Joyce Frieden

WASHINGTON — The National Institutes of Health needs to partner more with the pharmaceutical industry in order to create a better pipeline for new drugs, Dr. Francis Collins said at the annual meeting of the Endocrine Society.

Dr. Collins, who recently began work as NIH director, said that with all the developments now occurring in genomic research, “pharmaceutical companies are a little overwhelmed about where to start” when it comes to figuring out which genes would make good targets for drug therapy.

“Academic investigators should get more intentionally involved in the translational process of going from basic research to drug development,” Dr. Collins said before his nomination and confirmation as NIH director.

“There is an opportunity now, more than ever, to bring together academic investigators and the private sector to put together a really exciting version of a drug development pipeline,” he said.

Such a collaboration “involves more of academics taking the front-end risk of developing promising compounds so they become attractive and licensable by the private sector.”

Dr. Collins noted that many academic researchers are identifying promising targets for drugs, “but relatively few are taking that information and turning it into an assay … to see if there is something promising that might turn out to become a therapeutic.”

Some targets start out looking promising, but when they get to a point where they need support for preclinical development, “that's where things often die,” he said. “Congress just a few months ago put $24 million into the fiscal year 2009 budget to start this process in an NIH-funded way, and I hope the money will go up substantially in the next 5 years.”

Conflicts of interest on the part of pharmaceutical companies “would have to be factored in,” Dr. Collins said in an interview. Drugmakers' interest in commercialization would be a factor. “You want to start a project that is going to get somewhere,” he said. “But there are companies across the board that are interested in almost any disease—even very rare ones—as long as it won't cost a fortune to get that drug approved. For the rare diseases, you may have to push things further down the pipeline with public money before the company says, 'Okay, I'll start with that one now,' but I don't know that that should discourage consideration of working on even a very rare disease in this pipeline.”

“We have an opportunity to take [the new technologies] that have started to appear and apply them in a vigorous way to understand fundamentals of biology, That would include genomics and nanotechnology and a wide variety of approaches to epigenetics,” he said.

“I would also think we need to take seriously the charge coming from the Congress and the Administration to provide useful information to guide health care reform. That would mean, in some instances, comparative effectiveness research, but we need to be careful not to lose the personalized aspects of individual [health] along the way.”

Global health should also be an NIH focus, he said. “The U.S. is in a position to spread more soft power instead of hard power around the world; NIH ought to be able to play a useful role in that. And we should encourage the research community, including young investigators, and increase the diversity of our workforce, to make it vigorous and effective. I think if we focus on a few of those things … we can really get some stuff done.”

'There is an opportunity now … to put together a really exciting version of a drug development pipeline.'

Source DR. COLLINS

WASHINGTON — The National Institutes of Health needs to partner more with the pharmaceutical industry in order to create a better pipeline for new drugs, Dr. Francis Collins said at the annual meeting of the Endocrine Society.

Dr. Collins, who recently began work as NIH director, said that with all the developments now occurring in genomic research, “pharmaceutical companies are a little overwhelmed about where to start” when it comes to figuring out which genes would make good targets for drug therapy.

“Academic investigators should get more intentionally involved in the translational process of going from basic research to drug development,” Dr. Collins said before his nomination and confirmation as NIH director.

“There is an opportunity now, more than ever, to bring together academic investigators and the private sector to put together a really exciting version of a drug development pipeline,” he said.

Such a collaboration “involves more of academics taking the front-end risk of developing promising compounds so they become attractive and licensable by the private sector.”

Dr. Collins noted that many academic researchers are identifying promising targets for drugs, “but relatively few are taking that information and turning it into an assay … to see if there is something promising that might turn out to become a therapeutic.”

Some targets start out looking promising, but when they get to a point where they need support for preclinical development, “that's where things often die,” he said. “Congress just a few months ago put $24 million into the fiscal year 2009 budget to start this process in an NIH-funded way, and I hope the money will go up substantially in the next 5 years.”

Conflicts of interest on the part of pharmaceutical companies “would have to be factored in,” Dr. Collins said in an interview. Drugmakers' interest in commercialization would be a factor. “You want to start a project that is going to get somewhere,” he said. “But there are companies across the board that are interested in almost any disease—even very rare ones—as long as it won't cost a fortune to get that drug approved. For the rare diseases, you may have to push things further down the pipeline with public money before the company says, 'Okay, I'll start with that one now,' but I don't know that that should discourage consideration of working on even a very rare disease in this pipeline.”

“We have an opportunity to take [the new technologies] that have started to appear and apply them in a vigorous way to understand fundamentals of biology, That would include genomics and nanotechnology and a wide variety of approaches to epigenetics,” he said.

“I would also think we need to take seriously the charge coming from the Congress and the Administration to provide useful information to guide health care reform. That would mean, in some instances, comparative effectiveness research, but we need to be careful not to lose the personalized aspects of individual [health] along the way.”

Global health should also be an NIH focus, he said. “The U.S. is in a position to spread more soft power instead of hard power around the world; NIH ought to be able to play a useful role in that. And we should encourage the research community, including young investigators, and increase the diversity of our workforce, to make it vigorous and effective. I think if we focus on a few of those things … we can really get some stuff done.”

'There is an opportunity now … to put together a really exciting version of a drug development pipeline.'

Source DR. COLLINS

WASHINGTON — The National Institutes of Health needs to partner more with the pharmaceutical industry in order to create a better pipeline for new drugs, Dr. Francis Collins said at the annual meeting of the Endocrine Society.

Dr. Collins, who recently began work as NIH director, said that with all the developments now occurring in genomic research, “pharmaceutical companies are a little overwhelmed about where to start” when it comes to figuring out which genes would make good targets for drug therapy.

“Academic investigators should get more intentionally involved in the translational process of going from basic research to drug development,” Dr. Collins said before his nomination and confirmation as NIH director.

“There is an opportunity now, more than ever, to bring together academic investigators and the private sector to put together a really exciting version of a drug development pipeline,” he said.

Such a collaboration “involves more of academics taking the front-end risk of developing promising compounds so they become attractive and licensable by the private sector.”

Dr. Collins noted that many academic researchers are identifying promising targets for drugs, “but relatively few are taking that information and turning it into an assay … to see if there is something promising that might turn out to become a therapeutic.”

Some targets start out looking promising, but when they get to a point where they need support for preclinical development, “that's where things often die,” he said. “Congress just a few months ago put $24 million into the fiscal year 2009 budget to start this process in an NIH-funded way, and I hope the money will go up substantially in the next 5 years.”

Conflicts of interest on the part of pharmaceutical companies “would have to be factored in,” Dr. Collins said in an interview. Drugmakers' interest in commercialization would be a factor. “You want to start a project that is going to get somewhere,” he said. “But there are companies across the board that are interested in almost any disease—even very rare ones—as long as it won't cost a fortune to get that drug approved. For the rare diseases, you may have to push things further down the pipeline with public money before the company says, 'Okay, I'll start with that one now,' but I don't know that that should discourage consideration of working on even a very rare disease in this pipeline.”

“We have an opportunity to take [the new technologies] that have started to appear and apply them in a vigorous way to understand fundamentals of biology, That would include genomics and nanotechnology and a wide variety of approaches to epigenetics,” he said.

“I would also think we need to take seriously the charge coming from the Congress and the Administration to provide useful information to guide health care reform. That would mean, in some instances, comparative effectiveness research, but we need to be careful not to lose the personalized aspects of individual [health] along the way.”

Global health should also be an NIH focus, he said. “The U.S. is in a position to spread more soft power instead of hard power around the world; NIH ought to be able to play a useful role in that. And we should encourage the research community, including young investigators, and increase the diversity of our workforce, to make it vigorous and effective. I think if we focus on a few of those things … we can really get some stuff done.”

'There is an opportunity now … to put together a really exciting version of a drug development pipeline.'

Source DR. COLLINS

Dr. Francis S. Collins, former director of the National Human Genome Research Institute, become director of the National Institutes of Health on Aug. 17 after being approved unanimously by the Senate earlier in the month.

