. SO IN MANY -- DECISION. SO IN MANY RESPECTS ONE AND TWO ARE CLOSELY RELATED. AND IN FACT I DON'T THINK YOU COULD -- NUMBER ONE ISN'T GOING TO DO YOU ANY GOOD AT ALL IF THERE IS NO EVIDENCE TO SUPPORT COVERAGE. SO THERE -- THEY'RE CLOSELY ALIGNED. THE QUESTION IS WHETHER WE CAN GET TO NUMBER TWO ON ITS OWN IN THE ABSENCE OF ANY CONGRESSIONAL ACTIVITY. EMILY. BARBBARBARA WAS FIRST AND THEN EMILY.

I WAS JUST GOING TO SAY THAT NUMBER THREE MAKES ME CRINGE A LITTLE BIT. WE HAVEN'T TALKED ABOUT IT VERY MUCH. BUT I JUST DIDN'T KNOW, WE WERE DEFINITELY TALKING ABOUT TWO AND FEELINGS ARE GOING TOWARD TWO AND A COMBINATION OF ONE IF WE CAN TO TKO THAT. BUT JUST -- DO THAT. BUT JUST TO KIND OF PUT OUT THERE THAT THESE PRESYMPTOMATIC AND PREDICTIVE TESTS ARE -- ARE DIAGNOSTIC FOR THE MUTATION THAT MAY BE FOUND BUT NOT DIAGNOSTIC OF A DISEASE PER SE AND, YOU KNOW, THE LIMITED GENETIC LITERACY SOMETIMES THAT WE ARE DEALING WITH OUT THERE JUST TO BE WEARY OF THAT. SO I JUST THOUGHT I WOULD KIND OF GET OUR CONVERSATIONS OFF OF THREE IF WE EVER DO GO THERE TO JUST BE CAREFUL ABOUT THAT.

EMILY?

I THINK RESPONSE TO TERENCE'S COMMENT THAT ONE THING THAT WE MIGHT THINK ABOUT IS REALLY WHAT TESTS DO WE KNOW ABOUT TODAY THAT WE WOULD WANT TO SEE MEDICARE APPLY THIS TO? I'M HAVING A HARD TIME REALLY THINKING ABOUT ANYTHING WHERE YOU WOULD SCREEN SOMEONE AT A GENETICS LEVEL WHERE YOU WOULD WAIT UNTIL THEY WERE 65 TO DO THAT. SO I THINK WE NEED TO THINK AS COMMITTEE ABOUT ARE THERE SOME SPECIFIC SCAM EXAMPLES THAT WE MIGHT PUT FORWARD INSTEAD OF A MORE BROAD STRATEGY. IS THIS JUST A FEW SMALLER THINGS WE SHOULD PUT FORWARD SPECIFICALLY AND IT IS DIFFERENT THAN THE CONCEPT OF CHOLESTEROL SCREENING OR MAMMOGRAMS WHERE YOU TEST EVERY YEAR AND CONTINUE TO BE TESTED AS YOU AGE, ONLY A QUESTION OF WHEN YOU START SCREENING. THE GENETIC IS A ONCE IN A LIFETIME TEST AND THE QUESTION I WOULD ASK IS UNDER MEDICARE HOW OFTEN WOULD WE WANT TO BE DOING THIS ONCE IN A LIFETIME TEST IN THIS POPULATION? I'M HAVING -- HAVING PARTICIPATED IN THIS PROGRAM, I FEEL SORT OF STUPID BRINGING THAT UP AT THIS POINT IN TIME, BUT IT HELPS I THINK TO BE SPECIFIC AND THIS YOU CAN WORK TO A SPECIFIC EXAMPLE OF WHAT YOU WOULD LIKE TO SEE AND WHY YOU WOULD LIKE TO SEE IT.

AGNES AND THEN KIMBERLY.

JUST AS A FOLLOW-UP TO YOUR COMMENTS, EMILY, IS THAT I KNOW THAT IN WHAT TERRENCE HAD MENTIONED ABOUT THE CASE-BY-CASE BASIS FOR LOOKING AT SOME OF THESE SCREENING TESTS THAT THE TESTING FOR BREAST AND OVARIAN CANCER IS NOW APPROVED BY MEDICARE AND THEY APPROVE IT UNDER A SPECIFIC CODE THAT STATES HEREDITARY BREAST OVARIAN CANCER SO THAT MAYBE IN VIEW OF LOOKING AT THE USE OF THE FAMILY HISTORY AS A TOOL ONE OF THE THINGS THAT WE DO IN THE CANCER SETTING IS ACTUALLY GIVE A DIAGNOSIS TO THE FAMILY HISTORY AS WHETHER IT LOOKS SPORSPORADIC, WHICH WOULD BE MORE THE ACQUIRED MUTATIONS, SOMETHING FAMILIAL THAT WE ARE NOT SURE OF, SEEING SOMETHING GOING ON IN THE FAMILY OR TRULY SOMETHING THAT FITS A HEREDITARY PATTERN WHERE YOU ARE ACTUALLY PROVIDING A SPECIFIC SORT EVER DIAGNOSTIC CATEGORY TO THAT GIVEN CRE CREEDENCE TO WHY SOMEBODY WOULD GO ON FOR A SCREENING TEST AND IN MANY SITUATIONS WHEN MEDICARE FIRST APPROVED THE COVERAGE FOR THE TESTING FOR BREAST AND OH OVARIAN CANCER THE WOMAN HAD TO HAVE THE -- HAVE HAD BREAST CANCER SO SHE ALREADY HAD THE DISEASE BUT THEN IT WAS ACTUALLY TO FIND WHETHER A GENE WAS PRESENT MOST PROBABLY TO HELP OTHER MEMBERS OF THE FAMILY.

I DON'T KNOW IF --

NOT SCREENING. THAT IS IN THE PRESENCE OF SIGNS AND SYMPTOMS WHICH WOULD ALREADY BE COVER.

THEY DID EXPAND IT NOW COVER PEOPLE WITHOUT THE DISEASE. SO THAT THAT WOULD BE SCREENING.

UM-H'M.

AND THIS WOULD BE A SMALL PERCENTAGE OF THE POPULATION BUT YOU KNOW, MEDICARE IS ALSO FOR THE DISABLED IF THEY ARE ON MEDICARE BECAUSE OF DISABILITY THEY HAVE SIGNS AND SYMPTOMS OF SOME PROBLEM BUT THEORETICALLY I SUPPOSE THERE COULD BE A SCREENING COMPONENT WHERE THEY HAD OTHER PROBLEMS GOING ON YOU WITH ON BUT THAT IS PROBABLY THE SMALL PERCENTAGE OF THE POPULATION WE ARE DEALING WITH.

WE EVEN HERE HAD AN EXAMPLE OF THAT WITH MR. HARDT THAT HAD HEMOPHILIA B AND THEN ALSO THE RISK FOR HUNTINGTON'S DISEASE. IT CAN HAPPEN. YOU MAY HAVE PEOPLE ON MEDICAID WHO NEED A SCREENING TEST THAT MAY BE UNRELATED BUT THEY HAVE A POSITIVE FAMILY HISTORY.

BARBARA RAISED SOME ANGST ABOUT NUMBER THREE. ANY ONE WANT TO COMMENT ON THAT? DO THIS HE SHARE HER CONCERNS ABOUT THAT? DOES SOMEONE FEEL STRONGLY THAT WE NEED TO KEEP NUMBER FLEE ON -- NUMBER THREE ON THE TABLE AS A RECOMMENDATION?

NUMBER THREE IS FOR CMS TO REDEFINE PREDISPOSITION AND PREATHENS TESTS AS DIAGNOSTIC TESTS THROUGH A RULE MAKING PROCESS OR NATIONAL COVERAGE DECISION SO IN THE PRESENCE OF STRONG FAMILY HISTORY DISEASE THESE TESTS WOULD BE CONSIDERED DIAGNOSTIC AND SUBJECT TO THE SCREENING EX-CLUE EXCLUSION.

CAN YOU CLARIFY? WE'RE TRYING TO DO HERE. THE CSH FROM A VERY, VERY, VERY BIG PICTURE WE ARE TRYING TO GET COVERAGE COVER FOR TESTS THAT SOMETIMES DON'T GET COVERED, RIGHT. WE HAVE FOUR SHOTS AT IT. YOU TOLD US THAT NUMBER U FOUR IS A REALLY PRETTY MUCH LONG SHOT. NUMBER ONE IS CERTAINLY NOT TRIVIAL. THAT LEAVES US WITH TWO AND THREE A AND, YOU KNOW, TWO SAYS THAT YOU MAKE TESTS THAT ARE REASONABLE AND NECESSARY AND THAT MIX MAKES IT QUALIFIED TO BE REIMBURSED AND THREE INSTEAD OF BEING REASONABLE AND NECESSARY INSTEAD A DIAGNOSTIC. DO YOU HAVE TO PICK ONE OF THESE OR GIVE THEM TWO AND THREE TO ASK THEM TO PICK ONE AND GIVES US MULTIPLE SHOTS ON GOAL? YOU KNOW, I MEAN.

I DON'T THINK -- CORRECT ME IF I'M WRONG BUT MY IMPRESSION IS THAT THESE ARE NOT MUTUALLY EXCLUSIVE. THERE MAY BE SOME ON HERE THAT PEOPLE DON'T WANT TO PURSUE AND DON'T FEEL THAT AS COMMITTEE WE SHOULD KNOT FORWARD AS A ID -- PUT THAT FORWARD AS A RECOMMENDATION TO THE SECRETARY. ON THE OTHER HAND IF WE THINK ALL OF THESE SEEM VIABLE AND IT IS PERHAPS POSSIBLE AND PERHAPS EVEN LIKELY THAT THE SECRETARY WOULD REJECT NUMBER FOUR AND SAY THAT IS NOT FEASIBLE THAT IS HIS DECISION TO MAKE AND WE THAT LEAST ARE OFFERING THAT UP AS SOMETHING TO CONSIDER?

DOES THE TASK FORCE OR STAFF SEE ANY NEGLECT -- NEGATIVES TO ANY OF THESE FOUR? ARE THERE ANY NEGATIVES?

FOR EACH OF IF YOU TURN TO PAGE 53 WE TRIED TO LIST SOME OF THE LIMITATIONS OF EACH ONE. CERTAINLY AS CINDY ALREADY POINTED OUT FOR THE FIRST ONE IN TERMS OF THE LEGISLATIVE PROCESS ISN'T ALWAYS THE SIMPLEST. IN TERMS OF DOING A NATIONAL COVERAGE DECISION MY UNDERSTANDING OF THAT PROCESS IS IT IS GENERALLY DONE ON A TECHNOLOGY BY TECHNOLOGY AND SO DOING AN ACROSS-THE-BOARD CHANGE OR MAKING A CHANGE TO THE FAMILY HISTORY DEFINITION ISN'T SOMETHING THAT IS GENERALLY DONE AND CERTAINLY CORRECT ME IF I'M WRONG, TIRR CE, ON THAT, BUT IT IS PROBABLY SOMETHING THAT THE ADVISORY COMMITTEE, THE MEDICARE COVERAGE ADVISORY COILICOMMITTEE DOESN'T TYPICALLY PROCEED IN THAT MANNER. IT IS ON A CASE-BY-CASE WITH SPECIFIC TECHNOLOGIES. MAYBE YOU COULD CLARIFY IF TWO AND THREE ARE APPROACHES THAT COULD BE TAKEN EVEN THOUGH THEY ARE NOT YOUR TYPICAL PROCESS?

I GUESS MY COMMENT WOULD BE THAT I COULD SEE WOULD BE WITHIN THE REALM OF POSSIBILITIES. IT IS CLEARLY NOT SORT OF TYPICAL. BELIEVE ME, THE AGENCY IS VERY INTERESTED IN MAKING SURE THAT THE BENEFICIARIES HAVE ACCESS TO, YOU KNOW, PROPER MEDICAL CARE AND NEW TECHNOLOGY AND TALL KIND OALLTHAT KIND OF THING. CLEARLY I WOULD WANT TO BE IN A POSITION TO RULE IN OUR OUT NGWEE WOULD LOOK AT WHATEVER YOU WOULD RECOMMEND BUT AGAIN JUST SORT OF REEMPHASIZING WHAT I SAID ELGEAR. I HAVE BEEN AT THE -- EARLIER. I HAVE BEEN AT AGENCY SINCE THE MID 80s SO SORT OF HAD THE ADVANTAGE OF KINDING SEEING, I MEAN MEDICARE IS USUALLY DESCRIBED AS NOT HAVING A LOT OF PREVENTATIVE SERVICES BUT IT TURNS OUT THAT IF YOU TAKE A LOOK AT ALL PREVENTATIVE SERVICES THAT THE U.S. PREVENTATIVE HEALTH SERVICES TASK FORCE HAS RECOMMENDED, I THINK MEDICARE HAS JUST ABOUT GOTTEN TO THE POINT WHERE WE COVER JUST ABOUT EVERY ONE OF THEM. SO WE ARE, YOU KNOW, VERY.

HAVE PROPER CARE AS CONGRESS CLEARLY MADE CHANGES AND IT JUST SEEMS STRATEGY WISE WHETHER YOU ARE GOING TO MAKE RECOMMENDATIONS FOR CONGRESSIONAL CHANGE OR FOR THE AGENCY TO MAKE A CHANGE STILL FOLKS NEED A COMFORT LEVEL OF WHAT REALLY WOULD IT MEAN TO MAKE A R EG CHANGE LIKE THAT BECAUSE AT THE AGENCY WE GET -- YOU KNOW, WE GET THE DEPARTMENT'S CLEARANCE, OF COURSE. WE HAVE OFFICE OF OF MANAGEMENT AND BUDGET TO DEAL WITH. AND IN ALL OF THESE CLEARANCES WE WOULD NEED SPECIFICS ABOUT WHAT WOULD LIKELY HAPPEN IF WE WOULD DO THIS CHANGE. THAT IS WHY I'M NOT SAYING THAT YOU SHOULD ONLY FOCUS ON INDIVIDUAL SERVICES BUT IF YOU WANT TO GO BROADER I THINK IT STILL IS HELPFUL TO IDENTIFY SOME LIST OF SPECIFIC EXAMPLES TO SHOW THERE IS A BIG PROBLEM HERE, MEDICARE DOESN'T COVER THESE SERVICES AS AN EXAMPLE AND WHY CARE WOULD BE BETTER IF MEDICARE COVERED THEM. THEN I THINK IT IS EASIER TO HAVE THE MORE THEORETICAL CONVERSATION, YOU KNOW, ABOUT SOME OF THESE THINGS. BUT I THINK IN REGARDS OF WHETHER YOU GO GENERAL OR SPECIFIC, IT IS HELPFUL TO HAVE, YOU KNOW, A FEW CRISP EXAMPLES OF WHY THERE IS A PROBLEM IN MEDICARE AND, YOU KNOW, WHAT CHANGES SHOULD BE MADE TO IMPROVE THE PROGRAM.

THAT GETS TO THE POINT THAT EMILY RAISED EARLIER WHICH IS IS THE COMMITTEE AWARE OF SPECIFIC TESTS THAT ARE NEEDED BY THE MEDICARE POPULATION THAT ARE NOT CURRENTLY COVERED BECAUSE OF THIS SCREENING EXCLUSION AND IF THERE ARE SHOULD WE PERHAPS IDENTIFY THEM IN THE REPORT AND LIST THEM AS PARTIAL JUSTIFICATION FOR THIS CHANGE IN POLICY BECAUSE YOU'RE RIGHT, TERENCE, I CAN'T IMAGINE A FEDERAL AGENCY WOULD JUST UP AND CHANGE THEIR POLICY WITHOUT ANY REAL DEMONSTRATION OF NEED BASED ON CONCRETE PRACTICE. I DEFER TO OTHERS ON THAT. SUZANNE?

I ALSO WANTED TO ANOTHER IMPORTANT CONSIDERATION IN TERMS OF FOR ESPECIALLY FOR -- WELL, ACTUALLY FOR ALL OF THEM. YOU ARE BASICALLY TALKING ABOUT CHANGING HOW CMS DEALS WITH PREVENTIVE SERVICES IN GENERAL AND CERTAINLY GENETIC TESTS ARE ONE ASPECT OF A PREVENTIVE SERVICE BUT FROM CMS' PERSPECTIVE YOU HAVE TO TAKE INTO CONSIDERATION THAT IN MAKING THE CAGE FOR GENETIC TESTS YOU ARE -- THE CHANGE FOR GENETIC TESTS YOU ARE OPENING A CAN OF WORMS FOR OTHER TESTS THAT MIGHT NOT NECESSARILY BE GENETIC TESTS BUT THAT WOULD FALL UNDER THE RUBRIC OF A GENETIC SERVICE.

SO IF YOU HAD TESTS THAT PREDICTED WHETHER SOMEONE WOULD HAVE AN ADVERSE REACTION TO A DRUG OR EFFICACY WOULD THAT BE A TEST THAT WOULD ALSO FALL IN IN THIS CATEGORY OF MAYBE NOT BEING COVERED?

THAT TYPE OF SERVICE AS YOU ZEDESCRIBE IT TO ME SOUNDS LIKE THE KIND OF SERVICE MEDICARE COULD POTENTIALLY COVER AND WE PROBABLY ALREADY DO. I THINK THEY WILL PROBABLY GET INCREASINGLY MORE ATTENTION ON THAT KIND OF AN ISSUE BECAUSE IN 2006 MEDICARE WILL HAVE THE PRESCRIPTION DRUG BENEFIT SO TO DATE WE HAVE HAD A LIMITED LIST OF DRUGS WE COVER BUT AS YOU DESCRIBE, I DON'T SEE WHY THOSE KIND OF SERVICES WOULD NOT ALREADY BE POTENTIALLY COVERABLE.

THERE WAS SOMEONE IN THE AUDIENCE. YES, SIR? DOES THAT MICROPHONE WORK?

YES.

STATE YOUR NAME PLEASE. IS IT ON?

CAN YOU HEAR ME.

ME IS JIM ROLLINS AND I'M A MEDICAL OFFICER FOR CMS. SOME OF THE QUESTIONS THAT YOU HAVE BEEN ANSWERING -- ASKING TURNS HAVE GIVE -- TERENCE HAS GIVEN YOU A LOT OF INFORMATION AND BASICALLY I WANT TO REITERATE. ONE OF THE QUESTIONS ASKED A MINUTE AGO ABOUT PHARMACOGENETICS, THAT IS PROBABLY SOMETHING THAT WOULD BE COVERED BECAUSE IT IS CONSIDERED DIAGNOSTIC AS OPPOSED TO A SCREENING TEST. IF A PERSON ALREADY HAS THE ILLNESS AND IS EXHIBITING -- AND TESTS ARE BEING DONE TO DETERMINE WHETHER OR NOT AN APPROPRIATE MEDICATION LEVEL OR MEDICATION IS BEING APPLIED, YES, THAT WOULD FALL UNDER WHAT WE WOULD CONSIDER AS DIAGNOSTIC TESTS SO THAT IS SOMETHING THAT WOULD BE COVERED. IN TERMS OF THE RECOMMENDATIONS THAT THE FOUR RECOMMENDATIONS, ONE IN FOUR ARE VERY -- WOULD BE VERY DIFFICULT FOR THE AGENCY TO PURSUE SIMPLY BECAUSE OF THE CURRENT MANDATES WHICH ARE IN PLACE. AS FAR AS NUMBER TWO GOES, NATIONAL COVERAGE DECISION, THAT IS SOMETHING THAT CAN BE THE INISH INITIATED BY AN INDIVIDUAL, AN ORGANIZATION, A GROUP, AND WE WOULD TAKE INTO CONSIDERATION THE EVIDENCE THAT IS IN THE LITERATURE TO DETERMINE WHETHER OR NOT THERE IS SUFFICIENT EVIDENCE TO SUPPORT ITS USE. SO THAT WOULD BE AN OPTION TO TRY TO ADJUST THIS PARTICULAR ISSUE.

ARE MY -- AM I RIGHT IN DETECTING THAT YOUR MESSAGE TO US IS THAT YOU WOULD PREFER TO HAVE IT ON CASE-BY-CASE OR TEST BY TEST RATHER THAN THAT THIS IS BEING SO BROAD STROKE AS LIKELY TO BE TOO SCARY TO DO?

I THINK THAT IT WOULD HAVE TO BE ON AN INDIVIDUAL CASE-BY-CASE BASIS JUST LIKE WE LOOK AT ALL TECHNOLOGIES THE SAME WAY.

ED.

