Naseem S. Miller

Multimodality imaging is among the highlights of this year's American Society of Echocardiography meeting, which starts on June 30 at the National Harbor, Maryland.

The society is pushing forward the concept, looking at different diseases and integrating different kinds of imaging such as echo plus nuclear, cardiac CT, or cardiac MR, in order to get the best diagnoses, said Dr. Melissa Wood, co-director of Massachusetts General Hospital Heart Center Women's Heart Health Program, Boston, and the chair of ASE Public Relations Committee.

"This isn't just about echo, it's also about all the other imaging techniques that are out there and how we can work together and deliver the highest quality of care," said Dr. Wood in an interview. "It's also about what's superfluous, and what we don't need to do."

On the policy front, Accountable Care Organizations will be in the forefront during the meeting. Dr. Wood said that the speakers will address how "ACOs affect those of us who read echos and do them, and how they affect practices."

Echocardiography will also leave this planet for a bit during a symposium. ASE president Dr. James Thomas has long been actively involved in doing research with the space program and helping pick the right echo machine for use up there, said Dr. Wood. "There's substantial interest in microgravity and the heart, and how heart changes its function in space. It's something that's very unique, and there are lessons that can be learned from that, and that experience will be somehow useful in our clinical practices, whether it's specific type of research techniques or specific types of information that are gained in that environment."

Echocardiography is the second most commonly ordered test after ECG, according to Dr. Wood, and with the aging population, the use of the test is likely to increase. 

"I see echo take off more because of this concern about heart failure being an epidemic. Echo as a way to diagnose heart failure before it becomes profound," she said. And given the appropriate use criteria, "we're tying to moderate the reasons echos are ordered, so they'll continue to be fairly reimbursed by third parties and the Centers for Medicare and Medicaid Services," said Dr. Wood. 

You can find the meeting's program here. And be sure to check our coverage on ecardiologynews.com.

By Naseem S. Miller (@NaseemSMiller)

Multimodality imaging is among the highlights of this year's American Society of Echocardiography meeting, which starts on June 30 at the National Harbor, Maryland.

The society is pushing forward the concept, looking at different diseases and integrating different kinds of imaging such as echo plus nuclear, cardiac CT, or cardiac MR, in order to get the best diagnoses, said Dr. Melissa Wood, co-director of Massachusetts General Hospital Heart Center Women's Heart Health Program, Boston, and the chair of ASE Public Relations Committee.

"This isn't just about echo, it's also about all the other imaging techniques that are out there and how we can work together and deliver the highest quality of care," said Dr. Wood in an interview. "It's also about what's superfluous, and what we don't need to do."

On the policy front, Accountable Care Organizations will be in the forefront during the meeting. Dr. Wood said that the speakers will address how "ACOs affect those of us who read echos and do them, and how they affect practices."

Echocardiography will also leave this planet for a bit during a symposium. ASE president Dr. James Thomas has long been actively involved in doing research with the space program and helping pick the right echo machine for use up there, said Dr. Wood. "There's substantial interest in microgravity and the heart, and how heart changes its function in space. It's something that's very unique, and there are lessons that can be learned from that, and that experience will be somehow useful in our clinical practices, whether it's specific type of research techniques or specific types of information that are gained in that environment."

Echocardiography is the second most commonly ordered test after ECG, according to Dr. Wood, and with the aging population, the use of the test is likely to increase. 

"I see echo take off more because of this concern about heart failure being an epidemic. Echo as a way to diagnose heart failure before it becomes profound," she said. And given the appropriate use criteria, "we're tying to moderate the reasons echos are ordered, so they'll continue to be fairly reimbursed by third parties and the Centers for Medicare and Medicaid Services," said Dr. Wood. 

You can find the meeting's program here. And be sure to check our coverage on ecardiologynews.com.

By Naseem S. Miller (@NaseemSMiller)

Multimodality imaging is among the highlights of this year's American Society of Echocardiography meeting, which starts on June 30 at the National Harbor, Maryland.

The society is pushing forward the concept, looking at different diseases and integrating different kinds of imaging such as echo plus nuclear, cardiac CT, or cardiac MR, in order to get the best diagnoses, said Dr. Melissa Wood, co-director of Massachusetts General Hospital Heart Center Women's Heart Health Program, Boston, and the chair of ASE Public Relations Committee.

"This isn't just about echo, it's also about all the other imaging techniques that are out there and how we can work together and deliver the highest quality of care," said Dr. Wood in an interview. "It's also about what's superfluous, and what we don't need to do."

On the policy front, Accountable Care Organizations will be in the forefront during the meeting. Dr. Wood said that the speakers will address how "ACOs affect those of us who read echos and do them, and how they affect practices."

Echocardiography will also leave this planet for a bit during a symposium. ASE president Dr. James Thomas has long been actively involved in doing research with the space program and helping pick the right echo machine for use up there, said Dr. Wood. "There's substantial interest in microgravity and the heart, and how heart changes its function in space. It's something that's very unique, and there are lessons that can be learned from that, and that experience will be somehow useful in our clinical practices, whether it's specific type of research techniques or specific types of information that are gained in that environment."

Echocardiography is the second most commonly ordered test after ECG, according to Dr. Wood, and with the aging population, the use of the test is likely to increase. 

"I see echo take off more because of this concern about heart failure being an epidemic. Echo as a way to diagnose heart failure before it becomes profound," she said. And given the appropriate use criteria, "we're tying to moderate the reasons echos are ordered, so they'll continue to be fairly reimbursed by third parties and the Centers for Medicare and Medicaid Services," said Dr. Wood. 

You can find the meeting's program here. And be sure to check our coverage on ecardiologynews.com.

By Naseem S. Miller (@NaseemSMiller)

Insurance companies that did not meet the medical loss ratio specified by the Affordable Care Act will pay more than $1.1 billion to nearly 13 million Americans this year, Health and Human Services Secretary Kathleen Sebelius announced June 21.

Also known as the 80/20 rule, the medical loss ratio rule requires that companies spend 80% of premium dollars collected on medical care; the remaining 20% may be spent on salaries, administration, and marketing.

Under the ACA, insurance companies that do not meet the specified loss ratio must rebate to consumers and other health insurance purchasers the portion of premium dollars that exceeded the limit, HHS officials said.

Loss ratio reports are filed yearly on June 1, and based on preliminary reports, the rebates will amount to an average $151 per household for Americans receiving the rebate. The rebate will go to individuals and small and large employers. Rebates will be distributed by Aug. 1.

Meanwhile, nearly 70 million insured Americans are covered by companies that met the 80/20 rule, Michael Hash, director of the HHS Office of Health Reform, said during a press conference. He added that the provision was "a critical piece of the Affordable Care Act."

Information on average rebate by state and market is available and additional information about insurance companies will be posted in the coming weeks, HHS officials said.

Insurance companies that did not meet the medical loss ratio specified by the Affordable Care Act will pay more than $1.1 billion to nearly 13 million Americans this year, Health and Human Services Secretary Kathleen Sebelius announced June 21.

Also known as the 80/20 rule, the medical loss ratio rule requires that companies spend 80% of premium dollars collected on medical care; the remaining 20% may be spent on salaries, administration, and marketing.

Under the ACA, insurance companies that do not meet the specified loss ratio must rebate to consumers and other health insurance purchasers the portion of premium dollars that exceeded the limit, HHS officials said.

Loss ratio reports are filed yearly on June 1, and based on preliminary reports, the rebates will amount to an average $151 per household for Americans receiving the rebate. The rebate will go to individuals and small and large employers. Rebates will be distributed by Aug. 1.

Meanwhile, nearly 70 million insured Americans are covered by companies that met the 80/20 rule, Michael Hash, director of the HHS Office of Health Reform, said during a press conference. He added that the provision was "a critical piece of the Affordable Care Act."

Information on average rebate by state and market is available and additional information about insurance companies will be posted in the coming weeks, HHS officials said.

Insurance companies that did not meet the medical loss ratio specified by the Affordable Care Act will pay more than $1.1 billion to nearly 13 million Americans this year, Health and Human Services Secretary Kathleen Sebelius announced June 21.

Also known as the 80/20 rule, the medical loss ratio rule requires that companies spend 80% of premium dollars collected on medical care; the remaining 20% may be spent on salaries, administration, and marketing.

Under the ACA, insurance companies that do not meet the specified loss ratio must rebate to consumers and other health insurance purchasers the portion of premium dollars that exceeded the limit, HHS officials said.

Loss ratio reports are filed yearly on June 1, and based on preliminary reports, the rebates will amount to an average $151 per household for Americans receiving the rebate. The rebate will go to individuals and small and large employers. Rebates will be distributed by Aug. 1.

Meanwhile, nearly 70 million insured Americans are covered by companies that met the 80/20 rule, Michael Hash, director of the HHS Office of Health Reform, said during a press conference. He added that the provision was "a critical piece of the Affordable Care Act."

Information on average rebate by state and market is available and additional information about insurance companies will be posted in the coming weeks, HHS officials said.

GAITHERSBURG, MD. – The benefits of Edwards SAPIEN transcatheter heart valve outweigh its risks for older patients with severe, symptomatic aortic stenosis who are at a high risk for surgery, voted the majority of an advisory panel to the Food and Drug Administration on June 13.

All panel members also voted that the valve was effective, and 10 of 12 members said that it was safe. Two members said no to the safety issue.

If approved by the FDA, the valve’s indications will expand its application to a wider group of patients.

The valve entered the U.S. market last November after receiving FDA approval for patients who have severe aortic stenosis and are deemed too sick to undergo surgical heart valve replacement (Cohort B of the pivotal PARTNER trial). (N. Engl. J. Med. 2010;363:1597-607)

On June 12, Edwards Lifescience, the makers of the SAPIEN transcatheter heart valve, said that based on the results of the PARTNER pivotal trial, the valve is also safe and effective in the high-risk cohort (Cohort A) when used according to approved labeling.

Although FDA officials agreed that the trial met its primary end points, they expressed concern with the higher risk of stroke in patients who underwent transcatheter aortic valve replacement (TAVR), compared with those who underwent surgery. They also raised questions about the long-term durability of the device, for which there are no data yet available yet.

In his final remarks, Dr. Craig R. Smith, chair of the department of surgery at Columbia University and coprinciple investigator of the PARTNER trial, said that although the risks associated with the procedures must be taken seriously, they should not an obstacle to the indication’s approval.

The panel’s recommendation is not a definitive predictor of the FDA’s final decision, but if the valve is eventually approved for such indication, "there will be a tendency to say to everybody that we have a winner," said David C. Naftel, Ph.D., a voting member of the panel from the University of Alabama, Birmingham. "But it’s not a winner, it’s a noninferiority trial."

