Joyce Frieden

BALTIMORE — Although some local carriers already cover vertebral augmentation through vertebroplasty or kyphoplasty, the Centers for Medicare and Medicaid Services does not intend to consider a national coverage policy for the procedures, especially given the lack of solid data available, Stephen Phurrough, M.D., said at a meeting of the Medicare Coverage Advisory Committee.

“We have no open national coverage determination, and we have no plans to open a national coverage determination,” said Dr. Phurrough, who is head of Medicare's coverage and analysis group.

The group does plan to “produce some type of guidance document that may distill what we think about this particular field of spinal disease,” he said. That document will then be made available for comment.

Dr. Phurrough's remarks came after a day of mostly favorable testimony on vertebral augmentation. “We are showing that these patients are better, and we're making a difference in their pain,” said Isador H. Lieberman, M.D., a surgeon at the Cleveland Clinic Foundation.

Dr. Lieberman and colleagues performed a prospective controlled trial on 329 vertebral augmentation patients, 70% of whom had osteoporosis. Duration of symptoms prior to the procedure was 1 week to 5 years; mean follow-up was 55 weeks; and the average hospital stay was 1.1 days.

The researchers found that the vertebral augmentation patients showed a “statistically significant improvement in bodily pain, mental health, physical function, social function, and vitality,” compared with the controls, said Dr. Lieberman, who serves as a consultant to several companies that make surgical equipment for vertebral augmentation. “Overall, these patients do well with this intervention.”

Dr. Lieberman gave several reasons why no randomized controlled trials had been done on the benefits of one procedure vs. the other. “I've been involved in five attempts. To sum it up, it's lack of collaboration—we haven't been able to get various factions to decide on how to do the study or whether to participate,” he said.

There are also study design and institutional review board (IRB) issues. “One study I was potentially involved in demanded a sham procedure; my IRB would not let me do a sham procedure,” he said. Getting funding for the study also is a problem.

But probably the most important problem is recruitment. “We're dealing with an elderly population who don't have time or patience to come back for all these follow-ups or fill out all this paperwork,” Dr. Lieberman said.

Kevin McGraw, M.D., a Columbus, Ohio, radiologist, testified that conservative treatment of vertebral fractures—usually bed rest—is not without its risks.

“During bed rest, virtually every organ system is adversely affected,” said Dr. McGraw, who testified on behalf of the Society of Interventional Radiology. “Bone density declines about 2% per week, and muscle strength declines about 10%–15% per week. Nearly half of normal strength is lost during the first 3–4 weeks of bed rest.”

Other serious consequences of bed rest include pressure sores, deep vein thrombosis, and pulmonary emboli, he continued. “If we subject patients to 6 weeks of bed rest, they've lost 12% of bone density and half of their muscle strength, they have developed a decubitus ulcer, and they have a 10% chance of a pulmonary embolism. The Society of Interventional Radiology believes that since vertebroplasty results in early mobilization, it is superior to conservative treatment.”

Fergus McKiernan, M.D., of the Center for Bone Diseases at the Marshfield (Wisc.) Clinic, sounded a note of caution about the available data on vertebral augmentation.

First, he noted that one common method of reporting vertebral height restoration following vertebral augmentation invariably favored smaller restorations. For example, “if a 4-mm regression of the superior endplate is followed by a 3-mm restoration, one could say this 3 mm constituted a 75% vertebral height restoration,” he said. “Using this same method, if a 25-mm regression of the superior endplate is followed by a 5-mm elevation, this reporting method would assign a 20% vertebral height restoration.”

Journal editors should require disclosure of anterior, middle, and posterior heights when reporting height restoration “as the vertebrae may fail in the middle portion, and yet there may be no change in anterior height,” said Dr. McKiernan. “Without knowledge of all vertebral heights, claims of vertebral height restoration based [solely] on middle height may not be clinically relevant.”

He also said that one recent article touting the benefits of kyphoplasty cited two papers from his own research group. This citation was problematic because his group does not perform kyphoplasties, only vertebroplasties. In addition, the authors used his group's papers to make a point about vertebral compression fractures less than 4 weeks old, “and our average fracture age is four months,” Dr. McKiernan said. “The notion of less-than-4-week-old fractures appears nowhere in the text of either article.”

Panel members appeared to agree with some of Dr. McKiernan's points when it came to voting on the questions put before them. When asked to rate how well the evidence addresses vertebroplasty's effectiveness on a scale of 1–5—with 1 being “poor” and 5 being “very well”—the panel's average vote was 2.0. When asked about mortality data, the panel was particularly skeptical, giving it an average score of 1.5. Results of a vote on the evidence for kyphoplasty were similar.

“As the technology diffuses a lot more, and as patients expect this, a whole group of patients you wouldn't think of doing this on will receive it,” said panel member Alexander Krist, M.D., a family physician in Fairfax, Va. “There is [an unsystematic] process for figuring out who gets it and who doesn't. That would be my fear.

BALTIMORE — Although some local carriers already cover vertebral augmentation through vertebroplasty or kyphoplasty, the Centers for Medicare and Medicaid Services does not intend to consider a national coverage policy for the procedures, especially given the lack of solid data available, Stephen Phurrough, M.D., said at a meeting of the Medicare Coverage Advisory Committee.

“We have no open national coverage determination, and we have no plans to open a national coverage determination,” said Dr. Phurrough, who is head of Medicare's coverage and analysis group.

The group does plan to “produce some type of guidance document that may distill what we think about this particular field of spinal disease,” he said. That document will then be made available for comment.

Dr. Phurrough's remarks came after a day of mostly favorable testimony on vertebral augmentation. “We are showing that these patients are better, and we're making a difference in their pain,” said Isador H. Lieberman, M.D., a surgeon at the Cleveland Clinic Foundation.

Dr. Lieberman and colleagues performed a prospective controlled trial on 329 vertebral augmentation patients, 70% of whom had osteoporosis. Duration of symptoms prior to the procedure was 1 week to 5 years; mean follow-up was 55 weeks; and the average hospital stay was 1.1 days.

The researchers found that the vertebral augmentation patients showed a “statistically significant improvement in bodily pain, mental health, physical function, social function, and vitality,” compared with the controls, said Dr. Lieberman, who serves as a consultant to several companies that make surgical equipment for vertebral augmentation. “Overall, these patients do well with this intervention.”

Dr. Lieberman gave several reasons why no randomized controlled trials had been done on the benefits of one procedure vs. the other. “I've been involved in five attempts. To sum it up, it's lack of collaboration—we haven't been able to get various factions to decide on how to do the study or whether to participate,” he said.

There are also study design and institutional review board (IRB) issues. “One study I was potentially involved in demanded a sham procedure; my IRB would not let me do a sham procedure,” he said. Getting funding for the study also is a problem.

But probably the most important problem is recruitment. “We're dealing with an elderly population who don't have time or patience to come back for all these follow-ups or fill out all this paperwork,” Dr. Lieberman said.

Kevin McGraw, M.D., a Columbus, Ohio, radiologist, testified that conservative treatment of vertebral fractures—usually bed rest—is not without its risks.

“During bed rest, virtually every organ system is adversely affected,” said Dr. McGraw, who testified on behalf of the Society of Interventional Radiology. “Bone density declines about 2% per week, and muscle strength declines about 10%–15% per week. Nearly half of normal strength is lost during the first 3–4 weeks of bed rest.”

Other serious consequences of bed rest include pressure sores, deep vein thrombosis, and pulmonary emboli, he continued. “If we subject patients to 6 weeks of bed rest, they've lost 12% of bone density and half of their muscle strength, they have developed a decubitus ulcer, and they have a 10% chance of a pulmonary embolism. The Society of Interventional Radiology believes that since vertebroplasty results in early mobilization, it is superior to conservative treatment.”

Fergus McKiernan, M.D., of the Center for Bone Diseases at the Marshfield (Wisc.) Clinic, sounded a note of caution about the available data on vertebral augmentation.

First, he noted that one common method of reporting vertebral height restoration following vertebral augmentation invariably favored smaller restorations. For example, “if a 4-mm regression of the superior endplate is followed by a 3-mm restoration, one could say this 3 mm constituted a 75% vertebral height restoration,” he said. “Using this same method, if a 25-mm regression of the superior endplate is followed by a 5-mm elevation, this reporting method would assign a 20% vertebral height restoration.”

Journal editors should require disclosure of anterior, middle, and posterior heights when reporting height restoration “as the vertebrae may fail in the middle portion, and yet there may be no change in anterior height,” said Dr. McKiernan. “Without knowledge of all vertebral heights, claims of vertebral height restoration based [solely] on middle height may not be clinically relevant.”

He also said that one recent article touting the benefits of kyphoplasty cited two papers from his own research group. This citation was problematic because his group does not perform kyphoplasties, only vertebroplasties. In addition, the authors used his group's papers to make a point about vertebral compression fractures less than 4 weeks old, “and our average fracture age is four months,” Dr. McKiernan said. “The notion of less-than-4-week-old fractures appears nowhere in the text of either article.”

Panel members appeared to agree with some of Dr. McKiernan's points when it came to voting on the questions put before them. When asked to rate how well the evidence addresses vertebroplasty's effectiveness on a scale of 1–5—with 1 being “poor” and 5 being “very well”—the panel's average vote was 2.0. When asked about mortality data, the panel was particularly skeptical, giving it an average score of 1.5. Results of a vote on the evidence for kyphoplasty were similar.

“As the technology diffuses a lot more, and as patients expect this, a whole group of patients you wouldn't think of doing this on will receive it,” said panel member Alexander Krist, M.D., a family physician in Fairfax, Va. “There is [an unsystematic] process for figuring out who gets it and who doesn't. That would be my fear.

BALTIMORE — Although some local carriers already cover vertebral augmentation through vertebroplasty or kyphoplasty, the Centers for Medicare and Medicaid Services does not intend to consider a national coverage policy for the procedures, especially given the lack of solid data available, Stephen Phurrough, M.D., said at a meeting of the Medicare Coverage Advisory Committee.

“We have no open national coverage determination, and we have no plans to open a national coverage determination,” said Dr. Phurrough, who is head of Medicare's coverage and analysis group.

The group does plan to “produce some type of guidance document that may distill what we think about this particular field of spinal disease,” he said. That document will then be made available for comment.

Dr. Phurrough's remarks came after a day of mostly favorable testimony on vertebral augmentation. “We are showing that these patients are better, and we're making a difference in their pain,” said Isador H. Lieberman, M.D., a surgeon at the Cleveland Clinic Foundation.

Dr. Lieberman and colleagues performed a prospective controlled trial on 329 vertebral augmentation patients, 70% of whom had osteoporosis. Duration of symptoms prior to the procedure was 1 week to 5 years; mean follow-up was 55 weeks; and the average hospital stay was 1.1 days.

The researchers found that the vertebral augmentation patients showed a “statistically significant improvement in bodily pain, mental health, physical function, social function, and vitality,” compared with the controls, said Dr. Lieberman, who serves as a consultant to several companies that make surgical equipment for vertebral augmentation. “Overall, these patients do well with this intervention.”

Dr. Lieberman gave several reasons why no randomized controlled trials had been done on the benefits of one procedure vs. the other. “I've been involved in five attempts. To sum it up, it's lack of collaboration—we haven't been able to get various factions to decide on how to do the study or whether to participate,” he said.

There are also study design and institutional review board (IRB) issues. “One study I was potentially involved in demanded a sham procedure; my IRB would not let me do a sham procedure,” he said. Getting funding for the study also is a problem.

But probably the most important problem is recruitment. “We're dealing with an elderly population who don't have time or patience to come back for all these follow-ups or fill out all this paperwork,” Dr. Lieberman said.

Kevin McGraw, M.D., a Columbus, Ohio, radiologist, testified that conservative treatment of vertebral fractures—usually bed rest—is not without its risks.

“During bed rest, virtually every organ system is adversely affected,” said Dr. McGraw, who testified on behalf of the Society of Interventional Radiology. “Bone density declines about 2% per week, and muscle strength declines about 10%–15% per week. Nearly half of normal strength is lost during the first 3–4 weeks of bed rest.”

Other serious consequences of bed rest include pressure sores, deep vein thrombosis, and pulmonary emboli, he continued. “If we subject patients to 6 weeks of bed rest, they've lost 12% of bone density and half of their muscle strength, they have developed a decubitus ulcer, and they have a 10% chance of a pulmonary embolism. The Society of Interventional Radiology believes that since vertebroplasty results in early mobilization, it is superior to conservative treatment.”

