Mark B McClellan
Professor of the Practice of Business Administration
Mark McClellan, MD, PhD, is Director and Robert J. Margolis, M.D., Professor of Business, Medicine and Policy at the Margolis Center for Health Policy at Duke University. He is a physician-economist who focuses on quality and value in health care, including payment reform, real-world evidence and more effective drug and device innovation. His current work on responding to the COVID-19 public health emergency spans virus containment and testing strategies, reforming health care toward more resilient models of delivering care, and accelerating the development of therapeutics and vaccines. He is former administrator of the Centers for Medicare & Medicaid Services and former commissioner of the U.S. Food and Drug Administration, where he developed and implemented major reforms in health policy. Dr. McClellan is an independent board member on the boards of Johnson & Johnson, Cigna, Alignment Healthcare, and PrognomIQ; co-chairs the Guiding Committee for the Health Care Payment Learning and Action Network; and serves as an advisor for Blackstone Life Sciences, Arsenal Capital Partners, and MITRE.
Current Appointments & Affiliations
- Professor of the Practice of Business Administration, Fuqua School of Business, Duke University 2016
- Director, Duke-Margolis Center for Health Policy, Duke - Margolis Center For Health Policy, Initiatives 2019
- Professor of the Practice in the Sanford School of Public Policy, Sanford School of Public Policy, Duke University 2016
- Executive Core Faculty Member, Duke-Margolis Center for Health Policy, Duke - Margolis Center For Health Policy, Initiatives 2019
- Associate of the Duke Initiative for Science & Society, Duke Science & Society, Initiatives 2021
Contact Information
- Margolis Center for Health Policy, Jb Duke Buildkng, 230 Science Drive, Durham, NC 27708
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mark.mcclellan@duke.edu
(919) 419-2501
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Duke-Margolis Center for Health Policy
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Fuqua Faculty Profile
- Background
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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, Austin 1985
- Recognition
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In the News
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DEC 18, 2021 Interdisciplinary Studies -
NOV 9, 2021 Duke Global Health Institute -
SEP 20, 2021 -
MAR 18, 2021 -
OCT 30, 2020 -
SEP 18, 2020 -
SEP 14, 2020 -
SEP 11, 2020 Rockefeller Foundation -
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MAY 1, 2020 -
APR 24, 2020 -
MAR 19, 2020 -
FEB 18, 2020 -
DEC 18, 2019 -
OCT 21, 2019 -
FEB 9, 2017 -
NOV 10, 2016 -
OCT 23, 2016 NPR -
SEP 6, 2016 The Hill -
JUN 28, 2016 The Washington Post -
MAY 23, 2016 -
APR 5, 2016
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Awards & Honors
- Research
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Selected Grants
- Identifying Policy Strategies to Support Home-Based Care 2023 - 2025
- NC Medicaid Value-Based Payment Implementation 2022 - 2025
- Next-Gen COVID-19 Detection and Response in the United States awarded by Bill and Melinda Gates Foundation 2022 - 2024
- 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 - 2023
- 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
- The Next Phase of Antimicrobial Resistance Payment Policy 2022 - 2023
- HLC 2.0 - Public-Private Sector Pandemic Response 2022 - 2023
- Accelerating Value-Based Care Impact at the State and National Level 2020 - 2023
- Accelerating Value-Based Care Impact at the State and National Level 2020 - 2023
- Reshaping the Future of Health and Healthcare 2022 - 2023
- COVID Commission Planning Group 2022 - 2023
- Informing Policy Options to Integrate Care for Dual Eligible North Carolinians 2021 - 2022
- Improving Heart Health thru Value-Base Payment: Maximizing the Impact of Value-Based Payment Models on Heart Disease Risk Factors and Outcomes awarded by American Heart Association 2021 - 2022
- Health Care System Transformation and COVID-19: The Case of Medically Complex Older Adults awarded by National Bureau of Economic Research 2021 - 2022
- Leveraging Payment Reforms to Transform and Expand Home-Based and Virtual Care for Complex and Underserved Populations 2021 - 2022
- Leveraging Payment Reforms to Transform and Expand Home-Based and Virtual Care for Complex and Underserved Populations 2021 - 2022
- Leveraging Payment Reforms to Transform and Expand Home-Based and Virtual Care for Complex and Underserved Populations 2021 - 2022
- COVID-19 Real World Evidence for Monoclonal Antibodies 2021 - 2022
- Coordinated and Affordable Care in Employer Sponsored Health Programs: A Pathway for Reform 2021 - 2022
- Understanding the Value of AI-Enabled Diagnostic Support Software 2019 - 2022
- Healthcare and Learning Action Network (37PRJ931) 09/17/2019 - 09/11/2021 2019 - 2021
- Overcoming the Impediments to Biosimilar Adoption in the United States¿What Can Be Learned from the Success of Other Countries? 2020 - 2021
