Mark McClellan | |
---|---|
12th Administrator of the Centers for Medicare and Medicaid Services | |
In office March 25, 2004 –October 14, 2006 | |
President | George W. Bush |
Preceded by | Dennis Smith (Acting) |
Succeeded by | Leslie Norwalk (Acting) |
18th Commissioner of Food and Drugs | |
In office November 14,2002 –March 25,2004 | |
President | George W. Bush |
Preceded by | Jane Henney |
Succeeded by | Lester Crawford |
Personal details | |
Born | Austin,Texas,U.S. | June 26,1963
Political party | Republican |
Education | University of Texas,Austin (BA) Harvard University (MPA,MD) Massachusetts Institute of Technology (PhD) |
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. 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. [1] McClellan served as commissioner of the United States Food and Drug Administration under President George W. Bush from 2002 through 2004,and subsequently as administrator of the Centers for Medicare and Medicaid Services from 2004 through 2006. [2] [3] [4]
After graduating from the University of Texas in 1985 majoring in English,Biology,and Plan II, [5] he earned his M.D. degree from the Harvard–MIT Division of Health Sciences and Technology in 1992 and his Ph.D. in economics from MIT in 1993. [6] He also earned a Master of Public Administration degree from Harvard Kennedy School in 1991. He completed his residency training in internal medicine at Brigham and Women's Hospital,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. [7]
From 1998 to 1999,McClellan served as deputy assistant secretary of the Treasury for Economic Policy,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. He was a member of the president's Council of Economic Advisers,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 (FDA) beginning November 14,2002,becoming the first economist to hold that position. [8] Originally from Austin,Texas,he is the brother of former White House Press Secretary Scott McClellan and the son of Texas comptroller Carole Keeton Strayhorn and attorney Barr McClellan.
He was administrator for the Centers for Medicare and Medicaid Services in the United States Department of Health and Human Services from 2004 to 2006. In this position,he was responsible for administering the Medicare and Medicaid programs,including Medicare Part D,the prescription drug benefit program engendered by the Medicare Prescription Drug,Improvement,and Modernization Act.
Following the resignation of Health &Human Services Secretary Tommy Thompson in 2004,McClellan was mentioned as a possible replacement,but President Bush ultimately nominated former Utah governor Mike Leavitt. On September 5,2006,McClellan announced his resignation from his post in the department. He told The Associated Press he would be leaving the agency in about five weeks and would probably work for a think tank 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 and industry.
Previously,McClellan was associate professor of economics at Stanford University,associate professor of medicine at the Stanford University School of Medicine,a practicing internist,and director of the Program on Health Outcomes Research at Stanford University. He was also a research associate of the National Bureau of Economic Research and a visiting scholar at the American Enterprise Institute. Additionally,he was a member of the National Cancer Policy Board of the National Academy of Sciences,associate editor of the Journal of Health Economics ,and co-principal investigator of the Health and Retirement Study (HRS),a longitudinal study of the health and economic well-being of older Americans.
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). [9] 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. [10] McClellan suggests that PPS may not optimally incentivize cost sharing among insurers and health providers due to the income effect by which hospitals may seek out particular diagnoses with higher reimbursement rates,akin to skimming in the insurance arena. [9] [11] Conversely,retrospective cost sharing allows for possible supply induced demand,minimizing the hospital's incentive to decrease resource utilization and costs in more complicated cases. [9] [12]
This paper presents an econometric model 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 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. [13] The author considers the increase in case mix index,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 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. Generosity estimates indicate that virtually all hospitals do some cost sharing. [14] 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. [15]
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. The Patient Protection and Affordable Care Act continues to drive home the message of cost sharing by reducing reimbursements in the Inpatient Prospective Payment System. [16]
During McClellan's tenure as Commissioner of the Food and Drug Administration (FDA),the makers of Plan B emergency contraception applied for over-the-counter status.
In May 2004,FDA commissioner Steven Galson rejected over-the-counter status for Plan B. The Center for Reproductive Rights 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. [17]
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. [17] [18] The litigation is ongoing;no finding has been made for either side.
