WELCOME EVERYBODY TO THE BRAIN NEWG WITH THE CONTINUING TRIAL RESPONSIBILITIES. FROM THE DIRECTOR OF THE NIH BRAIN INITIATIVE I WANT TO THANK EVERYBODY WHO MADE THIS WORKSHOP HAPPEN. STARTING WITH CHRISTINE AND THE COCHAIRS NEWG AND THE REST OF THE NEWG MEMBERS AND THE STAFF AT NIH WHO ARE FOCUSED AND DEDICATED TO ADDRESSING THESE ISSUES OF NEURAL ETHICS AND WITH ALL THE WORK TO PUT THIS TOGETHER. WE ARE EXCITED TO BRING TOGETHER COMMUNITIES. BUT WE ARE MOTIVATED BY THAT COLLECTIVE SUGGESTION FROM PEOPLE FROM DIFFERENT DOMAINS. VERY IMPORTANTLY ARE THE HUMAN PARTICIPANTS WE REALLY DO SEE THE NEED TO LOOK AT A SHARED RESPONSIBILITY TO FACILITATE RESEARCH RELATED CARE AFTER THE TRIAL FORMALLY ENDS BUT QUITE HONESTLY IT'S NOT CLEAR HOW TO MAKE THIS HAPPEN HOW WE SPECIFY OR OPERATIONALIZE WHAT NEEDS TO BE DONE IN REALITY. SO THE WORKSHOP IS STRUCTURED THROUGH A SERIES OF FOUR PANELS. TODAY WE WILL START WITH THE FIRST TWO. WE WILL START WITH THE PANEL RIGHT AFTER THIS TO EXPLORE THE NEEDS THE STUDY PARTICIPANTS HAVE IN RELATION. THE SECOND PANEL OF THE AFTERNOON ABOUT THE STAKEHOLDERS CURRENTLY PROVIDE AND WHAT IS IN THE REALM OF POSSIBILITIES FOR WHAT THEY COULD FACILITATE FOR RESEARCH CARE. TOMORROW WE CONTINUE THE CONVERSATION AND THE THIRD PANEL SEEK PERSPECTIVES AT A REASONABLE LEVEL THAT IS ASSOCIATED AND THEN THE LAST SESSION WILL FOCUS ON THE UNMET NEEDS AND HOW IT CAN FILL THOSE AND HOW I'M LOOKING FORWARD TO EVERYBODY'S PARTICIPATION LEVEL TODAY AND TOMORROW IT WILL HAVE THE REASONABLE EXPECTATIONS THAT COULD INFORM GUIDELINES AND BEST PRACTICES. THANK YOU FOR BEING HERE THESE ARE TOUGH QUESTIONS WE ARE ASKING NOT THE LEAST OF WHICH OF HOW TO MAKE THINGS HAPPEN AFTER WE DECIDE WHAT MIGHT NEED TO HAPPEN AND THEN WILL DISCUSS THE INTRODUCTION OF BACKGROUND. >> THANK YOU. I WILL START WITH QUICK INTRODUCTION AND BACKGROUND SO WE'RE ON THE SAME PAGE FOR THE REST OF THE WORKSHOP. FIRST LET ME SPEAK TO WHY WE NEED THE SCIENCE THAT IS RELEVANT TODAY DISORDERS CAUSE A HIGH BURDEN OF DISEASE IN THE US AND WORLDWIDE THAT EXCITING PERIOD OF NEUROSCIENCE THAT SCIENTIST HAVE DEVICES TO TRACK THESE CONDITIONS. HOWEVER THE DEVELOPMENT OF THEM TO BE USED ON HUMAN SUBJECTS. WE CANNOT ADVANCE THE FIELD WITHOUT THE GENEROUS CONTRIBUTION THAT PATIENTS MAKE ON TIFFANY'S TRIALS. IT IS WORTH NOTING THESE ARE PATIENTS THEY FOUND THEIR TREATMENT RESISTANT MAY NOT HAVE OTHER OPTIONS THEY MAY OR MAY NOT HELP THESE PATIENTS THEY CONTRIBUTE TO THESE TRIALS SO IT IS IMPERATIVE WE HAVE HIGH ETHICAL STANDARDS. THIS WORKSHOP IS RELATED TO THAT GENERAL GOAL OF NIH. SO SPECIFICALLY WE WILL GET THE NEEDS THAT PATIENTS MAY HAVE AFTER THE TRIAL HAS ENDED WE ARE LOOKING AT RESEARCH RELATED NEEDS TO THE DEVICE THAT WAS IMPLANTED AFTER THE TRIAL HAS ENDED FOR EXAMPLE PATIENTS MAY USE EXPERIENCE BENEFITS FROM THE DEVICE AND THEN THEY WANT TO KEEP IT AFTER THE TRIAL ENDS. AND THEN THEY NEED MAINTENANCE LIKE REPLACING BATTERIES OR THE EXPECTATION. SO WITH OTHER DEVICE TRIALS IN THE NEEDS THAT PATIENTS HAVE RELATED TO THE TRIALS AFTER THE TRIAL HAS ENDED. SO THE CLASSIC SCENARIO IS ONCE THE TRIAL HAS ENDED BUT BEFORE IT HAS BEEN APPROVED FOR CLINICAL USE OF THOSE SCENARIOS ARE POSSIBLE IF THE TRIAL DISCONTINUES PREMATURELY BY THERE IS NO REGULATORY ROLE FOR THE DEVICE THOSE FORMER PARTICIPANTS MAY NOT HAVE COVERAGE OPTIONS WITH THEIR INSURANCE OR IF AT ANY POINT IN TIME MAY DISCONTINUE THE PRODUCT SO I WENT TO HIGHLIGHT THE CLASSIC SCENARIO IS TIME-LIMITED THAT AT LAST UNTIL IT IS APPROVED. IT MAY LAST LONGER SO SEVERAL REASONS HAVE BEEN EXPRESSED BY OTHERS INVOLVED IN THESE TRIALS MAY HAVE RESPONSIBILITIES OF ATTENDING TO THESE NEEDS SO IF YOU ARE PROFESSIONAL STAKEHOLDER TO RECEIVE AN EXTRA RENTAL DEVICE YOU RESPONSIBILITY FOR HELPING PARENTS TO HARM OF THOSE INDIVIDUALS WE ALSO HAVE RESPONSIBILITY TO HELP ADVANCE PATIENTS INTEREST AND WHILE OVER TIME THEY DON'T NECESSARILY STOP AT THE TIME THE TRIAL ENDS. IT'S OFTEN REGARDED AND SECOND AND WITH THAT RECIPROCITY AND WITH THOSE RISK THEY UNDERTAKE AS PARTICIPANTS SO FOR EXAMPLE OF THIS RESEARCH PARTICIPANT EXPRESSED IT FELT LIKE HE LUCK IF I IMPLANT THINGS IN MY BRAIN AND I'M WALKING AROUND WITH THIS YOU HAVE A RESPONSIBILITY TO LOOK AFTER ME. AND THIRD BUT ALTHOUGH MANY AS A MEANS TO AN END AND THEN WITH THE CONCERNS OF THE X PER AND WITH THAT RELATIONSHIP BETWEEN THE PARTICIPANTS AND THOSE INVOLVED IN THE TRIAL HAS SOME TYPES OF RELATIONAL DUTIES. WITH THAT POSTTRIAL RESPONSIBILITIES HAVE LIMITS AND OPPORTUNITY COSTS STAKEHOLDERS ALSO HAVE IMPORTANT TRIALS WITH THE POPULATION AT LARGE AND IN THE MOST EXTREME FORMS THEY MAY NOT BE ABLE TO CONNECT ANY TRIALS AT ALL FOR THEIR CARE NEEDS. SOME PREFER TO ORDER MORE THAT FUNDING THAT IS MEANT FOR RESEARCH SO I WILL SAY THIS ARGUMENT IS IN THE CONTEXT OF THE IMPLANTED DEVICES IT'S OBVIOUS BETWEEN RESEARCH AND CLINICAL CARE. SOME WOULD ARGUE SO CONSENTING TO A LACK OF INFORMATION. AND THIS LACK OF ARRANGEMENT IS ACCEPTABLE. AND THEN HOLDING A WORKSHOP IN 2017 WITH TOPICS AROUND CARE. BUT THEN TO GO THROUGH THE FRAMEWORKS AND STANDARD PRACTICES. AND THEN WITH THE MEDICAL DEVICES AND THE NEWG WORKING GROUP DRAFTED THE FOLLOWING TREATY OF THINGS TO CONSIDER. FIRST PROCESSED TRIAL NEEDS SHED ANTICIPATE AHEAD OF THE TRIAL IN DIFFERENT SCENARIO SHOULD BE PLANNED FOR. SECOND. PROFESSIONAL STAKEHOLDERS HAVE A LIMITED SHARED RESPONSIBILITY TO TAKE REASONABLE STEPS TO FACILITATE CONTINUED ACCESS TO DEVICES THAT BENEFIT PARTICIPANTS AND THEY MAY HAVE FURTHER RESPONSIBILITIES. FINALLY PATIENTS SHOULD BE INFORMED ABOUT POSTTRIAL NEEDS AND PLANS. I WENT TO EMPHASIZE TWO THINGS. FIRST IN THIS WORKSHOP THE RESULTS OF WHICH WERE PUBLISHED IN THERE APPEARS TO BE A CONSENSUS IN THE FIELD OF THESE THREE POINTS SO WE WOULD LIKE TO TAKE THESE THREE POINTS AND BASICALLY START FROM THERE. THIS ALSO MEANS WE WOULD LIKE TO LIMIT THE TIME SPENT WITH THE APPLICABLE FOUNDATIONS OF THE STATEMENTS AND THE THING IT MADE PROGRESS ON THE SPECIFICATIONS. SO IT'S CURRENTLY GOING ON IN THE FIELD THERE IS STILL SOME VARIETY AND THE EXTENT OF POSTTRIAL CARE AND WHAT THIS ENTAILS. BUT THAT IS NOT SURPRISING CONSIDERING FROM THE WORKING GROUP I JUST QUOTED WAS PRETTY HIGH LEVEL IT DOESN'T REALLY SAY THAT THIS IS APPROPRIATE BUT TO ENCOURAGE TO MAKE PLANS AND THAT HELPS WITH THEIR LONG-TERM CARE AND SOME FORMER PARTICIPANTS TO EXPERIENCE ANXIETY AROUND THE UNCLEAR INDIAN ACCESS TO THE DEVICE FOLLOW-UP CARE AND MAINTENANCE. EVEN A LOSS OF ACCESS TO BENEFICIAL DEVICES. SO THE VERY HELPFUL FOR THE FIELDS RELATED TO SPECIFICATION AND IMPLEMENTATION OF THOSE HIGHER-LEVEL PRINCIPLES I JUST OUTLINED WHAT ARE THOSE STAKEHOLDERS TO PROVIDE. AND HOW ARE THEY PROVIDED FOR AND WITH THOSE DIALOGUE TO THE STAKEHOLDER AND IN ORDER TO PREPARE FOR IT. AND SOME OF THE MEMBERS IF THERE WERE POINTS THAT ARE NOT BEING BROUGHT UP THEN STAFF MEMBERS WILL MAKE SURE TO ADD THESE TO THE CONVERSATION. THE GOAL OF THE WORKSHOP IS TO TALK REASONABLE EXPECTATIONS FOR THAT CARE PLANS THAT CAN INFORM BEST PRACTICES IN THE COMMUNITY EVENTUALLY. NOW I JUST WANT TO HIGHLIGHT THE FOUR PANELS THAT WILL HOPEFULLY BUILD ON EACH OTHER. FIRST WE WILL IDENTIFY THE POSTTRIAL NEEDS AND IN THOSE ARE CURRENTLY OVER ALREADY COVERED IN TOMORROW WE WILL TAKE THIS LIST OF NEEDS AND SAY WHAT IS THE MINIMUM OF THE RESEARCH RELATED CARE? AND THEN FINALLY THE DIFFERENCE BETWEEN PANEL NUMBER THREE INTO WHAT SHOULD BE FACILITATED AND HOW DOES IT FILL THE GAPS? THANK YOU AGAIN FOR BEING HERE AND SPECIAL THANKS TO THE NIH PLANNING COMMITTEE WHO HAVE LED THIS EFFORT. I WILL HAND IT OVER TO PANEL NUMBER ONE. >> THANK YOU SO MUCH. WE WILL KICKOFF PANEL NUMBER ONE SO LOOKING AT THE RELATION TO THEIR TRIAL PARTICIPATION AFTER THE TRIAL ENDS. THE FIRST SPEAKER IS MISS BRANDY ELLIS WHO IS A PATIENT PARTICIPANT FROM THE DEVICE CLINICAL TRIALS IN FIRST ENROLLED IN 2011 AS PART OF THE PHYSICIAN SPONSORED EXPERIMENTAL STUDY THAT INVOLVES DEEP BRAIN STIMULATION FOR TREATMENT RESISTANT DEPRESSION USING DEVICES. SINCE THEN SHE HAS RECEIVED ONGOING CARE AND NEGOTIATES WITHOUT IT FOR HER DEVICE MAINTENANCE. >> IT AFTERNOON. IT IS A PLEASURE TO BE HERE. I WILL BREEZE THROUGH THE INTRODUCTION BECAUSE I CAN TALK ABOUT THIS FOR HOURS SO WE WILL GO TO THE NEXT SLIDE AND YOU CAN SEE THIS IS WHAT IS CURRENTLY IN MY BRAIN. BEFORE YOU ASK WHY SOMEBODY WOULD DO THIS, LET'S GO TO THE NEXT SLIDE, YOU WILL SEE WHY. I LITERALLY HAD TRIED EVERYTH EVERYTHING. IF A DOCTOR COULD THINK OF IT I WOULD TRY IT. FOUR YEARS. WAS COMPLETELY DISABLED. NOTHING HAS WORKED. AT THAT POINT I DECIDED IF I COULD NOT FIND DATA ON WHAT WORKED FOR TREATMENT RESISTANT DEPRESSION BECAUSE EVERYTHING WAS GOAL ORIENTED TO PEOPLE WHO WERE FEELING LITERALLY EVERYTHING. AND I HAD A BELIEVE THAT NOTHING WOULD WORK BUT STILL IT WOULD BE BENEFIT DESIGNED FOR THE PEOPLE WHO COME AFTER ME SO IF YOU GO TO THE NEXT SLIDE THIS IS A STUDY I WAS IN AND THEN GO TO THE NEXT SLIDE YOU CAN SEE IT IS A REALLY LONG RECOVERY PROCESS. I AM VERY THANKFUL IT DID WORK AND IN THE NEXT SLIDE IT WAS YEARS FROM THE TIME I DEVICE WAS IMPLANTED UNTIL I FELT WELL. THIS IS NOT A QUICK FIX. AS PATIENT YOU ARE REALLY COMMITTING TO THE LONG HAUL AND FOR ME BECAUSE MY DEPRESSION WAS SO SEVERE, THE INITIAL WE NEED YOU TO NOT DIE FOR THE FIRST YEAR PLEASE YOU WILL MESS UP OUR EXPERIMENT. THEY DID NOT SAY THAT BUT THAT'S HOW SOMEBODY WOULD INTERNALIZE IT. IT WAS QUITE A COMMITMENT IF YOU GO TO THE NEXT SLIDE THESE ARE THINGS I HAVE EXPERIENCED OUR FRIENDS HAVE EXPERIENCED AND THIS LEADS ON WHAT I WOULD LIKE OF POSTTRIAL CARE. I WILL GO SPECIFICALLY INTO SOME OF THE SUGGESTIONS THAT I HAVE I HAD BATTERY REPLACEMENTS MY BATTERIES WERE LASTING BETWEEN 11 AND 13 MONTHS WITH ORIGINAL SETTINGS. I WAS IN MY THIRTIES. SO POTENTIALLY FACING 30 OR 40 SURGERIES FOR BATTERY REPLACEMENTS CUTTING INTO THE SAME AREA. NOW I HAVE A RECHARGEABLE BATTERY BUT IT IS NOT FDA APPROVED SO THERE IS A RISK I HAVE TO GO BACK TO A STANDARD BATTERY AND THOSE ANNUAL SURGERIES. I HAVE HAD VARIOUS MALFUNCTIONS WITH THE IMPLANTED DEVICE OR THE DEVICE THAT I USED TO RECHARGE. AND I AM STILL ENGAGING AND FOLLOW UP AND I WILL HELP THEM AS LONG AS THEY FIND MY HELP BENEFICIAL. THERE ARE OTHER THINGS I WOULD LIKE TO SEE IMPROVED GENERAL SECURITY WERE GETTING TO WHERE EVERYTHING IS TRACKABLE AND I'M DEPEND UPON THE FACT THAT THOSE PEOPLE CLOSE TO ME WANT TO KEEP ME AND WILL NOT BE HACKING MY DEVICE. SO MY FIRST SURGERY WAS ACTUALLY COVERED BY MY PRIVATE INSURANCE AND IT IS MY UNDERSTANDING THE FIRST PARTICIPANT WHO HAD THEIR INSURANCE COVER THE INITIAL PROCEDURE. I HAVE TO ASSUME THAT WAS IN PART BECAUSE OF THE LIST OF ALL OF THE THINGS I HAVE TRIED WAS VERY EXPENSIVE. NOTHING WAS WORKING. SO THIS WAS CONSIDERED A CHANCE FOR ME TO SURVIVE WITH LESS EXPENSE AND IT HAS WORKED MY MEDICAL CARE EXPENSES PLUMMETED ONCE I WAS NOT NEEDING AS MUCH CARE. BUT ONGOING SURGERIES AND THOSE SORTS OF ISSUES IS I CAN UNDERSTAND THE INITIAL TRIAL. THAT IS THE EXPERIMENT I COMPLETELY UNDERSTAND WHY INSURANCE WOULD NOT COVER SOMETHING EXPERIMENTAL. BUT FOR ME HAVE HAD THIS DEVICE FOR TEN YEARS IT IS NOT AN EXPERIMENT FOR ME ANYMORE. WE KNOW THIS WORKS THIS IS THE ONLY THING THAT DID WORK AND IF I NEED TO HAVE BATTERY REPLACEMENT OR ANYONE OF THOSE THINGS, IT'S A WAY TO KEEP ME ALIVE IT IS NOT AN EXPERIMENT ANYMORE WE KNOW THIS WORKS I HAD UNFORTUNATE BLINDED INCIDENT I DID NOT KNOW HIS OFF FOR A COUPLE OF WEEKS AND I GOT UNWELL AND THEN WE FOUND OUT IT WAS OFTEN THAT WE FOUND OUT IT REALLY DOES WORK AND I REALLY DO NEED IT. THE SECOND THING I WOULD FOCUS ON IS COMPATIBILITY. I AM CURRENTLY USING A RECHARGEABLE BATTERY AT THIS POINT IN TIME HAS SAVED ME SIX SURGERIES. BUT THAT BATTERY IS NOT FDA APPROVED. MOST PEOPLE WHO GET DBS GET IT FOR PARKINSON'S AND THEY ARE OLDER AND THE DEVICE DOES NOT DRAIN THE BATTERY AS QUICKLY SO THEY WOULD NOT NEED SURGERY EVERY SINGLE YEAR. MAYBE RECHARGEABLE IS NOT AS NECESSARY FOR THEM BUT FACING 30 OR 40 SURGERIES OVER MY LIFE EXPECTANCY THAT IS A BIG DEAL THEY DON'T HAVE A BATTERY THAT IS FDA APPROVED AND WENT TO DISCONTINUE PRODUCTION. SO WHAT I WOULD LIKE IS TO HAVE INCENTIVES TO MAINTAIN COMPATIBILITY. IF YOU GO TO THE NEXT SLI SLIDE, THERE ARE MULTIPLE DEVICE MANUFACTURERS BUT THERE IS NO INCENTIVE FOR ONE COMPANY TO INVEST IN MAKING THEIR BATTERY COMPATIBLE WITH EVERYBODY OR IF THEY WANT TO START MAKING THIS BATTERY THAT THERE IS AN APPROPRIATE SUBSTITUTION. BECAUSE EXPECTING SOMEONE WHO IS RELYING ON A DEVICE TO LIVE AND HAVE AN OPERATION EVERY YEA YEAR, EVEN IF THIS BATTERY ENDED AFTER FIVE YEARS THAT IS STILL A NUMBER OF SURGERIES ALSO I HAVE HAD DEVICE FAILURES WITH MY RECHARGER AND I AM VERY CONCERNED AT SOME POINT SO I WOULD LIKE TO QUICKLY BRING UP THE NEXT SLIDE WHICH IS MY WISH LIST AND THAT OVERCOMES THOSE SUGGESTIONS AND THEN WE CAN GET INTO QUESTIONS. MY WISH LIST WOULD INCLUDE THAT I WAS FORTUNATE I HAD PARENTS THAT WERE WILLING TO SUPPORT ME WHEN I WAS DISABLED FROM THE DEPRESSION AND HELPED I HAD PRIVATE HEALTH INSURANCE FROM THEM. I HAD THE ABILITY TO BE UNEMPLOYED AND HAVE THEM SUPPORT ME. IF YOU REQUIRE PARTICIPANTS TO FOOTBALL THE BILLS THEMSELVES TO LIVE THEN YOU ONLY GET PARTICIPANTS LIKE ME WHO HAVE AN AFFLUENT FAMILY AND CAN AFFORD TO SUPPORT THEM WHILE THEY ARE IN THE TRIAL. AND THAT IS NOT GOOD FOR ANYBO ANYBODY. WE NEED MORE DIVERSE PEOPLE WITH THESE TRIALS AND TO MAKE THAT HAPPEN THERE HAS TO BE A WAY TO GIVE THEM SUPPORT. I WAS DISABLED AND NOT WORKING BUT CHILDCARE, ANY OF THOSE MIGHT HAVE MADE THE DIFFERENCE IN MY RECOVERY. I WAS VERY FORTUNATE BUT WE NEED PEOPLE ACROSS ALL DIFFERENT BACKGROUNDS TO PARTICIPATE IN THESE TRIALS AND SUPPORT IS ONE OF THOSE THINGS THAT IS NECESSARY. THE NEXT ISSUE OF GUARANTEED COVERAGES LIKE I SAID I AM RELYING ON THIS DEVICE. THE LIKELIHOOD THAT I SURVIVE IF I CANNOT USE THIS ANYMORE IS NOT 100 PERCENT SO I AM CONCERNED I WILL NEVER KNOW FROM ONE SURGERY TO THE NEXT IF THE NEXT ONE WILL BE COVERED BY INSURANCE. I WILL NEVER KNOW IF I GET INTO A CAR ACCIDENT IF THE BRAIN SURGERY IS COVERED BY MY INSURANCE OR FACE THE PROSPECT OF NO LONGER HAVING THIS DEVICE. I WOULD LIKE THERE TO BE AWAY TO SAY YOU DID THIS EXPERIMENT AS PART OF THE CLINICAL TRIAL THAT WAS APPROVED AND SINCE IT WORKS FOR YOU THIS IS NO LONGER AN EXPERIMENT FOR YOU. I HAVE NO CONTROL. PERPETUAL POINT OF CONTRACT THEY HAVE SUPPORTED ME FOR ALL TEN YEARS WITHOUT QUESTION FOR 30 YEARS FROM NOW WHEN I'M IN THE RETIREMENT HOME I DON'T KNOW WHO WILL BE RESPONSIBLE FOR CHECKING MY DEVICE SETTINGS. AND I WOULD VERY MUCH LIKE THERE TO BE A REQUIREMENT IF IT'S IN MY HEAD AND IT WORKS TO SAY WE'VE DECIDED NOT TO MAKE THIS ANYMORE AND NOT TO COVER THIS ANYMORE THAT IF YOU STOP MAKING THIS BATTERY THERE HAS TO BE A COMPATIBLE ALTERNATIVE AND UNTIL THERE IS YOU CANNOT ABANDON THE PATIENT'S SO SOME MINOR THINGS I WOULD LIKE AS FAR AS DOCUMENTATION I THINK A REGISTRY OR SOMETHING THE MATTER WHERE YOU ARE SOMEBODY CAN FIND OUT THE SETTINGS IF I AM TIRED OF PORTUGAL I WILL NEED A SHEET OF PAPER TO TAKE TO A DOCTOR TO SAY THIS IS WHAT I HAVE IN THESE ARE THE SETTINGS AND THIS IS WHAT YOU NEED TO VERIFY. I THINK PARTICIPANTS SHOULD AUTOMATICALLY GET ACCESS TO ALL PUBLICATIONS. BECAUSE I'M ONE OF THE PEOPLE THAT READS ALL OF THE PUBLICATIONS. THAT IS MY RECOMMENDATIONS THOSE THAT HAVE DONE FOLLOW UP AND I'M HAPPY TO ANSWER ANY QUESTIONS IF ANYBODY HAS ANY. >> WE HAVE TIME FOR ONE QUESTION AND THEN WE CAN GET INTO THE ISSUES BUT THE QUESTION. >> 90 PERCENT IS A THANK YOU FOR CONVEYING THE STARTS WE HAVE PLENTY OF WORK TO DO AND AMAZING IT IS TO FOLLOW UP ON. IT'S VERY COURAGEOUS OF YOU. THANK YOU. I'M HAPPY YOU HAVE DONE WELL. YOU HAD HAD QUITE A BIT OF TIME TO REFLECT THE EXPERIENCE OVER THE YEARS SO IS THERE A COMMUNITY OUT THERE THAT YOU HAD TIME TO THINK ABOUT THIS AND THEN TO SPEAK TO WHAT IS THAT EXPERIENCE IS THERE A LOT OF DISCUSSION ABOUT THIS HOW IS THIS DISCUSSED BETWEEN YOURSELF AND OTHERS. >> ABSOLUTELY IT IS AN EXCELLENT QUESTION I HAVE A VERY CLOSE FRIEND I MET IN THE TRIAL AND WHEN MY CHARGER BROKE SHE LET ME BORROW HERS I UNDERSTAND THEY CANNOT HAND OUT INFORMATION FOR OTHER PARTICIPANTS TO LET YOU BORROW THEIR EQUIPMENT. AND FOUR YEARS SHE HAD A FACEBOOK GROUP FOR PEOPLE WHO WERE CONSIDERING DEEP BRAIN STIMULATION I WAS IN A DOCUMENTARY PUT ON BY PBS AND IN THE COURSE OF LIFE TREATING THAT RELEASE I HAVE HAD PEOPLE FROM BRAZIL AND OTHER COUNTRIES REACH OUT TO ME ON SOCIAL MEDIA AND SAY HEY I AM FACING SIMILAR ISSUES WHAT ARE THOSE THINGS I SHOULD BE AWARE OF? THERE IS A COMMUNITY AND PLATFORMS THAT DISCUSS THIS AND WHEN I WAS TALKING TO MY FRIEND ABOUT POSTTRIAL WISH LIST WE ALL HAVE SIMILAR EXPERIENCES IN THESE DISCUSSIONS DO HAPPEN THAT MY FRIEND IS ONE OF THE PEOPLE WHO THE INSURANCE COVERED IN AND SAID WE WILL NOT COVER THIS ANYMORE BECAUSE WE DON'T COVER EXPERIMENTS. WE ARE CHANGING A POLICY. THOSE FEARS ARE FOUNDED BASED ON THE EXPERIENCE OF PEOPLE I INTERACT WITH I CAN SPEAK PERIOD PUBLICLY WITH MY ISSUES WITH DEPRESSION AND WHAT THE TRIAL HAS DONE FOR ME AND THEY DO THAT IN PART BECAUSE PEOPLE CANNOT DISCUSS THIS BECAUSE THERE IS STILL'S A LOT OF STIGMA. SO I SPEAK UP BECAUSE I CAN AND NOT EVERYBODY ELSE CAN. BACK IN THE DAYS THERE WAS A GOOGLE PLUS I HAD AMA WHERE PEOPLE JUST ASK QUESTIONS ABOUT THE DEVICE AND THE TRIAL AND MY EXPERIENCES AND EVERYTHING FROM AN ENGINEER SO HOW DO YOU RECHARGE THAT TO WHAT IS ALL DAY BRAIN SURGERY WHEN YOU ARE AWA AWAKE. SO I NEEDED THAT WHEN WE FIRST STARTED THE TRIAL. YOU TALK TO THE OTHER PATIENTS AND THAT SUPPORT WAS CRUCIAL. I UNDERSTAND THAT'S NOT NECESSARILY SOMETHING THE TRIAL TEAM CAN COORDINATE BUT IT ENDED UP TO BE CRITICAL FOR MY LONG-TERM PARTICIPATION. AND I WOULD NOT BE DOING AS WELL I —- AS I AM IF I DID NOT DEVELOP THOSE RELATIONSHIPS WITH PEOPLE. >> I HAVE SO MANY MORE QUESTIONS I WILL PUT THEM IN THE Q&A. >> NOW WE WILL MOVE ON TO THE NEXT PANELISTS. THE ONE ISSUE THE QUESTIONS IN THE Q&A THEY WILL NOT GO TO THE PUBLIC RECORDING BUT WE WILL DO OUR BEST TO RECYCLE SOME OF THESE WITH THE PANEL DISCUSSION. >> SO NOW WE WILL MOVE ON TO MISS JENNIFER FRENCH. AS A RESULT OF THE SNOWBOARDING ACCIDENT SHE BECAME A QUADRA COLLEGIATE FROM 1988 FROM C SIX AND SEVEN SHE HAS A IMPLANTED NEURAL PRODUCT THESIS SYSTEM SHE'S FOUNDER OF THE EUROTECH NETWORK A 501(C)3 NONPROFIT ORGANIZATION THAT FOCUSES ON EDUCATION AND SUPPORT FOR NEUROTECHNOLOGY. AND THEN THE AUTHOR OF BIONIC PERIOD PIONEERS. >> BRANDY, FANTASTIC JOB YOU'RE A HARD ACT TO FOLLOW. AND THAT GRATEFUL FOR THAT IMPLICATION THE NEXT COUPLE OF DAYS IT IS INCREDIBLY IMPORTANT TO LOOK AT THE EXPANSION OF THE IMPLANTED DEVICES. IF WE THINK OF THE DIFFERENT ROLES THAT WE PLAY IN NEUROTECHNOLOGY DEVICES THEY CAN BE AND USERS AND TRIAL PARTICIPANTS IN MAKING DECISIONS THAT ALL OF THOSE WITH LIVED EXPERIENCE WITH INDIVIDUAL EXPERIENCES WITH NEUROLOGICAL CONDITIONS. AS A NONPROFIT AND THOSE LIVING WITH NEUROLOGICAL CONDITIONS. NOT JUST THE FOUNDER BUT SOMEBODY WITH THE CONDITIONS OF 24 YEARS AGO I HAD AN ACCIDENT THAT LEFT ME QUADRIPLEGIC AND A YEAR AND A HALF LATER I WAS IMPLANTED WITH A NARROW PROSTHESIS AND WITH LONG-TERM PARALYSIS I REALIZE HAVING THIS DEVICE OF HOW MUCH IT HAS IMPACTED MY MEDICAL HEALTH AND MY ABILITY TO COMBAT SECONDARY CONDITIONS THAT THE ABILITY TO STAND USING PARALYZED MUSCLES HAS A LIFE IMPACT. IT TO BE IN OTHER AREAS OF THE BODY THOSE THAT ARE PUTTING THEIR BODIES FORWARD WITH THE ADVANCE OF NARROW TECHNOLOGY AND THEN THE FIRST PARTICIPANT TO USE THE BRAIN INTERFACE TO INTERACT WITH PEOPLE WHO WAS A LONG TIME TRIAL PARTICIPANT TO REAP THE REWARDS AND WITH THAT SPINAL CORD DEVICE LIVED WITH CHRONIC PLANE AND NEVER FOUND SOLUTION UNTIL SHE HAD THIS DEVICE AND THEN THOSE WHO WAS A PARTICIPANT TO RESTORE SENSATION FOR A PROSTHETIC LENS SO ALL OF THE'S