“The National Institutes of Health stands as a model when it comes to science and research,” President Obama said when he nominated Dr. Collins for the post in July. “My administration is committed to promoting scientific integrity and pioneering scientific research, and I am confident that Dr. Francis Collins will lead the NIH to achieve these goals. Dr. Collins is one of the top scientists in the world, and his groundbreaking work has changed the very ways we consider our health and examine disease. I look forward to working with him in the months and years ahead.”

Dr. Collins oversaw the federal Human Genome Project, which finished the complete mapping of the human genome in April 2003, at about the same time as a parallel private effort. Dr. Collins' research also has led to the discovery of several genes. He is interested in the intersection of science and faith and has written two books on the topic.

Dr. Collins received a bachelor's degree in chemistry from the University of Virginia, a Ph.D. in physical chemistry from Yale University, and a medical degree from the University of North Carolina. Before coming to NIH in 1993, he spent 9 years on the faculty of the University of Michigan, where he was an investigator at the Howard Hughes Medical Institute. He is a member of the Institute of Medicine and the National Academy of Sciences, and was awarded the Presidential Medal of Freedom in November 2007.

Dr. Francis S. Collins, former director of the National Human Genome Research Institute, become director of the National Institutes of Health on Aug. 17 after being approved unanimously by the Senate earlier in the month.

“The National Institutes of Health stands as a model when it comes to science and research,” President Obama said when he nominated Dr. Collins for the post in July. “My administration is committed to promoting scientific integrity and pioneering scientific research, and I am confident that Dr. Francis Collins will lead the NIH to achieve these goals. Dr. Collins is one of the top scientists in the world, and his groundbreaking work has changed the very ways we consider our health and examine disease. I look forward to working with him in the months and years ahead.”

Dr. Collins oversaw the federal Human Genome Project, which finished the complete mapping of the human genome in April 2003, at about the same time as a parallel private effort. Dr. Collins' research also has led to the discovery of several genes. He is interested in the intersection of science and faith and has written two books on the topic.

Dr. Collins received a bachelor's degree in chemistry from the University of Virginia, a Ph.D. in physical chemistry from Yale University, and a medical degree from the University of North Carolina. Before coming to NIH in 1993, he spent 9 years on the faculty of the University of Michigan, where he was an investigator at the Howard Hughes Medical Institute. He is a member of the Institute of Medicine and the National Academy of Sciences, and was awarded the Presidential Medal of Freedom in November 2007.

Dr. Francis S. Collins, former director of the National Human Genome Research Institute, become director of the National Institutes of Health on Aug. 17 after being approved unanimously by the Senate earlier in the month.

“The National Institutes of Health stands as a model when it comes to science and research,” President Obama said when he nominated Dr. Collins for the post in July. “My administration is committed to promoting scientific integrity and pioneering scientific research, and I am confident that Dr. Francis Collins will lead the NIH to achieve these goals. Dr. Collins is one of the top scientists in the world, and his groundbreaking work has changed the very ways we consider our health and examine disease. I look forward to working with him in the months and years ahead.”

Dr. Collins oversaw the federal Human Genome Project, which finished the complete mapping of the human genome in April 2003, at about the same time as a parallel private effort. Dr. Collins' research also has led to the discovery of several genes. He is interested in the intersection of science and faith and has written two books on the topic.

Dr. Collins received a bachelor's degree in chemistry from the University of Virginia, a Ph.D. in physical chemistry from Yale University, and a medical degree from the University of North Carolina. Before coming to NIH in 1993, he spent 9 years on the faculty of the University of Michigan, where he was an investigator at the Howard Hughes Medical Institute. He is a member of the Institute of Medicine and the National Academy of Sciences, and was awarded the Presidential Medal of Freedom in November 2007.

WASHINGTON — A Health and Human Services Department advisory committee is moving to make it easier for physicians to meet federal requirements for adopting electronic health records.

The Health IT Policy Committee has recommended that providers who adopt EHRs after 2011 or 2012—the first years that federal stimulus money for adoption will be available—have to meet only 2011/2012 requirements for "meaningful use" of EHRs in their first year of adoption. They will then need to meet additional requirements each year in order to continue getting the money, although they will receive less than they would have if they had adopted EHRs earlier.

"A rising tide floats all boats, but if you're not in the water, it just doesn't help," said Dr. Paul Tang, cochair of the committee's meaningful use working group. "So we're just trying to find a way to get people to deal with it, even if it's a little bit late."

Under the Recovery Act, $19 billion in stimulus money has been set aside to encourage adoption of health information technology, including EHRs. The money includes up to $44,000 in financial incentives for each physician who purchases a certified EHR system and who makes "meaningful use" of it.

To put the law into effect, the government has to define "meaningful use" and set standards for system certification and health information exchange. The HIT Policy Committee, chaired by Dr. David Blumenthal, national coordinator for health information technology at HHS, will make recommendations; the actual regulations will be written by staff members at the Centers for Medicare and Medicaid Services (CMS).

At a recent HIT Policy Committee meeting, committee member Gayle Harrell, former Florida state legislator, expressed concern that some of the meaningful use requirements were aimed more at primary care physicians and would not be appropriate for specialists. Dr. Tang agreed that the working group would try to make sure that specialists' needs were addressed when the recommendations were finalized, and noted that not all measures would apply to all specialties. The committee agreed to accept the meaningful use working group's recommendations.

Ms. Harrell also raised the question of whether specialists would now be liable for information presented in the EHR that falls outside of their purview. "Would an ophthalmologist have to verify whether or not I had a mammogram?" she asked.

Dr. Blumenthal said he didn't think the liability issue was within the committee's scope. "I think we have to stay focused on what we think appropriate good care should be, and we can't sort" the system out here.

The standards and certification subcommittee also presented the following five recommendations to the committee:

▸ Focus certification on meaningful use.

▸ Leverage the certification process to improve progress on security, privacy, and interoperability.

▸ Improve the objectivity and transparency of the certification process.

▸ Expand certification to include a range of software sources, such as open-source and self-developed systems.

▸ Develop a short-term transition plan for certification.

Dr. Neil Calman, a family physician and CEO of the Institute for Family Health in New York, said he was concerned that the last recommendation would send the wrong message to providers who were already certified by the Certification Commission for Health Information Technology (CCHIT), currently the government's only approved certifying body. "It basically makes it sound like CCHIT is temporary," he said.

But working group cochair Paul Egerman said that was not the message the group meant to convey. "I would be very surprised if … CCHIT wasn't equally involved with this [process] going forward. Basically, they're the ones that know how to do it," he said.

The committee agreed to adopt the working group's main recommendations but to let working group members rework some of the specifics.

WASHINGTON — A Health and Human Services Department advisory committee is moving to make it easier for physicians to meet federal requirements for adopting electronic health records.

The Health IT Policy Committee has recommended that providers who adopt EHRs after 2011 or 2012—the first years that federal stimulus money for adoption will be available—have to meet only 2011/2012 requirements for "meaningful use" of EHRs in their first year of adoption. They will then need to meet additional requirements each year in order to continue getting the money, although they will receive less than they would have if they had adopted EHRs earlier.

"A rising tide floats all boats, but if you're not in the water, it just doesn't help," said Dr. Paul Tang, cochair of the committee's meaningful use working group. "So we're just trying to find a way to get people to deal with it, even if it's a little bit late."

Under the Recovery Act, $19 billion in stimulus money has been set aside to encourage adoption of health information technology, including EHRs. The money includes up to $44,000 in financial incentives for each physician who purchases a certified EHR system and who makes "meaningful use" of it.

To put the law into effect, the government has to define "meaningful use" and set standards for system certification and health information exchange. The HIT Policy Committee, chaired by Dr. David Blumenthal, national coordinator for health information technology at HHS, will make recommendations; the actual regulations will be written by staff members at the Centers for Medicare and Medicaid Services (CMS).

At a recent HIT Policy Committee meeting, committee member Gayle Harrell, former Florida state legislator, expressed concern that some of the meaningful use requirements were aimed more at primary care physicians and would not be appropriate for specialists. Dr. Tang agreed that the working group would try to make sure that specialists' needs were addressed when the recommendations were finalized, and noted that not all measures would apply to all specialties. The committee agreed to accept the meaningful use working group's recommendations.

