Confirmation Number:272543
Event Started: 10/19/2004 8:30AM
PLEASE STAND BY. THE CONFERENCE WILL BEGIN AT 8:30 A.M. EASTERN TIME.
PLEASE STAND BY, THE SECRETARY'S ADVISORY COMMITTEE ON GENETICS, HEALTH AND SOCIETY MEETING WILL BEGIN AT 8:30 A.M. EASTERN TIME.
PLEASE STAND BY. I WANT TO WELCOME EVERYONE TO THE SECOND DAY OF OUR MEETING. WE -- BY THE WAY AT OUTSET PUBLIC COMMENTS ARE ALWAYS REQUESTED AND HAPPILY RECEIVED. AND IF THERE IS ANY ONE THAT WANS TO SIGN UP FOR -- WANTS TO SIGN UP FOR THE PUBLIC COMMENT TIME GOO TO THE ACE PEOPLE HERE AT THE TABLE.
AT REGISTRATION DESK UP THERE.
GO TO THIS TABLE HERE AND THEY WILL DIRECT YOU TO THE TABLE OUTSIDE AND YOU CAN SIGN UP SO.
DEPENDS ON HOW SIMPLE YOU WANT TO MAKE IT. WE GOT A LOT DONE YESTERDAY AND WE GOT I THINK VERY SERIOUS ABOUT 6 OR 7 INITIATIVES WHICH WE WILL REVIEW FOR YOU WHEN WE GET THROUGH NEAR THE END OF THE DAY ON THE ANTIDISCRIMINATION ISSUES. I THINK WE HAVE GOT TO STICK TO THAT LEVEL OF FOCUSED SERIOUS RECOMMENDATIONS TODAY IF WE ARE TO HAVE AN OVERALL SUCCESSFUL MEETING SO WE'RE GOING TO HAVE TO REALLY THINK VERY CAREFULLY ABOUT WHAT TO DO WITH THE REMAINING RECOMMENDATIONS IN THIS REPORT ON COVER AND AND REIMBURSEMENT AND THEN ON POPULATION. ONE THING THAT I WILL ASK SARA AND HER TEAM TO GIVE OUT IS -- WHICH WE WILL DO PROBABLY AT THE BREAK AND PUT IN FRONT OF YOU AT THE BREAK WILL BE A LITTLE FLOWCHART OF ALL OF THE THINGS THAT WE HAVE ON OUR PLATE RIGHT NOW AND SOME THINGS WHICH LOOK LIKE THEY ARE SUPPOSED TO COME ON TO OUR PLATE AND WHAT WE LOOK LIKE FROM A TIME SEQUENCE POINT OF VIEW. A BIG PICTURE VIEW OF ALL THE STUFF. THE REASON I WANT THAT FOR US TO HAVE AROUND THE BREAK OR SO IS AS WE GET NEAR THE END OF THE DAY I THINK WE HAVE TO START TO LOOK VERY CAREFULLY AT AGAIN FOCUSING ON HOW MUCH WE CAN BITE OFF, EXACTLY AGAIN WHAT WE ARE INTENDING TO BUY THE OFF AND HOW WE CAN TURN EACH OF THOSE INTO DEFINITE WIN PROJECTS FOR US. SO I JUST WANT TO MAKE SURE WE DON'T GET OVERWHELMED AND NOT REALLY SEE WHAT WOO HAVE IN FRONT OF US -- WHAT WE HAVE IN FRONT OF US SO WE'LL GIVE YOU THAT AROUND BREAK TIME. WE WELCOME OUR PEOPLE WATCHING BY WEBCAST IF THEY ARE IN FACT WATCHING. IS THAT ON?
YEAH.
YESTERDAY THEY WERE SAYING WE HAD 35-48 PEOPLE.
I DO KNOW FROM E-MAILS THAT THE PEOPLE WERE -- AS I SAID THEY WERE MAINLY TALKING ABOUT ED'S TIE BUT THEY WERE THERE SO THEY ARE THERE. AND IT WAS INCONSEQUENTIAL I I HEARD. WE THANK EVERYONE WHO IS WATCHING. LET'S GO BACK WITH CINDY BERRY AND TAKE UP WHERE WE RESUMED YESTERDAY.
EVERYONE SHOULD HAVE A HANDOUT THAT WAS DISTRIBUTED THIS MORNING. THE FRONT PAGE GOES OVER WHAT WE AT LEAST TEMPORARILY TENTIVELY DECIDED IN TERMS OF RECOMMENDATION ABOUT REGARD TO THE SCREENING EX-CLUE OBJECTION AND THE NATIONAL VERSUS LOCAL COVERAGE DECISION. I WON'T GO OVER THOSE AGAIN. BUT TAKE A LOOK. THE REVERSE SIDE ADDRESSES GENETIC COUNSELING AND WE STARTED THAT BUT DIDN'T WRAP IT UP. WE WENT BACK WITH STAFF AND CAME UP WITH A REVISED SET OF POTENTIAL RECOMMENDATIONS AND WANTED TO START THIS MORNING GOING OVER THAT. THE FIRST RECOMMENDATION TALKS ABOUT THE ANALYSIS THAT WE DISCUSSED. WE DIDN'T SPECIFY WHO COULD DO THE ANALYSIS. THE ANALYSIS COULD BE SIMPLY RELIANCE ON WHAT HERSA IS DOING OR IF NOT TH ENSUIT OF MEDICINE. WE ARE TRYING TO DETERMINE THE STATE OF PLAY OF THE HERSA EFFORT AND DETERMINING WHETHER ADDITIONAL ANALYSIS IS NEEDED. WE LEFT THAT VAGUE BUT THE EYE TEE IS THAT SOMEONE NEEDS TO DO A COMPREHENSIVE LOOK THAT WHO IS QUALIFIED TO PROVIDE GENETIC COUNSELING SERVICES SHOULD THEY BE SUPER VICED AND THE EFFECTIVENESS AND VALUE OF PROVIDE THESE SERVICES. IF THERE ARE ANY GAPS IN THAT ANALYSIS THAT ARE UNCOVERED THAT COULD IMMEDIATE TO A MEDICARE DEMONSTRATION PROJECT WHICH WOULD BRO VIDE US WITH ADDITION -- PROVIDE US WITH ADDITIONAL DATA TO HELP OUTLINE THE BARRIERS OUTLINED IN THE REPORT ON GENETIC COUNSELING ACCESS. THE THIRD PROPOSED RECOMMENDATION HAS TO DO WITH A LEGISLATIVE CHANGE. IN THE DATA ANALYSIS AND THE DATA GLEANED FROM THE DEMONSTRATION PROJECT INDICATE AND SUPPORT THIS AND WE ALL THINK IT WILL THEN PERHAPS WE WOULD BE IN A POSITION TO ADVOCATE A LEGISLATIVE CHANGE, A CONGRESSIONAL FIX WHERE WE WOULD ADD ALL OF THE APPROPRIATE MEDICAL PROVIDERS. WE PURPOSELY LEFT THAT OPEN, NOT WANTING TO LIMIT IT TO ONE SPECIALTY OR ANOTHER BECAUSE THERE ARE MANY DIFFERENT HEALTHCARE PROVIDERS WHO ARE ABLE AND CAPABLE OF PROVIDING THESE TYPES OF SERVICES SO THE ANALYSIS AND THE DEMONSTRATION PROJECT IF WE HAVE ONE WILL HELP INFORM O WHO THOSE PEOPLE SHOULD BE. THE FOURTH POTENTIAL RECOMMENDATION ADDRESSES THE ISSUE OF LICENSURE OF GENETIC GENETIC COUNSELORS IN PARTICULAR. FEELING IS WE NEED MORE DISCUSSION ON THAT. IS THIS SOMETHING THAT THIS COMMITTEE SHOULD PROMOTE? DO WE HAVE ANY AUTHORITY OR DOES THE SECRETARY HAVE ANY ABILITY TO INFLUENCE STATES IN WHETHER THEY SET UP SOME SORT OF LICENSURE PROCESS FOR DIFFERENT HEALTHCARE PROVIDERS SUCH AS GENETIC COUNSELINGS. THAT IS A QUESTION MARK IN MY MIND AND WOULD WELCOME FURTHER DISCUSSION. I WISH BARB A WERE HERE BECAUSE I KNOW SHE WILL HAVE INPUT ON THAT AS WELL. ED AND THEN DEBRA.
I THINK IT IS A CRITICAL PIECE BECAUSE WITHOUT LICENSURE IT IS GOING TO BE DIFFICULT TO BILL. IT IS HARD FOR US TO HAVE AN IMPACT BECAUSE THIS IS A STATE BY STATE ISSUE. IT COULD BE BUILT INTO THE LOGIC OF THE ARGUMENT THAT IT IS A CRITICAL PIECE BUT I THINK -- I THINK WE SHOULD TRY AND RECOMMEND THINGS THAT ARE DOABLE EVEN IF THEY ARE A BIT OF A REACH AND I THINK THIS ONE IS PROBABLY NOT REALLY DOABLE BUT SHOULD CERTAINLY BE COMMENTED UPON IN THE LOGIC OF THE ARGUMENT.
DO YOU THINK, ED, JUST A FOLLOW-UP THAT PERHAPS THE ISSUE WOULD BE ADDRESSED IN THE MEAT OF THE REPORT BUT NOT CONSTITUTE A RECOMMENDATION OR DO YOU HAVE A THOUGHT FOR HOW WE COULD PHRASE THE RECOMMENDATION THAT WOULD ADDRESS THIS?
I THINK IT SHOULD BE DEFINITELY IN THE MEAT OF THE REPORT. I DON'T KNOW -- IT COULD BE UNDER NUMBER ONE BECAUSE THAT ADDRESSES IF WE LOOK AT THE FIRST BIT AN ANALYSIS IS NEEDD THAT WILL DETERMINE WHICH HEALTHCARE PROVIDERS ARE QUALIFIED TO PROVIDE GENETIC COUNSELING, UNDER WHAT PROVISIONS AND UNDER WHAT SUPER VISION AND I THINK IT IS THE SUPERVISION POINT IF THERE IS LICENSURE THEN THERE IS LESS NEED FOR SUPERVISION SO THAT ONE COULD BUILD IT INTO THAT FIRST SENTENCE PERHAPS IN A PAIR REN THETICAL.
DEBRA, DID YOU HAVE A COMMENT?
I KNOW THAT GENETIC COUNSELORS ARE VERY, VERY VALUABLE TODAY IN THE SERVICES THAT THEY PROVIDE. AND THEY CAN'T BILL AND THEY CAN'T BE PAID FOR WHAT THEY DO AND THESE SERVICES ARE UNDERWRITTEN BY DEPARTMENTS JUST BECAUSE IT IS A NECESSARY PART OF MEDICAL GENETICS AND I FEEL LIKE ONLY ASKING FOR A STUDY ALTHOUGH MAYBE NECESSARY IS LEAVING THOSE GENETIC COUNSELORS WHO ARE OUT THERE PRACTICING STILL FLAPPING IN THE WIND AND I DON'T KNOW IF IF THAT IS A VERY EFFECTIVE THING COULD BE DOING. IF IF I WAS A GENETIC COUNSELOR LOOKING AT THESE RECOMMENDATIONS I WOULD PROBABLY BE VERY ANGRY AND FEEL LIKE I WASN'T GETTING ANY ASSISTANCE IN THIS COMMITTEE BECAUSE A STUDY IS GOING TO TAKE AT LEAST 6 MONTHS TO BE COMMISSIONED AND ABOUT A YEAR TO 18 MONTHS TO DO AND THERE ARE PEOPLE OUT THERE CURRENTLY PRACTICING AND ADDING A LOT OF VALUE IN THE MEDICAL GENETICS AREA.
DO YOU HAVE A SPECIFIC IDEA ON HOW YOU MIGHT ADDRESS THAT OR SOME OF THEIR CONCERNS? IS LICENSURE WHERE YOU WOULD PUT THE FOCUS OR ARE THERE OTHER AREAS THAT YOU THINK WE SHOULD FOCUS ON?
WELL, THERE IS LICENSURE COMING IN TWO STATES SO THERE IS A MOVE TOWARD LICENSURE AND MAYBE WE SHOULD CREATE A MECHANISM WHERE BY LICENSED, PEOPLE LICENSED TO PROVIDE GENETIC COUNSELING SERVICES CAN BE RECOGNIZED AS ALLEYED PROFESSIONALS AND GET A U PIN TO BILL FOR THE SERVICES THEY ARE PROVIDING AS LICENSED HEALTHCARE PROFESSIONALS.
EMILY, HUNT AND THEN ED.
I THINK WE ALSO HEARD STRONGLY FROM BARBRA YESTERDAY SO I WILL TRY AND REPRESENT THIS AGAIN THAT THERE IS ALREADY A NATIONAL ACCREDITATION PROGRAM FOR GENETIC COUNSELORS. I FOR ONE HAD A LITTLE TROUBLE UNDERSTANDING WHY A NATIONALLY ACCREDITED COUNSELOR ALSO NEEDS TO GO THROUGH A STATE LICENSURE AND WHY THAT NATIONAL REVEL OF ACCREDITATION ISN'T ACCEPTABLE PER SE. I UNDERSTAND YOU MIGHT HAVE TO SEND AND GET A PIECE OF PAPER BUT I MEAN I THINK WE ALSO OUGHT TO ENCOURAGE THAT PEOPLE WHO HAVE RECEIVED THAT LEVEL OF NATIONAL ACCREDITATION ON THE BASIS OF, YOU KNOW, A MASTERS DEGREE IN GENETIC COUNSELING THAT THAT OUGHT TO BE SUFFICIENT AS WELL.
BUT IT IS NOT IN ANY HEALTHCARE PROFESSION SO PHYSICIANS WHO HAVE GONE TO MEDICAL SCHOOL, RESIDENCY TRAINING, BOARD CERTIFICATION EVERYTHING ELSE CAN'T PRACTICE UNLESS THEY GET A LICENSE FROM THE STATE IN WHICH THEY PRACTICE SO THIS IS STANDARD FOR BEING ABLE TO BILL SO I DO THINK YOU CAN'T GET AROUND THE LICENSURE. THAT IS GOING TO HAVE TO BE DONE ON A STATE BY STATE BASIS BUT IF THERE ARE STATES THAT ARE LICENSING THEN IF WE ALLOW THOSE STATES TO BILL MAYBE IT WOULD ENCOURAGE OTHER STATES -- I BUT GENETIC COUNSELORS IN THE STATES TO BILL BECAUSE THE LICENSING CAN GET A UPIN AND BILL MAYBE THERE WOULD BE OTHER STATES THAT WOULD LICENSE AS WELL.
I WOULD LIKE TO URGE THE COMMITTEE NOT TO BE A BIT MY ONIC IN ITS VIEW BECAUSE RIGHT NOW I THINK YOU -- NOT TO BE MYOPIC ON THE VIEW. RIGHT NOW I THINK YOU ARE FOCUSING WITH TUNNEL VISION ON THE SPECIALTY OF GENETIC COUNSELING. IF YOU THINK ABOUT THE PRACTICE OF MEDICINE IN THE NEXT 10 TO 20 TO 30 YEARS THERE IS GOING TO BE THE DELIVERY OF GENETIC INFORMATION, NOT ONLY FOR THE DIAGNOSIS AND MANAGEMENT OF GENETIC DISEASES WHICH ACCOUNT FOR 5% OF ALL HUMAN DISEASE BUT IN THE MANAGEMENT AND PREVENTION AND DIAGNOSIS FOR ALL DISEASES WHETHER THEY ARE GENETIC OR NOT. SO IF YOU KIND OF STEP BACK HERE AND YOU WANT TO PROVIDE THE MAXIMUM VALUE-ADDED ADVICE TO HHS AND ASK THE QUESTION HOW ARE WE GOING TO BE READY IN DELIVERING GENETIC INFORMATION, I'M NOT SAYING GENETIC COUNSELING IS NOT IMPORTANT BECAUSE GENETIC COUNSELING IS OF PARAMOUNT IMPORTANCE AT LEAST IN A FRACTION OF THE DELIVERY OF THE GENETIC INFORMATION AND WHAT HAS HAPPENED OVER THE YEARS IS THAT GENETIC COUNSELING HAS AN IN STEWINGS -- INSTITUTION HAS REALLY GROWN UP TO HAVE A VERY WELL DEFINED WAY OF DOING BUSINESS PRIMARILY IN A NONDIRECTED FASHION WITH THE USUAL WAY OF DELIVERY OF GENETIC SERVICES WHERE AS THE NEW PRACTICE OF MEDICINE IN THE 21st CENTURY IS GOING TO BE DICTATING A NEW PARADIGM SHIFT IN HOW INFORMATION IS GOING BE DELIVERED. FOR A FRACTION OF THAT OF CASES OR PEOPLE WHO COME THROUGH THE CLINIC THE TRADITIONAL GENETIC SERVICES PARADIGM WILL STILL HOLD BUT INCREASINGLY WE ARE GOING TO BE FACED WITH APPLICATIONS FROM PHARMACOGENOMICS. INSTEAD OF SAYING AN ANALYSIS IS NEEDED THAT WILL DETERMINE WHICH HEALTH PROVIDERS ARE QUALIFIED TO PROVIDE GENETIC COUNSELING IF YOU KIND OF EXPAND YOUR LOOK AND SAY, OF COURSE, WE ARE EXPECTING HEALTHCARE PROVIDERS TO PROVIDE GENETIC INFORMATION IN THE FUTURE HOW DO WE GET THERE AND UNDER WHAT CIRCUMSTANCES DO WE RELY ON GENETIC COUNSELORS TO DO THAT PART OF THE WORK. TO ME THE PRACTICE OF 21ST GENETICS OF 21st CENTURY IS GOING TO BE LIKE THE PRACTICE OF INFECTIOUS DISEASES. RIGHT NOW ANY HEALTHCARE PROVIDER CAN ORDER A CULTURE AND PRESCRIBE ANTIBUY YOTICS. THE ROLE OF THE INFECTIOUS DISEASE SPECIALIST IS PROBABLY TO TEACH THE HEALTHCARE PROVIDERS WHAT THE RIGHT THING TO DO AND IN A SAUL SUB SET OF COMPLEX CASES TO TICK TAKE THEM ON AND BE CONSULTED ON. I WOULD URGE THE COMMITTEE TO HAVE A MORE OPEN VIEW OF THE PRACTICE OF MEDICINE AND ASKING THE GENETIC COUNSELING QUESTION UNDER THE UMBRELLA OF THE DELIVERY OF GENETIC INFORMATION. ONCE YOU OPEN THAT DOOR GENETIC COUNSELING WILL HAVE IT ALL IN IT BUT IT WON'T BE THE ONLY THING THAT YOU WILL FOCUS ON.
HUNT?
I CAN'T ADD MUCH TO MUIN'S TYPICALLY ARTICULATE PHRASING OF THE ISSUE. I SCRIBBLED DOWN MANY OF THE SAMISH SHIEWRS IN TERMS OF TRYING TO BROADEN THIS TO GENETIC AND GENOME SERVICES OF WHICH GENETIC COUNSELING IS ONE AVENUE INSTEAD OF CARVING OUT WITH WHAT I HEARD DEBRA SAY THAT IT PARTICULAR SUBSET OF THE WORK FORCE. ALTHOUGH ANY OF US AS INDIVIDUALS MAY BRING THAT TO THE TABLE I DON'T THINK THAT IS A PARTICULAR CHARGE TO THE COMMITTEE BUT AS MUIN SAID IT IS THE CHARGE TO THE COMMITTEE TO HELP ORIGINAL NICE THE PROVISION OF GENETIC AND GENOME INFORMATIONAL SERVICES AND TO ME LICENSURE ISSUES ARE WAY, WAY DOWN THE LIST ESPECIALLY IF ONE TRIES TO CREATE A LINKAGE TO BILLING. LICENSE YOUR OF PHYSICIANS IS NOT A LICENSE -- THEY ARE NOT GETTING A LICENSE TO BILL. THEY ARE GETTING A LICENSE TO PRACTICE MEDICINE EVEN IF THEY WEREN'T BILLING, EVEN IF THEY WERE DOING IT FOR FREE THEY STILL HAVE TO HAVE A LICENSE. THERE IS NO CONNECTION BETWEEN THE ACT OF LICENSE YOUR AND THE YOUR AND THE RIGHT TO BILL, I WOULD PULL UP TO THE 5,000-FOOT LEVEL OF HOW DO WE ORGANIZE THE SCENE TO PROVIDE SERVICES GLOBALLY FOR ALL THE GROUPS WE MIGHT EMERGENCY WOULD BE INVOLVED IN PROVIDING GENETIC AND GENOMIC SERVICES OF WHICH BORT CERTIFIED GENETIC COUNSELORS ARE ONE.
ED. IN.
TO MOVE US FORWARD I HAVE WRITTEN TOWN SOME THINGS HERE TAKING THE COMMENTS AND SOME OF MY OWN THOUGHTS RELABEL THIS SECTION AND GENETIC SERVICES AND COUNSELING. WE COULD SAY THAT SACGHS BELIEVES THAT DELIVERING GENETIC SERVICES INCLUDING GENETIC COUNSELING IS A CRITICALLY IMPORTANT COMPONENT. WE COULD ADD A SENTENCE AT THE END OF NUMBER ONE AND I UNDERSTAND DEBRA'S CONCERN ABOUT ANALYSIS BUT I THINK UNFORTUNATELY IT NEEDS TO BE DELIBERATE AND IT MAY BE THAT THESE ANALYSES ARE UNDERWAY AND THAT WOULD SPEED THINGS UP BUT I WOULD ADD A SENTENCE AT THE END OF NUMBER ONE THIS ANALYSIS SHOULD ADDRESS WORK FORCE NEEDS INDEPENDENT PRACTICE OF HEALTHCARE PROVIDER DELIVER IS GENETIC COUNSELING AND OTHER GENETIC SERVICES. TO BROAD TEN OUT. IT IS NO THE AS BROAD AND AS HIGH AN ALTITUDE LEVEL AS RECOMMENDED BUT IT DOES BROADEN IT A BIT AND GIVES US SOME SPECIFIC LANGUAGE.
EMILY?
OKAY SO I THINK WE SHOULD MAKE SURE THAT IF WE ARE GOING TO BROAD TEN BEYOND GENETIC COUNSELING RIGHT NOW THIS BOX SITS IN A SECTION ENTITLED SUPPLY CHAIN WHICH I THINK, HUNT, IS WHY IT WAS LIMITED TO GENETIC COUNSELING. BUT ONE THING I THINK THAT WE HAVEN'T CAPTURED IN THIS BOX THAT WE DISCUSSED TO SOME EXTENT YESTERDAY WAS THE PROVISION OF COUNSELING BY OTHER INDIVIDUALS THAN OFFICIALLY DESIGNATED GENETIC COUNSELORS SUCH AS ONCOLOGY NURSES, SUCH AS, YOU KNOW, PRACTICE NURSES WHO HAVE SPECIALIZED KNOWLEDGE OF A DISEASE AREA WHERE THEY ARE WORKING IN A CYSTIC FIBROSIS CLINIC OR WHATEVER KIND OF A DISEASE SPECIALTY AREA AND I THINK WE SHOULDN'T IGNORE THE -- AND I THINK THIS IS MAYBE WHERE HUNT WAS COMING FROM WE SHOULDN'T IGNORE ALL THESE OTHER PEOPLE THAT ARE -- ARE DOING THIS TODAY PROVIDING COUNSELING SERVICES WITHOUT THE OFFICIAL BEING A GENETIC COUNSELOR AND ALSO THE FACT THAT AS WE MOVE INTO THE GENETICS OF COMMON COMPLEX DISEASE THAT THIS WILL HAVE TO BE A MUCH MORE DISTRIBUTED EFFORT AND NOT -- THERE IS NO WAY WE COULD CONCENTRATE IT IN A SINGLE SMALL SUBSPECIALTY.
ED? ED AND THEN DEBRA.
THAT'S WHY I BROADENED IT TO SAY GENETIC SERVICES INCLUDING GENETIC COUNSELING. I THINK THAT WOULD ALLOW ONE TO ADDRESS THE OTHER HEALTH PROVIDERS AND EVALUATE WHAT THE ROLES OF THESE INDIVIDUALS COULD BE.
AND I THINK IT WAS MENTIONED YESTERDAY ALSO THAT THE PEOPLE -- NURSES WHO ARE PROVIDING THESE GENETIC COUNSELING SERVICES ARE CERTIFIED. SO THERE IS A CERTIFICATION PROCESS THAT SAYS THEY ARE QUALIFIED TO DO THESE THINGS.
I'M NOT IN ANY WAY SAYING THAT THE PEOPLE WHO DO IT SHOULDN'T BE QUALIFIED. I'M SAYING THAT THERE ARE PEOPLE WHO ARE NOT DESIGNATED OFFICIALLY AS GENETIC COUNSELORS WHO ARE DOING IT. THEY RECEIVED THE TRAINING AND KNOWLEDGE AND ARE PREPARED TO DO IT. SOME OF THEM ARE PHYSICIANS AND NURSES AND SOME ARE PROBABLY SOCIAL WORKERS IN SOME CASES SO.
WHAT WE TRIED TO DO YESTERDAY WAS TO BROADEN THIS BECAUSE THERE WAS SOME SENSITIVITY ABOUT LIMITING IT TO ONE SPECIALTY OR WHAT ONE AREA OF PRACTICE BUT ED'S CHANGES I THINK WITH THE RECOMMENDATION IMPROVE UPON THAT AND PERHAPS THEN TO ADDRESS EMILY'S POINT WE BEEF UP THE SUBSTANCE OF THE REPORT BECAUSE I DON'T THINK THERE IS ENOUGH DISCUSSION OF ALL OF THE DIFFERENT SPECIALTIES. IT WAS INITIALLY DRAFTED AS A DC PIECE SO AS YOU -- AS A GENETIC COUNSELING PIECE SO AS YOU POINTED OUT EMILY WE NEED TO MAKE THE SUBSTANCE FIT IN WITH THE RECOMMENDATION SO TO SPEAK.
COULD YOU REREAD IN THE LAST DRAFT OF WHAT WE GOT FROM ED?
FROM ED.
AND OR WITH THE MOLINE MODIFICATION?
THE SECTION THEN WOULD BE ENTITLED GENETIC SERVICES AND COUNSEL ARE OR COULD BE DELIVERY OF GENETIC SERVICES AND COUNSELING SACGHS BELIEVES THAT DELIVERING GENETIC SERVICES INCLUDING GENETIC COUNSELING IS A CRITICALLY IMPORTANT COMPONENT OF THE APPROPRIATE USE AND INTERGRAIBS OF TEST AND SERVICES AND WE MIGHT ADD IN THERE INTO THE PRACTICE OF MEDICINE OR DELIVERY OF HEALTHCARE. THEN THE FIRST RECOMMENDATION IS AS IT APPEARS UP THERE BUT ADDING A SENTENCE AND I DO ACTUALLY THINK WE NEED BECAUSE IT REFERENCES ONLY GENETIC COUNSELING SO WE WILL NEED TO CHANGE THAT TO TALK ABOUT GENETIC AND GENOMIC SERVICES OR SOME OTHER BROADER TERM AND THEN ADD A SENTENCE THAT WOULD READ "THIS ANALYSIS SHOULD ADDRESS WORK FORCE NEEDS INDEPENDENT PRACTICE AND LICENSURE OF HEALTHCARE PROVIDERS DELIVERING GENETIC COUNSELING AND OTHER GENETIC SERVICES." THE IDEA BEING WHERE GENETIC COUNSELING IS MENTIONED SPECIFICALLY THAT COULD BE INCLUDED IN A COMPONENT BUT THE BROADER TERMINOLOGY WHICH WOULD BE SOMETHING LIKE GENETIC DELIVERY OF GENETIC AND GENOMIC SERVICES WOULD BE INSERTED IN ITS PLACE.
ALL RIGHT. SO IF I GINNED STAND IT THEN IS THAT -- IF I UNDERSTAND IT THEN WHAT P HAS HERE IS THAT WE IN EFFECT WE ARE SAYING THAT THAT WHOLE FIELD, THERE ARE A NUMBER OF INTERVENTIONS WHETHER COUNSELING AND OR PROCEDURES AND OR OTHER THINGS RELATED TO THAT NEW FIELD THAT REQUIRE CLARITY AROUND QUALIFICATION, SCOPE OF PRACTICE AND SO FORTH AND SO ON.
AND THAT THAT WORK HAS TO OCCUR AND WE ARE CALLING FOR SOME ORDERLINESS TO THAT. THE LINK IS IN ABSENCE OF THAT IT IS VERY DIFFICULT TO RECOMMEND REIMBURSEMENT FOR THOSE SERVICES GIVEN THAT YOU DON'T HAVE THIS FUNDAMENTAL PREDICATE WELL ENOUGH ESTABLISHED OR IN PLACE. WE ARE CALLING ATTENTION TO THE NEED TO BE ABLE TO CREATE CLARITY OR GUIDANCE AROUND REIMBURSEMENT BUT MAKING IT CLEAR THERE IS A PREDICATE STEP THAT HAS TO OCCUR FIRST. IS THAT ESSENTIALLY WHAT WE ARE DOING HERE?
I THINK YOU HAVE GOT IT -- YOU CAPTURED IT, REED.
AND THEN I GUESS THE SECOND QUESTION WOULD BE THEN IS, IS THERE ANY PARTICULAR REASON WHY OR THAT WE SHOULD FROM THAT MAKE A SPECIAL MENTION OF GENETIC COUNSELING AND THE REALITY TODAY FOR THAT PARTICULAR DOMAIN? OKAY NOW, WE SAID THIS FOR THE WHOLE SCRIBBISH, RIGHT NOW GIVEN THERE IS A NOT OF LOT OF INTERVEPTIONS TO TALK ABOUT BUT THERE IS A LOT OF COUNSELING GOING ON AND DO WE NEED TO FOR THE SAKE OF THE COUNSELING COMMUNITY SAY AND THERE NEEDS TO BE SOME SORT OF PRIORITIZATION OF MOVING THIS ALONG FOR THE COUNSELING COMMUNITY?
I THINK THAT WE -- I THINK THAT WE ACTUALLY -- WE SAY GENETIC COUNSELING AND WE PUT IT IN SMALL LETTERS RATHER THAN IN CAPS BUT IT IS DEFINITELY THERE IN SEVERAL PLACES. WHAT IT DOES IS IT RECOGNIZES THOSE THAT ARE DOING GENETIC COUNSELING WHICH CLEARLY WOULD BE IN CAPITAL LETTERS THE GENETIC COUNSELORS, MASTERS BOARD CERTIFIED GENETIC GENETIC COUNSELS BUT IT WAS THE INTENT TO ALSO ADDRESS THE OTHER INDIVIDUALS PROVIDING GENETIC SERVICES INCLUDING GENETIC COUNSELING.
THE THESIS OF MY SECOND POINT IS SIMPLY TO RECOGNIZE I GUESS A SORT OF AND AGAIN I'M JUST THROWING IT OUT THERE IS THE RECOGNITION OF A CERTAIN URGENCY AND PRIORITIZATION THAT SAYS LOOK WE GOT TO GET ALL THIS STUFF DONE BUT RIGHT NOW WE REALLY GOT THIS REAL IMMEDIATE MESS ON OUR HANDS THAT WE HAVE TO HAVE RESOLVED SO SAYING THE FIRST PRIORITY IS THESE PEOPLE THAT WE WANT TO BE LOOKED AT. I DON'T KNOW PHILOSOPHICALLY IF THAT IS WHERE THE COMMITTEE IS GOING OR NOT.
TO BE CONSISTENT WE HAVE BEEN TALKING ABOUT SERVICES AND FRAMING IT AS GENETIC COUNSELING SERVICES IS AT THAT LEVEL THAT WE HAVE BEEN REVISING THE WHOLE THING TO LOOK AT SERVICES JUST IN THE LANGUAGE OF NOT GOING TO INDIVIDUALS BUT KEEPING IT AT GENETIC COUNSELING SERVICES I THINK ENCOMPASSES ALL THE ISSUES WE HAVE BEEN TALKING ABOUT. DEBRA?
I AGREE WITH YOU, REED, THAT WE DO NEED TO ADDRESS THE GENETIC COUNSELING THAT IS GOING ON NOW AS AN URGENT ISSUE AND I WAS IN KNOW WAY SAYING THAT GENETIC COUNSELORS WERE GOING TO BE PROVIDING EVERYTHING IN THE FUTURE. BUT WE DO KNOW THAT THERE IS AN EDUCATION GAP IN THE MEDICAL WORK FORCE AND THOSE THAT ARE TRAINED IN GENETIC COUNSELING BE THEY OFFICIAL BENITO COUNSELORS OR NURSES OR WHO EVER WHO HAVE GOTTEN THE TRAINING IN GENETICS WILL BE FACILITATING THE INTEGRATION OF GENETICS INTO HEALTHCARE, HELPING THOSE WHO DON'T KNOW GENETICS TO LEARN THAT. AND JUST A CLARIFICATION, LICENSURE DOES NOT ALLOW YOU TO BILL BUT WITHOUT A LICENSE YOU CAN'T BILL SO YOU DO HAVE TO HAVE THAT STEP BEFORE YOU EVEN HAVE THE POSSIBILITY OF BILLING.
DOES ANY ONE HAVE ANY FURTHER COMMENT ON THE THREE RECOMMENDATIONS AS REVISED? ARE WE GOING TO ADD A FOURTH ON THE LINES OF WHAT REED SUGGESTED? SUZANNE, DO YOU HAVE -- HAVE YOU CAPTURED ( LAUGHTER )
I HAVE ANOTHER IDEA HERE. ONE OF THE THINGS THAT GOT DELETED FROM YESTERDAY IS CALLING FOR AN IOM ANALYSIS OF THE EFFECTIVENESS OF GENETIC COUNSELING. THIS IS ONE OF THE KIND OF STICKY POINTS RIGHT NOW IN THE PRACTICE OF GENETICS RIGHT NOW BECAUSE OF THE LACK OF BILLABLE ENTITY RELATED TO GENETIC COUNSELING WHERE PEOPLE SPEND A LOT OF TIME IMPORTING INFORMATION THAT COULD BE USFUL TO PEOPLE AND THEIR FAMILIES AND I THINK IF WE ARE TO CALL FOR RECOMMENDATION AS NUMBER ONE RELATED TO THE DELIVERY OF GENETIC INFORMATION AND SERVICES IN GENERAL I THINK WE OWE IT TO THE PRACTICING COMMUNITY RIGHT NOW TO KIND OF EVALUATE IN SORT OF BROAD DETERMINES THE -- THE WAY YOU CULTURE IT HERE IS EFFECTIVENESS AND, OF COURSE, PEOPLE WHO ARE PRACTICING THE SPECIALTY, OF COURSE, WILL SAY OF COURSE, IT IS EFFECTIVE, WE ARE IMPORTING INFORMATION THAT WILL BE USEFUL TO PEOPLE BUT WHEN I HAVE HAD A LOT OF DISCUSSIONS WITH A LOT OF MY FRIENDS IN GENETIC COUNSELING WHAT SEEMS TO BE LACKING IS A LOT OF OUTCOME RESEARCH THAT COULD BE MEASURABLE IN A SENSE TO SHOW THE CLINICAL UTILITY OF THAT INFORMATION. AND I THINK AS A GROUP I MEAN GENETIC COUNSELING AS AN ENTITY COULD BENEFIT FROM A CLOSER LOOK AT AS TO THE VALUE AND UTILITY OF THIS. SO, IN OTHER WORDS, IF YOU ARE TO DO A RANDOMIZED CLINICAL TRIAL TODAY, WHICH I DON'T THINK ANY ONE WILL DO, WHERE YOU HAVE PEOPLE COMING IN AND YOU IMPORT INFORMATION ON WITH OR WITHOUT GENETIC COUNSELING, I MEAN YOU CAN GIVE THEM A DIAGNOSIS AND YOU CAN SEND THEM HOME OR YOU CAN SPEND AN HOUR OR TWO OF GENETIC COUNSELING. NO ONE IS GOING TO DO THAT STUDY FOR ETHICAL REASONS BUT IF THAT STUDY CANNOT BE DONE, THEREFORE GENETIC COUNSELING OR THAT HOUR AND TWO HOURS SHOULD BE BILLABLE BECAUSE IT HAS IMPORTED USEFUL INFORMATION SO WE ARE KIND OF IN A CATCH # 22 HERE WITH RESPECT TO DELIVERY OF SERVICES FOR GENE DISORDERS AND I THE UTILITY OF THAT APPROACH IS USEFUL AND MAYBE SOMEBODY HAS DONE THAT SOMETIME BUT I'M NOT AWARE OF IT.
I JUST WANTED TO COMMENT BECAUSE WHEN YOU SAID THAT IT WOULDN'T BE ETHICALLY APPROPRIATE TO DO IT, ACTUALLY THERE ARE SOME TRIALS ONGOING RIGHT NEW WITH PEDIATRIC SURGERY LOOKING AT SURGICAL PROCEDURES IN CLINICAL TRIALS WHICH IS ALMOST UNHEARD OF IN SURGERY TO ACTUALLY LOOK AT THE EFFICACY OF VARIOUS SURGICAL PROCEDURES SO I THINK ONE COULD DESIGN A TRIAL THAT WOULD BE ACCEPTABLE TO IRBs AND WOULD ANSWER THESE QUESTIONS.
THIS IS BARBRA. I THINK THERE ARE ALSO STUDIES OUT THERE THAT SHOW DIFFERENT WAYS TO DO COUNSELING. WHETHER IS IS DONE BY A PHYSICIAN VERSUS A TRAINED GENETIC COUNSELOR AND OUTCOMES FROM THAT KIND OF DATA SO THERE ARE SOME STUDIES OUT THERE THAT SHOW THE EFFICACY OF COUNSELING AND I THINK A LITERATURE REVIEW EFFORT COULD UNEARTH SOME OF THOSE. OTHERWISE, I JUST WANT TO MAKE SURE AND I THINK IT IS GETTING IN THERE NOW THAT I GUESS MY TWO KEY ISSUES ARE LICENSURE TO PUT OUR SUPPORT BEHIND THAT BEING DONE AS WELL AS I THINK IDENTIFYING GENETIC COUNSELING SEPARATELY AS A KEY POINT.
I WAS ASKED TO PUT MY THOUGHT UP THIS AND IT IS ACTUALLY IN NUMBER ONE. I DON'T THINK IT IS A SEPARATE FOUR AND I THINK AT THE VERY END OF NUMBER ONE IF WE WERE TO SAY NEXT-TO-THE-LAST SENTENCE THIS ANALYSIS SHOULD ALSO ADDRESS WORK FORCE NEEDS IN DEEP PENDENT PRACTICE -- INDEPENDENT PRACTICE AND LICENSURE OF HEALTHCARE PROVIDERS DELIVERING GENETIC SERVICES THE COMMITTEE RECOMMENDS THAT GENETIC COUNSELING SERVICES BE A PRIORITY FOR THIS ACTIVE. GET THE WHOLE AND THEN COME BACK ASSAY THAT GENETIC COUNSELING IS A PRIORITY.
AS I MENTIONED YESTERDAY JUST A REMINDER OF THE STUDY FUNDED BY HERSA LED BY DR. JUDITH COOKS A IS ENDING ITS THREE YEARS. I DON'T HAVE THE FINDINGS AT THIS POINT IN TIME BUT I WANT TO REMIND YOU THAT THAT HAS BEEN GOING ON AND THAT MAY HELP INFORM THIS DISCUSSION SO YOU ARE NOT STARTING FROM A BLANK SLATE IN YOU ARE RECOMMENDING ANOTHER STUDY.
I DIDN'T GET TO HEAR ALL OF MAUREEN'S COMMENT BUT I THINK -- TO HEAR ALL OF MUINS COMMENT BUT I THINK WE NEED TO BE HOW SERIOUS ARE WE ABOUT PUSHING A RECOMMENDATION BECAUSE THIS HAS ITS OWN, DO THE STUDY OR CALL FOR THE STUDY OR TAKE FORWARD ON THIS AND THIS IS A TAKE HOME ISSUE AND WE HAVE TO DECIDE IF THIS IS GOING TO BE ONE OF THE TOP PRIORITIES THAT COME OUT OF THIS MEETING OR NOT OR WHETHER IT IS ENOUGH THAT WE PUT IT IN OUR REPORT AND SEND IT FORWARD TO THE SECRETARY OR DO WE REALLY WANT TO COME BACK AND CONSIDER THIS TO BE ONE OF THE TAKE-HOMES THAT DEFINE WHETHER OUR COMMITTEE WAS A SUCCESS OR NOT. I'M LISTENING FOR MY COLLEAGUES TO GIVE US A SENSE OF ONCE IT IS IN THE REPORT IS THIS AN EVALUATIVE ISSUE FOR OUR COMMITTEE.
IS THE HERSA STUDY, DOES IT APPLY TO PHYSICIANS AND GENETICISTS.
IT LOOKING AT GENETICIST INCLUDING PHYSICIANS AND NONSPECIALISTS.
DOES THE COMMITTEE HAVE ANY VIEWS ON WHETHER WE SHOULD BE FOCUSING THAT BROADLY? IS THAT TOO BROAD A FOCUS OR SHOULD WE HONE IN A LITTLE BIT MORE ON THE ALLIED HEALTH PROFESSIONAL WORLD? RIGHT NOW IT IS VERY BROAD. AND IT INCOME PASSES ALL -- ENCOMPASSES ALL -- THE WAY IT IS WORDED, ALL SPECIALTIES, ALL PROFESSIONS THAT DELIVER OR POTENTIALLY COULD DELIVER GENETIC SERVICES. INCLUDING PHYSICIANS.
THE COMMITTEE IS NOTSTERED IN ASKING FOR AN ANALYSIS OF PROVIDERS THAT ARE NOW LICENSED, ARE WE? IT IS ONLY THOSE WHO ARE NOT CURRENTLY LICENSED OR WHOSE LICENSE IS WITHIN A CERTAIN SCOPE AND MAY NEED TO BE BROADENED? THIS WOULDN'T INCLUDE M.D. GENETICISTS, WOULD IT? IT WOULD?
I KNOW BUT I'M WONDERING IF WE INTENDED TO BE -- TO MEAN THAT, I GUESS. BECAUSE WHAT ARE THE ISSUES THERE FOR THAT WE ARE TRYING TO GET AT, I GUESS IS WHAT I --
I MEAN I THINK THE ISSUES AND BARBRA RAISED IT AT WELL, THE ISSUE IS WHICH HEALTHCARE PROVIDERS ARE BEST SUITED TO PROVIDE THE BEST GENETIC AND GENOME HEALTHCARE. IT MAY BE NURSE PRACTITIONERS, ET CETERA ET CETERA SO THAT IS HOW I READ THAT WAS SORT OF A VERY BROAD LOOK AT THE ENTIRE LANDSCAPE OF GENETIC AND GENOMIC SERVICES AND SAYING WHO IS LINED UP TO DO THE BEST JOB UNDER THE BEST CIRCUMSTANCES AND HOW IS LICENSURE RELEVANT TO ANY OF THOSE DETERMINATIONS? THAT IS HOW I READ THAT.
ED AND THEN EMILY.
AND THAT IS WHY I THOUGHT THAT IT IS IMPORTANT AGAIN TO BE DELIBERATE AND ANALYTICAL IN THIS AND DEVELOP AN EVIDENCE BASE BECAUSE I THINK THERE IS SOME LITERATURE THERE BUT I THINK AS WE MOVE FORWARD THERE NEEDS TO BE A LARGER LITERATURE TO REALLY ADDRESS THE WORKFORCE NEEDS AND TO IDENTIFY WHETHER I THINK BURIED WITHIN THAT ARE ISSUES THAT WE HAVE ADDRESSED BEFORE IN THIS COMMITTEE AND THAT HAS TO DO WITH EDUCATION AND ARE WE EDUCATING OUR PHYSICIANS IN FACT? IF THE MANAGEMENT OF GENETIC DISEASE AND I AGREE WITH MUIN, I THINK IT IS GOING TO DIE FUSE FUSE -- DIFFUSE THROUGH ALL OF MEDICINE BUT ARE MEDICAL STUDENTS BEING PREPARED. I DON'T THINK WE NEED TO BE DELIBERATE FOR THE NEXT TWO DECADES BUT I THINK WE NEED TO DEVELOP THE APPROPRIATE EVIDENCE BASE TO JUSTIFY THE RECOMMENDATIONS THAT MANY OF US WOULD MAKE FROM OUR GUT IN TERMS WHAT JOB BETTER. . BE BARBRA SAYS THERE IS EVIDENCE COMPARING PHYSICIANS AND GENETIC COUNSELORS THAT IS A NO BRAINER, GENETIC GENETIC COUNSELORS DO A FAR BETTER JOB IN MY EXPERIENCE BUT THAT LITERATURE NEEDS TO BE REVIEWED AND ANALYZED AND MADE MORE PUBLIC.
SINCE WE ARE WORKING ON SOMETHING THAT IS FOCUSED AS SORT OF AN OVERARCHING SUBJECT FOR THIS DISCUSSION AND COVERAGE AND REIMBURSEMENT I MEAN A LOT OF THESE ISSUES THAT WE ARE TALKING ABOUT ARE MORE BROAD WORKFORCE PREPAREDNESS ISSUES, IF YOU WILL, BUT I THINK WHAT MIGHT BE HELPFUL IF STAFF COULD PUT IN THIS A LITTLE BOX CHART THAT JUST HAS WHO ARE THE ALLIED HEALTH PROFESSIONALS THAT ARE DELIVERING GENETIC COUNSELING TODAY AND WHAT IS THEIR CURRENT STATUS? ARE THEY LICENSED? YOU KNOW, WHO IS -- WHO IS REIMBURSABLE? WHO IS NOT? AND THAT MIGHT MAKE IT VERY CLEAR WHERE WE NEED TO FOCUS ANY -- ANY FURTHER WORK BECAUSE OBVIOUSLY PHYSICIANS ARE ALREADY LICENSED AND THEY CAN ALREADY BILL FOR THEIR TIME SO THAT MIGHT NOT BE WHERE WE NEED TO FOCUS SERVICES ALTHOUGH SOME OF THOSE PHYSICIANS MIGHT NEED MORE EDUCATION SO THEY CAN DO A BETTER JOB OF DOING THE COUNSELING BUT FROM A COVERAGE AND REIMBURSEMENT POINT OF VIEW I THINK WE NEED TO JUST SORT OF REMEMBER WHERE THIS SECTION IS APPEARING IN WHICH REPORT AND NOT GET TOO FAR OFF THE FOCUS OF THAT ISSUE BECAUSE I THINK WE ARE TRYING TO ADDRESS THE BARRIERS TO SERVICE PROVISION AND WE WANT TO MAKE SURE THAT THE PEOPLE WHO ARE ACTUALLY DOING THE SERVICES CAN GET PAID FOR THEIR WORK SO THAT THEY ARE INSPIRED TO COME IN AND CONTINUE TO DO THAT EVERY DAY.
MUIN, DID YOU HAVE -- I THOUGHT I REMEMBERED YOU EXPRESSING CONCERN ABOUT THE LINE WHERE IT TALKS ABOUT ASSESSING THE EFFECTIVENESS. IS THERE A DIFFERENT WORDING THAT YOU WOULD PROPOSE?
SEE, THE -- WHAT EMILY WAS TRYING TO TELL US IS TO FOCUS A BIT ON THIS SECTION IN THE REPORT WHICH IS ABOUT COVERAGE AND REIMBURSEMENT. AND IF WE LIVE IN A WORLD WHERE GENETIC SERVICES AND GENETIC COUNSELING IS NOT COVERED OR REIMBURSED THE QUESTION TO ASK IS WHY? I MEAN IF THESE PEOPLE WHOEVER THEY ARE ARE PROVIDING SERVICES THAT ARE USEFUL TO AND FAMILIES, WHY CAN'T WE ANALYZE TO SEE WHAT KIND OF SERVICES WOULD BE LOSE IF THE SERVICES ARE NOT PROVIDED? AND IF WE LOSE THOSE SERVICES AND, YOU KNOW, THE HEALTH OUTCOMES OR PSYCHOLOGICAL OUTCOMES ARE SO MUCH WORSE OFF THEN WHY AREN'T WE PAYING FOR THEM -- SO IT SEEMS TO ME THAT -- AND I DON'T LIVE IN THIS WORLD. IF PEOPLE SAY THERE IS JUT COME RESEARCH OUT THERE -- OUTCOME RESEARCH OUT THERE PUT IT TOGETHER AND THIS COMMITTEE CAN RECOMMEND THAT IT CAN BE DONE AND ACTUALLY WE CAN DO IT BETWEEN NOW AND THE NEXT MEETING AND MAKE THOSE RECOMMENDATIONS STAND BETTER ON THEIR FEET. I MEAN I AGREE. THIS IS NOT ABOUT THE EDUCATION OF THE WORK FORCE BECAUSE THAT IS NOT IN THIS REPORT. IT IS ABOUT COVERAGE AND REIMBURSEMENT. SO GIVEN THAT RUBRIC AND THE DID I FUSION OF ALL OF GENETIC IN ALL OF MEDICINE RIGHT NOW GENETICS IS CONCENTRATED IN GENETIC DISEASES SO WE HAVE TO HAVE THAT PART BEFORE WE BEGIN TO DIFFUSE GENETICS IN ALL OF MEDICINE AND THE FIRST PART WHICH IS SINGLE GENE DISEASES HASN'T REALLY BEEN SOLVED IN TERMS OF COVERAGE AND REIMBURSEMENT. I THINK IT COMMITTEE CAN MAKE A DECISIVE RECOMMENDATION TO AT LEET ADDRESS AND ASSESS THESE ISSUES.
REED?
JUST A SUBTLE ADDITION AND IT DOESN'T CHANGE ANY OF THE FLAVOR OF WHAT MUIN SAID. I HAVE HEARD THAT WE -- I HAVE NOT HEARD THAT WE SAID THAT THE TASK OF THIS IS TO MAKE SURE THAT PEOPLE DON'T GET RIPPED OFF AND THERE IS A PROTECTION IN THE PUBLIC ON THIS AS WELL. WE FOCUSED THIS ON WHAT ARE THE GOOD THINGS. SOMEBODY SETS UP SHOP ON THE CORNER AND SAYS YOU GOT A GENETIC DISEASE I'LL TALK TO YOU ABOUT IT AND I MEAN INSURANCE WON'T PAY FOR IT BUT I ONLY CHARGE $30 AN HOUR IT IS LIKE HR BLOCK OR SOMETHING LIKE THAT OR TELEPHONE HOT LINES WHICH ARE GOING TO CSH YOU , YOU KNOW, ARE ALREADY THERE AND SPRINGING UP AND WE HAVE A TELEPHONE HOT LINE THING AND WE TAKE CREDIT CREDIT CARDS. HOW DOES THE PUBLIC KNOW WHETHER THESE PEOPLE ARE ANY GOOD. PART OF THE REIMBURSEMENT ISSUE AS WELL. I JUST WANT TO ADD THAT PERSPECTIVE TO IT.