The main results of the cohort A trial showed that all-cause mortality at 30 days favored TAVR at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin, yet again, neurologic complications occurred more frequently after TAVR.

Stroke was a major secondary end point and was defined as a focal deficit lasting greater than 24 hours or a focal deficit lasting greater than 24 hours with positive neuron-imaging studies. Each event was adjudicated in a blinded review by an independent clinical events committee and subclassified (ischemic, hemorrhagic, or undetermined etiology).

Surgical valve replacement has evolved over the past 50 years, and although TAVR is radical, it’s the next logical step in that evolution, Dr. Smith told the panel. The results of the cohort A of PARTNER, he said, bring the field one step closer to the day that valves can be replaced with no large incisions, no heart-lung machine, and potentially no general anesthesia.

The Centers for Medicare and Medicaid Services decided in May that it will cover the procedure in inoperable patients, under certain conditions, including the presence of a heart team during the procedure and evaluation of the patient by two cardiac surgeons.

Heart teams, collaboration between industry and cardiology societies, and continuing development of the TVT registry were also discussed during the meeting.

Dr. Gregory J. Dehmer, professor of medicine at Texas A&M University, said that the field was only at its infancy. In 35 years, a similar panel might be discussing the transradial approach to TAVR, he said, pointing to his wrist.

Dr. Naftel and Dr. Dehmer had no disclosures. Dr. Smith is a coprinciple investigator for the PARTNER trial.

GAITHERSBURG, MD. – The benefits of Edwards SAPIEN transcatheter heart valve outweigh its risks for older patients with severe, symptomatic aortic stenosis who are at a high risk for surgery, voted the majority of an advisory panel to the Food and Drug Administration on June 13.

All panel members also voted that the valve was effective, and 10 of 12 members said that it was safe. Two members said no to the safety issue.

If approved by the FDA, the valve’s indications will expand its application to a wider group of patients.

The valve entered the U.S. market last November after receiving FDA approval for patients who have severe aortic stenosis and are deemed too sick to undergo surgical heart valve replacement (Cohort B of the pivotal PARTNER trial). (N. Engl. J. Med. 2010;363:1597-607)

On June 12, Edwards Lifescience, the makers of the SAPIEN transcatheter heart valve, said that based on the results of the PARTNER pivotal trial, the valve is also safe and effective in the high-risk cohort (Cohort A) when used according to approved labeling.

Although FDA officials agreed that the trial met its primary end points, they expressed concern with the higher risk of stroke in patients who underwent transcatheter aortic valve replacement (TAVR), compared with those who underwent surgery. They also raised questions about the long-term durability of the device, for which there are no data yet available yet.

In his final remarks, Dr. Craig R. Smith, chair of the department of surgery at Columbia University and coprinciple investigator of the PARTNER trial, said that although the risks associated with the procedures must be taken seriously, they should not an obstacle to the indication’s approval.

The panel’s recommendation is not a definitive predictor of the FDA’s final decision, but if the valve is eventually approved for such indication, "there will be a tendency to say to everybody that we have a winner," said David C. Naftel, Ph.D., a voting member of the panel from the University of Alabama, Birmingham. "But it’s not a winner, it’s a noninferiority trial."

The main results of the cohort A trial showed that all-cause mortality at 30 days favored TAVR at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin, yet again, neurologic complications occurred more frequently after TAVR.

Stroke was a major secondary end point and was defined as a focal deficit lasting greater than 24 hours or a focal deficit lasting greater than 24 hours with positive neuron-imaging studies. Each event was adjudicated in a blinded review by an independent clinical events committee and subclassified (ischemic, hemorrhagic, or undetermined etiology).

Surgical valve replacement has evolved over the past 50 years, and although TAVR is radical, it’s the next logical step in that evolution, Dr. Smith told the panel. The results of the cohort A of PARTNER, he said, bring the field one step closer to the day that valves can be replaced with no large incisions, no heart-lung machine, and potentially no general anesthesia.

The Centers for Medicare and Medicaid Services decided in May that it will cover the procedure in inoperable patients, under certain conditions, including the presence of a heart team during the procedure and evaluation of the patient by two cardiac surgeons.

Heart teams, collaboration between industry and cardiology societies, and continuing development of the TVT registry were also discussed during the meeting.

Dr. Gregory J. Dehmer, professor of medicine at Texas A&M University, said that the field was only at its infancy. In 35 years, a similar panel might be discussing the transradial approach to TAVR, he said, pointing to his wrist.

Dr. Naftel and Dr. Dehmer had no disclosures. Dr. Smith is a coprinciple investigator for the PARTNER trial.

GAITHERSBURG, MD. – The benefits of Edwards SAPIEN transcatheter heart valve outweigh its risks for older patients with severe, symptomatic aortic stenosis who are at a high risk for surgery, voted the majority of an advisory panel to the Food and Drug Administration on June 13.

All panel members also voted that the valve was effective, and 10 of 12 members said that it was safe. Two members said no to the safety issue.

If approved by the FDA, the valve’s indications will expand its application to a wider group of patients.

The valve entered the U.S. market last November after receiving FDA approval for patients who have severe aortic stenosis and are deemed too sick to undergo surgical heart valve replacement (Cohort B of the pivotal PARTNER trial). (N. Engl. J. Med. 2010;363:1597-607)

On June 12, Edwards Lifescience, the makers of the SAPIEN transcatheter heart valve, said that based on the results of the PARTNER pivotal trial, the valve is also safe and effective in the high-risk cohort (Cohort A) when used according to approved labeling.

Although FDA officials agreed that the trial met its primary end points, they expressed concern with the higher risk of stroke in patients who underwent transcatheter aortic valve replacement (TAVR), compared with those who underwent surgery. They also raised questions about the long-term durability of the device, for which there are no data yet available yet.

In his final remarks, Dr. Craig R. Smith, chair of the department of surgery at Columbia University and coprinciple investigator of the PARTNER trial, said that although the risks associated with the procedures must be taken seriously, they should not an obstacle to the indication’s approval.

The panel’s recommendation is not a definitive predictor of the FDA’s final decision, but if the valve is eventually approved for such indication, "there will be a tendency to say to everybody that we have a winner," said David C. Naftel, Ph.D., a voting member of the panel from the University of Alabama, Birmingham. "But it’s not a winner, it’s a noninferiority trial."

The main results of the cohort A trial showed that all-cause mortality at 30 days favored TAVR at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin, yet again, neurologic complications occurred more frequently after TAVR.

Stroke was a major secondary end point and was defined as a focal deficit lasting greater than 24 hours or a focal deficit lasting greater than 24 hours with positive neuron-imaging studies. Each event was adjudicated in a blinded review by an independent clinical events committee and subclassified (ischemic, hemorrhagic, or undetermined etiology).

Surgical valve replacement has evolved over the past 50 years, and although TAVR is radical, it’s the next logical step in that evolution, Dr. Smith told the panel. The results of the cohort A of PARTNER, he said, bring the field one step closer to the day that valves can be replaced with no large incisions, no heart-lung machine, and potentially no general anesthesia.

The Centers for Medicare and Medicaid Services decided in May that it will cover the procedure in inoperable patients, under certain conditions, including the presence of a heart team during the procedure and evaluation of the patient by two cardiac surgeons.

Heart teams, collaboration between industry and cardiology societies, and continuing development of the TVT registry were also discussed during the meeting.

Dr. Gregory J. Dehmer, professor of medicine at Texas A&M University, said that the field was only at its infancy. In 35 years, a similar panel might be discussing the transradial approach to TAVR, he said, pointing to his wrist.

Dr. Naftel and Dr. Dehmer had no disclosures. Dr. Smith is a coprinciple investigator for the PARTNER trial.

Available data are not strong enough to show a definitive association between vitamin D levels and risk of obesity, diabetes, cancer, heart disease, or maternal-fetal health, according to a comprehensive review of available research.

"The efficacy issue [of vitamin D] remains a major question mark," said Dr. Clifford J. Rosen in an interview. He chaired the group that wrote the scientific statement published by Endocrine Society (Endocr. Rev. 2012 May 17 [doi:10.1210/er.2012-1000]).

© Kaspri/Fotolia.com

The scientific statement takes a comprehensive look at basic and clinical evidence related to the effect of vitamin D and various organ systems.

Although some observational studies have shown that benefits of vitamin D may extend beyond bone health, the findings are inconsistent, the authors noted.

"We need large randomized controlled trials and dose-response data to test the effects of vitamin D on chronic disease outcomes including autoimmunity, obesity, diabetes, hypertension, and heart disease," said Dr. Rosen, professor of medicine at Tufts University, Boston, in a statement.

Dr. Robert H. Eckel, past president of the American Heart Association, said he agreed with the findings of the report. He said that physicians should be aware of low vitamin D levels and should correct the deficiencies, but they should not make any strong statements about vitamin D levels and risk for conditions such as heart disease or cancer, due to lack of sufficient evidence.

He added that ultimately, data from large, well-designed trials "may be informative in uncovering a relationship that’s more meaningful." Dr. Eckel, who is a professor of medicine at University of Colorado at Denver, Aurora, was not involved in the study.

Interest in vitamin D as a therapeutic option for the prevention of chronic disease has been growing in recent years, the authors noted. "In a 2-month span during the summer of 2011, there were more than 500 publications centered on vitamin D, most of which were related to its relationship to nonskeletal tissues," they wrote. But the results, they added, are confounded and difficult to interpret.

By organ or disorder, the authors came to the following conclusions:

• Skin. "There are no large-scale, randomized, placebo-controlled clinical trials demonstrating that vitamin D metabolites are superior to other types of treatment for various proliferative skin disorders or for the prevention of skin cancer."

• Obesity and diabetes mellitus. "The ever-expanding obesity epidemic has been associated with a rising prevalence of vitamin D deficiency, but a cause-and-effect relationship has not been established. ... There remains a paucity of randomized controlled trials of vitamin D for the prevention of diabetes; hence, few conclusions can be firmly established."

• Fall prevention and improvement in quality of life. Citing the public health implication of fall prevention, and the report by the Institute of Medicine, the authors wrote, "The absolute threshold level of [vitamin D] needed to prevent falls in an elderly population is not known in part because of lack of true dose-ranging studies. ... Selecting patients at risk for falls and defining the appropriate dose remains as areas in need of further research."

• Cancer. "Despite biological plausibility for a role of vitamin D in cancer prevention, most recent systematic reviews and meta-analyses, as well as a comprehensive review by the IOM Committee, have found that the evidence that vitamin D reduces cancer incidence and/or mortality is inconsistent and inconclusive as to causality."