Ms. Harrell also raised the question of whether specialists would now be liable for information presented in the EHR that falls outside of their purview. "Would an ophthalmologist have to verify whether or not I had a mammogram?" she asked.

Dr. Blumenthal said he didn't think the liability issue was within the committee's scope. "I think we have to stay focused on what we think appropriate good care should be, and we can't sort" the system out here.

The standards and certification subcommittee also presented the following five recommendations to the committee:

▸ Focus certification on meaningful use.

▸ Leverage the certification process to improve progress on security, privacy, and interoperability.

▸ Improve the objectivity and transparency of the certification process.

▸ Expand certification to include a range of software sources, such as open-source and self-developed systems.

▸ Develop a short-term transition plan for certification.

Dr. Neil Calman, a family physician and CEO of the Institute for Family Health in New York, said he was concerned that the last recommendation would send the wrong message to providers who were already certified by the Certification Commission for Health Information Technology (CCHIT), currently the government's only approved certifying body. "It basically makes it sound like CCHIT is temporary," he said.

But working group cochair Paul Egerman said that was not the message the group meant to convey. "I would be very surprised if … CCHIT wasn't equally involved with this [process] going forward. Basically, they're the ones that know how to do it," he said.

The committee agreed to adopt the working group's main recommendations but to let working group members rework some of the specifics.

WASHINGTON — A Health and Human Services Department advisory committee is moving to make it easier for physicians to meet federal requirements for adopting electronic health records.

The Health IT Policy Committee has recommended that providers who adopt EHRs after 2011 or 2012—the first years that federal stimulus money for adoption will be available—have to meet only 2011/2012 requirements for "meaningful use" of EHRs in their first year of adoption. They will then need to meet additional requirements each year in order to continue getting the money, although they will receive less than they would have if they had adopted EHRs earlier.

"A rising tide floats all boats, but if you're not in the water, it just doesn't help," said Dr. Paul Tang, cochair of the committee's meaningful use working group. "So we're just trying to find a way to get people to deal with it, even if it's a little bit late."

Under the Recovery Act, $19 billion in stimulus money has been set aside to encourage adoption of health information technology, including EHRs. The money includes up to $44,000 in financial incentives for each physician who purchases a certified EHR system and who makes "meaningful use" of it.

To put the law into effect, the government has to define "meaningful use" and set standards for system certification and health information exchange. The HIT Policy Committee, chaired by Dr. David Blumenthal, national coordinator for health information technology at HHS, will make recommendations; the actual regulations will be written by staff members at the Centers for Medicare and Medicaid Services (CMS).

At a recent HIT Policy Committee meeting, committee member Gayle Harrell, former Florida state legislator, expressed concern that some of the meaningful use requirements were aimed more at primary care physicians and would not be appropriate for specialists. Dr. Tang agreed that the working group would try to make sure that specialists' needs were addressed when the recommendations were finalized, and noted that not all measures would apply to all specialties. The committee agreed to accept the meaningful use working group's recommendations.

Ms. Harrell also raised the question of whether specialists would now be liable for information presented in the EHR that falls outside of their purview. "Would an ophthalmologist have to verify whether or not I had a mammogram?" she asked.

Dr. Blumenthal said he didn't think the liability issue was within the committee's scope. "I think we have to stay focused on what we think appropriate good care should be, and we can't sort" the system out here.

The standards and certification subcommittee also presented the following five recommendations to the committee:

▸ Focus certification on meaningful use.

▸ Leverage the certification process to improve progress on security, privacy, and interoperability.

▸ Improve the objectivity and transparency of the certification process.

▸ Expand certification to include a range of software sources, such as open-source and self-developed systems.

▸ Develop a short-term transition plan for certification.

Dr. Neil Calman, a family physician and CEO of the Institute for Family Health in New York, said he was concerned that the last recommendation would send the wrong message to providers who were already certified by the Certification Commission for Health Information Technology (CCHIT), currently the government's only approved certifying body. "It basically makes it sound like CCHIT is temporary," he said.

But working group cochair Paul Egerman said that was not the message the group meant to convey. "I would be very surprised if … CCHIT wasn't equally involved with this [process] going forward. Basically, they're the ones that know how to do it," he said.

The committee agreed to adopt the working group's main recommendations but to let working group members rework some of the specifics.

Mary Ellen Schneider contributed to this article.

WASHINGTON — The federal Red Flags Rule that requires creditors to check for identity theft may mean a few new procedures for office-based physicians, Patricia King said at the American Health Lawyers Association's annual meeting.

"Do health care providers have to comply with the Red Flags Rule? Yes, if they're [considered] creditors," said Ms. King, assistant general counsel at Swedish Covenant Hospital in Chicago.

The rule requires creditors to establish formal identity theft prevention programs to protect consumers. Aimed primarily at the financial industry, the regulation was originally scheduled to go into effect on Nov. 1, 2008. However, to give small businesses more time to prepare for compliance, the Federal Trade Commission (FTC) delayed enforcement until May 1, and then until Aug. 1, and most recently until Nov. 1.

Earlier this year, the AMA and physician specialty societies argued that physicians are not creditors because they bill insurance companies, not individual consumers, Ms. King said. "But the patient does get billed for copays, deductibles, and excluded services, so unless all those charges are collected up front, the health care provider is billing and possibly deferring payment for the cost of services."

To address providers' concerns, the FTC has published guidance and developed a template for identity theft prevention program for low-risk creditors. (Information available at www.ftc.gov/bcp/edu/pubs/articles/art11.shtm

Low-risk providers who see the same patients regularly can adopt a simple identity theft program, she said, adding that personnel involved with front desk, medical records, and patient account functions should be involved in the program.

Physicians need to identify which patient accounts will be covered by the rule—such as those patients who need to make repeat payments—and develop appropriate policies and procedures, Ms. King said. "The final [Red Flags] rule had 26 examples of identity theft. Look through them and see which ones are most applicable to you."

Providers also need to look at what information they collect when patients register. "Many of us need to re-think our standard registration procedures and beef them up," said Ms. King. One example might be to ask for a photo ID.

Procedures to fight identity theft need to be approved by the organization's board of directors and overseen by senior management, according to the rule, "because this is intended to be a high-priority program, not something that's delegated to a lower-level manager," she said.

Typical "red flags" include:

▸ Insurance information that cannot be verified.

▸ No identification.

▸ A photo ID that doesn't match the patient.

▸ Documents that appear to be altered or forged.

▸ Information given that is different from information already on file.

▸ An invalid Social Security number.

▸ A patient who receives a bill or an explanation of benefits for services he or she didn't receive.

▸ A patient who finds inaccurate information on their credit report or on a medical record.

▸ A payer that says its patient information does not match that supplied by the provider.

When a patient raises one or more red flags, the practice has two options. It could refuse to provide service, although this might raise a problem under the Emergency Medical Treatment and Labor Act, which prohibits providers from not treating persons with questionable identification who require emergency care.

Or the practice could provide the service, but ask the patient to bring in the correct information to his or her next visit. Ms. King cautioned providers about freely providing medical records to a patient suspected of identity theft, because it could lead to more identity theft.

Patients will have to be educated about the new rule, Ms. King said. "Providers are going to run into problems with patient expectations. Patients have gotten used to coming to their doctor … with either no identifying documents or only their insurance card. They will need some education in advance."

She encountered a case of identity theft at her own hospital involving two elderly women, one of whom had a public assistance card, while the other one didn't. They thought it would be okay if the woman without the card used her friend's card. The identity theft was discovered by a hospital radiologist who noticed that the women's scans were different.

Providers also should note that compliance with the Health Insurance Portability and Accountability Act (HIPAA) does not shield them from complying with the Red Flags Rule.

"One of the questions we get is, 'I already comply with HIPAA; aren't I done?' The answer is, 'Probably not,'" said Naomi Lefkowitz of the Federal Trade Commission's division of privacy and identity protection. "The Red Flags Rule is really about fraud protection, and HIPAA is more about data security. There is certainly some overlap, and to the extent that, for example, someone is checking photo IDs … to make sure that the person only has access to their [own] medical record, that's a policy that might do double duty under the client's identity theft program as far as verifying ID … Having the HIPAA program is probably not going to make [providers] compliant."

