M. Alexander Otto

LOS ANGELES – A few key questions must be answered before starting children on ADHD stimulants to protect them from the small but real risk the drugs pose of sudden cardiac death, according to Dr. James J. McGough.

Has the child ever fainted while exercising? Is there a family history of early sudden death? Does the child have any known cardiac abnormalities? Is there a click or murmur on physical exam?

"If you get a ‘yes’ to any of [those questions], that is the time to refer," Dr. McGough of the division of child and adolescent psychiatry at the University of California, Los Angeles, said at the meeting.

An "EKG is reasonable, if you want it," he added; a recent study showed a small benefit prior to stimulant treatment (Circulation 2010;121:1329-37).

In general, the sudden death risk with ADHD stimulants is low, on par with the "risk of sudden death [at] Saturday morning soccer," Dr. McGough said. Still, "this is something where you really do need to be thoughtful," he said.

An audience member asked whether he thought the arrhythmia risk increased when alpha2-adrenergic agonists (clonidine or guanfacine, for example) are used with stimulants to increase ADHD control, or for other reasons.

"We will be able to answer that," Dr. McGough said, because he and his colleagues are completing a 200-child ADHD study of that and other questions. But in the meantime, "I would not have those concerns," he said.

In fact, Dr. McGough and his colleagues use the combination "commonly. I think it is a really good treatment," he said.

Dr. McGough noted that he has treated children with cardiac abnormalities, with the help of a pediatric cardiologist. "I had one boy who could not function without stimulants. He has an aortic outflow obstruction. The parents and the boy knew the risk, [and] we were very careful. So you can do it, but you should get the further work-up," he said.

Once cardiac issues are dealt with, ADHD treatment starts with methylphenidate or amphetamines. "There’s nothing to direct you one way or the other. If [patients] fail one, it suggests you try the other class. I can think of no good reason to prescribe an amphetamine and a methylphenidate in the same kid," Dr. McGough said.

To maintain effect, "you need to keep the [drug] blood level rising" throughout the day, he said.

That’s possible with immediate-release formulations if they are given every few hours, but extended-release medications save the hassle. Because of that, "I would never start with immediate-release stimulants," Dr. McGough said.

The conference moderator, Dr. Gabrielle Carlson, director of child and adolescent psychiatry at the State University of New York at Stony Brook, objected to the comment.

She noted that sometimes children do not respond to extended-release medications but do respond to immediate-release formulations. In addition, sometimes children are unable to tolerate ascending blood levels and become toxic; with immediate-release stimulants, you can often tell in the office whether the drug will work.

Dr. McGough acknowledged the concerns but said he still prefers to initiate treatment with extended-release products.

"What I typically do is send people out with usually around 30 small-dose, extended-release tablets [and instructions to] take one a day for 5 days; two a day for 5 days; and three a day for 5 days," then return for reevaluation, he said. "That’s how I do it, and it’s effective for me."

Dr. McGough had a tip about one long-acting medication in particular: Adderall XR. "You only get 10-12 hours of benefit from it, but the actual half-life is much longer," he said. As a result – and especially if doses are increased to maintain effect – the drug can build up in children’s systems.

Eventually, a wall might be hit where the drug no longer seems to work. The problem is that children "have this swamp of amphetamine doing nothing for [them]. You’ve got to ramp up out of that before you get effect," Dr. McGough said.

Once the dosage is above 30 mg/day and the child is still nonresponsive, consider that "maybe they’re getting too much medicine. Let their bodies clear out, and start again on a lower dose," he suggested.

Should stimulants fail even with proper dosing, nonstimulants are the next step for ADHD management. "Research suggests atomoxetine, but I think we could now move the alpha2-agonists up [to be] equal with that, because there’s evidence those medicines work," Dr. McGough said.

Those drugs can also be used with stimulants to reduce stimulant doses when appetite loss, insomnia, cognitive freezing, or other stimulant side effects are a problem.

Dr. McGough disclosed that he is an adviser or consultant to Eli Lilly and Shire Pharmaceuticals, and also receives research funding from Lilly.

LOS ANGELES – A few key questions must be answered before starting children on ADHD stimulants to protect them from the small but real risk the drugs pose of sudden cardiac death, according to Dr. James J. McGough.

Has the child ever fainted while exercising? Is there a family history of early sudden death? Does the child have any known cardiac abnormalities? Is there a click or murmur on physical exam?

"If you get a ‘yes’ to any of [those questions], that is the time to refer," Dr. McGough of the division of child and adolescent psychiatry at the University of California, Los Angeles, said at the meeting.

An "EKG is reasonable, if you want it," he added; a recent study showed a small benefit prior to stimulant treatment (Circulation 2010;121:1329-37).

In general, the sudden death risk with ADHD stimulants is low, on par with the "risk of sudden death [at] Saturday morning soccer," Dr. McGough said. Still, "this is something where you really do need to be thoughtful," he said.

An audience member asked whether he thought the arrhythmia risk increased when alpha2-adrenergic agonists (clonidine or guanfacine, for example) are used with stimulants to increase ADHD control, or for other reasons.

"We will be able to answer that," Dr. McGough said, because he and his colleagues are completing a 200-child ADHD study of that and other questions. But in the meantime, "I would not have those concerns," he said.

In fact, Dr. McGough and his colleagues use the combination "commonly. I think it is a really good treatment," he said.

Dr. McGough noted that he has treated children with cardiac abnormalities, with the help of a pediatric cardiologist. "I had one boy who could not function without stimulants. He has an aortic outflow obstruction. The parents and the boy knew the risk, [and] we were very careful. So you can do it, but you should get the further work-up," he said.

Once cardiac issues are dealt with, ADHD treatment starts with methylphenidate or amphetamines. "There’s nothing to direct you one way or the other. If [patients] fail one, it suggests you try the other class. I can think of no good reason to prescribe an amphetamine and a methylphenidate in the same kid," Dr. McGough said.

To maintain effect, "you need to keep the [drug] blood level rising" throughout the day, he said.

That’s possible with immediate-release formulations if they are given every few hours, but extended-release medications save the hassle. Because of that, "I would never start with immediate-release stimulants," Dr. McGough said.

The conference moderator, Dr. Gabrielle Carlson, director of child and adolescent psychiatry at the State University of New York at Stony Brook, objected to the comment.

She noted that sometimes children do not respond to extended-release medications but do respond to immediate-release formulations. In addition, sometimes children are unable to tolerate ascending blood levels and become toxic; with immediate-release stimulants, you can often tell in the office whether the drug will work.

Dr. McGough acknowledged the concerns but said he still prefers to initiate treatment with extended-release products.

"What I typically do is send people out with usually around 30 small-dose, extended-release tablets [and instructions to] take one a day for 5 days; two a day for 5 days; and three a day for 5 days," then return for reevaluation, he said. "That’s how I do it, and it’s effective for me."

Dr. McGough had a tip about one long-acting medication in particular: Adderall XR. "You only get 10-12 hours of benefit from it, but the actual half-life is much longer," he said. As a result – and especially if doses are increased to maintain effect – the drug can build up in children’s systems.

Eventually, a wall might be hit where the drug no longer seems to work. The problem is that children "have this swamp of amphetamine doing nothing for [them]. You’ve got to ramp up out of that before you get effect," Dr. McGough said.

Once the dosage is above 30 mg/day and the child is still nonresponsive, consider that "maybe they’re getting too much medicine. Let their bodies clear out, and start again on a lower dose," he suggested.

Should stimulants fail even with proper dosing, nonstimulants are the next step for ADHD management. "Research suggests atomoxetine, but I think we could now move the alpha2-agonists up [to be] equal with that, because there’s evidence those medicines work," Dr. McGough said.

Those drugs can also be used with stimulants to reduce stimulant doses when appetite loss, insomnia, cognitive freezing, or other stimulant side effects are a problem.

Dr. McGough disclosed that he is an adviser or consultant to Eli Lilly and Shire Pharmaceuticals, and also receives research funding from Lilly.

LOS ANGELES – A few key questions must be answered before starting children on ADHD stimulants to protect them from the small but real risk the drugs pose of sudden cardiac death, according to Dr. James J. McGough.

Has the child ever fainted while exercising? Is there a family history of early sudden death? Does the child have any known cardiac abnormalities? Is there a click or murmur on physical exam?

"If you get a ‘yes’ to any of [those questions], that is the time to refer," Dr. McGough of the division of child and adolescent psychiatry at the University of California, Los Angeles, said at the meeting.

An "EKG is reasonable, if you want it," he added; a recent study showed a small benefit prior to stimulant treatment (Circulation 2010;121:1329-37).

In general, the sudden death risk with ADHD stimulants is low, on par with the "risk of sudden death [at] Saturday morning soccer," Dr. McGough said. Still, "this is something where you really do need to be thoughtful," he said.

An audience member asked whether he thought the arrhythmia risk increased when alpha2-adrenergic agonists (clonidine or guanfacine, for example) are used with stimulants to increase ADHD control, or for other reasons.

"We will be able to answer that," Dr. McGough said, because he and his colleagues are completing a 200-child ADHD study of that and other questions. But in the meantime, "I would not have those concerns," he said.

In fact, Dr. McGough and his colleagues use the combination "commonly. I think it is a really good treatment," he said.

Dr. McGough noted that he has treated children with cardiac abnormalities, with the help of a pediatric cardiologist. "I had one boy who could not function without stimulants. He has an aortic outflow obstruction. The parents and the boy knew the risk, [and] we were very careful. So you can do it, but you should get the further work-up," he said.

Once cardiac issues are dealt with, ADHD treatment starts with methylphenidate or amphetamines. "There’s nothing to direct you one way or the other. If [patients] fail one, it suggests you try the other class. I can think of no good reason to prescribe an amphetamine and a methylphenidate in the same kid," Dr. McGough said.

To maintain effect, "you need to keep the [drug] blood level rising" throughout the day, he said.

That’s possible with immediate-release formulations if they are given every few hours, but extended-release medications save the hassle. Because of that, "I would never start with immediate-release stimulants," Dr. McGough said.

The conference moderator, Dr. Gabrielle Carlson, director of child and adolescent psychiatry at the State University of New York at Stony Brook, objected to the comment.

She noted that sometimes children do not respond to extended-release medications but do respond to immediate-release formulations. In addition, sometimes children are unable to tolerate ascending blood levels and become toxic; with immediate-release stimulants, you can often tell in the office whether the drug will work.

Dr. McGough acknowledged the concerns but said he still prefers to initiate treatment with extended-release products.

"What I typically do is send people out with usually around 30 small-dose, extended-release tablets [and instructions to] take one a day for 5 days; two a day for 5 days; and three a day for 5 days," then return for reevaluation, he said. "That’s how I do it, and it’s effective for me."

Dr. McGough had a tip about one long-acting medication in particular: Adderall XR. "You only get 10-12 hours of benefit from it, but the actual half-life is much longer," he said. As a result – and especially if doses are increased to maintain effect – the drug can build up in children’s systems.

Eventually, a wall might be hit where the drug no longer seems to work. The problem is that children "have this swamp of amphetamine doing nothing for [them]. You’ve got to ramp up out of that before you get effect," Dr. McGough said.

Once the dosage is above 30 mg/day and the child is still nonresponsive, consider that "maybe they’re getting too much medicine. Let their bodies clear out, and start again on a lower dose," he suggested.

Should stimulants fail even with proper dosing, nonstimulants are the next step for ADHD management. "Research suggests atomoxetine, but I think we could now move the alpha2-agonists up [to be] equal with that, because there’s evidence those medicines work," Dr. McGough said.

Those drugs can also be used with stimulants to reduce stimulant doses when appetite loss, insomnia, cognitive freezing, or other stimulant side effects are a problem.

Dr. McGough disclosed that he is an adviser or consultant to Eli Lilly and Shire Pharmaceuticals, and also receives research funding from Lilly.

VANCOUVER, B.C. – At a time when only about half of health care workers are immunized against influenza, a concerted effort by a hospital in Omaha, Neb., led to a remarkable upswing in the number of employees there who got a flu shot, without being mandated to do so, according to Dr. Archana Chatterjee.

Through common sense approaches like offering employees shots after hours and on weekends, and requiring those who refused a shot to wear a surgical mask, Children's Hospital and Medical Center saw its health care worker vaccination rates climb steadily from about 52% in 2002 to 86% in 2008.

To get the remaining holdouts, the hospital did enact a mandate in 2009, but “I think the important thing is that we did not have protests; we did not have people refusing vaccinations when it came to the mandate in 2009,” Dr. Chatterjee said at the meeting.

There were no legal challenges to the mandate or widespread employee dissatisfaction, unlike at other institutions. Today, the vaccination rate at the hospital is about 97% among the 1,860 employees. Health care workers at the hospital are not unionized, said Dr. Chatterjee, a hospital epidemiologist and pediatrics professor at Creighton University, Omaha.

