Alicia Ault

The Food and Drug Administration announced on Nov. 9 that it is taking steps to improve its postmarketing surveillance of medical device safety, including moving ahead on a proposal to require electronic reporting of adverse events.

The agency said it has created an action plan based on a major review that was completed in 2005. That review looked at how the Center for Radiological Devices and Health (CDRH) handles recalls and enforcement actions against manufacturers that are not in compliance with FDA rules.

“Today's report details a number of action items that we believe will transform the postmarketing safety program,” said Dr. Daniel Schultz, director of CDRH, in a briefing with reporters.

The FDA will focus on making improvements in four major areas: collaboration among experts within CDRH, data systems, communications with patients and physicians about risks and benefits, and enforcement.

CDRH leaders will encourage more cross-organizational collaboration so that premarket, postmarket, and enforcement efforts are better coordinated, Dr. Schultz said.

Some of the biggest changes will come in data collection and analysis. The agency hopes to integrate its passive adverse events reporting system (Manufacturer and User Facility Device Experience Database, also known as MAUDE) and its active system, the Medical Product Safety Device Network (MedSun), Dr. Schultz said. Currently, 350 hospitals have been trained to report device problems on MedSun. One goal is to recruit more facilities and find a way to upgrade reporting so it is closer to real time.

The agency also hopes to require manufacturers and others to electronically report adverse events. Currently, the FDA receives about 200,000 reports to MAUDE each year, and the majority are on paper, which delays entry into the system and analysis for any kind of safety signal, said Dr. Schultz. The FDA has been piloting an electronic reporting program, and is in the process of writing a rule to require electronic reporting, he said.

Once data are being reported and analyzed more quickly, enforcement will be more timely also, he said. It will also let the FDA focus enforcement efforts on the highest-risk products, Dr. Schultz said. “When enforcement is necessary, it needs to be done quickly, accurately, and in a way that's meaningful and corrects problems,” he said.

The FDA also aims to improve its communications to health professionals and consumers—whether the communications are notices about unsafe devices or simply background on safety and efficacy of products. CDRH will redesign its Web site to be more consumer-friendly. It will also take a closer look at how best to give out data—and when—on a potentially faulty device.

CDRH is hoping to accomplish most of its planned “action points” without seeking additional funding, at least in the near term, Dr. Schultz said.

The Food and Drug Administration announced on Nov. 9 that it is taking steps to improve its postmarketing surveillance of medical device safety, including moving ahead on a proposal to require electronic reporting of adverse events.

The agency said it has created an action plan based on a major review that was completed in 2005. That review looked at how the Center for Radiological Devices and Health (CDRH) handles recalls and enforcement actions against manufacturers that are not in compliance with FDA rules.

“Today's report details a number of action items that we believe will transform the postmarketing safety program,” said Dr. Daniel Schultz, director of CDRH, in a briefing with reporters.

The FDA will focus on making improvements in four major areas: collaboration among experts within CDRH, data systems, communications with patients and physicians about risks and benefits, and enforcement.

CDRH leaders will encourage more cross-organizational collaboration so that premarket, postmarket, and enforcement efforts are better coordinated, Dr. Schultz said.

Some of the biggest changes will come in data collection and analysis. The agency hopes to integrate its passive adverse events reporting system (Manufacturer and User Facility Device Experience Database, also known as MAUDE) and its active system, the Medical Product Safety Device Network (MedSun), Dr. Schultz said. Currently, 350 hospitals have been trained to report device problems on MedSun. One goal is to recruit more facilities and find a way to upgrade reporting so it is closer to real time.

The agency also hopes to require manufacturers and others to electronically report adverse events. Currently, the FDA receives about 200,000 reports to MAUDE each year, and the majority are on paper, which delays entry into the system and analysis for any kind of safety signal, said Dr. Schultz. The FDA has been piloting an electronic reporting program, and is in the process of writing a rule to require electronic reporting, he said.

Once data are being reported and analyzed more quickly, enforcement will be more timely also, he said. It will also let the FDA focus enforcement efforts on the highest-risk products, Dr. Schultz said. “When enforcement is necessary, it needs to be done quickly, accurately, and in a way that's meaningful and corrects problems,” he said.

The FDA also aims to improve its communications to health professionals and consumers—whether the communications are notices about unsafe devices or simply background on safety and efficacy of products. CDRH will redesign its Web site to be more consumer-friendly. It will also take a closer look at how best to give out data—and when—on a potentially faulty device.

CDRH is hoping to accomplish most of its planned “action points” without seeking additional funding, at least in the near term, Dr. Schultz said.

The Food and Drug Administration announced on Nov. 9 that it is taking steps to improve its postmarketing surveillance of medical device safety, including moving ahead on a proposal to require electronic reporting of adverse events.

The agency said it has created an action plan based on a major review that was completed in 2005. That review looked at how the Center for Radiological Devices and Health (CDRH) handles recalls and enforcement actions against manufacturers that are not in compliance with FDA rules.

“Today's report details a number of action items that we believe will transform the postmarketing safety program,” said Dr. Daniel Schultz, director of CDRH, in a briefing with reporters.

The FDA will focus on making improvements in four major areas: collaboration among experts within CDRH, data systems, communications with patients and physicians about risks and benefits, and enforcement.

CDRH leaders will encourage more cross-organizational collaboration so that premarket, postmarket, and enforcement efforts are better coordinated, Dr. Schultz said.

Some of the biggest changes will come in data collection and analysis. The agency hopes to integrate its passive adverse events reporting system (Manufacturer and User Facility Device Experience Database, also known as MAUDE) and its active system, the Medical Product Safety Device Network (MedSun), Dr. Schultz said. Currently, 350 hospitals have been trained to report device problems on MedSun. One goal is to recruit more facilities and find a way to upgrade reporting so it is closer to real time.

The agency also hopes to require manufacturers and others to electronically report adverse events. Currently, the FDA receives about 200,000 reports to MAUDE each year, and the majority are on paper, which delays entry into the system and analysis for any kind of safety signal, said Dr. Schultz. The FDA has been piloting an electronic reporting program, and is in the process of writing a rule to require electronic reporting, he said.

Once data are being reported and analyzed more quickly, enforcement will be more timely also, he said. It will also let the FDA focus enforcement efforts on the highest-risk products, Dr. Schultz said. “When enforcement is necessary, it needs to be done quickly, accurately, and in a way that's meaningful and corrects problems,” he said.

The FDA also aims to improve its communications to health professionals and consumers—whether the communications are notices about unsafe devices or simply background on safety and efficacy of products. CDRH will redesign its Web site to be more consumer-friendly. It will also take a closer look at how best to give out data—and when—on a potentially faulty device.

CDRH is hoping to accomplish most of its planned “action points” without seeking additional funding, at least in the near term, Dr. Schultz said.

WASHINGTON — The direct thrombin inhibitor bivalirudin seems to be more effective than heparin in reducing major bleeding episodes in patients undergoing percutaneous coronary intervention, according to a study presented at a symposium sponsored by the Cardiovascular Research Foundation.

The study, ACUITY-PCI, is a substudy of the Acute Catheterization and Urgent Intervention Triage Strategy trial. ACUITY was presented at the American College of Cardiology meeting in March; the ACUITY-PCI results were presented at a symposium sponsored by the Cardiovascular Research Foundation (CRF).

In ACUITY-PCI, 7,789 patients who underwent catheterization were randomized to one of three arms: unfractionated heparin or enoxaparin (Lovenox), depending on local hospital practice, combined with a glycoprotein IIb/IIIa inhibitor; bivalirudin (Angiomax) with a glycoprotein IIb/IIIa inhibitor; or bivalirudin alone. These were high-risk patients: 65% in each arm—about 1,690 patients in each group—had elevated troponin levels at baseline. Patients underwent PCI within 20 hours of admission. There was a mean of 1.5 lesions attempted per patient.

The majority of patients in each arm had a stent implanted, with 60% getting a drug-eluting stent, said Dr. Gregg Stone, CRF vice-chairman and a professor of medicine at Columbia University, New York.

The study measured three primary end points at 30 days postcatheterization: a composite net clinical benefit, an ischemic composite, and major bleeding. Major bleeding was defined as noncoronary artery bypass-related bleeding, intracranial hemorrhage, intraocular bleeding, retroperitoneal bleeding, reoperation for bleeding, and major transfusion.

Overall, bivalirudin alone reduced major bleeding by 48%. There was a 50% reduction in the need for transfusions, said Dr. Stone.

At 30 days, 7% of patients in the heparin plus glycoprotein IIb/IIIa inhibitor, 8% of patients receiving bivalirudin plus a glycoprotein IIb/IIIa inhibitor, and 4% of patients receiving bivalirudin alone had major non- coronary artery bypass graft bleeding.

There was no difference among the three arms in the components of the composite end point of ischemia: death, myocardial infraction, or unplanned revascularization for ischemia, said Dr. Stone.

In addition, there was no difference among the arms in patients who had elevated troponin levels in net clinical outcomes, ischemic composite, or major bleeding.

The study authors also examined patients who had exposure to a thienopyridine—usually clopidogrel (Plavix). Again, there was a major reduction in bleeding with bivalirudin alone, whether patients had taken a thienopyridine or not, said Dr. Harvey White, of Green Lane Hospital in Auckland, New Zealand, who briefed reporters on the results.

The study authors concluded that in patients with moderate and high-risk acute coronary syndrome undergoing contemporary PCI, replacing the standard of heparin and a glycoprotein IIb/IIIa inhibitor with bivalirudin alone results in similar rates of ischemia and a 50% reduction in bleeding, said Dr. White.

The study also helped assuage concerns about using bivalirudin in troponin-positive patients.

And, he added, the findings are consistent with the results seen in Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2), in which there was a 41% reduction in major bleeding with bivalirudin alone.

Dr. Stone noted that ACUITY-PCI did have some limitations, including that it is not technically a randomized trial and that it was underpowered for noninferiority testing and subgroup analysis. It should be considered a hypothesis-generating study, he said.

In discussing the ACUITY-PCI, Dr. Eric Topol, chairman of the department of cardiovascular medicine at Case Western Reserve University, Cleveland, said that the subgroups were still interesting to examine, especially the impressive results in patients with troponin elevations.

One interesting note—despite large amounts of antiplatelet therapy, there was still a stent thrombosis rate of about 1.4% at 30 days, said Dr. Topol.

Overall, “There is a trade-off with a slight increase in MI, which is small, but it's compared with a significant, greater than 50% reduction in bleeding,” said Dr. Topol.

He also agreed that the replication of the REPLACE-2 results give “key validation” to bivalirudin's utility.

Dr. Topol had no conflicts to report. Dr. White served briefly as a consultant to the Medicines Company, which makes bivalirudin. Dr. Stone is on the speaker's bureau for the Medicines Company and also receives significant research support.

Bivalirudin alone reduced major bleeding by 48% and cut the need for transfusions by 50%. DR. STONE

WASHINGTON — The direct thrombin inhibitor bivalirudin seems to be more effective than heparin in reducing major bleeding episodes in patients undergoing percutaneous coronary intervention, according to a study presented at a symposium sponsored by the Cardiovascular Research Foundation.