MUIN, I WOULD ALSO SAY THAT FOR SINGLE GENE DISORDERS THERE ARE A LOT OF PEOPLE WHO DON'T GET GENETIC COUNSELING WHO WOULD BENEFIT FROM GENETIC COUNSELING BECAUSE MOST OF THEIR INFORMATION COMES FROM THEIR PHYSICIAN AND EVEN, YOU , SOME OF THE SPECIALIZED PHYSICIANS ARE NOT VERY GOOD AT GIVING GENETIC ADVICE AND PERHAPS THE COVERAGE AND REIMBURSEMENT ISSUE RESTRICTS PEOPLE FROM GETTING GENETIC COUNSELING AND A LOT OF PEOPLE GET THE INFORMATION OVER THE INTERNET OR WHATEVER THEY CAN DO TO FIND THE RESOURCES BUT I THINK THAT CERTAINLY WE SHOULD DO WHAT WE CAN DO TO ENCOURAGE PEOPLE PARTICULARLY WITH THE SINGLE GENE DISORDER *TD AND AS WE MOVE ON TALKING ABOUT GENOMIC MEDICINE HOPEFULLY WE CAN WORRY ABOUT THE EDUCATION COMPONENT AND GET PROBABLY MORE PHYSICIANS INVOLVED IN THE COUNSELING PROCESS BUT I CERTAINLY THINK WITH SINGLE GENE DISORDERS I THINK THERE IS A LARGE PERCENTAGE OF THE POPULATION WHO DOES NOT GET GENETIC COUNSELING. PROBABLY I WOULD GUESS BECAUSE THEY ARE NOT -- YOU KNOW, GENETIC COUNSELING ISN'T A PAID-FOR SERVICE AND IT IS NOT GETTING RECOMMENDED BY PHYSICIANS.
I THINK WE HAVE GOT SOME WORK TO DO IN TERMS OF FRAMING THIS ISSUE MORE BROADLY AND INCORPORATING ALL THE COMMENTS THAT WE ARE -- THAT WE HEARD THIS MORNING AND WE WILL DO THAT AND THERE IS SOME WORK THAT WAS DONE BY SACGT THAT I THINK WE CAN LIFT FROM AND TEEING UP THE ISSUE THAT WAY WILL HELP PUT CONTEXT TO THESE RECOMMENDATIONS SO IF I CAN KIND OF BRING US TO A CLOSE ON THIS ISSUE, UNDERSTANDING THE POINTS THAT EVERYONE HAD RAISED AND ACCEPTING THE FACT THAT WE ARE GOING TO WORK ON LANGUAGE IN THE SUBSTANCE OF THE REPORT THAT PROVIDES THAT LEVEL OF EXPLANATION AND CONTEXT ARE THESE THREE -- DOES EVERYONE FEEL COMFORTABLE WITH THESE THREE RECOMMENDATIONS AS THEY ARE CURRENTLY PRESENTED? ANY OBJECTION? REED?
JUST TRYING TO MAKE SURE SO AN ANALYSIS IS NEEDED. TRYING TO SEE TO.
IT COULD BE MORE AFFIRMATIVELY WORDD THAT WE --
SO THEREFORE.
CALL FOR.
THEREFORE AT THE END OF THIS SOMEONE WE CALL FOR THAT IS THE DEAL.
RIGHT.
SOME WHERE MAYBE AT THE VERY END WE ARE CALLING FOR SOMEBODY TO DO SOMETHING, I GUESS THAT IS WHAT WE'RE NOT SURE OF YET. ED?
ONE COULD STATE OR JUST RESTATE THAT FIRST SENTENCE. WE RECOMMEND AN ANALYSIS TO DETERMINE WHICH HEALTH PROVIDERS AND IF YOU WANTED BECAUSE WE HAVE LOST THE IOM PIECE YOU COULD PUT IN PARENTHESES WE RECOMMEND AN ANALYSIS PA RENS EG, IOM, HERSA, ET CETERA, PARENS CLOSED BECAUSE WE KNOW THAT HERSA HAS BEEN TRYING TO GET THAT INFORMATION BUT ALSO THE IOM LEVEL WHICH WOULD RECOGNIZE THE IMPORTANCE OF IT TO THE HEALTHCARE IN THE UNITED STATES.
I THINK THAT IS GOOD AND I WISH WE ALL KNEW MORE ABOUT EXACTLY WHERE IS THE LEVERAGE POINT. IS IT THAT WE -- I MEAN -- COULD IT -- WOULD IT BE WONDERFUL IF IT WAS AS SIMPLE AS IF WE THEN SORT OF SENT THE LETTERS TO THE THREE ORGANIZATIONS WHO HAVE THE MOST OPPORTUNITY TO COME TOGETHER AND NAIL THIS THING AND MAYBE CMS WOULD CONVENE IT OR SOMETHING AND WE COULD ACTUALLY CALL FOR THAT LEVEL OF SPES FICKITY. SPES FIESITY.
I KNOW ONE OF THE THINGS THAT YOU HAVE RECOMMENDED IS A CZAR OF GENETICS AND AGAIN THAT IS AN ISSUE THAT I THINK THAT WE DISCUSSED THAT THE GNZ SERVICES IS REALLY QUITE FRAGMENTED WITHIN HHS, LET ALONE THE REST OF THE GOVERNMENT.
WHAT ABOUT THAT COMMITTEE, THE -- THE HEALTH PROFESSIONS COMMITTEE AT YOUR PLACE, ALLAN? YOU GUYS CO--CHAIR IT, I THINK? ABOUT 30-40 DIFFERENT ORGANIZATIONS THAT COME TOGETHER? MICH PEG.
IT IS FOCUSED ON HEALTH PROFESSIONAL EDUCATION IN IN AND IS TRYING TO BE A BIG TENT AND INVITE EVERYONE IN WHO MIGHT BE INTERESTED AND I SUSPECT THAT PART OF WHAT WE MIGHT BE TALKING ABOUT MIGHT BE TO THROW SOME PEOPLE OUT OF THE TENT AND MIGHT BE CONTRARY TO MISH PEG.
WHAT HAPPENED WHY DID.
WE THROW OUT THE IOM.
BECAUSE IT WOULD BE A METAANALYSIS AND A BIG PICTURE LEVEL ONLY USING ANALYSIS THAT EVERYBODY HAD DONE AND DRAWING THEM TOGETHER. WE NEEDED TO DO HOMEWORK AND FIGURE OUT IF IT EXISTS AND IF THEY DON'T EXIST RECOMMENDING IOM WOULD BE KIND OF.
DID LET ME DO THIS. IF WE APPROVE EVERYTHING ELSE TO THIS POINT AND THEN MAYBE FIRST ACTIVELY SOLICIT FROM THE GENETICS COUNSELING COMMUNITY AND WE ALSO HAVE YOU AS CHAIR OR SOMEONE ELSE START IDENTIFYING POTENTIAL PLACES TO GET THIS STUDY DONE AND THEN COME BACK WITH SOME KIND OF A RECOMMENDATION BUT I THINK -- I THINK WHAT WE ARE HEARING IS WE CAN'T SOLVE THIS ONE AT THE TABLE BUT THAT THIS IS A PRIORITY LOW HANGING FRUIT THAT WE WANT TO KNOCK DOWN BETWEEN NOW AND THE NEXT MEETING.
ED?
THE REASON WHY I PUT IOM BACK IN. I THINK HERSA IS DOING A STUDY. IOM WOULD BE A MED ANALYSIS BUT IT WOULD PROBABLY BE MORE BACK TO THAT 35-50,000-FOOT LEVEL THAT WE WERE TALKING ABOUT AND THE IOM WOULD DO, I THINK, WOULD IDENTIFY GAPS. THE OTHER REASON TO PUT IT IN AS A SPECIFIC RECOMMENDATION IS THAT THE IOM DOESN'T HAVE FUNDING FOR THIS. FUNDING WOULD HAVE TO COME FROM SOME PLACE AND THAT IS THE REASON TO PUT IT IN THE RECOMMENDATION TO THE SECRETARY SO THAT THERE MILT BE A CONSIDERATION FOR -- TO THAT THERE MIGHT BE A CONSIDERATION FOR FUNDING OF SUCH A STUDY. I DON'T THINK WE ARE SAYING THAT THIS WOULD BE ONE STUDY NECESSARILY. THERE MIGHT BE A VARIETY OF STUDIES LOOKING AT DIFFERENT LEVELS OF THE ISSUE.
DEBRA?
RIGHT NOW THOSE THREE RECOMMENDATIONS ARE FAIRLY BROAD CALLING FOR STUDIES AND YET WE HAVE HEARD FROM A NUMBER OF PEOPLE ON THE COMMITTEE, KIMBERLY AND OTHERS WHO SAY THAT THE CURRENT GENETIC COUNSELING IS USEFUL, THERE IS NOT ENOUGH OF IT AND PEOPLE DON'T GET PAID. AND THIS IS, AS EMILY POINTED OUT, A COVERAGE AND REIMBURSEMENT DOCUMENT AND I DON'T FEEL LIKE WE ARE ADDRESSING THE ELEPHANT IN THE ROOM WHICH IS THAT GENETIC COUNSELORS CAN'T BE PAID.
THE PROBLEM IS, THOUGH, JUST TO PLAY DEVIL'S ADVOCATE AND I AGREE WITH YOU THAT IN ORDER TO GET THEM PAID PARTICULARLY UNDER MEDICARE A CASE NEEDS TO BE MADE -- CONGRESS WILL NOT -- WE JUST CAN'T SHOW UP AT CMS OR CONGRESS AND SAY WE LIKE THESE PEOPLE AND THEY DO GREAT WORK AND THEY SHOULD BE PAID. THEY WILL SAY SHOW US WHY AND IF THE EVIDENCE EXISTS OUT THERE, THE DATA EXISTS AND HAS BEEN ANALYZED AND COLLECTED THAT DEMONSTRATE THE VALUE, THE EFFECTIVENESS, THE IMPORTANCE OF REIMBURSING FOR THESE SERVICES IT SHALL BE DONE BUT I DON'T KNOW THAT WE HAVE THAT YET. I GUESS THAT IS WHAT THESE RECOMMENDATIONS ARE AIMED AT MAKING SURE THAT WE HAVE GOT THE INFORMATION THAT CMS WOULD REQUIRE, THAT CONGRESS WOULD REQUIRE. THEY WON'T JUST TAKE OUR WORD FOR IT.
BUT THERE ARE AT LEAST TWO STATES THAT ARE GOING TO BE LICENSING GENETIC COUNSELORS. THERE MUST BE A BODY OF EVIDENCE THAT SAYS LICENSURE IS REASONABLE. WHERE IS THAT BODY OF EVIDENCE THAT GOT THOSE TWO STATES TO PROVIDE LICENSURE? IT MUST EXIST.
BUT LICENSURE ISN'T NECESSARILY A GUARANTEE OF REIMBURSTMENT.
TRUE. BUT IT IS NECESSARY FOR REIMBURSEMENT.
AGAIN, I THINK WE HAVE SOME WORK TO DO. I THINK WE NEED TO BRING THAT STUFF FORWARD RIGHT AWAY AND SO I GUESS DEBRA, THE QUESTION FOR YOU WOULD BE -- CAN WE GO BACK AND REMIND US ON THIS REPORT WHERE WE ARE IN TERMS OF WHEN THIS -- WHEN WE WANT THIS TO HIT THE STREETS? IS THIS SUPPOSED TO BE LOCKED AND LOADED BY THE END OF THIS MEETING?
NO. WE ARE -- THE PLAN WAS TO GO OUT FOR PUBLIC COMMENT AND I MEAN I -- AND I GUESS THERE IS SOME DISCUSSION WE NEED TO HAVE ABOUT WHEN THE COMMITTEE WANTS TO BE ABLE TO FINALIZE THE REPORT IS, YOU KNOW, FEBRUARY EVEN POSSIBLE OR IS IT GOING TO TAKE UNTIL JUNE BUT WE DO NEED TO -- THAT IS WHAT YOU ARE ASKING?
NO QUESTION. JUST TO BE CLEAR SO WE ARE ALL ON THE SAME PAGE. OBVIOUSLY WE DON'T WANT THIS REPORT TO TAKE 99 YEARS. DOES EVERYTHING HAVE TO BE, YOU KNOW, SOLID AND TIGHT AND REALLY TERRIFIC BEFORE THE WHOLE THING GOES OUT OR CAN YOU REFERENCE THAT MORE WORK MAY COME ON CERTAIN PARTS OF IT AND THEN SPECIFICALLY ON THIS ONE GIVEN THAT WE HAVE EVIDENCE TO UNCOVER, A LITTLE MORE WORK TO DO ON THIS TOPIC, WOULD YOU BE WILLING TO GET THAT WORK DONE AND SEE IT IN THE FULL REPORT OR REFERENCE IT AS STUFF COMING AFTER THE REPORT IS RELEASED? > HOW IMPORTANT IS THIS ISSUE TO THIS REPORT AND HAVING THIS ONE SORT OF NAILED DOWN WITH A LITTLE GREATER SPECIFICITY?
THE ENEMY OF THE GOOD IS THE PERFECT.
I THINK WE ARE TALKING ABOUT TWO FILL LOW SOVICAL DIFFERENCES. WE COULD ASK FOR AN UPDATE ON THE HERSA STUDY AND STATUS OF THAT AND LOOK AT WHAT HAS BEEN PRESENTED FOR LICENSURE, YOU KNOW, AND I'M SURE GENETIC COUNSELING OUR AMERICAN BOARD PETER WAS JUST SAYING THAT ANDREW FAUCET IS SPEAKING TO US IN THE PUBLIC COMMENTS SECTION THIS AFTERNOON AND MAYBE HE IS HERE AND COULD PROVIDE INFORMATION TO STAFF ON WHAT INFORMATION EXISTS. AND BETWEEN NOW AND THE NEXT TIME WE HAVE THIS DISCUSSION MAYBE WE DO NEED TO JUST SAY WE NEED STUDIES. BUT I WOULD THINK THAT IF TWO STATES ARE PROVIDING LICENSURE THAT INFORMATION IS OUT THERE AND WE COULD GET IT AND WE COULD THEN MAKE MORE RECOMMENDATIONS NEXT TIME.
EX-POLICE SIT IN YOUR COMMENT IF I UNDERSTAND IT IS THAT IT APPRECIATES THAT THIS REPORT WILL COME BACK FOR ANOTHER DISCUSSION ANY WAY AT THE NEXT MEETING AND THAT THERE IS ANOTHER MEETING THAT WE WILL DISCUSS THIS SO WE WILL ALL SEE THIS AGAIN AS A FULL COMMITTEE AND IN THE INTERIM CERTAIN WORK CAN OCCUR.
PETER, DID YOU HAVE?
MY COMMENT WAS JUST SIMPLY TO POINT OUT THAT ANDREW FAUCET WAS LISTED AS A PUBLIC SPEAKER AND THAT AS DEBRA SAID SO THAT HE COULD A I DRESS THIS ISSUE -- ADDRESS THIS ISSUE.
EMILY?
SO ONE OTHER SUGGESTION MIGHT BE TO INVITE PEOPLE WHO ARE INVOLVED IN THE CREATION OF THE LICENSURE PRO TKPRA*PLS IN I THINK CALIFORNIA AND UTAH TO COME AND GIVE US THEIR INPUT. WHAT DID THEY DO AND WHAT WERE THE STU DID IS THEY USED AND WHAT WERE THEIR CRITERIA AND WHAT WERE THEIR GOALS? ARE THEY WORKING TOWARDS THIS ON A STATE LEVEL AND IS THIS SOMETHING THAT WE COULD LEVERAGE OR SPECIFICALLY RECOMMEND THAT WHATEVER THE CALIFORNIA PILOT PROGRAM BE USED AS THE DEMONSTRATION PROJECT SO RATHER THAN JUST CALLING FOR A DEMONSTRATION PROJECT WE MIGHT BE ABLE TO BE MORE SPECIFIC IF WE KNEW MORE ABOUT WHAT WAS GOING ON AT THE STATE LEVEL BECAUSE I MEAN TO DEBRA'S POINT IT SEEMS LIKE THOSE STATES MUST BE PUSHING TOWARDS THIS FOR A REASON, NOT JUST TO HAVE LICENSED PROFESSIONALS BUT PROBABLY TO DEAL WITH THE ISSUE THAT WE HAVE BEFORE US OF HOW TO NOT JUST GET THEM LICENSED AND CREDENTIALED BUT ALSO TO GET THEM PAID FOR THE SERVICES THEY RENDERED.
NOT TO PUT YOU ON THE SPOT BUT MR. FAUCET I DON'T KNOW IF YOU WANTED TO MAKE ANY CBHENTS COMMENTS NOW TO INFORM THIS DISCUSSION OR WOULD YOU LIKE TO WAIT UNTIL THE PUBLIC COMMENT PERIOD? WHAT IS YOUR PREFERENCE? WE CERTAINLY COULD BENEFIT FROM YOUR INSIGHT.
I'M WILLING TO DO EITHER ONE.
YOU CAN INTRODUCE YOURSELF. I THINK NOW IS A GOOD TIME.
I'M ANDY FAUCET. A BOARD CERTIFIED GENETIC COUNSELORS AND I'M HERE REPRESENTING THE AMERICAN BOARD OF GENETIC COUNSELING WHICH CREDENTIALS ABOUT 1400 GENETIC CON SERALS. IN REFERENCE TO LICENSURE THERE ARE THREE STATES. ILLINOIS WAS RECENTLY ADDED TO THE LIST CURRENTLY WORKING ON THE PROCESS. IT IS IMPORTANT TO SEPARATE THE DISTINCTION BETWEEN LICENSURE AND BILLING AND REIMBURSEMENT BECAUSE ONE OF THE THINGS WE ALL LEARNED THAT LICENSURE IS TO PROTECT THE PUBLIC IT DOES REIMBURSEMENT BUT THE TWO SHOULD NOT BE DIRECTLY CONNECTED. BUT I'M HERE AS A RESOURCE TO ANSWER ANY QUESTIONS THAT THE COMMITTEE HAS. YES, BARBRA?
I GUESS JUST SPECIFICALLY ON THE LITERACY OUT THERE SHOWING THE EFFICACY OF GENETIC COUNSELING?
I'M NOT SURE THERE IS A LOOT. I KNOW THERE IS SOME AND I KNOW IT IS PRETTY POWERFUL THAT IS THERE AND IT MIGHT BE WORTH PULLING TOGETHER.
DO YOU -- DO YOU HAVE ANY SENSE OF THE THE SIMILARITY AND OR DIFFERENCES BETWEEN THE CRITERIA THAT ARE USED BY THE THREE STATES? IS THIS VERY HOMOGENERIC OR STATE BY STATE.
SOME HAVE TO HAVE ANOTHER DOOR IN BECAUSE TO GET AGB CERTIFIED YOU HAVE TO SO BE TRAINED IN ANOTHER PROGRAM SO SOME STATES HAVE TO HAVE ANOTHER DOOR AND ALSO FOR PEOPLE THAT CHOSE NOT TO GET CREDENTIALED FOR YEARS BECAUSE IT WAS OPTION TO DO THAT. AND WE MADE A STATEMENT THAT WE WOULD WORK WITH ANY STATE TO PROVIDE A PROGRAM THAT MET THEIR NEEDS. CURRENTLY ALL OF THE STATES ARE USING ABGC CERTIFICATION.
AND IS SCOPE OF PRACTICE DEFINED AND IS THAT SIMILAR STATE TO STATE SO FAR?
YES, IT IS. I THINK THE ONLY DIFFERENCE IS CALIFORNIA HAS A PROVISION ABOUT PHYSICIAN SUPERINVESTOR RELATIONS AND THE OTHER STATES DO NOT. THAT WILL BE DIFFERENT YAITION FROM STATE TO STATE. IT AT COME BE TENTCY BASED PROCESS SO YOU CAN SEE THE COME BE TENTCIES THEY ARE TRAINED UNDER AND THAT THEN THAT THEY ARE EXPECTED TO SHOW.
BARB BARBRA AND THEN HUNT.
I DON'T KNOW IF KELLY ORDER ORDMAN MAY HAVE MORE INFORMATION ABOUT THE SPECIFIC GENETIC STUDIES?
THANKS, BARBRA, HAVING BEEN ONE OF THE PEOPLE INVOLVED IN THE ILLINOIS LICENSURE I ACTUALLY WAS PRETTY INVOLVED IN TRYING TO COME UP WITH SOME OF THAT DOCUMENTATION AND I I'LL GEE THAT THERE IS NOT MUCH OF IT -- I WILL AGREE THAT THERE IS NOT MUCH OF IT OUT THERE. THAT IS IMPORTANT TO RECOGNIZE SO I STRONGLY SUPPORT THE COMMITTEE IDEA OF TRYING TO PULL TOGETHER WHAT LITERATURE IS OUT THERE IN A COMPREHENSIVE MANNER BECAUSE THAT WILL BE ENORMOUSLY HELPFUL FOR STATES GOING THROUGH THE PROCESS. ONE OF THE THINGS THAT WE DID CITE IN OUR PROCESS WAS THE LITERATURE BARBARA WAS REFERENCING WHICH LOOKED AT OUTCOMES AND IN. BUT THERE IS ALMOST NOTHING ABOUT EFFECTIVENESS OR USEFULNESS AND I THINK THAT ONE OF THE THINGS THAT NSGC HAS DONE RECENTLY IS PUT OUT AN RFP ALMOST COMPLETE THAT LOOKED AT DEVELOPING A PRENATAL MODEL FOR GENETIC COUNSELING AND WHERE YOU HAVE HAVE IMPACT AND TRYING TO DEVELOP THOSE SORTS OF MODELS AND WE WOULD STRONGLY ENCOURAGE STUDIES IN THAT AREA.
HUNT AND THEN MUIN.
WE HAVE TO BE CAREFUL AND ESPECIALLY IN THIS CONVERSATION. THE ISSUE IS NOT IS GENETIC COUNSELING EFFECTIVE. THE ISSUE IS IS THERE IS DIFFERENCE BETWEEN SUPER VICED AND UN SUPERVISED GENETIC COUNSELING. NO WHERE IS THE ISSUE OF EFFECTIVENESS ON THE TABLE HERE. EITHER WE ASSUME AS MUIN IMPLICITLY DID EARLIER WHICH IS, OF COURSE, IT IS IMPORTANT AND EFFECTIVE AND THAT IS WHY WE WANT TO DO IT. THE ISSUE IS TO WE NEED TO HAVE A PHYSICIAN SIGN OFF ON IT AND BILL UNDER HIS OR HER NAME OR ARE WE CORRECT -- AM I INCORRECT ON THIS.
MANY DON'T BILL FOR THAT REASON. THEY PROVIDE BUT DON'T BILL FOR THEM BECAUSE THE INSTITUTION DOESN'T BELIEVE THAT HE CAN BILL FOR THEM UNDER A PHYSICIAN. IT IS NOT AS SIMPLE AS WHETHER OR NOT IT IS UNDER A PHYSICIAN.
WHEN I WAS RUNNING THROUGH THIS SERVICE WE WENT THROUGH THAT DISCUSSION WHETHER WE WANTED TO CHARGE OR NOT.
BUT I WOULD SAY THAT IS THE LARGEST INTER PRA EXPECTATION CURRENTLY.
IT AND IT IS PARTLY UP TO CONGRESS BECAUSE IT IS MY UNDERSTANDING THE REASON WHY GENETIC COUNSELING -- THE REASON WHY IT IT IS NOT ACCEPTABLE FOR US TO BILL UNDER THE PHYSICIANS IS BECAUSE WE ARE NOT LISTED UNDER THE CBS. I FORGOT THE WORDING OF IT AS RECOGNIZED PROFESSIONS SO THAT IS ONE OF THE ISSUES.
IN THE CONTEXT OF THIS REPORT IT DOES SEEM REASONABLE FOR ONE OF THE GAPS THAT WE MIGHT IDENTIFY TO SAY THAT THERE ARE -- THERE IS A RANGE OF INTERPRA EXPECTATIONS AND THE -- INTERPRETATIONS AND THE BAR THAT ONE HAS TO ADDRESS. A PHYSICIAN IN THE SAME SUITE AND WHAT DOES IT MEAN TO BE SUPERVISING AND IS THAT FRANKLY WORTH THE DOLLARS LOST TO PROVIDE THE SUPER VISION VERSUS THE DOLLARS YOU MIGHT GAIN GETTING REIMBURSED FOR IT. IT IS RELEVANT FOR THIS COMMITTEE TO ADDRESS THAT PARTICULAR ISSUE BECAUSE THAT IS A REAL LIFE ISSUE THAT EVERY INSTITUTION GOES THRAO IN TRYING TO MEET THE BOTTOMLINE BUT TH ISSUE AND THE POINT I WAS MAKING, IT IS NOT A QUESTION OF IS GENETIC COUNSELING EFFECTIVE. THAT IS NOT PARTICULAR TO THE REIMBURSEMENT.
MUIN.
I'M NOT SURE HOW TO STAY THIS. WE ARE DEALING WITH REIMBURSEMENT ISSUES HERE AND WE ARE DEALING WITH THE ELEPHANT SITTING IN THE MIDDLE OF THE ROOM. AND I HEARD THAT THERE IS NOT ENOUGH COUNSELORS OUT THERE THAT CAN PROVIDE SERVICES TO PEOPLE WHO NEED THEM WITH GENETIC DISEASES. ON THE OTHER HAND, THOSE THAT DO PROVIDE THE SERVICES ARE NOT REIMBURSED FOR THEM SO WE HAVE A CATCH 22 HERE AND IF WE WERE TO COMMISSION AN OIM REPORT TO -- AN IOM REPORT TO EXAMINE THE ISSUES THEY WOULD GO ENOUGH TO A CORNER AROUND STUDY FOR TWO YEAR *RS AND GATHER DATA AND INFORMATION AND WRITE A BIG REPORT ON IT AND IT WOULD SEEM TO ME THAT THIS COMMITTEE WOULD BE SERVED BY COMMISSIONING A PAPER BY SOMEBODY OR EITHER A SMALLER SUBSET OF THE COMMITTEE OR GETTING SOMEBODY FROM THE OUTSIDE TO WRITE A REVIEW OF THE AVAILABLE LITERATURE AND HERE I MIGHT KIND OF DEFER A LITTLE BIT WITH YOUR, HUNT, ON THE -- I MEAN THERE ARE MANY NUANCES AROUND EFFECTIVENESS AND UTILITY OF GENETIC SERVICES AND COUNSELING AND YOU CAN DEFINE THAT ANY WAY YOU WANT. WE ALL HAPPEN TO THINK IT IS WONDERFUL AND USEFULFUL. THERE IS AN INHERENT BIAS THERE AND IF WE CAN THROUGH SYSTEMATIC REVIEWS OF THE LITERATURE PUTTING ALL THAT STUFF TOGETHER AND WITH WELL DEFINED OUTCOMES, I THINK AND I HEARD FROM ANDY THAT MAYBE THERE IS NOT -- OR FROM HER THAT THERE IS NOT ENOUGH OF THAT BEING PUT TOGETHER. I THINK THAT THIS COMMITTEE CAN GO A LONG WAY TO ADDRESS THE ISSUES OF COVERAGE AND REIMBURSEMENT FOR THESE SERVICES BY BEGINNING TO PULL THAT LITERATURE TOGETHER AND IDENTIFYING THE GAPS. ED YOU SAID EARLIER THAT IT IS COMPLETELY ETHICAL TO DO A STUDY IN THIS AREA AND I NEVER THOUGHT THAT IT WOULD BE ETHICAL TO HAVE 50 PEOPLE WITH THE SAME DISEASE AND PUT THEM INTO TWO GROUPS. 25 PEOPLE THAT YOU DON'T PROVIDE GENETIC COUNSELING FOR, JUST GIVE THEM A DIAGNOSIS OR DIFFERENT NUANCES. SUPERVISED VERSUS UNSUPERVISED. THERE IS MANY ISSUES THAT WE CAN TALK ABOUT BUT IF THE FUNDAMENTAL TENET THAT THESE SERVICES ARE USEFUL IN SOME FASHION IN TERMS OF OUTCOMES, EVEN PSYCHOLOGICAL, IT DOESN'T HAVE TO BE HEALTH THEN WHY AREN'T THEY REIMBURSED AND I THINK THIS COMMITTEE IS PLAYING THE CHICKEN AND EGG HERE. WE ARE IN A CATCH 22. SOMEBODY HAS TO TAKE THAT ON AND IF THE IOM TAKES IT ON THAT'S FINE BUT I THINK WE CAN DO A BIT OF MORE HOMEWORK FOR THE IOM BY PULLING THAT LITERATURE TOGETHER OUR SERVICE OR COMMISSIONING SOMEBODY TO DO IT.
I WASN'T INDICATEING THAT THE PLACEBO WOULD BE NO COUNSELING. WHAT I WAS SAYING WAS THAT IF WE CAN DO CONTROLLED CLINICAL TRIALS IN AN OPERATING ROOM WHERE THEY ARE COMPARING DIFFERENT APPROACHES WE COULD CERTAINLY LOOK AT DIFFERENT APPROACHES AND IDENTIFY WHAT IS THE BEST APPROACH HERE SO I THINK -- I THINK IT WAS MORE A -- A -- IT HAS BEEN UNHEARD OF TO DO CLINICAL TRIALS IN SURGERY BECAUSE EVERY SURGERY WAS DIFFERENT BUT PEOPLE ARE BEGINNING TO DO THOSE NOW.
REED?
I THINK WE OBVIOUSLY WE NEED TO MOVE THIS FORWARD AND I THINK MUIN'S RECOMMENDATION GETS AT WHAT WE NEED TO DO. I WOULD SPEAK IN SUPPORT OF IT. AS I UNDERSTAND IT WHAT IT ACCOMPLISHES IS IT ALLOWS US HAVE TO THE RECOMMENDATION THAT IS ON THE BOARD FOR NOW. ALLOWS US TO DO IS TO PUSH THAT RECOMMENDATION FORWARD WITH A DEFINITIVE CONCRETE ACTION THAT WE CAN SKETCH OUT THE ACTUAL PAPER, THE STUDY, THE ACCUMULATION OF DATA AND ANALYSIS THAT WE LOOK FOR AND DO THAT LITTLE BIT OF DETAIL OFFLINE BUT ALLOWS US HAVE TO SOMETHING DEFINITIVE AND PREPARED FOR US BY THE TIME WE SET DOWN AGAIN AND THEREBY PUTS AN URGENCY TOWARDS MOVING FORWARD AND GETS US OFF THE TIME TODAY BECAUSE WE CAN'T SOLVE THIS PROBLEM TODAY BECAUSE WE DON'T KNOW ENOUGH TO BE ABLE TO SOLVE IT.
WOULD YOU TWO BE WILLING TO WORK TOGETHER TO PROVIDE AND WORK WITH STAFF TO PROVIDE AS MUCH OF THIS LITERATURE AND SOME SORT OF SUMMATION FORM WITH THE PAPERS?
ABSOLUTELY.
TO THE COMMITTEE.
YES.
BY SOME POINT?
ABSOLUTELY.
IT WOULDN'T BE THE NEXT MEETING, PROBABLY SLIGHTLY BEFORE.
YES.
AS WELL AS THEN I DON'T KNOW WEATHER JUDITH COOKSY CAN PROVIDE INFORMATION ON THE HERSA STUDY BUT THOSE TWO SOURCES WE KNOW ARE OUT THERE AND CAN BE USED TO INFORM OUR DISCUSSION NEXT TIME TO MAYBE BE ABLE TO MAKE MORE DEFINITIVE REQUESTS.
AS I HEAR DEBRA'S POINT IS THAT THE PROJECT LEADER FOR THIS -- I THINK THAT STILL FITS, CINDY, WITHIN YOUR TEAM ( LAUGHTER ). AND CINDY, I THINK THAT YOUR TEAM IS TAKING RESPONSIBILITY FOR PULLING THAT PAPER TOGETHER. I THINK WHAT WE HAVE GOTTEN IS A COMMITMENT ON THE PART OF TWO MAJOR STAKEHOLDERS TO BE AT THE FOREFRONT OF HELPING US TO SHAPE THAT PAPER PROVIDING INFORMATION, GUIDANCE AND SO FORTH. NOT EXCLUSIVELY THOSE TWO BUT OTHERS THAT WILL PROBABLY BE ADDED TO YOU BUT YOU ARE TRULY THE TWO LYNCHPINS IN ALL OF THIS AND I THINK WE REALLY APPRECIATE YOUR WILLINGNESS TO DO THAT AND LET THE COMMITTEE UNDER CINDY'S LEADERSHIP DETERMINE OTHERS THAT NEED TO BE INVOLVED. MUIN, IF YOU ARE NOT ON THE COMMITTEE YOU ARE TASKED TO PROVIDE HELP
AGNES?
I THINK, TOO, THAT MAYBE WHAT WE COULD ALSO DO IS ASK THE NATIONAL SOCIETY OF NURSES AND GENETICS. I KNOW THAT THEY WERE KEEPING A RUNNING LIST OF ALL THE STUDIES AND LITERATURES DONE BY NURSES IN THE FIELD OF GENETICS SO THAT MAY ALSO ADD TO THIS.
CAN I PROPOSE THAT WE LEAVE THESE THREE RECOMMENDATIONS AS IS WITH THE UNDERSTANDING THAT WE GOING TO BE IN THE PROCESS OF COLLECTING INFORMATION FROM THE UNTILINGS HERE TODAY, FROM OTHER ORGANIZATIONS, ANALYZING THAT, TALKING TO HERSA AND FINDING OUT THE STATUS OF THEIR REPORT AND WE MAY AFTER THAT BE IN A POSITION TO PROPOSE SOME CHANGES TO THESE RECOMMENDATIONS IN ADDITION TO THE SUBSTANCE OF THE REPORT WHERE THESE RECOMMENDATIONS ARE FOUND?
SOUNDS GOOD TO ME. TERRIFIC. THANKS TO BOTH OF YOU FOR STEPPING UP TO THE PLATE LIKE THAT ON NO NOTICE.
MOVING TO THE CLINICAL LABORATORY FEE SCHEDULE ISSUE. WE HAVE HEARD TIME AND TIME AGAIN FROM THE PUB LIVE AND FROM OTHER -- PUBLIC AND FROM OTHER STAKE HOLDSER THAT OFTEN TIMES THE COSTS OF PROVIDING THESE TESTS EXCEED WHAT MEDICARE WILL PAY AND REMEMBER WE ARE STILL IN THE CONTEXT OF THE MEDICARE PROGRAM. LAB FEES AS WE HAVE HEARD PREVIOUSLY ARE FROZEN. SO THERE IS THE REAL DANGER THAT FOR THE FORESEEABLE FUTURE WE WILL HAVE THIS -- THIS GAP BETWEEN WHAT IT COSTS TO PROVIDE THESE TESTS AND WHAT A LAB CAN BE REIMBURSED, THEREBY PROVIDING A DISINCENTIVE FOR THE PROVISION OF THESE SERVICES. THIS RECOMMENDATION IS NOT WITHOUT CONTROVERSY. THE IDEA WAS TO SET UP SOME SORT OF TEMPORARY MECHANISM FOR ADDRESSING SOME EXTREME DISCREPANCIES BETWEEN THE COST OF DELIVERING THE SERVICE, THE TESTS AND WHAT MEDICARE WILL PAY. THIS IS THE INHERENT REASONABLENESS CAPABILITY, I SUPPOSE, FOR LACK OF A BETTER TERM THAT CMS COULD EXERCISE. BUT THERE ARE SOME CONCERNS WITH USING THIS APPROACH. IS ANYTHING REALLY TEMPORARY? SOME PEOPLE WOULD VIEW THIS AS A SLIPPERY SLOPE. IS THIS A DANGEROUS COURSE TO TAKE? IT WAS THE ONLY RECOMMENDATION THAT SURFACED TO ADDRESS THIS PROBLEM GIVEN THE FACT THAT WE DO HAVE A FREEZE AND PAYMENT RATES SET BY LAW ARE DIFFICULT TO CHANGE. SO, WE WOULD BE VERY INTERESTED IN HEARING FROM INDIVIDUALS WHO ARE MOST DIRECTLY AFFECTED BY THIS AS TO WHAT THE THINKING IS ON THIS SORT OF TEMPORARY APPROACH TO ADDRESSING SOME OF THE MOST EXTREME CASES. DEBRA.
I FOUND VERY INTERESTING THE ARTICLE PROVIDED TO US I BELIEVE BY AZMED BY GREGORY ROBB AND JOAN LOW AND IT IS ASOUNDING TO ME TO LOOK AT SOME OF THE DISCREME NANCIES THAT EBBSIST ACROSS THE BOARD IN THE LABORATORY FEE SCHEDULE AS IMPLEMENTED ON A STATE LEVEL. AND THEY HAD SOME RECOMMENDATIONS AT THE END OF THEIR ARTICLE THEY WOULD BE MORE GENETIC THAN JUST GENETICS. IF WE WANT TO DO THE INHERENT REASONABLENESS NOR GENETIC TIFTS WE ARE TALKING ABOUT 14 CODE IS. CPT CODES, BILLING CODES AND THE REIMBURSEMENTS FOR THOSE. THIS WOULD BE A MUCH MORE LIMITED AND DIRECTED EFFORT THAT MAY BE POSSIBLE TO ACCOMPLISH. I JUST DON'T KNOW WHETHER CMS IS WILLING TO LOOK AT JUST THOSE 14 CODES IN THE ABSENCE OF LOOKING AT THE ENTIRE LABORATORY FEE SCHEDULE WHICH IS A DISASTER, WELL, IT IS NOT VERY GOOD AND HASN'T BEEN LOOKED AT FOR A VERY LONG TIME. CMS THE LAST TIME THEY WERE HERE SAID THAT IT IS THE OLDEST FEE SCHEDULE IN EXISTENCES.
EMILY?
I WONDER IF WE COULDN'T BE A LITTLE BIT MORE FIRM IN OUR RECOMMENDATION RATHER THAN JUST SORT OF ASKING CMS TO LOOK AT THIS AGAIN UNDER INHERENT REASONABLENESS TO SAY SPECIFICALLY THAT WE BELIEVE ALLSTATES SHOULD BE REIMBURSING AT THE NATIONAL LEVEL TODAY. SO THAT WE DON'T HAVE UNEVEN PLAYING FIELD AMONG THE 50 STATES WHERE WE KNOW THAT REIMBURSEMENT IS SOMEONE EVEN THE NATIONAL PAYMENT SCHEDULE IS NOT REALLY COVERING COSTS AND I DON'T KNOW IF WE HAVE THE FLEXIBILITY AS AN HHS COMMITTEE TO TRY AND TELL STATES HOW TO IMPLEMENT MEDICARE PRO PROGRAMS BUT I OF INHERENT UNREASONABLENESS THAT WE SEE WHEN WE ASK OUR LAB COLLEAGUES TO COME AND TALK TO US ABOUT YOU KNOW, IT SEEMS CAPRICIOUS AND ARBITRARY.
THIS IS IN THE MEDICARE SECTION. THERE ISN'T ANY DEVIATION, IS THERE AT THE STATE LEVEL FOR MEDICARE REIMBURSEMENT?
HOW IS IT THAT MEDICARE WOULDN'T BE DIRECTLY PAYING?
THERE IS NATIONAL -- A NATIONAL LIMIT FOR EACH CPT CODE AND THEN LOCAL CARRIERS HAVE THE DISCRETION TO PAY UP TO THAT NATIONAL LIMIT BUT CERTAINLY IT CAN BE LOWER THAN THE NATIONAL LIMIT AND SO THAT IS WHERE THE STATE VAIR YITION OR THE LOCAL CARRIER VAIR VARIATION COMES IN.
OKAY. ED?
ACTUALLY, AS -- FROM WHAT I KNOW, IT IS NOT COMPLETELY BY STATE BUT MORE BY EARRING. REGION.
REGION.
IS THE WAY THE LOCAL CARRIERS ARE BUT THERE IS QUITE A BIT OF VARIATION FROM ONE CARRIER TO ANOTHER. ONE CARRIER MAY DENY SERVICES THAT ANOTHER FINDS QUITE REASONABLE. I THINK THE SYSTEM OF THIS INHERENT REASONABLENESS WHILE IF SOUNDS LIKE A BIZARRE BUREAUCRATIC TERM IS IN FACT A MECHANISM FOR TRYING TO ADDRESS THE LACK OF UNIFORMITY FROM REGION TO REGION SO WHILE IT SOUNDS BUREAUCRATESE, IT IS BUREAUCRATESE BUT IT IS THE WAY THE PAYMENTS WORK AND THE WAY THE APPROVALS ARE SET SO I THINK IT AS FAIRLY CONCRETE APPROACH TO ADDRESS A PROBLEM AND NEED.
DEBRA?
BUT WHEN YOU DO THIS PROCESS I DON'T UNDERSTAND IT WELL ENOUGH TO KNOW WHAT THE IMPACT IS BECAUSE THIS WOULD BE A NATIONAL DECISION AND SO I DON'T KNOW WHAT IMPACT THAT WOULD ACTUALLY HAVE IN PRACTICE AT THE STATE AND LOCAL LEVEL.
I GUESS THAT WAS MY CONCERN THAT IF EVEN TODAY WITH A NATIONAL COVERAGE AMOUNT THAT IS NOT TAKEN UP BY ALL REGIONS, YOU KNOW, AND WE ALL KNOW THAT EVEN IF YOU GOT REIMBURSED FULLY FOR EVERY TEST AT THE NATIONAL COVERAGE AMOUNT THAT YOU'RE NOT MAKE ANYTHING MONEY DELIVERING THESE SERVICES, SO, YOU KNOW, IT IS A QUESTION OF HOW MUCH OF THE LABS LOSING MONEY EVERY TIME THAT THEY DELIVER TEST RESULTS? THE LEAST WE COULD DO IS ASK THE STATES OR REGIONS OR WHATEVER TO STEP UP AND BE REASONABLE.
WOULDN'T IT BE THAT CMS WOULD ISSUE A GUIDANCE TO THE CARRIERS THAT WOULD ASSIST IN THE IMPLEMENTATION OF A MORE FAIR FEE SCHEDULE FOR -- IN OTHER WORDS, THE GOAL WOULD BE TO ELIMINATE THE GREAT VARIATION THAT WOULD EXIST BETWEEN REGIONS AND IT WOULD BE DONE THROUGH A GUIDANCE ISSUED BY CMS? ED?
C M SMD S ISN'T HERE SO WE ARE -- LEFT A LITTLE BIT IN THE DARK. I DON'T THINK CMS IS HERE.
OH, YES.
OH, DR. ROLLINS, YES, PLEASE.
JIM ROLLINS, MEDICAL OFFICER, CMS.
COULD YOU HELP US UNDERSTAND WHAT THE IMPACT OF THIS WOULD BE? MY UNDERSTANDING IS THAT IT WOULD PROVIDE A CENTRAL GUIDANCE, IT WOULD STILL BE UP TO THE LOCAL CARRIERS AS TO WHETHER THEY PURSUED THAT BUT BY GIVING IT SOME INCREASED VISIBILITY AT THE FEDERAL LEVEL THERE MIGHT BE AN IMPACT IN -- BY THE LOCAL CARRIERS. COULD YOU CLARIFY THAT, PLEASE. IN.
THAT'S CORRECT. ESSENTIALLY THE LOCAL CARRIERS HAVE THE DISCRETION TO MAKE A DECISION BASED ON WHAT THEY FEEL IS REASONABLE. AND BE SOME DISCREPANCIES COMPARING ONE REGION TO ANOTHER. AND TO MAKE THE REQUEST THAT CMS REVIEW THE EXTREMES IN TERMS OF VARIATION I THINK IS A REASONABLE REQUEST FOR SOMETHING FOR CMS TO EVALUATE.
DEBRA, DID YOU HAVE A COMMENT? I SAW YOUR HAND GO UP.
AND IT IS OKAY TO JUST LOOK AT THE 14 CODES THAT RELATE TO GENETIC TESTING AND IGNORE THE REST OF THE LABORATORY FEE SCHEDULE? THAT'S OKAY?
I THINK, YEAH, RESTRICTING IT TO THE 14 CODES IS A REASONABLE REQUEST.
OKAY.
ANY OTHER COMMENT? ED?
MADAME CHAIR PERSON COULD WE INVITE DOCTOR ROLLINS TO SIT AT THE TABLE SO THAT WE CAN HAVE HIS COUNSEL IN FUTURE DISCUSSIONS?
ABSOLUTELY.
I WOULD BE GLAD TO, THANK YOU.
I THINK THERE IS A SPOT FOR CMS AT THE TABLE.
IF THERE ARE NO OBJECTIONS, SHOULD WE CLOSE THIS ONE OUT, LEAVE THE RECOMMENDATION AS IS OR WORDING THAT ANY ONE WOULD LIKE TO THE NEXT SECTION? DEBRA?
I -- I WOULD LIKE TO MAKE IT A LITTLE MORE FORCEFUL AND NOT CMS TO DETERMINE WHETHER FEES SHOULD BE CHANGED BUT BUT TO BASICALLY ASK CMS TO USE THE INHERENT REASONABLENESS TO LOOK AT THE CPT CODES AND REIMBURSEMENT THAT ARE USED IN GENETIC TESTING AND ASSURE THAT THE CURRENT REIMBURSEMENT LEVEL AT LEAST COVERS COST. THAT WOULD WOULD REQUIRE INPUT ON WHAT IT COSTS TO DO THE TESTING, BUT RIGHT NOW IT DOESN'T COVER COST.
CAN WE CAPTURE THE WHOLE LOCAL VERSUS NATIONAL ISSUE SOMEHOW ON THAT, TOO? TO ENCOURAGE ALL LOCAL PROVIDERS TO COME UP TO THE NATIONAL LEVEL?
SOMETHING TO THE EFFECT THAT CMS OR THAT WE ARE DIRECTING CMS OR REQUESTING CMS TO USE INHERENT REASONABLENESS TO EXAMINE THE VARIATION IN PAYMENT RATES OR REIMBURSEMENT RATES FOR GENETIC TEST LABORATORY FEES AND -- WITH THE VIEW TOWARDS ENSURING THAT THE REIMBURSEMENT LEVEL IN ALL REGIONS OF THE COUNTRY AT LEAST COVER COSTS, SOMETHING LIKE THAT?
I -- I DON'T KNOW -- I JUST -- THIS IS PROBABLY A MINORITY VIEW ON THIS. I THINK WE WANT TO BE CAREFUL. SOMETIMES WE HAVE A BIAS AS IT WERE ABOUT SOMETHING IN THIS CASE I THINK WE TIEWT -- I THINK WE OUGHT TO BE SIGNALING THAT WE HAVE A CONCERN ABOUT THIS AND IT NEEDS TO BE STUDIED IN A CLEAR AND DISPASSIONIATE WAY BECAUSE WE ARE TALKING ABOUT MONEY AND DA-DA. FOR US TO CONCLUDE THAT WHAT WE WANT IS -- THIS SORT OF SIGNALS THE WAY IT STANDS IS THAT WE EXPECT THEM TO PAY MORE MONEYND I THINK WE NEED TO BE A LITTLE MORE CAREFUL ABOUT BEING TOO PASSIONIATE ABOUT THAT AND LET THEM DO THEIR WORK AND SEE WHERE IT COMES.
I THINK THAT THE REQUEST IN TERMS OF WHAT IS CURRENTLY ON THE BOARD IS VERY REASONABLE. I THINK THAT TO GO BEYOND THAT IS SOMETHING THAT I -- I MYSELF FEEL THAT I COULD NOT MAKE THAT COMMITMENT BUT I DO THINK THAT THAT IS SOMETHING THAT WOULD BE STUDIED AND IF IT WAS MELT THAT THERE WAS A MARKED DISCREPANCY AND NEEDED TO BE ADDRESSED THEN THAT IS SOMETHING THAT CMS WOULD ADDRESS IN THE FEATURE.
I GUESS WHAT I WANTED IS THAT IF THERE IS A DISCREPANCY FOUND THAT THEY FIX IT. BECAUSE THEY COULD DO ALL THE STUDIES IN THE WORLD AND SAY, YEP IT'S BROKEN AND THERE WE WOULD STILL SIT.
AND I WOULD RESPOND AND SAY I HOPE THAT CORRECT THAT, YOU KNOW, CORRECTIVE MEASURES WOULD BE PUT IN PLACE.
THAT WE ARE MAKING ADEQUATELY THE CASE PRIOR TO THIS RECOMMENDATION THAT IN FACT THERE HAS BEEN A HARM AND A FOUL. SO OTHER THAN WHAT I ACCEPT FULLY WHICH IS THAT LABORATORIES HAVE A TOUGH TIME MAKING ENDS MEET AND THEY ARE UNDER BUDGETARY PRESSURE, ET CETERA, ET CETERA, ET CETERA, FROM THE SECRETARY STANDPOINT I'M NOT SURE THAT IS HIGH ON HIS PERSONAL AGENDA UNLESS WE CAN ARGUE THAT BECAUSE LABORATORIES ARE UNDERREIMBURSTED OR IF IT IS FOUND THAT THEY ARE UNDER REIMBURSED THAT HAS AN EFFECT ON HEALTH IN THE COUNTRY AND THE HEFT TESTS ARE NOT BEING TAKEN ADVANTAGE OF. UNLESS WE MAKE THAT CASE I'M NOT SURE THE SIMPLE ISSUE OF WE WANT GENETICISTS AND PATHOLOGISTS TO MAKE THE MONEY ANY COULD LIKE TO MAKE, I'M NOT SURE THAT WOULD RESONATE TERRIBLY WELL NO MATTER HOW WELL IT IS STATED.
WE COULD TAKE A 5 HOW TO FOOT VIEW ON THIS IS IF WE ARE MOVING TOWARDS GENOMIC MEDICINE THEN IT IS A BIG PROBLEM THAT LABORATORIES DON'T GET EVEN PAID WHAT IT COSTS TO DO THE TESTING.
EMILY?
I THINK WE HAVE HEARD SOME TESTIMONY BEFORE THIS COMMITTEE AND WE HAVE ANOTHER COMMENTARY IN HERE FROM LAB CORE WHICH IS ONE OF THE LARGEST REFERENCE LABS IN THE COUNTRY THAT IT IS A PROBLEM AND THAT THE CHOICE THEY HAVE IS TO BILL THE PATIENT FOR THE DIFFERENCE AND I DON'T THINK IT IS TOO BIG A LACK OF FAITH TO TAKE THAT JUMP THAT SOME PATIENTS WON'T BE ABLE TO PAY THAT.
I PERSONALLY DON'T DISAGREE. I'M SUGGESTING THE COMMITTEE NEEDS TO CONNECT THOSE DAWTS IN THE REPORT SO IT DOESN'T SEEM LIKE JUST A REQUEST FOR MORE MONEY FOR THOSE PROVIDING THE TESTS, THAT'S ALL.