- Transforming the Market to Address Antimicrobial Resistance 2020 - 2021
- Support for work on state-focused deliverables related to vaccine distribution and access 2020 - 2021
- Margolis-HLC Collaboration 2020 - 2021
- 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
- West Health Foundation 2018 - 2019
- Sustainable Biodefense Industrial Base for the Assistant Secretary for Preparedness and Response 2016 - 2019
- Convener of Discussions on Medical Policy Issues Impacting Drug Development awarded by Food and Drug Administration 2014 - 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
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External Relationships
- Alignment Health Care
- Arsenal Capital
- Blackstone Life Sciences
- CRG
- Cigna
- Grail
- Institute for Accountable Care
- Johnson & Johnson
- Mitre
- National Alliance for Hispanic Health
- National Resilience
- Peterson Center on Healthcare
- PrognomIQ
- Research!America
- SalioGen
- Publications & Artistic Works
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Selected Publications
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Academic Articles
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Dzau, Victor J., Mark B. McClellan, J Michael McGinnis, Jessica C. Marx, Rebecca D. Sullenger, and William ElLaissi. “Vital Directions For Health And Health Care: Priorities For 2021.” Health Aff (Millwood) 40, no. 2 (February 2021): 197–203. https://doi.org/10.1377/hlthaff.2020.02204.Full Text Open Access Copy Link to Item
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Psotka, Mitchell A., Elizabeth A. Singletary, William K. Bleser, Rachel A. Roiland, Marianne Hamilton Lopez, Robert S. Saunders, Tracy Y. Wang, Mark B. McClellan, Nancy Brown, and Nancy American Heart Association Prior Authorization Learning Collaborative*. “Streamlining and Reimagining Prior Authorization Under Value-Based Contracts: A Call to Action From the Value in Healthcare Initiative's Prior Authorization Learning Collaborative.” Circulation. Cardiovascular Quality and Outcomes 13, no. 7 (July 2020): e006564. https://doi.org/10.1161/circoutcomes.120.006564.Full Text
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Lopez, Marianne Hamilton, Gregory W. Daniel, Nicholas C. Fiore, Aparna Higgins, and Mark B. McClellan. “Paying For Value From Costly Medical Technologies: A Framework For Applying Value-Based Payment Reforms.” Health Affairs (Project Hope) 39, no. 6 (June 2020): 1018–25. https://doi.org/10.1377/hlthaff.2019.00771.Full Text
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Joynt Maddox, Karen, William K. Bleser, Hannah L. Crook, Adam J. Nelson, Marianne Hamilton Lopez, Robert S. Saunders, Mark B. McClellan, Nancy Brown, and Nancy American Heart Association Value-Based Models Learning Collaborative. “Advancing Value-Based Models for Heart Failure: A Call to Action From the Value in Healthcare Initiative's Value-Based Models Learning Collaborative.” Circulation. Cardiovascular Quality and Outcomes 13, no. 5 (May 2020): e006483. https://doi.org/10.1161/circoutcomes.120.006483.Full Text
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McClellan, Mark B., William K. Bleser, and Karen E. Joynt Maddox. “Advancing Value-Based Cardiovascular Care: The American Heart Association Value in Healthcare Initiative.” Circulation. Cardiovascular Quality and Outcomes 13, no. 5 (May 2020): e006610. https://doi.org/10.1161/circoutcomes.120.006610.Full Text
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Joynt Maddox, Karen E., and Mark B. McClellan. “Toward Evidence-Based Policy Making to Reduce Wasteful Health Care Spending.” Jama 322, no. 15 (October 2019): 1460–62. https://doi.org/10.1001/jama.2019.13977.Full Text
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Moseley, Connor A., Madhulika Vulimiri, Robert S. Saunders, William K. Bleser, Eliana M. Perrin, Sarah C. Armstrong, Gary X. Wang, Peter A. Ubel, Mark McClellan, and Charlene A. Wong. “Medicaid and CHIP Child Health Beneficiary Incentives: Program Landscape and Stakeholder Insights.” Pediatrics 144, no. 2 (August 2019). https://doi.org/10.1542/peds.2018-3161.Full Text Link to Item
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Augustovski, Federico, and Mark B. McClellan. “Current Policy and Practice for Value-Based Pricing.” Value in Health : The Journal of the International Society for Pharmacoeconomics and Outcomes Research 22, no. 6S (June 2019): S4–6. https://doi.org/10.1016/j.jval.2019.04.1918.Full Text
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Bleser, William K., Robert S. Saunders, Lia Winfield, Mark Japinga, Nathan Smith, Brystana G. Kaufman, Hannah L. Crook, David B. Muhlestein, and Mark McClellan. “ACO Serious Illness Care: Survey And Case Studies Depict Current Challenges And Future Opportunities.” Health Aff (Millwood) 38, no. 6 (June 2019): 1011–20. https://doi.org/10.1377/hlthaff.2019.00013.Full Text Link to Item
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Bleser, William K., Robert S. Saunders, David B. Muhlestein, and Mark McClellan. “Why Do Accountable Care Organizations Leave The Medicare Shared Savings Program?” Health Affairs (Project Hope) 38, no. 5 (May 2019): 794–803. https://doi.org/10.1377/hlthaff.2018.05097.Full Text
