/ en Fri, 25 Apr 2025 20:17:27 -0500 Mon, 14 Apr 25 12:57:08 -0500 /role-hospitals-massachusetts-general-hospital-team-performs-second-xenotransplant-genetically-edited-pig-kidney-living <div class="container"><div class="row"><div class="col-md-9"><div class="col-md-7"><p><img src="/sites/default/files/2025-04/ths-mass-general-pig-kidney-700x532.jpg" data-entity-uuid data-entity-type="file" alt="Massachusetts General Hospital. Tatsuo Kawai, M.D., Tim Andrews, Leonardo Riella, M.D. (left to right)" width="700" height="532"></p><p><small class="sm">Tatsuo Kawai, M.D., Tim Andrews, Leonardo Riella, M.D. (L to R)</small><br><small class="sm">Photo courtesy of Kate Flock/Massachusetts General Hospital</small></p></div><p>Massachusetts General Hospital in Boston performed its second successful transplant of a genetically edited pig kidney into a living recipient in January 2025. MGH surgeons performed the world’s first such transplant in March 2024. Xenotransplantation, the term for the transplantation of organs from one species to another, is an experimental treatment being researched as a “potential solution” to the global organ shortage.</p><p>The patient in the second transplantation surgery, 66-year-old Tim Andrews, was discharged from the hospital about a week after the transplant and is doing well. Andrews had been on dialysis for more than two years due to end-stage kidney disease. His blood type is group O, and people with O positive and O negative blood types typically wait five to 10 years for a donor organ, compared to three to five years for most patients.</p><p>Advancements in the field of transplantation have helped address a worldwide organ shortage. According to the <a href="https://www.organdonor.gov/learn/organ-donation-statistics" target="_blank">Health Resources & Services Administration</a>, more than 103,000 people in the U.S. await an organ for transplant, and 17 people die each day waiting for an organ. MGH received approval from the Food and Drug Administration to proceed with this surgery and plans to perform two more xenotransplants in 2025.</p><p>Andrews said he awoke from the transplant surgery feeling “reenergized and revitalized,” noting that “the magnitude of what these doctors and nurses accomplished is unbelievable.”</p><p>Leonardo Riella, M.D., medical director for kidney transplantation at MGH and Andrews’ nephrologist, observed that the milestone operation “reminds us of the transformative potential” of xenotransplantation. “We remain committed to learning from this experience to make it a safe, viable option for every patient in need. Together, we are working toward a future where no one has to die waiting for a kidney,” Riella said.</p><p> </p><p><a class="btn btn-primary" href="https://www.massgeneral.org/news/press-release/mgh-performs-second-xenotransplant-of-genetically-edited-pig-kidney-into-living-recipient" target="_blank">READ MORE</a></p><p> </p></div><div class="col-md-3"><div><h4>Resources on the Role of Hospitals</h4><ul><li><a href="/topics/innovation">Innovation, Research and Quality Improvement</a></li><li><a href="/roleofhospitals">All Case Studies</a></li></ul></div></div></div></div> Mon, 14 Apr 2025 12:57:08 -0500 Organ Transplantation <div class="container"><div class="row"><div class="col-md-8"><p>The Center for Medicare and Medicaid Innovation (CMMI) Nov. 26 <a href="https://www.federalregister.gov/public-inspection/2024-27841/medicare-program-alternative-payment-model-updates-and-the-increasing-organ-transplant-access-model" target="_blank">finalized</a> a new mandatory payment model that will begin on July 1, 2025 and test whether hospital performance-based incentive payments or penalties will increase access to kidney transplants while preserving or enhancing the quality of care and reducing Medicare expenditures. The rule also includes standard provisions that will apply to all CMMI models whose first performance period begins on or after Jan. 1, 2025.</p><div class="panel module-typeC"><div class="panel-heading"><h2>Key Highlights</h2><p>CMMI’s IOTA model will:</p><ul><li>Require participation from 103 eligible kidney transplant hospitals. Eligible hospitals include non-pediatric transplant hospitals in select markets performing 11 or more kidney transplants across all payers in a three-year baseline period. </li><li>Run for six years, from July 1, 2025, through June 30, 2031. </li><li>Assess performance across three domains: achievement (60% of score), efficiency (20% of score) and quality (20% of score). </li><li>Provide incentive payments or penalties based on hospitals’ aggregate performance scores. Hospitals will be eligible for incentive payments of up to $15,000 per case or penalties of up to $2,000 per case. </li><li>Provide a one-year glidepath to downside risk.