Low-risk providers who see the same patients regularly can adopt a simple identity theft program. MS. KING

'Having the HIPAA program is probably not going to make [providers] compliant' with Red Flags. ms. Lefkowitz

Mary Ellen Schneider contributed to this article.

WASHINGTON — The federal Red Flags Rule that requires creditors to check for identity theft may mean a few new procedures for office-based physicians, Patricia King said at the American Health Lawyers Association's annual meeting.

"Do health care providers have to comply with the Red Flags Rule? Yes, if they're [considered] creditors," said Ms. King, assistant general counsel at Swedish Covenant Hospital in Chicago.

The rule requires creditors to establish formal identity theft prevention programs to protect consumers. Aimed primarily at the financial industry, the regulation was originally scheduled to go into effect on Nov. 1, 2008. However, to give small businesses more time to prepare for compliance, the Federal Trade Commission (FTC) delayed enforcement until May 1, and then until Aug. 1, and most recently until Nov. 1.

Earlier this year, the AMA and physician specialty societies argued that physicians are not creditors because they bill insurance companies, not individual consumers, Ms. King said. "But the patient does get billed for copays, deductibles, and excluded services, so unless all those charges are collected up front, the health care provider is billing and possibly deferring payment for the cost of services."

To address providers' concerns, the FTC has published guidance and developed a template for identity theft prevention program for low-risk creditors. (Information available at www.ftc.gov/bcp/edu/pubs/articles/art11.shtm

Low-risk providers who see the same patients regularly can adopt a simple identity theft program, she said, adding that personnel involved with front desk, medical records, and patient account functions should be involved in the program.

Physicians need to identify which patient accounts will be covered by the rule—such as those patients who need to make repeat payments—and develop appropriate policies and procedures, Ms. King said. "The final [Red Flags] rule had 26 examples of identity theft. Look through them and see which ones are most applicable to you."

Providers also need to look at what information they collect when patients register. "Many of us need to re-think our standard registration procedures and beef them up," said Ms. King. One example might be to ask for a photo ID.

Procedures to fight identity theft need to be approved by the organization's board of directors and overseen by senior management, according to the rule, "because this is intended to be a high-priority program, not something that's delegated to a lower-level manager," she said.

Typical "red flags" include:

▸ Insurance information that cannot be verified.

▸ No identification.

▸ A photo ID that doesn't match the patient.

▸ Documents that appear to be altered or forged.

▸ Information given that is different from information already on file.

▸ An invalid Social Security number.

▸ A patient who receives a bill or an explanation of benefits for services he or she didn't receive.

▸ A patient who finds inaccurate information on their credit report or on a medical record.

▸ A payer that says its patient information does not match that supplied by the provider.

When a patient raises one or more red flags, the practice has two options. It could refuse to provide service, although this might raise a problem under the Emergency Medical Treatment and Labor Act, which prohibits providers from not treating persons with questionable identification who require emergency care.

Or the practice could provide the service, but ask the patient to bring in the correct information to his or her next visit. Ms. King cautioned providers about freely providing medical records to a patient suspected of identity theft, because it could lead to more identity theft.

Patients will have to be educated about the new rule, Ms. King said. "Providers are going to run into problems with patient expectations. Patients have gotten used to coming to their doctor … with either no identifying documents or only their insurance card. They will need some education in advance."

She encountered a case of identity theft at her own hospital involving two elderly women, one of whom had a public assistance card, while the other one didn't. They thought it would be okay if the woman without the card used her friend's card. The identity theft was discovered by a hospital radiologist who noticed that the women's scans were different.

Providers also should note that compliance with the Health Insurance Portability and Accountability Act (HIPAA) does not shield them from complying with the Red Flags Rule.

"One of the questions we get is, 'I already comply with HIPAA; aren't I done?' The answer is, 'Probably not,'" said Naomi Lefkowitz of the Federal Trade Commission's division of privacy and identity protection. "The Red Flags Rule is really about fraud protection, and HIPAA is more about data security. There is certainly some overlap, and to the extent that, for example, someone is checking photo IDs … to make sure that the person only has access to their [own] medical record, that's a policy that might do double duty under the client's identity theft program as far as verifying ID … Having the HIPAA program is probably not going to make [providers] compliant."

Low-risk providers who see the same patients regularly can adopt a simple identity theft program. MS. KING

'Having the HIPAA program is probably not going to make [providers] compliant' with Red Flags. ms. Lefkowitz

Mary Ellen Schneider contributed to this article.

WASHINGTON — The federal Red Flags Rule that requires creditors to check for identity theft may mean a few new procedures for office-based physicians, Patricia King said at the American Health Lawyers Association's annual meeting.

"Do health care providers have to comply with the Red Flags Rule? Yes, if they're [considered] creditors," said Ms. King, assistant general counsel at Swedish Covenant Hospital in Chicago.

The rule requires creditors to establish formal identity theft prevention programs to protect consumers. Aimed primarily at the financial industry, the regulation was originally scheduled to go into effect on Nov. 1, 2008. However, to give small businesses more time to prepare for compliance, the Federal Trade Commission (FTC) delayed enforcement until May 1, and then until Aug. 1, and most recently until Nov. 1.

Earlier this year, the AMA and physician specialty societies argued that physicians are not creditors because they bill insurance companies, not individual consumers, Ms. King said. "But the patient does get billed for copays, deductibles, and excluded services, so unless all those charges are collected up front, the health care provider is billing and possibly deferring payment for the cost of services."

To address providers' concerns, the FTC has published guidance and developed a template for identity theft prevention program for low-risk creditors. (Information available at www.ftc.gov/bcp/edu/pubs/articles/art11.shtm

Low-risk providers who see the same patients regularly can adopt a simple identity theft program, she said, adding that personnel involved with front desk, medical records, and patient account functions should be involved in the program.

Physicians need to identify which patient accounts will be covered by the rule—such as those patients who need to make repeat payments—and develop appropriate policies and procedures, Ms. King said. "The final [Red Flags] rule had 26 examples of identity theft. Look through them and see which ones are most applicable to you."

Providers also need to look at what information they collect when patients register. "Many of us need to re-think our standard registration procedures and beef them up," said Ms. King. One example might be to ask for a photo ID.

Procedures to fight identity theft need to be approved by the organization's board of directors and overseen by senior management, according to the rule, "because this is intended to be a high-priority program, not something that's delegated to a lower-level manager," she said.

Typical "red flags" include:

▸ Insurance information that cannot be verified.

▸ No identification.

▸ A photo ID that doesn't match the patient.

▸ Documents that appear to be altered or forged.

▸ Information given that is different from information already on file.

▸ An invalid Social Security number.

▸ A patient who receives a bill or an explanation of benefits for services he or she didn't receive.

▸ A patient who finds inaccurate information on their credit report or on a medical record.

▸ A payer that says its patient information does not match that supplied by the provider.

When a patient raises one or more red flags, the practice has two options. It could refuse to provide service, although this might raise a problem under the Emergency Medical Treatment and Labor Act, which prohibits providers from not treating persons with questionable identification who require emergency care.

Or the practice could provide the service, but ask the patient to bring in the correct information to his or her next visit. Ms. King cautioned providers about freely providing medical records to a patient suspected of identity theft, because it could lead to more identity theft.

Patients will have to be educated about the new rule, Ms. King said. "Providers are going to run into problems with patient expectations. Patients have gotten used to coming to their doctor … with either no identifying documents or only their insurance card. They will need some education in advance."

She encountered a case of identity theft at her own hospital involving two elderly women, one of whom had a public assistance card, while the other one didn't. They thought it would be okay if the woman without the card used her friend's card. The identity theft was discovered by a hospital radiologist who noticed that the women's scans were different.

Providers also should note that compliance with the Health Insurance Portability and Accountability Act (HIPAA) does not shield them from complying with the Red Flags Rule.