WE CAN PERHAPS TAKE A LOOK AGAIN AT THE LANGUAGE IN THE SUBSTANCE OF THE REPORT JUST TO MAKE SURE THAT IT FORCEFULLY ENOUGH STATES THE CASE THAT YOU ARE ARTICULATING, HUNT, THAT WE ARE NOT JUST CALLING FOR A CHANGE IN REIMBURSEMENT JUST FOR GIGGLES, I MEAN THERE IS A COMPELLING NEED THERE RELATED TO ACCESS AND IT FALLS WITHIN THE REIMBURSEMENT CHARGE THAT WE HAVE IN DOING THIS REPORT SO WE WILL TAKE A LOOK AT THAT, BEEF IT UP IF NECESSARY AND THAT WILL BE PRESENTED TO EVERYONE, ONCE AGAIN. JUST TO TIE THIS UP WE FLOATED SOME LANGUAGE BUT IT SOUNDED LIKE DR. ROLLINS WAS UNCOMFORTABLE WITH THE REVISED VERSION. SHOULD WE GO BACK TO THE RECOMMENDATION AS CURRENTLY STATED OR ARE THERE SOME TWEAKS THAT WOULD STILL STATE WHAT WE NEED TO ACCOMPLISH AND CMS WOULD NEVERTHELESS BE COMFORTABLE WITH IT? WE DON'T WANT TO RECOMMEND SOMETHING THAT IS JUST NOT GOING TO BE IMPLEMENTED AND THAT WILL PRODUCE NO BENEFIT AT ALL SO. ED?
I THINK WE HEARD THAT CMS WOULD BE MOST COMFORTABLE WITH THE LANGUAGE AS IT IS ON THE BOARD. I THINK WE COULD PUT THE RHETORIC INTO THE TEXT AND NOT OF THE RECOMMENDATION BUT OF THE LOGIC THAT CONCERN HAS BEEN EXPRESSED TO THIS COMMITTEE REGARDING THE ABILITY FOR THE LABORATORY TO MEET ITS EXPENSES, SOMETHING TO THAT EFFECT. I WOULD PUT THE RHETORIC IN THE REPORT AND LEAVE THE RECOMMENDATION FAIRLY DISPASSIONIATE.
ANY OBJECTIONS? ALL RIGHT. LET'S MOVE ON TO MEDICARE AND.
COULD WE GO BACK ONE SECOND. YOU MAY JUST WANT TO SAY IN THERE SO THAT YOU ARE DEFINING THE -- IS THAT TO LOOK AT THE SPECIFIC CPT CODE. I MEAN -- NO, NO, NO, NOT THAT EXISTS BUT THE ONES THAT DO EXIST SO YOU ARE NOT TALKING ABOUT -- WELL, MAYBE THAT IS IMPLIED BY GENETIC TEST LABORATORY FEES. BUT IT IS A LIMITED SCOPE THAT WE ARE ASKING THEM TO LOOK AT.
EXISTING CPT CODES OR WHATEVER. I DON'T -- MAYBE -- NEVER MIND.
OKAY. WE WILL FIX THAT. MEDICARE S-CHIP BARRIERS. OF COURSE, THERE IS A GREAT DEAL OF VARIETY FROM STATE TO STATES BECAUSE EACH STATE HAS ITS OWN PROGRAMS WITH RECORD TO MEDICAID AND CHILDREN'S HEALTH INSURANCE AND THERE ARE SOME REPORTS THAT WE HAVE HEARD ABOUT WITH REGARD TO INSTABILITY IN COVERAGE FOR GENETIC SERVICES, STATES ARE HAVING DIFFICULTY BALANCE THEIR BUDGETS SO WE HAVE TWO RECOMMENDATIONS TO PROPOSE FOR THE COMMITTEE'S CONSIDERATION. ONE WOULD BE REALLY AN INFORMATION DISSEM I NATION FUNCTION FOR CMS THAT STATES COULD BENEFIT BY HHS PROVIDING THE STATES WITH INFORMATION, THE BEST INFORMATION ESTABLISHING THE SOLID FOUNDATION AND EVIDENCE BASE FOR COVERING AND PROVIDING GENETIC SERVICES. THE IDEA BEING THAT IF PRESENTED WITH THIS INFORMATION THAT THEY MAY OR MAY NOT ALREADY HAVE THE STATES WOULD BE MORE LIKELY TO COVER THESE SERVICES IN THE PROGRAMS THAT THEY IMPLEMENT. THE SECOND RECOMMENDATION IS A LITTLE BIT MORE OF A CARROT WHICH WOULD BE TO PROVIDE STATES WITH ACTUAL INCENTIVES, PRESUMABLY FINANCIAL INCENTIVES TO COVER GENETIC SERVICES THAT ARE WARRANTED BY THE EVIDENCE BASE. THAT IS A LITTLE BIT MORE DIFFICULT BECAUSE IT MOVES MONEY THAT MAY NOT BE THERE BUT THOSE RT TWO POTENTIAL -- THOSE ARE THE TWO POTENTIAL RECOMMENDATIONS FOR ENCOURAGING STATES TO PROVIDE THESE SERVICES AND COVERING THESE SERVICES RECOGNIZING THAT WE REALLY AREN'T IN A POSITION TO MANDATE THAT THESE SERVICES BE COVERED. DOES ANY ONE HAVE ANY COMMENTS ON THESE POTENTIAL RECOMMENDATIONS? LIKE THEM. IN HATE THEM? REVISIONS? DEBRA?
DO WE HAVE AN IDEA OF WHERE THIS EVIDENCE BASE IS COMING FROM? I MEAN MAYBE WE SHOULD PUT E.G.E-GAP OR OTHER HHS INITIATIVES THAT MAY INFORM -- WHAT IS GOING TO BE PROVIDED TO STATE IS AS EXAMPLES? AND MAYBE HHS REPRESENTATIVES COULD INFORM US ABOUT WHICH PROGRAMS TO PUT THERE AS EXAMPLES THAT COULD INFORM THIS.
BARBRA.
AND THEN TO ADD TO THAT, WHATEVER THEY ARE ABLE TO UNCOVER ABOUT GENETIC COUNSELING SPECIFICALLY. THAT TENDS TO BE A GREAT CHALLENGE WITH MEDICARE OR MEDICAID RATHER.
I GUESS I'M A LITTLE CONFUSED ON THIS ONE IN TERMS OF IT INCENTIVES BUSINESS. WE A 50KATRILLION DOLLAR DEFICIT AND HHS -- BOY, I'M JUST TRYING TO FIGURE OUT WHAT WOULD BE THE FINANCIAL INCENTIVES THAT THEY WOULD -- HOW WOULD THEY THINK THROUGH THAT? WHAT DO YOU DO WHEN YOU GET THIS RECOMMENDATION? EITHER IF YOU JUST HAVE A SOUND EVIDENCE BASE BUT IS IT A PRIORITY? I MEAN DO YOU -- DO YOU PROVIDE THE INCENTIVE FOR THIS AND NOT THE FIRST TRIMESS TER PRENATAL CARE CHAINIC IN DELTA MISSISSIPPI? HOW ARE YOU CANNING THEM TO THINK THIS -- HOW ARE YOU ASKING THEM TO THINK THIS THROUGH. THERE IS NO NEW MONEY SO THEY HAVE TO TAKE IT FROM SOME ARE WITH.
I THROW THIS OUT THERE BECAUSE IT HAS WORKED IN THE PAST. MY OWN VIEW IS IT IS NOT A RECOMMENDATION IN TERMS OF THE CURRENT BUDGET. WE COULD USING PRECEDENT RECOMMEND THAT THERE BE SOME SORT OF GRANT PROGRAM. I KNOW THAT THE SECRETARY HAS ISSUED GRANTS FOR INFORMATION TECHNOLOGY, FOR EXAMPLE, UNRELATED TO THIS, OF COURSE. BUT THERE CAN BE STATES AND LOCAL COMMUNITIES THAT WOULD BENEFIT FROM A GRANT THAT WOULD PROVIDE AN INCENTIVE TO OFFER THESE SERVICES AND AGAIN WE WOULD HAVE TO ANSWER YOUR QUESTION WHICH IS RIGHT ON OF COURSE, REED, WHICH IS DOES THIS RISE TO THAT PRIORITY LEVEL GIVEN ALL OF THE OTHER SERVICES AND NEEDS THAT ARE OUT THERE. EMILY?
SO I GUESS I HAVE A LITTLE -- EXCUSE ME -- A LITTLE PROBLEM WITH RECOMMENDING GRANTS WHEN WE DON'T EVEN HAVE A STANDARDIZED NEW BORN SCREENING PROGRAM WHICH WE KNOW WORKS AND WE KNOW THERE IS A LOT OF EVIDENCE THAT THAT PAYS ITSELF BACK. AND WE AS A COUNTRY HAVE NOT BEEN SUCCESSFUL IN TAKING SOME KIND OF A NATIONAL MINIMUM STANDARD APPROACH AND DISSEMINATING THAT OUT. RIGHT NOW WE ARE BEING EMBARRASSED BY THE MARCH OF DIMES INTO TRYING TO DO THAT BUT THEY ARE REALLY LEADING THE CHARGE NOT -- YOU KNOW, NOT THE FEDERAL GOVERNMENT. YOU KNOW, I WOULD -- I WOULD FEEL COMFORTABLE WITH US SAYING THAT, YOU KNOW, WHEN STUFF GETS TO A CERTAIN LEVEL OF EVIDENCE WHATEVER THAT IS, THAT THEN THAT INFORMATION SHOULD BE DISSEMINATED TO THE STATES AND THE RECOMMENDATION FROM THE FEDERAL LEVEL SHOULD BE THAT ALL STATE PROGRAMS ADOPT THAT. WHETHER THEY ARE ABLE TO ADOPT IT IMMEDIATELY OR THEY HAVE TO THINK ABOUT WHAT THE TRADEOFFS ARE WITHIN THEIR WUTH BUDGET, YOU KNOW -- BUDGET, YOU KNOW, I DON'T THINK WE CAN REALLY A PROPOSE ANYTHING MORE THAN GUIDANCE TO THE STATES. YOU KNOW, I DON'T KNOW -- MAYBE SUZANNE, DO YOU HAVE MORE INFORMATION ABOUT ARE THERE ANY GRANTS FOR NEWBORN SCREENING OR ANY OTHER KIND OF UNDERWRITING FOR BASIC PROGRAMS LIKE THAT?
THOSE -- THAT IS PART OF THE -- FROM MCHB FOR '05 AND WHAT THEY HAVE DONE IN '04. ALSO AND REED TUCKSON IS OUR REPRESENTATIVE FROM THIS GROUP FROM THE COMMITTEE AND INHERITABLE DISORDERS AND GENETIC DISEASES IN NEW BORNS AND CHILDREN AND THAT REPORT IS THAT THE MY UNDERSTANDING ITING SPECIFICALLY ADVICE THE SECRETARY REGARDING THE UNIVERSAL NEW BORN TECHNOLOGY TESTS AND SCREENING PROGRAMS.
THE GOOD NEWS IS THAT I HAVE BEEN MERCIFULL FIRED FROM THAT COMMITTEE AND NEW REPRESENTATION HAS BEEN FOUND. WHO IS THE PERSON THAT -- IT IS IMPORTANT ACTUALLY THAT YOU NODE TOO KNOW THAT WE UPGRADED OUR SPREPTH STRENGTH ON OUR TEAM.
WE HAVEN'T ASKED HIM YET SO MAYBE WE SHOULD NOT SAY.
IN PROCESS AND HE WHO IT IS THAT WILL BE DOING IT EVEN THOUGH HE DON'T NOT KNOW IT YET WE THANK HIM FOR IT AND HE IS BETTER THAN I AM. A POINT THAT WE HAVE ON THE TABLE. THANK HIM, SARA. ASK HIM AT THE BREAK TO WE CAN ANNOUNCE IT, WILL YOU? HE'S ALREADY AGREED.
I THINK WITH THE ISSUES ON THE TABLE AS I UNDERSTAND IT IS FIRST WE HAVE GOT ENORMOUS STATE VARIABILITY IN TERMS OF OF VARIOUS MANDATES FOR PROGRAMS AND IT DRIVES ANY ONE NUTS BECAUSE THEY ARE ALL -- THE EVIDENCE IS THERE OR ISN'T THERE AND YOU HAVE ALL THIS UP AND DOWN ALL OVER THE STATES. WE HAVE CLEARLY GOT HERE THE IDEA THAT THERE IS SASS AS A PRIORITY OF GENETIC OR SINCE WE PUT S-CHIP THERE WHICH MEANS THE CHILDREN IS THAT YOU HAVE GOT THE NEW BORN SCREENING ACT WHICH IS ALL OVER THE PLACE AND WHAT YOU SAID AND WHAT YOU WILL HEAR IS THAT YOU WILL SEE THAT EVERY STATE, IT IS CALL A COMPLETE MISHMOSH OF WHAT KIDS ARE GETTING ACCESS TO OR NOT. THEY ARE TRYING TO RATIONALIZE AND SCREEN THAT OUT. THAT MIGHT BE A PLACE TO START. THE FINAL THING AS A PERSPECTIVE FOR YOUR COMMITTEE IS ONE OF THE THINGS WE OUGHT TO BE CALLING FOR PROVIDING IS SOME SENSE OF A COMMON EVIDENCE BASIS THAT CAN INFORM THE DECISIONS THAT PEOPLE MAKE AS OPPOSED TO SAYING YOU OUT TO PROVIDE INCENTIVES FOR COVERING THINGS THAT HAVE AN EVIDENCE BASIS, THAT THERE ARE DECISIONS THAT PEOPLE HAVE TO MAKE BASED ON PRIORITIES. THE ONLY WAY THIS WILL MAKE SENSE TO THE READERS IS IF WE GIVE TANGIBLE EXAMPLES OF THE THINGS WE ARE TALKING ABOUT HERE.
NCHB LAST YEAR PROVIDED FUNDING LAST FOR REGIONAL NEW BORN SCREENING AND COLLABORATE IVES AND AND SEVERAL WERE FUNDED LOCATED THROUGH THE NATIONAL COLLEGE OF GENETICS. IS IT IS RECOGNITION OF THE ISSUES YOU ARE SAYING ABOUT THAT FUNDING IS IN ORDER TO TRY TO ADDRESS THE ISSUES THAT YOU ARE TALKING ABOUT AND AGAIN THAT IS RESPONDING TO THE FACT THAT NCHB IS FOUNDING THESE TYPES OF EFFORTS.
ED M. D.
AND JICHD HAS RECENT -- NICHD HAS BEGUN AN INITIATIVE IN NEW BORN SCREENING AND RECRUITED THE FORMER CHAIR OF THE UNIVERSITY OF MIAMI ROD HOW HOWLE TO TAKE THAT ON. THIS A A BROADENING AND RECOGNITION IN HHS WITH THE IMPORTANCE OF NEW BORN SCREENING AND WITH TWO AGENCIES TAKING AN ACTIVE -- ACTUALLY, THREE, BECAUSE CDC HAS FOR A LONG TIME HAD QUALITY ASSURANCE ACTIVITIES THERE SO I THINK AND THERE MAY BE OTHERS WHO I'M NOT MENTIONING BUT I THINK THERE IS A BROADENING RECOGNITION THAT NEW BORN SCREENING AS WE HAVE HEARD BEFORE WILL BE THE LEADING GENETIC TESTING FOR THE NEXT DECADE. MOST LIKELY WITH FOUR MILLION BABIES BORN EVERY YEAR AND EVERY BABY HAVING SOME WHERE BETWEEN FOUR AND 30 PLUS TESTS THIS IS A HUGE GENETIC TESTING UNDERTAKING AND CERTAINLY NEEDS TO -- NEEDS TO BE STANDARDIZED.
DO WE WANT TO MAKE A SPECIFIC COMMENT THAT WE SU SPORT CURRENT EFFORTS UNDERWAY TO ACHIEVE A STANDARDIZED LEVEL OF OR NATIONALIZED LEVEL OF NEW BORN SCREENING AS, YOU KNOW, A GOOD STARTING POINT FOR THAT?
NOT TO -- NOT TO GET INTO TURF ISSUES BUT I THINK IT IS A BIT OF A TURF ISSUE. THERE IS ANOTHER SECRETARY'SED ADVISORY COMMITTEE AND I THINK THAT WE PROBABLY -- I WOULD -- I WOULD -- I WOULD THINK IT WOULD BE MORE APPROPRIATE FOR THAT GROUP TO REPORT TO THIS COMMITTEE AFTER SUCH A REPORT THEN GO FORWARD WITH THE RECOMMENDATION. I THINK IT WOULD BE ACTING ON HERE SAY AT THIS POINT -- HEARSAY AT THIS POINT NOT TO HAVE A FORMAL RELATIONSHIP AND A FORMAL REPORT.
ACTUALLY, DURING THE LAST SESSION OF THE DAY WE WERE GOING TO CONSIDER OTHER TOPICS THAT TO COME UP IN FEBRUARY AND CHRIS HOOK WHO IS NOT HERE TODAY BUT VERY INTERESTED IN NEW BORN SCREENING IS -- HAD ACTUALLY SUGGEST TAD WE HEAR -- SUGGESTD THAT WE HEAR, HAVE A PRESENTATION FROM THAT COMMITTEE ABOUT THEIR RECOMMENDATIONS AND SO WE WERE GOING TO TALK ABOUT THAT LATER TODAY TO SEE WHETHER OR WE CAN DECIDE NOW IF YOU WOULD RATHER TO HAVE THAT IN FEBRUARY.
MUIN?
IF WE ARE TALKING ABOUT DISSEMINATING EVIDENCE BASE FOR GENETIC TESTING SERVICES IN GENERAL, MAYBE I MISSED PART OF THAT CONVERSATION, I THINK THERE IS ONGOING EFFORTS OTHER THAN THE NEWBORN SCREENING AREA THAT ARE GOING ON WITH STATES. THE CDC FUNDED FOUR STATE'S CHRONIC DISEASE PROGRAMS TO BEGIN TO TAKE A LOOK AT THESE THINGS, I MEAN SORT OF WHAT YOU ARE ALLUDING TO HERE, TRYING TO FIGURE OUT HOW GENETIC TESTING AND SERVICES CAN BE USED OUTSIDE OF THE SCOPE OF TRADITIONAL MCH ARENA IN GENETICS AND WE HAVE FUNDED SCHOOLS OF PUBLIC HEALTH TO BEGIN TO BUILD THAT EVIDENCE BASE AND PROVIDE TECHNICAL ASSISTANCE TO STATE CHRONIC DISEASE PROGRAMS SO SORT OF ANOTHER THING IN THE HOPPER HERE.
WOULD EVERYONE BE COMFORTABLE IF WE KEPT THE FIRST RECOMMENDATION SUBJECT TO ANY REVISIONS OR TWEAKING THAT ANY ONE MIGHT WANT TO PROPOSE BUT ELIMINATE NUMBER TWO? I SORT OF HEARD MIXED THINGS. ONE IS THAT, YOU KNOW, THE BUDGET REALITY IS SUCH THAT IT WOULD BE DIFFICULT FOR US TO PROPOSE OR FOR THE SECRETARY TO OFFER ACTUAL DOLLARS TO STATES. ON THE OTHER HAND, THERE ARE GRANT PROGRAMS THAT CURRENTLY EXIST AND WE DON'T WANT TO IMPEDE THAT PROGRESS. I DON'T THINK -- AN OH MISSION OF -- I DON'T THINK AN OH MISSION OF NUMBER TWO WITH HAVE ANY ADVERSE IMPACT ON EXISTING GRANT PROGRAMS. WHAT ARE PEOPLE THINKING IN THAT REGARD? EMILY?
I THINK MAYBE WHAT WE NEED TO DO IS CHANGE THE WORDS FROM INCENTIVE PAYMENT WHICH IS IN MY MIND LIKE A LITTLE CARROT THAT YOU ARE HOLDING OUT TO ACTUAL SPECIFIC GRANTS WHICH I THINK IS WHAT IS ACTUALLY HAPPENING TO PROVIDE DEMONSTRATION PROJECTS AND, YOU KNOW, TO ASSIST IN GETTING SOME OF THESE THINGS IMPLEMENTED. I THINK THAT MIGHT BE MORE REFLECTIVE OF ACTUAL PRACTICE WITHIN HHS WHICH I MEAN IF THAT IS ALREADY HAPPENING THERE IS OBVIOUSLY SOME FUNDING SET ASIDE TO DO THAT SO I WOULD BE OKAY WITH THAT.
AND IT COULD BE WORDD THAT HHS CONTINUE TO PROVIDE STATES WITH SUPPORT OR GRANTS INDICATING THAT THEY ARE DOING THAT BY VARIOUS MECHANISMS AND CONTINUE TO DO THAT TO IMPLEMENT THE SOUND EVIDENCE BASE OF TESTING. QUESTION, WE NARROWED THIS DOWN TO MEDICAID AND KHIP BUT WE WANT IT TO BE USED ON A EVIDENCE BASED MECHANISM FOR ALL OF GENETICS. DO WE WANT TO BROADEN THIS POTENTIALLY?
WOULD THERE BE ANY UTILITY, MUIN SH -- I KNOW YOU ARE LOOKING DOWN SO I CAN TELL YOU ARE WORKING ON YOUR BLACKBERRY SO I WILL GET YOUR ATTENTION FIRST.
I KNOW HOW TO MULTITASK.
BUT THIS WASN'T ONE OF THE TASKS. SO IS IT USEFUL MAKING RECOMMENDATIONS AT THE STATE LEVEL FOR MEDICARE AND MAYBE THIS IS MORE CMS BUT YOU ARE THE ONE GENERATING THE EVIDENCE BASE SO COULD WE BROADEN THIS TO BE MEDICARE MEDICAID CHIP COVERAGE DECISIONS BECAUSE I DON'T KNOW HOW MUCH MEDICARE IS AT THE NATIONAL LEVEL VERSUS ALSO BEING INFLUENCED AT THE STATE AND LOCAL LEVELS?
LATER ON IN THE REPORT AS WELL TO REMIND EVERYONE THERE IS THE SECTION THAT DEALS WITH ALL PAYORS AND SO THERE ARE SOME RECOMMENDATIONS THAT WE ARE GOING TO BE WORKING ON WHICH ADDRESS, GET TO THE EVIDENCE BASE AND GET TO HOW DO WE MAKE THESE DECISIONS AND WHO COVERS WHAT UNDER WHAT CIRCUMSTANCES SO I DON'T KNOW IF THAT IS A GOOD PLACE TO GET AT YOUR POINT.
MAYBE SOMETHING ONCE WE WORK THROUGH ALL OF THE RECOMMENDATIONS I'M GETTING THE FEELING THAT THEY ARE NOT LUMPED AND THIS IS THE PROCESS YOU HAVE TO GO THROUGH IS YOUR TAKELE BODY OF WHAT YOU HAVE WRITTEN AND DUPLICATE THAT IN CREATING RECOMMENDATIONS LIKE THE U PIN FOR GENETIC COUNSELORS COULD GO WITH THE GENETIC COUNSELING. IF THERE IS SOMETHING AND MEDICARE AND PRIVATE MAYBE THIS COULD BE LUMPED INTO ONE SO WE DON'T END UP WITH 50 RECOMMENDATIONS IF WE CAN LUMP THEM AND MAKE FEWER IT MIGHT HAVE GREATER IMPACT. EVEN IF IT'S DOWN THE ROAD AFTER WE WORKED THROUGH ABSOLUTELY ALL OF THESE INDIVIDUALLY.
HAVE TO -- WE ARE ALREADY REORGANIZING THE PAPER FROM YESTERDAY'S DISCUSSION SO WE WILL DEFINITELY NEED TO DO THAT AFTER WE GET THROUGH THESE. MUIN. DID YOU HAVE -- I SORT OF INTERVENED. NO? OKAY.
SO ANY FINAL THOUGHTS OR -- SO WHEY HEARD THEN MOST RECENTLY IS WE KEEP NUMBER ONE. NUMBER TWO REVISE SLIGHTLY TO REFERENCE THE FACT THAT HHS IS ALREADY PROVIDING SOME GRANT OR SOME ASSISTANCES TO AND WE WOULD URGE THEM TO CONTINUE TO DO SO AND THAT GETS AWAY FROM HHS MUST SET UP SOME NEW PROGRAM AND PROVIDE ACTUAL DOLLARS TO PEOPLE BUT MORE ENCOURAGEMENT OF EXISTING POLICY AND TO THE EXTENT POSSIBLE AND FEASIBLE THEY COULD EXPAND THAT WITHIN THEIR DISCRETION. ANY OTHER COMMENTS? ALL RIGHT. NOW, WE ARE IN THE.
WE MIGHT -- CINDY, WOULD YOU -- WE ARE AT THE BREAK TIME, ACTUALLY. WOULD YOU MIND IF WE STOPPED A HERE NOR A MINUTE?
NOT AT ALL.
LET'S DO A PROCESS CHECK AGAIN. WE ARE AT, YOU KNOW, OUR 10:15 BREAK. WE THEN HAVE FROM 10:30 WHICH WE WILL MOVE BACK A LITTLE BIT TO 12:30 TO CONCLUDE THIS SECTION. WE HAVE 15 PAGES LEFT SO I THINK WE ARE ON TIME. I THINK WE WILL PROBABLY GET RIGHT TO THE END RIGHT WHEN WE NEED TO BE. I'M NOT SO CONCERNED. DOING A GREAT JOB, CINDY. WHY DON'T WE RECONVENE AT TEN MINUTES -- AT 40. 1040. 10:40. SO WE SLIPPED TEN MINUTES BECAUSE OF SOMEBODY. (CONFERENCE ON BREAK)
COME ON DOWN. CLEAR THE HALLS.
JUST KNOW, THOUGH, THAT EVERY ONCE IN AWHILE SOMEBODY GETS IT GOES. IF YOU CAN'T DO THE TIME, DO THE CRIME. ( LAUGHTER )
OKAY. WHERE IS CINDY?
GOT YOUR BACK.
CINDY, TAKE IT AWAY.
ALL RIGHT, WE ARE NOW IN THE SECTION WHERE WE ARE ADDRESSING BARRIERS THAT APPLY TO BOTH PUBLIC AND PRIVATE INSURERS. THE FIRST SECTION IN THIS PART OF THE REPORT DEALS WITH THE FACT THAT MEDICARE IS OFTEN A MODEL IN MANY OTHER CIRCUMSTANCES FOR PRIVATE INSURERS SO TO THE EXTENT THAT MEDICARE HAS COVERAGE AND REIMBURSEMENT PROBLEMS WITH ART TO GENETIC TESTS AND GENETIC SERVICES IT COULD HAVE A RIPPLE EFFECT AND ADVERSE EFFECT ON COVERAGE AND REIMBURSEMENT IN THE PRIVATE SECTOR. HOWEVER, AS A TASK FORCE AND IT AS A COMMITTEE IN THE PAST WE HAVE STRUGGLED A LITTLE BIT WITH THIS BECAUSE WHILE THAT MAY BE TRUE IN MANY OTHER FIELDS IT DOES SEEM BECAUSE WE HAD HEARD TESTIMONY AND RECEIVED COMMENTS FROM FOLKS IN THE PRIVATE SECTOR THAT IN THE AREA OF GENETICS MANY TIMES THE PRIVATE INSURERS ARE A LITTLE BIT MORE ADVANCED THAN MEDICARE BECAUSE THEY DON'T HAVE SOME OF THE SAME LEGISLATIVE RESTRAINTS THAT SHACKLE CMS IN TERPS OF WHAT CAN AND -- IN TERMS OF WHAT CAN AND CAN'T BE COVERED. FOR EXAMPLE THE SCREENING EXCLUSION ES DOESN'T REALLY EBBS SIFT IN MANY HEALTH CAN PLANS. WE RECOGNIZE THAT MEDICARE IS A MODEL AND THIS IS ONE OF THE REASONS FOREX ANDING POLICIES BUT WE STRUGGLED A BIT WITH WHAT THE RECOMMENDATION SHOULD BE. OF A RECOMMENDATION. IT IS MORE OF A STATEMENT WHICH BASICALLY SAYS THAT PRIVATE INSURERS SHOULD NOT WAIT FOR MEDICARE TO MAKE THESE DETERMINATIONS AND THAT THEY SHOULD ESSENTIALLY WITHOUT DIRECTLY SAYING IT MAKE THEIR OWN DECISIONS BASED ON THE EVIDENCE BASE. THIS MAY NOT BE WORTHY OF RECOMMENDATION BECAUSE IT DOESN'T A DECLARATORY STATEMENT. WE TALKED ABOUT SOME OUTSIDE ORGANIZATION WHETHER AHIP OR SOME OTHER ENTITY TO DEVELOP VOLUNTARY GUIDELINES OR SOME STANDARDS THAT WOULD NOT BE MANDATORY BUT BE A MODEL FOR PRIVATE INSURERS TO ADDRESS IF REGARDS TO GENETIC TESTS AND SERVICES. WE DIDN'T PUT THAT UP THERE. THIS IS ONE THAT WE STRUGGLED WITH AND WE COULD CERTAINLY BENEFIT WITH THE COMMITTEE'S VIEW ON.
I THINK IT IS IMPORTANT FOR IT TO BE THERE. IT IS A DECLARATIVE STATEMENT. I WOULD MAKE A COUPLE OF MINOR WORD SMITHING THINGS. THE LAST LINE IN THE BOOK AT LEAST. LET ME READ THE SECOND SENTENCE. SUCH SERVICES SHOULD BE CONSIDERED SPECIFICALLY WITH RESPECT TO THE BENEFITS -- LET'S BE POSITIVE -- TO THE BEN BENEFITS THEY OFFER THE POPULATION THEY SERVE. I WOULD GET RID OF DIFFERENT ALSO. I MEAN I JUST THINK WE WAFFLE WHAT THEY CAN OFFER. I MEAN THEY SHOULD -- IF THERE ARE BENEFITS THEY SHOULD PROVIDE THOSE BENEFITS TO THEIR CLIENTS.
HUNT?
I WOULD DISAGREE WITH ED ONLY FROM THE STANDPOINT THAT THIS IS WE ARE PROVIDING RECOMMENDATIONS TO THE SECRETARY SO HAVING IT IN THE TEXT AS A DISCUSSION TO PROVIDE BACKGROUND IS FIND BUT TO MAKE A RECOMMENDATION TO THE SECRETARY THAT OTHERS ARE WELL BEYOND HIS REACH SHOULD DO WHEN THEY WANT TO DO SEEMS LIKE AN ODD THING TO BE DOING.
AGNES, DID YOU HAVE A COMMENT?
I WAS GOING TO COMMENT THAT SINCE WE HAVE BEEN TALKING ABOUT EVIDENCE BASED PRACTICE THAT MANY OF THE INSURERS HAVE THEIR OWN TECHNOLOGY EVALUATION COMMITTEES THAT MAY BE IN THE TEXT ITSELF AS HUNT WAS JUST SAYING THAT WE COULD SAY THAT WITH THEIR OWN APPROPRIATE EVIDENCE-BASED REVIEW THAT GENETIC TESTS WHEN APPROPRIATE THAT, YOU KNOW, THEY DON'T HAVE TO WAIT FOR MEDICARE, THEY COULD MOVE AHEAD WITH THE TESTING.
I WILL POINT OUT THAT LATER ON IN THE REPORT AND WE WILL GET TO THAT, THERE IS A SECTION THAT IS -- AND IN FACT WE ARE GOING TO RESTRUCTURE IT EVEN MORE THAN WHAT CURRENTLY EXISTS IN FRONT OF YOU. A SECTION ON INFORMATION UTILITY AND A FACT OF FACTORING COSTS INTO COVERAGE DECISIONS AND ANOTHER THING THAT WE WERE TALKING WITH MOVING AND ALL LEADS TO TO THE EVIDENCE BASED DISCUSSION. THE WORKING GROUP TO COME UP WITH A SET OF PRINCIPLES THAT WOULD HELP GUIDE INSURERSION PUBLIC OR PRIVATE, IN DETERMINING WHAT SHOULD BE COVERED, WHEN THEY SHOULD BE COVERED -- WHEN CERTAIN SERVICES AND TESTS SHOULD BE COVERED AND THAT KIND OF A THING. SO I DON'T KNOW IF THAT COULD SERVE AS A RECOMMENDATION FOR THIS SCENARIO. MAYBE WE ARE LUMPING INSTEAD OF THREE OR FOUR IT IS ALL FIVE OF THE BARRIERS THAT HAVE BEEN IDENTIFIED THIS BEING ONE OF THEM AND HAVE THAT RECOMMENDATION SERVE AS THE RECOMMENDATION FOR ALL FOUR OR FIVE. ED?
I HAVE NO -- I UNDERSTAND THE REASON FOR REMOVING IT AS A RECOMMENDATION TO THE SECRETARY. I HAVE NO OBJECTION TO THAT BUT THEN IN THE TEXT LET'S MAKE IT CLEAR THAT WE RECOMMEND THAT PRIVATE INSURERS NOT WAIT FOR MEDICARE. SO LET'S MAKE IT CLEAR BECAUSE I DON'T WANT TO GIVE THE PRIVATE INSURERS AN OUT THAT UNTIL MEDICARE IS READY WE ARE NOT READY. IF WE DO THAT THEN WE NEED TO ALSO LOOK AT THE OTHER RECOMMENDATIONS WITHIN THE SECTION BY THAT PRINCIPLE BUT WE CAN STATE THEM AS RECOMMENDATIONS, HIGHLIGHT THEM IN THE TEXT SOMEHOW BUT NOT AS A RECOMMENDATION TO THE SECRETARY.
SUZANNE AND REED?
I THINK TO GET AT HUNT'S POINT AND ALSO ED'S, CERTAINLY THE -- THE DIRECT AUDIENCE THAT THIS COMMITTEE HAS IS TO THE SECRETARY BUT CERTAINLY I WOULD LIKE TO REMIND YOU THAT YOU ALSO HAVE A NATIONAL ODD YENTS AND WHILE YOU -- AUDIENCE AND WHILE YOU MIGHT NOT HAVE AS MUCH WEIGHT IN ADDRESSING IT THIS REPORT IS GOING TO BE AVAILABLE TO THE PUBLIC AND I WOULD HOPE AND ESPECIALLY IN ADDRESSING THE VARIOUS RECOMMENDATIONS OR THE BARRIERS IN THIS SECTION YOU WOULD KEEP THAT BROAD AUDIENCE IN MIND AND NOT FEEL LIMITED IN ANY WAY TO ADDRESSING YOUR RECOMMENDATIONS TO THE SECRETARY. SO I HOPE THAT PROVIDES SOME CLARIFICATION TO YOU AS YOU WORK THROUGH SOME OF THE ISSUES. AND CERTAINLY THIS TOPIC IN PARTICULAR HAS BROADER RELEVANCE THAN JUST MEDICARE SO I HOPE THAT YOU JUST FEEL LIMITED TO CRAFTING ANY RECOMMENDATIONS DIRECTLY TO AREAS THAT THE SECRETARY HAS CONTROL OVER.
REED?
TWO THINGS. I THINK FIRST THAT LAST POINT, BOTH THAT LAST DIALOGUE IS IMPORTANT. I CONTINUE TO COME BACK TO THE IDEA THAT THE COMMITTEE WILL BE BEST SERVED BY FOCUSING AS MUCH AS POSSIBLE ON ITS PRIORITY AND IF WE ARE SCATTER SHOT ALL OVER THE PLACE WE ARE NOT GOING TO BE AS EFFECTIVE AS WE WOULD BE IF WE FOCUSSED IN ON THE THINGS THAT ARE THE MOST IMPORTANT. HAVING SAID THAT I THINK THAT THE RECOGNITION THAT THERE IS A BROADER AUDIENCE THAN THE SECRETARY THAT WE DO SPEAK TO IT IMPORTANT AND I THINK WE SHOULDN'T SPEAK ONLY TO THOSE THINGS MAYBE BRING IT TO THE ATTENTION OF OTHERS OR IN THE COURSE OF OUR DELIBERATIONS WE HAVE UNCOVERED THIS ISSUE AND IF IT IS IMPORTANT ENOUGH WE MIGHT WANT TO SPEAK TO IT. THE ONLY ISSUE I HAVE WITH THIS RECOMMENDATION HERE IS THAT THE PRIVATE SECTOR AS THE TEXT SAYS IS DOING THESE THINGS. AND THAT I THINK WE WANT TO BE CAREFUL IF WE ARE GOING TO MAKE A RECOMMENDATION THAT IT TOES DOESN'T LOOK INSULTING SO IT SAYS IS THAT, YOU KNOW, YOU KNOW, THE WAY IT APPEARS NOW IS AS IF THE PRIVATE SECTOR WAS SIMPLY NOT DOING ANYTHING AND WAITING FOR MEDICARE TO ACT AND THAT IS NOT WHAT THE TEXT SAYS. I THINK YOU WANT TO SORT OF MAYBE ENCOURAGE THEM. THE OTHER THING IS IF WE ARE GOING TO ADD THE INSURERS ON THIS ONE, IT IS ALSO THE PAYORS. THE WAY WE SET THIS UP IN THE EARLIER PREAMBLES, THE COMBINATION IS ULTIMATELY DETERMINED BY THE PURCHASERS, EXCUSE ME ALL OF THOSE FOLKS WORKING TOGETHER. AND THE OTHER FINAL POINT IS JUST REALLY GROUNDING THIS STUFF IN, AGAIN, YOU KNOW EVIDENCE BASES AND PRIORITIES.
DOES ANY ONE HAVE ANY SUGGESTIONS AS TO WHETHER THIS SHOULD STAY AS A STAND ALONE PIECE AS THIS RECOMMENDATION AS REVISED BY SOME OF THE COMMENTS WE JUST HEARD OR WHETHER IT SHOULD IN FACT PERHAPS WE CAN'T MAKE THAT DETERMINATION UNTIL WE GET TO IT BUT LUMP IT IN THE OTHER SECTION WHICH HAS A RECOMMENDATION DEALING WITH EVIDENCE-BASED? DOES THIS MERIT REALLY STANDING ALONE IN ISOLATION BECAUSE OF THE CRITICAL IMPORTANCE OF A STATEMENT THAT WE WANT TO MAKE HERE? OR CAN THIS BE MERGED IN WITH THE OTHER ITEMS? DOES ANY ONE HAVE ANY STRONG OPINION? DEBRA?
I THINK GIVEN THAT PRIVATE INSURERS ARE TO SOME EXTENT AT LEAST DOING THIS, I DON'T KNOW THAT WE NEED IT TO STAND ALONE AND I THINK BY INCORPORATING IT INTO THE EVIDENCE-BASED SECTION WE COULD STILL MAKE THE SAME IMPACT AND HAVE FEWER RECOMMENDATIONS OVERALL.
I THINK THAT IS A GOOD APPROACH. DOES ANY ONE OBJECT TO THAT? SO WE WOULD REMOVE THIS RECOMMENDATION BUT MERGE IT IN WITH THE OTHER SECTION DEALING WITH EVIDENCE-BASED PRACTICE. WE WOULD STILL RETAIN THE TEXT, IT JUST WOULD BE IN A DIFFERENT SECTION. ALL RIGHT. HEARING NO OBJECTION, THAT IS WHAT WE WILL DO ON THAT SECTION. WE ALSO HAD DISCUSSED VERY BRIEFLY THE UPIN ISSUE AND DISCUSSED MOVING IT INTO THE SECTION THAT WE ADDRESSED EARLIER, GENETIC SERVICES AND COUNSELING. SO IT WOULDN'T BE A STAND ALONE HERE, IT WOULD MOVE INTO THAT SECTION. SO WE CAN STILL GO INTO THE RECOMMENDATION BUT JUST KNOW THAT IT WILL BE MOVED INTO THE EARLIER SECTION THAT WE TALKED ABOUT. AND THIS IS AN ISSUE, OF COURSE, THAT IDENTIFIES THE FACT THAT GENETIC COUNSELORS ARE NOT ENLEGIBLE FOR A U-PIN AND MANY HEALTH PLANS USE THE U PIN SYSTEM SO IF YOU ARE NOT ELIGIBLE AND THE HEALTH PLANS USE THE U PIN SIS THEM THAT MAY ADVERSELY AFFECT THE ABILITY FOR THE GENETIC COUNSELORS TO BILL PRIVATE INSURERS. THE RECOMMENDATION WOULD BE UNTIL THE NATIONAL PROVIDER IDENTIFIER SYSTEM IS IMPLEMENTED THAT PERHAPS PRIVATE HEALTH PLANS COULD CREATE THEIR OWN PROVIDER NUMBERS FOR GENETIC COUNSELORS TO USE FOR BILLING PURPOSES. THIS ALSO FALLS INTO A SIMILAR TYPE OF SITUATION AS THE EARLIER RECOMMENDATION. IT IS RECOMMENDATION THAN A DECLARATORY STATEMENT BUT I THINK HEALTH PLANS DO KNOW THAT THEY ARE AT LIBERTY TO SET UP THEIR OWN NUMBERS IF THEY WISH, THE QUESTION IS IF THE COMMITTEE FEELS IT IS IMPORTANT TO MAKE THIS STATEMENT AND URGE THEM TO DO SO. ED?
I WOULD MAKE THE STATEMENT BUT I WOULD INCLUDE IT IN THAT STRING. I THINK IT TWO BE NUMBER FOUR, IF I RECALL, THREE OR FOUR IN THAT STRING THAT WE HAD -- THAT WE STARTED THE MORNING OFF WITH.
I.
DEBRA?
I WOULD SAY THAT THIS POTENTIALLY COULD BE INFORMED BY WHATEVER INFORMATION IS BROUGHT BACK TO THE COMMITTEE AT THE NEXT MEETING AND WE COULD MOVE THIS ONE UP THERE BUT THERE ARE CERTAIN STEPS THAT WILL HAVE TO BE TAKEN IN ORDER FOR GENETIC COUNSELORS AND THOSE PROVIDING GENETIC COUNSELING SERVICES TO BILL AND BE REIMBURSED FOR THOSE SERVICES THAT ARE CURRENTLY GOING ON AND THAT THIS IS ONE OF THE STEPS THAT NEEDS TO BE DONE THEN MAYBE INFORMATION COULD BE PROVIDED ABOUT HOW THAT WOULD HAPPEN. SO INCLUDING THIS IN THAT DISCUSSION WOULD BE USEFUL.
DOES ANY ONE HAVE ANY OTHER COMMENTS ON THIS? SUZANNE, DO YOU HAVE WHAT YOU NEED TO -- ALL RIGHT. THE NEXT THREE BARRIERS THAT HAVE BEEN IDENTIFIED, THERE IS NOT ONE RECOMMENDATION THAT WILL COME AFTER EACH ONE. YOU WILL SEE IN THE REPORT THEY'RE LUMPED TOGETHER. THE RECOMMENDATION WOULD APPLY TO ALL THREE. SO IT IS INFORMATIONAL UTILITY AND MEDICAL EFFECTIVENESS IS ONE ISSUE. THE NEXT ONE IS THE PREVENTIVE NATURE OF GENETIC SERVICES. THE THIRD IS FACTORING COSTS INTO COVERAGE DECISIONS. AND THOSE THREE THINGS AFTER A DISCUSSION IN THE REPORT LEADS -- THEY LEAD TO ONE RECOMMENDATION WHICH WE WILL GET TO IN A SECOND BUT I WANT WANTED TO CALL YOUR ATTENTION TO THAT. THIS ONE THE INFORMATIONAL UTILITY AND MEDICAL EFFECTIVENESS PIECE FOCUSES ON THE FACT THAT HEALTH PLANS USE MEDICAL EFFECTIVENESS TO MAKE SURE THAT THE SERVICES THAT THEY COVER MEET EVIDENCE STANDARDs. IT ALSO IN THE TEXT DISCUSSES THE FACT THAT THERE ARE SOME GENETIC TESTS AND SERVICES THAT PEOPLE MAY FIND USEFUL AND INFORMATIVE BUT MAY NOT WARRANT COVERAGE BECAUSE OF THE MEDICAL EFFECTIVENESS CRITERION. AND THIS THE ISSUE ABOUT WHETHER INFORMATIONAL UTILITY ON ITS OWN REALLY WARRANTS COVERAGE. THE SECOND BARRIER DEALS WITH THE PREVENTIVE NATURE OF GENETIC SERVICES HIGHLIGHTING THE FACT THAT, OF COURSE, THERE ARE LONG-TERM BENEFITS TO PROVIDING THESE SERVICES AND THEY CAN BE COST-EFFECTIVE OVER THE HONG HAUL BUT IN THE -- OVER THE LONG HAUL BUT IN THE SHORT-TERM BECAUSE PEOPLE CHANGE HEALTH PLANS IS ONE REASON. COVER ONLY FOR PREVENTIVE SERVICES MIGHT BE DIFFICULT TO JUSTIFY AND INSURERS MAY OR MAY NOT FEEL THAT COVERAGE WOULD BE WARRANTED. THE THIRD BARRIER ISSUE THAT IS ADDRESSED HERE IN THE SECTION DEALS WITH THE FACT THAT THERE IS SOME UNCERTAINTY ABOUT WHETHER AND HOW BEST TO INCORPORATE COST-EFFECTIVENESS DATA IN COVERAGE DECISION MAKING AND THERE SEEMS TO BE A LACK OF DATA ON COST-EFFECTIVENESS OF GENETIC TEFS AND SERVICES. -- GENETIC TESTS AND SERVICES AND THAT HAS POTENTIALLY AN ADVERSE IMPACT ON HEALTH PLAN COVERAGE DECISION-MAKING. SO WE CAME UP WITH A RECOMMENDATION THAT POTENTIALLY COULD ADDRESS ALL THREE OF THESE ISSUES AND THAT WOULD INVOLVE THE SECRETARY TASKING AN APPROPRIATE GROUP OR A BOD BODY, ESTABLISHING A TASK FORCE SO TO SPEAK OF ESTABLISHING PRINCIPLES FOR COVERAGE MAKING FOR GENETIC TESTS THAT WOULD ASSIST EMPLOYERS AND HEALTH PLANS. IT WOULDN'T BE A MANDATE, IT WOULD BE MORE IN THE FORM OF GUIDANCE. THESE PRINCIPLES WOULD IDENTIFY CRITERIA THAT WOULD HELP HEALTH PLANS AND OTHER PAYORS DETERMINE WHEN SHOULD GENETIC TESTS BE COVERED. WHEN SHOULD THEY ALWAYS BE COVERED, WHICH TESTS SHOULD NEVER BE COVERED AT LEAST UNDER THE CURRENT EVIDENCE BASE. WHICH GENETIC TESTS FALL INTO THAT GREY ZONE WHERE IT MIGHT NEED TO BE DERMD ON A CASE-BY-CASE BASIS. COST-EFFECTIVENESS COULD BE ADDRESSED HERE AS WELL AS THE NATURE OF GENETIC TESTS AND SERVICES. AGAIN, EMPHASIZEING THAT THIS WOULD BE MORE IN THE LINES OF GUIDANCE. I DON'T KNOW TO WHAT EXTENT SOME OF THIS WORK IS ALREADY BEING DONE. AND WE MIGHT WANT TO REFERENCE THAT. DOES ANY ONE HAVE ANY SUGGESTIONS, COMMENTS, THOUGHTS? MUIN?
MAYBE YOU CAN HELP US FLESH IT OUT A BIT MORE BECAUSE I THOUGHT THE SET OF PRINCIPLES RELATED TO GENETIC TESTS HAVE BEEN KIND OF SET FORTH BY SACGT EARLIER, SORT OF THE ACE PARADIGM BUT IT DIDN'T GO FAR ENOUGH WITH RESPECT TO REIMBURSEMENT. I MEAN IT BASICALLY TALKED ABOUT THE ISSUES THAT NEED TO BE CONSIDERED WHEN A GENETIC TEST IS BEING LOOKED AT FROM THE ANALYTIC VALIDITY ALL THE WAY TO THE LC ISSUES AND WHAT WE HAVE TAKEN WITH THE ACE PROJECT IS TRIED TO MOVE THAT, THE BALL A BIT FURTHER DOWN THE FIELD, IF YOU WILL. AND I THINK WHERE YOU END UP IN A STUMBLING BLOCK IS WHAT IS IS THAT THRESHOLD AT THE END OF THE DAY WHEN YOU COLLECTED ALL THE INFORMATION AND IDENTIFIED ALL THE GAPS, THEN THE PRINCIPLES THAT ARE ON THE CRITERIA FOR WHAT TO FUND AND WHAT NOT TO FUND IS ALWAYS A STICKY POINT SO I'M -- I'M STRUGGLING WITH THE NOTION HERE AND MAYBE OTHERS CAN HELP BY JUMPING IN, IDENTIFYING THE PRINCIPLES WHICH, I THINK, SACGT AND YOU AND OTHERS HAVE KIND OF -- IT IS EASY ENOUGH TO SAY THESE ARE GENERAL PRINCIPLES BUT HOW TO MOVE THEM FORWARD AT THE QUESTION OFFER THISHOLD AND THAT IS -- THRESH THRESHOLD AND THAT IS A MORE STICKY POINT. SO I'LL JUST STOP HERE AND MAYBE COLLECT MY THOUGHTS MORE.
DEBRA?
I DON'T UNDERSTAND HOW THIS IS DIFFERENT THAN THE ACE E-GAP. YOU HAVE TO PROVIDE INFORMATION ABOUT SPECIFIC TESTS, THEIR UTILITY, WHAT THEY DO, WHEN THEY SHOULD BE COVERED AND WHAT POPULATIONS AND I THINK THAT IS WHAT ACE AND EGAP ARE DOING AND TO ME THIS SOUNDS LIKE NOT ONLY YOU ARE GOING TO PROVIDE THAT INFORMATION TO MEDICAID AND MEDICARE AND PRIVATE INSURERS YOU BASICALLY WANT DISTRIBUTION OF THAT INFORMATION COMING OUT OF ACE AND EGAP. I THINK THAT IS WHAT IS BEING ASKED FOR HERE. I DON'T KNOW THAT WE CAN DO THE COST ANALYSIS. EACH PROVIDER HAS TO FIGURE OUT WHAT THEY CAN PAY FOR AND WHAT THEY CAN'T BUT ONCE IT IS MEDICALLY USEFUL MORE THAN LIKELY IT WILL BE PAID BY SOME GROUPS AN INCREASING NUMBER OF GROUPS AT SOME TIME.
YES, DR. ROLLINS?
YOU MIGHT WANT TO CONSIDER REMOVING COST-EFFECTIVENESS OR PUT IT TO THE END BECAUSE HEALTH INSURERS DON'T TAKE INTO ACCOUNT THE COST OF THE TECHNOLOGY AT LEAST AT THE INITIAL ASSESSMENT. THAT WOULD BE THE CONSIDERATION THAT COST BEING TAKEN INTO CONSIDERATION FOR A PLAN TO CONSIDER A CERTAIN TECHNOLOGY. ELIMINATE IT OR IF YOU WANT TO KEEP IT I WOULD STRESS IT AS THE VERY LAST COMPONENT OF THAT SENTENCE.
