Mary Ellen Schneider

Dr. David Blumenthal, a Harvard professor and a senior health adviser to President Obama's campaign, was appointed in March to the position of National Coordinator for Health Information Technology in the Health and Human Services Department. He is assuming the post at a critical time, with Congress recently setting aside billions in incentives for physicians and hospitals to adopt health IT as part of the American Recovery and Reinvestment Act.

One of Dr. Blumenthal's challenges will be how to define the “meaningful use” criteria mentioned in the law, a definition that will play a major role in determining who is eligible to receive incentives.

In an interview with this news organization, Dr. Blumenthal talked about some of the challenges and progress so far.

CLINICAL PSYCHIATRY NEWS: What do you see as the biggest challenge for physicians in adopting interoperable electronic health records by 2014? Cost? Misaligned incentives? Products that don't meet their needs? Security?

Dr. Blumenthal: Surveys have shown all of those to be issues. I think security is a lesser issue, according to the surveys that my group did at Harvard when I was there. But the cost of acquisition, the lack of return on investment, [and] concern about the usefulness of products all ranked high in our survey results. So I think all are important issues for physicians right now.

CPN: The Recovery Act includes about $17 billion in incentives for physicians and hospitals to adopt health IT. What impact do you expect this to have on the sluggish adoption rate and the health IT marketplace?

Dr. Blumenthal: Let me first make a minor correction in the number: $17 billion is a Congressional Budget Office number, and it is actually a combination of two numbers: a spending number and a cost savings number. Both are estimates. The actual CBO projections of spending are about $29 billion, and they project a $12 billion savings, which gets you to $17 billion. Some estimates of the spending are that it will be considerably higher than that, and how much is spent depends on how many physicians adopt, how many hospitals adopt, and how fast they adopt. So if we think more on the order of $30 billion or even more than that, I do think that's enough to change the dynamic in the marketplace.

We are also counting on peer-to-peer influence and on a growing appreciation among physicians of the value of health information technology and of the fact that it will be difficult to practice up-to-date, high-quality, professional medicine in the 21st century without an electronic health record. We are counting to some degree on professionalism to complement the incentives.

If physicians were only about money, it would be a much less happy world, and the quality of care would be much lower than it is. Physicians don't expect the government to help them buy stethoscopes, examining tables, treadmills for stress tests. They know these are essential to their work as professionals, and I think that is where we are heading with electronic health records as well.

CPN: Everyone is curious to see how HHS defines the “meaningful use” criteria outlined in the Recovery Act. Is there a consensus building around this term, and what is the schedule for issuing a definition?

Dr. Blumenthal: I think there is a consensus building. We haven't pinned it down finally. We [are] discussing this issue before our Health Information Technology Policy Committee. I think at that point some of the major options will be on the table for review and for public comment. We will ultimately have to go through a regulatory process to finally determine the effective definition, but I'm hoping that over the summer, the HHS view of the definition will become clear. It will then have to go through the government clearance process and the regulatory process, which will include copious public comment and undoubtedly will result in some modifications.

CPN: Can you say where there is consensus so far?

Dr. Blumenthal: I don't want to get into specifics, but I will tell you that I think the consensus is clear around one thing, and that is that we should concentrate on performance and usability rather than on technical specifications. We should be constantly linking our definition of meaningful use to clinically meaningful capabilities and performance attributes.

CPN: You and the president frequently have said that health IT is a tool, not a fix for our health care system. What can we reasonably expect to achieve through the widespread adoption of health IT in terms of reducing health care spending? And can physicians expect to realize any of those savings within their own practices?

Dr. Blumenthal: I think you've correctly captured my view of the role of health information technology. There are three essential components for achieving the president's goal and the administration's goal and, I think, the public's goal for a higher-performing health system. The first is better information on what works and what doesn't in the daily practice of medicine.

The second is the ability to apply that knowledge rapidly to practice. And it's in that setting that I think health care information technology becomes a vital tool. It enables practitioners to access in real-time and have the benefit of… the latest information that is approved by their peers and recognized by their peers as valid and useful for patient care. And it helps overcome the human factors that limit the ability of clinicians to do their best at all times and in all places. Of course, it provides better information about individual patients to factor into decision making as well.

The third element is changes in the financing and organization of care that make it more valuable and more rewarding for physicians and easier for physicians to take cost and quality into account when they make their decisions.

Health information technology is the major part of the second [component], but can't function optimally unless all three are in place. So we are vitally dependent for the savings and the quality improvement that could come out of HIT, we are vitally dependent on health care reform more generally.

If physicians are going to realize savings in their practice and gain the benefit of those savings, there will have to be some change in the way that we pay for care and some change in the way that we recognize excellence in medicine so that physicians, as well as their patients, feel very directly and personally the benefits of making the health care system a better health care system.

CPN: The Recovery Act provides for incentives for HIT adoption starting in 2011, but there are many areas where there are still not uniform standards. Can the industry keep up with this aggressive timetable, and what is the government doing to accelerate that process?

Dr. Blumenthal: Frankly, I think we have most of what we need in the way of standards to permit the physicians to get to meaningful use as it is likely to be defined by 2011. I also think that the industry can reconfigure their software in time to make it possible for physicians to meet those standards. I'm not very concerned about that. What I'm mostly concerned about is that–in recognizing those standards and in certifying the software and hardware that we need to certify–we also make certain that we are laying the groundwork for a dramatically improved set of technologies as we go forward. We are looking very hard at how we [can ensure] that when we certify a system and we set a set of standards, we are leaving room for innovation and improvement.

DAVID BLUMENTHAL, M.D.

Dr. David Blumenthal, a Harvard professor and a senior health adviser to President Obama's campaign, was appointed in March to the position of National Coordinator for Health Information Technology in the Health and Human Services Department. He is assuming the post at a critical time, with Congress recently setting aside billions in incentives for physicians and hospitals to adopt health IT as part of the American Recovery and Reinvestment Act.

One of Dr. Blumenthal's challenges will be how to define the “meaningful use” criteria mentioned in the law, a definition that will play a major role in determining who is eligible to receive incentives.

In an interview with this news organization, Dr. Blumenthal talked about some of the challenges and progress so far.

CLINICAL PSYCHIATRY NEWS: What do you see as the biggest challenge for physicians in adopting interoperable electronic health records by 2014? Cost? Misaligned incentives? Products that don't meet their needs? Security?

Dr. Blumenthal: Surveys have shown all of those to be issues. I think security is a lesser issue, according to the surveys that my group did at Harvard when I was there. But the cost of acquisition, the lack of return on investment, [and] concern about the usefulness of products all ranked high in our survey results. So I think all are important issues for physicians right now.

CPN: The Recovery Act includes about $17 billion in incentives for physicians and hospitals to adopt health IT. What impact do you expect this to have on the sluggish adoption rate and the health IT marketplace?

Dr. Blumenthal: Let me first make a minor correction in the number: $17 billion is a Congressional Budget Office number, and it is actually a combination of two numbers: a spending number and a cost savings number. Both are estimates. The actual CBO projections of spending are about $29 billion, and they project a $12 billion savings, which gets you to $17 billion. Some estimates of the spending are that it will be considerably higher than that, and how much is spent depends on how many physicians adopt, how many hospitals adopt, and how fast they adopt. So if we think more on the order of $30 billion or even more than that, I do think that's enough to change the dynamic in the marketplace.

We are also counting on peer-to-peer influence and on a growing appreciation among physicians of the value of health information technology and of the fact that it will be difficult to practice up-to-date, high-quality, professional medicine in the 21st century without an electronic health record. We are counting to some degree on professionalism to complement the incentives.

If physicians were only about money, it would be a much less happy world, and the quality of care would be much lower than it is. Physicians don't expect the government to help them buy stethoscopes, examining tables, treadmills for stress tests. They know these are essential to their work as professionals, and I think that is where we are heading with electronic health records as well.

CPN: Everyone is curious to see how HHS defines the “meaningful use” criteria outlined in the Recovery Act. Is there a consensus building around this term, and what is the schedule for issuing a definition?

Dr. Blumenthal: I think there is a consensus building. We haven't pinned it down finally. We [are] discussing this issue before our Health Information Technology Policy Committee. I think at that point some of the major options will be on the table for review and for public comment. We will ultimately have to go through a regulatory process to finally determine the effective definition, but I'm hoping that over the summer, the HHS view of the definition will become clear. It will then have to go through the government clearance process and the regulatory process, which will include copious public comment and undoubtedly will result in some modifications.

CPN: Can you say where there is consensus so far?

Dr. Blumenthal: I don't want to get into specifics, but I will tell you that I think the consensus is clear around one thing, and that is that we should concentrate on performance and usability rather than on technical specifications. We should be constantly linking our definition of meaningful use to clinically meaningful capabilities and performance attributes.

CPN: You and the president frequently have said that health IT is a tool, not a fix for our health care system. What can we reasonably expect to achieve through the widespread adoption of health IT in terms of reducing health care spending? And can physicians expect to realize any of those savings within their own practices?

Dr. Blumenthal: I think you've correctly captured my view of the role of health information technology. There are three essential components for achieving the president's goal and the administration's goal and, I think, the public's goal for a higher-performing health system. The first is better information on what works and what doesn't in the daily practice of medicine.

The second is the ability to apply that knowledge rapidly to practice. And it's in that setting that I think health care information technology becomes a vital tool. It enables practitioners to access in real-time and have the benefit of… the latest information that is approved by their peers and recognized by their peers as valid and useful for patient care. And it helps overcome the human factors that limit the ability of clinicians to do their best at all times and in all places. Of course, it provides better information about individual patients to factor into decision making as well.

The third element is changes in the financing and organization of care that make it more valuable and more rewarding for physicians and easier for physicians to take cost and quality into account when they make their decisions.

Health information technology is the major part of the second [component], but can't function optimally unless all three are in place. So we are vitally dependent for the savings and the quality improvement that could come out of HIT, we are vitally dependent on health care reform more generally.

If physicians are going to realize savings in their practice and gain the benefit of those savings, there will have to be some change in the way that we pay for care and some change in the way that we recognize excellence in medicine so that physicians, as well as their patients, feel very directly and personally the benefits of making the health care system a better health care system.

CPN: The Recovery Act provides for incentives for HIT adoption starting in 2011, but there are many areas where there are still not uniform standards. Can the industry keep up with this aggressive timetable, and what is the government doing to accelerate that process?

Dr. Blumenthal: Frankly, I think we have most of what we need in the way of standards to permit the physicians to get to meaningful use as it is likely to be defined by 2011. I also think that the industry can reconfigure their software in time to make it possible for physicians to meet those standards. I'm not very concerned about that. What I'm mostly concerned about is that–in recognizing those standards and in certifying the software and hardware that we need to certify–we also make certain that we are laying the groundwork for a dramatically improved set of technologies as we go forward. We are looking very hard at how we [can ensure] that when we certify a system and we set a set of standards, we are leaving room for innovation and improvement.

DAVID BLUMENTHAL, M.D.

Dr. David Blumenthal, a Harvard professor and a senior health adviser to President Obama's campaign, was appointed in March to the position of National Coordinator for Health Information Technology in the Health and Human Services Department. He is assuming the post at a critical time, with Congress recently setting aside billions in incentives for physicians and hospitals to adopt health IT as part of the American Recovery and Reinvestment Act.

One of Dr. Blumenthal's challenges will be how to define the “meaningful use” criteria mentioned in the law, a definition that will play a major role in determining who is eligible to receive incentives.

In an interview with this news organization, Dr. Blumenthal talked about some of the challenges and progress so far.

CLINICAL PSYCHIATRY NEWS: What do you see as the biggest challenge for physicians in adopting interoperable electronic health records by 2014? Cost? Misaligned incentives? Products that don't meet their needs? Security?

Dr. Blumenthal: Surveys have shown all of those to be issues. I think security is a lesser issue, according to the surveys that my group did at Harvard when I was there. But the cost of acquisition, the lack of return on investment, [and] concern about the usefulness of products all ranked high in our survey results. So I think all are important issues for physicians right now.

CPN: The Recovery Act includes about $17 billion in incentives for physicians and hospitals to adopt health IT. What impact do you expect this to have on the sluggish adoption rate and the health IT marketplace?

Dr. Blumenthal: Let me first make a minor correction in the number: $17 billion is a Congressional Budget Office number, and it is actually a combination of two numbers: a spending number and a cost savings number. Both are estimates. The actual CBO projections of spending are about $29 billion, and they project a $12 billion savings, which gets you to $17 billion. Some estimates of the spending are that it will be considerably higher than that, and how much is spent depends on how many physicians adopt, how many hospitals adopt, and how fast they adopt. So if we think more on the order of $30 billion or even more than that, I do think that's enough to change the dynamic in the marketplace.

We are also counting on peer-to-peer influence and on a growing appreciation among physicians of the value of health information technology and of the fact that it will be difficult to practice up-to-date, high-quality, professional medicine in the 21st century without an electronic health record. We are counting to some degree on professionalism to complement the incentives.

If physicians were only about money, it would be a much less happy world, and the quality of care would be much lower than it is. Physicians don't expect the government to help them buy stethoscopes, examining tables, treadmills for stress tests. They know these are essential to their work as professionals, and I think that is where we are heading with electronic health records as well.

CPN: Everyone is curious to see how HHS defines the “meaningful use” criteria outlined in the Recovery Act. Is there a consensus building around this term, and what is the schedule for issuing a definition?

Dr. Blumenthal: I think there is a consensus building. We haven't pinned it down finally. We [are] discussing this issue before our Health Information Technology Policy Committee. I think at that point some of the major options will be on the table for review and for public comment. We will ultimately have to go through a regulatory process to finally determine the effective definition, but I'm hoping that over the summer, the HHS view of the definition will become clear. It will then have to go through the government clearance process and the regulatory process, which will include copious public comment and undoubtedly will result in some modifications.

CPN: Can you say where there is consensus so far?

Dr. Blumenthal: I don't want to get into specifics, but I will tell you that I think the consensus is clear around one thing, and that is that we should concentrate on performance and usability rather than on technical specifications. We should be constantly linking our definition of meaningful use to clinically meaningful capabilities and performance attributes.

CPN: You and the president frequently have said that health IT is a tool, not a fix for our health care system. What can we reasonably expect to achieve through the widespread adoption of health IT in terms of reducing health care spending? And can physicians expect to realize any of those savings within their own practices?

Dr. Blumenthal: I think you've correctly captured my view of the role of health information technology. There are three essential components for achieving the president's goal and the administration's goal and, I think, the public's goal for a higher-performing health system. The first is better information on what works and what doesn't in the daily practice of medicine.