</li></ul></div></div><h2>AHA TAKE </h2><p>We applaud CMMI for making adjustments to certain model design elements, as we <a href="/lettercomment/2024-07-16-aha-letter-cms-increasing-organ-transplant-access-iota-model" target="_blank">recommended</a>. For example, the agency increased the maximum incentive payment from $8,000 to $15,000 per case; withdrew certain burdensome transparency requirements; and removed three problematic quality measures from the performance scoring methodology. </p><p>However, we still have deep concerns about the IOTA model. Specifically, we believe the model may have unintended consequences by focusing so heavily on volume (possibly incentivizing subpar matches). Furthermore, a model based solely on three quality measures is not robust enough for either patients or hospitals. Additionally, we are concerned the model requires mandatory participation, thus negating organizations’ ability to assess whether a model is appropriate to best serve their patients’ and communities’ needs. Finally, while the agency did delay the start date to July 1, 2025, we are concerned that this still will not provide sufficient lead time to implement such a complex model, especially in light of the transformation already occurring in the organ transplant space. We look forward to continuing to work with the agency to address our members’ concerns. </p><p>Additional details are below:</p><h3>MODEL PERFORMANCE PERIODS </h3><p>CMMI finalizes its proposal that IOTA will include a six-year model performance period. However, the agency delayed the start date from Jan. 1, 2025, to July 1, 2025, with the model now ending June 30, 2031. </p><h3>PARTICIPATION AND MARKET SELECTION </h3><p><strong>Participant Eligibility. </strong>CMMI finalizes its proposal that eligible participants will include non-pediatric kidney transplant hospitals that perform 11 or more transplants annually across all payers across baseline years. </p><p><strong>Mandatory Participation.</strong> Despite AHA’s concerns, all kidney transplant hospitals meeting eligibility criteria in selected geographic areas will be required to participate in the IOTA model. The agency asserts that mandatory participation is necessary to ensure enough hospitals participate in the model, and that its low-volume thresholds will exclude smaller transplant hospitals that may not have financial resources to support the model. </p><p><strong>Geographic Selection.</strong> To determine which hospitals are required to participate, CMMI selected half of all donation service areas (DSAs) nationally using a stratified sampling method – all eligible hospitals in these DSAs will be required to participate. The agency posted a list of these 103 hospitals on their website (<a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Flinks-2.govdelivery.com%2FCL0%2Fhttps%3A%252F%252Fwww.cms.gov%252Fpriorities%252Finnovation%252Ffiles%252Fiota-participant-dsa-list.xlsx%2F1%2F010101936a6edbbe-60e75cf8-c8f4-433c-9e59-3b1a241c42cd-000000%2Fa1bU4h7YjRScXjfuAdaUJfMIBgcKdRd6Xa1ahDWMK_o%3D381&data=05%7C02%7Cjholloman%40aha.org%7Cad23849b107e458f4e4108dd0e6936d7%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638682567240761794%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=RK40EoIflD6B4sv3pcFnTPYiU1DLJaJi7ey7AFR6SN8%3D&reserved=0" target="_blank">list of hospitals selected to participate</a>). </p><h3>ATTRIBUTION </h3><p>CMMI finalizes its attribution methodology as proposed. Specifically, patients will be attributed to IOTA model participants based on their registration for waitlists, regardless of payer type or waitlist status, or based on completed transplant procedures. If a patient is on multiple waitlists, they could be attributed to multiple IOTA participants. Patients will be attributed through an initial attribution process and then quarterly. At the end of each performance year (PY), CMMI will create a final list of attributed and deattributed patients. </p><h3>IOTA PERFORMANCE ASSESSMENT </h3><p>CMMI finalizes its proposals to assess performance across three domains — achievement, efficiency, and quality. The agency also finalizes weights for each of the domains, with a final maximum possible score of 100 points. It did modify measures in the quality domain by removing three measures that were included in the proposed rule. Table 1 below summarizes the measures and points assigned to each domain.</p><p class="text-align-center"><strong>Table 1: IOTA Model Performance Score Domains, Points, and Measures</strong></p><table><tbody><tr><td>Domain</td><td>Points</td><td>Measures</td></tr><tr><td>Achievement  </td><td>60 </td><td>Number adult kidney transplants compared to a historical target. </td></tr><tr><td>Efficiency </td><td>20 </td><td>Organ offer acceptance rate ratio.</td></tr><tr><td>Quality </td><td>20 </td><td>Post-transplant composite graft survival rate.</td></tr></tbody></table><p> </p><p><strong>Achievement Domain. </strong>CMMI finalizes its proposal to include only one measure in the achievement domain — the number of kidney transplants performed on adults 18 years and older compared to a historical target. The agency did not finalize the health equity adjustment it had proposed. The Centers for Medicare & Medicaid Services (CMS) will use all-payer Organ Procurement and Transplantation Network (OPTN) and Medicare claims data to calculate the number of kidney transplants performed by the IOTA participant during a PY. Performance will be calculated inclusive of all payers. </p><p><u>Historical Target.