BARBRA?
I JUST WANT TO UNDERSTAND ARE GROUPS LIKE EGAP WHICH I GUESS FOLLOWS THE ACE MODEL, ARE WE SAY TAG WE DON'T NEED TO ESTABLISH A GROUP THEN, IS THERE A GROUP ESTABLISHED?
THAT IS THE QUESTION, DO WE FEEL LIKE THE WORK THAT IS ALREADY ABOUT BEING DONE, IS THAT SUFFICIENT, DOES THAT PROVIDE SUFFICIENT GUIDANCE FROM OUR STANDPOINT TO HEALTH PLANS AND PAYORS? OR DOES THERE NEED TO BE A NEW GROUP THAT KIND OF SYNTHESIZES AND BRINGS TOGETHER ALL OF THE WORK THAT IS CURRENTLY BEING DONE AND PERHAPS FILLS IN GAPS AND THEN SERVES AS A GUIDE? MUIN?
I THINK IT SEEMS TO ME THAT THIS COMMITTEE CAN MAKE MAKE A RECOMMENDATION TO HHS ALONG THOSE LINES BECAUSE EGAP IS AN EXPERIMENT AND THREE YEARS FROM NOW IT WILL DISAPPEAR. AND WHETHER THIS COULD PRECEDE OR SUCCEED OR BE PART OF EGAP OR EGAP COULD BE INDEPENDENT DOESN'T MATTER. I THINK HHS SHOULD TAKE THE LEAD AND ALL THE AGENCIES REPRESENTED HERE CAN COME TOGETHER IN BEGINNING TO TAKE WHAT HAS BEEN DONE SO FAR AND THEN MELDING IT INTO THE SET OF PRINCIPLES AND THE AGENCIES CAN FIGURE OUT HOW TO WORK TOGETHER OR HHS CAN TELL US. WE HAVE BEEN STRUGGLING WITH THIS FOR A LONG TIME AND I FEEL LIKE EVERY YEAR WE MAKE A LITTLE MORE PROGRESS IN THE AREA AND AT END OF THE DAY WHERE YOU GET AT THE STUMBLING BLOCK OF PEOPLE LOOKING THE THE AIM DATA BUT MAKING DID I RENT CONCLUSIONS WITH RESPECT TO COVERAGE BECAUSE WHERE YOU SET THE BAR YOU WANT MORE OR LESS MEDICAL EFFECTIVENESS VERSUS OTHER THINGS. FOR EXAMPLE THIS IS A CLEAR DISTINCTION BETWEEN WHAT THE U.S. PREVENTIVE SERVICES TASK FOR AND MY FRIEND HERE IS NOT HERE TO DEFEND THEMSELF WITH RESPECT TO THE STRICT CRITERIA VERSUS SOME OF THE OTHER MODEL TECHNOLOGY ASSESSMENT INCLUDING ACE WHICH HAVE BEEN PROPOSED. WHAT IS WHY WHAT WE WANTED TO DO IS PUT ALL THE METHODOLOGIES TOGETHER AND TRY TO COME UP WITH HOPEFULLY A CONSENSUS METHODOLOGY FOR HOW THESE EVIDENCE BASED REVIEWS CAN BE DONE BECAUSE AGAIN AS I SAY IT IS A STEP ALONG THE WAY. IF YOU PUSH HHS TO KEEP -- TO KEEP ITS APPROPRIATE LEADERSHIP ROLE IN THIS AREA WITH ALL THE AGENCIES CONTRIBUTING TO THIS EFFORT I THINK IT WOULD BE A WONDERFUL GOAL.
SUZANNE, DID YOU HAVE -- OH, REED?
YEAH, I GUESS I'M STRUGGLING WITH THIS ONE AS WELL. I THINK MAYBE MUIN GOT US THERE. I DOING. LET ME ASK SPECIFICALLY. ARE WE TAKING A POSITION THAT IS AN ADVOCACY POSITION THAT SAYS THAT AT THE END OF THE DAY WHAT WE WANT TO SEE ACHIEVED IS FOR TESTS THAT DO NOT HAVE A THERAPEUTIC INPUT, WE WANT TO MAKE SURE THAT THOSE TESTS ARE COVERED AND THAT WE WANT TO SEE THEM PUSHED -- THAT IS OUR REAL ISSUE HERE IS TO PUSH IN A CERTAIN DIRECTION FOR CERTAIN KINDS OF THINGS TO GET COVERED AND AS SORT OF DICTATING THAT DIRECTION? OR ARE WE SAYING THIS IS A COMPLICATED WORLD WHERE THERE ARE NEW ISSUES THAT EMERGE BECAUSE YOU HAVE GOT DIAGNOSTIC TESTS NOW THAT ARE PREDICTIVE IN VALUE THAT MAY NOT BE RELATED TO THERAPEUTIC PREVENTIONS PER SE AND AS SUCH RAISES THE NEED FOR INFORMATION TO BE READILY AVAILABLE FOR DECISION-MAKERS TO BE ABLE TO MAKE APPROPRIATE DECISIONS AND THE CATEGORIES OF INFORMATION THAT MUST BE MADE AVAILABLE ARE EVIDENCE BASIS OF WORK, YOU KNOW, THE CLINICAL UTILITIES AND SO FORTH AND SO ON. COST-EFFECTIVENESS OF WHAT IT MEANS TO IMPLEMENT THIS. HOW THE NEW TEST RELATES TO EXISTISTING IF THERE ARE IN I WAYS OF EVALUATING THAT DISEASE CONDITION AND SO FORTH SO THAT WE ARE ULTIMATELY TRYING TO ASSURE IS THAT PEOPLE WHO HAVE TO MAKE TOUGH DECISIONS HAVE A KNOWLEDGE BASE FROM WHICH TO MAKE IT. AND I CAN'T TELL WHETHER IT IS THAT YOUR -- WE VIEW OUR RESPONSIBILITY AS ENSUREING THAT A KNOWLEDGE BASE EXISTS IN A SET OF AREAS THAT ARE DECISIONABLE OR ARE WE SAYING NO, WHAT WE WANT TO DO IS A HAVE A KNOWLEDGE BASE THAT ALLOWS CERTAIN THINGS TO ACTUALLY HAPPEN BECAUSE WE WANT THESE TESTS TO BE IMPLEMENTED TODAY? I CAN'T TELL WHICH ONE WE ARE ASKING FOR.
ALSO, I THINK AND JUST TO MENTION AGAIN LATER ON IN THE REPORT WE TALK ABOUT THE EVIDENCE-BASED ISSUE, EVIDENCE-BASED COVERAGE DECISION AND IN THAT SECTION THERE ARE RECOMMENDATIONS WHICH INCLUDE HHS TO TASK A GROUP TO ASSESS THE EVIDENCE FOR SPECIFIC TESTS AND DETERMINE WHETHER THE EVIDENCE IS SUFFICIENT. YOU CAN MAKE AN ARGUMENT THAT THAT WHOLE DISCUSSION AS YOU OUTLINED THE LATTER POINT, NOT YOUR FIRST POINT ABOUT -- I DON'T THINK WE ARE GOING IN THE DIRECTION OF WE SHOULD COVER EVERYTHING NO MATTER WHAT IT IS WHETHER IT LEADS TO SOME POTENTIAL THERAPEUTIC BENEFIT OR NOT, I DON'T THINK WE ARE THERE BUT MORE THE LATTER POINT WHICH YOU RAISED, REED, WHICH IS THERE MAY BE NEED PROVIDE GUIDANCE IN ASSESSING ALL OF THEIR FACTORS AND MAY BE THAT WE MERGE THIS SECTION IN WITH THE EVIDENCE-BASED SECTION AND TAKE A MORE GLOBAL APPROACH. I THINK MAYBE THE WAY ALSO -- THAT SORT OF MAKES SENSE TO ME IS WE SORT OF SAY A REASONABLE PRUDENT ANALYSIS OF THIS NEW WORLD THAT WE ARE IN MEANS THAT THESE NEW TESTS MUST BEEF BE CONSIDERED BY THE GROUP OF IN COST-EFFECTIVENESS AND YADA YADA. AND YOU GET TO WHAT MUIN SAID IN REGARDS TO SOME EFFORTS ARE ALREADY PULLING THIS TOGETHER, HOWEVER, THEY ARE IN OUR OPINION, INADEQUATE OR NEED TO BE BOLSTERED OR SUPPORTED BY SOME OTHER NEW THINGS THAT PEOPLE WILL HAVE TO HAVE AVAILABLE TO THEM. WHAT WE ARE SAYING TO THE SECRETARY IS YOU GOT A BUNCH OF FEDERAL AGENTS, NIH, FDA, ARC, CDC, YOU HAVE ALL THESE PEOPLE AND YOU CONTROL ACCESS TO THE KINDS OF DATABASES OR SHOULD WE CREATING THE KINDS OF DATABASES THAT ALLOW PRUDENT PEOPLE TO MAKE INTELLIGENT DECISIONS. WE GOT TO ALERT YOU, SIR, THAT WE NEED THIS INFORMATION INFRASTRUCTURE AVAILABLE RIGHT O NOW AND THAT MEANS YOU GOT TO BOLL TER THIS. OTHERWISE -- BOLSTER THIS. OTHERWISE CMS IS IN TROUBLE AS IS EVERYONE ELSE HERE IN THE WORLD.
AGNES?
I WANTED TO BRING UP COMMENTS THAT WERE MADE AT SOME OF OUR PAST MEETING FROM THE FDA OR EX-OH FISH YESES FROM THE FDA AND CDC THAT THEY REQUESTED THAT THE GUIDELINES COULD BE SHARED WITH THEIR RESPECTIVE DEPARTMENTS AND THAT WOULD HELP PROVIDE GUIDANCE IN THEIR OVERSIGHT OF SOME OF THESE TESTS.
YES?
SOMETHING ELSE THAT REED HAD JUST MENTIONED WHICH I JUST WANTED TO ADD TO ALSO. WHEN LOOKING AT A -- A SCREENING OR A DIAGNOSTIC TEST, THOSE TESTS SHOULD BE DONE IF BASED ON THE RESULTS OF IT THERE IS SOMETHING THAT YOU CAN DO WITH IT. IF THERE ARE DIAGNOSTIC TESTS AVAILABLE AND THEY MIGHT SHOW A CERTAIN SOMETHING BEING PRESENT OR ABSENT BUT IF YOU CAN'T DO ANYTHING ABOUT IT IN TERMS OF PATIENT MANAGEMENT WHICH WOULD RESULT IN A BETTER OUTCOME, PROBABLY NOT A GOOD THING TO DO. SO IN YOU SAID A FEW MINUTES AGO, I THINK THAT WE SHOULD ALSO TAKE INTO CONSIDERATION WHAT ACTIONABLE ACTION IS GOING TO RESULT FROM THOSE DIAGNOSTIC TEST.
WOULD YOU CONSIDER AND I THINK THE ESSENCE OF THIS SECTION AS I READ THE REPORT IS WOULD YOU CONSIDER A COUNSELING INTERVENTION HUNTINGTONS, WOULD YOU CONSIDER THAT COUNSELING OPPORTUNITY A SPECIFIC INTERVENTION THAT WOULD THEN MAKE THAT ACTIVITY WORTHY OF YOUR ANALYSIS?
YES, YES.
LET ME JUST FOR THE SAKE OF THE ARGUMENT, WOULD YOU -- I THINK THE -- SOME OF THESE CONTRA DISTINCTIONS HERE. WOULD YOU CONSIDER IN UTERO INFORMATION ABOUT THE SECTION SEX OF YOUR BABY OR THE COLOR OF THEIR EYES, WOULD YOU CONSIDER THAT INFORMATION WORTHY OF YOUR ANALYSIS?
NO.
DEBRA?
SUZANNE IS ASKING WHAT MAKES THE DISTINCTION AND THAT IS THE POINT IS THAT HOW DO YOU MAKE AND WHAT IS THE GUIDANCE OR IS PART OF THE RECOMMENDATION HERE HOW DO WE MAKE THIS SOME SENSE OF WHAT ARE THE GUIDANTS HERE. SHOULD THE AMERICAN PEOPLE PICK UP THE TAB FOR EVERYTHING POSSIBLE THAT A PERSON WOULD WANT TO KNOW WHO IS GETTING PUBLIC INSURANCE? OR SHOULD IT BE LIMITED TO CERTAIN THINGS AND I THINK THAT IS THE OTHER HALF OF THIS WHOLE RECOMMENDATION IS HOW DO YOU HELP PEOPLE TO THINK THROUGH. SO PART A IS YOU GOT THE INFORMATION. PART B IS HOW DO YOU HELP DECISIONMAKERS TO THINK THROUGH WHAT IS A REASONABLE USE OF THAT INFORMATION.
I'M ALWAYS DISTURBED BY THE ARGUMENT THAT IF THERE ISN'T ANYTHING YOU CAN DO THAT IT IS NOT WORTH WHILE DOING THE TEST BECAUSE I KNOW FROM A PERSONAL PERSPECTIVE IF THERE IS SOMETHING WRONG WITH ME AND THERE CAN BE A DIAGNOSTIC TEST THAT SAYS IT IS X OR Y AND THERE IS NOTHING THAT CAN BE DONE I WANT TO KNOW WHETHER IT IS X OR Y. I WANT TO KNOW WHAT MY DIAGNOSIS IS AND I THINK FROM A PHYSICIAN PERSPECTIVE ALSO IF YOU HAVE A DEFINITIVE DIAGNOSIS YOU STOP LOOKING AND YOU DON'T DO OTHER TESTS. THERE IS UTILITY IN DIAGNOSIS EVEN WHEN THERE IS NO THERAPEUTIC INTERVENTION.
SO WE GO BACK -- JUST TO BE PROVOCATIVE FOR A MINUTE. IF YOU COULD CHANGE -- WHAT I THINK MAKES SENSE FROM WHAT I HEAR YOU IS IF YOU KNEW YOU HAD A DIAGNOSIS THAT WOULD AFFECT YOUR REPRODUCTIVE DECISION-MAKING OR INFORM IT THAT MIGHT BE USEFUL. IF YOU HAD INFORMATION WHICH WOULD AFFECT THE WAY IN WAY YOU RELATED TO ENVIRONMENTAL TOX INS OR PERSONAL HEALTH BEHAVIOR, THAT MIGHT BE IMPORTANT. IF YOU JUST -- AGAIN, BUT TO KNOW WHAT THE SOMETHING ABOUT, YOU KNOW, THE COLOR OR THE SEX OF YOUR BABY, WOULD THAT BE ENOUGH REASON TO KNOW? IS THERE SOME WHERE IN BETWEEN?
I DON'T THINK COLOR OF EYES OR SEX OF AN INFANT IS CONSIDERED A DISEASE. SO I THINK THE DISTINCTION THERE IS THAT IS A PERSONAL CHARACTERISTIC, IF YOU WILL. I MEAN YOU GET INTO GREY ZONES WHERE THERE ARE CHARACTERISTICs THAT ARE SOMETIMES CONSIDERED PERSONAL LIKE OBESITY AND THINGS LIKE THAT ALTHOUGH ONE COULD ARGUE THAT OBESITY HAVE THE MOST PREVALENT DISEASE IN THE UNITED STATES. BUT SO BUT I THINK COLOR OF SKIN, COLOR OF EYES, SEX OF THE INFANT, NONE OF THOSE WOULD BE DEFINED AS A DISEASE.
EMILY, DID YOU HAVE A --
YEAH, I JUST WANTED TO REMIND PEOPLE THAT THIS IS IN THE SECTION THAT IS NOT JUST ON PUBLIC INSURANCE IT IS ON SORT OF ALL INSURERS SO WE DO NEED TO CONSIDER THAT THERE IS ALSO EACH INSURANCE COMPANY IN COLLABORATION WITH THEIR CUSTOMER, WHICH IS TYPICALLY AN EMPLOYER, BUYING A BENEFITS PACKAGE A BUY A BENEFITS PACKAGE A INCLUDES SOME TESTS AND DOESN'T AND AT SOME POINT IN THE FUTURE EMPLOYERS MIGHT WANT TO OFFER THE BLUE EYE BROWN EYE GENE TESTS FOR TUS FETUSES. GOD KNOWS WHY BUT IF THEY CHOSE WHO OFFER THAT AS A BENEFIT IF IT WAS ACCURATE AND VALID THEY WOULD HAVE THE RIGHT TO DO THAT. THERE IS A DIFFERENCE BETWEEN WHAT WE PAY FOR WITH PUBLIC MONEY AND WHAT SOMEBODY ELECTS TO DO ON A, YOU KNOW, A PRIVATE MONEY BASIS SO WE JUST NEED TO KEEP THAT IN MIND, TOO AND WHERE WE PUT THESE DIFFERENT KINDS OF STATEMENTS IN THE BODY OF THE DOCUMENT.
MARTIN, DID YOU HAVE YOUR HAND RAISED?
YEAH, I THINK THERE IS A QUESTION, I GUESS I HAD A QUESTION ON WHERE IS SAYS CLINICAL THERE AT THE BO BOTTOM. IS THAT SYNONOMOUS WITH THERAPEUTIC? I GUESS BASED ON THE DIALOG THAT REED HAS THERE IS THAT WHERE THAT IS BASED IS INFORMATIONAL VERSUS CLINICAL BENEFIT? I GUESS JUST IN GENERAL I THINK THIS IS A REAL TOUCHY AREA WHEN YOU GET INTO THE QUESTION OF WHETHER IT IS THERAPEUTIC IN THESE CASES. IS IT THERAPEUTIC TO THE INFANT AND I DON'T KNOW THAT YOU WILL HAVE A SITUATION WHERE THE GOVERNMENT IS GOING TO RECOMMEND SOMETHING TO PRIVATE INSURERS THAT IT IS NOT GOING TO PAY FOR ITSELF. THAT WOULD SEEM TO BE NOT, YOU NO IN SYNCH FOR THE GOVERNMENT TO DO THAT. GLL I ALSO WOULD JUST POINT OUT THERE MAY NOT BE ANY UTILITY, IMMEDIATE UTILITY TO CARRIER TESTING BUT I DON'T THINK THAT IS SOMETHING THAT WE SHOULD DISCOURAGE COVERAGE OF CARRIER TESTING.
BARBRA?
THINK LIKE WISE IF WE GO WITH THE HUNTINGTON'S EXAMPLE, YOU CAN'T DO ANYTHING WITH HUNTINGTONS KNOW AND IT DOESN'T HAVE MUCH PUBLIC UTILITY IN THAT BEFORE ACQUIRE SYMPTOMS THERE IS NOTHING THAT COULD BE DONE. THAT IS A WHOLE GROUP LIKE THIS WHO COULD MAKE THE DISTINCTION OF HUNTINGTONS VERSUS SEX OF THE CHILD. KIND OF DEPENDING WHAT YOUR ARGUMENTS ARE. THAT IS KIND OF THE PURPOSES FOR THINGS LIKE THIS AND NOT US TRYING TO FLUSH OUT WHAT A APPROPRIATE AND WHAT IS NOT.
IT IS ONLY GOING TO GET MORE COMPLICATED SO WE ARE TALKING WITH THE ASSUMPTION THAT A GENETIC TEST IS GOING TO BE AN ON OFF ANSWER AND IF WE ARE TALKING ABOUT TRAITS AND WHERE THE ANSWER IS GOING TO BE THAT YOU HAVE A 64% RISK INSTEAD OF A 30% RISK NOW YOU'RE GETTING MORE COMPLICATED WHERE PEOPLE ARE GOING TO WONDER WHAT THE UTILITY IS OF KNOWING IT. THIS WHOLE AREA IS GOING TO GET MESSIER AND MESSIER AS FAR AS IF YOU ARE HOLDING IT TO A STANDARD OF IT IS DEFINITELY ACTIONABLE OR NOT.
AGNES?
IT IS NOT ONLY GOING TO GET MISSYER, IT ALREADY IS -- MESSIER, IT ALREADY IS BECAUSE IN THE ONCOLOGY ARENA WE HAVE BEEN FACED ABOUT BY CALLS FROM PEOPLE WHERE GENETIC TESTS ARE MADE AVAILABLE TO THE PUBLIC AND ONE IS OVARIAN CANCER AND LUCKILY THE FDA STEPPED IN AND AT LEAST THE CRITERIA WAS THAT THERE WAS NOT ENOUGH VALIDITY STUDIES DONE YET THAT COULD CONCLUSIVELY SAY THIS TEST IS READY TO BE PROVIDED AS A SCREENING TOOL. I THINK THAT SOME OF THESE GENERAL PRINCIPLES THAT WE ARE TRYING TO COME UP WITH EVEN IF WE HAVE THINGS LIKE THAT HOW MANY VALIDATION STUDIES ARE NECESSARY TO SHOW THE EFFECTIVENESS OF A TEST THAT COULD THEN MOVE IN INTO THE PUBLIC REALM. SECONDLY, JUST RECENTLY A TEST FOR LOOKING AT MODIFIER GREENS THAT WILL BE USED FOR THE GENERAL PUBLIC. NOT JUST HIGH RISK BUT FOR THE GENERAL PUBLIC TO DETERMINE WHAT MEMBERS OF THE GENERAL PUBLIC WILL BE AT RISK FOR BREAST CANCER SO THEY ARE ALREADY OUT THERE.
MUIN, DID YOU HAVE A -- REED?
YOU KNOW, BRAD'S COMMENT IS ACTUALLY TERRIFIC AS WELL AS AGNES. I'M JUST STARTING TO WONDER THEN OBVIOUSLY WE CANNOT SOLVE THIS BUT WHAT WE HAVE TO -- I'M SORT OF THINKING IN MY MIND IS WHAT NEEDS TO BE DIFFERENT A YEAR FROM TODAY SO THAT WE ARE NOT SITTING AT THE SAME TABLE GOING OH, MY GOSH SOMEBODY OUGHT TO DO SOMETHING ABOUT MAKING THIS MAKE SENSE. I GUESS IT WOULD BE -- AT LEAST IN MY MIND I WOULD LOVE TO FRAME THE ISSUE EVEN TIGHTER THAT SAYS, YOU KNOW, HERE ARE THE SET OF CONUNDRUMS. HERE IT SOMETHING NEW THAT INTRODUCE A NEW LEVEL OF UNCERTAINTY AND COMPLEXITY THAT IS DIFFERENT FROM BEFORE. AS A RESULT OF THAT THERE ARE THE FOLLOWING KINDS OF DECISIONS THAT HAVE TO BE MADE AND THEY INVOLVE THESE CATEGORIES OF ISSUES. THE CURRENT ORGANIZATION OF KNOWLEDGE THAT SOLVES THOSE PROBLEMS IS COMPRISED OF THE FOLLOWING GROUPS. THEY ARE INADEQUATE. AND AS A RESULT THERE NEEDS TO BE SOMETHING ELSE IMMEDIATELY PUT IN PLACE THAT MER MITTS THIS WORK TO GO -- PERMITS THIS WORK TO GO FORWARD IN AN ORGANIZED WAY. I THINK WHAT WE OUGHT TO BE CALLING FOR HERE IS THE BODY OF PEOPLE -- THE RIGHT AGENCY THAT IT NEEDS TO BE LOCATED IN TO MAKE SURE THAT WE ARE NOT HERE A YEAR FROM NOW HAVING GONE NO WHERE. AND THAT IS TO ME -- I THINK THAT IS WHAT THE RECOMMENDATION ULTRAULTIMATELY IS TRYING TO SAY. MAYBE NOT PRESCRIPTIVE ABOUT WHAT THE GROUP DOES. WELL, WE NEED TO BE PRESCRIPTIVE. I GUESS I CAN'T TAKE IT ANY FURTHER THAN IN. BUT IS THERE ANYBODY -- IS THERE ANYBODY IN GOVERNMENT TODAY THAT IS CHARGED WITH THINKING THESE ISSUES THROUGH FOR THE GOVERNMENT? I MEAN WHO IS IN CHARGE OF THIS? SO THAT, YOU KNOW, BRAD SAYS -- WHAT HAPPENS WHEN THE TEST IS 64% VERSUS -- WHO THINKS ABOUT THIS?
PART OF THE PROBLEM HERE, REED, IS THAT THE EFFORTS ARE FRAGMENTED THROUGHOUT THE SISTER ATCIES HERE. WE ALL HAVE A PIECE OF THE ELEPHANT AND THAT WHOLE ELEPHANT NEEDS TO BE CONSTRUCTED IN A WAY THAT, YOU KNOW, THE WHOLE IS BIGGER THAN THE SUM OF THE PARTS AND I THINK, YOU KNOW, COMING BACK TO WAS IT YOU OR ED THAT MENTIONED ABOUT THIS SORT OF HHS LEVEL C ZAR OR CZARINE SO SORT OF PUT IT TOGETHER. WE HAVE FRAGMENTATION.
AND REED, DO YOU FEEL IT SHOULD BE ONE AGENCY OR GOVERNMENTAL ENTITY OR DOES THE GROUP THINK THAT PERHAPS WE MIGHT CONSIDER SOME SORT OF TASK FORCE OR COMMISSION THAT HAS THE RELEVANT AGENCIES INVOLVED BUT ALSO THE EXPERTS FROM THE PRIVATE INSURANCE WORLD AND OTHER STAKE HOLDERS?
BOY, I -- I WAS -- A GREAT QUESTION AND I THINK WHAT I'M REALLY INFLUENCED BY WHAT MUIN SAID AND THAT IS THAT IT SOUNDS LIKE THIS NEEDS TO BE AT A MINIMUM ACROSS HHS. I'M NOT SURE, I HAVE TO THINK SOME MORE ABOUT WHETHER IT OUGHT TO INVITE PRIVATE SECTOR PEOPLE TO IT OR NOT.
ED?
YOU KNOW, I WAS REALLY QUOTING OUR ESTEEMED LEADER WHEN I BROUGHT THAT UP BEFORE SO -- WHO HAD MADE THE COMMENT IN THE PAST. I THINK HUNT WILLARD MIGHT BE IN A POSITION TO COMMENT ON THIS BECAUSE HE HAS TAKEN A POSITION OF LEADERSHIP IN A UNIVERSITY WHERE GENETICS AND GENOMICS USED TO BE A DEPARTMENT AND NOW HAS BEEN ELEVATED TO A HIGHER LEADERSHIP ROLE AT DUKE UNIVERSITY. I DON'T KNOW IF YOU COULD COMMENT ON WHETHER THAT IS FOR PURPOSES OF INTEGRATION ACROSS THE UNIVERSITY OR BECAUSE I THINK IS THE KIND OF THING, WE ARE LOOKING FOR INTEGRATION OF GENETICS ACROSS HHS AND PERHAPS DUKE IS A MODEL.
WELL, I RARELY CONCLUDE THAT AUKDEMIA IS A ACADEM IA IS A RODLE FOR GOVERNMENT TO FOLLOW. WHETHER THERE IS A BODY IS THE QUESTION. OUR MANTRA AT DUKE IS THIS IS NOT JUST SCIENCE ANY MORE. THIS IS SCIENCE AND POLICY TOGETHER SO YOU CAN'T POINT TO ANY ONE OF THE HHS ENTITIES SPECIFICALLY AND SAY GREAT, YOU ARE THE ONE WHO SHOULD BE IN CHARGE BECAUSE THEY ARE THE ONES WHO SHOULD BE IN CHARGE OF SOME PART OF THE PIE BUT THEN THERE IS NO ONE TOOLLY WASHING THE ENTIRE PIE. IT IS A REASONABLE RECOMMENDATION FOR US TO DEBATE, ALTHOUGH ONE AT LEAST I PERSONALLY ALWAYS HESITATE TO RECOMMEND YET ANOTHER LEVEL OF BUREAUCRACY ABOVE THE EXISTING LEVELS OF BUREAUCRACY BUT IN THIS CASE A COORDINATING BODY OR A COORDINATING OFFICE MAYBE THERE IS SOMETHING TO BE SAID FOR THAT.
STEVEN D YOU HAVE --
MUIN'S COMMENT WHICH IS THAT IS IT IS A COLORFUL MOSAIC OF REGULATORY CONTROLS IN PLACE THAT ACTUALLY ARE DRIVEN BY VERY DIFFERENT STATUTORY BASIS AND CULTURE AND YOU HAVE THE BROAD BASE OF THE CLIA PROGRAM AND THE ANALYTICAL PERFORMANCE AND CLINICAL PERFORMANCE IN TERMS OF THE SURROGATE OUTCOME ON A DEVICE BY DEVICE SPECIFIC BASIS AND THEN CMS OR AETNA OR BLUE CROSS BLUE SHIELD OR KAISER OR ANYBODY ELSE TO ACTUALLY PAY FOR THE DAMN THING AND IN THAT CASE THEY ACTUALLY -- I DON'T KNOW THAT THEY WILL ALL UNIFORMLY FOLLOW DR. ROLLINS' SUGGESTION THAT YOU BEFORE ORDERING A TEST YOU DECIDE WHAT YOU WILL DO IF IT IS POSITIVE AND WHAT YOU DOLL DO IF IT'S NEGATIVE AND IF YOU DO THE SAME THING DON'T ORDER THE TEST AND IF YOU DON'T KNOW DON'T ORDER THE TEST. I DON'T KNOW WHO DOES OR WHO DOESN'T DO THAT. DO I KNOW WHEN THE RUBBER HITS THE ROAD AND CMS MAKES PAYMENT DECISIONS AND I ASSUME THE SAME IS TRUE FOR BLUE CROSS BLUE SHIELD, AETNA, KAISER AND OTHERS THAT THERE IS THE INTRODUCTION OF SOME KIND OF COST-EFFECTIVENESS DETERMINATION OR SOME KIND OF UTILITY DETERMINATION EVEN IF YOU DON'T ACTUALLY KNOW THE UTILITY WHICH PERHAPS TRANSCENDS BOTH CLIA AND FDA.
AL LAN AND THEN REED?
THIS IS A MULTITIERED ANALYSIS AND DIFFICULT. OBVIOUSLY I THINK EVERYBODY WHO WOULD BE AGAINST COORDINATION, I MEAN THE SAME PEOPLE AGAINST MOTHERHOOD AND APPLE PIE, I SUPPOSE. IF YOU TOO TIGHTLY COORDINATE, FIRST OF ALL, THE QUESTIONS WOULD BE LAG REGULATIONS AND -- REGULATIONS AND LAWS THAT WOULD ALLOW YOU TO DO THAT ARE ARE QUESTIONABLE. WE DON'T HAVE A CZAR WIN THE FEDERAL GOVERNMENT. MAYBE YOU WOULD ARGUE YOU WOULD BE BETTER FOR THAT. I'M NOT SURE THAT WE WOULD BE IF SOME WAYS HAVING A MULTITUDE OF DIFFERENT FOLKS COMING FROM DIFFERENT PERSPECTIVE IN THE FEDERAL GOVERNMENT IS A GOOD IDEA. COORDINATION WOULD BE A GOOD IDEA. WE WANT TO FAVOR THAT BUT THE QUESTION IS HOW DO WE FAVOR COORDINATION WITHIN WHAT SORT OF ALLOW SOME DIFFICULTY IN KEY CREATING COMPLETE DIFFERENT WAYS TERMS OF DEALING WITH GENETIC OR GENOMIC. AND ALSO THE QUESTION OF COORDINATING THINGS WITHOUT MAKING THINGS KIND OF MONOLITHIC KIND OF THINGS. IT IS A DIFFICULT KIND OF JUGGLING ACT.
REED AND MUIN?
WE HAVE A LOT ON THE TABLE HERE. FIRST I THINK ONE GOOD MODEL FOR HOW EVERYBODY BENEFITS FROM WHAT GOVERNMENT DOES AND PUBLIC RESOURCES AND SERVICE TO THE NATION IS THE U.S. PREVENTIVE SERVICES TASK FORCE. NOW, HERE IS THE PLACE WHERE GIN KNOW EVERYBODY UNDERSTANDS WHERE THAT THAT -- THAT WE HAVE THE BEST SCIENTISTS THAT WE HAVE FIND IN PREVENTION, YOU KNOW, WHO LOOK AT THE LITERATURE, CAREFULLY AND THOUGHTFULLY, ANALYZE THAT IN A PUBLICLY TRANSPARENT WAY AND MAKE VERY SPECIFIC RECOMMENDATIONS. AND THEN THOSE RECOMMENDATIONS ARE AVAILABLE FOR PEOPLE OUTSIDE OF GOVERNMENT TO BENEFIT FROM AND MAKE DECISIONS BASED UPON IT. IT IS A TERRIFIC PUBLIC SERVICE AND A GOOD USE OF TAX DOLLARS IN MY OPINION. SO, IF YOU TAKE THAT IDEA AND YOU SAY HERE IS A SPECIAL NEW AREA OF CONCERN, I WOULD SORT OF BE SAYING I DON'T THINK, ALAN THAT WE NEED TO NECESSARILY CREATE A WHOLE ANOTHER LASTING BUREAUCRACY. MAYBE IT IS THAT WE ASK THE GOVERNMENT TO BRING ITS BEST THINKERS TOGETHER FOR A TASK AND THE TASK IS WE IDENTIFY THAT THERE IS A CHALLENGE THAT NEEDS ORGANIZED THING ACROSS CLIA, ARC, CDC, ET CETERA, ET CETERA AND THE TASK IS THAT THERE ARE SOME SPECIFIC QUESTIONS AROUND THEW NEW TECHNOLOGY, THESE NEW INTERVENTIONS THAT ARE DIFFERENT AND THEREFORE REQUIRE SOME THOUGHTFULNESS. WE WANT YOU TO USE THE FEDERAL RESOURCES TO BRING IT TOGETHER TRANSPARENTLY AND THEN MAKE THAT INFORMATION AVAILABLE FOR CMS AND OTHERS TO BE ABLE TO TAKE ADVANTAGE OF AND WE DEFINE IT VERY SPECIFICALLY IN TERMS OF THE RANGE OF ISSUES THAT WE WANT. LET THE GOVERNMENT FIGURE OUT HOW TO PULL THE PEOPLE TOGETHER. DON'T CREATE ANOTHER BUREAUCRACY. WHEN THEY FINISH THEIR TASKS THEY ALL GO HOME AND THE INFORMATION IS THEN -- THEY NEED TO REVISIT IT AT SOME PERIOD AND REFRESH IT PERIODICALLY AND THAT IS FOR THEM TO DECIDE BUT THEN EVERYBODY HAS THE BENEFIT OF IT. JUST ONE IDEA FOR YOU TO SHOOT AT IS THE WAY TO GO.
MUIN?
I THINK THIS IS KIND MUCH THE MODEL THAT WE ADOPTED WITH THE EGAP INITIATIVE. WE HAD A LOT OF DISCUSSION WITH ARC BEFORE WE LAUNCHED THE EGAP INITIATIVE PAUSE THE U.S. PREVENTIVE SERVICES TASK FORCE IS THE GOLD STANDARD. THE PROBLEM IS AS LINDA PRESENTED YESTERDAY IS THAT THE U.S. PREVENTIVE SERVICES TASK FORCE FOCUSES A LOT ON CLINICAL UTILITY AND THE PRIMARY CARE SETTING AND IF YOU WERE TO DO AN ANALYSIS OF MOST GENETIC TESTS USING THE STRICT CRITERIA OF THE U.S. PREVENTIVE SERVICES TASK FORCE MOST OF THEM WILL NOT MEET THATTHRESHOLD. AS YOU SAID EARLIER, REED THAT THIS IS A COMPLETION NEW ARENA AND WE HERE THAT INFORMATION FOR THE SAKE OF INFORMATION, I.E. CLINICAL UTILITY COULD HAVE CLINICAL UTILITY BUILT IN BY KNOWLEDGE OF THE DIAGNOSIS BECAUSE IT COULD AVOID DIAGNOSTIC ODYSSEYS AND THEN YOU HAVE AN ACE ELEPHANT SITTING IN THE ROOM.
I DON'T WANT TO MOW KNOP LYZE THIS. I WANT TO -- MONOPOLIZE.
I DO NOT EMBRAZEN THE U.S. PROTECTIVE TASK FORS FORCE ARE IN ANY OTHER THING THAN THE PUBLIC ROLE OF MAKING AVAILABLE TO INFORM WHAT GOVERNMENT DOES AND THOSE OUTSIDE OF GOVERNMENT IN THE INTEREST OF THE NATION. IN DEFINITION ALMOST WHAT THAT TASK IS IS THE ANTITHESIS BECAUSE THE U.S. PREVENT IVG TASK FORCE IF IT DOESN'T HAVE 18 BA ZILLION ART CALS THEY DON'T RULE. THIS IS THE ANTITHESIS IN THE SENSE THAT THIS COULD BE GOING TO UNCHARTERED WATERS WHERE AS THE U.S. PREVENTIVE TASK FORCE ONLY GOES IN CHARTERED WATERS.
LINDA PRESENTED ON THIS YESTERDAY, I WOULD AGREE WITH YOU, ALLAN, THERE THERE IS NO NEED FOR AN INFECTIOUS DISEASE CZAR IN THE 21st CENTURY BUT IMAGINE INFECTIOUS DISEASE AT THE BEGINNING OF THE 20th OR 19th CENTURY WHEN THE TECHNOLOGY WAS NEW AND THIS IS WHAT WE ARE FACING WITH GENETICS. I DON'T KNOW HISTORICALLY WHETHER ANY ONE OF THE HHS WAS CHARGED WITH CONTROLLING INFECTIOUS DISEASES IN THE COUNTRY BUT I THINK THE CDC COMES AS CLOSE TO ONE AGENCY THAT WAS TASKED WITH -- ACTUALLY THE NAME WAS COMMUNICABLE DISEASE CENTER IN THE 40s AND 50s WHEN THIS WAS CREATED. I THINK THE MODEL REALLY APPLIES ONLY TO THE EXTENT THAT YOU JUST HAVE TO SUB EVACUATE 100 YEARS AND -- SUBTRACT 100 YEARS AND IF YOU LOOK AT GENETIC 100 YEARS FROM NOW THERE IS NO NEED FOR THAT KIND OF COORDINATION. I DON'T THINK THAT WE SHOULD TREAT GENETIC TESTS IN SUCH AN EXCEPTIONAL WAY. OTHERWISE WE WON'T HAVE ALL THE COMMITTEES FORMED FROM SA DPSMD HT TO SAGHS AND THE GOVERNMENT AND THE PRIVATE SECTOR DECIDED THAT GENETICS IS WORTHY OF A SPECIAL LOOK AND I THINK THE PRINCIPLES THAT WE ARE TALKING ABOUT AS WE MOVE FORWARD IN THE PRACTICE OF 21st CENTURY MEDICINE OR GENOMIC MEDICINE THAT WILL BE INTEGRATED AND CAN REALLY HAVE A LONG WAY IN TERMS MEDICINE IN GENERAL WHETHER OR NOT IT IS GENOMIC OR NOT, IN THE LONG RUN WE WANT HAVE TO GENOMICS AS AN INTEGRAL PART OF MEDICINE BUT HOW TO GET THERE IS SORT OF THE CHAL LEDGE THAT WE HAVE -- CHALLENGE THAT WE HAVE RIGHT NOW.
EMILY?
I SORT OF WANT TO AGREE WITH MUIN BUT GO A STEP EARLY. THE ISSUE IS REALLY WHAT DO YOU DO WITH EMERGING NEW MARKERS SO IT IS BROADER THAN JUST GENETICS EXCEPT THAT GENETICS IS PROBABLY THE VAST MAJORITY OF EMERGING NEW MARKERS AROUND ANY TIME THERE IS A NEW CANDIDATE MARKER FOR SOMETHING YOU GO THROUGH THIS PROCESS OF GATHERING EVIDENCE THAT THIS MARKER ACTUALLY HAS SOME USEFULNESS AND AT SOME POINT IN TIME WE NEED A GROUP THAT GETS TOGETHER AND SAYS OKAY WE AGREE THAT THIS IS READY AND IT SHOULD BE ADOPTED AND I THINK THAT IS PART OF THE THING THAT IS BEHIND THIS RECOMMENDATION IS HOW DO WE GET THERE AND THE FACT THAT A LOT OF THESE NEW MARKERS ARE GOING TO BE IN GENETICS JUST GIVES US SORT OF AN OPPORTUNITY TO PUT A GROUP WITH SOME SPECIAL EXPERTISE IN GENETICS TOGETHER TO DO THIS. BUT I THINK -- I GUESS I THINK WE ARE JUST SORT OF TALKING AROUND THIS AND NOT REALLY GETTING TO THE POINT OF MAKING A RECOMMENDATION AND I PERSONALLY THINK THE RECOMMENDATION IS NOT TOO BAD EXCEPT THAT I WOULD TAKE AND CHANGE THE WORD "COULD" TO "SHOULD." THE SECRETARY SHOULD TASK AN AAPPROPRIATE GROUP. AND THAT WOULD APPLY TO EMPLOYERS DOING PRIVATE INSURANCE AND TO PUBLIC HEALTH INTER. HEALTH INSURANCE. I ALSO THINK THAT THAT GROUP NEEDS TO HAVE REPRESENTATION NOT JUST FROM PEOPLE IN THE GOVERNMENT THAT IF IT GOING TO DEVELOP RECOMMENDATIONS THAT WOULD APPLY TO ALL THAT YOU HAVE TO BUILD CONSENSUS THAT EVERYONE WOULD AGREE THAT WHEN THIS GROUP MAKES A RECOMMENDATION EVERYBODY IS GOING TO BUY INTO IT AND YOU CAN'T GET THAT UNLESS YOU HAVE THE STAKEHOLDERS FROM THE PRIVATE SECTOR INVOLVED AS WELL.
EMILY, ARE YOU TALKING ABOUT AND ARE WE AS A GROUP TALKING ABOUT THE GROUP SPECIFYING WHEN A PARTICULAR TECHNOLOGY OR SERVICE SHOULD BE COVERED OR WOULD IT TAKE A STEP BACK AND BE A LITTLE BIT MORE VAGUE OR BROAD IN ESTABLISHED PRINCIPLES AND SAY THESE ARE THE PRINCIPLES THAT WE THINK EVERYBODY SHOULD APPLY AND THEN IN GOING THROUGH THAT PROCESS THEY WILL MAKE THEIR OWN INDIVIDUAL DETERMINATIONS AS TO WHETHER THEY WILL COVER SOMETHING OR NOT.
I THINK TO ESTABLISH A SET OF PRINCIPLES IS A GOOD AND USEFUL TASK FOR EVERYONE. I THINK SACGT TRIED TO DO THAT AND WENT THROUGH AN ALGORITHM OF WHEN DO YOU KNOW THAT SOMETHING HAS REACHED THE CLINICAL UTILITY THRESHOLD AND THERE THERE. A LOT OF MEDICAL SPECIALTY GROUPS STEPPED UP AND SAID ALL RIGHT WE'RE GOING TO MAKE A RECOMMENDATION WITHIN OUR DISEASE AREA SPECIALTY THAT THIS TEST IS READY AND SHOULD BE APPLIED IN THE FOLLOWING WAYS. IT AS FRAGMENTED THINK RIGHT NOW AND THE QUESTION IS JUST SHOULD WE AS A GROUP MAKE A RECOMMENDATION THAT THE SECRETARY OF HHS SOMEHOW CENTRALIZED THIS FUNCTION AND CREATE A GROUP THAT AT MINIMUM CREATES A SET OF PRINCIPLELES WHICH THEN COULD BE USED AND POTENTIALLY IF YOU READ THE WHOLE RECOMMENDATION HERE GOES FARTHER AND ACTUALLY SAYS OKAY AND OF THE TESTS WE KNOW TODAY HERE ARE THE ONES THAT ARE DEFINITELY NOT ON THE LIST AND HERE ARE THE ONES THAT ARE DEFINITELY ON THE LIST AND HERE ARE THE THINGS THAT ARE, YOU KNOW, WELL, BASICALLY EVERYTHING ELSE IS STILL IN THE GREY ZONE BECAUSE IT EITHER HASN'T BEEN EVALUATED YET OR THERE IS NOT ENOUGH BODY OF EVIDENCE TO PUT IT IN ONE BIN OR THE OTHER. THAT IS THE ONLY WAY YOU ARE GOING TO GET TO MAKE GOOD COVERAGE DECISION AND HAVE SOME UNIFIED COVERAGE OF NEW TESTS. AT SOME POINT THEY JUST CROSS THRESH ELD IN WE BELIEVE THIS IS USEFUL AND ALL CARRIERS PUBLIC AND PRIVATE SHOULD BE PAYING FOR IT.
IS IT SAFE TO SAY THAT THE GROUP FEELS THAT THERE IS SOMETHING SPECIAL ABOUT GENETICS AND GENOMICS THAT CRIES OUT FOR SOME ENTITY TRYING TO PROVIDE GUIDANCE TO EITHER THE PUBLIC SECTOR, THE PRIVATE SECTOR AND OTHERS? THAT IS THE FIRST QUESTION. DO WE FEEL THAT THERE REALLY IS A NEED FOR THIS GUIDANCE? AND THEN WE REQUEST GO ALL THROUGH THE -- ED?
I WOULD ARGUE THERE IS A NEED FOR THE GUIDANCE. I WOULD ARGUE THAT THERE IS A NOT A SPECIAL NEED FOR THE GUIDANCE BUT WE AREN'T TASKED WITH DEVELOPING GUIDANCE FOR INFECTIOUS DISEASES. WE ARE TASKED WITH DEVELOPING GUIDANCE FOR GENETICS. I BUT THERE IS A NEED.
WHAT WOULD BE THE MOST APPROPRIATE BODY TO ADDRESS THAT NEED? WOULD IT BE HHS AND LEAVE IT VIG? WOULD IT BE CONVENING A TASK FORCE THAT INCLUDES PUBLIC AND PRIVATE SECTOR STAKEHOLDERS? WOULD IT BE A PARTICULAR AGENCY? DO WE WANT TO RECOMMEND THE BODY OR DO WE KEEP IT AS IS WHERE IS SAYS HHS WILL CONVENE THIS GROUP AND WE DON'T SPECIFY ANY OTHER DETAILS? ED?
IN THE ORIGINAL IT SAYS THAT HHS WILL TASK A GROUP AND I ACTUALLY PREFER THAT LANGUAGE THAN ESTABLISH A GROUP BECAUSE IN FACT THE GROUPS MAY ALREADY BE ESTABLISHED AND I WOULD ALSO MAYBE EVEN MAKE IT VAGUE AND TASK GROUPS WITH THE "S" IN PARENTHESES BECAUSE THERE MAY BE A NEED FOR MORE THAN ONE KIND FROM ACE AND EGAP AND IT MAY NOT BE A ONE SIZE FITS ALL.
REED?
I WOULD AGREE WITH ED IN THAT IF I UNDERSTAND HIS POINT IS FIRST IT IS TASK INSTEAD OF ESTABLISH. THEREFORE IT DOESN'T LOOK LIKE YOU ARE CREATING A WHOLE SERIES OF REEXISTING BUREAUCRACY WHICH IS SOMETHING THAT HAS A LIFE OF ITS OWN. NUMBER TWO, I WE HAVE TO BE VERY SPECIFIC ABOUT WHAT THE PROBLEM THAT WE WANT TO GET VOFLED BUT LEAVE IT TO HHS TO FIGURE OUT HOW BEST TO DO IT BECAUSE AS WE HEARD FROM ALLAN AND MUIN, WE CAN'T POSSIBLY TRY TO FIGURE OUT ALL THE MACHINATIONS OF THE GOVERNMENT. ONLY THEY CAN FIGURE OUT HOW BEST TO USE THE RESOURCES AND WHO OUGHT TO BE IN CHARGE OF IT. IF THOSE ARE THE POINTS THAT ED IS ADDRESSING, I ENDORSE THOSE.
THERE SHOULD BE A GROUP TASK *F TASKED WITH PRODUCING THE GUIDANCE AND LEAVE IT TO HHS TO COME UP WITH THE APPROPRIATE GROUP O OR GROUPS TO DO THAT WORK? THEN THE NEXT LAYER IS WHAT IT THAT WORK? IF IT IS ESTABLISHING A SET OF PRINCIPLES AND GENERAL GUIDANCE THAT IS A GROUP THEN THAT COULD DO THE JOB AND THEN FOLD THEIR TENTS AND GO HOME. IF IT IS TO DO THAT PLUS ANALYZE SPECIFIC TECHNOLOGIES AND BE IN EXISTENCES IN PER TEW IN IN PER PA PER PA PER PA IN PERPETUITY.
WHAT IF WE GAVE THEM THE OPPORTUNITY AS PART OF THEIR CHARGE TO DETERMINE WHAT IF ANY THINGS NEED TO BE DONE AFTER THEY HAVE DONE THE WORK? AND MAYBE SORT OF MAKE THEM MAKE THE RECOMMENDATION BACK INSTEAD OF US TRYING TO PREDICT, YOU KNOW, WHETHER OR NOT -- I THINK THAT THE POINT WE TONIGHT HAVE ENOUGH INFORMATION, TO PUT IT TO THEIR CHARGE TO HAVE THEM DETERMINE WHAT IS THE MOST APPROPRIATE COURSE OF ACTION AND PUT A RECOMMENDATION BACK TO THE SECRETARY AND TO US.
DEBRA?
IS IS ONE THING TO DEVELOP THE GENERAL PRINCIPLES THAT COULD BE APPLIED TO TESTS X, Y AND Z OR THE PRINCIPLES APPLIED TO TESTS X, Y AND Z.
WE HAVE RECOMMENDATIONS TO PROVIDE THE EVIDENCE BASE TO MEDICAID AND MEDICARE AND I DON'T THINK THOSE WILL BE COMMUNICATED IN GENERAL PRINCIPLES SO IT HAS TO BE DONE ON A TEST BY TEST AND DISEASE BY DISEASE BASIS SO THE PROGRAMS CAN CHANGE WHAT THEY ARE DOING, WHAT YES ARE COVERING, WHAT THEY ARE REIMBURSING. I WOULD SEE A SERIES OF RECOMMENDATION. ONE WHERE YOU ESTABLISH THE GROUP TO PROVIDE THE PRINCIPLES BUT THEN THE PRINCIPLES HAVE TO BE SUPPLIED TO CREATE THE EVIDENCE BASE AND THEN THE EVIDENCE BASE IS DISTRIBUTED TO ALL THE PEOPLE WHO NEED TO KNOW THAT INFORMATION.