PEOPLE ARE JUST A FEW BUT WE PUT THEM FORWARD AND RIGHTFULLY SO THESE ARE THINGS THAT ARE HAPPENING IN THIS FIELD THAT WE TEND TO IGNORE AFTER THE HEADLINES FADE IN THE TRIAL IS OVER WITH AND THEN TO KEEP THAT EXCITEMENT OF HOW PEOPLE ARE LIVING. AND OTHER LIVING WITH THAT LONG-TERM AND THEN TO KEEP IN MIND OF THE WHY AND I DRAW YOUR ATTENTION TO THIS THE TOP THREE REASONS OF WHY PEOPLE PARTICIPATE IN CLINICAL TRIALS AND IT IS COMPELLING TO KEEP IN MIND AS WE MOVE TOWARD SOLUTIONS IT IS A HORSE RACE IT HAS POTENTIAL BENEFITS AND THEN TO HELP ADVANCE SCIENCE BUT ALSO ACCESS TO TREATMENTS AND DEVICES LOOKING AT ALL THE OTHER TREATMENTS THERE IS NOTHING ELSE AVAILABLE FOR HER IN A CLINICAL TRIAL IT WAS AN OPTION FOR HER AND ALSO FOR ME BUT LOOKING AT PERSONAL BENEFIT'S WE HAVE TO SEE HOW PEOPLE APPROACH CLINICAL TRIALS AND WHY THEY PARTICIPATE ONCE THE TRIAL IS OVER WANT TO SHARE WITH YOU WE RECENTLY PRESENTED THIS AT THE INSTITUTES A SCIENTIFIC RESEARCH AGENDA THAT THIS IS JUST A PIECE OF THE FRAMEWORK AS VALUE INTEGRATION WITH THE MEDICAL WORKING GROUP AND THE FACT THAT ETHICS NEED TO BE EMBEDDED INTO THE SPECTRUM IS NOT JUST THE INCEPTION AND PLANNING STAGES BUT ENGAGEMENT AND THOSE THAT CAN HELP PUT SOME SCOPE IN PLANNING AND IN THAT DEVELOPMENT STAGE THAT KEY AREA OF TRANSPARENCY AND ACCOUNTABILITY AND MOTIVATION OF THOSE PLAYERS THAT ARE ROOTED IN THAT DEVELOPMENT STAGE AND THEN FINALLY REGULATORY OVERSIGHT BUT ALSO THE ETHICAL ISSUES THAT CENTER AROUND CULTURAL AND SOCIETAL ISSUES AND THAT COULD BE VERY PRAGMATIC SO THAT IS A DRAFTED FRAMEWORK TO GIVE YOU AN IDEA SO WE HAD BEEN FOLLOWING PEOPLE THAT ARE EARLY ADOPTERS THERE ARE LOTS OF STORIES AND DIFFERENT EXPERIENCES SO LOOKING BACK AT THOSE STORIES AND INTERVIEWS THAT HAVE BEEN DONE IN PREPARATION WANT TO SHARE WITH YOU THE EMERGING THEMES SO ONE OF THE FIRST AREAS WAS MAINTENANCE AND REPAIR SO BEING ABLE TO LIVE WITH THE DEVICE AND HOW YOU GET IT REPAIRED IS A BIG QUESTION BUT A LOT OF TIMES ENGINEERS THINK OF BACKWARD COMPATIBILITY BUT WHAT WILL HAPPEN IN THE NEXT GENERATION TO BE COMPATIBLE AND THEN TO UPGRADE THE DEVICE LATER ON. WHAT IS THE ELIGIBILITY? AND THEN CONSUMABLES. OF COURSE THERE ARE BATTERIES BUT THERE ARE OTHER CONSUMABLES THAT GO WITH IMPLANTED DEVICES THAT COULD BE EXTERNAL TO THE BODY AND THE SECOND AREA OF SIMILARITIES AND THEN THE FINANCIAL BURDEN THAT COMES ALONG HAVING NO LONG-TERM IMPLANTED DEVICE SO THAT IS OUT OF COSTUME AND THE FUNDING ENDS IT GOES BACK TO THE PARTICIPANT AND ALSO TO TRACK THE USAGE OF THOSE DEVICES AND IF THAT IS WORTHWHILE AND THAT CONCERNED ABOUT LONG-TERM FOLLOW-UP AND THEN HOW LONG WILL IT BE FOR THE BENEFIT ONCE THE TRIAL IS OVER? >> THAT AREA OF EMERGING ISSUES IS STILL ADVERSE EVENTS AND LOSS OF FUNCTION. AND THOSE OTHER ISSUES. AND ALSO REFLECTING A LOSS OF FUNCTION. AND THEN HOW WILL THEY HAVE LOST FUNCTION WHEN THEY PLANT THE DEVICE AND THEN WHICH THE PARTICIPANTS AND WHAT THAT MIGHT ENTAIL AND WHAT THE OPTIONS MIGHT BE. IF THE TRIAL IS OVER WITH WHAT ABOUT INFECTIONS WITH THAT DEVICE AND THE PSYCHOLOGICAL IMPACT AND PEOPLE THAT HAVE BEEN IN VARIOUS TRIALS AND NOT JUST NEUROPSYCHIATRIC BUT ALL OF THE OTHER CONDITIONS OF ONCE THE TRIAL IS OVER WITH HOW DO WE HANDLE THE LOSS OF FUNCTION OR THE LOSS OF BENEFITS WE MAY HAVE ACHIEVED DURING THE TRIAL? >> AND FINALLY EXPECTATIONS TO UNDERSTAND THE RISK AND WE ALWAYS ASK THE QUESTION AND TO UNDERSTAND THAT RISK EARLY ON. BUT WITH THAT UNANTICIPATED EXPECTATIONS ARE. AND THAT IS PEPPERED WITH LINGO ONE —- LEGAL LANGUAGE AND WHAT THE PATHWAY COULD BE IN THAT EXPECTATION AND THEN TO RETAIN THE DEVICE WHAT THAT MIGHT BE. AND WITH THOSE IMPLANTED DEVICES OF TODAY I WENT TO HIGHLIGHT AND GO BACK TO GO BACK TO LOSS OF FUNCTION. AND A YEAR AND A HALF AFTER MY INJURY TRULY THE INITIAL TRIAL WAS 18 MONTHS THAT IS WHEN THE TRIAL WAS OVER WITH. IF I LOST THE ABILITY I COULD NOT STAND OR USE ANY OF MY PARALYZED MUSCLES. BUT I WAS FORTUNATE ENOUGH TO BE IN A TRIAL THAT WAS TO THE CLEVELAND CENTER IN OHIO AND IT ROLLED INTO A LONG-TERM FOLLOW-UP STUDY AND I HAVE BEEN THERE FOR THE LAST 23 YEARS. OVER THOSE 23 YEARS THEY HAVE FOLLOWING THE PROGRESSION AND HOW I USE IT. AND HOW PEOPLE USE IN SOCIETY AND HOW IT IS USED IN SOCIETAL I HAVE BEEN PARALYZED FOUR TIMES OVER THE PAST FEW YEARS THAT BECAUSE I AM INVOLVED IN A LONG-TERM FOLLOW-UP STUDY I CAN GET RE- IMPLANTED AND IN SOME CASES UPGRADED TO THE NEXT LEVEL OF DEVELOPMENT OF DEVICES. SO THAT LOSS OF FUNCTION IN FACT IT HAPPENED VERY RECENTLY DURING COVID MY SYSTEM FAILED AND JUST LAST YEAR I WAS REIMPLANTED SO IF YOU THINK OF LONG-TERM STUDIES THAT IS SOMETHING TO CONSIDER AND PUT ON THE TABLE. IS A MULTI AGENCY APPROACH. THERE IS A WORKSHOP TO THROW SOMETHING AGAINST THE WALL. AND ALSO LOOKING AT THE FDA. AND TO HAVE A MINIMAL PLAN IN THE STUDY. AND THEN HOW TO ADDRESS THEM AND WITH THE INCOME TRACKING AND THEN FUNDING MECHANISMS ON THE NIH SIDE TO SUPPORT LONG-TERM STUDIES WITH THE ADDITIONAL FIVE YEAR RULE WITH THESE PARTICIPANTS OVER A PERIOD OF TIME AND UNDERSTANDING THE EFFECTS BUT ALSO THE DATA THAT IS PUBLICLY AVAILABLE AND THERE'S AN OPPORTUNITY FOR CMS WITH A TRIAL PARTICIPANT IS A UNIQUE OPPORTUNITY TO HAVE DATA ANALYSIS FOR THOSE DECISIONS THAT YOU CAN USE WITH PAYMENT AND COVERAGE DECISION. BUT IT GAINS AN UNDERSTANDING OF WHAT AND WITH THOSE ADVERSE ADVANCE MY HAPPEN IT IS JUST ONE IDEA I WILL NOT CLAIM BUT I KNOW THE SOLUTION. AND THEN TO SPEAK WITH YOU AND THOSE THAT WE RELY ON FOR TECHNOLOGY. AND ANY QUESTIONS THAT THEY MAY HAVE. >> THANK YOU SO MUCH WE CAN ALLOW FOR ONE QUESTION. IS THERE ONE QUESTION. >> THANK YOU FOR THE PRESENTATION I HAVE ONE QUESTION TO FOLLOW UP ON WITH THE VALUE OF FRAMEWORK INTEGRATION PRESENTED AND WHAT TYPE OF ENGAGEMENT YOU THINK WILL BE MOST VALUABLE DURING THE PROJECT OF THE INCEPTION PHASE. THANK YOU. >> IT'S A GREAT QUESTION. I'M A BIG ADVOCATE AND WITH THAT EVEN IN THE EARLY PROCESS AND IT WILL ALL DEPEND ON WHAT YOU ARE DEVELOPING AND ALSO UNDERSTAND WHAT THE TRIAL MAY LOOK LIKE AND TO ENGAGEMENT EARLY ON. AND WITH THAT CLINICAL PROCESSES IMPORTANT BECAUSE AND IF WE HAVE SOMETHING EXTREMELY IMPRACTICAL IT'S DIFFICULT TO TRANSLATE THAT. AND WITH A CONSUMER ADVISORY BOARD AND THEN TO UNDERSTAND THOSE PREFERENCES IN THE PRIORITIES. I HOPE THAT ANSWERS YOUR QUESTION? >> YES. THANK YOU. >> AGAIN, Q&A IS OPEN MOVING ON TO THE THIRD SPEAKER FOR THIS PANEL ASSISTANT PROFESSOR AND WITH THE DEPARTMENT OF PSYCHIATRY TO COMBINE HIS BACKGROUND IN NEUROSCIENCE AND BIOETHICS TO EXAMINE THE IMPLICATIONS OF EMERGING BIO MEDICAL TECHNOLOGIES IN NEUROSCIENCE. HIS CURRENT RESEARCH EXAMINES WITH DEEP BRAIN STIMULATION ASSISTANCE. >> THANK YOU. AND LOOKING AT POSTTRIAL ACCESS. AND THANK YOU BRANDY AND JENNIFER FOR THEIR WONDERFUL THOUGHTS. YOU WILL SEE A LOT OF WHAT WE ARE SEEING CURRENT TRIAL PARTICIPANTS AND WITH THAT EXPERIENCE THAT BOTH OF THEM HAVE HAD. WE HAVE DATA ON RESEARCHERS WHERE THEY ASK ABOUT POSTTRIAL ACCESS ISSUES. AND THEN TO FOCUS ON THE PATIENT PERSPECTIVE IN THE PROCESS OF LOOKING FOR JOURNALS. >> AND WITH THAT DEEP BRAIN STIMULATION AND THOSE ASSOCIATED SYMPTOMS YOU TRY TO MANAGE AND THEN TO IDENTIFY TO BE ASSOCIATED WITH THE SYMPTOMS AND THEN FOR THE ONSET AND THEN ACTIVATING THAT STIMULATION FOR THAT BRAIN ACTIVITY AND FOR EPILEPSY BUT THAT CONDITIONS WE ARE DISCUSSING NO FDA APPROVAL. SO WE INTERVIEWED THESE PATIENTS BEFORE THE SURGERY. WE ASKED THEM QUESTIONS ABOUT POSTTRIAL DISCUSSIONS AND THEN WE ASKED THEM SIX MONTHS LATER WHAT TO DO REMEMBER? AND THEY WERE PARTICIPATING IN PARKINSON'S DISEASE TRIALS AND TOURETTE SYNDROME. SO WITH THE METHODS WE HAVE 21 PARTICIPANTS AND ALL TRANSCRIPT WERE RECORDED BY MEMBERS OF THE RESEARCH TEAM AND WITH THOSE EXTRACTIONS AND THEN TO EXTRACT THE THEME COMING FROM THE DATA WE ALSO HAVE AT LEAST TWO MEMBERS LOOKING AT IDENTIFYING AND THAT IS EMERGING SO WHAT IF ANYTHING THROUGH THE TRIAL. AND THE RESPONSES WERE NOT VERY DETAILED. SO WE LOWER THAT THRESHOLD SO DO THEY HAVE ANY RECOLLECTION OF HAVING DISCUSSED THIS OR NOT? AND AFTER THE CONSENT PROCESS EIGHT OF THEM SAID THEY DID NOT RECALL DISCUSSING THE ISSUE EIGHT OF THEM DID SAY THEY RECALL DISCUSSING THE ISSUE AND FIVE OF THEM WERE NOT VERY CLEAR SO ONE EXAMPLE OF NO RECOLLECTION I DON'T REMEMBER OR HAVING THAT DISCUSSION. SO NOW SIX MONTHS AFTER THE SURGERY, POST SURGERY WE ASKED AGAIN DO YOU REMEMBER HAVING DISCUSSED THIS WITH THE TEAM? SEVEN OF THEM SAID THEY STILL DID NOT REMEMBER DISCUSSING. 'S YOU HAVE AN ISSUE HERE THE UNETHICAL ISSUE OF CONSENT WHERE MANY OF THE PARTICIPANTS MAY BE UNDERGOING THE SURGERY AND NOT NECESSARILY KNOW OR AT LEAST IT WAS DISCUSSED IN THE CONSENT PROCESS BUT THERE IS A LOT GOING ON BUT THEY DON'T RECALL HAVING DISCUSSED THE ISSUES SO ONE EXAMPLE IS THAT I CANNOT AFFORD THE NEW DEVICE OR THE BATTERY OR WHAT IS RECHARGEABLE ONE PARTICIPANT IN THE SIX-MONTH POST SURGERY INTERVIEWS SAID IT WAS FUNNY BECAUSE AND THEN TO SAY THIS QUESTION CAME UP ABOUT BIOETHICS AND END OF TRIAL. HOW DO YOU FEEL ABOUT ME IT'S ON —- ASKING THAT QUESTION SO THE PATIENT IS THEY ARE ABOUT TO HAVE THE SURGERY AND THEN REMEMBERS HE HAD THIS DISCUSSION AND ONE OF THOSE RESEARCH ASSISTANTS AND THEN TO FEEL SOMEWHAT UNCOMFORTABLE AT THAT MOMENT. SO DO YOU THINK THEY SHOULD WHAT SHOULD HAPPEN TO THE DEVICE? AND THEN 76 PERCENT SAID THEY SHOULD KEEP THE DEVICE AND HOPING IT WOULD PROVIDE AND KEEPING IT. AND THEY WERE NOT PROVIDE THOSE ANSWERS AND WITH THAT RESPONSE WAS 76 PERCENT FOR MOST OF THEM AND THEY SAID WE SHOULD BE ABOUT TO KEEP IT SO 81 PERCENT SAID THEY SHOULD BE ABLE TO KEEP IT TOGETHER SAID IT WAS UNCLEAR IF IT IS STILL WORKING AND THEY HAVE TO FIGHT ME FOR IT. AND SO THEN THEY FEEL VERY STRONGLY THEY WANT TO KEEP USING THESE DEVICES AS IT WAS BROUGHT UP THEY TRIED MANY DIFFERENT TREATMENTS THAT ARE FDA APPROVED BUT NOTHING HAS WORKED WELL FOR THEM SO WHEN THEY DO FIND SOMETHING THAT IS WORKING THEY FEEL VERY STRONGLY. SO HOW DO YOU KEEPING THE DEVICE FUNCTIONING AT THE END OF THE STUDY SHOULD BE PAID FOR? AND INTERESTINGLY DURING THE PRESURGERY INTERVIEW MOST MENTIONED INSURANCE WHICH IS REASONABLE. FROM THEIR PERSPECTIVE ALSO FOR RESEARCHERS IF IT IS WORKING FOR THEM FOR A PERSON THAT DOES NOT HAVE OTHER MID- ON —- MEDICATIONS IF IT IS WORKING FOR THEM THEN IT BECOMES MEDICALLY NECESSARY FOR THE INDIVIDUAL AND THEN SHOULD ALLOW THIS FOR INSURANCE PROVIDERS AND WITH THE COST ASSOCIATED WITH THIS. BECAUSE THIS COULD STILL BE VERY EXPENSIVE FOR PARTICIPANTS TO MANAGE THE OTHER CALLS THAT ARE NOT COVERED BY INSURANCE BUT SIX MONTHS INTO THE SURGERY AND THE DEVICE THAT MENTIONS BASICALLY WHAT WE ARE PRESENTING HERE AND THEN THEY COULD MENTION MORE THAN ONE TO HAVE SOME RESPONSIBILITY FOR COVERING THE COST SO WE SEE A DECREASE IN THE NUMBER OF MENTIONS OF INSURANCE PROVIDERS AND WHAT WE SEE IS THERE IS AN INCREASE OF THE NUMBER OF PEOPLE WITH DEVICE MANUFACTURERS. SO DURING THE PROCESS THEY UNDERSTAND THE TRIAL PROCESS AND THE DATA COLLECTED AND I WILL MENTION SOME OF THE ISSUES. AND THEY WOULD SAY THEY HAVE RESPONSIBILITY. THEY MENTIONED THE RESEARCH TEAM WHERE IT IS TAKING PLACE AND SO FOR EXAMPLE THIS IS AN EXAMPLE OF THE RATIONALE FOR DEVICE MANUFACTURERS. SINCE THE COMPANY OR THE TEAM OR WHATEVER THEY DO HAVE A RESPONSIBILITY TO CARE FOR THEIR PEOPLE THAT HAVE THESE DEVICES I WOULD NOT WANT TO BE CUT LOOSE THERE ARE THINGS HERE ABOUT RECIPROCITY AND GETTING INFORMATION FROM THIS RESEARCH AND THEN THE OTHER PERSON THAT IS IMPORTANT TO KEEP IN MIND SO ONE EXAMPLE IS INSURANCE SHOULD PAY IS SOMETHING THEY SHOULD HAVE TO PAY FOR THE STUDY I THINK THEY SHOULD TAKE SOME RESPONSIBILITY AND IF THEY JUST PAT WHAT THEY ARE SUPPOSED TO DO THEN THEY SEE THIS HAVING A LOT OF EXPERIENCE TO GET INSURANCE TO COVER THE DIFFERENT TREATMENTS THAT THEY HAVE TRIED THAT HAVE NOT WORKED FOR THEM BUT THIS IS THE OBLIGATION WITH THE INSURANCE PROVIDER SO THE DEVICE HAS TO BECOME MEDICALLY NECESSARY FOR THE PATIENT EVEN THOUGH IT IS EXPERIMENTAL. IF YOU CAN AFFORD IT THEN YOU SHOULD PAY THE MAINTENANCE BUT IF YOU CAN'T THE SAME WAY I GOT INTO THE STUDY IS THE WAY IT SHOULD BE. BUT IT'S MORE THAN A FEW PENNIES. SO IT IS A FEAR THAT THE COMPASSION THERE IS A MEDICAL NEED THAT CANNOT BE MET OTHERWISE SO EVEN IF THERE IS A COST ASSOCIATED WITH THIS TO FIGURE OUT A WAY TO MAKE IT AVAILABLE IN CASE THEY CANNOT AFFORD IT BUT ONE EXAMPLE AS WELL THE STUDY SHOULD PAY FOR IT THE PARTICIPANTS TOOK THE RISK AND WHATEVER WAS NEEDED TO BE PAID FOR BY THE INDIVIDUAL PERSON IF THEY CANNOT PAY THAN IT SHOULD BE TAKEN CARE OF BY THE STUDY EVEN WHEN THE STUDY ENDS ONE EXAMPLE IS THERE IS A LIE THE TIME AND EFFORT HAD TO GO THROUGH BRAIN SURGERY I HAVE TO COME IN EVERY TWO WEEKS AND THAT TAKES UP THE WHOLE DAY EVERY TWO WEEKS AND THEN EVERY MONTH AND IT IS VERY TIME CONSUMING SO WE SEE THAT RECIPROCITY AND THEN COMPASSION TO TAKE REASONABLE STEPS TO MANAGE A NEED THAT CANNOT BE MET OTHERWISE. >> THANK YOU TO OUR COLLABORATORS FROM THE BRAIN RESEARCH. >> WE HAVE TIME AGAIN FOR ONE QUESTION. >> THERE IS THE QUESTION IN THE CHAT IF THE SUBJECTS IN YOUR RESEARCH OR THE INDUSTRY OR GOVERNMENT SPONSORED STUDIES ARE BOTH? >> MOSTLY GOVERNMENT-SPONSORED BS MOSTLY GOVERNMENT. >> NOW MOVING ON TO THE LAST SPEAKER FOR THIS PANEL YOU CAN CONTINUE TO ASK QUESTIONS FOR THE PANEL DISCUSSION SO THE LAST SPEAKER IS DOCTOR JAMES MAHONEY AN ASSISTANT PROFESSOR AND CLINICAL NEUROPSYCHOLOGIST DEPARTMENT BEHAVIORAL MEDICINE AND PSYCHIATRY AT WEST VIRGINIA UNIVERSITY SCHOOL OF MEDICINE. HE ALSO SERVES AS DIRECTOR OF INFECTIONS RESEARCH. IS INTERESTING TO THE INVESTIGATION OF NARROW PSYCHOLOGICAL ISSUES WITH SUBSTANCE USE DISORDER AS WELL AS INVESTIGATIONS OF NOVEL TREATMENTS INVOLVING NEUROMODULATION WITH SUBSTANCE DISORDER SUCH AS DEEP BRAIN STIMULATION AND FOCUSED ULTRASOUND AND MAGNETIC STIMULATION. >> THANK YOU FOR THAT INTRODUCTION. SO THANK YOU FOR THE INVITATION TO SPEAK AND IT'S GOOD TO SEE THERE IS A LOT OF OVERLAP AND WHEN IT COMES TO ENSURING THOSE NEEDS ARE MET LOOKING IN THE DEEP BRAIN STIMULATION FOR OPIOID USE DISORDER SOMEONE WITH ADDICTION AND SUBSTANCE ABUSE DISORDER THE FIRST INVASIVE TRIAL I WAS INVOLVED IN WE HAD THIS PROPOSAL SO IT WAS VERY WELL THOUGHT OUT. AND WITH THAT MEDICATION DEVELOPMENT THERE ISN'T AS MUCH POSTTRIAL THEY ARE NOT AS EXTENSIVE AS THE STUDY IT IS A GOOD OPPORTUNITY WITH THE SURGICAL TEAM ESPECIALLY. AND THOSE WHO JOINED US HERE IN WEST VIRGINIA UNIVERSITY AND THOSE WHO HAVE BEEN DOING THE DBS TRIALS. BECAUSE THAT IS SOMETHING FROM THE ONSET FOR WHEN THE STUDIES ARE OVER, THEY ARE NOT OVER AND THEN TO IMPACT DIFFERENT METHODS TO ENSURE THE PARTICIPANTS IN THE PATIENT'S THAT THAT COMES FIRST. SO SOME OF THOSE SPECIFIC ONES REGARDING HARDWARE REPLACEMENT IN THE FALSE GENERATOR REPLACEMENT HAS TO OCCUR. THE CURRENT STUDY I WAS DISCUSSING HAS A 52 WEEK PRIMARY COMPONENT AND THEN WITH AN EXTENDED FOLLOW-UP OVER FIVE YEARS. SO THAT GIVES US THE ABILITY BUT CLINICALLY BUT JUST RESEARCH PURPOSES AS WELL IN MY THAT'S IMPORTANT. AND DEVICE MAINTENANCE TO FOLLOW THE'S INDIVIDUALS FROM WHEN THE PROTOCOL AND JUST MAKE SURE THE DEVICE IS WORKING PROPERLY AND THEN ALSO SIDE EFFECT MANAGEMENT THAT DOESN'T AND WHEN THE STUDY ENDS. C HAVE TO CONTINUE TO KNOW THE SAFETY IS AT THE FOREFRONT. LOOKING AT THE RESPONSIBILITIES ASSUMED BY THE INVESTIGATIVE TEAM THEY NEED TO BE CONSIDERED VERY EARLY ON FROM THAT PROPOSAL IN THE PROTOCOLS DEVELOPED HOW DO YOU SET FUNDING SOURCES THESE ARE DISCUSSED IN THE APPLICATION PROCESS AND HOW WILL THE POST CARE TRIAL COMPLETION AND THEN THE PARTICIPANT WITH THE CONSENT PROCESS TO MAKE SURE IT IS AS INFORMED AS POSSIBLE WORKING WITH INDIVIDUALS WITH ADDICTION BECAUSE THERE IS ANXIETY AROUND DAY TODAY AND THE CLINIC LET ALONE THE UNCERTAINTY FOR WHEN THE TRIAL IS OVER HOW DO I MAKE SURE I AM TAKEN CARE OF AND THEN TO DISCUSS WITH THE FOLLOW-UP CARE WILL LOOK LIKE AND GOING FORWARD WITH CONSENTING AND TO BE COMPLETELY TRANSPARENT AND THEN THE INVESTIGATIVE TEAM THAT CAN HELP YOU BRIDGE THE COST AND THEN THE ULTIMATE GOAL MOVES TOWARDS FDA APPROVAL AND THEN HOPEFULLY IT COVERS SOME OF THOSE COSTS BUT WHAT CAN BE DONE IN THE MEANTIME BEFORE THAT HAPPENS? SO IT'S NOT JUST THE INVESTIGATOR IT IS A COLLABORATIVE EFFORT UNIVERSITY OF HEALTHCARE INSTITUTIONS WITH THOSE INSURANCE PROVIDERS AND INDUSTRY PARTNERS AS WELL FUNDING THE AGENCIES THROUGH PRIVATE DONORS WHEN THE INVESTIGATIVE TEAM IS DEVELOPING PLANS OF HOW THEY WILL BE FINANCIALLY SUPPORTED YOU ARE LOOKING AT ALL THE OPTIONS. AND THEN TO MAKE SURE WITH THE FINANCIAL BURDEN WHETHER ADDITIONAL STAFFING NEEDS AND TO MAKE SURE THOSE NEEDS ARE MET. ALSO SEPARATING OUT CLINICAL NEED AND FOR THOSE DEVICE TRIALS WITH THAT DEEP BRAIN STIMULATION THAT DBS WILL REPLACE ALL OF THEIR OTHER CLINICAL TREATMENT. WE DON'T THINK THAT THAT IT WILL JUST FLIP THE ADDICTION SWITCH AND NOW THEY NO LONGER NEED THERE BE. LOOKING AT IT AS A CONJUNCTIVE TREATMENT THIS IS JUST ANOTHER TOOL IN THE TOOLBOX WITH THE STANDARD LEVEL OF CARE. BUT IS JUST MEANT TO AUGMENT THE TREATMENT THEY ARE ALREADY GETTING AND THEN ALSO AND THEN THOSE INVESTIGATORS AND THEN TO RELOCATE AND RETIRE. AND THEN TO ENSURE THAT INDIVIDUAL CAN CONTINUE. TALKING SPECIFICALLY WITH THAT DEEP BRAIN STIMULATION PROTOCOL WE SAT DOWN AND ARE WRITING UP THE INITIAL PROPOSAL AND WE ARE DEFINITELY CONSIDERING WHAT WILL BE DONE WITH THAT ONE YEAR FOLLOW-UP PHASE AND LOOKING AT THE LONG-TERM FOLLOW-UP WE HAVE EXTENDED THE FOLLOW-UP TO FIVE YEARS AND ONCE WE GET TO THAT POINT HOPEFULLY EVEN LONGER AND THEN WITH DBS THEY PARTNER WITH THEM AND ALSO INSTITUTIONAL SUPPORT WITH THE ADMINISTRATION FOR THE COVERAGE AFTER THE TRIAL IS COMPLETED AND THEN ALWAYS HAVING INCLUSION OF OTHER INVESTIGATORS WHO HAVE TRADING AND EXPERTISE AND THAT IF IT IS NO LONGER AVAILABLE WE HAVE CONSIDER THESE FACTORS WITH THAT PROTOCOL THAT WE HAD OF OUTPATIENT MONITORING THAT WE EXTEND THAT AND THEN TO LOOK INTO OTHER SUPPLEMENTARY SUPPORT TO COVER THOSE COSTS AND OTHER FINANCIAL CONSIDERATIONS AND THEN LOOKING INTO SECONDARY AND EXPLORATORY AND FROM THE ONSET AND AS A TRIAL PROGRESSES BASED OFF ON THE PATIENTS RESPONSES THAT IS A PLANET - - PRELIMINARY ANALYSIS TO SEE IF THERE WAS SUPPLEMENTARY FUNDING AND TO COVER THOSE HARDWARE COST WITH THE GOAL OF MOVING TOWARDS FDA APPROVAL IN THE MEANTIME. SO SPECIFIC TO US WE HAVE A PROPOSAL FROM 2018 THE NEUROSTIMULATOR FROM THE ACTIVA PC THERE WAS A NEW DEVICE AND THAT CAPABILITY OF THOSE POTENTIALS THAT GAVE US ANOTHER DATA POINT THAT DIDN'T INCLUDE THE ORIGINAL PROPOSAL TO GIVE US THE OPPORTUNITY AFTER HE SUBMITTED THE AMENDMENT WITH THE FDA REQUESTING THAT DEVICE AND NOW WE COULD GET PRELIMINARY DATA TO POTENTIALLY WRITE SUPPLEMENTARY GRANTS AND PROPOSALS TO USE THE SAID ADDITIONAL DATA CAPTURING MECHANISM AND CONTINUOUS LONGER-TERM CARE PAST THE FIVE YEARS. SO DEFINITELY IT'S ONE WAY TO LOOK AT SUPPLEMENTARY FUNDING TO CARRY OVER FOR FDA APPROVAL AND UNTIL THAT IS SECURED. SO IN SUMMARY THE INVESTIGATIVE TEAM THAT ALSO IN COLLABORATION WITH OTHERS THAT SHOULD BE CONSIDERED VERY EARLY ON YOU DON'T WANT TO WAIT UNTIL THE END OF THE STUDY WHAT WE DO WITH POSTTRIAL CARE AND BEFORE THAT IS SUBMITTED VERY EARLY ON ALWAYS HAVE TO KEEP THE PARTICIPANTS AT THE FOREFRONT. THAT TRANSPARENCY WITH THE PARTICIPANTS WHEN DISCUSSING POST TRIAL CARE WHAT IS EXPECTED OF THEM AND OF THE TEAM AND WHAT METHODS ARE PUT INTO PLACE TO MAKE SURE THEIR CARE WILL BE MET WITH THE POST STUDY COMPLETION AND THEN ALSO LOOKING INTO THOSE OTHER FUNDING MECHANISMS TO MAKE SURE THOSE POSTTRIAL NEEDS ARE MET AND CONTINUOUSLY REVISITING THAT AND THEN ALSO LOOKING AT THE OTHER OPTIONS AND THEN I'LL ANSWER ANY QUESTIONS. >> WITH THE QUESTION SPECIFICALLY FOR THIS PRESENTATION ANY QUESTION SPECIFICALLY FOR DOCTOR MAHONEY? >> THIS IS A