I WOULD COMMENT, THOUGH, THAT THERE THERE ARE THOUSAND TESTS AND WE HAD TO DO THIS TEST BY TEST I THINK PART OF THE CONCERN OF THE COMMITTEE IS THAT IT COULD TAKE A DECADE OR TWO TO WORK THROUGH AND SO I THINK PART OF THE GOAL WAS TO TRY AND GET, WHILE MORE DIFFICULT, TO GET A BROADER DISCUSSION OF THESISH THESE ISSUES AND SEE IF MORE THAN ONE TEST AT A TIME COULD BE ROLLED INTO THIS. IS THAT NOT POSSIBLE?

I WOULD -- I -- IT IS POSSIBLE. I WOULD ALSO HOPE THAT IN SUBMITTING THOSE TESTS PERHAPS THE FREQUENCY OR THE PREV VALENC PREV LENSEMY BE USED AS A MEANS OF DETERMINING WHICH ONES YOU WANT TO ABOUT UR SUE FIRST.

SUZANNE?

I HAD A FOLLOW-UP QUESTION REGARDING FORM -- PHARMACOGENETIC TESTING. I UNDERSTAND THAT CMS IS DEVELOPING A GUIDANCE DOCUMENT IN REGARDS TO PHARMACOGENETIC TESTING AND I WONDER IF YOU COULD ELABORATE ON THAT.

WE HAD AN OPEN DOOR MEETING IN THE MEDICARE MODERNIZATION ACT TO PROVIDE GUIDANCE DOCUMENTS AND WE ASKED FOR PUBLIC COMMENT AND SUGGESTIONS SO THAT WAS ABOUT MAYBE TWO OR THREE WEEKS AGO SO WE ARE STILL SORT OF IN THE PROCESS OF EVALUATING OUR COMMENTS AND WE HAVE NOT DECIDED ON SPECIFIC DOCUMENTS THAT WERE GOING TO BE. CLEARLY THIS IS AN EXAMPLE OF THE KIND OF GUIDANCE WE MIGHT PROVIDE IN THE FUTURE DEPENDING ON REVIEW OF OUR PUBLIC COMMENTS.

CAN YOU ARE TICK LATE WHAT WOULD BE THE NATURE OF THAT -- ARTICULATE THE NATURE OF THAT DOCUMENT? WOULD IT SIMPLY CLARIFY WHAT PHARMACOGENETIC TESTS WOULD AND WOULD NOT BE COVERED UNDER CMS STATUTE AND POLICIES?

RIGHT, OUR GUIDANCE DOCUMENTS BASICALLY WOULD BE TO PROVIDE INFORMATION TO THE PUBLIC ABOUT OUR CURRENT COVERAGE AND COVERAGE PROCESSES. IT WOULD NOT BE THE MECHANISM TO MAKE REFINEMENTS.

DEBRA?

I WOULD LIKE TO GO BACK TO THE POINT THAT BARBARA RAISED. HAVING HAD BARBARA MAKE STATEMENT ABOUT BEING CONCERNED ABOUT REDEFINING PREDISPOSITION OF GENETIC TESTS AND DIAGNOSTIC LABORATORY TESTS I'M WORRIED ABOUT NUMBER THREE BECAUSE WHEN YOU ARE DOING PREDISPOSITION AND PREDICTIVE IT IS NOT DIAGNOSTIC BECAUSE DIAGNOSTIC BY DEFINITION MEAN MEANS THERE ARE SECONSYMPTOMS PRESENT AND I DON'T WANT TO CREATE WORRIES FOR THE PATIENT ABOUT AND CONFUSION. SO I DON'T KNOW IF THERE IS A DIFFERENT WAY TO WORD THAT OTHER THAN REDEFINING THEM AS DIAGNOSTIC LABORATORY TESTS. MAYBE YOU COULD SAY REDEFINING THEM AS -- I DON'T KNOW WHAT BUT THAT WORRIES ME AND IF TWO IS DOING THE SAME THING MAYBE WE CAN JUST GET RID OF THREE. BECAUSE THEY ARE BOTH BASICALLY ASKING FOR --

I THINK THREE IS JUST A CREATIVE WAY TO GET AROUND STATUTORY LANGUAGE. I MEAN IT IS WORDSMITHING AND CREATIVE ARGUMENT. I THINK IT IS NOTHING MORE THAN THAT. I AGREE BECAUSE IT CERTAINLY COULD OPEN UP DOORS THAT WE DON'T WANT OPENED AND IF WE COULD ACCOMPLISH THE SAME GOAL WITH OTHER RECOMMENDATIONS WE MIGHT WANT TO GO THAT ROUTE UNLESS ANY ONE FEELS VERY WEDDED TO NUMBER THREE, IT SOUNDS LIKE THERE IS SOME CONCERN ABOUT THAT APPROACH AND PERHAPS WE SHOULD FOCUS OUR ATTENTION ON ONE OF THE OTHER RECOMMENDATIONS OR A FEW OF THE OTHER RECOMMENDATIONS. ANY ONE HAVE ANY STRONG SUPPORT AND WANT TO ARGUE IN FAVOR OF THREE? LET'S GET RID OF IT. NUKE IT. ANY OTHER SUGGESTIONS OR COMMENTS?

EMILY?

CAN I JUST ASK ON THE ASYMPTOMATIC TESTING FOR BRCA1 AND 2 WAS THAT NATIONAL COVERAGE DECISION THAT WAS BASICALLY BROUGHT UP AND PUT THROUGH ON A NATIONAL COVERAGE DECISION BASIS? IS THAT THE WAY THAT GOT TO BE REIMBURSABLE?

UNLESS DOCTOR ROLLINS HAPPENS TO KNOW, I WOULD HAVE TO LOOK IT UP. HISTORICALLY, WHAT HAS HAPPENED IS THAT OUR CURRENT COVERAGE PROCESS HAS EVOLVED, FRANKLY, OVER THE LAST FIVE YEARS AND WITHOUT KNOWING THE EXACT TIMING OF EACH COVERAGE DECISION I DON'T KNOW WHAT PROCESS WAS FOLLOWED. I.

I ALSO CAN'T GIVE YOU SPECIFICS ON THAT BUT WHAT I CAN SAY IS THAT I THINK THAT THAT WAS ONE OF THE PREVENTATIVE TESTS WHICH WAS MANDATED AND FOR THAT REASON IT WAS COVERED. IN TERMS EVER HAVING A NATIONAL COVERAGE DECISION FOR THAT, I DON'T THINK WE HAVE ONE FOR THAT. I'M NOT SURE.

YOU THINK IT MAY HAVE GOTTEN THROUGH ON THE BREAST CANCER CONGRESSIONAL MANDATE? WHERE MAMMOGRAMS GOT THROUGH AS REIMBURSABLE.

I ACTUALLY LOOKED THAT THE RECENTLY. THERE IS NO NATIONAL COVERAGE DECISION FOR BRCA1 AND 2 SCREENING. ITHERE ARE I BELIEVE A COUPLE OF LOCAL COVERAGE DECISIONS REGARDING THAT BUT THERE MAY BE JUST ONE OR TWO. AND THOSE ARE LIMITED TO THE SPECIFIC GEOGRAPHIC AREAS THAT THOSE LOCAL CARRIERS COVER. IS THAT -- IS THERE ANY --

UNFORTUNATELY, YOU KNOW, AGAIN WITHOUT SORT OF LOOKING IT UP IN THE COVERAGE BOOK, WHICH WE CAN DO AND GELT YOU HAT FOR TOMORROW MORING IF YOU WOULD LIKE -- FOR TOMORROW MORNING, IF YOU WOULD LIKE, NO PROBLEM. I DON'T RECALL THE HISTORY.

I'M TRYING TO THINK ABOUT AS WE GO FOR RECOMMENDATIONS HERE IF THERE IS ANY TASTE WE WOULD PUT IN IT THIS CATEGORY THAT HAS SUCCESSFULLY BECOME REIMBURSABLE AND COVERED UNDER MEDICARE THEN IT WOULD BE HELPFUL TO KNOW HOW THAT PROCESS HAPPENED AND WHETHER IT IS SOMETHING WE SHOULD RECOMMEND AS A REPLICATION PROCESS OR IF THERE IS NOTHING THAT HAS EVER BEEN APPROVED THEN WE HAVE TO CONSIDER EVERYTHING SORT OF FROM A DE NOVO POINT OF VIEW.

I WAS GOING TO SAY I WOULD BE HAPPY TO TAKE A MINUTE NOW AND MAKE CALLS TO THE AGENCY IF THAT WOULD HELP THE COMMITTEE JUST SO YOU HAVE THOSE FACTS. I WOULD BE HAPPY TO DO THAT NOW.

BEFORE YOU GO, CAN I ASK A QUESTION? NUMBER FOUR JUST IN THE PROCESS OF ELIMINATION HERE. WOULD THIS CAUSE A GREAT ANGST AT CMS IF WE INCLUDED A RECOMMENDATION SUCH AS THIS IN THIS REPORT, KNOWING THAT IT IS A VERY UNLIKELY OPTION TO OCCUR? IS THERE A REAL DOWNSIDE TO INCLUDING IT IN THERE. IN OR IS CMS RECOMMENDING THAT IS IS TO UNLIKELY THAT AND WORST THAN UNLIKELY JUST SHOULDESHOULDN'T BE INCLUDED AT ALL IN THE REPORT, IS THERE A DOWNSIDE TO THAT?

I GUESS AGAIN SORT OF THE CMS STAFF, WE'RE NOT REALLY WANTING TO, YOU KNOW, RULE ANYTHING IN OR OUT. IF THE COMMITTEE WANTS TO GO IN A CERTAIN DIRECTION WE WILL GIVE IT A LOOK. I WOULD SAY THE ADVICE THAT YOU RECEIVED IN THE PAST THAT IT WOULD BE A TOUGH HURDLE TO GET NUMBER FOUR TO GET THE AGENCY TO AGREE ON NUMBER FOUR I WOULD AGREE THAT WOULD BE TOUGH TO DO ON 1862 THE MEDICAL NECESSITY PORTION OF THE LAW IS JUST A MAJOR -- A MAJOR ISSUE FOR MEDICARE AND DETERMINING WHAT IT DOES OR DOESN'T COVER AND I THINK IF COULD BE VERY DIFFICULT TO CRAFT, YOU KNOW, A POLICY CHANGE IN SOME WAY THAT JUST DIDN'T HAVE WIDE RANGING IMPLICATIONS FOR, YOU KNOW, JUST ABOUT ANYTHING ELSE THAT, YOU KNOW, AS YOU CAN IMAGINE, AT THE AGENCY, WE SORT OF GET A LOT OF REQUESTS FOR A LOT OF SERVICES AND THAT PORTION OF THE LAW HAS -- IS.

RIGHT.

-- IS ONE OF THE MAJOR DEFINING ELEMENTS OF WHAT MEDICARE DOES OR DOESN'T COVER AND IT IS GOING TO BE, YOU KNOW.

ANYTHING THAT WE OFFEND YOU THAT COMES TO THE SECRETARY AND NOT STRAIGHT FROM US SO YOU HAVE A LITTLE IMMUNIZATION IF THAT IS WHAT YOU ARE WORRIED ABOUT.

WE HAVE TO CRAFT A DEAL FOR THE AGENCY RIGHT HERE ON THE SPOT.

I JUST WANTED TO COMMENT THAT IN THERE HAS NOT BEEN A NATIONAL COVERAGE DECISION ON BRCA1 AND BRICK 12 I THINK THAT ILLUSTRATES SOME OF THE PROBLEMS THAT WE FACE AND, YOU KNOW, THE PREVENTATIVE SERVICES TASK FORCE IS A VERY GOOD MECHANISM BUT IT IS ALSO QUITE CONSERVATIVE IN WHAT IT CONSIDERS EVIDENCE SO THAT I THINK THAT'S SORT OF AN EXAMPLE IN POINT OF WHAT THE PROBLEMS ARE IF A TEST, YOU KNOW, WE HEARD THIS MORNING, FROM INDIVIDUALS WHO HAVE UTILIZED THIS TEST OR BEEN AFRAID TO UTILIZE THIS TEST IN THEIR FAMILY. IT IS VEILABLE. IT IS RECOGNIZED -- IT IS AVAILABLE. IT IS RECOGNIZED TO BE BENEFICIAL TO THE HEALTH OF INDIVIDUALS. SO I THINK THAT THAT WOULD BE ONE THAT I WOULD BE VERY CONCERNED IF IT HASN'T HAD A NATIONAL COVERAGE DECISION.

DOES ANY ONE HAVE A PROPOSAL IN TERMS OF WHAT WE WOULD LIKE TO PUT FORWARD IN THE REPORT? I'M SORRY, ELLEN, DID YOU HAVE A COMMENT?

JUST ON THE -- ON PAGE 345 34-- 34OF THE REPORT IT SAYS OF THE APPROXIMATELY 274 NATIONAL COVERAGE DECISIONS RELATED TO CMS ONLY ONE RELATES TO GENETIC TESTING SERVICES. [ INDISCERNIBLE ] SEEMS TO BE THE SEEMS TO ANSWER THE QUESTION ABOUT WHAT NATIONAL COVERAGE DECISIONS HAVE BEEN --

JUST AS A -- AS AN ADDITION TO THAT, THAT RELATES -- THAT IS NOT A SCREENING TEST. THAT IS DONE IN SYMPTOMATIC INDIVIDUALS.

SO IT SHOULD BE GENOMIC I GUESS INSTEAD OF GENETIC.

AN OBSERVATION?

YES.

JUST IN FOLLOW-UP TO THE QUESTION ABOUT THE UCPS PREVENTATIVE SERVICES TASK FORCE AN OBSERVATION THAT GROUP ALSO CONSIDERS THE STRENGTH OF THE EVIDENCE AS WELL, IS AT STRENGTH OF RECOMMENDATIONS THAT IT MAKES AND I WOULD ENE. ENCOURAGE AS THE GROUP MOVES FORWARD WITH CONSIDERING THESE FULL RECOMMENDATIONS TO UNDERPIN THEM AS THEY MOVE FORWARD WITH THE STRENGTH OF EVIDENCE THAT WOULD SUPPORT THEM IT MIGHT ALLOW THE GROUP TO THINK ABOUT LEVELS OF RECOMMENDATION IF YOU FEEL STRONGLY, FOR EXAMPLE AMONGST THE FOUR IN TERMS OF HOW YOU WOULD POSITION THEM AS YOU MOVE THEM FORWARD TOWARD THE SECRETARY YOU MIGHT USE THAT EVIDENCE THAT WOULD UNDERPIN RECOMMENDATION TWO OR THREE TO SOLIDIFY THE TWO OR THREE THAT YOU MOVE FORWARD TO THE SECRETARY. IN THE PERSPECTIVE OF A FEDERAL AGENCY THAT IS GOING TO BE THE COMPONENT OF MAKING THE CASE.

IN THAT REGARD IF WE COULD ALSO -- WAIB E. WAYNE, IF YOU COULD UPDATE US QUICKLY ALSO ON THE FAMILY HISTORY DEAL AND APPARENTLY I THINK I'M SOMEHOW AWARE THAT CDC IS DOGE A REVIEW OREVIEW -- DOING A REVIEW OF THE VALIDITY OF THE FAMILY HISTORY AS A CLINICAL TOOL. CAN WE FIND OUT WHERE IT IS NOW AND WHETHER WE CAN BE UPDATED ON THAT PROGRESS AS WELL?

SURE. ACTUALLY, TWO YEARS AGO, I MEAN I TRIED TO UPDATE THE GROUP EARLIER BUT I GUESS I FAILED TO DO THAT PROPERLY. TWO YEARS AGO WE CONVENED AN EXPERT PANEL TO TAKE A LOOK AT FAMILY HISTORY AS A TOOL FOR DISEASE PREVENTION AND IT BECAME VERY QUICKLY OBVIOUS TO THE GROUP THAT FAMILY HISTORY WHILE IT IS GOOD AND GREAT AND SHOULD BE IN EVERYBODY'S MEDICAL RECORD AND IT IS THE ULTIMATE GENOMIC TEST THAT ITS VALIDITY FOR MOST PREVENTION EFFORTS HAVE BEEN BEEN EVALUATED. WE EMBARKED ON A PROCESS TO EVALUATE FAMILY HIS HISTORY FOR SIX COMMON CHRONIC DISEASES. THREE CANCERS, BREAST, OVARIAN, COLORECTAL CANCER, DIABETES, HEART DISEASE AND STROKE AND WE ARE ACTUALLY IN THE MITTS OF FUNDING A CONTROLLED CLINICAL TRIAL AS WE SPEAK THAT HOPEFULLY WILL HAVE RESULTS TWO YEARS FROM NOW. THE DISCUSSIONS ON FAMILY HISTORY HERE, ESPECIALLY WITH THE GENETIC TESTING SHOULD -- I MEAN SHOULD UNDERSCORE THAT THESE TWO THINGS WHILE THEY SEEM TO BE IN INDEPENDENT FROM EACH OTHER BUT THEY BOTH SHOULD FOLLOW EVIDENCE-BASED PROCESSES AND I THINK FAMILY HISTORY MAY BE THE EASIEST OF THE TWO BECAUSE, YOU KNOW, WE ALL HAVE IT -- WE JUST HAVE TO REMEMBER IT SOMEHOW AND MOVE FORWARD WITH IT. BUT IN TERMS OF MAKING A RECOMMENDATIONS FOR THE REIMBURSEMENT, I THINK THE UNDERSCORING PRINCIPLE HERE IS EVIDENCE-BASED GUIDELINES AND I MEAN TO ECHO WHAT FRANCIS JUST SAID EARLIER, THE U.S. PREVENT ATAIPREVENTATIVE SERVICES TASK FORCE THEY ARE TAKING ON BRCA1 WHICH THEY NEVER TOOK OVER SOMETHING LIKE THAT BEFORE. THEYTHEY ARE STRUGGLING WITH IT BECAUSE THE EVIDENCE BASE IS NOT IN THE TRADITIONAL STRENGTHS OF WHAT SOMETHING CAN BE BROUGHT TO YOU AS PREVENTIVE SERVICES TASK FORCE AND THAT IS ONE OF THE FOR THE PROJECT BECAUSE IT TAKES INTO ALL AVAILABLE EVIDENCE AS A FIRST LOOK AS LINDA BRADLEY SUGGESTED TO US EARLIER AND THEN HAVING SORT OF A PRESPRENTATIVE TIVE SERVICES TASK FORCE THAT WOULD PUT THE TESTS AND PACK PRACTICES IN PLAY WHILE FURTHER DATA ARE BEING COLLECTED AND FURTHER TKPWA PBEING PLUGGED AND WE HAVE KNOWLEDGE GAPS IN FAMILY HISTORY AND GENETIC TESTS. IF YOU ASK TODAY THE QUESTION HOW MANY GENETIC TESTS FULFILL THE VIGOROUS UTILITY LOOK FROM AS PREVENTIVE SERVICES TASK FORCE I WOULD SAY THAT NUMBER IS FROM BETWEEN ZERO OR MINUS ONE OR PLUS ONE OR PLUS TWO. THERE IS NOTHING THAT COMES TO MIND THAT MEETS THE RIGOROUS CRITERIA OF THE U.S. PREVENTIVE SERVICES TASK FORCE. HA IS NOT GOOD FLUFF NOSER THE COMTHE -- NOT GOOD ENOUGH FOR THE CONSUMERS OR RESEARCHERS OR AXIS. WHAT WE NEED IS A PROCESS THAT CAN DO THAT ONGOING EVALUATION WHILE DATA ARE CONTINUOUSLY COLLECTED SO THAT GAPS ARE PLUG ED AND WITH DOING THAT COLLABORATIVELY WITH THE AGENCIES FOR FAMILY HISTORY AND THE GENETIC TESTS. AND FOR BOTH. FOR DRIBBING BRCA1 YOU CAN'T DO IT WITHOUT FAMILY HISTORY. AND FOR MOST OF THE DISORDERS FAMILY HISTORY GOES HAND IN HAND WITH THE GENETIC TESTS.

SHOULD WE MAYBE CONSIDER AMENDING ONE AND TWO TO BRING HOME THE BENEFIT -- I DON'T THINK ANYBODY IS SUGGESTING THAT WE ADD A CATEGORY FOR PREVENTATIVE SERVICES AND HAVE A FAMILY HISTORY AND GENETIC TESTING AND BOOM IT IS COVERED. I THINK WITH WHAT WE NEED TO STATE IS WHEN THE EVIDENCE SUR SUPPORTS COVERAGE CMS WILL HAVE THE FLEX FLEXIBILITY WHICH THEY MAY NOT THINK THEY HAVE BECAUSE OF THE COVERAGE EXCLUSION.