The study, ACUITY-PCI, is a substudy of the Acute Catheterization and Urgent Intervention Triage Strategy trial. ACUITY was presented at the American College of Cardiology meeting in March; the ACUITY-PCI results were presented at a symposium sponsored by the Cardiovascular Research Foundation (CRF).

In ACUITY-PCI, 7,789 patients who underwent catheterization were randomized to one of three arms: unfractionated heparin or enoxaparin (Lovenox), depending on local hospital practice, combined with a glycoprotein IIb/IIIa inhibitor; bivalirudin (Angiomax) with a glycoprotein IIb/IIIa inhibitor; or bivalirudin alone. These were high-risk patients: 65% in each arm—about 1,690 patients in each group—had elevated troponin levels at baseline. Patients underwent PCI within 20 hours of admission. There was a mean of 1.5 lesions attempted per patient.

The majority of patients in each arm had a stent implanted, with 60% getting a drug-eluting stent, said Dr. Gregg Stone, CRF vice-chairman and a professor of medicine at Columbia University, New York.

The study measured three primary end points at 30 days postcatheterization: a composite net clinical benefit, an ischemic composite, and major bleeding. Major bleeding was defined as noncoronary artery bypass-related bleeding, intracranial hemorrhage, intraocular bleeding, retroperitoneal bleeding, reoperation for bleeding, and major transfusion.

Overall, bivalirudin alone reduced major bleeding by 48%. There was a 50% reduction in the need for transfusions, said Dr. Stone.

At 30 days, 7% of patients in the heparin plus glycoprotein IIb/IIIa inhibitor, 8% of patients receiving bivalirudin plus a glycoprotein IIb/IIIa inhibitor, and 4% of patients receiving bivalirudin alone had major non- coronary artery bypass graft bleeding.

There was no difference among the three arms in the components of the composite end point of ischemia: death, myocardial infraction, or unplanned revascularization for ischemia, said Dr. Stone.

In addition, there was no difference among the arms in patients who had elevated troponin levels in net clinical outcomes, ischemic composite, or major bleeding.

The study authors also examined patients who had exposure to a thienopyridine—usually clopidogrel (Plavix). Again, there was a major reduction in bleeding with bivalirudin alone, whether patients had taken a thienopyridine or not, said Dr. Harvey White, of Green Lane Hospital in Auckland, New Zealand, who briefed reporters on the results.

The study authors concluded that in patients with moderate and high-risk acute coronary syndrome undergoing contemporary PCI, replacing the standard of heparin and a glycoprotein IIb/IIIa inhibitor with bivalirudin alone results in similar rates of ischemia and a 50% reduction in bleeding, said Dr. White.

The study also helped assuage concerns about using bivalirudin in troponin-positive patients.

And, he added, the findings are consistent with the results seen in Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2), in which there was a 41% reduction in major bleeding with bivalirudin alone.

Dr. Stone noted that ACUITY-PCI did have some limitations, including that it is not technically a randomized trial and that it was underpowered for noninferiority testing and subgroup analysis. It should be considered a hypothesis-generating study, he said.

In discussing the ACUITY-PCI, Dr. Eric Topol, chairman of the department of cardiovascular medicine at Case Western Reserve University, Cleveland, said that the subgroups were still interesting to examine, especially the impressive results in patients with troponin elevations.

One interesting note—despite large amounts of antiplatelet therapy, there was still a stent thrombosis rate of about 1.4% at 30 days, said Dr. Topol.

Overall, “There is a trade-off with a slight increase in MI, which is small, but it's compared with a significant, greater than 50% reduction in bleeding,” said Dr. Topol.

He also agreed that the replication of the REPLACE-2 results give “key validation” to bivalirudin's utility.

Dr. Topol had no conflicts to report. Dr. White served briefly as a consultant to the Medicines Company, which makes bivalirudin. Dr. Stone is on the speaker's bureau for the Medicines Company and also receives significant research support.

Bivalirudin alone reduced major bleeding by 48% and cut the need for transfusions by 50%. DR. STONE

WASHINGTON — The direct thrombin inhibitor bivalirudin seems to be more effective than heparin in reducing major bleeding episodes in patients undergoing percutaneous coronary intervention, according to a study presented at a symposium sponsored by the Cardiovascular Research Foundation.

The study, ACUITY-PCI, is a substudy of the Acute Catheterization and Urgent Intervention Triage Strategy trial. ACUITY was presented at the American College of Cardiology meeting in March; the ACUITY-PCI results were presented at a symposium sponsored by the Cardiovascular Research Foundation (CRF).

In ACUITY-PCI, 7,789 patients who underwent catheterization were randomized to one of three arms: unfractionated heparin or enoxaparin (Lovenox), depending on local hospital practice, combined with a glycoprotein IIb/IIIa inhibitor; bivalirudin (Angiomax) with a glycoprotein IIb/IIIa inhibitor; or bivalirudin alone. These were high-risk patients: 65% in each arm—about 1,690 patients in each group—had elevated troponin levels at baseline. Patients underwent PCI within 20 hours of admission. There was a mean of 1.5 lesions attempted per patient.

The majority of patients in each arm had a stent implanted, with 60% getting a drug-eluting stent, said Dr. Gregg Stone, CRF vice-chairman and a professor of medicine at Columbia University, New York.

The study measured three primary end points at 30 days postcatheterization: a composite net clinical benefit, an ischemic composite, and major bleeding. Major bleeding was defined as noncoronary artery bypass-related bleeding, intracranial hemorrhage, intraocular bleeding, retroperitoneal bleeding, reoperation for bleeding, and major transfusion.

Overall, bivalirudin alone reduced major bleeding by 48%. There was a 50% reduction in the need for transfusions, said Dr. Stone.

At 30 days, 7% of patients in the heparin plus glycoprotein IIb/IIIa inhibitor, 8% of patients receiving bivalirudin plus a glycoprotein IIb/IIIa inhibitor, and 4% of patients receiving bivalirudin alone had major non- coronary artery bypass graft bleeding.

There was no difference among the three arms in the components of the composite end point of ischemia: death, myocardial infraction, or unplanned revascularization for ischemia, said Dr. Stone.

In addition, there was no difference among the arms in patients who had elevated troponin levels in net clinical outcomes, ischemic composite, or major bleeding.

The study authors also examined patients who had exposure to a thienopyridine—usually clopidogrel (Plavix). Again, there was a major reduction in bleeding with bivalirudin alone, whether patients had taken a thienopyridine or not, said Dr. Harvey White, of Green Lane Hospital in Auckland, New Zealand, who briefed reporters on the results.

The study authors concluded that in patients with moderate and high-risk acute coronary syndrome undergoing contemporary PCI, replacing the standard of heparin and a glycoprotein IIb/IIIa inhibitor with bivalirudin alone results in similar rates of ischemia and a 50% reduction in bleeding, said Dr. White.

The study also helped assuage concerns about using bivalirudin in troponin-positive patients.

And, he added, the findings are consistent with the results seen in Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2), in which there was a 41% reduction in major bleeding with bivalirudin alone.

Dr. Stone noted that ACUITY-PCI did have some limitations, including that it is not technically a randomized trial and that it was underpowered for noninferiority testing and subgroup analysis. It should be considered a hypothesis-generating study, he said.

In discussing the ACUITY-PCI, Dr. Eric Topol, chairman of the department of cardiovascular medicine at Case Western Reserve University, Cleveland, said that the subgroups were still interesting to examine, especially the impressive results in patients with troponin elevations.

One interesting note—despite large amounts of antiplatelet therapy, there was still a stent thrombosis rate of about 1.4% at 30 days, said Dr. Topol.

Overall, “There is a trade-off with a slight increase in MI, which is small, but it's compared with a significant, greater than 50% reduction in bleeding,” said Dr. Topol.

He also agreed that the replication of the REPLACE-2 results give “key validation” to bivalirudin's utility.

Dr. Topol had no conflicts to report. Dr. White served briefly as a consultant to the Medicines Company, which makes bivalirudin. Dr. Stone is on the speaker's bureau for the Medicines Company and also receives significant research support.

Bivalirudin alone reduced major bleeding by 48% and cut the need for transfusions by 50%. DR. STONE

The Food and Drug Administration announced on Nov. 9 that it is taking steps to improve its postmarketing surveillance of medical device safety, including moving ahead on a proposal to require electronic reporting of adverse events.

The agency said it has created an action plan based on a major review that was completed in 2005. That review looked at how the Center for Radiological Devices and Health (CDRH) handles recalls and enforcement actions against manufacturers that are not in compliance with FDA rules.

“Today's report details a number of action items that we believe will transform the postmarketing safety program,” said Dr. Daniel Schultz, director of CDRH, during a briefing with reporters.

The FDA will focus on making improvements in four major areas: collaboration among experts within CDRH, data systems, communications with patients and physicians about risks and benefits, and enforcement.

CDRH leaders will encourage more cross-organizational collaboration so that premarket, postmarket, and enforcement efforts are better coordinated, said Dr. Schultz.

Some of the biggest changes will come in data collection and analysis. The agency hopes to integrate its passive adverse events reporting system (Manufacturer and User Facility Device Experience Database, also known as MAUDE) and its active system, the Medical Product Safety Device Network (MedSun), said Dr. Schultz. Currently, 350 hospitals have been trained to report device problems on MedSun.

One goal is to recruit more facilities and find a way to upgrade reporting so it is closer to real-time.

The agency also hopes to require manufacturers and others to electronically report adverse events.

Currently, FDA receives about 200,000 reports to MAUDE each year, and the majority are on paper, which delays entry into the system and analysis for any kind of safety signal, Dr. Schultz said. The FDA has been piloting an electronic reporting program, and is in the process of writing a rule to require electronic reporting, he said.

Once data are being reported and analyzed more quickly, enforcement will be more timely also, he said. It will also let the FDA focus enforcement efforts on the highest-risk products, said Dr. Schultz. “When enforcement is necessary, it needs to be done quickly, accurately, and in a way that's meaningful and corrects problems,” he said.

The FDA also aims to improve its communications to health professionals and consumers—whether the communications are notices about unsafe devices or simply background on safety and efficacy of products.

CDRH will redesign its Web site to be more consumer-friendly. It will also take a closer look at how best to give out data—and when—on a potentially faulty device.

CDRH is hoping to accomplish most of its planned “action points” without seeking additional funding, at least in the near term, Dr. Schultz said.

The Food and Drug Administration announced on Nov. 9 that it is taking steps to improve its postmarketing surveillance of medical device safety, including moving ahead on a proposal to require electronic reporting of adverse events.

The agency said it has created an action plan based on a major review that was completed in 2005. That review looked at how the Center for Radiological Devices and Health (CDRH) handles recalls and enforcement actions against manufacturers that are not in compliance with FDA rules.

“Today's report details a number of action items that we believe will transform the postmarketing safety program,” said Dr. Daniel Schultz, director of CDRH, during a briefing with reporters.

The FDA will focus on making improvements in four major areas: collaboration among experts within CDRH, data systems, communications with patients and physicians about risks and benefits, and enforcement.

CDRH leaders will encourage more cross-organizational collaboration so that premarket, postmarket, and enforcement efforts are better coordinated, said Dr. Schultz.