The second is the ability to apply that knowledge rapidly to practice. And it's in that setting that I think health care information technology becomes a vital tool. It enables practitioners to access in real-time and have the benefit of… the latest information that is approved by their peers and recognized by their peers as valid and useful for patient care. And it helps overcome the human factors that limit the ability of clinicians to do their best at all times and in all places. Of course, it provides better information about individual patients to factor into decision making as well.

The third element is changes in the financing and organization of care that make it more valuable and more rewarding for physicians and easier for physicians to take cost and quality into account when they make their decisions.

Health information technology is the major part of the second [component], but can't function optimally unless all three are in place. So we are vitally dependent for the savings and the quality improvement that could come out of HIT, we are vitally dependent on health care reform more generally.

If physicians are going to realize savings in their practice and gain the benefit of those savings, there will have to be some change in the way that we pay for care and some change in the way that we recognize excellence in medicine so that physicians, as well as their patients, feel very directly and personally the benefits of making the health care system a better health care system.

CPN: The Recovery Act provides for incentives for HIT adoption starting in 2011, but there are many areas where there are still not uniform standards. Can the industry keep up with this aggressive timetable, and what is the government doing to accelerate that process?

Dr. Blumenthal: Frankly, I think we have most of what we need in the way of standards to permit the physicians to get to meaningful use as it is likely to be defined by 2011. I also think that the industry can reconfigure their software in time to make it possible for physicians to meet those standards. I'm not very concerned about that. What I'm mostly concerned about is that–in recognizing those standards and in certifying the software and hardware that we need to certify–we also make certain that we are laying the groundwork for a dramatically improved set of technologies as we go forward. We are looking very hard at how we [can ensure] that when we certify a system and we set a set of standards, we are leaving room for innovation and improvement.

DAVID BLUMENTHAL, M.D.

Public health advocates are applauding a new law that gives the Food and Drug Administration unprecedented authority to regulate the sale, marketing, and ingredients in tobacco products.

President Obama in late June signed into law the Family Smoking Prevention and Tobacco Control Act (H.R. 1256), which gives the FDA the power to regulate the levels of tar, nicotine, and other ingredients in tobacco products. The law does not give the FDA the authority to ban tobacco products, but it does give the agency broad authority to regulate labeling, packaging, and advertising of such products.

During a White House Rose Garden signing ceremony, President Obama said the law would “save lives and dollars” and would aid health reform efforts by reducing tobacco-related health care costs.

The law bans the use of cigarette additives or flavoring such as strawberry or grape that many public health advocates have said has been used by tobacco manufacturers to make smoking more appealing to minors. The law also prohibits tobacco companies from using descriptors such as “light” or “mild.”

Additionally, the bill calls on the FDA to consider fast-tracking the approval of new smoking cessation products. The new law also aims to prevent youth smoking by placing restrictions on outdoor tobacco advertising within 1,000 feet of schools and playground, as well as sponsorships of entertainment and sporting events.

Cigarette packs themselves will also be designed to deter smoking. Under the law, about half of the front and back of the package will be taken up by the warning label. Manufacturers will be able to choose from a selection of warnings such as “WARNING: Smoking can kill you” or “WARNING: Cigarettes cause cancer.”

These types of restrictions will help chip away at some of the ways tobacco companies have successfully created an aura of “cool” around smoking, said Danny McGoldrick, vice president for research at the Campaign for Tobacco-Free Kids.

Physician groups hailed enactment of the new law. “The new law represents an important break from the past, as it signifies broad acceptance that nicotine is a drug harmful to people's health,” Dr. J. James Rohack, president of the American Medical Association, said in a statement.

“This is great news for family doctors,” said Dr. Ted Epperly, president of the American Academy of Family Physicians. “To now have this kind of statement coming out in terms of control of tobacco products is a huge shot in the arm for the health of America.”

Dr. Epperly said he hopes the attention from this new law will spur physicians to make it routine to ask patients about smoking and follow up with advice on quitting. The AAFP has its own program–“Ask and Act”–which includes tools and information on prompts for physicians to ask about patients smoking, coding for cessation counseling, and resources for patients who want to quit (www.aafp.org

For those physicians who think they do not have the time, Dr. Epperly pointed out that it doesn't have to be the physician who asks about smoking, it can also be a nurse or medical assistant. He also advised physicians to be patient about seeing results from patients. “I've had multiple patients who aren't ready yet to stop smoking. But I always remind them, 'I'm here for you if and when you decide [to quit],'” Dr. Epperly said.

The American College of Physicians also praised the new law. Dr. Joseph W. Stubbs, ACP president, said it was “high time” the government began to regulate tobacco products, which contribute to so many chronic illnesses. Dr. Stubbs said he hopes that the law will lead to stronger efforts related to smoking cessation.

One of the ways the FDA will be able to use its new authority to assist in smoking cessation is by regulating the ingredients in tobacco products. But finding the best way to do that may take some time, said Erika Sward, director of national advocacy for the American Lung Association. For example, under the law the FDA is gaining the authority to reduce the amount of nicotine in cigarettes but scientists don't yet know if that would only lead people to compensate by smoking more, she said.

Aside from the concrete elements of the law, Ms. Sward said she hopes the law will also help people understand that tobacco addiction is powerful and that most people can't quit “cold turkey.”

It's important for physicians to talk to patients repeatedly about the need to quit smoking, she said.

Public health advocates are applauding a new law that gives the Food and Drug Administration unprecedented authority to regulate the sale, marketing, and ingredients in tobacco products.

President Obama in late June signed into law the Family Smoking Prevention and Tobacco Control Act (H.R. 1256), which gives the FDA the power to regulate the levels of tar, nicotine, and other ingredients in tobacco products. The law does not give the FDA the authority to ban tobacco products, but it does give the agency broad authority to regulate labeling, packaging, and advertising of such products.

During a White House Rose Garden signing ceremony, President Obama said the law would “save lives and dollars” and would aid health reform efforts by reducing tobacco-related health care costs.

The law bans the use of cigarette additives or flavoring such as strawberry or grape that many public health advocates have said has been used by tobacco manufacturers to make smoking more appealing to minors. The law also prohibits tobacco companies from using descriptors such as “light” or “mild.”

Additionally, the bill calls on the FDA to consider fast-tracking the approval of new smoking cessation products. The new law also aims to prevent youth smoking by placing restrictions on outdoor tobacco advertising within 1,000 feet of schools and playground, as well as sponsorships of entertainment and sporting events.

Cigarette packs themselves will also be designed to deter smoking. Under the law, about half of the front and back of the package will be taken up by the warning label. Manufacturers will be able to choose from a selection of warnings such as “WARNING: Smoking can kill you” or “WARNING: Cigarettes cause cancer.”

These types of restrictions will help chip away at some of the ways tobacco companies have successfully created an aura of “cool” around smoking, said Danny McGoldrick, vice president for research at the Campaign for Tobacco-Free Kids.

Physician groups hailed enactment of the new law. “The new law represents an important break from the past, as it signifies broad acceptance that nicotine is a drug harmful to people's health,” Dr. J. James Rohack, president of the American Medical Association, said in a statement.

“This is great news for family doctors,” said Dr. Ted Epperly, president of the American Academy of Family Physicians. “To now have this kind of statement coming out in terms of control of tobacco products is a huge shot in the arm for the health of America.”

Dr. Epperly said he hopes the attention from this new law will spur physicians to make it routine to ask patients about smoking and follow up with advice on quitting. The AAFP has its own program–“Ask and Act”–which includes tools and information on prompts for physicians to ask about patients smoking, coding for cessation counseling, and resources for patients who want to quit (www.aafp.org

For those physicians who think they do not have the time, Dr. Epperly pointed out that it doesn't have to be the physician who asks about smoking, it can also be a nurse or medical assistant. He also advised physicians to be patient about seeing results from patients. “I've had multiple patients who aren't ready yet to stop smoking. But I always remind them, 'I'm here for you if and when you decide [to quit],'” Dr. Epperly said.

The American College of Physicians also praised the new law. Dr. Joseph W. Stubbs, ACP president, said it was “high time” the government began to regulate tobacco products, which contribute to so many chronic illnesses. Dr. Stubbs said he hopes that the law will lead to stronger efforts related to smoking cessation.

One of the ways the FDA will be able to use its new authority to assist in smoking cessation is by regulating the ingredients in tobacco products. But finding the best way to do that may take some time, said Erika Sward, director of national advocacy for the American Lung Association. For example, under the law the FDA is gaining the authority to reduce the amount of nicotine in cigarettes but scientists don't yet know if that would only lead people to compensate by smoking more, she said.

Aside from the concrete elements of the law, Ms. Sward said she hopes the law will also help people understand that tobacco addiction is powerful and that most people can't quit “cold turkey.”

It's important for physicians to talk to patients repeatedly about the need to quit smoking, she said.

Public health advocates are applauding a new law that gives the Food and Drug Administration unprecedented authority to regulate the sale, marketing, and ingredients in tobacco products.

President Obama in late June signed into law the Family Smoking Prevention and Tobacco Control Act (H.R. 1256), which gives the FDA the power to regulate the levels of tar, nicotine, and other ingredients in tobacco products. The law does not give the FDA the authority to ban tobacco products, but it does give the agency broad authority to regulate labeling, packaging, and advertising of such products.

During a White House Rose Garden signing ceremony, President Obama said the law would “save lives and dollars” and would aid health reform efforts by reducing tobacco-related health care costs.

The law bans the use of cigarette additives or flavoring such as strawberry or grape that many public health advocates have said has been used by tobacco manufacturers to make smoking more appealing to minors. The law also prohibits tobacco companies from using descriptors such as “light” or “mild.”

Additionally, the bill calls on the FDA to consider fast-tracking the approval of new smoking cessation products. The new law also aims to prevent youth smoking by placing restrictions on outdoor tobacco advertising within 1,000 feet of schools and playground, as well as sponsorships of entertainment and sporting events.

Cigarette packs themselves will also be designed to deter smoking. Under the law, about half of the front and back of the package will be taken up by the warning label. Manufacturers will be able to choose from a selection of warnings such as “WARNING: Smoking can kill you” or “WARNING: Cigarettes cause cancer.”

These types of restrictions will help chip away at some of the ways tobacco companies have successfully created an aura of “cool” around smoking, said Danny McGoldrick, vice president for research at the Campaign for Tobacco-Free Kids.

Physician groups hailed enactment of the new law. “The new law represents an important break from the past, as it signifies broad acceptance that nicotine is a drug harmful to people's health,” Dr. J. James Rohack, president of the American Medical Association, said in a statement.

“This is great news for family doctors,” said Dr. Ted Epperly, president of the American Academy of Family Physicians. “To now have this kind of statement coming out in terms of control of tobacco products is a huge shot in the arm for the health of America.”

Dr. Epperly said he hopes the attention from this new law will spur physicians to make it routine to ask patients about smoking and follow up with advice on quitting. The AAFP has its own program–“Ask and Act”–which includes tools and information on prompts for physicians to ask about patients smoking, coding for cessation counseling, and resources for patients who want to quit (www.aafp.org

For those physicians who think they do not have the time, Dr. Epperly pointed out that it doesn't have to be the physician who asks about smoking, it can also be a nurse or medical assistant. He also advised physicians to be patient about seeing results from patients. “I've had multiple patients who aren't ready yet to stop smoking. But I always remind them, 'I'm here for you if and when you decide [to quit],'” Dr. Epperly said.

The American College of Physicians also praised the new law. Dr. Joseph W. Stubbs, ACP president, said it was “high time” the government began to regulate tobacco products, which contribute to so many chronic illnesses. Dr. Stubbs said he hopes that the law will lead to stronger efforts related to smoking cessation.

One of the ways the FDA will be able to use its new authority to assist in smoking cessation is by regulating the ingredients in tobacco products. But finding the best way to do that may take some time, said Erika Sward, director of national advocacy for the American Lung Association. For example, under the law the FDA is gaining the authority to reduce the amount of nicotine in cigarettes but scientists don't yet know if that would only lead people to compensate by smoking more, she said.

Aside from the concrete elements of the law, Ms. Sward said she hopes the law will also help people understand that tobacco addiction is powerful and that most people can't quit “cold turkey.”

It's important for physicians to talk to patients repeatedly about the need to quit smoking, she said.

Dr. Ron Greeno is a rare breed of physician—someone who gets excited about discussing the ins and outs of the physician and hospital payment systems.

As cofounder and chief medical officer of Cogent Healthcare, he has made a business out of helping hospitals to develop hospitalist programs. Over the years, he has become a nationally recognized expert on hospital medicine and became the first hospitalist to be listed as one of Modern Healthcare's “50 Most Powerful Physician Executives in Healthcare.”

Today, Dr. Greeno finds himself giving a lot of free advice, not to physicians and hospitals, but to lawmakers working on health care reform legislation. Lawmakers are interested in the successes that hospitalists have achieved in improving quality of care, patient satisfaction, and reducing costs. As a specialty, hospitalists represent a way to help reform the system, he said.

In the hospitalist model that Dr. Greeno promotes, hospitalist programs combine financial support from the hospital with traditional revenue from Medicare and other insurers for providing care. This gives hospitalists the resources needed to support physician staff and tackle quality issues, he said.

This “bundling” approach is not unlike some proposals in Congress aimed at reducing hospital readmissions by promoting a closer relationship between physicians in the hospital and those in the community. “To me, this is very exciting because it's the way that the American health care system should have been built from the ground up,” he said. Capitol Hill seems to be aware of the need to change the way physicians get paid so that their focus is less on patient volume and more on quality of care.

Dr. Greeno, who is trained in pulmonary and critical care medicine and is based in Los Angeles, has spent his career working in the hospital. He said he was drawn to hospital medicine out of a desire to take a step back from patient care and figure out a way to make the hospital function more efficiently.

Whatever comes out of the restructuring of the payment system will probably be well aligned with what hospitalist providers like Cogent are already doing, Dr. Greeno said. Lawmakers are looking to some of the successful hospitalist programs as possible models for health care reform. There are many examples of well-organized hospitalist programs that are delivering high-quality, cost-effective care. But, he added, the field is also undergoing a new cycle where many programs are being forced to retool after realizing that their initial design is not producing sufficient quality and cost savings.

As this retooling process goes on, many hospitals are assessing whether they are getting their money's worth out of their hospitalist program. They are looking at whether the program is able to deliver better, more cost-effective care that increases patient satisfaction and access. “For a lot of them currently, I'm afraid the answer is no,” Dr. Greeno said.

These variations among programs are typical of a young field that has experienced rapid expansion, he said. With so many programs implementing these models for the first time, it would be unrealistic for all of them to have success immediately. But Dr. Greeno said he expects hospitals to stick by hospitalists and find a way to make the programs work.

Although the field can't continue to grow at its current pace, Dr. Greeno said he expects hospitalists and other site-based specialists like emergency physicians and critical care physicians to be driving inpatient medicine into the future.