I DON'T THINK WE LEARNED IN THE THINGS WE LEARNED IN THE ACE PROJECT IS THAT YOU ARE DEALING WITH A LOT OF APPLES AND ORANGES AND WE HAVE ONLY TWO FIVE SIZE TEMPERATUREATIC REVIE -- SYSTEMATIC REVIEWS ALL THE WAY TO BRCA1 AND CHRONIC HEY MATOSIS. AT THE END OF THE DAY I HAVE TO AGREE THAT A GENERAL SET OF PRINCIPLES WILL NOT BE SUFFICIENT. AS A MATTER OF FACT, IT WON'T BE DIFFICULT TO COME UP WITH THE SET OF PRINCIPLES GIVEN ALL THE WORK THAT THE PREVIOUS COMMITTEES HAVE TON. IT IS THE APPLICATION OF THE GENERAL PRINCIPLES TO A TEST BY TEST BASIS IS GOING TO BE COME PLAY KATEED AND IT IS NOT ONLY A TEST BY TEST BASIS BUT BY INTENDED USE BECAUSE YOU HAVE USE THE SAME TEST FOR EITHER CARRIER TESTING OR SYMPTOMATIC AND PRESYMPTOMATIC AND ALL OF THE PARAMETERS CHANGE IN TERMS OF VAU LIDITY AND UTILITY AND IN TERMS OF THE ETHICAL ISSUES IF WE HAVE THE U.S. SERVICES TASK FORCE AS A GOLD STANDARD FOR HOW THOSE THINGS ARE DONE WITH EVIDENCE-BASED PRINCIPLES IN MIND THEN WE SHOULDN'T SHORT -- I MEAN WE SHOULDN'T SELL THIS VERY SHORT BECAUSE I THINK EACH ONE OF THESE TEST EVALUATION IS GOING TO INVOLVE A SYNTHESIS AND INTEGRATION OF THE AVAILABLE LITERATURE BOTH PUBLISHED AND NOT PUBLISHED. IT IS NOT CHEAP. IT MAY TAKE 6 MONTHS TO A YEAR TO EVALUATE WHAT IS GOING ON WITH A SPECIFIC TEST. I MEAN FOR ME IT IS NOT ROCKET SCIENCE TO FIGURE OUT THAT WHATEVER YOU TASK HHS TO DO WILL HAVE TO GO BEYOND COMING UP WITH THE SET OF PRINCIPLES BUT DEVELOPING THE APPROACH AND METHODOLOGY FOR HOW THE PRINCIPLES CAN BE APPLIED TO SPECIFIC SITUATIONS.
I HAVE GONE AHEAD AND FAST FORWARDED TO THE EVIDENCE-BASED RECOMMENDATION. WE WILL GO BACK TO THE OTHERS BUT WAND TO POSE THE QUESTION TO THE TSH BUT WANTED TO POSE THE QUESTION TO THE GROUP SHOULD THIS BE WOVEN INTO THE EARLIER RECOMMENDATION SO THAT WE TASK SOME SORT OF ENTITY, HHS TASKS ANEN AT THIS TIME TO COME UP WITH A SET OF PRINCIPLES THAT PROVIDES THE GENERAL GUIDANCE BUT THEN AS MUIN JUST MENTIONED AND DEBRA THAT THERE MAY BE A NEED TO GO FURTHER ON A TECHNOLOGY OR TEST BY TEST BASIS AND THAT IS WHAT THIS RECOMMENDATION GETS TO WHICH IS ASSESSING THE ACTUAL EVIDENCE FOR SPECIFIC TESTS AND TECHNOLOGY THIS GROUP WOULD ALSO BE CHARGED WITH THAT AFC AS WELL. DO -- CHARGED WITH THAT TASK AS WELL. DO WE WANT TO HAVE A TWO-PART COMPONENT TO THE CHARGE FOR THIS GROUP?
I WOULD ARGUE THAT THERE IS NO ONE GROUP THAT COULD DO ALL THE TESTS SO I THINK FOR EACH TEST YOU MAY HAVE TO HAVE A DIFFERENT GROUP WITH DIFFERENT ECK EXPERTISE, I DON'T KNOW. AND ONCE YOU HAVE THE PRINCIPLES I THINK THERE IS ANOTHER GAP WHICH IS HOW TO YOU DETERMINE WHICH TESTS TO DO THIS FOR? THE ONE WITH THE GREATEST PUBLIC HEALTH IMPACT? THE ONE WITH THE GREATEST PEN PENTRANTS IN THE POPULATION? THAT WOULD BE A COMPLEX PROCESS BECAUSE YOU'RE GOING TO DO THESE ONE AT A TIME AND IT WOULD TAKE TIME TO TO THAT.
I WISH HRX WAS HERE SO I'M PEEKING ON THEIR BEHALF SO FOR GIVE ME BUT IT IS ON THE WEBCAST. ONE OF THE PRINCIPLES OF THE TASK FORCE IS THAT YOU HAVE THIS INDEPENDENT BODY, 10-15 PEOPLE THAT MEETS THREE OR FOUR TIMES A YEAR. THEY CAN DECIDE, PEOPLE CAN COME TO THEM AND SAY OKAY, LET'S REVIEW THIS EVERYBODY FOR WHATEVER IT IS. WHETHER ASPIRIN PREVENTS HEART ATTACKS OR WHATEVER THE DECISION IS. AND THEN THEY DELIBERATION. THEY ARE INDEPENDENT AND THEY COMMISSION AN EVIDENCE-BASED CENTER AND THERE ARE MANY CENTERS AROUND THE COUNTRY THAT OBVIOUSLY PEOPLE SPECIALISTS IN CYSTIC FIBROSIS MAY NOT BE THE SAME AS BRCA1. BUT THEY LOOK AT THE EVIDENCE AND MAKE THE PRONOUNCE PTS UP OR DOWN AND CATEGORY OR QUALITY AND QUANTITY OF THE EVIDENCE. I GUESS THE EXPERIMENT WE ARE DOING THIS COLLABORATION WITH AHRQ TO DEFINE THE METHODOLOGY AND THEN EMULATE, SIMULATE THAT PRINCIPLE OF AN IN DEPENDENT BODY THAT DEALS WITH THE STATIONHOLDERS AND THEN COMMISSIONS THE SYSTEMATIC REVIEWS. BRING THEM BACK TO THE TABLE AND THEN MAKE SOME KIND OF PRO PRO PRONOUNCEMENT. I THINK WE FEEL THAT THIS IS AN AREA WHERE A LOT OF RESEARCH WILL HAVE TO BE DONE IS EYE IDENTIFY SPECIFICALLY THAT THE GAPS IN OUR KNOWLEDGE THAT CAN BE FUNDED IN THE PRIVATE SECTOR AND PUBLIC SECTOR SO THAT A YEAR DOWN THE ROAD THERE WILL BE A CHANGE IN THE RECOMMENDATION OR AT LEAST A STATEMENT ABOUT WHAT WE KNOW ABOUT THE GENETIC TESTS THAT WE WON'T GET STUCK FOR YEARS AND YEARS GOOD BUT NEXT YEAR MAYBE WE COME BACK AND REEVALUATE IT BASED ON NEW DATA. I THINK THIS IS A MOVING TARGET IN A LOT OF WAYS?
SO --
REED?
HOW DO YOU SEE -- I'M SORRY. HOW DO YOU SEE WHAT WE'RE PROPOSING HERE AS DIFFERENT FROM EGAP AND SHOULD WE JUST -- SHOULD WE JUST SUPPORT EGAP AND ASK THE SECRETARY TO GIVE THAT RESOURCES OR -- SO I THINK -- COMPARE AND CONTRAST.
NO, I DON'T THINK YOU SHOULD ENDORSE SPECIFIC ACTIVITY. YOU SHOULD ASK THE SECRETARY TO GET THE AGENCIES TO GET THEIR ACT TOGETHER AND SEE WHO IS DOING WHAT AND LET US COLLABORATE BECAUSE THERE MAY BE ANOTHER PRESCRIPTION TO DO THIS AND I CANNOT PRESUME THAT CDC HAS THE ONLY VALID WAY OF DOING THIS AND I THINK IT IS BETTER FOR YOU TO STAY A BIT OVER, YOU KNOW, 10,000 FEET RATHER THAN GO DOWN ON THE GROUND WITH US. BUT BY CONVENING -- BY ASKING FOR THIS THEN THE SECRETARY CAN POLL THE AGENCIES AND GET THEM TOGETHER AND SAY WHO IS DOING WHAT AND LET'S FIGURE OUT HOW TO DO IT BEST.
AS I'M LISTENING TO DEBRA AND MUIN I'M GETTING MORE AND MORE CONVINCED AND CONFIDENT THAT WE HAVE ASSESSD THAT THERE IS A PROBLEM. HERE IS THE PROBLEM. WE HAVE ASSESSD THAT CERTAIN THINGS ARE GOING ON BUT THEY ARE NOT ADEQUATE, THEREFORE, THIS NEEDS TO OCCUR, YOU NEED TO MAKE THIS HAPPEN. WE WANT THIS DONE BY A CERTAIN TIME PERIOD BECAUSE IT NEEDS TO BE DONE AND THAT IS WHAT IT REALLY KEEPS COMING DOWN TO. JAMES, I WONDER ON NUMBER ONE LET'S SAY FOR YOU GUYS, DON'T YOU DO THIS?
YES.
AND I I GUESS THE QUESTION ULTIMATELY COMES WHAT DO YOU DO OR WHAT IS LACKING OR WHAT WOULD YOU HAVE THAT WOULD MAKE YOUR JOB MORE EFFECTIVE IN THIS NEW ERA THAN YOU HAVE TODAY SGLSMT?
EVERYTHING THAT IS MENTIONED IN NUMBER ONE IS WHAT WE DO WE BE ASSESS A NEW TECHNOLOGY OR PROCEDURE OR SURGICAL TECHNIQUE OR LABORATORY TEST. THOSE ARE THE PROCESSES BY WHICH WE ESTABLISH SOMETHING HAS SHOWN SUFFICIENT EVIDENCE OR HAS NOT SHOWN SUFFICIENT EVIDENCE.
SO THE QUESTION COMES BACK TO IS IS CAN WE ARTICULATE AND I'M THIS, I THINK, CAN WE ARTICULATE THE SET OF ISSUES THAT ARE OF CONCERN, THE SET OF THINGS THAT REQUIRE NEW PRINCIPLES? THE SET OF CONNUNDRUMS THAT ARE UNIQUE TO THIS AREA? CAN WE DESCRIBE WITH GREATER SPECIFICITY THE CONFUSIONS BROUGHT BY PREDICTIVE TESTS THAT MAY NOT HAVE CLEAR CLINICAL CORRELATES? CAN WE DEFINE WITH PRECISION THE COST-EFFECTIVENESS DECISIONS AROUND INTRODUCING NEW TECHNOLOGY WHEN, IN FACT, THERE MAY NOT HAVE BEEN ANY INTERVENING INTERVENTION WHICH WHICH TO COMPARE IF THAT IS EVEN COST-EFFECTIVE TOO, IF THAT IS EVEN ENGLISH. START OFF WITH WHAT WOULD BE THE LIST OF CONCERNS AND THEN FRAME THOSE BACK AND SAY HERE IS WHAT WE ARE TALKING ABOUT AS THE RANGE OF ISSUES THAT WE THINK THAT THAT GROUP NEEDS TO LOOK AT AND THAT YOU, JIM, AND YOUR AGENCY WOULD BENEFIT FROM HAVING THAT INFORMATION TOGETHER SO THAT YOU CAN IN FACT THROUGH THE EXISTING PROCESS MAKE THE DECISIONS YOU NEED TO MAKE AND THE INFORMATION AVAILABLE TO THE PUBLIC FOR OTHER.
I THINK SOME OF THE THINGS THAT YOU ASKED SUP AS COST-EFFECTIVENESS AND THINGS ON THAT ORDER THAT IS SOMETHING THAT WE -- THAT IS SOMETHING THAT WE HAVE -- ACTUALLY NOT BEEN CHARGED TO DO. I'M -- BUT I'M SURE THAT INFORMATION CAN BE DERIVED FROM SOME OTHER SOURCE WHICH COULD USED TO SUPPLEMENT DECISIONS. IN TERMS OF SOME OF THE OTHER THINGS WHICH YOU HAVE RECOMMENDED, I DO THINK THAT BASED ON WHAT IT IS THAT WE CURRENTLY PROVIDE THATCY ADDITIONAL INFORMATION CAN SUPPLEMENT US IN TERMS OF PROVIDING ADDITIONAL INFORMATION OR PROVIDING ADDITIONAL INFORMATION FOR OTHER USES.
WE HAVE TO KEEP IN MIND AS WELL, THOUGH, THAT WE ARE ALSO TALKING ABOUT PRIVATE PLANS AND SOME PLANS HAVE VERY EYE -- AS IDENTIFIED IN THE REPORT VERY ELABORATE GUIDELINES AND PROCESSES THAT THEY GO THRAO AND HAVE RUN ABOUTING TO SHARE THAT PUBLICLY WHEN THEY MAKE THE DETERMINATIONS. OTHERS MAY NOT AND IT MAY NOT BE SO TRANSPARENT. SO THE EXTENT IT MAY BE THAT CMS THIS PROCESS IN PLACE BUT MAYBE IN THE PRIVATE SECTOR IT DOESN'T EXIST OR SOME DO AND SOME DON'T. SO THERE MAY BE SOME VALUE IN HAVING SOMEONE OUTLINE THAT SO THAT THE GENERAL PUBLIC WILL BE AWARE OF WHAT GOES INTO A COVERAGE DECISION-MAKING DECISION -- COVERAGE DECISION AND IT IS NOT JUST SOME HOLE THAT, YOU KNOW, THE REQUEST IS IN AND NOBODY KNOWS HOW THE DECISION IS REALLY REACH.
I'M AFRAID WE HAVE TO DO A SOME WHAT BETTER JOB OF ARTICULATING WHAT THE PROBLEM IS. I THINK WE PROBABLY ALL SOME WHERE IN OUR GUTS THINK THERE IS A PROBLEM BUT IF I JUST HEARD FROM DR. ROLLINS THAT CMS IS DOING NUMBER ONE THEN I EITHER NEED TO HEAR THAT CMS ISN'T HAPPY WITH THE JOB THEY ARE DOING OR THAT SOMEONE ELSE SNTD ISN'T HAPPY WITH THE JOB THEY ARE DOING SO SAY NOW WE IDENTIFIED A GAP. WE EITHER NEED MORE INFORMATION TO WITH A DIFFERENT ANSWER THAN CAME UP. THE SAME QUESTION COULD BE ASKED OVER AND OVER AGAIN. MY CONCERN IS WE JUST ARE NOT DRILLING DOWN TO A VERY CONCISE STATEMENT OF WHAT THE ISSUES ARE OTHER THAN THERE IS UNIFORM ANGST AND I THINK WE PROBABLY NEED MORE THAN THAT.
DR. ROLLINS, IS THAT THAT -- I KNOW THAT CMS UNDERTAKES THIS TYPE OF PROCESS IN NUMBER ONE FOR ALL MEDICAL SERVICES AND TECHNOLOGIES. WOULD YOU SAY THAT YOUR ABILITY TO UNDERTAKE THAT PROCESS IN THE AREA OF GENETICS IS HAMPERED IN ANY WAY BECAUSE OF THE LACK OF EVIDENCE OR DO YOU FEEL THAT CMS HAS WHAT IS NEEDS TO PROCEED WITH THAT PROCESS IN THAT AREA?
I THAIFERPG CMS IS -- I THINK THAT CMS IS CAPABLE OF PURSUING ANY REQUEST PERTAINING TO THE EFFECTIVENESS OF GENETIC TESTS. SO I DO THINK THAT THEY HAVE THE -- AS LONG AS THERE IS INFORMATION OUT THERE AVAILABLE TO ASSESS WE ARE IN A POSITION TO MAKE THOSE DECISIONS. ZWR.
THEN HUNT GOES BACK TO THE ORIGINAL THRESH ELD QUESTION IS IS THERE A UNIFORM FEELING THAT GUIDANCE IS NEEDED? IS THERE A PROBLEM OR DEFICIENCY IN THE FIELD OF GENETIC AND GENOMICS THAT CRIES OUT FOR SOME SORT OF GUIDANCE BAY FEDERAL BODY OR A FEDERALLY TASKED OR CHARGED BODY.
I'LL MAKE A QUICK COMMENT. WHEN ASSESSING THE -- WHEN LOOK AT A TECHNOLOGY NOT ONLY WITH CMS BUT ALSO THE COMMERCIAL PLANS IN TERMS OF COVERAGE DECISIONS THEY BASE THEIR DECISION ON THE EFFECTIVENESS OF THAT PARTICULAR TECHNOLOGY. IN THERE IS OTHER QUESTIONS WHICH GO BEYOND THAT SUCH AS COST-EFFECTIVENESS OR YOU -- CERTAIN TYPES OF UTILITY, THAT IS SOMETHING THAT, YOU KNOW IS, BEYOND WHAT IT IS THAT WE LOOK AT. WE ESSENTIALLY LOOK AT LITERATURE IN TERMS OF DETERMINING WHETHER OR NOT A TEST IS EFFECTIVE OR NOT EFFECTIVE. ANY ADDITIONAL QUESTIONS BEYOND THAT MIGHT BE SOMETHING ELSE THAT MIGHT, YOU KNOW, WE MAY NOT ADDRESS OR OTHER PLANS MAY NOT ADDRESS AND FOR THAT REASON ADDITIONAL INFORMATION MAY BE NEEDED OR ADDITIONAL DIRECTION MIGHT BE NEEDED TO ADDRESS THOSE ADDITIONAL QUESTIONS.
AGNES?
I JUST HAVE A QUESTION FOR YOU, DR. ROLLINS, THAT IF A TEST, THOUGH, WAS DEEMED TO BE A SCREENING TEST AND WOULD NOT BE COVERED BY MEDICARE AND MEDICAID WOULD THEN CMS UNDERTAKE THIS TYPE OF ASSESSMENT?
WE DO COVER DIAGNOSTIC SERVICE IS AS WE DISCUSSED YESTERDAY IN TERMS OF SCREENING SERVICES, SCREENING DIAGNOSTIC SERVICES. THAT IS SOMETHING THAT HAS NOT BEEN REQUIRED -- SOMETHING THAT HAS NOT BEEN MANDATED BY THE GOVERNMENT FOR US TO DO BUT AS I SAID, DIAGNOSTIC TESTS, YES.
HUNT. IN.
A ESSENCE THE ISSUE COMES DOWN AND I'M NOT SURE WHETHER WE CAN DO IT THAT EITHER WE HAVE TO OR WE NEED TO CHARGE -- RECOMMEND TO THE SECRETARY OF HHS THAT HE ATTEMPT TO DO WHAT THE SUPREME COURT REFUSED TO DO FOR PORNOGRAPHY DECADES AGO WHICH IS TO TRY TOO DEFINE EXACTLY WHERE THE GREY ZONE IS WHICH IS ALMOST OXY MORONIC. WE AGREED THAT TESTING FOR BLUE EYES OR BROWN EYES IS NOT OF VALUE AND WOULDN'T BE EFFECTIVE SO THOSE ARE POLE ARE. BUT THE AREA IN THE MIDDLE UNLESS WE FEEL WE CAN BRING SOMETHING NEW TO THE TABLE OR SOME OTHER GROUP IS GOING TO BRING SOMETHING NEW TO THE TABLE TO DEFINE BETTER THE GREY ZONE I'M NOT SURE WE HAVE MUCH TO ADD TO THE DIALOGUE EXCEPT THAT THERE IS A GREY ZONE AND IT IS GOING TO TAKE GREAT CARE AND THOUGHTFULNESS ON MANY PEOPLE'S PART TO CONTINUE TO EVALUATE THIS OVER TIME. ( INAUDIBLE ).
REMEMBER, WE WERE TALKING ABOUT TWO DIFFERENT -- TWO DIFFERENT PARTS TO THE CHARGE. THE FIRST WAS A SET OF PRINCIPLES WHICH WOULD LOOK AT ISSUES SUCH AS THE INFORMATIONAL UTILITY, MEDICAL EFFECTIVENESS, THE PREVENTIVE NATURE OF GENETIC SERVICES AND HAVE THESE GENERAL PRINCIPLES DEVELOP SO THAT THEY COULD SERVE PUBLIC AND PRY VOTE SECTORS. THE SECOND PART FTC THE TEST BY TEST TECHNOLOGY BY TECHNOLOGY BASED ON THE EVIDENCE AND IT SOUNDS LIKE THAT SECOND PART MAY ALREADY BE -- MAY NOT BE A PROBLEM. CMS FEELS THAT IT DOES THAT AND CAN DO THAT. THERE IS A QUESTION ABOUT WHETHER THE PRIVATE SECTOR UNIFORMLY DOES THAT OR WHETHER THERE IS SOME NEED FOR GUIDANCE THERE. BUT IF WE GR GOING BACK TO THE BEGINNING HUNT ARE YOU SUGGESTING IS FIRST CHARGE THAT WE TALKED ABOUT WHERE WE HAVE THEM ESTABLISH -- A GROUP ESTABLISH A SET OF PRINCIPLES MAYBE ISN'T CLEARLY NECESSARY?
I'M CERTAINLY OPEN TO THE POSSIBILITY THAT A GROUP COULD COME UP WITH A SET OF PRINCIPLES SAYING THIS IS WHAT WE MEAN BY THE FIVE PRY AND THESE ARE AT THE THREE AND THERE MIDDLE THAT WE CAN'T REALLY DECLARE. IF WE FELT THAT THERE WAS A GROUP THAT COULD PROVIDE SUFFICIENTLY PRO BUST AND SPECIFIC GUIDANCE ON WHAT IS AT THE LEFT AND WHAT IS ON THE RIGHT THEN THERE WOULD BE SOME VALUE TO SIMPLY TO DISCUSS YEAR AFTER YEAR TO SAY THERE ARE THINGS TO THE RIGHT AND THINGS TO THE LEFT AND THINGS RIGHT IN THE MIDDLE I'M NOT SURE IT IS WORTH THE RECOMMENDATION OR THE DOLLARS THAT WOULD FLOW THEREFROM TO PUT THE GROUP TOGETHER.
LET ME GIVE A PROCESS CHECK. WE ARE AT 12:07. WE SORT OF END THIS PART AT ABOUT 12:30 ALLOWING US TO DO A WORKING LUNGE AND BREAK IN LUNCH AND BREAK AND START AT 1:00 WITH THE TESTIMONY FROM THE PUBLIC. YOU HAVE THROUGH AS WELL SO I THINK WE NEED TO FIGURE OUT HOW TO NAIL THIS ONE DOWN. THE OTHER COMMENT IS WHAT THE SOLUTION.
YOU ARE WORKING FROM AN OLD SCHEDULE BECAUSE THAT IS NOT THE SCHEDULE IN OUR FOLDERS.
I HAVE GOT WE HAVE GOT THIS IDEA OF SUM UP AND DECISIONS AND PLANS FOR GATHERING PUBLIC COMMENT AROUND 12:30 ONE. SORT OF LIKE A PLACE HOLDER FOR FINISHING THIS SO THAT IS WHY I'M SAYING WE HAVE UNTIL 12:30 AND THEN WE HAVE THE WORKING LUNCH WHICH WE HAVE GOT TO DO.
DID I MISS SOMETHING?
OF COURSE,.
THERE IS --
OF COURSE. WHY WOULD YOU CALL ME TO TASK ON THAT.
I ABSOLUTELY HAVE SKIPPED A BREAK BECAUSE WE DON'T NEED TO TAKE A BREAK AND GO TO LUNCH.
THE BREAK IS TO GET HUNDRED GLCH WE GO TO 12:30 AND THEN TAKE THE BREAK AND GET THE LUNCH AND COME BACK AND DO PUBLIC COMMENTS.
WE ARE GOING TO TAKE THE TEN MINUTE BREAK AND THEN BRING THE LUNCHES BACK AND THEN KEEP TALKING BECAUSE YOU GOT TO TALK WHILE YOU EAT BECAUSE WE CAN'T -- OTHERWISE YOU GOT TO PAY MONEY FOR YOUR LUNCH. SO WE HAVE UNTIL 1230. YOU HAVE UNTIL 12 PO TO BRING IN TO CLOSURE.
BRAD AND EMILY?
MY SUGGESTION WAS IF WE ARE CONCERNED ABOUT TESTS THAT MIGHT NOT BE COVERED AND PARTICULARLY WITH CMS JUST TO CLARIFY WHAT DR. ROLLINS SAID IS IF THERE IS INFORMATION AVAILABLE THEN CMS EREVIEWS IT AND USES IT SO MAYBE WE CAN ADD IN SITUATIONS WHERE INFORMATION IS AVAILABLE THAT CMS COULD SPEAK UP ABOUT IT. WHAT WE ARE CONCERNED IS QHE -- CORRECT ME IF I'M WRONG THAT WE ARE CONCERNED THAT IN THIS CERTAIN SITUATIONS TESTS FALL IN L. A. L. A. LAND AND DON'T GET COVERED BECAUSE THERE HASN'T BEEN ANY ONE BUILDING A CASE FOR IT AND CMS IS OPEN TO REVIEWING INFORMATION AND USING IT IF INFORMATION FOR NECESSITY OR VALIDITY IS THERE BUT THAT IS ONLY WHEN THE INFORMATION IS THERE. SO IF THE INFORMATION ISN'T THERE, WHAT DO YOU DO? MAYBE WE WENT WITH THE RECOMMENDATION WOULD BE THAT IF THERE ARE GAPS TO HAVING THAT INFORMATION THEN SOMETHING HAS TO HAPPEN.
WELL, A POINT THAT WAS RAISED EARLIER, C MS WOULDN'T UNDERTAKE TO LOOK AT A PROCESS LIKE THAT FOR A PROCESS THAT THEY ARE STATUTER TOLY PROHIBITED FROM COVERING BY THEN THERE ARE OTHER PAYORS AND COMPONENTS OF THE HEALTHCARE SYSTEM THAT THAT DO REQUIRE SOME SORT OF PROCESS LIKE THAT THAT CAN'T JUST BE CMS. BECAUSE THEY ARE NOT BOUND BY THE SAME STATUTORY CONSTRAINTS.
I THINK THAT MOST PAYORS, COMMERCIAL AS WELL AS CMS FOLLOW THIS SAME TYPE PROCESS IS IN TERMS OF EVALUATING THE EVIDENCE WE ARE ALL PRETTY CONSISTENT. THE ONLY RESTRICTION IS AS I SAY BECAUSE WE -- BECAUSE WE -- WE DO NOT COVER SCREENING TESTS, THOSE SCREENING GENETIC TESTS, THOSE ARE SOMETHING THAT WE WOULD NOT REVIEW. COMMERCIAL INSURERS WOULD, YOU KNOW, THEY HAVE THE OPTION OF COVERING BOTH DIAGNOSTIC AS WELL AS SCREENING TESTS BUT AS I SAY WHETHER OR NOT IT IS DIAGNOSTIC OR SCREENING THEY FOLLOW THE SAME TYPE OF EVIDENCE-BASED REVIEW PROCESS.
EMILY, THEN DEBRA.
OKAY. SO IN THE INTEREST OF MOVING THIS AND THEN IN WHOLE BOX THAT WE ARE DISCUSSING ON PAGE 69 ARE REPETITIVE AND WE SHOULD GET THAT ORGANIZED IN SUCH A WAY THAT WE DON'T SAY THE SAME THINGS TWICE AND DON'T HAVE THE RECOMMENDATIONS ON TWO SEPARATE PAGES. IT SEEMS TO ME THAT WHAT IS -- WHAT IS LACKING IS NOT THAT THERE IS A PROCESS THAT HAPPENS AT CMS OR THAT THERE IS A PROCESS THAT OCCURS AT DIFFERENT PRIVATE INSURERS BUT WHAT IS LACKING IS SORT OF A PUBLICATION OF WHAT THAT PROCESS IS SO THAT PEOPLE WORKING IN THE FIELD WITH EMERGING TESTS, MANY OF WHICH ARE THESE TESTS THAT WE ARE TALKING ABOUT KNOW EXACTLY WHAT ARE THE QUESTIONS THAT ARE GOING TO BE ASKED TO THAT DATA CAN BE GENERATED TO ADDRESS THOSE QUESTIONS. MAYBE ONE OF THE THINGS WE COULD HAVE THE SECRETARY TO DO IS TO HAVE CMS PUBLISH IN SOME MANNER F YOU DON'T RAILROAD THAT LIST OF QUESTIONS. WHAT ARE THE CRITERIA THAT YOU USE AND THAT YOU GO THRAO IN THE PROCESS. IF YOU HAVE A STANDARDIZED PROCESS, WHAT IS IT. CAN IT BE TRANSPARENT? AND THEN THE SECOND PART WHICH IS THE WHOLE ISSUE OF RFAs IS I THINK A WAY TO ADDRESS THE ISSUE OF LACK OF EVIDENCE AND I'M NOT SAYING THAT -- A LOT OF THINGS ARE IN THE GREY ZONE BECAUSE WE JUST DON'T HAVE ENOUGH INFORMATION YET TO SAY THAT THEY BELONG IN A BLACK OR A WHITE CATEGORY. SO I PERSONALLY WOULD LIKE TO ADVOCATE FOR CONTINUED NIH KIND OF RFA GRANT SUPPORT TO CONTINUE TO GENERATE INFORMATION. MAYBE IT IS CDC STUDIES OR SOME OF -- WHATEVER STUDIES ARE REQUIRED TO GET THINGS TO THE POINT WHERE YOU HAVE ENOUGH EVIDENCE TO SAY THIS IS RIGHT, THIS ISN'T RIGHT AND I THINK THAT HEREDITARY HEMOT OMA ON THE NEXT PAGE, THEY CAN TEST AND CLARIFY A DIAGNOSIS IN SOMEBODY PRESENTING WITH SIGNS AND SYMPTOMS BUT WE DON'T YET HAVE THE BODY OF EVIDENCE SAYING IT IS WORTH WHILE TO DO A POPULATION SCREENING AND SO WE ARE DOING A STUDY FUNDED BY THE NIH TO ANSWER THAT QUESTION. I JUST WOULD LIKE TO SORT OF BRING IN TO CLOSURE. I THINK THE GAP IS THAT WE NEED CLARITY ON WHAT THE CRITERIA ARE THAT AGAIN RIT COVERAGE AND REIMBURSEMENT PRO SIBS AND THEN A WAY TO FILL THE GAP FOR NEW THINGS FOR EVIDENCE THAT IS REQUIRED TO GO THROUGH THAT PROCESS?
SUZANNE?
THE MEDICARE PRESCRIPTION DRUG ACT TASKS THE SECRETARY WITH MAKING AVAILABLE TO THE PUBLIC THE FACTORS THAT ARE CONSIDERED WHEN MAKING NATIONAL COVERAGE DECISIONS SO THIS AND I BELIEVE CMS HAS TAKEN THE FIRST STEPS IN THAT PROCESS. SO IT IS NOT AVAILABLE YET BUT IT IS SOMETHING THAT IS BEING DONE AT THE MOMENT.
DEBRA?
IN ADDITION TO THE PREVENTIVE ASPECT THAT IS NOT COVERED BY CMS, I WOULD ALSO ARGUE THAT WHAT WOULD BE COVERED BY MEDICARE WITH AN OVER 65 POPULATION IS VERY DIFFERENT AND MAY NOT BE CONSIDERED FOR THE 5-YEAR-OLD AND THE 20-YEAR-OLD AND THE 40-YEAR-OLD SO I DON'T KNOW THAT CMS'POLICY COVERAGE DECISIONS APPLY TO THE ENTIRE POPULATION THAT IS GOING TO BENEFIT FROM GENETIC TESTING AS OPPOSED TO BEING RESTRICTED TO THE ELDERLY POPULATION?
I GUESS I JUST MEANT THAT THERE MUST BE A LIST OF QUESTIONS THAT THEY GO THROUGH AND THAT SET OF QUESTIONS THAT THEY GO THROUGH ASIDE FROM THE FACT THAT ONE OF THE QUESTIONS MAYBE IS THIS A SCREENING TEST YES OR NO AND IF THE ANSWER IS , YES, IT IS OFF THE TABLE. I THINK THE LIST OF QUESTIONS AND PROCESS WOULD BE INFORMATIVE FOR MOST TESTS.
HOW MUCH DO YOU TAKE INTO CONSIDERATION FOR THESE DECISIONS THAT YOU ARE TALKING ABOUT THE OVER 65 OR ELDERLY POPULATION AS OPPOSED TO WHAT WOULD BE GOOD FOR A 20-YEAR-OLD?
I WOULD RESPOND AND SAY THAT ABOUT I THINK 85% OF THE MEDICARE POP POPULATION ARE PERSONS 65 AND OVER AND 14% FOR DISABLED PERSONS SO IT WOULD APPLY TO THAT GROUP. IN TERMS OF A PROCESS CMS DOES CURRENTLY HAVE A PROCESS AND A PERSON CAN ACTUALLY GO TO THE C MS WEBSITE BASICALLY IN TERMS OF TELLING THEM HOW TO IN INISH INITIATE A PROCESS AND THAT INFORMATION OUT THERE WOULD ALSO HELP HELPING THEM TO DETERMINE WHAT TYPE OF INFORMATION IS NECESSARY FOR THAT PROCESS TO TAKE PLACE.
BARBRA?
I DON'T WANT TO GET US INTO ANOTHER WHOLE TOPIC BUT WE HAVE BEEN TALKING A LOT ABOUT TESTING BUT WE HAVEN'T BEEN TALKING ABOUT THE ACCOMPANYING SERVICES TO TESTING AND I.E. GENETIC COUNSELING AND HOW DECISIONS ARE MADE ABOUT WHETHER THAT IS COVERED OR NOT OR WHETHER A PHYSICIAN FEELS THAT HE COULD BILL FOR THAT OR NOT SINCE WE KNOW GENETIC AGAIN GENETIC CON SERALS CAN'T. WOULD IT BE A SIMILAR PROCESS IF SOMEONE WAS TRYING TO REEVE COVERAGE FOR GENETIC COUNSELING?
I DON'T KNOW BUT I WOULD THINK IT WOULD PROBABLY BE A SIMILAR PROCESS.
THE OTHER LIST WHERE WE READ OUT SOME OF THE PRINCIPLES THAT THAT GROUP SHOULD WORK WITH I WANTED TO PROPOSE IF WE STAY WITH THAT WHICH I'M NOT SURE IF WE ARE GOING TO. IF WE DO STAY WITH IT I THINKING IS TO THE EFFECT THE PRINCIPLE SHOULD ADDRESS THE ACCOMPANYING SERVICES NECESSARY LIKE GENETIC COUNSELING AND GENETIC EVALUATION TO ASSURE QUALITY OF CARE AND RECOMMENDATION OF TESTS TO MAKE SURE THAT THERE ARE TESTS THAT CAN BE AVAILABLE BUT SOME TESTS SHOULD PROBABLY ONLY BE AVAILABLE IF THEY ARE RECOMMENDED BY A GENETICS PROFESSIONAL AS OPPOSED TO A GENERAL PHYSICIAN OR NURSE OR SOMETHING ELSE.
REED?
IN -- ACTUALLY IN DANGER OF VIOLATING MY ALL COMMENTS MUST LEAD TO CONCLUSIONS STATEMENT, EMILY, I'M GLAD YOU BROUGHT US BACK TO THE HEMOCHROME MATOSIS CASE STUDY. WERE THE WORKING GROUPS IN GOVERNMENT OR OUT OF GOVERNMENT THAT CREATED THESE CONCLUSIONS DOES ANYBODY KNOW WHERE THAT CAME FROM?
I KNOW THAT THERE WAS A PAPER FROM THE PREVENTIVE TASK FOR FOR HEMOCROW MATOSIS SO I THINK THAT IS FROM THE UNITED STATES TASK FORCE.
IF YOU LOOK THAT THE EMILY I THINK IS RIGHT TO BRING ITTH OUT. HERE A GREAT EXAMPLE. A COMPLICATED ISSUE THAT HAS A SIGNIFICANT PREVALENTNESS AND IMPLICATION IN TESTIMONY AND THERE IS A LOT OF PEOPLE INVOLVED. AND THE QUESTION IS DO YOU OFFER THIS OR NOT AND THEY MAKE A COGENT SENSE ASP CLEAR EVALUATIVE PROCESS THAT ULTIMATELY CONCLUDES UNDER WHICH CONDITIONS THIS IS APPROPRIATE AND WHICH CONDITIONS IT IS NOT APPROPRIATE. HOW MANY OF THESE -- I MEAN HAVING THIS KIND OF ANALYSIS AVAILABLE FOR DECISION-MAKING YOU KNOW IT EXTREMELY IMPORTANT BECAUSE HOW TO YOU ORGANIZE YOURSELVES TO BE ABLE TO CREATE IN KIND OF ANALYSIS IN A TEST BY TEST BASIS BUT IF THIS CAME OUT OF GOVERNMENT I'M JUST WONDERING WHAT THE ORGANIZATION OF GOVERNMENT SERVICES ARE THAT MADE THIS HAPPEN.
THE PART OF -- THIS CASE STUDY WAS INCLUDED BASED ON A CONVERSATION AT A PREVIOUS MEETING WHERE I THINK YOU BROUGHT UP THIS EXAMPLE. ARE YOU FAMILIAR WITH THE WORKING GROUPS?
I'M SURE I WAS AT ONE POINT. THAT'S FINE.
I HAVE ALL THE PAPER IN MY OFFICEKY SEND YOU.
I WAS TRYING TO SEE WHETHER OR NOT THIS WAS A MODEL OF A WAY OF PROCEEDING AND JAMES IF YOU HAD THIS AVAILABLE -- I MEAN IS THIS THE KIND OF INFORMATION THAT IF YOU ALL HAD AVAILABLE YOU COULD MAKE DECISIONS?
I THINK THAT TYPE OF OF INFORMATION WOULD HELP SUPPLEMENT US IN MAKING A DECISION, YES.
YEAH. AND THE QUESTION IS IS WITHOUT -- WHERE DO YOU GET -- IF YOU LOOK AT THE GENETIC TESTS THAT ARE OUT THERE FOR YOU TO HAVE TO MAKE DECISIONS ABOUT TODAY, DO YOU HAVE A PLACE TO GO TO GET THIS KIND OF DATA?
WE REVIEW PEER REVIEWED LITERATURE AND VIEW INFORMATION AVAILABLE ON SOME OUR PUBLIC WEBSITES SUCH AS ARC. WE SOMETIMES COMMUNICATE WITH VARIOUS SOCIETIES TO GET THEIR PERSPECTIVE ON THE UTILITY OF THE TESTS SO.
MUIN?
I GUESS I -- WAS THE QUESTION SPECIFICALLY POSED TO ME OR SHOULD I JUMP?
WE WANTED TO KNOW WHAT THE BACKGROUND IS IF IT WAS ALL GOVERNMENT OR PUBLIC PRIVATE?
WE HEMOCHROME TOE SIS WE HAD A NUMBER OF MEETINGS TO LOOK AT EVIDENCE FOR POPULATION SCREENING BUT THE MOST RECENT ACTIVITY IS THE ACE REPORT WHICH IS A SYSTEMATIC REVIEW OF THE WHOLE ELEMENTS OF POPULATION SCREENING AND LOOKED AT ANALYSTIC VALIDITY ALL THE WAY TO THE ETHICAL ISSUES AND THAT WAS PUT TOGETHER BY THE FOUNDATION FOR BLOOD RESEARCH IN COLLABORATION WITH PEOPLE WHO ARE SORT OF THE EXPERTS IN HEMOCROW MATOSIS.
I WAS WONDERING IS THIS A CASE STUDY OF THE WAY IN WHICH THE SYSTEM CAN WORK TO ORGANIZE DATA AND INFORMATION AND AVAL SIS AND THEN FEED IT -- ANALYSIS AND FEED IT BACK FOR DECISION MAKING FOR GOVERNMENT AND OTHERS SO THAT YOU EX-PA EXPEDITE THE CONCERNS THAT WE HAD HERE? IS THIS A MOD THAT WILL CAN WORK OR DOES IT TELL US THAT THE RANGES OF PER ME EXPECTATIONS AND COME PEW EXPECTATIONS IS THAT YOU CAN'T CREATE A FREE-STANDING BODY THAT IS GOING TO DO IT ALL THE TIME AND THAT YOU BAY SLICK JUST HAVE TO -- BASICALLY JUST HAVE TO DO IT CASE BY CASE THE BEST YOU CAN?
I THINK THIS WAS BROUGHT TO SACGT AS A SAYS STUDY FOR HOW GOVERNMENT STUDIES WORK TOGETHER. ONCE THE GENE WAS FOUND IN 199 1996 TWO AGENCIES CAME TOGETHER AND SAID LET'S LOOK AT IT AND THERE WERE EARLY CALLS FOR POPULATION SCREENING. HOWEVER, HAVING SAID THAT, I DON'T THINK UNLESS THERE IS SOME KIND OF A -- A SITUATION WHERE THESE THINGS ARE ANTICIPATED BECAUSE I MEAN THERE WILL BE MANY, MANY HEMOCHROMEATOE SIS TO MOM. WHO IS GOING TO BE KEEPING TABS ON THAT. THAT IS THE ISSUE. CASE-BY-CASE BASIS OR SOMETHING A BIT MORE OVERARCHING?
SARA?
WHAT I WAS WONDERING ABOUT IS HOW IF THESE ARE DONE IN A -- YOU KNOW, SORT OF AD HOC WAY HOW ARE THE DECISIONS MADE ABOUT WHAT NEXT ISSUE TO LOOK AT? IS THAT WHERE SOME -- IS THAT WHERE SOME HELP IS NEEDED THAT THERE BE A BODY THAT WOULD HELP OKAY SAY WELL NOW THE NEXT THING WE NEED TO LOOK AT AND EVALUATE THROUGH THIS SORT OF PROCESS IS THIS TEST OR THIS MUTATION AND BECAUSE OTHERWISE IT IS GOING TO BE DECIDED I GUESS THROUGH SPECIFIC, YOU KNOW, SUPREME WHO ARE INTERESTED IN THAT -- PREEM WHO PEOPLE WHO ARE INTERESTED IN THAT AREA SO THAT IS WHERE THE COMMITTEE MIGHT CONSIDER SOME MORE SYSTEMATIC APPROACH.
RIGHT NOW THERE IS NO SUCH PROCESS IN PLACE. IT ALL DEPENDS ON SORT OF THE NETWORKING AND THE DISCUSSIONS THAT GO ON IN THE HALLWAYS AND BEHIND THE SCENES AND WITH THE PROFESSIONAL SOCIETY SOMEBODY MIGHT SAY WE HAVE A TEST THAT WE THINK IS REASONABLE THERE IS REALLY NO TEST THAT WAS ESTABLISHED AND WE WERE HOPING AS FOR SUCH A PROCESS. MAYBE NOT THE PROCESS ITSELF BUT OVER THE NEXT THREE YEARS WE CAN LEARN FROM IT AND SEE HOW IT WILL WORK.
ALL RIGHT, HOW ABOUT JUST TO TRY TO WRAP THIS UP TO GO BACK TO THE BEGINNING, IS THERE A CONSENSUS THAT WE DO NEED SOME GUIDANCE IN THE AREA OF GENETICS AND GENOMICS FOR PUBLIC AND PRIVATE PAYORS THAT WOULD TAKE THE FORM OF AN ENTITY OR SEVERAL GROUPS TASKED BY HHS TO ESTABLISH A SET OF PRINCIPLES ALONG THESE LINES THAT WOULD ASSIST IN MAKING COVERAGE DETERMINATIONS? THAT SORT OF THTHRESHOLD QUESTION. IS THE PROBLEM OF LACK OF GUIDANCE SEVERE ENOUGH THAT IT MERITS THIS GROUP MAKING A RECOMMENDATION SPECIFICALLY TO THE SECRETARY SETTING UP SOME SORT TIME?
I COME BACK TO THE HUNTINGTON'S POINT. I'M NOT SURE WE DEFINED ENOUGH THE PROBLEM. I DON'T SEE HOW WE CAN MAKE THE RECOMMENDATION TODAY UNTIL WE ALL AT LEAST HAVE A FEELING THAT CAN REHEARSE ON THE SAME GOSPEL HYMN THE PROBLEM. I DON'T KNOW WHETHER WE ALL HAVE IN OUR MIND WHAT WE ARE TRYING TO SOLVE. MAYBE I'M THE ONLY ONE.
COULD WE ASK THE AGENCY REPRESENTATIVES TO PROVIDE INPUT IF THEY FEEL THERE IS A GAP WHAT THAT GAP IS AND SO THAT IT COULD INFORM OUR DISCUSSION WHEN WE COME BACK TO THIS NEXT TIME?
I REFER YOU TO LINDA'S PRESENTATION YESTERDAY. MAYBE I CAN GO OVER IT AGAIN BUT I THINK THE CASE CAN BE MADE AGAIN AND AGAIN THAT THERE IS A BIG GAP RIGHT NOW. IT IS A KNOWLEDGE GAP. IT IS A POLICY GAP. IT IS A REIMBURSEMENT GAP AND ALL OF THESE THINGS GO TOGETHER. AND THE NUMBER OF TESTS THAT ARE COMING DOWN ON THE MARKET ARE NOT GOING AWAY. THEY ARE ONLY INCREASING AND WITH ALL DUE RESPECT WITH THE CMS WORK THEY ARE DOING THERE IS A SCREENING EXCLUSION AND THEY ARE MOSTLY DEALING WITH OLD PEOPLE SO WE HAVE A DEVELOP SOMETHING A BIT MORE SUSTAINABLE AND I THINK THAT PULLS ALL THE AGENCIES TOGETHER.
COULD YOU DEFINE IT AND SAY IN YOUR MIND WHAT WOULD BE -- YOU KNOW, THE PREAMBLE WOULD BE DEAR SECRETARY WE HAVE DISCOVERED THIS PROBLEM AND IT IS -- THEREFORE DO THIS.
I --
WITH THE UNDERSTANDING THAT YOU WON'T BE SAYING THAT, WE WILL BE.
NO, I MEAN -- OKAY. WELL, LET ME STEP BACK HERE. IF WE ARE TRYING TO DEVELOP A ROBUST PROCESS FOR EVALUATING GENETIC APPLICATIONS AND PRACTICE, OKAY, AND WHAT WE HAVE TO DO, I MEAN YOU AS A COMMITTEE HAVE TAKE AND LOOK AT ISSUES FROM DISCRIMINATION TO REIMBURSEMENT AND COVERAGE AND EVIDENCE BASED ON CRITERIA. AND IN F. YOU THINK THAT THERE IS NO PROBLEM THEN WE CAN ALL GO HOME. A CASE WHERE I SAID I THINK THAT THERE IS A MAJOR PROBLEM BECAUSE THE NUMBER OF GENETIC TESTS THAT ARE COMING DOWN THE PIKE HAVE NO WAY TO GO BUT UP. EACH ONE OF THEM DEFIES OUR CONVENTION WISDOM OF EVALUATING CLINICAL UTILITY IN THE TRADITIONAL AHRQ OR CMS MODEL BECAUSE WE ARE DEALING WITH DIFFERENT PARAMETERS OF ETHIC ISSUES AND CLINICAL VALIDITY. AND BASICALLY THERE IS REALLY NO PROCESS RIGHT NOW IN PLACE THAT TAKES CARE OF ALL THESE ISSUES TOGETHER. I MEAN THERE ARE FRAGMENTATION OF EFFORTS. AHRQ HAS NOT UP TO THIS YEAR TAKEN ON ANY GENETIC TESTS FOR PRY PERI-CARE AND WHAT THEY TELL -- FOR PRIMARY TESTS. THEY TELL ME IF WE USE THEM THROUGH THE PREVENTIVE TASK FORCE MODEL THEY WILL ALL FAIL AND WHY THEY WILL FAIL IS IS THEY HAVE A CLINICAL EFFECTIVENESS IN MIND AND A TRADITIONAL WAY OF DOING BUSINESS THAT I'M SURE THE GENETICS COMMUNITY MAY WANT TO MOD ANY TO HAVE A FURTHER LOOK AT THIS. THERE IS COVERAGE AND REIMBURSEMENT AND PEOPLE CALLING FOR SERVICES. WE HEARD FROM THE CONSUMERS YESTERDAY. I CAN'T REINVENT THE WHEEL. I THOUGHT THAT THE WE WILL HAS BEEN REINVENTED.
WE ALL UNDERSTAND ISSUES. YOU ARE SAYING WE DON'T HAVE REBUST ENOUGH UTILITY TO EVALUATE THE CLINICAL UTILITY OF THESE NEW TESTS BECAUSE THERE IS SOMETHING SPECIAL ABOUT THE NEW TESTS, I.E., PREDICTIVE AND SOMETHING ELSE ABOUT THEM. IT HAS TO DO AS YOU BOILED IT DOWN. ABILITY TO EVALUATE CLINICAL UTILITY OF A NEW KIND OF TEST.
IN THAT, YOU WILL HAVE KNOWLEDGE FROM TESTING ONE PERSON THAT APPLIES TO AN ENTIRE GROUP OF PEOPLE, WHOEVER IS RELATED TO THAT PERSON, AND WITH THOSE OTHER PEOPLE INSTEAD OF WAITING FOR SIGNS AND SYMPTOMS TO DEVELOPMENT, DOING A DIAGNOSTIC TEST AND TREATING THEM, WE WILL HAVE THE CAPABILITY OF POTENTIALLYITATIONING PREVENTIVE STRATEGIES FOR THE OTHER FAMILY MEMBERS, NOT WAITING UNTIL THEY HAVE SIGNS AND SYMPTOMS, SO HOW YOU IMPLEMENT THAT IS DIFFICULT. BECAUSE WE'RE USED TO THINKING OF MEDICAL PRACTICE IN TERMS OF INDIVIDUALS AND NOT IN TERMS OF FAMILIES.
LET ME JUST DO THIS. CINDY STILL GOT THE HELM HERE, BUT LET'S JUST DO IT, A REALITY CHECK. WE'RE AT 12:30 AND WE HAVE A GUEST AT 1:00 AND WE HAVE TO EAT. AND WE HAVE A REAL CRAMMED SCHEDULE HERE. I THINK WE HAVE HEARD JUST NOW ONE PERSON DESCRIBE WHAT THEY, WHAT THE PROBLEM, WE HEARD DEBRA AND CURT SHOT AT IT AND, AND WE DIDN'T GIVE HER A CHANCE TO GET INTO THE LEVEL OF DETAILS. SHE'S TALKING NOW ABOUT IT. THERE IS A PARADIME SHIFT AND THE PARADIGM SHIFT CAN BE DEFINED, I'M SURE, BY A SET OF CHARACTERISTICS. CINDY, LET ME COME BACK TO TIMELINES. WE, THIS IS REALLY IMPORTANT WORK AND IT'S IMPORTANT TO GET THIS ONE RIGHT, AND I STILL THINK WE HAVE MORE DRILLING DOWN TO DO. PARTICULARLY DEFINING THE PROBLEM AND THEN BEING ABLE TO HAVE A COACH INSTEAD OF RECOMMENDATIONS, JUST FOR THIS SECTION, MUCH LESS A COUPLE OFING SECS. CINDY WHEN, AGAIN, I CAN'T REMEMBER, IS THERE A DROP-DEAD DATE BY WHICH THIS COMMITTEE COMMITTED THAT IT WOULD HAVE THIS REPORT OUT AND IS THERE A REASON THAT THIS REPORT HAS TO BE OUT THE DOOR ON A CERTAIN DATE?