• Cardiovascular disease. Although there is a possibility that vitamin D supplementation may lower cardiovascular risk, "additional research, particularly from randomized trials, is needed."

• The placenta and maternal-fetal health. "There is insufficient evidence to recommend a particular maternal intake of vitamin D or [serum 25-hydroxyvitamin D] blood level during pregnancy to achieve any purported nonskeletal benefit of vitamin D," the authors wrote, but they added that "the biological plausibility may be sufficient to justify clinical trials to test whether vitamin D supplementation during pregnancy will prevent type 1 diabetes in the offspring."

"We’re hopeful that some of the intervention trial [on vitamin D] will get underway, and although they’re expensive, their findings can help change practice," said Dr. Rosen.

Dr. Rosen reported no relevant conflicts of interest.

Available data are not strong enough to show a definitive association between vitamin D levels and risk of obesity, diabetes, cancer, heart disease, or maternal-fetal health, according to a comprehensive review of available research.

"The efficacy issue [of vitamin D] remains a major question mark," said Dr. Clifford J. Rosen in an interview. He chaired the group that wrote the scientific statement published by Endocrine Society (Endocr. Rev. 2012 May 17 [doi:10.1210/er.2012-1000]).

© Kaspri/Fotolia.com

The scientific statement takes a comprehensive look at basic and clinical evidence related to the effect of vitamin D and various organ systems.

Although some observational studies have shown that benefits of vitamin D may extend beyond bone health, the findings are inconsistent, the authors noted.

"We need large randomized controlled trials and dose-response data to test the effects of vitamin D on chronic disease outcomes including autoimmunity, obesity, diabetes, hypertension, and heart disease," said Dr. Rosen, professor of medicine at Tufts University, Boston, in a statement.

Dr. Robert H. Eckel, past president of the American Heart Association, said he agreed with the findings of the report. He said that physicians should be aware of low vitamin D levels and should correct the deficiencies, but they should not make any strong statements about vitamin D levels and risk for conditions such as heart disease or cancer, due to lack of sufficient evidence.

He added that ultimately, data from large, well-designed trials "may be informative in uncovering a relationship that’s more meaningful." Dr. Eckel, who is a professor of medicine at University of Colorado at Denver, Aurora, was not involved in the study.

Interest in vitamin D as a therapeutic option for the prevention of chronic disease has been growing in recent years, the authors noted. "In a 2-month span during the summer of 2011, there were more than 500 publications centered on vitamin D, most of which were related to its relationship to nonskeletal tissues," they wrote. But the results, they added, are confounded and difficult to interpret.

By organ or disorder, the authors came to the following conclusions:

• Skin. "There are no large-scale, randomized, placebo-controlled clinical trials demonstrating that vitamin D metabolites are superior to other types of treatment for various proliferative skin disorders or for the prevention of skin cancer."

• Obesity and diabetes mellitus. "The ever-expanding obesity epidemic has been associated with a rising prevalence of vitamin D deficiency, but a cause-and-effect relationship has not been established. ... There remains a paucity of randomized controlled trials of vitamin D for the prevention of diabetes; hence, few conclusions can be firmly established."

• Fall prevention and improvement in quality of life. Citing the public health implication of fall prevention, and the report by the Institute of Medicine, the authors wrote, "The absolute threshold level of [vitamin D] needed to prevent falls in an elderly population is not known in part because of lack of true dose-ranging studies. ... Selecting patients at risk for falls and defining the appropriate dose remains as areas in need of further research."

• Cancer. "Despite biological plausibility for a role of vitamin D in cancer prevention, most recent systematic reviews and meta-analyses, as well as a comprehensive review by the IOM Committee, have found that the evidence that vitamin D reduces cancer incidence and/or mortality is inconsistent and inconclusive as to causality."

• Cardiovascular disease. Although there is a possibility that vitamin D supplementation may lower cardiovascular risk, "additional research, particularly from randomized trials, is needed."

• The placenta and maternal-fetal health. "There is insufficient evidence to recommend a particular maternal intake of vitamin D or [serum 25-hydroxyvitamin D] blood level during pregnancy to achieve any purported nonskeletal benefit of vitamin D," the authors wrote, but they added that "the biological plausibility may be sufficient to justify clinical trials to test whether vitamin D supplementation during pregnancy will prevent type 1 diabetes in the offspring."

"We’re hopeful that some of the intervention trial [on vitamin D] will get underway, and although they’re expensive, their findings can help change practice," said Dr. Rosen.

Dr. Rosen reported no relevant conflicts of interest.

Available data are not strong enough to show a definitive association between vitamin D levels and risk of obesity, diabetes, cancer, heart disease, or maternal-fetal health, according to a comprehensive review of available research.

"The efficacy issue [of vitamin D] remains a major question mark," said Dr. Clifford J. Rosen in an interview. He chaired the group that wrote the scientific statement published by Endocrine Society (Endocr. Rev. 2012 May 17 [doi:10.1210/er.2012-1000]).

© Kaspri/Fotolia.com

The scientific statement takes a comprehensive look at basic and clinical evidence related to the effect of vitamin D and various organ systems.

Although some observational studies have shown that benefits of vitamin D may extend beyond bone health, the findings are inconsistent, the authors noted.

"We need large randomized controlled trials and dose-response data to test the effects of vitamin D on chronic disease outcomes including autoimmunity, obesity, diabetes, hypertension, and heart disease," said Dr. Rosen, professor of medicine at Tufts University, Boston, in a statement.

Dr. Robert H. Eckel, past president of the American Heart Association, said he agreed with the findings of the report. He said that physicians should be aware of low vitamin D levels and should correct the deficiencies, but they should not make any strong statements about vitamin D levels and risk for conditions such as heart disease or cancer, due to lack of sufficient evidence.

He added that ultimately, data from large, well-designed trials "may be informative in uncovering a relationship that’s more meaningful." Dr. Eckel, who is a professor of medicine at University of Colorado at Denver, Aurora, was not involved in the study.

Interest in vitamin D as a therapeutic option for the prevention of chronic disease has been growing in recent years, the authors noted. "In a 2-month span during the summer of 2011, there were more than 500 publications centered on vitamin D, most of which were related to its relationship to nonskeletal tissues," they wrote. But the results, they added, are confounded and difficult to interpret.

By organ or disorder, the authors came to the following conclusions:

• Skin. "There are no large-scale, randomized, placebo-controlled clinical trials demonstrating that vitamin D metabolites are superior to other types of treatment for various proliferative skin disorders or for the prevention of skin cancer."

• Obesity and diabetes mellitus. "The ever-expanding obesity epidemic has been associated with a rising prevalence of vitamin D deficiency, but a cause-and-effect relationship has not been established. ... There remains a paucity of randomized controlled trials of vitamin D for the prevention of diabetes; hence, few conclusions can be firmly established."

• Fall prevention and improvement in quality of life. Citing the public health implication of fall prevention, and the report by the Institute of Medicine, the authors wrote, "The absolute threshold level of [vitamin D] needed to prevent falls in an elderly population is not known in part because of lack of true dose-ranging studies. ... Selecting patients at risk for falls and defining the appropriate dose remains as areas in need of further research."

• Cancer. "Despite biological plausibility for a role of vitamin D in cancer prevention, most recent systematic reviews and meta-analyses, as well as a comprehensive review by the IOM Committee, have found that the evidence that vitamin D reduces cancer incidence and/or mortality is inconsistent and inconclusive as to causality."

• Cardiovascular disease. Although there is a possibility that vitamin D supplementation may lower cardiovascular risk, "additional research, particularly from randomized trials, is needed."

• The placenta and maternal-fetal health. "There is insufficient evidence to recommend a particular maternal intake of vitamin D or [serum 25-hydroxyvitamin D] blood level during pregnancy to achieve any purported nonskeletal benefit of vitamin D," the authors wrote, but they added that "the biological plausibility may be sufficient to justify clinical trials to test whether vitamin D supplementation during pregnancy will prevent type 1 diabetes in the offspring."

"We’re hopeful that some of the intervention trial [on vitamin D] will get underway, and although they’re expensive, their findings can help change practice," said Dr. Rosen.

Dr. Rosen reported no relevant conflicts of interest.

Stroke is one of the new measures that hospitals must report on starting Jan. 1, 2013, to receive full Medicare reimbursement for stroke care delivered in 2015. The requirement is part of the Centers for Medicare and Medicaid Services’ (CMS) Hospital Inpatient Quality Reporting Program, which was established in 2003, with the goal of improving inpatient care.

The latest additions include 17 areas and have a total of 76 new measures. The eight measures added under stroke include venous thromboembolism prophylaxis; discharge on antithrombotic therapy; anticoagulation therapy for atrial fibrillation/flutter; thrombolytic therapy; antithrombotic therapy by end of hospital day 2; discharge on statin medication; stroke education; and assessment for rehabilitation.

Providing stroke metrics to CMS will be less challenging for primary stroke centers – those that are state or nationally certified and already collecting data on those measures, said Tim Shephard, Ph.D., vice president of Bon Secours Neuroscience Institute, Richmond, Va.

The process, however, can be challenging and costly for other hospitals, which have to figure out how to collect and report the data, he said.

Dr. Shephard, who has helped establish dozens of primary stroke centers, had the following advice:

• Be very intentional about the process: Hospitals should realize that by capturing, analyzing, and acting on these data you can reduce readmissions, complications, length of stay, and cost while improving patient outcomes. The goal should be more than just collecting and reporting the data. You should understand why the metric is important and implement robust performance improvement actions to increase adherence rates.

• Review your stroke documentation: Decide how and where you’re going to document each measure and standardize the process in multisite systems. This applies to paper, hybrid, and fully implemented electronic medical record systems. This will save time and resources when abstracting the data from the record.

• Consult early with an expert in stroke and/or neuroscience: There is a shortage of physicians, nurses, and administrative with neuroscience expertise. If this is a new process or you’re a small hospital and don’t have in-house neuroscience resources, tap into your nearest primary stroke center, the National Stroke Association’s Stroke Center Network, or the American Heart/Stroke Association for help understating the measures and implementing performance improvement action plans.

He also stressed the importance of being deliberate about the process. "Look at your stroke volume, readmission, and complication rates, and at tPA /reperfusion utilization rates. Establish your baseline performance, define your PI action plans, targets, and timeline, and ask your financial department to define your return on investment for successful implementation of this process."

Dr. Shephard added that nonstroke centers should expect some upfront costs. "If you don’t have the process in place for stroke metrics, then your cost will be higher since there will be a cost for abstracting every ischemic stroke record and collating the data.