“I think the reason [there were no protests] is that in previous years, we had worked with the employees to respond to their concerns [and to] educate them. That's what resulted in relatively high rates of immunization against influenza, even before the mandate was put in place,” she said.

Dr. Chatterjee gave an example of the education efforts. “We had a surgeon who thought he never had influenza. Those are the kinds of myths that we have to dispel to help people recognize that influenza can be mild or even asymptomatic in some people,” but they are still able to spread it, she said.

Other steps included not charging for the shots, taking the shot cart to where people were working on the patient floors and having coworker colleagues administer the vaccine, offering vaccinations during annual physicals, and putting reminders about flu shots on the hospital's computer system.

Also, “last year there was a request to provide vaccine to family members, and we actually did do that, as well, at various venues at various times.” Dr. Chatterjee said that the key to the program's success was that “we were responsive to the issues that were being raised. There was something that they saw changed as a result of bringing that issue to us,” she said.

The hospital also updated the form employees must sign if they refused the vaccine.

“The original form just said 'I refuse to have the vaccine',” Dr. Chatterjee said.

The updated one “made it very clear that if they refuse the vaccine, they are putting their patients at risk and putting their coworkers at risk,” she said.

The form also requires employees to wear a surgical mask throughout the influenza season if they refuse the vaccine, even if they produce a medical exemption.

The updated refusal form states that “those who do not comply with the mask requirement will be subject to corrective action up to and including termination.”

When employees ignored the order, “we would get reports from people saying, 'You know xyz has not been vaccinated and is not wearing a mask' ”; everyone on the unit knew who was not vaccinated.

In those cases, infection control nurses would visit the workers and remind them that they had signed the document.

“A couple of people actually started [wearing the masks] and then realized what an onerous job wearing a mask for the entire shift was. Those medical exemptions quickly disappeared,” Dr. Chatterjee said.

“It was pretty clear to us that there were some key changes that made big differences, and the mask issue was one of those,” she said.

Dr. Andrew Pavia, chief of the division of infectious disease in the department of pediatrics at the University of Utah, Salt Lake City, noted that such voluntary programs go only so far in raising vaccination rates. “The best possible voluntary programs only get health care worker vaccination rates into the mid-80% range. This is the reason that so many health care organizations have endorsed mandatory immunization.”

There isn't an adequate percentage below 100% at which you stop transmission, and “so we need to target something that approaches 100%. It appears, right now, that mandatory immunization is the policy that works.”

Dr. Chatterjee and Dr. Pavia reported having no conflicts of interest.

The flu vaccination rate is 97% among employees at one Omaha hospital.

Source ©Kirby Hamilton/iStockphoto.com

VANCOUVER, B.C. – At a time when only about half of health care workers are immunized against influenza, a concerted effort by a hospital in Omaha, Neb., led to a remarkable upswing in the number of employees there who got a flu shot, without being mandated to do so, according to Dr. Archana Chatterjee.

Through common sense approaches like offering employees shots after hours and on weekends, and requiring those who refused a shot to wear a surgical mask, Children's Hospital and Medical Center saw its health care worker vaccination rates climb steadily from about 52% in 2002 to 86% in 2008.

To get the remaining holdouts, the hospital did enact a mandate in 2009, but “I think the important thing is that we did not have protests; we did not have people refusing vaccinations when it came to the mandate in 2009,” Dr. Chatterjee said at the meeting.

There were no legal challenges to the mandate or widespread employee dissatisfaction, unlike at other institutions. Today, the vaccination rate at the hospital is about 97% among the 1,860 employees. Health care workers at the hospital are not unionized, said Dr. Chatterjee, a hospital epidemiologist and pediatrics professor at Creighton University, Omaha.

“I think the reason [there were no protests] is that in previous years, we had worked with the employees to respond to their concerns [and to] educate them. That's what resulted in relatively high rates of immunization against influenza, even before the mandate was put in place,” she said.

Dr. Chatterjee gave an example of the education efforts. “We had a surgeon who thought he never had influenza. Those are the kinds of myths that we have to dispel to help people recognize that influenza can be mild or even asymptomatic in some people,” but they are still able to spread it, she said.

Other steps included not charging for the shots, taking the shot cart to where people were working on the patient floors and having coworker colleagues administer the vaccine, offering vaccinations during annual physicals, and putting reminders about flu shots on the hospital's computer system.

Also, “last year there was a request to provide vaccine to family members, and we actually did do that, as well, at various venues at various times.” Dr. Chatterjee said that the key to the program's success was that “we were responsive to the issues that were being raised. There was something that they saw changed as a result of bringing that issue to us,” she said.

The hospital also updated the form employees must sign if they refused the vaccine.

“The original form just said 'I refuse to have the vaccine',” Dr. Chatterjee said.

The updated one “made it very clear that if they refuse the vaccine, they are putting their patients at risk and putting their coworkers at risk,” she said.

The form also requires employees to wear a surgical mask throughout the influenza season if they refuse the vaccine, even if they produce a medical exemption.

The updated refusal form states that “those who do not comply with the mask requirement will be subject to corrective action up to and including termination.”

When employees ignored the order, “we would get reports from people saying, 'You know xyz has not been vaccinated and is not wearing a mask' ”; everyone on the unit knew who was not vaccinated.

In those cases, infection control nurses would visit the workers and remind them that they had signed the document.

“A couple of people actually started [wearing the masks] and then realized what an onerous job wearing a mask for the entire shift was. Those medical exemptions quickly disappeared,” Dr. Chatterjee said.

“It was pretty clear to us that there were some key changes that made big differences, and the mask issue was one of those,” she said.

Dr. Andrew Pavia, chief of the division of infectious disease in the department of pediatrics at the University of Utah, Salt Lake City, noted that such voluntary programs go only so far in raising vaccination rates. “The best possible voluntary programs only get health care worker vaccination rates into the mid-80% range. This is the reason that so many health care organizations have endorsed mandatory immunization.”

There isn't an adequate percentage below 100% at which you stop transmission, and “so we need to target something that approaches 100%. It appears, right now, that mandatory immunization is the policy that works.”

Dr. Chatterjee and Dr. Pavia reported having no conflicts of interest.

The flu vaccination rate is 97% among employees at one Omaha hospital.

Source ©Kirby Hamilton/iStockphoto.com

VANCOUVER, B.C. – At a time when only about half of health care workers are immunized against influenza, a concerted effort by a hospital in Omaha, Neb., led to a remarkable upswing in the number of employees there who got a flu shot, without being mandated to do so, according to Dr. Archana Chatterjee.

Through common sense approaches like offering employees shots after hours and on weekends, and requiring those who refused a shot to wear a surgical mask, Children's Hospital and Medical Center saw its health care worker vaccination rates climb steadily from about 52% in 2002 to 86% in 2008.

To get the remaining holdouts, the hospital did enact a mandate in 2009, but “I think the important thing is that we did not have protests; we did not have people refusing vaccinations when it came to the mandate in 2009,” Dr. Chatterjee said at the meeting.

There were no legal challenges to the mandate or widespread employee dissatisfaction, unlike at other institutions. Today, the vaccination rate at the hospital is about 97% among the 1,860 employees. Health care workers at the hospital are not unionized, said Dr. Chatterjee, a hospital epidemiologist and pediatrics professor at Creighton University, Omaha.

“I think the reason [there were no protests] is that in previous years, we had worked with the employees to respond to their concerns [and to] educate them. That's what resulted in relatively high rates of immunization against influenza, even before the mandate was put in place,” she said.

Dr. Chatterjee gave an example of the education efforts. “We had a surgeon who thought he never had influenza. Those are the kinds of myths that we have to dispel to help people recognize that influenza can be mild or even asymptomatic in some people,” but they are still able to spread it, she said.

Other steps included not charging for the shots, taking the shot cart to where people were working on the patient floors and having coworker colleagues administer the vaccine, offering vaccinations during annual physicals, and putting reminders about flu shots on the hospital's computer system.

Also, “last year there was a request to provide vaccine to family members, and we actually did do that, as well, at various venues at various times.” Dr. Chatterjee said that the key to the program's success was that “we were responsive to the issues that were being raised. There was something that they saw changed as a result of bringing that issue to us,” she said.

The hospital also updated the form employees must sign if they refused the vaccine.

“The original form just said 'I refuse to have the vaccine',” Dr. Chatterjee said.

The updated one “made it very clear that if they refuse the vaccine, they are putting their patients at risk and putting their coworkers at risk,” she said.

The form also requires employees to wear a surgical mask throughout the influenza season if they refuse the vaccine, even if they produce a medical exemption.

The updated refusal form states that “those who do not comply with the mask requirement will be subject to corrective action up to and including termination.”

When employees ignored the order, “we would get reports from people saying, 'You know xyz has not been vaccinated and is not wearing a mask' ”; everyone on the unit knew who was not vaccinated.

In those cases, infection control nurses would visit the workers and remind them that they had signed the document.

“A couple of people actually started [wearing the masks] and then realized what an onerous job wearing a mask for the entire shift was. Those medical exemptions quickly disappeared,” Dr. Chatterjee said.

“It was pretty clear to us that there were some key changes that made big differences, and the mask issue was one of those,” she said.

Dr. Andrew Pavia, chief of the division of infectious disease in the department of pediatrics at the University of Utah, Salt Lake City, noted that such voluntary programs go only so far in raising vaccination rates. “The best possible voluntary programs only get health care worker vaccination rates into the mid-80% range. This is the reason that so many health care organizations have endorsed mandatory immunization.”

There isn't an adequate percentage below 100% at which you stop transmission, and “so we need to target something that approaches 100%. It appears, right now, that mandatory immunization is the policy that works.”

Dr. Chatterjee and Dr. Pavia reported having no conflicts of interest.

The flu vaccination rate is 97% among employees at one Omaha hospital.

Source ©Kirby Hamilton/iStockphoto.com

Many physicians have wondered how – and even if – they will be able to work together to form accountable care organizations without violating federal antitrust and fraud and abuse laws.

A federal regulatory meeting held earlier this fall offered possible answers to both questions. Federal regulators are considering exemptions to those laws that would allow providers who meet certain requirements to form ACOs.

“It is not easy to craft safe harbors that can replace an antitrust review that analyzes the specific facts of each case and market. But we're going to try to do this,” said Jon Leibowitz, chairman of the Federal Trade Commission.

Similarly, Daniel Levinson, inspector general of the U.S. Department of Health and Human Services, noted that the Affordable Care Act gives the HHS secretary the authority to waive some fraud and abuse laws as needed to help ACO programs develop.

“We and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively,” Mr. Levinson said, according to the meeting transcript.

The FTC, the HHS Office of Inspector General, and the Centers for Medicare and Medicaid Services conducted the workshop in Baltimore to hear the opinions of panelists and audience members on a variety of ACO issues.

However, much of the questioning focused on how antitrust and fraud and abuse exemptions could be applied to ACOs.

The Affordable Care Act promotes ACO creation to reduce health-care fragmentation, improve outcomes, and cut health spending by, for instance, keeping patients out of hospitals when possible.

The goal is for providers to come together and contract with the CMS to integrate and manage the care of at least 5,000 patients, and to share a portion of the savings their efforts generate for Medicare, so long as quality parameters are met.

Once formed, ACOs could pursue similar types of contracts with commercial insurance companies.

The catch is that encouraging independent providers to jointly negotiate contracts and payment rates with health plans raises concerns about joint price fixing, reduced competition, and other antitrust matters.

Likewise, the shared-savings provision, among others, raises antikickback, self-referral, and other fraud and abuse concerns, according to health care attorney Douglas Hastings, board chair of Epstein Becker & Green, Washington, and a meeting panelist who offered his insights during a later interview.

Regulators are interested in applying to ACOs those same antitrust protections that already exist for providers who are clinically integrated and jointly accept significant financial risk.

“In those cases, [collaboration is] not viewed as an antitrust matter, since they are behaving as an integrated organization,” explained meeting panelist and health policy expert Harold Miller, executive director of the Center for Health Care Quality and Payment Reform, who also offered his insights during a later interview.

Defining the extent of integration required for protection, and the time frame to achieve it, remain key issues for regulators, as does the possible creation of additional antitrust safe harbors related to market share and other matters. Regulators also said that they want to foster multiple ACOs in a given market to increase competition.

Which providers would be covered under fraud and abuse waivers also remains an issue, as well as whether waivers should apply only to shared savings payments or to other financial relationships ACOs create, Troy Barsky, director of the CMS Division of Technical Payment Policy, explained during the meeting.

Overall, the hope is to spur “coordination [and] cooperation among the people and the entities that provide health care,” while at the same time ensure “appropriate corporate behaviors,” said Dr. Donald Berwick, CMS administrator.

Proposed ACO regulations are expected from the CMS in late December.

In the meantime, Mr. Miller advised physicians that “if you want to be an ACO, you have to start looking at the data you have – or get access to data from payers, Medicare, and others – to identify opportunities for savings.

“Once you know where they are, figure out what programs to put in place to achieve those savings,” he said.