WHAT WE WANT TO TO DO FROM A PROCESS CHECK IS RESOLVE THIS ISSUE AND BRING THE PIECE TO CLOSURE. AND THEN WE WILL TAKE THE BREAK. DRIVE THE POINT TO CLEESE CLOSURE AND NAIL IT RIGHT DOWN.

I WOULD THINK WE WOULD BE SUFFICIENT IN REMING A COMBINATION OF ONE AND TWO BASED ON EVIDENCE. II'M UNCOMFORTABLE RECOMMENDING FOUR. IT WOULD BE LIKE SOMEBODY RECOMMENDING TO IN THE COMMITTEE THAT WE GO TALK TO CONGRESS. IT IS INTO THE WITHIN OUR PURVIEW TO DO. I FEEL WITH FOUR WE ARE MAKING A RECOMMENDATION FOR CMS TO DO SOMETHING THAT REALLY ISN'T PART OF THEIR ABILITY TO DO SO WHY DO IT. IT MAKES OUR RECOMMENDATIONS WEAKER. WHEREYA'S ONE AND TWO, A COMBINATION OF THOSE BASED ON EVIDENCE THAT IS OUT THERE AND THAT COMES BACK TO EMILY'S POINT I'M NOT QUITE SURE WHAT IS OUT THERE AND I DON'T KNOW THAT WE WANT TO GO MAKING A BLANKET RECOMMENDATION THAT ALL 30,000 GENES WORTH OF GENETIC TESTS BE PREVENTIVE, YOU KNOW, PRESYMPTOMATICLY COVERED SO I WOULD SAY COMBINING ONE AND TWO WITH THE EVIDENCE BASED INTO MAYBE EVEN A SINGLE RECOMMENDATION BECAUSE I DON'T THINK THERE IS A LOT OF URGENCY WITH THIS. I THINK IF MAYBE THERE ARE GENETIC TESTS IN THE FUTURE THAT PREDICT LATE ONSET ALZHEIMER'S DISEASE AND LATE ONSET OSTEOPOROSIS AND THINKS THAT ARE DEGENERATIVE IN OLDER PEOPLE SO YOU CAN PREVENT THOSE IT MIGHT BE USEFUL BUT RIGHT NOW I'M STRUGGLING TO COME UP WITH TESTS THAT I WOULD URGENTLY WANT COVERED IN THE MEDICARE AREA.

I THINK IT WOULD BE WORTH THE ADVISORY GROUP'S EFFORT TO INVESTIGATE AN EXAMPLE OR CASE IN THE MEDICARE POPULATION IN WHICH THIS WOULD BE RELEVANT. IT WOULD CERTAINLY MAKE THE CASE FOR CMS TO THEN DO THE WORK THAT YOU ARE ASKING CMS SO TO DO.

I'M NOT AGAINST RECOMMENDATION NUMBER TWO. BUT I THINK EARLIER SOMEONE SAID THAT US PREVENTIVE TASK FORCE WOULD BE THE UNDERPINNING OF THE RECOMMENDATION. I HAVE SOME CONCERNS ABOUT THAT ONLY BECAUSE A NUMBER OF THEIR RECOMMENDATIONS ARE CON SEB CERUS BASED AS OPPOSED TO DENVER CONSENSUS BASED AS OPPOSED TO EVIDENCE BASE.

JUST A POINT OF FACT. THEY ARE EVIDENCE-BASED RECOMMENDATIONS. I WAS TRYING TO SAY RATHER THAN USING THE U.S. PRE VENTIVE SERVICES TASK FORCE THIS THIS GROUP -- NOT USING THE U.S. PREVENT ATAIPREVENT AATIVE TAVTION FORC RUBRIC WHICH IS -- SO IT ALLOWS YOU WALK THROUGH A GRID IN TERMS OF THE AMOUNT OF EVIDENCE THAT EXISTS AS YOU TRY GET TO A RECOMMENDATION SUCH AS THIS.

IMNAYI'M IN AGREEMENT. I THINK THE METHODOLOGIES ENGS PLAINED I THINK IN THE PREVIOUS LECTURE IS STHOOG WE COULD USE IN TERMS OF SOME EVIDENCE-BASED MODEL FOR MAKING THESE RECOMMENDATIONS.

I MIGHT SUGGEST TO GO ALONG WITH WHAT DEBRA HAS OFFERED UP, ACTUALLY, I DON'T THINK WE NECESSARILY HAVE TO MERGE ONE AND TWO. WE COULD LEAVE THEM SEPARATE AND DISCRETE BUT AMEND NUMBER ONE TO TRACK WHAT THE LEGISLATION THAT HAD BEEN INTRODUCED THE LAST SESSION OF CONGRESS WOULD DO BECAUSE IT DOES ESSENTIALLY MERGE THOSE TWO THINGS. SETS UP A PREVENTATIVE SERVICES CATEGORY BUT ALSO ENABLES CMS TO MOVE FORWARD WITH AN NCD AND ASSESS THE EVIDENCE AND MAKE A COVERAGE DETERMINATION. SO, NUMBER ONE IS A LEGISLATIVE FIX BUT IT ALSO WOULD INCORPORATE IN THAT AUTHORITY FOR CMS AND WEIGHING THE EVIDENCE AND WHAT DC NOT. NUMBER ONE AMENDED COULD BE THE MERGER THAT YOU TALKED ABOUT AND NUMBER TWO COULD BE A FREE STANDING THING SHOULD THEY CHOSE TO DO SO AND UPON FURTHER REFLECTION AND GETTING INPUT FIND THAT THERE ARE SPECIFIC EXAMPLES THAT REQUIRE CMS' STEPHEN ISSACS THAT COULD BE IMPLEMENT -- THAT COULD BE IMPLEMENTED IN THE -- I PUT FORWARD IN THE SAKE OF NARROWING THIS DOWN AND SO REED WON'T GET MAD AT ME FOR PROPER HE PRO CSH PROLONGING THIS. AMENDING ONE FOR WHAT THE LEGISLATION WOULD DO AND MAKING SURE THAT EVIDENCE BASED IS PART OF THAT A THAT WE ARE NOT AUTOMATICALLY PROMOTING AUTOMATIC COVERAGE AND TO NUMBER TWO THE SAME THING MAKING SLUR THAT SURE THAT IT IS BASED ON EVIDENCE BASED AND GETTING RID OF NUMBER THREE AND NUMBER FOUR AND JUST HAVING AMENDED VERSIONS OF ONE AND TWO BE PART OF OUR RECOMMENDATION. ANY OPPOSED? SUGGESTIONS? IN FAVOR?

ALL THOSE IN FAVOR SAY AYE.

AYE.

NO? CONFERENCE PRES [NO RESPONSE]

YOU ALL WORKED HARD AND YOU DESERVE THE FULL TEN MINUTES. WE STOPPED THIS SESSION AT 4:30 AND THEN WE HAVE PUBLIC TESTIMONY SO THAT 10 MINUTE BREAK IS IMPORTANT BECAUSE IT ONLY GIVES US A LITTLE TIME TO COME BACK. ONE THING I DON'T WANT TO LOSE FROM DEBRAS IT POINT.

YOU'RE GOING ON THE BREAK TIME.

YOU ARE.

THE POINT THAT DEBRA MADE IS KEY IS WE HAVE TO -- I THINK WE WANT TO START EVALUATING OUR SUCCESS AS A COMMITTEE AND THE WAY IN WAY YOU ARE GOING TO LOOK AT HOW WE EVALUATE IS HOW MANY OF THE THINGS WE RECOMMEND GOT DONE SO IF WE HAVE A RANGE OF 99 THINGS OF WHICH SOME OF THEM WHICH NOBODY CAN DO ANYTHING ABOUT OUR SCORECARD WILL LOOK TERRIBLE. DEBRA WAS RIGHT ON ON THAT, THANK YOU.

HOW MANY OF THE COMMITTEE MEMBERS ARE NOT HERE? WHO IS NOT HERE? SPEAK UP.

BY THE WAY, I WILL LET YOU KNOW THAT WE ARE QUITE HAPPILY AWARE THAT THERE ARE PEOPLE OUT THERE ON THE WEBCAST WHO ARE LISTENING AND SENDING E-MAILS IN. YEAH, YES. THEY LIKE ED'S TIE APPARENTLY. BUT THERE ARE PEOPLE OUT THERE SO BE AWARE THAT -- TKHA RB YOU ARE BEING WATCHED ( LAUGHTER )

AND THOUSANDS AND TRILLIONS OF PEOPLE WHOM YOU CANNOT SEE ARE HANGING ON TO YOUR EVERY WORD. SO BRAD, BEHAVE! BLAF( LAUGHTER )

THERE IS NO -- HE WILL DISAPPEAR. WITH THAT WE ARE GOING TO GO AHEAD AND MARCH THROUGH APPARENTLY WE HAVE ACTUALLY ONLY GOTTEN THROUGH TWO PAGES! ( LAUGHTER ) SO WE ARE GOING TO HAVE TO LIKE

5454 --

THAT IS WHAT I SAY BUT THEN THEY SAID YEAH, THE ACTION DIDN'T START UNTIL PAGE 50 SO APPARENTLY WE ARE NOT DOING AS WELL AS WE THOUGHT.

WE WILL MOTOR THROUGH THIS. THE NEXT SECTION OF THE REPORT DEALS WITH THE NATIONAL AND LOCAL COVERAGE DECISION-MAKING PROCESSES THAT CMS UNDERTAKES. THE LOCAL COVERAGE DECISION PROCESS OB OBVIOUSLY ALLOWS A CERTAIN AMOUNT OF FLEXIBLE, TAKING INTO ACCOUNT LOCAL PRESS TIS AND MORE RAPID AND THE NATIONAL REDICTION MAKING POLICY HAS BROAD AM APPROXIMATE CAN'T APROS THE COUNTRY. THIS ONE WE MIGHT BE ABLE TO GET THROUGH, REED, PRETTY QUICKLY. WE DON'T REALLY HAVE TOO MUCH IN THE WAY OF A FORMAL RECOMMENDATION OF THE TASK FORCE AND IN OUR PREVIOUS REPORT WE RECOGNIZED THAT REALLY THEY THERE PROBABLY ALWAYS WILL BE AND PROBABLY ALWAYS SHOULD BE A HEALTHY MIX BETWEEN LOCAL AND NATIONAL DECISION-MAKING PROCESSES. NO ONE IS ADVOCATING OR ELIMINATING ONE OR ANOTHER. BUT IN THE NEW MEDICARE LAW THAT PASSED THERE IS A NEW SECTION, SECTION 31 WHICH REQUIRES THE PLAN TO EVALUATE TO DETERMINE WHICH OF THOSE SHOULD BE ADOPTED NATIONALLY. THE IDEA BEING TO PROVIDE GREATER CONSISTENCY IN MEDICARE COVERAGE POLICY WHERE A3R0E7 TRIOT AND POSSIBLE. THIS WOULD BE -- APPROPRIATE AND POSSIBLE. THIS WOULD BE TO ENCOURAGE TO MOVE FORWARD WITH THE PLAN AS OUTLINED IN THE MEDICARE LAW TO HAVE THE ULTIMATE GOAL OF TRYING WHERE APPROPRIATE AND WHERE POSSIBLE TO HAVE MORE CON SISTENCY IN MEDICARE COVERAGE POLICY BUT RETAINING THE LOCAL NATIONAL MIX. ED?

IT IS NOT STATED IN HERE. I THINK IT IS IMPLICIT BUT GIVEN THAT SOMEBODY MIGHT LOOK AT THE RECOMMENDATION IN ISOLATION DO WE WANT TO SAY AS IT A I PLIES TO GENETIC AND NICGENOMIC TESTING OR SOMETHING TO THAT EFFECT? IT IS ALL LCDS TO NCDS AND GIVEN THE CON DESKTOP OF THE REPORT IT WOULD -- CONTEXT OF THE REPORT IT WOULD RELATE TO GENETICS AND GENOMICS BUT I THINK WOULD BE GOOD TO STATE HA IN THE RECOMMENDATION.

KIMBERLY?

I HAVE A QUESTION AND TERRY, MAYBE YOU IS ANSWER THIS. DO THE MEDICARE POMLICIES HAVE ANY INFLUENCE AS FAR AS MEDICAID? I REALIZE IT IS STATE BY STATE BUT DO THEY HAVE ANY IN FLIENCE OVER MEDICAID TESTING POLICIES? BECAUSE OBVIOUSLY THAT WOULD HAVE A GREATER IMPACT ON CERTAINLY RARE GENETIC TESTING BUT THAT WOULD INVOLVE CHILDREN.

AT CENTRAL OFFICE AT CMS WE ACTUALLY DON'T HAVE A LOT OF DETAILED INFORMATION ON EACH STATE MEDICAID PROGRAM. THEY ARE STATE RUN. I HAVE CERTAINLY HEARD THE THAT SOMEONE SAID THAT SOME MEDICARE PROGRAMS ADOPT MEDICARE POLICIES BUT I DON'T REALLY HAVE ANY INFORMATION THON AND I ALSO JUST NOTE AS AN EXAMPLE MAYBE TWO OR THREE YEARS AGO THERE WERE ISSUES RELATED TO FLU SHOTS COMPLETELY DIFFERENT FROM TODAY'S ISSUES AND THERE WERE CONCERNS THAT MEDICAID WOULD BE ADOPTING SOME POLICIES THAT MEDICARE HAD AND IT TURNED OUT THAT WAS NOT THE CASE AT ALL, THAT THE MEDICAID PROGRAMS MAINTAINED THEIR OWN POLICIES. SO, I DON'T THINK THERE IS A DIRECT CORRELATION BUT, YOU KNOW, NOT TO SAY THAT THERE COULDN'T BE SOME STATES THAT ADOPT MEDICARE POLICIES.

ANY OTHER COMMENTS OR QUESTIONS? SUGGESTS? HOW ABOUT IF WE INCLUDE A REVISED VERSION OF THIS RECOMMENDATION ALONG THE LINES OF WHAT ED SUGGESTED WHERE WE DO REFERENCE THE GENETIC COMPONENT? ANY OBJECTION TO THAT? WE'RE DONE!

THE NEXT SOMEONE GOING TO BE HARDER. GENETIC COUNSELING. AS WE ALL KNOW, THE MEDICARE LAW, MEDICARE STATUTE DOES NOT PERMIT GENETIC COUNSELORS TO DIRECTLY BILL MEDICARE AND THE THINKING IS THAT THAT IS OR CERTAINLY POTENTIALLY IS A BARRIER TO ACCESS REIMBURSEMENT OBVIOUSLY, EVEN IF THEY COULD DIRECTLY BILL WOULD BE LIMITED BY THE OTHER RESTRICTIONS THAT WE TALKED ABOUT EARLIER ON SCREENING TESTS. WE DID, HOWEVER, COME UP WITH A LIST OF FIVE POTENTIAL RECOMMENDATIONS TO CONSIDER ADDRESSING THAT BARRIER WITH REGARD TO GENETIC COUNSELING. INCREASE THE STATE LICENSURE OF CERTIFIED GENETIC COUNSELORS. ADDING GENETIC COUNSELORS TO THE LIST OF NONPHYSICIAN PROVIDERS ELIGIBLE TO BILL MEDICARE DIRECTLY. A DEMONSTRATION PROJECT CONDUCTED BY CMS THAT WOULD EXAMINE GENETIC COUNSELING ITS VALUE AND EFFECTIVENESS AN INSTITUTE OF MEDICINE STUDY TO ASSESS THE EFFECTIVENESS OF GENETIC COUNSELORS AND THEN THE FIFTH RECOMMENDATION IS NOT SO MUCH A RECOMMENDATION BUT MORE A STATEMENT OF THE NEED FOR A CONSENSUS ON WHICH HEALTH DISCIPLINES SHOULD BE PROVIDING THESE SERVICES, WHAT WOULD BE THE APPROPRIATE LEVEL OF SUPER VISION FOR EACH AND UNDER WHAT CONDITIONS SHOULD THEY BE REIMBURSED, SHOULD THEY BE ALLOWED TO BILL MEDICARE. I'LL JUST START OFF AND THEN JUMP IN. THE FIRST RECOMMENDATION DEALING WITH PROFESSIONAL LICENSURE, I DON'T KNOW THAT THAT IS -- I THINK THAT IS A PIECE OF A SOLUTION. I DON'T KNOW IF THEY ARE EXCLUDED FROM BILLING DIRECTLY UNDER MEDICARE YOU COULD BE LICENSED IN THE STATES ALL YOU WANT AND IT IS NOT GOING TO CHANGE THAT. SO IT IS NOT A COME COMPLETE SOLUTION TO THAT PROBLEM BUT THE THINKING WOULD BE THAT IT MAY REDUCE OR LOWER THE BARRIER TO DIRECT REIMBURSEMENT BUT IT CERTAINLY WILL NOT GUARANTEE THAT. AND THE QUESTION I WOULD POSE IS HOW COULD WE -- WHAT WOULD BE THE NATURE OF OUR RECOMMENDATION? HOW DO YOU GO ABOUT INCREASING STATE LICENSURE? THERE MAY BE RECOMMENDATIONS THAT WOULD BE NEEDED, SUBR EPLGSS UNDER THAT RECOMMENDATION. THE SECOND ONE OBVIOUSLY REQUIRES A LEGISLATIVE FIX. IT WOULD REQUIRE CONGRESS TO PASS A LOU TO SPECIFICALLY ADD GENETIC COUNSELORS TO THE LIST OF NONPHYSICIAN PROVIDERS AND WE HAVE DISCUSSED PREVIOUSLY THAT ISN'T EASY TO DO. NOT THAT WE CAN'T RECOMMEND AND NOT THAT WE SHOULDN'T BUT IT IS NOT SOMETHING THAT WE SHOULD EXPECT WOULD HAPPEN IN SHORT ORDER. AND MY ONLY OTHER COMMENT WOULD BE THAT PERHAPS WE MIGHT CONSIDER MERGING NUMBER FOUR AND NUMBER FIVE AND IT DOESN'T HAVE TO BE THE INSTITUTE OF MEDICINE BUT THAT IT SOMETHING THAT WE CAME UP WITH. THE IDEA WOULD BE WHEN YOU STUDY AND EXAMINE GENETIC COUNSELORS AND SERVICES THAT THEY PROVIDE AND EFFECTIVENESS AND VALUE YOU MIGHT AS WELL GO AHEAD AND DO AN ASSESSMENT OF ALL THE HEALTH PRO PROFESSIONS THAT PROVIDE THESE TYPES OF SERVICES IF THAT IS THE ROUTE THAT WE WANT TO GO. THE QUESTION IS DO WE FEEL THAT THAT IS NECESSARY OR IS THAT

AKE WORK. I THINK WE HAVE SPOKEN QUITE A BIT ABOUT ACCESS TO GENETIC TEFS AND TECHNOLOGIES AS LONG AS PEOPLE HAVE ACCESS TO THE APPROPRIATE COUNSELING THAT GENETIC TESTS BY ITSELF, A CONSUMER HAVING DIRECT ACCESS WITHOUT THE RECK WHICH SITE COUNSELING AND MEDICAL GUIDANCE ISN'T THE BEST SCENARIO AND COULD DO MORE HARM THAN GOOD. SO I THROW THAT OUT. THOSE ARE THE COMMENTS THAT I HAD ON THOSE RECOMMENDATIONS AND THROW THAT OUT FOR DISCUSSION. EMILY, REED, ED.

SO AGAIN I QUESTION WHY THIS IS LIMITED TO MEDICARE. IS THERE SOMETHING UNIQUE ABOUT MEDICARE THAT WE ONLY WANT TO TALK ABOUT GENETIC COUNSELING REIMBURSEMENT UNDER MEDICARE OR SHOULD WE PUT THIS UNDER SORT OF THE ALL INSURERS UMBRELLA AND TALK ABOUT IT AS A GENETIC PROBLEM OF GETTING REIMBURSEMENT FOR GENETIC COUNSELING? BECAUSE I THINK, YOU KNOW, THE ONLY THING THAT IS UNDER THE PUBLIC AND PRIVATE THING IS UPNS WHICH I DON'T THINK IS NECESSARILY THE ONLY ISSUE THAT IS COMING UP WITH GENETIC COUNSELING IN THE PRIVATE INSURANCE SECTOR. I ALMOST THINK THAT THIS SHOULD BE THE WLOAL GENETIC COUNSELING SECTION SHOULD BE UNDER THE UMBRELLA OF PUBLIC AND PRIVATE AND THEN WE CAN TALK ABOUT IF THERE IS ANYTHING SPECIFICALLY UNIQUE TO MEDICARE THAT WE NEED TO MAKE A RECOMMENDATION SPECIFIC FROM MEDICARE FROM A GENERIC RECOMMENDATION THAT COUNSELING SHOULD BE RECOGNIZED AND REIMBURSED FOR THE BALANCE THAT IT BRINGS TO.