"It can take 15-45 minutes to abstract these data from a single patient chart. It’s not going to be cost-free, but a hospital that’s deliberate about the process realizes the benefit to patients and the cost-savings downstream," he said.

Stroke is one of the new measures that hospitals must report on starting Jan. 1, 2013, to receive full Medicare reimbursement for stroke care delivered in 2015. The requirement is part of the Centers for Medicare and Medicaid Services’ (CMS) Hospital Inpatient Quality Reporting Program, which was established in 2003, with the goal of improving inpatient care.

The latest additions include 17 areas and have a total of 76 new measures. The eight measures added under stroke include venous thromboembolism prophylaxis; discharge on antithrombotic therapy; anticoagulation therapy for atrial fibrillation/flutter; thrombolytic therapy; antithrombotic therapy by end of hospital day 2; discharge on statin medication; stroke education; and assessment for rehabilitation.

Providing stroke metrics to CMS will be less challenging for primary stroke centers – those that are state or nationally certified and already collecting data on those measures, said Tim Shephard, Ph.D., vice president of Bon Secours Neuroscience Institute, Richmond, Va.

The process, however, can be challenging and costly for other hospitals, which have to figure out how to collect and report the data, he said.

Dr. Shephard, who has helped establish dozens of primary stroke centers, had the following advice:

• Be very intentional about the process: Hospitals should realize that by capturing, analyzing, and acting on these data you can reduce readmissions, complications, length of stay, and cost while improving patient outcomes. The goal should be more than just collecting and reporting the data. You should understand why the metric is important and implement robust performance improvement actions to increase adherence rates.

• Review your stroke documentation: Decide how and where you’re going to document each measure and standardize the process in multisite systems. This applies to paper, hybrid, and fully implemented electronic medical record systems. This will save time and resources when abstracting the data from the record.

• Consult early with an expert in stroke and/or neuroscience: There is a shortage of physicians, nurses, and administrative with neuroscience expertise. If this is a new process or you’re a small hospital and don’t have in-house neuroscience resources, tap into your nearest primary stroke center, the National Stroke Association’s Stroke Center Network, or the American Heart/Stroke Association for help understating the measures and implementing performance improvement action plans.

He also stressed the importance of being deliberate about the process. "Look at your stroke volume, readmission, and complication rates, and at tPA /reperfusion utilization rates. Establish your baseline performance, define your PI action plans, targets, and timeline, and ask your financial department to define your return on investment for successful implementation of this process."

Dr. Shephard added that nonstroke centers should expect some upfront costs. "If you don’t have the process in place for stroke metrics, then your cost will be higher since there will be a cost for abstracting every ischemic stroke record and collating the data.

"It can take 15-45 minutes to abstract these data from a single patient chart. It’s not going to be cost-free, but a hospital that’s deliberate about the process realizes the benefit to patients and the cost-savings downstream," he said.

Stroke is one of the new measures that hospitals must report on starting Jan. 1, 2013, to receive full Medicare reimbursement for stroke care delivered in 2015. The requirement is part of the Centers for Medicare and Medicaid Services’ (CMS) Hospital Inpatient Quality Reporting Program, which was established in 2003, with the goal of improving inpatient care.

The latest additions include 17 areas and have a total of 76 new measures. The eight measures added under stroke include venous thromboembolism prophylaxis; discharge on antithrombotic therapy; anticoagulation therapy for atrial fibrillation/flutter; thrombolytic therapy; antithrombotic therapy by end of hospital day 2; discharge on statin medication; stroke education; and assessment for rehabilitation.

Providing stroke metrics to CMS will be less challenging for primary stroke centers – those that are state or nationally certified and already collecting data on those measures, said Tim Shephard, Ph.D., vice president of Bon Secours Neuroscience Institute, Richmond, Va.

The process, however, can be challenging and costly for other hospitals, which have to figure out how to collect and report the data, he said.

Dr. Shephard, who has helped establish dozens of primary stroke centers, had the following advice:

• Be very intentional about the process: Hospitals should realize that by capturing, analyzing, and acting on these data you can reduce readmissions, complications, length of stay, and cost while improving patient outcomes. The goal should be more than just collecting and reporting the data. You should understand why the metric is important and implement robust performance improvement actions to increase adherence rates.

• Review your stroke documentation: Decide how and where you’re going to document each measure and standardize the process in multisite systems. This applies to paper, hybrid, and fully implemented electronic medical record systems. This will save time and resources when abstracting the data from the record.

• Consult early with an expert in stroke and/or neuroscience: There is a shortage of physicians, nurses, and administrative with neuroscience expertise. If this is a new process or you’re a small hospital and don’t have in-house neuroscience resources, tap into your nearest primary stroke center, the National Stroke Association’s Stroke Center Network, or the American Heart/Stroke Association for help understating the measures and implementing performance improvement action plans.

He also stressed the importance of being deliberate about the process. "Look at your stroke volume, readmission, and complication rates, and at tPA /reperfusion utilization rates. Establish your baseline performance, define your PI action plans, targets, and timeline, and ask your financial department to define your return on investment for successful implementation of this process."

Dr. Shephard added that nonstroke centers should expect some upfront costs. "If you don’t have the process in place for stroke metrics, then your cost will be higher since there will be a cost for abstracting every ischemic stroke record and collating the data.

"It can take 15-45 minutes to abstract these data from a single patient chart. It’s not going to be cost-free, but a hospital that’s deliberate about the process realizes the benefit to patients and the cost-savings downstream," he said.

Medicare will cover transcatheter aortic valve replacement, or TAVR, under certain conditions, including the presence of a heart team during the procedure and evaluation of the patient by two cardiac surgeons, according to an official document released on May 1.

The Centers for Medicare and Medicaid Services’ (CMS) final national coverage decision for TAVR arrives as planned, nearly 3 months after the agency released its coverage proposal.

"This decision is particularly important as it highlights cooperative efforts among CMS, the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality, medical societies, and the medical device industry," said CMS Acting Administrator Marilyn Tavenner in a statement.

Because TAVR is relatively new, the final decision uses "coverage with evidence development," meaning certain criteria must be met as a condition of coverage, according to the statement.

The criteria outlined by CMS include:

• Two cardiac surgeons independently examine the patient face-to-face and evaluate the patient’s suitability for open valve replacement surgery.

• Before and after the surgery, the patient is under the care of a heart team, which is "a cohesive, multidisciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care," according to the decision document. The document breaks down these criteria by centers with or without previous TAVR clinical trial experience.

• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must work together on the intraoperative technical aspects of TAVR.

• The heart team and hospital are also participating in a prospective, national, audited registry.

The agency will cover the procedure in clinical trials that follow criteria listed in the decision memo.

Meanwhile, Medicare patients whose comorbidities would prevent them from benefiting from the procedure will not be covered.

CMS also responded to comments, making some changes.

For instance, 23 commenters had disagreed with the requirement that unlabeled uses of TAVR be covered in clinical studies that have superiority designs. Eight had requested that CMS remove the requirement, according to CMS’s final decision memo.

Among those commenters was Edwards Lifesciences, the maker of the Sapien valve.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued U.S.-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Removing the requirement, CMS explained in its final decision memo that "while we believe superiority trial designs provide important advantages that are not completely addressed by non-inferiority design, we recognize that non-inferiority trials have a place in the conduct of medical device regulatory trials.

"Therefore, we believe a broad non-coverage of non-inferiority trials may have unintended consequences for certain important studies."

CMS opened the national coverage determination analysis in September 2011, before the Edwards Lifesciences Sapien valve was approved, in response to a request from the Society of Thoracic Surgeons and the American College of Cardiology to establish the criteria for national Medicare coverage of the minimally invasive valve procedure.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011 for use in inoperable patients with severe aortic stenosis.

The FDA’s Circulatory System Devices Panel will be meeting in order to evaluate the Sapien valve’s performance in severe aortic stenosis patients who are at high surgical risk for use in this application on June 13. Medtronic’s CoreValve is also in being studied in large U.S. trials.

Medicare will cover transcatheter aortic valve replacement, or TAVR, under certain conditions, including the presence of a heart team during the procedure and evaluation of the patient by two cardiac surgeons, according to an official document released on May 1.

The Centers for Medicare and Medicaid Services’ (CMS) final national coverage decision for TAVR arrives as planned, nearly 3 months after the agency released its coverage proposal.

"This decision is particularly important as it highlights cooperative efforts among CMS, the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality, medical societies, and the medical device industry," said CMS Acting Administrator Marilyn Tavenner in a statement.

Because TAVR is relatively new, the final decision uses "coverage with evidence development," meaning certain criteria must be met as a condition of coverage, according to the statement.

The criteria outlined by CMS include:

• Two cardiac surgeons independently examine the patient face-to-face and evaluate the patient’s suitability for open valve replacement surgery.

• Before and after the surgery, the patient is under the care of a heart team, which is "a cohesive, multidisciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care," according to the decision document. The document breaks down these criteria by centers with or without previous TAVR clinical trial experience.

• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must work together on the intraoperative technical aspects of TAVR.

• The heart team and hospital are also participating in a prospective, national, audited registry.

The agency will cover the procedure in clinical trials that follow criteria listed in the decision memo.

Meanwhile, Medicare patients whose comorbidities would prevent them from benefiting from the procedure will not be covered.

CMS also responded to comments, making some changes.

For instance, 23 commenters had disagreed with the requirement that unlabeled uses of TAVR be covered in clinical studies that have superiority designs. Eight had requested that CMS remove the requirement, according to CMS’s final decision memo.

Among those commenters was Edwards Lifesciences, the maker of the Sapien valve.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued U.S.-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Removing the requirement, CMS explained in its final decision memo that "while we believe superiority trial designs provide important advantages that are not completely addressed by non-inferiority design, we recognize that non-inferiority trials have a place in the conduct of medical device regulatory trials.

"Therefore, we believe a broad non-coverage of non-inferiority trials may have unintended consequences for certain important studies."

CMS opened the national coverage determination analysis in September 2011, before the Edwards Lifesciences Sapien valve was approved, in response to a request from the Society of Thoracic Surgeons and the American College of Cardiology to establish the criteria for national Medicare coverage of the minimally invasive valve procedure.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011 for use in inoperable patients with severe aortic stenosis.

The FDA’s Circulatory System Devices Panel will be meeting in order to evaluate the Sapien valve’s performance in severe aortic stenosis patients who are at high surgical risk for use in this application on June 13. Medtronic’s CoreValve is also in being studied in large U.S. trials.

Medicare will cover transcatheter aortic valve replacement, or TAVR, under certain conditions, including the presence of a heart team during the procedure and evaluation of the patient by two cardiac surgeons, according to an official document released on May 1.

