Mark B McClellan | Scholars@Duke

Mark B McClellan
Professor of the Practice of Business Administration

Mark McClellan, MD, PhD, is the Robert J. Margolis Professor of Business, Medicine, and Policy, and Director of the Duke-Margolis Center for Health Policy at Duke University with offices at Duke and in Washington DC. The new Center will support and conduct research, evaluation, implementation, and educational activities to improve health policy and health, through collaboration across Duke University and Health System, and through partnerships between the public and private sectors. It integrates the social, clinical, and analytical sciences to integrate technical expertise and practical capabilities to develop and apply policy solutions that improve health and the value of health care locally, nationally, and worldwide.

Current Appointments & Affiliations

Professor of the Practice of Business Administration, Fuqua School of Business, Duke University 2016
Professor of the Practice in the Sanford School of Public Policy, Sanford School of Public Policy, Duke University 2016

Contact Information

100 Fuqua Drive, Box 90120, Durham, NC 27708
mark.mcclellan@duke.edu (919) 660-7963
Fuqua Faculty Profile

Background
Education, Training, & Certifications
- Ph.D., Massachusetts Institute of Technology 1993
- M.D., Harvard Medical School 1992
- M.P.A., Harvard University 1991
- B.A., University of Texas at Austin 1985
Recognition
In the News
- FEB 9, 2017
  
  Duke-Margolis Center For Health Policy Launches
- NOV 10, 2016
  
  The 2016 Elections' Implications for Health Care Policy
- OCT 23, 2016 NPR
  
  Dr. Mark McClellan comments: Small savings for drugs made to mimic biotech blockbusters
- SEP 6, 2016 The Hill
  
  Medicares Bundled Payment Proposal: Progress on Health Care Payment Reform
- JUN 28, 2016 The Washington Post
  
  Biden holding cancer summit to pump up support for 'moonshot' effort
- MAY 23, 2016
  
  Medicare Proposed Rule Clarifies, But Leaves Work To Be Done, Experts Say
- APR 5, 2016
  