FASCINATING STUDY. I SEE SUCH SIMILARITIES WITH HER TALK AND THINKING ABOUT THE AGE OF WHAT IS LIKELY IN THE PREDICTION STUDY AND I AM JUST WONDERING IT SEEMS FANTASTIC IN SOME WAYS HE WILL BE THAT I JUST WONDER THOSE PEOPLE THAT WILL HAVE 30 PLUS YEARS WITH A DEVICE IF IT IS WORKING FOR THEM. IS THE UNIVERSITY OFFERING HAVE THEY TALKED ABOUT A TIME LIMIT? HOW HAS THAT BEEN HANDLED QUICK. >> ABSOLUTELY NOT AND FROM THE BEGINNING THIS IS THE ANALYSIS WITH A VERY HIGH RISK OF DEAF AND THEY HAVE TO HAVE MULTIPLE OVERDOSES SO THAT THE HIGH RISK OF DEAF BUT I BROUGHT THAT UP IN THE BEGINNING SO WITH 30 YEARS OF AGE THERE IS NO REASON BUT THEN EVERY COUPLE OF YEARS WITH THOSE BATTERY REPLACEMENTS AND IN THE ONGOING SUPPORT SO THAT FIVE YEARS AND THAT ATTENTION IS FURTHER ON FOR THE FIRST TEN OR 15 YEARS SO WE ARE VERY FORTUNATE TO HAVE THEIR SUPPORT AND WHAT'S GOING ON RIGHT NOW ESPECIALLY IN WEST VIRGINIA IN TERMS OF THE ADDICTION CRISIS WE DO HAVE THAT SUPPORT HERE BUT IT IS A GREAT POINT WITH THE RECHARGEABLE ONES BUT WITH THIS INITIAL STUDY GIVEN ALL THE CHAOS FROM THE SUBSTANCE USE DISORDER RELYING ON HOW TO RECHARGE IT AND ALL OF THAT BUT THEN SOMETHING ME WILL EXPLORE IN THE FUTURE DEFINITELY BUT YOU ARE RIGHT THAT'S WHY IT'S GREAT TO HAVE WORKSHOPS LIKE THIS BECAUSE THIS NEEDS TO BE DISCUSSED AND CONSIDERED EARLY ON IN THE PROCESS BECAUSE WE ARE RECRUITING INDIVIDUALS WITH A HIGH RISK OF DEAF BUT POTENTIALLY WE ARE GIVING THEM THEIR LIVES BACK. THAT'S THE CASE WE NEED TO ENSURE WE TAKE CARE OF THEM CONTINUOUSLY. >> SO WHAT MISS ALICE OR MS. FRENCH HAD AND THEN WE HAD SOME EXPERIENCE WITH PEOPLE WHO HAD DEVICES OVER DECADES SO WE ARE CURIOUS TO HEAR ABOUT THAT EXPERIENCE AND THEN TO INVITE THE OTHER PANELIST TO TURN ON THEIR CAMERAS I AM A NEUROLOGIST AND THE DIRECTOR OF BIOETHICS. >> I AM A SPECIALIST WORKING WITH THE BRAIN NEWG. >> SAID TO ANSWER THE QUESTION WE WOULD LIKE TO HEAR A LITTLE MORE ABOUT HOW FAR INTO THE FUTURE THEWERE THINKING ATTHE TD WAS 18 MONTHS ANOTHER MAY HAVE BEEN LESS CLEAR BUT WHAT KIND OF CONVERSATIONS DID WE HAVE WHAT CONVERSATIONS SHOULD WE BE HAVING WHERE THE HORIZON IS VERY MURKY? >> BEFORE WE BEGIN TO ANSWER THE QUESTION I WANT TO WELCOME TYLER WHO IS A PATIENT PARTICIPANT HE CAN JOIN TODAY'S WE WELCOME YOUR INPUT AS WELL AS PERSPECTIVES AS PART OF THE PANEL. >> WITH MY ORIGINAL TRIAL I WENT TO THE ATLANTA AREA I HAD TO AGREE TO BE FOLLOWED UP FOR AT LEAST ONE YEAR AND AFTER THAT IT NATIONALLY TRANSITIONED AND THE DISCUSSIONS ORIGINALLY WERE ALONG THE LINES OF TEN YEARS OR FDA APPROVAL WHICHEVER COMES FIRST. THE TEN YEARS CAME FIRST I UNDERSTAND THAT IS A FINITE NUMBER BECAUSE A PARTICIPANT IN THE EXPERIMENTAL TRIAL FOR THE REST OF MY LIFE WITH NO DEFINED TERMS. IT'S MY UNDERSTANDING IS SOMETHING CHANGES I NEED IT REPLACED OR THERE'S SOMETHING WITH THE IMPLANT I NEED TO BE WE CONSENTED. BUT THE TRANSITION FROM YOUR NUMBER ONE THROUGH TWO OR THREE OR FOUR WAS NOT A BIG CHANGE. MY TRIAL TEAM HAS BEEN VERY COMMUNICATIVE FOR AS LONG AS I'M WILLING TO DO FOLLOW-UPS , THEY WOULD LIKE THAT. AND I'M TRYING TO HELP IN ANY WAY THAT I CAN. BUT THERE WERE ALLIED OF QUESTIONS ABOUT WHAT HAPPENS AFTER TEN YEARS? AND IT IS FRUSTRATING THAT NOBODY KNOWS ANYTHING MORE THAN I DO NOBODY KNOWS WERE THIS WILL BE TEN OR 20 OR 30 YEARS DOWN THE ROAD AND WHAT MY OPTIONS WILL BE OR WHERE I MIGHT HAVE SURGERY IF I NEED ANOTHER SURGERY. THOSE ARE KNOWN UNKNOWNS AND THEY DO CAUSE ANXIETY FOR PARTICIPANTS BUT I DON'T KNOW IF IT IS REASONABLE TO EXPECT MY TRIAL TEAM TO KNOW HOW I WILL BE TREATED 20 YEARS FROM NOW. BUT THIS PAST NOVEMBER WAS MADE TEN YEARS I AM NOW GRADUATED. HOW TO PHRASE THAT BUT I AM NOT UNDER CONSENT ANYMORE. >> IT'S INTERESTING BRANDY COME I HAD A SIMILAR EXPERIENCE. MY NOW HUSBAND WE MOVED TO CLEVELAND TO PARTICIPATE SO ONLY THOSE THAT ARE FLUENT IN THE SUPPORT SYSTEM AROUND THEM WE HAVE TO THINK OF THOSE FINANCIAL BURDENS FOR PARTICIPATION BECAUSE IT IS A HUGE PERIOD FOR A LOT OF CAN CLINICAL TRIAL PARTICIPANTS AND FOR ME PERSONALLY I WAS INJURED 24 YEARS AGO AND I HAD NO IDEA I WOULD BE INJURED THIS LONG OR THAT THE DEVICE WOULD CONTINUE TO WORK THIS LONG MANY INVESTIGATORS ARE STILL AMAZED ONE OF MY ORIGINAL IPG IS STILL TAKING KNOCK ON WOOD. BUT THAT ALLOWS FOR FUNCTION AND THEN TO APPLY THE FORESIGHT WITH THE RESEARCH AND DEVELOPMENT PORTFOLIO THEY TOOK A DISTINCT INTEREST TO FOLLOW LONG-TERM TO UNDERSTAND WHAT THEY ARE OF THOSE DEVICES AND WHEN WE THINK ABOUT VERY EXPERIMENTAL DEVICES LONG-TERM STUDIES CAN HELP US FURTHER DEVELOP THAT TECHNOLOGY AS WE GO ALONG SO IT'S IN OUR BEST INTEREST HOW WE PUT THESE DEVICES AT WORK AND ALSO WITH THE CLINICAL TRIAL PARTICIPANTS. >> AND THEN TO SEE IF WE WANT TO WEIGH IN AS WELL? >> I AM IN THE SAME STUDY AS BRANDY. I'M JUST TRYING TO THINK WHEN I FIRST HAD THE SURGERY IF IT WAS THAT BUT THERE WERE NOT MANY OPTIONS. WASN'T THINKING ABOUT THE FUTURE TOO MUCH AND NOW I'M THREE YEARS INTO THIS AND NOW WITH YOUR NUMBER THREE IN MY PART OF THE TRIAL WAS OVER MAYBE ONLY FOR SIX MONTHS THE DOCTOR THAT I COMMUNICATED WITH IT WAS THE ACTUAL NUMBER BUT I WASN'T THINKING ABOUT ANY OF THESE THINGS BUT IN MY BATTERY WAS RECHARGEABLE MUSCLES TO LAST 15 YEARS BUT AGAIN BEFORE BRANDY SHARED AND NEVER CROSSED MY MIND THAT IT COULD MALFUNCTION OR IF IT DID I HAVE TO LIVE DAY BY DAY OR MY EXAM ZAIDI WILL GET OUT OF CONTROL SO I CROSS THOSE BRIDGES WHEN I COME TO IT AND IT WOULD BE GREAT TO HAVE THOSE THINGS THAT RANDY MENTIONED AND THAT WOULD BE INCREDIBLE BECAUSE THE PAST YEAR AND THEN I DO HAVE INSURANCE AT THIS POINT AND IT DOES CARE FOR THOSE MAINTENANCE PROCEDURES BUT WHO KNOWS WHAT THE FUTURE WILL HOLD THAT NOBODY KNOWS WHAT WILL HAPPEN TOMORROW WITH B OR C OR D BECAUSE OF THIS DOESN'T WORK I DON'T HAVE A LIFE. I'M 31 YEARS OLD AND I HAVE ALREADY LAST TEN YEARS TO A TREATMENT RESISTANT DEPRESSION AND I WOULD LIKE TO START PICKING UP THE PACE A LITTLE BIT AND AGAIN HAVING JENNIFER HERE AS WELL 24 YEARS OF THIS EXPERIENCES EYE-OPENING AS WELL SO I AGREE WITH ALL THE POINTS THAT THEY MADE AS FAR AS PLAN OF ATTACK AND THE GUARANTEED COVERAGE IS HELPFUL AND WE ARE NOT MADE OF MONEY PER SE BUT WE HAVE BEEN ABLE TO FIND WAYS TO PURSUE THIS EDGES LIFE OR DEAF OF FIVE TO ACCUMULATE DEBT TO STAY ALIVE THAN IT'S WORTH IT FOR ME BECAUSE THEN I HAVE THE OPPORTUNITY TO PAY OFF THE DEBT. BUT IT WOULD BE GREAT TO GET HELP WITH AS WE HAVE TO KEEP BUILDING THAT UP. THANK YOU. >> SO FURTHER ALONG IN THE COMMERCIALIZATION OF THE DEVICE SOME OF THOSE MAY REMEMBER MORE RECENTLY THE SECOND SITE AND WITH THAT DEVELOPMENT OF THOSE DEVICES VERY EARLY ON TO BRING PROFOUND IMPACT AND TO THINK WHAT HAPPENS WHEN A COMPANY GOES OUT OF BUSINESS ARE NO LONGER AVAILABLE AND HOW SOMEONE TRANSITIONS AWAY FROM THAT AND WHAT THAT MIGHT LOOK LIKE THERE WAS A REALLY GOOD COMMENTS IN THE CHAT IF SOMEONE IS GOING TO RECEIVE COVERAGE THEY WOULD BE A LONG-TERM TRIAL PARTICIPANTS SO IT IS A TWO WAY STREET THOSE WHO ARE A PARTNERSHIP OR A COLLABORATION WE ARE TRY TO GET TO THE POINT AND TO ENCOUNTER HEALTHWISE. >> THESE VOICES ARE REALLY POWERFUL AND HEARING YOU ALL ARE ALL VERY GRATEFUL AND WITH THE TOPICS WITH A Q&A WITH THE PANEL DISCUSSION AS WELL SO TO HAVE THE OPPORTUNITY TO INJECT SOME THOUGHTS INTO THE DISCUSSION. >> FIRST OF ALL THANK YOU THE PANEL WAS WONDERFUL AND FOOD FOR THOUGHT. WITH THE REAFFIRMED TO THE NEEDS AND THAT'S WHAT I UNDERSTAND ARE INCREDIBLY IMPORTANT BUT I HAVE HEARD TO THE HAVE NOT HEARD BEFORE SO ONE WAS THAT JENNIFER MENTIONED REGISTRY OR PUBLIC DATA AND I WANT TO UNDERSTAND HOW THAT IS MEETING ONE OF YOUR NEEDS? ONE OF THE REASONS THAT IS HELPFUL AND SIMILARLY I THINK IT IS BRANDY THAT MENTIONED INCENTIVES TO MAINTAIN COMPATIBILITY. HOW DOES THAT HELP IN TERMS OF LONG-TERM NEEDS? THANK YOU. >> YES. I'M HAPPY TO SPEAK TO MY POINT FOR ME THE REASON I MENTIONED REGISTRY IS THAT I AM CONTEMPLATING IF I DECIDE TO RETIRE TO PANAMA AND MY TRIAL TEAM IS ALSO RETIRED IS HAVING A CENTRAL DATABASE THAT SAYS THIS PERSON WAS LEGITIMATELY INVOLV INVOLVED. HERE IS THERE SETTINGS AND HERE IS WHERE THEY CAN GET A DEVICE. AND THAT SORT OF INFORMATION THAT CAN BE, LIKE MY MEDICAL RECORD DOESN'T ACTUALLY CONTAIN THE TRIAL. IT CONTAINS MY SURGERIES BUT IT DOESN'T HAVE MY TRIAL INFORMATION. SO I WORRY ABOUT BEING SOMEWHERE ELSE AND BEING ABLE TO PROVIDE DOCUMENTATION WHAT THE SETTINGS ARE SUPPOSED TO BE WITH THAT INFORMATION BECAUSE I CANNOT CHANGE MY SETTINGS. TO HAVE ANY IMPACT SO IN THE ABSENCE IF ATLANTA IS NOT ACCESSIBLE FOR THERE TO BE A WAY TO GET THAT INFORMATION AND WITH BUT I CONSENTED TO I KNOW I CAN ASK FOR THEM BUT AT THE SAME TIME IT'S BEEN TEN YEARS BUT FOR INCENTIVES, IT IS TWOFOLD FOR THOSE THAT ARE UNDERREPRESENTED TO GET THE OPPORTUNITY TO PARTICIPATE IN THESE TRIALS. BECAUSE WE NEED THAT. BUT WHEN RATINGS TAKE ALL DAY, IF YOU ARE CAPABLE OF WORKING THEN YOU NEED MORE THAN JUST YOUR PARKING VALIDATED IT IS SIMILAR TO JURY DUTY IF NOBODY DOES IT FOR THE MONEY AND THERE NEEDS TO BE A WAY TO MAKE IT POSSIBLE FOR PEOPLE WITH DIFFERENT MEANS AND UNDERREPRESENTED TO HAVE ASSISTANCE WITH RELOCATION WERE TAKING TIME OFF OF WORK AND SEPARATE FROM THAT I WOULD LOVE FOR MY DEVICE MANUFACTURER TO CREATE AND HARNESS THAT WHICH ALLOWS MY ELECTRODES TO BE SWAPPED OUT WITH ANY BATTERY ON THE MARKET BUT WHY WOULD THEY DO THAT IF THEY DON'T HAVE AN INCENTIVE TO STANDARDIZE THE THINGS THEY ARE IMPLANTING? AND TO MAKE THEM CROSS COMPATIBLE. I WANT THEM TO HAVE A REASON WHY MY DEVICE CAN BE SWAPPED OUT BECAUSE I MOVE SOMEWHERE ELSE AND DON'T HAVE ACCESS TO THIS PARTICULAR DEVICE MANUFACTURER ANYMORE. SO WITH WANTING INSURANCE COVERAGE AND COMPATIBILITY AND I UNDERSTAND THAT BUSINESSES THAT ARE INVOLVED IN THIS ARE NOT NECESSARILY DOING THIS OUT OF THE KINDNESS OF THEIR HEART THAT TO HAVE A REASON TO MAKE THESE TRIALS SUCCESSFUL LONG-TERM AND TO HAVE THEM BE ABLE TO COUNT ON IF THEY CREATE A DEVICE THAT THEY WILL NOT LOSE OUT ON WHATEVER BUSINESS. SO THAT WAS THAT YOU NEED THE DEVICE PEOPLE TO STICK AROUND YOU NEED PARTICIPANTS TO BE REPRESENTED AND YOU NEED OUTSIDE SOURCES TO GET ALL OF THE DATA THAT THEY NEED AND INCENTIVES ARE REALLY THE ONLY LANGUAGE THAT I KNOW OF HOW TO GET THAT COMMUNICATED. I THAT HELPS TO CLARIFY. >> I WOULD LIKE TO TAKE A FEW SECONDS TO ADD ON. WHEN YOU LOOK AT INCENTIVES WHEN WE ARE DESIGNING CLINICAL TRIALS IS MAPPING OUT THE PATIENT JOURNEY INTO HAVE AN IDEA WHERE THE PAIN POINTS ARE AND WHAT ARE THEIR MOTIVATIONS FOR JOINING THE TRIALS THAT IS THE INCENTIVE NOT NECESSARILY THE FINE LINE OF PAYMENT BUT A LOT OF INCENTIVES AND DIFFERENT FORMATS AND THEN GOING INTO PUBLICATIONS IT'S IMPORTANT NOT TO PUBLISH ONLY NOT WHAT WENT WRONG BUT WHAT WENT RIGHT SO WHAT YOU ARE DEVELOPING IS ALIGNING TO BE ADDRESSED AMONG THE POPULATION SO PUBLISHING THAT DATA IS INCREDIBLY IMPORTANT NOT JUST FOR THE SCIENTIFIC COMMUNITY BUT THE LAY COMMUNITY AS WELL BECAUSE TO TAKE US TO THE PRIMARY CARE NOT ALWAYS UP ON THE RESEARCH OF CONDITIONS IS SOMETHING WE CAN BRING FORWARD TO IT SCIENCE IS DOING TO HAVE AN INFORMED CONVERSATION WITH YOUR CLINICIAN AND THEN FINALLY AN INCREDIBLY IMPORTANT POINT TO EVEN WITH THE PROSTHETIC STUDIES AND YEARS AGO TO GET THEIR PERSPECTIVE THAT THEY WERE JOINING THE REGISTRY VOLUNTARILY THEY COULD DO SO WITH BACKGROUND INFORMATION TO REALLY UNDERSTAND WHAT WENT WRONG AND WHAT WENT WELL SO WE CAN LEARN FROM PREVIOUS TRIALS. >> WE ARE AT TIME THAT I WAS HOPING WE COULD EXTEND DISCUSSION FOR ANOTHER TEN MINUTES BECAUSE THE PRESENTATIONS RAN LONG. WE STILL HAVE A 35 MINUTES OF BREAK I AM HOPING WE CAN CONTINUE THIS DISCUSSION A LITTLE LONGER. >> SO ONE QUESTION I WANTED TO POST TO THE PANELIST IS THAT INFORMATION GATHERING DIALOGUE ONE OF THE NEEDS THAT WAS RAISED WAS RELATED TO DEVICE EXPECTATION OR TO THE MEDICAL INDICATIONS SO WE WANTED TO GET THE PANELIST THOUGHTS IF THAT RESONATES AND THE THOUGHTS AROUND THAT PARTICULAR MISTRIAL NEED. >> SO WERE HAPPY TO JUMP IN TO THE PARTICIPANTS OF THE STUDIES SO ONE ISSUE IS WHEN THEY ARE GOING IN I'M HOPEFUL THAT THIS WILL WORK FIRST ON WILL SAY I DON'T KNOW IF IT'S GOING TO WORK BUT THEY'RE NOT THINKING OF HAVING THE DEVICE REMOVED AND I HAVE SEEN SOME DISCUSSIONS SO THIS CREATES AN INTERESTING RELATIONSHIP AND THAT YOU WILL BE IN THIS PATIENT'S BRAIN FOR THE DURATION OF THEIR LIFETIME SO TO CREATE A LINK PLUS WITH THE DEVICE TO CREATE A CONNECTION THAT WILL LAST A LIFETIME AND THE LIFETIME OF THE PATIENT. SO I HAVE SEEN SOME PEOPLE SAY THEN WE SHOULD REMOVE THE DEVICE OR OFFER TO REMOVE THE DEVICE WHICH OBVIOUSLY THEY HAVE TO PROVIDE CONSENT BUT THERE ARE CONCERNS ABOUT THE SURGERY AND WHEN PATIENTS DO WANT THE DEVICE REMOVED AND IF IT IS SAFE TO REMOVE THE DEVICE THERE IS A NUMBER OF CONSIDERATIONS. BUT WE ONLY HEARD OF ONE GROUP THAT IS ACTUALLY REQUESTING FUNDS TO NIH TO HAVE ONE OR TWO DEVICE REMOVALS. PEOPLE ARE THINKING ABOUT IT AND IT IS POSSIBLE TO REQUEST THOSE FUNDS AS I UNDERSTAND , BUT IT'S NOT SOMETHING THAT PEOPLE ARE OFTEN DOING BECAUSE THAT THEN IN THAT SENSE THAT THEY MAY NEED THOSE FUNDS. >> THAT IS A GREAT POINT. IT CAME UP DURING THE PRE- INTERVIEWS IN PREPARATION FOR THIS MEETING WITH THE BRAIN COMPUTER INTERFACE PARTICIPANTS BUT MAYBE THEY WERE NOT READY AT THAT TIME. AND THEN THE FUNDS RUN OUT. AND THEN PUTTING ASIDE FUNDS FOR THE INDIVIDUAL. AND THEN CONCERNS TO HAVE A VERY QUICK DECISION EVEN THOUGH IT MAY HAVE BEEN BROUGHT FORWARD HOW DOES SOMEBODY PREPARE FOR THAT AND BE EMPATHETIC AND WHAT IS THE DECISION TREE OR THE CONTINGENCY FOR A TRIAL PARTICIPANT? >> AND WITH THOSE SOLUTIONS THAT ARE OFFERED NOW AND TO MAKE THE POINT THAT ONLY THE LATER PANELS AND MAKING USE OF THOSE DEVICE USERS AND SOMETHING WE ALL WANT TO DISCUSS. SARAH AND ON —- SARAH? >> THIS IS FANTASTIC. IT SEEMS THAT THE THREE PEOPLE WHO ARE HERE TALKING ABOUT THE TRIALS IT HAS BEEN WONDERFUL TO HEAR YOUR PERSPECTIVE. ALL PEOPLE WHO ARE WITH YOU DAY BY DAY BENEFIT YOU DAY BY DAY? NEURAL DEVICE STUDIES ARE DIFFERENT WINSTON'S GROUP SO IS THERE ANYTHING DIFFERENT ABOUT WHAT IS OWED TO A PARTICIPANT IN TERMS OF MAINTENANCE OR UPKEEP TO CONTINUE BENEFITS IF THEY MAINLY USE THE DEVICE IN WAYS THAT ARE VERY BENEFICIAL IN A LAB SETTING? THE DEVICE IS STILL IN SOMEBODY SAID THAT MAYBE THE ONLY MAKE USE OF IT IN THE LAB SETTING BUT A LOT OF THIS STUDIES THEY ARE THERE IT IS A LONG-TERM INVESTMENT PEOPLE ARE MAKING AND THEY GAIN ABILITIES IN THAT CONTEXT IS IT DIFFERENT ARE NOT DIFFERENT YOUR CASES ARE SO COMPELLING BRANDY AND TYLER SAY IT IS LIFE-SAVING. I DON'T SEE HOW ANYBODY CAN NOT RESPOND TO THAT CLAIM. BUT FOR OTHER PEOPLE THAT MAY NOT BE SO LIFE-SAVING AS LIFE ALTERING SO DO WE THINK THAT TRIAL MATTERS ARE THE KIND OF BENEFIT THEY ARE GETTING? >> AND I YIELD BACK TO LOSS OF FUNCTION AND THEN TO COMMUNICATE WITH THEIR CAREGIVER AND THEN TO APPLAUD ONE OF THE STUDIES BECAUSE THEY GAVE HER ANOTHER COMMUNICATION TOOL SO THAT WAS THINKING OF THE CONTINGENCY PLANS SO WHAT IS THE NEXT STEP AND THEN SUDDENLY THEY LOSE THE ABILITY TO COMMUNICATE SO THAT WILL BE DIFFERENT PER TRIAL BUT LOOKING AT THOSE TREATMENT OPTIONS ARE AND WORKING WITH THE PARTICIPANTS BUT THERE ARE GUIDELINES WE CAN DO IN THE DEVELOPMENT IT IS LIFE-THREATENING FOR THOSE WITHOUT TREATMENT RESISTANT DEPRESSION BUT THEN THE ABILITY TO FEED YOURSELF IF YOU ARE A QUADRIPLEGIC SO ALL OF THOSE DIFFERENT FUNCTIONS APPROACH PEOPLE IN DIFFERENT WAYS. >> SO WHAT IS REEMERGING IS THE IMPORTANCE OF MAPPING AND TO PARTICIPATE IN THIS TRIAL AND WHAT MY LIFE AS A PATIENT OF THIS DEVICE LOOKS LIKE THAT SOMETHING WE HEAR CAREGIVERS SPRING UP OR PARTNERS. BUT THEY ALSO BRING THAT UP THAT WOULD BE HELPFUL OF HOW THINGS WILL LOOK LIKE BECAUSE THEY ARE INVOLVED IN THE CARE AND I CAN BE IN A SITUATION AT THE MOMENT WHERE THEY WILL PROVIDE CONSENT THINKING OF MANY THINGS AND WITH TREATMENT SEARCH FATIGUE AND A LONG PROCESS THEY HAVE TRIED TO FIND SOMETHING AND FIND SOMETHING AND THEN YOU GET TO THE POINT YOU ARE UNDERGOING 30 PAGE RESEARCH COORDINATOR IT'S A DOCUMENT. I'M ALSO A LAWYER I HAVE LOOKED AT THIS AND I TRY TO FIND AND THEN TO FIND OUT WHAT WILL HAPPEN BUT AT THE END OF THE TRIAL YOU ARE THE INSURANCE PROVIDER BUT IT'S EVENT HARD TO IDENTIFY AND THAT THEY DON'T COVER IT THEN I HAVE TO PAY FOR THAT IS A PARTICIPANT THEN MANY TIMES THAT IS WHAT THE DOCUMENT IS SAYING. THERE IS SO MUCH INFORMATION THEY HAVE TO PROCESS AND THEN TO ILLUSTRATE WHAT THIS WOULD LOOK LIKE WITH A TRAJECTORY BUT ALSO WITH CARE PARTNERS IN THAT CONSENT PROCESS AND I KNOW THAT THE RESEARCHERS TRY TO DO THIS BUT MAYBE MORE STRUCTURED WAYS TO INVOLVED IN THE PROCESS. >> THIS HAS BEEN A GREAT PANEL AND A GREAT WAY TO END. JUST A REMINDER THAT TREMENDOUS DIVERSITY OF DIFFERENT STUDIES THAT ARE BEING DONE. AND THOSE OF PATIENT PARTICIPANTS AND TRIALS AND A DIFFERENT SITUATIONS OF RESEARCH TEAMS AND THAT'S THE GREAT WAY TO GO INTO THE DISCUSSION. WITH THAT DIVERSITY THAT IS SOMETHING WE WILL NEED TO KEEP DISCUSSING I HOPE THE PANELIST WILL STICK AROUND AND THAT THESE VOICES HAVE BEEN SO POWERFUL AND WE GOT SO MUCH FROM THE DISCUSSION. THANK YOU TO OUR PANEL. NOW WE WILL GO TO A BREAK WE WILL START THE SECOND PANEL AT 2:30 P.M. WE WILL SEE YOU THERE. WELCOME BACK, EVERYBODY. I HOPE YOU HAD A GOOD BREAK. IT'S MY PLEASURE TO ANNOUNCE THE SECOND PANEL THIS AFTERNOON. WHICH IS FOCUSING ON WHAT DIFFERENT STAKEHOLDER GROUPS CURRENTLY PROVIDE AND WHAT THEY CAN OR COULD PROVIDE IN TERMS OF THE RESEARCH-RELATED CARE NEEDS THAT WE SO POWERFULLY HEARD ABOUT DURING PANEL ONE. SO WITH THAT, I WOULD LIKE TO GIVE IT OVER TO THE CO-MODERATORS OF THIS SECOND PANEL, WHICH ARE DR. SHAMIR AND DR. HSU. >> WE'LL KICK IT OFF AND AFTER THIS WE'LL HAVE A PANEL PRESENTATIONS FIRST SPEAKER IS DR. YAGNA PATHAK, ENGAGING IN TRANSLATIONAL RESEARCH FOCUSED ON LEVERAGING DIGITAL HEALTH TOOLS TO IMPROVE THE CLINICAL APPLICATION OF NEUROMODULATION THERAPY. PRIOR TO HER CURRENT ROLE WE INVESTIGATED NEUROMODULAR FOR DISEASES AND PH.D. FROM MARQUETTE UNIVERSITY FROM DR. CHRISTOPHER HUDSON AND FELLOWSHIP COLUMBIA UNIVERSITY WORKING WITH DR. SHAMIR SHA. THANK YOU, SHERRY AND THANK YOU, ALL. SHERRY, I THINK YOU CAN MOVE ON TO THE NEXT SLIDE, PLEASE. SO I REALLY JUST WANTED TO TALK ABOUT WE HEARD A NUMBER OF TALKS THIS MORNING FROM PATIENTS AT THE PATIENT ADVOCATE GROUP BUT THE KEY STAKEHOLDERS OF THE SITUATION INCLUDE INDUSTRY SPONSORS, REGULATORY AND REIMBURSEMENT BODIES AS WELL AS CLINICAL TEAMS BUT MOST IMPORTANTLY WE NEED TO RECOGNIZE THAT PATIENTS ARE STILL AT THE CENTER HERE. THE BURDEN OF RESPONSIBILITY MAY DEFER BASED ON THE TYPE OF STUDY THAT WE'RE TALKING ABOUT BUT THE EFFORT SHOULD BE TO WORK IN A COLLABORATIVE WAY TO BEST SUPPORT PATIENT CARE. NEXT SLIDE, PLEASE. SO CURRENT ITEMS FOR TREATMENT ACCESS BEYOND THE DURATION OF THE CLINICAL TRIAL REALLY COMES FROM TWO SPECIFIC DOCUMENTS. THE DECLARATION OF HELSINKI AND THE GUIDELINES BY WHO. THE DOCUMENTS ACCOUNT FOR ASSESSMENTS OF WHETHER THE TREATMENT IS EFFECTIVE AND HOW PATIENTS WERE PREPPED FOR PATIENTS BEYOND THE TRIAL. AND SO IF EVERYTHING IS IDEAL, FOR A STUDY OUTCOME, THEN THESE ARE SOME REALLY GREAT THINGS TO THINK ABOUT. SO WHAT IS AN IDEAL PATIENT CONTINUUM. NEXT SLIDE. IDEALLY WE EXPECT IT TO BE A NEAR PROCESS WITH CERTAIN PROCESSES. THIS JOURNEY STARTS WITH THE PATIENT PARTICIPATION IN A CLINICAL TRIAL FOLLOWED BY OUR REGULATORY APPROVAL AND REIMBURSEMENT COVERAGE HOPEFULLY LEADING TO A MARKET LAUNCH FOR THE DEVICE OR THE SYSTEM SO THAT THERAPY IS EVENTUALLY ACCESSIBLE AS STANDARD OF CARE. HOWEVER, THIS IS THE IDEAL SCENARIO AND WE ALL KNOW THAT SELDOM DO WE HAVE IDEAL SCENARIOS IN REAL LIFE. SO THE REALITY IS SOMETHING COMPLETELY DIFFERENT. NEXT SLIDE, PLEASE. SO IN REALITY, THE PATIENT JOURNEY IS NOT SO STRAIGHTFORWARD. WHAT REALLY HAPPENS WHEN, WHAT HAPPENS WHEN REGULATORY APPROVAL IS DELAYED? THERE ARE