</u> CMMI modifies the methodology for calculating the historical target for the achievement domain. Instead of using as the target the highest number of deceased and living donor kidney transplants per year during a rolling baseline period, the agency will use an average of annual deceased and living donor kidney transplants across baseline years. This number will then be projected forward using a national growth rate that CMS will calculate for all IOTA participants. Each baseline year will reflect 12 months and run from July 1 to June 30. </p><p>The national growth rate will be defined as the percentage increase or decrease in kidney transplants performed over 12 months by all kidney transplant hospitals (excluding pediatric kidney transplant hospitals). The agency modified one aspect of the methodology for calculating the national growth rate in that it will not exclude transplant hospitals falling below CMS’ low-volume threshold. </p><p><u>Scoring Approach. </u>CMMI made adjustments to the proposed scoring approach by reducing the threshold for a maximum score in the achievement domain. Specifically, instead of requiring hospitals to increase volume by 150% or more as compared to their target, the agency will require hospitals to increase volume by 125%. The agency also modified the rest of the scoring to create a more graduated scale as depicted in table 2.</p><p class="text-align-center"><strong>Table 2: Scoring Approach for Achievement Domain</strong></p><table><tbody><tr><td><strong>Performance Relative to Target Number</strong> </td><td><strong>Points</strong></td></tr><tr><td>Less than 75%  </td><td>0</td></tr><tr><td>75% to less than 85% </td><td>10 </td></tr><tr><td>85% to less than 95% </td><td>20 </td></tr><tr><td>95% to less than 105%  </td><td>30</td></tr><tr><td>105% to less than 115% </td><td>40 </td></tr><tr><td>115% to less than 120%  </td><td>50</td></tr><tr><td>120% to less than 125% </td><td>55 </td></tr><tr><td>Greater than 125% </td><td>60</td></tr></tbody></table><p> </p><p><u>Health Equity Performance Adjustment</u>. Due to stakeholder feedback and potential unintended consequences, the agency is not finalizing the proposed health equity performance adjustment at this time. The agency stated that it will monitor impacts to low-income individuals’ access and will consider new or updated policies in future rulemaking. </p><p><strong>Efficiency Domain. </strong>CMMI will use OPTN’s organ offer acceptance rate ratio as the sole measure in the efficiency domain. This measure is calculated by dividing the number of kidney transplant organs accepted by each IOTA participant by the riskadjusted number of expected organ acceptances. The measure uses logistic regression with risk adjustment for several characteristics, including donor quality and recipient characteristics; donor-candidate interactions, such as size and age differences; number of previous offers; and distance of potential recipient from the donor. Additional details on the measure are available on the e Health Resources and Services Administration (HRSA) <a href="https://optn.transplant.hrsa.gov/media/qfuj3osi/mpsc-enhance-transplant-program-performance-monitoring-system_srtr-metrics.pdf" target="_blank" title="Health Resources and Services Administration (HRSA)">website</a>, and risk adjustment models are available on the Scientific Registry of Transplant Recipients (SRTR) <a href="https://www.srtr.org/tools/offer-acceptance/" target="_blank" title="Scientific Registry of Transplant Recipients (SRTR) website.">website</a>. </p><p>To translate measure performance into a score, CMMI finalizes its proposal to calculate two separate scores for each IOTA participant: an "achievement score" reflecting its current level of performance and an "improvement score” reflecting changes in its performance over time. Participants would receive points equal to the higher of the two scores, up to a maximum of 20 points. </p><p>For achievement scores, CMMI will award points based on an IOTA participant’s national quintile of performance. CMMI will rank IOTA hospitals against national performance inclusive of all eligible kidney transplant hospitals regardless of whether they are included in the IOTA model.</p><p>For improvement scores, CMMI modifies its proposal for maximum points, although the scoring methodology comparing performance to a benchmark score remains the same. Specifically, a participant can receive up to 15 points for improvement scores (not 12 points). CMMI will calculate an “improvement benchmark rate,” which it defines as 120% of the IOTA participant’s performance on the organ offer acceptance rate measure during the third baseline year of each PY. CMMI will then compare the PY performance to the benchmark or performance during the third baseline year to determine eligibility for improvement points using the approach in table 3 below:</p><p class="text-align-center"><strong>Table 3: Improvement Scoring for IOTA Efficiency Domain</strong></p><table><tbody><tr><td>Performance </td><td>Points</td></tr><tr><td>At or above improvement benchmark rate </td><td><p class="text-align-center">15 </p></td></tr><tr><td>At or below measure rate for third baseline year </td><td><p class="text-align-center">0 </p></td></tr><tr><td>Greater than third baseline year but less than improvement benchmark </td><td><p class="text-align-center">Up to 15 points based on following formula: 15 x (Rate in Performance Year-Third Baseline Year Rate) (Improvement Benchmark Rate-Third Baseline Year Rate)</p></td></tr></tbody></table><p> </p><p><strong>Quality Domain.