  Report: Nation Should Implement a Medical Device Evaluation System for Safer, Innovative Medical Devices
Research
Selected Grants
- Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities awarded by Food and Drug Administration 2019 - 2024
- Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) awarded by Food and Drug Administration 2018 - 2023
- Explainability and Trade Secrecy in AI-Enabled Clinical Decision Support, Diagnostic, and Predictive Software awarded by Greenwall Foundation 2019 - 2020
- AHA project awarded by American Heart Association 2018 - 2019
- Convener of Discussions on Medical Policy Issues Impacting Drug Development awarded by Food and Drug Administration 2014 - 2019
- Sustainable Biodefense Industrial Base for the Assistant Secretary for Preparedness and Response 2016 - 2019
- West Health Foundation 2018 - 2019
- Guiding Committee Co-Chair role for the Health Care Payment LAN 2016 - 2019
- Exploring the Evidence on the Potential Impact of Reducing Areas of Low-Value Care 2018 - 2019
- Support of Regulatory Research to FDA Commitment under the 2012 PDUFA Act awarded by Food and Drug Administration 2013 - 2018
- Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic awarded by Food and Drug Administration 2016 - 2018
- Challenges to Reducing Low-Value Care: Lessons Learned and Future Directions 2017 - 2018
- Accountable Care Policy Gaps and Lessons from the UK and US: A Bi-Directional Study 2016 - 2018
- Special Analysis of Part D Drug Prices 2018
- Improving our Understanding of Risk Sharing Agreements: A Survey to Learn from Non-Public Activities 2017 - 2018
- Developing a path to value-based reimbursement for Oncology therapies 2017 - 2018
- Person Generated Health Data: A new generation of evidence for regulatory decision-making 2016 - 2017
- Model Portfolio Plan 2016 - 2017
- GHTC R&D Mapping 2016 - 2017
- Emerging Models of Collaborative Chronic Cardiac Care 2016
Industry Relationships
- Accountable Care Learning Collaborative/Leavitt Partners
- Aledade
- Alignment Health Care
- CRG
- Cigna
- Cota
- Gary and Mary West Foundation
- Johnson & Johnson
- Long-Term Quality Alliance
- Mitre
- National Alliance for Hispanic Health
- National Council on Aging
- National Institute for Health Care Management
- Reagan-Udall Foundation
- Renova
- Research!America
Publications & Artistic Works
Selected Publications
- Academic Articles
  - Mahendraratnam, Nirosha, Corinna Sorenson, Elizabeth Richardson, Gregory W. Daniel, Lisabeth Buelt, Kimberly Westrich, Jingyuan Qian, Hilary Campbell, Mark McClellan, and Robert W. Dubois. “Value-based arrangements may be more prevalent than assumed..” Am J Manag Care 25, no. 2 (February 2019): 70–76.
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  - Sharma, Abhinav, Robert A. Harrington, Mark B. McClellan, Mintu P. Turakhia, Zubin J. Eapen, Steven Steinhubl, James R. Mault, et al. “Using Digital Health Technology to Better Generate Evidence and Deliver Evidence-Based Care..” J Am Coll Cardiol 71, no. 23 (June 12, 2018): 2680–90. https://doi.org/10.1016/j.jacc.2018.03.523.
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  - Engelgau, Michael M., KM Venkat Narayan, Majid Ezzati, Luis A. Salicrup, Deshiree Belis, Laudan Y. Aron, Robert Beaglehole, et al. “Implementation Research to Address the United States Health Disadvantage: Report of a National Heart, Lung, and Blood Institute Workshop..” Global Heart 13, no. 2 (June 2018): 65–72. https://doi.org/10.1016/j.gheart.2018.03.003.
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  - Wong, Charlene A., James M. Perrin, and Mark McClellan. “Making the Case for Value-Based Payment Reform in Children's Health Care..” Jama Pediatr 172, no. 6 (June 1, 2018): 513–14. https://doi.org/10.1001/jamapediatrics.2018.0129.
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  - Alexander, John H., Jacqueline Corrigan-Curay, and Mark McClellan. “The Clinical Trials Transformation Initiative: Looking back, looking forward..” Clin Trials 15, no. 1_suppl (February 2018): 3–4. https://doi.org/10.1177/1740774518755052.
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  - Aronson, Solomon, Dev Sangvai, and Mark B. McClellan. “Why a Proactive Perioperative Medicine Policy Is Crucial for a Sustainable Population Health Strategy..” Anesth Analg 126, no. 2 (February 2018): 710–12. https://doi.org/10.1213/ANE.0000000000002603.