Fergus McKiernan, M.D., of the Center for Bone Diseases at the Marshfield (Wisc.) Clinic, sounded a note of caution about the available data on vertebral augmentation.

First, he noted that one common method of reporting vertebral height restoration following vertebral augmentation invariably favored smaller restorations. For example, “if a 4-mm regression of the superior endplate is followed by a 3-mm restoration, one could say this 3 mm constituted a 75% vertebral height restoration,” he said. “Using this same method, if a 25-mm regression of the superior endplate is followed by a 5-mm elevation, this reporting method would assign a 20% vertebral height restoration.”

Journal editors should require disclosure of anterior, middle, and posterior heights when reporting height restoration “as the vertebrae may fail in the middle portion, and yet there may be no change in anterior height,” said Dr. McKiernan. “Without knowledge of all vertebral heights, claims of vertebral height restoration based [solely] on middle height may not be clinically relevant.”

He also said that one recent article touting the benefits of kyphoplasty cited two papers from his own research group. This citation was problematic because his group does not perform kyphoplasties, only vertebroplasties. In addition, the authors used his group's papers to make a point about vertebral compression fractures less than 4 weeks old, “and our average fracture age is four months,” Dr. McKiernan said. “The notion of less-than-4-week-old fractures appears nowhere in the text of either article.”

Panel members appeared to agree with some of Dr. McKiernan's points when it came to voting on the questions put before them. When asked to rate how well the evidence addresses vertebroplasty's effectiveness on a scale of 1–5—with 1 being “poor” and 5 being “very well”—the panel's average vote was 2.0. When asked about mortality data, the panel was particularly skeptical, giving it an average score of 1.5. Results of a vote on the evidence for kyphoplasty were similar.

“As the technology diffuses a lot more, and as patients expect this, a whole group of patients you wouldn't think of doing this on will receive it,” said panel member Alexander Krist, M.D., a family physician in Fairfax, Va. “There is [an unsystematic] process for figuring out who gets it and who doesn't. That would be my fear.

WASHINGTON — The new database on hospital quality from the Centers for Medicare and Medicaid Services may herald a new era in patient assertiveness in terms of health care preferences, several experts said at a briefing sponsored by the Alliance for Health Reform.

“We're beginning a change in how doctor-patient relations are established and [considering] how paternalistic they have been, I think we'll see major changes in the future where they become less that way,” said Elliot Sussman, M.D., president and CEO of Lehigh Valley Hospital and Health Network in Allentown, Pa. “When people come into a community, they'll look at measures like this and say, 'Which are the kinds of places I want to be cared for at, and who are doctors on staff at those places?'”

In fact, such changes have already begun to occur, he said. “We've seen experiences where people change their doctor relationship because 'I really like Dr. Jones, but he's not on the staff of what seems to be the best hospital. Either he does that or I'm going to find myself a new physician.'”

CMS launched its “Hospital Compare” database on April 1. Available at www.hospitalcompare.hhs.gov

Gerald M. Shea, assistant to the president for government affairs at the AFL-CIO, said that the feeling of partnership that comes from empowering consumers should spill over onto the physician side of the equation. “I could make the argument that there are very serious limits to how much consumers can drive change in the health decision making process,” he said. “An equally fruitful strategy would be trying to change the preparation and education of physicians, so they come to this suggesting that a partnership would be a good idea.”

In fact, physicians also have much to gain from being able to access hospital quality data, said Margaret E. O'Kane, president of the National Committee for Quality Assurance.

“Physicians have been working in an information vacuum as well—both doctors involved in performing particular procedures in the hospital, and the primary care physicians who are making referrals to specialists,” she said.

“We can't underestimate the impact that transparency has on changing everything. I feel very optimistic this will lead to lot of positive changes.” Ms. O'Kane commented.

One panelist warned that empowerment does have its limits. Charles N. “Chip” Kahn, president of the Federation of American Hospitals, said that as databases such as Hospital Compare begin adding more measures, “it will be more and more difficult for the average consumer … to figure things out other than, 'This is either an okay place or a dreadful place' and you obviously want to stay away from dreadful places.”

In the end, he said, databases like this “are more about using accountability to improve care than they are about consumers making more decisions.”

Ms. O'Kane said she was confident that “intermediaries” would rise up to help consumers interpret the database information. And she also had a prediction.

“What we've seen so far is not hospitals that are excellent at everything or terrible at everything, but hospitals that are excellent at one thing and maybe not so great at others. “As process engineering becomes more core to the hospitals, you'll see hospitals that will break out and be excellent across the board.

WASHINGTON — The new database on hospital quality from the Centers for Medicare and Medicaid Services may herald a new era in patient assertiveness in terms of health care preferences, several experts said at a briefing sponsored by the Alliance for Health Reform.

“We're beginning a change in how doctor-patient relations are established and [considering] how paternalistic they have been, I think we'll see major changes in the future where they become less that way,” said Elliot Sussman, M.D., president and CEO of Lehigh Valley Hospital and Health Network in Allentown, Pa. “When people come into a community, they'll look at measures like this and say, 'Which are the kinds of places I want to be cared for at, and who are doctors on staff at those places?'”

In fact, such changes have already begun to occur, he said. “We've seen experiences where people change their doctor relationship because 'I really like Dr. Jones, but he's not on the staff of what seems to be the best hospital. Either he does that or I'm going to find myself a new physician.'”

CMS launched its “Hospital Compare” database on April 1. Available at www.hospitalcompare.hhs.gov

Gerald M. Shea, assistant to the president for government affairs at the AFL-CIO, said that the feeling of partnership that comes from empowering consumers should spill over onto the physician side of the equation. “I could make the argument that there are very serious limits to how much consumers can drive change in the health decision making process,” he said. “An equally fruitful strategy would be trying to change the preparation and education of physicians, so they come to this suggesting that a partnership would be a good idea.”

In fact, physicians also have much to gain from being able to access hospital quality data, said Margaret E. O'Kane, president of the National Committee for Quality Assurance.

“Physicians have been working in an information vacuum as well—both doctors involved in performing particular procedures in the hospital, and the primary care physicians who are making referrals to specialists,” she said.

“We can't underestimate the impact that transparency has on changing everything. I feel very optimistic this will lead to lot of positive changes.” Ms. O'Kane commented.

One panelist warned that empowerment does have its limits. Charles N. “Chip” Kahn, president of the Federation of American Hospitals, said that as databases such as Hospital Compare begin adding more measures, “it will be more and more difficult for the average consumer … to figure things out other than, 'This is either an okay place or a dreadful place' and you obviously want to stay away from dreadful places.”

In the end, he said, databases like this “are more about using accountability to improve care than they are about consumers making more decisions.”

Ms. O'Kane said she was confident that “intermediaries” would rise up to help consumers interpret the database information. And she also had a prediction.

“What we've seen so far is not hospitals that are excellent at everything or terrible at everything, but hospitals that are excellent at one thing and maybe not so great at others. “As process engineering becomes more core to the hospitals, you'll see hospitals that will break out and be excellent across the board.

WASHINGTON — The new database on hospital quality from the Centers for Medicare and Medicaid Services may herald a new era in patient assertiveness in terms of health care preferences, several experts said at a briefing sponsored by the Alliance for Health Reform.

“We're beginning a change in how doctor-patient relations are established and [considering] how paternalistic they have been, I think we'll see major changes in the future where they become less that way,” said Elliot Sussman, M.D., president and CEO of Lehigh Valley Hospital and Health Network in Allentown, Pa. “When people come into a community, they'll look at measures like this and say, 'Which are the kinds of places I want to be cared for at, and who are doctors on staff at those places?'”

In fact, such changes have already begun to occur, he said. “We've seen experiences where people change their doctor relationship because 'I really like Dr. Jones, but he's not on the staff of what seems to be the best hospital. Either he does that or I'm going to find myself a new physician.'”

CMS launched its “Hospital Compare” database on April 1. Available at www.hospitalcompare.hhs.gov

Gerald M. Shea, assistant to the president for government affairs at the AFL-CIO, said that the feeling of partnership that comes from empowering consumers should spill over onto the physician side of the equation. “I could make the argument that there are very serious limits to how much consumers can drive change in the health decision making process,” he said. “An equally fruitful strategy would be trying to change the preparation and education of physicians, so they come to this suggesting that a partnership would be a good idea.”

In fact, physicians also have much to gain from being able to access hospital quality data, said Margaret E. O'Kane, president of the National Committee for Quality Assurance.

“Physicians have been working in an information vacuum as well—both doctors involved in performing particular procedures in the hospital, and the primary care physicians who are making referrals to specialists,” she said.

“We can't underestimate the impact that transparency has on changing everything. I feel very optimistic this will lead to lot of positive changes.” Ms. O'Kane commented.

One panelist warned that empowerment does have its limits. Charles N. “Chip” Kahn, president of the Federation of American Hospitals, said that as databases such as Hospital Compare begin adding more measures, “it will be more and more difficult for the average consumer … to figure things out other than, 'This is either an okay place or a dreadful place' and you obviously want to stay away from dreadful places.”

In the end, he said, databases like this “are more about using accountability to improve care than they are about consumers making more decisions.”

Ms. O'Kane said she was confident that “intermediaries” would rise up to help consumers interpret the database information. And she also had a prediction.

“What we've seen so far is not hospitals that are excellent at everything or terrible at everything, but hospitals that are excellent at one thing and maybe not so great at others. “As process engineering becomes more core to the hospitals, you'll see hospitals that will break out and be excellent across the board.

As the public focuses on problems with the safety and cost of prescription drugs, insurers are training their sights on a different cost issue: imaging procedures.

On average, costs of imaging—especially high-tech procedures, such as MRI, CT, and magnetic resonance angiograms—have been going up 20% a year for the last several years, according to Thomas Dehn, M.D., cofounder of National Imaging Associates, a radiology utilization-management firm in Hackensack, N.J.

“Some will say it's the aging of the population, but the key issue is really demand,” said Dr. Dehn, the company's executive vice president and chief medical officer. “Patients are bright. They're good consumers. They want a shoulder MRI if their shoulder hurts.”

Physician demand is also an important part of the equation, he said. “If you have physicians who want increased [patient volume] in their offices, it is possible that rather than spending cognitive time, for which they're poorly reimbursed, they may choose to use a technical alternative.”

For example, a doctor trying to figure out the source of a patient's chronic headaches “may get frustrated and refer the patient for an MRI of the brain, just to show them they're normal,” Dr. Dehn said. “The treating physician knows in the back of his mind that there isn't going to be anything [there], but it will calm the patient down.”

As to which physicians are responsible for the increase in imaging, the answer depends on whom you ask. The American College of Radiology contends that the growth is largely due to self-referral by nonradiologists who have bought their own imaging equipment. But others say that all specialties are doing more imaging, largely because of improved technology and the improvement in care that it brings.

Whatever the reason that more scans are being done, insurers have decided they've had enough. Take Highmark Blue Cross and Blue Shield, a Pittsburgh-based insurer whose imaging costs have risen to $500 million annually in the last few years.

One Highmark strategy for paring down its imaging costs is to shrink their network of imaging providers. To be included in Highmark's network, outpatient imaging centers must now offer multiple imaging modalities, such as mammography, MRIs, CTs, and bone densitometry.

“We were seeing many facilities that were single modality—just CT or just MRI,” said Cary Vinson, M.D., Highmark's vice president of quality and medical performance management. “They were being set up by for-profit companies to siphon away high-margin procedures from hospitals and other multimodality freestanding facilities. We were seeing access problems for referring physicians because the single modality centers were outcompeting the multimodality centers, and they couldn't keep up.”

In addition to credentialing the imaging centers, Highmark is going to start requiring providers to preauthorize all CT, MRI, and PET scans. At first, while everyone adapts to the new system, the preauthorization procedure will be voluntary and no procedures will be denied. But eventually—perhaps by the end of this year—the preauthorization will become mandatory, Dr. Vinson said.

Harvard Pilgrim Health Care (HPHC) of Wellesley, Mass., is taking a slightly different approach. Instead of mandatory preauthorization, HPHC is using a “soft denial” process in which physicians must call for imaging preauthorization, but they can overrule a negative decision if they want to.

“We made a decision based on our network being a very sophisticated, highly academic referral environment, that a hard denial program might not be the best way to go,” said William Corwin, M.D., the plan's medical director for utilization management and clinical policy. “Instead, we elected to use a more consultative approach.” The program started in July, so no concrete results are available yet, he noted.