</strong> CMMI removed three of the four proposed measures from the quality domain measure set. </p><p><u>Composite Graft Survival Rates.</u> CMMI finalizes its proposal to include in the model the composite graft survival rates measure. This measure will be defined as the cumulative number of functioning grafts divided by the cumulative number of all kidney transplants performed by the IOTA participant. For the first model year, CMS will calculate the rate using only data from PY 1. However, the graft survival rate will be cumulative for the remainder of the IOTA model. </p><p>CMS will rank IOTA hospitals against national performance inclusive of all eligible kidney transplant hospitals regardless of whether they are included in the IOTA model. CMMI did receive concerns from stakeholders about the lack of risk adjustment in this measure. However, it asserts that since PY 1 is upside only, it will evaluate risk adjustment for future rulemaking. </p><p>In light of the fact that three measures were removed from the quality domain, as described below, the composite graft survival rates measure will account for all 20 points in the quality domain. Points will be awarded based on the national quintiles for performance as depicted in table 4.</p><p class="text-align-center"><strong>Table 4: Scoring Approach for Quality Domain</strong></p><table><tbody><tr><td><strong>Performance Relative to Target </strong></td><td><strong>Points</strong></td></tr><tr><td>Greater than 80th percentile </td><td>20</td></tr><tr><td> 60th to 80th percentile </td><td>18</td></tr><tr><td>40th to 60th percentile  </td><td>16</td></tr><tr><td>20th to 40th percentile  </td><td>14</td></tr><tr><td>10th to 20th percentile  </td><td>12</td></tr><tr><td>Less than 10th percentile </td><td>10</td></tr></tbody></table><p> </p><p><u>Other Quality Measures.</u> CMMI did not finalize its other proposed quality measures for the quality domain. Specifically, the agency will not include the CollaboRATE shared decision-making measure, colorectal cancer screening rate measure, or Three-item Care Transition Measure (CTM-3) in the IOTA quality domain. </p><p>The agency indicates that it will assess processes to add, remove or replace quality measures in future rulemaking. </p><h3>HEALTH EQUITY REQUIREMENTS </h3><p><strong>Health Equity Plan.</strong> CMMI modified provisions pertaining to the health equity plans. Specifically, submission of health equity plans will be voluntary across all PYs. </p><p><strong>Demographic and Health-related Social Need (HRSN) Data Reporting.</strong> CMMI did not finalize requirements for demographic and HRSN data reporting. The agency stated that it will continue to review feedback for future rulemaking. </p><h3>PAYMENT </h3><p>CMMI finalizes its proposal that IOTA will include both upside and downside risk for Medicare fee-for-service (FFS) payments for kidney transplants. </p><p><strong>Alternative Payment Model Design for Kidney Transplants. </strong>CMMI finalizes that payments to participants will be limited to Medicare FFS cases. Specifically, while aggregate performance for participants is based on attributed patients regardless of payer, the payment portion of IOTA will include kidney transplants furnished to attributed patients whose primary or secondary insurance is Medicare FFS (since payment is made on a per-case basis). </p><p><strong>Performance-Based Payment.</strong> Participants will be assigned to payment categories based on their performance score. As shown below in Table 5, incentive payments will be made to participants with a performance score of 60 or more. For PY 1, hospitals below this threshold will not receive a payment or be required to make a repayment. Starting in PY 2, hospitals with a score of 40 or lower will be required to pay CMS.</p><p class="text-align-center"><strong>Table 5: Performance Scores and Payment Methodology by PY</strong></p><table><tbody><tr><td><strong>Final Score</strong></td><td><strong> PY 1 </strong></td><td><strong>PY 2-PY 6</strong></td></tr><tr><td>60-100 </td><td>Payment to hospital </td><td>Payment to hospital</td></tr><tr><td>41-59 </td><td>Neutral Zone (no payment adjustment) </td><td>Neutral Zone (no payment adjustment) </td></tr><tr><td>0-40 </td><td>Neutral Zone (no payment adjustment) </td><td>Repayment to CMS</td></tr></tbody></table><p> </p><p><u>Payments to Hospitals.</u> CMMI increased the potential upside payments to participants in the final rule. Hospitals will be eligible for up to $15,000 per case based on their aggregate performance score (compared to the $8,000 per case that was proposed). Payment will be calculated based on the following formula: </p><p class="text-align-center">Payment = $15,000*((Final Performance Score-60)/40)*Medicare Kidney Transplants </p><p><u>Repayment.