Some of the biggest changes will come in data collection and analysis. The agency hopes to integrate its passive adverse events reporting system (Manufacturer and User Facility Device Experience Database, also known as MAUDE) and its active system, the Medical Product Safety Device Network (MedSun), said Dr. Schultz. Currently, 350 hospitals have been trained to report device problems on MedSun.

One goal is to recruit more facilities and find a way to upgrade reporting so it is closer to real-time.

The agency also hopes to require manufacturers and others to electronically report adverse events.

Currently, FDA receives about 200,000 reports to MAUDE each year, and the majority are on paper, which delays entry into the system and analysis for any kind of safety signal, Dr. Schultz said. The FDA has been piloting an electronic reporting program, and is in the process of writing a rule to require electronic reporting, he said.

Once data are being reported and analyzed more quickly, enforcement will be more timely also, he said. It will also let the FDA focus enforcement efforts on the highest-risk products, said Dr. Schultz. “When enforcement is necessary, it needs to be done quickly, accurately, and in a way that's meaningful and corrects problems,” he said.

The FDA also aims to improve its communications to health professionals and consumers—whether the communications are notices about unsafe devices or simply background on safety and efficacy of products.

CDRH will redesign its Web site to be more consumer-friendly. It will also take a closer look at how best to give out data—and when—on a potentially faulty device.

CDRH is hoping to accomplish most of its planned “action points” without seeking additional funding, at least in the near term, Dr. Schultz said.

The Food and Drug Administration announced on Nov. 9 that it is taking steps to improve its postmarketing surveillance of medical device safety, including moving ahead on a proposal to require electronic reporting of adverse events.

The agency said it has created an action plan based on a major review that was completed in 2005. That review looked at how the Center for Radiological Devices and Health (CDRH) handles recalls and enforcement actions against manufacturers that are not in compliance with FDA rules.

“Today's report details a number of action items that we believe will transform the postmarketing safety program,” said Dr. Daniel Schultz, director of CDRH, during a briefing with reporters.

The FDA will focus on making improvements in four major areas: collaboration among experts within CDRH, data systems, communications with patients and physicians about risks and benefits, and enforcement.

CDRH leaders will encourage more cross-organizational collaboration so that premarket, postmarket, and enforcement efforts are better coordinated, said Dr. Schultz.

Some of the biggest changes will come in data collection and analysis. The agency hopes to integrate its passive adverse events reporting system (Manufacturer and User Facility Device Experience Database, also known as MAUDE) and its active system, the Medical Product Safety Device Network (MedSun), said Dr. Schultz. Currently, 350 hospitals have been trained to report device problems on MedSun.

One goal is to recruit more facilities and find a way to upgrade reporting so it is closer to real-time.

The agency also hopes to require manufacturers and others to electronically report adverse events.

Currently, FDA receives about 200,000 reports to MAUDE each year, and the majority are on paper, which delays entry into the system and analysis for any kind of safety signal, Dr. Schultz said. The FDA has been piloting an electronic reporting program, and is in the process of writing a rule to require electronic reporting, he said.

Once data are being reported and analyzed more quickly, enforcement will be more timely also, he said. It will also let the FDA focus enforcement efforts on the highest-risk products, said Dr. Schultz. “When enforcement is necessary, it needs to be done quickly, accurately, and in a way that's meaningful and corrects problems,” he said.

The FDA also aims to improve its communications to health professionals and consumers—whether the communications are notices about unsafe devices or simply background on safety and efficacy of products.

CDRH will redesign its Web site to be more consumer-friendly. It will also take a closer look at how best to give out data—and when—on a potentially faulty device.

CDRH is hoping to accomplish most of its planned “action points” without seeking additional funding, at least in the near term, Dr. Schultz said.

WASHINGTON – The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in Congress and generated interest among state legislatures, but it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met in early November at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the “health court” concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was “avoidable” or “preventable” (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, based on scientific evidence and what is known about avoidability of errors. Decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation but decrease the size of awards, Ms. Mello said.

Unlike the current tort system, a health court system could also help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses, she explained.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that awards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said patients should not be required to start the claims process, as is proposed under the health court system. An audience member representing Consumers Union said that her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Eighty-five percent of errors are due to systems issues; only 15% are competency related, so solutions should focus on systems design, Dr. O'Leary said.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events–maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides–the top category–and surgical misadventures, the No. 2 category, Dr. O'Leary said. Surprisingly, at least eight cases a month of wrong-site surgery are reported, he added.

WASHINGTON – The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in Congress and generated interest among state legislatures, but it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met in early November at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the “health court” concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was “avoidable” or “preventable” (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, based on scientific evidence and what is known about avoidability of errors. Decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation but decrease the size of awards, Ms. Mello said.

Unlike the current tort system, a health court system could also help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses, she explained.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that awards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said patients should not be required to start the claims process, as is proposed under the health court system. An audience member representing Consumers Union said that her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Eighty-five percent of errors are due to systems issues; only 15% are competency related, so solutions should focus on systems design, Dr. O'Leary said.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events–maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides–the top category–and surgical misadventures, the No. 2 category, Dr. O'Leary said. Surprisingly, at least eight cases a month of wrong-site surgery are reported, he added.

WASHINGTON – The concept of using administrative law judges instead of civil jury trials to settle malpractice suits has gained some admirers in Congress and generated interest among state legislatures, but it is uncertain whether such a system is the solution to skyrocketing malpractice premiums and jury awards, according to academics, attorneys, and consumer and legislative representatives who met in early November at a meeting sponsored by Common Good and the Harvard School of Public Health, Boston.

Under the “health court” concept, fleshed out earlier this year by Michelle Mello and David Studdert of Harvard, specially trained judges would make compensation decisions according to whether an injury was “avoidable” or “preventable” (Milbank Quarterly 2006;3:459–92). The plaintiff would have to show that the injury would not have happened if best practices were followed. Impartial experts would help set compensation, based on scientific evidence and what is known about avoidability of errors. Decisions would be made quickly.

Such a system would likely increase the number of people eligible for compensation but decrease the size of awards, Ms. Mello said.

Unlike the current tort system, a health court system could also help deter medical errors by collecting data that would then be given back to hospitals and practitioners for root-cause analyses, she explained.

In 2005, Sen. Michael Enzi (R-Wyo.) and Sen. Max Baucus (D-Mont.) introduced the Fair and Reliable Medical Justice Act (S. 1337), which would provide money for demonstration projects on alternative methods to address malpractice, including health courts. The Senate Health, Education, Labor, and Pensions Committee held a hearing on the bill in June 2006, but there has been no further action.

At the symposium, Stephen Northrup, the health policy staff director for that committee, said it is not clear whether the newly Democratic-controlled Congress will consider alternatives such as health courts. Because Democrats are unlikely to approve of caps on damages as a tort reform, he said, it is incumbent on physicians to promote alternatives.

The National Committee for Quality Assurance supports the move toward an administrative court, said NCQA general counsel Sharon Donohue. But there is no evidence that awards will decrease, and with an expanding number of claimants, malpractice premiums might still increase because they are based on the number of claims paid, she said.

Some consumer groups oppose the idea. Linda Kenney, president of the advocacy group Medically Induced Trauma Support Services, said patients should not be required to start the claims process, as is proposed under the health court system. An audience member representing Consumers Union said that her group did not like the idea of taking away a patient's right to a jury trial.

Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations, also said he saw some basic impediments to using the courts to improve patient safety. Eighty-five percent of errors are due to systems issues; only 15% are competency related, so solutions should focus on systems design, Dr. O'Leary said.

Despite JCAHO's voluntary reporting requirements of the last 10 years, there are few reports of adverse events–maybe 450–500 a year, he said. Most reports concern errors that are not easy to hide, such as patient suicides–the top category–and surgical misadventures, the No. 2 category, Dr. O'Leary said. Surprisingly, at least eight cases a month of wrong-site surgery are reported, he added.

College Psoriasis Campaign

The National Psoriasis Foundation is seeking to increase awareness and knowledge about psoriasis among college students, partly because the disease usually first appears between the ages of 15 and 25 years. The College-Age Psoriasis Awareness Campaign will be anchored by television news segments provided by the foundation that feature Dr. Stephen Feldman, professor of dermatology and pathology at Wake Forest University and a 21-year-old psoriasis patient and college student discussing the physical, social, and psychological consequences of the disease. "Misperceptions about psoriasis can negatively affect [college students'] comfort level with dating, participating in sports and going on job interviews," said Gail Zimmerman, Psoriasis Foundation president and CEO, in a statement. "The goal of CAPAC is to educate this group and alleviate the potentially adverse social effects of psoriasis," she said.

Cosmetic Surgeons' Calif. Victory

A California judge has ruled that the state's Medical Board must grant equivalency status to the American Board of Cosmetic Surgery (ABCS). The decision by Judge Jack Sapunor in the Superior Court of California, Sacramento County, means that the ABCS would be given the same footing as other boards recognized by the American Board of Medical Specialties. The Medical Board of California had refused applications for equivalency by ABCS in 1999 and again in November 2005. That meant that cosmetic surgeons in the state could not use the phrase "board-certified" in advertising, and that they had difficulty getting hospital privileges, according to the American Academy of Cosmetic Surgery. The ABCS challenged the Medical Board's decision, calling it arbitrary and capricious. The Judge agreed and said that the ABCS met or exceeded the requirements. The Medical Board is appealing. The AACS said that the ruling could pave the way for equivalency in other states.

AAD Targets Indoor Tanning

The American Academy of Dermatology is launching a public service campaign on the dangers of indoor tanning using teen-centric instant-messaging shorthand. The print, television, and radio ads use language typically employed while "IM-ing." According to the AAD, 70% of indoor tanning customers are white females aged 16–49 years. "This campaign is to specifically target teenage girls at a young age before they start tanning and educate them in a peer-to-peer manner that will encourage them to avoid this unnecessary health risk," said Dr. Arielle N.B. Kauvar, chairman of the AAD's Council on Communications, in a statement.

CMS Curbs Improper Claims

Medicare's on track in 2006 to further reduce the number of fraudulent and inappropriate claims being submitted. The Centers for Medicare and Medicaid Services reported that 4% of claims were improper in 2006, down from 5% the previous year and from 14% in 1996, leading to $11 billion less in improper payments over the last 2 years. To determine the error rate, CMS randomly sampled 160,000 claims submitted from April 2005 to March 2006. Since it has been able to more closely identify errors, CMS has been providing more accurate information to contractors, resulting in improved system edits and updated coverage policies, the agency said in a statement.

Ex-FDA Chief Guilty

Former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., has pleaded guilty to lying about stock he held during his tenure, in violation of federal conflict-of-interest and stock ownership rules. Dr. Crawford was charged with two misdemeanors and is scheduled to be sentenced Jan. 22 in Federal District Court in Washington. He could receive a year in prison and could be fined $200,000. According to the plea, Dr. Crawford failed to sell shares in Sysco, Pepsico, and Kimberly-Clark, all of which have products that are regulated by the FDA. Federal rules require senior officials to divest shares in companies that their agency regulates. Dr. Crawford also did not disclose his wife's ownership of Wal-Mart stock. Dr. Crawford was charged with conflict of interest for owning the Pepsico and Sysco shares while he was chairman of FDA's Obesity Working Group. Rep. Maurice Hinchey (D-N.Y.) said he will push for a completion of an Office of Inspector General inquiry into Dr. Crawford's resignation and financial holdings. "Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical," Rep. Hinchey said in a statement.