One option among many is to hire a nurse to help chronically ill patients manage their diseases, Mr. Miller said. That's been proved to help reduce emergency department visits and hospitalizations, he added (Arch. Intern. Med. 2003;163:585-91).

To make such programs cost effective, however, “a small practice will need to think about how to partner with other practices in order to have enough patients who can benefit,” he said.

Mr. Miller added that he does not believe recent election results will derail ACO efforts or other aspects of the Affordable Care Act. Despite Republican victories, “I think it would be a near impossibility to pass a repeal by a veto-proof margin. And the ACO stuff is not really controversial – yet,” he noted.

The meeting's audio and transcript – as well as public comments on ACO concerns – are available online at www.ftc.gov/opp/workshops/aco/index.shtml

Many physicians have wondered how – and even if – they will be able to work together to form accountable care organizations without violating federal antitrust and fraud and abuse laws.

A federal regulatory meeting held earlier this fall offered possible answers to both questions. Federal regulators are considering exemptions to those laws that would allow providers who meet certain requirements to form ACOs.

“It is not easy to craft safe harbors that can replace an antitrust review that analyzes the specific facts of each case and market. But we're going to try to do this,” said Jon Leibowitz, chairman of the Federal Trade Commission.

Similarly, Daniel Levinson, inspector general of the U.S. Department of Health and Human Services, noted that the Affordable Care Act gives the HHS secretary the authority to waive some fraud and abuse laws as needed to help ACO programs develop.

“We and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively,” Mr. Levinson said, according to the meeting transcript.

The FTC, the HHS Office of Inspector General, and the Centers for Medicare and Medicaid Services conducted the workshop in Baltimore to hear the opinions of panelists and audience members on a variety of ACO issues.

However, much of the questioning focused on how antitrust and fraud and abuse exemptions could be applied to ACOs.

The Affordable Care Act promotes ACO creation to reduce health-care fragmentation, improve outcomes, and cut health spending by, for instance, keeping patients out of hospitals when possible.

The goal is for providers to come together and contract with the CMS to integrate and manage the care of at least 5,000 patients, and to share a portion of the savings their efforts generate for Medicare, so long as quality parameters are met.

Once formed, ACOs could pursue similar types of contracts with commercial insurance companies.

The catch is that encouraging independent providers to jointly negotiate contracts and payment rates with health plans raises concerns about joint price fixing, reduced competition, and other antitrust matters.

Likewise, the shared-savings provision, among others, raises antikickback, self-referral, and other fraud and abuse concerns, according to health care attorney Douglas Hastings, board chair of Epstein Becker & Green, Washington, and a meeting panelist who offered his insights during a later interview.

Regulators are interested in applying to ACOs those same antitrust protections that already exist for providers who are clinically integrated and jointly accept significant financial risk.

“In those cases, [collaboration is] not viewed as an antitrust matter, since they are behaving as an integrated organization,” explained meeting panelist and health policy expert Harold Miller, executive director of the Center for Health Care Quality and Payment Reform, who also offered his insights during a later interview.

Defining the extent of integration required for protection, and the time frame to achieve it, remain key issues for regulators, as does the possible creation of additional antitrust safe harbors related to market share and other matters. Regulators also said that they want to foster multiple ACOs in a given market to increase competition.

Which providers would be covered under fraud and abuse waivers also remains an issue, as well as whether waivers should apply only to shared savings payments or to other financial relationships ACOs create, Troy Barsky, director of the CMS Division of Technical Payment Policy, explained during the meeting.

Overall, the hope is to spur “coordination [and] cooperation among the people and the entities that provide health care,” while at the same time ensure “appropriate corporate behaviors,” said Dr. Donald Berwick, CMS administrator.

Proposed ACO regulations are expected from the CMS in late December.

In the meantime, Mr. Miller advised physicians that “if you want to be an ACO, you have to start looking at the data you have – or get access to data from payers, Medicare, and others – to identify opportunities for savings.

“Once you know where they are, figure out what programs to put in place to achieve those savings,” he said.

One option among many is to hire a nurse to help chronically ill patients manage their diseases, Mr. Miller said. That's been proved to help reduce emergency department visits and hospitalizations, he added (Arch. Intern. Med. 2003;163:585-91).

To make such programs cost effective, however, “a small practice will need to think about how to partner with other practices in order to have enough patients who can benefit,” he said.

Mr. Miller added that he does not believe recent election results will derail ACO efforts or other aspects of the Affordable Care Act. Despite Republican victories, “I think it would be a near impossibility to pass a repeal by a veto-proof margin. And the ACO stuff is not really controversial – yet,” he noted.

The meeting's audio and transcript – as well as public comments on ACO concerns – are available online at www.ftc.gov/opp/workshops/aco/index.shtml

Many physicians have wondered how – and even if – they will be able to work together to form accountable care organizations without violating federal antitrust and fraud and abuse laws.

A federal regulatory meeting held earlier this fall offered possible answers to both questions. Federal regulators are considering exemptions to those laws that would allow providers who meet certain requirements to form ACOs.

“It is not easy to craft safe harbors that can replace an antitrust review that analyzes the specific facts of each case and market. But we're going to try to do this,” said Jon Leibowitz, chairman of the Federal Trade Commission.

Similarly, Daniel Levinson, inspector general of the U.S. Department of Health and Human Services, noted that the Affordable Care Act gives the HHS secretary the authority to waive some fraud and abuse laws as needed to help ACO programs develop.

“We and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively,” Mr. Levinson said, according to the meeting transcript.

The FTC, the HHS Office of Inspector General, and the Centers for Medicare and Medicaid Services conducted the workshop in Baltimore to hear the opinions of panelists and audience members on a variety of ACO issues.

However, much of the questioning focused on how antitrust and fraud and abuse exemptions could be applied to ACOs.

The Affordable Care Act promotes ACO creation to reduce health-care fragmentation, improve outcomes, and cut health spending by, for instance, keeping patients out of hospitals when possible.

The goal is for providers to come together and contract with the CMS to integrate and manage the care of at least 5,000 patients, and to share a portion of the savings their efforts generate for Medicare, so long as quality parameters are met.

Once formed, ACOs could pursue similar types of contracts with commercial insurance companies.

The catch is that encouraging independent providers to jointly negotiate contracts and payment rates with health plans raises concerns about joint price fixing, reduced competition, and other antitrust matters.

Likewise, the shared-savings provision, among others, raises antikickback, self-referral, and other fraud and abuse concerns, according to health care attorney Douglas Hastings, board chair of Epstein Becker & Green, Washington, and a meeting panelist who offered his insights during a later interview.

Regulators are interested in applying to ACOs those same antitrust protections that already exist for providers who are clinically integrated and jointly accept significant financial risk.

“In those cases, [collaboration is] not viewed as an antitrust matter, since they are behaving as an integrated organization,” explained meeting panelist and health policy expert Harold Miller, executive director of the Center for Health Care Quality and Payment Reform, who also offered his insights during a later interview.

Defining the extent of integration required for protection, and the time frame to achieve it, remain key issues for regulators, as does the possible creation of additional antitrust safe harbors related to market share and other matters. Regulators also said that they want to foster multiple ACOs in a given market to increase competition.

Which providers would be covered under fraud and abuse waivers also remains an issue, as well as whether waivers should apply only to shared savings payments or to other financial relationships ACOs create, Troy Barsky, director of the CMS Division of Technical Payment Policy, explained during the meeting.

Overall, the hope is to spur “coordination [and] cooperation among the people and the entities that provide health care,” while at the same time ensure “appropriate corporate behaviors,” said Dr. Donald Berwick, CMS administrator.

Proposed ACO regulations are expected from the CMS in late December.

In the meantime, Mr. Miller advised physicians that “if you want to be an ACO, you have to start looking at the data you have – or get access to data from payers, Medicare, and others – to identify opportunities for savings.

“Once you know where they are, figure out what programs to put in place to achieve those savings,” he said.

One option among many is to hire a nurse to help chronically ill patients manage their diseases, Mr. Miller said. That's been proved to help reduce emergency department visits and hospitalizations, he added (Arch. Intern. Med. 2003;163:585-91).

To make such programs cost effective, however, “a small practice will need to think about how to partner with other practices in order to have enough patients who can benefit,” he said.

Mr. Miller added that he does not believe recent election results will derail ACO efforts or other aspects of the Affordable Care Act. Despite Republican victories, “I think it would be a near impossibility to pass a repeal by a veto-proof margin. And the ACO stuff is not really controversial – yet,” he noted.

The meeting's audio and transcript – as well as public comments on ACO concerns – are available online at www.ftc.gov/opp/workshops/aco/index.shtml

Major Finding: HSV-infected infants with CNS involvement who were randomized to 6 months of oral acyclovir suppression following initial parenteral therapy had significantly higher mean mental scores on the Bayley Scales of Infant Development, compared with infants randomized to placebo (88.24 vs. 68.12, P value .046).

Data Source: Two phase III, double-blind, placebo-controlled trials enrolling a total of 74 infants.

Disclosures: The studies were funded by the National Institutes of Health. Dr. Kimberlin said he has no conflicts of interest. Dr. Gershon reported that she is a Merck grant investigator and scientific adviser to GlaxoSmithKline.

VANCOUVER, B.C. — Treating infants with herpes simplex virus infectious who have central nervous system involvement with 6 months of oral acyclovir improved neurodevelopmental outcomes at 1 year, according to findings from two phase III, double-blind, placebo-controlled studies.

Achieving prolonged antiviral suppression also prevented recurrence of HSV skin lesions, said Dr. David Kimberlin.

Following the usual course of intravenous acyclovir therapy for neonatal CNS or skin-eye-mouth herpes simplex virus (HSV) disease, “our data strongly support that [infants] should then be started on 6 months of oral acyclovir suppressive therapy, with periodic monitoring of [their] white blood cell counts,” said Dr. Kimberlin, a pediatric infectious disease specialist at the University of Alabama at Birmingham.

“This is a very important advance” that is “expected to change clinical practice involving babies who are diagnosed with neonatal HSV,” said Dr. Anne Gershon, director of the division of pediatric infectious disease at Columbia University Medical Center, New York. Dr. Gershon was not involved in the studies.

The trials ran concurrently from 1997 to 2008, and were conducted by the National Institute of Allergy and Infectious Diseases' Collaborative Antiviral Study Group.

In the first study, 24 infants with herpes simplex virus CNS disease were randomized to acyclovir suppression at 300 mg/m

In the second study, following parenteral therapy, 15 infants with skin-eye-mouth (SEM) HSV disease were randomized to the same dosage of oral acyclovir; 14 to placebo.

In both studies, children who developed blisters or other HSV skin manifestations were taken off their blinded intervention and treated with open-label acyclovir; following resolution, the blinded interventions were resumed. After a second skin recurrence, however, the blinded intervention was halted and infants were allowed to be switched to the acyclovir suppression regimen.

Because of skin eruptions, only eight infants in the CNS study and four in the SEM study completed 6 months of blinded placebo. Others in the placebo groups “ended up getting suppressive therapy but for something less than 6 months,” Dr. Kimberlin said.

Baseline demographics were balanced between the placebo and acyclovir groups, except that babies randomized to acyclovir in the CNS study were smaller at delivery and lighter at the time of enrollment than were those randomized to placebo; acyclovir-treated babies in the SEM study were lighter at enrollment, as well, he said.

At 12-month follow-up, after adjustment for covariates, children in the CNS study randomized to acyclovir had significantly higher mean mental scores on the Bayley Scales of Infant Development, second edition, compared with subjects on placebo (88.24 vs. 68.12, P = .046).

A Bayley score of 100 represents the mean mental score, with a standard deviation of plus or minus 15; a score below 70 is 2 standard deviations below the mean (Pediatrics 2005;116:123-9).

“For the group randomized to immediate suppressive therapy, 60% of them had normal development at 12 months of age. In contrast, [in] the group randomized to placebo, about 30% of them had normal development at 12 months of age,” Dr. Kimberlin said.

Longer durations of acyclovir treatment correlated with higher Bayley scores in infants treated with acyclovir for less than 6 months.

In both the SEM and CNS trials, acyclovir delayed HSV skin recurrences by more than 2 months (P value .009).

Dr. Kimberlin and his colleagues were concerned at the outset of the trials that prolonged acyclovir suppression would lead to neutropenia, but “we fortunately saw much less of that than we anticipated we might,” he said.

Overall, incidence and degree of neutropenia were not different between the acyclovir and placebo groups (CNS, P = .94; SEM, P = .24).

However, absolute neutrophil counts of 500 cells/mm

There were no statistically significant differences in blood and chemistry labs and adverse events between the two groups. “The safety is much better than I feared it might be, and there is benefit, so benefit in my view outweighs risk,” he said.

'The safety is much better than I feared it might be, and there is benefit, so benefit in my view outweighs risk.'