IN THE TIMELINE THAT THE STAFF HAS SUGGESTED, THE DUE DATE FOR ADDITIONAL EDITS AFTER THE MEETING WOULD BE OCTOBER 29th.
UH-HUH.
AND NOVEMBER, THE STAFF WOULD PREPARE THE NEXT DRAFT AND THE FEDERAL REGISTER REQUEST FOR PUBLIC COMMENT.
UH.
THE PUBLIC COMMENT PERIOD WOULD BE GENERALLY DECEMBER TO JANUARY AND THEN THE NEXT SACGHS MEETING IS FEBRUARY 28th TO MARCH 1st WHERE WE WOULD REVIEW THE PUBLIC COMMENTS RECEIVED AT THAT TIME AND FINALIZE RECOMMENDING AS.
IT SEENS TO ME THAT WE WOULD LIKE TO KEEP THAT, I MEAN, AT LEAST TO THE LAST DATE, WHICH IS THE MARCH 1, YOU KNOW, GETTING IT OUT THE DOOR IN THE END OF MARCH IS LIKE A REASONABLE TIMELINE. I'M NOT SURE, BUT WHAT I THINK WE WILL DO IS DURING THE LUNCH PERIOD, CLEARLY YOU AS A COMMITTEE ARE GOING TO HAVE TO WEIGH IN ON SOME MORE OF THESE ISSUES AND I DON'T THINK THE SUBCOMMITTEE ITSELF CAN DO YET ALL WITHOUT YOU BEING INVOLVED. AND THERE'S A DISCUSSION THAT HAS TO OCCUR BEYOND THE TIME THAT WE HAVE AVAILABLE RIGHT NOW. AND SO WE'RE GOING TO HAVE TO FIGURE OUT WHAT WEATHER THAT MONEYS, -- WHETHER OR NOT, AGAIN, THAT MEANS THROUGH A CONFERENCE CALL, WHAT IT MEANS THAT WE PUSH EVERYTHING BACK AND BRING MORE WORK BACK TO THIS COMMITTEE. WE'RE GOING TO HAVE TO FIGURE OUT A OF TACTICS HERE. WE CAN'T RESOLVE THIS ISSUE RIGHT THIS SECOND AND I DON'T KNOW, I'M TRYING TO, AS I'M LOOKING FOR YOU ALL ON GUIDANCE AS TO HOW YOU WANT TO MOVE FORWARD. WE HAVE TO DECIDE THIS RIGHT NOW.
COULD I JUST MENTION A PROCEDURAL ISSUE. IF THE COMMITTEE WERE TO MEET AGAIN IN FULL COMMITTEE THROUGH A CONFERENCE CALL, WE WOULD NEED TO MAKE THAT AVAILABLE TO THE PUBLIC. SO, YOU CAN MEET, YOU KNOW, IN A CLOSED SESSION, A TAKE GROUP OR SOME GROUP OF THE COMMITTEE, BUT NOT THE FULL COMMITTEE.
LET ME ASK, CINDY, AS CHAIR OF THIS GROUP, WHAT YOU'RE THINKING IS ON BEHALF OF THE COMMITTEE, AND THAT IS IS THIS -- IS THIS: THE ONE THING WE DON'T WANT TO DO AS A COMMITTEE IS TO EXTEND EVERY DOGGONE REPORT EVERY 20 CYCLES AND NEVER ISSUE ANYTHING OF IMPORTANCE AND LOOK LOOK AN INEFFECTIVE GROUP. DO YOU FEEL, THOUGH, THAT THIS WILL NEED TO MOVE BACK ONE MEETING CYCLE SO THAT WE CAN COME BACK AND REVISIT AND TIGHTEN DOWN ON THESE ISSUES THAT ARE UNRESOLVED OR SHOULD WE GO AHEAD AND TRY TO GET SOME STUFF, SOME WORK DONE BETWEEN THE SUBCOMMITTEE AND THE FULL COMMITTEE BETWEEN NOW AND THE NEXT SCHEDULED MEET SOMETHING SO SHOULD WE TRY TO GO AHEAD AND KEEP TO OUR SCHEDULE AND GET IT DONE OUTSIDE OF A FORMAL MEETING ROOM.
I THINK WE CAN -- THE ISSUES THAT ARE REMAINING THAT WE HAVEN'T YET GOTTEN TO HERE PROBABLY CAN BE DISPOSED OF PRETTY QUICKLY, AND I THINK WE CAN STICK TO THE ORIGINAL TIMEFRAME. THE BIG KAHUNA, OF COURSE, IS THIS BIG ISSUE THAT I DON'T HAVE A SENSE THAT WE CAN REALLY GO BACK AND DRAFT ANYTHING BECAUSE THERE REALLY ISN'T A CONSENSUS YET, SO IT MAY REQUIRE A CONDITIONS CALL OF THE WHOLE COMMITTEE TO DO AND I THINK BY DOING THAT, WE STILL CAN STICK TO THE ORIGINAL --
CAN I ASK THE FULL COMMITTEE, DEBRA AND PART OF YOUR RESPONSE, WOULD YOU BE WILLING, AND I KNOW YOU ALL WORKED REAL HARD ON THIS COMMITTEE. I'M LOATHED TO ASK TO YOU DO EXTRA WORK, BUT WOULD YOU BE WILLING, IF WE COULD STRUCTURE A VERY TIGHTLY-FRAMED CALL THAT WAS VERY CLEAR WELL THE ISSUES TO BE DISCUSSED, WOULD YOU BE WILLING TO PARTICIPATE IN THAT BETWEEN NOW AND THE NEXT MEETING?
I -- YES. THAT'S A SHORT-ANSWER TO YOUR QUESTION. I THINK GIVEN OUR EARLIER DISCUSSIONS ON THE GENETIC COUNSELING ISSUE DATA GATHERING THAT IS GOING TO HAPPEN IN INFORMED DISCUSSIONS AT THE NEXT MEETING, I DON'T SEE ANY WAY THAT STAFF CAN GENERATE A REPORT TO GO OUT FOR PUBLIC COMMENT BEFORE OUR NEXT MEETING AND GATHER THIS PUBLIC COMMENT. I, SO I SEE NO CHOICE BUT TO MOVE BACK BY ONE CYCLE. UNLESS THERE, THEY SAY CAN YOU WORK MIRACLES.
MAY I JUST SAY --
YES, YOU DO, I MEAN, BUT ESPECIALLY ON THIS TOPIC.
I THINK THE COMMITTEE'S RAISED A NUMBER OF REALLY SIGNIFICANT QUESTIONS. I THINK WE FEEL THE THAT COMING INTO THIS THERE WOULD BE MORE, AND I KNOW THAT I'M, I'M SOMEWHAT DIVERTING FROM WHAT CINDY JUST SAID, BUT I THINK THIS FEELING I HAVE IS THAT YOU HAVE RAISED VERY FUNDAMENTAL QUESTIONS THAT WE NEED TO GATHER MORE INFORMATION FOR YOU ABOUT AND AS DEBRA JUST SAID, THERE IS ALSO THE, A LOT OF THE, A LOT MORE INFORMATION NEEDS TO BE GATHERED ABOUT THE COUNSELING AND THE LICENSEURE ISSUE AND SO FORTH. I, MY INCLINATION IS TO PUSH IT BACK ONE, EVEN THOUGH I WAS RARING TO GO AND HOPING THIS WOULD BE DONE BY THE NEXT MEETING.
GREAT, CINDY WOULD YOU EXPECT -- EXCEPT THE PUSHING IT BACK WITH ONE.
SURE.
AND I THINK WHAT WE WANT TO DO IS, SO WE DON'T LOSE THE MOMENTUM, AND WE HAVE TO BRAKE OFF, SO WE DON'T LOSE THE MOMENTUM, I WOULD URGE THE COMMITTEE, CINDY, THROUGH STAFF AND SUZANNE AND EVERYBODY ELSE, LET'S TRY TO GET SOMETHING BACK OUT TO US RIGHT AWAY THAT, LAYS OUT WHERE WE ARE, WHAT IS UNCERTAIN SO WHILE IT'S FRESH IN OUR MINDS, WE CAN THINK ABOUT IT AND NOT LOSE THE MOMENTUM -- MOMENTUM OF TRYING TO DRIVE THIS FORWARD AND START CLARIFYING WHAT HAS TO OXCUR NEXT. WE'LL GET THAT OUT TO YOU RIGHT AWAY. LET ME CLOSE BY SAYING TO, TO CINDY AND THE COMMITTEE YOU KNOW, IT'S -- YOU'VE DONE US A GREAT FAVOR TO GET US THIS FAR. THIS IS HARD, AND SO I DON'T THINK WE SHOULD BE DESAX OWNED AND TO THE STAFF, UM, YOU WORKED YOUR [ INDISCERNIBLE ] -- TAILS OFF FOR THIS THING AND WE WANT TO THANK YOU FOR THAT THE. WE'LL GET IT DONE IN SHORT ORDER W.THAT, I THINK YOU'RE A VERY WISE COMMITTEE ON, AND I THINK YOU GRACED A WIDE JUDGEMENT. LET'S STOP, GRAB LUNCH. WE HAVE A GUEST COMING EXACTLY AT 1:00, AND SO, UM, YOU NEED TO BE BACK IN HERE AROUND 10 OF. WE HAVE FIVE MINUTES OF CONVERSATION TO JUSTIFY THE FREE FOOD. AND PROGRESS TO DATE. AND SO DAVID WILL PROVIDE US WITH I'M SURE ABSOLUTELY THE MAXIMUM AMOUNT OF INFORMATION THAT HE CAN POSSIBLY PROVIDE US WITH THIS MOMENT. HE MAY NOT BE ABLE TO PROVIDE US WITH EVERYTHING.
MUCH FOR THE PRIVILEGE OF BEING HERE TODAY TO TALK ABOUT THIS COMMITTEE WHICH HE HAD A ROLE IN INSTIGATING I THINK IS THE FAIR THING TO SAY BUT I ALSO HAVE TO TELL YOU THAT THE NATIONAL ACADEMY HAS VERY IRONCLAD RULES ABOUT WHAT CAN AND CANNOT BE SAID ABOUT ANY COMMITTEE THAT IS UNDERWAY SO IT IS SORT OF LIKE I CAN GIVE YOU MY NAME, RANK AND SERIAL NO., SIR, AND THAT IS ABOUT IT. BUT, NO, IT CAN BE BETTER THAT THAT BUT I REALLY CANNOT EVEN HINT AT PRESENTING TO YOU ANY FLAVOR OF DISCUSSIONS OR CONJECTURE ABOUT POSSIBLE FINDINGS AND RECOMMENDATIONS OF THE COMMITTEE. IT IS SIMPLE.
FOR BODEN. IN ANY EVENT THIS COMMITTEE WAS PUT TOGETHER AND THE MEMBERS OF THE COMMITTEE ARE SHOWN ON THIS SLIDE. I THINK ITING WORTH NOTING SHIRLEY TILLMAN WHO IS AN EMINENT BIOLOGIST IN HER PAST LIFE AND NOW THE PRESIDENT OF PRINCETON UNIVERSITY CO-SHARES THIS COMMITTEE WITH ROD MCILVEY, WHO IS VERY WELL KNOWN IN THE PATENT LAW BUSINESS, FORMER JUDGE IN DELAWARE IN WHICH MORE COMPANIES ARE INCORPORATED THAN ANY OTHER STATE IN THE UNITED STATES SO DELAWARE COURTS HAVE A RICH HISTORY IN DEALING WITH CORPORATE ISSUES INCLUDING INTELLECTUAL PROPERTY. AND SUCH HAS SPENT A LOT OF HIS RECENT CAREER STUDYING THE INNOVATION. HELEN BURRMAN FROM RUTGERS AND THE CURE RATEOR AND JOIN HAS BEEN SNED A RETEARING NOW THE DIRECTOR OF TECHNOLOGY TRANSFER AT HARVARD UNIVERSITY.
TODD DICKINSON IS NOW THE INTELLECTUAL COUNSEL GENERAL ELECTRIC AND UNDER THE CLINTON ADMINISTRATION WAS COMMISSIONER OF THE U.S. PATENT AND TRADEMARK -- BY YALE UNIVERSITY. ONE OF HIS BETTER-KNOWN AND MORE RECREENT WORKS CONCERNS THE DAVID BALTIMORE CASE, THAT SOME OF YOU MAY HAVE BEEN FAMILIAR WITH. GEORGE MELNE IS A FORMER SENIOR CORPORATE OFFICER OF PFIZER, NOW DABBLING IN INVESTMENTS AND BIOTECH START-UPS. RICHARD'S A FORMER FACULTY MEMBER OF MINE AT STANFORD WHO IS NOW THE EXECUTIVE RESEARCHER ATGENEN TECH. ROCHELLE SIDE IS A LITIGATOR, SHE'S IN THE PRIVATE PRACTICE OF LAW, SPECIALIZING IN INTELLECTUAL PROPERTY LAW. BOB WATERSTON'S NAME IS KNOWN, I THINK, TO ALL OF YOU, ONE OF THE KEY CONTRIBUTORS TO THE HUMAN GENOME MAP NOW IN SEATTLE. NANCY WEXLER IS WELL-KNOWN TO ALL OF YOU FOR HER WORK IN HEREDITARY DISEASE, ESPECIALLY HUNTINGTON'S DISEASE, AND BRIAN WRIGHT IS A PROFESSOR OF AGRICULTURE AND RESOURCE ECONOMICS AT UC BERKELEY, A VERY STRONG DEPARTMENT AT BERKELEY. WHAT WONDER ASKED TO DO BY THE NIH WAS TO EXAMINE TRENDS IN THE NUMBER AND NATURE BASICALLY WHAT KIND OF PATENTS ARE BEING ISSUED AND GRANTED TO TECHNOLOGIES RELED TO GENOMICS AND PROTOO ONLYICS. SOME -- PROTEOMICS. SOME STUDIES OF THE PROCEDURES THAT OUR PATTENT AND TRADEMARK OFFICE IS USING RELATIVE TO THOSE USED BY OTHERS SPECIFICALLY IN EUROPE AND JAPAN HOW THE PATENTING IN PROTEOMICS AND LICENSING PRACTICES MIGHT BE AFFECTING RESEARCH AND INNOVATION, AND BASED ON OUR FINDINGS, RECOMMENDS STEPS THE NIH AND OTHERS MIGHT TAKE TO ENSURE THE PRODUCTIVITY OF RESEARCH AND INNOVATION AND SO FORTH. THE --
DAVID, COULD YOU CLARIFY. I THOUGHT PART OF THE CHARGE WAS TO ALSO LOOK AT CLIN CAN -- CLINICAL IMPACT, BUT I'M NOT SEEING THAT ON YOUR LIST.
THE, THE CHARGE SLIDE THAT WAS GIVEN ME BY THE COMMITTEE DIDN'T LIST IT, BUT I WILL COME TO IT. IT'S A TOPIC THE COMMITTEE HAS BEEN LOOKING INTO. SO. I JUST WANTED TO POINT OUT TO YOU THERE IS A WEBSITE THAT HAS ALL OF THE DOCUMENTS AND AGENDA OF ALL THE MEETINGS, ALMOST ANYTHING YOU WANT TO KNOW ABOUT THIS COMMITTEE, CAN YOU FIND ON THAT WEBSITE. SO, WHAT SORT OF THINGS HAVE WE LOOKED AT TO DATE. ONE HAS BEEN THE POLICIES, PROCEDURES AND OPERATIONS OF THE PATENT AND TRADEMARK OFFICE, AND THAT FOCUSES, OF COURSE, ON THE CRITERIA WHICH ARE ESTABLISHED IN U.S. LAW AND ABOUT ANY ONE OF WHICH WE COULD PROBABLY SPEND HALF A DAY TALKING AND ARGUING BECAUSE EVERY ONE OF THESE CRITERIA IS, HAS BEEN CHALLENGED IN THE AREA ESPECIALLY OF JEEP PATENTS. THAT IS -- GENE PATENTS. THAT IS PATENTS THAT HAVE BEEN ISSUED HAVE BEEN CHALLENGED ON THE BASIS OF THE UTILITY, ON THE BASIS OF THEIR NOVELTY AND NONOBVIOUSNESS. THAT MEANS TO A PERSON SKILLED IN THE FIELD ON THEIR WRITTEN DESCRIPTION AND ENABLEMENT, ESPECIALLY VIS-A-VIS, THE SCOPE OF THEIR CLAIMS. THAT IS YOU CLAIM SOMETHING WHEN YOU FILE A PATENT APPLICATION AND YOU ARE SUPPOSED TO DEMONSTRATION CONVINCINGLY THAT YOU HAVE WHAT YOU ARE CLAIMING AND THAT YOU HAVE ACTUALLY GOT IT, NOT YOU'RE THINKING ABOUT IT OR WISHING ABOUT IT, BUT THAT THEY ACTUALLY HAPPENED AND THERE HAS BEEN SOME QUITE HEATED DISCUSSION IN THE LITERATURE ABOUT PATENTS REGARDING THE PERCEIVED VARIANCE BETWEEN THE SCOPE OF SOME CLAIMS AND THE WRITTEN DESCRIPTION ENABLEMENT BACKING THEM UP. THEN THEY'RE SUPPOSED TO WE'RE GOING TO BE LOOKING AT INTERNATIONAL POLICIES AND PRACTICES IN EUROPE AND JAPAN. WE'RE LOOKING AT, FOR EVIDENCE ABOUT WAYS THAT INDIVIDUALS AND ENTITIES, COMPANIES HAVE MANAGED WITH REBECK -- WHAT REBECCAIZENBERG HAS DUBBED THE PATENT THICKET. REBECCA EISENBERG. PATENT THICKENED MEANS YOU WANT TO DO SOMETHING. IN ORDER TO FOND IT, YOU FIND YOU HAVE TO NEGOTIATE INTELLECTUAL PROPERTY RIGHTS WITH A DOZEN, TWO DOZEN OR EIGHT DOZEN OWNERS AND DIFFERENT BITS AND PIECES OF WHAT YOU WANT TO DO. A VERY INTERESTING EXAMPLE OF A CASE WHERE THAT HAS RECENTLY OCCURRED IS IN GOLDEN RICE, WHICH WAS DEVELOPED FOR THE SPECIFIC PURPOSE OF DEALING WITH VITAMIN A DEFICIENCY, AND IN ORDER TO GET FROM THE DISCOVERY, THE INVENTION OF GOLDEN RICE, A VERY DIFFICULT AND LONG TEEM GENETIC TECHNOLOGY PROBLEM IN AG BIOTECH, UM, THEY HAD TO WORK THEIR WAY THROUGH ABOUT 40 OR 60, I THINK. PATENTS ON DIFFERENT BITS AND PIECES ON WHAT THEY HAD DONE TO GET THE PRODUCT, AND ALL OF THAT HAD TO BE NEGOTIATED BEFORE THE DISCOVERY COULD BE THEN REDUCED INTO BENEFITS FOR PEOPLE. THAT IS BEFORE CAN YOU GET A COMPANY TO BEGIN MANUFACTURING THEM. ALL OF THIS INTELLECTUAL PROPERTY STUFF HAD TO BE NEGOTIATED, AND THEN I GATHER FROM A PAPER AND SCIENCE LAST FALL, THAT IT TOOK WELL OVER A YEAR TO DO THAT, AND ONE OF THE REASONS IT SUCCEEDED WAS NOBODY THOUGHT ANYBODY WAS GOING TO MAKE MUCH MONEY ON THIS, BECAUSE IT'S GOING TO BE AIMED MANLY AT DEVELOPING WORLD -- MAINLY AT A DEVELOPING WORLD WHERE PEOPLE NEED THIS FOOD STUFF AND THERE IS CERTAINLY NOT A LOT OF MONEY TO REAP THERE. HAS BEEN A FILM OF DISCUSSION OF THE RESEARCH EXEMPTION. DOES IT EXIST, AND I'M GOING TO DIVERT, IF I MAY FOR A COUPLE OF SECS, BECAUSE I'M INTERESTED, MINUTES, BECAUSE I'M VERY INTERESTED IN THIS FOR OBVIOUS REASONS. THERE'S A CASE THAT WAS DECIDED BY THE APPELLATE COURT IN THE UNITED STATES THAT DEALS WITH INTELLECTUAL PROPERTY. IT'S CALLED THE COURT OF APPEALS FOR THE FEDERAL CIRCUIT OR THE CIFC. UNLIKE ALL OTHER JURISDICTION IN THE FEDERAL CERC, IN THE FEDERAL NEXT THIS COUNTRY, THERE IS ONLY ONE APPELLATE COURT THAT DEALS WITH ALL INTELLECTUAL PROPERTY CASES THAT COME OUT OF DISTRICT COURTS. ONE APPELLATE COURT AND IT BASICALLY MAKES THE LAW ON PATENTS AND IS REALLY, REALLY DOES THE -- RARELY DOES THE CASE GET BUMPED UP TO THE SUPREME COURT FROM THIS COURT THAT. IS THE SUPREME COURT SHOWS THIS COURT GREAT DIFFERENCE. SO WHAT IS THE ISSUE? THE ISSUE IS THAT AFTER THE PATENT STATUTE, AFTER -- THE CONSTITUTION DEFINES THE RIGHTS OF ARTISTS AND INVENTORS TO HAVE EXCLUSIVE USE OF THEIR INVENTIONS FROM A PERIOD OF TIME TO PROMOTE PROGRESS IN THE ARTS AND, AND, UM, TECHNOLOGIES, I THINK, IT SAYS. BUT IN 1813, JUSTICE, IN THE CASE KNOWN AS -- [ INDISCERNIBLE ] CAUGHT AND WROTE AN OPINION ABOUT A PATENT INFRINGEMENT, THESE WORDS THAT IT COULD NEVER HAVE BEEN THE INTENTION OF THE LEGISLATURE TO PUNISH A MAN WHO CONSTRUCTED A PATENTED MACHINE NEARLY FOR PHILO SOFICAL EXPERIMENTS OR -- PHILO SOFICAL EXPERIMENTS OR FOR THE PURPOSE TO OBTAIN THE MACHINE TO PRODUCE ITS DESIRED EFFECTS. THAT WAS THE FIRST LEGAL WRITING THAT SAID IT MIGHT BE POSSIBLE TO, QUOTE, INYINCH -- ENFRINGE A PATENT AND NOT REALLY BE INFRINGEING IT IN TERMS OF THE LEGAL STATUS, THAT YOU COULD DO THINGS WITH IT AND NOT BE INFRINGES -- INFRINGING. THE SAME JUSTICE IN THE SAME YEAR AND ANOTHER CASE, SOME MONTHS LATER, WENT ON TO SAY THAT PATENT INFRINGEMENT MUST CONCERN THE MAKING OF THE PATENTED THING WITH THE INTENT TO USE FOR PROFIT AND NOT FOR THE MERE PURPOSE OF PHILOSOPHICAL EXPERIMENTATION OR TO ASSTAIN -- ASCERTAIN THE SEVERITY AND EXACTNESS OF THE SPECIFICATION. SO, WORKING ON THE PATENT TO UNDERSTAND IT BETTER, WORKING ON THE PATENT FOR NOT FOR PROFIT, BUT FOR PILLOW SOFICAL EXPERIMENTATION, -- PILLOW SOFICAL EXPERIMENTATION, HE SAID, WERE ALLOWED AND FOR 200, ALMOST 200 YEARS, UM, THAT HAS EESSENTIALLY BEEN THE BASE OF CASE LAW. THIS, THAT MOPES THIS IS NOT IN STATUTE, BUT IT HAS BEEN -- MEANS THAT THIS IS NOT IN STATUTE BUT HAS BEEN ACCEPTED IN CASE LAW BY OTHER JUDGES. WHY IS IT IMPORTANT IN BECAUSE AT LEAST IN UNIVERSITIES WHERE A LOT OF THIS RESEARCH IS THAT YOU'RE CONCERNED WITH GETS DONE, IT'S GENERALLY BEEN ASSUMED THAT THEY'RE OPERATING IN NONCOMMERCIAL, NOT-FOR-PROFIT SEEKING KNOWLEDGE AND UNDERSTAND -- UNDERSTANDING FASHION, AND THEY HAVE BEEN CLOAKED, PROTECTED BY THIS EXPERIMENTAL USE EXEMPTION. WELL, ALONG CAME A PROFESSOR NAMED JOHN MAITY, A PHYSICAL SCIENTIST OF SOME ACCOMPLISHMENT WHO SUED DUKE UNIVERSITY IN A CASE THAT WENT UP TO THE APPELLATE COURT, OVER THE USE OF SOME FORM FREE ELECTRON LASER EQUIPMENT ON WHICH HE HELD PATENTS. HE HAD BEEN A MAJOR INVENTOR IN THE LASERS. IN THIS COURT, 202, SAID ANY ACT ON THE INFRINGEMENTS OF LEGITIMATE BUSINESS AND NOT SOLELY FOR AMUSEMENT TO SATISFY IDLE CURIOSITY OF PHILOSOPHICALP QUEERY, THAT'S ACT, ENGLISH IS NOT A STRONG POINT FOR THE COURT, DOES NOT QUALIFY FOR THE VERY NARROW AND STRICTLY-LIMITED EXPERIMENTAL USE OF THE FACT. I DON'T KNOW WHETHER HUNT RILARD -- WILLIAMARD AND OTHERS SAY WHETHER WHAT THEY DO EVERY DAY IN THEIR UNIVERSITY WORK IS TO SATISFY CURIOSITY OR AMUSE METOR PHILOSOPHICAL INQUIRY, BUT THE COURT THEN WENT ON TO SAY OUR PRESIDENT IS NONIMMUNIZED USE ANY COMMERCIAL, NOR ANY CONDUCT IN KEEPING WITH THE ALLEGED INFRINGES LEGITIMATE BUSINESS REGARDLESS OF COMMERCIAL IMPLICATIONS. FOR THE FIRST TIME NOW IN THE LAW, SINCE 1813, THE IDEA THAT YOU COULD DO THESE THINGS IF IT WAS NOT COMMERCIAL HAS NOW BEEN BLOWN AWAY BY THIS CIFC HOLDING, AND IT WENT ON, JUST TO RUB THE SALT IN A LITTLE MORE, THAT SUCH ACTIVITIES AS OBTAINING RESEARCH GRANTS AND EDUCATING STUDENTS AND ILLUMINATING FACULTY, UNMISTAKEN -- UNMISTAKIBLY FRAUDED THE INSTITUTION, WHICH WAS DUKE UNIVERSITY, LEGITIMATE BUSINESS. NOW, GIVEN THAT, I THINK THE ANSWER TO WHO THERE IS A RESEARCH EXEMPTION, AT THIS MOMENT, IT'S HIGHLY IN DOUBT. AND THIS HAS SOME RELEVANCE TO THE POINT THAT I THINK DEBRA WANTED ME TO GET TO, WHICH I WILL. WE'RE TRYING WITH OTHER ORGANIZATIONS HERE IN TOWN AND THE TRIPLE AS TO DO A BLINDED SURVEY OF UNIVERSITY EXPERIENCE TO SEE WHETHER THERE ARE INDEED CHALLENGES AND DEMANDS FOR LICENSES AND PAYMENTS POST-MAITY, WHAT DID HE USE, VARIOUS KINDS OF PATTENTED INVENTIONS WIDELY USED AS RESEARCH TOOLS, WIDELY USED AND ALMOST ANYBODY WORKING IN CURRENT GENOMICS AND PROTEOMICS IS USING SOMEBODY'S PRESEARCH TOOLS. ONE WAY OR ANOTHER. THERE IS ALSO AN EFFORT TO DRAFT A STATUTORY EXEMPTION FOR RESEARCH, SUCH AS THAT BY THE AMERICAN PROPERTY LAWYERS ASSOCIATION. BUT I WON'T TAKE YOUR TIME WITH THAT. THEIR PROPOSED USE, THEIR PROPOSED EXEMPTION IS EXCEEDINGLY NARROW AND WOULD NOT COVER MOST OF THE KINDS OF RESEARCH USES THAT UNIVERSITY FACTULATEY AND BUSINESSES DOING RESEARCH AND NOT, I MONEY, BASIC RESEARCH AND NOT NECESSARILY PRODUCT DEVELOPMENT WOULD BE PROTECTED BY. WE HAVE BEEN LOOKING AT THE ISSUE OF LICENSES, AS WELL AS PATENTS AND MATERIAL TRANSFER AGREEMENTS WHICH ARE THESE CONTRACTUAL DOCUMENTS FACULTY USE WHEN THEY'RE SHARING MATERIALS, REAGENTS, ORGANISMS, CELL LINES, WHATEVER, WITH OTHERS EITHER IN INDUSTRY OR IN UNIVERSITIES. THESE THINGS HAVE BECOME A MAJOR BURDENSOME IMPEDIMENT TO THE SHARING OF RESEARCH REAGENTS AND TOOLS AND, AND LIVING ORGANISMS. THIS IS NOT THE PATENT LAW. THESE ARE MATERIAL TRANSFER AGREEMENTS. AND THEN AT THE LAST MEETING, THEY DID TURN THEIR ATTENTION TO THE AFFECTIVE PATENTS ON GENETIC TESTING AND GENETIC, GENE PATENTS ON THE PARAGRAPH MEDICINE. THE ISSUE HERE IS THIS: THAT THERE ARE, AS YOU MAY KNOW, A NUMBER OF CASES NOW WHERE A GENETIC MUTATION HAS BEEN DESCRIBED THAT HAS, LET'S SAY, SOME KIND OF CORRELATION WITH AN INTERESTING PHENOTYPE. IT MAY, IN FACT, BE THE DOMINANT GENE OR A JEEP WITH SOME STATISTICAL CORE LATING, AND ONE DOESN'T REALLY KNOW WHAT THE PHYSIOLOGICAL ROLE IS. IN THE PATENT OF THE GENE CAN ESSENTIALLY OBTAIN A PATENT OF THE MUTATION, CAN ESSENTIALLY OBTAIN A PATENT TO PREVENT ANYONE FROM USING THAT PATENT WITHOUT THAT OWNER'S PERMISSION. AND WHAT HAS HAPPENED IN SOME OF THESE CASES SUCH AS CANAVANS AND ONE OF THE HUMAN CHROMOTOSIS GENES AND I KNOW THEY CAN GIVE YOU OTHERS, THE OWNER, WHO HAS FREQUENTED THE UNIVERSITY, BY THE WAY, ALMOST ALWAYS A UNIVERSITY, GIVES A HIGHLY-RESTRICTED LICENSE TO, A, PROVIDER OF THE TEST. LET'S TAKE BACA, PROVIDER IS MYRIAD GENETICS. THEY HAVE A WORLDWIDE EXCLUSIVE ON THE PRACTICE OF THE TEST. AND THE FACT IS THAT IF THEY CHOOSE TO ENFORCE THEIR LICENSE, WHICH THEY DO, THEY WILL SAY THAT NO ONE IN THE WORLD HAS THE RIGHT TO DO A BACKUP TEST ON ANY SPECIMEN EXCEPT THEM. THAT'S A NICE BUSINESS POSITION TO BE IN. LET ME MAKE CLEAR NOW I AM EXPRESSING MY PERSONAL VIEWS ABOUT THIS. I THINK I'M BEING FACTUAL ABOUT WHAT I AM DESCRIBING, BUT THE VIEWS ARE MINE AND NOT THE COMMITTEE'S, AND I DON'T WANT ANY MISUNDERSTANDING ABOUT THAT. SO, THE ISSUE THAT I THINK PEOPLE LIKE DEBRA LEONARD AND OTHERS WHO ARE IN HER FIELD OF MEDICINE ARE CONCERNED ABOUT IS THAT THESE PATENT OWNERS AND LICENSEES ARE NOT IMPENDING TO DEVELOP THEIR PATENT BY PROVIDING TEST KITS OR SPECIAL EQUIPMENT OR SPECIAL INSTRUMENTS OR SPECIAL REAGENTS THAT OTHER USERS WOULD PROBABLY, EAGERLY BUY IF THEY WERE OF HIGH QUALITY AND RELIABLE. THEY'RE SIMPLY SAYING NOBODY ELSE CAN DO IT. AND THERE IS AN ARGUMENT MADE HERE THAT THIS ESSENTIALLY IS SAYING THAT AN OWNER OF A PIECE OF KNOWLEDGE, A QUANTUM OF INFORMATION, A BIT OF INFORMATION CAN, SENSUALLY PREVENT OTHER EQUAL -- ESSENTIALLY PREVENT OTHER QUALIFIED PROFESSIONALS, PHYSICIANS IN THIS CASE, FROM USING THAT KNOWLEDGE TO DEAL WITH THEIR PATIENTS. THEY HAVE TO GO TO THE EXCLUSIVE LICENSEE IN ORDER TO GET THE WORK DONE THAT WILL TELL THEM WHAT IS GOING ON WITH THE PATIENT. AND THIS IS THE ISSUE THAT EMBODIED IN THE WORDS THAT ARE HERE ON THIS SLIDE. NOW, I WILL TELL YOU THAT IN OUR COUNTRY, THERE ARE TWO STATUTORY EXEMPTIONS. STATUTORY. THAT IS IN LAW PASSED BY CONGRESS TO THE PATENTS, PATENT ACT. ONE OF THEM IN 1984. KNOWN BY ITS AUTHORS, SENATOR HATCH AND CONGRESSMAN WAXMAN, ALLOWS ACTIVITIES AND USES REASONABLY RELATED SOLELY TO THE DEVELOPING INFORMATION REQUIRED TO SECURE FDA APPROVAL. WHAT THIS IS REALLY ABOUT IS GENERICS AND ALLOWING THOSE WHO WANT TO MAKE GENERIC COPIES OF PATENTED PRODUCTS TO BEGIN TO DEVELOP THE INFORMATION ON THEIR GENERIC THAT THEY NEED IN ORDER TO GO TO THE FDA AND GET APPROVAL TO SELL THAT GENERIC WHEN THE PATENT TERM HAS EXPIRED. BUT THEY DON'T HAVE TO WAIT UNTIL THE PATENT -- PATENT TERM EXPIRES TO BEGIN ALL OF THAT PREPARATORY WORK. THEY GAIN SOME YEARS BY BEING ABLE TO START WORKING ON IT AHEAD OF TIME. AND HAVING THEIR PACKAGE READY TO GIVE TO THE FDA. OKAY, THAT EXEMPTION HAS ALSO BEEN REDUCED BY THIS APPELLATE COURT IN ANOTHER RECENT CASE. THEY CLEARLY DON'T LIKE EXSEESM EEXISMTIONS, THIS COURT, BUT -- EXEMPTION, THIS COURT. IT DOES EXIST. THE OTHER ONE THAT IS MORE PERTINENT TO THE DEBRA LEONARD AND HER COLLEAGUES ISSUE, IS THE SENATOR FRIST, CONGRESSMAN GANSKY AMENDMENT OF 1994, WHICH PERMITS MEDICAL BACK TIGGERS TO PRACTICE PATENTED MEDICAL AND SURGICAL PROCEDURE WHAT. IS A PATENTED MEDICAL AND SURGICAL PROCEDURE? IN THIS INSTANT, -- INASSISTANCE IT WAS AN OPHTHALMOLOGIST WHO WANTED TO PATENT A TYPE OF CURVED INCISION IN THE CORNEA. WANTED TO OWN IT, PATENT IT AND CONTROL ITS USE AND THERE WAS A LOT OF UNHAPPINESS ABOUT THAT SORT OF THING, AND SO THIS AMENDMENT WAS PASSED TO PHYSICIANS, FRIST AND GANSKY. PATENTED AND SURGICAL PROCEDURES ON A BODY THAT'S YOUR BODY, MY BODY, A BODY, BUT EXCLUDES THE PRACTICE OF PROCESSES THAT WOULD VIOLATE BIOTECH PATENTS AND THE CLINICAL LABORATORY SERVICES REGULATED UNDER THE CLINICAL LABORATORIES IMPROVEMENT AMENDMENTS WHICH, ARE KNOWN AS CLEO, THE STATUTORY, IT'S THE BODY OF LAW THAT BASICALLY REGULATES DIAGNOSTIC LABORATORY SERVICES PERFORMED IN THE PRACTICE OF MEDICINE. THESE ARE THE ONLY TWO STATUTORY EXCISMTIONS, AS I SAY, AND THEST FROM-GANSKY -- THE FREST-GANSKY EXCLUDES DIAGNOSTICS, WHICH WOULD BE THE MEDICAL PRACTICE WE ARE TALKING ABOUT HERE WITH MUTATION, USE OF MUTATIONS AND DIAGNOSIS. SO THEY ARE EXPLICITLY EXCLUDED. AND JUST TO FINISH, THE COMMITTEE'S ON A VERY FAST PACE CONSIDERING THE COMPLEXITY OF THIS TOPIC AND EXPECTS TO BE FINISHED, FINISHED IN AN APRIL MEETING AND RELEASE A REPORT BY JUNE, WHICH I THINK WILL BE AN EXTREMELY, A LOT OF EXTREME AMOUNT OF WORK THAT HAS TO BE DONE TO GET TO A REPORT, BUT THAT IS THE SCHEDULE THE COMMITTEE IS ON. SO, I THINK THAT'S WHAT THE COMMITTEE ON IS UP TO. THOSE ARE THE TOPICS THAT IT'S LOOKED AT AND I THINK I'LL STOP HERE AND I WILL BE HAPPY TO TAKE ANY QUESTIONS THAT THE CHAIR PERMITS.
DR. , YOU MENTIONED THE CANAVAN EXAMPLE WHERE, AND YOU TALKED ABOUT EXCLUSIVE LICENSING, BUT TANAVAN TAKES THAT FURTHER, WHERE EXCLUSIVE, AN ATTEMPT EXCLUSIVITY THAT BASICALLY REMOVES A DIAGNOSTIC FROM A PATIENT AVAILABILITY. CAN YOU COMMENT ON THAT, PLEASE.
WELL, LET ME -- LET ME TRY, DR. McCABE AND SEE IF I DO IT ON ADDRESSING YOUR ISSUE. THE ARGUMENT IS RAISED THAT, THAT IF A PARTICULAR, AND THIS IS, THIS IS ALL DAVID CORN AND NOT THE NATIONAL ACADEMY AND ITS COMMITTEE ON. OKAY. THIS IS MY OPINION. THE ARGUMENT HAS BEEN THAT WHEN THERE IS AN EXCLUSIVE PROVIDER OF THE LABORATORY DIAGNOSTIC TEST, ONE, THEY CAN SET WHATEVER PRICE THEY WANT. THAT IS THERE IS NO COMPETITION. TWO, THERE MIGHT BE INCONVENIENCE IN GETTING SAMPLES FROM WHEREVER THE PATIENTS ARE TO WHEREVER THE PRIVILEGED PROVIDER MIGHT BE. AND, THREE, THAT THERE IS NO REAL INDEPENDENT CHECK ON THE VALIDITY OF THE WORK BEING PERFORMED BY THAT PROVIDER THAT. IS IF YOU GET IT RESOLVED, YOU CAN'T GO TO ANOTHER LICENSED, CREDIBLE LABORATORY AND HAVE THAT RESOLVE CHECKED, BUT SOMETIMES RESULTS ARE WRONG. AND IF YOU DON'T GET AN INDEPENDENT CHECK, CAN YOU HAVE SOME REALLY UNFORTUNATE CONSEQUENCES THAT WERE NOT NECESSARY BECAUSE YOU ARE PROCEEDING ON A, ON A PROBLEM THAT MAY NOT EXIST.
WELL, THE PROBLEM THAT IS DIFFERENT FROM WHAT YOU WERE TOLD. ALL OF THESE ARE ARGUMENTS ABOUT THE UNDESIREABILITY OF HAVING AN EXCLUSIVE PROVIDER OF A DIAGNOSTIC TEST AND YOU PROBABLY KNOW, IF YOU READ THE NEWSPAPERS, THAT IN FRANCE, AND I BELIEVE IN CANADA, THE GOVERNMENT IS ACTUALLY BACKING PROFESSIONALS WHO ARE CHALLENGING THE MYRIAD PATENT ON BRCA 1, AND THEY'RE DOING IT ON THE GROUNDS OF PROTECTING THE PUBLIC HEALTH OF THEIR PARTICULAR SOCIETIES. I, ALL RIGHT. THAT'S AN ANSWER. NOW, I AM A POSSIBILITIOLOGIST. AT LEAST I USED TO -- PATHOLOGIST, AT LEAST I USED TO BE. TO MY KNOWLEDGE, THERE HAS NEVER BEEN NEXT THE PRACTICE OF PATHOLOGY, AND DEBRA CAN CORRECT ME, ANY SUCH EXCLUSIVITY OF, IMPOSED ON THE PRACTICING CREDENTIAL COMMUNITY. THERE CERTAINLY HAVE BEEN INSTANCES WHERE PRACTITIONERS WILL CHOOSE TO SEND SPESYMENS TO REFERENCE LABORATORIES. THEY MIGHT BE VERY RARE DISEASES OR THEY MIGHT BE VERY DIFFICULT TESTS THAT REQUIRE A LOT OF SPECIAL EXPERT -- EXPERTISE, AND IT'S OFTEN IN ECONOMIC AND EFFICIENCY AN EQUALITY DECISION THAT IS BETTER TO SEND IT OVER THERE TO THAT LAB. THEY DO THEM ALL AND THEY KNOW WHAT THEY'RE DOING, RATHER THAN HAVE OUR LAB TRY TO DO SOMETHING WE MIGHT SEE ONCE OR TWICE A YEAR OR TWO. SO, CERTAINLY THERE ARE REFERENCE LABS THAT DO HAVE SOME NONOPOLIES ON CERTAIN TESTS. THAT'S -- MONOPOLIES ON CERTAIN TESTS. THAT'S USUALLY THE DESIRES BY THE PROFESSIONALS AND THE BEST WAY TO DELIVER THE CARE. IT'S NOT IMPOSED. THERE ARE CERTAINLY COMPANIES THAT HAVE BEEN VERY SUCCESSFUL MAKING IMPORTANT DIAGNOSTIC LABORATORY EQUIPMENT LIKE FAX ORDERS AND ROBOT CHEMISTS AND ALL, AND THEY HAVE -- THEY HAVE A RIGHT TO PROTECT THEIR PATENTS AND MAKE SURE YOU DON'T TRY TO BUILD THEIR OWN AND COPY YOUR MACHINE AND USE IT FOR YOUR PRACTICE. BUT MOST PEOPLE WHO WANT ON AREN'T NUTS WOULD BE HAPPY TO BUY GOOD EQUIPMENT AND GOOD REAGENTS AND GOOD KITS BECAUSE, FIRST OF ALL, THEY'RE RELY -- RELIABLE. SECONDLY, IT'S EASIER AND EASIER TO TEACH THE TECHNICIANS HOW TO DO IT, AND SO THERE IS, THERE IS A GREAT DESIRE TO HAVE THESE KINDS OF THIGS AND PEOPLE WILL BUY THEM AND USE IF THEY'RE AVAILABLE. IN THOSE INSTANCES, THAT'S NOT WHAT WE'RE TALKING ABOUT. IT'S NOT A PRODUCT THAT SOMEBODY IS TRYING TO USE ELICITLY. IT'S A PIECE OF INFORMATION, AND THAT'S WHAT IS DIFFERENT AND IT WORRIES ME ABOUT WHAT IT MEANS FOR THE FUTURE OF MEDICAL PRACTICE, FRANKLY, BECAUSE WE'RE STILL AT THE DAWN OF THE GENOMIC REVOLUTION. WE'RE STILL AT THE DAWN. I MEAN THERE WILL BE GAZILLIONS MORE SEQUENCES THAT ARE GOING TO HAVE SOME KIND OF RELATIONSHIP WITH VARIOUS, UM, HUMAN TRAITS AND DISORDERS OF INTEREST AND THE IDEA THAT EVERY SINGLE ONE OF THEM MIGHT BE RESTRICTED FROM USE IN THIS WAY, UM, I JUST FIND A VERY DISTASTEFUL SCENARIO. IT JUST SEEMS TO ME A PATH THAT MEDICINE IS NOT TROD ON BEFORE, AND I, I DON'T SEE IT AS A HAPPY PATH. BUT THAT'S MY PERSONAL OPINION.
NEXT, AND THEN WE'LL GO AROUND LIKE THAT.
I JUST WANTED TO ASK YOU IF YOU COULD SAY A LITTLE BIT MORE THAN YOU'RE GOING TO GENERATE A REPORT. CAN YOU TALK ABOUT, AT LEAST SORT OF MAYBE THE TABLE OF CONTENTS. IS THIS GOING TO BE JUST A REVIEW OF THE STATE-OF-THE-STATE OR DO YOU INTEND TO MAKE SOME SPECIFIC RECOMMENDING AS. WOULD YOU LIKE TO SAY WHAT THE RECOMMENDATIONS ARE. I UNDERSTAND -- [ INDISCERNIBLE ]
I THINK THE COMMITTEE IS FULLY EM -- EMPOWERED TO MAKE RECOMMENDING AS, AND I DON'T KNOW WHAT KIND OF RECOMMENDSATION -- RECOMMENDATIONS THEY WILL CHOOSE TO MAKE. I DO BELIEVE THAT, UM, THAT THERE IS A WEALTH OF PERSPECTIVE AND EXPERTISE, AND EXPERIENCE FROM THE ROSTER. IT'S A VERY DISKING -- DISTINGUISHED GROUP OF PEOPLE, AND I EXPECT THAT THEY WILL MAKE FINDINGS AND THEY WILL MAKE RECOMMENDATIONS.
GOOD. [ LAUGHTER ] BRET.
CAN YOU HELP ME AGAIN WITH THE DISTINCTION WITH GENETIC INFORMATION. IT SEEMS ANY PATENT GIVES THE INVENTOR A MONOPOLY AND THAT CAN BE TROUBLING, BUT THAT'S THE WAY OUR SYSTEM IS AND IT'S NECESSARY FOR A LOT OF REASONS. SO, IT SEEMS LIKE THE EXPLANATION IN THIS CASE IS THAT IT'S DIFFERENT BECAUSE SOMEHOW HUMAN HEALTH IS INVOLVED AND THERE'S MORE RISK THAT IT MIGHT NOT BE MADE AVAILABLE TO EVERYONE. AND I UNDERSTAND THAT, EXCEPT -- THE THINGS IN BETWEEN GENETIC INFORMATION AND ANY DRUG WHICH, IS A MONOPOLY, AND THERE IS THE RISK THAT FIZER OR MERCK WON'T SELL THEIR DRUG TO EVERYONE IN THE WORLD OR MAKE IT AVAILABLE TO EVERYONE AND JUST IN THE SAME WAY, THE TESTS WOULDN'T BE AVAILABLE, THE DRUG MAY NOT BE AVAILABLE, AND YET NO ONE IS SUGGESTING THAT WE DON'T PATENT THE DRUGS. THE DIFFERENT -- DIFFERENCE IS IT'S PILL INSTEAD OF A PIECE OF INFORMATION. CAN YOU ELABORATE ON THAT? I MEAN IN EITHER CASE, IT COULD HAVE TAKEN 20 YEARS TO DEVELOP THAT PIECE OF INFORMATION BECAUSE IT TAKES 20 YEARS TO BUILD THE DRUG.
WELL, AS A MATTER OF FACT , A LOT OF TIMES INFORMATION IS AVAILABLE TO THOSE USING THE INFORMATION WELL BEFORE PATENTS IS NEVER ISSUED, AS IT TURNS OUT. THAT'S NOT THE POINT. I THINK THE ISSUE IS THAT HISTORICALLY, AT LEAST, THE PRACTICE OF MEDICINE HAS NOT BEEN LIMITED IN TERMS OF WHAT PRACTITIONERS MAY KNOW AND APPLY TO THEIR PATIENTS, OR DO TO THEIR BODIES BECAUSE SOMEBODY OWNS SOMETHING. IF YOU LOOK BACK AT THE HISTORY OF MEDICINE, IT'S VERY EPONEMIC. THAT IS PEOPLE GOT THEIR GOODIES, THEIR KICKS BY PUTTING THEIR NAMES ON THINGS. YOU HAVE A LOT OF SURGICAL PROCEDURES THAT HAVE GREAT SURGEON'S NAMES ASSOCIATED WITH THEM. JOINSES ERROR ERRORS APPROACH TO THE GULL BAD -- JONESES APPROACH TO THE GAL BLADDER AND THE KID -- KIDNEY. THEY GOT THEIR PLEASURE BY ZREECK THEM AND PEOPLE USED THEIR NAME. THEY DIDN'T SAY I'M GOING TO BE THE ONLY ONE WHO CAN DO THIS, OR I AND THOSE TWO PEOPLE THAT I'M APPOINTING ARE THE ONLY TWO PEOPLE IN THE WORLD ABLE TO DO IT. THEY LET THE PROFESSIONALS USE THE INFORMATION. I THINK THAT IS A TRADITION IN MADISON -- MEDICINE THAT I HAVE GREAT RESPECT FOR, AND I AM JUST, I JUST FIND IT OFFENSIVE, PERSONALLY, TO BE TOLD THIS IS A PIECE OF INFORMATION YOU MAY USE IN YOUR PRACTICE, AND YOU'RE NOT ALLOWED TO. IT DOESN'T MONEY IT'S WRONG, IT'S CERTAINLY LEGAL. CERTAINLY LEGAL. I FIND IT VERY DESTASTEFUL, AND I HAVE TROUBLE ENVISIONING MEDICINE IN 2050, WHEN THERE IS, AS I SAID, GAZILLIONS OF THE BITS AND PIECES OF INFORMATION THAT ALL HAVE INTELLECTUAL PROPERTY. NOW, YOU CAN SAY TO ME, YOU KNOW, THAT'S JUST TOUGH COOKIES, AND YOU'RE LIVING IN A NEW AGE --
MOST TODAY WILL BE -- [ INDISCERNIBLE ]
WELL, MAYBE, BUT THE POINT OF THE MATTER IS, AND I WOULD CERTAINLY DEFER TO YOUR EXPERTISE ON THIS, UM, I IMAGINE THAT IF YOU ARE THE SOLE REPOSITIVE ITITORY OF THE MUTATION -- REPOSITORY OF THE PARTICULAR GENES OF INTEREST, YOU CAN ALWAYS SELECTIVELY FILE FROM MORE PATENTS ON A DIFFERENT MUTATION IN THE SAME GENE THAT MIGHT HAVE EQUALLY INTERESTING CLINICAL CORRULUX, AND KIND OF KEEP ROLLING YOUR OWNERSHIP OF THE GENE OUT FOREVER AND EVER AND EVER. I DON'T KNOW. ISN'T THAT POSSIBLE?
