Chapter 10.A.3: Certificate of Need Regulation

The Federal Trade Commission called on states to re-examine the need for CON laws, noting their anticompetitive risks. Improving Health Care: A Dose of Competition (July 2004). 

The next battleground in the medical arm's race appears to be taking shape around "proton beam therapy":

Hospitals Look to Nuclear Tool to Fight Cancer, Andrew Pollack, NY Times, December 26, 2007,

 There is a new nuclear arms race under way — in hospitals. Medical centers are rushing to turn nuclear particle accelerators, formerly used only for exotic physics research, into the latest weapons against cancer. . . . The machines accelerate protons to nearly the speed of light and shoot them into tumors. Scientists say proton beams are more precise than the X-rays now typically used for radiation therapy, meaning fewer side effects from stray radiation and, possibly, a higher cure rate. But a 222-ton accelerator — and a building the size of a football field with walls up to 18-feet thick in which to house it — can cost more than $100 million. . . .

Until 2000, the United States had only one hospital-based proton therapy center. Now there are five, with more than a dozen others announced. Still more are under consideration. Some experts say there is a vast need for more proton centers. But others contend that an arms race mentality has taken hold, as medical centers try to be first to take advantage of the prestige — and the profits — a proton site could provide.  Once hospitals have made such a huge investment, experts [say] doctors will be under pressure to guide patients toward proton therapy when a less costly alternative might suffice.  . . . Dr. Anthony L. Zietman, a radiation oncologist at Harvard and Massachusetts General Hospital, . . . said that while protons were vital in treating certain rare tumors, they were little better than the latest X-ray technology in dealing with prostate cancer, the common disease that many proton centers are counting on for business. . . . Medicare pays about $50,000 to treat prostate cancer with protons, almost twice as much as with X-rays.

Proponents, however, are adamant that proton centers provide better treatment. “It all comes down to the physics,” said Dr. Jerry D. Slater, the head of radiation medicine at Loma Linda University Medical Center in Southern California. “Every X-ray beam I use puts most of the dose where I don’t want it.” By contrast, he said, proton beams put most of the dose in the tumor. . . . Tumors in or near the eye, for instance, can be eradicated by protons without destroying vision or irradiating the brain. . . .

One of the biggest and most costly projects, with a bill exceeding $140 million, is being undertaken by Hampton University in Virginia, a historically black college that does not have a medical school. “Here at Hampton we dream no small dreams,” said William R. Harvey, the president. He said a proton center would help African-Americans, who have higher rates of some cancers than whites. And he said a medical school was not needed — that doctors would be hired to run the outpatient center. . . .

The institutions building the centers say there is a need for many more of them. The existing centers, which collectively can treat only several thousand patients a year, are turning people away. And patients who are accepted often have to spend weeks in a city far from their homes.  Proponents say that more than 800,000 Americans — representing nearly two-thirds of new cancer cases — undergo radiation therapy each year. If only 250,000 of them could benefit from protons, they would fill more than 100 centers. . . .

Protons are also valuable for treating tumors in brains, necks and spines, and tumors in children, who are especially sensitive to the side effects of radiation. When 10-year-old Brooke Bemont was about to undergo X-ray treatment for a brain tumor last summer, a doctor warned her mother, “Do not plan on your daughter ever going to Harvard.” The radiation would damage Brooke’s mental capacity, she said. So the family, from St. Charles, Ill., spent five weeks in Boston as Brooke was treated with protons at Massachusetts General Hospital Cancer Center. “If there was a potential to save even a little of her brain tissue, there was no question that we would do it,” said Christal Bemont, Brooke’s mother. . . .

Head, spine and childhood cancers are rare, though. Most people undergoing proton treatment are men with localized prostate cancer.  Proton therapy can help avoid the worst side effects, like impotence . . . [but there] “are no solid clinical data that protons are better” said Dr. Theodore S. Lawrence . . . . Lack of data aside, men are flocking to proton treatment. “I’m 67 years old, and the last thing I want to do is wear a diaper for the rest of my life,” said Pete Freeman of Spokane, Wash. . . .