THE DIDN'T IT BOUNCE BACK? I HAD THE SAME REACTION BUT I THOUGHT THIS BOUNCED BACK AND FORTH. I THOUGHT I COULD BE WRONG. I THOUGHT IT WAS UNDER THE OTHER SECTION OR THERE WAS SOME CONSIDERATION. IT MAKES SENSE EXCEPT TO THE EXTENT THAT WE ARE LOOKING AT NUMBER TWO MEDICARE NOT ALLOWING THEM TO BILL DIRECTLY IS A MEDICARE SPECIFIC BARRIER BUT THERE IS NOTHING THAT PRECLUDES US IF WE DECIDED TO INCLUDE THE GENETIC COUNSELING SESSION IN THE PART OF THE REPORT THAT COVERS BOTH PUBLIC AND PRIVATE IDENTIFYING ONE OF THE MEDICARE SPECIFIC BARRIERS AND THEN A POTENTIAL RECOMMENDATION THAT APPLIES OM ONLY TO MEDICARE, I DON'T THINK WE ARE PRECLUDED FROM THAT AT ALL.

DO WE HAVE THE ABILITY TO INFLUENCE PRIVATE INSURANCE COMPANIES AND WHAT THEY PAY FOR AND COVER AND I THOUGHT WE WERE DIRECTING IT AT MEDICARE BECAUSE IF WE CAN CHANGE WHAT MEDICARE DOES THEN OTHER INSURERS ARE LIKELY TO FOLLOW. WE CAN'T -- I DON'T KNOW THAT WE HAVE ANY INFLUENCE IN THAT ARENA. WE CAN MAKE A STATEMENT THAT GENETIC COUNSELING SERVICES WILL BE INCREASINGLY USEFUL AND NEED TO BE COVERED AS MEDICAL SERVICES BUT I DON'T THINK WE HAVE INFLUENCE THAT OTHER THAN THROUGH MEDICARE.

I AGREE WITH THAT BUT WHAT WE HAVE UNDER PUBLIC AND PRIVATE INSURERS IS JUST THIS UPIN ISSUE AND I DON'T THINK THAT IS THE ONLY ISSUE. THE WHOLE ISSUE OF, YOU KNOW, THAT -- GENETIC COUNSELORS CURRENT STATUS SEEMS TO VARY BY STATE. SOME HAVE LICENSURE AND SOME DON'T. WE NEED TO GET A MORE UNIFIED SORT OF MAYBE NATIONAL LEVEL OF APPROACH TO IT.

I THINK THAT WE HAVE GOT TESTIMONY. I THINK IT IS A GREAT QUESTION DEBENTURE WRA AND I DEBENTURE BA AND I THINK WE HAVE TESTIMONY AND KNOWLEDGE THAT ONE OF THE DEBRA AND ONE OF THE BARRIERS FOR ALL PAYORS IN THE AREA WHETHER PUBLIC OR PRIVATE IS THE CONCERN AROUND WHO IS ACTUALLY QUALIFIED TO DO GENETIC COUNSELING AND WHAT IS THE SCOPE OF PRACTICE FOR THEM AND WHAT IS THE LICENSURE SO TO THE EXTENT THAT WE CAN SAY THAT WE ROW COG NICE THIS IS A GENERIC ISSUE FOR ALL PAYORS AND THEN BE ABLE TO SAY WHILE THERE BE SOME SPECIFIC MEDICARE RECOMMENDATIONS BUT THAT AT SOME POINT THIS LICENSURE ISSUE AND DEFINITION OF SCOPE OF PRABBLPRACTICE ISSUES ARE GERMANE TO THE WHOLE FIELD WE COULD SOLVE IS THAT WAY I THINK. WHICH SORT OF LEADS ME TO MY COMMENTS ON THIS IS THAT I THINK THAT WHAT THE SECTION DOESN'T GET AT ADEQUATE ENOUGH IS WHAT ARE IN FACT THE QUALIFICATIONS FOR THESE GENETIC COUNSELORS TO BE ABLE TO SAY THAT THIS IS A REAL GENETIC COUNSELOR AND THIS IS WHAT THEIR SCOPE OF PRACTICE IS. I THINK THERE IS A LOT OF LANGUAGE AROUND DISTRIRCHGIVENESS OR EFFECTIVENESS OF GENETIC COUNSELORS. WE JULY UNDERSTAND THERE THERE IS ON THE FACE OF IT A VALUABLE ROLE. I MEAN THAT IS MOTHER TKPO D AND COUNTRY IN A WAY BUT THE QUESTION IS WHO IS A WILL GIT MAT COUNSELOR AND WHAT SHOULD WE EXPECT AND I THINK THAT I WOULD URGE THAT WE SPEND A LITTLE MORE ATTENTION TO THAT. THE FIFTH REPRESENTATION RECOMMENDATION IS GOOD IN THAT IT TRIES TO GET TO THE SENSE THAT WHAT HAPPENS IF YOU HAVE THE GENETIC COUNSELOR BILLS FOR THE AND AGAIN THE DOCK DECIDES TO BILL AND THEN THE GENETIC NURSE WHO IS THE ACCOUNTABLE ENTITY. HOW DO YOU WORK THAT OUT AND ALL THREE OF THEM ARGUING WITH EACH OTHER AROUND WHO DID WHAT YOU KNOW FOR THE PATIENT SO JUST SOME THROUGHOUT THERE. THE REAL CORE HERE IS AS I THINK TRYING TO CREATE AND I THINK IF WE COULD MAYBE DEVELOP SOME, YOU KNOW, AT LEAST BE ABLE TO DESCRIBE WHERE WE ARE WITH THE NATIONAL STANDARDS FOR WHAT IS A GENETIC COUNSELOR AND THEN HOPE HOPE THAT THAT GETS TRANSLATED DOWN TO THE STATE LEVEL MAYBE THAT IS ONE OF THEM.

ED?

THESE ARE REALLY MORE TECHNICAL EDITORIAL COMMENTS BUT, FIRST OF ALL, I LIKE YOUR BULLETS AS OPPOSED TO THESE LONG I THINK IT WOULD BE GOOD PERHAPS TO USE THOSE AS HEADINGS. THE KIND OF THINGS YOU HAVE ON THE BOARD HERE SO THAT THEY ARE ALMOST LIKE THE EXECUTIVE SUMMARY OF THE RECOMMENDATION THEY ARE THE ACTION ITEM. AS OPPOSED TO THE WHOLE PARAGRAPH FOR SOME OF THESE. SECONDLY, I WOULD SUGGEST THAT THESE BE COLLAPSED INTO ONE RECOMMENDATION WITH PARTS ABCDE PERHAPS BECAUSE BY MY COUNT SO FAR WE HAVE TWO RECOMMENDATIONS OR IF WE INCLUDED THESE WE WOULD HAVE 7, FIVE OF WHICH WOULD BE RELATED TO GENETIC COUNSELING AND I THINK THEY ARE INTERTWINED SO YOU COULD SAY SOMETHING BECAUSE SACGHS RECOGNIZES THAT GENETIC COUNSELORS ARE CRITICALLY IMPORTANT TO THE EFFECTIV DELIVERY OF GENETIC SERVICES THEREFORE WE MAKE THE FOLLOWING RECOMMENDATIONS, A, B, ET CETERA TO TIE THEM TOGETHER BUT HAVE THEM REALLY BE ONE RECOMMENDATION WITH SUBPARTS.

GOOD YES.

BARBARA AND THEN.

DEBRA.

JUST TO RESPOND TO REED'S COMMENT. I THINK ADJUSTING OUR POINT THAT WE CAN USE AS TO WHO IS QUALIFIED TO DO GENETIC COUNSELING I THINK A LOGICAL ANSWER TO THAT WOULD BE CERTIFIED GENETIC COUNSELORS CERTIFIED BY THE AMERICAN BOARD OF BENITO COUNSELLING TO DO SUCH WORK. AND THAT COULD BE JUMPING OFF THE POINT. WHETHER WE IDENTIFY AUXILLIARY PEOPLE THAT CAN COULD THAT AS WELL IF WE HAVE PARTICULAR CALL FIXES THAT IS A DISCUSSION POINT BUT I THINK AT THE CORE WE CAN IDENTIFY THE CALL CALLED PEOPLE AS BEING CERTIFIED GENETIC COUNSELORS CERTIFIED BIT AMERICAN BOARD.

A QUESTION ABOUT THAT AND THEN I HAVE A DIFFERENT QUESTION. THERE DR LIKE I -- I SONG HAS GENETIC COUNSELORS THAT DO CANCER RELATED GENETIC COUNSELING AND I CAN IMAGINE THAT IF THERE IS I DON'T KNOW A NURSE THAT WORKS IN A PARTICULAR TYPE OF GENETIC CLINIC SHE MAY -- SHE ORE HE MAY BE QUALIFIED TO DO GENETIC COUNSELING FOR SPECIFIC DUTIES. HOW DO YOU LINK THOSE IN WITHOUT BEING A BROADLY TRAINED GENETIC COUNSELOR BECAUSE THEY ACTUALLY MAY KNOW MORE ABOUT THAT SPECIFIC DISEASE THAN THE GENETIC COUNSELING THAN A GENERALLY TRAINED GENETIC COUNSELOR AND SO THEIR MEDICAL SERVICESS ARE EQUALLY VALID SO HOW -- AND THEY WOULDN'T -- I DON'T THINK WE CERTIFIED BY THE AMERICAN BOARD OF GENETIC COUNSELORS.

I AGREE WITH THAT. I THINK WE DO HAVE SOME KIND OF SISTER ALLIED HEALTH PEOPLE LIKE ESPECIALLY NURSES I THINK IN ONCOLOGY THAT CAN PROVIDE QUITE A BIT OF INFORMATION THAT WE ARE NOT EVEN ALWAYS TRAINED TO GIVE. SO IN THAT I DON'T THINK I HAVE AN ANSWER FOR YOU EXCEPT I CAN SEE THAT WE NEED TO MAKE ALLOW NCES FOR THAT AND I DON'T KNOW IF MAYBE CONVERSATIONS BETWEEN THE GENETIC NURSES AND THE AMERICAN BOARD MAYBE CAN COME TO SOME AGREEMENT ABOUT THAT. I'M NOT SURE.

I SHAW AS BEING COVER THE UNDER THREE AND FOUR. I THINK THAT IS WHERE THAT ISSUE WOULD BE CONSIDERED AND EVALUATED.

R50EU9, I WAS CONCERNED ABOUT THE DEFINITION OF -- I MEAN ONE OF THE THINGS -- WHEN ONE THINKS OF A BENITO CON SERAL YOU DO ONE WITH ALL KINDS OF GENETIC COUNSELING AS OPPOSED TO THE OTHER ALLIED HEALTH PROFESSIONALS THAT COULD DO FOCUSED TYPES OF GENETIC COUNSELING AND I DON'T KNOW HOW YOU BRING THEM IN BUT I DON'T THINK THEY SHOULD BE LEFT OUT.

AS A CLARE FIEKZ EVEN TO REED'S POINT AND YOUR QUESTIONS REGARDING NURSES AND THE QUALIFICATIONS ISSUE IS THAT THE NATIONAL SOCIETY OF NURSES AND GENETICS DOES HAVE A CERT FICATION FOR NURSES AND WORKING IN THIS WHOLE AREA BOTH AT AN ADVANCED PRACTICE LEVEL AND AT A BASIC LEVEL. TRYING TO INCORPORATE SOME OF THE RECOMMENDATIONS OF NICHE PEG THAT ALL HEALTH PROFESSIONALS SHOULD BE AT LEAST TRAINED HOW TO TAKE A GOOD FAMILY HISTORY SO THAT THERE IS A WHOLE SCOPE AND STANDARDS OF PRACTICE THAT ARE PUT OUT BY THE INTERNATIONAL SOCIETY SORT OF GIVING RECOMMENDATIONS FOR WHAT IS THE SCOPE OF PRACTICE FOR A NURSE AT THE BASIC LEVEL AND AT THE ADVANCED LEVEL AND THAT A NURSE WHO IS ACTUALLY PRACTICING IN THIS FIELD COULD GO ON FOR CERTIFICATION SO THEN THEY WOULD MEET SPECIFIC QUALIFICATIONS FOR CERTIFICATION AND THE INTERNATIONAL SOCIETY OF NURSES AND GENETICS HAS THE SCOPE AND STANDARDS OF PRACTICE APPROVED THROUGH THE AMERICAN NURSES ASSOCIATION. SO I THINK THAT AT THE OTHER ASPECT OR THE FIRST COMMENT HERE ABOUT INCREASING THE LICENSURE IS THAT IN NURSES ALREADY ARE LICENSED IN THEIR OWN STATE SO THAT IT GIVES THEM SPECIFIC QUALIFICATIONs. THEY ALREADY HAVE SCOPE AND STANDARDS OF PRACTICE IN WHICH TO WORK AND COUNSELING HEALTH PRO MOTION, FALL UNDER THE PURVIEW OF THE NURSES FIELD SO IN MANY INSTANCES NURSES ARE BEING TRAINED TO PROVIDE SOME GENETIC COUNSELING SERVICES SO I THINK YOU KNOW WE WOULD HAVE TO LOOK AT ALL OF THESE ASPECTS BEFORE WE START TO KIND OF SPECIFY JUST ONE PARTICULAR DISCIPLINE AND I THINK AS BARBARA POINTED OUT THERE IS LOTS OF WORK ALREADY UNDERFOOT LOOKING AT THE COLLABORATIONS BETWEEN SPECIFICALLY NURSES AND GENETIC COUNSELORS.

NURSE PRACTITIONERS AND ADVANCED PRACTICE NURSES IN SOME STATES CAN BE REIMBURSED FOR THEIR SERVICES BUT UNFORTUNATELY IN THE FIELD OF GENETICS THE QUESTION JUST COME IS AS THAT THERE IS NOT REIMBURSEMENT FOR THE GENETIC COUNSELING IS WHAT THE PROBLEM.

THAT IS THE KEY THING IS WE ARE BASICALLY SAYING THEN IS HOW TO GET -- I THINK THIS IS A NARROWER PART OF THE DEBATE AND THAT IS SIMPLY NOT SO MUCH WHO CAN DO THE COUNSELING IT IS WHO CAN BILL INDEPENDENTLY FOR THEIR SERVICES AND I JUST DON'T SEE, QUITE FRANKLY, ANYWAY THAT ANYBODY IS GOING TO ALLOW SOMEBODY TO PAY A BILL FOR A PROFESSIONAL SERVICE IF THERE IS NOT SUFFICIENT EVIDENCE THAT THAT PERSON IS QUALIFIED TO ACT INDEPENDENTLY OF ANY ONE ELSE AND PROVIDE THAT SERVICE. AND I THINK THAT IT GOING TO BE A TOUGH RODE TO HOA AND SO I THINK THAT IF WE -- OUR DECISION I THINK WE HAVE TO MAKE HERE IS -- IS WHETHER WE CALL FOR THE -- THIS -- THIS CERTIFICATION AS IT WERE TO BECOME CLARIFIED AND THAT THAT BECOMES THE BIGGEST AND ACKNOWLEDGE THAT THAT IS THE RATE LIMITING STEP AND THEN DETERMINE AND SORT OF CALL FOR THAT TO GET FIXED OR WHETHER WE CAN DOMINO OVER THAT, JUMP OVER THAT AND SAY OKAY, IN THE ABSENCE OF THAT CERTIFICATION WE RECOMMEND THAT YOU JUST PAY PEOPLE AND I'M NOT SURE HOW TO -- I THINK THAT IS WHAT I WOULD SEE THE ULTIMATE ARGUMENT BOILING DOWN TO HERE.

SEE, THAT --

MY COMMENTS BUILD OFF OF EVERYTHING YOU SAID. IN THE BEGINNING OF THE DOCUMENT FOCUSES ON ACCESS. WE HAVE TALK PD PRY PERI-CARE AS A POINT OF ENTRY AND THAT GENETIC COUNSELING AND GENETIC SERVICES AS FUNDAMENTAL TO WHAT IS NEEDED IN THE REIMBURSEMENT IS A MAJOR PIECE OF IT SO I WOULD ENCOURAGE THE THEME I'M NOW HEARING IS THAT THERE IS A GENETIC ISSUE OF ACCESS, GENETIC SERVICES OF WHICH GENETIC COUNSELING AND BOTTOM LINE REIMBURSEMENT IS THE BASIC LINE THAT RATHER THAN FOCUSING ON JUST A DISCIPLINE IT SEEMED LIKE WE JUMPED A WHOLE LOT AND LOST SOME OF THE BASIC ESSENCE WE HAVE BEEN TALKING ABOUT IN OUR OTHER MEETINGS.

EMILY?

SO I GUESS THE QUESTION IS DO WE WANT TO ENCOURAGE THAT THERE IS SOME MECHANISM PUT IN PLACE THAT RECOGNIZES THAT CERTAIN LICENSED HEALTH PROFESSIONALS -- LET'S JUST LEAVE IT OPEN FOR RIGHT NOW, DO PROVIDE GENETIC COUNSELING THAT THIS IS VALUED AND SHOULD BE REIMBURSED. BECAUSE CERTAINLY WHEN YOU GO FOR A GENETIC COUNSELING SESSION THIS IS NOT A -- YOU KNOW, OFFICE VISIT BRIEF THIS IS GENERALLY, YOU KNOW, AN EXTENDED INTERACTION AND MAYBE EVEN MULTIPLE INTERACTIONS BY THE TIME YOU GET THROUGH, YOU NOW, A COUPLE OF COUNSELING SESSIONS PREAND POST TESTING. SO, WE WANT TO MAKE SURE THAT THAT IS VALUED AND THAT THOSE PEOPLE ARE BEING PROPERLY COMPENSATED. SO THE QUESTION I GUESS IS DO WE NEED THEM TO BE SEPARATELY BILLABLE OR IS THE UMBRELLA UNDER, YOU KNOW, A PHYSICIAN SUPER VICING THEM THE SAME WAY THAT THE NURSES AND THE PHYSICIAN OFFICES ARE TYPICALLY PART OF THE "OVERHEAD RATE" THAT THE PHYSICIAN CHARGES THE NURSES AREN'T BILLING YOU FOR THE TIME THAT YOU SPENT WITH THEM GETTING YOUR HEIGHT AND WEIGHT TAKEN AND LOW BLOOD PRESSURE AND ALL THAT. I THINK WE NEED TO BE VERY CONCRETE ABOUT WHAT IT IS THAT WE THINK AS A COMMITTEE WE WANT TO RECOMMEND, KEEPING IN MIND THAT WE ALL UNDERSTAND AND I THINK THERE IS A CONSENSUS THAT GENETIC COUNSELING IS A VALUABLE SERVICE AND THAT IT NEEDS TO BE PART OF THE CONTINUE YUM AS APPROPRIATE FOR THE SEVERITY OF A SPECIFIC CONDITION.

BRAD?