Payment bundling is how 'the American health care system should have been built from the ground up.' DR. GREENO

Dr. Ron Greeno is a rare breed of physician—someone who gets excited about discussing the ins and outs of the physician and hospital payment systems.

As cofounder and chief medical officer of Cogent Healthcare, he has made a business out of helping hospitals to develop hospitalist programs. Over the years, he has become a nationally recognized expert on hospital medicine and became the first hospitalist to be listed as one of Modern Healthcare's “50 Most Powerful Physician Executives in Healthcare.”

Today, Dr. Greeno finds himself giving a lot of free advice, not to physicians and hospitals, but to lawmakers working on health care reform legislation. Lawmakers are interested in the successes that hospitalists have achieved in improving quality of care, patient satisfaction, and reducing costs. As a specialty, hospitalists represent a way to help reform the system, he said.

In the hospitalist model that Dr. Greeno promotes, hospitalist programs combine financial support from the hospital with traditional revenue from Medicare and other insurers for providing care. This gives hospitalists the resources needed to support physician staff and tackle quality issues, he said.

This “bundling” approach is not unlike some proposals in Congress aimed at reducing hospital readmissions by promoting a closer relationship between physicians in the hospital and those in the community. “To me, this is very exciting because it's the way that the American health care system should have been built from the ground up,” he said. Capitol Hill seems to be aware of the need to change the way physicians get paid so that their focus is less on patient volume and more on quality of care.

Dr. Greeno, who is trained in pulmonary and critical care medicine and is based in Los Angeles, has spent his career working in the hospital. He said he was drawn to hospital medicine out of a desire to take a step back from patient care and figure out a way to make the hospital function more efficiently.

Whatever comes out of the restructuring of the payment system will probably be well aligned with what hospitalist providers like Cogent are already doing, Dr. Greeno said. Lawmakers are looking to some of the successful hospitalist programs as possible models for health care reform. There are many examples of well-organized hospitalist programs that are delivering high-quality, cost-effective care. But, he added, the field is also undergoing a new cycle where many programs are being forced to retool after realizing that their initial design is not producing sufficient quality and cost savings.

As this retooling process goes on, many hospitals are assessing whether they are getting their money's worth out of their hospitalist program. They are looking at whether the program is able to deliver better, more cost-effective care that increases patient satisfaction and access. “For a lot of them currently, I'm afraid the answer is no,” Dr. Greeno said.

These variations among programs are typical of a young field that has experienced rapid expansion, he said. With so many programs implementing these models for the first time, it would be unrealistic for all of them to have success immediately. But Dr. Greeno said he expects hospitals to stick by hospitalists and find a way to make the programs work.

Although the field can't continue to grow at its current pace, Dr. Greeno said he expects hospitalists and other site-based specialists like emergency physicians and critical care physicians to be driving inpatient medicine into the future.

Payment bundling is how 'the American health care system should have been built from the ground up.' DR. GREENO

Dr. Ron Greeno is a rare breed of physician—someone who gets excited about discussing the ins and outs of the physician and hospital payment systems.

As cofounder and chief medical officer of Cogent Healthcare, he has made a business out of helping hospitals to develop hospitalist programs. Over the years, he has become a nationally recognized expert on hospital medicine and became the first hospitalist to be listed as one of Modern Healthcare's “50 Most Powerful Physician Executives in Healthcare.”

Today, Dr. Greeno finds himself giving a lot of free advice, not to physicians and hospitals, but to lawmakers working on health care reform legislation. Lawmakers are interested in the successes that hospitalists have achieved in improving quality of care, patient satisfaction, and reducing costs. As a specialty, hospitalists represent a way to help reform the system, he said.

In the hospitalist model that Dr. Greeno promotes, hospitalist programs combine financial support from the hospital with traditional revenue from Medicare and other insurers for providing care. This gives hospitalists the resources needed to support physician staff and tackle quality issues, he said.

This “bundling” approach is not unlike some proposals in Congress aimed at reducing hospital readmissions by promoting a closer relationship between physicians in the hospital and those in the community. “To me, this is very exciting because it's the way that the American health care system should have been built from the ground up,” he said. Capitol Hill seems to be aware of the need to change the way physicians get paid so that their focus is less on patient volume and more on quality of care.

Dr. Greeno, who is trained in pulmonary and critical care medicine and is based in Los Angeles, has spent his career working in the hospital. He said he was drawn to hospital medicine out of a desire to take a step back from patient care and figure out a way to make the hospital function more efficiently.

Whatever comes out of the restructuring of the payment system will probably be well aligned with what hospitalist providers like Cogent are already doing, Dr. Greeno said. Lawmakers are looking to some of the successful hospitalist programs as possible models for health care reform. There are many examples of well-organized hospitalist programs that are delivering high-quality, cost-effective care. But, he added, the field is also undergoing a new cycle where many programs are being forced to retool after realizing that their initial design is not producing sufficient quality and cost savings.

As this retooling process goes on, many hospitals are assessing whether they are getting their money's worth out of their hospitalist program. They are looking at whether the program is able to deliver better, more cost-effective care that increases patient satisfaction and access. “For a lot of them currently, I'm afraid the answer is no,” Dr. Greeno said.

These variations among programs are typical of a young field that has experienced rapid expansion, he said. With so many programs implementing these models for the first time, it would be unrealistic for all of them to have success immediately. But Dr. Greeno said he expects hospitals to stick by hospitalists and find a way to make the programs work.

Although the field can't continue to grow at its current pace, Dr. Greeno said he expects hospitalists and other site-based specialists like emergency physicians and critical care physicians to be driving inpatient medicine into the future.

Payment bundling is how 'the American health care system should have been built from the ground up.' DR. GREENO

With the national conversation turning to quality improvement in the nation's hospitals, officials at the American Heart Association are touting their database of in-hospital resuscitation events as a tool for physicians looking to identify problem areas and measure progress.

The National Registry of Cardiopulmonary Resuscitation (NRCPR) has been around for nearly a decade and includes data on more than 154,000 cardiopulmonary resuscitation events from more than 560 hospitals in the United States. The registry collects data on adult, pediatric, and neonatal acute respiratory compromise, cardiopulmonary arrest, and medical emergency team response.

One of the goals of the voluntary registry program is to help individual hospitals improve their performance on cardiac and respiratory emergencies by providing targeted feedback about their individual performance, as well as on how the hospitals' performance compares with that of other similar facilities and to current practice guidelines.

For hospitalists, the data could raise important red flags. For example, it would highlight whether most cardiac arrests were occurring in a single unit or at a certain time of day. The data might also indicate a need to increase staffing or place equipment in a different location, said Beth Mancini, RN, Ph.D., chair of the NRCPR Science Advisory Board.

“It provides the individual hospitalist the data necessary to make discrete changes,” said Dr. Mancini, who is the associate dean for undergraduate nursing programs and professor of health care research at the University of Texas in Arlington.

A recent analysis of the NRCPR details specific ways that hospitals have used this type of feedback to advance quality improvement (Jt. Comm. J. Qual. Patient Saf. 2009;35:13-20). For example, one hospital that had implemented a postresuscitation hypothermia protocol found during the NRCPR's chart abstraction process that a number of cardiopulmonary arrest patients who met criteria for the treatment had not received it. They used the information to ramp up education efforts and added a copy of the hypothermia protocol to the drug tray in each crash cart.

Another hospital used NRCPR patient and event demographic reports to demonstrate the need to test the use of a medical emergency team to improve patient survival following cardiopulmonary arrest. Later, the hospital used data from the NRCPR to show that the medical emergency team had improved outcomes.

The NRCPR provides feedback indicating where the outliers are, but the hospital staff then has to do the detective work to figure out what caused the problem, said Dr. William Kaye, professor emeritus of surgery and medicine at Brown University, Providence, R.I., and a special consultant to the NRCPR. “There is no easy solution,” he said.

In the aggregate, the national data trends have helped researchers to identify key areas that every hospital should examine, Dr. Mancini said. For example, past reports based on NRCPR data have shown that the time of day and day of the week when a cardiac arrest occurs impacts the likelihood of survival to discharge.

Another goal of the NRCPR is to use the national-level data to help understand why the success rate for cardiac arrest treatment has not changed much over the past few decades, Dr. Mancini said. Current estimates of rates of survival to hospital discharge are about 27% among children and 18% among adults.

One of the reasons that figure has been difficult to improve is that the outcomes depend not only on the medical response to the cardiac arrest, but also on the underlying disease of the patient.

“All we can do is look at the processes and improve those processes,” he said.

The NRCPR does not publish national-level data on survival outcomes, but the individual hospital data do show some positive signs in terms of improved processes, Dr. Mancini said. For example, more hospitals are implementing medical emergency teams to respond to cardiac arrest events.

As part of the voluntary registry program, hospitals pay an annual fee of $1,500-$1,800 to cover data support and report generation. Hospitals can generate reports using their own data at any time and also receive quarterly and annual reports with comparison data. The reports include information on location and time of events, system response variables, patient demographics, pre-event and event data, interventions, immediate causes of an event, patient outcomes, and areas for potential improvement.

One of the advantages of reporting data to the NRCPR, instead of auditing your own data, is that the NRCPR has a common set of operational definitions that allows hospitals to compare themselves to other facilities, Dr. Mancini said. Participating hospitals also share best practice information when they achieve improved outcomes.

The biggest challenge in using the system is the time required to track and abstract patient records, an average of 30 minutes per chart when the charts are not available electronically, she said.

More information on the registry is available at www.nrcpr.org

With the national conversation turning to quality improvement in the nation's hospitals, officials at the American Heart Association are touting their database of in-hospital resuscitation events as a tool for physicians looking to identify problem areas and measure progress.

The National Registry of Cardiopulmonary Resuscitation (NRCPR) has been around for nearly a decade and includes data on more than 154,000 cardiopulmonary resuscitation events from more than 560 hospitals in the United States. The registry collects data on adult, pediatric, and neonatal acute respiratory compromise, cardiopulmonary arrest, and medical emergency team response.

One of the goals of the voluntary registry program is to help individual hospitals improve their performance on cardiac and respiratory emergencies by providing targeted feedback about their individual performance, as well as on how the hospitals' performance compares with that of other similar facilities and to current practice guidelines.

For hospitalists, the data could raise important red flags. For example, it would highlight whether most cardiac arrests were occurring in a single unit or at a certain time of day. The data might also indicate a need to increase staffing or place equipment in a different location, said Beth Mancini, RN, Ph.D., chair of the NRCPR Science Advisory Board.

“It provides the individual hospitalist the data necessary to make discrete changes,” said Dr. Mancini, who is the associate dean for undergraduate nursing programs and professor of health care research at the University of Texas in Arlington.

A recent analysis of the NRCPR details specific ways that hospitals have used this type of feedback to advance quality improvement (Jt. Comm. J. Qual. Patient Saf. 2009;35:13-20). For example, one hospital that had implemented a postresuscitation hypothermia protocol found during the NRCPR's chart abstraction process that a number of cardiopulmonary arrest patients who met criteria for the treatment had not received it. They used the information to ramp up education efforts and added a copy of the hypothermia protocol to the drug tray in each crash cart.

Another hospital used NRCPR patient and event demographic reports to demonstrate the need to test the use of a medical emergency team to improve patient survival following cardiopulmonary arrest. Later, the hospital used data from the NRCPR to show that the medical emergency team had improved outcomes.

The NRCPR provides feedback indicating where the outliers are, but the hospital staff then has to do the detective work to figure out what caused the problem, said Dr. William Kaye, professor emeritus of surgery and medicine at Brown University, Providence, R.I., and a special consultant to the NRCPR. “There is no easy solution,” he said.

In the aggregate, the national data trends have helped researchers to identify key areas that every hospital should examine, Dr. Mancini said. For example, past reports based on NRCPR data have shown that the time of day and day of the week when a cardiac arrest occurs impacts the likelihood of survival to discharge.

Another goal of the NRCPR is to use the national-level data to help understand why the success rate for cardiac arrest treatment has not changed much over the past few decades, Dr. Mancini said. Current estimates of rates of survival to hospital discharge are about 27% among children and 18% among adults.

One of the reasons that figure has been difficult to improve is that the outcomes depend not only on the medical response to the cardiac arrest, but also on the underlying disease of the patient.

“All we can do is look at the processes and improve those processes,” he said.

The NRCPR does not publish national-level data on survival outcomes, but the individual hospital data do show some positive signs in terms of improved processes, Dr. Mancini said. For example, more hospitals are implementing medical emergency teams to respond to cardiac arrest events.

As part of the voluntary registry program, hospitals pay an annual fee of $1,500-$1,800 to cover data support and report generation. Hospitals can generate reports using their own data at any time and also receive quarterly and annual reports with comparison data. The reports include information on location and time of events, system response variables, patient demographics, pre-event and event data, interventions, immediate causes of an event, patient outcomes, and areas for potential improvement.

One of the advantages of reporting data to the NRCPR, instead of auditing your own data, is that the NRCPR has a common set of operational definitions that allows hospitals to compare themselves to other facilities, Dr. Mancini said. Participating hospitals also share best practice information when they achieve improved outcomes.

The biggest challenge in using the system is the time required to track and abstract patient records, an average of 30 minutes per chart when the charts are not available electronically, she said.

More information on the registry is available at www.nrcpr.org

With the national conversation turning to quality improvement in the nation's hospitals, officials at the American Heart Association are touting their database of in-hospital resuscitation events as a tool for physicians looking to identify problem areas and measure progress.

The National Registry of Cardiopulmonary Resuscitation (NRCPR) has been around for nearly a decade and includes data on more than 154,000 cardiopulmonary resuscitation events from more than 560 hospitals in the United States. The registry collects data on adult, pediatric, and neonatal acute respiratory compromise, cardiopulmonary arrest, and medical emergency team response.

One of the goals of the voluntary registry program is to help individual hospitals improve their performance on cardiac and respiratory emergencies by providing targeted feedback about their individual performance, as well as on how the hospitals' performance compares with that of other similar facilities and to current practice guidelines.

For hospitalists, the data could raise important red flags. For example, it would highlight whether most cardiac arrests were occurring in a single unit or at a certain time of day. The data might also indicate a need to increase staffing or place equipment in a different location, said Beth Mancini, RN, Ph.D., chair of the NRCPR Science Advisory Board.

“It provides the individual hospitalist the data necessary to make discrete changes,” said Dr. Mancini, who is the associate dean for undergraduate nursing programs and professor of health care research at the University of Texas in Arlington.

A recent analysis of the NRCPR details specific ways that hospitals have used this type of feedback to advance quality improvement (Jt. Comm. J. Qual. Patient Saf. 2009;35:13-20). For example, one hospital that had implemented a postresuscitation hypothermia protocol found during the NRCPR's chart abstraction process that a number of cardiopulmonary arrest patients who met criteria for the treatment had not received it. They used the information to ramp up education efforts and added a copy of the hypothermia protocol to the drug tray in each crash cart.