</u> As was proposed, CMMI finalizes that hospitals in the repayment category will be required to repay CMS up to $2,000 per case based on their aggregate performance score. This is estimated to be 8% of the average kidney transplant MSDRG cost. Repayment to CMMI will be calculated based on the following formula: Repayment = $2,000*((40-Final Performance Score)/40)*Medicare Kidney Transplants </p><p><u>Neutral Zone.</u> Hospitals scoring below 60 in PY 1 or from 41 through 59 in PYs 2-6 will be in the neutral zone and, as such, will neither receive payments nor be subject to repayment.</p><h3>TRANSPARENCY REQUIREMENTS </h3><p><strong>Publication of Patient Selection Criteria for Kidney Transplant Evaluation. </strong>The agency finalizes its proposal to require IOTA participants to publicly post by the end of PY 1, on a website, their selection criteria for evaluating patients for addition to their kidney transplant waitlist. </p><p><strong>Transparency into Kidney Transplant Organ Offers. </strong>The agency did not finalize its proposals that would require an IOTA participant to inform IOTA Medicare waitlist patients of the number of times an organ is declined on their behalf and the reason(s) for the decline on a monthly basis. </p><p>However, the agency did modify requirements for reviewing organ offer acceptance criteria (rather than acceptance criteria and organ offer filters) with IOTA Medicare waitlist patients at least once every six months. </p><p>The agency will consider additional requirements to increase transparency in future rulemaking.</p><h3>FRAUD AND ABUSE WAIVER AND OIG SAFE HARBOR AUTHORITY </h3><p>The Health and Human Services (HHS) Secretary has the authority per Section 1115A of the Social Security Act to waive specified fraud and abuse laws to test payment models. However, no fraud and abuse waivers are issued in the final rule. Therefore, as it stands, any arrangement or agreement under the model that implicates these laws would not be protected unless it falls under an existing exception or safe harbor. </p><p>The final rule notes that any fraud and abuse waivers would be promulgated separately. The AHA will work to ensure that CMS and the HHS Office of Inspector General (OIG) provide necessary waivers so that participating hospitals can pursue the program’s goals without running afoul of fraud and abuse laws. These legal protections are critical to hospitals’ ability to coordinate care among all caregivers. </p><p>CMMI stated that it expects that all financial relationships established between IOTA participants and providers or suppliers for purposes of IOTA would only be those permitted under applicable laws and regulations, including the applicable fraud and abuse laws and all applicable payment and coverage requirements. </p><p>CMS did make a determination that a federal anti-kickback statute safe harbor for CMSsponsored model arrangements and CMS-sponsored model patient incentives is available to protect remuneration exchanged pursuant to certain financial arrangements and patient incentives that may be permitted under the final rule. Specifically, the agency determined that the CMS-sponsored models safe harbor would be available to protect the following financial arrangements and incentives: the IOTA Model Sharing Arrangement’s gainsharing payments and alignment payments, the Distribution Arrangement’s distribution payments, the Part B and Part D immunosuppressive drug cost sharing support policy and attributed patient engagement incentives.</p><h3>GENERAL PROVISIONS FOR ALL INNOVATION CENTER MODELS </h3><p>CMS finalizes standard provisions that will apply more broadly to all CMMI models that begin on or after Jan. 1, 2025. Specifically, it finalizes sections pertaining to beneficiary protections, cooperation in model evaluation and monitoring, audits and record retention, rights in data and intellectual property, monitoring and compliance, remedial action, model termination by CMS, limitations on review and bankruptcy, reconsideration review processes and other notifications be applied across models. </p><h3>FURTHER QUESTIONS </h3><p>If you have further questions regarding IOTA, please contact Jennifer Holloman, AHA’s senior associate director of policy, at <a href="mailto:jholloman@aha.org" title="jholloman@aha.org">jholloman@aha.org</a>.</p></div><div class="col-md-4"><p><a href="/system/files/media/file/2024/11/2024-11-27_SB_IOTA-f.pdf" target="_blank" title="Click here to download the Special Bulletin: CMMI Issues Increasing Organ Transplant Access (IOTA) Model Final Rule PDF."