SO THESE ALL SEEM LIKE NO BRAINERS TO ME. I THINK WE ALL AGREE. I DON'T THINK WE DISAGREE. IT IS ABSURD THAT AFTER ALL THESE SESSIONS WE SAT THROUGH THAT WE WOULD THINK THAT ON GENETICS COUNSELORS CAN'T EVEN FIND A BOX ON THE THING REPRESENTING THEM. THAT IS GIVEN AND THEN THE MORE COMPLICATED THING WE HAVE HEARD TESTIMONY FROM PEOPLE WHO COULD VM AND TALKED ABOUT PHYSICIANS OR NURSES THAT COULDN'T BILL FOR THEIR TIME SO THEY WERE RUNNING PEOPLE OUT OF THEIR OFFICES INSTEAD OF PROVIDING COUNSELING. BUT ALL THAT BEING SAID, I THINK -- I APPRECIATE WHOEVER'S IDEA IT WAS TO STICK THE COUPLE LAST BULLETS ON WHERE YOU WHERING TO BUILD A CASE -- WHERE YOU ARE GOING TO BUILD A CASE FOR IT BECAUSE TO PLAY THE GREED REQUEST BUSINESSMAN I STILL -- GREEDY BUSINESSMAN I STILL THINK YOU GET THE PUSHBACK WHERE THEY SAY TOMORROW WE ARE REEMBURSTING A WHOLE NEW CLASS AND THEN WE ALSO HAVE A WOLE NEW WHOLE NEW CATEGORY BY WHICH NURSES AND PHYSICIANS CAN BILL AND YOU KNOW, EVEN IF THEY DID ONLY THE SAME AMOUNT OF COUNSELING THAT THEY ARE DOING TODAY, ISN'T ENOUGH BUT HOW MUCH MORE DOES IT COST AND THEN NOW IF THE FLOOD GATES ARE OPENED, HOW MUCH COULD IT REALLY AMOUNT TO THAT THIS COULD END UP COSTING THE SYSTEM AND IT IS PRETTY DAUNTING. I CAN SEE PEOPLE JUSTIFYING NEEDING, YEAH, DAYS WITH PATIENTS TO WALK THEM THROUGH GENETICS AND THERE IS A REAL CONCERN ABOUT THAT KIND OF COST AND PEOPLE ARE GOING TO PUSH BACK COMPLETELY. I'M 100% IN FAVOR OF THE FIRST THREE BUT THE LAST TWO AND I DON'T KNOW IF THE IOM -- THE BIG QUESTION THERE IS, YOU KNOW, THOSE OF YOU WITH MORE HISTORY ON THESE COMMITTEES CAN MAYBE STAY BUT MAYBE THIS HAS BEEN DONE NUMEROUS TIMES WHERE IT HAS BEEN DONE AND PEOPLE WOULD FIGURE OUT WHAT THE IMPACT WOULD BE BUT IF IT HASN'T BEEN OR HASN'T BEEN DONE RECENTLY SEEMS IF YOU DON'T BUILD A BETTER CASE FOR IT FROM A VERY COLD ECONOMIC POINT OF VIEW AND QUALITY OF CARE POINT OF VIEW AND YOU ARE NOT GOING TO EVER SELL IT. THAT IS THE SCARY PART. I ALWAYS TRY TO THINK ABOUT WHAT COULD THE OTHER SIDE BE THINKING. AS YOU DID EARLIER WITH THE CONGRESS. AND WHY WOULD ANY ONE BE OPPOSED TO GENETIC COUNSELING? SOMEONE HAS A DEVASTATING POSSIBLE DIAGNOSIS OR RISK SUDDENLY AND WHY CAN'T THAT BE PART OF THE TREATMENT AND THE SCARY THING MUST BE THAT THERE IS THIS WHOLE NEW AREA THAT PEOPLE ARE AFRAID MIGHT END UP COSTING AN AWFUL LOT AND MIGHT NOT BE PROPERLY REGULATE THE OR THERE AREN'T ENOUGH STANDARDS. HAVE STANDARDS BEEN SET UP THAT IF YOU HAVE THIS AND THIS POSSIBLE GENETIC RISK NOW YOU ARE ENTITLED TO 1.7 HOURS OF COUNSELING. I DON'T KNOW HOW TO WORKS BUT HAVE THOSE THINGS BEEN PUT IN PLACE AND PEOPLE ARE GOING TO BE CONCERNED THAT YOU ARE PUTTING THE CART IN FRONT OF THE HORSE IF YOU DON'T FIGURE IT OUT. I'M PUTTING A PLUG IN FOR THE LAST TWO THAT SEEM TO BE PREMISED ON BUILDING A CASE FOR IT.

RELATED TO THAT I WANTED TO ASK AND GET SOME INPUT ON NUMBER THREE WHICH CALLS UPON CMS TO CONDUCT A DEMONSTRATION PROJECT AND THEORETICALLY THAT COULD BE PART OF, BRAD, THE IDEA OF BUILDING A CASE. I QUESTION WHETHER THAT IS THE MOST EFFECTIVE WAY TO BUILD THE CASE OR WHETHER AN ASSESSMENT AND COMPREHENSIVE STUDY IS THE MOST EFFECTIVE WAY TO BUILD A CASE.

THAT JUST FELT REALLY SLOW TO ME.

SORRY?

THAT FELT REALLY SLOW TO ME.

WHICH JUAN?

NE. IN.

NUMBER THREE COMPARED TO FOUR OR FIVE.

EFFECTIVE. NOT MUTUALLY EXCLUSIVE BUT IF ONE IS MORE EFFECTIVE THAN THE OTHER AND THE GOAL IN THE END IS THE SAME WHICH IS TO BUILD A CASE AND DEMONSTRATE THERE IS A SERVICE THAT IS BEING PROVIDED AND SHOULD BE PROVIDED AND A VALUE TO PEOPLE AND IMPROVE THE ACCESS TO CARE AND THE QUALITY OF CARE WHAT IS THE BEST WAY TO ACHIEVE THAT RESULT. THROUGH LIMITED DEMONSTRATION PROJECT IN A FEW CITIES OR IS IT THROUGH MORE COMPREHENSIVE LOOK A LA AN IOM ASSESSMENT.

I FORGOT TO MENTION REMEMBER DOCTOR JUDITH COOKCY PRESENTED LAST YEAR ON THE STUDY BEING FUNDED THROUGH HERSA ON GENETIC SERVICES AND COUNSELORS AND OTHER GENETIC SPECIALISTS ARE PART OF THAT. THAT STUDY IS WINDING DOWN OR IS ABOUT AT ITS END. JUST A REMINDER THAT YOU ARE MOVING FORWARD SUGGESTING ADDICTIONAL ACTIVITIES WHEN YOU MAY BE HAVING DATA FROM THAT THAT WOULD HELP ADDRESS SOME OF THE THINGS THAT YOU ARE TALK ABOUT. FRANCES, DID YOU HAVE -- FRANCES, DID YOU HAVE?

IN REFLECTING ON YOUR QUESTION IS OCCURS TO ME THAT WHAT THE IOM WOULD DO IS LOOK AT EXTEND EVIDENCE SO THEY WILL BE ABLE TO PUT THAT IN A NEAT PACKAGE WITH A BOW AND PRESENT IT TO YOU. IF THE QUESTION IS DEMONSTRATING THE EFFECTIVENESS THROUGH A DEM MON VATION STUDY THAT COMES THROUGH IT FROM A DIFFERENT PERSPECTIVE ZWLA SAYS THOSE DATA DON'T EXIST WE NEED TO DO A STUDY TO GENERATE THOSE DATA. THAT THAT IS THE QUESTION FOR THE GROUP IS WHETHER OR NOT THOSE DATA EXIST ALREADY. QUICK QUERY ON THAT. AND IF THIS HE EBBSIST EXIST, GETTING THE UNDERPINNING FOR SUCH RECOMMENDATION.

EMILY?

I SEE SORT OF TWO THINGS. ONE IS ABOUT RECOMMENDATION NUMBER ONE WHICH SORT OF DEALS WITH THE WHOLE WHO IS QUALIFIED ISSUE AND I THINK WE COULD MAKE A VERY SPECIFIC RECOMMENDATION THAT SORT OF NO BRAIN ERNIE ONE WHO IS CERTIFIED WITH SOME BULLET POINT LIST OF ORGANIZATIONS SHOULD BE QUALIFIED TO DELIVER GENETIC COUNSELING. IT DOESN'T SAY GET PAID FOR IT BUT AT LEAST THAT IS OUR ENDORSEMENENDORSE, IF YOU WILL, OF THOSE PROGRAMS AS PROVIDING SOME SPECIFIC LEVEL OF TRAINING THAT GIVES PEOPLE THE RIGHT QUALIFICATIONs. THE NEXT QUESTION IS -- IS THIS WHOLE DIRECT BILLING AND I THINK IT IS ALMOST GOING TO BE IMPOSSIBLE TO JUSTIFY DIRECT BILLING WITHOUT HAVING A SPECIFIC SET OF DATA TO SUPPORT THAT. SO, I AM LESS INCLINED TO TRY AND GO FOR NUMBER TWO. OR PUT THAT AS SORT OF THE THIRD LEVEL SO THE FIRST IS IDENTIFY WHAT WE BELIEVE ARE WILL LEGITIMATE QUALIFICATION PROGRAMS, IF YOU WILL. THE SECOND IS WHERE IS THE DATA THAT SHOWS THAT THIS SERVICE HAS VALUE. AND THE THIRD THEN IS, YOU KNOW, WHAT IS THE BEST MECHANISM FOR REIMBURSEMENT? IS IT STILL UNDER THE UMBRELLA OF THE PHYSICIAN OR SHOULD THEY BE ALLOWED TO SEPARATELY BILL FOR SOME SPECIFIC SERVICES? I DON'T THINK ANY ONE WHO SITS DOWN AND CHATS WITH YOU AND GIVES YOU INFORMED CONSENT FORMS TO SIGN SHOULD NECESSARILY BE BILLING BUT I DO THINK THAT PEOPLE WHO SPEND THEIR LIVES WORKING ON COUNSELING PEOPLE SHOULD BE ABLE TO GET RECOGNITION AND COMPENSATION FOR THAT.

DEBRA?

THAT WAS ONE OF MY CONCERNS IS WHERE DOES THIS GO WHEN WE MOVE TOWARDS GENOMIC MEDICINE BECAUSE WE THINK OF GENETIC COUNSELORS MORE WITH SINGLE GENE DISEASE COUNSELING AND AS WE MOVE MORE TOWARDS GENOMIC MEDICINE WHERE YOU CAN DO OR ASTHMA AND CONGESTIVE HEART FAILURE AND WHO KNOWS WHAT, WILL THAT REQUIRE THE SAME LEVEL OF GENETIC COUNSELING AND WE'RE IMAGINING THAT THAT WILL BE DONE BY PRIMARY CARE PHYSICIANS POTENTIALLY? GET BACK INTO THE EDUCATION ISSUE AND IF PEOPLE AREN'T EDUCATED THEN CAN THEY -- BUT IN THE CURRENT HEALTHCARE ECONOMIC SITUATION ANYTHING ELSE YOU WOULD BILL FOR WOULD BE HIGHLY VALUABLE BECAUSE YOU WOULD GET MORE MONEY THAN FOR THE SERVICES THAT YOU CURRENTLY PROVIDE SO WOULD THIS END UP BEING A MONTREAL MECHANISM THAT YOU USE.

I THOUGHT PCPs HAVE A MECHANISM ALTHOUGH IT MAY STILL BE INADEQUATE BECAUSE THEY CAN BILL FOR OFFICE VISITS OF SAIRRYING DURVARYING DURATION SO IF THEY ARE PROVIDEING THAT DISCUSSION ITH THE PATIENT ABOUT ANYTHING, ABOUT CANCER, ABOUT HEART DISEASE, ABOUT, YOU KNOW, HIGHLY PEN TRANT GENETIC DISORDER THAT THEY HAVE A MECHANISM TO BE RECOGNIZED AS QUALIFIED AND TO GET PAID FOR THE TIME THEY SPEND WITH SOMEONE. I THOUGHT WE WERE REALLY SORT OF FOCUSING ON THE COUNSELING PART WHERE THE COUNSELORS RIGHT NOW ARE NOT EITHER OFFICIALLY RECOGNIZED OR OFFICIALLY ABLE TO BILL AND DIRECTLY GET COMPENSATED. I DON'T WANT TO DISMISS THE FACT THAT PCPs ARE HOPEFULLY GOING TO PROVIDE A LOT OF THIS COUNSELING AND CERTAINLY IN SOME SITUATIONS I WOULD SAY PROBABLY IN THE CANCER SCENARIOS THE REFERRING ONCOLOGIST IS PROBABLY PROVIDING A LOT OF THE COUNSELING.

THERE IS NO QUESTION THAT WE ARE REALLY ENTERING A WHOLE NEW AREA AND I'M SURE PRIMARY CARE PHYSICIANS ARE FRUSTRATED WITH HOW MUCH THEY ARE ABLE TO GET REIMBURSED FOR COGNITIVE AS OPPOSED TO PROCEDURAL SERVICES AND THAT IS JUAN F ONE MUCH THE CHALLENGES -- THAT IS ONE OF THE CHALLENGES OF A MARRY CARE IMARY CARE PHYSICIAN IS YOU DON'T GET TO DO STUFF. WHAT I HEAR DEBRA AND EMILY GOING HERE AND BRAD'S POINT WAS IF YOU SORT OF FAST FORWARD THIS THING WHEN GENETICS IS THE ESSENCE OF MEDICINE, BASICALLY THEN IT MEANS ALMOST EVERY ENCOUNTER ULTIMATELY IS GOING TO HAVE A GENETIC COMPONENT. I MEAN YOU'RE GOING TO BE TALKING -- IF THIS FAMILY HISTORY DEAL IS A TERRIFIC SUCCESS THEN BY THE DAY AFTER THANKSGIVING, YOU KNOW, EVERYBODY IS INTO THEIR DOC'S OFFICE TALKING ABOUT COUSIN SUE AND THEN WHAT DO I DO AND THEN WELL, TOES THE DOC SIT THERE AND CHAT WITH YOU OR REFER THAT OUT LIKE YOU WOULD A NUTRITIONAL CONSULT AND THEN EXPECT THAT SOMEBODY WOULD NEED TO BE COME COMPENSATED FOR THE SERVICES AND YOU OPENED UP A HECK OF A BOX WHICH I DON'T THINK WE ARE GOING TO SOLVE. I THINK WHAT THIS BOILS BACK DOWN TO AGAIN IS -- AND THIS IS NOT -- I'M SORT OF PUTTING THIS OUT THERE AS A WAY OF GIVE YAG SOMETHING TO AT FOR THE REPORT -- TO SHOOT AT FOR THE REPORT IS DO WE ACKNOWLEDGE THIS IS A BIG ISSUE, THIS INDEPENDENT -- FIRST OF ALL, DO WE ACKNOWLEDGE AS YOU WENT THROUGH, EMILY, THAT FIRST, WE DO SUPPORT AND RECOGNIZE THAT IT IS IMPORTANT TO HAVE GENETIC COUNSELING BEING DONE NOT ONLY FOR ALL THE GOOD REASONS THAT ARE MOTHER GOD AND COUNTRY BUT, BRAD, FOR THE BUSINESS REASON IS THAT IN THE ABSENCE OF IT YOYOU ARE GOING TO GET A WHOLE LOT OF INAPPROPRIATE TESTING. GENETIC COUNSELING OUGHT TO DECREASE HEALTHCARE COSTS AND INCREASE IT IN THE AGGREGATE. THAT WOULD BE THE HIGH HIGH HYPOTHESIS. WE OUT TO ENCOURAGE THAT. NUMBER TWO 19 -- NUMBER TWO IS THE INDEPENDENT BILL BILLING. GIVE THAN THIS IS IMPORTANT WE WOULD URGE THE LOGICAL STEPS TO GET THESE THINGS IN PLACE. AND I THINK FIEALLY, TO -- FINALLY, TO BE MORE COMPLETE THAN WE ARE HERE WOULD BE TO ACKNOWLEDGE THOSE EFFORTS THAT ARE ONGOING NOW TO RESOLVE THIS MATTER. I STILL HAVE TO GO BACK AND REREAD THE TESTIMONY FROM THE COUNSELING COMMUNITY. I DON'T REMEMBER WHAT ELSE IS GOING ON TO GET NATIONAL STANDARDS AND GET THEM IMPLEMENTED. I CAN'T IMAGINE THAT LAYING DORMENT. -- DORMENT.

AND THEN FINALLY ADD TO THAT THE CALL FOR SOME OF THESE DEMONSTRATIVE STUDIES THAT WE THINK NEEDS TO BE DONE TO FINALLY GET THAT DONE AND THEN WHETHAT BODY OF WORK IS COMPLETE TEN THE ISSUE OF INDEPENDENT BILLING MAY BE ABLE TO BE ADDRESSED AND WE WILL TAKE THAT UP AS EVENTS

YOU KNOW, WE'RE ABLE, IF WE'RE LICENSED AND FINE, BUT I THINK IT'S BEEN VERY CLEAR TO US PREVIOUS TESTIMONY THAT COUNCILORS ARE DOING THIS JOB NOW -- COUNSELORS ARE DOING THIS JOB NOW AND NOT GETTING REIMBURSED. IT'S A THREAT TO THE COUNSELING COMMITTEE, ET CETERA. YOU KNOW, SELF-SERVING AS IT MIGHT BE, I THINK IT'S IMPORTANT THAT WE DON'T JUST SAY WE CAN'T DO ANYTHING ABOUT THE BILLING, SO WE'LL MAKE SURE LIFE INSURANCE IS SOME KNOWS.

I THINK THAT'S IMPORTANT. WE NEED TO ACKNOWLEDGE THAT EXPLICITLY AS PART OF OUR NARRATIVE, THAT WITHOUT REIMBURSEMENT, ALMOST LIKE WHICH COMES FIRST, THE CHICKEN OR THE EGG. ONE DAY, WHAT I THINK ABOUT -- WHAT I HAVE BEEN SORT OF SAYING, I GUESS, WITHOUT THE LIFE INSURER, IT'S GOING TO BE HARD TO GET REIMBURSED. WE NEED TO GIVE EQUAL CREDENCE THAT WITHOUT THE REIMBURSEMENT, WHO CARES ABOUT LIFE INSURANCE, WHAT IT COMES DOWN TO. WE DON'T WANT TO KILL OFF OR STIFLE THE GROWTH IN THE NUMBER OF COUNSELORS, GIVEN WE HAVE TOO FEW NOW. I THINK ALSO,IOR POINT ABOUT SOME OF THE EXAMPLES GOING ON, HOPEFULLY WE CAN APPENDIX THIS IN THE HAVEN'T -- IN THE REPORT. I THINK FEW PEOPLE ARE AWARE OF, YOU KNOW, THESE GROUND-BREAKING INITIATIVES IN A COUPLE OF STATES AND WE HAVE TO APPEND SEIZE THOSE TO MOVE IT FORWARD. I WHERE I WOULD MOVE WITH YOU, BARBARA, IT'S ONE PERSON'S OPINION WITH THIS. WE WANT TO MOVE IT FASTER AND I DON'T WANT IT TO LOOK LIKE WE'RE PUT A LOT OF STEPS IN PLACE THAT LOOK LIKE WE'RE NOT URGING, SEEING THE URGENCY OF IT. I THINK WE SHOULD BE URGENT AND GIVE EXAMPLES OF CONCRETE THINGS THAT WE OUGHT TO BUILD UPON.

BRAD AND THEN DEBRA.

THIS IS JUST THE, THE COMPLAINTS ROOT NOW ABOUT THE DISCRIMINATION THAT NOT ENOUGH PEOPLE ARE BEING HARMED. I THINK IT WOULD BE GREAT IF WE COULD ALSO POINT TO THINGS THAT AREN'T RIGHT BECAUSE COUNSELORS, TOO MANY OF THEM ARE NOT BEING REIMBURSED, I MEAN YOU KEEP HAVING CONGRESS UP THERE. CONGRESS SEEMS TO RESPOND TO A PROBLEM THAT WON'T GO AWAY, AND AS LONG AS IT'S NOT A NOISY PROBLEM RIGHT NOW, I DON'T KNOW HOW THEY'RE GOING TO REACT. IF WE COULD POINT TO SERIOUS PROBLEMS, DAMAGES BEING DONE BECAUSE PEOPLE AREN'T GETTING COUNSELING, AND I'M SURE THERE ARE AS GOOD ANECDOTES FOR THAT AS THERE ARE DISCRIMINATION, MAYBE MORE. THEY WOULD BE PROBABLY HELPFUL STATING OUR CASE.

CINDY, COULD YOU TRY TO, JUST GIVEN THAT WE HAVE TO STOP HERE AND NOT, GOT TO, WE'RE EXCITED TO STOP AND TURN TO PUBLIC TESTIMONY IN THE LAST HALF HOUR. WE HAVE GIVEN EACH OF THEM THEIR AMOUNT OF TIME, SUPPOSED TO STOP AT 5:00, CAN YOU, CAN WE CHAL EDGE YOU RIGHT NOW TO -- CHALLENGE YOU RIGHT NOW TO SORT OF FRAME WHERE YOU THINK WE MIGHT BE, AND MAY BE JUST TAKE THIS, START AT THIS POINT TOMORROW MORNING BRIGHT AND EARLY? GIVE US SOMETHING TO HELP US SEE WHETHER DO WE NEED TO NEEDLE OVER THIS A LITTLE MORE TONIGHT AND COME RIGHT IN AND ATTACK THIS, OR DO YOU WANT TO PUT THIS PART OF THE REPORT TO CLOSURE RIGHT NOW?

I THINK MAYBE WE SHOULD REWORK BASED ON THIS DISCUSSION, I THINK WE CAN MERGE SOME RECOMMENDATIONS. I ALSO THINK THAT WHAT I HEARD AND, IF I DID HEAR IT CORRECTLY, I AGREE WITH IT THAT, NUMBER 2, THE CONGRESSIONAL COMPONENT IS PROBABLY PREMATURE GIVEN THAT WE'RE CALLING FOR THESE OTHER THINGS AS SORT OF A PREREQ SIT SO WE CAN MAYBE TAKE THAT ONE OUT. MAYBE WE CAN NEEDLE AROUND, COME UP WITH REVISED RECOMMENDATIONS AND PUT THEM ON UP ON THE SCREEN FIRST THING IN THE MORNING, AND I'LL JUST GET WITH SUZANNE AND OTHERS AND WE'LL TRY TO COME UP WITH SOMETHING AND THEN HOPEFULLY WITH THE LIMITED AMOUNT OF DISCUSSION TOMORROW MORNING, WE CAN CLOSE THAT. CLOSE THAT OUT.