Another hospital used NRCPR patient and event demographic reports to demonstrate the need to test the use of a medical emergency team to improve patient survival following cardiopulmonary arrest. Later, the hospital used data from the NRCPR to show that the medical emergency team had improved outcomes.

The NRCPR provides feedback indicating where the outliers are, but the hospital staff then has to do the detective work to figure out what caused the problem, said Dr. William Kaye, professor emeritus of surgery and medicine at Brown University, Providence, R.I., and a special consultant to the NRCPR. “There is no easy solution,” he said.

In the aggregate, the national data trends have helped researchers to identify key areas that every hospital should examine, Dr. Mancini said. For example, past reports based on NRCPR data have shown that the time of day and day of the week when a cardiac arrest occurs impacts the likelihood of survival to discharge.

Another goal of the NRCPR is to use the national-level data to help understand why the success rate for cardiac arrest treatment has not changed much over the past few decades, Dr. Mancini said. Current estimates of rates of survival to hospital discharge are about 27% among children and 18% among adults.

One of the reasons that figure has been difficult to improve is that the outcomes depend not only on the medical response to the cardiac arrest, but also on the underlying disease of the patient.

“All we can do is look at the processes and improve those processes,” he said.

The NRCPR does not publish national-level data on survival outcomes, but the individual hospital data do show some positive signs in terms of improved processes, Dr. Mancini said. For example, more hospitals are implementing medical emergency teams to respond to cardiac arrest events.

As part of the voluntary registry program, hospitals pay an annual fee of $1,500-$1,800 to cover data support and report generation. Hospitals can generate reports using their own data at any time and also receive quarterly and annual reports with comparison data. The reports include information on location and time of events, system response variables, patient demographics, pre-event and event data, interventions, immediate causes of an event, patient outcomes, and areas for potential improvement.

One of the advantages of reporting data to the NRCPR, instead of auditing your own data, is that the NRCPR has a common set of operational definitions that allows hospitals to compare themselves to other facilities, Dr. Mancini said. Participating hospitals also share best practice information when they achieve improved outcomes.

The biggest challenge in using the system is the time required to track and abstract patient records, an average of 30 minutes per chart when the charts are not available electronically, she said.

More information on the registry is available at www.nrcpr.org

In March, Dr. David Blumenthal, a Harvard professor and a senior health adviser to President Obama's campaign, was appointed to the position of National Coordinator for Health Information Technology in the Health and Human Services Department.

With Congress setting aside billions of dollars in incentives for physicians and hospitals to adopt health IT as part of the American Recovery and Reinvestment Act, one of Dr. Blumenthal's challenges will be defining the “meaningful use” criteria in the law, a definition that will play a major role in determining who is eligible to receive incentives.

In an interview with INTERNAL MEDICINE NEWS, Dr. Blumenthal talked about some of the challenges ahead.

INTERNAL MEDICINE NEWS: As a primary care physician, what do you see as the biggest challenge for physicians in adopting interoperable electronic health records by 2014? Cost? Misaligned incentives? Products that don't meet their needs? Security?

Dr. Blumenthal: Surveys have shown all of those to be issues. I think security is a lesser issue, according to the surveys that my group did at Harvard when I was there. But the cost of acquisition, the lack of return on investment, [and] concern about the usefulness of products all ranked high in our survey results.

IMN: The Recovery Act includes about $17 billion in incentives for physicians and hospitals to adopt health IT. What impact do you expect this to have?

Dr. Blumenthal: Let me first make a minor correction in the number: $17 billion is a Congressional Budget Office number and it is actually a combination of two numbers: a spending number and a cost savings number. Both are estimates. The actual CBO projections of spending are about $29 billion, and they project a $12 billion savings, which gets you to $17 billion. So if we think more on the order of $30 billion or even more than that, I do think that's enough to change the dynamic in the marketplace.

We are also counting to some degree on professionalism to complement the incentives. If physicians were only about money, it would be a much less happy world and the quality of care would be much lower than it is. Physicians don't expect the government to help them buy stethoscopes, examining tables, treadmills for stress tests. They know these are essential to their work as professionals, and I think that is where we are heading with electronic health records as well.

IMN: Everyone is curious to see how the HHS defines the “meaningful use” criteria outlined in the Recovery Act. Is there a consensus building around this term?

Dr. Blumenthal: I think there is a consensus building. We haven't pinned it down finally. We [are] discussing this issue before our Health Information Technology Policy Committee. I think at that point some of the major options will be on the table for review and for public comment. We will ultimately have to go through a regulatory process to finally determine the effective definition, but I'm hoping that over the summer the HHS view of the definition will become clear.

IMN: Can you say where there is consensus so far?

Dr. Blumenthal: I don't want to get into specifics, but I will tell you that I think the consensus is clear around one thing, and that is that we should concentrate on performance and usability rather than on technical specifications. We should be constantly linking our definition of meaningful use to clinically meaningful capabilities and performance attributes.

IMN: You and the president frequently have said that health IT is a tool, not a fix for our health care system. What can we reasonably expect to achieve through the widespread adoption of health IT?

Dr. Blumenthal: There are three essential components for achieving the president's goal and the administration's goal and, I think, the public's goal for a higher-performing health system. The first is better information on what works and what doesn't in the daily practice of medicine.

The second is the ability to apply that knowledge rapidly to practice. And it's in that setting that I think health care information technology becomes a vital tool. It enables practitioners to access in real-time and have the benefit of … the latest information that is approved by their peers and recognized by their peers as valid and useful for patient care.

The third element is changes in the financing and organization of care that make it more valuable and more rewarding for physicians and easier for physicians to take cost and quality into account when they make their decisions.

Health information technology is the major part of the second [component], but can't function optimally unless all three are in place. So we are vitally dependent for the savings and the quality improvement that could come out of HIT; we are vitally dependent on health care reform more generally.

If physicians are going to realize savings in their practice and gain the benefit of those savings, there will have to be some change in the way that we pay for care and some change in the way that we recognize excellence in medicine so that physicians, as well as their patients, feel very directly and personally the benefits of making the health care system a better health care system.

IMN: The Recovery Act provides for incentives for HIT adoption starting in 2011, but there are many areas where there are still not uniform standards. Can the industry keep up with this aggressive timetable?

Dr. Blumenthal: Frankly, I think we have most of what we need in the way of standards to permit the physicians to get to meaningful use as it is likely to be defined by 2011. I also think that the industry can reconfigure their software in time to make it possible for physicians to meet those standards. What I'm mostly concerned about is that—in recognizing those standards and in certifying the software and hardware that we need to certify—we also make certain that we are laying the groundwork for a dramatically improved set of technologies as we go forward. We are looking very hard at how we [can ensure] that when we certify a system and we set a set of standards, we are leaving room for innovation and improvement.

DAVID BLUMENTHAL, M.D.

In March, Dr. David Blumenthal, a Harvard professor and a senior health adviser to President Obama's campaign, was appointed to the position of National Coordinator for Health Information Technology in the Health and Human Services Department.

With Congress setting aside billions of dollars in incentives for physicians and hospitals to adopt health IT as part of the American Recovery and Reinvestment Act, one of Dr. Blumenthal's challenges will be defining the “meaningful use” criteria in the law, a definition that will play a major role in determining who is eligible to receive incentives.

In an interview with INTERNAL MEDICINE NEWS, Dr. Blumenthal talked about some of the challenges ahead.

INTERNAL MEDICINE NEWS: As a primary care physician, what do you see as the biggest challenge for physicians in adopting interoperable electronic health records by 2014? Cost? Misaligned incentives? Products that don't meet their needs? Security?

Dr. Blumenthal: Surveys have shown all of those to be issues. I think security is a lesser issue, according to the surveys that my group did at Harvard when I was there. But the cost of acquisition, the lack of return on investment, [and] concern about the usefulness of products all ranked high in our survey results.

IMN: The Recovery Act includes about $17 billion in incentives for physicians and hospitals to adopt health IT. What impact do you expect this to have?

Dr. Blumenthal: Let me first make a minor correction in the number: $17 billion is a Congressional Budget Office number and it is actually a combination of two numbers: a spending number and a cost savings number. Both are estimates. The actual CBO projections of spending are about $29 billion, and they project a $12 billion savings, which gets you to $17 billion. So if we think more on the order of $30 billion or even more than that, I do think that's enough to change the dynamic in the marketplace.

We are also counting to some degree on professionalism to complement the incentives. If physicians were only about money, it would be a much less happy world and the quality of care would be much lower than it is. Physicians don't expect the government to help them buy stethoscopes, examining tables, treadmills for stress tests. They know these are essential to their work as professionals, and I think that is where we are heading with electronic health records as well.

IMN: Everyone is curious to see how the HHS defines the “meaningful use” criteria outlined in the Recovery Act. Is there a consensus building around this term?

Dr. Blumenthal: I think there is a consensus building. We haven't pinned it down finally. We [are] discussing this issue before our Health Information Technology Policy Committee. I think at that point some of the major options will be on the table for review and for public comment. We will ultimately have to go through a regulatory process to finally determine the effective definition, but I'm hoping that over the summer the HHS view of the definition will become clear.

IMN: Can you say where there is consensus so far?

Dr. Blumenthal: I don't want to get into specifics, but I will tell you that I think the consensus is clear around one thing, and that is that we should concentrate on performance and usability rather than on technical specifications. We should be constantly linking our definition of meaningful use to clinically meaningful capabilities and performance attributes.

IMN: You and the president frequently have said that health IT is a tool, not a fix for our health care system. What can we reasonably expect to achieve through the widespread adoption of health IT?

Dr. Blumenthal: There are three essential components for achieving the president's goal and the administration's goal and, I think, the public's goal for a higher-performing health system. The first is better information on what works and what doesn't in the daily practice of medicine.

The second is the ability to apply that knowledge rapidly to practice. And it's in that setting that I think health care information technology becomes a vital tool. It enables practitioners to access in real-time and have the benefit of … the latest information that is approved by their peers and recognized by their peers as valid and useful for patient care.

The third element is changes in the financing and organization of care that make it more valuable and more rewarding for physicians and easier for physicians to take cost and quality into account when they make their decisions.

Health information technology is the major part of the second [component], but can't function optimally unless all three are in place. So we are vitally dependent for the savings and the quality improvement that could come out of HIT; we are vitally dependent on health care reform more generally.

If physicians are going to realize savings in their practice and gain the benefit of those savings, there will have to be some change in the way that we pay for care and some change in the way that we recognize excellence in medicine so that physicians, as well as their patients, feel very directly and personally the benefits of making the health care system a better health care system.

IMN: The Recovery Act provides for incentives for HIT adoption starting in 2011, but there are many areas where there are still not uniform standards. Can the industry keep up with this aggressive timetable?

Dr. Blumenthal: Frankly, I think we have most of what we need in the way of standards to permit the physicians to get to meaningful use as it is likely to be defined by 2011. I also think that the industry can reconfigure their software in time to make it possible for physicians to meet those standards. What I'm mostly concerned about is that—in recognizing those standards and in certifying the software and hardware that we need to certify—we also make certain that we are laying the groundwork for a dramatically improved set of technologies as we go forward. We are looking very hard at how we [can ensure] that when we certify a system and we set a set of standards, we are leaving room for innovation and improvement.

DAVID BLUMENTHAL, M.D.

In March, Dr. David Blumenthal, a Harvard professor and a senior health adviser to President Obama's campaign, was appointed to the position of National Coordinator for Health Information Technology in the Health and Human Services Department.

With Congress setting aside billions of dollars in incentives for physicians and hospitals to adopt health IT as part of the American Recovery and Reinvestment Act, one of Dr. Blumenthal's challenges will be defining the “meaningful use” criteria in the law, a definition that will play a major role in determining who is eligible to receive incentives.

In an interview with INTERNAL MEDICINE NEWS, Dr. Blumenthal talked about some of the challenges ahead.

INTERNAL MEDICINE NEWS: As a primary care physician, what do you see as the biggest challenge for physicians in adopting interoperable electronic health records by 2014? Cost? Misaligned incentives? Products that don't meet their needs? Security?

Dr. Blumenthal: Surveys have shown all of those to be issues. I think security is a lesser issue, according to the surveys that my group did at Harvard when I was there. But the cost of acquisition, the lack of return on investment, [and] concern about the usefulness of products all ranked high in our survey results.

IMN: The Recovery Act includes about $17 billion in incentives for physicians and hospitals to adopt health IT. What impact do you expect this to have?

Dr. Blumenthal: Let me first make a minor correction in the number: $17 billion is a Congressional Budget Office number and it is actually a combination of two numbers: a spending number and a cost savings number. Both are estimates. The actual CBO projections of spending are about $29 billion, and they project a $12 billion savings, which gets you to $17 billion. So if we think more on the order of $30 billion or even more than that, I do think that's enough to change the dynamic in the marketplace.

We are also counting to some degree on professionalism to complement the incentives. If physicians were only about money, it would be a much less happy world and the quality of care would be much lower than it is. Physicians don't expect the government to help them buy stethoscopes, examining tables, treadmills for stress tests. They know these are essential to their work as professionals, and I think that is where we are heading with electronic health records as well.

IMN: Everyone is curious to see how the HHS defines the “meaningful use” criteria outlined in the Recovery Act. Is there a consensus building around this term?

Dr. Blumenthal: I think there is a consensus building. We haven't pinned it down finally. We [are] discussing this issue before our Health Information Technology Policy Committee. I think at that point some of the major options will be on the table for review and for public comment. We will ultimately have to go through a regulatory process to finally determine the effective definition, but I'm hoping that over the summer the HHS view of the definition will become clear.

IMN: Can you say where there is consensus so far?

Dr. Blumenthal: I don't want to get into specifics, but I will tell you that I think the consensus is clear around one thing, and that is that we should concentrate on performance and usability rather than on technical specifications. We should be constantly linking our definition of meaningful use to clinically meaningful capabilities and performance attributes.

IMN: You and the president frequently have said that health IT is a tool, not a fix for our health care system. What can we reasonably expect to achieve through the widespread adoption of health IT?

Dr. Blumenthal: There are three essential components for achieving the president's goal and the administration's goal and, I think, the public's goal for a higher-performing health system. The first is better information on what works and what doesn't in the daily practice of medicine.

The second is the ability to apply that knowledge rapidly to practice. And it's in that setting that I think health care information technology becomes a vital tool. It enables practitioners to access in real-time and have the benefit of … the latest information that is approved by their peers and recognized by their peers as valid and useful for patient care.

The third element is changes in the financing and organization of care that make it more valuable and more rewarding for physicians and easier for physicians to take cost and quality into account when they make their decisions.

Health information technology is the major part of the second [component], but can't function optimally unless all three are in place. So we are vitally dependent for the savings and the quality improvement that could come out of HIT; we are vitally dependent on health care reform more generally.