><img src="/sites/default/files/2024-11/CMMI-Issues-Increasing-Organ-Transplant-Access-p1.png" data-entity-uuid data-entity-type="file" alt="Special Bulletin: CMMI Issues Increasing Organ Transplant Access (IOTA) Model Final Rule cover." width="600" height="779"></a></p></div></div></div> Wed, 27 Nov 2024 11:49:52 -0600 Organ Transplantation /news/headline/2024-11-26-cms-issues-final-rule-mandatory-organ-transplant-payment-model <p>The Centers for Medicare & Medicaid Services Nov. 26 released a <a href="https://www.federalregister.gov/public-inspection/2024-27841/medicare-program-alternative-payment-model-updates-and-the-increasing-organ-transplant-access-model" target="_blank">final rule</a> for the Increasing Organ Transplant Access Model. This new mandatory payment model will test whether performance-based incentives or penalties for participating transplant hospitals will increase access to kidney transplants for patients with end-stage renal disease while preserving or enhancing quality of care, improving equitable access to kidney transplant care and reducing Medicare expenditures. The model will run for six years. Participation will be mandatory for all eligible hospitals (i.e. nonpediatric kidney transplant hospitals meeting minimum volume thresholds) located within half of the nation’s donation service areas. CMS posted a <a href="https://www.cms.gov/priorities/innovation/innovation-models/iota" target="_blank">list of the 103 hospitals required to participate</a> on their website.<br><br>In response to stakeholder feedback, including concerns <a href="/lettercomment/2024-07-16-aha-letter-cms-increasing-organ-transplant-access-iota-model" target="_blank">raised by the AHA</a>, the agency made some adjustments to the model. These adjustments include delaying the start date to July 1, 2025, increasing the maximum upside payment from $8,000 to $15,000 per case, adjusting transplant targets to reflect the average number of deceased or living transplants during baseline years (versus the highest count as proposed), and removing three quality measures. The agency also did not finalize transparency requirements, which would have required IOTA participants to inform beneficiaries of the number of times an organ is declined on the Medicare beneficiary’s behalf and the reason(s) for the decline.<br><br>AHA will provide additional details about the IOTA final rule in a Special Bulletin.</p> Tue, 26 Nov 2024 17:01:08 -0600 Organ Transplantation /news/headline/2024-11-26-hhs-issues-final-rule-expanding-kidney-and-liver-transplant-access-people-hiv <p>The Department of Health and Human Services Nov. 26 issued a <a href="https://www.federalregister.gov/public-inspection/2024-27410/organ-procurement-and-transplantation-implementation-of-the-hiv-organ-policy-equity-act" target="_blank">final rule</a> that expands access to kidney and liver transplants for individuals with HIV by removing clinical research requirements. Specifically, the rule implements a stipulation under the HIV Organ Policy Equity Act, eliminating the need for approval from the clinical research and institutional review board for kidney and liver transplants between donors with HIV and recipients with HIV. The change was based on research showing the safety and effectiveness of such transplants, HHS said. The final rule is effective Nov. 27.</p><p>In tandem with the final rule, the National Institutes of Health <a href="https://www.federalregister.gov/public-inspection/2024-27733/draft-revised-human-immunodeficiency-virus-hiv-organ-policy-equity-act-safeguards-and-research" target="_blank">published a notice</a> seeking public comment on a proposed revision to its research criteria for HOPE Act transplants of other organs, such as heart, lung and pancreas, with a 15-day comment period.</p> Tue, 26 Nov 2024 15:38:07 -0600 Organ Transplantation /news/headline/2024-10-23-cms-anticipates-later-start-date-mandatory-organ-transplant-payment-model <p>The Centers for Medicare & Medicaid Services recently <a href="https://www.cms.gov/priorities/innovation/innovation-models/iota">announced</a> that they anticipate a later start date for the Increasing Organ Transplant Access Model. The agency stated that it is “continuing to work on the final rule and is consequently anticipating a later start date for the model than the proposed start date of January 1, 2025.” The mandatory payment model would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals would increase kidney transplant access while preserving or enhancing the quality of care and reducing Medicare expenditures. In July, the AHA informed the Center for Medicare and Medicaid Innovation that the IOTA model would add unnecessary disruption and uncertainty to the transplant ecosystem, potentially incentivize sub-par matches given the heavy emphasis on volume and would be discordant with other regulatory requirements. </p><p>"Complex (not to mention successful) payment model implementation requires significant time, resources and staffing by hospital participants," <a href="/lettercomment/2024-07-16-aha-letter-cms-increasing-organ-transplant-access-iota-model">AHA wrote</a>. "But, CMMI has proposed an IOTA start date of Jan. 1, 2025 — less than six months from now and an even briefer time from when the rule will be in its final form. It would notify participants of their mandatory participation with as little as three months’ notice. Given the organ transplant system’s transformation already occurring as mentioned above, this aggressive timeline is untenable."