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Daniel, Gregory W., Morgan H. Romine, and Mark B. McClellan. “Can Innovation in Regulatory Science Address Health Care Cost Burdens?” Clinical Pharmacology and Therapeutics 105, no. 4 (April 2019): 809–11. https://doi.org/10.1002/cpt.1334.Full Text
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Parekh, Natasha, Mark McClellan, and William H. Shrank. “Payment Reform, Medication Use, and Costs: Can We Afford to Leave Out Drugs?” Journal of General Internal Medicine 34, no. 3 (March 2019): 473–76. https://doi.org/10.1007/s11606-018-4794-y.Full Text
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Vulimiri, Madhulika, William K. Bleser, Robert S. Saunders, Farrah Madanay, Connor Moseley, Hunter F. McGuire, Peter A. Ubel, Aaron McKethan, Mark McClellan, and Charlene A. Wong. “Engaging Beneficiaries In Medicaid Programs That Incentivize Health-Promoting Behaviors.” Health Aff (Millwood) 38, no. 3 (March 2019): 431–39. https://doi.org/10.1377/hlthaff.2018.05427.Full Text Link to Item
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Volk, Michael L., Jessica Mellinger, Meena B. Bansal, Ziad F. Gellad, Mark McClellan, and Fasiha Kanwal. “A Roadmap for Value-Based Payment Models Among Patients With Cirrhosis.” Hepatology 69, no. 3 (March 2019): 1300–1305. https://doi.org/10.1002/hep.30277.Full Text Link to Item
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McClellan, Mark, Nancy Brown, Robert M. Califf, and John J. Warner. “Call to Action: Urgent Challenges in Cardiovascular Disease: A Presidential Advisory From the American Heart Association.” Circulation 139, no. 9 (February 2019): e44–54. https://doi.org/10.1161/cir.0000000000000652.Full Text
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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.Link to Item
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Califf, Robert M., Margaret Hamburg, Jane E. Henney, David A. Kessler, Mark McClellan, Andrew C. von Eschenbach, and Frank Young. “Seven Former FDA Commissioners: The FDA Should Be An Independent Federal Agency.” Health Affairs (Project Hope) 38, no. 1 (January 2019): 84–86. https://doi.org/10.1377/hlthaff.2018.05185.Full Text
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McClellan, Mark B. “Inconsistent Reporting of Potential Conflicts of Interest in JAMA Pediatrics.” Jama Pediatrics 173, no. 1 (January 2019): 103–4. https://doi.org/10.1001/jamapediatrics.2018.4610.Full Text
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McClellan, Mark B. “Inconsistent Reporting of Potential Conflicts of Interest in JAMA Cardiology.” Jama Cardiology 4, no. 1 (January 2019): 84. https://doi.org/10.1001/jamacardio.2018.4194.Full Text
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McClellan, Mark B. “Inconsistent Reporting of Potential Conflicts of Interest in JAMA.” Jama 320, no. 24 (December 2018): 2601–2. https://doi.org/10.1001/jama.2018.18490.Full Text
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Platt, Richard, Jeffrey S. Brown, Melissa Robb, Mark McClellan, Robert Ball, Michael D. Nguyen, and Rachel E. Sherman. “The FDA Sentinel Initiative - An Evolving National Resource.” The New England Journal of Medicine 379, no. 22 (November 2018): 2091–93. https://doi.org/10.1056/nejmp1809643.Full Text
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Zafar, S Yousuf, Blase N. Polite, and Mark McClellan. “Engaging Patients in Value-Based Cancer Care: A Missed Opportunity.” Jama Oncol 4, no. 11 (November 1, 2018): 1479–80. https://doi.org/10.1001/jamaoncol.2018.2826.Full Text Link to Item
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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.Full Text Link to Item
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Daniel, Gregory W., Monika Schneider, Marianne Hamilton Lopez, and Mark B. McClellan. “Implementation of a Market Entry Reward within the United States.” The Journal of Law, Medicine & Ethics : A Journal of the American Society of Law, Medicine & Ethics 46, no. 1_suppl (June 2018): 50–58. https://doi.org/10.1177/1073110518782915.Full Text
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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.Full Text
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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.Full Text Link to Item
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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.Full Text
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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.Full Text Link to Item
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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.Full Text Link to Item
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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.Full Text
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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.Full Text
