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.