George Sigounas, MS, Ph.D. Administrator Health Resources and Services Administration Department of Health and Human Services

Transcription

1 TO: FROM: Gerge Sigunas, MS, Ph.D. Administratr Health Resurces and Services Administratin Department f Health and Human Services Sue Dunn President, OPTN/UNOS Bard f Directrs Brian Shepard OPTN Executive Directr CEO, United Netwrk fr Organ Sharing DATE: RE: August 13, 2018 Plan fr Amending Organ Allcatin Plicies Yur letter dated July 31, 2018 cntained the fllwing directin t the OPTN: submit a detailed reprt by August 13, 2018, fr review by HRSA utlining the OPTN s plans t eliminate DSAs and Regins frm ther (nn-liver) rgan-specific allcatin plicies, fr ensuring that such plicies satisfy the requirements f the OPTN final rule (including the OPTN s plans fr ensuring that the OPTN Bard prvides an apprpriate ratinale), and steps and timelines that will be fllwed. The fllwing respnds t this request. Executive Summary Wrk t eliminate DSAs and regins frm rgan allcatin plicies is already underway. The Plicy Oversight Cmmittee (POC) and Executive Cmmittee reviewed and apprved new prject plans t remve DSAs and regins frm all f the rgan-specific allcatin plicies by June New tls and prcesses are being implemented t ensure that the revised plicies are cnsistent with the final rule and that the OPTN Bard identifies the ratinale supprting cmpliance with these requirements.

2 The chart belw summarizes the timeframe fr cmpleting this wrk. Appraches We have divided this wrk int five related prjects: liver and intestine; kidney and pancreas; heart and lung; vascular cmpsite allgrafts (VCA); and ther plicies. These rgan cmbinatins were selected because they currently have verlapping allcatin plicies. Maintaining these rgan cmbinatins will allw changes t be develped and implemented in a timely and infrmed manner. Additinally, changes t general allcatin plicies that refer t DSA and reginal bundaries will be develped cncurrently with the abve plicy prjects. Staff frm the plicy, research, IT, and ther departments will cntinue t prvide analysis and recmmendatins t the spnsring cmmittees fr these prjects. We have already discussed these timelines with the SRTR in rder t cnfirm that they are able t prvide the necessary mdeling t meet this timeline. We will expedite the decisin-making prcess by using a mdified versin f ur typical plicy develpment prcess that maintains the key cmpnents f data review, public cmment, and Bard apprval. HRSA will cntinue t receive meeting materials fr and invitatins t participate in all cmmittee meetings. HRSA will als receive regular updates thrugh cnversatins with HRSA s OPTN Cntracting Officer s Representative. UNOS will cntinue t be available t answer questins frm HRSA. UNOS staff cntinues t update the dnatin and transplantatin cmmunity regarding allcatin changes thrugh cmmittee and reginal meetings, as well as cmmunity updates and the OPTN website. Cmpliance with the Final Rule The OPTN Bard f Directrs will ensure that allcatin plicies are based upn the requirements f NOTA and the OPTN Final Rule, using a cmbinatin f tls and prcesses t direct the cmmittees wrk and dcument supprting ratinale fr plicy decisins: 2

3 Tls: Prcesses: Meeting materials will structure cmmittee decisins in the cntext f the requirements f the OPTN Final Rule. This includes presentatins used during cmmittee discussins and any reference materials sent in advance f the meetings. OPTN Cmmittee Data Analysis Requests and SRTR Simulatin Requests will cntain an explanatin f hw the request is related t the requirements f the OPTN Final Rule. Analysis f prpsed plicy revisin impacting gegraphic distributin will be cnducted utilizing the recently apprved Gegraphic Principles f Organ Distributin and the requirements f the Final Rule. Dcumentatin: Meeting summaries, public cmment prpsals, and bard briefing papers will synthesize cmmittee discussins and decisins t clearly identify the basis fr and ratinale supprting plicy revisins in the cntext f the requirements f the OPTN Final Rule. The ratinale fr gegraphic bundaries in allcatin will include supprtive data describing the need fr the bundaries and linking the decisin t the requirements f the Final Rule. Organ-Specific Tasks and Timelines Belw are the majr tasks and timelines fr the varius cmmittee prjects. Liver and Intestine 3 rd Quarter 2018: The Liver-Intestine Cmmittee s first task was t submit their mdeling request t the SRTR. This was cmpleted in July 2018 fr a mdel distributin system that uses distance-based circles fr liver distributin. Subsequently, the cmmittee s fcus turned t the transitin plan fr the Natinal Liver Review Bard (NLRB). The NLRB plicy apprved by the Bard in December 2017 ties the exceptin scres t the Median MELD at Transplant (MMaT) t the DSA f the candidate. The Cmmittee is develping a new methd t calculate the MMaT that is nt restricted by DSA r regin. The Cmmittee will cnsider changes t simultaneus liver-kidney allcatin and liverintestine allcatin. The Cmmittee will als discuss changes t any liver variances that restrict rgan allcatin by DSA r regin. 1 The Cmmittee expects t receive the results f SRTR mdeling requests in late September 2018, at which time they will then analyze the ptins fr cmpliance with the Final Rule and determine which mdel will be released fr public cmment. The POC and Executive Cmmittee will review the Cmmittee s ratinale and evidence supprting the prpsed mdel and apprve the 1 Sme variances use DSA r regin fr administrative purpses. Fr example, Plicy 9.9.A, Open Variance fr Segmental Liver Transplantatin, cntains a requirement fr each DSA r regin t discuss the results f the variance. This is administratively efficient and des nt restrict access t rgans. We d nt intend t change these variances. 3