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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.Full Text
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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.Full Text
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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.Full Text
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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.Full Text
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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.Full Text Link to Item
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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.Full Text Link to Item
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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.Full Text Link to Item
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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.Full Text
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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.Full Text
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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.Full Text
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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.Full Text
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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.Full Text Link to Item
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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.Full Text
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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.Full Text
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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.Full Text
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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.Full Text
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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.Full Text Link to Item
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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.
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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): e20154367. https://doi.org/10.1542/peds.2015-4367.Full Text
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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.Full Text Link to Item
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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.Full Text
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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.Full Text
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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.
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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.Full Text
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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.Full Text
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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.Full Text
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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.Full Text
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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.Full Text
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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.
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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.Full Text
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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.Full Text
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Mostashari, Farzad, Darshak Sanghavi, and Mark McClellan. “Primary care physician-led health reform--reply.” Jama 312, no. 14 (October 2014): 1472. https://doi.org/10.1001/jama.2014.10106.Full Text
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McClellan, Mark, James Kent, Stephen J. Beales, Samuel I. A. Cohen, Michael Macdonnell, Andrea Thoumi, Mariam Abdulmalik, and Ara Darzi. “Accountable care around the world: a framework to guide reform strategies.” Health Affairs (Project Hope) 33, no. 9 (September 2014): 1507–15. https://doi.org/10.1377/hlthaff.2014.0373.Full Text
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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.Full Text
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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.
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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.Full Text
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McClellan, Mark, Kavita Patel, and Darshak Sanghavi. “Medicare physician payment reform: will 2014 be the fix for SGR?” Jama 311, no. 7 (February 2014): 669–70. https://doi.org/10.1001/jama.2013.286100.Full Text
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McClellan, Mark, and Merrill Goozner. “Moving physicians from fee-for-service first step to 'doc fix,' mcClellan says.” Modern Healthcare 44, no. 8 (February 2014): 30.