Plans that start a preauthorization program must first figure out who should be authorized to perform scans. At Highmark, the plan tried to be as inclusive as possible, Dr. Vinson said.

“In some cases within a specialty, we tried to determine who was qualified and who was not,” he said. “For instance, for breast ultrasound, we listed radiologists, but we also included surgeons with breast ultrasound certification from the American Society of Breast Surgeons.”

Highmark ran into a turf battle as it tried to credential providers. In this case, the American College of Cardiology and the American College of Radiology “definitely have differences of opinion about who's qualified and who's not” when it comes to cardiology-related imaging exams, Dr. Vinson said. “Highmark took the approach of accepting either society's qualifications. They clearly wanted us to decide between the two, and we would not do that.”

To design their preauthorization programs, both Highmark and Harvard Pilgrim worked with National Imaging Associates, which now has “more than two dozen” clients nationwide and is active in 32 states, according to Dr. Dehn.

He predicts that at least one more specialty will come into the picture, as more and more molecular imaging is being done to design tumor-specific antibodies. “You may have immunologists who are doing diagnostic imaging,” he said.

As the public focuses on problems with the safety and cost of prescription drugs, insurers are training their sights on a different cost issue: imaging procedures.

On average, costs of imaging—especially high-tech procedures, such as MRI, CT, and magnetic resonance angiograms—have been going up 20% a year for the last several years, according to Thomas Dehn, M.D., cofounder of National Imaging Associates, a radiology utilization-management firm in Hackensack, N.J.

“Some will say it's the aging of the population, but the key issue is really demand,” said Dr. Dehn, the company's executive vice president and chief medical officer. “Patients are bright. They're good consumers. They want a shoulder MRI if their shoulder hurts.”

Physician demand is also an important part of the equation, he said. “If you have physicians who want increased [patient volume] in their offices, it is possible that rather than spending cognitive time, for which they're poorly reimbursed, they may choose to use a technical alternative.”

For example, a doctor trying to figure out the source of a patient's chronic headaches “may get frustrated and refer the patient for an MRI of the brain, just to show them they're normal,” Dr. Dehn said. “The treating physician knows in the back of his mind that there isn't going to be anything [there], but it will calm the patient down.”

As to which physicians are responsible for the increase in imaging, the answer depends on whom you ask. The American College of Radiology contends that the growth is largely due to self-referral by nonradiologists who have bought their own imaging equipment. But others say that all specialties are doing more imaging, largely because of improved technology and the improvement in care that it brings.

Whatever the reason that more scans are being done, insurers have decided they've had enough. Take Highmark Blue Cross and Blue Shield, a Pittsburgh-based insurer whose imaging costs have risen to $500 million annually in the last few years.

One Highmark strategy for paring down its imaging costs is to shrink their network of imaging providers. To be included in Highmark's network, outpatient imaging centers must now offer multiple imaging modalities, such as mammography, MRIs, CTs, and bone densitometry.

“We were seeing many facilities that were single modality—just CT or just MRI,” said Cary Vinson, M.D., Highmark's vice president of quality and medical performance management. “They were being set up by for-profit companies to siphon away high-margin procedures from hospitals and other multimodality freestanding facilities. We were seeing access problems for referring physicians because the single modality centers were outcompeting the multimodality centers, and they couldn't keep up.”

In addition to credentialing the imaging centers, Highmark is going to start requiring providers to preauthorize all CT, MRI, and PET scans. At first, while everyone adapts to the new system, the preauthorization procedure will be voluntary and no procedures will be denied. But eventually—perhaps by the end of this year—the preauthorization will become mandatory, Dr. Vinson said.

Harvard Pilgrim Health Care (HPHC) of Wellesley, Mass., is taking a slightly different approach. Instead of mandatory preauthorization, HPHC is using a “soft denial” process in which physicians must call for imaging preauthorization, but they can overrule a negative decision if they want to.

“We made a decision based on our network being a very sophisticated, highly academic referral environment, that a hard denial program might not be the best way to go,” said William Corwin, M.D., the plan's medical director for utilization management and clinical policy. “Instead, we elected to use a more consultative approach.” The program started in July, so no concrete results are available yet, he noted.

Plans that start a preauthorization program must first figure out who should be authorized to perform scans. At Highmark, the plan tried to be as inclusive as possible, Dr. Vinson said.

“In some cases within a specialty, we tried to determine who was qualified and who was not,” he said. “For instance, for breast ultrasound, we listed radiologists, but we also included surgeons with breast ultrasound certification from the American Society of Breast Surgeons.”

Highmark ran into a turf battle as it tried to credential providers. In this case, the American College of Cardiology and the American College of Radiology “definitely have differences of opinion about who's qualified and who's not” when it comes to cardiology-related imaging exams, Dr. Vinson said. “Highmark took the approach of accepting either society's qualifications. They clearly wanted us to decide between the two, and we would not do that.”

To design their preauthorization programs, both Highmark and Harvard Pilgrim worked with National Imaging Associates, which now has “more than two dozen” clients nationwide and is active in 32 states, according to Dr. Dehn.

He predicts that at least one more specialty will come into the picture, as more and more molecular imaging is being done to design tumor-specific antibodies. “You may have immunologists who are doing diagnostic imaging,” he said.

As the public focuses on problems with the safety and cost of prescription drugs, insurers are training their sights on a different cost issue: imaging procedures.

On average, costs of imaging—especially high-tech procedures, such as MRI, CT, and magnetic resonance angiograms—have been going up 20% a year for the last several years, according to Thomas Dehn, M.D., cofounder of National Imaging Associates, a radiology utilization-management firm in Hackensack, N.J.

“Some will say it's the aging of the population, but the key issue is really demand,” said Dr. Dehn, the company's executive vice president and chief medical officer. “Patients are bright. They're good consumers. They want a shoulder MRI if their shoulder hurts.”

Physician demand is also an important part of the equation, he said. “If you have physicians who want increased [patient volume] in their offices, it is possible that rather than spending cognitive time, for which they're poorly reimbursed, they may choose to use a technical alternative.”

For example, a doctor trying to figure out the source of a patient's chronic headaches “may get frustrated and refer the patient for an MRI of the brain, just to show them they're normal,” Dr. Dehn said. “The treating physician knows in the back of his mind that there isn't going to be anything [there], but it will calm the patient down.”

As to which physicians are responsible for the increase in imaging, the answer depends on whom you ask. The American College of Radiology contends that the growth is largely due to self-referral by nonradiologists who have bought their own imaging equipment. But others say that all specialties are doing more imaging, largely because of improved technology and the improvement in care that it brings.

Whatever the reason that more scans are being done, insurers have decided they've had enough. Take Highmark Blue Cross and Blue Shield, a Pittsburgh-based insurer whose imaging costs have risen to $500 million annually in the last few years.

One Highmark strategy for paring down its imaging costs is to shrink their network of imaging providers. To be included in Highmark's network, outpatient imaging centers must now offer multiple imaging modalities, such as mammography, MRIs, CTs, and bone densitometry.

“We were seeing many facilities that were single modality—just CT or just MRI,” said Cary Vinson, M.D., Highmark's vice president of quality and medical performance management. “They were being set up by for-profit companies to siphon away high-margin procedures from hospitals and other multimodality freestanding facilities. We were seeing access problems for referring physicians because the single modality centers were outcompeting the multimodality centers, and they couldn't keep up.”

In addition to credentialing the imaging centers, Highmark is going to start requiring providers to preauthorize all CT, MRI, and PET scans. At first, while everyone adapts to the new system, the preauthorization procedure will be voluntary and no procedures will be denied. But eventually—perhaps by the end of this year—the preauthorization will become mandatory, Dr. Vinson said.

Harvard Pilgrim Health Care (HPHC) of Wellesley, Mass., is taking a slightly different approach. Instead of mandatory preauthorization, HPHC is using a “soft denial” process in which physicians must call for imaging preauthorization, but they can overrule a negative decision if they want to.

“We made a decision based on our network being a very sophisticated, highly academic referral environment, that a hard denial program might not be the best way to go,” said William Corwin, M.D., the plan's medical director for utilization management and clinical policy. “Instead, we elected to use a more consultative approach.” The program started in July, so no concrete results are available yet, he noted.

Plans that start a preauthorization program must first figure out who should be authorized to perform scans. At Highmark, the plan tried to be as inclusive as possible, Dr. Vinson said.

“In some cases within a specialty, we tried to determine who was qualified and who was not,” he said. “For instance, for breast ultrasound, we listed radiologists, but we also included surgeons with breast ultrasound certification from the American Society of Breast Surgeons.”

Highmark ran into a turf battle as it tried to credential providers. In this case, the American College of Cardiology and the American College of Radiology “definitely have differences of opinion about who's qualified and who's not” when it comes to cardiology-related imaging exams, Dr. Vinson said. “Highmark took the approach of accepting either society's qualifications. They clearly wanted us to decide between the two, and we would not do that.”

To design their preauthorization programs, both Highmark and Harvard Pilgrim worked with National Imaging Associates, which now has “more than two dozen” clients nationwide and is active in 32 states, according to Dr. Dehn.

He predicts that at least one more specialty will come into the picture, as more and more molecular imaging is being done to design tumor-specific antibodies. “You may have immunologists who are doing diagnostic imaging,” he said.

WASHINGTON — It doesn't surprise most physicians to hear that populations in certain cities—especially cities with a high percentage of minorities—have higher rates of chronic disease. But small-area analysis can help pinpoint exactly which areas of a city suffer from a higher disease burden, Robert Bonow, M.D., said.

For example, Dallas is a complicated area when it comes to cardiovascular mortality, said Dr. Bonow at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

He and Sean Cleary, Ph.D., associate professor of epidemiology and statistics at George Washington University, Washington, performed small-area analysis on the city using data from state Vital Statistics offices and the 2000 U.S. Census. The study showed that there are disparities in mortality from cardiovascular disease not only between minority and nonminority populations, but also within minority neighborhoods themselves.

The question is, Why would that be true? “Is one area more Hispanic, and one area more African American?” asked Dr. Bonow chief of the division of cardiology at Northwestern Memorial Hospital, in Evanston, Ill. Of course, there could be other factors driving differences in mortality, such as differing opportunities for exercise, lesser or greater availability of fresh fruits and vegetables, or more fast-food restaurants in one community than in another, he added.

Dr. Bonow noted that the maps produced by small-area analysis could be a lobbying tool for health care advocates. “Imagine walking into [a Congressman's office] with a map showing that minority areas in his district have very high rates of cardiovascular disease,” he said. And if the analysis also found that there were very few neighborhood health centers in the area, advocates could argue that services are not being offered where they are needed.

Dr. Bonow hopes to eventually get data for all the Zip codes in the United States. “The results hopefully will inform community-based intervention and treatment programs targeting higher-risk uninsured areas,” he said.

WASHINGTON — It doesn't surprise most physicians to hear that populations in certain cities—especially cities with a high percentage of minorities—have higher rates of chronic disease. But small-area analysis can help pinpoint exactly which areas of a city suffer from a higher disease burden, Robert Bonow, M.D., said.

For example, Dallas is a complicated area when it comes to cardiovascular mortality, said Dr. Bonow at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

He and Sean Cleary, Ph.D., associate professor of epidemiology and statistics at George Washington University, Washington, performed small-area analysis on the city using data from state Vital Statistics offices and the 2000 U.S. Census. The study showed that there are disparities in mortality from cardiovascular disease not only between minority and nonminority populations, but also within minority neighborhoods themselves.

The question is, Why would that be true? “Is one area more Hispanic, and one area more African American?” asked Dr. Bonow chief of the division of cardiology at Northwestern Memorial Hospital, in Evanston, Ill. Of course, there could be other factors driving differences in mortality, such as differing opportunities for exercise, lesser or greater availability of fresh fruits and vegetables, or more fast-food restaurants in one community than in another, he added.

Dr. Bonow noted that the maps produced by small-area analysis could be a lobbying tool for health care advocates. “Imagine walking into [a Congressman's office] with a map showing that minority areas in his district have very high rates of cardiovascular disease,” he said. And if the analysis also found that there were very few neighborhood health centers in the area, advocates could argue that services are not being offered where they are needed.

Dr. Bonow hopes to eventually get data for all the Zip codes in the United States. “The results hopefully will inform community-based intervention and treatment programs targeting higher-risk uninsured areas,” he said.

WASHINGTON — It doesn't surprise most physicians to hear that populations in certain cities—especially cities with a high percentage of minorities—have higher rates of chronic disease. But small-area analysis can help pinpoint exactly which areas of a city suffer from a higher disease burden, Robert Bonow, M.D., said.