Source DR. KIMBERLIN

Major Finding: HSV-infected infants with CNS involvement who were randomized to 6 months of oral acyclovir suppression following initial parenteral therapy had significantly higher mean mental scores on the Bayley Scales of Infant Development, compared with infants randomized to placebo (88.24 vs. 68.12, P value .046).

Data Source: Two phase III, double-blind, placebo-controlled trials enrolling a total of 74 infants.

Disclosures: The studies were funded by the National Institutes of Health. Dr. Kimberlin said he has no conflicts of interest. Dr. Gershon reported that she is a Merck grant investigator and scientific adviser to GlaxoSmithKline.

VANCOUVER, B.C. — Treating infants with herpes simplex virus infectious who have central nervous system involvement with 6 months of oral acyclovir improved neurodevelopmental outcomes at 1 year, according to findings from two phase III, double-blind, placebo-controlled studies.

Achieving prolonged antiviral suppression also prevented recurrence of HSV skin lesions, said Dr. David Kimberlin.

Following the usual course of intravenous acyclovir therapy for neonatal CNS or skin-eye-mouth herpes simplex virus (HSV) disease, “our data strongly support that [infants] should then be started on 6 months of oral acyclovir suppressive therapy, with periodic monitoring of [their] white blood cell counts,” said Dr. Kimberlin, a pediatric infectious disease specialist at the University of Alabama at Birmingham.

“This is a very important advance” that is “expected to change clinical practice involving babies who are diagnosed with neonatal HSV,” said Dr. Anne Gershon, director of the division of pediatric infectious disease at Columbia University Medical Center, New York. Dr. Gershon was not involved in the studies.

The trials ran concurrently from 1997 to 2008, and were conducted by the National Institute of Allergy and Infectious Diseases' Collaborative Antiviral Study Group.

In the first study, 24 infants with herpes simplex virus CNS disease were randomized to acyclovir suppression at 300 mg/m

In the second study, following parenteral therapy, 15 infants with skin-eye-mouth (SEM) HSV disease were randomized to the same dosage of oral acyclovir; 14 to placebo.

In both studies, children who developed blisters or other HSV skin manifestations were taken off their blinded intervention and treated with open-label acyclovir; following resolution, the blinded interventions were resumed. After a second skin recurrence, however, the blinded intervention was halted and infants were allowed to be switched to the acyclovir suppression regimen.

Because of skin eruptions, only eight infants in the CNS study and four in the SEM study completed 6 months of blinded placebo. Others in the placebo groups “ended up getting suppressive therapy but for something less than 6 months,” Dr. Kimberlin said.

Baseline demographics were balanced between the placebo and acyclovir groups, except that babies randomized to acyclovir in the CNS study were smaller at delivery and lighter at the time of enrollment than were those randomized to placebo; acyclovir-treated babies in the SEM study were lighter at enrollment, as well, he said.

At 12-month follow-up, after adjustment for covariates, children in the CNS study randomized to acyclovir had significantly higher mean mental scores on the Bayley Scales of Infant Development, second edition, compared with subjects on placebo (88.24 vs. 68.12, P = .046).

A Bayley score of 100 represents the mean mental score, with a standard deviation of plus or minus 15; a score below 70 is 2 standard deviations below the mean (Pediatrics 2005;116:123-9).

“For the group randomized to immediate suppressive therapy, 60% of them had normal development at 12 months of age. In contrast, [in] the group randomized to placebo, about 30% of them had normal development at 12 months of age,” Dr. Kimberlin said.

Longer durations of acyclovir treatment correlated with higher Bayley scores in infants treated with acyclovir for less than 6 months.

In both the SEM and CNS trials, acyclovir delayed HSV skin recurrences by more than 2 months (P value .009).

Dr. Kimberlin and his colleagues were concerned at the outset of the trials that prolonged acyclovir suppression would lead to neutropenia, but “we fortunately saw much less of that than we anticipated we might,” he said.

Overall, incidence and degree of neutropenia were not different between the acyclovir and placebo groups (CNS, P = .94; SEM, P = .24).

However, absolute neutrophil counts of 500 cells/mm

There were no statistically significant differences in blood and chemistry labs and adverse events between the two groups. “The safety is much better than I feared it might be, and there is benefit, so benefit in my view outweighs risk,” he said.

'The safety is much better than I feared it might be, and there is benefit, so benefit in my view outweighs risk.'

Source DR. KIMBERLIN

Major Finding: HSV-infected infants with CNS involvement who were randomized to 6 months of oral acyclovir suppression following initial parenteral therapy had significantly higher mean mental scores on the Bayley Scales of Infant Development, compared with infants randomized to placebo (88.24 vs. 68.12, P value .046).

Data Source: Two phase III, double-blind, placebo-controlled trials enrolling a total of 74 infants.

Disclosures: The studies were funded by the National Institutes of Health. Dr. Kimberlin said he has no conflicts of interest. Dr. Gershon reported that she is a Merck grant investigator and scientific adviser to GlaxoSmithKline.

VANCOUVER, B.C. — Treating infants with herpes simplex virus infectious who have central nervous system involvement with 6 months of oral acyclovir improved neurodevelopmental outcomes at 1 year, according to findings from two phase III, double-blind, placebo-controlled studies.

Achieving prolonged antiviral suppression also prevented recurrence of HSV skin lesions, said Dr. David Kimberlin.

Following the usual course of intravenous acyclovir therapy for neonatal CNS or skin-eye-mouth herpes simplex virus (HSV) disease, “our data strongly support that [infants] should then be started on 6 months of oral acyclovir suppressive therapy, with periodic monitoring of [their] white blood cell counts,” said Dr. Kimberlin, a pediatric infectious disease specialist at the University of Alabama at Birmingham.

“This is a very important advance” that is “expected to change clinical practice involving babies who are diagnosed with neonatal HSV,” said Dr. Anne Gershon, director of the division of pediatric infectious disease at Columbia University Medical Center, New York. Dr. Gershon was not involved in the studies.

The trials ran concurrently from 1997 to 2008, and were conducted by the National Institute of Allergy and Infectious Diseases' Collaborative Antiviral Study Group.

In the first study, 24 infants with herpes simplex virus CNS disease were randomized to acyclovir suppression at 300 mg/m

In the second study, following parenteral therapy, 15 infants with skin-eye-mouth (SEM) HSV disease were randomized to the same dosage of oral acyclovir; 14 to placebo.

In both studies, children who developed blisters or other HSV skin manifestations were taken off their blinded intervention and treated with open-label acyclovir; following resolution, the blinded interventions were resumed. After a second skin recurrence, however, the blinded intervention was halted and infants were allowed to be switched to the acyclovir suppression regimen.

Because of skin eruptions, only eight infants in the CNS study and four in the SEM study completed 6 months of blinded placebo. Others in the placebo groups “ended up getting suppressive therapy but for something less than 6 months,” Dr. Kimberlin said.

Baseline demographics were balanced between the placebo and acyclovir groups, except that babies randomized to acyclovir in the CNS study were smaller at delivery and lighter at the time of enrollment than were those randomized to placebo; acyclovir-treated babies in the SEM study were lighter at enrollment, as well, he said.

At 12-month follow-up, after adjustment for covariates, children in the CNS study randomized to acyclovir had significantly higher mean mental scores on the Bayley Scales of Infant Development, second edition, compared with subjects on placebo (88.24 vs. 68.12, P = .046).

A Bayley score of 100 represents the mean mental score, with a standard deviation of plus or minus 15; a score below 70 is 2 standard deviations below the mean (Pediatrics 2005;116:123-9).

“For the group randomized to immediate suppressive therapy, 60% of them had normal development at 12 months of age. In contrast, [in] the group randomized to placebo, about 30% of them had normal development at 12 months of age,” Dr. Kimberlin said.

Longer durations of acyclovir treatment correlated with higher Bayley scores in infants treated with acyclovir for less than 6 months.

In both the SEM and CNS trials, acyclovir delayed HSV skin recurrences by more than 2 months (P value .009).

Dr. Kimberlin and his colleagues were concerned at the outset of the trials that prolonged acyclovir suppression would lead to neutropenia, but “we fortunately saw much less of that than we anticipated we might,” he said.

Overall, incidence and degree of neutropenia were not different between the acyclovir and placebo groups (CNS, P = .94; SEM, P = .24).

However, absolute neutrophil counts of 500 cells/mm

There were no statistically significant differences in blood and chemistry labs and adverse events between the two groups. “The safety is much better than I feared it might be, and there is benefit, so benefit in my view outweighs risk,” he said.

'The safety is much better than I feared it might be, and there is benefit, so benefit in my view outweighs risk.'

Source DR. KIMBERLIN

VANCOUVER, B.C. — An adenovirus outbreak in a Chicago neonatal intensive care unit led to an important realization about infection control.

“Soaking ophthalmology equipment in 70% isopropyl alcohol – which is commonly done in NICUs for retinopathy of prematurity equipment – is probably not sufficient to eradicate adenovirus contamination,” said Dr. Emily Mawdsley of the University of Chicago.

Seven infants in the NICU developed adenovirus keratoconjunctivitis in March 2009; four more with the condition, soon identified, had recently been discharged.

“Our initial call was to the pediatric ophthalmologist. He told us that he was at home sick with conjunctivitis,” said Dr. Mawdsley, who works in the university medical center's infectious diseases and global health section.

“After a discussion with him, he recalled that a pediatric ophthalmology resident had [recently] worked with symptomatic conjunctivitis. He'd been sent home, but not until after he had seen a few patients in the NICU,” she said.

All the infants had recently been examined for retinopathy of prematurity. Virus typing by the Centers for Disease Control and Prevention revealed that the infants had the same virus strain as did the resident.

“So we took a look at the ophthalmology equipment,” said Dr. Mawdsley, to see if that was the transmission vector.

Scleral specula and ocular depressors, which were reused on the unit after being soaked for 10-30 minutes in 70% isopropyl alcohol, were positive for adenovirus on polymerase chain reaction assay. They had been set aside in a sterile bowl several days earlier.

The ophthalmology cart handles, miscellaneous supply bags, a lens case, a headlight and battery pack, the contents of an eye spray irrigation bottle, and the alcohol bottle used for disinfection were also positive for adenovirus. Three samples grew live virus.

To keep the virus in check, NICU staff started to clean equipment and surfaces with bleach or quaternary ammonium wipes and nurses wore gloves and gowns during their shifts. Sick children were segregated from well children and contact precautions were used, among other measures.

The outbreak was contained within a few weeks. Previously ill infants returned negative viral cultures, and the unit reopened to transfers.

Dr. Mawdsley said she has no disclosures.

VANCOUVER, B.C. — An adenovirus outbreak in a Chicago neonatal intensive care unit led to an important realization about infection control.

“Soaking ophthalmology equipment in 70% isopropyl alcohol – which is commonly done in NICUs for retinopathy of prematurity equipment – is probably not sufficient to eradicate adenovirus contamination,” said Dr. Emily Mawdsley of the University of Chicago.

Seven infants in the NICU developed adenovirus keratoconjunctivitis in March 2009; four more with the condition, soon identified, had recently been discharged.

“Our initial call was to the pediatric ophthalmologist. He told us that he was at home sick with conjunctivitis,” said Dr. Mawdsley, who works in the university medical center's infectious diseases and global health section.

“After a discussion with him, he recalled that a pediatric ophthalmology resident had [recently] worked with symptomatic conjunctivitis. He'd been sent home, but not until after he had seen a few patients in the NICU,” she said.

All the infants had recently been examined for retinopathy of prematurity. Virus typing by the Centers for Disease Control and Prevention revealed that the infants had the same virus strain as did the resident.

“So we took a look at the ophthalmology equipment,” said Dr. Mawdsley, to see if that was the transmission vector.

Scleral specula and ocular depressors, which were reused on the unit after being soaked for 10-30 minutes in 70% isopropyl alcohol, were positive for adenovirus on polymerase chain reaction assay. They had been set aside in a sterile bowl several days earlier.

The ophthalmology cart handles, miscellaneous supply bags, a lens case, a headlight and battery pack, the contents of an eye spray irrigation bottle, and the alcohol bottle used for disinfection were also positive for adenovirus. Three samples grew live virus.

To keep the virus in check, NICU staff started to clean equipment and surfaces with bleach or quaternary ammonium wipes and nurses wore gloves and gowns during their shifts. Sick children were segregated from well children and contact precautions were used, among other measures.

The outbreak was contained within a few weeks. Previously ill infants returned negative viral cultures, and the unit reopened to transfers.

Dr. Mawdsley said she has no disclosures.

VANCOUVER, B.C. — An adenovirus outbreak in a Chicago neonatal intensive care unit led to an important realization about infection control.

“Soaking ophthalmology equipment in 70% isopropyl alcohol – which is commonly done in NICUs for retinopathy of prematurity equipment – is probably not sufficient to eradicate adenovirus contamination,” said Dr. Emily Mawdsley of the University of Chicago.

Seven infants in the NICU developed adenovirus keratoconjunctivitis in March 2009; four more with the condition, soon identified, had recently been discharged.