</p> Wed, 23 Oct 2024 15:27:52 -0500 Organ Transplantation /news/headline/2024-09-20-hrsa-begin-awarding-multi-vendor-contracts-organ-transplantation-services <p>The Health Resources and Services Administration Sept. 19 <a href="https://www.hhs.gov/about/news/2024/09/19/hrsa-makes-first-ever-multi-vendor-awards-to-modernize-the-nations-organ-transplant-system.html">announced</a> that it will award multi-vendor contracts for organ transplantation services, continuing an overhaul of the national organ transplant system. HRSA is awarding Organ Procurement and Transplantation Network contracts to support efforts which include improving patient safety, supporting OPTN information technology modernization, increasing transparency and public engagement in OPTN policy development, strengthening patient-centered communications and improving OPTN financial management. In <a href="/news/headline/2024-09-03-hrsa-announces-shift-organ-transplant-program-governance">August</a>, HRSA announced that the American Institutes for Research would support the OPTN Board of Directors, separating the board from the United Network for Organ Sharing which previously managed it.</p> Fri, 20 Sep 2024 14:01:03 -0500 Organ Transplantation /news/headline/2024-09-03-hrsa-announces-shift-organ-transplant-program-governance <p>The Health Resources and Services Administration Aug. 29 <a href="https://www.hrsa.gov/about/news/press-releases/historic-overhaul-optn">announced</a> that it awarded a contract to the American Institutes for Research to support the Organ Procurement and Transplantation Network Board of Directors. Previously, the United Network for Organ Sharing managed the OPTN board, but the <a href="https://www.hrsa.gov/optn-modernization/march-2023">HRSA OPTN modernization plan</a> announced last year included this separation. The OPTN board is responsible for developing national organ allocation policy. </p> Tue, 03 Sep 2024 15:34:42 -0500 Organ Transplantation /news/headline/2024-08-19-organ-donation-and-transplant-alliance-launches-new-educational-guide-workshop <p>The Organ Donation and Transplantation Alliance has created new resources for health care providers to encourage more organ donation and transplants. It has launched an <a href="https://www.organdonationalliance.org/resources/donation-after-circulatory-death-educational-guide/">educational guide </a>to enhance collaboration between organ procurement organizations, transplant centers and hospitals. The Alliance last week <a href="https://www.organdonationalliance.org/events/2024-dcd-workshop/">hosted a workshop</a> complementing the guide launch. An on-demand learning pathway video and other supporting materials will be available in September.</p> Mon, 19 Aug 2024 16:02:09 -0500 Organ Transplantation /news/headline/2024-07-16-aha-urges-cmmi-not-implement-proposed-mandatory-organ-transplant-payment-model <p>The AHA July 16 <a href="/lettercomment/2024-07-16-aha-letter-cms-increasing-organ-transplant-access-iota-model">urged</a> the Center for Medicare and Medicaid Innovation not to implement its newly proposed Increasing Organ Transplant Access Model as currently constructed, expressing concerns about many of its design features. The proposed mandatory payment model would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals would increase access to kidney transplants while preserving or enhancing the quality of care and reducing Medicare expenditures. AHA said that IOTA features could exacerbate inequities and negatively impact quality of care. Specifically, AHA said the IOTA model would add unnecessary disruption and uncertainty to the transplant ecosystem, potentially incentivize sub-par matches given the heavy emphasis on volume and would be discordant with other regulatory requirements. </p> Tue, 16 Jul 2024 15:43:01 -0500 Organ Transplantation /lettercomment/2024-07-16-aha-letter-cms-increasing-organ-transplant-access-iota-model <p>July 16, 2024</p><p>The Honorable Chiquita Brooks-LaSure<br>Administrator<br>Centers for Medicare & Medicaid Services<br>Hubert H. Humphrey Building<br>200 Independence Avenue, S.W., Room 445-G<br>Washington, DC 20201</p><p><em>Submitted Electronically</em></p><p><em><strong>RE: Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model</strong></em></p><p>Dear Administrator Brooks-LaSure,</p><p>On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, the ���������� Association (AHA) appreciates the opportunity to provide feedback on the proposed Increasing Organ Transplant Access (IOTA) Model.</p><p>Our members have long supported the Center for Medicare and Medicaid Innovation (CMMI) in testing innovative payment models to improve health care quality and reduce costs. However, to accomplish these objectives, models must be carefully designed to ensure that they align with intended goals, are feasible to implement and do not have unintended negative consequences. In fact, we have <a href="/testimony/2024-06-13-aha-statement-energy-and-commerce-subcommittee-assessing-value-based-care">recommended</a> that CMMI consider common principles in developing such models to make participation more attractive for potential participants. We are concerned that the IOTA model would not meaningfully advance the move to value.