For example, Dallas is a complicated area when it comes to cardiovascular mortality, said Dr. Bonow at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

He and Sean Cleary, Ph.D., associate professor of epidemiology and statistics at George Washington University, Washington, performed small-area analysis on the city using data from state Vital Statistics offices and the 2000 U.S. Census. The study showed that there are disparities in mortality from cardiovascular disease not only between minority and nonminority populations, but also within minority neighborhoods themselves.

The question is, Why would that be true? “Is one area more Hispanic, and one area more African American?” asked Dr. Bonow chief of the division of cardiology at Northwestern Memorial Hospital, in Evanston, Ill. Of course, there could be other factors driving differences in mortality, such as differing opportunities for exercise, lesser or greater availability of fresh fruits and vegetables, or more fast-food restaurants in one community than in another, he added.

Dr. Bonow noted that the maps produced by small-area analysis could be a lobbying tool for health care advocates. “Imagine walking into [a Congressman's office] with a map showing that minority areas in his district have very high rates of cardiovascular disease,” he said. And if the analysis also found that there were very few neighborhood health centers in the area, advocates could argue that services are not being offered where they are needed.

Dr. Bonow hopes to eventually get data for all the Zip codes in the United States. “The results hopefully will inform community-based intervention and treatment programs targeting higher-risk uninsured areas,” he said.

WASHINGTON — Improving health information technology could go a long way toward eliminating disparities in health care, Newt Gingrich said at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

“The challenge is not to be futurist but to bring health care up to the world of the last 20 years,” said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.

He criticized a recently adopted Florida law that requires physicians to print legibly when they write prescriptions. “First, it's a fantasy to think legislation will convince doctors to print legibly. Secondly, it's the wrong direction for change,” he said. “Even a clearly printed prescription remains a paper prescription and misses all the opportunities for checking medication errors, checking other medications, and seeing if there are contraindications. In the long run, the future is an electronic prescription with an expert system to make sure you get the right medication.”

People will need to think more creatively, he continued. Imagine doing emergency diagnostics by cell phone camera.

At the same time, the health care industry needs to find better ways to standardize itself and to disperse information about best practices in medicine, Mr. Gingrich continued. “It can take 17 years for a best practice to reach the average doctor,” he said. “We want to set a standard and migrate everybody to that standard.”

He gave an example of how electronic health records could improve the standard of care. “A friend's father went in for an MRI, and her mother went in with him. They filled out five paper forms before the MRI. The mother happened to go into the doctor's office as they were preparing to do the MRI, and she said, 'You did know he has a pacemaker?' They stopped right there.”

But if the patient had had an electronic health record, “that would have been obvious and automatic, and the expert system would check against it,” he said, noting that his center is trying to develop “a 21st-century intelligent health system which we believe will end health disparities in America in terms of the delivery of services.”

However, such a system would not improve disparities based on culture or ethnicity unless certain problems are addressed, he continued. For example, “diabetes is largely a cultural issue. How you treat diabetes is a medical issue, but how you avoid diabetes is a cultural issue.”

Since obesity plays a part in the development of diabetes, he urged audience members to push their home states to institute mandatory, 1-hour daily physical education in public schools and also to ban unhealthy foods from the schools. States that don't do these things “are not serious about obesity in children,” he said.

After electronic health records are in place in hospitals and physicians' offices, the next step should be a “Personal Health Knowledge System,” Mr. Gingrich continued. The system would be accessible to patients online and would contain genetic profiles that might tell patients such things as whether they have a particular genetic makeup that puts them in the 10% of people who should not eat too many high-fiber foods because doing so could trigger colon cancer, he said.

“You should actually know your DNA before you go grocery shopping,” he said. “Within a decade, we'll have an expert system where you'll be able to punch in your health status and it will print out a grocery list.”

In fact, food purchases also can be used as an incentive: “If you want to truly help health disparities among the poor, you may want to give bonus points if you use food stamps for the right foods,” Mr. Gingrich said. “That sounds like micromanagement, but we've got to be practical about how to shift behavior patterns when people are used to eating food that kills them.”

An intelligent computer system also could help people maintain their health in other ways, he added. “An intelligent system would tell you your health status, including weight, blood pressure, and blood sugar. And maybe it can be tied to your cell phone so it can remind you six times a day that you need to take a pill or check your blood sugar. We need to get people into a system that's supportive.”

WASHINGTON — Improving health information technology could go a long way toward eliminating disparities in health care, Newt Gingrich said at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

“The challenge is not to be futurist but to bring health care up to the world of the last 20 years,” said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.

He criticized a recently adopted Florida law that requires physicians to print legibly when they write prescriptions. “First, it's a fantasy to think legislation will convince doctors to print legibly. Secondly, it's the wrong direction for change,” he said. “Even a clearly printed prescription remains a paper prescription and misses all the opportunities for checking medication errors, checking other medications, and seeing if there are contraindications. In the long run, the future is an electronic prescription with an expert system to make sure you get the right medication.”

People will need to think more creatively, he continued. Imagine doing emergency diagnostics by cell phone camera.

At the same time, the health care industry needs to find better ways to standardize itself and to disperse information about best practices in medicine, Mr. Gingrich continued. “It can take 17 years for a best practice to reach the average doctor,” he said. “We want to set a standard and migrate everybody to that standard.”

He gave an example of how electronic health records could improve the standard of care. “A friend's father went in for an MRI, and her mother went in with him. They filled out five paper forms before the MRI. The mother happened to go into the doctor's office as they were preparing to do the MRI, and she said, 'You did know he has a pacemaker?' They stopped right there.”

But if the patient had had an electronic health record, “that would have been obvious and automatic, and the expert system would check against it,” he said, noting that his center is trying to develop “a 21st-century intelligent health system which we believe will end health disparities in America in terms of the delivery of services.”

However, such a system would not improve disparities based on culture or ethnicity unless certain problems are addressed, he continued. For example, “diabetes is largely a cultural issue. How you treat diabetes is a medical issue, but how you avoid diabetes is a cultural issue.”

Since obesity plays a part in the development of diabetes, he urged audience members to push their home states to institute mandatory, 1-hour daily physical education in public schools and also to ban unhealthy foods from the schools. States that don't do these things “are not serious about obesity in children,” he said.

After electronic health records are in place in hospitals and physicians' offices, the next step should be a “Personal Health Knowledge System,” Mr. Gingrich continued. The system would be accessible to patients online and would contain genetic profiles that might tell patients such things as whether they have a particular genetic makeup that puts them in the 10% of people who should not eat too many high-fiber foods because doing so could trigger colon cancer, he said.

“You should actually know your DNA before you go grocery shopping,” he said. “Within a decade, we'll have an expert system where you'll be able to punch in your health status and it will print out a grocery list.”

In fact, food purchases also can be used as an incentive: “If you want to truly help health disparities among the poor, you may want to give bonus points if you use food stamps for the right foods,” Mr. Gingrich said. “That sounds like micromanagement, but we've got to be practical about how to shift behavior patterns when people are used to eating food that kills them.”

An intelligent computer system also could help people maintain their health in other ways, he added. “An intelligent system would tell you your health status, including weight, blood pressure, and blood sugar. And maybe it can be tied to your cell phone so it can remind you six times a day that you need to take a pill or check your blood sugar. We need to get people into a system that's supportive.”

WASHINGTON — Improving health information technology could go a long way toward eliminating disparities in health care, Newt Gingrich said at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

“The challenge is not to be futurist but to bring health care up to the world of the last 20 years,” said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.

He criticized a recently adopted Florida law that requires physicians to print legibly when they write prescriptions. “First, it's a fantasy to think legislation will convince doctors to print legibly. Secondly, it's the wrong direction for change,” he said. “Even a clearly printed prescription remains a paper prescription and misses all the opportunities for checking medication errors, checking other medications, and seeing if there are contraindications. In the long run, the future is an electronic prescription with an expert system to make sure you get the right medication.”

People will need to think more creatively, he continued. Imagine doing emergency diagnostics by cell phone camera.

At the same time, the health care industry needs to find better ways to standardize itself and to disperse information about best practices in medicine, Mr. Gingrich continued. “It can take 17 years for a best practice to reach the average doctor,” he said. “We want to set a standard and migrate everybody to that standard.”

He gave an example of how electronic health records could improve the standard of care. “A friend's father went in for an MRI, and her mother went in with him. They filled out five paper forms before the MRI. The mother happened to go into the doctor's office as they were preparing to do the MRI, and she said, 'You did know he has a pacemaker?' They stopped right there.”

But if the patient had had an electronic health record, “that would have been obvious and automatic, and the expert system would check against it,” he said, noting that his center is trying to develop “a 21st-century intelligent health system which we believe will end health disparities in America in terms of the delivery of services.”

However, such a system would not improve disparities based on culture or ethnicity unless certain problems are addressed, he continued. For example, “diabetes is largely a cultural issue. How you treat diabetes is a medical issue, but how you avoid diabetes is a cultural issue.”

Since obesity plays a part in the development of diabetes, he urged audience members to push their home states to institute mandatory, 1-hour daily physical education in public schools and also to ban unhealthy foods from the schools. States that don't do these things “are not serious about obesity in children,” he said.

After electronic health records are in place in hospitals and physicians' offices, the next step should be a “Personal Health Knowledge System,” Mr. Gingrich continued. The system would be accessible to patients online and would contain genetic profiles that might tell patients such things as whether they have a particular genetic makeup that puts them in the 10% of people who should not eat too many high-fiber foods because doing so could trigger colon cancer, he said.

“You should actually know your DNA before you go grocery shopping,” he said. “Within a decade, we'll have an expert system where you'll be able to punch in your health status and it will print out a grocery list.”

In fact, food purchases also can be used as an incentive: “If you want to truly help health disparities among the poor, you may want to give bonus points if you use food stamps for the right foods,” Mr. Gingrich said. “That sounds like micromanagement, but we've got to be practical about how to shift behavior patterns when people are used to eating food that kills them.”

An intelligent computer system also could help people maintain their health in other ways, he added. “An intelligent system would tell you your health status, including weight, blood pressure, and blood sugar. And maybe it can be tied to your cell phone so it can remind you six times a day that you need to take a pill or check your blood sugar. We need to get people into a system that's supportive.”

BALTIMORE — Although some local carriers already cover vertebral augmentation through vertebroplasty or kyphoplasty, the Centers for Medicare and Medicaid Services does not intend to consider a national coverage policy for the procedures, especially given the lack of solid data available, Stephen Phurrough, M.D., said at a meeting of the Medicare Coverage Advisory Committee.

“We have no open national coverage determination, and we have no plans to open a national coverage determination,” said Dr. Phurrough, who is head of Medicare's coverage and analysis group.

The group does plan to “produce some type of guidance document that may distill what we think about this particular field of spinal disease,” he said. That document will then be made available for comment.

Dr. Phurrough's remarks came after a day of mostly favorable testimony on vertebral augmentation. “We are showing that these patients are better, and we're making a difference in their pain,” said Isador H. Lieberman, M.D., a surgeon at the Cleveland Clinic Foundation.

Dr. Lieberman and colleagues performed a prospective controlled trial on 329 vertebral augmentation patients, 70% of whom had osteoporosis. Duration of symptoms prior to the procedure was 1 week to 5 years, mean follow-up was 55 weeks, and the average hospital stay was 1.1 days.

The researchers found that the vertebral augmentation patients showed a “statistically significant improvement in bodily pain, mental health, physical function, social function, and vitality,” compared with the controls, said Dr. Lieberman, who serves as a consultant to several companies that make surgical equipment for vertebral augmentation. “Overall, these patients do well with this intervention.”

Dr. Lieberman gave several reasons why no randomized controlled trials had been done on the benefits of one procedure vs. the other. “I've been involved in five attempts. To sum it up, it's lack of collaboration—we have not been able to get various factions to decide on how to do the study or whether to participate,” he said.

There are also study design and institutional review board (IRB) issues. “One study I was potentially involved in demanded a sham procedure; my IRB would not let me do a sham procedure,” he said. Getting funding for the study also is a problem.

But probably the most important problem is recruitment. “We're dealing with an elderly population who don't have time or patience to come back for all these follow-ups or fill out all this paperwork,” Dr. Lieberman said.

Kevin McGraw, M.D., a Columbus, Ohio radiologist, testified that conservative treatment of vertebral factures—usually bed rest—is not without its risks.