“Our initial call was to the pediatric ophthalmologist. He told us that he was at home sick with conjunctivitis,” said Dr. Mawdsley, who works in the university medical center's infectious diseases and global health section.

“After a discussion with him, he recalled that a pediatric ophthalmology resident had [recently] worked with symptomatic conjunctivitis. He'd been sent home, but not until after he had seen a few patients in the NICU,” she said.

All the infants had recently been examined for retinopathy of prematurity. Virus typing by the Centers for Disease Control and Prevention revealed that the infants had the same virus strain as did the resident.

“So we took a look at the ophthalmology equipment,” said Dr. Mawdsley, to see if that was the transmission vector.

Scleral specula and ocular depressors, which were reused on the unit after being soaked for 10-30 minutes in 70% isopropyl alcohol, were positive for adenovirus on polymerase chain reaction assay. They had been set aside in a sterile bowl several days earlier.

The ophthalmology cart handles, miscellaneous supply bags, a lens case, a headlight and battery pack, the contents of an eye spray irrigation bottle, and the alcohol bottle used for disinfection were also positive for adenovirus. Three samples grew live virus.

To keep the virus in check, NICU staff started to clean equipment and surfaces with bleach or quaternary ammonium wipes and nurses wore gloves and gowns during their shifts. Sick children were segregated from well children and contact precautions were used, among other measures.

The outbreak was contained within a few weeks. Previously ill infants returned negative viral cultures, and the unit reopened to transfers.

Dr. Mawdsley said she has no disclosures.

DENVER – The fourth year of medical school needs a curriculum brush-up to better prepare students for residencies, based on discussions raised at the congress.

“In many meetings over the past 2 years, I've heard residency directors say first-year residents today are less well prepared than in the past. If it's true, this is a serious matter for all of us,” said Dr. Douglas Henley, the CEO of the AAFP, who noted that his group's education committee plans to look into the issue.

A recent study of 30 residency directors in 10 fields – including family medicine and pediatrics – said that common problems with interns include the need for greater medical knowledge, professionalism, self-reflection, and organizational skill (Acad. Med. 2009;84:823-9).

With health care delivery evolving toward patient-centered medical homes and other newer models, the concerns are particularly pressing, Dr. Perry Pugno, director of the AAFP's division of medical ducation, said in an interview.

The changes will place a premium on teamwork, solid primary care skills, and good communication skills – all skills that could be fostered in the fourth year.

Instead, “many medical schools allow a large portion of the fourth year to be elective, and students use it to hone their resumes for specialties, not their skills. They [develop] an extensive knowledge base of esoteric stuff, but don't learn how to talk to people,” Dr. Pugno said.

With so much emphasis on technology and careerism, the arts of diagnosis and patient communication are not valued,.he said.

The study's senior author, Dr. Michael Harper, observed in an interview that “there's a lot of medical tourism in the fourth year.” Students often end up acting as “an appendage to in-patient consult services. They often are not integrated. The primary care role [of students' making decisions under supervision] seems to be missing.”

Dr. Harper of the department of medicine and director of the geriatrics fellowship program at the University of California, San Francisco, said that UCSF is brainstorming solutions.

One possible step is extended ambulatory care rotations – in which students are typically more involved with patients – to “allow for ongoing authentic roles in patient care.” Another fourth-year concept is individual learning plans, pat are tailored to fill gaps in students' skills.

DENVER – The fourth year of medical school needs a curriculum brush-up to better prepare students for residencies, based on discussions raised at the congress.

“In many meetings over the past 2 years, I've heard residency directors say first-year residents today are less well prepared than in the past. If it's true, this is a serious matter for all of us,” said Dr. Douglas Henley, the CEO of the AAFP, who noted that his group's education committee plans to look into the issue.

A recent study of 30 residency directors in 10 fields – including family medicine and pediatrics – said that common problems with interns include the need for greater medical knowledge, professionalism, self-reflection, and organizational skill (Acad. Med. 2009;84:823-9).

With health care delivery evolving toward patient-centered medical homes and other newer models, the concerns are particularly pressing, Dr. Perry Pugno, director of the AAFP's division of medical ducation, said in an interview.

The changes will place a premium on teamwork, solid primary care skills, and good communication skills – all skills that could be fostered in the fourth year.

Instead, “many medical schools allow a large portion of the fourth year to be elective, and students use it to hone their resumes for specialties, not their skills. They [develop] an extensive knowledge base of esoteric stuff, but don't learn how to talk to people,” Dr. Pugno said.

With so much emphasis on technology and careerism, the arts of diagnosis and patient communication are not valued,.he said.

The study's senior author, Dr. Michael Harper, observed in an interview that “there's a lot of medical tourism in the fourth year.” Students often end up acting as “an appendage to in-patient consult services. They often are not integrated. The primary care role [of students' making decisions under supervision] seems to be missing.”

Dr. Harper of the department of medicine and director of the geriatrics fellowship program at the University of California, San Francisco, said that UCSF is brainstorming solutions.

One possible step is extended ambulatory care rotations – in which students are typically more involved with patients – to “allow for ongoing authentic roles in patient care.” Another fourth-year concept is individual learning plans, pat are tailored to fill gaps in students' skills.

DENVER – The fourth year of medical school needs a curriculum brush-up to better prepare students for residencies, based on discussions raised at the congress.

“In many meetings over the past 2 years, I've heard residency directors say first-year residents today are less well prepared than in the past. If it's true, this is a serious matter for all of us,” said Dr. Douglas Henley, the CEO of the AAFP, who noted that his group's education committee plans to look into the issue.

A recent study of 30 residency directors in 10 fields – including family medicine and pediatrics – said that common problems with interns include the need for greater medical knowledge, professionalism, self-reflection, and organizational skill (Acad. Med. 2009;84:823-9).

With health care delivery evolving toward patient-centered medical homes and other newer models, the concerns are particularly pressing, Dr. Perry Pugno, director of the AAFP's division of medical ducation, said in an interview.

The changes will place a premium on teamwork, solid primary care skills, and good communication skills – all skills that could be fostered in the fourth year.

Instead, “many medical schools allow a large portion of the fourth year to be elective, and students use it to hone their resumes for specialties, not their skills. They [develop] an extensive knowledge base of esoteric stuff, but don't learn how to talk to people,” Dr. Pugno said.

With so much emphasis on technology and careerism, the arts of diagnosis and patient communication are not valued,.he said.

The study's senior author, Dr. Michael Harper, observed in an interview that “there's a lot of medical tourism in the fourth year.” Students often end up acting as “an appendage to in-patient consult services. They often are not integrated. The primary care role [of students' making decisions under supervision] seems to be missing.”

Dr. Harper of the department of medicine and director of the geriatrics fellowship program at the University of California, San Francisco, said that UCSF is brainstorming solutions.

One possible step is extended ambulatory care rotations – in which students are typically more involved with patients – to “allow for ongoing authentic roles in patient care.” Another fourth-year concept is individual learning plans, pat are tailored to fill gaps in students' skills.

SAN ANTONIO – A primary care initiative combining patient pledges with random pill counts and urine screens significantly reduced prescription narcotics diversion in North Carolina's rural Caldwell County.

As part of the program, most primary care patients with chronic, nonmalignant pain sign a contract agreeing to those measures – and pledging not to doctor-shop for narcotics – prior to receiving their prescriptions, explained Dr. Ed Bujold, a family physician in the Caldwell County town of Granite Falls who helped spearhead the initiative.

Physicians in the western North Carolina county began to use the contracts in 2007, which coincided with a 300% drop in prescription narcotics seizures by county law enforcement between 2005 and the end of that year.

“I believe most of the impact on the 300% decrease took place in [2007],” Dr. Bujold said.

There's been no evidence the measures keep patients who truly need narcotics from getting them, he added.

In fact, patients “are in complete agreement with this. I have had several say, 'I am so thankful you are doing this. I don't want these drugs to go out to places they are not supposed to be,'” Dr. Bujold said at the meeting.

Dr. Bujold said he is also more confident prescribing Percocet (oxycodone and acetaminophen), OxyContin (oxycodone), Vicodin (hydrocodone and acetaminophen), and other narcotics to the few hundred chronic pain sufferers among his roughly 3,500 patients. A survey found other primary care physicians participating in the initiative are as well.

“I feel very comfortable treating patients now, because I know that I am not dealing with the riffraff,” Dr. Bujold said. “This system pretty much takes them out of the picture.”

The idea was born in 2006 after a church service, when the Caldwell County sheriff approached Dr. Bujold, a fellow parishioner. The sheriff confided in him that prescription narcotics threatened to become the county's main drug problem, ahead of methamphetamine and cocaine. Local law enforcement officials recently had found two houses stocked with prescription narcotics for street sale, he added.

A few local physicians had been too trusting, prescribing narcotics “without even thinking some might end up on the street,” Dr. Bujold explained.

Over the next year, Dr. Bujold, two county narcotics officers, a pharmacist, a community nurse, and the regional director of Community Care of North Carolina worked on a solution.

The contract was its centerpiece, downloaded from the American Society of Anesthesiologists Web site. Patients who sign it pledge to get their narcotics from one physician and one pharmacy, and submit to random pill counts and urine drug screens.

Once the plan was in place, the nurse visited local primary care practices to explain the diversion problem and contract initiative.

At the same time, North Carolina created an online narcotics registry accessible to doctors and pharmacists.

“It closed the loop for us. If we have somebody who comes in as a new patient, and their story sounds a little fishy, we can go to the narcotics registry,” explained Dr. Bujold. “If they're getting prescriptions from 10 physicians and 5 pharmacists, we know right away that this is not somebody we are probably going to work with.”

By 2008, narcotics officers reported cocaine and methamphetamine were again the main drug problems in Caldwell County. There were also reports that drug-seeking patients were leaving the county.

Currently, around 90% of local physicians use the contracts, and patients submit to urine screens and pill counts about twice a year when their names come up on a randomly generated list.

Not finding narcotics in the urine of patients prescribed narcotics is a red flag. Marijuana detection is, too, because it's not legal in North Carolina for medical purposes, Dr. Bujold said.

If patients violate their contract, they are cut off from narcotics, something that happens about twice a month in Dr. Bujold's practice, he said.

SAN ANTONIO – A primary care initiative combining patient pledges with random pill counts and urine screens significantly reduced prescription narcotics diversion in North Carolina's rural Caldwell County.

As part of the program, most primary care patients with chronic, nonmalignant pain sign a contract agreeing to those measures – and pledging not to doctor-shop for narcotics – prior to receiving their prescriptions, explained Dr. Ed Bujold, a family physician in the Caldwell County town of Granite Falls who helped spearhead the initiative.

Physicians in the western North Carolina county began to use the contracts in 2007, which coincided with a 300% drop in prescription narcotics seizures by county law enforcement between 2005 and the end of that year.

“I believe most of the impact on the 300% decrease took place in [2007],” Dr. Bujold said.

There's been no evidence the measures keep patients who truly need narcotics from getting them, he added.

In fact, patients “are in complete agreement with this. I have had several say, 'I am so thankful you are doing this. I don't want these drugs to go out to places they are not supposed to be,'” Dr. Bujold said at the meeting.

Dr. Bujold said he is also more confident prescribing Percocet (oxycodone and acetaminophen), OxyContin (oxycodone), Vicodin (hydrocodone and acetaminophen), and other narcotics to the few hundred chronic pain sufferers among his roughly 3,500 patients. A survey found other primary care physicians participating in the initiative are as well.

“I feel very comfortable treating patients now, because I know that I am not dealing with the riffraff,” Dr. Bujold said. “This system pretty much takes them out of the picture.”

The idea was born in 2006 after a church service, when the Caldwell County sheriff approached Dr. Bujold, a fellow parishioner. The sheriff confided in him that prescription narcotics threatened to become the county's main drug problem, ahead of methamphetamine and cocaine. Local law enforcement officials recently had found two houses stocked with prescription narcotics for street sale, he added.

A few local physicians had been too trusting, prescribing narcotics “without even thinking some might end up on the street,” Dr. Bujold explained.

Over the next year, Dr. Bujold, two county narcotics officers, a pharmacist, a community nurse, and the regional director of Community Care of North Carolina worked on a solution.

The contract was its centerpiece, downloaded from the American Society of Anesthesiologists Web site. Patients who sign it pledge to get their narcotics from one physician and one pharmacy, and submit to random pill counts and urine drug screens.

Once the plan was in place, the nurse visited local primary care practices to explain the diversion problem and contract initiative.

At the same time, North Carolina created an online narcotics registry accessible to doctors and pharmacists.

“It closed the loop for us. If we have somebody who comes in as a new patient, and their story sounds a little fishy, we can go to the narcotics registry,” explained Dr. Bujold. “If they're getting prescriptions from 10 physicians and 5 pharmacists, we know right away that this is not somebody we are probably going to work with.”

