Mark McClellan
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Mark Barr McClellan (born June 26, 1963) is the director of the Robert J Margolis Center for Health Policy and the Margolis Professor of Business, Medicine and Health Policy at
Duke University Duke University is a private research university in Durham, North Carolina. Founded by Methodists and Quakers in the present-day city of Trinity in 1838, the school moved to Durham in 1892. In 1924, tobacco and electric power industrialist James ...
. Formerly, he was a senior fellow and director of the Health Care Innovation and Value Initiative at the Engelberg Center for Health Care Reform at The Brookings Institution, in
Washington, D.C. ) , image_skyline = , image_caption = Clockwise from top left: the Washington Monument and Lincoln Memorial on the National Mall, United States Capitol, Logan Circle, Jefferson Memorial, White House, Adams Morgan, ...
McClellan served as
commissioner A commissioner (commonly abbreviated as Comm'r) is, in principle, a member of a commission or an individual who has been given a commission (official charge or authority to do something). In practice, the title of commissioner has evolved to in ...
of the
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under
President President most commonly refers to: *President (corporate title) *President (education), a leader of a college or university *President (government title) President may also refer to: Automobiles * Nissan President, a 1966–2010 Japanese ful ...
George W. Bush George Walker Bush (born July 6, 1946) is an American politician who served as the 43rd president of the United States from 2001 to 2009. A member of the Republican Party, Bush family, and son of the 41st president George H. W. Bush, he ...
from 2002 through 2004, and subsequently as administrator of the
Centers for Medicare and Medicaid Services The Centers for Medicare & Medicaid Services (CMS), is a federal agency within the United States Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer M ...
from 2004 through 2006.


Education

After graduating from the
University of Texas The University of Texas at Austin (UT Austin, UT, or Texas) is a public research university in Austin, Texas. It was founded in 1883 and is the oldest institution in the University of Texas System. With 40,916 undergraduate students, 11,075 ...
in 1985 majoring in English, Biology, and Plan II, he earned his
M.D. Doctor of Medicine (abbreviated M.D., from the Latin ''Medicinae Doctor'') is a medical degree, the meaning of which varies between different jurisdictions. In the United States, and some other countries, the M.D. denotes a professional degree. T ...
degree from the Harvard-MIT Division of Health Sciences and Technology in 1992 and his
Ph.D. A Doctor of Philosophy (PhD, Ph.D., or DPhil; Latin: or ') is the most common degree at the highest academic level awarded following a course of study. PhDs are awarded for programs across the whole breadth of academic fields. Because it is ...
in
economics Economics () is the social science that studies the Production (economics), production, distribution (economics), distribution, and Consumption (economics), consumption of goods and services. Economics focuses on the behaviour and intera ...
from
MIT The Massachusetts Institute of Technology (MIT) is a private land-grant research university in Cambridge, Massachusetts. Established in 1861, MIT has played a key role in the development of modern technology and science, and is one of the m ...
in 1993. He also earned a
Master of Public Administration The Master of Public Administration (M.P.Adm., M.P.A., or MPA) is a specialized higher professional post graduate degree in public administration, similar/ equivalent to the Master of Business Administration but with an emphasis on the issues of ...
degree from
Harvard Kennedy School The Harvard Kennedy School (HKS), officially the John F. Kennedy School of Government, is the school of public policy and government of Harvard University in Cambridge, Massachusetts. The school offers master's degrees in public policy, public ...
in 1991. He completed his residency training in internal medicine at
Brigham and Women's Hospital Brigham and Women's Hospital (BWH) is the second largest teaching hospital of Harvard Medical School and the largest hospital in the Longwood Medical and Academic Area, Longwood Medical Area in Boston, Massachusetts. Along with Massachusetts Gener ...
, and he is board-certified in internal medicine. McClellan's research studies have addressed measuring and improving the quality of health care, the economic and policy factors influencing medical treatment decisions and health outcomes, estimating the effects of medical treatments, technological change in health care and its consequences for health and medical expenditures, and the relationship between health and economic well-being. He has twice received the Arrow Award for Outstanding Research in Health Economics.