In the United States,Medicaid is a government program that provides health insurance for adults and children with limited income and resources. The program is partially funded and primarily managed by state governments,which also have wide latitude in determining eligibility and benefits,but the federal government sets baseline standards for state Medicaid programs and provides a significant portion of their funding.
Medicare is a federal health insurance program in the United States for people age 65 or older and younger people with disabilities,including those with end stage renal disease and amyotrophic lateral sclerosis. It was begun in 1965 under the Social Security Administration and is now administered by the Centers for Medicare and Medicaid Services (CMS).
Diagnosis-related group (DRG) is a system to classify hospital cases into one of originally 467 groups,with the last group being "Ungroupable". This system of classification was developed as a collaborative project by Robert B Fetter,PhD,of the Yale School of Management,and John D. Thompson,MPH,of the Yale School of Public Health. The system is also referred to as "the DRGs",and its intent was to identify the "products" that a hospital provides. One example of a "product" is an appendectomy. The system was developed in anticipation of convincing Congress to use it for reimbursement,to replace "cost based" reimbursement that had been used up to that point. DRGs are assigned by a "grouper" program based on ICD diagnoses,procedures,age,sex,discharge status,and the presence of complications or comorbidities. DRGs have been used in the US since 1982 to determine how much Medicare pays the hospital for each "product",since patients within each category are clinically similar and are expected to use the same level of hospital resources. DRGs may be further grouped into Major Diagnostic Categories (MDCs). DRGs are also standard practice for establishing reimbursements for other Medicare related reimbursements such as to home healthcare providers.
Prescription drug list prices in the United States continually are among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century,leading up to the American health care reform debate of 2009,and received renewed attention in 2015. One major reason for high prescription drug prices in the United States relative to other countries is the inability of government-granted monopolies in the American health care sector to use their bargaining power to negotiate lower prices,and the American payer ends up subsidizing the world's R&D spending on drugs.
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 Medicare Modernization Act of 2003 and went into effect on January 1,2006. Under the program,drug benefits are provided by private insurance plans that receive premiums from both enrollees and the government. Part D plans typically pay most of the cost for prescriptions filled by their enrollees. However,plans are later reimbursed for much of this cost through rebates paid by manufacturers and pharmacies.
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 performance measures. Clinical outcomes,such as longer survival,are difficult to measure,so pay for performance systems usually evaluate process quality and efficiency,such as measuring blood pressure,lowering blood pressure,or counseling patients to stop smoking. This model also penalizes health care providers for poor outcomes,medical errors,or increased costs. Integrated delivery systems where insurers and providers share in the cost are intended to help align incentives for value-based care.
The United States government provides funding to hospitals that treat indigent patients through the Disproportionate Share Hospital (DSH) programs,under which facilities are able to receive at least partial compensation.
Pharmaceutical policy is a branch of health policy that deals with the development,provision and use of medications within a health care system. It embraces drugs,biologics,vaccines and natural health products.
Medicare Advantage is a type of health plan offered by Medicare-approved private companies that must follow rules set by Medicare. Most Medicare Advantage Plans include drug coverage. Under Part C,Medicare pays a sponsor a fixed payment. The sponsor then pays for the health care expenses of enrollees. Sponsors are allowed to vary the benefits from those provided by Medicare's Parts A and B as long as they provide the actuarial equivalent of those programs. The sponsors vary from primarily integrated health delivery systems to unions to other types of non profit charities to insurance companies.
Healthcare reform in the United States has had a long history. Reforms have often been proposed but have rarely been accomplished. In 2010,landmark reform was passed through two federal statutes:the Patient Protection and Affordable Care Act (PPACA),signed March 23,2010,and the Health Care and Education Reconciliation Act of 2010,which amended the PPACA and became law on March 30,2010.