CERTAIN OPTIONS FOR CONTINUED PARTICIPATION IN OPEN LABEL EXTENSION STUDIES OR EVEN ROLLOVER CLINICAL TRIALS, IF THIS SPONSOR WISHES TO CONDUCT THESE ADDITIONAL EVIDENCE. HOWEVER, THE OTHER POTENTIAL OPTIONS THAT CURRENTLY EXIST LIKE EXPANDED ACCESS ARE OFTEN COUPLED WITH CONTINGENCIES INVOLVING SEVERAL OF THE STAKEHOLDERS THAT I MENTIONED EARLIER. AND SO OVERALL THERE'S REALLY A LACK OF PROVISION FOR INCONCLUSIVE STUDIES MAKING THESE UNIDEAL SITUATIONS CHALLENGING TO NAVIGATE. WHAT HAPPENS WHEN REGULATORY APPROVAL IS DELAYED. WHAT HAPPENS IF A STUDY DOESN'T REALLY MEET ITS PRIMARY ENDPOINT? WHAT ARE POTENTIAL OPTIONS AND WHO REALLY BEARS THE BURDEN OF RESPONSIBILITY HERE? AND SO RIGHT NOW WE REALLY DO NOT HAVE PROVISIONS TO KIND OF ACCOUNT FOR THESE UNIDEAL SITUATIONS. NEXT SLIDE, PLEASE. SO IN THIS LANDSCAPE, THERE SHOULD BE CONSIDERATIONS FOR CONTINUED CARE THAT REALLY COVER CLINICAL NEEDS, TECHNOLOGY NEEDS AND COVERAGE. SO WE NEED TO ANSWER QUESTIONS ABOUT HOSPITAL AND CLINICIAN RESOURCES, SPECIFICALLY AROUND INTEGRATING RESEARCH AND INVESTIGATIONAL THERAPY IN EXISTING PATHWAYS. UNIQUE TO IMPLANTED DEVICES WE ALSO NEED TO CONSIDER THE CONSEQUENCES OF EXPLANTING A DEVICE OR EXPLANTING A SYSTEM VERSUS MAINTAINING OR REPLACING THE SYSTEMS. FROM A DEVELOPMENT PERSPECTIVE, WE REALLY SHOULD BE THINKING ABOUT HOW THESE INVESTIGATIONAL DEVICES WILL INTERACT WITH FUTURE SYSTEMS, WHAT HAPPENS TO THE DATA BEYOND THE TRIAL, AND LASTLY, WHAT IS COVERED, WHO PAYS FOR WHICH PIECE, AND THAT LAST PIECE IS ESPECIALLY CHALLENGING IN LARGER CLINICAL TRIALS THAT TEND TO BE MULTISITE OR MULTIGEOGRAPHY BECAUSE REIMBURSEMENT AND REGULATORY RULES ARE OFTEN REGION SPECIFIC. SO THESE ARE SOME BUCKET CATEGORIES IN WHICH WE SHOULD BE THINKING ABOUT CONTINUED CARE AND HOW RESPONSIBILITIES SHOULD BE DIVIDED FOR POST-TRIAL ACCESS. NEXT SLIDE, PLEASE. SO REALLY THE QUESTION IS HOW CAN WE DO BETTER? AND I THINK THIS WORKSHOP IS A REALLY GREAT INITIATIVE TOWARDS SOLVING THIS PROBLEM BECAUSE WE REALLY SHOULD BEGIN CLINICAL TRIAL PLANNING WITH THE END IN MIND. SO AS OPTIMISTIC AS WE MIGHT WANT TO BE WE SHOULD CONSIDER ALL POTENTIAL OUTCOMES, EVEN IF THOSE OUTCOMES ARE NOT ALWAYS FAVORABLE OUTCOMES, BECAUSE ULTIMATELY IT'S IN THOSE SITUATIONS WHEN WE DO HAVE UNFAVORABLE OUTCOMES WHERE THE CHALLENGES ARE THE GREATEST AND WE REALLY SHOULD BE ACCOUNTING FOR WHAT IS BEST FOR THE PATIENT AND I KNOW SOMEONE MENTIONED THIS MORNING WHAT ARE INCENTIVES FOR INDUSTRY SPONSORS, WHAT ARE INCENTIVES FOR SOME OF THE OTHER KEY STAKEHOLDERS INVOLVED, BUT I DO ULTIMATELY BELIEVE THAT EVERYONE IS IN THIS TO REALLY IMPROVE THE OUTCOMES FOR PATIENTS THAT WE ARE DEVELOPING OUR TECHNOLOGIES FOR, THAT WE'RE DEVELOPING OUR TREATMENTS FOR, AND THAT WE ULTIMATELY WISH TO SERVE. SO WE REALLY SHOULD BE KIND OF COMING BACK TO WHAT CAN WE DO TO REALLY MAKE THIS A PATIENT-CENTRIC APPROACH AND CAN YOU START THINKING ABOUT SORT OF THESE POTENTIAL OUTCOMES AT THE BEGINNING OF THE CLINICAL TRIAL PLANNING. NEXT SLIDE, PLEASE. AND SO FOR THAT WE CAN REALLY START BY DEFINING THE PATIENT CONTINUUM DURING PROTON DEVELOPMENT. WHAT DOES INFORMED CONSENT LOOK LIKE? HOW MANY PROCEDURES CAN WE SUPPORT DURING THE TRIAL? HOW MANY PROCEDURES CAN WE SUPPORT BEYOND THE TRIAL? WHAT ARE THE CONSEQUENCES TO THE PATIENT IF THEY'RE ASKED TO PARTICIPATE IN ADDITIONAL RESEARCH? HOW DO WE COMPLY WITH PRIVACY AND SECURITY PRACTICES IF WE NEED TO EXTEND DATA COLLECTION BEYOND THE TRIAL? SO WE HAD A PATIENT THIS MORNING TALK ABOUT WHAT'S IN HER CLINICAL HISTORY VERSUS REALLY INFORMATION ABOUT HER TRIAL. HOW DO WE BALANCE THE RESEARCH CONTINUUM WITH CLINICAL STANDARDS AND THAT SHOULD BE SOMETHING THAT WE START PLANNING FOR AND DEFINING DURING THE PROTON DEVELOPMENT STAGE AND NOT SORT OF AT THE END OF THE TRIAL WHEN IT MIGHT BE TOO LATE TO ASK FOR EXPANDED INFORMED CONSENT FROM THESE PATIENTS OR TO ALLOCATE MORE BUDGET. AND SO THAT BRINGS US TO THE NEXT POINT, WHICH IS FROM A MINDSET PERSPECTIVE WE REALLY NEED TO OPT FOR A PREVENTIVE OR AN ANTICIPATORY APPROACH AND ALIGNMENT WITH KEY STAKEHOLDERS AND EXPLICIT DEFINITION ABOUT POST TRIAL GROWTH AND BUDGET BECAUSE WE ALL KNOW THAT THESE TRIALS CAN BE VERY EXPENSIVE AND IT'S AN INTRICATE PLAY BETWEEN A LOT OF DIFFERENT PARTICIPANTS THAT ARE ULTIMATELY TRYING TO IMPROVE CARE FOR THE PATIENT. HOWEVER, IF THERE ISN'T SOMETHING DEFINED AHEAD OF TIME THEN WHO SORT OF TAKES THE BURDEN WHEN THE TIME FOR THAT COMES TO. SO I THINK A LOT OF THAT NEEDS TO BE DEVELOPED FROM A PREVENTIVE OR ANTICIPATORY APPROACH THAT SHOULD WE HAVE UNFAVORABLE OUTCOMES HOW DO WE ACCOUNT FOR THAT? AND LASTLY, WE NEED A THOROUGH BUT ITERATIVE RISK BENEFIT ASSESSMENT. SO WE ALL KNOW FROM ALL OF OUR EXPERIENCES THAT THERE ISN'T THE ONE-SIZE-FITS-ALL FOR ALL PARTICIPANTS. ALL PARTICIPANTS MAY NOT BENEFIT WITH THERAPY, AND SOME PARTICIPANTS MAY HAVE LIFE-CHANGING OUTCOMES AS WE ALSO SAW THIS MORNING. SO AS WE HAVE MORE INFORMATION WE SHOULD REALLY STRIVE TO MAKE DATA DRIVEN DECISIONS AND ADJUST ACCORDING TO THE EVIDENCE THAT WE HAVE AT HAND. SO WE SHOULD BE DOING THIS IN A VERY ITERATIVE WAY. THESE SUGGESTIONS ARE ULTIMATELY ALIGNED WITH THE EXISTING GUIDELINES THAT I TALKED ABOUT INITIALLY, BUT ALSO TAKE INTO ACCOUNT NUANCES THAT ARE PARTICULARLY ASSOCIATED WITH THE UNIQUE CHALLENGE OF SUPPORTING IMPLANTABLE SYSTEMS FOR TREATING CHRONIC DEBILITATING DISORDERS LIKE THE ONES WE DO. WE NEED TO WORK COLLABORATIVELY BETWEEN DIFFERENT STAKEHOLDER GROUPS AND CONTINUE TO RECENTER AND CONSIDER PATIENT'S BEST INTERESTS AS WE THINK ABOUT PROBLEM SOLVING FOR TRIALS THAT WE ARE GOING TO BE PLANNING FOR IN THE FUTURE. WITH THAT, I WOULD LIKE TO END HERE AND I CAN TAKE QUESTIONS. THANK YOU. I SEE USUAL HAND UP. >> THANK YOU SO MUCH. THAT WAS WONDERFUL. I WAS HOPING YOU COULD SPEAK TO A LITTLE BIT WHAT THE CURRENT PRACTICES ARE IN MAYBE BROADLY FROM DEVICE MANUFACTURERS, POST-TRIAL CARE, COULD YOU SPEAK TO THAT FOR A MOMENT. >> THERE ISN'T ONE SPECIFIC ANSWER TO THAT QUESTION, RIGHT. SO I THINK WITH TRIALS THAT WE HAVE CONDUCTED WHERE PATIENTS NEEDED POST-TRIAL ACCESS -- AS I SAID IT'S A COMPLEX NUANCE TOPIC AND THERE ARE A LOT OF FACTORS THAT GO INTO DECISION-MAKING WHAT WE SUPPORT AND HOW WE SUPPORT THAT. RIGHT NOW IT'S SITUATION BASED WHAT THE PATIENT NEEDS AND THAT'S WHAT WE TAKE INTO ACT IN MAKING THE DECISION HOW DO WE SUPPORT THE PATIENT. THAT'S WHERE IT COMES FROM, WE KNOW FROM OUR EXPERIENCE IT'S NOT GOING TO BE A ONE-SIZE-FITS-ALL. IT'S KIND OF HARD TO SAY THERE'S A STANDARD PRACTICE BECAUSE WE KNOW THAT A STANDARD PRACTICE MAY NOT BE BENEFICIAL TO EVERYONE THAT'S INVOLVED. SO I THINK WE SHOULD COME UP WITH A STANDARD PRACTICE AND MAYBE THAT STANDARD PRACTICE NEEDS TO BE DEFINED AHEAD OF TIME SO THAT EVERYONE, SO THERE'S ENOUGH TRANSPARENCY BUILT IN EVEN FOR THE PATIENTS THAT ARE PARTICIPATING IN THESE TRIALS SO THEY KNOW KIND OF WHAT TO EXPECT IF THINGS DON'T GO AS WE ALL HOPED THEY WOULD GO. BECAUSE I THINK WE ALL TEND TO BE VERY OPTIMISTIC BY NATURE WHICH IS GOOD. BUT YOU SHOULD ALSO KIND OF PLAN FOR THE REALISTIC SCENARIOS. >> THAT'S GREAT. MAYBE WE'LL KEEP MOVING. THERE'S GOING TO BE I THINK A BUNCH OF QUESTIONS THAT CAN LIGHT -- FURTHER FLESH OUT HOW THAT PARTICIPATION MIGHT LOOK LIKE. I THINK IT WOULD BE GREAT TO COME BACK TO THAT. >> THAT'S GREAT. THANKS AMIR. >> LET ME GO AHEAD AND INTRODUCE OUR SECOND SPEAKER OF THE SESSION. PLEASURE TO INTRODUCE DR. MARTY MORRELL FROM STANFORD UNIVERSITY. HAS ACTIVELY BEEN INVOLVED IN HELPING TO BRING NEW MEDICAL AND DEVICE THERAPIES TO PATIENTS WITH EPILEPSY. SINCE 2004, SHE SERVED AS THE CHIEF MEDICAL OFFICER AT NEUROCASE A COMPANY THAT DEVELOPED A RESPONSIVE NEUROSTIMULATE TER FOR TREATMENT OF UNCONTROLLABLE PARTIAL SEIZURES. PAST PRESIDENT AND PRINCIPAL INVESTIGATOR OF A GRANT FOR RESPONSE FOR LINUX GASTO SYNDROME, RARE FORM OF EPILEPSY. THANK YOU. >> THANK YOU SO MUCH, SAMIR. AND I'M SO PLEASED BECAUSE YOU NEVER WANT TO COME AND SPEAK WHEN YOU'RE SAYING THE SAME THING AS EVERYBODY ELSE, BUT I THINK THERE'S GOING TO BE A FAIR AMOUNT OF THAT, WHICH I BELIEVE IS GOOD IN THIS CONTEXT. SO JUST TO TELL YOU, I HAVE SOME POTENTIAL CONFLICTS WHICH I'LL MAKE VERY APPARENT. I'M CHIEF MEDICAL OFFICER NEURO, AS SAMIR SAID AND I'M ALSO AT STANFORD AND I'M BEING FUNDED FORTUNATELY BY NIH. THESE ARE MY OWN VIEWS. THEY DON'T REPRESENT ANYBODY ELSE'S. BUT LET ME GIVE YOU MY PERSPECTIVE. I AM FIRST AND FOREMOST A PHYSICIAN. I'M A NEUROLOGIST WHO IS SPECIAL TRAINED IN EPILEPSY. AND SPEND THE MAJORITY OF MY CAREER IN ACADEMICS AS A CLINICIAN TEACHER AND TRANSLATIONAL RESEARCH PERSON. I THEN, AS PART OF ALL OF THAT TRANSITIONED INTO INDUSTRY WITH A STARTUP DEVELOPING A NEW PRODUCT FOR THE DISORDER THAT I WAS TREATING IN MY PATIENTS EPILEPSY. I CONSIDER MYSELF A PATIENT ADVOCATE. I'VE BEEN VERY INVOLVED WITH PATIENT ADVOCACY ORGANIZATIONS AND I AM ALSO NOW IN THE SECOND PART OF MY CAREER VERY SENSITIVE TO WHAT IT TAKES TO BRING SOMETHING ENTIRELY NEW TO PATIENTS AND HOW HARD THAT IS. SO I MAY ACTUALLY EMPHASIZE A LITTLE BIT MORE THE SMALL COMPANY PERSPECTIVE WHICH MAY NOT BE AS FAMILIAR WITH EVERYONE. BUT WHAT DO WE HAVE HERE? I WAS READING THE PREWORK THAT WAS DONE, A LOT OF STUFF ABOUT SHARED BURDEN, BUT IT'S ALSO A SHARED OPPORTUNITY. AND THE OPPORTUNITY FOR THE PATIENT AND HER LOVED ONES IS THAT THE TREATMENT WILL BRING HEALTH AND BETTER QUALITY OF LIFE. AND FOR THE ACADEMIC RESEARCH INSTITUTE, THAT'S A BUSINESS, AS MUCH AS ANYTHING ELSE, BUT OF COURSE IT'S MISSION DRIVEN BUSINESS. FOR PHYSICIANS, ALTHOUGH OBVIOUSLY PHYSICIANS MAKE MONEY, THEY HAVE TO, I THINK MOST PEOPLE GO INTO HEALING PROFESSIONS BECAUSE THEY'RE MOTIVATED TO HELP REDUCE SUFFERING AND SOCIETY RECOGNIZES THAT IT'S NOT JUST THE MONEY, IT'S THE COST OF MISSED OPPORTUNITIES. IT'S THE LIFE THAT IS NOT LIVED. AND FOR INDUSTRY, IN ORDER TO SURVIVE MUST BE A COMMERCIALLY VIABLE PRODUCT BUT I WOULD SAY PEOPLE CAN DO VIDEO GAME SOFTWARE OR HEALTHCARE TECHNOLOGY THERE'S THAT MOTIVATION. FOR INSURERS, I THINK THE MOTIVATION IS REALLY TO MAINTAIN THE HEALTH OF THIS SUBSCRIBER AND THAT OF COURSE REDUCES MEDICAL COSTS. THERE ARE FINANCIAL INCENTIVES AND ALSO A MISSION AND ALTRUISM AND I THINK THE MOTIVATION TO BENEFIT INDIVIDUALS IN SOCIETY IS SOMETHING THAT IS UNIFYING. WE HAVE A SHARED RESPONSIBILITY. NOW I WANT TO SHARE ABOUT THE COMPANY I'M WORKING WITH TO SET IS CONTEXT. THIS IS A COMPANY THAT WAS FOUNDED IN 1997 THE CONCEPT AND PROVIDE THEM TO AN HE SOUGHTIC DISORDER EPILEPSY AND THE COMPANY SPENT A YEAR DOING DEVELOPMENT AND PROOF OF CONCEPT SO BY 2002 THERE WAS AN IMPLANTABLE DEVICE THAT COULD BE TESTED IN 2004 THE TRIALS BEGAN OF FIRST ENDED UP 256 PEOPLE IMPLANTED. THESE INDIVIDUALS WERE FOLLOWED FOR NINE YEARS. AND IN 2010 AN APPLICATION WAS APPLIED FOR AN APPROVAL PREMARKET APPROVAL APPLICATION FOR FDA'S CLASS 3 IMPLANTABLE DEVICE. FOR HUMOR, 2010 FDA WANTED EVERYTHING IN PAPER COPIES AND THREE COPIES. SO THIS IS WHAT IT LOOKED LIKE, AND THAT'S THAT. AND OF COURSE IT BEING A NOVEL DEVICE, THERE WAS AN ADVISORY PANEL IN 2011 AND THEN DOING THIS THE RIGHT WAY THEN FINALLY IN 2003, NOVEMBER, THE END OF NOVEMBER, FDA PROVIDED APPROVAL FOR PARTIAL SEIZURES. AND THEN IN 2015, WE WERE ABLE TO HAVE OUR TWO-YEAR PATIENT CELEBRATION WHICH WAS VERY MOVING. NOW, WHAT DOES THIS MEAN WITH 16 YEARS? AND OVER $350 MILLION IN A COMPANY THAT EXISTED ONLY FOR THIS. AND SO THERE WERE MANY NEAR DEATHS ALONG THE WAY FOR A NUMBER OF REASONS, EVEN THOUGH THE RESULTS WERE VERY STRONG. THERE WAS JUST A LONG TIME, A LOT OF MONEY, A LOT OF RISK. MY OTHER STORY IS TO TALK ABOUT THE APPLICATION OF THE TECHNOLOGY TO A TERRIBLE DISORDER. AND THIS IS AN INVESTMENT THAT NIH IS MAKING. SUPPLYING APPLYING THIS TECHNOLOGY AND APPLYING IT TO A EPILEPSY CALLED LINUX GASTO, INJURY AND HIGH RISK OF DEATH AND THERE AREN'T ANY OTHER OPTIONS. THIS IS NOT ONLY TERRIFICALLY IMPACTFUL TO PATIENT BUT ALSO CAREGIVERS. SO OTHER SOLUTIONS ARE NEEDED. THIS IS A RARE DISEASE. IT'S AN ORPHAN INDICATION. THERE IS NO COMMERCIAL MOTIVATION TO DELIVER A THERAPY FOR THIS PATIENT POPULATION, BUT THERE SURE IS THE CLINICAL MOTIVATION, THE ALTRUISM, THE WANT TO HELP EASE SUFFERING. SO A GRANT WAS SUBMITTED WITH SIX ACADEMIC MEDICAL CENTERS TO APPLY SOME OF THE DEVICE OF THIS DEVICE, AND IT WAS TERRIFIC. IN MARCH 2020, NIH INDICATED THAT FUNDING WAS LIKELY BUT DID SAY THAT PROBABLY IT WOULD REQUIRE AN ACCEPTABLE PLAN TO PROVIDE POST STUDY CARE. AND SO OUR PROJECT OFFICERS, FABULOUS, SAID, SEE WHAT YOU CAN DO. SO WE EXPLORED OPTIONS. WE COULD NOT GUARANTEE THAT AFTER THIS TRIAL WE WOULD BE FINANCIALLY ABLE TO PROVIDE CARE BECAUSE EVEN AT THAT POINT YOU DON'T EVEN KNOW IF COMPANY IS GOING TO BE VIABLE. NEUROPATIENTS IS OKAY, BUT FOR YOUNG COMPANIES, WHAT IF IT DOESN'T EXIST ANY LONGER? AND IN GOING TO EACH OF THE ACADEMIC INSTITUTIONS AND HOSPITALS, THEY WERE NOT WILLING TO COMMIT TO ANY FUNDS IN THE FUTURE AND WE REACH OUT TO ENSURER, EVEN OUTSIDE THE UNITED STATES, THE ONES THAT INSURE JENNIFER ANISTON'S HAIR AND EARTHQUAKES, THESE RARE EVENTS, TO SEE IF THEY WOULD BE WILLING TO CREATE A POLICY FOR POST STUDY CARE THAT NEUROPACE COULD PAY FOR. BUT THERE'S NO PRECEDENT FOR THAT. AND IT WAS NOT POSSIBLE TO GET A SUPPLEMENT TO THE NIH GRANT. NIH TO PROVIDE FOR THIS AND WE COULD GO TO CMS BUT THEY HAVE NO MECHANISM FOR ESTABLISHING POST STUDY CARE EITHER. SO I FELT LIKE THERE WAS ALL OF THIS GOING ON. AND WE ALL WANTED THE SAME THING. SO THAT'S NOT GOING TO WORK. SO WE HAVE TO FIGURE OUT HOW TO DO THIS. AND WHAT HAPPENED? WELL, IT WAS THE YEAR OF GETTING TO SOMEPLACE OF AGREEMENT. AND EVERYONE WAS SATISFIED THAT THESE INDIVIDUALS HAVE TERRIBLE EPILEPSY, THEY WILL BE GETTING ROUTINE EPILEPSY CARE SO REGULAR ACCESS TO PHYSICIANS WILL BE COVERED. NEUROPACE COMMITTED TO DONATING THE DEVICE AND PROVIDING SUPPORT FOR THE DEVICE. IT'S NOT COVERED BY THE INSURER. AND THE PARTICIPATING PHYSICIANS SAID THEY WOULD PROVIDE PROGRAMMING FOR THE CHARGE FOR UNINSURED PATIENTS. HOWEVER, THE INSTITUTIONS AND THE HOSPITALS WERE NOT WILLING TO DO THAT. BUT THOUGH DID SAY AND PUT IN WRITING THEY WOULD AGREE TO WORK VERY HARD TO GET THIS. AND THEN FINALLY THE PATIENT AND IN THIS CASE MOSTLY THEIR FAMILY MEMBERS DO HAVE IN THE CONSENT AND ASCENT, THAT IF ALL THE INSURANCE OPTIONS ARE EXHAUSTED THEN THERE MAY BE INDIVIDUAL RESPONSIBILITY FOR COSTS. SO IN THIS CASE MOST EVERYBODY HAS A PIECE OF THE SOLUTION. BUT IT TOOK A LONG TIME. SO IT WAS WELL OVER A YEAR FROM THE TIME THAT WE HEARD THAT IT WAS LIKELY THAT THE GRANT WOULD BE FUNDED UNTIL WE RECEIVED OUR YOU YOUNGEST SINGLE AWARD. IT WAS NOT FOR THE LACK OF THE NIH TEAM HELPING AND TRYING THEY ABSOLUTELY DID. BUT IN THE MEANTIME THESE ARE PEOPLE WITH NO TREATMENT WHO WERE DYING FROM THEIR DISEASE. SO IT'S HAVING THINGS TOGETHER AHEAD OF TIME IN SOME UNDERSTANDING. TIME IS REALLY OF THE ESSENCE. SO WHO SHOULD PAY FOR POST STUDY CARE IF THE DEVICE IS NOT APPROVED? OR THE COMPANY DOESN'T EXIST. WE JUST HEARD A WONDERFUL PRESENTATION. THAT'S ABBOTT. THEY'RE NOT GOING TO SEIZE TO EXIST BUT A COMPANY LIKE NEUROPACE CERTAINLY COULD. SO IF IT'S A PROFITABLE COMPANY THEN YOU CAN EXPECT THE COMPANY TO OFFSET I BELIEVE FROM SOME EXTENT TO OTHER REVENUES. IF IT'S NONPROFIT TABLE NONEXTENT COMPANY, THEN THE ONLY WAY THE COMPANY CAN DO SOMETHING, PUT IT ASIDE BOOK FOR THE TRIAL. AND SO I BELIEVE THAT IT IS ACTUALLY REASONABLE WHEN SMALL COMPANIES OR BIG COMPANIES ARE DOING STUDIES TO PLAN AHEAD OF TIME FOR MAKING SOME KIND OF COMMITMENT FOR THE THINGS DON'T GO WELL. FOR MEDICAL INSURERS, IF THE PATIENT BENEFITS, THEN I THINK IT'S IN MY OPINION. TO CONTINUE ON THE CARE. IF THE PATIENT DOESN'T BENEFIT, I WOULD HOPE THAT THE MEDICAL CARE INSURER WOULD PARTICIPATE IN COVERAGE FOR THE DEVICE EXPLANT. AND ACADEMIC INSTITUTIONS, THEY BENEFIT FROM THE TRIAL. THE ACADEMIC INSTITUTIONS ARE OUR BIG INSTITUTIONS. THEY ARE OUR ENTERPRISES. THEY'RE COMPANIES. THEY MAKE MONEY. THAT THEY THEN PUT BACK INTO YOUR MISSION. BUT IF THEY ARE GOING TO MAKE THAT COMMITMENT, THEN I BELIEVE THERE'S SOME SHARED RESPONSIBILITY FOR OUTCOMES. AND THAT WOULD BE PERHAPS PROVIDING PARTIAL CHARGES FOR HOSPITAL PHYSICIAN SERVICES AND THEN FOR PATIENTS I BELIEVE AS WE HAVE IN OUR CONSENT FORM, THERE'S BEEN A LOT OF DISCUSSION ABOUT THAT THERE IS A PATIENT AND FAMILY MEMBER PIECE OF THIS AS HARD AS THAT IS SOMETIMES TO THINK. BUT CERTAINLY PEOPLE DO NEED TO UNDERSTAND WHAT IS THE POTENTIAL OUTCOME OF A NONAPPROVED DEVICE. SO AND THEN GOVERNMENT FUNDERS. AND WE'VE TALKED ABOUT NIH, BUT FDA TOO. FDA'S ORGANIZED TO PROTECT PATIENT, PUBLIC SAFETY. AND THEY DO ABSOLUTELY A WONDERFUL JOB. BUT THEY ALSO ARE DEVOTED TO THE HEALTH OF THE PUBLIC. AND PROBABLY RESEARCH IS PART OF THAT. AS IT IS FOR THE DEPARTMENT OF DEFENSE, AS IT IS FOR MEDICARE AND OTHERS. WHAT WE NEED ARE CERTAINLY ETHICAL PRINCIPLES GUIDING THIS, AND THOSE HAVE GOT TO BE CORE. BUT WE NEED PRACTICING PLAT MAT TICK SOLUTIONS, I BELIEVE EVERYONE IS INVOLVED IN THIS AND ENJOYS THE GLORY. THANKS, I'LL TURN IT OVER TO MARTY >> THANKS FOR THE OVERVIEW OF THE SUBJECT. WE HAVE TIME FOR ONE QUICK QUESTION IF ANYBODY HAS ONE. >> SARA. >> INTERESTING, ALL THE FINGERS ARE POINTING, THEY WANT EVERYONE TO PAY. AND YOU LIST THAT NEUROPACE COVERS THE DEVICE IF IT'S NOT COVERED BY INSURANCE. AND THE UNIVERSITY HOSPITAL DOING SOMETHING MAYBE NOT QUITE DOING IT. I'M WONDERING BECAUSE I DON'T KNOW THE FIGURES, WHAT'S THE PROPORTIONAL COST OF WHAT IT IS TO PROVIDE THIS CARE, SO HOW MUCH OF IT IS COVERED BY NEUROPACE, HOW MUCH ARE THE DEVICES RELATIVE TO THE CARE THAT MIGHT BE NEEDED FOR YEARS AND YEARS? YOU KNOW THE COST OF SOMETHING IS VERY HARD TO DETERMINE BECAUSE THERE ARE THE COSTS OF MANUFACTURING THE DEVICE. BUT MOST OF THE COSTS ARE RELATED TO THE PROCEDURE TO IMPLANT THE DEVICE AND WHICH IS THE SURGICAL PROCEDURE AND THE BRIEF HOSPITALIZATION AND THEN THE MANAGEMENT OF THE DEVICE, THE MEDICAL CARE. SO THERE ARE -- AND THE COSTS OF THE SURGERY AND THE OTHER PROCEDURES ARE DETERMINED BY THE HOSPITAL AND THE ACADEMIC INSTITUTION. THEY SET THOSE COSTS. SO A COMPANY LIKE NEUROPACE OR ABBOTT OR MEDTRONIC OR THE TINIEST COMPANY HAS NO CONTROL OVER WHAT THE MEDICAL COSTS ACTUALLY ARE BECAUSE THOSE ARE NOT SET. SO THEY HAVE CONTROL OVER THE DEVICE AND THEY HAVE CONTROL OVER WHAT EVER SUPPORT IF THEY'RE CLINICAL ENGINEERS AND PEOPLE IN OR WITH THE DEVICE THEY HAVE CONTROL OVER THAT. BUT THEY HAVE NO CONTROL OF ANY OF THE OTHER, WHICH IS WHY IT HAS TO BE DONE MULTIPLE PARTIES. >> AND THE ANALYSIS GROUP IN THE CENTER FOR CLINICAL STANDARDS AND QUALITY. PART OF THE CENTERS FOR MEDICARE AND MEDICAID SERVICES ON THE MEDICARE SIDE. DR. LI. >> GOOD AFTERNOON. WANT TO THANK YOU FOR THE OPPORTUNITY TO TALK ABOUT THE MEDICARE PERSPECTIVE ON POST-TRIAL CARE. I SEE THE SLIDES ARE COMING UP. I'LL GO AHEAD AND START. TALKING. AND NEXT SLIDE. I WANTED TO GET THIS PARTICULAR DISCLAIMER THIS PRESENTATION IS NOT A LEGAL DOCUMENT. IF THERE'S FURTHER QUESTIONS ABOUT WHAT MEDICARE PROVIDERS, THE CRITERIA ARE, SO IT'S COVERAGE DECISIONS, THEN ONE WOULD HAVE TO GO BACK LOOK AT THE RULES AND REGULATIONS RELATED TO THAT QUESTION. SO NEXT SLIDE, PLEASE. SO OUR WORK AT MEDICARE, I WORK AS PREVIOUSLY DESCRIBED COVERAGE ANALYSIS GROUP. WHAT THAT MEANS IS THAT MY GROUP DETERMINES WHAT ITEMS OR SERVICES SHOULD BE COVERED AND THEREFORE REIMBURSED AND THEN WHAT I'M GOING TO DO IS DESCRIBE THAT PROCESS OF COMING TO GET A DECISION. AND SO UNDERNEATH ALL OF THIS IS THE CONTRACT THAT OUR AGENCY WAS ESTABLISHED BY THE SOCIAL SECURITY ACT OF 1965. AND HOW WE DETERMINE WHAT'S COVERED OR WHAT'S REIMBURSED IS BASED ON THE EVIDENCE AND THE EVIDENCE SHOWS THAT THE BIAS, THE ITEM OR DEVICE IS REASONABLY NECESSARY FOR DIAGNOSIS CONFIDENT TREATMENT OR INJURY OR TIM PROVES THE FUNCTION OF A MALFORMED BODY. AND NEXT COUPLE OF