Career


In government

From 1998 to 1999, McClellan served as deputy assistant secretary of the
Treasury for Economic Policy A treasury is either *A government department related to finance and taxation, a finance ministry. *A place or location where treasure, such as currency or precious items are kept. These can be state or royal property, church treasure or in p ...
, where he supervised economic analysis and policy development on a wide range of domestic policy issues. During 2001 and 2002, McClellan served in the
White House The White House is the official residence and workplace of the president of the United States. It is located at 1600 Pennsylvania Avenue NW in Washington, D.C., and has been the residence of every U.S. president since John Adams in 1800. ...
. He was a member of the president's
Council of Economic Advisers The Council of Economic Advisers (CEA) is a United States agency within the Executive Office of the President established in 1946, which advises the President of the United States on economic policy. The CEA provides much of the empirical resea ...
, where he advised on domestic economic issues. He also served during this time as a senior policy director for health care and related economic issues for the White House. McClellan served as commissioner for the
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) beginning November 14, 2002, becoming the first economist to hold that position. Originally from
Austin, Texas Austin is the capital city of the U.S. state of Texas, as well as the county seat, seat and largest city of Travis County, Texas, Travis County, with portions extending into Hays County, Texas, Hays and Williamson County, Texas, Williamson co ...
, he is the brother of former White House Press Secretary
Scott McClellan Scott McClellan (born February 14, 1968) is the former White House Press Secretary (2003–06) for President George W. Bush, he was the 24th person to hold this post. He was also the author of a controversial No. 1 ''New York Times'' bestseller ...
and the son of Texas
comptroller A comptroller (pronounced either the same as ''controller'' or as ) is a management-level position responsible for supervising the quality of accounting and financial reporting of an organization. A financial comptroller is a senior-level executi ...
Carole Keeton Strayhorn Carole Stewart Keeton (born September 13, 1939), formerly known as Carole Keeton McClellan, Carole Keeton Rylander and Carole Keeton Strayhorn, is an American politician and the former Texas Comptroller of Public Accounts. Elected to the comptro ...
and attorney
Barr McClellan Oliver Barr McClellan (born 1939 in Cuero (aka Rawhide), Texas) is an American entrepreneur, counsel and author who became widely known by his 2003 book ''Blood, Money & Power'' on the Kennedy assassination. He has also written on globalization. ...
. He was administrator for the
Centers for Medicare and Medicaid Services The Centers for Medicare & Medicaid Services (CMS), is a federal agency within the United States Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer M ...
in the
United States Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is ...
from 2004 to 2006. In this position, he was responsible for administering the Medicare and
Medicaid Medicaid in the United States is a federal and state program that helps with healthcare costs for some people with limited income and resources. Medicaid also offers benefits not normally covered by Medicare, including nursing home care and pers ...
programs, including
Medicare Part D Medicare Part D, also called the Medicare prescription drug benefit, is an optional United States federal-government program to help Medicare beneficiaries pay for self-administered prescription drugs. Part D was enacted as part of the Medica ...
, the prescription drug benefit program engendered by the
Medicare Prescription Drug, Improvement, and Modernization Act The Medicare Prescription Drug, Improvement, and Modernization Act, also called the Medicare Modernization Act or MMA, is a federal law of the United States, enacted in 2003. It produced the largest overhaul of Medicare in the public health progr ...
. Following the resignation of Health & Human Services Secretary
Tommy Thompson Tommy George Thompson (born November 19, 1941) is an American Republican politician who most recently served as interim president of the University of Wisconsin System from 2020 to 2022. A member of the Republican Party, he previously served ...
in 2004, McClellan was mentioned as a possible replacement, but President Bush ultimately nominated former
Utah Utah ( , ) is a state in the Mountain West subregion of the Western United States. Utah is a landlocked U.S. state bordered to its east by Colorado, to its northeast by Wyoming, to its north by Idaho, to its south by Arizona, and to it ...
governor
Mike Leavitt Michael Okerlund Leavitt (born February 11, 1951) is an American politician who served as the List of Governors of Utah, 14th Governor of Utah from 1993 to 2003 in the Republican Party (United States), Republican Party, as Administrator of the E ...
. On September 5, 2006, McClellan announced his resignation from his post in the department. He told
The Associated Press The Associated Press (AP) is an American non-profit news agency headquartered in New York City. Founded in 1846, it operates as a cooperative, unincorporated association. It produces news reports that are distributed to its members, U.S. newspa ...
he would be leaving the agency in about five weeks and would probably work for a
think tank A think tank, or policy institute, is a research institute that performs research and advocacy concerning topics such as social policy, political strategy, economics, military, technology, and culture. Most think tanks are non-governmenta ...
where he could write about improving health care in the United States. In 2007, he was appointed as the chair of the Reagan-Udall Foundation, a public-private partnership between the
U.S. Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
and industry.