By 2008, narcotics officers reported cocaine and methamphetamine were again the main drug problems in Caldwell County. There were also reports that drug-seeking patients were leaving the county.

Currently, around 90% of local physicians use the contracts, and patients submit to urine screens and pill counts about twice a year when their names come up on a randomly generated list.

Not finding narcotics in the urine of patients prescribed narcotics is a red flag. Marijuana detection is, too, because it's not legal in North Carolina for medical purposes, Dr. Bujold said.

If patients violate their contract, they are cut off from narcotics, something that happens about twice a month in Dr. Bujold's practice, he said.

SAN ANTONIO – A primary care initiative combining patient pledges with random pill counts and urine screens significantly reduced prescription narcotics diversion in North Carolina's rural Caldwell County.

As part of the program, most primary care patients with chronic, nonmalignant pain sign a contract agreeing to those measures – and pledging not to doctor-shop for narcotics – prior to receiving their prescriptions, explained Dr. Ed Bujold, a family physician in the Caldwell County town of Granite Falls who helped spearhead the initiative.

Physicians in the western North Carolina county began to use the contracts in 2007, which coincided with a 300% drop in prescription narcotics seizures by county law enforcement between 2005 and the end of that year.

“I believe most of the impact on the 300% decrease took place in [2007],” Dr. Bujold said.

There's been no evidence the measures keep patients who truly need narcotics from getting them, he added.

In fact, patients “are in complete agreement with this. I have had several say, 'I am so thankful you are doing this. I don't want these drugs to go out to places they are not supposed to be,'” Dr. Bujold said at the meeting.

Dr. Bujold said he is also more confident prescribing Percocet (oxycodone and acetaminophen), OxyContin (oxycodone), Vicodin (hydrocodone and acetaminophen), and other narcotics to the few hundred chronic pain sufferers among his roughly 3,500 patients. A survey found other primary care physicians participating in the initiative are as well.

“I feel very comfortable treating patients now, because I know that I am not dealing with the riffraff,” Dr. Bujold said. “This system pretty much takes them out of the picture.”

The idea was born in 2006 after a church service, when the Caldwell County sheriff approached Dr. Bujold, a fellow parishioner. The sheriff confided in him that prescription narcotics threatened to become the county's main drug problem, ahead of methamphetamine and cocaine. Local law enforcement officials recently had found two houses stocked with prescription narcotics for street sale, he added.

A few local physicians had been too trusting, prescribing narcotics “without even thinking some might end up on the street,” Dr. Bujold explained.

Over the next year, Dr. Bujold, two county narcotics officers, a pharmacist, a community nurse, and the regional director of Community Care of North Carolina worked on a solution.

The contract was its centerpiece, downloaded from the American Society of Anesthesiologists Web site. Patients who sign it pledge to get their narcotics from one physician and one pharmacy, and submit to random pill counts and urine drug screens.

Once the plan was in place, the nurse visited local primary care practices to explain the diversion problem and contract initiative.

At the same time, North Carolina created an online narcotics registry accessible to doctors and pharmacists.

“It closed the loop for us. If we have somebody who comes in as a new patient, and their story sounds a little fishy, we can go to the narcotics registry,” explained Dr. Bujold. “If they're getting prescriptions from 10 physicians and 5 pharmacists, we know right away that this is not somebody we are probably going to work with.”

By 2008, narcotics officers reported cocaine and methamphetamine were again the main drug problems in Caldwell County. There were also reports that drug-seeking patients were leaving the county.

Currently, around 90% of local physicians use the contracts, and patients submit to urine screens and pill counts about twice a year when their names come up on a randomly generated list.

Not finding narcotics in the urine of patients prescribed narcotics is a red flag. Marijuana detection is, too, because it's not legal in North Carolina for medical purposes, Dr. Bujold said.

If patients violate their contract, they are cut off from narcotics, something that happens about twice a month in Dr. Bujold's practice, he said.

SEATTLE – After 2 years, a pilot medical home project in a Seattle suburb cut emergency department visits by 29% and hospitalizations by 6%, recouping $1.50 for every $1.00 invested.

"We thought it would take years to see savings," but after 1 year, the pilot was "so successful that we’ve spread the model to all of our 26 primary care sites," said Dr. Claire Trescott, primary care medical director at Group Health Cooperative, a nonprofit, Seattle-based health care system.

[Medical Education Reforms Needed to Implement Medical Home Model]

Patients involved in the pilot reported better doctor interactions, better care, and increased access to care, compared with those at other Group Health clinics, Dr. Trescott reported at a symposium held by Swedish Medical Center.

Work-life improved for physicians, too. Compared with colleagues at other clinics, those in the pilot had lower mean emotional exhaustion and depersonalization scores on the Maslach Burnout Inventory.

"Group Health’s experience demonstrates that primary care investments in the form of the medical home can improve patients’ experiences ... and providers’ work environment, and at the same time save money," according to Dr. Robert Reid, a scientific investigator with the Group Health Research Institute and lead author on a review of the project (Health Affairs 2010 May [doi:10.1377/hlthaff.2010.0158]).

Group Health launched its medical home in 2007 at its Factoria, Wash., clinic.

Managers "wanted to see if there really were savings and quality improvements from better primary care," Dr. Reid said in an interview.

[Medical Home Intervention Improves Hypertension]

They also wanted to see if it would make the clinic a better place to work. The situation there had not been "favorable in terms of recruiting and sustaining the workforce. There was a large motivation to try something different," Dr. Reid said.

Better staffing was the key change at Factoria. Managers hired additional physicians and nurses. They also hired more pharmacists, medical assistants, and licensed practical nurses, and increased their involvement in direct patient care.

As a result, physician panels at Factoria dropped from 2,300 to 1,800 patients per doctor. For every 10,000 patients, there were 5.6 physicians, 5.6 medical assistants, 2 licensed practical nurses, 1.5 physician assistants or nurse practitioners, 1.2 registered nurses, and 1 pharmacist.

To deemphasize rapid patient turnover, Group Health eliminated productivity incentives for Factoria physicians.

Patients in the pilot were assigned to care teams; nurses, pharmacists, and other staff helped them manage their conditions with personalized care plans, medication monitoring, test result updates, chronic illness workshops, and other measures. When patients called the clinic, they were connected directly with their team, instead of having to struggle through a phone tree.

It was no longer about "the physician being responsible to do everything," but instead about team care led by the physician, Dr. Reid said.

Daily, short, all-team meetings helped to coordinate the efforts, distribute tasks, and troubleshoot problems. To help with the planning, medical assistants called patients before each appointment to learn the reason for their visit.

The clinic’s existing electronic health records system helped, too, enabling patients to access after-visit summaries, review lab results, and refill prescriptions. The system also sent health maintenance reminders and other alerts.

The changes led to a drop in patient visits during the pilot, but visit duration went from a mean of 20 minutes up to 30.

There were also 80% more e-mail exchanges between patients and providers, and 5% more telephone encounters, compared with other those at Group Health sites.

To assess the results, Dr. Reid and his colleagues compared the utilization and cost numbers for Factoria’s 7,018 continuously enrolled adults with those of the 200,970 adults enrolled at Group Health’s other clinics.

Primary care cost $1.60 more per member per month in Factoria, and specialty care there approximately $5.80 more per member per month.

But Factoria patients visited emergency departments and urgent care clinics less often, saving $4 per member per month, and had fewer inpatient admissions, saving $14.18 per member per month. Balanced against increased staffing and other costs, Factoria saved an estimated $10.30 per member per month.

The changes have had another benefit, as well: It’s easier to fill positions at Group Health now.

"My suspicion is that being a physician here is being seen now as a doable job. The panel sizes are manageable, and you have a supportive team in place. It’s the type of place many physicians would want to work in," Dr. Reid said.

For those thinking of their own medical home project, Dr. Reid suggested making changes gradually, not all at once.

"Managers should assist care teams in breaking the changes into manageable parts so the teams are not overwhelmed," he and his colleagues wrote.

The pilot and review were both conducted by Group Health Cooperative. The investigators are employees and shareholders of Group Health Permanente, the physician group affiliated with the Group Health Cooperative.

SEATTLE – After 2 years, a pilot medical home project in a Seattle suburb cut emergency department visits by 29% and hospitalizations by 6%, recouping $1.50 for every $1.00 invested.

"We thought it would take years to see savings," but after 1 year, the pilot was "so successful that we’ve spread the model to all of our 26 primary care sites," said Dr. Claire Trescott, primary care medical director at Group Health Cooperative, a nonprofit, Seattle-based health care system.

[Medical Education Reforms Needed to Implement Medical Home Model]

Patients involved in the pilot reported better doctor interactions, better care, and increased access to care, compared with those at other Group Health clinics, Dr. Trescott reported at a symposium held by Swedish Medical Center.

Work-life improved for physicians, too. Compared with colleagues at other clinics, those in the pilot had lower mean emotional exhaustion and depersonalization scores on the Maslach Burnout Inventory.

"Group Health’s experience demonstrates that primary care investments in the form of the medical home can improve patients’ experiences ... and providers’ work environment, and at the same time save money," according to Dr. Robert Reid, a scientific investigator with the Group Health Research Institute and lead author on a review of the project (Health Affairs 2010 May [doi:10.1377/hlthaff.2010.0158]).

Group Health launched its medical home in 2007 at its Factoria, Wash., clinic.

Managers "wanted to see if there really were savings and quality improvements from better primary care," Dr. Reid said in an interview.

[Medical Home Intervention Improves Hypertension]

They also wanted to see if it would make the clinic a better place to work. The situation there had not been "favorable in terms of recruiting and sustaining the workforce. There was a large motivation to try something different," Dr. Reid said.

Better staffing was the key change at Factoria. Managers hired additional physicians and nurses. They also hired more pharmacists, medical assistants, and licensed practical nurses, and increased their involvement in direct patient care.

As a result, physician panels at Factoria dropped from 2,300 to 1,800 patients per doctor. For every 10,000 patients, there were 5.6 physicians, 5.6 medical assistants, 2 licensed practical nurses, 1.5 physician assistants or nurse practitioners, 1.2 registered nurses, and 1 pharmacist.

To deemphasize rapid patient turnover, Group Health eliminated productivity incentives for Factoria physicians.

Patients in the pilot were assigned to care teams; nurses, pharmacists, and other staff helped them manage their conditions with personalized care plans, medication monitoring, test result updates, chronic illness workshops, and other measures. When patients called the clinic, they were connected directly with their team, instead of having to struggle through a phone tree.

It was no longer about "the physician being responsible to do everything," but instead about team care led by the physician, Dr. Reid said.

Daily, short, all-team meetings helped to coordinate the efforts, distribute tasks, and troubleshoot problems. To help with the planning, medical assistants called patients before each appointment to learn the reason for their visit.

The clinic’s existing electronic health records system helped, too, enabling patients to access after-visit summaries, review lab results, and refill prescriptions. The system also sent health maintenance reminders and other alerts.

The changes led to a drop in patient visits during the pilot, but visit duration went from a mean of 20 minutes up to 30.

There were also 80% more e-mail exchanges between patients and providers, and 5% more telephone encounters, compared with other those at Group Health sites.

To assess the results, Dr. Reid and his colleagues compared the utilization and cost numbers for Factoria’s 7,018 continuously enrolled adults with those of the 200,970 adults enrolled at Group Health’s other clinics.

Primary care cost $1.60 more per member per month in Factoria, and specialty care there approximately $5.80 more per member per month.

But Factoria patients visited emergency departments and urgent care clinics less often, saving $4 per member per month, and had fewer inpatient admissions, saving $14.18 per member per month. Balanced against increased staffing and other costs, Factoria saved an estimated $10.30 per member per month.

The changes have had another benefit, as well: It’s easier to fill positions at Group Health now.

"My suspicion is that being a physician here is being seen now as a doable job. The panel sizes are manageable, and you have a supportive team in place. It’s the type of place many physicians would want to work in," Dr. Reid said.

For those thinking of their own medical home project, Dr. Reid suggested making changes gradually, not all at once.

"Managers should assist care teams in breaking the changes into manageable parts so the teams are not overwhelmed," he and his colleagues wrote.

The pilot and review were both conducted by Group Health Cooperative. The investigators are employees and shareholders of Group Health Permanente, the physician group affiliated with the Group Health Cooperative.

SEATTLE – After 2 years, a pilot medical home project in a Seattle suburb cut emergency department visits by 29% and hospitalizations by 6%, recouping $1.50 for every $1.00 invested.

"We thought it would take years to see savings," but after 1 year, the pilot was "so successful that we’ve spread the model to all of our 26 primary care sites," said Dr. Claire Trescott, primary care medical director at Group Health Cooperative, a nonprofit, Seattle-based health care system.

[Medical Education Reforms Needed to Implement Medical Home Model]

Patients involved in the pilot reported better doctor interactions, better care, and increased access to care, compared with those at other Group Health clinics, Dr. Trescott reported at a symposium held by Swedish Medical Center.