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Daniel, Gregory W., Erin K. Rubens, and Mark McClellan. “Coverage with evidence development for Medicare beneficiaries: challenges and next steps.” Jama Internal Medicine 173, no. 14 (July 2013): 1281–82. https://doi.org/10.1001/jamainternmed.2013.6793.Full Text
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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.Full Text
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Patel, K. K., A. J. Morin, J. L. Nadel, and M. B. McClellan. “Meaningful physician payment reform in oncology.” Journal of Oncology Practice 9, no. 6 SUPPL. (January 1, 2013). https://doi.org/10.1200/JOP.2013.001248.Full Text
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McClellan, Mark. “Mark McClellan. Interview by Asher Mullard.” Nature Reviews. Drug Discovery 11, no. 9 (September 2012): 668. https://doi.org/10.1038/nrd3837.Full Text
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Naylor, Mary D., Ellen T. Kurtzman, David C. Grabowski, Charlene Harrington, Mark McClellan, and Susan C. Reinhard. “Unintended consequences of steps to cut readmissions and reform payment may threaten care of vulnerable older adults.” Health Affairs (Project Hope) 31, no. 7 (July 2012): 1623–32. https://doi.org/10.1377/hlthaff.2012.0110.Full Text
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McClellan, Mark. “Implementation through collaboration: The Brookings-Dartmouth ACO Learning Network.” Maryland Medicine : Mm : A Publication of Medchi, the Maryland State Medical Society 13, no. 2 (January 2012): 15–16.
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Fisher, Elliott S., Mark B. McClellan, and Dana G. Safran. “Building the path to accountable care.” The New England Journal of Medicine 365, no. 26 (December 2011): 2445–47. https://doi.org/10.1056/nejmp1112442.Full Text
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Roberts, Samantha A., Erin K. Karnes, Jeffrey D. Allen, Joshua S. Benner, Ellen V. Sigal, and Mark McClellan. “Achieving the goals of effective, safe, and individualized cancer care.” Clinical Cancer Research : An Official Journal of the American Association for Cancer Research 17, no. 21 (November 2011): 6632–33. https://doi.org/10.1158/1078-0432.ccr-11-1104.Full Text
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Roski, Joachim, and Mark McClellan. “Measuring health care performance now, not tomorrow: essential steps to support effective health reform.” Health Affairs (Project Hope) 30, no. 4 (April 2011): 682–89. https://doi.org/10.1377/hlthaff.2011.0137.Full Text
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Behrman, R. E., J. S. Benner, J. S. Brown, M. McClellan, J. Woodcock, and R. Platt. “Developing the sentinel system - A national resource for evidence development.” New England Journal of Medicine 364, no. 6 (February 10, 2011): 498–99. https://doi.org/10.1056/NEJMp1014427.Full Text
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McClellan, Mark, Joshua Benner, Richard Schilsky, David Epstein, Ray Woosley, Stephen Friend, David Sidransky, Cindy Geoghegan, and David Kessler. “An accelerated pathway for targeted cancer therapies.” Nature Reviews. Drug Discovery 10, no. 2 (February 2011): 79–80. https://doi.org/10.1038/nrd3360.Full Text
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Antos, Joseph, John Bertko, Michael Chernew, David Cutler, Francois de Brantes, Dana Goldman, Bob Kocher, et al. “Bending the curve through health reform implementation.” The American Journal of Managed Care 16, no. 11 (November 2010): 804–12.