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  - Nussbaum, Sam, Mark McClellan, and Grischa Metlay. “Principles for a Framework for Alternative Payment Models..” Jama 319, no. 7 (February 2018): 653–54. https://doi.org/10.1001/jama.2017.20226.
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  - Farmer, Steven A., Paul N. Casale, Linda D. Gillam, John S. Rumsfeld, Shari Erickson, Neil M. Kirschner, Kevin de Regnier, Bruce R. Williams, R Shawn Martin, and Mark B. McClellan. “Payment Reform to Enhance Collaboration of Primary Care and Cardiology: A Review..” Jama Cardiology 3, no. 1 (January 2018): 77–83. https://doi.org/10.1001/jamacardio.2017.4308.
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  - Gajewski, James L., Mark B. McClellan, Navneet S. Majhail, Parameswaran N. Hari, Christopher N. Bredeson, Richard T. Maziarz, Charles F. LeMaistre, et al. “Payment and Care for Hematopoietic Cell Transplantation Patients: Toward a Specialized Medical Home for Complex Care Patients..” Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation 24, no. 1 (January 2018): 4–12. https://doi.org/10.1016/j.bbmt.2017.09.012.
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  - McClellan, Mark, and Mark Japinga. “The Affordable Care Act: What's Next?.” Annual Review of Medicine 69 (January 2018): 41–52. https://doi.org/10.1146/annurev-med-061516-112359.
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  - Maru, Duncan, Sheela Maru, Isha Nirola, Jonathan Gonzalez-Smith, Andrea Thoumi, Prajwol Nepal, Pushpa Chaudary, Indira Basnett, Krishna Udayakumar, and Mark McClellan. “Accountable Care Reforms Improve Women's And Children's Health In Nepal..” Health Affairs (Project Hope) 36, no. 11 (November 2017): 1965–72. https://doi.org/10.1377/hlthaff.2017.0579.
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  - McClellan, Mark, Krishna Udayakumar, Andrea Thoumi, Jonathan Gonzalez-Smith, Kushal Kadakia, Natalia Kurek, Mariam Abdulmalik, and Ara W. Darzi. “Improving Care And Lowering Costs: Evidence And Lessons From A Global Analysis Of Accountable Care Reforms..” Health Affairs (Project Hope) 36, no. 11 (November 2017): 1920–27. https://doi.org/10.1377/hlthaff.2017.0535.
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  - Daniel, Gregory W., Monika Schneider, and Mark B. McClellan. “Addressing Antimicrobial Resistance and Stewardship: The Priority Antimicrobial Value and Entry (PAVE) Award..” Jama 318, no. 12 (September 2017): 1103–4. https://doi.org/10.1001/jama.2017.10164.
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  - Japinga, Mark, Robert Saunders, Ziad F. Gellad, and Mark McClellan. “The Evolving Payment Reform Landscape: New Opportunities for Gastroenterology Leadership..” Clin Gastroenterol Hepatol 15, no. 9 (September 2017): 1322–25. https://doi.org/10.1016/j.cgh.2017.07.008.
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  - Dzau, Victor J., Mark B. McClellan, J Michael McGinnis, Sheila P. Burke, Molly J. Coye, Angela Diaz, Thomas A. Daschle, et al. “Vital Directions for Health and Health Care: Priorities From a National Academy of Medicine Initiative..” Jama 317, no. 14 (April 11, 2017): 1461–70. https://doi.org/10.1001/jama.2017.1964.
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  - Fraiche, Ariane M., Zubin J. Eapen, and Mark B. McClellan. “Moving Beyond the Walls of the Clinic: Opportunities and Challenges to the Future of Telehealth in Heart Failure..” Jacc Heart Fail 5, no. 4 (April 2017): 297–304. https://doi.org/10.1016/j.jchf.2016.11.013.
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  - McGlynn, Elizabeth A., and Mark McClellan. “Strategies For Assessing Delivery System Innovations..” Health Affairs (Project Hope) 36, no. 3 (March 2017): 408–16. https://doi.org/10.1377/hlthaff.2016.1373.
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  - Farmer, Steven A., Margaret L. Darling, Meaghan George, Paul N. Casale, Eileen Hagan, and Mark B. McClellan. “Existing and Emerging Payment and Delivery Reforms in Cardiology..” Jama Cardiology 2, no. 2 (February 2017): 210–17. https://doi.org/10.1001/jamacardio.2016.3965.
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  - Shrank, William H., Robert S. Saunders, and Mark McClellan. “Better Evidence to Guide Payment Reforms: Recognizing the Importance of Perspective..” Jama 317, no. 8 (February 2017): 805–6. https://doi.org/10.1001/jama.2017.0034.