In academia

Previously, McClellan was associate
professor Professor (commonly abbreviated as Prof.) is an Academy, academic rank at university, universities and other post-secondary education and research institutions in most countries. Literally, ''professor'' derives from Latin as a "person who pr ...
of
economics Economics () is the social science that studies the Production (economics), production, distribution (economics), distribution, and Consumption (economics), consumption of goods and services. Economics focuses on the behaviour and intera ...
at
Stanford University Stanford University, officially Leland Stanford Junior University, is a private research university in Stanford, California. The campus occupies , among the largest in the United States, and enrolls over 17,000 students. Stanford is consider ...
, associate professor of
medicine Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care pract ...
at the
Stanford University School of Medicine Stanford University School of Medicine is the medical school of Stanford University and is located in Stanford, California. It traces its roots to the Medical Department of the University of the Pacific, founded in San Francisco in 1858. This ...
, a practicing internist, and director of the Program on Health Outcomes Research at
Stanford University Stanford University, officially Leland Stanford Junior University, is a private research university in Stanford, California. The campus occupies , among the largest in the United States, and enrolls over 17,000 students. Stanford is consider ...
. He was also a research associate of the
National Bureau of Economic Research The National Bureau of Economic Research (NBER) is an American private nonprofit research organization "committed to undertaking and disseminating unbiased economic research among public policymakers, business professionals, and the academic c ...
and a visiting scholar at the
American Enterprise Institute The American Enterprise Institute for Public Policy Research, known simply as the American Enterprise Institute (AEI), is a center-right Washington, D.C.–based think tank that researches government, politics, economics, and social welfare. ...
. Additionally, he was a member of the National Cancer Policy Board of the
National Academy of Sciences The National Academy of Sciences (NAS) is a United States nonprofit, non-governmental organization. NAS is part of the National Academies of Sciences, Engineering, and Medicine, along with the National Academy of Engineering (NAE) and the Nati ...
, associate editor of the ''
Journal of Health Economics The ''Journal of Health Economics'' is a peer-reviewed academic journal that publishes articles about health economics and related fields concerning human health care and medicine. The journal is published six times annually by Elsevier. The edit ...
'', and co-principal investigator of the
Health and Retirement Study The Health and Retirement Study (HRS) is a longitudinal survey of a representative sample of Americans over age 50 conducted by the Survey Research Center (SRC) at the Institute for Social Research (ISR) at the University of Michigan in Ann Arbor ...
(HRS), a longitudinal study of the health and economic well-being of older Americans.


Publications


Hospital Reimbursement Incentives: An Empirical AnalysisMcClellan, M. (1997). Hospital reimbursement incentives: An empirical analysis. ''Journal of Economics and Management Strategy'', 6(1), 91-128.

Published in 1997 in the ''Journal of Economics and Management Strategy'', McClellan's paper serves as a review and analysis of provider payment incentives resulting from the Medicare prospective payment system (PPS). Implemented in the 1980s, PPS was intended to incentivize hospitals to drive down costs by limiting the use of costly technologies that added little benefit. The hallmark of the program is the use of fixed payments via diagnosis-related groups (DRGs) in a prospective manner based on diagnosis at the time of admission. McClellan suggests that PPS may not optimally incentivize
cost sharing In health care, cost sharing occurs when patients pay for a portion of health care costs not covered by health insurance. The "out-of-pocket" payment varies among healthcare plans and depends on whether or not the patient chooses to use a healthca ...
among insurers and health providers due to the
income effect The theory of consumer choice is the branch of microeconomics that relates preferences to consumption expenditures and to consumer demand curves. It analyzes how consumers maximize the desirability of their consumption as measured by their pref ...
by which hospitals may seek out particular diagnoses with higher
reimbursement Reimbursement is the act of compensating someone for an out-of-pocket expense by giving them an amount of money equal to what was spent. Companies, governments and nonprofit organizations may compensate their employees or officers for necessary a ...
rates, akin to skimming in the insurance arena. Conversely, retrospective cost sharing allows for possible supply
induced demand In economics, induced demand – related to latent demand and generated demandSchneider, Benjamin (September 6, 2018"CityLab University: Induced Demand"''CityLab'' – is the phenomenon whereby an increase in supply results in a decline ...
, minimizing the hospital's incentive to decrease resource utilization and costs in more complicated cases. This paper presents an
econometric model Econometric models are statistical models used in econometrics. An econometric model specifies the statistical relationship that is believed to hold between the various economic quantities pertaining to a particular economic phenomenon. An econome ...
to summarize these reimbursement incentives, present information on cost sharing and generosity in the PPS model, and discuss the implications of these findings. McClellan points out repeatedly that the PPS has increasingly permitted more retrospective adjustments to the payments. This has been primarily driven through
outliers In statistics, an outlier is a data point that differs significantly from other observations. An outlier may be due to a variability in the measurement, an indication of novel data, or it may be the result of experimental error; the latter are ...
and treatment-driven DRG's developed during the admission, rather than diagnosis-driven DRG's identified at the time of admission. Outlier payments allow for supplemental payments for unusually lengthy or expensive admissions and make up no more than 5% of all hospital admissions. The author considers the increase in
case mix index Case mix index (CMI) within health care and medicine, is a relative value assigned to a diagnosis-related group of patients in a medical care environment. The CMI value is used in determining the allocation of resources to care for and/or treat the ...
, a measure of the intensity of care delivered, to have the most important influence on overall PPS payments. He adds that these retrospective adjustments may be hampering the program's effectiveness in implementing cost sharing. McClellan's model allows individual aspects of PPS to be evaluated for their contribution to cost sharing rates and reimbursement variance. He used
linear regression In statistics, linear regression is a linear approach for modelling the relationship between a scalar response and one or more explanatory variables (also known as dependent and independent variables). The case of one explanatory variable is call ...
to approximate how the cost sharing reimbursement is derived, using fixed and variable components. Lower costs equaled lower reimbursement; however, higher costs led to higher reimbursements only if the costs were driven by a procedure. This was most true for men aged 65 to 69 with surgery requiring ICU care and an increased
length of stay Length of stay (LOS) is the duration of a single episode of hospitalization. patient, Inpatient days are calculated by subtracting day of admission from day of :wikt:discharge, discharge. Analysis A common statistic associated with length of stay ...
. Generosity estimates indicate that virtually all hospitals do some cost sharing. Higher generosity is usually associated with greater retrospective limits on cost sharing. In the 1990s, high-tech hospitals saw more generous reimbursements and were more likely to survive, whereas for-profit hospitals were more likely to exit the market. In summary, the Medicare "Prospective" Payment System has multiple retrospective factors that limited cost sharing in 1990. McClellan's review serves as a harbinger of current attempts to model a health care reimbursement program focused on pay for performance criteria such as penalties for readmissions and incentives for
value-based purchasing In the healthcare industry, pay for performance (P4P), also known as "value-based purchasing", is a payment model that offers financial incentives to physicians, hospitals, medical groups, and other healthcare providers for meeting certain performa ...
. The
Patient Protection and Affordable Care Act The Affordable Care Act (ACA), formally known as the Patient Protection and Affordable Care Act and colloquially known as Obamacare, is a landmark U.S. federal statute enacted by the 111th United States Congress and signed into law by Presi ...
continues to drive home the message of cost sharing by reducing reimbursements in the Inpatient Prospective Payment System.