If physicians are going to realize savings in their practice and gain the benefit of those savings, there will have to be some change in the way that we pay for care and some change in the way that we recognize excellence in medicine so that physicians, as well as their patients, feel very directly and personally the benefits of making the health care system a better health care system.

IMN: The Recovery Act provides for incentives for HIT adoption starting in 2011, but there are many areas where there are still not uniform standards. Can the industry keep up with this aggressive timetable?

Dr. Blumenthal: Frankly, I think we have most of what we need in the way of standards to permit the physicians to get to meaningful use as it is likely to be defined by 2011. I also think that the industry can reconfigure their software in time to make it possible for physicians to meet those standards. What I'm mostly concerned about is that—in recognizing those standards and in certifying the software and hardware that we need to certify—we also make certain that we are laying the groundwork for a dramatically improved set of technologies as we go forward. We are looking very hard at how we [can ensure] that when we certify a system and we set a set of standards, we are leaving room for innovation and improvement.

DAVID BLUMENTHAL, M.D.

The chances of passing health reform legislation this year could depend on whether lawmakers can resolve their differences over the public insurance plan option.

The proposal to include a government-sponsored health plan that would compete against private insurance became a major wedge in the health care debate, and how much to pay physicians under such a plan emerged as a key sticking point, according to observers.

“It could wind up bringing down the whole agenda,” said Grace-Marie Turner, president of the Galen Institute, a nonprofit research organization that advocates for free market ideas in health care.

Ms. Turner, who opposes the public plan option, said that although Democrats have control of the presidency and both chambers of Congress, there is disagreement within their own ranks, with many moderate and conservative Democrats opposed to a public plan.

The idea of a public plan was debated extensively at the recent policy-making meeting of the American Medical Association, where the delegates ended up endorsing “health system reform alternatives that are consistent with AMA principles of pluralism, freedom of choice, freedom of practice, and universal access for patients.”

The AMA has stated publicly that it does not support any plan that would force physicians to participate in a public plan or that would pay physicians based on Medicare rates. The AMA has said, however, that it will consider some of the variations on a public plan that are being discussed in Congress now, such as a federally chartered co-op health plan.

Officials at the American College of Physicians agree that provider participation in any plan should be voluntary and not tied to current participation in Medicare. The college also advocates for payment rates to be competitive with commercial payers, rather than based on the low rates now offered by Medicare.

But the ACP also sees potential advantages to creating a public plan, according to its president, Dr. Joseph W. Stubbs. A public plan could provide a “nationwide blanket” of fall-back coverage, which would be especially helpful in areas of low penetration by insurance carriers. It could also offer a mechanism for rapidly introducing new models of care and reimbursement, such as the medical home concept. A public plan could also be a way to hold private plans accountable in areas where there is little competition.

“The devil will be in the details as far as whether this is a good idea or not,” Dr. Stubbs said.

Meanwhile, other physicians have been disappointed by talk of a public plan for different reasons. Dr. David Himmelstein, an associate professor of medicine at Harvard University in Boston and the cofounder of Physicians for a National Health Program, said what's being discussed in Congress now is really “just a clone of private insurance.”

Dr. Himmelstein, who favors a single-payer health system, said a public plan would fall far short of realizing the savings that could be seen with a single-payer system. A public plan wouldn't even be able to achieve the type of low overhead seen with Medicare, he said, which benefits from automatic enrollment and easy premium collection, and has no need to spend money on marketing.

President Obama, who reached out to physicians for support at the AMA meeting last month, said he understands that many physicians are skeptical about how they would fare under a public plan. In his speech to the AMA, President Obama said he intended to change the way physicians get paid, rewarding best practices and good patient care. “The public option is not your enemy,” he said. “It is your friend.”

Part of the problem with evaluating the public plan option is that there isn't just one. Among the health care reform proposals circulating in both the House and the Senate, some include a government-run or quasi-government-run option to compete with private insurance.

The purest form of a so-called public plan would be one that is something like Medicare, where federal dollars, not just premiums, are used to support it, said Kathleen Stoll, health policy director at Families USA, which supports the general idea of a public plan but hasn't thrown its support to a particular proposal. But many lawmakers and analysts have said this design would give the public plan an advantage over private insurance products and cause private payers to leave the market, she said.

A proposal put forward by leaders in the House would create a public plan on the same footing as other insurance plans. For example, public and private plans alike would have to adhere to the same benefit requirements and insurance market reforms and would have to be financially self-sustaining based on premiums. This proposal would not require participation by physicians but initially would use payment rates similar to those of Medicare. Rates would be unlinked from Medicare rates over time as other payment mechanisms were developed.

In the Senate, an approach getting a lot of attention is to create not a public plan but rather a federally chartered, nonprofit cooperative plan, Ms. Stoll said. This proposal is seen by many as a compromise between a government-run plan and no public plan at all.

Overall, the discussion on a public plan is heading in a direction that is positive for physicians, said Elizabeth Carpenter, associate policy director for the Health Policy Program at the New America Foundation, a nonpartisan think tank.

At the beginning of discussions on health care reform, the thinking was that a public plan would use Medicare rates in paying physicians and other providers. Now that idea seems to be losing support, Ms. Carpenter said. Instead, in those cases where reform proposals are referencing Medicare rates, those rates are intended only as a starting point, she said.

The chances of passing health reform legislation this year could depend on whether lawmakers can resolve their differences over the public insurance plan option.

The proposal to include a government-sponsored health plan that would compete against private insurance became a major wedge in the health care debate, and how much to pay physicians under such a plan emerged as a key sticking point, according to observers.

“It could wind up bringing down the whole agenda,” said Grace-Marie Turner, president of the Galen Institute, a nonprofit research organization that advocates for free market ideas in health care.

Ms. Turner, who opposes the public plan option, said that although Democrats have control of the presidency and both chambers of Congress, there is disagreement within their own ranks, with many moderate and conservative Democrats opposed to a public plan.

The idea of a public plan was debated extensively at the recent policy-making meeting of the American Medical Association, where the delegates ended up endorsing “health system reform alternatives that are consistent with AMA principles of pluralism, freedom of choice, freedom of practice, and universal access for patients.”

The AMA has stated publicly that it does not support any plan that would force physicians to participate in a public plan or that would pay physicians based on Medicare rates. The AMA has said, however, that it will consider some of the variations on a public plan that are being discussed in Congress now, such as a federally chartered co-op health plan.

Officials at the American College of Physicians agree that provider participation in any plan should be voluntary and not tied to current participation in Medicare. The college also advocates for payment rates to be competitive with commercial payers, rather than based on the low rates now offered by Medicare.

But the ACP also sees potential advantages to creating a public plan, according to its president, Dr. Joseph W. Stubbs. A public plan could provide a “nationwide blanket” of fall-back coverage, which would be especially helpful in areas of low penetration by insurance carriers. It could also offer a mechanism for rapidly introducing new models of care and reimbursement, such as the medical home concept. A public plan could also be a way to hold private plans accountable in areas where there is little competition.

“The devil will be in the details as far as whether this is a good idea or not,” Dr. Stubbs said.

Meanwhile, other physicians have been disappointed by talk of a public plan for different reasons. Dr. David Himmelstein, an associate professor of medicine at Harvard University in Boston and the cofounder of Physicians for a National Health Program, said what's being discussed in Congress now is really “just a clone of private insurance.”

Dr. Himmelstein, who favors a single-payer health system, said a public plan would fall far short of realizing the savings that could be seen with a single-payer system. A public plan wouldn't even be able to achieve the type of low overhead seen with Medicare, he said, which benefits from automatic enrollment and easy premium collection, and has no need to spend money on marketing.

President Obama, who reached out to physicians for support at the AMA meeting last month, said he understands that many physicians are skeptical about how they would fare under a public plan. In his speech to the AMA, President Obama said he intended to change the way physicians get paid, rewarding best practices and good patient care. “The public option is not your enemy,” he said. “It is your friend.”

Part of the problem with evaluating the public plan option is that there isn't just one. Among the health care reform proposals circulating in both the House and the Senate, some include a government-run or quasi-government-run option to compete with private insurance.

The purest form of a so-called public plan would be one that is something like Medicare, where federal dollars, not just premiums, are used to support it, said Kathleen Stoll, health policy director at Families USA, which supports the general idea of a public plan but hasn't thrown its support to a particular proposal. But many lawmakers and analysts have said this design would give the public plan an advantage over private insurance products and cause private payers to leave the market, she said.

A proposal put forward by leaders in the House would create a public plan on the same footing as other insurance plans. For example, public and private plans alike would have to adhere to the same benefit requirements and insurance market reforms and would have to be financially self-sustaining based on premiums. This proposal would not require participation by physicians but initially would use payment rates similar to those of Medicare. Rates would be unlinked from Medicare rates over time as other payment mechanisms were developed.

In the Senate, an approach getting a lot of attention is to create not a public plan but rather a federally chartered, nonprofit cooperative plan, Ms. Stoll said. This proposal is seen by many as a compromise between a government-run plan and no public plan at all.

Overall, the discussion on a public plan is heading in a direction that is positive for physicians, said Elizabeth Carpenter, associate policy director for the Health Policy Program at the New America Foundation, a nonpartisan think tank.

At the beginning of discussions on health care reform, the thinking was that a public plan would use Medicare rates in paying physicians and other providers. Now that idea seems to be losing support, Ms. Carpenter said. Instead, in those cases where reform proposals are referencing Medicare rates, those rates are intended only as a starting point, she said.

The chances of passing health reform legislation this year could depend on whether lawmakers can resolve their differences over the public insurance plan option.

The proposal to include a government-sponsored health plan that would compete against private insurance became a major wedge in the health care debate, and how much to pay physicians under such a plan emerged as a key sticking point, according to observers.

“It could wind up bringing down the whole agenda,” said Grace-Marie Turner, president of the Galen Institute, a nonprofit research organization that advocates for free market ideas in health care.

Ms. Turner, who opposes the public plan option, said that although Democrats have control of the presidency and both chambers of Congress, there is disagreement within their own ranks, with many moderate and conservative Democrats opposed to a public plan.

The idea of a public plan was debated extensively at the recent policy-making meeting of the American Medical Association, where the delegates ended up endorsing “health system reform alternatives that are consistent with AMA principles of pluralism, freedom of choice, freedom of practice, and universal access for patients.”

The AMA has stated publicly that it does not support any plan that would force physicians to participate in a public plan or that would pay physicians based on Medicare rates. The AMA has said, however, that it will consider some of the variations on a public plan that are being discussed in Congress now, such as a federally chartered co-op health plan.

Officials at the American College of Physicians agree that provider participation in any plan should be voluntary and not tied to current participation in Medicare. The college also advocates for payment rates to be competitive with commercial payers, rather than based on the low rates now offered by Medicare.

But the ACP also sees potential advantages to creating a public plan, according to its president, Dr. Joseph W. Stubbs. A public plan could provide a “nationwide blanket” of fall-back coverage, which would be especially helpful in areas of low penetration by insurance carriers. It could also offer a mechanism for rapidly introducing new models of care and reimbursement, such as the medical home concept. A public plan could also be a way to hold private plans accountable in areas where there is little competition.

“The devil will be in the details as far as whether this is a good idea or not,” Dr. Stubbs said.

Meanwhile, other physicians have been disappointed by talk of a public plan for different reasons. Dr. David Himmelstein, an associate professor of medicine at Harvard University in Boston and the cofounder of Physicians for a National Health Program, said what's being discussed in Congress now is really “just a clone of private insurance.”

Dr. Himmelstein, who favors a single-payer health system, said a public plan would fall far short of realizing the savings that could be seen with a single-payer system. A public plan wouldn't even be able to achieve the type of low overhead seen with Medicare, he said, which benefits from automatic enrollment and easy premium collection, and has no need to spend money on marketing.

President Obama, who reached out to physicians for support at the AMA meeting last month, said he understands that many physicians are skeptical about how they would fare under a public plan. In his speech to the AMA, President Obama said he intended to change the way physicians get paid, rewarding best practices and good patient care. “The public option is not your enemy,” he said. “It is your friend.”

Part of the problem with evaluating the public plan option is that there isn't just one. Among the health care reform proposals circulating in both the House and the Senate, some include a government-run or quasi-government-run option to compete with private insurance.

The purest form of a so-called public plan would be one that is something like Medicare, where federal dollars, not just premiums, are used to support it, said Kathleen Stoll, health policy director at Families USA, which supports the general idea of a public plan but hasn't thrown its support to a particular proposal. But many lawmakers and analysts have said this design would give the public plan an advantage over private insurance products and cause private payers to leave the market, she said.

A proposal put forward by leaders in the House would create a public plan on the same footing as other insurance plans. For example, public and private plans alike would have to adhere to the same benefit requirements and insurance market reforms and would have to be financially self-sustaining based on premiums. This proposal would not require participation by physicians but initially would use payment rates similar to those of Medicare. Rates would be unlinked from Medicare rates over time as other payment mechanisms were developed.

In the Senate, an approach getting a lot of attention is to create not a public plan but rather a federally chartered, nonprofit cooperative plan, Ms. Stoll said. This proposal is seen by many as a compromise between a government-run plan and no public plan at all.

Overall, the discussion on a public plan is heading in a direction that is positive for physicians, said Elizabeth Carpenter, associate policy director for the Health Policy Program at the New America Foundation, a nonpartisan think tank.

At the beginning of discussions on health care reform, the thinking was that a public plan would use Medicare rates in paying physicians and other providers. Now that idea seems to be losing support, Ms. Carpenter said. Instead, in those cases where reform proposals are referencing Medicare rates, those rates are intended only as a starting point, she said.

Obese women should gain no more than 20 pounds during pregnancy, according to new guidelines released by the Institute of Medicine and the National Research Council.

The IOM hasn't updated its guidelines on weight gain during pregnancy since 1990. The revised recommendations are designed to reflect the increasing number of overweight and obese Americans, women having children at an older age, and multiple births, and the increase in weight gain during pregnancy, as well as other changing demographic factors.

The new guidelines set an upper and lower threshold for weight gain among obese women, advising women with a body mass index of greater than 30 kg/m

The new guidelines also include charts on the recommended rate of weight gain at various stages throughout pregnancy. For example, normal-weight women are advised to gain a mean of 1 pound per week during the second and third trimesters.

“The committee intends that the new guidelines will be used in concert with good clinical judgment and include a discussion between the woman and her health care provider about diet and exercise,” Kathleen M. Rasmussen, Sc.D., professor in the division of nutritional sciences at Cornell University, Ithaca, N.Y., and chair of the committee, said during a press briefing to release the report.