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  - Sorenson, Corinna, Gabriela Lavezzari, Gregory Daniel, Randy Burkholder, Marc Boutin, Edmund Pezalla, Gillian Sanders, and Mark McClellan. “Advancing Value Assessment in the United States: A Multistakeholder Perspective..” Value Health 20, no. 2 (February 2017): 299–307. https://doi.org/10.1016/j.jval.2016.11.030.
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  - Valuck, Tom, David Blaisdell, Donna P. Dugan, Kimberly Westrich, Robert W. Dubois, Robert S. Miller, and Mark McClellan. “Improving Oncology Quality Measurement in Accountable Care: Filling Gaps with Cross-Cutting Measures..” Journal of Managed Care & Specialty Pharmacy 23, no. 2 (February 2017): 174–81. https://doi.org/10.18553/jmcp.2017.23.2.174.
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  - Audibert, Céline, Morgan Romine, Alexis Caze, Gregory Daniel, Jonathan Leff, and Mark McClellan. “Building a drug development database: challenges in reliable data availability..” Drug Development and Industrial Pharmacy 43, no. 1 (January 2017): 74–78. https://doi.org/10.1080/03639045.2016.1220565.
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  - Zineh, I., D. Abernethy, Ceca Hop, A. Bello, M. B. McClellan, G. W. Daniel, and M. H. Romine. “Improving the tools of clinical pharmacology: Goals for 2017 and beyond..” Clinical Pharmacology and Therapeutics 101, no. 1 (January 2017): 22–24. https://doi.org/10.1002/cpt.530.
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  - Feinberg, David T., and Mark B. McClellan. “More Value From Payment Reform in Health Care and Biomedical Innovation..” Jama 316, no. 16 (October 2016): 1653–54. https://doi.org/10.1001/jama.2016.14670.
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  - McClellan, Mark B., and Mike O. Leavitt. “Competencies and Tools to Shift Payments From Volume to Value..” Jama 316, no. 16 (October 2016): 1655–56. https://doi.org/10.1001/jama.2016.14205.
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  - Dzau, Victor J., Mark McClellan, and J Michael McGinnis. “Vital Directions for Health and Health Care: An Initiative of the National Academy of Medicine..” Jama 316, no. 7 (August 16, 2016): 711–12. https://doi.org/10.1001/jama.2016.10692.
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  - Farmer, Steven A., Joel Shalowitz, Meaghan George, Frank McStay, Kavita Patel, James Perrin, Ali Moghtaderi, and Mark McClellan. “Fully Capitated Payment Breakeven Rate for a Mid-Size Pediatric Practice..” Pediatrics 138, no. 2 (August 2016). https://doi.org/10.1542/peds.2015-4367.
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  - Pines, Jesse M., Frank McStay, Meaghan George, Jennifer L. Wiler, and Mark McClellan. “Aligning payment reform and delivery innovation in emergency care..” The American Journal of Managed Care 22, no. 8 (August 2016): 515–18.
  - Clough, Jeffrey D., and Mark McClellan. “Implementing MACRA: Implications for Physicians and for Physician Leadership..” Jama 315, no. 22 (June 14, 2016): 2397–98. https://doi.org/10.1001/jama.2016.7041.
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  - Patel, Kavita, Elise Presser, Meaghan George, and Mark McClellan. “Shifting Away From Fee-For-Service: Alternative Approaches to Payment in Gastroenterology..” Clinical Gastroenterology and Hepatology : The Official Clinical Practice Journal of the American Gastroenterological Association 14, no. 4 (April 2016): 497–506. https://doi.org/10.1016/j.cgh.2015.06.025.
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  - McClellan, Mark B., and Ellen V. Sigal. “The 21st Century Cures Act..” The New England Journal of Medicine 373, no. 17 (October 2015): 1677–78. https://doi.org/10.1056/nejmc1509640.
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  - Valuck, Tom, Donna Dugan, Robert W. Dubois, Kimberly Westrich, Jerry Penso, and Mark McClellan. “Solutions for filling gaps in accountable care measure sets..” The American Journal of Managed Care 21, no. 10 (October 2015): 723–28.
  - Sanghavi, Darshak, Kate Samuels, Meaghan George, Kavita Patel, Sarah Bleiberg, Frank McStay, Andrea Thoumi, and Mark McClellan. “Case study: Transforming cancer care at a community oncology practice..” Healthcare (Amsterdam, Netherlands) 3, no. 3 (September 2015): 160–68. https://doi.org/10.1016/j.hjdsi.2014.07.005.
