By Kevin Schulman, M.D.

Duke Medicine has just announced a $700 million expansion of its physical plant to add 847,000 square feet, including adding 16 operating rooms and renovating 160 beds (that’s over $800 per square foot if you’re doing the math).

This will add a new cancer hospital facility within the Duke campus, and expand the number of intensive care rooms at Duke Hospital. This is a significant investment in infrastructure for the health system, but how will this investment impact the care delivered to patients by Duke Medicine?

Duke Medicine is a fee-for-service hospital system and physician network. This is one of the oldest forms of a provider organizational structure in existence, and pre-dates the development of health insurance in the US. This model is managed to allow patients access to high-end specialty and hospital services. Within this model, hospitalization is not considered a failure, but rather a core service offering. Competition between Duke and other providers is on the basis of technology and specialty service offerings. This type of competition can lead to improvements in the performance of specialist physicians, but can also lead to a phenomena described as a “medical arms race” where hospitals “must” acquire certain technologies to remain attractive in these specific markets.

Hospitals like to point out that their high-tech facilities and services are better than those of competitors (see Robinson and Luft JAMA 1987). This type of competition has been criticized as driving to higher investment in technology, overcapacity, and higher health care costs. There’s some local evidence of this arms race concept with UNC’s investment in a similar cancer facility only nine miles from the Duke campus.

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By Kevin Schulman, M.D.

The policy goals for health care reform are so clear it should be easy: 1) improve access to health care services — defined as access to insurance; 2) improve the quality of health care services — through health IT; and 3) reduce the cost of health care — through competition or structural changes in the system, such as reform of the small group market. From a policy standpoint, we can debate the intricacies of these various issues and use data or theory to support our arguments.

What is happening now in Washington is not health policy, but health politics. Politicians are searching for policies that would gain the most political support (or looking to offer promises to specific members to make the rest of the program more palatable to them). Negotiations are not with the public over the broad agenda, but with specific political interest groups that constitute the Washington lobby core. This is the legislative process of the US at its most transparent. The populist rhetoric has been lost in the tricky business of legislation, lobbying, and politics.

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The following post was written by Kevin Schulman, M.D., Director of Duke’s Health Sector Management Program:

As Director of Fuqua’s HSM Program, I hereby nominate the physicians and hospital managers of McAllen, Texas, for a special joint Nobel Prize in Medicine and Economics for their brilliant experiment demonstrating, beyond a shadow of a doubt, that PHYSICIANS DO RESPOND TO ECONOMIC INCENTIVES. In recognition of this work, all physicians and hospitals in McAllen should receive a bonus payment equal to their 2009 Medicare billings, and then should be permanently excluded from the program (the public system responds to few incentives beyond those of special interests, but when you’re the subject of a must-read report at the White House, you’re out of luck).

So if you’re one of the few people who has yet to find time to read Atul Gawande’s piece in the New Yorker (and it is must-read material). Here are the major highlights:

For over 40 years, Jack Wennberg and his group at Dartmouth (now including Elliott Fisher and Jonathan Skinner) have shown there is significant variation in medical practice — more variation in “discretionary” services like imaging vs. essential services like appendectomy. This group has also created a database called the Dartmouth Atlas of Medical Practice, which reports variations in medical care according to hospital referral regions in the United States. From this database, a region that was identified as one of the highest utilizing sites was McAllen, Texas. Gawandi of the New Yorker visited to try to gain a better understanding the case and uncover reasons for the high utilization.

Less developed in Gawande’s article is the idea that the Medicare program has known about this practice for years. Annually $1 billion dollars is spent on a national program of Quality Improvement Organizations. These spends are allocated for the review of medical practices within the Medicare program. State Medicare medical directors, contracted health plan managers, and Office of the Inspector General at HHS are all involved in the review. All seemed powerless to take action in the case. (In terms of the public-private plan debate, it seems the private plans in the market had the same incentives and observed the same results in McAllen, so private plans aren’t the automatic fix to this practice pattern issue).

So what are the implications of this study? Read the rest of this entry »

New research by Duke Health Sector Management Director Kevin Schulman and Fuqua alumnus Seth Glickman was featured in this week’s New England Journal of Medicine, and also covered by the Wall Street Journal and New York Times.

DURHAM, N.C. – Top-tier U.S.-based pharmaceutical companies are moving their clinical trials overseas at warp speed, raising questions about ethics, quality control, and even the scientific value of their findings for people back in the U.S.

Many of the trials are taking place in developing countries in Eastern Europe and Asia where study participants are often poorer and less educated than are study participants in the U.S., according to researchers at Duke Clinical Research Institute (DCRI).

“The FDA is supposed to provide oversight for such trials, but it simply wasn’t designed to handle this kind of situation,” says Kevin Schulman, M.D., the senior author of the report appearing in the New England Journal of Medicine. Schulman says the number of Food and Drug Administration investigators based outside the U.S. has grown by 15 percent every year since 2002, while the number of U.S.-based investigators has fallen just over 5 percent during the same period.

Schulman and a research team led by Seth Glickman, M.D., a senior scholar at Duke’s Fuqua School of Business, used the clinicaltrials.gov registry to examine recruitment patterns in industry-sponsored Phase 3 trials in 2007. Phase 3 trials are typically the largest and most meaningful trials, often involving thousands of patients. They found that about a third of the trials (157 of 509) were being solely conducted outside the U.S. They also discovered that over half the study sites (13,521 of 24,206) lay outside U.S. borders. Read the rest of this entry »