SLIDES I'LL DESCRIBE HOW TO DO THAT. NEXT SLIDE, PLEASE. AND SO FIRST QUESTION IS WHAT IS ACTUAL COVERAGE DETERMINATION. THIS IS HOW WE DETERMINE WHAT SHOULD BE COVERED, WHICH ITEM OR DEVICE SHOULD BE COVERED ON A NATIONAL BASIS. SO WHAT WE DO BRIEFLY IS REVIEW THE PUBLISHED EVIDENCE TO DETERMINE WHETHER OR NOT THAT ITEM OR DEVICE IN FACT IMPROVES A HEALTH OUTCOME THAT'S MEANINGFUL TO THE MEDICARE POPULATION. SO WE GO AHEAD REVIEW THE PUBLISHED EVIDENCE. LOOK FOR QUALITY, STRENGTHEN THE TOTAL OF THE EVIDENCE, WHETHER TO DETERMINE WHAT QUALITY IT'S AT, WHAT TYPE OF STRENGTH IT HAS AND WHETHER OR NOT IT IMPROVES MEANINGFUL PATIENT-CENTERED OUTCOMES. AND TYPICALLY OUR GOLD STANDARD OUTCOME IS MORTALITY THOUGH DEPENDING ON THE ITEM OR DEVICE WE'LL USE OTHER OUTCOMES. NEXT SLIDE, PLEASE. AND AS PART THAT HAD NATIONAL COVERAGE DETERMINATION WE WILL GO THROUGH THE EVIDENCE IF WE FIND THE PUBLISHED EVIDENCE IS INSUFFICIENT TO MAKE A APPROPRIATION DECISION THE DEVICE TO COVER OR NOT COVER IT. WE HAVE A SEPARATE PATHWAY WHERE WE WILL SUPPORT A CLINICAL TRIAL WHICH THE CLINICAL TRIALS DEVELOPING THE EVIDENCE TO HELP US BETTER UNDERSTAND WHETHER OR NOT THE ITEM WAS SERVICE RELATED TO THE OUTCOME OF THE MEDICARE POPULATION. THOSE CLINICAL TRIALS COULD INCLUDE RANDOMIZED OBSERVATIONAL STUDIES REGISTRATION STUDIES AND JUST THOSE DIFFERENT TYPES OF CLINICAL TRIALS. AND SO NEXT SLIDE PLEASE. THE EXAMPLE I WANT TO USE TODAY IS THIS PARTICULAR NATIONAL COVERAGE DETERMINATION WHICH WE HAD COMPLETED A NUMBER OF YEARS AGO IT'S LOOKING AT VAGUS NERVE STIMULATION OR TRD. AND SO NEXT SLIDE, PLEASE WE LOOK AT EVIDENCE AND DETERMINE THAT LOOKING AT OVERALL QUALITY OF THE EVIDENCE THAT THE EVIDENCE IS REALLY PROMISING BUT NOT CONVINCING. CONCERNS ABOUT THE QUALITY IN TERMS OF EPIDEMIOLOGIC ISSUES, FOUND THE STRENGTH OF EVIDENCE WAS NOT STRONG ENOUGH FOR US TO ALLOW US TO MAKE AN APPROPRIATE DECISION WHETHER OR NOT VNS OR VAGUS NERVE THAT TREATS TREATMENT DEPRESSION AS A RESULT WE PROPOSE THE PATHWAY COVERAGE WITH EVIDENCE DEVELOPMENT. NEXT SLIDE, PLEASE. AND SO WHAT THAT MEANS IS THAT THE NEXT COUPLE OF SLIDES IS THE POLICY THAT I WILL NOT GO THROUGH THE EVIDENCE THAT WAS A LONG PROCESS TO GET TO THIS POINT. BUT SO IN ESSENCE WE DECIDED WE WOULD COVER FDA APPROVED VAGUS NERVE STIMULATION DEVICES FROM TREATMENT RESISTANT DEPRESSION THROUGH THIS PATHWAY WE CALLED COVERAGE WITH EVIDENCE DEVELOPMENT. AND SO WHEN DNS IS OFFERED FROM A CNS APPROVED CLINICAL TRIAL AT LEAST ONE YEAR WE COULD COVER THE DEVICE AND SERVICES DURING THE DURATION OF THE RANDOMIZED CLINICAL TRIAL. HOWEVER, WE WOULD ALSO -- WHAT WE DID WAS MAKE SURE THE CLINICAL TRIAL WAS VALID AND WELL-DESIGNED ONE IN THE SENSE WE HAD ONLY COVERED THE STUDY IF IT, IF THE MAIN RESEARCH QUESTION, THE PURPOSE OF THE STUDY WAS TO ADDRESS WHETHER OR NOT DNS IMPROVES HEALTH OUTCOMES FOR TRD PATIENTS. SO WE REQUIRED THAT THE CLINICAL STUDIES ANSWER THERE'S A LARGE NUMBER OF RESEARCH QUESTIONS. I ONLY PUT TWO OF THEM HERE. 10 OR 15 QUESTIONS. IN TERMS OF BREVITY. THE MAIN QUESTION IS THAT WE WANT THE CLINICAL TRIAL TO ANSWER IS WHAT WAS THE RATE OF RESPONSE OF USING THE VNS DEVICE TO TREAT TREATMENT RESISTANT DEPRESSION PATIENTS. ANOTHER MAIN QUESTION WHAT IS THE RATE OF REMISSION WHEN THE VNS DEVICE IS USED FOR TREATMENT RESISTANT DEPRESSION. SO THERE'S A WHOLE LIKE I SAID THERE'S A WHOLE LARGER NUMBER OF OTHER QUESTIONS THAT WERE VERY IMPORTANT BUT THE POINT WAS THE PURPOSE OF THIS STUDY WAS THAT IT HAD TO ANSWER THE QUESTION OF WHETHER OR NOT DNS IN FACT IMPROVES HEALTH OUTCOME OF MAJORITY OF PATIENTS. NEXT SLIDE, PLEASE. AS PART OF THE DECISION, WE ALSO INCLUDE PATIENT CRITERIA THAT IS THE PATIENT HAD TO REACH CERTAIN ENROLLMENT CRITERIA TO BE A PART OF THE CLINICAL TRIAL. SO THE PATIENT HAD TO BE, HAD TO HAVE HAD A MAJOR DEPRESSIVE EPISODE FOR AT LEAST TWO YEARS OR MORE IN THE PAST TWO AND A HALF YEARS, TWO YEARS. THE PATIENT WOULD ALSO HAVE TO HAVE HAD FOUR PRIOR FAILED TREATMENTS OF ADEQUATE DOSE AND DURATION OF THE DRUG TO QUALIFY FOR THIS PARTICULAR STUDY. AND JUST SKIPPING DOWN TO THE LAST BULLET THAT I THINK THIS PARTICULAR CRITERIA IS RELEVANT TO THE WORKSHOP IN TERMS OF POST-TRIAL RESPONSIBILITIES. AT LEAST FROM THE MEDICARE, FROM MY AGENCY'S PERSPECTIVE. SO INDIVIDUALS WHO RECEIVE THE PLACEBO VNS WILL BE OFFERED ACTIVE VNS AT THE END OF THE TRIAL. AND SO WHAT THAT MEANS IS THAT AFTER THE CLINICAL TRIAL IS DONE, THOSE INDIVIDUALS IN THE CONTROL GROUP, THOSE WHO WERE GETTING A PLACEBO VNS DEVICE WILL BE OFFERED THE ACTIVE VNS DEVICE, THEY WOULD RECEIVE THE DEVICE THAT WAS BEING USED. THIS WOULD BE AT THE END OF THE TRIAL. AND THEN THIS WAS WRITTEN INTO THE DECISION, THE DETERMINATION. NEXT SLIDE, PLEASE. AND SO AS I STATED BEFORE, PART OF THIS DECISION WE INCLUDE WHAT'S CALLED A CD PATHWAY, COVERAGE DEPENDENT PATHWAY THE STUDIES HAD TO MEET 13 CRITERIA. BELOW THERE WERE ONLY FOUR OF THOSE CRITERIA AND I INCLUDED TWO OF THE CRITERIA THAT WE CONSIDERED. NOT JUST CONSIDERING OF IMPORT BUT WE CONSIDERED IT KEY TO THE CLINICAL TRIAL. SO AS I STATED BEFORE, THE FIRST BULLET, THE PRINCIPAL PURPOSE OF THE STUDY IS TO TEST WHETHER OR NOT THE ITEM OR SERVICE MEANINGFULLY IMPROVES THE HEALTH OUTCOMES OF AFFECTED BENEFICIARIES WHO ARE REPRESENTED BY THE SUBJECT. SO CLEARLY THE STUDY HAD TO SHOW IMPROVEMENT IN HEALTH OUTCOME. IN THIS CASE IT WAS THE RATE OF RESPONSE OF THE RATE OF REMISSION WITH USE OF THE VNS DEVICE VAGUS NERVE STIMULATION DEVICE IN TERMS OF ADDRESSING TREATMENT RESISTANT DEPRESSION. AND IF YOU LOOK AT THE FOURTH BULLET, STUDY DESIGN IS METHODOLOGICALLY APPROPRIATE IN ANTICIPATED NUMBER OF THE SUBJECTS SUFFICIENT TO ANSWER THE RESEARCH QUESTIONS BEING ASKED ACTUAL COVERAGE DETERMINATION. WHAT THAT MEANS IS THAT WE WOULD REVIEW THESE CLINICAL TRIALS, WHETHER IT'S A REGISTRY OR DOUBLE BLIND RANDOMIZED CLINICAL TRIAL TO MAKE SURE THE METHODOLOGY WAS APPROPRIATE. THAT IS, THAT THERE'S COMPARISON GROUP. THERE'S A CONTROL GROUP SO THAT YOU CAN COMPARE THE EFFECT OF THE VNS DEVICE IN TREATMENT RESISTANT DEPRESSION PATIENTS AND THERE'S DOUBLE BLINDING IF IT'S RANDOMIZED CLINICAL TRIAL. IF THE REGISTER THAT IT HAD A LARGE ENOUGH CATCHMENT AREA TO GET A SENSE OF WHAT'S HAPPENING NATIONALLY. WE'LL TALK ABOUT SAMPLE SIZE. WE WANT TO MAKE SURE THAT THE STUDY WAS POWERED ADEQUATELY TO ANSWER THE VARIOUS RESEARCH QUESTIONS, A SAMPLE SIZE WAS LARGE ENOUGH, ENROLLMENT WAS LONG ENOUGH. FOLLOW-UP WAS APPROPRIATE TO MAKE SURE THAT THERE'S ADEQUATE FOLLOW-UP FOR AS MANY PATIENTS AS POSSIBLE AND WE LOOKED AT A LOT OF THE OTHER VARIOUS HEMATOLOGIC QUESTIONS CONCERNS ABOUT THE LIMITATIONS THAT MIGHT BE EXISTING IN THESE CLINICAL TRIALS. NEXT SLIDE, PLEASE. AND THESE LAST TWO OR LAST THREE BULLETS, I THINK, ALSO ADDRESS, I THINK, THE QUESTIONS RAISED IN THIS PARTICULAR WORKSHOP RELATED TO POST-TRIAL RESPONSIBILITIES. AT LEAST FROM THE CMS PERSPECTIVE. IF YOU LOOKED AT THE FIRST BULLET. I'LL GO AHEAD AND READ IT. WE'RE THINKING OF NONCOVERAGE EDUCATION. THE FIRST TWO BULLETS. THE FIRST ONE IS DNS IS NONCOVERED FOR THE TREATMENT OF TRD WHEN FURNISHED OUTSIDE THE CMS STUDY. MEANING THAT IF VNS IS BEING USED AT A STUDY WE HAD NOT LOOKED AT HAD NOT APPROVED YET -- THANK YOU -- THIS LAST SLIDE, THEN IT'S OUTSIDE OF THE CN APPROVED CD STUDY WE'RE NOT GOING TO COMPLEMENT IT. THAT MAKES SENSE HADN'T LOOKED AT THE CD STUDY THE CLINICAL TRIAL THAT WE WILL NOT COVER THE DEVICE. THE SECOND BULLET IS INDICATIONS OF VNS FOR TREATMENT OF DEPRESSION NOT NATURALLY COVERED THAT IS IF THE DEVICE IS BEING USED OUTSIDE OF TREATMENT OF RESISTANT -- OUTSIDE OF TREATMENT RESISTANT DEPRESSION, THAT WE'RE NOT GOING TO COVER THE DEVICE. THE LAST BULLET IS PATIENTS ARE IMPLANTED WITH A VNS DEVICE FOR GRD MAY RECEIVE A VNS DEVICE REPLACEMENT IF IT'S REQUIRED DUE TO END OF BATTERY LIFE OR ANY OTHER DEVICE-RELATED MALFUN MALFUNCTION, MEANING -- I THINK THIS IS RELEVANT FOR THIS PARTICULAR WORKSHOP -- IF THE VNS DEVICE NEEDS TO BE REPLACED BECAUSE THE BATTERY PROBLEMS OR ANOTHER DEVICE RELATED MALFUNCTION, CMS WILL REPLACE THE DEVICE. NEXT SLIDE, PLEASE. SO I THINK WE SHOULD BE ON THE LAST SLIDE. NEXT SLIDE. ANY QUESTIONS? >> THERE'S TIME FOR ONE QUESTION. >> OKAY. >> CAN I ASK IT? >> GO AHEAD. >> SO I JUST WANTED TO MAKE SURE -- THANK YOU DR. LI FOR THAT PRESENTATION. MAKE SURE I UNDERSTAND. IF A DEVICE IS IN A TRIAL THAT COMES UNDER CED, THEN MEDICARE WILL PAY FOR IT. IF IT'S ALREADY, IF THE DEVICE HAS ALREADY BEEN APPROVED UNDER A NATIONAL COVERAGE DETERMINATION THEN CMS OR MEDICARE WILL PAY FOR IT. WHAT ABOUT THE KINDS OF SITUATIONS THAT PEOPLE ARE TALKING ABOUT EARLIER WHERE IT'S IN A TRIAL THAT'S OVER, THAT IT IS NOT THE -- THE DEVICE IS NOT BEING PURSUED FOR THAT INDICATION. BUT THE PERSON OR PERSONS IN THE TRIAL ARE BENEFITTING FROM IT. IS THERE ANY WAY THAT THOSE KINDS OF CARE WOULD BE COVERED? >> AGAIN I GUESS YOU ASK A VERY COMPLEX QUESTION. DEPENDS ON THE FACTS OF THE MATTER. BUT WHAT WE DEFINE AS PROVIDING PATIENTS THE BENEFITS OF PATIENT WOULD HAVE TO BE BASED ON THE EVIDENCE. BASED ON THE RESULTS OF THE CLINICAL TRIAL. IT'S NOT JUST THAT IT BENEFITS THAT PATIENT. ALL OF THOSE PATIENTS. FOR THAT INDICATION THAT HAS BEEN TESTED FOR. AND SO YOU SAID IT'S SOMETHING THAT'S BEING PURSUED FOR THAT INDICATION NOT BEING PURSUED BEING PURSUED FOR THAT INDICATION. NOT THAT THERE'S A WRINKLE IN IT. OUR NATIONAL DETERMINATION OF COVERAGE WHETHER IT'S UNDER CDC AND IF IT'S A TEST TYPICALLY IF IT'S AN FDA APPROVED PRODUCT WE'RE TESTING LOOKING AT THE EVIDENCE FOR THAT INDICATION. WE'RE TALKING ABOUT OFF LABEL INDICATIONS THAT IT'S DIFFICULT TO ANSWER WITHOUT LOOKING AT THE FACTS OF THE MATTER. >> CAN I ASK ONE OTHER WRINKLE ON THAT. BETWEEN THE TIME A TRIAL LET'S SAY A TRIAL IS NOT UNDER CED BUT IT'S ENDING TAKES A WHILE FOR FDA APPROVAL, IS THERE ANY BRIDGE IN THAT INTERSPACE? >> I WOULD SAY IF WE'RE COVERING ON THE FRONT END. DEPENDS ON THE FACTS OF THE MATTER. BUT ACTUALLY WE USUALLY LOOK AT FDA APPROVED DEVICES. SO THEY'RE APPROVED ALREADY THEORETICALLY. BUT TO YOUR QUESTION, IF THE TRIAL HAS ENDED IS NOT IN THE CED AND IT TAKES A WHILE FOR US TO APPROVE, DO WHAT'S CALLED RECONSIDERATION LATER, BUT THERE'S -- IF WE HAVE ALREADY APPROVED IT UNDER THE CED WE WILL STILL CONTINUE TO COVER IT IN THE FUTURE. THAT IS IT DEPENDS ON WHAT IS THE STATUS OF THE DEVICE IN TERMS OF APPROVAL FROM OUR END AT THE TIME IT'S IMPLANTED AND MAY NOT CHANGE AFTER THAT. UNTIL WE RECONSIDER THE WHOLE ISSUE. THAT'S A SHORT AND DIRTY ANSWER. OKAY. >> THAT'S GREAT. IF YOU DON'T MIND HOLDING YOUR QUESTION IN WORKING MEMORY FOR A LITTLE BIT LONGER. WE'VE GOT THREE MORE PRESENTATIONS HALFWAY THROUGH THE PRESENTATIONS WE HAVE 45 MINUTES SCHEDULED AFTER THIS FOR PANEL DISCUSSION. IT WILL BE AN EXERCISE IN WORKING MEMORY FOR ALL OF US BECAUSE A LOT OF BALLS TO KEEP UP IN THE AIR IN ORDER TO HAVE A FULFILLING AND THOROUGH DISCUSSION AT THE END OF THIS. I'D LOVE TO INTRODUCE NOW OUR NEXT SPEAKER, DR. ROBINSON BEALE. DR. RHONDA ROBINSON BEALE IS A SENIOR HEALTHCARE EXECUTIVE 30 YEARS OF EXPERIENCE IN HEALTHCARE SYSTEMS MANAGED CARE QUALITY IMPROVEMENT BEHAVIORAL HEALTH MEDICAL CARE. SVP DEPUTY CHIEF MEDICAL OFFICER FOR MENTAL HEALTH SERVICES FOR UNITED HEALTH GROUP PREVIOUSLY SERVED AS CHIEF MEDICAL OFFICER AND PHYSICIAN EXECUTIVE WITHIN SEVERAL LARGE NATIONAL AND LOCAL HEALTH ORGANIZATIONS. OPTUM SUB SUBSIDIARY OF UNITED, SIGNA AND BLUE CROSS/BLUE SHIELD MICHIGAN AND HEALTH BLINDS IN MICHIGAN. WELCOME DR. BEALE. WOULD YOU MIND UNMUTING, PLEASE. >> IF YOU'RE ON A PHONE UNMUTE BY HITTING STAR 6. >> HELLO. >> THERE YOU ARE. >> THAT'S BETTER NOW, I THINK. >> OKAY. ALL RIGHT. [INAUDIBLE] THE CHALLENGES I'VE HAD TODAY. AND FIRST OF ALL, I WANT TO THANK YOU FOR THE OPPORTUNITY TO BE HERE FOR THIS IMPORTANT SUBJECT. AND IT'S CERTAINLY ONES THAT ALL THE OTHER PREVIOUS PANELIST [INAUDIBLE] BEING COMPLEX AND MULTIFACTORIAL. AND [INAUDIBLE] VERY, VERY COMPLEX AND IF IT WAS SIMPLE TO RESOLVE, IT WOULD HAVE BEEN RESOLVED BY NOW. I DO THINK THAT HAVING THIS KIND OF CONVERSATION WITH MULTISTAKEHOLDERS AND [INAUDIBLE] CAN HELP GET [INAUDIBLE] TO A SOLUTION OR A DIRECTION OF SOLUTIONS. I AM NOT ABLE TO SHARE MY SLIDES WITH YOU GUYS SO I WILL TALK FROM THEM. AND TO TALK ABOUT A PAYER'S PERSPECTIVE. FIRST OF ALL, TO SAY THAT MY COMMENTS THAT I'M GOING TO PRESENT ARE NOT MEANT TO BE A REPRESENTATIVE OF ANY ONE HEALTH INSURANCE COMPANY. I'M REALLY BRINGING THE EXPERIENCE [INAUDIBLE] TO INCLUDING UNITED BUT OTHERS IN TERMS OF [INAUDIBLE] HOW THEY'VE ADDRESSED THIS PARTICULAR SUBJECT. LET'S OVERALL TALK ABOUT INSURANCE [INAUDIBLE] [INAUDIBLE] LEVEL SETTING HERE TO MAKE SURE THAT WE'RE ALL [INAUDIBLE]. >> EVERY FIFTH WORD OR SO IS DROPPING OUT. I WONDER IF THERE'S A WAY TO GET THE MIC CLOSER. >> ALL RIGHT. IS THIS BETTER? >> I THINK SO. THANK YOU. SORRY. >> OKAY. SORRY. SO [INAUDIBLE] HEALTHCARE INNOVATION DIAGNOSTICS [INAUDIBLE] MUST BE SUFFICIENTLY AND CONSISTENTLY [INAUDIBLE] TO BE IMPACTFUL WITH PATIENT -- THAT'S KIND OF THE BOTTOM IN TERMS OF THE THRESHOLD THAT NEEDS TO BE [INAUDIBLE] COVERAGE. INSURANCE [INAUDIBLE] THEN BENEFIT COVERAGE. [INAUDIBLE] TO INSURANCE DIFFERENT PAYERS CAN HAVE DIFFERENT PATHS AS TO WHEN AND WHAT THEY WILL COVER OF THOSE TECHNOLOGIES EVEN THOUGH THEY ARE PROVEN AND EVEN THOUGH THEY'RE FDA APPROVED. KEEP IN MIND [INAUDIBLE] >> DR. ROBINSON BEALE, I'M SORRY, WONDER IF THERE'S A DIFFERENT WAY TO CONNECT YOUR AUDIO. SEVERAL OF US ARE STILL GETTING AUDIO DROPOUT. >> ARE YOU ABLE TO USE AUDIO ON YOUR COMPUTER, LOOKS LIKE YOU WEREN'T ABLE TO EARLIER THAT'S WHY YOU'RE ON YOUR PHONE. >> THAT'S WHY I CAN'T SEE THE ICON I TRIED SEVERAL THINGS AS I WAS SITTING [INAUDIBLE] WOULD YOU WANT TO GO ON WITH THE DIFFERENT SPEAKER UNTIL I GET A DIFFERENT MECHANISM FOR THIS? >> I THINK THAT'S A GOOD IDEA. IF YOU DON'T MIND SORRY TO INCONVENIENCE YOU MAYBE WE CAN TRY THAT SEE IN THE MEANWHILE IF WE CAN WORK BACK TO SOME OF THE OTHER AUDIO OPTIONS. >> I'LL REACH BACK OUT TO YOU. >> THANK YOU. >> WE'LL MOVE FORWARD TO THE NEXT PANEL SPEAKER AS WE WORK WITH THE TECH ISSUES WITH DR. ROBINSON BEALE. WITH THAT I'LL INTRODUCE SHIRLEY MCCARTNEY SERVES AS DIRECTOR OF NEUROLOGICAL SURGERY RESEARCH FOR BOTH CLINICAL TRIALS AND INVESTIGATOR INITIATIVE CLINICAL RESEARCH IN THE SCHOOL OF MEDICINE AT OREGON HEALTH AND SCIENCE UNIVERSITY. THE RESPONSIBILITIES INCLUDE TEACHING AND DIRECTING FACULTY AND STAFF OF THE DEPARTMENT OF NEUROLOGICAL SURGERY ON OHSU INSTITUTIONAL REVIEW BOARD POLICIES, CLINICAL TRIAL MANAGEMENT AND ACADEMIC PUBLISHING ETHICS. DR. MCCARTNEY. >> GOOD AFTERNOON. CAN YOU HEAR ME? >> YES, WE CAN HEAR YOU. >> THANK YOU. I THINK I MENTIONED EARLIER I HAVE A DEMENTED HEADSET. I WOULD MOVE YOU ALL IN FRONT OF MY NOTES. I'LL MOVE YOU ALL. I'D LIKE TO BEGIN THAT THE LAND FOR OREGON HEALTH SCIENCE RESTS ON THE TRADITIONAL VILLAGE SITES OF THE CHINOOK AND OTHER TRIBES WHO MADE THEIR HOMES AND FORMED COMMUNITIES ALONG THE COLUMBIA RIVER. I'D LIKE TO YOU JOIN ME IN TAKING THIS OPPORTUNITY TO PAY RESPECT HONOR AND THANK PAST, PRESENT AND FUTURE TRIBAL GENERATIONS FOR THEIR SACRIFICE AND CARE OF THE LAND. I DO NOT HAVE ANY DISCLOSURES. MY THOUGHTS AND COMMENTS TODAY ARE MY OWN. I DO NOT REPRESENT THOSE OF OREGON HEALTH AND SCIENCE UNIVERSITY. I TRULY APPRECIATE HEARING FROM THE PARTICIPANTS THIS MORNING, IT WAS VERY INFORMATIVE AND VERY HUMBLING. AS WE HEARD EARLIER TODAY, WHAT IS THE BOUNDARY BETWEEN RESEARCH AND CLINICAL CARE? AND AT A PREVIOUS MEETING, FOUR TOPICS WERE HIGHLIGHTED FOR DISCUSSION AROUND POST-TRIAL CARE. AND I'M GOING TO FOCUS MY DISCUSSION WITH YOU ON THOSE FOUR TOPICS. MINIMUM CARE. SETTING EXPECTATIONS, FACTORS THAT IMPACT CARE AND COVERAGE AND GAPS IN CARE. SO NEXT SLIDE. MINIMUM CARE. WHILST TRIAL CARE IS A DIFFICULT DEFINITION AND CAN BE CONFUSING TO PATIENTS, WE HAVE HAD STANDARD OF CARE PATIENTS CALL OUR CLINK THINKING THEY'RE IN A CLINICAL TRIAL WHEN IN FACT THEY'RE NOT. MANY INSTITUTIONS IMPLANT DEVICES WITH THE TRIAL OF THE DEVICE TO DETERMINE EFFICACY BEFORE PERMANENT DEVICE IMPLANTATION, AS IS THE CASE FOR SPINAL CORD STIMULATION. AND IT'S WORTH REMEMBERING THAT MANY INSTITUTIONS PROVIDE STATE-OF-THE-ART POST IMPLANT DEVICE TRIAL CARE ALREADY FOR DEVICES THAT ARE APPROVED. AND ADDED TO THAT, MANUFACTURER REPRESENTATIVETIVES ARE OFTEN INVOLVED AND PLAY A PIVOTAL ROLE IN STANDARD OF CARE. THE QUESTION IS, DID THE DEVICE RECEIVE FDA APPROVAL, YES OR NO. AND THIS ANSWER LIKELY DICTATES TWO POTENTIAL PATHS FOR MINIMUM OF CARE. PATH ONE. A DEVICE IS APPROVED AND WILL BE USED COMMERCIALLY. WAS THERE A PREDETERMINED THRESHOLD ACROSS STUDIES THAT DETERMINED BENEFIT? BENEFIT IN TERMS OF CARE? WHAT DOES CARE EXTEND TO IN THIS INSTANCE? A CLEAR UNDERSTANDING OF BENEFIT TO THE PATIENTS DOES THIS INCLUDE CLINICAL BENEFIT ONLY? IS THE DEVICE PROVIDING CLINICAL MEASURABLE BENEFIT TO PATIENTS AND IS THE DEVICE ALSO APPROVED FOR USE MEDICARE MEDICAID SERVICES JUST AS WE HEARD. AND IS THERE ACCESS TO DATA GENERATED DURING THE CLINICAL TRIAL PATIENTS PERSONAL DATA AND GLOBAL DATA AGAIN WE HEARD THAT EARLIER THIS MORNING. AND WAS THERE SUFFICIENT TIME FOR THE PATIENT TO DECIDE IF HE WISHED TO TRANSITION TO COMMERCIAL USE OR NOT, THAT IS TO INSTITUTIONAL STANDARD OF CARE PROTONS, EVEN IF THOSE ARE AVAILABLE. AND I JUST WANT US TO NOT FORGET AND CONTINUE TO REMEMBER PATIENTS THEMSELVES PROVIDE THE DATA THAT IS NEEDED FOR THE DEVICE APPROVAL. ETHICALLY, WHO IS REALLY RESPONSIBLE FOR CONTINUATION OF CARE IN THIS INSTANCE? AND PATH TWO, A DEVICE IS NOT APPROVED. IF NOT APPROVED, IS THERE AN AVENUE FOR CONTINUED ACCESS TO AN INVESTIGATIONAL DEVICE IF IN A CASE WHERE THERE IS CLINICAL BENEFIT TO THE PATIENT? DID THE STUDY INCLUDE COST OF APPROVAL REPLACEMENT REACHING END OF LIFE AND ALTERNATE RESOURCES THAT WERE NOT RELATED TO THE DEVICE? WHAT IF THE SPONSOR DECIDES NOT TO PURSUE FURTHER RESEARCH AND/OR DEVICE APPROVAL AFTER STUDY END, WHAT THEN IS THE SPONSORS ROLE? AND ONCE AGAIN ETHICALLY WHO IS RESPONSIBLE FOR THE CARE OF WHAT COULD NOW BE REFERRED TO AS A TRIAL ABANDONED PATIENT? AS ENDORSED HERE WE ALL AGREE MAINTAINING COORDINATION OF CARE IS CRITICAL FOR STUDY PATIENTS LEAVING A DEVICE TRIAL. NEXT SLIDE. SETTING EXPECTATIONS FOR ME PERSONALLY THIS COMES DOWN TO THREE QUESTIONS, EDUCATION AND TRUST COMMUNICATION AND NAVIGATION OF THE HEALTHCARE SYSTEM ITSELF. TIME SPENT WITH SUBJECTS IN A CLINICAL STUDY CAN BE LONG AND THERE ARE LONG REPEATED VISITS, VISITS MAY LAST FOR YEARS AND RELATIONSHIP IS BUILT WITH THE STUDY TEAM AND THE PRINCIPAL INVESTIGATOR. AND SINCE THAT RELATIONSHIP DEVELOPS OVER TIME, I WONDER IF THERE'S AN OPPORTUNITY IN THE INFORMED CONSENT PROCESS TO WORK ON LANGUAGE, LANGUAGE THAT SETS EXPECTATIONS RELATED TO POST-TRIAL CARE, FINANCIAL COST COULD BE ESTABLISHED DURING RECRUITMENT AND INFORMED CONSENT PROCESS, LONG BEFORE THE TRIAL IS EVEN COMPLETED. FOR SOME CLINICAL TRIALS THE INFORMED CONSENT PROCESS INVOLVES PROVIDING THE PATIENTS WITH FINANCIAL INFORMATION ABOUT THE COST OF COVERAGE THROUGHOUT THE TRIAL BUT NOT NECESSARILY AFTER THE TRIAL HAS ENDED AND WE'VE HEARD THAT ALREADY TODAY ALSO. WHAT I'M SUGGESTING IS TO PROVIDE PATIENTS WITH INFORMATION RELATED TO POSSIBLE FINANCIAL BURDEN OR NOT THAT MIGHT OCCUR AT A LATER DATE LONG BEFORE THEY AGREE TO PARTICIPATE. HOWEVER, THAT BEING SAID, FORECASTING THE POSSIBLE NEEDS OF A PATIENT WITH A DEVICE SUCH AS A BATTERY REPLACEMENT OR A NEED OR COMPATIBILITY AS WE HEARD EARLIER TODAY CAN ALSO BE DIFFICULT. AND PATIENTS MAY STILL NEED ADDITIONAL SURGERY. WITH INPUT FROM SOME OF MY NEUROSURGICAL COLLEAGUES. HAVE TWO EXAMPLES OF TRIAL PATIENTS, WHERE SETTING EXPECTATIONS EARLY ON MAY HAVE HELPED. IN A STUDY FOR DEEP BRAIN STIMULATION FOR DEPRESSION, SPONSOR, PAYING FOR GENERATOR REPLACEMENTS, AND THE PATIENTS WERE LEFT WITH NO RECOURSE. AFTER