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  - Thoumi, Andrea, Krishna Udayakumar, Elizabeth Drobnick, Andrea Taylor, and Mark McClellan. “Innovations In Diabetes Care Around the World: Case Studies Of Care Transformation Through Accountable Care Reforms..” Health Affairs (Project Hope) 34, no. 9 (September 2015): 1489–97. https://doi.org/10.1377/hlthaff.2015.0403.
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  - McClellan, Mark. “Accountable care organizations and evidence-based payment reform..” Jama 313, no. 21 (June 2015): 2128–30. https://doi.org/10.1001/jama.2015.5087.
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  - McClellan, M. B., G. W. Daniel, D. Dickson, J. Perlmutter, D. P. Berger, V. Miller, S. Nussbaum, J. Malin, M. H. Romine, and R. L. Schilsky. “Improving evidence developed from population-level experience with targeted agents..” Clinical Pharmacology and Therapeutics 97, no. 5 (May 2015): 478–87. https://doi.org/10.1002/cpt.90.
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  - McClellan, Mark B., and Andrea I. Thoumi. “Oncology payment reform to achieve real health care reform..” Journal of Oncology Practice 11, no. 3 (May 2015): 223–30. https://doi.org/10.1200/jop.2015.004655.
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  - Patel, Kavita, Andrea Thoumi, Jeffrey Nadel, John O’Shea, and Mark McClellan. “Transforming oncology care: payment and delivery reform for person-centered care..” The American Journal of Managed Care 21, no. 5 (May 2015): 388–93.
  - Daniel, Gregory W., Alexis Cazé, Morgan H. Romine, Céline Audibert, Jonathan S. Leff, and Mark B. McClellan. “Improving pharmaceutical innovation by building a more comprehensive database on drug development and use..” Health Affairs (Project Hope) 34, no. 2 (February 2015): 319–27. https://doi.org/10.1377/hlthaff.2014.1019.
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  - Outterson, Kevin, John H. Powers, Gregory W. Daniel, and Mark B. McClellan. “Repairing the broken market for antibiotic innovation..” Health Affairs (Project Hope) 34, no. 2 (February 2015): 277–85. https://doi.org/10.1377/hlthaff.2014.1003.
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  - Mostashari, Farzad, Darshak Sanghavi, and Mark McClellan. “Primary care physician-led health reform--reply..” Jama 312, no. 14 (October 2014). https://doi.org/10.1001/jama.2014.10106.
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  - McClellan, Mark, and Ellen Sigal. “New FDA breakthrough-drug category--implications for patients..” The New England Journal of Medicine 371, no. 1 (July 2014): 87–88. https://doi.org/10.1056/nejmc1405337.
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  - Wachter, Bob, Mark McClellan, and Maureen McKinney. “Wachter, McClellan offer takes on measuring quality..” Modern Healthcare 44, no. 28 (July 2014): 35–36.
  - Mostashari, Farzad, Darshak Sanghavi, and Mark McClellan. “Health reform and physician-led accountable care: the paradox of primary care physician leadership..” Jama 311, no. 18 (May 2014): 1855–56. https://doi.org/10.1001/jama.2014.4086.
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  - McClellan, M., K. Patel, and D. Sanghavi. “Medicare physician payment reform: Will 2014 be the fix for SGR?.” Jama Journal of the American Medical Association 311, no. 7 (February 24, 2014): 669–70. https://doi.org/10.1001/jama.2013.286100.
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  - Kocot, S Lawrence, Christine Dang-Vu, Ross White, and Mark McClellan. “Early experiences with accountable care in Medicaid: special challenges, big opportunities..” Population Health Management 16 Suppl 1 (January 2013): S4-11. https://doi.org/10.1089/pop.2013.0058.
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- Conference Papers
  - McClellan, Mark. “Reforming payments to healthcare providers: the key to slowing healthcare cost growth while improving quality?.” In The Journal of Economic Perspectives : A Journal of the American Economic Association, 25:69–92, 2011. https://doi.org/10.1257/jep.25.2.69.
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Education, Training, & Certifications

In the News

Selected Grants

Industry Relationships

Selected Publications

Academic Articles

Conference Papers