"One of the questions we get is, 'I already comply with HIPAA; aren't I done?' The answer is, 'Probably not,'" said Naomi Lefkowitz of the Federal Trade Commission's division of privacy and identity protection. "The Red Flags Rule is really about fraud protection, and HIPAA is more about data security. There is certainly some overlap, and to the extent that, for example, someone is checking photo IDs … to make sure that the person only has access to their [own] medical record, that's a policy that might do double duty under the client's identity theft program as far as verifying ID … Having the HIPAA program is probably not going to make [providers] compliant."

Low-risk providers who see the same patients regularly can adopt a simple identity theft program. MS. KING

'Having the HIPAA program is probably not going to make [providers] compliant' with Red Flags. ms. Lefkowitz

Dr. Francis S. Collins, former director of the National Human Genome Research Institute, became director of the National Institutes of Health on Aug. 17 after being approved unanimously by the Senate earlier in the month.

"The National Institutes of Health stands as a model when it comes to science and research," President Obama said when he nominated Dr. Collins for the post in July. "My administration is committed to promoting scientific integrity and pioneering scientific research, and I am confident that Dr. Francis Collins will lead the NIH to achieve these goals. Dr. Collins is one of the top scientists in the world, and his groundbreaking work has changed the very ways we consider our health and examine disease."

Dr. Collins oversaw the federal Human Genome Project, which resulted in the complete mapping of the human genome in April 2003, finishing at about the same time as a parallel private effort.

Dr. Collins' research also has resulted in the discovery of several genes, including those responsible for cystic fibrosis, neurofibromatosis, Huntington's disease, and type 2 diabetes. Dr. Collins is interested in the intersection of science and faith and has written two books on the subject.

Dr. Francis S. Collins, former director of the National Human Genome Research Institute, became director of the National Institutes of Health on Aug. 17 after being approved unanimously by the Senate earlier in the month.

"The National Institutes of Health stands as a model when it comes to science and research," President Obama said when he nominated Dr. Collins for the post in July. "My administration is committed to promoting scientific integrity and pioneering scientific research, and I am confident that Dr. Francis Collins will lead the NIH to achieve these goals. Dr. Collins is one of the top scientists in the world, and his groundbreaking work has changed the very ways we consider our health and examine disease."

Dr. Collins oversaw the federal Human Genome Project, which resulted in the complete mapping of the human genome in April 2003, finishing at about the same time as a parallel private effort.

Dr. Collins' research also has resulted in the discovery of several genes, including those responsible for cystic fibrosis, neurofibromatosis, Huntington's disease, and type 2 diabetes. Dr. Collins is interested in the intersection of science and faith and has written two books on the subject.

Dr. Francis S. Collins, former director of the National Human Genome Research Institute, became director of the National Institutes of Health on Aug. 17 after being approved unanimously by the Senate earlier in the month.

"The National Institutes of Health stands as a model when it comes to science and research," President Obama said when he nominated Dr. Collins for the post in July. "My administration is committed to promoting scientific integrity and pioneering scientific research, and I am confident that Dr. Francis Collins will lead the NIH to achieve these goals. Dr. Collins is one of the top scientists in the world, and his groundbreaking work has changed the very ways we consider our health and examine disease."

Dr. Collins oversaw the federal Human Genome Project, which resulted in the complete mapping of the human genome in April 2003, finishing at about the same time as a parallel private effort.

Dr. Collins' research also has resulted in the discovery of several genes, including those responsible for cystic fibrosis, neurofibromatosis, Huntington's disease, and type 2 diabetes. Dr. Collins is interested in the intersection of science and faith and has written two books on the subject.

egmnblog.wordpress.com

Obesity Increasing, CDC Says

The proportion of U.S. adults who are obese increased to 26.1% in 2008 compared with 25.6% in 2007, according to data from the Centers for Disease Control and Prevention. A telephone survey of more than 400,000 people found that adult obesity prevalence was 30% or more in six states: Alabama, Mississippi, Oklahoma, South Carolina, Tennessee, and West Virginia. Another 26 states had obesity prevalence of 25% or more, while only 1 state, Colorado, had a prevalence of obesity less than 20%. No state showed a significant decrease in obesity prevalence from 2007 to 2008, and none of the 50 states nor the District of Columbia has achieved the Healthy People 2010 goal of reducing obesity prevalence to 15% or less. “The latest … survey data show that the obesity problem in this country is getting worse,” said Liping Pan, a CDC epidemiologist and the lead author of the analysis. “If this trend continues, we will likely see increases in health care costs for obesity-related diseases.”

Kendall Tapped for ADA Post

The American Diabetes Association has named Dr. David M. Kendall as its chief scientific and medical officer. Dr. Kendall is currently medical director and chief of clinical and professional services at the International Diabetes Center in Minneapolis. He succeeds Richard A. Kahn, Ph.D., who retired from the ADA on June 30. “David brings an impressive range of clinical and scientific expertise to this position,” said Larry Hausner, CEO at the ADA. “I am confident that through his leadership, the association will continue to reinforce its position as the authoritative voice and trusted leader in the diabetes community.”

Malpractice Payments Are Down

Medical malpractice payments were at record low levels in 2008, according to an analysis by the consumer advocacy group Public Citizen. For the third straight year, 2008 saw the lowest number of malpractice payments since the federal government's National Practitioner Data Bank began tracking such data in 1990, the group said. The data showed that 11,037 payments were made last year, which Public Citizen said was nearly one-third lower than the historical average. The monetary value of payments was either the lowest or second-lowest since 1990, depending on how inflation was calculated, the group said. The total cost of all malpractice insurance premiums fell to much less than 1% of the total $2.1 trillion in annual health costs in 2006 (the most recent year for which full data were available). The cost of actual malpractice payments to patients fell to 0.2% of overall health costs, the group said. David Arkush, director of Public Citizen's Congress Watch division, said in a statement that the numbers indicate that many victims of medical malpractice receive no compensation for their injuries.

FTC Wants 'Pay-for-Delay' Outlawed

A new law to eliminate deals in which pharmaceutical companies agree with their competitors to keep low-cost generic drugs off the market could save consumers and the federal government $3.5 billion a year over the next decade, according to Federal Trade Commission Chairman Jon Leibowitz. In a speech, Mr. Leibowitz said that stopping these “pay-for-delay” deals is one of the commission's top priorities, although a series of recent court rulings has allowed some of the arrangements to continue. For instance, the United States Supreme Court recently declined to hear a case in which consumers and health plans challenged a $398 million payment by drug maker Bayer AG to Barr Laboratories Inc. to settle the companies' patent dispute over a generic version of the antibiotic Cipro (ciprofloxacin). “The FTC is continuing to bring cases to protect consumers from these anticompetitive settlements … but waiting for a potential judicial solution is a time-consuming and expensive prescription, so the agency strongly supports legislation to eliminate pay-for-delay deals,” Mr. Leibowitz said.

Germino Named to NIDDK Job

Dr. Gregory G. Germino has been appointed deputy director of the National Institute of Diabetes and Digestive and Kidney Diseases. “Dr. Germino is a highly regarded physician-scientist, a committed mentor to the next generation of researchers, an experienced manager of budgets and people, and a compassionate communicator to professional and patient advocacy organizations,” said Dr. Griffin P. Rodgers, director of the NIDDK. “We are very fortunate to have him join us.” Dr. Germino was professor of medicine in the nephrology division, and professor of molecular biology and genetics, at Johns Hopkins University, Baltimore. In addition to his leadership responsibilities at NIDDK, he will continue his own research in polycystic kidney disease. Dr. Germino will help oversee an annual budget of $1.9 billion and a staff of 630 scientists, physician-scientists, and administrators at NIDDK's research facilities in Bethesda, Md. and Phoenix.