McClellan Accepts Think Tank Post

Former Medicare Chief Mark McClellan has accepted a new post as a visiting senior fellow with the AEI-Brookings Joint Center for Regulatory Studies in Washington. The new job will keep Dr. McClellan involved in health care policy issues. He also will remain as an associate professor of economics and an associate professor of medicine at Stanford (Calif.) University. Dr. McClellan had been on leave from Stanford for several years while working in the federal government. Before taking the post as administrator of the Centers for Medicare and Medicaid Services, Dr. McClellan served from 2002 to 2004 as the commissioner of the Food and Drug Administration. He also served as an economic and health care advisor to President Bush from 2001 to 2002.

College Psoriasis Campaign

The National Psoriasis Foundation is seeking to increase awareness and knowledge about psoriasis among college students, partly because the disease usually first appears between the ages of 15 and 25 years. The College-Age Psoriasis Awareness Campaign will be anchored by television news segments provided by the foundation that feature Dr. Stephen Feldman, professor of dermatology and pathology at Wake Forest University and a 21-year-old psoriasis patient and college student discussing the physical, social, and psychological consequences of the disease. "Misperceptions about psoriasis can negatively affect [college students'] comfort level with dating, participating in sports and going on job interviews," said Gail Zimmerman, Psoriasis Foundation president and CEO, in a statement. "The goal of CAPAC is to educate this group and alleviate the potentially adverse social effects of psoriasis," she said.

Cosmetic Surgeons' Calif. Victory

A California judge has ruled that the state's Medical Board must grant equivalency status to the American Board of Cosmetic Surgery (ABCS). The decision by Judge Jack Sapunor in the Superior Court of California, Sacramento County, means that the ABCS would be given the same footing as other boards recognized by the American Board of Medical Specialties. The Medical Board of California had refused applications for equivalency by ABCS in 1999 and again in November 2005. That meant that cosmetic surgeons in the state could not use the phrase "board-certified" in advertising, and that they had difficulty getting hospital privileges, according to the American Academy of Cosmetic Surgery. The ABCS challenged the Medical Board's decision, calling it arbitrary and capricious. The Judge agreed and said that the ABCS met or exceeded the requirements. The Medical Board is appealing. The AACS said that the ruling could pave the way for equivalency in other states.

AAD Targets Indoor Tanning

The American Academy of Dermatology is launching a public service campaign on the dangers of indoor tanning using teen-centric instant-messaging shorthand. The print, television, and radio ads use language typically employed while "IM-ing." According to the AAD, 70% of indoor tanning customers are white females aged 16–49 years. "This campaign is to specifically target teenage girls at a young age before they start tanning and educate them in a peer-to-peer manner that will encourage them to avoid this unnecessary health risk," said Dr. Arielle N.B. Kauvar, chairman of the AAD's Council on Communications, in a statement.

CMS Curbs Improper Claims

Medicare's on track in 2006 to further reduce the number of fraudulent and inappropriate claims being submitted. The Centers for Medicare and Medicaid Services reported that 4% of claims were improper in 2006, down from 5% the previous year and from 14% in 1996, leading to $11 billion less in improper payments over the last 2 years. To determine the error rate, CMS randomly sampled 160,000 claims submitted from April 2005 to March 2006. Since it has been able to more closely identify errors, CMS has been providing more accurate information to contractors, resulting in improved system edits and updated coverage policies, the agency said in a statement.

Ex-FDA Chief Guilty

Former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., has pleaded guilty to lying about stock he held during his tenure, in violation of federal conflict-of-interest and stock ownership rules. Dr. Crawford was charged with two misdemeanors and is scheduled to be sentenced Jan. 22 in Federal District Court in Washington. He could receive a year in prison and could be fined $200,000. According to the plea, Dr. Crawford failed to sell shares in Sysco, Pepsico, and Kimberly-Clark, all of which have products that are regulated by the FDA. Federal rules require senior officials to divest shares in companies that their agency regulates. Dr. Crawford also did not disclose his wife's ownership of Wal-Mart stock. Dr. Crawford was charged with conflict of interest for owning the Pepsico and Sysco shares while he was chairman of FDA's Obesity Working Group. Rep. Maurice Hinchey (D-N.Y.) said he will push for a completion of an Office of Inspector General inquiry into Dr. Crawford's resignation and financial holdings. "Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical," Rep. Hinchey said in a statement.

McClellan Accepts Think Tank Post

Former Medicare Chief Mark McClellan has accepted a new post as a visiting senior fellow with the AEI-Brookings Joint Center for Regulatory Studies in Washington. The new job will keep Dr. McClellan involved in health care policy issues. He also will remain as an associate professor of economics and an associate professor of medicine at Stanford (Calif.) University. Dr. McClellan had been on leave from Stanford for several years while working in the federal government. Before taking the post as administrator of the Centers for Medicare and Medicaid Services, Dr. McClellan served from 2002 to 2004 as the commissioner of the Food and Drug Administration. He also served as an economic and health care advisor to President Bush from 2001 to 2002.

College Psoriasis Campaign

The National Psoriasis Foundation is seeking to increase awareness and knowledge about psoriasis among college students, partly because the disease usually first appears between the ages of 15 and 25 years. The College-Age Psoriasis Awareness Campaign will be anchored by television news segments provided by the foundation that feature Dr. Stephen Feldman, professor of dermatology and pathology at Wake Forest University and a 21-year-old psoriasis patient and college student discussing the physical, social, and psychological consequences of the disease. "Misperceptions about psoriasis can negatively affect [college students'] comfort level with dating, participating in sports and going on job interviews," said Gail Zimmerman, Psoriasis Foundation president and CEO, in a statement. "The goal of CAPAC is to educate this group and alleviate the potentially adverse social effects of psoriasis," she said.

Cosmetic Surgeons' Calif. Victory

A California judge has ruled that the state's Medical Board must grant equivalency status to the American Board of Cosmetic Surgery (ABCS). The decision by Judge Jack Sapunor in the Superior Court of California, Sacramento County, means that the ABCS would be given the same footing as other boards recognized by the American Board of Medical Specialties. The Medical Board of California had refused applications for equivalency by ABCS in 1999 and again in November 2005. That meant that cosmetic surgeons in the state could not use the phrase "board-certified" in advertising, and that they had difficulty getting hospital privileges, according to the American Academy of Cosmetic Surgery. The ABCS challenged the Medical Board's decision, calling it arbitrary and capricious. The Judge agreed and said that the ABCS met or exceeded the requirements. The Medical Board is appealing. The AACS said that the ruling could pave the way for equivalency in other states.

AAD Targets Indoor Tanning

The American Academy of Dermatology is launching a public service campaign on the dangers of indoor tanning using teen-centric instant-messaging shorthand. The print, television, and radio ads use language typically employed while "IM-ing." According to the AAD, 70% of indoor tanning customers are white females aged 16–49 years. "This campaign is to specifically target teenage girls at a young age before they start tanning and educate them in a peer-to-peer manner that will encourage them to avoid this unnecessary health risk," said Dr. Arielle N.B. Kauvar, chairman of the AAD's Council on Communications, in a statement.

CMS Curbs Improper Claims

Medicare's on track in 2006 to further reduce the number of fraudulent and inappropriate claims being submitted. The Centers for Medicare and Medicaid Services reported that 4% of claims were improper in 2006, down from 5% the previous year and from 14% in 1996, leading to $11 billion less in improper payments over the last 2 years. To determine the error rate, CMS randomly sampled 160,000 claims submitted from April 2005 to March 2006. Since it has been able to more closely identify errors, CMS has been providing more accurate information to contractors, resulting in improved system edits and updated coverage policies, the agency said in a statement.

Ex-FDA Chief Guilty

Former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., has pleaded guilty to lying about stock he held during his tenure, in violation of federal conflict-of-interest and stock ownership rules. Dr. Crawford was charged with two misdemeanors and is scheduled to be sentenced Jan. 22 in Federal District Court in Washington. He could receive a year in prison and could be fined $200,000. According to the plea, Dr. Crawford failed to sell shares in Sysco, Pepsico, and Kimberly-Clark, all of which have products that are regulated by the FDA. Federal rules require senior officials to divest shares in companies that their agency regulates. Dr. Crawford also did not disclose his wife's ownership of Wal-Mart stock. Dr. Crawford was charged with conflict of interest for owning the Pepsico and Sysco shares while he was chairman of FDA's Obesity Working Group. Rep. Maurice Hinchey (D-N.Y.) said he will push for a completion of an Office of Inspector General inquiry into Dr. Crawford's resignation and financial holdings. "Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical," Rep. Hinchey said in a statement.

McClellan Accepts Think Tank Post

Former Medicare Chief Mark McClellan has accepted a new post as a visiting senior fellow with the AEI-Brookings Joint Center for Regulatory Studies in Washington. The new job will keep Dr. McClellan involved in health care policy issues. He also will remain as an associate professor of economics and an associate professor of medicine at Stanford (Calif.) University. Dr. McClellan had been on leave from Stanford for several years while working in the federal government. Before taking the post as administrator of the Centers for Medicare and Medicaid Services, Dr. McClellan served from 2002 to 2004 as the commissioner of the Food and Drug Administration. He also served as an economic and health care advisor to President Bush from 2001 to 2002.

TORONTO — The injectable filler Radiesse appears to offer an edge over Sculptra when it comes to ease of use, cost-effectiveness, and patient satisfaction, Dr. Stuart Bentkover said at the annual fall meeting of the American Academy of Facial and Reconstructive Plastic Surgery.

Dr. Bentkover offered results on 216 patients using both products at his facial plastic surgery practice in Worcester, Mass.

Radiesse "is, out of the box, very easy to use on day 1," he said. There is an immediate augmentation with the product, but about 10% will be lost by 2–6 months. He tells patients that the full effect lasts about 10–14 months.

The product, composed of calcium hydroxylapatite microspheres and sold by BioForm Medical Inc., is approved by the Food and Drug Administration for oral and maxillofacial defects, vocal fold insufficiency, and radiographic tissue marking. Approval is pending for HIV-related lipoatrophy and nasolabial folds (SKIN & ALLERGY NEWS, October 2006, p. 1).

Sculptra (injectable poly-L-lactic acid) is approved by the FDA for facial fat loss in HIV-infected patients and is used off-label for cosmetic purposes. It is not as patient- or user-friendly because patients must massage the area five times daily for 5 minutes for 5 days after injection, he said.

Sculptra is sold by Dermik Laboratories, a subsidiary of Sanofi-Aventis.

Unlike Radiesse, which can be used quickly, Sculptra has to be reconstituted 2 hours before the procedure. The product does not stay in suspension easily and often requires multiple syringes, as they tend to clog, Dr. Bentkover said.

He calculated the surgeon cost per session at $304 with Radiesse, compared with $480 for Sculptra. The costs are not radically different, but the need for a second session is higher with Sculptra, he said.