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Benner, Joshua S., Marisa R. Morrison, Erin K. Karnes, S Lawrence Kocot, and Mark McClellan. “An evaluation of recent federal spending on comparative effectiveness research: priorities, gaps, and next steps.” Health Affairs (Project Hope) 29, no. 10 (October 2010): 1768–76. https://doi.org/10.1377/hlthaff.2010.0687.Full Text
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Tunis, Sean R., Joshua Benner, and Mark McClellan. “Comparative effectiveness research: Policy context, methods development and research infrastructure.” Statistics in Medicine 29, no. 19 (August 2010): 1963–76. https://doi.org/10.1002/sim.3818.Full Text
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Williams, David R., Mark B. McClellan, and Alice M. Rivlin. “Beyond the Affordable Care Act: achieving real improvements in Americans' health.” Health Affairs (Project Hope) 29, no. 8 (August 2010): 1481–88. https://doi.org/10.1377/hlthaff.2010.0071.Full Text
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McClellan, Mark, Aaron N. McKethan, Julie L. Lewis, Joachim Roski, and Elliott S. Fisher. “A national strategy to put accountable care into practice.” Health Affairs (Project Hope) 29, no. 5 (May 2010): 982–90. https://doi.org/10.1377/hlthaff.2010.0194.Full Text
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Schilsky, Richard L., Jeff Allen, Joshua Benner, Ellen Sigal, and Mark McClellan. “Commentary: tackling the challenges of developing targeted therapies for cancer.” The Oncologist 15, no. 5 (January 2010): 484–87. https://doi.org/10.1634/theoncologist.2010-0079.Full Text
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Antos, Joseph, John Bertko, Michael Chernew, David Cutler, Dana Goldman, Mark McClellan, Elizabeth McGlynn, Mark Pauly, Leonard Schaeffer, and Stephen Shortell. “Bending the curve: effective steps to address long-term healthcare spending growth.” The American Journal of Managed Care 15, no. 10 (October 2009): 676–80.
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Platt, Richard, Marcus Wilson, K Arnold Chan, Joshua S. Benner, Janet Marchibroda, and Mark McClellan. “The new Sentinel Network--improving the evidence of medical-product safety.” The New England Journal of Medicine 361, no. 7 (August 2009): 645–47. https://doi.org/10.1056/nejmp0905338.Full Text
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Fisher, Elliott S., Mark B. McClellan, John Bertko, Steven M. Lieberman, Julie J. Lee, Julie L. Lewis, and Jonathan S. Skinner. “Fostering accountable health care: moving forward in medicare.” Health Affairs (Project Hope) 28, no. 2 (March 2009): w219–31. https://doi.org/10.1377/hlthaff.28.2.w219.Full Text
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Other Articles
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McClellan, Mark, victor Dzau, Michael McGinness, Jessica Marx, Rebecca Sullenger, and William ElLaissi. “Vital Directions For Health And Health Care: Priorities For 2021.” Health Affairs. health affairs, January 21, 2021.Open Access Copy Link to Item
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McClellan, Mark, and Scott Gottlieb. “A Light Regulatory Touch to Keep Covid Drugs Current.” Wall Street Journal (Eastern Ed.). Dow Jones & Co., Inc., January 10, 2021.Link to Item
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McClellan, Mark, and Scott Gottlieb. “Why Are Covid Antibody Drugs Sitting on Shelves?” Wall Street Journal (Eastern Ed.). Dow Jones & Co., Inc., December 20, 2020.Link to Item
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McClellan, Mark, Sahil Sandhu, Robert Saunders, and Charlene Wong. “Health Equity Should Be A Key Value In Value-Based Payment And Delivery Reform.” Health Affairs. Health Affairs Blog: Project HOPE, November 25, 2020.Link to Item
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McClellan, Mark, and Scott Gottlieb. “You Can Trust the FDA’s Vaccine Process.” Wall Street Journal (Eastern Ed.). Wall Street Journal: Dow Jones & Co., Inc., September 20, 2020.Open Access Copy Link to Item
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McClellan, Mark, and Scott Gottlieb. “Betting on Better Drug Trials to Beat Covid-19.” Wall Street Journal (Eastern Ed.). Dow Jones & Co., Inc., August 23, 2020.Open Access Copy Link to Item
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McClellan, Mark, Caitlin Caitlin Rivers, and Christina Silcox. “Legislative and Regulatory Steps for a National COVID-19 Testing Strategy,” August 5, 2020.Open Access Copy Link to Item
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McClellan, Mark, Margaret Hamburg, Robert Califf, and Scott Gottlieb. “4 Former FDA Commissioners: Blood plasma might be the covid-19 treatment we need,” August 3, 2020.Link to Item
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McClellan, Mark, Isha Sharma, Marta Wosinska, Haley Sullivan, and adam Kroetsch. “COVID-19 Manufacturing for Monoclonal Antibodies,” August 1, 2020.Open Access Copy
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Duke-Margolis Center for Health Policy, Miroslav, Miroslav Families USA, and Miroslav United States of Care. “COVID-19 Health Care Response and Resilience Program,” July 30, 2020.Open Access Copy Link to Item
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McClellan, Mark, and Scott Gottlieb. “Covid Shows the Need for a Diagnostic Stockpile.” Wall Street Journal (Eastern Ed.). Dow Jones & Co., Inc., July 26, 2020.Open Access Copy Link to Item
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McClellan, Mark, and Scott Gottlieb. “Reinvent Health Care to Beat COVID-19.” Wall Street Journal: https://www.wsj.com/, June 28, 2020.Link to Item
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McClellan, Mark, and Scott Gottlieb. “Rules for Clinical Trials in a Pandemic.” Wall Street Journal, June 21, 2020.