THE TRIAL WAS CLOSED AND THE RENEWAL INSURANCE COVERAGE, GANGLING STIMULATION PER CLUSTER THE SPONSOR FILED FOR BANKRUPTCY AND THE UNIVERSITY FOUND THEMSELVES IN A POSITION THAT THEY HAD TO FIND RESOURCES TO COVER A IMPLEMENTATION OF THE DEVICE. ETHICALLY, WHO'S RESPONSIBLE FOR THE CONTINUATION OF CARE, AND THE CONTINUATION OF COVERING COST. NEST SLIDE. FACTORS THAT IMPACT COVERAGE. THE HEALTH CARE SYSTEM ITSELF. MEDICALLY UNDER SERVED COMMUNITIES AND POPULATIONS JUST GENERALLY DO NOT HAVE ACCESS. TRUST. IF THE PANDEMIC HAS TAUGHT US ANYTHING, THAT IS THERE IS A LACK OF TRUST IN MANY COMMUNITIES RELATED TO HEALTH CARE ISSUES. STATE AND FEDERAL LIMITATIONS, AND I HAVE TWO EXAMPLES, I CAN TELL YOU THAT IN OREGON PSYCHO SURGERY IS AMONG THE LIST OF CONDUCT THAT IS GROUND FOR DISCIPLINE. PSYCHOSURGERY IS DEFINED AS ANY OPERATION DESIGNED TO PRODUCE AN IRREVERSIBLE LESION OR DESTROY BRAIN TISSUE FOR THE PRIMARY PURPOSE OF ALTERING THE THOUGHTS, EMOTIONS, OR BEHAV BEHAVIOROF A HUMAN BEING. HOWEVER THE TERM DOES NOT INCLUDE PROCEDURES UNDER TAKEN TO CURE WELL DEFINED DISEASE STATES, SUCH AS BRAIN TUMOR EPILEPTIC FOCI AND CERTAIN CHRONIC PAIN SYNDROMES.IN ADDITION SHE NOTIC BRAIN SURGERY FOR OTHER PURPOSES, ALSO ACCEPTABLE. SO SOME OF YOU WHO ARE IN THE PANEL THIS MORNING WOULD NOT BE HAVE ACCESS TO THIS PROCEDURE, IN OREGON. HIGHLY EX-PER EXPERIENCEDED TEAM PERFORMING THE FIRST DEEP BRAIN SURGERY FOR PARKINSON'S DISEASE IN THE UNITED STATES, IN 1991, AND THIS HAS EXPERTISE IN OUR STATE, THAT CANNOT BE UTILIZED AND THIS IS A LOST OPPORTUNITY. ALSO ADD THE OREGON IS A VERY INTERESTING STATE. WE DO HAVE REALIZED PSILOCYBIN FOR TREATMENT OF DEPRESSION. SO IT'S AN INTERESTING PLACE TO LIVE. PERIPHERAL NERVE STIMULATION WAS INVENTED IN THE 1960S, EVEN BEFORE SPINAL CORD STIMULATION, STARTING IN 2012 A NUMBER OF THERAPEUTIC DEVICES THAT STIMULATE PERIPHERAL NERVES OR THAT PROVIDE PERIPHERAL NERVE FIELD STIMULATION RECEIVED WITH THE APPROVAL IN A NUMBER OF REGIONS AROUND THE WORLD FOR THE TREATMENT OF NEUROPATHIC PAIN, AND, AND SOME GEOGRAPHIC AREAS MIGRAINE HEADACHES AND OVERACTIVE BLADDER, BUT NOT IN ALL GEOGRAPHIC AREAS. AGAIN, THIS COMES DOWN TO ACCESS. GEOGRAPHY CAN BE A CHALLENGE. SOME RESEARCH STUDIES INCLUDE TRAVEL COMPENSATION FOR SUBJECTS. ONE ASSUMES THAT THIS WOULD NO LONGER BE AVAILABLE IF A DEVICE IS SUBSEQUENTLY APPROVED FOR USE. AND THEN WHAT THAT MEANS THERE'S LOCAL ACCESS TO CARE AND INDIVIDUALS WHO CAN HELP COORDINATE OR SUPPORT THE TRANSITION FROM CLINICAL RESEARCH TRIAL PARTICIPANTS TO STANDARD OF CARE JUST MAY NOT BE AVAILABLE. FINANCIAL CONCERNS AND ADEQUATE INSURANCE COVERAGE IS LIKELY IN MOST CASES AT THE COST OF THE INVESTIGATIONAL DEVICE AND CARE WERE COVERED WHILE THE PAYMENT IN THE STUDY AND AN ACTIVE PARTICIPANT. AS REFERENCED EARLIER, DE PRIORITIZED BY THE FUNDING ENTITYPATIENTS MAY BE LEFT WITHOUT SUPPORT. THAT IS THE BECOME TRIAL ABANDONED. THE TYPE OF SPONSOR, IS IT FEDERAL OR INDUSTRY SPONSOR, I WONDER ALSO IF THERE IS AN OPPORTUNITY TO CONSIDER LANGUAGE AND CONTRACTS WITH REGARDS TO THE LEVEL OF FUNDING FROM THE ENTY IF THEY DO NOT COVER COST, PARTICULARLY THOSE WITH DEVICE MAINTENANCE. AND GAPS. MAINTAINING COORDINATION OF CARE IS CRITICAL FOR STUDY PARTICIPANTS LEAVING A TRIAL. PERHAPS NIH PARTNERSHIP WITH CENTERS FOR MEDICARE AND MEDICAID SERVICES, AND SPONSORS COULD WORK TO PROVIDE RESOURCES FOR SUCH SITUATIONS, AND IT SOUNDS LIKE THAT'S HAPPENED IN SOME SITUATIONS AS IT WAS DISCUSSED FOR NEUROCASE. FUNDING FOR POST TRAIL CARE FOR ALL PARTICIPANTS, A MINIMUM WAGE FOR INVESTIGATIONAL DEVICE REMOVAL SHOULD THE PATIENT DESIRE THAT. A SOLUTION COULD BE EMPLOYED TO A SOLUTION COULD BE TO EMPLOY PATIENT ADVOCATES, MUCH LIKE COORDINATORS WHO SERVE AS LIAISONS BETWEEN THE CLINICAL TRIAL TEAM, AND PATIENTS THROUGHOUT THE PATIENT'S LIFE. TO ENSURE THAT ONE, ARE IS PROPERLY COORDINATED. TWO, NEW FINDINGS FROM CLINICAL TRIAL ANALYSIS ARE SHARED WITH THE PATIENTS AND THREE: PATIENTS CAN OBTAIN SUPPORT FOR THEIR IMPLANTED DEVICES, AND WE COULD THINK OF THIS AS SIMILAR TO THE MANUFACTURER REPRESENTATIVES WHO ARE OFTEN INVOLVED IN STANDARD OF CARE, POST DEVICE. HOWEVER, IN MOST CASES, ACCESS TO SUPPORT AND RESOURCES, EG. FOR EXAMPLE, SOCIAL WORKERS OR STUDY COORDINATORS MAY BE LIMITED TO THE PERIOD DIRECTLY FOLLOWING CLINICAL TRIAL INVOLVEMENT, RATHER THAN AN EXTENDED THROUGHOUT THE PATIENT'S LIFETIME, EAVING PATIENTS WITH NO LONG TERM SUPPORT TO COORDINATE CARE AND ABILITY TO NAVIGATE INSURANCE ISSUES. IT'S IMPERATIVE THAT SOLUTION BE IDENTIFIED TO ENSURE NO GAPS BETWEEN PATIENT CARE COORDINATION AND SUPPORT, THANK YOU. I REALLY LOOK FORWARD TO DISCUSSING OPPORTUNITIES WHERE GROWTH AND DEVELOPMENT MIGHT BE. DOES ANYONE HAVE ANY QUESTIONS? WE HAVE TIME FOR QUESTIONS, IF ANYONE HAS ONE. >> I CAN ASK A QUESTION. SO THIS WAS REALLY HELPFUL. THANK YOU FOR YOUR INSIGHTS. I WAS WONDERING IF YOU COULD GIVE SOME SORT OF INSIGHTS INTO WHAT FROM AN INSTITUTIONAL PERSPECTIVE IS SORT OF -- SOMETIMES PROVIDED, ALWAYS PROVIDED, NEVER PROVIDED WHEN IT COMES TO POST-TRIAL CARE. >> IT'S REALLY, REALLY HARD TO NAVIGATE EVEN WITHIN A STUDY. AND I WOULD PUSH BACK TO A COMMENT A LITTLE BIT EARLIER, MY EXPERIENCE FROM RESEARCH ADMINISTRATION STANDPOINT, WE DO NOT MAKE MONEY OUT OF STUDIES AND BARELY BREAK EVEN, IN MANY CASES WE LOSE FUNDING, ON THE PLUS SIDE THE PATIENTS DO GET TO BILLED UP A REALLY CLOSE RELATIONSHIP WITH PROVIDERS. IN THIS CASE THE STUDY COORDINATORS. AND ONE THING I HAVE BEEN THINKING ABOUT ALSO IN A BIGGER SENSE IS THAT NO ONE REALLY OFFERS CLINICAL RESEARCH COORDINATOR EXPERIENCE AS A CAREER. AND I DO SEE THAT NOW AS BEING A CAREER. BECAUSE, THEY ARE DEFINITELY THE PEOPLE WHO CAN BEST NAVIGATE WHAT'S IN THE CONSENT FORM, IN THE CONTRACT, AND WORK REALLY CLOSELY WITH PATIENTS FOR THEIR BENEFIT. BUT NAVIGATING WHAT IS PROVIDED, AND NOT PROVIDED IS REALLY, REALLY DIFFICULT FOR THE COORDINATORS OFTEN. >> THANK YOU. >> THANK YOU. >> DR. ROBINSON BEALE, LET'S CHECK IN AGAIN IF YOU HAD A CHANCE WITH A DIFFERENT AUDIO STRATEGY. >> ALL RIGHT, CAN YOU HEAR ME THIS TIME? >> YES, YOU SOUND WAY BETTER. >> VERY PROMISING. >> PERFECT. >> ALL RIGHT, GREAT. THANK YOU SO MUCH. SAMEER FOR YOUR GUIDANCE ON THAT. I WAS VERY PANICKED BY THIS, I WANT YOU TO KNOW. LET ME GO BACK AGAIN AND QUICKLY SAY THAT WHAT I'M GOING TO PRESENT IS NOT REPRESENTATIVE OF ANY ONE INSURANCE. WHAT I DID IN PREPARATION WAS TALK TO MANY COLLEAGUES FROM DIFFERENT INSURERS TO GET A COMMON THEME AS TO HOW THEY APPROACH THESE ISSUES AND WHAT ARE THE ISSUES AND CONCERNS THAT THEY HAVE. AS AN OVERVIEW, IT'S REAL IMPORTANT TO UNDERSTAND THAT THE GENERAL THRESHOLD FOR COVERAGE BY INSURERS IS THAT THE TECHNOLOGY WHETHER FOR DIAGNOSTIC TREATMENTS AND DEVICES AND OTHERS, MUST BE SUFFICIENTLY AND CONSISTENTLY RESEARCH-PROVEN, AND NEEDS TO SHOW IT HAS IMPACT, AND EFFICACIOUS AND PROVIDES PATIENT SAFETY. THIS IS FOR INSURANCE COVERAGE THAT IS DIFFERENT THAN A BENEFIT. MEANING THAT THERE IS SPECIFIC INFORMATION WITHIN THE INSURANCE CONTRACT THAT SAYS THAT THIS PARTICULAR TYPE OF SERVICE IS SOMETHING THAT IS COVERED. IN MOST CASES THE THE GENERAL ACCEPTED TREATMENTS ARE, BUT THERE ARE SOME EXCEPTIONS THAT CAN POP UP. THE REASON WHY I BRING THIS UP IS BECAUSE WHEN YOU LOOK AT PAIRS THERE ARE DIFFERENT TYPES OF PAYERS. YOU HAVE EMPLOYERS WHO FUND MAJORITY OF HEALTH CARE, MEDICARE IS NEXT MEDICAID IS NEXT AND AFTER THAT MEDICAID CHIP AND AFFORDABLE CARE ACT. THERE ARE ALSO THOSE PROVIDERS -- LARGE SYSTEMS THAT ARE CAPITATED. THEY DON'T NECESSARILY CREATE THEIR OWN INSURANCE BENEFITS AND GENERAL COVER THE INSURANCE COVERAGE, THE SCOPE OF SERVICES COVERED BY THE INSURER THAT SET THEM UP IN CAPITATED ARRANGEMENT, AND THEN LAST CATEGORY OF PAYERS ARE INDIVIDUALS WHO PAY FOR THEIR OWN, AND THAT'S PORTAL OF DIRECT TO CONSUMER TYPE OF CARE, AND MANY TIMES THOSE ARE CARE OR SERVICES THAT HAVE NOT BEEN PROVEN TO BE THROUGH RESEARCH. AND WHAT I WOULD CALL THE GROUND-UP TYPE OF RESEARCH THAT IS DONE BY PROVIDERS WHO ARE FINDING NEW WAYS TO APPLY EXISTING TECHNOLOGIES AND MANY TIMES ARE FINDING WITH INDIVIDUAL PATIENTS SOME POSITIVE EFFECT. I BRING THAT UP, BECAUSE THAT IS A WHOLE DIFFERENT ROAD TO INSURANCE COVERAGE AS OPPOSED TO THOSE COMING THROUGH THE TYPICAL RO ROUTE OF CLINICAL TRIALS AND RESEARCH, AND OTHER METHODOLOGIES. THE FACTORS THAT IMPACT INSURANCE COVERAGE ARE THE DIFFERENCE IN THE PAYER SOURCES AS I MENTIONED. POLICY VERSUS BENEFIT WHICH I JUST MENTIONED AND THE DIVE DIVERGENCE OF COST OFFSET. THAT HAS BEEN ALLUDED TO BY MANY OF THE PANELISTS THAT ON THE MANUFACTURERS SIDE BUT ALSO ON THE INSURANCE COVERAGE SIGN. THERE IS A CONSIDERATION, CERTAINLY NOT THE ONLY CONSIDERATION, BUT IT IS A CONSIDERATION IN LOOKING AT COVERAGE IS THAT, OF HAVING A COST OFFSET. REASON BEING IS IF YOU LOOK AT INSURANCE OR PAYERS -- I WON'T SAY BANKERS -- BUT THE ADMINISTRATOR OVER A TRUST. AND THE TRUST HAS A CERTAIN AMOUNT OF MONEY IN IT. AND IT IS TO BE APPLIED TO THE POPULATION IT SERVES. SO PART OF THE DECISION-MAKING IS AS NEW TECHNOLOGIES COME IN, HOW DO YOU FIT THAT WITHIN THE CERTAIN AMOUNT OF MONEY THAT IS THERE TO BE DISTRIBUTED TO THE POPULATION THAT WOULD BE UTILIZING SERVICES. WE KNOW NOW THAT 5-7% OF THE POPULATION CONSUMES 82% OF THE DOLLARS, FOR MEDICAL COVERAGE. RECOGNIZING THIS DIFFERENCE IT IS VERY IMPORTANT TO UNDERSTAND WHEN SOMETHING IS PROVEN EFFICACIOUS AND MANY OTHER QUESTIONS THAT NEED TO BE ASKED. I THINK DR. LI STARTED SOME OF THOSE, AND I'LL JUST ADD TO SOME OF THOSE QUESTIONS. IT'S NOT ONLY LOOKING AT WHETHER IT'S EFFICACIOUS BUT HOW LONG IS IT EFFICACIOUS? DOES IT NEED TO BE REPEATED? WHAT'S THE LONG TERM RAMIFICATIONS OF USING THIS PARTICULAR TREATMENT, OR THIS DIAGNOSTIC SO THAT ONE BEGINS TO UNDERSTAND THIS THIS PERSON GOING TO NEED TO HAVE ONGOING CARE, WE TALKED ABOUT REPLACEMENT REPEAT SURGERY, ALL OF THOSE PIECES NEED TO BE TAKEN IN CONSIDERATION AS WELL AS IDENTIFIED IN ANSWERED TO GIVE A FULL SCOPE OF WHAT THIS PARTICULAR PROCEDURE IN THE LONG RUN IS GOING TO CAUSE AND HOW IT FITS INTO THIS GENERAL POT THAT I'VE DESCRIBED. THAT IS THE GENERAL POT OF MONEY THAT IS USED FOR THE TOTAL POPULATION. THE REASON WHY THAT IS IMPORTANT AND AS WE ALL ARE AWARE IN UNITED STATES HEALTH CARE IS EXTREMELY EXPENSIVE. AND OVERALL OUTCOME AND COMPARISON TO OTHER COUNTRIES IS VERY POOR. BUT ALSO EXPERIENCING CONTINUING EXPERIENCE OF ESCALATING HEALTH CARE COSTS THAT GETS PASSED ON TO INDIVIDUALS TERMS OF PREMIUMS AND COPAYMENTS AND COINSURANCE ON A WAY TO TRY AND CURB SOME OF THAT COST. IN TERMS OF LOOKING AT THOSE TECHNOLOGIES AND WHETHER OR NOT COVERED. DR. LI MENTIONED THE WHOLE EVIDENCE -- THE HIERARCHY OF EVIDENCE USED. METAANALYSIS, RANDOMIZED CLINICAL TRIALS, AND THOSE IN LARGE RANDOMIZED TRIALS. WHAT IS REALLY IMPORTANT IN MOST HEALTH PLANS, THERE IS A POLICY COMMITTEE THAT LOOKS AT THE EVIDENCE, REVIEWS THE EVIDENCE AND DETERMINES WHETHER OR NOT THE EVIDENCE THAT HAS BEEN PRESENTEDED DEMONSTRATES EFFECT EFFICACIOUSNESS IN TERMS OF A PATIENT POPULATION. HOPEFULLY THAT IT'S SPECIFIC ENOUGH THAT ONE CAN IDENTIFY THE PATIENTS THAT PARTICULAR TECHNOLOGY WILL WORK BEST FOR AND IDENTIFY WHO IS WHAT TYPE OF TRAINING IS NECESSARY FOR THAT TECHNOLOGY TO BE RENDERED, AND RENDERED WELL WITH FIDELITY. AS FELL, AS I MENTIONED BEFORE, HOW LONG DOES TREATMENT OCCUR. . WHAT'S THE LONG TERM EFFECT, ALL OF THOSE PIECES. EVEN IF THE EVIDENCE IS NOT PRESENT, AND PARTICULARLY IF IT'S A CONDITION THAT THERE IS THE POSSIBILITY OF IMMINENT DEATH. THERE ARE REGULATIONS THAT REALLY REQUIRE PAYERS TO COVER NONPROVEN TECHNOLOGIES WITH A CERTAIN LEVEL OF RIGOR IN THOSE TECHNOLOGIES, AND MOST COMMONLY APPLIED TO CANCER. THE OTHER AREAS THAT ARE USED TO DETERMINE THINGS THAT ARE COVERED ARE THOSE THAT ARE CONSIDERED WIDELY ACCEPTED MEDICAL PRACTICES, AND GENERALLY THOSE ARE THINGS THAT HAVE BEEN LONG STANDING AND HAVE NOT NECESSARILY GONE THROUGH THE RIGOR OF RESEARCH, FORMAL RESEARCH, BUT HAS BEEN VETTED THROUGH THE WIDE POPULATION EXPOSURE TO THOSE PARTICULAR SERVICES. OTHERS ARE PROVIDED ORGANIZATIONS THAT GENERATE EVIDENCE-BASED GUIDELINES THAT IS COMBINATION OF RESEARCH, AND ALSO PRACTICE WHERE THEY BRING IN EXPERIENCE OF PROVIDERS RENDERING THE SERVICES AND HELP TO COMBINE THAT INFORMATION TOGETHER TO DEVELOP GUIDELINES, PRACTICAL GUIDELINES. AND THEN NATIONAL CONSENSUS STATEMENTS AND PUBLICATIONS THAT ARE USED. >> I THINK WE LOST THE CONNECTION. >>OUR LAST SPEAKER OF THE SESSION, A PLEASURE TO INTRODUCE IS DR. LANGHALS. WHO SERVES AS SUPERVISORY PROGRAM DIRECTOR, LEADING THE TRANSLATIONAL DEVICES TEAM WITH WITHIN THE DIVISION OF TRANSLATIONAL RESEARCH E IS A TEAM LEAD IN BOTH THE UNITED BRAIN INITIATIVE, AS WELL AS THE BLUEPRINT MED TECH PROGRAM AND HIS TEAM ALSO LEADS EFFORTS WITHIN THE STIMULATING PERIPHERAL ACTIVITY TO RELIEVE CONDITIONS SPARK PROGRAM, AND LONG TERM THE HEAL INITIATIVE. CURRENTLY OVERSEES THE GRANT PORTFOLIO IN THE AREAS OF NEURO TECHNOLOGY DEVELOPMENT VALIDATION AND TRANSLATION FOR APPLICATIONS IN NEUROSCIENCE AND PHYSIOLOGY MOVING DISORDERS. DR. LANGHALS. >> I'LL JUST WALK THROUGH LITTLE BIT OF THE NIH SIDE OF THINGS. ND WHAT I'VE DONE AND WE'VE DONE WITHIN SEVERAL OF OUR TRANSLATION WILL PROGRAMS AS IT RELATES TO LOOKING AT CONTINUING TRIAL RESPONSIBILITIES AND POST-TRIAL CARE. NEXT SLIDE. SO OVERALL IN OUR PROGRAMS, AND THE BRAND INITIATIVE IN PARTICULAR, WE SUPPORT VARIOUS DIFFERENT FUNDING OPPORTUNITIES FROM VERY EARLY STAGE AND OF CONCEPT GENERATION AND DEVICE DEVELOPMENT ALL THE WAY THROUGH LOTS OF THE THESE ACTIVITIES IN FIRST IN HUMAN TRIALS OF NEW DEVICES, EARLY FEASIBILITY STUDIES AND AN ADDITIONAL ACTIVITIES IN THE CLINICAL TRIALS PIPELINE. IN PARTICULAR, AS NOTED HERE, WITH WITHIN MY GROUP WE'RE MANAGING ACTIVITIES BOTH WITHIN THESE BRAIN INITIATIVE PROGRAMS IN THE SUPPORT BOTH THE LATE STAGE PRECLINICAL DEVELOPMENT. AND FIRST IN HUMAN TRIALS IN THE PHASE 2 AWARD. AND AS WELL AS APPLICATION FOR DIRECT TO UH3'S, FOR THOSE READY TO BEGIN THE CLINICAL TRIAL OF THE TECHNOLOGY IN NEW TARGET OR NEW INDICATION. AND SIMILARLY, WE SYNERGIZED A LOT OF THE LANGUAGE IN OUR FUNDING OPPORTUNITIES ACROSS THE NEWLY LAUNCHED BLUEPRINT MED TECH PROGRAM THAT IS DESIGNED AROUND FACILITATING SOME OF THESE ACTIVITIES AND PROGRAMS THAT ALSO SUPPORT THESE AREAS OF TECHNOLOGY DEVELOPMENT. NEXT SLIDE. SO KIND OF THE MAIN DIFFERENCES AS I MENTIONED, THESE PROGRAMS ARE TO SUPPORT THESE TECHNOLOGY DEVELOPMENT ACTIVITIES. PROGRAM SUPPORT THOSE WITHIN OUR MISSION. HOWEVER FOR THE BRAIN INITIATIVE PROGRAMS. THERE ARE 10 PARTICIPATING INSTITUTES AND CENTERS THAT WE ARE MANAGING THESE VARIOUS DIFFERENT TRANSLATIONAL ACTIVITIES ON BEHALF OF THE FED IN THE AREA OF INVASIVE NEURAL DEVICES FOR BOTH RECORDING AND STIMULATING TO TREAT AND DIAGNOSE DISORDERS OF THE CENTRAL NERVOUS SYSTEM AS WELL AS TO ACCOMPLISH THE GOALS OF THE BRAIN INITIATIVE WHICH INCLUDING TO BETTER UNDERSTAND THE CIRCUITS WITHIN THE BRAIN. AND THE SECONDARY GOAL OF OUR PROGRAMS IN THE BRAIN INITIATIVE OR FACILITATE THESE PUBLIC PRIVATE PARTNERSHIPS BETWEEN INVESTIGATORS AND MANUFACTURERS HAVE THE LATEST GENERATION WITH THE STIMULATING AND RECORDING DEVICES. AND SIMILARLY WITHIN THE BLUE PRINT MEDICINE TECH PROGRAM IS DESIGNED TO NOT ONLY PROVIDE FUNDING FOR SUPPORTING THESE ACTIVITY, BUT ALSO SETTING UP VARIOUS CONTRACT AND CONSULTAN CONSULTANTSY RESOURCES AND INCUBATOR HUBS TO HELP THE INVESTIGATORS WORK AT ALONG THIS DEVELOPMENT PIPELINE FOR BRINGING NEW TECHNOLOGIES AND NOVEL TECHNOLOGIES ALONG THAT PIPELINE TOWARDS DE RISKING THEM FOR THE FIRST IN HUMAN DEMONSTRATION IN THE BRAIN INITIATIVE HAS HAS SIGNED ON TO THAT BLUEPRINT MED TECH PROGRAM AS WELL TO POTENTIALLY SUPPORT ACTIVITIES WITHIN THE BRAIN INITIATIVE'S MISSION. . NEXT SLIDE. IN TERMS OF OVERALL PUBLIC PRIVATE PARTNERSHIP PROGRAM, ONE OF THE THINGS TO NOTE IS THAT IN GENERAL NIH IS SERVING A ROLE TO HELP FACILITATE THESE PARTNERSHIPS, BUT NOT NECESSARILY A PARTY FROM THE LEGAL PERSPECTIVE TO THE INDIVIDUAL AGREEMENT. SO YOU CAN SEE THE GENERAL PROCESS, WHEREBY THE APPLICANT, THE ACADEMIC PI IDENTIFIES THE COMPANY COLLABORATOR, VICE VERSA AND SIGN THEIR OWN CONFLICT DISCLOSURE AGREEMENT BETWEEN THE VARIOUS ORGANIZATIONS. AND THEN CAN USE THAT PARTNERSHIP TO SUBMIT APPLICATION TO EITHER THESE BRAIN UG3 OR UH3 OR DIRECT UHV FUNDING OPPORTUNITIES THAT INCLUDE A LETTER OF SUPPORT FROM THE COMPANY. AND FOR APPLICATIONS THAT SCORE WELL AND LOOKING AT PROPOSING FOR FUNDING, WE DO REQUIRE THAT THE ACADEMIC INVESTIGATOR, AND/OR INVESTIGATORS AS WELL AS THE COMPANY SIGN A COLLABORATIVE RESEARCH AGREEMENT OR CLINICAL TRIALS AGREEMENT PRIOR TO THE NOTICE OF GRAND AWARD. HOWEVER WE CAN NOT DICTATE THE TERMS OF THOSE AGREEMENTS BETWEEN THE VARIOUS DIFFERENT PARTIES. SO AS PART OF OUR CURRENT PUBLIC PRIVATE PARTNERSHIP ACTIVITIES WE HAVE SEVERAL DIFFERENT COMPANIES THAT HAVE SIGNED ON WITH MOU, MEMORANDUM OF UNDERSTANDING WITH THE NIH TO SHARE INFORMATION ABOUT THEIR TECHNOLOGIES, AND YOU CAN SEE THE LIST OF COMPANIES CURRENTLY PARTICIPATING ON THE PLOT HERE, AND NOTE SEVERAL OF THE COMPANIES YOU HEARD ABOUT TODAY ARE ACTIVELY PARTICIPATING. NEXT SLIDE. SO, AS PART OF THE GRANT APPLICATIONS, IT WAS MENTIONED EARLIER TODAY, WE DO HAVE THE ABILITY TO SET UP LONG TERM CARE PLAN ATTACHMENTS AS PART OF OUR FUNDING OPPORTUNITIES AND WITH EACH ONE OF MY PROGRAMS WITHIN THE BRAIN INITIATIVE. WE HAVE MADE THIS REQUIREMENT FOR APPLICANTS COMING INTO THE FUNDING OPPORTUNITY, AND SEPARATE ATTACHMENT, SO DOESN'T TAKE AWAY FROM THE PAGE LIMITS OF THE REST OF THE APPLICATION. AND THEY CAN HAVE INSTRUCTIONS AS PART OF THE FUNDING OPPORTUNITIES, DICTATING THE APPLICANTS REALLY SHOULD BE DESCRIBING THE ANTICIPATED CARE NEEDS AS IT RELATES TO STUDIES, AND LOOKING AT APPLICATIONS TO POST-TRIAL SCENARIOS AND WHETHER THE DEVICE IS TRIAL OR FAILURE OR SUCCESS. AND BASED ON THE PREDESCRIBED OUTCOMES, AND AS WELL WHAT MAY HAPPEN IN THE DEVICE MANUFACTURES DISCONTINUE THE PRODUCT OR FAIL TO COMMERCIALIZE IT. IN PARTICULAR THE APPLICANTS SHOULD REALLY BE LOOKING AT END OF TRIAL STUDY PLANS, AND VARIOUS DIFFERENT SITUATIONS RELATED TO THE RISKS AND BENEFITS OF RECEIVING THE CARE OR NOT RECEIVING THE CARE. AND PROVIDE SOME EXAMPLES OF THE THINGS THAT THE PLANS MAY INCLUDE THAT YOU HEARD ABOUT EARLIER TODAY INCLUDING PLAN TO THE DEVICES. ONCE IT'S COMPLETE. POTENTIAL SURGICAL REMOVAL OF THE BATTERY AND CAPPING THE LEADS TO MINIMIZE SOME OF THE RISKS, AS NOTED SOME MANUFACTURERS HAVE OFFERED TO PROVIDE THE DEVICE RELATED MAINTENANCE FOR PATIENTS RESPONDING TO THE THERAPY, AND AS WELL AS MANUFACTURE SUPPORT FOR FILING COMPASSIONATE USE EXEMPTIONS OR OTHER ACTIVITIES TO HELP SUPPORT THOSE AREAS. AND THEN ALL THE PLANS SHOULD REALLY INCLUDE THOSE POST TRIAL OBLIGATIONS AS WELL AS CAN BUDGET FOR THE EXPENSES ASSOCIATED WITH THAT GRANT APPLICATION. NEXT SLIDE. SO COMMON ELEMENTS WE HAVE SEEN OVER THE YEARS WITH VARIOUS DIFFERENT ACTIVITIES. AS MENTIONED THE DEVICE REMOVAL AT THE END OF THE STUDY, THAT CAN BE COVERED BY THE GRANT FUNDS, POTENTIALLY DEVICE REPLACEMENT AND SUBSEQUENT PATIENT MONITORING, AND POTENTIALLY ABLE TO BE COVERED THROUGH INSURANCE MECHANISMS AND GRANT FUNDS AS WELL. THERE IS THE POSSIBILITY OF SOME OF THEM PROPOSING CONTINUEDED USE AFTER THE STUDY HAS ENDED. BUT HAVING PLANS FOR REPAIRING THE EXISTING HARDWARE AND LOOKING AT ON GOING MONITORING, AND MEDICAL SUPPORT ON GOING COVERAGE, OR POTENTIALLY-TIME HOSPITAL CARE. SOME HAVE PROPOSED THE PURCHASE DESIGNATED PRIVATE INSURANCE PLAN SPECIFIC TO THOSE POST TRIAL NEEDS. AS WE HEARD ABOUT EARLIER TODAY, WE'VE SEEN THAT THAT SUCCESSFULLY AND FROM IMPLEMENTED OVERSEAS, BUT NOT SO FAR IN THE US. AND MOST OF THE PROPOSALS GIVE THE PATIENTS THE OPTION TO CONSIDER AT THE END OF THE STUDY TO EITHER CONTINUE WITHIN ONE OF THE VARIOUS DIFFERENT STRATEGIES AND