With Radiesse, he has seen persistent erythema in two patients, a viral infection, and skin slough. The most common complication is superficial injection. Four patients who received Sculptra injections developed nodules, mostly around their eyes.

Overall complication rates in his experience were 4.6% for Radiesse and 19% for Sculptra. These are, however, based on a small number of patients, he said.

Dr. Bentkover said that he has stopped using Sculptra because of the complication rate.

Another surgeon, Dr. Phillip Langsdon, chief of facial plastic surgery at the University of Tennessee in Memphis, said that he thinks Sculptra is a good product with few side effects. "I've been injecting Sculptra for 2 years and haven't seen any nodules yet," he told meeting attendees.

Dr. Langsdon said that he had no interest in Dermik or Sanofi-Aventis.

Dr. Bentkover is on the national teaching faculty for Radiesse and lectures for Rhytec Inc.

TORONTO — The injectable filler Radiesse appears to offer an edge over Sculptra when it comes to ease of use, cost-effectiveness, and patient satisfaction, Dr. Stuart Bentkover said at the annual fall meeting of the American Academy of Facial and Reconstructive Plastic Surgery.

Dr. Bentkover offered results on 216 patients using both products at his facial plastic surgery practice in Worcester, Mass.

Radiesse "is, out of the box, very easy to use on day 1," he said. There is an immediate augmentation with the product, but about 10% will be lost by 2–6 months. He tells patients that the full effect lasts about 10–14 months.

The product, composed of calcium hydroxylapatite microspheres and sold by BioForm Medical Inc., is approved by the Food and Drug Administration for oral and maxillofacial defects, vocal fold insufficiency, and radiographic tissue marking. Approval is pending for HIV-related lipoatrophy and nasolabial folds (SKIN & ALLERGY NEWS, October 2006, p. 1).

Sculptra (injectable poly-L-lactic acid) is approved by the FDA for facial fat loss in HIV-infected patients and is used off-label for cosmetic purposes. It is not as patient- or user-friendly because patients must massage the area five times daily for 5 minutes for 5 days after injection, he said.

Sculptra is sold by Dermik Laboratories, a subsidiary of Sanofi-Aventis.

Unlike Radiesse, which can be used quickly, Sculptra has to be reconstituted 2 hours before the procedure. The product does not stay in suspension easily and often requires multiple syringes, as they tend to clog, Dr. Bentkover said.

He calculated the surgeon cost per session at $304 with Radiesse, compared with $480 for Sculptra. The costs are not radically different, but the need for a second session is higher with Sculptra, he said.

With Radiesse, he has seen persistent erythema in two patients, a viral infection, and skin slough. The most common complication is superficial injection. Four patients who received Sculptra injections developed nodules, mostly around their eyes.

Overall complication rates in his experience were 4.6% for Radiesse and 19% for Sculptra. These are, however, based on a small number of patients, he said.

Dr. Bentkover said that he has stopped using Sculptra because of the complication rate.

Another surgeon, Dr. Phillip Langsdon, chief of facial plastic surgery at the University of Tennessee in Memphis, said that he thinks Sculptra is a good product with few side effects. "I've been injecting Sculptra for 2 years and haven't seen any nodules yet," he told meeting attendees.

Dr. Langsdon said that he had no interest in Dermik or Sanofi-Aventis.

Dr. Bentkover is on the national teaching faculty for Radiesse and lectures for Rhytec Inc.

TORONTO — The injectable filler Radiesse appears to offer an edge over Sculptra when it comes to ease of use, cost-effectiveness, and patient satisfaction, Dr. Stuart Bentkover said at the annual fall meeting of the American Academy of Facial and Reconstructive Plastic Surgery.

Dr. Bentkover offered results on 216 patients using both products at his facial plastic surgery practice in Worcester, Mass.

Radiesse "is, out of the box, very easy to use on day 1," he said. There is an immediate augmentation with the product, but about 10% will be lost by 2–6 months. He tells patients that the full effect lasts about 10–14 months.

The product, composed of calcium hydroxylapatite microspheres and sold by BioForm Medical Inc., is approved by the Food and Drug Administration for oral and maxillofacial defects, vocal fold insufficiency, and radiographic tissue marking. Approval is pending for HIV-related lipoatrophy and nasolabial folds (SKIN & ALLERGY NEWS, October 2006, p. 1).

Sculptra (injectable poly-L-lactic acid) is approved by the FDA for facial fat loss in HIV-infected patients and is used off-label for cosmetic purposes. It is not as patient- or user-friendly because patients must massage the area five times daily for 5 minutes for 5 days after injection, he said.

Sculptra is sold by Dermik Laboratories, a subsidiary of Sanofi-Aventis.

Unlike Radiesse, which can be used quickly, Sculptra has to be reconstituted 2 hours before the procedure. The product does not stay in suspension easily and often requires multiple syringes, as they tend to clog, Dr. Bentkover said.

He calculated the surgeon cost per session at $304 with Radiesse, compared with $480 for Sculptra. The costs are not radically different, but the need for a second session is higher with Sculptra, he said.

With Radiesse, he has seen persistent erythema in two patients, a viral infection, and skin slough. The most common complication is superficial injection. Four patients who received Sculptra injections developed nodules, mostly around their eyes.

Overall complication rates in his experience were 4.6% for Radiesse and 19% for Sculptra. These are, however, based on a small number of patients, he said.

Dr. Bentkover said that he has stopped using Sculptra because of the complication rate.

Another surgeon, Dr. Phillip Langsdon, chief of facial plastic surgery at the University of Tennessee in Memphis, said that he thinks Sculptra is a good product with few side effects. "I've been injecting Sculptra for 2 years and haven't seen any nodules yet," he told meeting attendees.

Dr. Langsdon said that he had no interest in Dermik or Sanofi-Aventis.

Dr. Bentkover is on the national teaching faculty for Radiesse and lectures for Rhytec Inc.

Ex-FDA Chief Pleads Guilty

Former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., has pleaded guilty to lying about stock he held during his tenure, in violation of federal conflict-of-interest and stock ownership rules. Dr. Crawford was charged with two misdemeanors and is scheduled to be sentenced Jan. 22 in Federal District Court in Washington. He could receive a year in prison and could be fined $200,000. According to the plea, Dr. Crawford failed to sell shares in Sysco, Pepsico, and Kimberly-Clark, all of which have products that are regulated by the FDA. Federal rules require senior officials to divest shares in companies that their agency regulates. Dr. Crawford also did not disclose his wife's ownership of Wal-Mart stock. Dr. Crawford was charged with conflict of interest for owning the Pepsico and Sysco shares while he was chairman of FDA's Obesity Working Group. Rep. Maurice Hinchey (D-N.Y.) said he will push for a completion of an Office of Inspector General inquiry into Dr. Crawford's resignation and financial holdings. “Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical,” Rep. Hinchey said in a statement.

P4P For Small Practices

The Centers for Medicare and Medicaid Services is seeking 800 solo and small- to medium-sized group practices to participate in a pilot pay-for-performance project. The 3-year pilot, called the Medicare Care Management Performance Demonstration, is limited to practices in Arkansas, California, Massachusetts, and Utah that are the main providers of primary care to at least 50 Medicare beneficiaries. Physicians will be required to submit data each year on up to 26 quality measures in diabetes, heart failure, coronary artery disease, and preventive care. During the first year, participating physicians will be paid for reporting baseline information. In the 2 succeeding years, practices will submit quality data; they can earn up to $10,000 per physician or up to $50,000 per practice for meeting the benchmarks, which have been endorsed by the National Quality Forum. The measures are similar to those being used in Medicare's Physician Voluntary Reporting Program. At the end of the 3-year project, CMS and the Agency for Healthcare Research and Quality will review the impact on patient outcomes and Medicare expenditures. For more information, go to

www.cms.hhs.gov/DemoProjectsEvalRpts/MD/list.asp

CMS Curbs Improper Claims

Medicare's on track in 2006 to further reduce the number of fraudulent and inappropriate claims being submitted. CMS is reporting that 4% of claims were improper in 2006, down from 5% the previous year and from 14% in 1996, leading to $11 billion less in improper payments over the last 2 years. To determine the error rate, CMS randomly sampled 160,000 claims submitted from April 2005 to March 2006. Since it has been able to more closely identify errors, CMS has been providing more accurate information to contractors, resulting in improved system edits and updated coverage policies, the agency said in a statement. “I welcome the news that the government's increased attention to oversight of Medicare payments has paid off,” Sen. Chuck Grassley (R-Iowa), chairman of the committee charged with Medicare oversight, said in a statement. He added that CMS has work to do, as it is “still paying for medically unnecessary services and undocumented or poorly documented services.”

Wal-Mart Expands Generic Access

Wal-Mart has expanded its $4 generic drug program to an additional 14 states. The program, which was launched in September in Florida, covers 30-day supplies of generic drugs at commonly prescribed dosages and includes 314 generic drugs including 143 compounds in 24 therapeutic categories. Wal-Mart had originally planned to pilot the program in Florida and roll it out to additional states sometime next year, but accelerated expansion due to consumer demand. The move by Wal-Mart is likely to be good for the company's bottom line, according to the results of a Wall Street Journal Online/Harris Interactive poll. The poll of 2,493 adults found that currently only 13% of adults most often purchase drugs from a discount store like Wal-Mart or Target. However, when told about the availability of discounted generic drugs, 50% of respondents said they would be likely, very likely, or absolutely certain to fill their prescriptions for generic drugs from discount retailers. The program is now available at Wal-Mart stores in Alaska, Arizona, Arkansas, Delaware, Florida, Illinois, Indiana, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Texas, and Vermont.

McClellan Accepts Think Tank Post

Former Medicare Chief Mark McClellan has accepted a new post as a visiting senior fellow with the AEI-Brookings Joint Center for Regulatory Studies in Washington. The new job will keep Dr. McClellan involved in health care policy issues. He also will remain as an associate professor of economics and an associate professor of medicine at Stanford (Calif.) University. Dr. McClellan had been on leave from Stanford for several years while working in the federal government. Before taking the post as administrator of the Centers for Medicare and Medicaid Services, Dr. McClellan served from 2002 to 2004 as the commissioner of the Food and Drug Administration. He also served as an economic and health care advisor to President Bush from 2001 to 2002.

Ex-FDA Chief Pleads Guilty

Former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., has pleaded guilty to lying about stock he held during his tenure, in violation of federal conflict-of-interest and stock ownership rules. Dr. Crawford was charged with two misdemeanors and is scheduled to be sentenced Jan. 22 in Federal District Court in Washington. He could receive a year in prison and could be fined $200,000. According to the plea, Dr. Crawford failed to sell shares in Sysco, Pepsico, and Kimberly-Clark, all of which have products that are regulated by the FDA. Federal rules require senior officials to divest shares in companies that their agency regulates. Dr. Crawford also did not disclose his wife's ownership of Wal-Mart stock. Dr. Crawford was charged with conflict of interest for owning the Pepsico and Sysco shares while he was chairman of FDA's Obesity Working Group. Rep. Maurice Hinchey (D-N.Y.) said he will push for a completion of an Office of Inspector General inquiry into Dr. Crawford's resignation and financial holdings. “Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical,” Rep. Hinchey said in a statement.