Work-life improved for physicians, too. Compared with colleagues at other clinics, those in the pilot had lower mean emotional exhaustion and depersonalization scores on the Maslach Burnout Inventory.

"Group Health’s experience demonstrates that primary care investments in the form of the medical home can improve patients’ experiences ... and providers’ work environment, and at the same time save money," according to Dr. Robert Reid, a scientific investigator with the Group Health Research Institute and lead author on a review of the project (Health Affairs 2010 May [doi:10.1377/hlthaff.2010.0158]).

Group Health launched its medical home in 2007 at its Factoria, Wash., clinic.

Managers "wanted to see if there really were savings and quality improvements from better primary care," Dr. Reid said in an interview.

[Medical Home Intervention Improves Hypertension]

They also wanted to see if it would make the clinic a better place to work. The situation there had not been "favorable in terms of recruiting and sustaining the workforce. There was a large motivation to try something different," Dr. Reid said.

Better staffing was the key change at Factoria. Managers hired additional physicians and nurses. They also hired more pharmacists, medical assistants, and licensed practical nurses, and increased their involvement in direct patient care.

As a result, physician panels at Factoria dropped from 2,300 to 1,800 patients per doctor. For every 10,000 patients, there were 5.6 physicians, 5.6 medical assistants, 2 licensed practical nurses, 1.5 physician assistants or nurse practitioners, 1.2 registered nurses, and 1 pharmacist.

To deemphasize rapid patient turnover, Group Health eliminated productivity incentives for Factoria physicians.

Patients in the pilot were assigned to care teams; nurses, pharmacists, and other staff helped them manage their conditions with personalized care plans, medication monitoring, test result updates, chronic illness workshops, and other measures. When patients called the clinic, they were connected directly with their team, instead of having to struggle through a phone tree.

It was no longer about "the physician being responsible to do everything," but instead about team care led by the physician, Dr. Reid said.

Daily, short, all-team meetings helped to coordinate the efforts, distribute tasks, and troubleshoot problems. To help with the planning, medical assistants called patients before each appointment to learn the reason for their visit.

The clinic’s existing electronic health records system helped, too, enabling patients to access after-visit summaries, review lab results, and refill prescriptions. The system also sent health maintenance reminders and other alerts.

The changes led to a drop in patient visits during the pilot, but visit duration went from a mean of 20 minutes up to 30.

There were also 80% more e-mail exchanges between patients and providers, and 5% more telephone encounters, compared with other those at Group Health sites.

To assess the results, Dr. Reid and his colleagues compared the utilization and cost numbers for Factoria’s 7,018 continuously enrolled adults with those of the 200,970 adults enrolled at Group Health’s other clinics.

Primary care cost $1.60 more per member per month in Factoria, and specialty care there approximately $5.80 more per member per month.

But Factoria patients visited emergency departments and urgent care clinics less often, saving $4 per member per month, and had fewer inpatient admissions, saving $14.18 per member per month. Balanced against increased staffing and other costs, Factoria saved an estimated $10.30 per member per month.

The changes have had another benefit, as well: It’s easier to fill positions at Group Health now.

"My suspicion is that being a physician here is being seen now as a doable job. The panel sizes are manageable, and you have a supportive team in place. It’s the type of place many physicians would want to work in," Dr. Reid said.

For those thinking of their own medical home project, Dr. Reid suggested making changes gradually, not all at once.

"Managers should assist care teams in breaking the changes into manageable parts so the teams are not overwhelmed," he and his colleagues wrote.

The pilot and review were both conducted by Group Health Cooperative. The investigators are employees and shareholders of Group Health Permanente, the physician group affiliated with the Group Health Cooperative.

Many physicians have wondered how – and even if – they will be able to work together to form accountable care organizations without violating federal antitrust and fraud and abuse laws.

A federal regulatory meeting held earlier this fall offered possible answers to both questions. Federal regulators are considering exemptions to those laws that would allow providers who meet certain requirements to form accountable care organizations (ACOs).

“It is not easy to craft safe harbors that can replace an antitrust review that analyzes the specific facts of each case and market. But we're going to try to do this,” said Jon Leibowitz, chairman of the Federal Trade Commission (FTC).

Similarly, Daniel Levinson, inspector general of the U.S. Department of Health and Human Services, noted that the Affordable Care Act gives the HHS secretary the authority to waive some fraud and abuse laws as needed to help ACO programs develop.

“We and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively,” Levinson said, according to the meeting transcript.

The FTC, the HHS Office of Inspector General, and the Centers for Medicare and Medicaid Services conducted the workshop in Baltimore to hear the opinions of panelists and audience members on a variety of ACO issues.

However, much of the questioning focused on how antitrust and fraud and abuse exemptions could be applied to ACOs.

The Affordable Care Act promotes ACO creation to reduce health-care fragmentation, improve outcomes, and cut health spending by, for instance, keeping patients out of hospitals when possible.

The goal is for providers to come together and contract with the CMS to integrate and manage the care of at least 5,000 patients, and to share a portion of the savings their efforts generate for Medicare, so long as quality parameters are met.

Once formed, ACOs could pursue similar types of contracts with commercial insurance companies.

The catch is that encouraging independent providers to jointly negotiate contracts and payment rates with health plans raises concerns about joint price fixing, reduced competition, and other antitrust matters.

Likewise, the shared-savings provision, among others, raises antikickback, self-referral, and other fraud and abuse concerns, according to health care attorney Douglas Hastings, board chair of Epstein Becker & Green, Washington, and a meeting panelist who offered his insights during a later interview.

Regulators are interested in applying to ACOs antitrust protections that already exist for providers who are clinically integrated and jointly accept significant financial risk.

“In those cases, [collaboration is] not viewed as an antitrust matter, since they are behaving as an integrated organization,” explained meeting panelist and health policy expert Harold Miller, executive director of the Center for Health Care Quality and Payment Reform, who also offered his insights during a later interview.

Defining the extent of integration required for protection, and the time frame to achieve it, remain key issues for regulators, as does the possible creation of additional antitrust safe harbors related to market share and other matters. Regulators also said that they want to foster multiple ACOs in a given market to increase competition.

Which providers would be covered under fraud and abuse waivers also remains an issue, as well as whether waivers should apply only to shared savings payments or to other financial relationships ACOs create, Troy Barsky, director of the CMS Division of Technical Payment Policy, explained during the meeting.

Overall, the hope is to spur “coordination [and] cooperation among the people and the entities that provide health care,” while at the same time ensure “appropriate corporate behaviors,” said Dr. Donald Berwick, CMS Administrator.

Proposed ACO regulations are expected from the CMS in late December.

In the meantime, Mr. Miller advised physicians, “If you want to be an ACO, you have to start looking at the data you have – or get access to data from payers, Medicare, and others – to identify opportunities for savings.

“Once you know where they are, figure out what programs to put in place to achieve those savings,” he said.

One option among many is to hire a nurse to help chronically ill patients manage their diseases, Mr. Miller said. That's been proven to help reduce emergency department visits and hospitalizations, he added (Arch. Intern. Med. 2003; 163:585-91).

To make such programs cost effective, however, “a small practice will need to think about how to partner with other practices in order to have enough patients who can benefit,” he said.

Mr. Miller added that he does not believe recent election results will derail ACO efforts or other aspects of the Affordable Care Act. Despite Republican victories, “I think it would be a near impossibility to pass a repeal by a veto-proof margin. And the ACO stuff is not really controversial – yet,” he noted.

The meeting's audio and transcript – as well as public comments on ACO concerns – are available online at www.ftc.gov/opp/workshops/aco/index.shtml

Many physicians have wondered how – and even if – they will be able to work together to form accountable care organizations without violating federal antitrust and fraud and abuse laws.

A federal regulatory meeting held earlier this fall offered possible answers to both questions. Federal regulators are considering exemptions to those laws that would allow providers who meet certain requirements to form accountable care organizations (ACOs).

“It is not easy to craft safe harbors that can replace an antitrust review that analyzes the specific facts of each case and market. But we're going to try to do this,” said Jon Leibowitz, chairman of the Federal Trade Commission (FTC).

Similarly, Daniel Levinson, inspector general of the U.S. Department of Health and Human Services, noted that the Affordable Care Act gives the HHS secretary the authority to waive some fraud and abuse laws as needed to help ACO programs develop.

“We and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively,” Levinson said, according to the meeting transcript.

The FTC, the HHS Office of Inspector General, and the Centers for Medicare and Medicaid Services conducted the workshop in Baltimore to hear the opinions of panelists and audience members on a variety of ACO issues.

However, much of the questioning focused on how antitrust and fraud and abuse exemptions could be applied to ACOs.

The Affordable Care Act promotes ACO creation to reduce health-care fragmentation, improve outcomes, and cut health spending by, for instance, keeping patients out of hospitals when possible.

The goal is for providers to come together and contract with the CMS to integrate and manage the care of at least 5,000 patients, and to share a portion of the savings their efforts generate for Medicare, so long as quality parameters are met.

Once formed, ACOs could pursue similar types of contracts with commercial insurance companies.

The catch is that encouraging independent providers to jointly negotiate contracts and payment rates with health plans raises concerns about joint price fixing, reduced competition, and other antitrust matters.

Likewise, the shared-savings provision, among others, raises antikickback, self-referral, and other fraud and abuse concerns, according to health care attorney Douglas Hastings, board chair of Epstein Becker & Green, Washington, and a meeting panelist who offered his insights during a later interview.

Regulators are interested in applying to ACOs antitrust protections that already exist for providers who are clinically integrated and jointly accept significant financial risk.

“In those cases, [collaboration is] not viewed as an antitrust matter, since they are behaving as an integrated organization,” explained meeting panelist and health policy expert Harold Miller, executive director of the Center for Health Care Quality and Payment Reform, who also offered his insights during a later interview.

Defining the extent of integration required for protection, and the time frame to achieve it, remain key issues for regulators, as does the possible creation of additional antitrust safe harbors related to market share and other matters. Regulators also said that they want to foster multiple ACOs in a given market to increase competition.

Which providers would be covered under fraud and abuse waivers also remains an issue, as well as whether waivers should apply only to shared savings payments or to other financial relationships ACOs create, Troy Barsky, director of the CMS Division of Technical Payment Policy, explained during the meeting.

Overall, the hope is to spur “coordination [and] cooperation among the people and the entities that provide health care,” while at the same time ensure “appropriate corporate behaviors,” said Dr. Donald Berwick, CMS Administrator.

Proposed ACO regulations are expected from the CMS in late December.

In the meantime, Mr. Miller advised physicians, “If you want to be an ACO, you have to start looking at the data you have – or get access to data from payers, Medicare, and others – to identify opportunities for savings.

“Once you know where they are, figure out what programs to put in place to achieve those savings,” he said.

One option among many is to hire a nurse to help chronically ill patients manage their diseases, Mr. Miller said. That's been proven to help reduce emergency department visits and hospitalizations, he added (Arch. Intern. Med. 2003; 163:585-91).

To make such programs cost effective, however, “a small practice will need to think about how to partner with other practices in order to have enough patients who can benefit,” he said.

Mr. Miller added that he does not believe recent election results will derail ACO efforts or other aspects of the Affordable Care Act. Despite Republican victories, “I think it would be a near impossibility to pass a repeal by a veto-proof margin. And the ACO stuff is not really controversial – yet,” he noted.

The meeting's audio and transcript – as well as public comments on ACO concerns – are available online at www.ftc.gov/opp/workshops/aco/index.shtml

Many physicians have wondered how – and even if – they will be able to work together to form accountable care organizations without violating federal antitrust and fraud and abuse laws.

A federal regulatory meeting held earlier this fall offered possible answers to both questions. Federal regulators are considering exemptions to those laws that would allow providers who meet certain requirements to form accountable care organizations (ACOs).

“It is not easy to craft safe harbors that can replace an antitrust review that analyzes the specific facts of each case and market. But we're going to try to do this,” said Jon Leibowitz, chairman of the Federal Trade Commission (FTC).

Similarly, Daniel Levinson, inspector general of the U.S. Department of Health and Human Services, noted that the Affordable Care Act gives the HHS secretary the authority to waive some fraud and abuse laws as needed to help ACO programs develop.

“We and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively,” Levinson said, according to the meeting transcript.

The FTC, the HHS Office of Inspector General, and the Centers for Medicare and Medicaid Services conducted the workshop in Baltimore to hear the opinions of panelists and audience members on a variety of ACO issues.

However, much of the questioning focused on how antitrust and fraud and abuse exemptions could be applied to ACOs.

The Affordable Care Act promotes ACO creation to reduce health-care fragmentation, improve outcomes, and cut health spending by, for instance, keeping patients out of hospitals when possible.

The goal is for providers to come together and contract with the CMS to integrate and manage the care of at least 5,000 patients, and to share a portion of the savings their efforts generate for Medicare, so long as quality parameters are met.

Once formed, ACOs could pursue similar types of contracts with commercial insurance companies.