Many Young Adults Uninsured

Approximately 5 million U.S. adults aged 19-23 years had no health insurance in 2006 for the entire year, and 30% of them said they didn't think it was worth the cost, according to the Agency for Healthcare Research and Quality. The AHRQ found that 46% of uninsured young adults worked full time and 26% worked part time. Only 19% of those who were uninsured throughout 2006 were full-time students, the agency said. About two-thirds of the young adults who went without insurance for the whole year never saw a doctor, the AHRQ found.

egmnblog.wordpress.com

Obesity Increasing, CDC Says

The proportion of U.S. adults who are obese increased to 26.1% in 2008 compared with 25.6% in 2007, according to data from the Centers for Disease Control and Prevention. A telephone survey of more than 400,000 people found that adult obesity prevalence was 30% or more in six states: Alabama, Mississippi, Oklahoma, South Carolina, Tennessee, and West Virginia. Another 26 states had obesity prevalence of 25% or more, while only 1 state, Colorado, had a prevalence of obesity less than 20%. No state showed a significant decrease in obesity prevalence from 2007 to 2008, and none of the 50 states nor the District of Columbia has achieved the Healthy People 2010 goal of reducing obesity prevalence to 15% or less. “The latest … survey data show that the obesity problem in this country is getting worse,” said Liping Pan, a CDC epidemiologist and the lead author of the analysis. “If this trend continues, we will likely see increases in health care costs for obesity-related diseases.”

Kendall Tapped for ADA Post

The American Diabetes Association has named Dr. David M. Kendall as its chief scientific and medical officer. Dr. Kendall is currently medical director and chief of clinical and professional services at the International Diabetes Center in Minneapolis. He succeeds Richard A. Kahn, Ph.D., who retired from the ADA on June 30. “David brings an impressive range of clinical and scientific expertise to this position,” said Larry Hausner, CEO at the ADA. “I am confident that through his leadership, the association will continue to reinforce its position as the authoritative voice and trusted leader in the diabetes community.”

Malpractice Payments Are Down

Medical malpractice payments were at record low levels in 2008, according to an analysis by the consumer advocacy group Public Citizen. For the third straight year, 2008 saw the lowest number of malpractice payments since the federal government's National Practitioner Data Bank began tracking such data in 1990, the group said. The data showed that 11,037 payments were made last year, which Public Citizen said was nearly one-third lower than the historical average. The monetary value of payments was either the lowest or second-lowest since 1990, depending on how inflation was calculated, the group said. The total cost of all malpractice insurance premiums fell to much less than 1% of the total $2.1 trillion in annual health costs in 2006 (the most recent year for which full data were available). The cost of actual malpractice payments to patients fell to 0.2% of overall health costs, the group said. David Arkush, director of Public Citizen's Congress Watch division, said in a statement that the numbers indicate that many victims of medical malpractice receive no compensation for their injuries.

FTC Wants 'Pay-for-Delay' Outlawed

A new law to eliminate deals in which pharmaceutical companies agree with their competitors to keep low-cost generic drugs off the market could save consumers and the federal government $3.5 billion a year over the next decade, according to Federal Trade Commission Chairman Jon Leibowitz. In a speech, Mr. Leibowitz said that stopping these “pay-for-delay” deals is one of the commission's top priorities, although a series of recent court rulings has allowed some of the arrangements to continue. For instance, the United States Supreme Court recently declined to hear a case in which consumers and health plans challenged a $398 million payment by drug maker Bayer AG to Barr Laboratories Inc. to settle the companies' patent dispute over a generic version of the antibiotic Cipro (ciprofloxacin). “The FTC is continuing to bring cases to protect consumers from these anticompetitive settlements … but waiting for a potential judicial solution is a time-consuming and expensive prescription, so the agency strongly supports legislation to eliminate pay-for-delay deals,” Mr. Leibowitz said.

Germino Named to NIDDK Job

Dr. Gregory G. Germino has been appointed deputy director of the National Institute of Diabetes and Digestive and Kidney Diseases. “Dr. Germino is a highly regarded physician-scientist, a committed mentor to the next generation of researchers, an experienced manager of budgets and people, and a compassionate communicator to professional and patient advocacy organizations,” said Dr. Griffin P. Rodgers, director of the NIDDK. “We are very fortunate to have him join us.” Dr. Germino was professor of medicine in the nephrology division, and professor of molecular biology and genetics, at Johns Hopkins University, Baltimore. In addition to his leadership responsibilities at NIDDK, he will continue his own research in polycystic kidney disease. Dr. Germino will help oversee an annual budget of $1.9 billion and a staff of 630 scientists, physician-scientists, and administrators at NIDDK's research facilities in Bethesda, Md. and Phoenix.

Many Young Adults Uninsured

Approximately 5 million U.S. adults aged 19-23 years had no health insurance in 2006 for the entire year, and 30% of them said they didn't think it was worth the cost, according to the Agency for Healthcare Research and Quality. The AHRQ found that 46% of uninsured young adults worked full time and 26% worked part time. Only 19% of those who were uninsured throughout 2006 were full-time students, the agency said. About two-thirds of the young adults who went without insurance for the whole year never saw a doctor, the AHRQ found.

egmnblog.wordpress.com

Obesity Increasing, CDC Says

The proportion of U.S. adults who are obese increased to 26.1% in 2008 compared with 25.6% in 2007, according to data from the Centers for Disease Control and Prevention. A telephone survey of more than 400,000 people found that adult obesity prevalence was 30% or more in six states: Alabama, Mississippi, Oklahoma, South Carolina, Tennessee, and West Virginia. Another 26 states had obesity prevalence of 25% or more, while only 1 state, Colorado, had a prevalence of obesity less than 20%. No state showed a significant decrease in obesity prevalence from 2007 to 2008, and none of the 50 states nor the District of Columbia has achieved the Healthy People 2010 goal of reducing obesity prevalence to 15% or less. “The latest … survey data show that the obesity problem in this country is getting worse,” said Liping Pan, a CDC epidemiologist and the lead author of the analysis. “If this trend continues, we will likely see increases in health care costs for obesity-related diseases.”

Kendall Tapped for ADA Post

The American Diabetes Association has named Dr. David M. Kendall as its chief scientific and medical officer. Dr. Kendall is currently medical director and chief of clinical and professional services at the International Diabetes Center in Minneapolis. He succeeds Richard A. Kahn, Ph.D., who retired from the ADA on June 30. “David brings an impressive range of clinical and scientific expertise to this position,” said Larry Hausner, CEO at the ADA. “I am confident that through his leadership, the association will continue to reinforce its position as the authoritative voice and trusted leader in the diabetes community.”

Malpractice Payments Are Down

Medical malpractice payments were at record low levels in 2008, according to an analysis by the consumer advocacy group Public Citizen. For the third straight year, 2008 saw the lowest number of malpractice payments since the federal government's National Practitioner Data Bank began tracking such data in 1990, the group said. The data showed that 11,037 payments were made last year, which Public Citizen said was nearly one-third lower than the historical average. The monetary value of payments was either the lowest or second-lowest since 1990, depending on how inflation was calculated, the group said. The total cost of all malpractice insurance premiums fell to much less than 1% of the total $2.1 trillion in annual health costs in 2006 (the most recent year for which full data were available). The cost of actual malpractice payments to patients fell to 0.2% of overall health costs, the group said. David Arkush, director of Public Citizen's Congress Watch division, said in a statement that the numbers indicate that many victims of medical malpractice receive no compensation for their injuries.

FTC Wants 'Pay-for-Delay' Outlawed

A new law to eliminate deals in which pharmaceutical companies agree with their competitors to keep low-cost generic drugs off the market could save consumers and the federal government $3.5 billion a year over the next decade, according to Federal Trade Commission Chairman Jon Leibowitz. In a speech, Mr. Leibowitz said that stopping these “pay-for-delay” deals is one of the commission's top priorities, although a series of recent court rulings has allowed some of the arrangements to continue. For instance, the United States Supreme Court recently declined to hear a case in which consumers and health plans challenged a $398 million payment by drug maker Bayer AG to Barr Laboratories Inc. to settle the companies' patent dispute over a generic version of the antibiotic Cipro (ciprofloxacin). “The FTC is continuing to bring cases to protect consumers from these anticompetitive settlements … but waiting for a potential judicial solution is a time-consuming and expensive prescription, so the agency strongly supports legislation to eliminate pay-for-delay deals,” Mr. Leibowitz said.