P4P For Small Practices

The Centers for Medicare and Medicaid Services is seeking 800 solo and small- to medium-sized group practices to participate in a pilot pay-for-performance project. The 3-year pilot, called the Medicare Care Management Performance Demonstration, is limited to practices in Arkansas, California, Massachusetts, and Utah that are the main providers of primary care to at least 50 Medicare beneficiaries. Physicians will be required to submit data each year on up to 26 quality measures in diabetes, heart failure, coronary artery disease, and preventive care. During the first year, participating physicians will be paid for reporting baseline information. In the 2 succeeding years, practices will submit quality data; they can earn up to $10,000 per physician or up to $50,000 per practice for meeting the benchmarks, which have been endorsed by the National Quality Forum. The measures are similar to those being used in Medicare's Physician Voluntary Reporting Program. At the end of the 3-year project, CMS and the Agency for Healthcare Research and Quality will review the impact on patient outcomes and Medicare expenditures. For more information, go to

www.cms.hhs.gov/DemoProjectsEvalRpts/MD/list.asp

CMS Curbs Improper Claims

Medicare's on track in 2006 to further reduce the number of fraudulent and inappropriate claims being submitted. CMS is reporting that 4% of claims were improper in 2006, down from 5% the previous year and from 14% in 1996, leading to $11 billion less in improper payments over the last 2 years. To determine the error rate, CMS randomly sampled 160,000 claims submitted from April 2005 to March 2006. Since it has been able to more closely identify errors, CMS has been providing more accurate information to contractors, resulting in improved system edits and updated coverage policies, the agency said in a statement. “I welcome the news that the government's increased attention to oversight of Medicare payments has paid off,” Sen. Chuck Grassley (R-Iowa), chairman of the committee charged with Medicare oversight, said in a statement. He added that CMS has work to do, as it is “still paying for medically unnecessary services and undocumented or poorly documented services.”

Wal-Mart Expands Generic Access

Wal-Mart has expanded its $4 generic drug program to an additional 14 states. The program, which was launched in September in Florida, covers 30-day supplies of generic drugs at commonly prescribed dosages and includes 314 generic drugs including 143 compounds in 24 therapeutic categories. Wal-Mart had originally planned to pilot the program in Florida and roll it out to additional states sometime next year, but accelerated expansion due to consumer demand. The move by Wal-Mart is likely to be good for the company's bottom line, according to the results of a Wall Street Journal Online/Harris Interactive poll. The poll of 2,493 adults found that currently only 13% of adults most often purchase drugs from a discount store like Wal-Mart or Target. However, when told about the availability of discounted generic drugs, 50% of respondents said they would be likely, very likely, or absolutely certain to fill their prescriptions for generic drugs from discount retailers. The program is now available at Wal-Mart stores in Alaska, Arizona, Arkansas, Delaware, Florida, Illinois, Indiana, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Texas, and Vermont.

McClellan Accepts Think Tank Post

Former Medicare Chief Mark McClellan has accepted a new post as a visiting senior fellow with the AEI-Brookings Joint Center for Regulatory Studies in Washington. The new job will keep Dr. McClellan involved in health care policy issues. He also will remain as an associate professor of economics and an associate professor of medicine at Stanford (Calif.) University. Dr. McClellan had been on leave from Stanford for several years while working in the federal government. Before taking the post as administrator of the Centers for Medicare and Medicaid Services, Dr. McClellan served from 2002 to 2004 as the commissioner of the Food and Drug Administration. He also served as an economic and health care advisor to President Bush from 2001 to 2002.

Ex-FDA Chief Pleads Guilty

Former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., has pleaded guilty to lying about stock he held during his tenure, in violation of federal conflict-of-interest and stock ownership rules. Dr. Crawford was charged with two misdemeanors and is scheduled to be sentenced Jan. 22 in Federal District Court in Washington. He could receive a year in prison and could be fined $200,000. According to the plea, Dr. Crawford failed to sell shares in Sysco, Pepsico, and Kimberly-Clark, all of which have products that are regulated by the FDA. Federal rules require senior officials to divest shares in companies that their agency regulates. Dr. Crawford also did not disclose his wife's ownership of Wal-Mart stock. Dr. Crawford was charged with conflict of interest for owning the Pepsico and Sysco shares while he was chairman of FDA's Obesity Working Group. Rep. Maurice Hinchey (D-N.Y.) said he will push for a completion of an Office of Inspector General inquiry into Dr. Crawford's resignation and financial holdings. “Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical,” Rep. Hinchey said in a statement.

P4P For Small Practices

The Centers for Medicare and Medicaid Services is seeking 800 solo and small- to medium-sized group practices to participate in a pilot pay-for-performance project. The 3-year pilot, called the Medicare Care Management Performance Demonstration, is limited to practices in Arkansas, California, Massachusetts, and Utah that are the main providers of primary care to at least 50 Medicare beneficiaries. Physicians will be required to submit data each year on up to 26 quality measures in diabetes, heart failure, coronary artery disease, and preventive care. During the first year, participating physicians will be paid for reporting baseline information. In the 2 succeeding years, practices will submit quality data; they can earn up to $10,000 per physician or up to $50,000 per practice for meeting the benchmarks, which have been endorsed by the National Quality Forum. The measures are similar to those being used in Medicare's Physician Voluntary Reporting Program. At the end of the 3-year project, CMS and the Agency for Healthcare Research and Quality will review the impact on patient outcomes and Medicare expenditures. For more information, go to

www.cms.hhs.gov/DemoProjectsEvalRpts/MD/list.asp

CMS Curbs Improper Claims

Medicare's on track in 2006 to further reduce the number of fraudulent and inappropriate claims being submitted. CMS is reporting that 4% of claims were improper in 2006, down from 5% the previous year and from 14% in 1996, leading to $11 billion less in improper payments over the last 2 years. To determine the error rate, CMS randomly sampled 160,000 claims submitted from April 2005 to March 2006. Since it has been able to more closely identify errors, CMS has been providing more accurate information to contractors, resulting in improved system edits and updated coverage policies, the agency said in a statement. “I welcome the news that the government's increased attention to oversight of Medicare payments has paid off,” Sen. Chuck Grassley (R-Iowa), chairman of the committee charged with Medicare oversight, said in a statement. He added that CMS has work to do, as it is “still paying for medically unnecessary services and undocumented or poorly documented services.”

Wal-Mart Expands Generic Access

Wal-Mart has expanded its $4 generic drug program to an additional 14 states. The program, which was launched in September in Florida, covers 30-day supplies of generic drugs at commonly prescribed dosages and includes 314 generic drugs including 143 compounds in 24 therapeutic categories. Wal-Mart had originally planned to pilot the program in Florida and roll it out to additional states sometime next year, but accelerated expansion due to consumer demand. The move by Wal-Mart is likely to be good for the company's bottom line, according to the results of a Wall Street Journal Online/Harris Interactive poll. The poll of 2,493 adults found that currently only 13% of adults most often purchase drugs from a discount store like Wal-Mart or Target. However, when told about the availability of discounted generic drugs, 50% of respondents said they would be likely, very likely, or absolutely certain to fill their prescriptions for generic drugs from discount retailers. The program is now available at Wal-Mart stores in Alaska, Arizona, Arkansas, Delaware, Florida, Illinois, Indiana, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Texas, and Vermont.

McClellan Accepts Think Tank Post

Former Medicare Chief Mark McClellan has accepted a new post as a visiting senior fellow with the AEI-Brookings Joint Center for Regulatory Studies in Washington. The new job will keep Dr. McClellan involved in health care policy issues. He also will remain as an associate professor of economics and an associate professor of medicine at Stanford (Calif.) University. Dr. McClellan had been on leave from Stanford for several years while working in the federal government. Before taking the post as administrator of the Centers for Medicare and Medicaid Services, Dr. McClellan served from 2002 to 2004 as the commissioner of the Food and Drug Administration. He also served as an economic and health care advisor to President Bush from 2001 to 2002.

Computerized physician order entry has been hailed as a breakthrough for reducing medication errors, but the systems can introduce new types of mistakes that can themselves lead to adverse drug reactions and other errors, according to research conducted by Dr. Kathleen E. Walsh of the University of Massachusetts, Boston, and her colleagues.

The investigators sought to determine the rates and incidence of computerized physician order entry (CPOE) in pediatrics, noting that computer-related errors are the fourth leading cause of medication errors, according to the U.S. Pharmacopeia's MedMARx system (Pediatrics. 2006;118:1872–9).

Their review looked at use of CPOE over a 9-month period in a single urban teaching hospital with 40 general and surgical pediatric inpatient beds, 4 pediatric intensive care unit beds, and 15 neonatal intensive care unit beds. (The emergency department, operating room, and postanesthesia care unit were not included in the study because they did not have the system.) Only residents could write and enter orders.

Forty patients per month were randomly selected. Reviews of the charts, hospital incident reports, and order-entry logs were done by two pediatric nurses and then two physicians. Overall, they reviewed 352 of 975 PICU, NICU, and inpatient ward admissions and 6,916 medication orders.

The researchers detected 104 errors, of which 20 were computer-related. Seven were serious medication errors, and 13 were errors with little potential for harm. The rate of computer-related errors was 10 per 1,000 patient-days; the rate for serious computer-related errors was 3.6 per 1,000 patient-days.

Two of the serious errors were duplicate medication orders, four were menu selection errors, and one was a serious keypad entry error. There were eight order set errors, none serious.

Three of the 7 serious errors were orders for ceftriaxone overdoses that generated alerts, but physicians overrode the alerts. None of the computer-related errors reached a patient.

They concluded that the rate of serious medication errors in their study was slightly higher than that found in similar studies. The researchers found fewer types of errors than had been previously reported, but, they said, “our findings do support the assertion that problems with the human-machine interface can pose a risk to patients.”

The study was limited by the fact that it was done in a single hospital that relied on a single order-entry system. But some design features are similar across different software programs, the authors said.

Computerized physician order entry has been hailed as a breakthrough for reducing medication errors, but the systems can introduce new types of mistakes that can themselves lead to adverse drug reactions and other errors, according to research conducted by Dr. Kathleen E. Walsh of the University of Massachusetts, Boston, and her colleagues.

The investigators sought to determine the rates and incidence of computerized physician order entry (CPOE) in pediatrics, noting that computer-related errors are the fourth leading cause of medication errors, according to the U.S. Pharmacopeia's MedMARx system (Pediatrics. 2006;118:1872–9).

Their review looked at use of CPOE over a 9-month period in a single urban teaching hospital with 40 general and surgical pediatric inpatient beds, 4 pediatric intensive care unit beds, and 15 neonatal intensive care unit beds. (The emergency department, operating room, and postanesthesia care unit were not included in the study because they did not have the system.) Only residents could write and enter orders.

Forty patients per month were randomly selected. Reviews of the charts, hospital incident reports, and order-entry logs were done by two pediatric nurses and then two physicians. Overall, they reviewed 352 of 975 PICU, NICU, and inpatient ward admissions and 6,916 medication orders.

The researchers detected 104 errors, of which 20 were computer-related. Seven were serious medication errors, and 13 were errors with little potential for harm. The rate of computer-related errors was 10 per 1,000 patient-days; the rate for serious computer-related errors was 3.6 per 1,000 patient-days.