Role in Center for Reproductive Rights lawsuit

During McClellan's tenure as Commissioner of the
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA), the makers of Plan B
emergency contraception Emergency contraception (EC) is a birth control measure, used after sexual intercourse to prevent pregnancy. There are different forms of EC. Emergency contraceptive pills (ECPs), sometimes simply referred to as emergency contraceptives (ECs), o ...
applied for
over-the-counter Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescr ...
status. In May 2004, FDA commissioner Steven Galson rejected over-the-counter status for Plan B. The
Center for Reproductive Rights The Center for Reproductive Rights (CRR) is a global legal advocacy organization that seeks to advance reproductive rights, such as abortion. The organization's stated mission is to "use the law to advance reproductive freedom as a fundamental huma ...
then filed a lawsuit, and deposed Dr John Jenkins, director of the FDA's Office of New Drugs. Jenkins alleges that he learned in early 2004 that McClellan, then Commissioner of the FDA, had decided against approval even before the staff could complete their analysis. "I think many of us were very concerned that there were policy or political issues that came to play in the decision," Jenkins stated. He later said he did not know if anyone outside FDA influenced the decision.Plan B decision made before data review - FDA staff
. Reuters via MSNBC.com: 4 August 2006. Accessed 4 August 2006.
McClellan said in his deposition that he was not involved in the decision to reject the initial Plan B application for non-prescription sales; he left the FDA in February 2004 to head the agency that runs Medicare and Medicaid. He also said that he was never told by anyone higher up in the Bush administration what to do about the application, although he did say that he "briefed" two White House domestic-policy advisors. The litigation is ongoing; no finding has been made for either side.


References


Selected publications

* * * * * * * * * *


External links


Search PubMed for McClellan's publications

FDA's economist in chief, Mark McClellan's views on healthcare make him popular with the drug industry
by Christopher Rowland, ''Boston Globe'', January 18, 2004.

* ttps://www.washingtonpost.com/wp-dyn/content/article/2006/01/13/AR2006011301738.html The States Step In As Medicare Falters; Seniors Being Turned Away, Overcharged Under New Prescription Drug Program by Ceci Connolly, ''Washington Post'', Saturday, January 14, 2006.
Troubles with Medicare Prescription Drug Program
PBS NewsHour with Jim Lehrer, January 16, 2006. * , - {{DEFAULTSORT:McClellan, Mark 1963 births Brookings Institution people Commissioners of the Food and Drug Administration Health economists Harvard Kennedy School alumni Living people MIT School of Humanities, Arts, and Social Sciences alumni Medicare and Medicaid (United States) People from Austin, Texas Physicians of Brigham and Women's Hospital United States Council of Economic Advisers United States Department of Health and Human Services officials University of Texas at Austin College of Liberal Arts alumni George W. Bush administration personnel Members of the National Academy of Medicine