{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T11:02:30Z","timestamp":1785150150876,"version":"3.55.0"},"reference-count":42,"publisher":"Academy of Managed Care Pharmacy","issue":"8","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMCP"],"published-print":{"date-parts":[[2026,8]]},"DOI":"10.18553\/jmcp.2026.32.8.896","type":"journal-article","created":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T10:41:00Z","timestamp":1785148860000},"page":"896-902","source":"Crossref","is-referenced-by-count":0,"title":["Evaluating the design and implementation challenges of the Centers for Medicare & Medicaid Services\u2019 Cell and Gene Therapy Access Model"],"prefix":"10.18553","volume":"32","author":[{"given":"Yuxuan","family":"Bo","sequence":"first","affiliation":[{"name":"University of Virginia School of Law, Charlottesville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Varun","family":"Thachil","sequence":"additional","affiliation":[{"name":"University of Oklahoma College of Medicine, Oklahoma City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacob T.","family":"Kannarkat","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Yale School of Medicine, New Haven, CT"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph T.","family":"Kannarkat","sequence":"additional","affiliation":[{"name":"Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"7818","reference":[{"key":"r1","unstructured":"American Society of Gene and Cell Therapy.\n                      Gene, Cell,\u2009+\u2009RNA Therapy Landscape Report: Q4 2023 Quarterly Data Report\n                      . 2024. https:\/\/www.asgct.org\/global\/documents\/asgct-citeline-q4-2023-report.aspx"},{"key":"r2","doi-asserted-by":"publisher","DOI":"10.1016\/j.omtm.2023.05.015"},{"key":"r3","unstructured":"Buntz B. With prices topping $4 million, high stakes define cell and gene therapy landscape. Drug Discovery and Development. April 26, 2024. Accessed November 27, 2025. https:\/\/www.drugdiscoverytrends.com\/how-price-safety-and-efficacy-shape-the-cell-and-gene-therapy-landscape\/"},{"key":"r4","doi-asserted-by":"publisher","DOI":"10.1038\/s41434-023-00419-9"},{"key":"r5","unstructured":"Center for Medicare and Medicaid Innovation.\n                      Cell & Gene Therapy (CGT) Access Model Overview Webinar\n                      . 2024. https:\/\/www.cms.gov\/files\/document\/cgt-model-ovw-webinar-2-6-24-slides.pdf"},{"key":"r6","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2018.07.826"},{"key":"r7","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000035237"},{"key":"r8","doi-asserted-by":"publisher","DOI":"10.1016\/j.ymthe.2025.03.016"},{"key":"r9","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2014-02-514760"},{"key":"r10","unstructured":"Macmillan C. Casgevy and Lyfgenia: Two Gene Therapies Approved for Sickle Cell Disease. Yale Medicine. December 19, 2023. Accessed November 27, 2025. https:\/\/www.yalemedicine.org\/news\/gene-therapies-sickle-cell-disease"},{"key":"r11","unstructured":"Sickle Cell Disease - Treatment | NHLBI, NIH. National Heart, Lung, and Blood Institute. September 30, 2024. Accessed May 18, 2026. https:\/\/www.nhlbi.nih.gov\/health\/sickle-cell-disease\/treatment"},{"key":"r12","unstructured":"FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease. Food and Drug Administration. December 8, 2023. Accessed November 27, 2025. https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease"},{"key":"r13","unstructured":"CASGEVY\n                      \u00ae\n                      (exagamglogene autotemcel) | Patient website. Vertex Pharmaceuticals. May 18, 2026. Accessed May 18, 2026. https:\/\/www.casgevy.com\/"},{"key":"r14","unstructured":"my bluebird support | LYFGENIATM (lovotibeglogene autotemcel). bluebird bio. May 18, 2026. Accessed May 18, 2026. https:\/\/www.lyfgenia.com\/support"},{"key":"r15","unstructured":"Form 8-K: Vertex Pharmaceuticals Inc. Published online December 8, 2023. Accessed May 29, 2026. https:\/\/www.sec.gov\/Archives\/edgar\/data\/875320\/000087532023000054\/vrtx-20231208.htm"},{"key":"r16","unstructured":"Form 8-K: bluebird bio, Inc. Published online December 8, 2023. Accessed May 29, 2026. https:\/\/www.sec.gov\/ix?doc=\/Archives\/edgar\/data\/0001293971\/000119312523292087\/d84993d8k.htm"},{"key":"r17","unstructured":"Fiedler M. Richard G. Frank. Assessing CMMI\u2019s proposals on Medicaid payment for cell and gene therapies. The Brookings Institution. Accessed November 27, 2025. https:\/\/www.brookings.edu\/articles\/assessing-cmmis-proposals-on-medicaid-payment-for-cell-and-gene-therapies\/"},{"key":"r18","unstructured":"CGT (Cell and Gene Therapy Access) Model. Centers for Medicare and Medicaid Services. Accessed May 21, 2026. https:\/\/www.cms.gov\/priorities\/innovation\/innovation-models\/cgt"},{"key":"r19","unstructured":"Centers for Medicare & Medicaid Services.