The Centers for Medicare and Medicaid Services’ (CMS) final national coverage decision for TAVR arrives as planned, nearly 3 months after the agency released its coverage proposal.

"This decision is particularly important as it highlights cooperative efforts among CMS, the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality, medical societies, and the medical device industry," said CMS Acting Administrator Marilyn Tavenner in a statement.

Because TAVR is relatively new, the final decision uses "coverage with evidence development," meaning certain criteria must be met as a condition of coverage, according to the statement.

The criteria outlined by CMS include:

• Two cardiac surgeons independently examine the patient face-to-face and evaluate the patient’s suitability for open valve replacement surgery.

• Before and after the surgery, the patient is under the care of a heart team, which is "a cohesive, multidisciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care," according to the decision document. The document breaks down these criteria by centers with or without previous TAVR clinical trial experience.

• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must work together on the intraoperative technical aspects of TAVR.

• The heart team and hospital are also participating in a prospective, national, audited registry.

The agency will cover the procedure in clinical trials that follow criteria listed in the decision memo.

Meanwhile, Medicare patients whose comorbidities would prevent them from benefiting from the procedure will not be covered.

CMS also responded to comments, making some changes.

For instance, 23 commenters had disagreed with the requirement that unlabeled uses of TAVR be covered in clinical studies that have superiority designs. Eight had requested that CMS remove the requirement, according to CMS’s final decision memo.

Among those commenters was Edwards Lifesciences, the maker of the Sapien valve.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued U.S.-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Removing the requirement, CMS explained in its final decision memo that "while we believe superiority trial designs provide important advantages that are not completely addressed by non-inferiority design, we recognize that non-inferiority trials have a place in the conduct of medical device regulatory trials.

"Therefore, we believe a broad non-coverage of non-inferiority trials may have unintended consequences for certain important studies."

CMS opened the national coverage determination analysis in September 2011, before the Edwards Lifesciences Sapien valve was approved, in response to a request from the Society of Thoracic Surgeons and the American College of Cardiology to establish the criteria for national Medicare coverage of the minimally invasive valve procedure.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011 for use in inoperable patients with severe aortic stenosis.

The FDA’s Circulatory System Devices Panel will be meeting in order to evaluate the Sapien valve’s performance in severe aortic stenosis patients who are at high surgical risk for use in this application on June 13. Medtronic’s CoreValve is also in being studied in large U.S. trials.

PHILADELPHIA – Patients who lived in rural areas and received tele-endocrinology consultations saw improvements in endocrine disorders such as diabetes, according to a small pilot study.

There was marked improvement in hemoglobin A_1c in patients with diabetes, marked improvement in some patients’ lipid profiles, "and we had some patients with thyroid disorders and we saw some euthyroid during the course of the study," said Dr. Rabia Rehman, an endocrinology fellow at the University of Tennessee Health Science Center, Memphis.

The study also highlighted the role of primary care providers in rural areas who referred the patients to the telemedicine consultations and helped with the continuity of their care.

Telemedicine is not a new concept and its potential benefits have been established in certain areas such as stroke care.

Dr. Rehman said tele-endocrinology can be beneficial today, when the rates of diabetes and other endocrine disorders are rising. That’s especially true in rural areas where there’s a lack of specialists and patients have to travel far to get to the nearest specialty provider or medical center, she said.

Sixty-six patients from five rural areas in Tennessee received remote consultations at the telemedicine unit of the University of Tennessee in Memphis over a period of 2½ years. The unit and the remote sites were connected by video cameras, television monitors, and Internet.

Recommendations for management of the conditions were faxed to the patients’ primary care providers, and specialists evaluated laboratory results per primary care providers’ requests.

Among the 66 patients, 35 (53%) had type 2 diabetes, 24 (41%) had hypertension, 30 (45%) had dyslipidemia, 20 (30%) had thyroid disease, and 8 (12%) had osteoporosis or hypercalcemia.

In the 20 of the 35 diabetic patients who had a 6-month follow-up, mean HbA_1c decreased by 1.7 percentage points, from 9.1% to 7.5%. The other 15 patients dropped out.

High dropout rate, in fact, was one of the limitations of the study. Dr. Rehman said the attrition could be due to the fact that the patients were comfortable with continuing their care with their primary care providers, and for other unknown reasons.

Follow-up data were available for 4 of the 20 patients with thyroid disease; all 4 became euthyroid, according to the study.

Also, data available on 17 patients with dyslipidemia showed that lipid profiles improved in 12 of them.

Almost all of the patients (97%) said they were comfortable with receiving care through videoconferencing.

Dr. Rehman said that the long-term cost savings due to improved health outcomes far outweighed the upfront cost of setting up the remote sites. She did not provide specific data on the cost of remote sites presented in this study.

These results show that "this is something that should be continued, and bigger, prospective studies should be done on effectiveness of telemedicine and bridging [the health care] gap," said Dr. Rehman, who indicated that she had no disclosures.

PHILADELPHIA – Patients who lived in rural areas and received tele-endocrinology consultations saw improvements in endocrine disorders such as diabetes, according to a small pilot study.

There was marked improvement in hemoglobin A_1c in patients with diabetes, marked improvement in some patients’ lipid profiles, "and we had some patients with thyroid disorders and we saw some euthyroid during the course of the study," said Dr. Rabia Rehman, an endocrinology fellow at the University of Tennessee Health Science Center, Memphis.

The study also highlighted the role of primary care providers in rural areas who referred the patients to the telemedicine consultations and helped with the continuity of their care.

Telemedicine is not a new concept and its potential benefits have been established in certain areas such as stroke care.

Dr. Rehman said tele-endocrinology can be beneficial today, when the rates of diabetes and other endocrine disorders are rising. That’s especially true in rural areas where there’s a lack of specialists and patients have to travel far to get to the nearest specialty provider or medical center, she said.

Sixty-six patients from five rural areas in Tennessee received remote consultations at the telemedicine unit of the University of Tennessee in Memphis over a period of 2½ years. The unit and the remote sites were connected by video cameras, television monitors, and Internet.

Recommendations for management of the conditions were faxed to the patients’ primary care providers, and specialists evaluated laboratory results per primary care providers’ requests.

Among the 66 patients, 35 (53%) had type 2 diabetes, 24 (41%) had hypertension, 30 (45%) had dyslipidemia, 20 (30%) had thyroid disease, and 8 (12%) had osteoporosis or hypercalcemia.

In the 20 of the 35 diabetic patients who had a 6-month follow-up, mean HbA_1c decreased by 1.7 percentage points, from 9.1% to 7.5%. The other 15 patients dropped out.

High dropout rate, in fact, was one of the limitations of the study. Dr. Rehman said the attrition could be due to the fact that the patients were comfortable with continuing their care with their primary care providers, and for other unknown reasons.

Follow-up data were available for 4 of the 20 patients with thyroid disease; all 4 became euthyroid, according to the study.

Also, data available on 17 patients with dyslipidemia showed that lipid profiles improved in 12 of them.

Almost all of the patients (97%) said they were comfortable with receiving care through videoconferencing.

Dr. Rehman said that the long-term cost savings due to improved health outcomes far outweighed the upfront cost of setting up the remote sites. She did not provide specific data on the cost of remote sites presented in this study.

These results show that "this is something that should be continued, and bigger, prospective studies should be done on effectiveness of telemedicine and bridging [the health care] gap," said Dr. Rehman, who indicated that she had no disclosures.

PHILADELPHIA – Patients who lived in rural areas and received tele-endocrinology consultations saw improvements in endocrine disorders such as diabetes, according to a small pilot study.

There was marked improvement in hemoglobin A_1c in patients with diabetes, marked improvement in some patients’ lipid profiles, "and we had some patients with thyroid disorders and we saw some euthyroid during the course of the study," said Dr. Rabia Rehman, an endocrinology fellow at the University of Tennessee Health Science Center, Memphis.

The study also highlighted the role of primary care providers in rural areas who referred the patients to the telemedicine consultations and helped with the continuity of their care.

Telemedicine is not a new concept and its potential benefits have been established in certain areas such as stroke care.

Dr. Rehman said tele-endocrinology can be beneficial today, when the rates of diabetes and other endocrine disorders are rising. That’s especially true in rural areas where there’s a lack of specialists and patients have to travel far to get to the nearest specialty provider or medical center, she said.

Sixty-six patients from five rural areas in Tennessee received remote consultations at the telemedicine unit of the University of Tennessee in Memphis over a period of 2½ years. The unit and the remote sites were connected by video cameras, television monitors, and Internet.

Recommendations for management of the conditions were faxed to the patients’ primary care providers, and specialists evaluated laboratory results per primary care providers’ requests.

Among the 66 patients, 35 (53%) had type 2 diabetes, 24 (41%) had hypertension, 30 (45%) had dyslipidemia, 20 (30%) had thyroid disease, and 8 (12%) had osteoporosis or hypercalcemia.

In the 20 of the 35 diabetic patients who had a 6-month follow-up, mean HbA_1c decreased by 1.7 percentage points, from 9.1% to 7.5%. The other 15 patients dropped out.

High dropout rate, in fact, was one of the limitations of the study. Dr. Rehman said the attrition could be due to the fact that the patients were comfortable with continuing their care with their primary care providers, and for other unknown reasons.

Follow-up data were available for 4 of the 20 patients with thyroid disease; all 4 became euthyroid, according to the study.

Also, data available on 17 patients with dyslipidemia showed that lipid profiles improved in 12 of them.

Almost all of the patients (97%) said they were comfortable with receiving care through videoconferencing.

Dr. Rehman said that the long-term cost savings due to improved health outcomes far outweighed the upfront cost of setting up the remote sites. She did not provide specific data on the cost of remote sites presented in this study.

These results show that "this is something that should be continued, and bigger, prospective studies should be done on effectiveness of telemedicine and bridging [the health care] gap," said Dr. Rehman, who indicated that she had no disclosures.

Four dermatology societies joined together to create the first appropriate use criteria for Mohs surgery, consenting that in two-thirds of nearly 300 possible scenarios the micrographic procedure is appropriate.

The American Academy of Dermatology (AAD) developed the appropriate use criteria (AUC) for 270 scenarios for Mohs surgery in collaboration with the American College of Mohs Surgery, the American Society for Dermatologic Surgery, and the American Society for Mohs Surgery.

The main driver behind the creation of the 46-page document, which is the first of its kind for any test or treatment option in the field of dermatology, is Medicare, said Dr. Mark J. Zalla, a member of the report’s ad hoc task force that developed the indications.

"The intent of the criteria is to help us maintain the value of Mohs in terms of reimbursement," added Dr. Zalla, who is in private practice in Florence, Ky.