4 prpsal fr revisins t the liver-intestine plicy befre it is released fr public cmment. 4 th quarter 2018: Public cmment is scheduled t begin in early Octber. Prir t public cmment, the POC and Executive Cmmittee will review the prpsal t ensure there is a ratinal basis with regard t gegraphic restrictin supprting cmpliance with the OPTN Final Rule. During this perid, we will hst webinars t cllect feedback frm the cmmunity. This will include targeted utreach t stakehlders such as the American Assciatin f the Study f Liver Diseases (AASLD). The Cmmittee will cnvene n Nvember 2 fr an in-persn meeting. At this meeting, the Cmmittee will review the results f public cmment and recmmend a plicy prpsal t the Bard f Directrs. The Bard will meet in December t review and cnfirm the ratinale fr the prpsed revisins in the cntext f the Final Rule requirement and apprve changes t the liver allcatin plicies. In anticipatin f this vte, UNOS staff will begin preparatins t implement the amended plicies, including IT prgramming and educatin fr members. 1 st quarter, 2019: Fllwing the December 2018 Bard f Directrs meeting, UNOS staff will implement the amended plicies, including cmmunity educatin in a variety f frmats. Kidney and Pancreas 3 rd quarter 2018: A wrking grup f the Kidney and Pancreas Transplantatin Cmmittees has been frmed. The Kidney Cmmittee will spnsr a prpsal t amend kidney and pancreas plicies with input frm the Pancreas Cmmittee. The Cmmittee s Q3 fcus will be t develp a mdeling request fr the SRTR which will include discussins f the ratinale and evidence fr restricting distributin including fr example the distance at which transprtatin methds change frm driving t flying as a justificatin fr restrictin based n efficient management f the system. Additinally, the Cmmittee will discuss the different cld ischemia time (CIT) limits f kidneys vs. pancreas and kidneys f varius KDPI scres as a relevant cnsideratin in distributin plicy t avid rgan wastage. The Cmmittee will als discuss which elements f distributin need t be cnsistent fr all kidneys and between kidneys and pancreata. 4 th quarter 2018: The Cmmittee will discuss any changes necessary fr ther kidney r pancreas plicies and guidance dcument that currently utilize DSAs r regins. Bth the Kidney and Pancreas Transplantatin Cmmittees are scheduled t hld in-persn Cmmittee meetings in Q4. The Cmmittees expect t receive the results f the SRTR mdeling request in Q4. Als during this time, the Cmmittee will evaluate the mdels fr cmpliance with the Final Rule and adapt their prpsal in respnse t that analysis as well as any lessns learned frm the Liver Cmmittee s public cmment prpsal and subsequent Bard discussins. The Kidney Cmmittee will advance a prpsal fr spring 2019 public cmment. 1 st quarter 2019: Public cmment is scheduled frm January t March, The Cmmittee will educate the cmmunity abut the prpsal and receive feedback during public cmment. This will include targeted utreach t stakehlders such as Natinal Kidney Fundatin (NKF), the American Sciety f Nephrlgy (ASN), and Internatinal Pancreas & Islet Transplant Assciatin (IPITA). 4