Currently, the average weight gain in pregnancy is about 30.5 pounds, but it varies considerably based on the woman's prepregnancy BMI category, Dr. Rasmussen said. For underweight and normal-weight women, the average weight gain is about 32 pounds, compared with 30 pounds among overweight women and 25 pounds among obese women. Between 40% and 73% of women are outside of the new recommended ranges, with some gaining more and some less than recommended.

A woman's weight at the time of conception, and weight gain that is outside the recommended ranges during pregnancy, can have health consequences, especially for obese and overweight women. If a woman is overweight or obese before she gets pregnant, she has a higher risk for complications such as preeclampsia and gestational diabetes. Add to that excessive weight gain during pregnancy and there is an increased risk of needing a cesarean delivery and an increased risk of retaining the weight in the postpartum period. Obese women also are at risk for having babies who are either small for gestational age or large for gestational age, committee members said.

Although the committee's recommendations are not dramatically different from those issued in 1990, fully implementing them would represent a shift in prenatal care in the United States, Dr. Rasmussen said. This shift begins with ob.gyns. and other providers of prenatal care offering overweight and obese women counseling on diet and exercise before they conceive. And all pregnant women should be offered counseling on diet and physical activity to help them stay within the recommended weight limits during pregnancy, she said.

Counseling on diet and exercise should also continue into the postpartum period, the committee recommended, so that women can return to a healthy weight before a future pregnancy.

But not all of this counseling needs to be on the shoulders of the ob.gyn. community, said committee member David A. Savitz, Ph.D., professor of community and preventive medicine at Mount Sinai School of Medicine in New York. “It's clear that we don't look at this issue as something that will be solely and fully managed within the confines of the obstetrician's office. This is a community issue.”

Tailoring diet and exercise advice to the individual woman also is critical, said Anna Maria Siega-Riz, Ph.D., of the department of maternal and child health at the University of North Carolina at Chapel Hill and a member of the committee. Many women are simply handed the guidelines, but aren't given a chance to talk through how the weight gain recommendations could fit into their individual lifestyles.

The report does offer “provisional” guidelines for women carrying twins to term. The committee advised that normal-weight women gain between 37 and 54 pounds; overweight women, between 31 and 50 pounds; and obese women, between 25 and 42 pounds. There was not enough information to develop recommendations on underweight women who are carrying twins.

This study was supported by funds from the Department of Health and Human Services Health Resources and Services Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, the Office on Women's Health, the Office of Disease Prevention and Health Promotion, the Office of Minority Health, and the March of Dimes.

The full report is available online at www.iom.edu/pregnancyweightgain

ELSEVIER GLOBAL MEDICAL NEWS

Obese women should gain no more than 20 pounds during pregnancy, according to new guidelines released by the Institute of Medicine and the National Research Council.

The IOM hasn't updated its guidelines on weight gain during pregnancy since 1990. The revised recommendations are designed to reflect the increasing number of overweight and obese Americans, women having children at an older age, and multiple births, and the increase in weight gain during pregnancy, as well as other changing demographic factors.

The new guidelines set an upper and lower threshold for weight gain among obese women, advising women with a body mass index of greater than 30 kg/m

The new guidelines also include charts on the recommended rate of weight gain at various stages throughout pregnancy. For example, normal-weight women are advised to gain a mean of 1 pound per week during the second and third trimesters.

“The committee intends that the new guidelines will be used in concert with good clinical judgment and include a discussion between the woman and her health care provider about diet and exercise,” Kathleen M. Rasmussen, Sc.D., professor in the division of nutritional sciences at Cornell University, Ithaca, N.Y., and chair of the committee, said during a press briefing to release the report.

Currently, the average weight gain in pregnancy is about 30.5 pounds, but it varies considerably based on the woman's prepregnancy BMI category, Dr. Rasmussen said. For underweight and normal-weight women, the average weight gain is about 32 pounds, compared with 30 pounds among overweight women and 25 pounds among obese women. Between 40% and 73% of women are outside of the new recommended ranges, with some gaining more and some less than recommended.

A woman's weight at the time of conception, and weight gain that is outside the recommended ranges during pregnancy, can have health consequences, especially for obese and overweight women. If a woman is overweight or obese before she gets pregnant, she has a higher risk for complications such as preeclampsia and gestational diabetes. Add to that excessive weight gain during pregnancy and there is an increased risk of needing a cesarean delivery and an increased risk of retaining the weight in the postpartum period. Obese women also are at risk for having babies who are either small for gestational age or large for gestational age, committee members said.

Although the committee's recommendations are not dramatically different from those issued in 1990, fully implementing them would represent a shift in prenatal care in the United States, Dr. Rasmussen said. This shift begins with ob.gyns. and other providers of prenatal care offering overweight and obese women counseling on diet and exercise before they conceive. And all pregnant women should be offered counseling on diet and physical activity to help them stay within the recommended weight limits during pregnancy, she said.

Counseling on diet and exercise should also continue into the postpartum period, the committee recommended, so that women can return to a healthy weight before a future pregnancy.

But not all of this counseling needs to be on the shoulders of the ob.gyn. community, said committee member David A. Savitz, Ph.D., professor of community and preventive medicine at Mount Sinai School of Medicine in New York. “It's clear that we don't look at this issue as something that will be solely and fully managed within the confines of the obstetrician's office. This is a community issue.”

Tailoring diet and exercise advice to the individual woman also is critical, said Anna Maria Siega-Riz, Ph.D., of the department of maternal and child health at the University of North Carolina at Chapel Hill and a member of the committee. Many women are simply handed the guidelines, but aren't given a chance to talk through how the weight gain recommendations could fit into their individual lifestyles.

The report does offer “provisional” guidelines for women carrying twins to term. The committee advised that normal-weight women gain between 37 and 54 pounds; overweight women, between 31 and 50 pounds; and obese women, between 25 and 42 pounds. There was not enough information to develop recommendations on underweight women who are carrying twins.

This study was supported by funds from the Department of Health and Human Services Health Resources and Services Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, the Office on Women's Health, the Office of Disease Prevention and Health Promotion, the Office of Minority Health, and the March of Dimes.

The full report is available online at www.iom.edu/pregnancyweightgain

ELSEVIER GLOBAL MEDICAL NEWS

Obese women should gain no more than 20 pounds during pregnancy, according to new guidelines released by the Institute of Medicine and the National Research Council.

The IOM hasn't updated its guidelines on weight gain during pregnancy since 1990. The revised recommendations are designed to reflect the increasing number of overweight and obese Americans, women having children at an older age, and multiple births, and the increase in weight gain during pregnancy, as well as other changing demographic factors.

The new guidelines set an upper and lower threshold for weight gain among obese women, advising women with a body mass index of greater than 30 kg/m

The new guidelines also include charts on the recommended rate of weight gain at various stages throughout pregnancy. For example, normal-weight women are advised to gain a mean of 1 pound per week during the second and third trimesters.

“The committee intends that the new guidelines will be used in concert with good clinical judgment and include a discussion between the woman and her health care provider about diet and exercise,” Kathleen M. Rasmussen, Sc.D., professor in the division of nutritional sciences at Cornell University, Ithaca, N.Y., and chair of the committee, said during a press briefing to release the report.

Currently, the average weight gain in pregnancy is about 30.5 pounds, but it varies considerably based on the woman's prepregnancy BMI category, Dr. Rasmussen said. For underweight and normal-weight women, the average weight gain is about 32 pounds, compared with 30 pounds among overweight women and 25 pounds among obese women. Between 40% and 73% of women are outside of the new recommended ranges, with some gaining more and some less than recommended.

A woman's weight at the time of conception, and weight gain that is outside the recommended ranges during pregnancy, can have health consequences, especially for obese and overweight women. If a woman is overweight or obese before she gets pregnant, she has a higher risk for complications such as preeclampsia and gestational diabetes. Add to that excessive weight gain during pregnancy and there is an increased risk of needing a cesarean delivery and an increased risk of retaining the weight in the postpartum period. Obese women also are at risk for having babies who are either small for gestational age or large for gestational age, committee members said.

Although the committee's recommendations are not dramatically different from those issued in 1990, fully implementing them would represent a shift in prenatal care in the United States, Dr. Rasmussen said. This shift begins with ob.gyns. and other providers of prenatal care offering overweight and obese women counseling on diet and exercise before they conceive. And all pregnant women should be offered counseling on diet and physical activity to help them stay within the recommended weight limits during pregnancy, she said.

Counseling on diet and exercise should also continue into the postpartum period, the committee recommended, so that women can return to a healthy weight before a future pregnancy.

But not all of this counseling needs to be on the shoulders of the ob.gyn. community, said committee member David A. Savitz, Ph.D., professor of community and preventive medicine at Mount Sinai School of Medicine in New York. “It's clear that we don't look at this issue as something that will be solely and fully managed within the confines of the obstetrician's office. This is a community issue.”

Tailoring diet and exercise advice to the individual woman also is critical, said Anna Maria Siega-Riz, Ph.D., of the department of maternal and child health at the University of North Carolina at Chapel Hill and a member of the committee. Many women are simply handed the guidelines, but aren't given a chance to talk through how the weight gain recommendations could fit into their individual lifestyles.

The report does offer “provisional” guidelines for women carrying twins to term. The committee advised that normal-weight women gain between 37 and 54 pounds; overweight women, between 31 and 50 pounds; and obese women, between 25 and 42 pounds. There was not enough information to develop recommendations on underweight women who are carrying twins.

This study was supported by funds from the Department of Health and Human Services Health Resources and Services Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, the Office on Women's Health, the Office of Disease Prevention and Health Promotion, the Office of Minority Health, and the March of Dimes.

The full report is available online at www.iom.edu/pregnancyweightgain

ELSEVIER GLOBAL MEDICAL NEWS

Sotomayor Tapped for High Court

President Barack Obama has nominated appellate court judge Sonia Sotomayor to the Supreme Court, but observers are waiting to see what her presence on the court could mean for abortion rights. Although neither President Obama nor Judge Sotomayor mentioned abortion when announcing her nomination last month, groups on both sides of the issue are watching this nomination closely. NARAL Pro-Choice America, which supports abortion rights, praised Judge Sotomayor for her professional accomplishments. In a statement, NARAL president Nancy Keenan, said that the organization looks forward to hearing more about Judge Sotomayor's views on the right to privacy and Roe v. Wade. However, Americans United for Life, a group which opposes abortion, called the nomination a “radical pick that divides America.” Despite the characterization by some opponents that Judge Sotomayor is a liberal activist, in 2002, she upheld the Bush administration's right to continue the Mexico City Policy, which banned foreign nongovernmental organizations from performing or promoting abortion if they received U.S. government funds. Judge Sotomayor currently serves on the U.S. Court of Appeals for the Second Circuit. Her nomination must be approved by the Senate.

Health Care System Fails Women

The health care system needs reform now because the current framework does not work for women, according to a new report from the Health and Human Services department. HHS released “Roadblocks to Health Care,” last month at a roundtable with women small business owners. The report says that 21 million women and girls were uninsured in the United States in 2007. About 14 million women had health coverage through the individual insurance market, where women may pay higher premiums than men, yet are unlikely to get comprehensive benefits in return. Women in their reproductive years are often charged higher premiums than men when purchasing insurance on the individual market, according to the report. Additionally, the majority of such policies do not cover maternity care. Find the report at

www.HealthReform.gov

Abstinence-Only Sex Education Cut

President Obama's proposed fiscal year 2010 budget would eliminate funding for abstinence-only sex education. The proposal includes $178 million for a new teen pregnancy prevention initiative featuring grants to states and communities. About 25% of the community-grants program would support demonstration projects and research into new sex education approaches. The move drew praise from reproductive-rights advocates who have been pushing for years for inclusion of information on contraception and protection against sexually transmitted diseases. “For too long we wasted money on programs that are proven to be ineffective,” Rep. Louise M. Slaughter (D-N.Y.), cochair of the congressional pro-choice caucus, said in a statement. “We are finally putting sound science ahead of politics. We have an obligation to our young women and men to empower them to make informed decisions about their own sexual health.” But some of the same groups that praised the Obama administration on its sex education policy took it to task for failing to go after government funding restrictions on abortion, such as the Hyde Amendment, which bars the federal government from paying for abortions under Medicaid.

States Tackle Reproductive Health

In the first quarter of 2009, states have already enacted 11 new laws related to reproductive health. Eight of those new laws are related to abortion, and most restrict access to the procedure. Some of the measures include a ban on “partial birth” abortion in Arkansas, limits on post-viability abortions in Utah, requirements that abortion clinics post signs about coercion in Kansas and Ohio, and a requirement in Utah that abortion clinics inform women about the possibility that a fetus can feel pain. Aside from its abortion law, Utah enacted a law allowing physicians to dispense sexually transmitted disease treatment to patients for use by their sex partners. Utah and Virginia have passed laws this year increasing access to emergency contraception.

Parental Notification Bill Introduced

Legislation in Congress would require that physicians notify parents if their teenage daughter is seeking an abortion. Under the “Parental Notification and Intervention Act” (H.R. 2061), physicians would have to send notice by certified mail at least 4 days before an abortion was to be performed. The parents would then have the option of seeking a court injunction to stop the procedure. The bill provides for some exceptions to notification, such as when there is clear evidence of physical abuse of the minor by the parent. Also, the requirement for notification would be waived if a medical emergency exists requiring the abortion to be performed to save the life of the minor. The bill, introduced by Rep. John Boozman (R-Ariz.), includes penalties of up to $1 million and 10 years in prison. Many states already have some type of parental-notification law on the books, but Rep. Boozman said a federal law is necessary so that girls can't hide their actions by going to a state without a notification requirement.

Sotomayor Tapped for High Court

President Barack Obama has nominated appellate court judge Sonia Sotomayor to the Supreme Court, but observers are waiting to see what her presence on the court could mean for abortion rights. Although neither President Obama nor Judge Sotomayor mentioned abortion when announcing her nomination last month, groups on both sides of the issue are watching this nomination closely. NARAL Pro-Choice America, which supports abortion rights, praised Judge Sotomayor for her professional accomplishments. In a statement, NARAL president Nancy Keenan, said that the organization looks forward to hearing more about Judge Sotomayor's views on the right to privacy and Roe v. Wade. However, Americans United for Life, a group which opposes abortion, called the nomination a “radical pick that divides America.” Despite the characterization by some opponents that Judge Sotomayor is a liberal activist, in 2002, she upheld the Bush administration's right to continue the Mexico City Policy, which banned foreign nongovernmental organizations from performing or promoting abortion if they received U.S. government funds. Judge Sotomayor currently serves on the U.S. Court of Appeals for the Second Circuit. Her nomination must be approved by the Senate.