Two of the serious errors were duplicate medication orders, four were menu selection errors, and one was a serious keypad entry error. There were eight order set errors, none serious.

Three of the 7 serious errors were orders for ceftriaxone overdoses that generated alerts, but physicians overrode the alerts. None of the computer-related errors reached a patient.

They concluded that the rate of serious medication errors in their study was slightly higher than that found in similar studies. The researchers found fewer types of errors than had been previously reported, but, they said, “our findings do support the assertion that problems with the human-machine interface can pose a risk to patients.”

The study was limited by the fact that it was done in a single hospital that relied on a single order-entry system. But some design features are similar across different software programs, the authors said.

Computerized physician order entry has been hailed as a breakthrough for reducing medication errors, but the systems can introduce new types of mistakes that can themselves lead to adverse drug reactions and other errors, according to research conducted by Dr. Kathleen E. Walsh of the University of Massachusetts, Boston, and her colleagues.

The investigators sought to determine the rates and incidence of computerized physician order entry (CPOE) in pediatrics, noting that computer-related errors are the fourth leading cause of medication errors, according to the U.S. Pharmacopeia's MedMARx system (Pediatrics. 2006;118:1872–9).

Their review looked at use of CPOE over a 9-month period in a single urban teaching hospital with 40 general and surgical pediatric inpatient beds, 4 pediatric intensive care unit beds, and 15 neonatal intensive care unit beds. (The emergency department, operating room, and postanesthesia care unit were not included in the study because they did not have the system.) Only residents could write and enter orders.

Forty patients per month were randomly selected. Reviews of the charts, hospital incident reports, and order-entry logs were done by two pediatric nurses and then two physicians. Overall, they reviewed 352 of 975 PICU, NICU, and inpatient ward admissions and 6,916 medication orders.

The researchers detected 104 errors, of which 20 were computer-related. Seven were serious medication errors, and 13 were errors with little potential for harm. The rate of computer-related errors was 10 per 1,000 patient-days; the rate for serious computer-related errors was 3.6 per 1,000 patient-days.

Two of the serious errors were duplicate medication orders, four were menu selection errors, and one was a serious keypad entry error. There were eight order set errors, none serious.

Three of the 7 serious errors were orders for ceftriaxone overdoses that generated alerts, but physicians overrode the alerts. None of the computer-related errors reached a patient.

They concluded that the rate of serious medication errors in their study was slightly higher than that found in similar studies. The researchers found fewer types of errors than had been previously reported, but, they said, “our findings do support the assertion that problems with the human-machine interface can pose a risk to patients.”

The study was limited by the fact that it was done in a single hospital that relied on a single order-entry system. But some design features are similar across different software programs, the authors said.

Ex-FDA Chief Crawford Guilty

Former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., has pleaded guilty to lying about stock he held during his tenure, in violation of federal conflict-of-interest and stock ownership rules. Dr. Crawford was charged with two misdemeanors and is scheduled to be sentenced Jan. 22 in Federal District Court in Washington. He could receive a year in prison and could be fined $200,000. According to the plea, Dr. Crawford failed to sell shares in Sysco, Pepsico, and Kimberly-Clark, all of which have products that are regulated by the FDA. Federal rules require senior officials to divest shares in companies that their agency regulates. Dr. Crawford also did not disclose his wife's ownership of Wal-Mart stock. Dr. Crawford was charged with conflict of interest for owning the Pepsico and Sysco shares while chairman of FDA's Obesity Working Group. Rep. Maurice Hinchey (D-N.Y.) said he will push for a completion of an Office of Inspector General inquiry into Dr. Crawford's resignation and financial holdings. “Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical,” Rep. Hinchey said in a statement.

Pilot P4P for Small Practices

The Centers for Medicare and Medicaid Services is seeking 800 solo and small- to medium-sized group practices to participate in a 3-year pilot pay-for-performance project. The Medicare Care Management Performance Demonstration is limited to practices in Arkansas, California, Massachusetts, and Utah that are the main providers of primary care to at least 50 Medicare beneficiaries. Physicians will be required to submit data each year on up to 26 quality measures in diabetes, heart failure, coronary artery disease, and preventive care. During the first year, participating physicians will be paid for reporting baseline information. In the 2 succeeding years, practices will submit quality data; they can earn up to $10,000 per physician or up to $50,000 per practice for meeting benchmarks endorsed by the National Quality Forum. The measures are similar to those being used in Medicare's Physician Voluntary Reporting Program. At the end of the 3-year project, CMS and the Agency for Healthcare Research and Quality will review the impact on patient outcomes and Medicare expenditures. For more information, go to

www.cms.hhs.gov/DemoProjectsEvalRpts/MD/list.asp

CMS Curbs Improper Claims

Medicare is on track in 2006 to further reduce the number of fraudulent and inappropriate claims being submitted. CMS is reporting that 4% of claims were improper in 2006, down from 5% the previous year and from 14% in 1996, leading to $11 billion less in improper payments over the last 2 years. To determine the error rate, CMS randomly sampled 160,000 claims submitted from April 2005 to March 2006. Since it has been able to more closely identify errors, CMS has been providing more accurate information to contractors, resulting in improved system edits and updated coverage policies, the agency said in a statement. “I welcome the news that the government's increased attention to oversight of Medicare payments has paid off,” Sen. Chuck Grassley (R-Iowa), chairman of the committee charged with Medicare oversight, said in a statement. He added that CMS has work to do, as it is “still paying for medically unnecessary services and undocumented or poorly documented services.”

Wal-Mart Expands Generic Access

Wal-Mart has expanded its $4 generic drug program to an additional 14 states. The program, which was launched in September in Florida, covers 30-day supplies of generic drugs at commonly prescribed dosages and includes 314 generic drugs including 143 compounds in 24 therapeutic categories. Wal-Mart had originally planned to pilot the program in Florida and roll it out to additional states sometime next year, but accelerated expansion due to consumer demand. The move by Wal-Mart is likely to be good for the company's bottom line, according to the results of a Wall Street Journal Online/Harris Interactive poll. The poll of 2,493 adults found that currently only 13% of adults most often purchase drugs from a discount store like Wal-Mart or Target. However, when told about the availability of discounted generic drugs, 50% of respondents said they would be likely, very likely, or absolutely certain to fill their prescriptions with generic drugs purchased on discount retailers. The program is now available at Wal-Mart stores in Alaska, Arizona, Arkansas, Delaware, Florida, Illinois, Indiana, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Texas, and Vermont.

McClellan Accepts Think Tank Post

Former Medicare Chief Mark McClellan has accepted a new post as a visiting senior fellow with the AEI-Brookings Joint Center for Regulatory Studies in Washington. The new job will keep Dr. McClellan involved in health care policy issues. He also will remain as an associate professor of economics and an associate professor of medicine at Stanford (Calif.) University. Dr. McClellan had been on leave from Stanford for several years while working in the federal government. Before taking the post as administrator of the Centers for Medicare and Medicaid Services, Dr. McClellan served from 2002 to 2004 as the commissioner of the Food and Drug Administration. He also served as an economic and health care advisor to President Bush from 2001 to 2002.

Ex-FDA Chief Crawford Guilty

Former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., has pleaded guilty to lying about stock he held during his tenure, in violation of federal conflict-of-interest and stock ownership rules. Dr. Crawford was charged with two misdemeanors and is scheduled to be sentenced Jan. 22 in Federal District Court in Washington. He could receive a year in prison and could be fined $200,000. According to the plea, Dr. Crawford failed to sell shares in Sysco, Pepsico, and Kimberly-Clark, all of which have products that are regulated by the FDA. Federal rules require senior officials to divest shares in companies that their agency regulates. Dr. Crawford also did not disclose his wife's ownership of Wal-Mart stock. Dr. Crawford was charged with conflict of interest for owning the Pepsico and Sysco shares while chairman of FDA's Obesity Working Group. Rep. Maurice Hinchey (D-N.Y.) said he will push for a completion of an Office of Inspector General inquiry into Dr. Crawford's resignation and financial holdings. “Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical,” Rep. Hinchey said in a statement.

Pilot P4P for Small Practices

The Centers for Medicare and Medicaid Services is seeking 800 solo and small- to medium-sized group practices to participate in a 3-year pilot pay-for-performance project. The Medicare Care Management Performance Demonstration is limited to practices in Arkansas, California, Massachusetts, and Utah that are the main providers of primary care to at least 50 Medicare beneficiaries. Physicians will be required to submit data each year on up to 26 quality measures in diabetes, heart failure, coronary artery disease, and preventive care. During the first year, participating physicians will be paid for reporting baseline information. In the 2 succeeding years, practices will submit quality data; they can earn up to $10,000 per physician or up to $50,000 per practice for meeting benchmarks endorsed by the National Quality Forum. The measures are similar to those being used in Medicare's Physician Voluntary Reporting Program. At the end of the 3-year project, CMS and the Agency for Healthcare Research and Quality will review the impact on patient outcomes and Medicare expenditures. For more information, go to

www.cms.hhs.gov/DemoProjectsEvalRpts/MD/list.asp

CMS Curbs Improper Claims

Medicare is on track in 2006 to further reduce the number of fraudulent and inappropriate claims being submitted. CMS is reporting that 4% of claims were improper in 2006, down from 5% the previous year and from 14% in 1996, leading to $11 billion less in improper payments over the last 2 years. To determine the error rate, CMS randomly sampled 160,000 claims submitted from April 2005 to March 2006. Since it has been able to more closely identify errors, CMS has been providing more accurate information to contractors, resulting in improved system edits and updated coverage policies, the agency said in a statement. “I welcome the news that the government's increased attention to oversight of Medicare payments has paid off,” Sen. Chuck Grassley (R-Iowa), chairman of the committee charged with Medicare oversight, said in a statement. He added that CMS has work to do, as it is “still paying for medically unnecessary services and undocumented or poorly documented services.”

Wal-Mart Expands Generic Access

Wal-Mart has expanded its $4 generic drug program to an additional 14 states. The program, which was launched in September in Florida, covers 30-day supplies of generic drugs at commonly prescribed dosages and includes 314 generic drugs including 143 compounds in 24 therapeutic categories. Wal-Mart had originally planned to pilot the program in Florida and roll it out to additional states sometime next year, but accelerated expansion due to consumer demand. The move by Wal-Mart is likely to be good for the company's bottom line, according to the results of a Wall Street Journal Online/Harris Interactive poll. The poll of 2,493 adults found that currently only 13% of adults most often purchase drugs from a discount store like Wal-Mart or Target. However, when told about the availability of discounted generic drugs, 50% of respondents said they would be likely, very likely, or absolutely certain to fill their prescriptions with generic drugs purchased on discount retailers. The program is now available at Wal-Mart stores in Alaska, Arizona, Arkansas, Delaware, Florida, Illinois, Indiana, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Texas, and Vermont.

McClellan Accepts Think Tank Post

Former Medicare Chief Mark McClellan has accepted a new post as a visiting senior fellow with the AEI-Brookings Joint Center for Regulatory Studies in Washington. The new job will keep Dr. McClellan involved in health care policy issues. He also will remain as an associate professor of economics and an associate professor of medicine at Stanford (Calif.) University. Dr. McClellan had been on leave from Stanford for several years while working in the federal government. Before taking the post as administrator of the Centers for Medicare and Medicaid Services, Dr. McClellan served from 2002 to 2004 as the commissioner of the Food and Drug Administration. He also served as an economic and health care advisor to President Bush from 2001 to 2002.