Germino Named to NIDDK Job

Dr. Gregory G. Germino has been appointed deputy director of the National Institute of Diabetes and Digestive and Kidney Diseases. “Dr. Germino is a highly regarded physician-scientist, a committed mentor to the next generation of researchers, an experienced manager of budgets and people, and a compassionate communicator to professional and patient advocacy organizations,” said Dr. Griffin P. Rodgers, director of the NIDDK. “We are very fortunate to have him join us.” Dr. Germino was professor of medicine in the nephrology division, and professor of molecular biology and genetics, at Johns Hopkins University, Baltimore. In addition to his leadership responsibilities at NIDDK, he will continue his own research in polycystic kidney disease. Dr. Germino will help oversee an annual budget of $1.9 billion and a staff of 630 scientists, physician-scientists, and administrators at NIDDK's research facilities in Bethesda, Md. and Phoenix.

Many Young Adults Uninsured

Approximately 5 million U.S. adults aged 19-23 years had no health insurance in 2006 for the entire year, and 30% of them said they didn't think it was worth the cost, according to the Agency for Healthcare Research and Quality. The AHRQ found that 46% of uninsured young adults worked full time and 26% worked part time. Only 19% of those who were uninsured throughout 2006 were full-time students, the agency said. About two-thirds of the young adults who went without insurance for the whole year never saw a doctor, the AHRQ found.

WASHINGTON — The federal Red Flags Rule that requires creditors to check for identity theft may mean a few new procedures for office-based physicians, Patricia King said at the American Health Lawyers Association's annual meeting.

“Do health care providers have to comply with the Red Flags Rule? Yes, if they're [considered] creditors,” said Ms. King, assistant general counsel at Swedish Covenant Hospital in Chicago.

The rule requires creditors to establish formal identify theft prevention programs to protect consumers.

Aimed primarily at the financial industry, the regulation was originally scheduled to go into effect on Nov. 1, 2008. However, to give small businesses more time to prepare for compliance, the Federal Trade Commission (FTC) delayed enforcement until May 1, and then until Aug. 1, and most recently until Nov. 1.

Earlier this year, the AMA and physician specialty societies argued that physicians are not creditors because they bill insurance companies, not individual consumers, Ms. King said. “But the patient does get billed for copays, deductibles, and excluded services, so unless all those charges are collected up front, the health care provider is billing and possibly deferring payment for the cost of services.”

To address health care providers' concerns, the FTC has published guidance and developed a template for identity theft prevention program for low-risk creditors. (The information is available at www.ftc.gov/bcp/edu/pubs/articles/art11.shtm

Low-risk providers who see the same patients regularly can adopt a simple identity theft program, she said, adding that personnel involved with front desk, medical records, and patient account functions should be involved in the program.

Physicians need to identify which patient accounts will be covered by the rule—such as those patients who need to make repeat payments—and develop appropriate policies and procedures, Ms. King said.

“The final [Red Flags] rule had 26 examples of identity theft. Look through them and see which ones are most applicable to you.”

Providers also need to look at what information they collect when patients register. “Many of us need to re-think our standard registration procedures and beef them up,” said Ms. King. One example might be to ask for a photo ID.

Procedures for guarding against identity theft need to be approved by the organization's board of directors and overseen by senior management, according to the rule, “because this is intended to be a high-priority program, not something that's delegated to a lower-level manager.”

Typical “red flags” that practices should watch for include:

▸ Insurance information that cannot be verified;

▸ No identification;

▸ A photo ID that does not match the patient;

▸ Documents that appear to be altered or forged;

▸ Information given that is different from information already on file;

▸ An invalid Social Security number;

▸ A patient who receives a bill or an explanation of benefits for services he or she didn't receive;

▸ A patient who finds inaccurate information on their credit report or on a medical record; or

▸ A payer that says its patient information does not match that supplied by the provider.

When a particular patient raises one or more red flags, the practice has two options, according to Ms. King. It could refuse to provide service, although this might raise a problem under the Emergency Medical Treatment and Active Labor Act (EMTALA), a law that prohibits providers from not treating persons with questionable identification who require emergency care.

Or the practice could provide the service, but ask the patient to bring in the correct information to his or her next visit. Ms. King cautioned providers about freely providing medical records to a patient suspected of identity theft, because it could lead to more identity theft.

Patients also will have to be educated about the new rule, Ms. King said. “Providers are going to run into problems with patient expectations. Patients have gotten used to coming to their doctor … with either no identifying documents or only their insurance card. They will need some education in advance by being informed when they call on the phone to schedule an appointment, or by signs in the waiting room, that you really need to have identifying documents with you.”

Ms. King encountered a case of identity theft at her own hospital involving two elderly women, one of whom had a public assistance card, while the other one didn't.

The two of them thought it would be all right if the woman without the card used her friend's public assistance card to get care. The identity theft was discovered by radiologist in the hospital who noticed that the women's scans were different.

She noted that under EMTALA, a hospital cannot delay performing the medical screening examination or stabilizing treatment, to inquire about insurance or payment, “but it can follow reasonable registration processes as long as the medical screening exam is not delayed by the process. So after the patient has been triaged and is sitting in the waiting room waiting to be seen for the medical screening exam, you can ask them for identifying information. But if they don't have identifying information, you can't turn them away. You have to provide the [screening exam] and necessary stabilizing treatment.”

Providers also should note that compliance with the Health Insurance Portability and Accountability Act (HIPAA) does not shield them from complying with the Red Flags Rule.

“One of the questions we get is, 'I already comply with HIPAA; aren't I done?' The answer is, 'Probably not,'” said Naomi Lefkowitz of the division of privacy and identity protection at the Federal Trade Commission.

“The Red Flags Rule is really about fraud protection, and HIPAA is more about data security. There is certainly some overlap, and to the extent that, for example, someone is checking photo IDs … to make sure that the person only has access to their [own] medical record, that's a policy that might do double duty under the client's identity theft program as far as verifying identification.

“But merely having the HIPAA program is probably not going to make [providers] compliant with Red Flags,” she added.

Mary Ellen Schneider contributed to this article.

WASHINGTON — The federal Red Flags Rule that requires creditors to check for identity theft may mean a few new procedures for office-based physicians, Patricia King said at the American Health Lawyers Association's annual meeting.

“Do health care providers have to comply with the Red Flags Rule? Yes, if they're [considered] creditors,” said Ms. King, assistant general counsel at Swedish Covenant Hospital in Chicago.

The rule requires creditors to establish formal identify theft prevention programs to protect consumers.

Aimed primarily at the financial industry, the regulation was originally scheduled to go into effect on Nov. 1, 2008. However, to give small businesses more time to prepare for compliance, the Federal Trade Commission (FTC) delayed enforcement until May 1, and then until Aug. 1, and most recently until Nov. 1.

Earlier this year, the AMA and physician specialty societies argued that physicians are not creditors because they bill insurance companies, not individual consumers, Ms. King said. “But the patient does get billed for copays, deductibles, and excluded services, so unless all those charges are collected up front, the health care provider is billing and possibly deferring payment for the cost of services.”

To address health care providers' concerns, the FTC has published guidance and developed a template for identity theft prevention program for low-risk creditors. (The information is available at www.ftc.gov/bcp/edu/pubs/articles/art11.shtm

Low-risk providers who see the same patients regularly can adopt a simple identity theft program, she said, adding that personnel involved with front desk, medical records, and patient account functions should be involved in the program.

Physicians need to identify which patient accounts will be covered by the rule—such as those patients who need to make repeat payments—and develop appropriate policies and procedures, Ms. King said.

“The final [Red Flags] rule had 26 examples of identity theft. Look through them and see which ones are most applicable to you.”

Providers also need to look at what information they collect when patients register. “Many of us need to re-think our standard registration procedures and beef them up,” said Ms. King. One example might be to ask for a photo ID.

Procedures for guarding against identity theft need to be approved by the organization's board of directors and overseen by senior management, according to the rule, “because this is intended to be a high-priority program, not something that's delegated to a lower-level manager.”