5 2 nd quarter 2019: The Kidney and Pancreas Cmmittees will review the results f public cmment and recmmend a plicy prpsal t the Bard f Directrs. The Bard f Directrs will meet in June 2019 and review and cnfirm the ratinale fr the prpsed revisins in the cntext f the Final Rule requirement and apprve changes t the kidney and pancreas allcatin plicies. In anticipatin f this vte, UNOS staff will begin preparatins t implement the amended plicies. This will include planning fr IT prgramming and educatin fr members. 3 rd and 4 th quarter 2019: Because current kidney plicy uses DSA and reginal bundaries mre extensively than ther rgans, designing a new plicy while aviding unintended cnsequences may take a secnd rund f revisins after the first public cmment cycle. If the Cmmittees believe a secnd rund f public cmment is necessary, they will reprt their prgress and reasn fr utilizing a secnd rund f public cmment t the Bard f Directrs in June, and then ffer a revised prpsal fr public cmment in August 2019 and a plicy prpsal t the Bard fr apprval in December Heart and Lung 3 rd quarter 2018: The Thracic Cmmittee will spnsr a prpsal fr changes t thracic rgan allcatin. Lung allcatin des nt currently cntain references t DSA r regin; hwever, heart allcatin plicies d utilize DSAs and therefre must be amended. The Cmmittee will cnsider whether lung and heart must use identical distributin mdels. In either situatin, the Cmmittee will discuss the ratinale and evidence cnsistent with the Final Rule fr selecting a replacement fr DSA in heart allcatin. Additinally, the Cmmittee will discuss whether a 250 nautical mile circle fr initial lung distributin shuld be further revised given data cllected since the new plicy went int effect and within the cntext f the Final Rule requirements. During Q3, the Cmmittee will submit a new mdeling request t the SRTR. 4 th quarter 2018: The Thracic Cmmittee will discuss any changes necessary fr ther thracic plicies and guidance dcuments that currently utilize DSAs r regins. These include heart-lung allcatin, sensitized patients, and review bard guidelines. The Cmmittee expects t receive the results f the SRTR mdeling in Q4. The Cmmittee will evaluate any prpsed revisins fr cmpliance with the Final Rule and als adapt their prpsal in respnse t any lessns learned frm the Liver Cmmittee s public cmment prpsal and subsequent Bard discussins. The Thracic Cmmittee will vte n the plicy prpsal fr spring 2019 public cmment. 1 st quarter 2019: Public cmment is scheduled frm January t March, The Cmmittee will educate the cmmunity abut the prpsal and receive feedback during public cmment. This will include targeted utreach t stakehlders such as The Internatinal Sciety fr Heart & Lung Transplantatin (ISHLT). 2 nd quarter 2019: The Cmmittee will review the results f public cmment and recmmend a plicy prpsal t the Bard f Directrs. The Bard f Directrs will meet in June 2019 t review and cnfirm the ratinale fr the prpsed revisins in the cntext f the Final Rule requirement and apprve changes t the thracic allcatin plicies. In anticipatin f this vte, UNOS staff will begin preparatins t implement the amended plicies. This will include planning fr IT prgramming and educatin fr members. 5

6 VCA 3 rd quarter 2018: The SRTR des nt currently prvide mdeling fr VCA, and the number f candidates and transplants are far fewer than fr ther rgans. The VCA cmmittee will discuss cnsideratins including transprtatin efficiency, rgan viability (such as differing CIT limits f varius types f VCAs) and ther factrs that supprt restricting distributin cnsistent with the Final Rule The Cmmittee will rely, in part, upn published research frm rthpedic and recnstructive surgery fields. Finally, the Cmmittee will discuss which elements f distributin need t be cnsistent fr all types f VCA. 4 th quarter 2018: The Cmmittee is scheduled t hld an in-persn meeting in Octber. At this meeting, the Cmmittee will frmulate a prpsed revisin t current distributin plicy, review and cnfirm the ratinale fr the prpsed revisins in the cntext f the Final Rule requirement and ffer the prpsed revisin fr spring 2019 public cmment. 1 st quarter 2019: Public cmment is scheduled fr January t March, The Cmmittee will educate the cmmunity abut the prpsal and receive feedback during public cmment during Q1. This will include targeted utreach t stakehlders such as American Sciety f Recnstructive Transplantatin (ASRT). 2 nd quarter 2019 The VCA Cmmittee will review the results f public cmment and recmmend a plicy prpsal t the Bard f Directrs. The Bard f Directrs will meet in June 2019 t review and cnfirm the ratinale fr the prpsed revisins in the cntext f the Final Rule requirement and apprve changes t the VCA allcatin plicies. In anticipatin f this vte, UNOS staff will begin preparatins t implement the amended plicies. This will include planning fr IT prgramming and educatin fr members. Mving twards ne distributin framewrk 3 rd quarter 2018: The Ad Hc Cmmittee n Gegraphy has ffered three distributin framewrks fr public cmment frm nw until Octber 3. The gal f this wrk is t receive stakehlder feedback n three identified distributin framewrks, all three f which can be custmized t accmmdate rgan-specific criteria in a manner that cmplies with the Final Rule. The Cmmittee will als educate the cmmunity abut the Bard s June 2018 adptin f Gegraphic Principles fr Organ Distributin, a tl t help cmmittees and the cmmunity understand the gegraphic requirements f the Final Rule. 4 th quarter 2018: The Ad Hc Gegraphy Cmmittee will meet mnthly t receive updates n the prpsals and prvide guidance fr the spnsring cmmittees t ensure plicy revisins are evidence-based and cmpliant with the Final Rule. The Cmmittee will review the results f public cmment and depending n the feedback, may identify a single distributin framewrk t recmmend t the Bard f Directrs. The Bard f Directrs will meet in December 2018 t review this recmmendatin and ptentially select a single distributin framewrk fr all rgan types ver time. 1 st quarter 2019: The Gegraphy Cmmittee will meet mnthly t receive updates n the prpsals and prvide guidance fr the spnsring cmmittees regarding any restrictin f rgan distributin and evaluatin f alignment with the Final Rule. 6

7 Cnclusin After these plicy revisins are implemented, the OPTN will cntinue t mnitr the results f new plicies, analyze data, and make timely revisins. The gal f the OPTN is t ensure the wrk, respnsive t yur letter, is cnducted in a time-frame that is as expeditius as pssible while ensuring apprpriate prcess and analysis t avid unintended harm t waiting patients and t cnfirm cmpliance with the Final Rule. 7