Ex-FDA Chief Crawford Guilty

Former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., has pleaded guilty to lying about stock he held during his tenure, in violation of federal conflict-of-interest and stock ownership rules. Dr. Crawford was charged with two misdemeanors and is scheduled to be sentenced Jan. 22 in Federal District Court in Washington. He could receive a year in prison and could be fined $200,000. According to the plea, Dr. Crawford failed to sell shares in Sysco, Pepsico, and Kimberly-Clark, all of which have products that are regulated by the FDA. Federal rules require senior officials to divest shares in companies that their agency regulates. Dr. Crawford also did not disclose his wife's ownership of Wal-Mart stock. Dr. Crawford was charged with conflict of interest for owning the Pepsico and Sysco shares while chairman of FDA's Obesity Working Group. Rep. Maurice Hinchey (D-N.Y.) said he will push for a completion of an Office of Inspector General inquiry into Dr. Crawford's resignation and financial holdings. “Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical,” Rep. Hinchey said in a statement.

Pilot P4P for Small Practices

The Centers for Medicare and Medicaid Services is seeking 800 solo and small- to medium-sized group practices to participate in a 3-year pilot pay-for-performance project. The Medicare Care Management Performance Demonstration is limited to practices in Arkansas, California, Massachusetts, and Utah that are the main providers of primary care to at least 50 Medicare beneficiaries. Physicians will be required to submit data each year on up to 26 quality measures in diabetes, heart failure, coronary artery disease, and preventive care. During the first year, participating physicians will be paid for reporting baseline information. In the 2 succeeding years, practices will submit quality data; they can earn up to $10,000 per physician or up to $50,000 per practice for meeting benchmarks endorsed by the National Quality Forum. The measures are similar to those being used in Medicare's Physician Voluntary Reporting Program. At the end of the 3-year project, CMS and the Agency for Healthcare Research and Quality will review the impact on patient outcomes and Medicare expenditures. For more information, go to

www.cms.hhs.gov/DemoProjectsEvalRpts/MD/list.asp

CMS Curbs Improper Claims

Medicare is on track in 2006 to further reduce the number of fraudulent and inappropriate claims being submitted. CMS is reporting that 4% of claims were improper in 2006, down from 5% the previous year and from 14% in 1996, leading to $11 billion less in improper payments over the last 2 years. To determine the error rate, CMS randomly sampled 160,000 claims submitted from April 2005 to March 2006. Since it has been able to more closely identify errors, CMS has been providing more accurate information to contractors, resulting in improved system edits and updated coverage policies, the agency said in a statement. “I welcome the news that the government's increased attention to oversight of Medicare payments has paid off,” Sen. Chuck Grassley (R-Iowa), chairman of the committee charged with Medicare oversight, said in a statement. He added that CMS has work to do, as it is “still paying for medically unnecessary services and undocumented or poorly documented services.”

Wal-Mart Expands Generic Access

Wal-Mart has expanded its $4 generic drug program to an additional 14 states. The program, which was launched in September in Florida, covers 30-day supplies of generic drugs at commonly prescribed dosages and includes 314 generic drugs including 143 compounds in 24 therapeutic categories. Wal-Mart had originally planned to pilot the program in Florida and roll it out to additional states sometime next year, but accelerated expansion due to consumer demand. The move by Wal-Mart is likely to be good for the company's bottom line, according to the results of a Wall Street Journal Online/Harris Interactive poll. The poll of 2,493 adults found that currently only 13% of adults most often purchase drugs from a discount store like Wal-Mart or Target. However, when told about the availability of discounted generic drugs, 50% of respondents said they would be likely, very likely, or absolutely certain to fill their prescriptions with generic drugs purchased on discount retailers. The program is now available at Wal-Mart stores in Alaska, Arizona, Arkansas, Delaware, Florida, Illinois, Indiana, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Texas, and Vermont.

McClellan Accepts Think Tank Post

Former Medicare Chief Mark McClellan has accepted a new post as a visiting senior fellow with the AEI-Brookings Joint Center for Regulatory Studies in Washington. The new job will keep Dr. McClellan involved in health care policy issues. He also will remain as an associate professor of economics and an associate professor of medicine at Stanford (Calif.) University. Dr. McClellan had been on leave from Stanford for several years while working in the federal government. Before taking the post as administrator of the Centers for Medicare and Medicaid Services, Dr. McClellan served from 2002 to 2004 as the commissioner of the Food and Drug Administration. He also served as an economic and health care advisor to President Bush from 2001 to 2002.

NEW ORLEANS — Charges for traumatic brain injury combined with other trauma are much higher than for trauma alone—and they climb in the months after discharge, a factor that should be taken into account when negotiating reimbursement rates with managed care organizations, Dr. Bartholomew Tortella said at the annual meeting of the American Association for the Surgery of Trauma.

Dr. Tortella, a trauma surgeon and professor of surgery at Drexel University, Philadelphia, presented an analysis of claims for 12,554 adults who were hospitalized for blunt or penetrating trauma from January 2003 to February 2005.

The data came from managed care claims tabulated by Ingenix Inc., a consulting subsidiary of UnitedHealth Group. The database included only charges, not actual costs, and was more representative of the South and Midwest than the North and West, said Dr. Tortella, who is also global trauma program director at Novo Nordisk Inc.

Dr. Tortella and his colleagues looked at charges for isolated trauma, isolated traumatic brain injury (TBI), and combined trauma and TBI. There were 8,203 patients with isolated trauma, 2,133 with isolated TBI, and 2,218 with trauma combined with TBI. The mean age was close to 50 years for each of the cohorts. The Abbreviated Injury Scale (AIS) at initial injury was 2.25 for trauma without TBI and 2.55 for isolated TBI. Half of the combined trauma and TBI group had an extremely high AIS score (16 or higher); the mean for the group was 2.98.

Although most patients with severe trauma were treated at level I trauma centers, 40% overall—and almost half of isolated trauma or isolated TBI patients—did not go to a trauma center, he said.

The combined trauma and TBI patients spent about 10 days as inpatients than did isolated trauma or isolated TBI patients, and 5 of those days were spent in the intensive care unit, he said.

Analysis of inpatient charges showed that isolated TBI was lowest at $32,000, trauma without TBI ran $43,000, and combination charges were $103,000.

In the months after discharge, outpatient costs were surprisingly high, Dr. Tortella said. For trauma without TBI, those charges ran $11,600, and for isolated TBI, they were $9,300. For combined trauma and TBI, outpatient and ancillary charges were $16,000.

“If you're not building [those charges] into the cost structure you negotiate with the insurers, that's a large opportunity for you to lose money,” he said.

Novo Nordisk funded the study.

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Charges for traumatic brain injury combined with other trauma are much higher than for trauma alone—and they climb in the months after discharge, a factor that should be taken into account when negotiating reimbursement rates with managed care organizations, Dr. Bartholomew Tortella said at the annual meeting of the American Association for the Surgery of Trauma.

Dr. Tortella, a trauma surgeon and professor of surgery at Drexel University, Philadelphia, presented an analysis of claims for 12,554 adults who were hospitalized for blunt or penetrating trauma from January 2003 to February 2005.

The data came from managed care claims tabulated by Ingenix Inc., a consulting subsidiary of UnitedHealth Group. The database included only charges, not actual costs, and was more representative of the South and Midwest than the North and West, said Dr. Tortella, who is also global trauma program director at Novo Nordisk Inc.

Dr. Tortella and his colleagues looked at charges for isolated trauma, isolated traumatic brain injury (TBI), and combined trauma and TBI. There were 8,203 patients with isolated trauma, 2,133 with isolated TBI, and 2,218 with trauma combined with TBI. The mean age was close to 50 years for each of the cohorts. The Abbreviated Injury Scale (AIS) at initial injury was 2.25 for trauma without TBI and 2.55 for isolated TBI. Half of the combined trauma and TBI group had an extremely high AIS score (16 or higher); the mean for the group was 2.98.

Although most patients with severe trauma were treated at level I trauma centers, 40% overall—and almost half of isolated trauma or isolated TBI patients—did not go to a trauma center, he said.

The combined trauma and TBI patients spent about 10 days as inpatients than did isolated trauma or isolated TBI patients, and 5 of those days were spent in the intensive care unit, he said.

Analysis of inpatient charges showed that isolated TBI was lowest at $32,000, trauma without TBI ran $43,000, and combination charges were $103,000.

In the months after discharge, outpatient costs were surprisingly high, Dr. Tortella said. For trauma without TBI, those charges ran $11,600, and for isolated TBI, they were $9,300. For combined trauma and TBI, outpatient and ancillary charges were $16,000.

“If you're not building [those charges] into the cost structure you negotiate with the insurers, that's a large opportunity for you to lose money,” he said.

Novo Nordisk funded the study.

ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Charges for traumatic brain injury combined with other trauma are much higher than for trauma alone—and they climb in the months after discharge, a factor that should be taken into account when negotiating reimbursement rates with managed care organizations, Dr. Bartholomew Tortella said at the annual meeting of the American Association for the Surgery of Trauma.

Dr. Tortella, a trauma surgeon and professor of surgery at Drexel University, Philadelphia, presented an analysis of claims for 12,554 adults who were hospitalized for blunt or penetrating trauma from January 2003 to February 2005.

The data came from managed care claims tabulated by Ingenix Inc., a consulting subsidiary of UnitedHealth Group. The database included only charges, not actual costs, and was more representative of the South and Midwest than the North and West, said Dr. Tortella, who is also global trauma program director at Novo Nordisk Inc.

Dr. Tortella and his colleagues looked at charges for isolated trauma, isolated traumatic brain injury (TBI), and combined trauma and TBI. There were 8,203 patients with isolated trauma, 2,133 with isolated TBI, and 2,218 with trauma combined with TBI. The mean age was close to 50 years for each of the cohorts. The Abbreviated Injury Scale (AIS) at initial injury was 2.25 for trauma without TBI and 2.55 for isolated TBI. Half of the combined trauma and TBI group had an extremely high AIS score (16 or higher); the mean for the group was 2.98.

Although most patients with severe trauma were treated at level I trauma centers, 40% overall—and almost half of isolated trauma or isolated TBI patients—did not go to a trauma center, he said.

The combined trauma and TBI patients spent about 10 days as inpatients than did isolated trauma or isolated TBI patients, and 5 of those days were spent in the intensive care unit, he said.

Analysis of inpatient charges showed that isolated TBI was lowest at $32,000, trauma without TBI ran $43,000, and combination charges were $103,000.

In the months after discharge, outpatient costs were surprisingly high, Dr. Tortella said. For trauma without TBI, those charges ran $11,600, and for isolated TBI, they were $9,300. For combined trauma and TBI, outpatient and ancillary charges were $16,000.

“If you're not building [those charges] into the cost structure you negotiate with the insurers, that's a large opportunity for you to lose money,” he said.

Novo Nordisk funded the study.

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