Health Care System Fails Women

The health care system needs reform now because the current framework does not work for women, according to a new report from the Health and Human Services department. HHS released “Roadblocks to Health Care,” last month at a roundtable with women small business owners. The report says that 21 million women and girls were uninsured in the United States in 2007. About 14 million women had health coverage through the individual insurance market, where women may pay higher premiums than men, yet are unlikely to get comprehensive benefits in return. Women in their reproductive years are often charged higher premiums than men when purchasing insurance on the individual market, according to the report. Additionally, the majority of such policies do not cover maternity care. Find the report at

www.HealthReform.gov

Abstinence-Only Sex Education Cut

President Obama's proposed fiscal year 2010 budget would eliminate funding for abstinence-only sex education. The proposal includes $178 million for a new teen pregnancy prevention initiative featuring grants to states and communities. About 25% of the community-grants program would support demonstration projects and research into new sex education approaches. The move drew praise from reproductive-rights advocates who have been pushing for years for inclusion of information on contraception and protection against sexually transmitted diseases. “For too long we wasted money on programs that are proven to be ineffective,” Rep. Louise M. Slaughter (D-N.Y.), cochair of the congressional pro-choice caucus, said in a statement. “We are finally putting sound science ahead of politics. We have an obligation to our young women and men to empower them to make informed decisions about their own sexual health.” But some of the same groups that praised the Obama administration on its sex education policy took it to task for failing to go after government funding restrictions on abortion, such as the Hyde Amendment, which bars the federal government from paying for abortions under Medicaid.

States Tackle Reproductive Health

In the first quarter of 2009, states have already enacted 11 new laws related to reproductive health. Eight of those new laws are related to abortion, and most restrict access to the procedure. Some of the measures include a ban on “partial birth” abortion in Arkansas, limits on post-viability abortions in Utah, requirements that abortion clinics post signs about coercion in Kansas and Ohio, and a requirement in Utah that abortion clinics inform women about the possibility that a fetus can feel pain. Aside from its abortion law, Utah enacted a law allowing physicians to dispense sexually transmitted disease treatment to patients for use by their sex partners. Utah and Virginia have passed laws this year increasing access to emergency contraception.

Parental Notification Bill Introduced

Legislation in Congress would require that physicians notify parents if their teenage daughter is seeking an abortion. Under the “Parental Notification and Intervention Act” (H.R. 2061), physicians would have to send notice by certified mail at least 4 days before an abortion was to be performed. The parents would then have the option of seeking a court injunction to stop the procedure. The bill provides for some exceptions to notification, such as when there is clear evidence of physical abuse of the minor by the parent. Also, the requirement for notification would be waived if a medical emergency exists requiring the abortion to be performed to save the life of the minor. The bill, introduced by Rep. John Boozman (R-Ariz.), includes penalties of up to $1 million and 10 years in prison. Many states already have some type of parental-notification law on the books, but Rep. Boozman said a federal law is necessary so that girls can't hide their actions by going to a state without a notification requirement.

Sotomayor Tapped for High Court

President Barack Obama has nominated appellate court judge Sonia Sotomayor to the Supreme Court, but observers are waiting to see what her presence on the court could mean for abortion rights. Although neither President Obama nor Judge Sotomayor mentioned abortion when announcing her nomination last month, groups on both sides of the issue are watching this nomination closely. NARAL Pro-Choice America, which supports abortion rights, praised Judge Sotomayor for her professional accomplishments. In a statement, NARAL president Nancy Keenan, said that the organization looks forward to hearing more about Judge Sotomayor's views on the right to privacy and Roe v. Wade. However, Americans United for Life, a group which opposes abortion, called the nomination a “radical pick that divides America.” Despite the characterization by some opponents that Judge Sotomayor is a liberal activist, in 2002, she upheld the Bush administration's right to continue the Mexico City Policy, which banned foreign nongovernmental organizations from performing or promoting abortion if they received U.S. government funds. Judge Sotomayor currently serves on the U.S. Court of Appeals for the Second Circuit. Her nomination must be approved by the Senate.

Health Care System Fails Women

The health care system needs reform now because the current framework does not work for women, according to a new report from the Health and Human Services department. HHS released “Roadblocks to Health Care,” last month at a roundtable with women small business owners. The report says that 21 million women and girls were uninsured in the United States in 2007. About 14 million women had health coverage through the individual insurance market, where women may pay higher premiums than men, yet are unlikely to get comprehensive benefits in return. Women in their reproductive years are often charged higher premiums than men when purchasing insurance on the individual market, according to the report. Additionally, the majority of such policies do not cover maternity care. Find the report at

www.HealthReform.gov

Abstinence-Only Sex Education Cut

President Obama's proposed fiscal year 2010 budget would eliminate funding for abstinence-only sex education. The proposal includes $178 million for a new teen pregnancy prevention initiative featuring grants to states and communities. About 25% of the community-grants program would support demonstration projects and research into new sex education approaches. The move drew praise from reproductive-rights advocates who have been pushing for years for inclusion of information on contraception and protection against sexually transmitted diseases. “For too long we wasted money on programs that are proven to be ineffective,” Rep. Louise M. Slaughter (D-N.Y.), cochair of the congressional pro-choice caucus, said in a statement. “We are finally putting sound science ahead of politics. We have an obligation to our young women and men to empower them to make informed decisions about their own sexual health.” But some of the same groups that praised the Obama administration on its sex education policy took it to task for failing to go after government funding restrictions on abortion, such as the Hyde Amendment, which bars the federal government from paying for abortions under Medicaid.

States Tackle Reproductive Health

In the first quarter of 2009, states have already enacted 11 new laws related to reproductive health. Eight of those new laws are related to abortion, and most restrict access to the procedure. Some of the measures include a ban on “partial birth” abortion in Arkansas, limits on post-viability abortions in Utah, requirements that abortion clinics post signs about coercion in Kansas and Ohio, and a requirement in Utah that abortion clinics inform women about the possibility that a fetus can feel pain. Aside from its abortion law, Utah enacted a law allowing physicians to dispense sexually transmitted disease treatment to patients for use by their sex partners. Utah and Virginia have passed laws this year increasing access to emergency contraception.

Parental Notification Bill Introduced

Legislation in Congress would require that physicians notify parents if their teenage daughter is seeking an abortion. Under the “Parental Notification and Intervention Act” (H.R. 2061), physicians would have to send notice by certified mail at least 4 days before an abortion was to be performed. The parents would then have the option of seeking a court injunction to stop the procedure. The bill provides for some exceptions to notification, such as when there is clear evidence of physical abuse of the minor by the parent. Also, the requirement for notification would be waived if a medical emergency exists requiring the abortion to be performed to save the life of the minor. The bill, introduced by Rep. John Boozman (R-Ariz.), includes penalties of up to $1 million and 10 years in prison. Many states already have some type of parental-notification law on the books, but Rep. Boozman said a federal law is necessary so that girls can't hide their actions by going to a state without a notification requirement.

The Obama administration plans to finance a portion of its ambitious health care reform plan through changes to the Medicare and Medicaid programs, including the bundling of payments for inpatient and postacute care.

The new details were provided as part of the administration's fiscal year 2010 budget request sent to Congress. President Barack Obama had released the highlights of his budget plans back in February but had not provided specifics on his legislative and regulatory proposals.

As expected, the centerpiece of the detailed budget proposal is health care reform. The budget would establish a “reserve fund” of about $635 billion over 10 years to finance at least part of the comprehensive health reform efforts, which would come from new revenue resulting from tax changes, as well as from savings within the Medicare and Medicaid programs.

“This budget sends a clear message that we can't afford to wait any longer if we want to get health care costs under control and improve our fiscal outlook,” said Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Services.

“Investing in health reform today will help bring down costs tomorrow and ensure all Americans have access to the quality care they need and deserve,” she said.

The Obama administration proposes to trim $287.5 billion from Medicare over 10 years, with $520 million in savings coming in FY 2010. The budget proposal also counts $22 billion in savings over 10 years from the Medicaid program, with $1.5 billion in savings being realized in FY 2010.

Among the legislative proposals that would contribute to those savings is a plan to tie a portion of hospital Medicare payments to performance on quality measures starting in 2011. The administration also is proposing to cut payments to hospitals with high readmission rates starting in 2012.

The budget proposal seeks to allow physicians to form voluntary groups to coordinate care for Medicare beneficiaries. Those groups would be eligible to receive bonus payments from Medicare if they improved the quality of care and produced savings.

The administration hopes to begin bundling Medicare payments for inpatient hospital services and postacute care within 30 days of discharge, beginning in 2013.

Savings would also be generated, according to the administration, by a new competitive bidding system for Medicare Advantage plans. Under such a system, payments to Medicare Advantage plans would be based on the average of plan bids submitted to Medicare.

This type of market-based system would reduce costs, according to the Obama administration.

The FY 2010 budget does not include a fix for the Medicare physician payment system, which is once again set to make significant cuts to physician payments in January 2010.

However, the budget document includes support for changing the payment formula, including assessing whether physician-administered drugs should be covered under the payment formula. The FY 2010 budget proposal includes a total of $879 billion for HHS, a $63 billion increase over FY 2009 levels.

The administration also is moving to bolster cancer research as part of the budget proposal. The proposal includes nearly $31 billion for the National Institutes of Health, with more than $6 billion dedicated to cancer research across the agency. This is the first installment in President Obama's plan to double NIH cancer research by FY 2017.

In addition, the budget addresses concerns about the response to the 2009-H1N1 “swine” flu. Aside from the $1.5 billion supplemental request, the administration is seeking $584 million in the FY 2010 budget proposal. The money would go toward developing, producing, and distributing antivirals, vaccines, and personal protective equipment. It would be used for surveillance and response efforts, as well.

The administration is planning to invest $1 billion into health care workforce initiatives including expanding loan repayment and scholarship programs for physicians, nurses, and dentists who work in underserved areas.

The administration asserted its commitment to lowering drug costs with a policy proposal in the Food and Drug Administration budget to create a regulatory pathway for the approval of generic biologicals. Under this pathway, innovative products would be given a period of exclusivity. However, brand name manufacturers would be barred from reformulating existing products into new products in order to restart the exclusivity process. Additionally, the FDA budget includes $5 million to explore ways for Americans to safely import drugs from other countries.

The FY 2010 budget documents are available online at www.hhs.gov/asrt/ob/docbudget/index.html

“This budget sends a clear message. … Investing in health reform today will help bring down costs tomorrow.' MS. SEBELIUS

The Obama administration plans to finance a portion of its ambitious health care reform plan through changes to the Medicare and Medicaid programs, including the bundling of payments for inpatient and postacute care.

The new details were provided as part of the administration's fiscal year 2010 budget request sent to Congress. President Barack Obama had released the highlights of his budget plans back in February but had not provided specifics on his legislative and regulatory proposals.

As expected, the centerpiece of the detailed budget proposal is health care reform. The budget would establish a “reserve fund” of about $635 billion over 10 years to finance at least part of the comprehensive health reform efforts, which would come from new revenue resulting from tax changes, as well as from savings within the Medicare and Medicaid programs.

“This budget sends a clear message that we can't afford to wait any longer if we want to get health care costs under control and improve our fiscal outlook,” said Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Services.

“Investing in health reform today will help bring down costs tomorrow and ensure all Americans have access to the quality care they need and deserve,” she said.

The Obama administration proposes to trim $287.5 billion from Medicare over 10 years, with $520 million in savings coming in FY 2010. The budget proposal also counts $22 billion in savings over 10 years from the Medicaid program, with $1.5 billion in savings being realized in FY 2010.

Among the legislative proposals that would contribute to those savings is a plan to tie a portion of hospital Medicare payments to performance on quality measures starting in 2011. The administration also is proposing to cut payments to hospitals with high readmission rates starting in 2012.

The budget proposal seeks to allow physicians to form voluntary groups to coordinate care for Medicare beneficiaries. Those groups would be eligible to receive bonus payments from Medicare if they improved the quality of care and produced savings.

The administration hopes to begin bundling Medicare payments for inpatient hospital services and postacute care within 30 days of discharge, beginning in 2013.

Savings would also be generated, according to the administration, by a new competitive bidding system for Medicare Advantage plans. Under such a system, payments to Medicare Advantage plans would be based on the average of plan bids submitted to Medicare.

This type of market-based system would reduce costs, according to the Obama administration.

The FY 2010 budget does not include a fix for the Medicare physician payment system, which is once again set to make significant cuts to physician payments in January 2010.

However, the budget document includes support for changing the payment formula, including assessing whether physician-administered drugs should be covered under the payment formula. The FY 2010 budget proposal includes a total of $879 billion for HHS, a $63 billion increase over FY 2009 levels.

The administration also is moving to bolster cancer research as part of the budget proposal. The proposal includes nearly $31 billion for the National Institutes of Health, with more than $6 billion dedicated to cancer research across the agency. This is the first installment in President Obama's plan to double NIH cancer research by FY 2017.

In addition, the budget addresses concerns about the response to the 2009-H1N1 “swine” flu. Aside from the $1.5 billion supplemental request, the administration is seeking $584 million in the FY 2010 budget proposal. The money would go toward developing, producing, and distributing antivirals, vaccines, and personal protective equipment. It would be used for surveillance and response efforts, as well.

The administration is planning to invest $1 billion into health care workforce initiatives including expanding loan repayment and scholarship programs for physicians, nurses, and dentists who work in underserved areas.

The administration asserted its commitment to lowering drug costs with a policy proposal in the Food and Drug Administration budget to create a regulatory pathway for the approval of generic biologicals. Under this pathway, innovative products would be given a period of exclusivity. However, brand name manufacturers would be barred from reformulating existing products into new products in order to restart the exclusivity process. Additionally, the FDA budget includes $5 million to explore ways for Americans to safely import drugs from other countries.

The FY 2010 budget documents are available online at www.hhs.gov/asrt/ob/docbudget/index.html

“This budget sends a clear message. … Investing in health reform today will help bring down costs tomorrow.' MS. SEBELIUS

The Obama administration plans to finance a portion of its ambitious health care reform plan through changes to the Medicare and Medicaid programs, including the bundling of payments for inpatient and postacute care.

The new details were provided as part of the administration's fiscal year 2010 budget request sent to Congress. President Barack Obama had released the highlights of his budget plans back in February but had not provided specifics on his legislative and regulatory proposals.

As expected, the centerpiece of the detailed budget proposal is health care reform. The budget would establish a “reserve fund” of about $635 billion over 10 years to finance at least part of the comprehensive health reform efforts, which would come from new revenue resulting from tax changes, as well as from savings within the Medicare and Medicaid programs.

“This budget sends a clear message that we can't afford to wait any longer if we want to get health care costs under control and improve our fiscal outlook,” said Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Services.

“Investing in health reform today will help bring down costs tomorrow and ensure all Americans have access to the quality care they need and deserve,” she said.

The Obama administration proposes to trim $287.5 billion from Medicare over 10 years, with $520 million in savings coming in FY 2010. The budget proposal also counts $22 billion in savings over 10 years from the Medicaid program, with $1.5 billion in savings being realized in FY 2010.