“During bed rest, virtually every organ system is adversely affected,” said Dr. McGraw, who testified on behalf of the Society of Interventional Radiology. “Bone density declines about 2% per week, and muscle strength declines about 10%–15% per week. Nearly half of normal strength is lost during the first 3–4 weeks of bed rest.”

Other serious consequences of bed rest include pressure sores, deep vein thrombosis, and pulmonary emboli, he continued. “If we subject patients to 6 weeks of bed rest, they've lost 12% of bone density and half of their muscle strength, they have developed a decubitus ulcer, and they have a 10% chance of a pulmonary embolism. The Society of Interventional Radiology believes that since vertebroplasty results in early mobilization, it is superior to conservative treatment.”

Fergus McKiernan, M.D., of the Center for Bone Diseases at the Marshfield (Wisc.) Clinic, sounded a note of caution about the available data on vertebral augmentation.

First, he noted that one common method of reporting vertebral height restoration following vertebral augmentation invariably favored smaller restorations. For example, “if a 4-mm regression of the superior endplate is followed by a 3-mm restoration, one could say this 3 mm constituted a 75% vertebral height restoration,” he said. “Using this same method, if a 25-mm regression of the superior endplate is followed by a 5-mm elevation, this reporting method would assign a 20% vertebral height restoration.”

Journal editors should require disclosure of anterior, middle, and posterior heights, “as the vertebrae may fail in the middle portion, and yet there may be no change in anterior height,” said Dr. McKiernan. “Without knowledge of all vertebral heights, claims of vertebral height restoration based [solely] on middle height may not be clinically relevant.”

He also said that one recent article touting the benefits of kyphoplasty cited two papers from his own research group. This citation was problematic because his group does not perform kyphoplasties, only vertebroplasties. In addition, the authors used his group's papers to make a point about vertebral compression fractures less than 4 weeks old, “and our average fracture age is 4 months,” Dr. McKiernan said. “The notion of less-than-4-week-old fractures appears nowhere in the text of either article.”

Panel members appeared to agree with some of Dr. McKiernan's points when it came to voting on the questions put before them. When asked to rate how well the evidence addresses vertebroplasty's effectiveness on a scale of 1–5—with 1 being “poor” and 5 being “very well”—the panel's average vote was 2.0. When asked about mortality data, the panel was particularly skeptical, giving it an average score of 1.5. Results of a vote on the evidence for kyphoplasty were similar.

“As patients expect this, a whole group of patients you wouldn't think of doing this on will receive it,” said panel member Alexander Krist, M.D., a family physician in Fairfax, Va. “There is [an unsystematic] process for figuring out who gets it and who doesn't. That would be my fear.”

BALTIMORE — Although some local carriers already cover vertebral augmentation through vertebroplasty or kyphoplasty, the Centers for Medicare and Medicaid Services does not intend to consider a national coverage policy for the procedures, especially given the lack of solid data available, Stephen Phurrough, M.D., said at a meeting of the Medicare Coverage Advisory Committee.

“We have no open national coverage determination, and we have no plans to open a national coverage determination,” said Dr. Phurrough, who is head of Medicare's coverage and analysis group.

The group does plan to “produce some type of guidance document that may distill what we think about this particular field of spinal disease,” he said. That document will then be made available for comment.

Dr. Phurrough's remarks came after a day of mostly favorable testimony on vertebral augmentation. “We are showing that these patients are better, and we're making a difference in their pain,” said Isador H. Lieberman, M.D., a surgeon at the Cleveland Clinic Foundation.

Dr. Lieberman and colleagues performed a prospective controlled trial on 329 vertebral augmentation patients, 70% of whom had osteoporosis. Duration of symptoms prior to the procedure was 1 week to 5 years, mean follow-up was 55 weeks, and the average hospital stay was 1.1 days.

The researchers found that the vertebral augmentation patients showed a “statistically significant improvement in bodily pain, mental health, physical function, social function, and vitality,” compared with the controls, said Dr. Lieberman, who serves as a consultant to several companies that make surgical equipment for vertebral augmentation. “Overall, these patients do well with this intervention.”

Dr. Lieberman gave several reasons why no randomized controlled trials had been done on the benefits of one procedure vs. the other. “I've been involved in five attempts. To sum it up, it's lack of collaboration—we have not been able to get various factions to decide on how to do the study or whether to participate,” he said.

There are also study design and institutional review board (IRB) issues. “One study I was potentially involved in demanded a sham procedure; my IRB would not let me do a sham procedure,” he said. Getting funding for the study also is a problem.

But probably the most important problem is recruitment. “We're dealing with an elderly population who don't have time or patience to come back for all these follow-ups or fill out all this paperwork,” Dr. Lieberman said.

Kevin McGraw, M.D., a Columbus, Ohio radiologist, testified that conservative treatment of vertebral factures—usually bed rest—is not without its risks.

“During bed rest, virtually every organ system is adversely affected,” said Dr. McGraw, who testified on behalf of the Society of Interventional Radiology. “Bone density declines about 2% per week, and muscle strength declines about 10%–15% per week. Nearly half of normal strength is lost during the first 3–4 weeks of bed rest.”

Other serious consequences of bed rest include pressure sores, deep vein thrombosis, and pulmonary emboli, he continued. “If we subject patients to 6 weeks of bed rest, they've lost 12% of bone density and half of their muscle strength, they have developed a decubitus ulcer, and they have a 10% chance of a pulmonary embolism. The Society of Interventional Radiology believes that since vertebroplasty results in early mobilization, it is superior to conservative treatment.”

Fergus McKiernan, M.D., of the Center for Bone Diseases at the Marshfield (Wisc.) Clinic, sounded a note of caution about the available data on vertebral augmentation.

First, he noted that one common method of reporting vertebral height restoration following vertebral augmentation invariably favored smaller restorations. For example, “if a 4-mm regression of the superior endplate is followed by a 3-mm restoration, one could say this 3 mm constituted a 75% vertebral height restoration,” he said. “Using this same method, if a 25-mm regression of the superior endplate is followed by a 5-mm elevation, this reporting method would assign a 20% vertebral height restoration.”

Journal editors should require disclosure of anterior, middle, and posterior heights, “as the vertebrae may fail in the middle portion, and yet there may be no change in anterior height,” said Dr. McKiernan. “Without knowledge of all vertebral heights, claims of vertebral height restoration based [solely] on middle height may not be clinically relevant.”

He also said that one recent article touting the benefits of kyphoplasty cited two papers from his own research group. This citation was problematic because his group does not perform kyphoplasties, only vertebroplasties. In addition, the authors used his group's papers to make a point about vertebral compression fractures less than 4 weeks old, “and our average fracture age is 4 months,” Dr. McKiernan said. “The notion of less-than-4-week-old fractures appears nowhere in the text of either article.”

Panel members appeared to agree with some of Dr. McKiernan's points when it came to voting on the questions put before them. When asked to rate how well the evidence addresses vertebroplasty's effectiveness on a scale of 1–5—with 1 being “poor” and 5 being “very well”—the panel's average vote was 2.0. When asked about mortality data, the panel was particularly skeptical, giving it an average score of 1.5. Results of a vote on the evidence for kyphoplasty were similar.

“As patients expect this, a whole group of patients you wouldn't think of doing this on will receive it,” said panel member Alexander Krist, M.D., a family physician in Fairfax, Va. “There is [an unsystematic] process for figuring out who gets it and who doesn't. That would be my fear.”

BALTIMORE — Although some local carriers already cover vertebral augmentation through vertebroplasty or kyphoplasty, the Centers for Medicare and Medicaid Services does not intend to consider a national coverage policy for the procedures, especially given the lack of solid data available, Stephen Phurrough, M.D., said at a meeting of the Medicare Coverage Advisory Committee.

“We have no open national coverage determination, and we have no plans to open a national coverage determination,” said Dr. Phurrough, who is head of Medicare's coverage and analysis group.

The group does plan to “produce some type of guidance document that may distill what we think about this particular field of spinal disease,” he said. That document will then be made available for comment.

Dr. Phurrough's remarks came after a day of mostly favorable testimony on vertebral augmentation. “We are showing that these patients are better, and we're making a difference in their pain,” said Isador H. Lieberman, M.D., a surgeon at the Cleveland Clinic Foundation.

Dr. Lieberman and colleagues performed a prospective controlled trial on 329 vertebral augmentation patients, 70% of whom had osteoporosis. Duration of symptoms prior to the procedure was 1 week to 5 years, mean follow-up was 55 weeks, and the average hospital stay was 1.1 days.

The researchers found that the vertebral augmentation patients showed a “statistically significant improvement in bodily pain, mental health, physical function, social function, and vitality,” compared with the controls, said Dr. Lieberman, who serves as a consultant to several companies that make surgical equipment for vertebral augmentation. “Overall, these patients do well with this intervention.”

Dr. Lieberman gave several reasons why no randomized controlled trials had been done on the benefits of one procedure vs. the other. “I've been involved in five attempts. To sum it up, it's lack of collaboration—we have not been able to get various factions to decide on how to do the study or whether to participate,” he said.

There are also study design and institutional review board (IRB) issues. “One study I was potentially involved in demanded a sham procedure; my IRB would not let me do a sham procedure,” he said. Getting funding for the study also is a problem.

But probably the most important problem is recruitment. “We're dealing with an elderly population who don't have time or patience to come back for all these follow-ups or fill out all this paperwork,” Dr. Lieberman said.

Kevin McGraw, M.D., a Columbus, Ohio radiologist, testified that conservative treatment of vertebral factures—usually bed rest—is not without its risks.

“During bed rest, virtually every organ system is adversely affected,” said Dr. McGraw, who testified on behalf of the Society of Interventional Radiology. “Bone density declines about 2% per week, and muscle strength declines about 10%–15% per week. Nearly half of normal strength is lost during the first 3–4 weeks of bed rest.”

Other serious consequences of bed rest include pressure sores, deep vein thrombosis, and pulmonary emboli, he continued. “If we subject patients to 6 weeks of bed rest, they've lost 12% of bone density and half of their muscle strength, they have developed a decubitus ulcer, and they have a 10% chance of a pulmonary embolism. The Society of Interventional Radiology believes that since vertebroplasty results in early mobilization, it is superior to conservative treatment.”

Fergus McKiernan, M.D., of the Center for Bone Diseases at the Marshfield (Wisc.) Clinic, sounded a note of caution about the available data on vertebral augmentation.

First, he noted that one common method of reporting vertebral height restoration following vertebral augmentation invariably favored smaller restorations. For example, “if a 4-mm regression of the superior endplate is followed by a 3-mm restoration, one could say this 3 mm constituted a 75% vertebral height restoration,” he said. “Using this same method, if a 25-mm regression of the superior endplate is followed by a 5-mm elevation, this reporting method would assign a 20% vertebral height restoration.”

Journal editors should require disclosure of anterior, middle, and posterior heights, “as the vertebrae may fail in the middle portion, and yet there may be no change in anterior height,” said Dr. McKiernan. “Without knowledge of all vertebral heights, claims of vertebral height restoration based [solely] on middle height may not be clinically relevant.”

He also said that one recent article touting the benefits of kyphoplasty cited two papers from his own research group. This citation was problematic because his group does not perform kyphoplasties, only vertebroplasties. In addition, the authors used his group's papers to make a point about vertebral compression fractures less than 4 weeks old, “and our average fracture age is 4 months,” Dr. McKiernan said. “The notion of less-than-4-week-old fractures appears nowhere in the text of either article.”

Panel members appeared to agree with some of Dr. McKiernan's points when it came to voting on the questions put before them. When asked to rate how well the evidence addresses vertebroplasty's effectiveness on a scale of 1–5—with 1 being “poor” and 5 being “very well”—the panel's average vote was 2.0. When asked about mortality data, the panel was particularly skeptical, giving it an average score of 1.5. Results of a vote on the evidence for kyphoplasty were similar.

“As patients expect this, a whole group of patients you wouldn't think of doing this on will receive it,” said panel member Alexander Krist, M.D., a family physician in Fairfax, Va. “There is [an unsystematic] process for figuring out who gets it and who doesn't. That would be my fear.”

WASHINGTON – Sen. Ron Wyden (D-Ore.) says the answer to America's health care problem does not lie with Congress–at least, not initially.

“I spent 2 years studying what went wrong in the Clinton debacle,” he said at a meeting sponsored by America's Health Insurance Plans.

Sen. Wyden was referring to the unsuccessful effort of President Bill Clinton and his wife, now-Sen. Hillary Rodham Clinton (D-N.Y.) to get Congress to pass health care reform in the 1990s.