Use of Mohs surgery increased by 400% between 1995 and 2009. (Dermatol. Clin. 2012;30:167-75). "And when Medicare sees use of a specific code increasing significantly over several years, they get concerned," said Dr. Zalla. Some Medicare carriers have already threatened to impose certain criteria for Mohs surgery reimbursement. "And if one carrier does it, it’s possible that [the criteria will become applicable] nationwide," he said.

But Dr. Zalla and advocates for the procedure argue that the sharp increase doesn’t necessarily mean that it is being overutilized. Rather, it’s most likely the result of several factors, including the nation’s skin cancer epidemic and an increase in the number of fellows trained in Mohs surgery.

The ACMS has been ramping up its efforts to raise awareness about the surgery among payers and policy makers. The college has so far spent $20,000 in education lobbying this year, according to the Center for Responsive Politics.

"The bottom line is that dermatologists and Mohs surgeons are the good guys," said Dr. Brett M. Coldiron, president of ACMS and a member of the AUC ad hoc task force. "We are part of the solution, not the problem."

The scenarios represent roughly 85% of anticipated clinical scenarios, the authors noted in their report.

The members of a 17-member rating panel, made up of Mohs surgeons and non-Mohs dermatologists, scored the scenarios on a 9-point scale. Scenarios scoring 7-9 were deemed appropriate, those scoring 4-6 were uncertain, and those scoring 1-3 were inappropriate.

"Those clinical situations for which use of Mohs was rated as uncertain are areas ripe for productive clinical research," said Dr. Suzanne M. Connolly, chair of the AUC task force.

The document breaks down the appropriateness of Mohs surgery by the following skin cancer types:

• For 69 basal cell carcinoma scenarios, 53 were rated appropriate, 6 uncertain, 10 inappropriate.

• For 143 squamous cell carcinoma scenarios, 102 were rated appropriate, 7 uncertain, and 34 inappropriate.

• For 12 lentigo maligna and melanoma in situ scenarios, 10 were rated appropriate, and 2 uncertain.

• For 46 rare cutaneous malignancies scenarios, 35 were rated appropriate, 9 uncertain, and 2 inappropriate.

• Invasive melanoma was not included in the AUC "due to the complexity of the issue," according to the task force.

A small number of low-risk tumors in trunk and extremities were rated as inappropriate for Mohs surgery.

Dr. Zalla said he anticipates a good reaction to the AUC. "There will be some minor changes in practice for some surgeons," he speculated.

Florida dermatologist and Mohs surgeon Terrence A Cronin Jr. noted in an interview that he was not expecting the AUC to change his practice. "But I think, optimistically, that this will help the lay people in the insurance world have a greater understanding of where Mohs is often the best choice for the treatment of skin cancer," noted Dr. Cronin, who was a member of the AUC’s ratings panel.

The document was approved by all four of the societies’ boards during the American Academy of Dermatology’s annual meeting in March. It will be published in the Journal of the American Academy of Dermatology and Dermatologic Surgery later this year.

Four dermatology societies joined together to create the first appropriate use criteria for Mohs surgery, consenting that in two-thirds of nearly 300 possible scenarios the micrographic procedure is appropriate.

The American Academy of Dermatology (AAD) developed the appropriate use criteria (AUC) for 270 scenarios for Mohs surgery in collaboration with the American College of Mohs Surgery, the American Society for Dermatologic Surgery, and the American Society for Mohs Surgery.

The main driver behind the creation of the 46-page document, which is the first of its kind for any test or treatment option in the field of dermatology, is Medicare, said Dr. Mark J. Zalla, a member of the report’s ad hoc task force that developed the indications.

"The intent of the criteria is to help us maintain the value of Mohs in terms of reimbursement," added Dr. Zalla, who is in private practice in Florence, Ky.

Use of Mohs surgery increased by 400% between 1995 and 2009. (Dermatol. Clin. 2012;30:167-75). "And when Medicare sees use of a specific code increasing significantly over several years, they get concerned," said Dr. Zalla. Some Medicare carriers have already threatened to impose certain criteria for Mohs surgery reimbursement. "And if one carrier does it, it’s possible that [the criteria will become applicable] nationwide," he said.

But Dr. Zalla and advocates for the procedure argue that the sharp increase doesn’t necessarily mean that it is being overutilized. Rather, it’s most likely the result of several factors, including the nation’s skin cancer epidemic and an increase in the number of fellows trained in Mohs surgery.

The ACMS has been ramping up its efforts to raise awareness about the surgery among payers and policy makers. The college has so far spent $20,000 in education lobbying this year, according to the Center for Responsive Politics.

"The bottom line is that dermatologists and Mohs surgeons are the good guys," said Dr. Brett M. Coldiron, president of ACMS and a member of the AUC ad hoc task force. "We are part of the solution, not the problem."

The scenarios represent roughly 85% of anticipated clinical scenarios, the authors noted in their report.

The members of a 17-member rating panel, made up of Mohs surgeons and non-Mohs dermatologists, scored the scenarios on a 9-point scale. Scenarios scoring 7-9 were deemed appropriate, those scoring 4-6 were uncertain, and those scoring 1-3 were inappropriate.

"Those clinical situations for which use of Mohs was rated as uncertain are areas ripe for productive clinical research," said Dr. Suzanne M. Connolly, chair of the AUC task force.

The document breaks down the appropriateness of Mohs surgery by the following skin cancer types:

• For 69 basal cell carcinoma scenarios, 53 were rated appropriate, 6 uncertain, 10 inappropriate.

• For 143 squamous cell carcinoma scenarios, 102 were rated appropriate, 7 uncertain, and 34 inappropriate.

• For 12 lentigo maligna and melanoma in situ scenarios, 10 were rated appropriate, and 2 uncertain.

• For 46 rare cutaneous malignancies scenarios, 35 were rated appropriate, 9 uncertain, and 2 inappropriate.

• Invasive melanoma was not included in the AUC "due to the complexity of the issue," according to the task force.

A small number of low-risk tumors in trunk and extremities were rated as inappropriate for Mohs surgery.

Dr. Zalla said he anticipates a good reaction to the AUC. "There will be some minor changes in practice for some surgeons," he speculated.

Florida dermatologist and Mohs surgeon Terrence A Cronin Jr. noted in an interview that he was not expecting the AUC to change his practice. "But I think, optimistically, that this will help the lay people in the insurance world have a greater understanding of where Mohs is often the best choice for the treatment of skin cancer," noted Dr. Cronin, who was a member of the AUC’s ratings panel.

The document was approved by all four of the societies’ boards during the American Academy of Dermatology’s annual meeting in March. It will be published in the Journal of the American Academy of Dermatology and Dermatologic Surgery later this year.

Four dermatology societies joined together to create the first appropriate use criteria for Mohs surgery, consenting that in two-thirds of nearly 300 possible scenarios the micrographic procedure is appropriate.

The American Academy of Dermatology (AAD) developed the appropriate use criteria (AUC) for 270 scenarios for Mohs surgery in collaboration with the American College of Mohs Surgery, the American Society for Dermatologic Surgery, and the American Society for Mohs Surgery.

The main driver behind the creation of the 46-page document, which is the first of its kind for any test or treatment option in the field of dermatology, is Medicare, said Dr. Mark J. Zalla, a member of the report’s ad hoc task force that developed the indications.

"The intent of the criteria is to help us maintain the value of Mohs in terms of reimbursement," added Dr. Zalla, who is in private practice in Florence, Ky.

Use of Mohs surgery increased by 400% between 1995 and 2009. (Dermatol. Clin. 2012;30:167-75). "And when Medicare sees use of a specific code increasing significantly over several years, they get concerned," said Dr. Zalla. Some Medicare carriers have already threatened to impose certain criteria for Mohs surgery reimbursement. "And if one carrier does it, it’s possible that [the criteria will become applicable] nationwide," he said.

But Dr. Zalla and advocates for the procedure argue that the sharp increase doesn’t necessarily mean that it is being overutilized. Rather, it’s most likely the result of several factors, including the nation’s skin cancer epidemic and an increase in the number of fellows trained in Mohs surgery.

The ACMS has been ramping up its efforts to raise awareness about the surgery among payers and policy makers. The college has so far spent $20,000 in education lobbying this year, according to the Center for Responsive Politics.

"The bottom line is that dermatologists and Mohs surgeons are the good guys," said Dr. Brett M. Coldiron, president of ACMS and a member of the AUC ad hoc task force. "We are part of the solution, not the problem."

The scenarios represent roughly 85% of anticipated clinical scenarios, the authors noted in their report.

The members of a 17-member rating panel, made up of Mohs surgeons and non-Mohs dermatologists, scored the scenarios on a 9-point scale. Scenarios scoring 7-9 were deemed appropriate, those scoring 4-6 were uncertain, and those scoring 1-3 were inappropriate.

"Those clinical situations for which use of Mohs was rated as uncertain are areas ripe for productive clinical research," said Dr. Suzanne M. Connolly, chair of the AUC task force.

The document breaks down the appropriateness of Mohs surgery by the following skin cancer types:

• For 69 basal cell carcinoma scenarios, 53 were rated appropriate, 6 uncertain, 10 inappropriate.

• For 143 squamous cell carcinoma scenarios, 102 were rated appropriate, 7 uncertain, and 34 inappropriate.

• For 12 lentigo maligna and melanoma in situ scenarios, 10 were rated appropriate, and 2 uncertain.

• For 46 rare cutaneous malignancies scenarios, 35 were rated appropriate, 9 uncertain, and 2 inappropriate.

• Invasive melanoma was not included in the AUC "due to the complexity of the issue," according to the task force.

A small number of low-risk tumors in trunk and extremities were rated as inappropriate for Mohs surgery.

Dr. Zalla said he anticipates a good reaction to the AUC. "There will be some minor changes in practice for some surgeons," he speculated.

Florida dermatologist and Mohs surgeon Terrence A Cronin Jr. noted in an interview that he was not expecting the AUC to change his practice. "But I think, optimistically, that this will help the lay people in the insurance world have a greater understanding of where Mohs is often the best choice for the treatment of skin cancer," noted Dr. Cronin, who was a member of the AUC’s ratings panel.

The document was approved by all four of the societies’ boards during the American Academy of Dermatology’s annual meeting in March. It will be published in the Journal of the American Academy of Dermatology and Dermatologic Surgery later this year.

Of 166 identified possible clinical scenarios that may warrant diagnostic catheterization, nearly half are appropriate, a third are uncertain, and about a quarter are inappropriate, according to the first document to detail the appropriate use criteria for the invasive cardiac procedure.

