Category: Government

(p. A15) As people age, the main valve controlling the flow of blood out of the heart can narrow, causing heart failure, and sometimes death. In the past the only way to repair the damage was risky open-heart surgery. But an ingenious medical device now allows the heart to be repaired using a catheter that introduces a replacement valve through a main artery in the leg–another miracle of modern medicine.
In 2011, more than four years after they hit the European market, the Food and Drug Administration finally approved aortic heart valves for use in the U.S. The total cost of the new procedure is about the same as open-heart surgery. But government bureaucrats feared that the new replacement valve’s lower risks and easier administration would mean that many more elderly patients would seek to fix their failing heart valves, pushing up Medicare’s total spending. To limit their use, regulators created coverage rules based on a set of strained medical criteria. It was a budget prerogative masquerading as clinical reasoning.
This episode is a vivid example of the government’s increasing practice to regulate medicine and ration care. A series of landmark studies published earlier this month in the Lancet and the New England Journal of Medicine, and presented at the annual meeting of the American College of Cardiology in Chicago, makes clear how contrived the original Medicare guidelines were.
For a patient to be qualified for the aortic valve device, Medicare required two cardiac surgeons to certify first that a patient wasn’t a candidate for the open-heart repair. Also mandated was the presence of a cardiothoracic surgeon and an interventional cardiologist in the operating room during the procedure.

For the full commentary, see:
SCOTT GOTTLIEB. “Warning: Medicare May Be Bad for Your Heart; Aortic valve replacements are superior to open-heart surgery and less risky. So why are they hard to get?” The Wall Street Journal (Tues., April 12, 2016): A15.
(Note: the online version of the commentary has the date April 11, 2016.)

The Lancet article mentioned above, is:
Thourani, Vinod H., Susheel Kodali, Raj R. Makkar, Howard C. Herrmann, Mathew Williams, Vasilis Babaliaros, Richard Smalling, Scott Lim, S. Chris Malaisrie, Samir Kapadia, Wilson Y. Szeto, Kevin L. Greason, Dean Kereiakes, Gorav Ailawadi, Brian K. Whisenant, Chandan Devireddy, Jonathon Leipsic, Rebecca T. Hahn, Philippe Pibarot, Neil J. Weissman, Wael A. Jaber, David J. Cohen, Rakesh Suri, E. Murat Tuzcu, Lars G. Svensson, John G. Webb, Jeffrey W. Moses, Michael J. Mack, D. Craig Miller, Craig R. Smith, Maria C. Alu, Rupa Parvataneni, Ralph B. D’Agostino, Jr., and Martin B. Leon. “Transcatheter Aortic Valve Replacement Versus Surgical Valve Replacement in Intermediate-Risk Patients: A Propensity Score Analysis.” The Lancet (April 3, 2016), DOI: 10.1016/S0140-6736(16)30073-3.

The New England Journal of Medicine article mentioned above, is:
Leon, Martin B., Craig R. Smith, Michael J. Mack, Raj R. Makkar, Lars G. Svensson, Susheel K. Kodali, Vinod H. Thourani, E. Murat Tuzcu, D. Craig Miller, Howard C. Herrmann, Darshan Doshi, David J. Cohen, Augusto D. Pichard, Samir Kapadia, Todd Dewey, Vasilis Babaliaros, Wilson Y. Szeto, Mathew R. Williams, Dean Kereiakes, Alan Zajarias, Kevin L. Greason, Brian K. Whisenant, Robert W. Hodson, Jeffrey W. Moses, Alfredo Trento, David L. Brown, William F. Fearon, Philippe Pibarot, Rebecca T. Hahn, Wael A. Jaber, William N. Anderson, Maria C. Alu, and John G. Webb. “Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients.” New England Journal of Medicine (April 2, 2016), DOI: 10.1056/NEJMoa1514616.

(p. A9) When the 124-bed StoneSprings Hospital Center opened in December, it became the first new hospital in Loudoun County, Va., in more than a century. That’s more remarkable than it might at first seem: In the past two decades, Loudoun County, which abuts the Potomac River and includes growing Washington suburbs, has tripled in population. Yet not a single new hospital had opened. Why? One big reason is that StoneSprings had to fight through years of regulatory reviews and court challenges before laying the first brick.
County officials and the Hospital Corporation of America, or HCA, began talking about building a new hospital in 2001. But Virginia is one of the 36 states with a “certificate of need” law, which requires health-care providers to obtain a state license before opening a new facility. Getting a license is supposed to take about nine months, according to the state Health Department. HCA first submitted an application in July 2002 but didn’t win approval for a new facility until early 2004.
Then the plan faced a series of legal challenges from the Inova Health System, an entrenched, multibillion-dollar competitor. Over decades Inova has become the dominant player in the Virginia suburbs.
. . .
It’s not hard to understand why Inova might fight so hard to keep out challengers: There’s a direct correlation between prices and competition. In a paper released in December, economists with Yale, Carnegie Mellon and the London School of Economics evaluated claims data from Aetna, Humana and UnitedHealth. They found that rates were 15.3% higher, on average, in areas with one hospital, compared with those serviced by four or more. In markets with a two-hospital duopoly, prices were 6.4% higher. Where only three hospitals compete they were 4.8% higher.
Research by Chris Koopman of the free-market Mercatus Center suggests that Virginia could have 10,000 more hospital beds and 40 more hospitals offering MRIs if the certificate of need restrictions did not exist. “In many instances, they create a quasi-monopoly,” he says. “In essence, it’s a government guarantee that no one will compete with you, until you get notice and an opportunity to challenge that person’s entry into that market.”

For the full commentary, see:
ERIC BOEHM. “CROSS COUNTRY; For Hospital Chains, Competition Is a Bitter Pill; Building a new medical center in Virginia can take a decade, because state laws favor entrenched players.” The Wall Street Journal (Sat., Jan. 30, 2016): A9.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date Jan. 29, 2016.)

The academic paper mentioned above that relates hospital charges to the number of hospitals in the area, is:
Cooper, Zack, Stuart V. Craig, Martin Gaynor, and John Van Reenen. “The Price Ain’t Right? Hospital Prices and Health Spending on the Privately Insured.” NBER Working Paper # 21815. National Bureau of Economic Research, Inc., 2015.

Chris Koopman’s research, mentioned above, can be found in:
Koopman, Christopher, and Thomas Stratmann. “Certificate-of-Need Laws: Implications for Virginia.” In Mercatus on Policy: Mercatus Center, George Mason University, 2015.