WHILE YOU'RE NEEDLING, CAN YOU -- I THINK THE -- NEEDELING, I THINK THE RECOMMENDATION ON 61, IF WE'RE GOING TO TALK ABOUT REIMBURSEMENT, THAT STUCK OUT THERE BY ITSELF. CAN THAT BE INCORPORATED INTO THE GENETIC COUNSELING RECOMMENDATIONS AS A WHOLE, AND I REALLY DON'T AGREE WITH DROPPING NUMBER TWO BECAUSE I, I REALLY THINK THAT IF THERE IS LICENSURE, THERE SHOULD BE PAYMENT, AND THEY HAVE TO BE RECOGNIZED AND THEY HAVE TO GET UPIN NUMBERS TO GET PAID. I DON'T THINK WE CAN TAKE TWO OFF, BUT MAYBE MAKE THAT, YOU KNOW, THAT BASICALLY ONCE THERE IS LICENSURE, THAT'S THE STATE SAYING THESE PEOPLE ARE QUALIFIED TO DO THIS MEDICAL SERVICE THAT THEY'RE DOING. THEY, THEY SHOULD GET PAID FOR IT.

ALL RIGHT, CINDY HAS GOT SOME STUFF TO LOOK AT TONIGHT, AND WE'LL WATCH AND SEE HOW MANY GLASSES OF WINE SHOW HAS AT DIPPER. [ LAUGHTER ]

SEE WHAT SHE'S ABLE TO DO. SO, THANK YOU FOR THAT. CINDY, THANK YOU FOR VOLUNTEERING TO TAKE EVEN MORE RESPONSIBILITY. LET ME THANK THE COMMITTEE FOR YOUR HARD WORK SO FAR TODAY AND NOW LET'S TURN, WITH GREAT ATTENTIVENESS TO THE PUBLIC COMMENTS. ONE OF OUR CRITICAL FUNCTIONS IS TO BE ABLE TO RECEIVE INPUT PUBLIC. AND SO WE APPRECIATE THE VIEWS THAT THEY'RE SHARING WITH US. WE ALSO HAVE RECEIVED WRITTEN COMMENTS THAT CAN BE FOUND ON OUR TABLE FOLDERS. IN THE INTEREST OF TIME, COMMENTATORS ARE TO KEEP THEIR REMARKS TO FIVE MINUTES. AND, I SAID, WE DO HAVE YOUR, YOUR WRITTEN TESTIMONY WHICH, WE WILL BE LOOKING AT VERY CAREFULLY. LET ME SAY THAT I HAVE GOT RIGHT NOW ON MY LIST, FIRST, KELLY ORMOND. FROM THE NATIONAL SOCIETY OF GENETIC COUNSELORS, WELL-TIMED. SHARON TERRY, FROM THE GENETIC ALLIANCE, MARION ODEY FROM THE ALPHA 1 ASSOCIATION, GARY MARTUSI FROM MYRIAD GENETICS, CHRISTINE BRODERICK, THE NATIONAL PARTNERSHIP FOR WOMEN AND FAMILIES AND DONALD HORDEOP -- HORTON, DIRECTOR OF PUBLIC POLICY AND ADVOCACY FOR LABORATORY CORPORATION OF AMERICA. I AM SURE THAT SARAH WILL GET ME IF I HAVE MESSED ANYONE ELSE. LET'S START WITH KELLY ORMOND FROM THE NATIONAL SOCIETY OF GENETIC COUNSELORS.

THANK YOU, IT'S A PLEASURE TO BE SPOKING HERE TODAY. I'M KELLY ORMOND, PRESIDENT OF THE NATIONAL SOCIETY OF GENETIC COUNSELORS. AS YOU'RE AWARE, THE NSGC IS THE LEADING VOICE, AUTHORITY AND ADVOCATE FOR THE GENETIC COUNSELING PROFESSION AND REPRESENTS 2,000 MEMBERS. TOGETHER, WE PROVIDE COUNSELING FOR PRINATAL, PEED@EC, WORKING IN ACADEMIA, BIOTECHNOLOGY COMPANIES. A HIGH PERCENTAGE OF OUR CLINICALLY-PRACTICING MEMBERS OFFER SOME FORM OF GENETIC TESTING ON A REGULAR BASIS, WHETHER CARRIER TESTING OR PRESYMPTOMATIC COPYING FOR ADULT OFFSET DISORDERS. TODAY WE WOULD LIKE TO ADDRESS TWO ISSUES RELATED TO THE PROVISION OF GENETIC SERVICES. GENETIC DISCREMINATION AND COVERAGE AND REIMBURSEMENT OF GENETIC COUNCILING SERVICES. NSGCRX WOULD LIKE TO FIRST ADDRESS THE ISSUE OF GENETIC DISCRIMINATION BY EMPLOYERS AND INSURERS AND THE RELATED TOPIC OF GENETIC NON-DISCRIMINATION LEGISLATION. WE TESTIFIED ON THIS ISSUE AT PAST MEETINGS. AND NSC -- NSGC PROVIDED TESTIMONY TO OTHER ORGANIZATIONS, INCLUDING THE NATIONAL CONFERENCE OF INSURANCE LEGISLATORS IN FEBRUARY AND JULY OF 2004. AND AS AN -- IS AN ACTIVE MEMBER OF THE COALITION OF GENETIC FAIRNESS. WE HAVE RECENTLY COLAB RATED WITH FORADIO, FORCE, A CANCER ADVOCACY INFORMATION TO HAVE A BROCHURE ON GENETIC DISCRIMINATION. OUR ORGANIZATION IS DISAPPOINTED THAT SENATE BILL S-001 53 WAS NOT TAKEN UP BY THE HOUSE IN THE PAST YEAR AND WE'RE COMMITTED WITH WORKING WITH ALL STAKEHOLDERS TO DEVELOP POLICIES EQUITABLE AND FAIR TO THE AMERICAN PUBLIC. WE WOULD WELLEC TO ADDRESS THREE POINTS IN REGARDS TO GENETICS DISCRIMINATION, BEGINNING BY REFLECTING UPON THE CURRENT STATUS OF DOCUMENTED GENETIC DISCREMINATION. IT'S CLEAR THERE ARE A FEW DOCUMENTED CASES OF GENETIC DISCREMINATION IN EITHER THE INSURANCE OR EMPLOYMENT SETTING BUT THE ORAL TESTIMONIES, WRITTEN TESTIMONIES AND CASES PRESENTED IN OTHER RESOURCES, INCLUDING THE FACES OF GENRHETT -- GENETIC DISCRIMINATION BOOKLET HAVE RE-ENFORCED IT'S CLEARLY AN ONGOING PROBLEM FOR AT LEAST A SMALL PERCENTAGE OF FAMILIES WITH INHERITED DISORDER N.A PAPER CURRENTLY IN PRESS, SEN% OF SURVEY RESPONDENTS AT RISK FOR COLON CANCER PROCEED THAT THEY OR A HEALTHY FAMILY MEMBER EXPERIENCED GENETIC DISCRIMINATION BASED ON TESTING OR HISTORY. THESE WERE AROUND DIFFICULTER OR DENIAL OBTAINING HEALTH OR LIFE INSURANCE COVERAGE OR IN DENIAL OF SCREENING COVERAGE. IT REMAINS UNCLEAR SINTS BULK REMAINS UNPUBLISHED, WHETHER THEY'RE FACING DISCRIMINATION BECAUSE OF A DISABILITY OR SOLELY BASED ON GENETIC STATUS, AN EXTENT TO WHICH DISCRIMINATION MAY OR MAY NOT BE OCCURRING. SECOND, REGARDLESS OF THE RATE AT WHICH GENETIC DISCRIMINATION OCCUR, DATA SUGGESTS INDIVIDUALS WANT TO KEEP THEIR GENETIC INFORMATION PRIEST AS THEY DO ALL HEALTH INFORMATION AND THEY'RE AFRAID THEY'LL BE DISCREMINATED AGAINST ON THE BASIS OF GENNETTEC INFORMATION. AS A RESULT, THE TOPIC OF POTENTIAL GENNEL -- GENETIC DISCRIMINATION IS FREQUENTLY DISCUSSED. IS WAS -- AS WAS RE-ENFORCED EARLIER, THIS IS USUALLY BROUGHT UP BY THE CLIENT REGARDING THAN THE GENETIC COUNSELOR. WE HEARD THAT DATA FURTHER BACKED UP BY PUBLISHED STUDIES SUGGEST A PROPORTION OF INDIVIDUALS WHO ARE CANDIDATES FOR GENNETTEC TESTING AND FOR WHO MEDICAL MANAGEMENT MIGHT BE CHANGED BASED ON TEST RESULTS, DECLEAN TESTING ON THE BASIS OF THE SPHERE OF GENETIC -- SPECIFICALLY, TWO RECENT STUDIES DOCUMENT THAT NEARLY HALF OF SURVEYED INDIVIDUALS ARE HIGHLY CONCERNED ABOUT GENNETTEC DISCRIMINATION. THIS MAY RESULT IN AT-RISK INDIVIDUALS DECLINING JEBETEC COUNSELING, AS WELL AS GENETIC TESTING. UNDERGOING TESTING USING AN ALIAS OR ANONYMOUS MANNER, NOT BILLING HEALTH INSURANCE FOR GENETIC TESTING OR OBTAINING LIFE INSURANCE OR OTHER POLICIES PRIOR TO UNDERGOING GENETIC TESTING. THERE ARE STUDIES THAT DOCUMENT A HIGH PERCENTAGE OF INDIVIDUALS AT RISK FOR BREAST OR COLON CANCER DON'T TELL THEIR PHYSICIANS OR ENSHOWERS ABOUT THE RISKS OR THEY ASK THAT THE INFORMATION NOT BE RECORDED IN THEIR MEDICAL RECORDS. SUCH BEAFTERIOR CERTAINLY HAS PERSONAL AND PUBLIC HEALTH IMPLICATIONS ON MEDICAL MANAGEMENT. IF INDIVIDUALS DON'T UNDERGO EARLY SCREENING OR IF THEY CHOOSE NOT TO SHARE GENETIC TEST RESULTS WITH HEALTHCARE PROVIDER. WHILE EDUCATION THROUGH THE MEDIA AND HEALTH PROFESSIONALS WILL BE USEFUL IN MILE PER HOUR NOISING THAT THE GENETIC INFORMATION IS DIFFERENT FROM OTHER PERSONAL HEALTH INFORMATION, FIRE ERROR ERROR RELATED TO GENETIC DISCRIMINATION APPEARS TO BE PERVASEF. AS WE DISCUSSED THIS MORNING, IT SEEMS CLEAR THE STATE LAWS SPECIFIC TO GENETIC DISCRIMINATION AROUND HEALTH INSURANCE OR EMPLOYMENT DISCRIMINATION AND THE FEDERAL ADA, HIPAA AND SEVERAL RIGHTS STATUTES MAY NOT BE COMPREHENSIVE AND THERE ARE GAPS BETWEEN STATE LEGISLATION THAT BECOME RELEVANT IN OUR HIGHLY MOBILE SOCIETY. ONE CRITICAL POINT THAT WAS NOT DISCUSSED EARLIER IS THAT RESEARCH DATA SUGGESTINGS THAT NEITHER PRIMARY CARE PROVIDERS OR THE GENERAL PUBLIC ARE APPEAR OF THE -- AWARE OF THE PROTECTS THE BILLS PROVIDE. AS WAS NOTED IN OUR 2002 POSITION STAM, AND I QUOTE, THE NSGC OPPOSES DISCRIMINATION AGAINST AN INDIVIDUAL WITH REGARDS TO ELIGIBILITY FOR MAINTENANCE OR EMPLOYMENT, MEDICAL BENEFITS OR INSURANCE ON THE BASIS OF GENETIC INFORMATION, RESULTING IN THE RESULTS OF GENETIC TESTING, OTHER TESTS REVEALING GENETIC INFORMITION AND -- INFORMATION AND INFORMATION GAINED ON FAMILY HISTORY. THIS IS APPROPRIATE ONLY WHEN USED TO PROTECT THE INDIVIDUAL'S BEST INTEREST. WHILE THE NSGC DOESN'T SUPPORT A POSITION OF GENETIC EXCEPTIONALISM, WE SUPPORT THE NONDISCRIMINATION LEGISLATION. SUCH LEGISLATION WOULD LIKELY ALLEVIATE THE MAJORITY OF CONCERNS REGARDING GENETIC DISCRIMINATION AND ALLOW MEMBERS OF OUR SOCIETY TO USE GENETIC INFORMATION TO HELP CLIENTS MAKE INFORM WOULD -- INFORMED MEDICAL AND PERSONAL DECISIONS 206789 QUOTE PAUL MILLER FROM A PUBLICATION SEVERAL YEARS AGO, WHETHER IT, GENETIC DISCRIMINATION SA HUGE PROBLEM OR A SMALL PROBLEM, IT SHOULD BE PROHIBITED.

TERRIFIC.

KELLY, LET ME ASK YOU TO DO THIS.

CAN I HAVE ONE MORE MINUTE TO FINISH QUICKLY.

CAN YOU DO IT IN A MINUTE IN.

YEAH.

GO FOR IT.

YES.

IN SUMMARY, NSGC SUPPORTS FEDERAL LEGISLATION FOR NONGENETIC DISCREMINATION AND WE'RE AVAILABLE TO WORK WITH S -- TO FURTHER THIS MATTER UNTIL SUCHLATION IS PASSED. WE'RE COMMITTED TO WORK WITH SACGHS AND OTHER ORGANIZATIONS TO WORK WITH THE SOCIETY AND TO ADDRESS THE MISCONCEPTIONS WHICH HAVE UNFORTUNATELY BECOME PREVALENT. FINALLY, I WOULD LIKE TO STATE THAT IN OUR QUEST TO IMPROVE THE AXIS OF OUR AMERICAN SOCIETY TO HIGH QUALITY GENOMIC MEDICINE, IT'S CRITICAL THIS COMMITTEE CONSIDER NOT ONLY THE NEED TO DECREASE RISK OF GENETIC DISCREMINATION, BUT ALSO WAYS TO INCREASE ACCESS TO HIGH-QUALITY AND AFFORDABLE GENETIC SERVICES. AT SUCH, I WOULD LIKE TO CONCLUDE BY ADDRESSING THE ISSUE OF COVERAGE AND REIMBURSEMENT OF GENETIC COUNCILING SERVICES, PROMMARILY ADDRESSING SERVICES PROVIDED BY MASTERS TRAINED GENETIC COUNSELORS MUCH ISSUES OF BILLING AND REIMBURSEMENT ARE THE MOST FACING THE MEMBERS OF NSGC, ONE OF THE THREE AREAS PRIORITIZED IN OUR PLAN. THROUGH THE PAST TESTIMONIES, THIS COMMITTEE IS AWARE THAT COVERAGE AND EMPLOYMENT ARE LIMITED BY THE LACK OF CPT CODES AND THE INELIGIBILITY FOR NONPHYSICIAN PROVIDER IDENTIFICATION. WHILE SOME PAYERS CONTRACT DIRECTLY WITH THE HEALTH PLANS TO INCLOUD GENETIC COUNCILING AS A COVERED SERVICES AND SOME SERVICES ARE COVERED BY MEDICADE AND MEDICARE WHEN PROVIDED TO INDIVIDUALS WITH DISABLES, THE BULLING ARE NOT CURRENTLY REIMBURSED. WE ONLY HAVE PRELIMINARILY REVIEWED THE NEWEST DRAFT RECOMMENDATIONS, NSGC IS PLEASED TO SEE SACGHS AND THE SECRETARY'S OFFICE CONSIDERS WAY TO ADDRESS THESE OWNS. WEIR HEARTENED TO SEE THAT IT'S PROMOTING THE FUNDING AND EVIDENCE-BASED FUNDINGS THROUGH ANY AGENCIES. NSGC OFFERS THE STRONG SUPPORT IN DEVELOPING AND CONDUCTING SUCH STUDIES AND HAVE REPEATEDLY BEEN TOLD THAT STUDIES DOCUMENTING SUCH VALUE WILL BE CRITICAL. WE'RE ALSO PLEASE SAID THAT AS -- SACGHS IS CONTINUING TO ADVOCATE FOR THE COUNSELORS AS RECOGNIZED PROVIDERS IN PRIVATE AND NATIONAL PROVIDER IDENTIFICATION SYSTEMS. IF NSGC CAN BE OF ANY HELP, INCLUDING OFFERING FORMAL TESTIMONY ON THE EFFORTS TOWARD VIOLENCE -- LICENSEURE OR DOCUMENTATION, DON'T HAZE -- .

ARE YOU GOING TO BE AROUND TOMORROW?

I'M GOING TO BE HERE UNTIL 1:00.

OKAY.

I'M HAPPY TO ADDRESS ANY OF THESE ISSUES AT THAT TIME.

I REALLY WANT TO THANK YOU, FIRST OF ALL, FOR COMING AND GETTING YOUR STUFF ON THE RECORD AND READING AS QUICKLY AS YOU DID.

I TRIED.

AND SO, YOU, YOU'RE VERY GOOD.

I'M SORRY IT WAS LONG.

I'M THE ONE IN TROUBLE.

BUT, THANK YOU FOR THAT. WE, ACTUALLY, YOU HEARD THE DISCUSSION EARLIER. I'M NOT GOING -- GOING TO DO MUCH. WE CAN'T STOP FOR QUESTIONS. IF YOU ALL COULD AMEND YOUR TESTIMONY BASED ON WHAT YOU JUST HEARD US GO THROUGH AND, IF YOU WANT TO, YOU KNOW, UNDERSCORE THAT, WE WOULD REALLY MUCH APPRECIATE EVEN MORE SPECIFICITY BASED ON WHAT YOU JUST HEARD. THANK YOU SO MUCH.

THANK YOU.

SHARON TERRY FROM THE GENETIC ALLIANCE.