A rural health clinic (RHC) is a clinic located in a rural,medically under-served area in the United States that has a separate reimbursement structure from the standard medical office under the Medicare and Medicaid programs. RHCs were established by the Rural Health Clinic Services Act of 1977,. The RHC program increases access to health care in rural areas by
A long-term acute care hospital (LTACH),also known as a long-term care hospital (LTCH),is a hospital specializing in treating patients requiring extended hospitalization. Hospitals specializing in long-term care have existed for decades in the form of sanatoriums for patients with tuberculosis and other chronic diseases. The modern hospital known as an LTACH came into existence as a result of the Medicare,Medicaid,and SCHIP Balanced Budget Refinement Act of 1999. The Act defines an LTACH as “a hospital which has an average inpatient length of stay of greater than 25 days.”Traditionally,LTACHs provide care for patients receiving prolonged mechanical ventilation.
Bundled payment is the reimbursement of health care providers "on the basis of expected costs for clinically-defined episodes of care." It has been described as "a middle ground" between fee-for-service reimbursement and capitation,given that risk is shared between payer and provider. Bundled payments have been proposed in the health care reform debate in the United States as a strategy for reducing health care costs,especially during the Obama administration (2009–2016). Commercial payers have shown interest in bundled payments in order to reduce costs. In 2012,it was estimated that approximately one-third of the United States healthcare reimbursement used bundled methodology.
An accountable care organization (ACO) is a healthcare organization that ties provider reimbursements to quality metrics and reductions in the cost of care. ACOs in the United States are formed from a group of coordinated health-care practitioners. They use alternative payment models,normally,capitation. The organization is accountable to patients and third-party payers for the quality,appropriateness and efficiency of the health care provided. According to the Centers for Medicare and Medicaid Services,an ACO is "an organization of health care practitioners that agrees to be accountable for the quality,cost,and overall care of Medicare beneficiaries who are enrolled in the traditional fee-for-service program who are assigned to it".
A prospective payment system (PPS) is a term used to refer to several payment methodologies for which means of determining insurance reimbursement is based on a predetermined payment regardless of the intensity of the actual service provided.
The 340B Drug Pricing Program is a US federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. The intent of the program is to allow covered entities to "stretch scarce federal resources as far as possible,reaching more eligible patients and providing more comprehensive services." Maintaining services and lowering medication costs for patients is consistent with the purpose of the program,which is named for the section authorizing it in the Public Health Service Act (PHSA) It was enacted by Congress as part of a larger bill signed into law by President George H. W. Bush.
Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals classified as high-cost,high complexity and/or high touch. Specialty drugs are often biologics—"drugs derived from living cells" that are injectable or infused. They are used to treat complex or rare chronic conditions such as cancer,rheumatoid arthritis,hemophilia,H.I.V. psoriasis,inflammatory bowel disease and hepatitis C. In 1990 there were 10 specialty drugs on the market,around five years later nearly 30,by 2008 200,and by 2015 300.
A safety net hospital is a type of medical center in the United States that by legal obligation or mission provides healthcare for individuals regardless of their insurance status or ability to pay. This legal mandate forces safety net hospitals (SNHs) to serve all populations. Such hospitals typically serve a proportionately higher number of uninsured,Medicaid,Medicare,Children's Health Insurance Program (CHiP),low-income,and other vulnerable individuals than their "non-safety net hospital" counterpart. Safety net hospitals are not defined by their ownership terms;they can be either publicly or privately owned. The mission of safety net hospitals is rather to provide the best possible care for those who are barred from health care due to the various possible adverse circumstances. These circumstances mostly revolve around problems with financial payments,insurance plans,or health conditions. Safety net hospitals are known for maintaining an open-door policy for their services.
Health care efficiency is a comparison of delivery system outputs,such as physician visits,relative value units,or health outcomes,with inputs like cost,time,or material. Efficiency can be reported then as a ratio of outputs to inputs or a comparison to optimal productivity using stochastic frontier analysis or data envelopment analysis. An alternative approach is to look at latency times and delay times between a care order and completion of work,and stated accomplishment in relation to estimated effort.
Yuting Zhang is a professor of health economics at the University of Melbourne,and an expert on economic evaluations of health policy and healthcare reforms. She is a journal editor,award recipient,and has written numerous articles in influential journals in her field.