BRAD, CAN I DISTENSION WISH BETWEEN DRUGS WHICH HAVE PROTECTION AND THE GENE SEQUENCES, WHICH ALSO HAVE PATENT PROTECTION. WITH A DRUG, YOU'RE, YOU'RE PATENTING A CHEMICAL COMPOUND THAT REACTS IN SOME WAY IN THE BODY TO PREVENT THE DISEASE OR TREAT A DISEASE OR CHANGE HOW SOMETHING WORKS. YOU'RE NOT PATENTING HOW THAT SOMETHING IN THE BODY WORKS, SO ANYONE WHO WANTS TO CREATE A DIFFERENT CHEMICAL TO TREAT THAT SAME DISEASE CAN DO SO. THEY JUST CAN'T CREATE THE SAME CHEMICAL AND PRODUCE IT AND MAKE IT. WITH GENE PATENT, YOU ARE REALLY PATENTING SOME OF THE PATENT, THE SEQUENCE ANY WAY WHATSOEVER CAN YOU IMAGINE UNDER THE SUN OF LOOKING AT THAT SEQUENCE OR DETECTING IT IN SOMEONE'S BODY OR IN A SPECIMEN OR ANYTHING. IT'S LIKE PATENTING THE DISEASE RATHER THAN THE CHEMICAL COMPOUND THAT TREATS THAT DISEASE. THERE IS REALLY A FUNDAMENTAL DIFFERENCE BETWEEN DRUG PATENTS AND THOSE GENE PATENTS.
THANK YOU FOR THAT CLARIFICATION. HUNT.
JUST BEFORE I GET TO DAVID ON THAT POINT, OF COURSE, THERE ARE PATENTS, DEPENDS ON HOW SWEEPING THE CLAIMS ARE. THERE ARE CLAIMS BROAD ENOUGH TO CAPTURE AN ENTIRE BIOCHEMICAL PATHWAY REGARDLESS OF THE PARTICULAR DRUG. TO DAVID, IS YOUR COMMITTEE, IF CAN YOU SAY, ALSO LOOKING AT THE CONCEPT OF DEFENSIVE PATENTS AND DEPOSITING, UM, RIGHTS AND SORT OF A SCIENTIFIC COMMONS FOR EVERY MAN'S USE? EAR IS THAT SOMEONE THAT IS OFFLIN -- ON OR IS THAT SOMETHING YOU'RE LOOKING AT OFFLINE AS YOU'RE LOOKING AT THAT.
I BELIEVE, THERE HAS BEEN CONVERSATION ABOUT DEFENSIVE PATENTS. AND CERTAINLY THEY ARE AWARE, VERY AWARE OF THE INITIATIVES LIKE THE BERMUDA RULES AND THE HUMAN GENOME SEQUENCE AND THE SNIP CONSORGZ, WHICH IS AN INDUSTRY, LARGELY AN INDUSTRY CONSORTIUM, AND THE, THE HAPMAP PROJECT, THEY'RE VERY AWARE, AND THEY'RE AWARE OF THE, OF HELEN BERMAN'S PROTEIN STRUCTURE BANK. PLEASE BE AWARE THAT IF THERE IS AN ISSUE HERE WORTH YOUR ATTENTION, THAT IT'S NOT BUSINESS VERSUS ACADEMIC OR COMMERCE VERSUS UNIVERSITY BECAUSE I BELIEVE THAT THE LARGEST HOLDER OF HUMAN GENOME SEQUENCE PATENTS IN THE UNITED STATES IS THE UNIVERSITY OF CALIFORNIA SYSTEM. SO, THIS IS NOT UNIVERSITIES OR GOOD GUYS AND BUSINESSES OF BAD GUYS. NOT AT ALL. THIS HAS NOTHING TO DO WITH WHETHER OR NOT YOUR UNIVERSITY OR START UP OR A MAJOR COMPANY. IT'S AN ISSUE OF, WELL, TO ME IT'S AN ISSUE OF IS IT IN THE INTEREST OF THE HEALTH OF THE PUBLIC TO PROCEED ALONG THIS KIND OF PATHWAY OR NOT? AND I THINK YOU ALL HAVE PLENTY OF CAPACITY TO DEBATE THAT PROBLEM. AND AS I SAY, FRANCE AND CANADA ARE AT LEAST -- IT'S NOT IN THE INTEREST OF THE HEALTH OF THEIR PEOPLE TO RECOGNIZE SUCH A SWEEPING EXCLUSIVE PATENT.
WE'VE GOT THREE PEOPLE IN LINE. ONE IS THE AFOREMENTIONED PERSON FROM THE UNIVERSITY OF CALIFORNIA SYSTEM. ED McCABE, AND THEN WE HAVE DEBRA AND THEN TIM.
I TAKE FULL RESPONSIBILITY FOR EVERYTHING THAT OCCURS IN THE UNIVERSITY OF CALIFORNIA SYSTEM. BUT I WAS FALLING -- FOLLOW UP, YOU TALKED ABOUT SOME OF THE DIFFERENT ISSUES WITH EXCLUSIVE LICENSURE, AND ONE OF THE AREAS THE AMERICAN COLLEGE OF MEDICAL GENETICS DISCUSSED IN THEIR STATEMENT ALSO HAD TO DO WITH EDUCATION. IF THERE ARE PATENTS ON METHODS OR PROCESSES, THAT ARE EXCLUSIVE, THEN IT'S HARD TO EDUCATE THE NEXT GENERATION OF YOUNG PEOPLE REGARDING HOW TO UTILIZE THOSE BY THE TIME THEY GO OFF PATENT. WE COULD LOSE THE EXPERTISE AND, THAT I'M NOT ASKING FOR A CONCLUSION, I'M JUST WONDERING IF THE COMMITTEE ON'S TAKING THIS UP.
I DON'T KNOW THE ANSWER TO THAT, OR I CAN'T REMEMBER WHETHER IT'S COME UP OR NOT I THINK -- DEBRA PRESENTED IT TO THE COMMITTEE AT ITS MOST RECENT MEETING A FEW WEEKS AGO, AND I DON'T REMEMBER WHETHER YOU MENTIONED TRAINING .
DAVID, IS THERE ANY WAY, UM, ANY WAY THIS COMMITTEE COULD HELP THIS COMMITTEE, YOUR COMMITTEE ON. IS THERE ANYTHING WE COULD DO TO INFORM THE COMMITTEE OR, YOU KNOW, ANYTHING?
IT SEEMS TO ME THAT YOUR CHARGE IS THE HEALTH, GENETICS HEALTH AND SOCIETY IS IT? IT SEEMS TO ME YOU THAT MIGHT, IF YOU CHOOSE, PUT MORE ENERGY INTO THE ISSUE OF HOW THOSE SORTS OF INTELLECTUAL PROPERTY RIGHTS SHOULD BE MANAGED TO MAKE SURE THE HEALTH OF THE PUBLIC WHICH, IS YOUR RESPONSIBILITY, IS MAXIMIZED OR CERTAINLY NOT IMPAIRED AND, AND HOW YOU WOULD DO THAT AND WHAT RECOMMENDATION YOU MIGHT MAKE ABOUT IT, I DON'T KNOW. IT SEEMS TO ME THAT THAT WOULD BE VERY AIRLY WITHIN YOUR CHARGE -- SQUARELY WITHIN YOUR CHARGE. AS I SAY, I'M A CAPITALIST, I'M A PRODUCT OF THE CAPITALIST SOCIETY. I'M NOT TRYING TO UNDERMINE OUR ECONOMY AT ALL AS I HAVE BEEN ACOT -- ACCUSED OF DOING BY SOME, BUT I DO THINK IT'S A GENUINE ISSUE HERE OF WHAT IS BEST FOR THE FUTURE -- FUTURE HEALTH OF THE PUBLIC. IF THIS IS THE BEST WAY TO DO IT, THAT'S FINE. IF NOT, THEN THERE NEEDS TO BE SOME MOSQUE.
JUST AS AN AMENDMENT, DAVID, TO THE ANSWER YOU GAVE DEBRA. DO YOU THINK THAT FROM YOUR SENSE WHAT HAVE YOUR COMMITTEE IS GOING TO PRODUCE, THAT, THAT OUR, UM, TAEBDING TO, YOU KNOW -- ATTENDING TO, YOU KNOW, THE CHARGE YOU SORT OF RECOMMENDED FOR US, WILL, SHOULD, SHOULD WAIT BEFORE WE LOOK AT THAT AND UNTIL YOUR COMMITTEE FINISHES ITS WORK IS THERE SOMETHING --
I THINK AT THE SECRETARY'S ADVISORY COMMITTEE, YOU'RE FREE TO DO WHATEVER YOU LIKE WHEN YOU WISH. [ LAUGHTER ]
LET ME REPHRASE THAT. WE LOVE THAT FREEDOM. I GUESS I'M WONDERING FROM YOUR SENSE, DO YOU THINK YOUR COMMITTEE WILL INTRODUCE INFORMATION THAT WOULD BE USEFUL TO US IN UNDERTAKING THAT.
I DON'T THINK I CAN ANSWER THAT. I DON'T KNOW.
OKAY, THANK YOU. TIM.
I JUST WANTED TO SAY AS THE LIAISON FROM THE NEXT, -- NIH, THANK YOU FOR THE WORK AND THE COMMITTEE YOU'RE DOING ON THIS WORK. IT'S IMPORTANT TO WHAT WE'RE DOING AT THE INSTITUTE. I WONDER IF YOU MIGHT TALK A LITTLE BIT ABOUT SOME OF THE DIFFICULTY GATHERING DATA TO ASSESS THE IMPACT THAT THE PATENTS ARE HAVING ON GENETICS AND GENOMICS AND PROTEOMICS RESEARCH.
YEAH, THANK YOU. THANK YOU FOR THAT, TIM. IT'S VERY HARD TO DO THIS. APPARENT -- APPARENTLY, I MEAN, WHAT YOU'RE DEALING WITH ARE ANECDOTES, YEAH, ANECDOTES, RATHER THAN DATA IN MANY INSTANCES. UM, THAT'S WHY I MENTIONED THE GOLDEN RICE EXAMPLE AS ONE THAT IS NOT AN ANECDOTE. IT WAS ACTUALLY DESCRIBED IN A SCIENCE OR MAGAZINE POLICY FORM A YEAR AGO . THE COMMIT , ANY, ANY NATIONAL ACADEMY COMMITTEE FEELS THAIT'S IMPORTANT, AND IT'S VERY UNDERSTANDABLY SO, THAT THEIR RECOMMENDING AS AND CONCLUSIONS, CONCLUSIONS AND RECOMMENDATIONS BE DATA-SUPPORTED. SUPPORTED DIE DATE -- BY DATA, DRIVEN BY DATA, NOT BY, UM, YOUR SIDE. -- HERE'S. ANY, -- HERESAY. ANY ACADEMY COMMITTEE, AND I THINK THAT THE, THE COMMIT EYE IS VERY INTERESTED IN OBTAINING GOOD CREDIBLE DATA THAT WOULD SHED LIGHT ON SOME OF THESE HYPOTHETICAL CONCERNS. IT SEEMS TO BE, THIS IS NOT MY FIELD, OF COURSE, BUT IT SEEMS TO BE VERY, VERY HARD TO DO SO. AND, AND CERTAINLY WITHIN THE TIMELINE OF, UM, THE COMMITTEES, IT'S CERTAINLY NOT POSSIBLE TO DO A THOROUGH 3-YEAR STUDY OR SOMETHING OF THIS SORT TO CAN VASS THE UNIVERSE, BUT THEY'RE VERY INTERESTED IN OBTAINING DATA THAT WOULD HELP THEM TO UNDERSTAND AND THEN THINK ABOUT WHAT THEY MIGHT RECOMMEND ON THESE ISSUES. I WILL OFFER ANOTHER PERSONAL OBSERVE SAYING, HOWEVER. THERE IS -- MANY INDUSTRIES HAVE, UM, AND I WISH THERE WERE A GOOD PATENT LAWYER IN THE ROOM, BUT MANY INDUSTRIES HAVE COME TO THE DESIREABILITY OF PATENT POOLING, DEVELOPING MECHANISMS TO SHARE THEIR PATENTS SO THAT THE WHOLE DEVELOPMENT DOES, ALL OF THE, THE WHOLE PROCESS OF DEVELOPMENT DOESN'T GET SWAMPED IN A MIRE THAT NOBODY CAN MOVE IN, WHERE NOBODY CAN MOVE BECAUSE EVERYBODY OWNS A BIT OF WHAT HAS TO BE DONE, AND THE IDEA OF PATENT POOLING, TO MY KNOWLEDGE IN BIOTECHNOLOGY, OR BIOMEDICAL RESEARCH AND BIOTECHNOLOGY HASN'T YET EXISTED. IT'S NOT A, SOMETHING THAT COMES EASY WHEN YOU TALK ABOUT BIOMEDICAL AND BIOTECHNOLOGY RESEARCH. NOW, IT MAY, IT -- FOR EXAMPLE, I'M TOLD BY THE EXPERTS THAT PATENT POOLING WERE ESSENTIAL TO THE DEVELOPMENT OF THE AIRCRAFT, RADIO, CERTAINLY MORE RECENTLY IN OUR LIFETIMES, YOU KNOW, IN SEMI CONDUCTORS. THERE IS A WHOLE TRADITION IN SEMI CONDUCTORS OF COMPANIES, BITTER COMPETITORS, SHARING RESEARCH INVESTMENTS AND KNOWLEDGE AT A VERY FUNDAMENTAL LEVEL OF THE SCIENCE. I KNOW THAT. BUT IN BIOMEDICINE, THE, THE EARLY CAPTURE OF DISCOVERY, VERY EARLY CAPTURE IN THE PATHWAY FROM DISCOVERY TO SOME PRODUCT, THE EARLY CAPTURE SEEMS TO BE THE NAME OF THE GAME. OF COURSE, YOU HAVE WHOLE BIOTECH COMPANIES FOUNDED ON BITS OF KNOWLEDGE. REALLY EARLY STUFF, SO THERE IS A TRADITION OF NOT HAVING A LOT OF PATENT POOLING. YOU KNOW, IT MIGHT BE THAT IN TIME, IF THINGS GET MIRED DOWN ENOUGH, THAT PATENT POOLING WILL APPEAR TO BE A VERY MUTUALLY BENEFICIAL WAY FOR EVERYBODY TO GO, WHERE THEY PUT ALL OF THEIR PATENTS IN A POOL ON AGREEABLE GROUND RULES AND PEOPLE CAN USE THAT PATENT POOL TO MOVE THE FIELD FURTHER ON. BUT IT, IT DOESN'T, TO MY KNOWLEDGE, I MIGHT BE WRONG. IT DOESN'T SEEM TO BE SOMETHING THAT COMES NATURAL TO OUR PARTICULAR AREA OF WORK.
WE ARE REALTY ON SCHEDULE, BUT I -- RIGHT ON SCHEDULE. I WANT THE COMMITTEE TO MAKE SURE THAT WE TAKE, IF THERE IS ONE FURTHER BURNING QUESTION, TO TAKE GOOD VICTIM OF DAVID CORN. -- ADVANTAGE OF DAVID CORN.
I NEED TO MAKE A COMMENT. TODAY IS MY LAST DAY ON THIS COMMITTEE, I HAVE BEEN DYING TO MAKE A COMMENT THAT MEAN A LITTLE MORE INFLAMMATORY. SO HERE IT GOES. TO PREFACE EVERYONE, REMIND EVERYONE I'M EXTREMELY CONFLICTED AND BIAS IN THIS COMMENT. I'M CONFLICTED BECAUSE, FIRST, I RUN A COMPANY THAT IS IN THE GENE-FINDING BUSINESS AND I'M ALSO CONFLICTED BECAUSE A SPENT A LOT OF YEARS TRYING TO FIND A JEEP FOR MY KID -- GENE FOR MY KIDS DISEASE, ONE OF THOSE OBSCUSH -- OBSCURE, RARE DISEASE AND IT WAS HARD TO FIND ANYONE TO WORK ON IT. FOR ALL OF THOSE REASONS, I GUESS, THE ONLY THING I WOULD LIKE TO ENCOURAGE IN THE PATENT REVIEWING PROCESS COMMITTEE IS THAT TO NOT FORGET THE RAISE TO FIND THE GENES -- THE RACE TO FIND THE JEEPS CAN BE IMPORTANT. EVEN IF IT SEEMS LIKE WE'RE SOMETIMES OVERWHELMED AND FLOODED WITH SO MUCH INFORMATION AND WE HAVE ENOUGH TO WORK ON FOR NOW, THAT I THINK CONTINUING TO ENCOURAGE THAT, THOSE GENE DISCOVERIES AND THERE ARE A LOT MORE TO BE DISCOVERED, IS CRITICAL TO ACCELERATING AND FOCUSING BIOMEDICAL RESEARCH. AND SO IF, I ABSOLUTELY AGREE THAT IF SOMEONE CAME ALONG WHO FOUND OR REPLICATED A TRUE ASSOCIATION BETWEEN POLYMORPHISM AND FEPO TYPE OF IMPORTANCE AND THEY DIDN'T -- PHENOTYPE OF IMPORTANCE AND DIDN'T MAKE A TEST AVAILABLE TO THE WORLD SO THE PEOPLE ARE BEING DEPRIFD, MAYBE THE GOVERNMENT SHOULD BE MADE MARCHING RIGHTS OR THE PATENT RIGHTS SHOULD BE MADE SHORTER. AT THE SAME TIME FROM THE BIOTECH INDUSTRY, AS YOU KNOW, THERE IS A NEED TO FIND INIT -- INVESTORS AND THEY ONLY FUND EXPENSIVE PROEC -- PROJECTS TO FIND JENS.
.
-- GENES IF THERE IS SOME KIND OF EXCLUSIVITY OR, QUOTE, UNQUOTE, MONOPOLY. IT'S POSSIBLE. THAT'S THE HOT-PUT ABOUT -- BUTTON FOR EVERY INVESTOR. ON THE ONE HAND, WE WANT TO PROTECT PEOPLE FROM NOT HAVING AN IMPORTANT TEST. ON THE OTHER HAND, I WOULD HATE TO HEAR THAT SOMETHING WAS DONE WHERE SUDDENLY THERE IS NOT ENOUGH INTEREST IN CONTINUING TO FIND GENES AND I KNOW THE NIH HAS A LOT OF FUNDING BUT DOESN'T HAVE ENOUGH FUNDING FOR ALL DAY WORK TICKET TO BE DONE ON GENETICS.
I ABSOLUTELY SHARE YOUR VIEW. I CERTAINLY WISH TO DO NOTHING EVER, MYSELF, THAT WOULD SHUT DOWN AN INCENTIVE TO FIND GENES, BUT I JUST WOULD SAY THERE ARE WAYS THAT, THAT INCENTIVE CAN REMAIN, AND THERE STILL COULD BE MORE FREEDOM OF APPLICABILITY OF THE DISCOVERY THROUGH COMPULSEORY LICENSING SCHEMES. I'M NOT RECOMMENDING THESE, BUT THEY'RE THINGS THAT HE'S TALKING ABOUT, COMPULSEORY LICENSING SCHEMES, ROYALTIES THAT ARE NOT SO PUNITIVE, THAT NOBODY IN THEIR RIGHT MIND COULD MAKE IT WORK. [PAUSING TO SWITCH CAPTIONERS] WAY OF DEALING WITH THAT. WHERE THEY HAVE CREATED A NATIONAL FOR PROFIT FOUNDATION -- A NOT FOR PROFIT FOUNDATION. THEY WILL CONTROL THE GOODS AND SPECIMENS AND TISSUES AND HOLD THE INTELLECTUAL PROPERTY AND HAVE A VOICE IN WHAT HAPPENS IF GENES ARE DISCOVERED THAT ARE OF USE CLINICALLY. THEY WILL HAVE A SAY IN HOW THE FRUITS OF THE INVENTION ARE DISTRIBUTED AMONG THE PEOPLE. THAT IS INTO THE BAD ADE. THAT IS NOT A BAD WAY TO GO. THERE ARE OTHER SUCH DISEASE GROUPS THAT HAVE FORMED SIMILAR CONTROL MECHANISMS TO KEEP A HAND ON WHAT HAPPENS TO THE STUFF THEY ARE PROMOTING.
AND GIVEN THE COVERAGE AND REIMBURSEMENT ISSUE THAT WE WERE DISCUSSING EARLIER FOR GENETIC TESTING IS SO INADEQUATE THAT I CAN'T BELIEVE IT IS A STRONG BUSINESS MODEL FOR A LOT OF GENETIC DISEASES. RATHER I THINK THAT YOUR INVESTORS WOULD BE MORE INTERESTED IN WHAT DRUGS YOU COULD DEVELOP OR TEST KITS AND OTHER THINGS THAT HAVE TRUE MARKET POTENTIAL.
SO WHEN WE DISCUSS PHARMACOGENOMICS YOU WILL KNOW HOW THEY ARE ALL TRIED TOGETHER.
YOU WILL HAVE OPPORTUNITIES IN THE COMING MINUTES TO BE PROVOCATIVE BUT LET ME THANK DAVID KORN. REMIND OF US YOUR REPORT. I CAN'T REMEMBER THE DATE YOU THOUGHT THIS WAS GOING TO BE SUB SMITED? I THINK IT WAS JUNE 2005.
JUNE.
SO WITH THAT WE WILL --
COULD I DO ONE LITTLE SALES PITCH? IN DECEMBER OF 2002 WE PUT OUT A SLOAN FOUNDATION SUPPORT SPECIAL ISSUE OF THE JOURNAL OF ACADEMIC MEDICINE THAT PRESENTS AN UNBIASSED ANALYSIS OF THE GENE PATENTING ISSUES.
I GAVE SARA.
THE COMMITTEE HAS A COPY OF IT.
IF ANYBODY WANTS MORE, LET ME KNOW.
DAVID, THANK YOU. AS FAR AS THIS ISSUE IS CONCERNED ON OUR PLATE OF ACTIVITIES CAN I GET A GENERAL CONSENSUS FROM THE COMMITTEE THAT WE WILL REVISIT THIS ISSUE UPON THE COMPLETION OF THE NAS COMMITTEE REPORT IN JUNE AND THAT WE FEEL LIKE THEY ARE MOVING FORWARD ALTHOUGH, YOU KNOW, WE GOT A LOT TO SEE IN TERMS OF WHAT ACTUALLY COMES OUT BUT YOU CAN'T FIND A MORE STELLAR COMMITTEE WORKING MORE ACIDOUSLY AND RAPIDLY TO GET A CONCLUSION DONE. IS ANYBODY IN DISAGREEMENT WITH THAT? THAT'S TERRIFIC. LET'S MOVE ON TO THE DISCUSSION OF OUR PROPOSED PLANS FOR DEALING WITH OTHER PRIORITY ISSUES AND START WITH LARGE POPULATION STUDIES AND HUNT WILLARD.
THANK YOU, REED. I'M SUPPOSED TO LEAD THE DISCUSSION FOR US TO AS A COMMITTEE PLAN HOW WE WISH TO MOVE FORWARD OR NOT MOVE FORWARD ON PLANNING A SESSION OR MEETING FOR LARGE POPULATION STUDIES. THE TASK FORCE THAT WAS TO DEAL WITH THIS ISSUE IS -- WAS A DREAM TASK FORCE FOR THOSE WHO ALWAYS CRINGED AT THE THOUGHT OF BEING APPOINTED TO SUCH THINGS IN THAT WE ACTUALLY NEITHER MET NOR EVEN WERE ABLE TO SCHEDULE A -- A TELEPHONE CONFERENCE SO WE ALL WORKED INDIRECTLY BY E-MAIL AND RETURNS OF FAXES TO AMANDA AND SARA AND THE TEAM. WHAT YOU HAVE IN YOUR -- IN FRONT OF YOU IS A THREE-PAGER SETTING OUT FROM THE STAFF PERSPECTIVE WITH INPUT FROM MEMBERS OF THE TASK FORCE ON POTENTIAL POPICS AND I STRESS -- TOPICS AND I STRESS THE WORD POTENTIAL FOR AREAS THAT WE MIGHT PRODUCTIVELY SPEND SOME TIME FOCUSING ON. MY ADVICE TO THIS DISCUSSION HERE WOULD BE TO BRIEFLY DISCUSS THE PROS AND CONS OF THE POTENTIAL TOPICS AND THEN MOVE INTO A DISCUSSION, A REALITY BASED DISCUSSION OF HOW ACTUALLY WE WOULD FIT THIS INTO THIS COMMITTEE P. GAME PLAN MOVING FORWARD. IT IS EASY TO SAY EVERYTHING IS A PRIORITY AND YET WE ARE BACKLOGGING OUR FUTURE MEETINGS. I HAVE GREAT ENTHUSIASM FOR THIS TOPIC AS BEING AN IMPORTANT ONE THAT THIS COMMITTEE COULD WEIGH IN ON, NEED TO WEIGH IN ON AND THE SECRETARY NEEDS TO BE INFORMED OF BUT THERE ARE OTHER GROUPS THAT TAKE THIS ISSUE EQUALLY SERIOUSLY WITHIN HSS. IN FRONT OF YOU ARE FOUR -- REALLY THREE DIFFERENT TOPICS AND THEN THE FOURTH ONE IS SORT OF AN ALL-PURPOSE WRAPUP. FOUR POTENTIAL TOPICS DEALING WITH ALLOWING THIS COMMITTEE TO BECOME MORE INFORMED ABOUT THE NATURE OF COHORT STUDIES THAT ARE UNDERWAY IN OTHER COUNTRIES AROUND THE GLOBE. PROJECTS THAT ARE EITHER UNDERWAY OR UNDER DISCUSSION IN THIS COUNTRY. AND THEN THE INEVITABLE BUT CERTAINLY IMPORTANT SOCIAL AND ETHICAL AND POLICY ISSUES THAT ARE RELEVANT TO THE PLANNING OF A COHORT STUDY IN THIS COUNTRY. TO ME, JUST TRYING TO FRAME THE ISSUE THERE REALLY ARE TWO QUESTIONS BUT BOTH OF THEM REALLY ARE AROUND THE ISSUE OF SHOULD THIS COUNTRY -- SHOULD WE ADVISE THE SECRETARY TO SUPPORT FINDING RESOURCES TO MOUNT A LARGE COHORT STUDY IN THIS COUNTRY AND WHAT INFORMATION DO WE NEED IN OR THE TO MAKE THAT ASSESSMENT. THE UNITED STATES IS ORGANIZED DIFFERENTLY BOTH AS A SOCIETY AND CERTAINLY AS A HEALTH SYSTEM THAN OTHER COUNTRIES AROUND THE GLOBE AND IT MAY BE THAT THERE ARE BOTH SOME ADVANTAGES AS WELL AS DYSADVANTAGES TO TRY -- DISADVANTAGES TO TRYING TO MOUNT AN EFFORT LIKE THAT IN THIS COUNTRY THAT WE WOULD NEED TO DEBATE AND BECOME INFORMED IN DOING SO BY LEARNING MORE ABOUT EFFORTS IN OTHER COUNTRIES WHERE THERE ARE DIFFERENT ORGANIZATIONAL STRUCTURES BOTH IN TERMS OF SOCIETY AND THEIR HEALTH SYSTEMS THAT HAVE ENABLED THEM TO DO WHAT THEY ARE DOING. THE SUGGESTED NAMES THAT ARE ON THIS LIST IN FRONT OF YOU ARE NOTHING MORE THAN SORT OF A MENU OF POSSIBLE INDIVIDUALS WHO MIGHT BE CALLED UPON. IT IS NOT AN EXHAUSTIVE LIST BY MY MEANS AND SO I WOULD URGE THE COMMITTEE NOT TO TAKE THESE AS BEING PRESCRIPTIVE IN ANY WAY OR LIMITING IN ANY WAY BUT SECOND BASEMAN MANIY POTENTIAL -- BUT SIMPLY POTENTIAL OPPORTUNITIES. SO, MR. CHAIRMAN, I WOULD JUST OPEN IT UP TO COMMITTEE DISCUSSION. WE CAN EITHER TAKE IT TOPIC BY TOPIC OR JUST GENERAL COMMENTS ON THIS PARTICULAR ISSUE.
BEFORE WE DO THAT CAN I ASK ONE BACKGROUND QUESTION. I THINK AIM ALSO CONFUSED ABOUT AND MAYBE THE STATE OF THE ART STATUS NOW WITHIN HHS AROUND THIS POPULATION STUDIES ISSUE? BECAUSE I KNOW THAT SOME WHERE ALONG THE LINE SOMEBODY IS KICKING AROUND AND I THINK ITING AL ALLAN IN YOUR AREA AND SHERRI FROM THE V.A. MIGHT KNOW SOMETHING. CAN I WHERE THEY ARE TODAY?
YES, THAT'S A VERY GOOD QUESTION. THANK YOU, REED. THE WAY YOU PUT IS IT IS INTERESTING AND PROBABLY ACCURATE, BEING KICKED AROUND WITHIN HHS. I THINK THAT IS PROBABLY THE TERM FOR THIS CONTRIBUTION THIS IS A GROUP IN THE NIH TRYING TO FIGURE OUT WHAT THE SCIENCE OF *F SUCH A STUDY WOULD LOOK LIKE AND A WORKING GROUP WAS IMPANELLED TO EXPLORE THIS TOPIC OVER THE COURSE OF THE SUMMER. THEY EXPLORED IT. STAFF OF A COUPLE OF NIH INSTITUTES ARE LOOKING AT THIS AND TRYING TO DEVELOP A DOCUMENT OR AT LEAST SOME SORT OF SUMMARY OF THE SCIENCE OF THIS FOR HIGHER UPS IN THE NIH AND POTENTIALLY THE DEPARTMENT TO TAKE A LOOK AT. SO THAT IS WHERE WE ARE AT THE MOMENT IS TRYING TO FIGURE OUT WHAT THE SCIENCE OF SUCH A STUDY WOULD LOOK LIKE. WHAT THE PROS AND CONS OF DIFFERENT PARTICIPANT SIZES WOULD LOOK LIKE AND WHAT THE COSTS WOULD BE AND WHAT TYPE OF PHENO TIPIC AND GENO TIPIC ZWR CDV AND OTHER AGENCIES HAVE BEEN SOME WHAT INVOLVED THROUGH THE WORKING GROUP BUT THIS IS PRIMARILY AN EFFORT WITHIN NIH TO FIGURE OUT THE SCIENCE OF THAT WITH SOME COMMUNICATIONS WITH OTHER AGENCIES FOR THEIR EXPERTISE, ET CETERA.
OKAY.
REALLY I WOULD SAY V.A. IS AT A SIMILAR SPOT IF PERHAPS EVEN EARLIER THAN WHAT ALLAN JUST DESCRIBED. WE ARE KICKING AROUND THE IDEA AS WELL. TAKING A STEP BACK AND ARE SPENDING SOME TIME TALK TOGETHER COMMUNITIES THAT WOULD BE INVOLVED BOTH INTERNAL AND EXTERNAL CONSTITUENTS ABOUT THIS SO IT IS EARLY ON IN THE DISCUSSION OF WHAT WE MIGHT BE INTERESTED IN --
AND FINALLY, DO WE HAVE IN I IDEA OF -- DO YOU ALL HAVE ANY TIMELINE BY WHICH YOU WANT TO BRING YOUR FACT FINDING EFFORT TO CLOSURE OR IS THIS AN OPEN-ENDED PROCESS?
I SURE OPEN IT IS NOT OPEN-ENDED. I -- WE WOULD CERTAINLY ASPIRE TO HAVE SOMETHING MORE THAT WE COULD SHARE WITH THE COMMITTEE FOR INSTANCE, NEXT MEETING. THAT WOULD BE OUR HOPE. WHETHER THAT WOULD BE REALISTIC I'M NOT SURE IN TERMS OF TRYING TO GET THE SCIENTISTS GATHERED BUT ALSO DEPENDING ON WHAT THAT SAYS IN TERMS OF PEOPLE HIGHER UP IN THE DEPARTMENT OR OTHER PARTS OF THE FEDERAL GOVERNMENT FEELING THAT IT WAS READY TO -- TO BRING SOMETHING OUT FOR COMMENT. I DON'T KNOW WHETHER THAT CAN BE REALIZED BY FEBRUARY OR NOT. THAT WOULD BE MY HOPE.
GIVEN THE DOOR THAT HUNT OPENED UP HERE, AT THIS TIME IS THERE ANYTHING THAT WE CAN DO THAT WE NEED TO DO TO FACILITATE Y'ALL'S EFFORTS? DO WE NEED TO -- I'M JUST MAKING SURE IT IS NOT SOMETHING AS EASY AND SIMPLE AS WE SENT A LETTER TO THE SECRETARY AND SAY GET ALL ON THE SAME PAGE OR PRETTY MUCH CAPABLE OF DOING THAT WITHOUT SPURRING FROM US?
I THINK WE ARE ABLE TO DO THAT WITHOUT BEING SPURRED BECAUSE IF THE FEDERAL GOVERNMENT WERE IN ANY WAY TO PARTICIPATE IN SUCH A LARGE STUDY IT WOULD REQUIRE BOTH THE EXPERTISE, THE LOGISTICAL OW SUPPORT AND FINANCES OF MORE THAN ANY ONE OF THOSE AGENC. EVEN IF THEY DIDN'T WANT TO PLAY TOGETHER, WHICH I BELIEVE THEY DO, THEY WOULD HAVE TO PLAY TOGETHER TO ACHIEVE IT.
IT MIGHT BE HELPFUL IF THE COMMITTEE THOUGHT THAT WAS APPROPRIATE TO THEM TO RECOMMEND TO THE SECRETARY THAT SUCH A LARGE COHORT STUDY HAS THE POTENTIAL TO BE OF HELP AND YOU WOULD RECOMMEND THAT THE DEPARTMENT TAKE SERIOUSLY THE QUESTION OF EXPLORING SUCH A THING AND THAT IT HAS POTENTIAL REAL BENEFIT TO THE HEALTH AND WELL BEING OF THE AMERICAN PUBLIC.
AND BY THE WAY, I APPRECIATE THE WAY YOU PHRASED THAT AND ANSWERED THAT. BUT I THINK THAT WHAT YOU SAID AND I WANT TO JUST BE EXPLICIT IS THAT THE WORK OF DETERMINING WHETHER THERE IS SOMETHING THERE AND THAT CAN BE DONE IS REALLY GOING FORWARD AND SO.
YES.
AND SO YOU REALLY DON'T NEED US TO BE BUGGING ANYBODY ABOUT IT RIGHT NOW.
I DON'T THINK YOU NEED TO BUG IT BUT I THINK IT IS HELPFUL FOR A GROUP OUTSIDE OF THOSE DOING THIS WORK THAT HAVE EXPERTISE SAYING THAT AS THE SECRETARY'S ADVISORY COMMITTEE ON GENETICS, HEALTH AND SOCIETY REALIZE THAT IS COHORT STUDY BEING DONE IS OF VALUE. I THINK HAVING THE SECRETARY HEARING THAT FROM THE COMMITTEE COULD BE QUITE USEFUL.
I WOULD SEE IT A LITTLE BIT DIFFERENTLY BECAUSE I THINK THEY'RE PROBABLY GOING TO BE COMPETING INFLUENCES OR COMPETING PROJECTS WITHIN HHS. YOU KNOW, WE HAVE ALL -- AND SO THAT I WOULD BE CAUTIOUS THAT WE NOT FIND OURSELVES SAYING, A, OR -- MAYBE WE COULD SAY A OR THE CONCEPT IS APPROPRIATE BUT NOT THE LARGE POPULATION STUDY I DON'T THINK THAT IS WHAT YOU WERE IMPLYING.
ABSOLUTELY. I'M NOT SURE WHAT "THE" WOULD DESCRIBE. I'M NOT SURE THERE WILL BE COMPETING THINGS THAT COME UP. WHETHER THEY DO OR NOT, I'M NOT CARD FOR THE COMMITTEE TO ENDORSE ANYTHING WHICH THEY HAVEN'T SEEN BUT TO ENDORSE THE CONCEPT OF SUCH THINGS.
RIGHT. ON THE OTHER HAND, I THINK WE SHOULD HEAR WHAT ARE THE U.S. ACTIVITIES IN THIS AREA AND PLANS ALSO HAVE SOME FOLKS FROM OTHER COUNTRIES AROUND THE WORLD WHO MAY BE A LITTLE FURTHER ALONG THAN US. CERTAINLY THE UK BIOBANK HAS HAD A NUMBER OF SPEED BUMPS ALONG THE WAY, SOME OF THEM SEVERAL STORIES TALL FROM WHAT I UNDERSTAND AND I THINK IT WOULD BE GOOD FOR US ALL TO HEAR SOME OF THOSE LESSONS. I THINK HAVING HEARD DAVID KORN AND I'LL NOW GIVE A PERSONAL OPINION ON THIS AND SEEING WHAT OTHER POPULATIONS AROUND THE WORLD ARE DOING, AND KNOWING THAT THERE MAY BE INTELLECTUAL PROPERTY THAT FLOWS FROM THIS, THIS IS THE BUSINESS PLAN OF DECOD GENETICS THAT IS IS IMPORTANT TO RECOGNIZE WHAT THE ISSUES ARE AND IMPORTANT FOR US TO -- TO KNOW HA IS GOING ON IN THIS COUNTRY AND TO RECOGNIZE THE IMPORTANCE OF THIS IN TERMS OF INTELLECTUAL PROPERTY AND WHETHER WE THE AMERICAN PEOPLE WILL OWN OUR GENES OR THE INTELLECTUAL PROPERTY FLOWING FROM OUR GENES IN THE FUTURE. I WOULD ENDORSE THAT WE NEED FURTHER DISCUSSION OF THIS.
A QUESTION I WOULD POSE FOR THE COMMITTEE IS WHETHER WE SHOULD PLAN SUCH A SESSION IF WE WERE INTERESTED IN ONE NOW O OR WHETHER WE WAIT UNTIL WE HAVE SOME COMMUNICATION FROM THE HHS GROUP SO WE HAVE SOMETHING TO SORT OF REFLECT OFF OF AND LOOK AT THAT POTENTIAL PROPOSAL AND CONCEPT PAPER AND THEN SAY WELL, WHAT IT MAY BE MISSING IS THIS AND THAT IS WHERE WE NEED INFORMATION OR DON'T NEED INFORMATION AND I WOULD THROW THAT OPEN TO THE COMMITTEE.
I WOULD AGAIN, I DON'T THINK WE ARE IN A POSITION TO REFLECT ON THE SCIENCE OF THE PROPOSAL. I REALLY THINK THAT THERE ARE EXCELLENT PEOPLE DOING THAT. BUT I THINK IF OUR CHARGE IS GENETICS HEALTH AND SOCIETY WE CAN BRING NOT A BROADING VIE VIEW BOS THERE IS THE BREADTH TO DEAL WITH THIS. IT IS RELATED TO THE GENETIC HEALTH AND SOCIETY AND I THINK THAT WOULD BE ONE OF THE VALUES IN THIS PRESENTATION.
MY CONCERN WOULD ONLY BE TRYING TO AVOID DUPE PLI CATION OF EFFORT WHEN WE HAVE PLENTY OF COMPETING THINGS ON OUR PLATE FOR THE COMING MEETING OR TWO. IS THERE ANY -- ALLAN, IS THERE ANY WRITTEN SUMMARY OF WHO THE ACTUAL GROUP IS THAT IS EXPLORING THE SCIENCE HERE? ED PROFESSED GREAT CONFIDENCE IN IT BUT I DON'T KNOW WHO OR WHAT "IT" IS.
INSTANCE THE WORKING GROUP INVOLVED HAVING FOLKS FROM THE UK BIOBANK AND DECODE TO WORK IN THE WORKING GROUP MEETINGS AND CONSISTED OF PEOPLE FROM WITHIN THE FEDERAL GOVERNMENT AND OUTSIDE EXPERTS SOME OF WHOM ACTUALLY I NOTICE WERE SUGGESTED FOR THE PANELS ON THIS SHEET. SO, YOU KNOW, IT IS GENERAL EXPERTISE.
I DON'T THINK CLEARLY THE COMMITTEE SHOULD DECIDE THIS FOR ITSELF, THE KIND OF MEANING THAT YOU HAVE ON PAPER HERE SEEMS LIKE A LOGICAL WAY TO INFORM THE COMMITTEE SO THAT EVERYONE WILL BE APPROACHING IT WITH A GOOD FUND OF KNOWLEDGE OF IT BUT OTHERS MAY NOT SORT OF HAVE THAT FIRST, WHETHER IDEALLY AGAIN WE COULD THEN HAVE SOMETHING FOR FOR YOU ALL TO REACT TO IF NOT YOU WOULD STILL HAVE DONE THE GROUND WORK OF PREPARING THE COMMITTEE WELL TO BE ABLE TO CONSIDER THE NEXT MEETING.
I'M REMINDED OF SARA THAT THIS IS A FORMAL RELATIONSHIP BETWEEN OUR COMMITTEE AND YOUR WORK AND THAT IS CHRIS HOOK AS OUR LIAISON TO THE EFFORT. IT IS A LITTLE MORE FORMAL.
IN EARLS IT OF BRINGING THIS -- IN TERMS OF BRINGING THIS TO A CLOSURE WHAT I HAVE GOT ON MY NOTES AND SEE IF THIS IS WHAT YOU ARE PROPOSING IS THAT WE SEND A LETTER TO THE SECRETARY SAYING THAT WE HAVE INDICATED THIS IS ONE OF OUR PRIORITY ISSUES, THAT WE ARE -- THAT WE BELIEVE THAT THERE MAY BE SOME GOOD POSSIBILITIES OF -- OF -- IT MAY BE A GOOD IDEA, THERE MIGHT BE DEN KNITS KNITS -- BENEFITS THAT ARE DESTRIVED SUPERA POPULATION STUDY AND THAT WE ARE ENCOURAGEING THAT SUCH A STUDY BE UNDERTAKEN URGENTLY AND WE HOPE THAT THAT WILL BE DONE EX-PA DID I SHUSLY AND WITH ATTENTIVENESS FROM HIS OFFICE.
COMMENTS, DEBRA AND ED.
I DIDN'T THINK WE ARE READY TO SEND A LETTER YET. I THOUGHT WE WERE GOING TO HAVE A MEETING FIRST TO INFORM THE COMMITTEE AND GET A BETTER IDEA WHETHER WE WANTED TO WRITE A LETTER OR NOT. IN LOOKING AT WHAT IS PROPOSED HERE, IT IS QUITE THOROUGH. I WOULD ASK THAT WHEN YOU HAVE THE NATIONAL COHORT INDIVIDUALS COME THERE MAY BE SOME INFORMATION THEY COULD PROVIDE ABOUT COST. AND ALSO DEPENDING UPON HOW FAR ALONG THESE ARE, WHAT ARE THEY LEARNING? IS THE EFFORT SCIENTIFICALLY AND MEDICALLY PRODUCTIVE, USEFUL. SO SOME OF THESE ARE FURTHER ALONG AND WHAT -- IS IT WORTH THE MONEY THAT THEY SPENT DOING IT. AND ASKING ALSO ED'S QUESTION OF HOW ARE THEY HANDLING THE IP ISSUES AND WHEN THEY ARE MAKING THESE DISCOVERIES. AND A LOT OF THE PEOPLE INVITED SEEM TO BE MORE ACADEMIC BASED. I KNOW THERE IS A LOT OF INDUSTRY EFFORTS IN THIS AREA.
THESE ARE SIMPLY WHAT IF NAMES. NO ONE HAS BEEN INVITED.
I KNOW. BUT LOOKING AT THE LIST IT DOES SEEM TO BE MUCH MORE ACADEMICALLY THAN INDUSTRY OR ORIENTED. I THINK THERE ARE OTHER INDUSTRY EFFORTS THAT MIGHT INFORM THE MEETING.
AND I THINK THE QUESTION YOU RAISED DEBRA, WHETHER WE SHOULD WRITE A VERY GENERAL SUPPORT THE CONCEPT LETTER NOW OR WAIT UNTIL AFTER WE HAVE BEEN BETTER INFORMED, IT IS RELEVANT, THE REALITY IS IF WE ARE GOING TO HAVE EVEN A HALF OR ONE DAY MEETING THAT WE ARE LOOKING AT JUNE OF '05 BEFORE WE CAN HAVE SUCH A SESSION. IS THAT TRUE, SARA?
SORT OF DEPENDS ON WHAT THE COMMITTEE DECIDES REGARDING PHARMACOGENOMICS AND THEN WE WANTED TO CONCLUDE WITH OTHER POSSIBLE TOPICS FOR FEBRUARY SO WE WILL HAVE TO KIND OF ADD UP BUT I DO THINK THAT YOU ALL HAVE TO MAKE SOME DECISIONS ABOUT PRIORITY TOPICS FOR THE MEETING. THE OTHER THING I WANTED TO SAY ABOUT THE LETTER TO THE SECRETARY, IT IS NOT THE SAME THING BUT THE SECRETARY WILL KNOW AS SOON AS HE RECEIVES YOUR ROAD MAP REPORTS THAT THIS IS A TOPIC OF VERY -- OF GREAT IMPORTANCE TO THE COMMITTEE SO, YOU KNOW, YOU CAN REST ASSURED THAT HE WILL BE AWARE OF THAT. IT DOESN'T GET EXACTLY TO THE ENDORSEMENT OF THE CONCEPT, BUT AT LEAST, YOU KNOW, HE IS AWARE THAT WE ARE LOOKING AT IT IF YOU DECIDE TO DO THAT, I MEAN.
OTHER COMMENTS FROM THE GROUP? ED?
YEAH, JUST WANTED TO LAY OUT THE CONCERN WHEN I MENTIONED ABOUT COMPETING INITIATIVES, A TOPIC THAT I AM ALMOST AS PASSIONIATE ABOUT AS GENETIC DISCRIMINATION IS CHILDREN AND SO ONE OF THE ISSUES THAT I WOULD DEFINITELY WANT TO BE SURE BECAUSE I KNOW WHENEVER THERE ARE COMPETING INITIATIVES CHILDREN USUALLY LOSE OUT AND SO PART OF MY CONCERN IS THAT WE NOT ENDORSE ONE INITIATIVE, KNOWING, OF COURSE, THAT THAT WILL MEAN THAT THE KIDS WOULD NOT BENEFIT FROM A SINGLE INITIATIVE. SO I JUST WANTED TO LAY THAT OUT, KNOWING THAT DEPENDING ON DECISIONS THAT ARE MADE AND MY TERM ON THIS COMMITTEE I MIGHT NOT BE HERE TO -- TO EXPRESS THAT PASSION LOUDLY AS I HAVE THE ANTIGENETIC DISCRIMINATION PASSION.
IF I CAN JOIN AS ANOTHER MEMBER OF THE AMERICAN ACADEMY OF SPEEDAT TRICKS THAT THE -- PEDIATRICS THAT THE STUDY IS IMPORTANT AND THE COMMITTEE AND THE FOLKS LOOKING AT THIS AT NIH INCLUD PEOPLE WHO ARE IN VINCEIC AND LOOKING AT HOW YOU MIGHT HAVE BOTH A CHILDREN'S STUDY AND A STUDY THAT LOOKED AT OLDER INDIVIDUALS AS COMPLEMENTARY ONES BUT UNDERSCORES THE NEED TO IF THE COMMITTEE DECIDES TO WRITE ANY KIND OF LETTER TO BE ONE THAT ENDORSES THE CONCEPT IN GENERAL. IT WOULD BE FAIR, WHILE I HAVE GOT THE FAIR IF YOU WANT TO SAY ANY EFFORT TO LOOK AT THIS SHOULD BE COGNIZANT OF EFFORTS DONE IN OTHER COUNTRY. THAT WOULD BE WISE COUNSEL AS HUNT WAS IMPLYING BEFORE NOT TO ACT THAT WE ARE INVENTING THIS FOR THE FIRST TIME. THE OTHER THING WE HAVE DONE A LOT OF IS LOOKING AT HOW ONE MIGHT INTERDIGITIATE THIS WITH OTHER PLANNED OR COHORT STUDIES THERE THAT ARE ALREADY THERE SO AS NOT TO BE TOO DUPLICATIVE.
THE PREVIOUS MEETINGS AVAILABLE THAT WE COULD GET COMPILED SO WE HAVE AT LEAST THE BACKGROUND INFORMATION ON WHERE YOU ARE TO DATE WITH THAT PROGRAM?
THERE ARE NO PUBLICLY AVAILABLE MINUTES. THERE ARE NOTES THAT ARE WORKING GROUP MEMBERS HAVE AND THAT IS ALL THERE ARE.
AND I THINK THAT IS ONE OF THE ADVANTAGES OF BRINGING THIS TOPIC TO THIS COMMITTEE, WHICH IS BRINGS IT IN TO PUBLIC DISCUSSION.
I JUST MAKE A SMALL SUGGESTION THAT I THINK THE WOMEN'S HEALTH INITIATIVE MIGHT BE A GROUP YOU WRANT WANT TO INVITE, TOO. THEY COLLECT 165,000 SAMPLES OR SOMETHING AND MUST HAVE TREMENDOUS EXPERIENCE.
HUNT, CLARIFY WHERE YOU SEE WE ARE IN TERMS OF THE DECISION MAKING HERE AND ARE WE SORT OF SAYING NOW THAT WE WANT TO HAVE A MEETING? DO WE WANT TO START TRYING TO PLAN FOR THAT? IS IT WAITING SEQUENTIAL BASED ON OTHER WORK?
I'M HEARING SOME ENTHUSIASM FOR A SESSION. I MIGHT SUGGEST THAT WE TABLE THE DISCUSSION AT THE MOMENT AND GO ON TO PHARMACOGENOMICS WHICH IS MORE MATURE IN TERMS OF THE THINKING IN TERMS OF THE TASK FORCE AND MAKE A DECISION ON THAT AND THEN COME BACK TO THIS IF THERE IS ROOM AT THE FEBRUARY/MARCH ISSUE FOR HALF A DAY TO HAVE SOME DISCUSSION.
PUT A COMMA IN THIS AND LET'S BUT THE PHARMACOGENOMICS.
I WANT SARA TO PRESENT WHAT IS ON THE BOARD NOW. I WANT TO MAKE SURE THAT EVERYBODY HAS IN FRONT OF THEM AND THIS IS NOW ALREADY CHANGED BASED ON WHAT HAPPENED ON THE REIMBURSEMENT ONE YOU HAVE THIS LITTLE CHART AT YOUR TABLE BUT IT IS BASICALLY JUST TRYING TO INFORMALLY AND QUICKLY SKETCH OUT WHAT IS ON THE PLATE NOW. WHICH THINGS, WHAT THE SEQUENCE IS AND WHICH THINGS ARE IN PLAY NOW AND BY WHAT DATE AND WHAT IS YOUR APPETITE FOR NEW THINGS AND KEEP THIS IN THE BACK OF YOUR HEAD AND THEN WE WILL MOVE TO PHARMACOGENOMICS IN A SECOND. SARA, COULD YOU WALK US THROUGH THIS?