\n                      CGT Access Model Overview Factsheet\n                      . 2024. https:\/\/www.cms.gov\/files\/document\/cgt-model-ovw-fact-sheet.pdf"},{"key":"r20","unstructured":"Biden-Harris Administration Announces Action to Increase Access to Sickle Cell Disease Treatments. Centers for Medicare and Medicaid Services. January 30, 2024. Accessed November 27, 2025. https:\/\/www.cms.gov\/newsroom\/press-releases\/biden-harris-administration-announces-action-increase-access-sickle-cell-disease-treatments"},{"key":"r21","unstructured":"CGT Access Model Frequently Asked Questions | CMS. Center for Medicare and Medicaid Innovation. 2025. Accessed November 27, 2025. https:\/\/www.cms.gov\/cgt-access-model-frequently-asked-questions"},{"key":"r22","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-021-90405-1"},{"key":"r23","doi-asserted-by":"publisher","DOI":"10.1001\/jamapediatrics.2020.7140"},{"issue":"4","key":"r24","first-page":"qxae029","volume":"2","author":"Speller J","year":"2024","journal-title":"Health Aff Sch"},{"key":"r25","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2019.10.009"},{"key":"r26","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2025.43421"},{"key":"r27","volume-title":"Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action","author":"Martinez RM","year":"2020"},{"key":"r28","author":"Centers for Medicare & Medicaid Services","year":"2024","journal-title":"Cell and Gene Therapy (CGT) Access Model: Request for Applications from Applicable Manufacturers"},{"key":"r29","unstructured":"Managed Care Enrollment Summary. May 19, 2026. Accessed May 19, 2026. https:\/\/data.medicaid.gov\/dataset\/52ed908b-0cb8-5dd2-846d-99d4af12b369"},{"key":"r30","doi-asserted-by":"publisher","DOI":"10.1257\/jep.31.4.23"},{"key":"r31","volume-title":"High Rates of Prior Authorization Denials by Some Plans and Limited State Oversight Raise Concerns About Access to Care in Medicaid Managed Care","author":"Grimm CA","year":"2023"},{"key":"r32","doi-asserted-by":"publisher","DOI":"10.1186\/s12958-022-00984-5"},{"key":"r33","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2021.4309"},{"key":"r34","unstructured":"Medicaid Payment Policy for Out-of-State Hospital Services. Published online January 2020. https:\/\/www.macpac.gov\/wp-content\/uploads\/2020\/01\/Medicaid-Payment-Policy-for-Out-of-State-Hospital-Services.pdf"},{"key":"r35","unstructured":"Manetto N, Greenberg J, Gaulin M. Medicaid\u2019s unnecessary barriers delay care for children with complex needs. STAT. May 1, 2018. Accessed November 27, 2025. https:\/\/www.statnews.com\/2018\/05\/01\/medicaid-barriers-delay-care-children-complex-needs\/"},{"key":"r36","unstructured":"McWright LT. Centers for Medicare & Medicaid Services, Cell and Gene Therapy Access Model. Published online December 4, 2024. Accessed May 20, 2026. https:\/\/www.cms.gov\/priorities\/innovation\/files\/cgt-letter-treatment-centers.pdf"},{"key":"r37","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2019003776"},{"key":"r38","doi-asserted-by":"publisher","DOI":"10.1111\/vox.13612"},{"key":"r39","unstructured":"LYFGENIA. Package insert. bluebird bio; 2023. Accessed November 27, 2025. https:\/\/www.fda.gov\/media\/174610\/download"},{"key":"r40","unstructured":"CASGEVY. Package insert. Vertex Pharmaceuticals; 2023. Accessed November 27, 2025. https:\/\/www.fda.gov\/media\/174615\/download"},{"key":"r41","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0334883"},{"key":"r42","doi-asserted-by":"publisher","DOI":"10.1016\/j.omtm.2020.04.013"}],"container-title":["Journal of Managed Care & Specialty Pharmacy"],"original-title":[],"language":"en","deposited":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T10:41:26Z","timestamp":1785148886000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.jmcp.org\/doi\/10.18553\/jmcp.2026.32.8.896"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":42,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2026,8]]}},"alternative-id":["10.18553\/jmcp.2026.32.8.896"],"URL":"https:\/\/doi.org\/10.18553\/jmcp.2026.32.8.896","relation":{},"ISSN":["2376-0540","2376-1032"],"issn-type":[{"value":"2376-0540","type":"print"},{"value":"2376-1032","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8]]}}}