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McClellan, Mark, Rachel Roiland, Mark Japinga, Elizabeth Singletary, Isha Sharma, Jonathan Gonzalez-Smith, Gary Wang, Jeremy Jacobs, William Bleser, and Robert Saunders. “Value-Based Care in the COVID-19 Era: Enabling Health Care Response and Resilience,” June 1, 2020.Open Access Copy
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McClellan, Mark, Hannah Crook, Robert Saunders, William Bleser, Travis Broome, and David Muhlestein. “Leveraging Payment Reforms For COVID-19 And Beyond: Recommendations For Medicare ACOs And CMS’s Interim Final Rule.” Health Affairs. Project HOPE, May 29, 2020.
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McClellan, Mark, and Andy Slavitt. “Health leaders: Let’s #OpenSafely,” May 20, 2020.Open Access Copy
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McClellan, Mark, Farzad Mostashari, and Tom Barker. “Health Care Payment to Support COVID-19 Detection and Containment,” May 1, 2020.Open Access Copy Link to Item
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McClellan, Mark, and Farzad Mostashari. “Data Interoperability and Exchange to Support COVID-19 Containment,” May 1, 2020.Open Access Copy Link to Item
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McClellan, Mark, Scott Gottlieb, Farzad Mostashari, Caitlin Rivers, and Lauren Silvis. “A National COVID-19 Surveillance System: Achieving Containment,” April 7, 2020.Open Access Copy Link to Item
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McClellan, Mark, Scott Gottlieb, Caitlin Rivers, Lauren Silvis, and Crystal Watson. “National coronavirus response: A road map to reopening.” American Enterprise Institute, March 28, 2020.Open Access Copy Link to Item
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McClellan, Mark, and Scott Gottlieb. “Achieving Widespread Availability of Timely and Efficient COVID-19 Testing,” March 26, 2020.Open Access Copy Link to Item
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McClellan, Mark, and Scott Gottlieb. “Advancing Treatments to Save Lives and Reduce the Risk of COVID-19,” March 19, 2020.Open Access Copy Link to Item
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Reports
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McClellan, Mark, Christina Silcox, David Anderson, Anna Zavodszky, Ethan Borre, Susan Dentzer, and Mara Aspinall. “A National Decision Point: Effective Testing and Screening for Covid-19.” Duke-Margolis Center for Health Policy/Rockefeller Foundation, September 9, 2020.Open Access Copy Link to Item
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McClellan, Mark, Monika Schneider, Susan Dentzer, Sarah Sheehan, Christina Silcox, Marianne Hamilton Lopez, and Marta Wosinska. “From Development to Market: Understanding COVID-19 Testing and Its Challenges.” Duke-Margolis Center for Health Policy, August 19, 2020.Open Access Copy Link to Item
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McClellan, Mark, Caitlin Rivers, and Christina Silcox. “Legislative and Regulatory Steps for a National COVID-19 Testing Strategy.” Duke-Margolis Center for Health Policy, August 5, 2020.Open Access Copy Link to Item
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Conference Papers
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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.Full Text
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