ON THE LEFT SIDE THIS SHOWS ALL THE 12 ISSUES THAT THE COMMITTEE IDENTIFIED AS HIGH PRIORITY ISSUES IN MARCH OF '04 BUT ALSO BEGINS WITH THE LIFE OF THE COMMITTEE IN JUNE '03 AND SHOWS THAT IN THAT MONTH DECIDED TO SEND A LETTER ON GENETIC DISCRIMINATION. AT EACH COMMITTEE THE ACTION OR FOCUS OF THE MEETING IS LISTED THERE AND THEN AT THE MARCH MEETING WHERE YOU ESTABLISHED THESE AS STUDY PRIORITIES WE HAVE SHOWN WHAT ELSE YOU ARE DOING AND THE LINE GOING TO THE END IS WHERE WE THINK YOU HAVE -- YOU HAVE INDICATED SOME INTEREST CONTINUING THROUGHOUT THE LIFE OF THE COMMITTEE. AND THE THING THAT WE HAVE SORT OF TAKEN CARE OF GENETICS EDUCATION AND TRAINING THROUGH THE RESOLUTION ALTHOUGH I DO THINK THE COMMITTEE IS INTERESTED IN CONTINUING TO BE INFORMED ABOUT HOW THAT IS DEVELOPING SO PERHAPS I SHOULD HAVE CONTINUED THAT ARROW BEYOND. AND THEN ON PATENTS AND ACCESS, WE HAD DECIDED IN MARCH TO DEFER, AS REED SAID EARLIER, FURTHER WORK ON THIS UNTIL THE ACADEMY STUDY WAS COMPLETE AND SO FOR THE MONTH OF OCTOBER THIS YEAR WE'RE SHOWING THAT YOU GATHERED INFORMATION ON THAT AND THEN WE ARE WAITING FOR JUNE '05 FOR THE ACADEMY STUDY. ON OVERSIGHT, THE DECISION MADE IN MARCH AND WE HAD SOME INFORMATION GATHERING IN OCTOBER '03. WE HEARD FROM FDA AND CMS ABOUT THE REGULATION OF GENETIC TECHNOLOGIES AND WE ALSO HEARD ABOUT PHARMACOGENOMICS THERE, THE REGULATORY ASPECT OF THAT AND THE DECISION WAS MADE THAT THIS IS A HIGH PRIORITY ISSUE BUT THE FUNCTION WE WOULD UNDERTAKE IN RELATION TO IT WAS TO MONITOR AND SO THE LINE GOES, YOU KNOW, WILL HAVE OPPORTUNITIES THROUGHOUT THE LIFE OF THE COMMITTEE TO LOOK INTO WHAT IS GOING ON IN THAT ISSUE. THE VISION STATEMENT HAS BEEN TRANSLATED INTO A REPORT CALLED THE ROAD MAP AND WE WILL BE SENDING THAT TO THE SECRETARY SHORTLY AND THAT WILL BE -- WE WE WILL THAT, I THINK. AND THEN WE ALSO DECIDED AT THE MARCH MEETING THAT THERE WERE FOUR ISSUES THAT WE THOUGHT WERE HIGH PRIORITY THAT REQUIRED INDEPTH STUDY AND THESE FOUR ARE LISTED HERE. FOR COVERAGE AND REIMBURSEMENT WE HAVE BEEN WORKING HARD AT THAT. GEARED INFORMATION IN MARCH AND THEN DRAFTED THE REPORT AND ARE CONTINUING AND IT SEEMS THAT BASED ON THE DECISION EARLIER WE WILL ACTUALLY PROBABLY -- I MEAN IT IS POSSIBLE WE MAY NOT ACTUALLY HAVE A FINAL REPORT UNTIL OCTOBER IT'S POSSIBLE I THINK BECAUSE WE WOULD WANT TO GO OUT FOR PUBLIC COMMENT AFTER FEBRUARY, I WOULD THINK. AND SO THAT KIND OF GOT SOME SLIGHTLY MODIFIED. AND THEN LARGE POPULATION STUDIES AND PHARMACOGENOMICS WE ARE REFLECTING HERE THAT WE ARE IN PLANNING STAGES AT THIS MEETING. THE DIRECT TO CONSUMER MARKETING ISSUE IS A HIGH PRIORITY ISSUE WARRANTING INDEPTH STUDY. WE DRAFTED A LETTER TO THE SECRETARY WITH INITIAL CONCERNS ON OUR PART AND DIRECTED THAT THE SECRETARY TAKE A COUPLE ACTIONS INCLUDING CHARGING THE RELEVANT AGENCIES TO WORK WITH FTC AND ALSO TO GATHER DATA ON THE PUBLIC HEALTH IMPACT ON DIRECT TO CONSUMER MARKETING AND THEN THE THREE ON THE BOTTOM, WERE ISSUES THAT THE COMMITTEE DECIDED WERE OVERARCHING OR INHERENT IN ALL OF THE OTHER ISSUES AND THEY ARE SHOWN HERE WITH THE DOT THE LINE. IN ALL OF OUR OTHER ACTIVITIES WE ARE TRYING TO HIGHLIGHT THESE ASPECTS OF FOR EXAMPLE ON COVERAGE AND REIMBURSEMENT YOULE FIND DISCUSSIONS IN THE -- ON THE ACCESS AND PUBLIC UNDERSTANDING AND EXCEPTIONALISM.
THAT IS EXACTLY IT. I JUST WANTED YOU TO KEEP IN FRONT OF YOU BECAUSE THIS IS AN EXTRAORDINARILY HARD WORKING COMMITTEE AND WANT TO MAKE SURE YOU DON'T OVERLOAD YOURSELF. WITH THAT BACKGROUND LET'S TURN TO THE PHARMACOGENOMICS AND THEN WE WILL ASSESS HOW WE WILL DO WITH THAT AND OR THE POPULATION STUDIES ONE. EMILY?
WELL, OUR TASK FORCE DID MEET. I ASSUME BECAUSE WE HAD A STAFF PERSON WHO IS A GREAT ORGANIZER AND MADE SURE WE ACTUALLY HAD A CONFERENCE CALL BUT IN THE PROCESS WE WENT THROUGH A DISCUSSION OF SORT OF THE FIRST DRAFT OF POTENTIAL THINGS AND CAME UP WITH WHAT YOU HAVE IN YOUR TABLE FOLDERS TODAY. ABOUT POTENTIAL AREAS TO DISCUSS. I'M NOT GOING TO GO THROUGH THEM ALL ONE BY ONE BUT I GUESS IN SUMMARY WHAT I'D LIKE TO SAY IS IT SEEMS LIKE THERE IS A LOT OF MEAT HERE AND IT IS ALSO AN AREA WHERE THERE IS A LOT GOING ON THAT WE MAY EITHER WANT TO JUST CONTINUE TO BE INFORMED OF OR AT SOME POINT TAKE SOME MORE AFFIRMATIVE ACTION TO EITHER SUPPORT THINGS SPECIFICALLY OR PROVIDE SOME FEEDBACK TO SOME OF THE PROGRAMS. WHAT WE TRIED TO DO IN TERMS OF SETTING OUT POTENTIAL TOPICS WAS TO GROUP THEM INTO FOUR AREAS, SETTING STAGE WAS BASICALLY DESIGNED TO GET EVERYBODY ON THE COMMITTEE UP TO SORT OF THE SAME LEVEL OF BASIC UNDERSTANDING. TRANSLATIONAL EFFORTS WAS BASICALLY, AGAIN, SORT OF SATE STATE OF THE ART WHERE ARE WE AND WHAT ARE THE ISSUES THAT WE ARE FACING. THE L.C. ISSUE SHES YOU KNOW, ARE THERE SPECIFIC L.C. ISSUES UNIQUE FOR PHARMACOGENOMICS AND WHAT MIGHT THOSE BE AND THEN FINALLY WHEN WE STARTED LISTING ALL THE GOVERNMENT AGENCIES THAT WE THOUGHT HHS HAD PURVIEW OVER AND WERE INVOLVED IN THIS THE LIST STARTED TO GET PRETTY LONG SO WE FELT FROM THE POINT OF VIEW FROM THE TASK FORCE AT LEAST THAT THERE DEFINITELY WAS SOME MEAT HERE WHICH BECAUSE OF THE INVOLVEMENT OF SO MANY HHS AGENCIES MIGHT MAKE THIS A GOOD AREA FOR OUR COMMITTEE TO SPEND SOME TIME ON AND TRY AT LEAST TO ASSURE THAT THERE IS COORDINATION OF EFFORT AND KNOWLEDGE OF WHAT IS GOING ON IN THE DIFFERENT ARENAS. SO, WITH THAT INTRODUCTION I'M HAPPY TO TAKE ANY COMMENTS AND QUESTIONS. I IS PUT DOCTOR GUTMAN ON NOTICE THAT WE MIGHT ASK HIM ABOUT SOME OF WHAT IS GOING ON AT THE FDA LEVEL BECAUSE THERE ARE SOME GUIDANCE DOCUMENTS UNDER DEVELOPMENT AND UNDER COMMENT. I KNOW THAT THERE IS THINGS GOING ON WITHIN NIH. I'M NOT SURE IF THEY ARE SPECIFICALLY IN NHGRI AS MUCH AS WITHIN THE INSTITUTE OF MEDICINE OR NAS -- YEAH, GENERAL MEDICINE. THE QUESTION IS JUST SHOULD WE LET THOSE TRICKLE ALONG OR TAKE SOME PROACTIVE STANCE ON THAT? COMMENTS? ED?
YEAH, I THINK THIS ONE TOPIC THAT MAYBE IT IS BURIED IN SOME OF THESE OTHERS BUT AS A DEPARTMENT CHAIR WHO WAS THREATENED WITH A PHARMACOGENOMICS LEGAL SUIT A COUPLE OF YEARS AGO BECAUSE OF A CHILD WHO HAD A HEARING PROBLEM AND RECEIVED AN AAMINO GLIKE SIDE I ARGUE THAT THE LAWYERS ARE GOING TO PUSH THIS PROBABLY MORE QUICKLY THAN THE CLINICAL SIDE OF THINGS. I DON'T KNOW IF THAT IS SOMETHING MAYBE WE DON'T WANT TO BRING THAT UP BUT I WOULD THINK THAT WE HAVE TO LOOK AT WHAT THE MEDICAL LEGAL IMPLICATIONS ARE OF IGNORING THIS AREA.
THAT SEEMS TO ME THAT THAT FITS UNDER THE L.C. ISSUES BUT MAYBE WHAT WE DIDN'T CALL OUT WAS SPECIFIC PHYSICIAN OR DRUG KNOWN AND AVAILABLE AND NOT USED AND THEN THERE WAS AN ADR, YOU KNOW, WHAT IS GOING ON IN THAT FRONT, WHICH, YOU KNOW, I THINK MAYBE THE GUYS FROM FIZER PFIZER. THERE HAS BEEN A LOT OF PRESS RECENTLY ON SEVERAL DRUGS WHERE THERE MIGHT BE A COMPONENT THAT PREDISPOSES PEOPLE TO BAD REACTIONS.
ALSO TO DOVE TAIL WITH OUR DISCUSSION THIS MORNING ABOUT THE COVERAGE AND REIMBURSEMENT WHERE WE WERE LOOKING AT SORT OF THE OVERRIDING PRINCIPLES THAT MIGHT HELP LOOK AT SPECIFIC GENETIC TESTS AND I THINK THE AREA OF PHARMACOGENOMICS WILL PROBABLY BE THE AREA THAT IS GOING TO ADVANCE MOST RAPIDLY SO THAT I THINK IT WOULD BE HELPFUL TO HAVE SOME FEEDBACK TO THE COMMITTEE REGARDING THAT BECAUSE I THINK THIS WILL BE THE AREA WHERE WE COULD THEN HELP MOVE THE TOPICS OF COVERAGE AND REIMBURSEMENT ALONG SPECIFICALLY WITH THAT -- THE ISSUES OF LOOKING AT WHAT DO WE NEED THEN TO HAVE IN PLACE FOR THE GOVERNMENT AGENCIES, FOR PRIVATE INSURERS TO EVEN KNOW WHEN A PHARMACOGENOMIC TEST WILL BE READY TO BE USED.
COULD YOU COMMENT JUST FOR THE SCHEDULING PURPOSES ON WHEN SOME OF THIS SORT OF GUIDANCE REVISIONS ARE COMING ALONG AND WHEN WOULD BE APPROPRIATE TO MAYBE HEAR ABOUT THOSE?
SURE. SURE. THERE ACTUALLY IS A FAIR AMOUNT OF ACTIVITY BOTH IN THE DIAGNOSTIC CENTER AND IN THE DRUG CENTER AT THE FDA. WE HAVE PUBLISHED A DOCUMENT ON GENERAL DIAGNOSTIC ISSUES RELATED -- ACTUALLY NOT SPECIFIC TO PHARMACOGENOMICS OR PHARMACOGENETICS BUT TO THE PLATFORMS WHICH SUPPORT TESTING IN THIS AFLEE WHICH WOULD BE MULL TIE LEX PRODUCTS AND PUBLISHED THAT ABOUT 18 MONTHS AGO AND GOTTEN USEFUL COMMENTS INCLUDING THE THOUGHT THAT A SINGLE DOCUMENT IS ATTEMPTING TO DO TOO MUCH AND WE ARE MOVING FORWARD WITH A MORE NARROW PHARMACOGENETICS DOCUMENT WHICH WE ARE HOPING TO PUBLISH BY THE END OF THE YEAR WHICH I'M NOT CERTAIN WE WILL MEET THAT TIMELINE. WE HAVE A WORKING GROUP. JOE HACKETT CONTINUES TO TAKE THE LEAD THAT IS VERY AGGRESSIVELY INTERACTING PARTICULARLY WITH INDUSTRY BUT WITH OTHER ACADEMIC AND GOVERNMENT GROUPS TO TRY AND EDUCATE OUR CORE REVIEW STAFF SO THAT WE WILL BE PREPARED FOR THE DIAGNOSTIC NUANCES OF THIS NEW TECHNOLOGY. IN THE CENTER FOR DRUGS DOCTOR LESKO IS TAKING THE LEAD. THEY ENCOURAGE THE SUBMISSION OF VOLUNTARY DATA SETS. I'M FLABER GHASTED BECAUSE I DIDN'T THINK ANYBODY WOULD SUBMIT VOLUNTARY DATA SETS BUT THAT PROGRAM DOES APPEAR TO AT LEAST BE GENERATING SOME LIGHT AS WELL AS HEAT. THERE ARE COMPANIES WILLING TO COME FORWARD AND SHARE INFORMATION. THERE IS A WORKING GROUP THAT IS BEING ESTABLISHED TO DEAL WITH THE COMPANIES THAT ARE BRAVE ENOUGH TO DO THAT AND CREATE THE APPROPRIATE FIREWALLS AND CONTROLS SO THE COMPANIES WON'T BE HARMED AND CREATE A WORK GROUP AND SOPs AND THAT GUIDANCE DOCUMENT ESTABLISHING THE CORE OF THAT PROGRAM IS ALSO BEING REVISED WITH A TARGET TIME OF BEING THE END OF THE YEAR. AGAIN, I DON'T PROMISE IT WILL MAKE THAT DEADLINE BUT I EXPECT BOTH WILL BE EARLY NEXT YEAR. NOT FOE FUSSED PHARMACOGENOMICS OR GENETICS BUT THE ISSUE ABOUT TH ERI NOS TICKS. PRODUCTS WHEN LINKED. IT HAS BEEN A COLORFUL PROBLEMATIC AND IMPERFECT PAST ON WHICH TO BUILD WITH SOME INTERESTING SUCCESSES AND ALSO SOME INTERESTING FAILURES. THERE WAS A -- A WORKSHIP ACTUALLY THAT -- WORKSHOP ACTUALLY THAT WAS HELD EARLIER THIS OVER THE SUMMER WITH PHARMA AND CDER AND CDRH DEVICES AND DRUGS ALL COLLABORATIVELY INVOLVED AND MANY PEOPLE IN THE ROOM ACTUALLY PRESENT AT THAT MEETING AND THERE WAS GENERAL ZUTION ABOUT THE SCIENCE THAT UNDERPINS HOW TO CONNECT AN OLD DIAGNOSE IX OR A NEW WITH AN OLD DRUG AND BASED ON A RICH AND INTERESTING DISCUSSION THERE IS A JOINT WORKING GROUP THAT INVOLVES ALL THREE HUMAN PRODUCT CENTERS, BIOLOGICS, DRUGS AND DEVICES. WE ARE FOR US AN AGGRESSIVE GUIDANCE DOCUMENT TIMELINE AND IT IS HOPED THAT WE WILL COMPLETE THE INTERNAL DRAFT OF THE DOCUMENT BY THE END OF THIS YEAR, HAVE IT VEDED IN TIME FOR THE THIRD PHARMACOGENOMICS WORKSHIP SPONSORED IN APRIL OF NEXT YEAR AND ALTHOUGH I SUSPECT THAT WORKSHIP WILL HAVE A WIDE VARIETY OF TOPICS ON ITS AGENDA BUT CERTAINLY FRONT AND CENTER AND FROM MY PERSPECTIVE MOST IMPORTANT WILL BE THE VEDING OF THE JOINT DIAGNOSTIC THERAPEUTIC GUIDANCE DOCUMENTS. AND THEN MOST RECENTLY THE AGENCY HAS PROMOTED AS PART OF ITS PERHAPS THE IN THE WAKE OF DOCTOR MCCLELLAN'S INFLUENCE MAKING SURE IT IS A PARTNER RATHER THAN IMPEDIMENTS IN THE CLINICAL RESEARCH. THEY INTRODUCED THE CLINICAL RESEARCH PROGRAM WHICH SEEKS TO BRING PRODUCTS TO MARKET MORE QUICKLY AND PHARMACOGENOMICS HAS BEEN TARGETED AS A PIE LOW PILOT OR AN OPPORTUNITY WITHIN THE PRODUCT LINES THAT WE REGULATE TO BE EXPLOITED IN A POSITIVE MANNER.
ED?
YES, AS I THINK ABOUT THIS, THERE IS NOT -- THERE IS SOME OVERLAP BETWEEN THE TWO TOPICS WE ARE DISCUSSING. LARGE POPULATION STUDIES AND PHARMACOGENOMICS BECAUSE TO GET AT RARE -- AT THE GENETIC BASIS FOR RARE SIDE EFFECTS WILL TAKE LARGE POPULATIONS. DON'T KNOW -- IT SOUNDS LIKE THESE ARE SOME WHAT COMPETING AND I DON'T KNOW IF THERE IS A STAGING -- I DON'T HAVE AN ANSWER TO THIS BUT PERHAPS THERE COULD BE SOME DISCUSSION OF STAGING IF IT IS BETTER FOR ONE TO GO BEFORE THE OTHER.
WELL, IT CERTAINLY SOUNDS LIKE THERE IS A LOT OF THINGS GOING ON ACTIVELY THAT MIGHT BE READY TO MAKE SOME REPORT ON AT WHATEVER IT IS, THE END OF FEBRUARY OR EARLY MARCH MEETING AT LEAST FROM THE REGULATORY SIDE OF THINGS. ALLAN, DO YOU KNOW IF YOUR LARGE POPULATION STUDIES, WAS THERE A PHARMACEUTICAL COMPONENT TO THAT OR WAS IT MORE TRYING TO UNDERSTAND THE GENETIC COMPONENTS OF COMMON COMPLEX DISEASE?
THE FOCUS IS CLEARLY TO UNDERSTAND THE GENETIC AND ENVIRONMENTAL FACTORS IN COMMON DISARDS. THE THOUGHT IS IF ONE WAS GOING TO A LARGE STUDY IT WOULD BE FOOLISH NOT TO TAKE ADVANTAGE OF THAT LOOK AT PHARMACOGENOMICS ISSUES AS WELL. ABSOLUTELY.
STEVE, YOU ARE PROBABLY NOT THE RIGHT FDA PERSON TO ASK THIS BUT I WILL ASK YOU ANYWAY. DO YOU KNOW FOR THE TWO BIG DRUGS THAT HAVE BEEN TAKEN OFF THE MARKET RECENTLY IF THERE IS ANY FEELING THAT THEY HAVE SOME POSSIBILITY FOR RESCUE BASED ON ANY KIND OF TEST SEGMENTATION?
YEAH, I ACTUALLY DON'T KNOW.
I THINK THIS IS AN AREA OF FAIRLY SUBSTANTIAL CONCERN ABOUT TRYING TO UNDERSTAND WHAT HEALTH RISKS WE ARE PUTTING PEOPLE TO AND WHETHER THERE ARE SIMPLE TESTS THAT COULD IDENTIFY WHO THOSE FOLKS AT HIGHEST RISK ARE.
ONLY ONE THING THAT CAME UP, I GUESS LAST MARCH MAYBE WHEN WE WERE STILL DISCUSSING WHETHER TO MAKE THIS A PRIORITY OR THERE WAS A DISCUSSION ABOUT PHARMACOGENOMICS AND WE DID HAVE SOME VISITORS, RIGHT, AND WITH REGARDS TO CMS, BESIDES THE CONCERN THAT TESTS WOULD BE COVERED THE OTHER ISSUE WAS THAT IF -- IF -- IF HUNDREDS OF MILLIONS OF DOLLARS ARE BEING SPENT REIMBURSING PEOPLE FOR DRUGS OF WHICH 40% OF THE PEOPLE WHO HAVE TAKEN THE DRUGS AREN'T ACTUALLY RESPONDING THERE IS A REAL ECONOMIC VALUE TO PHARMACOGENOMICS THAT CMS AND CERTAINLY OTHER, YOU KNOW, THE PRIVATE CARRIERS SHOULD BE VERY INTERESTED IN. AS A DIFFERENT ASPECT OF HOW CMS MIGHT BE INTERESTED OR HOW WE MIGHT ENCOURAGE C M SMD S BESIDES JUST COVERING THE TESTS.
ANY OTHER COMMENTS? I KNOW WE ARE SHORT ON TIME SO I'M GOING TO JUST YIELD THE FLOOR AND WE REQUEST GO TO PRIORITIZATION DISCUSSION.
LET ME COME BACK IT -- THANK YOU, BY THE WAY, FOR LEAVEING THAT EMILY. REMIND YOURSELVES AND IF YOU GO BACK TO THE GRID CHART HERE AS SARA TOOK US THROUGH IT. THE GENETIC DISCRIMINATION ISSUE WE HAVE GOT A LOT OF WORK THAT WE ARE GOING TO O BE DOING BETWEEN NOW AND THE NEXT MEETING AND WE WILL HAVE SOMETHING ON THE AGENDA AROUND GENETIC DISCRIMINATION. THAT IS GOING TO OCCUPY SOME CONSIDERABLE ATTENTION SO THAT IS AN ACTIVE BALL IN PLAY. THE -- THE GENETIC EDUCATION AND TRAINING IS PROBABLY NOT A BALL IN PLAY BUT CERTAINLY THE NEXT BALL IN PLAY THAT IS SERIOUS IS THE COVERAGE AND REIMBURSEMENT ZWLA IS GOING TO TAKE A LOT OF OUR TIME AT THE NEXT MEETING AND WE'RE GOING TO HAVE TO NAIL DOWN SOME CONSIDERABLE WORK THERE. SO THOSE TWO ARE BIG. THE OTHER THING THAT IS BIG -- LET ME JUST MAKE SURE I HAVE GOT MY LIST, KEEPING TRACK -- LET'S SEE. THOSE ARE THE BIG ONES. THE -- WE'RE NOT GOING TO WIND UP DOING MUCH ON THE INTELLECTUAL PROPERTY ONE UNTIL AFTER THE OTHER COMMITTEE MEETS SO WE REALLY DO HAVE THE OPPORTUNITY, I GUESS, TO REALLY START TO THINK ABOUT DO WE WANT TO GRAB ON TO FOR THE NEXT MEETING BOTH OR ONE OF THE LARGE POPULATION STUDIES OR PHARMACOGENOMICS AND MATURE THOSE? SARA, I'M SORRY AND THEN WE HAVE THE OTHER POTENTIAL TOPICS AS WELL. THANK YOU, SARA. TAKE US THROUGH THOSE, SARA.
OKAY. WELL, THE FIRST ONE WAS -- A REFLECTIVE OF INTEREST EXPRESSED BY THE COMMITTEE IN JUNE ON SOME OF THE -- AND IT SORT OF CONTEXT OF THE DISCUSSION OF THE EDUCATION AND TRAINING RESOLUTION BUT THERE WAS SOME RATHER SIGNIFICANT INTEREST EXPRESSED IN WHAT IS GOING ON IN HEALTH INFORMATION TECHNOLOGY AND SO WE JUST WANTED TO MAKE SURE THAT -- JUST PUT IT ON THE TABLE HERE FOR THE COMMITTEE TO DECIDE WHETHER YOU WOULD LIKE TO BE BRIEFED IN A FULLER WAY ABOUT WHAT IS GOING ON.
LET ME ON THAT ONE JUST SAY THAT GIVEN THE DISCUSSION WE HAD AT THIS MEETING REGARDING THE FAMILY HISTORY I THINK THAT TO LEVERAGE THAT DISCUSSION WE MAY WANT TO HAVE A BRIEF UPDATE ON THIS BECAUSE OF CLEARLY THE IMPLICATIONS FOR THE ELECTRONIC MEDICAL RECORD AND ALL THE TECHNOLOGY STUFF THAT IS GOING FORWARD AND I WILL TELL YOU FROM SOME OTHER HATS THAT I WEAR THAT WHOLE AREA IS MOVING SO RAPIDLY AND THE IDEA OF CREATING STANDARDS FOR THE ELECTRONIC MEDICAL RECORD IS MOVING FROM YAP PA, YAPPA, TO IMPLEMENTATION AT RAPID RATES. WE MAY WANT TO WELL START TO CONNECTION THOSE IN WITH FAMILY HIS TORE RYE AND LEVERAGE OUR TIME.
THAT HAS A LOT OF RELEVANCE TO THE PHARMACOGENOMICS BECAUSE THIS IS INFORMATION YOU WOULD BE TESTED FOR ONCE AND THAT INFORMATION WOULD BE GOOD FOR THE REST OF YOUR LIFETIME.
WE PRESENTATION ON THIS.
AND THEN A THIRD ASPECT WHICH ED MCCABE MIGHT WANT TO SPEAK TO AND THAT IS THE WAY IN WHICH ELECTRONIC HEALTH RECORDS ACTUALLY MIGHT HELP ENHANCE PRIVACY. ED, I WILL THINK YOU MENTIONED THAT YOU HAD A CONVERSATION WITH MARK ROTHSTEIN ABOUT THE GROWING REALIZATION THAT RATHER THAN DIMINISHING PRIVACY IT MIGHT ENHANCE IT. BUT THE SECOND ISSUE IS THE PRESENTATION FROM THE HERSA COMMITTEE ON NEWBORN SCREENING ABOUT THE RECOMMENDATIONS THEY ARE MAKING TO THE SECRETARY AND CHRIS HOOK FOR ONE WAS VERY INTERESTED IN HAVING SUCH A PRESENTATION.
AND GIVEN THAT WE ARE AGAIN OFFICIALLY LIAISONED TO THAT AND GIVE THAN THAT HAS COME UP PRETTY DIRECTLY TODAY I THINK THIS COMMITTEE DOES NEED TO HERE AT LEAST A BRIEF UPDATE ON THAT.
AND THE WORD I HAD IN TALKING TO DOCTOR CORIER THAT THAT WOULD BE TIMELY AND THAT REPORT WOULD BE READY.
THANK YOU FOR CHECKING THON.
AND THEN THE LAST TWO ARE PRESENTATIONS THAT WE COULD REQUEST OF CDC OR ON RARE DISEASE TESTING. THERE WAS A CONFERENCE A PUBLIC PRIVATE SPONSORED CONFERENCE THAT CAME UP WITH A LOT OF RECOMMENDATIONS ABOUT HOW TO ENHANCE ACCESS AND QUALITY GENETIC TESTING FOR RARE DISEASES AND THAT GROUP IS INTERESTED IN PRESENTING THEIR RECOMMENDATIONS TO THIS COMMITTEE AND GETTING SOME SENSE OF YOUR PERSPECTIVES ABOUT THEM. AND THEN A VERY QUICK PROVIDE A QUICK PRESENTATION ON THE WORK THEY ARE DOING TO ENHANCE QUALITY ASSURANCE AND QUALITY CONTROL THROUGH THE LABORATORY SERVICES PROGRAM. JOE BOON IS -- IS HE HERE IN CASE HE WANTS TO SAY ANYTHING FURTHER ABOUT THE TWO TOPICS? THEY WERE SUGGESTED BY JOE.
I HAVE BEEN INVOLVED IN THOSE THINGS THE AND I THINK THEY WOULD BE GERMANE TO GET AN UPDATE ON WHAT THEY ARE DOING TO TRY AND FILL WHAT IS A REALLY BIG VOID FOR GENETIC TESTING.
LET'S DO THIS AND WE WILL FINISH ON TIME AND THIS IS TERRIFIC SO LET'S SLOW DOWN A MINUTE MINUTE AND LOOK AT ALL THE STUFF WE GOT IN FRONT OF US. LET ME REMIND US OF AS WE CONSIDER WE GOT FOUR THINGS -- AS I HIT SARAH IN THE HEAD. WE HAVE FOUR THINGS THERE ARE THERE, PHARMACOGENOMICS AND POPULATION STUDIES. WE GOT TO KEEP THOSE THERE. THAT IS SIX. SO YOU GOT THOSE. NOW, WHAT WE DID THIS MEETING AND MY QUICK LIST HERE AND I CAN'T BELIEVE HOW MUCH WE ACTUALLY DID, IT IS AMAZING. FIRST, THE FAMILY HISTORY PROJECT WE ARE GOING TO GET BACK FROM THE FAMILY HISTORY PROJECT PEOPLE WHAT THE -- ALL THE PUBLIC EDUCATION MATERIALS THAT ARE GOING OUT THAT ARE RELEVANT TO GENETIC EDUCATION AND HOW THEY INTEND TO CONNECT THE FAMILY HISTORY PROJECT TO THE ELECTRONIC MEDICAL RECORD AND PARTICULARLY ALL THIS HIT INFRASTRUCTURE AND WE ARE SENDING A LETTER TO THE SECRETARY ENDORSING THE IMPORTANCE OF FAMILY HISTORY AS TOOL AND ENCOURAGED TO SEE THE HHS AGENCIES PLAYING NICE TOGETHER AND ENCOURAGED AND WOULD LIKE TO SEE THAT THOSE THAT AREN'T INVOLVED GET INVOLVED. NUMBER TWO IS GENETIC DISCRIMINATION. WE HAVE AGREED THAT WE ARE GOING TO COMPILE THE TESTIMONY FROM TODAY INCLUDING THE NAMES OF THE PEOPLE THAT PRESENTED AND THEIR CONGRESSIONAL DISTRICT AND A SLOUGH OF BACK BACKGROUND MATERIALS APROPOS MCCABE AND PUT ALL THAT TOGETHER AND THEN ASK TO MEET WITH THE SECRETARY TO DISCUSS THIS STUFF AS WELL AS TO HAVE HIM CONVENE AT THE SAME TIME THE LEADERS OF JUSTICE, LABOR AND COMMERCE SO THAT WE MIGHT TRY TO RESOLVE ANY DIFFERENCES THAT MAY EXIST WITHIN THE AGENCIES. EEOC, BY, THE WAY, IS GOING TO ANALYZE TKPWA*PS IN CURRENT STATE AND -- GAPS IN CURRENT STATE AND FEDERAL LEGISLATION. SEND THIS TO CONGRESS FOCUSING ON THE SPEAKER, MAJORITY LEADER AND CONGRESSMAN BARTMAN AND HAVE THE GENE COALITION TO SEND US THEIR MEMBER SP AND ANALYSIS AND WHAT TO WOULD TAKE FROM THEIR POINT OF VIEW TO SOLVE THE PROBLEM. ASKING AHIP FOR THEIR ANALYSIS OF WHAT IS WRONG AND WHY THEY CAN'T GET ON BOARD AND WHAT IS NECESSARY TO SOLVE THE PROBLEM. A LETTER TO THE GENETIC FAIRNESS WHETHER THEY HAVE SOME OTHER ISSUE THAT PREVENTS THEM FROM AGREEING ON A CONSENSUS. CONSIDERING BRINGING EITHER CONGRESSIONAL PEOPLE OR SENIOR STAFF HERE FOR THE NEXT MEETING TO SEE WHETHER OR NOT THAT WILL HELP TO TRY TO UNDERSTAND BETTER WHAT IT'S GOING TO TAKE TO GET TO SUCCESS. CONSIDERING HOLDING A ROUND TABLE DISCUSSION TO GET CONSENSUS OF THE PARTIES AT THE NEXT MEETING IE THE CHAMBER TYPE PEOPLE AND THE COALITION PEOPLE SO WE ARE TRYING TO THINK MAYBE THAT MAY BE NECESSARY TO DO AT THE NEXT MEETING. NEED A CONFERENCE CALL TO DISCUSS THE NEXT STEPS SO WE WILL KNOW BASICALLY HOW TO SPEED IN THIS REGARD AND -- HOW TO PROCEED IN IN REGARD. THE THIRD AREA IS COVERAGE AND REIMBURSEMENT. WE ARE MAKING GENETIC COUNSELING A PRIORITY. WE NEED TO DEAL WITH THE LICENSURE ISSUE AND COPE OF SCOPE OF WORK. AGREED TO DO A LITERATURE REVIEW AND ANALYSIS. THE NEWARK SOCIETY AND BOARDS MUCH GENETIC COUNSELORS ARE PROVIDING INPUT. AS FAR AS THE OVERALL REIMBURSEMENT REPORT ITSELF WE HAVE A SIGNIFICANT AMOUNT OF WORK TO DO AND THEY WILL BE SENDING NEXT STEPS BACK TO US. ON THE INTELLECTUAL PROPERTY RIGHTS ISSUE WE WILL WAIT FOR A FINAL REPORT FROM THE NAS COMMITTEE AND WE HAVE BEEN CHALLENGED TO BASED ON THAT HOW DO WE DEAL WITH THE ISSUE OF HOW THAT AFFECTS THE PRO TEXAS, TEXAS, OF THE HEALTH OF THE PUB LI -- PROTECTION MUCH THE HEALTH OF THE PUBLIC. LARGE POPULATION STUDIES AND PHARMACOGENOMICS. WHAT DID I MISS BY THE WAY IN TERMS OF WHAT WE DID?
THE ONLY THING YOU FORGOT ON THE GENETIC DISCRIMINATION IS TO INVITE MY FRIENDS AT THE CHAMBER TO COME AND APPEAR BEFORE US.
I -- DONE. I WILL GET THAT AND THEN NOT THEIR MOUTHPIECE, IF I RECALL.
UP.
SO THE CHAMBER GETS INVITED. SOMEBODY'S PET PEEVE OR ISSUE I DIDN'T SAY. IN WHAT DID I MISS IN TERMS OF WHAT WE DID OR COMMITTED TO THIS MEETING?
I THINK IT WAS VERY THOROUGH AND I WOULD ENCOURAGE YOU, I THINK IT IS TIME FOR CONSOLIDATION OF WHAT ALL YOU HAVE ACCOMPLISHED AND RATHER THAN TAKING ON ANOTHER MAJOR TOPIC, PHARMACOGENOMICS OR LARGE POPULATION STUDIES I WOULD ENCOURAGE YOU TO USE THE NEXT MEETING TO CONSOLIDATE AND MOVE FORWARD. I THINK THERE IS AN AWFUL LOT ON THE PLATE OF THIS COMMITTEE AND I WOULD BE CONCERNED THAT TAKING ON ANOTHER MAJOR POPIC WOULD BE TOO AMBITIOUS.
ALSO, AS PART OF THE DISCUSSION FROM THE REIMBURSEMENT STUDY WE HAD TALKED ABOUT THE FACT OR THE REIMBURSEMENT REPORT WE HAD TALKED ABOUT THE FACT OF HEARING BACK FROM THE HERSA STUDY AND THAT THAT MAY INFORM THAT DISCUSSION.
I'M SORRY. WHAT WAS THAT. SAY THAT ONE MORE TIME?
AS PART OF THE REIMBURSEMENT REPORT WE HAD TALKED ABOUT THE FACT OF HEARING THE LATEST REPORT BACK FROM THE HERSA GENETICS SERVICES STUDY TO SEE IF THAT WOULD INFORM THAT WORK.
DID YOU GET THAT DOWN FOR ME. IN THANK YOU. WHAT HAPPENED IS THAT ED IN HIS CHAIRMANSHIP LIKE WAY HAS MOVED US FROM ANY ERRORS OF OH MISSION FROM MY SUMMARY OF WHAT WE DECIDED TO ANALYZING THAT AND SAYING HIS CONCLUSION IS THAT WE HAVE GOT A LOT ON THE PLATE AND GIVEN THAT WE HAVE THESE OTHER TWO ISSUES HERE THAT WE DID AGREE THAT WE WANTED TO GET THE BRIEF UPDATE ON THE NEWBORN SCREENING WHICH I THINK IS IMPORTANT AND WE WANTED TO GET THE BRIEFING ON THE INFORMATICS INITIATIVE SO THOSE ARE TWO THINGS AND HE IS SAYING I THINK THEN THAT HE IS NOT URGING THAT BITE OFF THE PHARMACOGENOMICS SUD DID I OR LARGE POPP YOU LAGS STUD ZWRI THERE ARE TWO PRESENTATION *GS ON NEWBORN SCREENING AND TESTING FOR RARE GENETIC DISEASES WHICH ARE CLEARLY FOR THE INFORMATION OF THIS COMMITTEE BUT I'M TRYING TO FIGURE OUT WHETHER THOSE ARE IN OUR CRITICAL PATH TO GET TO SOME ACTION ITEM WHERE AS PHARMACOGENOMICS AND LARGE POPULATION STUDIES ARE PRIORITY ISSUES THAT WE WANT TO AT SOME POINT HINGE ON WHETHER WE HAVE FUTURE ACTION ITEM.
I THINK HUNTER, YOU ARE TERRIFIC. WHAT I'M THINKING IS THAT FOR THE BRIEF INFORMATIONAL ITEMS ONES THAT JUST TAKE A FEW MINUTES TO GIVE US ANOTHER UPDATE THEY DON'T IMPLY ANOTHER SET OF WORK WHEREAS THE PHARMACOGENOMICS AND LARGE POPULATION STUDIES SAYING THERE ARE SUB COMMITTEES AND GOING FORWARD. THE SEQUENTIAL NATURE OF THIS AND MAY BE JUST WHAT YOU ARE GETTING AT IS THAT WE CAN AT LEAST INTEREST SOME MORE MATURING OF THOSE PROJECTS AND THEN PUT THEM INTO THE QUEUE BECAUSE THEY WILL START TO BE MASSAGED OFFLINE.
THAT WAS MY SENSE IF WE CAN COULD DEVOTE A CERTAIN COUPLE OF HOURS TO PHARMACOGENOMICS AND LARGE POPULATION THAT WOULD ALLOW THE TASK FORCE TO JUMP INTO ACTION BETWEEN MEETINGS WHERE AS IF WE SKIP A METING THE TASK FORCE CAN'T DO ANYTHING ANYWAYS AND WE HAVE LOST 4-6 MONTHS.
AND IF YOU WANTED TO MOVE ONE OF THE TOPICS FORWARD I THINK A LITTLE PERHAPS A LITTLE MORE IN DEPTH BRIEFING ON WHAT IS GOING ON IN HHS MIGHT BE A WAY OF OCCUPYING AN HOUR BUT NO MORE TO KEEP THE MOMENTUM GOING IN THESE DIRECTIONS BUT I WOULD LEAVE THAT UP TO TASK FORCE.
SO THAT WOULD SAY IS THAT -- AND ED, IN THAT -- IN THAT COMMENT ARE YOU SAYING THAT BOTH OF THOSE HAVE AUK ALASKATIVEITYS GOING TO HHS OR IMPLY THAT YOU WANTED TO GET SOMETHING FROM HHS ON THE LARGE POPULATION ONE?
I KNOW THAT THERE ARE PLANS AFOOT IN HHS FOR THE LARGE POPULATION STUDIES. I DON'T KNOW IF THERE IS ANYTHING QUITE SO CONCRETE IN THE -- OR SOMETHING AS EASY TO GET ONE'S ARMS AROUND AS IN THE PHARMACOGENOMICS BUT PERHAPS WE COULD BE INFORMED.
I WOULD THINK IN SOME WAYS THEY MIGHT BE MORE EQUAL THAN YOU ARE IMPLYING BECAUSE I THINK THERE ARE NOT PLANS AFOOT. THERE IS SIMPLY EXPLORATION AFOOT. IT HASN'T GOTTEN TO THE POINT OF ANYTHING CLOSE TO PLANS, I WOULD SAY.
LET WHAT THE GUIDANCE IS FROM YOU AND GIVE YOU ALL ONE MORE CHANCE TO REACT TO THIS. I THINK THAT WHAT I LIKE FROM HUNT IS THAT WE DON'T WANT TO LOSE THE MOMENTUM OF THOSE COMMITTEES. WE DON'T HAVE TO DEDICATE OURSELVES TO SOLVING BOTH OF THOSE ISSUES TOMORROW BUT WHAT WE NEED TO DO IS HAVE THE COMMITTEES CREATE AT LEAST SOME TIME FOR THERE TO BE MORE DISCUSSION AND DISCOVERY AT THE NEXT MEETING WHICH THEN WILL ALLOW THIS THING -- THESE TO GO ON AND THEN BY THAT POINT BY THE END OF THE NEXT MEETING WE WILL BE READY TO START TO TACKLE SOME OF THESE TWO AND BASICALLY YOU WANT TO KEEP BOTH ALIVE AND MOVING AND UP TO SARAH AND I DO FIGURE OUT ON THE AGENDA HOW MUCH TIME WE CAN GIVE TO ALL OF THIS. THAT IS YOUR RECOMMENDATION. LET ME SEE HOW YOUR COLLEAGUES FEEL ABOUT THAT?
JUST FROM THE PHARMACOGENOMICS I THINK WE PROBABLY HAVE TWO OR THREE MEETINGS WORTH OF STUFF THAT WE COULD TALK ABOUT SO I WOULDN'T HAVE ANY PROBLEM IF WE SPLIT THAT UP AND DID A COUPLE HOURS HERE AND A COUPLE HOURS THERE AS JUST SORT OF THE LATEST HOTTEST THINGS GOING ON.
I DON'T SEE ANY STRONG OBJECTIONS SO I THINK SARAH AND I WILL WORK HARD TO GET ALL OF THESE ON THE AGENDA AND GIVE THEM THE APPROPRIATE AMOUNT OF TIME BUT I THINK WITH, ED, I THINK WE ARE PRETTY STRAIGHTFORWARD THAT WE ARE GOING TO KNOCK OUT THE ONES THAT WE HAVE GOT MATURE AND GET THOSE THINGS RESOLVED WELL. IN THE INTERIM BEFORE THE MEETING. TWO OTHER THINGS I WANT TO BRING UP QUICKLY WE WILL SEND YOU IN THE MAIL A COPY OF THIS FROM THE NATIONAL SERVICES -- GENERAL SERVICES ADMINISTRATION. I REALLY WAS CURIOUS ABOUT HOW YOU EVALUATE THE QUALITY OF A COMMITTEE LIKE OURS AND I WAS SURPRISED TO FIND QUITE A VERY THOUGHTFUL ANALYSIS THAT IS USED TO DETERMINE WHETHER OR NOT, YOU KNOW, WE ARE WORTH DIDDLY SQUAT SO I WANT YOU TO SEE THAT AND KEEP IT IN FRONT OF YOU BECAUSE IT DOES SORT OF GIVE YOU A REALITY CHECK. I THINK GIVEN ED'S LEADERSHIP IN THE PAST WE COMPORT PELL IN THAT ANALYSIS. I WONDER IF I COULD HAVE YOUR PERMISSION TO DRAFT A LETTER THAT I COULD SEND ON YOUR BEHALF AND, OF COURSE, YOU WILL RIGHT IT THAT WOULD URGE THE SECRETARY TO CREATE AND THIS IS NOT THE RIGHT WORD BUT SORT OF A CZAR, A COORDINATED PERSON, SOME SINGLE IDENTIFIED ENTITY FOR HHS. WE KEEP BOUNCING ALL OVER THE PLACE WITH THIS THING AND QUITE FRANKLY WHILE I'M COMFORTABLE THAT BEFORE I WOULD TAKE THIS POSITION THAT I DID TALK TO THE SECRETARIES OFFICE AS I MENTIONED IN MY OPENING REAR MARKS YESTERDAY THAT THIS WAS IMPORTANT TO THE SECRETARIES OFFICE I THINK I WOULD FEEL BETTER IF THERE WAS A PERSON HE IS SIGNIFICANT NATEED TO RECEIVE OUR WORK AND KNOW THAT THEY WERE ON POINT AND SERVE AS AN OFFICIAL COORDINATOR ACROSS THE AGENCIES TO FOR THE THINGS WE ARE TALKING ABOUT AND I FEEL LIKE I WOULD LIKE TO MAKE THAT MORE EXPLICIT AND DIRECT BUT I OPEN YOUR FOR THAT FOR GUIDANCE AT TO WHETHER THIS IS WORTH WHILE.
SO MOVED.
ARGUMENT? OTHER POINTS OF VIEW?
WOULD YOUR INTENT BE TO CIRCULATE THAT AND SEND IT QUICKLY AND *R OR CIRCULATE IT AND HAVE A DRAFT FOR FINAL DECISION AT THE FEBRUARY/MARCH MEETING?
GREAT QUESTION. AGAIN, JUST AS A POINT OF DEPARTURE, I THINK THAT I WOULD IN TERMS OF THERE SH SEVERAL THINGS WE ARE SENDING TO THE SECRETARY AS A RESULT OF THIS MEETING I WOULD PROBABLY PUT IT IN THAT LETTER AS PART OF THE OVERALL LETTER SAYING YOU HAVE A COMMITTEE WORKING ITS TAIL OFF ON ISSUES IMPORTANT TO THE AMERICAN PEOPLE AND THEY RANGE IN QUITE OF VARIETY OF AREAS AND AS SUCH I THINK WE WOULD LIKE TO KNOW THAT THERE IS SOMEBODY WHO IS PAYING ATTENTION TO THESE ISSUES. IT WOULD BE PACKAGED INTO OUR REPORT TO HIM ON THIS MEETING.
ALL RIGHT, WELL, I'M NOT HEARING ANY VIOLENT OPPOSITION TO THAT SO YOU WILL BE SEEING THAT AS WELL. WHO ON THE COMMITTEE HAS ANY FURTHER THOUGHTS, ANYTHING THAT DID NOT GET DISCUSSED. IN MISCELLANEOUS? YES.
I GET INCREASINGLY CONCERNED THAT THE PUBLIC DOESN'T NECESSARILY KNOW EVERYTHING THAT WE ARE DOING AND SO IN LIGHT OF THAT I KNEW IN THE PREVIOUS DISCUSSIONS THERE WAS SOME TALK ABOUT PUTING THAT VISION STATEMENT PRIOR ORDERS REPORT INTO AT LEAST THE SCIENTIFIC LITERATURE IF NOT EVEN TRYING TO COACH IT INTO THE LAY PERSON'S LITERATURE TO WE COULD INCREASE AWARENESS ABOUT OUR ACTIVITIES AND MAYBE GET MORE PUBLIC COMMENT THAN WE DO ALREADY FROM FOLKS THAT DON'T TRADITIONALLY READ THE FEDERAL REGISTER.
I THINK YOU ARE ON TO SOMETHING THERE.
THE TESTIMONY YESTERDAY WAS SO POWERFUL AND AGAIN THIS THIS ATMOSPHERE OF PEOPLE SAYING THAT GENETIC DISCRIMINATION DOESN'T EXIST AND THERE IS NOTHING IN THE LATE A TYRE TO SUPPORT THAT I THINK THE INFORMATION WE GOT YESTERDAY I WOULD THROW IT OUT THERE THAT POSSIBLY WE COULD COACH THAT INTO SOMETHING AGAIN THAT COULD GO INTO THE SCIENTIFIC LITERATURE SO THAT PEOPLE CAN REFERENCE IT IN THE FUTURE.
THOSE ARE TERRIFIC COMMENT *PS AND BARBRA ALSO NOT AS ELOQUENTLY AS YOU WHEN WE HAD THE FOLKS TESTIFYING SAYING IS THERE A WAY THAT YOU CAN TAKE BACK TO YOUR NEWS LETTERS AND SO FARTHER AND SO ON. I THINK WE OUGHT TO TRY TO FORMALIZE THAT A LITTLE BIT WITH THE MAJOR ADVOCATEY ORGANIZATIONS FOR THE GENETIC COMMUNITY IS TO REQUEST THAT SYNOPSIS VERSIONS ARE MADE AVAILABLE TO THE MEMBERSHIP AND I THINK WE SHOULD ACTIVELY IF WE HAVE NOT JUST FORMALLY REACH OUT,.
I SAW SOME OTHER HANDS.
I WANTED TO ASK IF WE WERE GOING TO VOTE ON THE DRAFT DIRECT TO CONSUMER LETTER GIVE YOU OUR BLESSING TO SEND THAT BECAUSE IT IS IN THE TABLE.
WE SEND IT OUT FOR COMMENTS ELECTRONICALLY BUT AS REED SAID IN THE BEGINNING WE ARE MORE THAN HAPPY TO GET MORE COMMENTS ABOUT IT.
I'M JUST TRYING TO DRIVE IT TO CONCLUSION. DONE WITH IT AND REDTY TO SEND IT.
THE ANSWER IS THAT YOU HAVE PHYSICAL THE END OF THIS MEETING OR BY THE TIME SARAH GETS BACK TO THE OFFICE MONDAY, TOMORROW TO SEND SOMETHING IN. BUT ABSENT THAT, IT IS GOING OUT. BUT THE ANSWER IS THAT YOU DO HAVE TIME SO IF YOU FORGOT TO READ IT AND DIDN'T LOOK AT IT AND DON'T REMEMBER IT, YES, YOU STILL A HAVE MOMENT TO COMMENT. YES, OTHER POINTS? THESE ARE TERRIFIC.
WE'RE SENDING THE ROADMAP TO THE SECRETARY BUT WE HAD ALSO DISCUSSED PUBLISHING IT AND I THINK THAT THAT IS A VERY, VERY IMPORTANT STEP.
ALL RIGHT, WE'LL WORK ON THAT. LISTEN, LET ME THANK ALL THE MEMBERS OF THE AUDIENCE, THERE ARE SOME OF YOU WHO HAVE BEEN HERE THE ENTIRE TWO DAYS. YOU ARE EXTRAORDINARILY RESILIENT AND WE THANK YOU FOR BEING PART OF OUR LITTLE COMMUNITY. AND TO SARAH AND THE TEAM, I MEAN GOOD LORD, MY GOODNESS Y'ALL WORK SOMETHING FIERCE AND IT IS VERY MUCH APPRECIATED. THE SUPPORT WE GET IS EMBARE RACING. EMBARRASSING. THANK YOU VERY MUCH TO EVERYONE. GOOD MEETING.