The catch is that encouraging independent providers to jointly negotiate contracts and payment rates with health plans raises concerns about joint price fixing, reduced competition, and other antitrust matters.

Likewise, the shared-savings provision, among others, raises antikickback, self-referral, and other fraud and abuse concerns, according to health care attorney Douglas Hastings, board chair of Epstein Becker & Green, Washington, and a meeting panelist who offered his insights during a later interview.

Regulators are interested in applying to ACOs antitrust protections that already exist for providers who are clinically integrated and jointly accept significant financial risk.

“In those cases, [collaboration is] not viewed as an antitrust matter, since they are behaving as an integrated organization,” explained meeting panelist and health policy expert Harold Miller, executive director of the Center for Health Care Quality and Payment Reform, who also offered his insights during a later interview.

Defining the extent of integration required for protection, and the time frame to achieve it, remain key issues for regulators, as does the possible creation of additional antitrust safe harbors related to market share and other matters. Regulators also said that they want to foster multiple ACOs in a given market to increase competition.

Which providers would be covered under fraud and abuse waivers also remains an issue, as well as whether waivers should apply only to shared savings payments or to other financial relationships ACOs create, Troy Barsky, director of the CMS Division of Technical Payment Policy, explained during the meeting.

Overall, the hope is to spur “coordination [and] cooperation among the people and the entities that provide health care,” while at the same time ensure “appropriate corporate behaviors,” said Dr. Donald Berwick, CMS Administrator.

Proposed ACO regulations are expected from the CMS in late December.

In the meantime, Mr. Miller advised physicians, “If you want to be an ACO, you have to start looking at the data you have – or get access to data from payers, Medicare, and others – to identify opportunities for savings.

“Once you know where they are, figure out what programs to put in place to achieve those savings,” he said.

One option among many is to hire a nurse to help chronically ill patients manage their diseases, Mr. Miller said. That's been proven to help reduce emergency department visits and hospitalizations, he added (Arch. Intern. Med. 2003; 163:585-91).

To make such programs cost effective, however, “a small practice will need to think about how to partner with other practices in order to have enough patients who can benefit,” he said.

Mr. Miller added that he does not believe recent election results will derail ACO efforts or other aspects of the Affordable Care Act. Despite Republican victories, “I think it would be a near impossibility to pass a repeal by a veto-proof margin. And the ACO stuff is not really controversial – yet,” he noted.

The meeting's audio and transcript – as well as public comments on ACO concerns – are available online at www.ftc.gov/opp/workshops/aco/index.shtml

DENVER — A once-daily combination of ezetimibe 10 mg and simvastatin 20 mg reduced the risk of major atherosclerotic events in patients with chronic kidney disease by 16.5%, according to a randomized, placebo-controlled trial funded by the drug's maker, Merck.

However, the combination (trade name Vytorin) did not slow progression to end-stage renal disease in the trial or significantly impact mortality.

The “trial results provide clear evidence that lowering cholesterol with [Vytorin] reduces the risk of major atherosclerotic events,” in patients with chronic kidney disease, said Dr. Colin Baigent, Oxford University professor of epidemiology, and the lead investigator of the Study of Heart and Renal Protection (SHARP) trial. He presented the study results at the meeting.

Merck will seek Food and Drug Administration approval for Vytorin use in chronic kidney disease (CKD) patients based on the SHARP trial results, the company said.

In SHARP, 4,650 patients with CKD were randomized to Vytorin, and 4,620 to placebo. The median duration of therapy was 4.9 years. The mean age at baseline was 62 years, and patients had no revascularization or MI histories; 23% had diabetes, and 15% had vascular disease.

About a third of the patients started the trial on dialysis; the remainder had a baseline average estimated glomerular filtration rate of 26.5 mL/minute per 1.73 m

The average LDL cholesterol at enrollment was 108 mg/dL. Midway through the trial, Vytorin lowered LDL cholesterol by an average of 32 mg/dL.

Major atherosclerotic events – coronary death, MI, nonhemorrhagic stroke, or revascularization – occurred in 11.3% (526) of patients in the Vytorin group, and in 13.4% (619) of patients in the placebo group. That translated to a significant 16.5% risk reduction among Vytorin users, results similar to previous statin studies in other populations, Dr. Baigent noted.

The rate of treatment compliance was about two-thirds among patients in both the placebo and Vytorin arms of the trial. “With full compliance, we would be likely to reduce the risk of vascular events by about a quarter,” he predicted.

However, lowering patients' LDL did not affect progression to end-stage renal disease, which developed in about a third of patients in each arm: 33.9% of the treatment group, and 34.6% of the controls.

Cancer was also on the minds of investigators during the trial, due to reports about possible carcinogenicity associated with use of ezetimibe (trade name Zetia). The FDA concluded in December 2009 that “it is unlikely that Vytorin or Zetia increases the risk of cancer or cancer-related death,” and the SHARP results supported the assertion.

There were 438 cancers diagnosed and 150 cancer deaths in the Vytorin group, compared with 439 cancers diagnosed and 128 cancer deaths in the placebo group. The differences were nonsignificant.

Overall, cardiac, renal, and vascular-related deaths were less frequent in Vytorin users, but nonvascular deaths were more frequent. As with cancer deaths, however, the differences between the groups were small and not significant.

Similarly, there were no significant differences in myopathy, rhabdomyolysis, liver dysfunction, pancreatitis, or gallstone complications between groups.

The study largely “confirms what we already know” – that statins benefit kidney patients, said nephrologist Pablo Pergola, clinical associate professor of medicine at the University of Texas Health Science Center, San Antonio.

Dr. Pergola was curious, however, about what role, if any, ezetimibe may have played in the outcomes.

“My guess is it's not something special ezetimibe is doing,” Dr. Baigent said. “It's lowering LDL cholesterol in the same way statins do.”

Dr. Baigent and Dr. Pergola said they have no conflicts of interest. Dr. Baigent added that the trial was run independently of Merck, and that he and his colleagues do not accept payments from the pharmaceutical industry, other than the costs of attending scientific meetings.

DENVER — A once-daily combination of ezetimibe 10 mg and simvastatin 20 mg reduced the risk of major atherosclerotic events in patients with chronic kidney disease by 16.5%, according to a randomized, placebo-controlled trial funded by the drug's maker, Merck.

However, the combination (trade name Vytorin) did not slow progression to end-stage renal disease in the trial or significantly impact mortality.

The “trial results provide clear evidence that lowering cholesterol with [Vytorin] reduces the risk of major atherosclerotic events,” in patients with chronic kidney disease, said Dr. Colin Baigent, Oxford University professor of epidemiology, and the lead investigator of the Study of Heart and Renal Protection (SHARP) trial. He presented the study results at the meeting.

Merck will seek Food and Drug Administration approval for Vytorin use in chronic kidney disease (CKD) patients based on the SHARP trial results, the company said.

In SHARP, 4,650 patients with CKD were randomized to Vytorin, and 4,620 to placebo. The median duration of therapy was 4.9 years. The mean age at baseline was 62 years, and patients had no revascularization or MI histories; 23% had diabetes, and 15% had vascular disease.

About a third of the patients started the trial on dialysis; the remainder had a baseline average estimated glomerular filtration rate of 26.5 mL/minute per 1.73 m

The average LDL cholesterol at enrollment was 108 mg/dL. Midway through the trial, Vytorin lowered LDL cholesterol by an average of 32 mg/dL.

Major atherosclerotic events – coronary death, MI, nonhemorrhagic stroke, or revascularization – occurred in 11.3% (526) of patients in the Vytorin group, and in 13.4% (619) of patients in the placebo group. That translated to a significant 16.5% risk reduction among Vytorin users, results similar to previous statin studies in other populations, Dr. Baigent noted.

The rate of treatment compliance was about two-thirds among patients in both the placebo and Vytorin arms of the trial. “With full compliance, we would be likely to reduce the risk of vascular events by about a quarter,” he predicted.

However, lowering patients' LDL did not affect progression to end-stage renal disease, which developed in about a third of patients in each arm: 33.9% of the treatment group, and 34.6% of the controls.

Cancer was also on the minds of investigators during the trial, due to reports about possible carcinogenicity associated with use of ezetimibe (trade name Zetia). The FDA concluded in December 2009 that “it is unlikely that Vytorin or Zetia increases the risk of cancer or cancer-related death,” and the SHARP results supported the assertion.

There were 438 cancers diagnosed and 150 cancer deaths in the Vytorin group, compared with 439 cancers diagnosed and 128 cancer deaths in the placebo group. The differences were nonsignificant.

Overall, cardiac, renal, and vascular-related deaths were less frequent in Vytorin users, but nonvascular deaths were more frequent. As with cancer deaths, however, the differences between the groups were small and not significant.

Similarly, there were no significant differences in myopathy, rhabdomyolysis, liver dysfunction, pancreatitis, or gallstone complications between groups.

The study largely “confirms what we already know” – that statins benefit kidney patients, said nephrologist Pablo Pergola, clinical associate professor of medicine at the University of Texas Health Science Center, San Antonio.

Dr. Pergola was curious, however, about what role, if any, ezetimibe may have played in the outcomes.

“My guess is it's not something special ezetimibe is doing,” Dr. Baigent said. “It's lowering LDL cholesterol in the same way statins do.”

Dr. Baigent and Dr. Pergola said they have no conflicts of interest. Dr. Baigent added that the trial was run independently of Merck, and that he and his colleagues do not accept payments from the pharmaceutical industry, other than the costs of attending scientific meetings.

DENVER — A once-daily combination of ezetimibe 10 mg and simvastatin 20 mg reduced the risk of major atherosclerotic events in patients with chronic kidney disease by 16.5%, according to a randomized, placebo-controlled trial funded by the drug's maker, Merck.

However, the combination (trade name Vytorin) did not slow progression to end-stage renal disease in the trial or significantly impact mortality.

The “trial results provide clear evidence that lowering cholesterol with [Vytorin] reduces the risk of major atherosclerotic events,” in patients with chronic kidney disease, said Dr. Colin Baigent, Oxford University professor of epidemiology, and the lead investigator of the Study of Heart and Renal Protection (SHARP) trial. He presented the study results at the meeting.

Merck will seek Food and Drug Administration approval for Vytorin use in chronic kidney disease (CKD) patients based on the SHARP trial results, the company said.

In SHARP, 4,650 patients with CKD were randomized to Vytorin, and 4,620 to placebo. The median duration of therapy was 4.9 years. The mean age at baseline was 62 years, and patients had no revascularization or MI histories; 23% had diabetes, and 15% had vascular disease.

About a third of the patients started the trial on dialysis; the remainder had a baseline average estimated glomerular filtration rate of 26.5 mL/minute per 1.73 m

The average LDL cholesterol at enrollment was 108 mg/dL. Midway through the trial, Vytorin lowered LDL cholesterol by an average of 32 mg/dL.

Major atherosclerotic events – coronary death, MI, nonhemorrhagic stroke, or revascularization – occurred in 11.3% (526) of patients in the Vytorin group, and in 13.4% (619) of patients in the placebo group. That translated to a significant 16.5% risk reduction among Vytorin users, results similar to previous statin studies in other populations, Dr. Baigent noted.

The rate of treatment compliance was about two-thirds among patients in both the placebo and Vytorin arms of the trial. “With full compliance, we would be likely to reduce the risk of vascular events by about a quarter,” he predicted.

However, lowering patients' LDL did not affect progression to end-stage renal disease, which developed in about a third of patients in each arm: 33.9% of the treatment group, and 34.6% of the controls.

Cancer was also on the minds of investigators during the trial, due to reports about possible carcinogenicity associated with use of ezetimibe (trade name Zetia). The FDA concluded in December 2009 that “it is unlikely that Vytorin or Zetia increases the risk of cancer or cancer-related death,” and the SHARP results supported the assertion.

There were 438 cancers diagnosed and 150 cancer deaths in the Vytorin group, compared with 439 cancers diagnosed and 128 cancer deaths in the placebo group. The differences were nonsignificant.

Overall, cardiac, renal, and vascular-related deaths were less frequent in Vytorin users, but nonvascular deaths were more frequent. As with cancer deaths, however, the differences between the groups were small and not significant.

Similarly, there were no significant differences in myopathy, rhabdomyolysis, liver dysfunction, pancreatitis, or gallstone complications between groups.

The study largely “confirms what we already know” – that statins benefit kidney patients, said nephrologist Pablo Pergola, clinical associate professor of medicine at the University of Texas Health Science Center, San Antonio.

Dr. Pergola was curious, however, about what role, if any, ezetimibe may have played in the outcomes.

“My guess is it's not something special ezetimibe is doing,” Dr. Baigent said. “It's lowering LDL cholesterol in the same way statins do.”

Dr. Baigent and Dr. Pergola said they have no conflicts of interest. Dr. Baigent added that the trial was run independently of Merck, and that he and his colleagues do not accept payments from the pharmaceutical industry, other than the costs of attending scientific meetings.