Cardiovascular care accounts for a substantial portion of Medicare and overall health care burden in the United States, so "the movement towards developing appropriate use criteria is to help inform when it’s reasonable to a do a procedure for both patients and clinicians who are referring for the procedure, and then payers who are thinking about understanding patterns of use," said Dr. Manesh R. Patel, cochair of the report’s writing committee, and an assistant professor and director of Catheterization Laboratory Research Program at Duke University.

The report was released on May 9 by the American College of Cardiology Foundation (ACCF) and the Society for Cardiovascular Angiography and Interventions (SCAI), in collaboration with a group of professional societies (J. Am. Coll. Cardiol. 2012 May 29 [doi:10.1016/jacc.2012.03.003]).

The diagnostic catheterization appropriate use criteria follow those focusing on coronary revascularization, released in January (J. Am. Coll. Cardiol. 2012 Jan. 20 [doi:10.1016/jacc.2011.12.001]).

"Many will ask, Why do we need this now?," said Dr. Patel. "In part, because the reality is, without us leading the field and developing criteria for use, others will do that for us, and this is an opportunity for us to show our professional responsibility," he said.

Appropriate use criteria reports in general help reduce variations in practice and improve quality of care, said Dr. Christopher J. White, president of SCAI and professor of medicine and chairman of the dept. of cardiovascular diseases at Ochsner Clinic, New Orleans.

The documents, however, are much softer and broader than guidelines and should not be looked at as rules, said Dr. White, who was not involved in drafting the statement.

In detailed charts, the document gives scores of 1–9 to 166 indications for diagnostic catheterization procedures, which include left heart and right heart catheterization, ventriculography, and coronary angiography.

The statement recommends, in part, that diagnostic coronary catheterization is:

• Appropriate for patients with definite or suspected acute coronary syndromes; patients with planned vascular surgery; preoperative catheterization for coronary anatomy; and patients with symptomatic and severe valvular heart disease with discordant clinical and noninvasive imaging findings.

• Uncertain or inappropriate for asymptomatic and symptomatic coronary artery disease patients with low or intermediate pretest probability and patients without symptoms but with severe disease.

• Inappropriate for asymptomatic patients who have had prior noninvasive testing with low-risk findings and patients without symptoms with mild to moderate stenosis or concordant clinical and noninvasive findings.

"It is hoped that payers would use these criteria to ensure that their members receive necessary, beneficial, and cost-effective cardiovascular care, rather than for other purposes," according to the document. "It is expected that services performed for appropriate and/or uncertain indications will receive reimbursement," adding that services performed for inappropriate indications may require additional documents for payment due the unique nature of the patient circumstance. "This additional documentation should not be required for uncertain indications."

Dr. White said that they key message from appropriate use criteria documents is that "these are good for doctors, and they only become problems when they’re misinterpreted. ... This is a document for physicians to help them reduce variations in their practice," he said, adding, "We have to understand that underuse is as powerful as overuse."

In the document the panel has also developed a worksheet where referring physicians can check the reasons they want the procedure to be performed and the reasons the patient is being referred. "Our hope is eventually that we’ll have real-time tools that can help with decision support for physicians and patients when they’re making decisions not just about cardiac catheterization, but about other procedures and patient care," said Dr. Patel.

Dr. Patel had no relevant disclosures. Dr. White is on the editorial advisory board for Cardiology News.

Of 166 identified possible clinical scenarios that may warrant diagnostic catheterization, nearly half are appropriate, a third are uncertain, and about a quarter are inappropriate, according to the first document to detail the appropriate use criteria for the invasive cardiac procedure.

Cardiovascular care accounts for a substantial portion of Medicare and overall health care burden in the United States, so "the movement towards developing appropriate use criteria is to help inform when it’s reasonable to a do a procedure for both patients and clinicians who are referring for the procedure, and then payers who are thinking about understanding patterns of use," said Dr. Manesh R. Patel, cochair of the report’s writing committee, and an assistant professor and director of Catheterization Laboratory Research Program at Duke University.

The report was released on May 9 by the American College of Cardiology Foundation (ACCF) and the Society for Cardiovascular Angiography and Interventions (SCAI), in collaboration with a group of professional societies (J. Am. Coll. Cardiol. 2012 May 29 [doi:10.1016/jacc.2012.03.003]).

The diagnostic catheterization appropriate use criteria follow those focusing on coronary revascularization, released in January (J. Am. Coll. Cardiol. 2012 Jan. 20 [doi:10.1016/jacc.2011.12.001]).

"Many will ask, Why do we need this now?," said Dr. Patel. "In part, because the reality is, without us leading the field and developing criteria for use, others will do that for us, and this is an opportunity for us to show our professional responsibility," he said.

Appropriate use criteria reports in general help reduce variations in practice and improve quality of care, said Dr. Christopher J. White, president of SCAI and professor of medicine and chairman of the dept. of cardiovascular diseases at Ochsner Clinic, New Orleans.

The documents, however, are much softer and broader than guidelines and should not be looked at as rules, said Dr. White, who was not involved in drafting the statement.

In detailed charts, the document gives scores of 1–9 to 166 indications for diagnostic catheterization procedures, which include left heart and right heart catheterization, ventriculography, and coronary angiography.

The statement recommends, in part, that diagnostic coronary catheterization is:

• Appropriate for patients with definite or suspected acute coronary syndromes; patients with planned vascular surgery; preoperative catheterization for coronary anatomy; and patients with symptomatic and severe valvular heart disease with discordant clinical and noninvasive imaging findings.

• Uncertain or inappropriate for asymptomatic and symptomatic coronary artery disease patients with low or intermediate pretest probability and patients without symptoms but with severe disease.

• Inappropriate for asymptomatic patients who have had prior noninvasive testing with low-risk findings and patients without symptoms with mild to moderate stenosis or concordant clinical and noninvasive findings.

"It is hoped that payers would use these criteria to ensure that their members receive necessary, beneficial, and cost-effective cardiovascular care, rather than for other purposes," according to the document. "It is expected that services performed for appropriate and/or uncertain indications will receive reimbursement," adding that services performed for inappropriate indications may require additional documents for payment due the unique nature of the patient circumstance. "This additional documentation should not be required for uncertain indications."

Dr. White said that they key message from appropriate use criteria documents is that "these are good for doctors, and they only become problems when they’re misinterpreted. ... This is a document for physicians to help them reduce variations in their practice," he said, adding, "We have to understand that underuse is as powerful as overuse."

In the document the panel has also developed a worksheet where referring physicians can check the reasons they want the procedure to be performed and the reasons the patient is being referred. "Our hope is eventually that we’ll have real-time tools that can help with decision support for physicians and patients when they’re making decisions not just about cardiac catheterization, but about other procedures and patient care," said Dr. Patel.

Dr. Patel had no relevant disclosures. Dr. White is on the editorial advisory board for Cardiology News.

Of 166 identified possible clinical scenarios that may warrant diagnostic catheterization, nearly half are appropriate, a third are uncertain, and about a quarter are inappropriate, according to the first document to detail the appropriate use criteria for the invasive cardiac procedure.

Cardiovascular care accounts for a substantial portion of Medicare and overall health care burden in the United States, so "the movement towards developing appropriate use criteria is to help inform when it’s reasonable to a do a procedure for both patients and clinicians who are referring for the procedure, and then payers who are thinking about understanding patterns of use," said Dr. Manesh R. Patel, cochair of the report’s writing committee, and an assistant professor and director of Catheterization Laboratory Research Program at Duke University.

The report was released on May 9 by the American College of Cardiology Foundation (ACCF) and the Society for Cardiovascular Angiography and Interventions (SCAI), in collaboration with a group of professional societies (J. Am. Coll. Cardiol. 2012 May 29 [doi:10.1016/jacc.2012.03.003]).

The diagnostic catheterization appropriate use criteria follow those focusing on coronary revascularization, released in January (J. Am. Coll. Cardiol. 2012 Jan. 20 [doi:10.1016/jacc.2011.12.001]).

"Many will ask, Why do we need this now?," said Dr. Patel. "In part, because the reality is, without us leading the field and developing criteria for use, others will do that for us, and this is an opportunity for us to show our professional responsibility," he said.

Appropriate use criteria reports in general help reduce variations in practice and improve quality of care, said Dr. Christopher J. White, president of SCAI and professor of medicine and chairman of the dept. of cardiovascular diseases at Ochsner Clinic, New Orleans.

The documents, however, are much softer and broader than guidelines and should not be looked at as rules, said Dr. White, who was not involved in drafting the statement.

In detailed charts, the document gives scores of 1–9 to 166 indications for diagnostic catheterization procedures, which include left heart and right heart catheterization, ventriculography, and coronary angiography.

The statement recommends, in part, that diagnostic coronary catheterization is:

• Appropriate for patients with definite or suspected acute coronary syndromes; patients with planned vascular surgery; preoperative catheterization for coronary anatomy; and patients with symptomatic and severe valvular heart disease with discordant clinical and noninvasive imaging findings.

• Uncertain or inappropriate for asymptomatic and symptomatic coronary artery disease patients with low or intermediate pretest probability and patients without symptoms but with severe disease.

• Inappropriate for asymptomatic patients who have had prior noninvasive testing with low-risk findings and patients without symptoms with mild to moderate stenosis or concordant clinical and noninvasive findings.

"It is hoped that payers would use these criteria to ensure that their members receive necessary, beneficial, and cost-effective cardiovascular care, rather than for other purposes," according to the document. "It is expected that services performed for appropriate and/or uncertain indications will receive reimbursement," adding that services performed for inappropriate indications may require additional documents for payment due the unique nature of the patient circumstance. "This additional documentation should not be required for uncertain indications."

Dr. White said that they key message from appropriate use criteria documents is that "these are good for doctors, and they only become problems when they’re misinterpreted. ... This is a document for physicians to help them reduce variations in their practice," he said, adding, "We have to understand that underuse is as powerful as overuse."

In the document the panel has also developed a worksheet where referring physicians can check the reasons they want the procedure to be performed and the reasons the patient is being referred. "Our hope is eventually that we’ll have real-time tools that can help with decision support for physicians and patients when they’re making decisions not just about cardiac catheterization, but about other procedures and patient care," said Dr. Patel.

Dr. Patel had no relevant disclosures. Dr. White is on the editorial advisory board for Cardiology News.

An updated standards document for cardiac catheterization laboratories lifts almost all restrictions on the types of patients eligible for diagnostic procedures in laboratories without cardiovascular surgical backup, details the role of hybrid cath labs, and emphasizes quality improvement and assurance programs.