The Oregon Democrat also took a look at a similar effort in the 1940s by President Harry S Truman.

Sen. Wyden's conclusion: “There is a remarkable parallel in 60 years of failure. … For 6 decades, the effort has involved trying to write a piece of federal legislation in Washington, D.C. [But] the special interests would attack the legislation and each other, and everything would fail.”

Instead, “I decided to go 180 degrees the other way,” he said. “We'll start it outside [Washington].”

A few months ago, Sen. Wyden, along with Sen. Orrin Hatch (R-Utah) and Comptroller General David Walker, announced the formation of the Citizens' Working Group on Health Care.

The group is made up of 14 people from across the country, including physicians, health advocates, hospital administrators, academicians, nurses, and a union representative. Health and Human Services Secretary Mike Leavitt will serve as the 15th member.

The group is one result of a new law known as the Health Care That Works for All Americans Act, which was cosponsored by the two senators.

One goal of the working group, according to Sen. Wyden, is “tell people where the $1.8 trillion spent on health care actually goes. … I think people will be pretty surprised.”

The information will be made available online as well as in booklets and in public libraries.

Another goal of the working group is to hold public hearings in an effort to get input on what should be done to reform the health care system.

“No one has walked the public through the choices and tradeoffs that come with a health care system that works for everybody,” he said.

“We're now going to have a real debate about how we create a system that works for everybody.”

After publishing the spending information and listening to public comment, the plan is for the working group to develop a set of tentative recommendations on a system that works for all Americans, Sen. Wyden said.

“When they have the tentative set of recommendations, they go back to the public again for another crack, so people will get to weigh in twice,” Sen. Wyden said.

Then the recommendations will go to Congress, and all committees with jurisdiction over health care will have to hold hearings within 60 days of receiving the recommendations.

Although there is no mandate for Congress to take any further action on the recommendations once it has held hearings, “you will have a citizens' road map of where the country feels we ought to be headed in health care, and if at that point the congressional committees decide they want to ignore what the citizens have to say, then it will be really clear who they're siding with–powerful Washington interests rather than the citizens,” he said.

Sen. Wyden gave a specific example of the type of issue he hopes the working group will address.

“We know that a big chunk of the health care dollar gets spent in the last few months of someone's life.

“And we know in many of those instances, the best doctors and hospitals can't do anything to increase the quality of the person's life, and they can't do anything that's medically effective,” he said.

“So the question for the country that the political leaders have been ducking–and that they aren't going to be able to duck any longer–is, in those kinds of instances, do we want to start spending more money on hospice and in-home services and less on expensive treatments and interventions, and use the savings for children, pregnant moms, and people who've fallen through the cracks in the system?

“It's a difficult conversation to have, but this is the kind of issue that we've got to have a discussion about.”

Even the semantics surrounding those issues are difficult to deal with, Sen. Wyden noted.

For example, Sen. Wyden said it took him 3 months to negotiate the title of this bill.

“When we started, the Democrats wanted the words 'universal coverage,' but the Republicans said, 'We're not going there; that's socialism.'

“The Republicans wanted to call it universal access, but the Democrats said, 'We're not going there; no one will ever get anything,'” Sen. Wyden said.

Finally, the senator came up with the current title, which “the Democrats think sounds a little universal and the Republicans say has enough flexibility.

“Before anybody could change their minds I made them sign the press release and that was it.”

For more information on the working group, go to www.gao.gov/special.pubs/citizenshealthpr0228.pdf

WASHINGTON – Sen. Ron Wyden (D-Ore.) says the answer to America's health care problem does not lie with Congress–at least, not initially.

“I spent 2 years studying what went wrong in the Clinton debacle,” he said at a meeting sponsored by America's Health Insurance Plans.

Sen. Wyden was referring to the unsuccessful effort of President Bill Clinton and his wife, now-Sen. Hillary Rodham Clinton (D-N.Y.) to get Congress to pass health care reform in the 1990s.

The Oregon Democrat also took a look at a similar effort in the 1940s by President Harry S Truman.

Sen. Wyden's conclusion: “There is a remarkable parallel in 60 years of failure. … For 6 decades, the effort has involved trying to write a piece of federal legislation in Washington, D.C. [But] the special interests would attack the legislation and each other, and everything would fail.”

Instead, “I decided to go 180 degrees the other way,” he said. “We'll start it outside [Washington].”

A few months ago, Sen. Wyden, along with Sen. Orrin Hatch (R-Utah) and Comptroller General David Walker, announced the formation of the Citizens' Working Group on Health Care.

The group is made up of 14 people from across the country, including physicians, health advocates, hospital administrators, academicians, nurses, and a union representative. Health and Human Services Secretary Mike Leavitt will serve as the 15th member.

The group is one result of a new law known as the Health Care That Works for All Americans Act, which was cosponsored by the two senators.

One goal of the working group, according to Sen. Wyden, is “tell people where the $1.8 trillion spent on health care actually goes. … I think people will be pretty surprised.”

The information will be made available online as well as in booklets and in public libraries.

Another goal of the working group is to hold public hearings in an effort to get input on what should be done to reform the health care system.

“No one has walked the public through the choices and tradeoffs that come with a health care system that works for everybody,” he said.

“We're now going to have a real debate about how we create a system that works for everybody.”

After publishing the spending information and listening to public comment, the plan is for the working group to develop a set of tentative recommendations on a system that works for all Americans, Sen. Wyden said.

“When they have the tentative set of recommendations, they go back to the public again for another crack, so people will get to weigh in twice,” Sen. Wyden said.

Then the recommendations will go to Congress, and all committees with jurisdiction over health care will have to hold hearings within 60 days of receiving the recommendations.

Although there is no mandate for Congress to take any further action on the recommendations once it has held hearings, “you will have a citizens' road map of where the country feels we ought to be headed in health care, and if at that point the congressional committees decide they want to ignore what the citizens have to say, then it will be really clear who they're siding with–powerful Washington interests rather than the citizens,” he said.

Sen. Wyden gave a specific example of the type of issue he hopes the working group will address.

“We know that a big chunk of the health care dollar gets spent in the last few months of someone's life.

“And we know in many of those instances, the best doctors and hospitals can't do anything to increase the quality of the person's life, and they can't do anything that's medically effective,” he said.

“So the question for the country that the political leaders have been ducking–and that they aren't going to be able to duck any longer–is, in those kinds of instances, do we want to start spending more money on hospice and in-home services and less on expensive treatments and interventions, and use the savings for children, pregnant moms, and people who've fallen through the cracks in the system?

“It's a difficult conversation to have, but this is the kind of issue that we've got to have a discussion about.”

Even the semantics surrounding those issues are difficult to deal with, Sen. Wyden noted.

For example, Sen. Wyden said it took him 3 months to negotiate the title of this bill.

“When we started, the Democrats wanted the words 'universal coverage,' but the Republicans said, 'We're not going there; that's socialism.'

“The Republicans wanted to call it universal access, but the Democrats said, 'We're not going there; no one will ever get anything,'” Sen. Wyden said.

Finally, the senator came up with the current title, which “the Democrats think sounds a little universal and the Republicans say has enough flexibility.

“Before anybody could change their minds I made them sign the press release and that was it.”

For more information on the working group, go to www.gao.gov/special.pubs/citizenshealthpr0228.pdf

WASHINGTON – Sen. Ron Wyden (D-Ore.) says the answer to America's health care problem does not lie with Congress–at least, not initially.

“I spent 2 years studying what went wrong in the Clinton debacle,” he said at a meeting sponsored by America's Health Insurance Plans.

Sen. Wyden was referring to the unsuccessful effort of President Bill Clinton and his wife, now-Sen. Hillary Rodham Clinton (D-N.Y.) to get Congress to pass health care reform in the 1990s.

The Oregon Democrat also took a look at a similar effort in the 1940s by President Harry S Truman.

Sen. Wyden's conclusion: “There is a remarkable parallel in 60 years of failure. … For 6 decades, the effort has involved trying to write a piece of federal legislation in Washington, D.C. [But] the special interests would attack the legislation and each other, and everything would fail.”

Instead, “I decided to go 180 degrees the other way,” he said. “We'll start it outside [Washington].”

A few months ago, Sen. Wyden, along with Sen. Orrin Hatch (R-Utah) and Comptroller General David Walker, announced the formation of the Citizens' Working Group on Health Care.

The group is made up of 14 people from across the country, including physicians, health advocates, hospital administrators, academicians, nurses, and a union representative. Health and Human Services Secretary Mike Leavitt will serve as the 15th member.

The group is one result of a new law known as the Health Care That Works for All Americans Act, which was cosponsored by the two senators.

One goal of the working group, according to Sen. Wyden, is “tell people where the $1.8 trillion spent on health care actually goes. … I think people will be pretty surprised.”

The information will be made available online as well as in booklets and in public libraries.

Another goal of the working group is to hold public hearings in an effort to get input on what should be done to reform the health care system.

“No one has walked the public through the choices and tradeoffs that come with a health care system that works for everybody,” he said.

“We're now going to have a real debate about how we create a system that works for everybody.”

After publishing the spending information and listening to public comment, the plan is for the working group to develop a set of tentative recommendations on a system that works for all Americans, Sen. Wyden said.

“When they have the tentative set of recommendations, they go back to the public again for another crack, so people will get to weigh in twice,” Sen. Wyden said.

Then the recommendations will go to Congress, and all committees with jurisdiction over health care will have to hold hearings within 60 days of receiving the recommendations.

Although there is no mandate for Congress to take any further action on the recommendations once it has held hearings, “you will have a citizens' road map of where the country feels we ought to be headed in health care, and if at that point the congressional committees decide they want to ignore what the citizens have to say, then it will be really clear who they're siding with–powerful Washington interests rather than the citizens,” he said.

Sen. Wyden gave a specific example of the type of issue he hopes the working group will address.

“We know that a big chunk of the health care dollar gets spent in the last few months of someone's life.

“And we know in many of those instances, the best doctors and hospitals can't do anything to increase the quality of the person's life, and they can't do anything that's medically effective,” he said.

“So the question for the country that the political leaders have been ducking–and that they aren't going to be able to duck any longer–is, in those kinds of instances, do we want to start spending more money on hospice and in-home services and less on expensive treatments and interventions, and use the savings for children, pregnant moms, and people who've fallen through the cracks in the system?

“It's a difficult conversation to have, but this is the kind of issue that we've got to have a discussion about.”

Even the semantics surrounding those issues are difficult to deal with, Sen. Wyden noted.

For example, Sen. Wyden said it took him 3 months to negotiate the title of this bill.

“When we started, the Democrats wanted the words 'universal coverage,' but the Republicans said, 'We're not going there; that's socialism.'

“The Republicans wanted to call it universal access, but the Democrats said, 'We're not going there; no one will ever get anything,'” Sen. Wyden said.

Finally, the senator came up with the current title, which “the Democrats think sounds a little universal and the Republicans say has enough flexibility.

“Before anybody could change their minds I made them sign the press release and that was it.”

For more information on the working group, go to www.gao.gov/special.pubs/citizenshealthpr0228.pdf

WASHINGTON — The use of at-home genetic tests raises ethical dilemmas for both patients and physicians, several speakers said at a forum sponsored by the Johns Hopkins University Genetics and Public Policy Center.

“Let's be practical,” said Richard T. Scott Jr., M.D., of Reproductive Medicine Associates of New Jersey in Morristown. “I'm fortunate because I'm a subspecialist—when I meet with my patients, I usually get an hour. But now you're an internist—you have7–10 minutes. The patients are going to walk in with their letter [summarizing their test results], and you've got 7 minutes to get through that, it's going to create a problem.”

In general, “things which move patients toward being better informed so they have a better understanding of their circumstances and make better decisions in their life, including treatment decisions, have to be good,” Dr. Scott added. “But when it comes to putting these tests together, the real question will be what tests are you going to offer, and how are you going to decide if those tests are appropriate?”

Whether physicians want them or not, at-home genetic tests are out there; many are for fertility- or gynecologic-related conditions. One company, San Francisco-based DNA Direct, offers tests for BRCA mutations, thrombophilia, hemochromatosis, cystic fibrosis, and ?1-antitrypsin deficiency. Prices for the tests range from $199 to $3,311 and include a “personalized report” of the results and phone consultation with a genetic expert.

Many of the tests are done with a cheek swab; the sample is sent through the mail. For tests that require a blood sample, the customer is directed to a federally certified lab that collects the sample and ships it in the manner required, according to Ryan Phelan, DNA Direct's founder and CEO. In either case, the customer remains anonymous throughout the process.