</p><p>IOTA’s goal of increasing access to kidney transplants is one that the AHA shares.  However, we are concerned that many of the model design features may in fact exacerbate inequities and negatively impact patients’ quality of care. We are particularly concerned that the model’s heavy focus on transplant volume may incentivize unintended consequences, such as sub-par matches. <strong>Given the potential negative impact on patient outcomes, we urge CMMI to not implement the IOTA model at this time. As written, it is not fully developed and contains fundamental flaws.</strong></p><p>The proposed rule’s most problematic design elements are delineated below and explained more thoroughly in the attached.</p><ul><li><strong>IOTA would add unnecessary disruption and uncertainty to the transplant ecosystem, which is already undergoing significant transformation. </strong>The organ transplant ecosystem is undergoing massive transformation under the Organ Procurement and Transplantation Network (OPTN) Modernization Initiative and Securing the U.S. Organ Procurement and Transplantation Network Act. These changes will result in significant workflow, staffing and reporting modifications for stakeholders, including hospitals. Implementing a mandatory organ transplant payment model simultaneously as these transformations would add risk and uncertainty to a complex and critical portion of the care continuum.</li><li><strong>IOTA’s timeline is untenable.</strong> Complex (not to mention successful) payment model implementation requires significant time, resources and staffing by hospital participants. But, CMMI has proposed an IOTA start date of Jan. 1, 2025 — less than six months from now and an even briefer time from when the rule will be in its final form. It would notify participants of their mandatory participation with as little as three months’ notice. Given the organ transplant system’s transformation already occurring as mentioned above, this aggressive timeline is untenable.</li><li><strong>IOTA’s mandatory participation is inappropriate.</strong> Hospitals must be able to assess whether CMMI models are appropriate for their patients’ and communities’ needs. Yet, the proposed rule would mandate certain hospitals’ participation in IOTA. Specifically, it would require participation for certain kidney transplant hospitals with 11 or more kidney transplants in a three-year baseline period — a threshold that does not come close to ensuring statistical significance and exposes organizations to unwarranted penalties for outlier cases.</li><li><strong>IOTA’s emphasis on volume could incentivize sub-par matches and exacerbate inequities. </strong>As proposed, IOTA heavily emphasizes transplant volume increases. Specifically, 60% of a hospital’s performance score would be determined by transplant volume. To receive a maximum score, the hospital would need to increase historical volume by 150% plus a national growth rate. By so heavily incentivizing increases in the number of transplants performed, we are concerned that CMMI is also incentivizing sub-par organ matches. Moreover, we are concerned that the lack of an appropriate risk adjustment incentivizes the selection of healthier patient populations and could exacerbate existing inequities concerning who receives transplants, which impacts underserved and geographically remote transplant facilities.</li><li><strong>IOTA’s other proposed measures run counter to CMS’ goal of broadening access to transplants and are discordant with other regulatory requirements. </strong>IOTA has built-in conflicting metrics by including measures such as offer-acceptance ratios and graft survival rates. On the one hand, the model would heavily incentivize volume increases, but on the other, offer-acceptance ratios would incentivize more conservative selection of organs for transplants. The methodology for these other measures also differs from the standards and reporting requirements established by OPTN.</li></ul><p>Our members are committed to improving access and reducing disparities in kidney transplants. However, the proposed IOTA model not only would fail to help achieve these goals but also may result in reduced quality and exacerbated care inequities.<strong> As such we recommend that CMMI not implement this model at this time.</strong> <strong>Instead, CMS should evaluate, after implementation of changes under the OPTN modernization initiative, the need for a voluntary payment model. </strong>That way, CMS would understand areas where further reform may be needed and could effectively test the model without confounding variables.</p><p>Our detailed comments are attached. Please contact me if you have questions or feel free to have a member of your team contact Jennifer Holloman, AHA’s senior associate director of policy, at <a href="mailto:jholloman@aha.org">jholloman@aha.org</a>.</p><p>Sincerely,</p><p>/s/</p><p>Ashley Thompson<br>Senior Vice President<br>Public Policy Analysis and Development</p><p>Cc:     Elizabeth Fowler<br>          Director, CMMI</p> Tue, 16 Jul 2024 13:13:58 -0500 Organ Transplantation