Compiling the 80-page document took nearly 3 years, a Herculean task according to some, but on May 8, the Society for Cardiovascular Angiography and Interventions (SCAI) and the American College of Cardiology Foundation (ACCF) released an update to the 2001 (J. Am. Coll. Cardiol. 2001;37:2170-214) Cardiac Catheterization Laboratory Standards (J. Am. Coll. Cardiol. 2012 May 8 [doi:10.1016/jacc.2012.02.010]).

"There have been a lot of changes since 2001, some of them dramatic," Dr. Thomas M. Bashore, chair of the writing committee and professor of medicine and clinical chief of cardiology at Duke University, Durham, N.C., said in a statement. "This document sets the stage for what’s really happening in cath labs today and updates everyone on accepted quality standards and best practices."

Over the last decade, advancements in technology have changed imaging and reporting systems, the authors wrote. Due to lower risk of invasive procedures, there are now cardiac cath labs without on-site surgical backup, a trend that highlights the importance of quality assurance and quality improvement initiatives. Meanwhile, the cath lab has become "multipurpose suite" for diagnostic and therapeutic procedures for pediatric and adult patients, the authors noted. And while hybrid cath labs are not a new phenomenon, more medical centers are looking into creating them as they consider starting transcatheter aortic valve replacement (TAVR) programs.

The consensus document details examples of procedures suitable for hybrid cath labs; staffing, location, and equipment requirements; room, floor, and ceiling design; and addition to audio/video input and output needs.

The document also addresses several issues including:

– Cardiac cath labs without on-site cardiac surgical back-up. The document proposes requirements for establishing off-site surgical back-up, but lifts many prior limitations on the types of patients eligible for diagnostic procedures. Specifically, age, heart failure status, severity of stress test abnormalities, left ventricular function, and valve disease no longer restrict patients from receiving diagnostic procedures at standalone cath labs. Therapeutic procedures that should still be done only in facilities with cardiovascular surgical back-up include those in adults with congenital heart disease and in children. Primary percutaneous coronary intervention in patients with acute coronary syndrome can be performed in a standalone cath lab, provided that the facility complies "with all current guidelines on the establishment of such a program."

– Quality assurance and improvement initiatives. The document details elements of such initiatives, such as benchmarking against peers, participation in a national clinical database, and monitoring the procedures’ quality and appropriateness.

– X-ray imaging. The document summarizes major changes in x-ray imaging that have occurred since the last statement in 2001, in addition to measurement and prevention of exposure to radiation.

– Training requirements. The document summarizes the already-established requirements for training. It also recommends "that both training and practice activity associated with structural heart disease intervention be concentrated among a limited number of laboratories and operators with a particular interest in these procedures."

Dr. Charles E. Chambers, who represented SCAI on the document’s writing committee, said that the document is also a resource for institutions and cath labs.

"Pay-for performance is what is potentially down the road, if we aren’t already there. And issues such as benchmarking and risk factor stratification are important in quality programs and tracking outcomes, and that’s what’s covered nicely in this paper," said Dr. Chambers, director of Cardiac Catheterization Laboratories at Penn State Hershey Heart and Vascular Institute, Hershey, Pa.

But will the document be embraced by practicing physicians?

"This document certainly shows best practice, and I think that’s what [physicians] are interested in. We want to give best patient care, and there are enough questions out there that I think this will be embraced as a reference when questions arise," said Dr. Chambers.

The authors’ disclosures are listed at in the consensus document. Dr. Bashore and Dr. Chambers had no relevant disclosures.

An updated standards document for cardiac catheterization laboratories lifts almost all restrictions on the types of patients eligible for diagnostic procedures in laboratories without cardiovascular surgical backup, details the role of hybrid cath labs, and emphasizes quality improvement and assurance programs.

Compiling the 80-page document took nearly 3 years, a Herculean task according to some, but on May 8, the Society for Cardiovascular Angiography and Interventions (SCAI) and the American College of Cardiology Foundation (ACCF) released an update to the 2001 (J. Am. Coll. Cardiol. 2001;37:2170-214) Cardiac Catheterization Laboratory Standards (J. Am. Coll. Cardiol. 2012 May 8 [doi:10.1016/jacc.2012.02.010]).

"There have been a lot of changes since 2001, some of them dramatic," Dr. Thomas M. Bashore, chair of the writing committee and professor of medicine and clinical chief of cardiology at Duke University, Durham, N.C., said in a statement. "This document sets the stage for what’s really happening in cath labs today and updates everyone on accepted quality standards and best practices."

Over the last decade, advancements in technology have changed imaging and reporting systems, the authors wrote. Due to lower risk of invasive procedures, there are now cardiac cath labs without on-site surgical backup, a trend that highlights the importance of quality assurance and quality improvement initiatives. Meanwhile, the cath lab has become "multipurpose suite" for diagnostic and therapeutic procedures for pediatric and adult patients, the authors noted. And while hybrid cath labs are not a new phenomenon, more medical centers are looking into creating them as they consider starting transcatheter aortic valve replacement (TAVR) programs.

The consensus document details examples of procedures suitable for hybrid cath labs; staffing, location, and equipment requirements; room, floor, and ceiling design; and addition to audio/video input and output needs.

The document also addresses several issues including:

– Cardiac cath labs without on-site cardiac surgical back-up. The document proposes requirements for establishing off-site surgical back-up, but lifts many prior limitations on the types of patients eligible for diagnostic procedures. Specifically, age, heart failure status, severity of stress test abnormalities, left ventricular function, and valve disease no longer restrict patients from receiving diagnostic procedures at standalone cath labs. Therapeutic procedures that should still be done only in facilities with cardiovascular surgical back-up include those in adults with congenital heart disease and in children. Primary percutaneous coronary intervention in patients with acute coronary syndrome can be performed in a standalone cath lab, provided that the facility complies "with all current guidelines on the establishment of such a program."

– Quality assurance and improvement initiatives. The document details elements of such initiatives, such as benchmarking against peers, participation in a national clinical database, and monitoring the procedures’ quality and appropriateness.

– X-ray imaging. The document summarizes major changes in x-ray imaging that have occurred since the last statement in 2001, in addition to measurement and prevention of exposure to radiation.

– Training requirements. The document summarizes the already-established requirements for training. It also recommends "that both training and practice activity associated with structural heart disease intervention be concentrated among a limited number of laboratories and operators with a particular interest in these procedures."

Dr. Charles E. Chambers, who represented SCAI on the document’s writing committee, said that the document is also a resource for institutions and cath labs.

"Pay-for performance is what is potentially down the road, if we aren’t already there. And issues such as benchmarking and risk factor stratification are important in quality programs and tracking outcomes, and that’s what’s covered nicely in this paper," said Dr. Chambers, director of Cardiac Catheterization Laboratories at Penn State Hershey Heart and Vascular Institute, Hershey, Pa.

But will the document be embraced by practicing physicians?

"This document certainly shows best practice, and I think that’s what [physicians] are interested in. We want to give best patient care, and there are enough questions out there that I think this will be embraced as a reference when questions arise," said Dr. Chambers.

The authors’ disclosures are listed at in the consensus document. Dr. Bashore and Dr. Chambers had no relevant disclosures.

An updated standards document for cardiac catheterization laboratories lifts almost all restrictions on the types of patients eligible for diagnostic procedures in laboratories without cardiovascular surgical backup, details the role of hybrid cath labs, and emphasizes quality improvement and assurance programs.

Compiling the 80-page document took nearly 3 years, a Herculean task according to some, but on May 8, the Society for Cardiovascular Angiography and Interventions (SCAI) and the American College of Cardiology Foundation (ACCF) released an update to the 2001 (J. Am. Coll. Cardiol. 2001;37:2170-214) Cardiac Catheterization Laboratory Standards (J. Am. Coll. Cardiol. 2012 May 8 [doi:10.1016/jacc.2012.02.010]).

"There have been a lot of changes since 2001, some of them dramatic," Dr. Thomas M. Bashore, chair of the writing committee and professor of medicine and clinical chief of cardiology at Duke University, Durham, N.C., said in a statement. "This document sets the stage for what’s really happening in cath labs today and updates everyone on accepted quality standards and best practices."

Over the last decade, advancements in technology have changed imaging and reporting systems, the authors wrote. Due to lower risk of invasive procedures, there are now cardiac cath labs without on-site surgical backup, a trend that highlights the importance of quality assurance and quality improvement initiatives. Meanwhile, the cath lab has become "multipurpose suite" for diagnostic and therapeutic procedures for pediatric and adult patients, the authors noted. And while hybrid cath labs are not a new phenomenon, more medical centers are looking into creating them as they consider starting transcatheter aortic valve replacement (TAVR) programs.

The consensus document details examples of procedures suitable for hybrid cath labs; staffing, location, and equipment requirements; room, floor, and ceiling design; and addition to audio/video input and output needs.

The document also addresses several issues including:

– Cardiac cath labs without on-site cardiac surgical back-up. The document proposes requirements for establishing off-site surgical back-up, but lifts many prior limitations on the types of patients eligible for diagnostic procedures. Specifically, age, heart failure status, severity of stress test abnormalities, left ventricular function, and valve disease no longer restrict patients from receiving diagnostic procedures at standalone cath labs. Therapeutic procedures that should still be done only in facilities with cardiovascular surgical back-up include those in adults with congenital heart disease and in children. Primary percutaneous coronary intervention in patients with acute coronary syndrome can be performed in a standalone cath lab, provided that the facility complies "with all current guidelines on the establishment of such a program."

– Quality assurance and improvement initiatives. The document details elements of such initiatives, such as benchmarking against peers, participation in a national clinical database, and monitoring the procedures’ quality and appropriateness.

– X-ray imaging. The document summarizes major changes in x-ray imaging that have occurred since the last statement in 2001, in addition to measurement and prevention of exposure to radiation.

– Training requirements. The document summarizes the already-established requirements for training. It also recommends "that both training and practice activity associated with structural heart disease intervention be concentrated among a limited number of laboratories and operators with a particular interest in these procedures."

Dr. Charles E. Chambers, who represented SCAI on the document’s writing committee, said that the document is also a resource for institutions and cath labs.

"Pay-for performance is what is potentially down the road, if we aren’t already there. And issues such as benchmarking and risk factor stratification are important in quality programs and tracking outcomes, and that’s what’s covered nicely in this paper," said Dr. Chambers, director of Cardiac Catheterization Laboratories at Penn State Hershey Heart and Vascular Institute, Hershey, Pa.

But will the document be embraced by practicing physicians?

"This document certainly shows best practice, and I think that’s what [physicians] are interested in. We want to give best patient care, and there are enough questions out there that I think this will be embraced as a reference when questions arise," said Dr. Chambers.

The authors’ disclosures are listed at in the consensus document. Dr. Bashore and Dr. Chambers had no relevant disclosures.