I WILL HELP YOU OUT. I TOLD KELLY I WOULD GIVE OVER SOME OF MY TIME TO HER. I'M ONLY GOING TO BE THREE MINUTES. I'M SHARON TERRY, PRESIDENT AND CEO OF THE GENETIC ALLIANCE, IN ALLIANCE WITH 600 DISEASE ADVOCACY ORGANIZATIONS THAT REPRESENTS 14 MILLION INDIVIDUALS. THE ALLIANCE IS A FOUNDING MEMBER OF THE COALITION FOR GENETIC FAIRNESS, A COALITION OF ORGANIZATIONS WORKING TOGETHER AGAINST GENETIC DISCRIMINATION. WE UNDERSTAND THE PROMISE OF BASIC AND MEDICAL RESEARCH AND ARE APPALLED THAT MANY FAMILIES AND INDIVIDUALS EXPERIENCE GENNETTEC DISCRIMINATION AND FEAR BOTH KNOWING THEIR OWN RISK AND PARTICIPATING IN RESEARCH AS WELL. YOU HAVE HEARD SOME OF THE THEIR STORIES HERE TODAY. THE COALITION FACES OF DESCREMINATION PROVIDES YOU WITH MORE STORIES. WE BELIEVE THAT ALL GENETIC INFORMATION, INCLUDING FAMILY HISTORY, DESERVES STRONG PROTECTION AGAINST MISUSE IN HEALTH INSURANCE AND EMPLOYMENT. SUCH SAFE GUARDS WILL PROTECT THE RIGHTS, PRIVACY AND CONFIDENTUALITY OF THE INDIVIDUAL AND THEIR FAMILY. THIS IS AN EXCITING AND HOPEFUL TIME FOR MEDICINE. IT'S IMPERATIVE, HOWEVER, THAT WE, THE PUBLIC, TAKE FULL ADVANTAGE OF NOW MEDICAL ADVANCES THATTING HELP PREVENT DISEASE BEFORE IT DEVELOPS. GENETIC NONDISCREMINATION LEGISLATION WILL REDUCE THE LIKELIHOOD OF GENETIC INFORMATION BES MISUSED IN HEALTH INSURANCE OR EMPLOYMENT DECISION MAKING. AS YOU WELL KNOW, HAVING A POSITIVE GENETIC TEST DOESN'T MEAN ONE WILL DEVELOP A DISEASE, US THIS THIS INFORMATION SHOULDN'T BE USED TO MAKE DECISIONS ABOUT INSURANCE COVER OR EMPLOY MET. YOU HAVE HEARD HERE FROM COURAGES AND PROFESSIONALS THAT AS BIOMEDICAL RESEARCH ADVANCES, GENETIC TESTING IS A CRITICAL TOOL IN THE PROVISION OF HEALTH CARE. AS A RESULT, MANY PEOPLE KNOW THEIR OWN GENETIC MAKEUP, PUTTING THEM AT RISK OF GENETIC DESCRIMINATION. PEOPLE WHO WOULD LIKE TO AVAIL THEMSELVES OF GENETIC TESTING ALREADY HAVE ENOUGH TO WORRY ABOUT. THEY SHOULDN'T HAVE THE BURDER -- BURDEN OF GENETIC DISCREMINATION. WE WHO CARRY MUTATIONS FOR DISEASES ARE ENCOURAGED TO PARTICIPATE IN GENETIC RESEARCH. A FEAR OF DISCRIMINATION DISCOURAGES THAT, ADDING ANOTHER HURDLE TO THE PATHWAY FROM BAKE SCIENCE TO HEALTHCARE SERVICES. THE GENNETTEC ALLIANCE AND COALITION FOR GENETIC FAIRNESS WORKED FOR YEARS ON THIS ISSUE. IN THE PAST WEIR, -- YEAR, WE PRESENTED A LETTER TO SPEAKER HASTERT SIGNED BY HUNDREDS OF ORGANIZATIONS AND INDIVIDUALS. WE HELD A PRESS CONFERENCE ON CAPITOL HILL WITH HEIDI WILLIAMS AND DR. COLLINS AND WORK TOGETHER AND PLAN TO GO FORWARD UNTIL LEGISLATION IS PASSED IN THE SPIRIT OF COOPERATION AND COMPROMISE. THEREFORE OBEHALF OF MILLIONS AND CONSUMERS AND ADVOCACY ORGANIZATIONS, I CONVEY TO YOU, OUR STRONG SUPPORT OF GENETIC INFORMATION NONDISCRIMINATION LEGISLATION THE SENATE PAST TENSE, 53 95-0, AS WE HEARD, AND PRESIDENT BUSH SAID HE WOULD SIGN IT AS WE HEARD. WE HAVE COME HERE TODAY TO ASK THAT YOU BE BOLD AND CLEAR IN YOUR COMMUNICATION WITH THE SECRETARY. PLEASE ASK THE SECRETARY TO ASK SPEAKER HASTERT, REPRESENTATIVE DELAY AND BARTON TO MOVE THIS LEGISLATION. PUBLIC POLICY MUST KEEP PACE WITH SCIENTIFIC ADVANCES AND PROVIDE THEM WITH A CLIMATE FOR HEALTH BENEFITS FOR ALL. THANK YOU FOR THIS OPPORTUNITY TO BRING THESE VOICES TO THE TABLE. THANK YOU ALSO FOR YOUR LEADERSHIP. WE NEED YOU IN THIS FIGHT. I WILL SUBMIT A LONGER DOCUMENT AND A COPY OF OUR LETTER AND THE SIGNERS TO YOU IN WRITING. THANK YOU.

WELL, THAT, THAT'S JUST TERRIFIC, SHARON. THANK YOU. YOU WMENT, YOU DID SO WELL AND YOU ONLY GO DID 2 1/2 MINUTES. LET'S TAKE A COUPLE OF QUESTIONS. GO AHEAD.

SHARON, YOU SAID, I THINK, 14, 4 MILLION PEOPLE. I COULDN'T TELL IF IT WAS 14 OR 40.

14. 14.

THAT SEEMS LIKE A LOT OF PEOPLE. WE HAVE BEEN TOLD THAT GENIT -- GENETIC DISCRIMINATION DOESN'T OCCUR. WE HAD LIMITED RESOURCES IN TERMS OF TIME TO HEAR ANECDOTES. I AM SURE WE'LL BE TOLD THIS WAS JUST SEVEN ANECDOTES, SO IT DOESN'T OCCUR. I WOULD ASK YOU TO PLEASE DOCUMENT AND HELP ASSIST US AS WE ACCUMULATE THIS DOCUMENTATION. AMONG THOSE 14 MILLION, I HOPED WE COULD FIND MORE THAN SEVEN ANECDOTES SO THAT WE COULD DOCUMENT THAT THIS IS, IN FACT, A SERIOUS PROBLEM THAT DOES OCCUR.

TERRIFIC. ANYONE ELSE? WE'RE AT 3 1/2 MINUTES. GREAT. WOULD YOU ALSO, IN TERMS OF WHAT YOU SUBMIT BACK, BECAUSE YOU HAD PREPARED YOUR COMMENTS BECAUSE YOU'RE ALWAYS PREPARED, UM, THAT YOU HEARD OUR DISCUSSION THIS MORNING AND I THINK YOU, YOU HIT ONE OF THEM FOR SURE, IN TERMS WHAT HAVE WE WERE GOING TO DO, AND THAT'S THE THREE-COMMITTEE, THE THREE MEMBERS OF THE HOUSE THAT WE NEED TO PRIORITYIZE. IF YOU HAVE ANY OTHER THINGS THAT COME UP AS A RESULT OF OUR CONVERSATION, UM, I WOULD ASK TO YOU BE A LITTLE MORE FLEXIBLE. TAKE WHAT YOU ALREADY SENT IN AND ADD TO IT. THAT WOULD HELP US OUT. THANK YOU SO MUCH. REALLY APPRECIATE YOU'RE BEING HERE. MARIONDAY FROM THE -- [ INDISCERNIBLE ]

YES, GOOD AFTERNOON AND THANK YOU FOR YOUR TIME TODAY. I HAVE SUBMITTED TO YOU A COPY OF THE ALPHA 1 ASSOCIATION, THE ALPHA 1 FOUNDATION STATEMENT. YOU HAVE HEARD FROM A PATIENT. SHE'S TALK -- SHE TALKED ABOUT HER CHILDREN'S CARRIER STATUS. YOU HEARD FROM A PROVIDER TODAY, AND MY TESTIMONY, I HOPE, WILL SORT OF ROUND IT OUT FROM THE ORGANIZATIONAL PERSPECTIVE OF ORGANIZATIONS THAT SERVE INDIVIDUALS WITH ALPHA 1. CERTAINLY, WE BELIEVE ALPHA 1 IS A VERY GOOD MODEL FOR A DISCUSSION ON GENETICS, HEALTH AND SOCIETIAL ISSUES. AS YOU KNOW, IT'S A PEDIATRIC LIVER DISEASE. IT'S PEED@IC PSORIASIS, THE SECOND LEADING CAUSE OF TRANSPLANTATION IN THE PEDIATRIC POPULATION. IT'S AN ADULT ON-SET LUNG DISEASE. IN FACT, IT'S GENETIC EMPHYSEMA. IT'S TREATED IN END STAGE WITH LUNG TRANSPLANTATIONS. LUNGS ARE NOW GOING THROUGH AN ALLOCATION PROCESS, AND WE FEEL THAT INDIVIDUALS WITH ALPHA 1 ARE BEING DISADVANTAGED IN THAT ALLOCATION PROCESS. WE HAVE A HUGE BATTLE AND BARRIER THERE. IT ALSO HAS, AS YOU HEARD DR. BRANTLY DISCUSS, A VERY LARGE ENVIRONMENTAL COMPONENT, AND, IN FACT, ALPHA 1 IS RELATED TO THE FORTH LEADING CAUSES OF DEATH. CHRONIC OBSTRUCTIVE PILLMONINARY DISEASE, AND THERE IS A BELIEF THAT COPD IS GOING TO HAVE VERY STRONG GENETIC COMPONENTS AND ALPHA 1 IS THE FIRST IDENTIFIED GENETIC COMPONENT. THE ORGANIZATIONS THAT I'M HERE REPRESENTING HAVE TAKEN RESPONSIBILITY FOR FINDING THEIR WAY AROUND THE LABYRINTH OF THE PATCHWORK THAT EXISTS IN THE STATE LEGISLATION AND AN ABSENCE OF FEDERAL PROTECTIVE LEGISLATION. WHAT WE HAVE DONE IS WE USE A WORKING GROUP. WE HAVE INVESTED HEAVILY IN BIOETHICS AND, IN FACT, WE HAD OUR ELSIE WORKING GROUP TAKE A LOOK AT THE QUESTION OF NEONATAL SCREENING AND POPULATION SCREENING, WHICH HAS BEEN SUGGESTED BY SOME OF THE PHYSICIANS WHO TREAT THESE PATIENTS. AND, IN FACT, OUR ELSIE FELT THAT IT'S NOT ETHICAL TO DO SO IN ABSENCE OF PROTECTIVE LEGISLATION AND SO WHAT WE DO IS WE DO TARGETED SCREENING AND DETECTION. SO THIS IS SERIOUSLY IMPACTED OUR ABILITY TO IDENTIFY THOSE 5% OF PATIENTS WITH ALPHA 1 THAT ARE UNFIVE -- UPIDENTIFIED. IN ADDITION TO THAT, AND I HAVE SHARED WITH YOU A COPY OF OUR ACT TRIAL BROCHURE. IT'S BEEN HANDED OUT TO COMMITTEE MEMBERS, OUR ACT TRIAL, WHICH IS FUNDED BY THE ALPHA 1 FOUNDATION AND CONDUCTED AT THE MEDICAL UNIVERSITY OF SOUTH CAROLINA, OFFERS A FREE AND CONFIDENTUAL FINGER STICK TEST THAT CAN BE COMPLETED AT HOME. THE RESULTS ARE MAILED DIRECTLY TO THE INDIVIDUAL PARTICIPANTS AND SINCE 2001, THE ACT TRIAL HAS DONE 2400 TEST KITS. WE HAVE SHARED THIS PROTOCOL WITH NEH AT THEIR REQUEST. WE HAVE BEEN VERY PLEASED TO MAKE IT AS PUBLIC AS POSSIBLE. THE TEST IS ADMINISTERED THROUGH A RESEARCH STUDY THAT EVALUATES THE PERCEIVED RISKS AND BENEFITS OF GENETIC TESTING. DOES THAT THROUGH SENDING OUT A FOLLOW-UP QUESTIONNAIRE N.THAT QUESTIONNAIRE ARE THE PEOPLE WHO HAVE RESPONDED TO OUR SURVEY. WE FOUND THAT OVER 30% REPORT FEAR OF LOSING INSURANCE AS A REASON FOR SEEKING CONFIDENTUAL TESTING. 34% REPORT CONCERN ABOUT FACING HIGHER HEALTH CARE COSTS IF THE RESULTS WERE MADE PUBLIC, AND 85% SEEK TESTING FOR THE GENETIC KNOWLEDGE. IN FACT, THAT WAS THE MOST POPULAR RESPONSE. WE WOULD BE VERY PLEASED TO PROVIDE YOU WITH ANY ADDITIONAL INFORMATION THAT YOU WOULD LIKE TO HAVE AS A COMMITTEE AND WE STRONGLY ENDORSE THE NEED FOR FEDERAL PROTECTIVE LEGISLATION. THANK YOU VERY MUCH FOR YOUR TIME.

TERRIFIC. THANK YOU SO MUCH. WE HAVE ABOUT 20 SECONDS FOR A QUESTION? THE ONE THINK THIS I WANT TO ADD FROM WHAT YOU HAVE DONE THAT YOU, THAT WE DIDN'T EXPLICITLY HAVE IN OUR EARLIER TESTIMONY AS I WROTE DOWN A LIST OF ALL THE ISSUES THAT COME OUT OF THE CONCERN AROUND DISCRIMINATION, WE HAVE THE HIPAA ISSUES THAT CAME UP, WE HAVE THE CHILLING AFFECT IT HAS ON RESEARCH, BUT JUST THE OVERALL SCREENING POLICY WAS NOT A CATEGORY THAT I RECALL WAS EXPLICITLY STATED. SO I WOULD URGE STAFF TO ADD THAT TO THE LIST OF CHILLING CONSEQUENCES OF THE ABSENCE OF THIS SCREENING POLICY. HERE WE HAVE AN ORGANIZATION THAT FEELS ETHICALLY IT COULDN'T RECOMMEND SCREENING IN THE ABSENCE OF THIS KIND OF THING, AND I THINK THAT'S A VERY IMPORTANT CATEGORY THAT YOU BROUGHT US TO.

THANK YOU.

I WOULD ASK BECAUSE THAT IS SOMETHING DIFFERENT THAN WE HEARD THIS MORNING, PERHAPS IT BE ADDED TO THIS PACKET OF MATERIAL WE WILL BE FORWARDING ALSO.

YES. YES. VERY, VERY NICE CONTRIBUTION.

THANK YOU.

GARY MARTUSE. I HOPE I'M SAYING THAT RIGHT.

MARTUCCI, CORRECT.

YOU'RE WITH MYRIAD GENRHETT -- GENETICS.

I'M WITH MYRIAD LABORATORIES. CORRECT. GOOD AFTERNOON. I THINK WE HEARD THE FAIR GENETIC DISCRIMINATION IS PREVENTING HIGH-RISK PATIENTS FROM ACCESSING APPROPRIATE CARE. MYRIAD BEGRAN PROVIDING TESTING FOR -- EIGHT YEARS AGO. IN 19 NEX, TWO OF THE GREATEST BEARIERS TO GENETIC TESTING WAS THE FEAR AND UNKNOWN RATE OF REIMBURSE -- REBETHLEHEM PURSE -- REIMBURSEMENT -- PAID BY INSURERS 90% OF THE TIME AND AN AVERAGE OF 90% COVERAGE. THEREFORE, THE INSURANCE COVERAGE BARRIER HAD BEEN ELIMINATED. HOWEVER, THE FEAR OF DISCRIMINATION HAS NOT BEEN. FOR ALMOST EIGHT YEARS, I'VE HAD THE OPPORTUNITY TO ZISS GENETIC SERVICES WITH HUNDREDS OF MEDICAL DIRECTORS, PHYSICIANS AND PATIENTS ACROSS THE UNITED STATES. THE CONCERN AND FEAR ABOUT DISCREMINATION ARISES IN EVERY DISCUSSION. TO REDUCE ANZIETY AROUND GENETIC DISCRIMINATION, MYRIAD IMPLEMENTED A POLICY THAT PATIENT TEST RESULTS ARE NOT RELEASED TO ANYONE EXCEPT THE ORDERING HEALTHCARE PROVIDER OR DESIGNATE WITHOUT THE PATIENT'S EXPRESS WRITTEN CONSENT. INSURERS PLANS REPRESENTING APPROXIMATELY 200 MILLION LIVES COMPLY WITH THIS POLICY BECAUSE THEY RECOGNIZE THE CLINICAL VALUE OF CANCER GENETIC TESTING, LEADING TO THE MOST AFFECTIVE MEDICAL INTERVENTIONS. OUR POLICY, ALONG WITH NUMEROUS STATE AND FEDERAL LAWS PROHIBITING EMPLOYMENT AND HEALTH INSURANCE DISCREMINATION, RESULT IN NUMEROUS PROTECTIONS FOR CONSUMERS OF CANCER GENETIC TESTS YET THERE STILL REMAIN GAPS. THE FEAR OF GENETIC DISCRIMINATION REMAINS THE REASON FOR BOTH PATIENT AND PROVIDER NOT TO UTILIZE GENETIC SERVICES TO PREVENT LIFE-THREATENING CANCER. WE FIND OURSELVES IN AN AWKWARD PLACE. A LARGE BODY OF LITERATURE DEMONSTRATES THE BENEFITS OF CLINICAL AND PSYCHOLOGICAL OF CANCER TESTING. WHILE LITERATURE SUGGESTS THE ACTUAL GENETIC DISCRIMINATION IS NOT A SIGNIFICANT PROBLEM, THE MEDIA CONTINUE TO PORTRAY GENETIC DISCRIMINATION AS A COMMON RISK TO INDIVIDUALS POISED TO TAKE ADVANTAGE OF THE HEALTH BENEFITS OFFERED BY GENETIC SERVICES. [ INDISCERNIBLE ] ECHO MANY EXPERTS OPINION WHEN THEY STATE, QUOTE, UNLESS THESE PEOPLE BELIEVE THAT THEY AND THEIR FAMILIES WILL BE ADEQUATELY PROTECTED FROM DISCRIMINATION AND THE POSSIBILITY OF LOSING OR BEING DENIED HEALTH INSURANCE, MANY WILL CHOOSE NOT TO BE TESTED FOR GENETIC CONDITIONS OR PREDISPOSITION TO DISEASE, END QUOTE. THEREFORE, COMPREHENSIVE LEGISLATION IS A NECESSITY FOR THE MEDIA AND OTHER UNINFORMED STAKEHOLDERS WILL CONTINUE TO USE THE FEAR OF DISCRIMINATION TO DISSUADE PATIENTS FROM AT APPROPRIATE HEALTH CARE. GENETIC SERVICES AND TESTING OFFER THE HOPE TO REDUCE THE BURDEN OF DISEASE MANY FAMILIES SUFFER. FORTUNATELY, TENS OF THOUSANDS OF INDIVIDUALS HAD BENEFITED FROM THE POWER OF GENETIC TESTS TO GUIDE THEIR PROVIDER IN THE MOST APPROPRIATE MEDICAL MANAGEMENT. WHILE THIS NUMBER MAY SEEM IMPRESSIVE, THERE ARE OVER A MILLION PEOPLE IN THE UNITED STATES WHO CARRY MUTATIONS PREDISPOSING THEM TO CANCER, YET FEWER THAN 2% KNOW IT. WE KNOW THERE ARE SEVERAL KEY ISSUES THAT UNDERLIE THOSE STATISTICS, SUCH AS A LACK OF AWARENESS OF GENETIC TESTS AND THE NEED FOR EDUCATION AND CLINICAL SUPPORT TO HEALTH CARE PROVIDER, WE FOUND CONSISTENTLY THE FEAR OF DISCRIMINATION IS THE TOP REASON FOR REFUSING GENETIC SERVICES AND TESTING. TO INTEGRATE THE PROMISE OF THE HUMAN GENOME PROJECT, PATIENTS, CLIPPISHIANS AND INSHUSHERS NEED THE BEST AVAILABLE INFORMATION TO COORDINATE MEDICAL MANAGEMENT WOU. THE INFORMATION AVAILABLE FROM GENETIC RISK ASSESSMENT, PARTS AND HEALTHCARE PROVIDERS ARE LEFT WITH A ELIMINATED KNOWLEDGE OF HOW TO KNOWLEDGE THE RISKS AND DISEASE. NOT ONLY DOES THIS DID OUT THE BENEFIT FOR THE PATIENT, IT OFTEN RESULTS IN POOR ALLOCATION OF RESOURCES, TRULY HIGH-RISK PATIENTS MAY NOT PURSUE WRECK-REDUCING OPTIONS. WHILE THE VERY LOW RISK INDIVIDUALS MAY, IN FACT, OVERUTILIZE THE MEDICAL SYSTEM DUE TO THEIR FEAR OF DISEASE. IT'S OUR EXPERIENCE THAT PATIENTS INTERESTED IN OBTAINS POTENTIALLY LIFE-ALTERING GENNETTEC SERVICES SIT IDLE IN FEAR OF DISCRIMINATION. THE SINCE OF -- SCIENCE OF TECHNOLOGY TO POSITIVELY INFLUENCE THE PATIENT'S OUTCOME ARE WITH US TODAY. IT'S OUR RESPONSIBILITY TO MAKE SURE PATIENTS ARE CONFIDENT THAT THERE WILL BE NO NEGATIVE CONSEQUENCES IN INSURANCE OR EMPLOYMENT FOR PURSUING THIS IMPORTANT INFORMATION. PERCEPTION IS REALITY, AND THE PUBLIC'S PERCEPTION IS THAT GENETIC DESCRIM NATION IS A SERIOUS THREAT. PEOPLE HAVE ALLOWED IT, NONEXISTENT OR LIMITED RISK FOR DISCRIMINATION TO PREVENT THEM FROM MANAGING A REAL RISK OF DEVELOPING CANCER. WE MUST ELIMINATE THE FEAR OF GENETIC DISCREMINATION TO ALLOW THE PUBLIC TO PARTICIPATE IN THE BENEFIT OF GENETIC MEDICINE. COMPREHENSIVE LEGISLATION WILL REASSURE THE PUBLIC AND GET MEDIA COVERAGE TO SPREAD THE WORD. COMPREHENSIVE LEGISLATION WILL ELIMINATE THE CONFUSION AND MIXED MESSAGES SENT TO INDIVIDUALS WHO NEED THESE TECHNOLOGIES THE MOST. LADIES AND GENTLEMEN OF THE COMMITTEE, COMPREHENSIVE LEGISLATION PROHIBBING AND BANNING GENETIC DISCREMINATION IS THE ANSWER.