Michael Mennuti, M.D., chair of the obstetrics and gynecology department at the Hospital of the University of Pennsylvania in Philadelphia, also expressed concerns. “When you have laboratory tests available to patients who have a problem, and you report a normal result [on the first test], then the patient's next question is, 'Well, what is causing this problem, and what's the next test?'” said Dr. Mennuti, who is also president-elect of the American College of Obstetricians and Gynecologists. “Here you're communicating with someone who has an employer-employee relationship with the laboratory. There is a potential for a conflict of interest.”

Customers have several reasons for using at-home tests, Ms. Phelan said. “One is access to a test that their physician did not know about, did not choose to offer, or did not recommend. Number two is to get it interpreted by experts who actually understand the nuances. And third is insurance discrimination or worry about insurance discrimination.”

Physicians' lack of genetic knowledge is a real issue, said R. Alta Charo, professor of law and medical ethics at the University of Wisconsin at Madison. When she worked for the now-defunct Federal Office of Technology Assessment about 15 years ago, the office surveyed physicians about which men they would allow to donate sperm for their patients.

“We discovered a woeful lack of understanding of basic genetics,” she said. “They would screen out perfectly healthy men who had first-degree relatives with hemophilia—apparently not recognizing that if they were healthy they couldn't have the hemophilia mutation—but would allow in men who had parents with Huntington's chorea and who were young enough not to have presented [with symptoms].”

Although medical schools have since made great strides in these areas, “I would suspect that there is still a relative lack of sophisticated understanding of modern genetics prevalent among many physicians,” Ms. Charo said.

Some panelists expressed concern about lack of regulation of at-home genetic tests. Gail Javitt, policy analyst at the Genetics and Public Policy Center, noted that state laws on at-home tests vary greatly. “Some states require a health care provider to order a test and get the results back; other states don't require this,” she said. But “even when a provider's involvement is required, it does not necessarily have to be the patient's personal physician. It can be a provider associated with the company offering the test.”

As for the actual tests, there is little government oversight, she noted. “Most genetic tests are provided by clinical laboratories, and the laboratory director decides when to offer the tests and what tests to offer. … Of the more than 800 tests currently out there, only a handful are regulated by the [Food and Drug Administration].”

Steve Gutman of the FDA's Office of In-Vitro Diagnostics, who was in the audience, said that the FDA is “not disinterested” in this area. The agency “is not unaware of very colorful array of forces that are operating here, and it does not have easy answers. The unanswered question is how the FDA might move from the small set of commercial tests it now regulates to broader regulation of building blocks of home-brewed tests or the home-brewed tests themselves. I can't make any promise about timelines, but I can make a promise that the last chapter hasn't been written. It's a novel in progress.”

WASHINGTON — The use of at-home genetic tests raises ethical dilemmas for both patients and physicians, several speakers said at a forum sponsored by the Johns Hopkins University Genetics and Public Policy Center.

“Let's be practical,” said Richard T. Scott Jr., M.D., of Reproductive Medicine Associates of New Jersey in Morristown. “I'm fortunate because I'm a subspecialist—when I meet with my patients, I usually get an hour. But now you're an internist—you have7–10 minutes. The patients are going to walk in with their letter [summarizing their test results], and you've got 7 minutes to get through that, it's going to create a problem.”

In general, “things which move patients toward being better informed so they have a better understanding of their circumstances and make better decisions in their life, including treatment decisions, have to be good,” Dr. Scott added. “But when it comes to putting these tests together, the real question will be what tests are you going to offer, and how are you going to decide if those tests are appropriate?”

Whether physicians want them or not, at-home genetic tests are out there; many are for fertility- or gynecologic-related conditions. One company, San Francisco-based DNA Direct, offers tests for BRCA mutations, thrombophilia, hemochromatosis, cystic fibrosis, and ?1-antitrypsin deficiency. Prices for the tests range from $199 to $3,311 and include a “personalized report” of the results and phone consultation with a genetic expert.

Many of the tests are done with a cheek swab; the sample is sent through the mail. For tests that require a blood sample, the customer is directed to a federally certified lab that collects the sample and ships it in the manner required, according to Ryan Phelan, DNA Direct's founder and CEO. In either case, the customer remains anonymous throughout the process.

Michael Mennuti, M.D., chair of the obstetrics and gynecology department at the Hospital of the University of Pennsylvania in Philadelphia, also expressed concerns. “When you have laboratory tests available to patients who have a problem, and you report a normal result [on the first test], then the patient's next question is, 'Well, what is causing this problem, and what's the next test?'” said Dr. Mennuti, who is also president-elect of the American College of Obstetricians and Gynecologists. “Here you're communicating with someone who has an employer-employee relationship with the laboratory. There is a potential for a conflict of interest.”

Customers have several reasons for using at-home tests, Ms. Phelan said. “One is access to a test that their physician did not know about, did not choose to offer, or did not recommend. Number two is to get it interpreted by experts who actually understand the nuances. And third is insurance discrimination or worry about insurance discrimination.”

Physicians' lack of genetic knowledge is a real issue, said R. Alta Charo, professor of law and medical ethics at the University of Wisconsin at Madison. When she worked for the now-defunct Federal Office of Technology Assessment about 15 years ago, the office surveyed physicians about which men they would allow to donate sperm for their patients.

“We discovered a woeful lack of understanding of basic genetics,” she said. “They would screen out perfectly healthy men who had first-degree relatives with hemophilia—apparently not recognizing that if they were healthy they couldn't have the hemophilia mutation—but would allow in men who had parents with Huntington's chorea and who were young enough not to have presented [with symptoms].”

Although medical schools have since made great strides in these areas, “I would suspect that there is still a relative lack of sophisticated understanding of modern genetics prevalent among many physicians,” Ms. Charo said.

Some panelists expressed concern about lack of regulation of at-home genetic tests. Gail Javitt, policy analyst at the Genetics and Public Policy Center, noted that state laws on at-home tests vary greatly. “Some states require a health care provider to order a test and get the results back; other states don't require this,” she said. But “even when a provider's involvement is required, it does not necessarily have to be the patient's personal physician. It can be a provider associated with the company offering the test.”

As for the actual tests, there is little government oversight, she noted. “Most genetic tests are provided by clinical laboratories, and the laboratory director decides when to offer the tests and what tests to offer. … Of the more than 800 tests currently out there, only a handful are regulated by the [Food and Drug Administration].”

Steve Gutman of the FDA's Office of In-Vitro Diagnostics, who was in the audience, said that the FDA is “not disinterested” in this area. The agency “is not unaware of very colorful array of forces that are operating here, and it does not have easy answers. The unanswered question is how the FDA might move from the small set of commercial tests it now regulates to broader regulation of building blocks of home-brewed tests or the home-brewed tests themselves. I can't make any promise about timelines, but I can make a promise that the last chapter hasn't been written. It's a novel in progress.”

WASHINGTON — The use of at-home genetic tests raises ethical dilemmas for both patients and physicians, several speakers said at a forum sponsored by the Johns Hopkins University Genetics and Public Policy Center.

“Let's be practical,” said Richard T. Scott Jr., M.D., of Reproductive Medicine Associates of New Jersey in Morristown. “I'm fortunate because I'm a subspecialist—when I meet with my patients, I usually get an hour. But now you're an internist—you have7–10 minutes. The patients are going to walk in with their letter [summarizing their test results], and you've got 7 minutes to get through that, it's going to create a problem.”

In general, “things which move patients toward being better informed so they have a better understanding of their circumstances and make better decisions in their life, including treatment decisions, have to be good,” Dr. Scott added. “But when it comes to putting these tests together, the real question will be what tests are you going to offer, and how are you going to decide if those tests are appropriate?”

Whether physicians want them or not, at-home genetic tests are out there; many are for fertility- or gynecologic-related conditions. One company, San Francisco-based DNA Direct, offers tests for BRCA mutations, thrombophilia, hemochromatosis, cystic fibrosis, and ?1-antitrypsin deficiency. Prices for the tests range from $199 to $3,311 and include a “personalized report” of the results and phone consultation with a genetic expert.

Many of the tests are done with a cheek swab; the sample is sent through the mail. For tests that require a blood sample, the customer is directed to a federally certified lab that collects the sample and ships it in the manner required, according to Ryan Phelan, DNA Direct's founder and CEO. In either case, the customer remains anonymous throughout the process.

Michael Mennuti, M.D., chair of the obstetrics and gynecology department at the Hospital of the University of Pennsylvania in Philadelphia, also expressed concerns. “When you have laboratory tests available to patients who have a problem, and you report a normal result [on the first test], then the patient's next question is, 'Well, what is causing this problem, and what's the next test?'” said Dr. Mennuti, who is also president-elect of the American College of Obstetricians and Gynecologists. “Here you're communicating with someone who has an employer-employee relationship with the laboratory. There is a potential for a conflict of interest.”

Customers have several reasons for using at-home tests, Ms. Phelan said. “One is access to a test that their physician did not know about, did not choose to offer, or did not recommend. Number two is to get it interpreted by experts who actually understand the nuances. And third is insurance discrimination or worry about insurance discrimination.”

Physicians' lack of genetic knowledge is a real issue, said R. Alta Charo, professor of law and medical ethics at the University of Wisconsin at Madison. When she worked for the now-defunct Federal Office of Technology Assessment about 15 years ago, the office surveyed physicians about which men they would allow to donate sperm for their patients.

“We discovered a woeful lack of understanding of basic genetics,” she said. “They would screen out perfectly healthy men who had first-degree relatives with hemophilia—apparently not recognizing that if they were healthy they couldn't have the hemophilia mutation—but would allow in men who had parents with Huntington's chorea and who were young enough not to have presented [with symptoms].”

Although medical schools have since made great strides in these areas, “I would suspect that there is still a relative lack of sophisticated understanding of modern genetics prevalent among many physicians,” Ms. Charo said.

Some panelists expressed concern about lack of regulation of at-home genetic tests. Gail Javitt, policy analyst at the Genetics and Public Policy Center, noted that state laws on at-home tests vary greatly. “Some states require a health care provider to order a test and get the results back; other states don't require this,” she said. But “even when a provider's involvement is required, it does not necessarily have to be the patient's personal physician. It can be a provider associated with the company offering the test.”

As for the actual tests, there is little government oversight, she noted. “Most genetic tests are provided by clinical laboratories, and the laboratory director decides when to offer the tests and what tests to offer. … Of the more than 800 tests currently out there, only a handful are regulated by the [Food and Drug Administration].”

Steve Gutman of the FDA's Office of In-Vitro Diagnostics, who was in the audience, said that the FDA is “not disinterested” in this area. The agency “is not unaware of very colorful array of forces that are operating here, and it does not have easy answers. The unanswered question is how the FDA might move from the small set of commercial tests it now regulates to broader regulation of building blocks of home-brewed tests or the home-brewed tests themselves. I can't make any promise about timelines, but I can make a promise that the last chapter hasn't been written. It's a novel in progress.”

WASHINGTON — The new database on hospital quality from the Centers for Medicare and Medicaid Services may herald a new era in patient assertiveness in terms of health care preferences, several experts said at a briefing sponsored by the Alliance for Health Reform.

"We're beginning a change in how doctor-patient relations are established and [considering] how paternalistic they have been, I think we'll see major changes in the future where they become less that way," said Elliot Sussman, M.D., president and CEO of Lehigh Valley Hospital and Health Network in Allentown, Pa.

"When people come into a community, they'll look at measures like this and say, 'Which are the kinds of places I want to be cared for at, and who are doctors on staff at those places?'" he pointed out.

In fact, such changes have already begun to occur, he said. "We've seen experiences where people change their doctor relationship because 'I really like Dr. Jones, but he's not on the staff of what seems to be the best hospital. Either he does that or I'm going to find myself a new physician.'"

CMS launched its "Hospital Compare" database on April 1.

Available online at www.hospitalcompare.hhs.gov

Users can search by hospital name or geographic location.

Gerald M. Shea, assistant to the president for government affairs at the AFL-CIO, said that the feeling of partnership that comes from empowering consumers should spill over onto the physician side of the equation.

"I could make the argument that there are very serious limits to how much consumers can drive change in the health decision-making process," he said. "An equally fruitful strategy would be trying to change the preparation and education of physicians, so they come to this suggesting that a partnership would be a good idea."

In fact, physicians also have much to gain from being able to access hospital quality data, said Margaret E. O'Kane, president of the National Committee for Quality Assurance.