Among the legislative proposals that would contribute to those savings is a plan to tie a portion of hospital Medicare payments to performance on quality measures starting in 2011. The administration also is proposing to cut payments to hospitals with high readmission rates starting in 2012.

The budget proposal seeks to allow physicians to form voluntary groups to coordinate care for Medicare beneficiaries. Those groups would be eligible to receive bonus payments from Medicare if they improved the quality of care and produced savings.

The administration hopes to begin bundling Medicare payments for inpatient hospital services and postacute care within 30 days of discharge, beginning in 2013.

Savings would also be generated, according to the administration, by a new competitive bidding system for Medicare Advantage plans. Under such a system, payments to Medicare Advantage plans would be based on the average of plan bids submitted to Medicare.

This type of market-based system would reduce costs, according to the Obama administration.

The FY 2010 budget does not include a fix for the Medicare physician payment system, which is once again set to make significant cuts to physician payments in January 2010.

However, the budget document includes support for changing the payment formula, including assessing whether physician-administered drugs should be covered under the payment formula. The FY 2010 budget proposal includes a total of $879 billion for HHS, a $63 billion increase over FY 2009 levels.

The administration also is moving to bolster cancer research as part of the budget proposal. The proposal includes nearly $31 billion for the National Institutes of Health, with more than $6 billion dedicated to cancer research across the agency. This is the first installment in President Obama's plan to double NIH cancer research by FY 2017.

In addition, the budget addresses concerns about the response to the 2009-H1N1 “swine” flu. Aside from the $1.5 billion supplemental request, the administration is seeking $584 million in the FY 2010 budget proposal. The money would go toward developing, producing, and distributing antivirals, vaccines, and personal protective equipment. It would be used for surveillance and response efforts, as well.

The administration is planning to invest $1 billion into health care workforce initiatives including expanding loan repayment and scholarship programs for physicians, nurses, and dentists who work in underserved areas.

The administration asserted its commitment to lowering drug costs with a policy proposal in the Food and Drug Administration budget to create a regulatory pathway for the approval of generic biologicals. Under this pathway, innovative products would be given a period of exclusivity. However, brand name manufacturers would be barred from reformulating existing products into new products in order to restart the exclusivity process. Additionally, the FDA budget includes $5 million to explore ways for Americans to safely import drugs from other countries.

The FY 2010 budget documents are available online at www.hhs.gov/asrt/ob/docbudget/index.html

“This budget sends a clear message. … Investing in health reform today will help bring down costs tomorrow.' MS. SEBELIUS

Physicians should stop accepting gifts or meals from industry representatives, according to a new report from the Institute of Medicine that offers 16 recommendations aimed at limiting financial conflicts of interest in medicine.

While some relationships with industry are beneficial, the widespread industry ties that have become common among physicians and researchers could undermine public confidence in medicine, according to the report from the IOM Committee on Conflict of Interest in Medical Research, Education, and Practice.

“This is a vital issue that really goes to the heart of patients' trust that they are receiving the best medical advice and medical care,” Dr. Bernard Lo, chair of the IOM committee and director of the program in medical ethics at the University of California, San Francisco, said during a press briefing.

In a 300-plus page report, the IOM committee provides recommendations for physicians and institutions to identify and manage financial conflicts of interest in medical research, education, and practice. The report focuses specifically on financial relationships with pharmaceutical, medical device, and biotechnology companies.

For starters, all institutions engaged in medical research, education, and practice should establish conflict of interest policies that require all physicians, researchers, and senior officials to disclose their ties to industry. The committee also recommended that the medical community come together to create a universal, standardized, electronic disclosure form to cut down on variation and reduce administrative burdens for physicians.

Beyond these voluntary disclosure efforts, the IOM committee recommended that Congress require drug and device makers and industry foundations to publicly report any payments to physicians, researchers, health care institutions, professional societies, patient advocacy and disease groups, continuing medical education (CME) providers, and related foundations.

This type of searchable public database would allow medical institutions and journal publishers to verify the disclosure information they receive from researchers and physicians, the committee said.

While disclosure of financial ties was a major focus of the committee's recommendations, it was only the beginning. Institutions also must act to prohibit certain relationships with industry and strictly manage others, Dr. Lo said. “Disclosure is a necessary first step, but it's a limited first step,” Dr. Lo said. “If you don't disclose relationships to the institution you work for, they can't figure out what to do.”

In addition to refusing to accept gifts and meals from industry, the IOM committee recommended that physicians set restrictions on their contacts with sales representatives and use drug samples only for patients who can't afford medications. The committee also recommended that physicians enter into only bona fide consultation arrangements with industry provided that these include written contracts and that physicians avoid presenting or publishing any material whose contract is controlled or ghostwritten by industry. The report includes similar recommendations for faculty, students, residents, and fellows at academic medical centers.

The IOM committee also challenged the medical community to come up with a new system for funding accredited continuing medical education that would be free of industry influence.

The report also addressed industry influence in the development of clinical practice guidelines. The committee recommended that groups involved in guideline development not accept direct funding from industry. Additionally, they should try to exclude individuals with conflicts of interest from serving on guideline development panels. If the necessary expertise can't be obtained from experts who are free of conflict, the IOM committee advised that conflicted individuals should be a minority on the panel and should be barred from voting on any topics in which they have a financial interest. The committee also recommended that the chair of the guideline panel be free of conflicts.

In the research arena, the IOM committee recommended that, in general, investigators should not conduct research involving human subjects if they have a financial stake in the outcome of the study. Exceptions are possible but should be made only if the researcher's participation is considered essential to the safety of the research. And, even then, a conflict of interest committee should approve the involvement and consider placing restrictions on his or her role in the study, according to the committee's recommendations.

The Pharmaceutical Research and Manufacturers of America (PhRMA) was still reviewing the IOM report at press time. However, the group cautioned policy makers and the medical community to balance the need to manage potential conflicts of interest against the possibility that “overly restrictive policies” could have unintended consequences. For example, prohibitions on the use of drug samples or on industry funding for continuing medical education could negatively affect patient care, according to the group.

“In the end, interactions between pharmaceutical sales representatives and health care professionals enhance public health and improve patient care,” Ken Johnson, PhRMA senior vice president, said in a statement. “Pharmaceutical research companies take this responsibility seriously and remain committed to ensuring that these interactions follow the highest standards.”

The IOM study was sponsored by the National Institutes of Health, the Robert Wood Johnson Foundation, the Greenwall Foundation, the American Board of Internal Medicine Foundation, the Burroughs Wellcome Fund, and the Josiah Macy Jr. Foundation.

The report is available online at www.nap.edu/catalog.php?record_id=12598#toc

Physicians should stop accepting gifts or meals from industry representatives, according to a new report from the Institute of Medicine that offers 16 recommendations aimed at limiting financial conflicts of interest in medicine.

While some relationships with industry are beneficial, the widespread industry ties that have become common among physicians and researchers could undermine public confidence in medicine, according to the report from the IOM Committee on Conflict of Interest in Medical Research, Education, and Practice.

“This is a vital issue that really goes to the heart of patients' trust that they are receiving the best medical advice and medical care,” Dr. Bernard Lo, chair of the IOM committee and director of the program in medical ethics at the University of California, San Francisco, said during a press briefing.

In a 300-plus page report, the IOM committee provides recommendations for physicians and institutions to identify and manage financial conflicts of interest in medical research, education, and practice. The report focuses specifically on financial relationships with pharmaceutical, medical device, and biotechnology companies.

For starters, all institutions engaged in medical research, education, and practice should establish conflict of interest policies that require all physicians, researchers, and senior officials to disclose their ties to industry. The committee also recommended that the medical community come together to create a universal, standardized, electronic disclosure form to cut down on variation and reduce administrative burdens for physicians.

Beyond these voluntary disclosure efforts, the IOM committee recommended that Congress require drug and device makers and industry foundations to publicly report any payments to physicians, researchers, health care institutions, professional societies, patient advocacy and disease groups, continuing medical education (CME) providers, and related foundations.

This type of searchable public database would allow medical institutions and journal publishers to verify the disclosure information they receive from researchers and physicians, the committee said.

While disclosure of financial ties was a major focus of the committee's recommendations, it was only the beginning. Institutions also must act to prohibit certain relationships with industry and strictly manage others, Dr. Lo said. “Disclosure is a necessary first step, but it's a limited first step,” Dr. Lo said. “If you don't disclose relationships to the institution you work for, they can't figure out what to do.”

In addition to refusing to accept gifts and meals from industry, the IOM committee recommended that physicians set restrictions on their contacts with sales representatives and use drug samples only for patients who can't afford medications. The committee also recommended that physicians enter into only bona fide consultation arrangements with industry provided that these include written contracts and that physicians avoid presenting or publishing any material whose contract is controlled or ghostwritten by industry. The report includes similar recommendations for faculty, students, residents, and fellows at academic medical centers.

The IOM committee also challenged the medical community to come up with a new system for funding accredited continuing medical education that would be free of industry influence.

The report also addressed industry influence in the development of clinical practice guidelines. The committee recommended that groups involved in guideline development not accept direct funding from industry. Additionally, they should try to exclude individuals with conflicts of interest from serving on guideline development panels. If the necessary expertise can't be obtained from experts who are free of conflict, the IOM committee advised that conflicted individuals should be a minority on the panel and should be barred from voting on any topics in which they have a financial interest. The committee also recommended that the chair of the guideline panel be free of conflicts.

In the research arena, the IOM committee recommended that, in general, investigators should not conduct research involving human subjects if they have a financial stake in the outcome of the study. Exceptions are possible but should be made only if the researcher's participation is considered essential to the safety of the research. And, even then, a conflict of interest committee should approve the involvement and consider placing restrictions on his or her role in the study, according to the committee's recommendations.

The Pharmaceutical Research and Manufacturers of America (PhRMA) was still reviewing the IOM report at press time. However, the group cautioned policy makers and the medical community to balance the need to manage potential conflicts of interest against the possibility that “overly restrictive policies” could have unintended consequences. For example, prohibitions on the use of drug samples or on industry funding for continuing medical education could negatively affect patient care, according to the group.

“In the end, interactions between pharmaceutical sales representatives and health care professionals enhance public health and improve patient care,” Ken Johnson, PhRMA senior vice president, said in a statement. “Pharmaceutical research companies take this responsibility seriously and remain committed to ensuring that these interactions follow the highest standards.”

The IOM study was sponsored by the National Institutes of Health, the Robert Wood Johnson Foundation, the Greenwall Foundation, the American Board of Internal Medicine Foundation, the Burroughs Wellcome Fund, and the Josiah Macy Jr. Foundation.

The report is available online at www.nap.edu/catalog.php?record_id=12598#toc

Physicians should stop accepting gifts or meals from industry representatives, according to a new report from the Institute of Medicine that offers 16 recommendations aimed at limiting financial conflicts of interest in medicine.

While some relationships with industry are beneficial, the widespread industry ties that have become common among physicians and researchers could undermine public confidence in medicine, according to the report from the IOM Committee on Conflict of Interest in Medical Research, Education, and Practice.

“This is a vital issue that really goes to the heart of patients' trust that they are receiving the best medical advice and medical care,” Dr. Bernard Lo, chair of the IOM committee and director of the program in medical ethics at the University of California, San Francisco, said during a press briefing.

In a 300-plus page report, the IOM committee provides recommendations for physicians and institutions to identify and manage financial conflicts of interest in medical research, education, and practice. The report focuses specifically on financial relationships with pharmaceutical, medical device, and biotechnology companies.

For starters, all institutions engaged in medical research, education, and practice should establish conflict of interest policies that require all physicians, researchers, and senior officials to disclose their ties to industry. The committee also recommended that the medical community come together to create a universal, standardized, electronic disclosure form to cut down on variation and reduce administrative burdens for physicians.

Beyond these voluntary disclosure efforts, the IOM committee recommended that Congress require drug and device makers and industry foundations to publicly report any payments to physicians, researchers, health care institutions, professional societies, patient advocacy and disease groups, continuing medical education (CME) providers, and related foundations.

This type of searchable public database would allow medical institutions and journal publishers to verify the disclosure information they receive from researchers and physicians, the committee said.

While disclosure of financial ties was a major focus of the committee's recommendations, it was only the beginning. Institutions also must act to prohibit certain relationships with industry and strictly manage others, Dr. Lo said. “Disclosure is a necessary first step, but it's a limited first step,” Dr. Lo said. “If you don't disclose relationships to the institution you work for, they can't figure out what to do.”

In addition to refusing to accept gifts and meals from industry, the IOM committee recommended that physicians set restrictions on their contacts with sales representatives and use drug samples only for patients who can't afford medications. The committee also recommended that physicians enter into only bona fide consultation arrangements with industry provided that these include written contracts and that physicians avoid presenting or publishing any material whose contract is controlled or ghostwritten by industry. The report includes similar recommendations for faculty, students, residents, and fellows at academic medical centers.

The IOM committee also challenged the medical community to come up with a new system for funding accredited continuing medical education that would be free of industry influence.

The report also addressed industry influence in the development of clinical practice guidelines. The committee recommended that groups involved in guideline development not accept direct funding from industry. Additionally, they should try to exclude individuals with conflicts of interest from serving on guideline development panels. If the necessary expertise can't be obtained from experts who are free of conflict, the IOM committee advised that conflicted individuals should be a minority on the panel and should be barred from voting on any topics in which they have a financial interest. The committee also recommended that the chair of the guideline panel be free of conflicts.

In the research arena, the IOM committee recommended that, in general, investigators should not conduct research involving human subjects if they have a financial stake in the outcome of the study. Exceptions are possible but should be made only if the researcher's participation is considered essential to the safety of the research. And, even then, a conflict of interest committee should approve the involvement and consider placing restrictions on his or her role in the study, according to the committee's recommendations.

The Pharmaceutical Research and Manufacturers of America (PhRMA) was still reviewing the IOM report at press time. However, the group cautioned policy makers and the medical community to balance the need to manage potential conflicts of interest against the possibility that “overly restrictive policies” could have unintended consequences. For example, prohibitions on the use of drug samples or on industry funding for continuing medical education could negatively affect patient care, according to the group.

“In the end, interactions between pharmaceutical sales representatives and health care professionals enhance public health and improve patient care,” Ken Johnson, PhRMA senior vice president, said in a statement. “Pharmaceutical research companies take this responsibility seriously and remain committed to ensuring that these interactions follow the highest standards.”

The IOM study was sponsored by the National Institutes of Health, the Robert Wood Johnson Foundation, the Greenwall Foundation, the American Board of Internal Medicine Foundation, the Burroughs Wellcome Fund, and the Josiah Macy Jr. Foundation.

The report is available online at www.nap.edu/catalog.php?record_id=12598#toc