KEEP THE INVESTIGATIONAL DEVICE EXEMPTION OPEN TO HELP SUPPORT AND THOSE KIND OF LONGER TERM FOLLOW UP TO, FOR THE PATIENTS. IN SOME OF THE INDICATIONS WHERE WE'RE SUPPORTING PROJECTS THERE MAY BE ALTERNATIVE TO CHANGE TO COMMERCIALLY AVAILABLE DEVICE, SO THERE AREN'T AS MANY CONCERNS WITH THAT ONGOING CARE OF RESEARCH DEVICE THAT'S BEEN IMPLANTED AS PART OF THE STUDY. IN SOME CASES THEY'RE GIVEN THE OPTION TO 0 OUT THE DEVICE AND TURN IT OFF, OR LEAVE IN PLACE. OR AS MENTIONED THE EXPLANTATION OPTION. AND IN SOME CASES HOSPITALS HAVE BEEN WILLING TO PROVIDE THAT CARE IN PERPETUITY. IN OTHER CASES THEY HAVE BEEN LESS ENTHUSIASTIC OF THOSE TYPES OF ACTIVITIES. NEXT SLIDE. I WAS GOING TO TALK A LITTLE BIT ABOUT CMS OPTIONS, BUT WE COVERED THOSE EARLIER, AND GO ON TO THE NEXT SLIDE, NOW. AND SO WHEN LOOKING AT MANAGING THESE TYPES OF PROJECTS FROM A PROGRAMMATIC STANDPOINT WE DO HAVE SOME TOOLS AVAILABLE THAT WE CAN USE AS NIH TO HELP FACILITATE INVESTIGATORS IMPLEMENTING THESE PLANS, ONE ARE USING NO COST EXTENSION SO WHERE THE INDIVIDUAL PROPOSAL PERIOD MAY BE FOUR OR FIVE YEARS THERE IS THAT POSSIBILITY FOR AT THE END OF THE PROJECT. TO REQUEST EITHER A FIRST, A NO COST EXTENSION IS GENERALLY AUTOMATIC. THERE'S A MANUAL PROCESS BUT WE CAN DO A SECOND NO COST EXTENSION, AND WE EVEN HAD CASE HAVE HAD CASES WHERE THE INVESTIGATORS SUCCESSFULLY CAN PROPOSE A THIRD, NO COST EXTENSION AT THE END WITH EACH ONE OF THOSE BEING UP TO A YEAR IN DURATION, THAT DOES PROVIDE THE ABILITY TO EXTEND THE OVERALL ACTIVE DIRECTORY PERIOD, UP TO 3 YEARS, TO THE END OF THE PROJECT. AND BENEFIT OF BEING ABLE TO EXTEND THE GRANT PERIOD KNOWING THE CARRY OVER FUNDS FOR EXPLOITATION OR UNEXPECTED PATIENT COSTS CAN BE CARRIED OVER TO WHEN NEEDED. SO FOR EXAMPLE IF AN INVESTIGATOR IN YEAR ONE OF THE PROJECT IS PROPOSING HAS BUDGETED IN HE POSSIBILITY FOR THE PATIENT CHOOSING TO BE EXPLANTED AT THE END OF THAT ONE YEAR STUDY PERIOD IN THE PATIENT FOR WHATEVER REASON DECIDES NOT TO NECESSARILY BE EXPLANTED AT THAT TIME, THOSE FUNDS CAN THEN BE CARRIED OVER INTO FUTURE YEARS FOR WHEN OR IF NEEDED. WITH THAT ONGOING PATIENT AND BEING ABLE TO APPLY THOSE FUNDS TO SO THAT THE COSTS ARE NOT NECESSARILY INCURRED BY THE SUBJECT OR THE HOSPITAL. SIMILARITY FOR UNEXPECTED EVENTS IN THE PROJECT, WE CAN CONSIDER ADMINISTRATIVE SUPPLEMENTS FOR THOSE UNEXPECTED PATIENT CARE EXPENSES AND POTENTIAL ADDITIONAL FOLLOW-UP IF NEEDED IN SOME OF THE PROJECTS THAT ARE GOING WELL. AND THEN THE OTHER OPTION THAT I THINK HAS BEEN MENTIONEDED EARLIER IS INVESTIGATORS APPLYING FOR NEW GRANT APPLICATIONS FOR LONG TERM FOLLOW ON STUDIES, OR IF THERE'S A NEW TECHNOLOGY ITERATION THAT THEY'RE LOOKING AT PURSUING, THEN THEY CAN APPLY FOR FUNDING FOR THAT APPLICATION AND DEPENDING UPON HOW THEY LINE UP THEIR INCLUSION ENROLLMENT FOR THE STUDY CAN RECRUIT PATIENTS THAT MAY HAVE HAD THE PRIOR VERSION OF THE TECHNOLOGY TO ALLOW THEM TO UPGRADE TO THE NEWEST VERSION THAT IS THEN BEING SUPPORTED. NEXT SLIDE. SO, YOU KNOW, THERE IS A FEW OF THE PROGRAMMATIC CHALLENGES TO HIGHLIGHT THAT WE RUN INTO ACROSS SEVERAL OF THESE VARIOUS DIFFERENT AWARDS, AND MOST OF THESE, YOU HAVE NOTED HAVE BEEN BROUGHT UP OVER THE COURSE OF TODAY. THE FIRST, YOU KNOW, WHEN LOOKING AT NIH, WE HAVE CONTROL OF RELEASE OF FUNDS DURING ACTIVE AWARD PERIODS. ONCE THAT AWARD IS NO LONGER ACTIVE WE NO LONGER HAVE THE AUTHORITY OR ABILITY TO GIVE ADDITIONAL FUNDS OR COVER ACTIVITIES THAT ARE NOT RELATED -- OR NOT WITHIN THAT PROJECT PERIOD. SO HENCE THE NOTE ABOUT USING THE NO-COST EXTENSIONS TO CARRY OVER SOME OF THOSE ADDITIONAL FUNDS. FOR ALMOST ALL OF THESE PROJECTS ARE MILESTONE DRIVEN COOPERATIVE AGREEMENTS WITH GO, NO-GO DECISION POINTS THAT MAY BE BASED ON EITHER SAFETY OUTCOMES FOR THE STUDY, OR PRELIMINARY EFFICACY DATA TO SHOW POTENTIAL IMPROVEMENTS, IN THE STUDIES SO FOR PROJECTS THAT FAIL TO MEET THE MILESTONES, THE FUNDS FOR THE PROJECT MAY BE REDUCED OR DISCONTINUED, WHICH CAN ADD SOME ADDITIONAL COMPLEXITY WHEN LOOKING AT SOME OF THE POST TRIAL OBLIGATIONS. THE VARIETY OF OPTIONS THAT CAN HAPPEN WITH THE INDUSTRY PARTNERS IN THESE WHETHER THE COMPANY FILES FOR BANKRUPTCY GOES COMPLETELY OUT OF BUSINESS AS ACQUIRED OR DECIDES TO NO LONGER PRODUCE THE VERSION OF THE TECHNOLOGY PRODUCED IN THE STUDY. EACH ONE OF THOSE CAN CAUSE INDIVIDUAL CHALLENGES AND DIFFERENT SITUATIONS FOR THE VARIOUS DIFFERENT PROJECTS. FOURTH ON THE LIST THERE IS WHEN THE PRINCIPAL INVESTIGATOR CHANGES INSTITUTIONS OR DEPARTS THE ACADEMIA ALL TOGETHER. AND NOTED EARLIER TODAY, A LOT OF THE TIES THE PATIENTS HAVE TO THE STUDIES TO GO BACK TO THE PHYSICIAN THAT IS RUNNING THE CLINICAL TRIAL AND IF THEY'RE NO LONGER ACCESSIBLE FOR THE STUDY, THOSE CAN HAVE VARIOUS IMPACTS, AND EACH ONE OF THE SITUATIONS THAT COULD STAY WITH NEW PI AT SAME INSTITUTION OR SOME CASES THE AWARD CHANGES INSTITUTIONS WHEN THE THE PI MOVES, WHICH CAN DEFINITELY AFFECT THE PROPOSED LONG TERM CARE PLANS, AND SIMILARLY, WHILE THERE ARE LETTERS OF SUPPORT IN THE PROJECTS OR PLANS FROM A UNIVERSITY PROVIDED SUPPORT, IF THE UNIVERSITY LEADERSHIP CHANGES, WHETHER THAT'S AT THE DEPARTMENT LEVEL, ON UP THROUGH TRANSFER, AND UNIVERSITY WIDE POLICIES CAN THAT CAN CHANGE. EVEN NOTED IN THE CASE OF OREGON YOU CAN HAVE LAWS THAT CAN CHANGE IN THE STATE THAT CAN INFLUENCE SOME OF THOSE PLANS. AND LAST POINT, IS THE PATIENT DOES HAVE THE CHOICE TO EXPLANT AT THE CONCLUSION OF THE STUDY. NIH HAS NO INTERACTIONS WITH THE PATIENT AND IS NOT PRIVY TO WHICH INFORMATION IS SHARED WITH THEM AS TO ENSURE THAT SOME OF THESE OPTIONS AND THE FINANCIAL IMPLICATIONS WITH THEM ARE FULLY CONVEYED AS IT RELATES TO THE MANAGEMENT OF THE GRANT AND WHETHER OR NOT THOSE FUNDS COULD POTENTIALLY BE AVAILABLE. SO THAT'S THE END OF MY PRESENTATION, HAPPY TO TAKE ANY QUESTIONS, AND GO BACK TO RHONDA, OR TURNOVER TO THE Q&A PORTION OF THE PANEL. >> YEAH, LET'S TAKE A QUESTION. CHRISTINE, GO AHEAD, PLEASE. >> THANK YOU, NICK. I JUST WANTED TO ASK ONE QUESTION ABOUT, YOU MENTIONED THERE WAS AN OPTION OF PURCHASING INSURANCE, BUT THAT HAS HAPPENED IN OTHER COUNTRIES AND NOT UNITED STATES. ANY QUESTION ARE IS THAT WITH NIH GRANT FUND, AND NUMBER ONE, AND WHY NOT UNITED STATES, IS THAT REGULATORY REASON OR JUST HASN'T HAPPENED. >> SO, I THINK IN TERMS OF THE POLICIES AS TO WHETHER OR NOT THAT'S ALLOWED WITH GRANT FUNDS, IT SORT OF DEPENDS ON THE NATURE OF HOW IT'S DESCRIBED IN THE POLICY, AND GRANT APPLICATION, WHETHER IT'S ALLOWABLE OR NOT: IN THEORY, COULD BE -- AS LONG AS JUSTIFIED TO THE RESEARCH TOOLS OF THE STUDIES AND ACCOMPLISHING THOSE. THE CHALLENGE THAT INVESTIGATORS HAVE FACED, AND IN PARTICULARLY NOTED EARLIER. YOU ARE SORT OF LOOKING AT TRYING TO HAVE AN INSURANCE POLICY IN AN AREA WHERE YOU ARE DEALING WITH SMALL NUMBER OF PATIENTS, THAT -- THE WAY MOST INSURANCE WORKS IS MATTERS OF SCALE, AND LOOKING TO TRY AND SUPPORT A POLICY OF TRIAL OF 5, 10, 15 SUBJECTS, THE INVESTIGATORS THAT HAVE TRIED TO REACH OUT TO INSURERS, HAVE HAD LIMITED SUCCESS IN GETTING THEM TO SUPPORT AN ACTIVITY LIKE THAT FROM A FINANCIAL STANDPOINT. FROM COST BENEFIT RATIO. DOESN'T MEAN THERE ISN'T AN OPTION OUT THERE, AND OTHER PROVIDERS THAT MAY BE INTERESTED IN OPERATING IN THE SPACE. >> THANK YOU. >> THANKS, NICK. LET'S -- RHONDA SHALL WE COME BACK TO YOU. I THINK YOU MAY HAVE HAD A LITTLE BIT TO SAY BEFORE WE LOST YOU AND LET YOU FINISH UP, AND MOVE ON TO THE PANEL -- OR THE DISCUSSION PART. >> ALL RIGHT, LET ME ASK "CAN YOU HEAR ME? " >> YES. >> OKAY. I DON'T... I REALLY APOLOGIZE FOR THESE TERRIBLE TECHNOLOGY PROBLEMS. I DON'T KNOW WHERE I LEFT OFF. BUT I HAVE BEEN ABLE TO HEAR THE LAST PRESENTATION. I THINK THE ONLY THING THAT I WOULD WANT TO ADD TO THIS, IS THE CONSIDERATION OF THE THINGS THAT IN TALKING WITH COLLEAGUES THAT SEEM TO BE DELIMITED AND NEED TO BE ADDRESSED. ONE OF THE MAJOR ONES WAS GOING FROM WHAT I CALL INDIVIDUALLY PROVEN TO POPULATION PROVEN. AND THIS IS WHERE, I THINK THIS QUESTION HAS COME UP AROUND PROVID PROVIDERS RESPONDING TO PATIENTS WHO HAVE NEEDS THAT ARE NOT BEING MET BY TECHNOLOGIES CURRENT TECHNOLOGIES THAT ARE OUT THERE. AND BEGIN TO USE CERTAIN TYPES OF TREATMENTS OFF LABEL AND IN SOME CASES HAVE SEEN IMPROVEMENT IN THOSE INDIVIDUALS WERE OTHER GENERALS TREATMENTS HAVE NOT BEEN SUCCESSFUL. THE ROAD FOR THAT PARTICULAR JOURNEY TO GET TO THE POINT OF BEING INSURANCE COVERED IS VERY DIFFICULT. BECAUSE OF THE FACT THAT PROVIDERS GENERALLY DO NOT HAVE ACCESS TO ENOUGH PATIENTS THAT THEY ARE ABLE TO APPLY THIS TECHNOLOGY UP LABEL, AND THEREFORE, IT WILL NEVER REACH THE LEVEL OF THRESHOLD FOR BEING PROVEN, EVEN FOR OBSERVATION SETTING THAT GENERALLY REQUIRES AT LEAST 1000S OF PATIENTS TO BE INVOLVED IN THAT. I THINK THAT'S A VERY IMPORTANT PIECE TO TAKE A LOOK AT. MANY TIMES A PLAN WILL REVIEW AN INDIVIDUAL WHO HAS HAD DIFFICULTY TREATMENT RESISTANT WHETHER IT'S DEPRESSION OR OTHER TYPES OF CONDITIONS, WITH CURRENT TREATMENTS AND WE'LL REVIEW IT ON AN INDIVIDUAL BASIS. LOOKING FOR ALL THE DATA OF ALL THE TREATMENTS RENDERED AND MAKING SURE THE TREATMENTS WERE RENDERED AT THE MOST EFFICACIOUS DOSAGES AND LENGTH OF TIME AND CAN MAKE AN INDIVIDUAL DECISION. THOSE ARE DIFFICULT ISSUES BECAUSE IT REQUIRES A LOT OF DOCUMENTATION AND IT IS DEPENDENT UPON THE CLINICAL INTERPRETATION BY THE REVIEWER IN THAT CASE. SO TO ME IT SEEMS AS THOUGH THIS IS ONE OF THE AREAS WHERE THERE IS A NEED FOR POLICY, OR THERE IS A NEED FOR PROCESS. THE OTHER THING I MENTIONED WAS, INCLUDING IN CLINICAL RESEARCH, WHAT I CALL COMPARATIVE RESEARCH, WHERE YOU ARE COMPARING A NEW TECHNOLOGY, NOT TO PLACEBO BUT OTHER EXISTING TECHNOLOGIES, PARTICULARLY THAT'S IMPORTANT BECAUSE ONE WANTS TO UNDERSTAND IF A NEW TECHNOLOGY IS COMING ON BOARD, AND ITS EFFICACIOUS HOW WELL DID IT WORK AGAINST WHAT IS ALREADY OUT THERE. AND TWO, TAKING A LOOK AT WHAT MIGHT BE THE COST DIFFERENTIAL. AND THIS IS HOW PAYERS WILL THINK ABOUT THIS IN THAT REGARD. AND I'LL STOP WITH THAT. AND AGAIN, APOLOGIZE AGAIN FOR THE TERRIBLE TECHNOLOGY ISSUES. >> NO, NO, PROBLEM. WE ARE GLAD WE COULD GET THAT IN. IT'S ALL VERY IMPORTANT INFORMATION TO FOLD INTO THE DISCUSSION. ANY DIRECT QUESTIONS FOR DR. ROBINSON BEALE? SASKIA, YEAH, >> I'LL GO AGAIN. THANK YOU SO MUCH. IN SOME OF THE PREMEETINGS WE LEARNED A COUPLE OF INSTANCES MAY GENERALLY BE COVERED BY PRIVATE INSURANCE. AND I JUST WANTED TO CHECK WITH YOU IF YOU HAVE THE SAME IMPRESSION, WE LEARNED THAT THINGS INCLUDING EMERGENCY MEDICAL CARE, RELATED TO A DEVICE. EXPLOITATION BECAUSE OF MEDICAL INDICATION. AND ROUTINE SERVICES THAT A PATIENT WOULD HAVE REQUIRED REGARDLESS OF THE EXPERIMENTAL STATUS OF THE DEVICE. THOSE ALL WOULD BE COVERED GENERALLY SPEAKING BY PRIVATE HEALTH INSURANCE INDEPENDENT OF WHETHER A DEVICE HAS BEEN COMMERCIALLY APPROVED FOR CERTAINLY INDICATION. IS THAT ABOUT RIGHT? >> YES, THAT'S CORRECT. I'M SORRY IN THE PART THAT GOT BLANKED OUT I DID GO OVER THAT. I DIDN'T KNOW WHETHER THAT WAS HEARD. ABSOLUTELY TRUE, MOST INSURERS I TALKED TO INCLUDED THAT IN THEIR PARTICULARLY COVERAGE. IT KIND OF AGAIN POINTS TO AN OPPORTUNITY AS NIH APPROACHES, SENDING OUT RFIS RFPS OR PARTICULAR TECHNOLOGY AS PLANNING WORK WITH INSURERS SO WE UNDERSTAND WHERE THERE MAY BE GAPS. PARTICULARLY IF ONE IS ABLE TO PUT TOGETHER WHAT'S CALLED A JOURNEY MAP OF WHAT A PATIENT'S GOING TO BE EXPERIENCING IF THEY TAKE PART IN THAT PARTICULAR TECHNOLOGY. AND I THINK KNOWING UPFRONT WHAT THE ISSUES ARE WILL HELP INSURERS WORK WITH CLINICAL TRIAL RESEARCHERS TO HELP CREATE SOME CONSISTENCY AS MUCH AS POSSIBLE. GIVEN THE CURRENT RULES AND POLICIES IN PLACE. AND THEN, IDENTIFY WHERE THERE IS NEED FOR NEW THINKING, AND NEW PROBLEM-SOLVING. >> GREAT, THANK YOU. DID YOU HAVE A COMMENT TO THAT? >> NO, ACTUALLY TO ALL OF THIS. SO, WHAT I'M HEARING, IS THAT WE HAVE THAT FDA PROCESS FOR DECIDING WHETHER SOMETHING IS SAFE AND EFFECTIVE. CMS HAS THEIR PERSPECTIVE, THE INSURERS HAVE THEIR PERSPECTIVE. AND OF COURSE THE CONSUMER COMMUNITY HAS THEIR PERSPECTIVE. OFTEN HAS TO DO NOT WITH THE PRIMARY END POINT OF STUDIES BUT QUALITY OF LIFE. AND THIS IS VERY INEFFICIENT PROCESS. SO IF YOU CONDUCT A TRIAL THAT IS SATISFACTORY TO FDA IT MAY NOT BE SATISFACTORY TO CMS AND TO PRIVATE INSURERS. AND THIS HAS TO BE RESOLVED. AGAIN, GO BACK TO MY PERSONAL EXPERIENCE, BECAUSE IT WAS VERY POSITIVE. SO WITH THIS DEVICE, WE ENGAGED WITH CMS, AND MAJOR INSURERS, AND BLUE CROSS, BLUE CHEELD TO HAVE A CONVERSATION ABOUT WHAT WOULD BE GOOD EVIDENCE. WHAT WOULD BE SATISFACTORY, AND DESIGNED A TRIAL TO BE ABLE TO DO THAT. AND THAT WORKED VERY WELL. AND I THINK THAT ESPECIALLY FOR THOSE WHO ARE DEVELOPING VERY NOVEL OR INNOVATIVE DEVICES, LIKE THE ONES THAT NICK IS FUELING, THESE ARE INDIVIDUALS WHO MAY NOT BE AS KNOWLEDGEABLE ABOUT HOW THAT KIND OF ACTIVITY HAS TO TAKE PLACE EARLIER. THEY JUST DON'T HAVE THE EXPERIENCE AND DON'T HAVE REGULATORY, AND QUALITY. AND SO MAYBE AS PART OF THE CLINICAL TRIAL ENTERPRISE, THERE COULD BE SOME TYPE OF EDUCATION TRAINING OR ENCOURAGEMENT AS THESE TRIALS ARE DESIGNED TO CONSIDER WHAT NEEDS TO BE ON THE OTHER END. THE OTHER END IS PROBABLY NOT FDA APPROVAL. BUT MAYBE THE KIND OF DATA, THAT WOULD BE ACCEPTED WORTHY OF GOING ON A FEASIBILITY STUDY OR PIFRTAL STUDY. I FEEL IF EVERYBODY IS MORE INVESTED ON WHAT IS HAPPENING UP FRONT, WILL BE EASIER TO BE INVESTED AFTER THE STUDY IS DONE. >> THAT'S A GREAT POINT. I THINK FOR NOW, IN THE DISCUSSION PORTION OF THIS, WHICH IS EXACTLY WHERE WE SHOULD BE AT THIS POINT, LET'S -- MARTY IF I MAY, SAY A FEW FRAMING COMMENTS AND THEN PICK UP RIGHT WHERE YOU HAVE US. REMEMBER THIS PANEL -- THE FIRST PANEL WAS ABOUT ISSUES THAT WE NEED TO FIX. THE PANEL IS ABOUT WHAT IS ALREADY BEING COVERED VERSUS NOT. AND WE OBVIOUSLY HEARD A LOT OF PERSPECTIVES ON THIS. AND CAN ASK TO FRAME THE WHOLE DISCUSSION WITH NEUROLOGICAL FOUNDATION, AND CONSIDER RESPECT TO PERSONS AND ALL THE THINGS YOU BILLED ALL THESE PRACTICAL APPROACHES. AND THE SPIRIT OF BEING PRACTICAL, LET'S DO SO. AND I WAS GOING TO SUGGEST MARTY, THAT WE START WITH THE EXAMPLE YOU GAVE. WITH YOUR LGS TRIAL, WHERE IT'S DEMOCRATIZED SORT OF DIVIDE AND CONQUER APPROACH, WHERE THE DEVICE MANUFACTURER THE PAYER, WHETHER IT'S GOVERNMENT OR A PRIVATE INSURANCE COMPANY, HEALTH CARE SYSTEM, INVESTIGATOR, THE PATIENT, FEDERAL SPONSOR, OF THE GRANT, YOU KNOW ALL HAVE PIECE OF BURDEN, AND PRICE TO PAY. AND I WONDER IF WE CAN START WITH THAT AS A RUBRIC THAT WE CAN EITHER CONTINUE TO ACCEPT AND WIDDLE, OR, YOU KNOW, DECIDE ON -- THIS DOESN'T WORK AT ALL. I WOULD LOVE TO HEAR FROM THE VARIOUS REPRESENTATIVES IN INVOLVED WHETHER THIS IS A RUBRIC THAT COULD WORK. YOU KNOW, THE COSTS ARE LARGE, AND TRIALS ARE EXPENSIVE. DOES THE DIVIDE AND CONQUER APPROACH MAKE SENSE FROM THE PERSPECTIVE OF THE VARIOUS INDIVIDUALS AND STAKEHOLDERS REPRESENTED HERE. . >> LET ME JUST ADD, THE COSTS COULD BE NORMAL. BUT IF EVERYTHING WENT WRONG, AND THE STUFF THAT WE TALKED ABOUT COULD HAPPEN. HIGHLY UNLIKELY, YOU CAN'T ANTICIPATE. WHAT THEN. AND SO TALKING TO COMPANIES TO CONSIDER OUT OF THE BOX INSURANCE POLICIES, AND I HAD ONE COMMENT FROM CARL THAT IT'S SO HARD TO CALCULATE. IT'S PROBABLY NOT GOING TO BE MUCH OF ANYTHING. BUT, IT COULD BE SOMETHING VERY LARGE. AND BECAUSE THESE ARE TRIALS, THERE IS SO MUCH UNKNOWN. AND SO IT'S VERY DIFFICULT TO HAVE ANY KIND OF COMPETENT EQUATION OF RISK. >> SO LET ME BE SPECIFIC TO GET STARTED. CARL, THANK YOU FOR THE PRESENTATION, I THINK THE EXAMPLE OF CED WAS A VERY ILLUMINATING ONE. ANOTHER ONE THAT I WONDER WOULD BE RELATED TO THE SITUATIONS WE HAVE HERE OFTENTIMES IS THIS: WHICH IS THAT, THERE IS A TRIAL FUNDED, AND FEDERALLY FUNDED. AND IT'S A SIGNIFICANT RISK DEVICE, AND HAS AN IDE APPROVAL FROM THE FDA. WHAT ARE THE MECHANISMS BY WHICH CMS WOULD ASSIST WITH COVERING THE COSTS OF, LET'S SAY DEVICE REPLACEMENT YEARS LATER AFTER THE PATIENT WAS DONE WITH THE TRIAL, SUPPOSE THE MANUFACTURER IS WILLING TO DONATE THE DEVICE, AND THE P PATIENT DOESN'T HAVE PRIVATE INSURANCE THAT WILL COVER THE COST OF THE JUST THE SURGICAL CARE, THE HOSPITAL CARE. WHAT DOES CMS ABLE TO DO IN THAT INSTANCE. . >> AGAIN, IT'S A LOT OF IT DEPENDS ON YOUR SITUATION, BECAUSE EVERYBODY'S I WOULD ACTUALLY WANT TO KIND OF MAYBE BACKTRACK A LITTLE BIT AND I KNOW ONE OF THE SLIDES THAT I THINK THE LAST PRESENTER PUT UP TO AND YOU JUST DISCUSSED IT I WANT TO SAY THAT IT HAPPENS TO BE MY GROUP BY SELF DIRECTED COLLECTION WERE INVOLVED WORKING WITH THE FDA ON THESE IDE SWITCHES, WHICH MEANS DEVICE FOR THE EARLIEST STAGE OF APPROVAL THROUGH THE FDA. AND SO, CMS HELPS TO MAKES COMMENTS ON THE CLINICAL TRIALS GOING ON THERE, EARLY FEASIBILITY STUDIES AND MAKE SURE THE EVIDENCE COLLECTED IN THE EARLY FEASIBILITY STUDY HELPS PROVIDE EVIDENCE THAT CMS COULD THEN REVIEW TO DETERMINE WHETHER OR NOT SHOULD CONTINUE TO PROVIDE COVERAGE. EVEN AFTER PIVOT TRIAL. SO WE WERE INVOLVED EARLY ON. NOW, IF THAT EVIDENCE LEADS TO NATIONAL COVERAGE DETERMINATION OF THE SPONSOR REQUESTS NATIONAL COVERAGE DETERMINATION, AFTER THE IDE, ALSO COMES INTO THE PLAY. BEING THAT. IF THERE IS ENOUGH EVIDENCE THAT DEVICE SHOULD BE COVERED. THE DEVICE AND EVIDENCE FOR MOB CLINICAL TRIALS. AND OBSERVATIONAL STUDIES THAT HAVE OCCURRED, AGENCY WILL COVER DEVICE AND ROUTINE SERVICES FROM THAT POINT FORWARD. AND ONCE THE NCD HAS GONE THROUGH THE PROCESS, AND APPROVED, AGENTS THEN SHOULD COVER IT. SO IT'S A LONG PROCESS. >> WHAT ABOUT EARLIER IN PROCESS, THERE IS QUESTION BY APHONNOWS ATTENDEE. 