THANK YOU VERY MUCH. RIGHT ON THE MONEY. THANK YOU SO MUCH. CHRISTINE BRODERICK FROM THE NATIONAL PARTNERSHIP FOR WOMEN AND FAMILIES.

GOOD AFTERNOON, ON BEHALF OF THE NATIONAL PARTNERSHIP FOR WOMEN AND FAMILIES AND ALSO THE COALITION FOR GENETIC FAIRNESS, THANK YOU FOR HOLING THIS HEARING TOGETHER. INFORMATION ABOUT THESCOPE AND -- SCOPE AND NATURE OF GENETIC INFORMATION. THE SENATE HAS TAKEN AN IMPORTANT STEP IN ADVANCING GENETIC RESEARCH BY PASSING THE GENETIC INFORMATION NAN DISCRIMINATIONAK. THIS IS LEGISLATION THAT WOULD PROVIDE MUCH NEEDED PROTECTION FOR ALL AMERICANS FROM GENETIC DISCRIMINATION AND HEALTH INSURANCE AND IN THE WORKPLACE. WE JOIN WITH YOU IN THE HOPES THAT THE EVIDENCE PRESENTED TODAY AND IN THE, ALSO THE DATA THAT WAS NOTED IN THE ACCOMPANYING ARTICLES WILL ENCOURAGE THE HOUSE OF REPRESENTATIVES TO TAKE ACTION TO ENACT THIS LEGISLATION. WITH THE COMPLETION OF THE HUMAN GENOME PROJECT LAST JUNE, THE POSSIBILITY OF GENNETTEC TESTING AND RESEARCH IS EXPANDING RAPIDLY. THERE ARE GENETIC TESTS FOR HUNDREDS OF DESERS AND SOME OF THE MOST WIDELY AVAILABLE ARE FOR WOMEN. WOMEN AND FAMILY STAND TO BENEFIT FROM PROTECTION AND DISEASES LIKE BREAST AND OVARIAN CANCERS. ALL THE ADVANCE IND -- IN THE WORLD WON'T HELP FAMILY&BY -- THEY FEAR OR CAN BE DENIED JOB OPPORTUNITIES, HEALTHCARE OR BOTH BASED ON THEIR GENNETTEC INFORMATION. IN ADDITION TO BEING LONGTIME PROPONENTS OF GENETIC NONDISCRIMINATION LEGISLATION, THE NATIONAL PARTNERSHIP FOR WOMEN AND FAMILIES LEADS THE COALITION FOR GENETIC FAIRNESS, A DIVERSE GROUP FOR DISABILITY, WOMEN'S ADVOCACY AND CIVIL RIGHTS GROUP ANNOUNCING THE NEED FOR GENETIC DISCRIMINATION. THE SCOPE REFLECTS THE IMPACT THIS ISSUE HAS ON ALL AMERICANS. TO WILL ILLUSTRATE THE IMPACT OF GENETIC INFORMATION AND THE FEAR OF GENETIC DISCRIMINATION, IT -- THE REPORT IS INCLUDED IN YOUR BRIEFING BOOK. THE REPORT NOTES TELLING STATISTINGS ABOUT OVERWHELMING, THE OVERWHELMING OPPOSITION OF INDIVIDUALS TO SHARING, TO ALLOWING EMPLOYERS AND INSURANCE -- ENSURERS TO ACCESS THEIR GENNETTEC INFORMATION AND SHARES THE STORIES OF INDIVIDUALS LIKE SOME OF THE, YOU HAVE HEARD TODAY, LIKE HEIDI, KIM, AND MARY. MARY WAS DENIED HEALTH INSURANCE FOR HER CHILDREN BECAUSE THEY WERE, I'M SORRY, HEIDI WAS DENIED HEALTH INSURANCE FOR HEAR CHILDREN BECAUSE THEY WERE CARRYY -- CARRIERS OF A GENE FOR A LIVER CONDITION. MEDICAL PROFESSIONALS KNEW THEY WOULD NEVER DEVELOP THE DISEASE THEM, -- THEMSELVES BUT THE INSURANCE COMPANY DENIED COVERAGE. KIM WAS FIRED BECAUSE OF HER EMPLOYER'S FEARS OF HER FAMILY'S HISTORY OF HUNTINGTON'S DISEASE, WHICH SHE REVEALED DURING A STAFF WORKSHOP. MARY HAS A FAMILY HISTORY OF BREAST CANCER BUT DECIDED AGAINST BEING TESTED FOR THE GENETIC MUTATION THAT MAKE WOMEN MORE SUENT ISIBLE. SHE FEARED A POSITIVE RESULT WOULD JEOPARDIZE HER CHANCES FOR A PROMOTION. TO ALLOW INDIVIDUALS LIKE THESE THREE TO REALLY THE FULL BENEFITS OF GENETIC TESTING AND KEEP GENETIC TESTING FROM STANDING IN THE WAY OF THE PUBLIC HEALTH, STRONG LEGISLATURE MUST BE IMPACTED. WE BELIEVE GENNETTING INFORMATION THAT PREDICTS FUTURE HEALTH RISKS, INCLUDING FAMILY HISTORY MUST BE PROTECTED. HEALTH INSURERS AND EMPLOYERS MUST NOT BE ALLOWED TO COLLECT PREDICTIVE GENETIC INFORMATION AND USE IT TO DISCRIMINATE IN THE HEALTH CARE OR WORKPLACE. THEY MUST HAVE THE RIGHT TO SEEK REDRESS THROUGH LEGAL ACTION WITH ACCESS TO REMEDIES AND UNDER THESE, HOLDING -- THEY MUST BE PROHIBITED FROM DESCLOSING IT TO THIRD PARTY -- PAIRINGS. AS SCIENCE PROGRESSES MORE SOUTHWESTLY, IT BECOMES MORE CRITICAL CONGRESS ACT TO MAKE SURE AMERICANS ARE PROTECTED FROM GENETIC DISCRIMINATION. THANK YOU.

I WOULD, FIRST OF ALL THANK YOU VERY MUCH. I WOULD URGE THE COMMITTEE ON TO REFER TO TAB 4 OF YOUR BRIEFING BOOKS OR A VERY IMPORTANT DOCUMENT CALLED FACES OF GENETIC DISCRIMINATION. HOW GENETIC DESCREMINATION AFFECTS REAL PEOPLE, WHICH I BELIEVE YOU ALL HAD A LOT TO DEAL DEAL, AND I THINK IT'S AN IMPORTANT EDITION TO OUR -- ADDITION TO OUR MATERIAL. I ALSO HOME HOPE THAT, AGAIN, IF THERE ARE SPECIFIC THINGS YOU WANT TO SEND FORWARD BASED ON THE DISCUSSION THIS MORNING ABOUT SPECIFIC THINGS THE COMMITTEE CAN DO TO TRY TO BE A PART OF THIS SOLUTION, THE PART OF THE LEVERAGE, THE COALITION BUILDING AND ALL OF THAT SORT OF THING. PLEASE, WOULD YOU SEND THAT FORWARD.

CERTAINLY.

ALL RIGHT, THANK YOU VERY MUCH FOR BE HERE AND CONGRATULATIONS ON THIS, REALLY AN EXCELLENT DOCUMENT.

THANK YOU.

TERRIFIC. ANYBODY -- .

THIS DOCUMENT WILL BE INCLUDED IN THE INFORMATION WE SENT. IT'S ROOT NOW IN OUR BOOK AND NOT IN THIS.

OH, THE POINT IS THAT THE, THE TAB 4 MATERIAL IS NOT IN THE BOUND MATERIAL AND SHE'S ASKING, DEBORAH'S SORT OF URGING, REQUESTING THAT WE --

YES.

-- AUGMENT THE MATERIAL WE SEND FORWARD WITH THIS REPORT. ANY, I DON'T --

IS THAT -- ARE YOU AMENABLE TO THAT TO MAKE THIS PART OF OUR RECORD IN.

WE WOULD BE. YEAH.

OKAY.

TERRIFIC.

ALL RIGHT, AND THAT'S, THAT'S GREAT. OUR LAST SPEAKER TODAY IS DONALD HORTON, DIRECTOR OF PUBLIC POLICY AND ADVOCACY. FOR LABORATORY CORPORATION OF AMERICA.

IT'S NOT WORKING. IS IT WORK SOMETHING OKAY. MR. CHAIRMAN, MEMBERS OF THE COMMITTEE, THANK YOU FOR THE OPPORTUNITY TO SPEAK WITH YOU TODAY. AS A NATIONAL LEADER IN GENOMIC AND GENETIC TESTING, LAB CORE USED GENETIC DISCRIMINATION AND THE COVERAGE AND REIMBURSEMENT OF GENETIC TESTS AND SERVICES AS BEING VERY SERIOUS, HIGHLY-IMPORTANT ISSUES. THE RESOLUTION OF WHICH WILL HAVE VERY LONG-LASTING, LONG-REACHING AFFECTS IN THE FUTURE OF GENOMICS AND, THEREFORE, ON THE FUTURE OF MEDICAL CARE IN GENERAL. I HAVE TO SALUTE THE INDIVIDUALS WHO VERY BRAVELY CAME HERE TODAY AND TOLD THEIR PERSONAL STORIES OF GENETIC DISCRIMINATION. THEY WERE VERY POWERFUL AND COMPELLING AND LOOK THOSE INDIVIDUALS AND LIKE THE PERSON WHO SPOKE HERE TODAY, LAB CORP SUPPORTS FEDERAL LEGISLATION TO PROHIBIT DISCRIMINATION ON THE BASIS OF GENETIC INFORMATION IN HEALTHCARE, IN HEALTH INSURANCE AND EMPLOYMENT MATTERS. WE BELIEVE THAT'S THE ONLY WAY THAT THE FULL BENEFITS OF GENETICS AND GENOMICS CAN BE FULLY REALIZED BECAUSE THAT'S THE ONLY WAY, WE BELIEVE, THAT THE FEAR OF GENETIC DISCRIMINATION AND ITS ACTUAL PRACTICE ARE GOING TO BE BANNED FROM THE HEALTHCARE SYSTEM ENTIRELY. WE SUPPORT THAT FOR MANY OF THE REASONS THAT YOU HEARD TODAY. EXISTING FEDERAL LAW IS SIMPLY INADEQUATE. WHEN YOU PUT TOGETHER HIP, WHEN YOU PUT THAT TOGETHER WITH THE ADA, TITLE 7 OF THE CIVIL RIGHTS ACT OF 1964, ALL OF THOSE TOGETHER DO NOT CREATE A COMPREHENSIVE FRAMEWORK TO PROTECT AGAINST GENETIC DISCREMINATION. WE DO HAVE GOOD STATE LAWS BUT THEY VERY SIGNIFICANTLY IN THEIR DENth AND SCOPE OF PROTECTION, AND EVEN WHEN YOU HAVE A STATE THAT DOES HAVE A GOOD STATE LAW, YOU HAVE A RISK THAT PREEMPTS THAT AND A RISK THAT DOES NOTHING TO PROTECT THAT INFORMATION. SO, IT'S CRITICALLY IMPORTANT THAT WE MOVE FORWARD. I THINK YOUR NEXT STEP THAT YOU IDENTIFIED TODAY, RIGHT ON TARGET, UM, I WOULD JUST THROW OUT A COUPLE OF THINGS. FIRST OF ALL, DON'T GIVE UP. THIS IS AN ISSUE THAT IS NOT GOING AWAY REGARDLESS OF WHAT HAPPENS IN THIS SESSION OF CONGRESS. IT'S EXTREMELY IMPORTANT THAT THIS REMAIN ON THE AGENDA AND THAT WE BE PERSISTENT AND CONSISTENT IN MOVING, UM, THIS IDEA FORWARD THAT WE NEED COMPREHENSIVE FEDERAL PROTECTION. SECONDLY, I WOULD SAY THAT LET'S NOT LET THE PERFECT BE THE ENEMY OF THE GOOD. THERE IS PROBABLY A LITTLE BIT OF ROOM FOR NEGOTIATION HERE AND THERE TO GET THE PARTIES TOGETHER. LET'S GET SOMETHING ON THE BOOKS AND THEN WE CAN DO WHAT WE NEED TO DO DOWN THE ROAD TO POLLIN ISSUE ON POLISH IT UP A BIT. WE'RE VERY, VERY CLOSE. WE NEED TO TAKE THIS OPPORTUNITY NOW THAT WE HAVE IT. JUST A MOMENT, IF I COULD, JUST TO SPEAK TO COVERAGE AND REBETHLEHEM -- REIMBURSEMENT ISSUES. I WOULD LIKE TO THANK YOU FOR CONSIDERING THE REAL-WORLD EXAMPLES THAT OUR OWN DR. PAUL BILLINGS AND TAMMY OFFERED TO YOUR COVERAGE AND RE-ENFORCEMENT TASK FORCE LAST MONTH. WE BELIEVE THOSE OBSERVATIONS WILL BE VERY HELPFUL TO YOU IN PUTTING TOGETHER A FINAL DRAFT OF THE REPORT. THANK YOU.

WELL, YOU ALL ARE TERRIFIC. COULD I MAKE A -- LET ME JUST STOP FIRST. LET ME SEE IF THERE IS A QUESTION ON THIS ISSUE. YES.

ACTUALLY NOT A QUESTION, BUT WHILE YOU WERE SPEAKING AND, AND REFERS -- REFERRING TO TAB 4, WAS LOOKING THROUGH OTHER MATERIALS THAT SHOULD BE INCLUDED. I WOULD THINK ALL THE CORRESPONDENTS, TO AND FROM THE VARIOUS SECRETARIES OF BOTH COMMITTEES MIGHT BE INCLUDED. AND I NOTED, WE WERE TOLD THAT, UM, THE U.S. CHANGEBER OF COMMERCE WAS NOT -- CHAMBER OF COMMERCE WAS NOT ADAMANTLY OPPOSING THIS. I WOULD REFER PEOPLE TO, AFTER THE FACES DOCUMENT AND THE TESTIMONY OF MR. LORBER BEFORE THE HEARING OF THE HOUSE COMMITTEE ON EDUCATIONAL WORKFORCE, SUBCOMMITTEE ON EMPLOYER-EMPLOYEE RELATIONS. READ THAT TESTIMONY AND READ HIS QUESTIONS UNDER THE END. WHEN WE WERE TOLD BY THEIR MOUTHPIECE, WHO WAS SENT HERE THIS MORNING, FOR THEM THAT THEY WERE NOT BALKING THIS LEGISLATION, IT'S VERY CLEAR THAT THEY BLOCK THE LEGISLATION SINGLE HANDEDLY IN THAT SUBCOMMITTEE. AND I CHALLENGE, AGAIN, INCLUDE THIS, LET'S NAME NAMES, LET'S RECOGNIZE WHO IS DOING THIS TO THE PEOPLE OF THE UNITED STATES AND IF THIS CONTINUES TO GO FORWARD, MR. CHAIRMAN, AND I KNOW THAT WE SHOULD NOT GIVE UP, AND I'M GLAD TO HEAR YOU SAY THAT, UM, THEN LET'S REQUEST YET AGAIN YOU'LL DO IT IN A MUCH MORE DIPRO -- DIPLOMATIC FASHION THAN I WOULD SETTING AS A MEMBER, I'M SURE. BUT I DO NOT THINK THEY SHOULD BE ABLE TO GET AWAY WITH THIS, AND THEN SEND A MOUTHPIECE.

YES. ME, ME DIPLOMATIC. I LIKE THAT. [ LAUGHTER ]

I WONDER IF I MIGHT ASK A QUESTION OF THE LAB CORE FOLKS. YOU, I ASSUME, HAVE, EMPLOYER OF FOLKS ALL OVER THE COUNTRY. SO YOU'RE A LARGE EMPLOYER WHO HAS TO DEAL WITH THESE LAWS, ON THE OTHER HAND, AS WELL. AND I'M WONDERING IF YOU HAVE EXPERIENCED IF ANY DIFFICULTY IN COMPLYING WITH THE VARIOUS LEGISLATIONS ALL OVER, IN MANY STATES, IN TERMS OF GENNETTEC DISCRIMINATION, AND IF SO, WOULD YOU THINK IT WOULD BE EASIER TO HAVE A FEDERAL PIECE OF LEGISLATION TO COMPLY, RATHER THAN THE MANY DIFFERENT STATE LAWS AS A LARGE EMPLOYER.

IT WOULD SYMPLIFY THINGS TO HAVE A SINGLE COMPREHENSIVE SET OF LAW, UM, WE, YOU KNOW, WE'RE IN ALL OF THE STATES. QUEST DIING NORTHEASTECS HAS THE SAME SITUATION AND OTHER LABS THAT FACE THAT VERY SAME SITUATION. SO, YES. IT WOULD SIMP FEW THINGS FURTHER.

TERRIFIC.

MAY BE YOU CAN TALK WITH YOUR COLLEAGUING AT THE CHANGEBER OF COMMERCE. YOU'RE A LARGE EMPLOYER AND MAYBE BE A CHOICE WITHIN THAT COMMUNITY AS WELL.

GREAT.

I DON'T THINK WE'RE MEMBERS, ACTUALLY.

LET ME, ANOTHER REQUEST AS WE CLOSE OUT HERE, AND THAT'S FOR THE PUBLIC, AGAIN. IF, IF WE COULD ALSO ASK YOU AS WE DEVELOP, YOU KNOW, EACH TIME WE DEVELOP MATERIALS, IF YOU COULD MAKE SURE THEY GOT TO YOUR CONSTETTIENCEY, WE WOULD APPRECIATE IT. I KNOW YOU KEEP THEM WELL AWARE OF WHAT WE'RE DOING AS A COMMITTEE, BUT, BUT I WOULD REALLY WANT TO EXPLICITLY GET FROM YOU A SENSE THAT YOU CAN DISTRIBUTE, UM, YOU KNOW, THE SUMMARIES OR WHATEVER IT IS THAT WE'RE DOING TO YOUR CONSTITUENCIES AND WHATEVER WAY. I WOULD HOPE, THROUGH YOUR NEWS LETTER, SOMETHING THAT KEEPS THIS POINTLINE GOING BACK AND FORTH BETWEEN YOU AND US. I THINK WOULD BE JUST TERRIFIC. AS FAR AS ED'S CHALLENGE TO US, I THINK WE WILL PROBABLY HAVE TO HAVE A STAFF MEETING TO FIGURE OUT. NO, I MONEY, THIS IS IMPORTANT. WE HAVE A LOT OF MATERIAL WE WANT TO TRANSMIT. WE'RE GOING TO HAVE TO FIGURE OUT HOW DO WE PUT A SUMMARY DOCUMENT IN, ON THE FRONT PIECE AND THEN HAVE, YOU KNOW, AN APPEND SEIZE. THAT'S, BECAUSE I THINK WE HAVE A LOT OF THINGS TO SAY. I THINK THAT'S THE CHALLENGE. I THINK ED APPROPRIATELY CHALLENGE US TO THINK ABOUT THAT.

I THINK IT'S IMPORTANT TO SEND A TELEPHONE BOOK, GIVEN WE HAVE BEEN TOLD THIS IS A PROBLEM THAT DOES NOT EXIST.

YEAH, YEAH, I THINK YOU'RE RIGHT ON THE MONEY. I THINK WE'LL WORK WITH HIM AND OTHERS ON TRYING TO GET THE SUMMARY DOCUMENT, AND THEN THE ADDITIVE MATERIAL. WE ARE STARTING TOMORROW AT 8:30, OH, MY GOSH, ON TIME. AND YOU ALL PUT IN A HECK OF A HARD DAY. AS A RESULT, YOU GET TO GET THIS REWARD THAT SARAH'S GOING TO TELL US ABOUT.

ALL THE COMMITTEE MEMBERS AND THE EX OFFICIATES ATTENDING DINNER SOME SHOULD MEET IN THE LOBBY AT 6:30 OR MEET US IN THE RESTAURANT IF YOU'RE COMING IN INDEPENDENTLY. THERE IS A LITTLE PURPLE SHEET IN THE TABLE FOLDER THAT HAS THE ADDRESS AND SO FORTH. SO, SEE YOU IN THE LOBBY AT 6:40 AND WHAT -- OH. OH, WELL, LET US KNOW IF YOU'RE GOING INDEPENDENTLY. WE'RE ROUNDING UP CARS, TOO. SO ANYONE WITH A CAR WHO WANTS TO TAKE A COUPLE OF PEOPLE, LET ME KNOW.

THANK YOU ALL. GOOD DAY'S WORK.