"Physicians have been working in an information vacuum as well—both doctors involved in performing particular procedures in the hospital, and the primary care physicians who are making referrals to specialists," she said. "We can't underestimate the impact that transparency has on changing everything. I feel very optimistic this will lead to lots of positive changes."

One panelist warned that empowerment does have its limits.

Charles N. "Chip" Kahn, who is president of the Federation of American Hospitals, said that as databases such as Hospital Compare begin to add more measures, "it will be more and more difficult for the average consumer … to figure things out other than, 'This is either an okay place or a dreadful place' and you obviously want to stay away from dreadful places."

In the end, he commented, databases like this "are more about using accountability to improve care than they are about consumers making more decisions."

Ms. O'Kane said she was confident that "intermediaries" would become available to help consumers interpret the database information. And she also had a prediction.

"What we've seen so far is not hospitals that are excellent at everything or terrible at everything, but hospitals that are excellent at one thing and maybe not so great at others.

"As process engineering becomes more core to the hospitals, you'll see hospitals that will break out and be excellent across the board."

WASHINGTON — The new database on hospital quality from the Centers for Medicare and Medicaid Services may herald a new era in patient assertiveness in terms of health care preferences, several experts said at a briefing sponsored by the Alliance for Health Reform.

"We're beginning a change in how doctor-patient relations are established and [considering] how paternalistic they have been, I think we'll see major changes in the future where they become less that way," said Elliot Sussman, M.D., president and CEO of Lehigh Valley Hospital and Health Network in Allentown, Pa.

"When people come into a community, they'll look at measures like this and say, 'Which are the kinds of places I want to be cared for at, and who are doctors on staff at those places?'" he pointed out.

In fact, such changes have already begun to occur, he said. "We've seen experiences where people change their doctor relationship because 'I really like Dr. Jones, but he's not on the staff of what seems to be the best hospital. Either he does that or I'm going to find myself a new physician.'"

CMS launched its "Hospital Compare" database on April 1.

Available online at www.hospitalcompare.hhs.gov

Users can search by hospital name or geographic location.

Gerald M. Shea, assistant to the president for government affairs at the AFL-CIO, said that the feeling of partnership that comes from empowering consumers should spill over onto the physician side of the equation.

"I could make the argument that there are very serious limits to how much consumers can drive change in the health decision-making process," he said. "An equally fruitful strategy would be trying to change the preparation and education of physicians, so they come to this suggesting that a partnership would be a good idea."

In fact, physicians also have much to gain from being able to access hospital quality data, said Margaret E. O'Kane, president of the National Committee for Quality Assurance.

"Physicians have been working in an information vacuum as well—both doctors involved in performing particular procedures in the hospital, and the primary care physicians who are making referrals to specialists," she said. "We can't underestimate the impact that transparency has on changing everything. I feel very optimistic this will lead to lots of positive changes."

One panelist warned that empowerment does have its limits.

Charles N. "Chip" Kahn, who is president of the Federation of American Hospitals, said that as databases such as Hospital Compare begin to add more measures, "it will be more and more difficult for the average consumer … to figure things out other than, 'This is either an okay place or a dreadful place' and you obviously want to stay away from dreadful places."

In the end, he commented, databases like this "are more about using accountability to improve care than they are about consumers making more decisions."

Ms. O'Kane said she was confident that "intermediaries" would become available to help consumers interpret the database information. And she also had a prediction.

"What we've seen so far is not hospitals that are excellent at everything or terrible at everything, but hospitals that are excellent at one thing and maybe not so great at others.

"As process engineering becomes more core to the hospitals, you'll see hospitals that will break out and be excellent across the board."

WASHINGTON — The new database on hospital quality from the Centers for Medicare and Medicaid Services may herald a new era in patient assertiveness in terms of health care preferences, several experts said at a briefing sponsored by the Alliance for Health Reform.

"We're beginning a change in how doctor-patient relations are established and [considering] how paternalistic they have been, I think we'll see major changes in the future where they become less that way," said Elliot Sussman, M.D., president and CEO of Lehigh Valley Hospital and Health Network in Allentown, Pa.

"When people come into a community, they'll look at measures like this and say, 'Which are the kinds of places I want to be cared for at, and who are doctors on staff at those places?'" he pointed out.

In fact, such changes have already begun to occur, he said. "We've seen experiences where people change their doctor relationship because 'I really like Dr. Jones, but he's not on the staff of what seems to be the best hospital. Either he does that or I'm going to find myself a new physician.'"

CMS launched its "Hospital Compare" database on April 1.

Available online at www.hospitalcompare.hhs.gov

Users can search by hospital name or geographic location.

Gerald M. Shea, assistant to the president for government affairs at the AFL-CIO, said that the feeling of partnership that comes from empowering consumers should spill over onto the physician side of the equation.

"I could make the argument that there are very serious limits to how much consumers can drive change in the health decision-making process," he said. "An equally fruitful strategy would be trying to change the preparation and education of physicians, so they come to this suggesting that a partnership would be a good idea."

In fact, physicians also have much to gain from being able to access hospital quality data, said Margaret E. O'Kane, president of the National Committee for Quality Assurance.

"Physicians have been working in an information vacuum as well—both doctors involved in performing particular procedures in the hospital, and the primary care physicians who are making referrals to specialists," she said. "We can't underestimate the impact that transparency has on changing everything. I feel very optimistic this will lead to lots of positive changes."

One panelist warned that empowerment does have its limits.

Charles N. "Chip" Kahn, who is president of the Federation of American Hospitals, said that as databases such as Hospital Compare begin to add more measures, "it will be more and more difficult for the average consumer … to figure things out other than, 'This is either an okay place or a dreadful place' and you obviously want to stay away from dreadful places."

In the end, he commented, databases like this "are more about using accountability to improve care than they are about consumers making more decisions."

Ms. O'Kane said she was confident that "intermediaries" would become available to help consumers interpret the database information. And she also had a prediction.

"What we've seen so far is not hospitals that are excellent at everything or terrible at everything, but hospitals that are excellent at one thing and maybe not so great at others.

"As process engineering becomes more core to the hospitals, you'll see hospitals that will break out and be excellent across the board."

WASHINGTON — Consumer-driven health care may be the "next big thing" in health insurance, but it won't go anywhere until more data on plans, providers, and outcomes become available, George Halvorson said at a health care congress sponsored by the Wall Street Journal and CNBC.

"It's time for an industrial revolution in health care," said Mr. Halvorson, chairman and CEO of Kaiser Foundation Health Plan, Oakland, Calif. "We need to set a much higher standard for ourselves as an industry."

Many major and expensive trends in care "too often lack scientific backing," citing the examples of hormone therapy for heart attack prevention in women, knee surgery to relieve osteoporosis pain, and cyclooxygenase-2 (COX-2) inhibitors for arthritis pain, where the therapy turned out not to work as well as expected. "These are significant issues. Because there's no consistent database in health care, people did not realize this kind of outcome was happening with something that was a very popular treatment," he said.

Mr. Halvorson recommended that health care executives follow the example of other industries that have turned themselves around. For example, General Electric instituted a program of "measure, analyze, improve, and control" to weed out errors in its manufacturing process.

Health care doesn't do any of those four steps with any great consistency, Mr. Halvorson continued. "Where does health care get the data that are used? We get it from paper medical records, which are not even complete per patient." For instance, he said, "we have one patient, four doctors—four unrelated, unconnected, noncommunicative, nonintuitive, noninteractive, too often inaccessible, and often illegible, paper medical records from which to derive the database."

In addition to well-known data-collection tools such as electronic medical records (EMRs) and computerized physician order-entry systems, the health care system also should systematically collect other information, such as whether patients fill prescriptions, Mr. Halvorson said.

Although the United States health care system is better than it's ever been, and the technology is better than it has ever been, "we will not be able to realize the full potential of it until we can get an information flow, and the flow has to come from an EMR," Mr. Halvorson said. He added that a single nationwide EMR system would not be necessary as long as local systems could transport data to one another if needed.

To make data collection part of the national agenda, the impetus needs to come from a large government program like Medicare. "Medicare is the key, and hospitals are the leverage point," he said. "Medicare accounts for about 40% of hospital revenue. If Medicare decided to do this, it could make this happen with a rewards system … relatively quickly. Investment dollars are needed, and Medicare needs to support that."

WASHINGTON — Consumer-driven health care may be the "next big thing" in health insurance, but it won't go anywhere until more data on plans, providers, and outcomes become available, George Halvorson said at a health care congress sponsored by the Wall Street Journal and CNBC.

"It's time for an industrial revolution in health care," said Mr. Halvorson, chairman and CEO of Kaiser Foundation Health Plan, Oakland, Calif. "We need to set a much higher standard for ourselves as an industry."

Many major and expensive trends in care "too often lack scientific backing," citing the examples of hormone therapy for heart attack prevention in women, knee surgery to relieve osteoporosis pain, and cyclooxygenase-2 (COX-2) inhibitors for arthritis pain, where the therapy turned out not to work as well as expected. "These are significant issues. Because there's no consistent database in health care, people did not realize this kind of outcome was happening with something that was a very popular treatment," he said.

Mr. Halvorson recommended that health care executives follow the example of other industries that have turned themselves around. For example, General Electric instituted a program of "measure, analyze, improve, and control" to weed out errors in its manufacturing process.

Health care doesn't do any of those four steps with any great consistency, Mr. Halvorson continued. "Where does health care get the data that are used? We get it from paper medical records, which are not even complete per patient." For instance, he said, "we have one patient, four doctors—four unrelated, unconnected, noncommunicative, nonintuitive, noninteractive, too often inaccessible, and often illegible, paper medical records from which to derive the database."

In addition to well-known data-collection tools such as electronic medical records (EMRs) and computerized physician order-entry systems, the health care system also should systematically collect other information, such as whether patients fill prescriptions, Mr. Halvorson said.

Although the United States health care system is better than it's ever been, and the technology is better than it has ever been, "we will not be able to realize the full potential of it until we can get an information flow, and the flow has to come from an EMR," Mr. Halvorson said. He added that a single nationwide EMR system would not be necessary as long as local systems could transport data to one another if needed.

To make data collection part of the national agenda, the impetus needs to come from a large government program like Medicare. "Medicare is the key, and hospitals are the leverage point," he said. "Medicare accounts for about 40% of hospital revenue. If Medicare decided to do this, it could make this happen with a rewards system … relatively quickly. Investment dollars are needed, and Medicare needs to support that."

WASHINGTON — Consumer-driven health care may be the "next big thing" in health insurance, but it won't go anywhere until more data on plans, providers, and outcomes become available, George Halvorson said at a health care congress sponsored by the Wall Street Journal and CNBC.

"It's time for an industrial revolution in health care," said Mr. Halvorson, chairman and CEO of Kaiser Foundation Health Plan, Oakland, Calif. "We need to set a much higher standard for ourselves as an industry."

Many major and expensive trends in care "too often lack scientific backing," citing the examples of hormone therapy for heart attack prevention in women, knee surgery to relieve osteoporosis pain, and cyclooxygenase-2 (COX-2) inhibitors for arthritis pain, where the therapy turned out not to work as well as expected. "These are significant issues. Because there's no consistent database in health care, people did not realize this kind of outcome was happening with something that was a very popular treatment," he said.

Mr. Halvorson recommended that health care executives follow the example of other industries that have turned themselves around. For example, General Electric instituted a program of "measure, analyze, improve, and control" to weed out errors in its manufacturing process.

Health care doesn't do any of those four steps with any great consistency, Mr. Halvorson continued. "Where does health care get the data that are used? We get it from paper medical records, which are not even complete per patient." For instance, he said, "we have one patient, four doctors—four unrelated, unconnected, noncommunicative, nonintuitive, noninteractive, too often inaccessible, and often illegible, paper medical records from which to derive the database."

In addition to well-known data-collection tools such as electronic medical records (EMRs) and computerized physician order-entry systems, the health care system also should systematically collect other information, such as whether patients fill prescriptions, Mr. Halvorson said.

Although the United States health care system is better than it's ever been, and the technology is better than it has ever been, "we will not be able to realize the full potential of it until we can get an information flow, and the flow has to come from an EMR," Mr. Halvorson said. He added that a single nationwide EMR system would not be necessary as long as local systems could transport data to one another if needed.

To make data collection part of the national agenda, the impetus needs to come from a large government program like Medicare. "Medicare is the key, and hospitals are the leverage point," he said. "Medicare accounts for about 40% of hospital revenue. If Medicare decided to do this, it could make this happen with a rewards system … relatively quickly. Investment dollars are needed, and Medicare needs to support that."