2:47 SEN RAL TIME ANYWAY IF PEOPLE WANT TO CHECK THE Q&A. AND I'LL JUST PARAPHRASE AN IDE STUDY OFTENTIMES, BY DEFINITION, EARLY IN THE PROCESS. AND SO NOT GOING TO BE EVIDENCE OF EFFICACY OF THAT DEVICE. AND MARTY HAS YOU SAID, WE SHOULDN'T ENTER INTO THESE THINGS PERHAPS WITHOUT HAVING THOUGHT ABOUT THEM AHEAD OF TIME. DISCIPLINARY APPROACH, RIGHT. SO WE SHOULDN'T START TRIALS WITHOUT HAVING SOME SENSE OF OF HOW THEY'RE GONNA GO WITH AN IDE WE DON'T HAVE WE'RE NOT GOING TO HAVE THE EVIDENCE SUGGESTING THE SHOWING EFFICACY AND SO WE WOULD, WE WOULD HAVE TO ENTER THAT WITHOUT THE EVIDENCE, BUT THE PATIENT PARTICIPANT WILL HAVE TO KNOW WHAT IS GOING TO HAPPEN WITH THEM AFTER THEY LEAVE THE TRIAL WAS REALLY BEFORE THERE'S ENOUGH EVIDENCE FOR AN NCD ETC. WHAT ABOUT THAT SITUATION. SO -- THAT'S A WHOLE ANOTHER PRESENTATION, I DID NOT -- I HAVE THE SLIDE, BUT NOT GOING TO PUT YOU THROUGH THAT. DURING THAT ID PROCESS. WE WORK CLOSELY WITH FDA. THE POINT IS WE ACTUALLY... WE ARE WILLING TO ACCEPT A LOT DETAIL, BUT SEEN SAMPLE SIZE OF 5 THAT SHOWS EFFICACY, AND NO HARMS, AND BENEFITS OUTWAY THE HARMS, AND WILL ACTUALLY PROVIDE COVERAGE FOR THE DEVICE AND THE RELATED SERVICES, EVEN AT THAT EARLY STAGE SO DURING THE EARLY FEASIBILITY STUDY, I MEAN, THE FDA CLEARED IT. AND, YOU KNOW, BELIEVES THAT THE, YOU KNOW, AGAIN, THE BENEFITS. THE BENEFITS OUTWEIGH THE HARMS ARE WILLING TO PROVIDE COVERAGE FOR THE DEVICE AND SERVICES EVEN DURING THE EARLY FEASIBILITY STUDY DURING THE ID PROCESS. SO, AGAIN IT DEPENDS ON THE EVIDENCE, BUT WE UNDERSTAND THAT VERY EARLY IN THE FDA APPROVAL PROCESS, THERE MIGHT BE VERY LITTLE EVIDENCE BUT WE DO -- DON'T WANT TO SAY REQUIRE -- BUT WE'RE INTERESTED IN LOOKING AT INTERNATIONAL STUDIES OF SAMPLE SIZE OF 5. AND PERHAPS THE EVIDENCE THERE IS PROMISING, AND WILLING TO TAKE THAT UP AS AS EVIDENCE OF POTENTIAL EFFICACY OF THE DEVICE AT THAT EARLY STAGE . >> MARTY IS THAT A FRESH RAISED HAND. >> NO, PROBABLY AN OLD ONE, BUT I WAS GOING TO RAISE MY HAND. SO THAT'S AN EFFICIENT HAND. I'LL TAKE MY HAND DOWN. DR. LI, I WOULD LIKE TO SAY, POLICY THAT CMS HAS FOR COVERING INVESTIGATIONAL TRIALS UNDER THESE CIRCUMSTANCES THAT YOU JUST OULTED, AND NOW MEDICAID, I UNDERSTAND THAT CONGRESS ENABLED THAT A COUPLE MONTHS AGO IS ONE OF THE REASONS WHY THINGS ARE HANG IN UNITED STATES, AND IT'S ALSO PROVIDINGS GUARANTEESES THAT STUDIES ARE WELL THOUGHT OUT AND SCIENTIFICALLY BALANCED AND THAT THE ENDPOINTS ARE MEANINGFUL JUSTIFIABLE. AND SO BUT WE GET IN THE SAME PLACE AS IT WANTS TO STUDIES DONE WHAT HAPPENS TO THE PATIENT. AND THIS IS, YOU KNOW I THINK UPFRONT, WE'RE ALL ACTUALLY DOING REALLY WELL. WE HAVE NIH THAT'S DOING EXTRAORDINARY WORK THROUGH, FROM MY PERSPECTIVE THE BRAIN INITIATIVE AND THE PUBLIC PRIVATE PARTNERSHIP WHICH IS REALLY QUITE INNOVATIVE, AND THAT'S REALLY EFFECTIVE. WE HAVE FDA WHO HAS BECOME REALLY QUITE ENGAGED AND FLEXIBLE, AND TRYING TO PROMOTE AND ADDRESS YOU WILL A THE CHECKS, AND TECHNOLOGY, WHICH HAPPENS SO QUICKLY THAT IT'S HARD AND REGULATORY ENVIRONMENT TO KEEP UP WITH THEM ALL. NOW WE HAVE THIS BUT THEN NONE OF US KNOW WHAT TO DO IN THE PATIENT FINISHES. IF THE STUDY ISN'T SUCCESSFUL, IF THE DEVICE DOESN'T RECEIVE APPROVAL AND CMS DECIDES THAT THE EVIDENCE IS NOT WHAT THEY WANT OR THE PRIVATE INSURER SO THIS IS WHERE WE HAVE THE ISSUE AND RHONDA WE NEED AN INSURANCE POLICY, WE NEED AN INSURANCE POLICY THAT EVERYBODY PAYS INTO. BECAUSE AGAIN YOU CAN'T ESTIMATE THE RISK. PROBABLY EVERY R -- THE RISKS AE VERY LOW. AND SO THESE ARE MY OPINIONS. >> LET ME FOLLOW-UP ON THAT. AND THEN SHIRLEY COME TO YOU IN A SECOND. AND SO LOOK AT THE QUESTION FROM THE Q&A, AND ALSO RHONDA FOR YOU, AND PERSPECTIVE OF PAYER AND SYSTEM IS PAYING. HOW QUALITY OF LIFE, INCORPORATED INTO THESE DECISIONS AS TERM OF CAN COVERAGE. CAN YOU ANSWER THAT QUESTION ALONG WITH MARTY'S? >> YES. VERY GOOD QUESTION. SO QUALITY OF LIFE IS ONE OF THE FACTORS THAT ONE LOOKS AT WHEN THEY ARE JUDGING THE TECHNOLOGY IN ITSELF. IT KIND OF GOES BACK TO LOOKING AT THE CONDITION ITSELF. AND WHAT IT DOES TO THE QUALITY OF THAT INDIVIDUAL'S LIFE, AND THE LIKELIHOOD OF DISABILITY, LIFELONG DISABILITY. THE PROBLEM WITH THAT, IS MANY OF THE INSURERS DON'T NECESSARILY HAVE A DESIGNATED POLICY, BECAUSE DISABILITY IS A VERY BROAD SUBJECT. AND IT'S VERY HARD TO PUT QUALIFIERS HOW DISABLED SOMEONE NEEDS TO BE. AND WHEN ARE THEY CONSIDERED DISABLED AND WHAT ARE THE DEFINIT DEFINITIONS, AND IN ORDER TO CREATE A SUBSET OF CONDITIONS AND LEVELS OF DISABILITY, SO THAT ONE CAN BECLEAR OUTLINELINE, WHEN SMIOMETHING I COVERED BY A DISABILITY AS OPPOSED TO SOMETHING THAT WAS VERY CLEAR IF SOMEONE'S GOING TO DIE IN A YEAR, OKAY? IT'S A LITTLE EASIER TO MAKE THAT DISTINCTION. DISABILITY IS VERY WIDE, WIDELY DEFINED AND THERE'S SO MANY DIFFERENT LEVELS. SO I THINK THAT MIGHT BE WHY YOU DON'T SEE POLICIES SO TO SPEAK, IN WRITING THAT DEAL WITH DISABILITY OR QUALITY OF LIFE AS A DETERMINANT IN DECISION MAKING, IT IS CONSIDERED NOT NECESSARILY A DRIVER UNLESS ABLE TO DEFINE DISABILITY AND ABLE TO PUT IN SOME TYPE OF DEFINITION, AND SOME TYPE OF REGULATION THAT WOULD ALLOW THAT INVESTIGATION AND CONSIDERATION IN TERMS OF COVERAGE. >> THANKS. SHIRLEY. >> LET ME LOWER MY HAND NOW. HAVE A COUPLE OF THOUGHTS. AS A RESEARCH ADMINISTRATOR IT IS MY MORAL OBLIGATION, TOLESSEN ADMINISTRATION AS MUCH AS POSSIBLE. BECAUSE IT JUST SEEMS LIKE A -- THAT GETS IN THE WAY OF ANYTHING HAPPENING. I HAVE A COUPLE OF THOUGHTS ABOUT STANDARD OF CARE, STANDARD OF CARE DOESN'T EVEN WORK, WE GET DENIALS ALL THE TIME, AND SEEMS LIKE THE GO-TO MOVE IS JUST TO DENY. I HAVE A COUPLE EXAMPLES. PATIENT HAS BRAIN SURGERY, SKULL CAP COMES OFF, AND DENIAL TO PUT IT BACK, IS DENIED BECAUSE IT'S CONSIDERED CONSTANT METTIC, AND SO THE PATIENT IS SUPPOSED TO WANDER AROUND WITH THE BRAIN HANGING OUT OF THEIR HEAD. THAT'S EXTREME EXAMPLE. BUT WE GET THOSE DENIALS AND STANDARDS OF CARE WITH DEEP BRAIN STIMULATION, WE STILL ROUTINELY GET DENIALS FOR DEEP BRAIN STIMULATION TO TREAT DYSTONIA, BECAUSE IT WAS APPROVED IN 2003 AS A HUMANITARIAN DEVICE THAT WAS 20 YEARS AGO. SO I GUESS MY QUESTION IS: DO YOU WANT TO FIX THE STANDARD OF CARE SYSTEM? OR DO YOU WANT TO TAKE WHAT HAPPENS IN CLINICAL TRIAL RESEARCH, AND BE INNOVATIVE. AND AS MARTHA SAID PUSH THAT TO PUSH STANDARD OF CARE TO ADAPT AND BECOME BETTER ALSO. AND SOMEONE WHO GREW UP IN SOCIALIZED COUNTRY, I STRUGGLE WITH THAT YOUR HEALTH CARE BENEFITS ARE TIED TO ACTUALLY HAVING A JOB THAT PROVIDES YOU THAT BENEFIT, WHICH I DON'T SEE AS A BENEFIT, BUT OTHER THAN THAT. AND ANOTHER THING ABOUT THE FDA, I HAVE NOTICED CHANGES, WHICH I THINK ARE GOOD. HOWEVER MY STUDY COORDINATOR CAME AND SAID, YOU HAVE A CD LIKE WHAT DO YOU NEED TO HAVE A CD FOR. THE FDA WANTS ME TO SEND THESE DOCUMENTS ON A CD. I'M LIKE, YOU'RE ABSOLUTELY KIDDING ME RIGHT. SO WE HAD TO SPEND TIME FOR A CD, AND THEN NOT EVEN THEN WE HAD TO FIND A COMPUTER THAT HAD A CD DRIVE, AND THEN A CASE TO PUT IT IN. SO, WE ARE MAKING PROGRESS BUT WHEN IT COMES TO THE ADMINISTRATION, WHICH IS WHAT I WANT TO FIX. THOSE ARE JUST COMMENTS FOR YOU TO TAKE AWAY WITH YOU TODAY. . >> THANK YOU FOR TRYING TO REDUCE THE ADMINISTRATIVE BURDEN FOR OUR CUSTOMERS. YOU HAD YOUR HAND UP EARLIER. >> IF YOU FOR MAKING US PARTNERS IN THERE, FROM EVERY STANDPOINT, AND I HAD A QUESTION FOR DR. LI, IN THE SENSE THAT, YOU KNOW, AS CLINICIAN MYSELF AND RESEARCHER, AND FIND THE CD MECHANISM FOR VAGUS NERVE STIMULATION IS REALLY TANGIBLE OPTION FOR PATIENTS WHO OTHERWISE, NOT ABLE TO BE ABLE TO ENCONTROL IN NIH SPONSORED TRIALS AND FOUR WEEKS OFF LABEL PROCEDURES, AND THE VAGUS NERVE STIMULATION APPROVAL BY FDA IN 2005. LED TO A PERIOD OF, YOU KNOW, 15, 20 YEARS OF DROUGHT UNTIL THIS NEW MECHANISM. IS THIS, YOU KNOW, CD WITHOUT AN FD APPLICATION BEFORE, FORESEEABLE FOR TRIALS THAT INVOLVE, FOR EXAMPLE DEEP BRAIN STIMULATION FOR NEW INDICATIONS, WHETHER IT'S, YOU KNOW, DEPRESSION OR OTHER PSYCHIATRIC INDICATI INDICATIONS.. >> , YOU KNOW, AGAIN, EACH SITUATION IT'S NUANCED. BUT I WOULD SAY IN GENERAL, OUR MECHANISMS, LIKE THE OTHER PATHWAY IS THE IDE PROCESS, THAT REQUIRES THAT INVOLVEMENT, THAT'S ONE OF OUR MAJOR PATHWAYS WITH THE CMS COVERAGE. AND THAT'S THE ID PROCESS, INVOLVED IN FDA. AND THE CD PROCESS, CVD PROCESS, WHEN THE SPONSOR OR MANUFACTURE COMES TO US INDIVIDUALLY, AND REQUEST NATIONAL COVERAGE. I CAN ONLY SPEAK TO SOME OF THE NTDS I'VE WORKED ON, ALL WE REQUIRE FDA APPROVAL OF THE DEVICE FOR THE SERVICE. BEFORE WE EVEN CONSIDER LOOKING AT THE, AT THAT QUESTION. ON THE OTHER HAND, THERE ARE... THERE IS ANOTHER PATHWAY, WHERE IF THERE ARE QUESTIONS ABOUT FDA APPROVAL PROCESS, I MEAN, YOU HAVE SOMETHING CALLED LOCAL MEDICARE ADMINISTRATIVE CONTRACTS THAT LOOK AT LOCAL COVERAGE OF THE ITEM OR DEVICE. >>KARL: WE SUCCESSFULLY DONE THAT FOR OUR PATIENTS WHO RECEIVE DEEP BRAIN STIMULATION FOR DEPRESSION AT EMORY, AND IT'S A UNIQUE ARRANGEMENT WE HAVE THAT MEDICARE COVERAGE FOR US, AND VERY THANKFUL FOR THAT. AND SOMETIMES SEE THE CD APPROACH AS WAY OF HAVING MEDICARE FUNDED KLEINICAL TRIAL. AND, YOU KNOW, BEING TONGUE IN CHEEK. >> THAT IS THE PURPOSE. BUT, TO DEVELOP THE EVIDENCE TO PROVIDE NATIONAL COVERAGE DETERMINATION. SO I MEAN, THAT IS IN FACT THE REASON FOR THE CDE PROCESS. EVIDENCE IS STILL SOMEWHAT EARLY, AND PROMISING, FOR EXAMPLE, OBSERVATIONAL STUDIES MAY BE TOO SMALL AND NOT THE BEST STUDY. SO THE EXAMPLE OF PROVIDING STANDARDIZED, AND, YOU KNOW, THAT EVIDENCE IS SHOWS THAT THE BENEFITS OUTWEIGH THE RISKS. THE ITEM RELIES ON THE FACT THAT THEY WILL PROVIDE A NATIONAL COVERAGE, RIGHT, BUT THE ISSUE THAT WE HAVE, AS INVESTIGATORS MANY TIMES HAS BEEN, YOU KNOW, IS THAT THE STANDARDS FOR FDA APPROVAL, GO BEYOND, YOU KNOW THE DOCUMENTATION OF SIGNIFICANT LONG TERM DATA SHOWING EFFICACY, LIKE THE INITIAL FDA APPROVAL FOR VAGUS NERVE STIMULATION IN 2005 AT CLINICAL TRIAL THEY HAVE NOT BEEN THAT STRONG, BUT THAT THE FDA APPROVAL, THEN THEY STOPPED COVERING FOR IT IN CMS, AND TOOK COMBINED PAPER OF 800 PATIENTS, YOU KNOW, DETERMINING LONG TERM DATA, SOMETHING THAT WOULD GO, CERTAINLY OUTSIDE THE COVERAGE OF ANY CLINICAL TRIAL THIS FIVE YEARS, 795 PATIENTS BE FINANCIALLY VIABLE, AS YOU KNOW, I ASSUME, BY A SINGLE COMPANY TO FUND AND SUPPORT. SO ALL THE STAKEHOLDERS HERE COULD SEE A LONG TERM PLAN FOR PATIENTS, ESPECIALLY WHEN -- THE LAST THING I WANT TO SAY. THE REASON WHY WE ARE SO INVESTED IN POSTCLINICAL TRIAL CARE, IS THAT IN MANY CASES, I'VE BEEN PRIVILEGED TO TREAT TWO OF MY PATIENTS THAT ARE HERE IN THE PANEL TODAY. THE BENEFITS, ESPECIALLY IN THE CHRONIC CONDITIONS, MANIFEST LONG AFTER THE ARBITRARY END POINT OF A PRIMARY CLINICAL TIME POINT, 6 MONTHS OR 12 MONTHS, ESPECIALLY TALKING ABOUT FUNCTIONALITY. RECOVERY. THESE TRIALS TAKE YEARS. THAT'S WHY IT WAS SO IMPORTANT ON THAT VAGUS NERVE STIMULATION STUDY, TO DEMONSTRATE CUMULATIVE EVIDENCE OVER 5 YEARS, SOMETHING NOT FEASIBLE IN STANDARD CLINICAL TRIAL DERIVED FROM DRUG TRIALS, 12 WEEKS. YOU KNOW, YOU WILL NEVER DEMONSTRATE THAT. SORRY, THAT WAS MY COMMENT. >> I'LL TRY AND ANSWER THE QUESTION, AND I'LL START OFF BY SAYING THAT, YOU KNOW, THE PURPOSE -- OR WHAT FDA LOOKS AT AND CMS LOOK AT ARE ACTUALLY COMPLEMENTARY. AND FDA LOOKS LIKE, LOOKS AT THE SAFETY OF THE DEVICE. CLINICAL VALIDITY, DOES THE DEVICE TEST ACTUALLY TEST WHAT IT'S SUPPOSED TO BE TESTING. AND LOOK AT CLINICAL UTILITY. AND LOOK AT WHETHER OR NOT, ITEM HAS LONG TERM IMPROVEMENT, YOU KNOW, THE OUTCOME, SUCH AS AGAIN, MORE WE USE MORTALITY, LIKE GOLD STANDARD, BUT IT CAN BE OTHER OTHER OUTCOMES LIKE QUALITY OF LIFE, INCLUDE THAT IN SOME OF OUR CD STUDIES. AND SO, BOTH AGENCIES NEED TO LOOK AT AND DETERMINE WHETHER OR NOT, YOU KNOW, ITEM MEETS THE OBJECTIVES OF INDIVIDUAL AGENCIES. SO AGAIN, IN GENERALITIES AND THERE'S SOMEONE IN THE FDA IN THIS WORKSHOP, BUT LOOK AT SAFETY IN PARTICULAR. CLINICAL VALIDITY, WE LOOK AT CLINICAL UTILITY AND SO THAT'S WHY ... . >> I'M TRULY SORRY TO INTERRUPT YOU, BUT DO YOU INCLUDE PATIENTS -- >> THE NCD IS ARE BASED ON PUBLISHED EVIDENCE. >> THAT'S NOT WHAT I'M ASKING. I'M ASKING IF YOU HAVE A PATIENT ADVOCACY GROUP, BECAUSE THE PATIENT S CORE AND CENTRAL TO THE QUESTION, AND CORE OF WHAT'S GOING ON. THE ONLY WAY TO ADDRESS EQUITY AND DIVERSITY IS TO INCLUDE PATIENTS IN THE CONVERSATION. >> SHORT ANSWER, THEY ARE NOT INVOLVED IN OUR NATIONAL COVERAGE DETERMINATION PROCESS. >> TYLER YOU HAVE BEEN VERY PATIENT. WOULD LOVE TO HEAR YOUR VOICE, HAD A GREAT PLEASURE OF HEARING YOU TALK IN ONE OF THE NEUROSURGICAL MEETINGS A FEW WEEKS AGO IN PHILADELPHIA. >> APPRECIATE THAT. YEAH, I WAS CHATTING WITH NINA IN THE CHAT, AND TRYING TO SOAK IT ALL IN. I WAS GOING TO ASK A SIMILAR QUESTION THAT DR. MCCARTNEY ASKED. NOT JUST IF PATIENTS ARE INVOLVED IN THE PROCESS, BUT HOW CAN WE BE? I HAVE BEEN LISTENING AND HEARING A LOT ABOUT AWARENESS AND RAISING FUNDS AND DATA. AND IT SEEMS LIKE THE BEST WAY TO GET IT IS FROM THE HORSES MOUTH. I'M IN DR. R P STUDY. AND LIKE BRANDY MENTIONED EARLIER, I'M CONTINUING TO GIVE THEM AS MUCH DATA AS POSSIBLE. IF IT HELPS WITH TREATMENT RESISTANT DEPRESSION. I'M ALL FOR IT. AND I WAS HONORED AND GRATEFUL TO BE ABLE TO SPEAK IN PHILADELPHIA, A FEW WEEKS AGO AT THE AMERICAN ASSOCIATION OF NEUROLOGICAL SURGEONS AND... I GUESS... I DIDN'T REALIZE HOW MANY HANDS ARE IN THE PIE HERE TRYING TO FIGURE OUT HOW TO DO THIS. IT'S A LITTLE OVERWHELMING, BUT, AGAIN, I GUESS MY QUESTION IS FOR -- ANYONE CAN ANSWER IT. ONE AT A TIME PLEASE. BUT, HOW CAN A PATIENT LIKE ME HELP AN AS FAR AS NOT JUST GIVING YOU GUYS MY PERSPECTIVE, BUT AGAIN RAISING THAT AWARENESS, AND BEING ABLE TO PROVIDE THAT DATA. LIKE, WHAT CAN I DO? AS AN INDIVIDUAL TO DO THAT? >> THAT'S IS A GREAT QUESTION. >> I'D LIKE TO MODIFY MY ANSWER AND GIVEN IT A LITTLE MORE THOUGHT. SO IN MY GROUP IN PARTICULAR WE HAVE MEDICARE EVIDENCE DEVELOPMENT AND COVERAGE ADVISORY COMMITTEE. SOMETHING CALLED MEDCAC. NOT SURE IF PEOPLE ARE FAMILIAR WITH THAT. THAT'S WHERE WE ASK FOR EXPERT ADVICE ON DEVELOPING TECHNOLOGY OR ADVICE. AND SO WE GET EXPERTS TOGETHER, AND PATIENT ADVOCATES AND MANUFACTURERS AND A ACACADEMIA IN THE FIELD. AND CAN BE ANY PARTICULAR TOPIC AND THEN ALSO INCLUDES GROUPS OR PATIENTS AS WELL, TO WRITE IN PERSON, ACCESS TO THE FUTURE DIRECTION OR, YOU KNOW, PARTICULAR QUESTION REGARDING HOW TO ACCESS AN ITEM OR DEVICE. SO THAT WAY WE DO A PATIENT INPUT. ALONG WITH THE MANUFACTURES. AND SO THAT'S USUALLY WHAT'S THE STATE OF THE ART OF INNOVATIVE TECHNOLOGY, SO THROUGH THAT MECHANISM, DO GET INPUT FROM PATIENTS. >> GO AHEAD, NINA. >> I WAS JUST GOING TO MENTION THAT ON THE AGENDA. THE DISCUSSION IS HERE SUPPOSED TO BEGIN TO START TO WRAP UP NOW. IT'S SO RICH, WE DO HAVE JUST A COUPLE OF EXTRA MINUTES OF WIGGLE ROOM WITH EVERYBODY'S PERMISSION TO CONTINUE THIS DISCUSSION FOR A FEW MORE MINUTES TO MAKE SURE THAT EVERYBODY'S VOICES ARE HEARD. AND YES, TRACY, PLEASE. HI I'M TRACY SALAZAR, I'M EXECUTIVE DIRECTOR OF THE LENNOX GASTAUT SYNDROME FOUNDATION LIKE DR. MOREAU WAS TALKING ABOUT FOR THE RNS STUDY VERY SEVERE SHAPE POPULATION SEES YOUR START IN CHILDHOOD AND THEY BECOME DISABLED ADULTS... I'VE HEARD A LOT ABOUT FRAMING VALUE AROUND ANY POLICY OR RETURN ON INVESTMENT OR MONEY MADE OR HELPING PATIENTS, BUT WHAT I NOT HEARD IS VALUE FRAMEWORK CENTERED AROUND PATIENT OUTCOMES. ONLY PATIENTS CAN WEIGH IN ON HOW ABSOLUTELY SHITTY THE DISEASE THAT HE ARE LIVING WITH. AND WHETHER VALUE HAS BEEN ADDED TO SOMETHING. WE DON'T HAVE TO INVENT THIS, BECAUSE THE FDA FOR THE LAST 10 YEARS, HAS BEEN MANDATED BY LEGISLATION TO CREATE A PATIENT FOCUSED DRUG DEVELOPMENT FRAMEWORK, WHICH CAN EASILY MOVED OVER TO THINKING ABOUT DEVICES, WE AT THE FOUNDATION DEVELOPMENT MEETING AND WE'VE COMPLETED THE RISK BENEFIT RATIO, ABOUT WHAT IT'S LIKE TO LIVE WITH THE CONDITION. WE'VE TALKED WAS LIKE TO INTERACT WITH CURRENTLY AVAILABLE TREATMENTS, AND THE FDA SET THE STANDARDS FOR SAFETY, EFFICACY AND TOLL RABLT. RIGHT, THINKING ABOUT MEDICATION, AND THEY SHIFTED THEIR THINKING, I WAS RECENTLY IN A MEETING WITH FDA WITH A LOT OF DRUG MAKER AND IS DWAGS MAKERS AND THE FDA KEPT SAYING TO CLINICIANS AND THE RESEARCHERS IN THE ROOM. WHAT IS IT THAT PATIENTS WANT AND GO A STEP FURTHER. IT'S IT'S MORE SOPHISTICATED THAN JUST ANECDOTALLY ASKING WHAT TRACY WANTS FOR HER DAUGHTER. IT'S ACTUALLY THAT PATIENT ADVOCACY GROUPS ARE DEVELOPING OUTCOME MEASURES AND THE WORK THAT WE'VE BEEN DOING IN THIS SPACE, YOU KNOW OUR KIDS DON'T ACHIEVE MILESTONES THEY BARELY ACHIEVED IN STONE, BUT WE SEE THEM MAKING PROGRESS, , AND YOU CAN'T MEASURE THE PROCESS OF MAKING WITH CURRENTLY AVAILABLE TOOLS, BECAUSE THE WORK THAT WE'VE BEEN DOING WITH OTHERS, WE CAN MEASURE THE INSTANT. WE HAVE FIGURED THAT OUT SO THE FDA IS DOING A FOUR PART SERIES ON PATIENT FOCUSED DRUG DEVELOPMENT THEY PUBLISHED THE FIRST TWO I ENCOURAGE YOU GUYS TO READ. THE SECOND AND THIRD, WE'RE LOOKING AT THE OUTCOME METRICS. SO I FEEL LIKE THREE THINGS I THINK THE FIRST THING IS WE NEED TO SHIFT OUR VALUE FRAMEWORK. SO WHAT MATTERS TO PATIENTS, PATIENTS SHOULD BE ON PATIENTS ARE VERY SOPHISTICATED, I HAVE A PHD IN NEUROSCIENCE, I'VE BEEN AN ADVOCATE FOR ALMOST 30 YE YEARS,I CAN WEIGH IN ON THIS STUFF FOR EVERYONE ON THIS CALL HAS BEEN DEALING WITH THIS AT THE PATIENT HAS BEEN DEALING WITH YOU CAN WEIGH IN ON EVERY ASPECT OF DEVELOPMENT, BE SPEAKING TO EVERYBODY AT EVERY LEVEL SHOULD BE SPEAKING TO CMS AND NIH. NOTHING ABOUT US WITHOUT US. FIRST THING I WISH I THINK WE DID HAVE VALUE FRAMEWORK SHIFT THE WAY WE'RE THINKING ABOUT THIS. THE SECOND THING I WOULD SAY IS IT'S ALREADY DONE AND EXECUTED WITH THE FDA. SO WE HAVE IT INVENTED. I THINK WE COULD THINK ABOUT THIS, AND I LOOK AT WHAT THEY'VE DONE. AND I WOULD SAY IS THAT I THINK WE NEED TO FIGURE OUT WHAT IMPROVEMENT LOOKS LIKE RIGHT? SO IT'S ONE THING TO SAY YOU KNOW WE DO CLINICAL TRIALS, IT'S A 50% REDUCTION IN SEIZURES DECADES, OR HUNDREDS WEEK. IF YOU DO A 50% REDUCTION IN SEIZURES TO GET FDA. DID YOU REALLY MEET THE PRIMARY AND TO DEVELOP TREATMENTS AND, YES, SEIZURES ARE CAN BE VERY DEADLY IN OUR POPULATION AND SO REDUCING THEM IT'S GOOD BUT YOU KNOW WHAT IS THINGS THAT REALLY MATTER IN ADDITION TO THAT, SO I THINK WE NEED TO SET-- AND WE CAN DO THIS. BECAUSE EVERY LITTLE INDIVIDUAL DISEASE IS HAVING THEIR OWN PATIENT FOCUSED DRUG DEVELOPMENT PLATFORM FOR DEVELOPING THEIR OWN, WHAT VALUE IS. AND THEN THAT CAN BE THE COMMON THEME RATHER THAN SORT OF SHELF PATIENTS INTO A POLICY THAT WE'RE GOING TO, BECAUSE ALL OF US ARE IN THIS TO HELP PATIENTS REALLY WANT TO HELP, WHAT'S BROKEN IS THE SYSTEM. AND SO INSTEAD OF TRYING TO USE THE CURRENTLY AVAILABLE SYSTEM TO SORT OF SHOVE IN A SOLUTION. MAYBE WE CAN THINK ABOUT A LITTLE BIT, JUST AS THE FDA HAS BEEN DOING FOR THE PAST 10 YEARS. AND SO JUST SOME THOUGHTS TO CONSIDER. >> THANK YOU TRACY FOR SHARING THAT. I THINK THAT MIGHT BE REALLY ELOQUENT WAY TO CLOSE THIS PANEL, AND FIRST DAY OF THE WORKSHOP. AND I THINK WE'RE ALL TAKING IN AND SOAKING IN A LOT OF THE PERSPECTIVES THAT HAVE BEEN SHARED. SO I'M GOING TO CLOSE THIS AFTERNOON'S PANEL, AND TURN IT OVER TO TO WRAP UP FOR DAY ONE. >> ALL RIGHT, THANK YOU, MODERATORS AND PANELISTS FOR THE GREAT SECOND PANEL. IT'S A LOT TO PIECE TOGETHER. I THINK JUST TO PROVIDE A VERY HIGH LEVEL SUMMERY, I THINK DURING THE FIRST PANEL TODAY, WE HEARD ABOUT MANY NEEDS THAT PARTICIPANTS MAY HAVE AFTER A TRIAL ENDS. THIS INCLUDES FOR EXAMPLE CONTINUED ACCESS TO THE DEVICE ALREADY IMPLANTED. FOLLOW-UP CARE RELATED TO THE DEVICE. AND DEVICE SUPPORT LIKE MAINTENANCE HARDWARE REPLACEMENT AND SOFTWARE UPDATES AND DEVICE REPLACEMENT IN CERTAIN CASES, THAT MAY NEED EMERGENCY CARE, AND SIDE EFFECTS OR COMPLICATIONS, AND POTENTIALLY NEED FOR CARE COORDINATOR, AND HEARD PATIENTS NAVIGATE PATHWAYS TO FINDING CARE. AND MIGHT NEED FOR PSYCHOLOGICAL SUPPORT, AND NEED FOR STRONG, ADEQUATE CONSENT, AND HEARD ABOUT PATIENTS THROUGH RESEARCH DESIGN. AND HEARD ABOUT THE NEEDS FOR REGISTRIES, WITH DEVELOPMENT INFORMATION PROVIDERS COULD HAVE ACCESS TO RELEVANT INFORMATION. AND APOLOGIZE IF I'M SKIPPING SOME NEEDS, BUT WE'LL WILL SURE TO REGISTER ALL OF THEM AT A LATER POINT IN TIME. AND DURING THE SECOND PANEL WE HEARD ONCE ALREADY BEING COVERED. IN PART, THE ANSWER THERE SOUNDS LIKE IT DEPENDS. THERE ARE A NUMBER OF THINGS THAT ARE USUALLY COVERED BY INSURANCE, INCLUDING EMERGENCY CARE, OR EXPLANTATION IF IT'S NEEDED FOR PROGRESSIVE COMPLICATION OF THE DEVICE. BUT IN MANY OTHER CASES, DIFFERENT STAKEHOLDERS MAY OR MAY NOT PROVIDE A CERTAIN TYPE OF CARE DEPENDING ON THE CASE. SOMETIMES IT'S A CASE BY CAY BASIS, AND HEARD OF POLICIES WHERE IT MAY FIT INSIDE OR OUTSIDE OF THE POLICY. I THINK FOR MANY OF THE TRIALS NEEDS, WE HAVEN'T HEARD THAT THERE IS CONSISTENT PROVISION OF THIS CARE. SO, I THINK THAT'S SOMEWHERE WE WILL PICK UP TOMORROW, AS WE START TO THINK ABOUT WHAT CARE NEEDS SHOULD BE COVERED. WHICH, I GUESS IS MY BRIDGE TO TALKING ABOUT TOMORROW, WHERE WE HOPE THAT ALL OF YOU WILL JOIN US THEN. WE'RE GOING TO HAVE ANOTHER TWO SESSIONS IN THE AFTERNOON. AND THE FIRST OF WHICH, IS GOING TO COVER WHAT POST-TRIAL NEEDS TO BE COVERED. AND SECOND PANEL IS GOING TO LOOK AT, OKAY, GIVEN THE THINGS... GIVEN THE THINGS THAT SHOULD BE COVERED -- SORRY ABOUT THAT -- WHAT ARE THE GAPS IN TERMS OF WHAT WE HEARD IN WHAT IS CURRENTLY COVERED AND HOW CAN WE BEST FILL THE GAPS, AND HOPING THAT IS WHERE SOME OF THE SOLUTIONS HAVE ALREADY BEEN PROPOSED, AND MIGHT COME BACK AND START TALKING ABOUT HOW WE CAN APPROACH THEM, AND WHAT THE NEXT STEPS COULD BE AND SO ON. SO WITH THAT, I WANT TO ASK THE CO-CHAIRS, AND THE EUROETHICS WORKING GROUP IF THEY HAVE SOMETHING ADDITIONAL TO ADD AND I WANT TO AGAIN THANK YOU, THANK YOU ALL FOR PARTICIPATING. THANK YOU ALL FOR ATTENDING AND I, I HOPE TO SEE YOU TOO,AND SEE IF YOU HAVE SOMETHING TO ADD. >> GREAT FIRST DAY, AND LOOKING FORWARD TO TOMORROW. >> PRETTY MUCH WHAT I WANTED TO SAY, WONDERFUL PRESENTATION AND DISCUSSION, AND LOTS TO THINK ABOUT, AND TALK ABOUT TOMORROW AS WELL. THANK YOU ALL. >> RIGHT WITH THAT WE CAN END TODAY'S MEETING AND THANK YOU ALL AGAIN, AND LOOKING FORWARD TO SEEING YOU TOMORROW AND THINKING ABOUT HOW TO RESOLVE THESE COMPLICATED ISSUES.