Typical “red flags” that practices should watch for include:

▸ Insurance information that cannot be verified;

▸ No identification;

▸ A photo ID that does not match the patient;

▸ Documents that appear to be altered or forged;

▸ Information given that is different from information already on file;

▸ An invalid Social Security number;

▸ A patient who receives a bill or an explanation of benefits for services he or she didn't receive;

▸ A patient who finds inaccurate information on their credit report or on a medical record; or

▸ A payer that says its patient information does not match that supplied by the provider.

When a particular patient raises one or more red flags, the practice has two options, according to Ms. King. It could refuse to provide service, although this might raise a problem under the Emergency Medical Treatment and Active Labor Act (EMTALA), a law that prohibits providers from not treating persons with questionable identification who require emergency care.

Or the practice could provide the service, but ask the patient to bring in the correct information to his or her next visit. Ms. King cautioned providers about freely providing medical records to a patient suspected of identity theft, because it could lead to more identity theft.

Patients also will have to be educated about the new rule, Ms. King said. “Providers are going to run into problems with patient expectations. Patients have gotten used to coming to their doctor … with either no identifying documents or only their insurance card. They will need some education in advance by being informed when they call on the phone to schedule an appointment, or by signs in the waiting room, that you really need to have identifying documents with you.”

Ms. King encountered a case of identity theft at her own hospital involving two elderly women, one of whom had a public assistance card, while the other one didn't.

The two of them thought it would be all right if the woman without the card used her friend's public assistance card to get care. The identity theft was discovered by radiologist in the hospital who noticed that the women's scans were different.

She noted that under EMTALA, a hospital cannot delay performing the medical screening examination or stabilizing treatment, to inquire about insurance or payment, “but it can follow reasonable registration processes as long as the medical screening exam is not delayed by the process. So after the patient has been triaged and is sitting in the waiting room waiting to be seen for the medical screening exam, you can ask them for identifying information. But if they don't have identifying information, you can't turn them away. You have to provide the [screening exam] and necessary stabilizing treatment.”

Providers also should note that compliance with the Health Insurance Portability and Accountability Act (HIPAA) does not shield them from complying with the Red Flags Rule.

“One of the questions we get is, 'I already comply with HIPAA; aren't I done?' The answer is, 'Probably not,'” said Naomi Lefkowitz of the division of privacy and identity protection at the Federal Trade Commission.

“The Red Flags Rule is really about fraud protection, and HIPAA is more about data security. There is certainly some overlap, and to the extent that, for example, someone is checking photo IDs … to make sure that the person only has access to their [own] medical record, that's a policy that might do double duty under the client's identity theft program as far as verifying identification.

“But merely having the HIPAA program is probably not going to make [providers] compliant with Red Flags,” she added.

Mary Ellen Schneider contributed to this article.

WASHINGTON — The federal Red Flags Rule that requires creditors to check for identity theft may mean a few new procedures for office-based physicians, Patricia King said at the American Health Lawyers Association's annual meeting.

“Do health care providers have to comply with the Red Flags Rule? Yes, if they're [considered] creditors,” said Ms. King, assistant general counsel at Swedish Covenant Hospital in Chicago.

The rule requires creditors to establish formal identify theft prevention programs to protect consumers.

Aimed primarily at the financial industry, the regulation was originally scheduled to go into effect on Nov. 1, 2008. However, to give small businesses more time to prepare for compliance, the Federal Trade Commission (FTC) delayed enforcement until May 1, and then until Aug. 1, and most recently until Nov. 1.

Earlier this year, the AMA and physician specialty societies argued that physicians are not creditors because they bill insurance companies, not individual consumers, Ms. King said. “But the patient does get billed for copays, deductibles, and excluded services, so unless all those charges are collected up front, the health care provider is billing and possibly deferring payment for the cost of services.”

To address health care providers' concerns, the FTC has published guidance and developed a template for identity theft prevention program for low-risk creditors. (The information is available at www.ftc.gov/bcp/edu/pubs/articles/art11.shtm

Low-risk providers who see the same patients regularly can adopt a simple identity theft program, she said, adding that personnel involved with front desk, medical records, and patient account functions should be involved in the program.

Physicians need to identify which patient accounts will be covered by the rule—such as those patients who need to make repeat payments—and develop appropriate policies and procedures, Ms. King said.

“The final [Red Flags] rule had 26 examples of identity theft. Look through them and see which ones are most applicable to you.”

Providers also need to look at what information they collect when patients register. “Many of us need to re-think our standard registration procedures and beef them up,” said Ms. King. One example might be to ask for a photo ID.

Procedures for guarding against identity theft need to be approved by the organization's board of directors and overseen by senior management, according to the rule, “because this is intended to be a high-priority program, not something that's delegated to a lower-level manager.”

Typical “red flags” that practices should watch for include:

▸ Insurance information that cannot be verified;

▸ No identification;

▸ A photo ID that does not match the patient;

▸ Documents that appear to be altered or forged;

▸ Information given that is different from information already on file;

▸ An invalid Social Security number;

▸ A patient who receives a bill or an explanation of benefits for services he or she didn't receive;

▸ A patient who finds inaccurate information on their credit report or on a medical record; or

▸ A payer that says its patient information does not match that supplied by the provider.

When a particular patient raises one or more red flags, the practice has two options, according to Ms. King. It could refuse to provide service, although this might raise a problem under the Emergency Medical Treatment and Active Labor Act (EMTALA), a law that prohibits providers from not treating persons with questionable identification who require emergency care.

Or the practice could provide the service, but ask the patient to bring in the correct information to his or her next visit. Ms. King cautioned providers about freely providing medical records to a patient suspected of identity theft, because it could lead to more identity theft.

Patients also will have to be educated about the new rule, Ms. King said. “Providers are going to run into problems with patient expectations. Patients have gotten used to coming to their doctor … with either no identifying documents or only their insurance card. They will need some education in advance by being informed when they call on the phone to schedule an appointment, or by signs in the waiting room, that you really need to have identifying documents with you.”

Ms. King encountered a case of identity theft at her own hospital involving two elderly women, one of whom had a public assistance card, while the other one didn't.

The two of them thought it would be all right if the woman without the card used her friend's public assistance card to get care. The identity theft was discovered by radiologist in the hospital who noticed that the women's scans were different.

She noted that under EMTALA, a hospital cannot delay performing the medical screening examination or stabilizing treatment, to inquire about insurance or payment, “but it can follow reasonable registration processes as long as the medical screening exam is not delayed by the process. So after the patient has been triaged and is sitting in the waiting room waiting to be seen for the medical screening exam, you can ask them for identifying information. But if they don't have identifying information, you can't turn them away. You have to provide the [screening exam] and necessary stabilizing treatment.”

Providers also should note that compliance with the Health Insurance Portability and Accountability Act (HIPAA) does not shield them from complying with the Red Flags Rule.

“One of the questions we get is, 'I already comply with HIPAA; aren't I done?' The answer is, 'Probably not,'” said Naomi Lefkowitz of the division of privacy and identity protection at the Federal Trade Commission.

“The Red Flags Rule is really about fraud protection, and HIPAA is more about data security. There is certainly some overlap, and to the extent that, for example, someone is checking photo IDs … to make sure that the person only has access to their [own] medical record, that's a policy that might do double duty under the client's identity theft program as far as verifying identification.

“But merely having the HIPAA program is probably not going to make [providers] compliant with Red Flags,” she added.

Mary Ellen Schneider contributed to this article.

WASHINGTON — A combination of metformin and the oral contraceptive Ortho Tri-Cyclen improves lipid profiles more than does an oral contraceptive alone in patients with polycystic ovary syndrome, according to preliminary data from a small pilot study.

“Insulin resistance with compensatory hyperinsulinemia plays a critical role in PCOS,” Dr. Paulina Essah said at the annual meeting of the Androgen Excess and PCOS Society. “Traditionally, oral contraceptives have been the treatment for PCOS, but oral contraceptives may worsen or have no effect on insulin sensitivity. There are also very little data on the effects of the combination of metformin and oral contraceptives on insulin resistance and cardiovascular risk,” said Dr. Essah of the division of endocrinology and metabolism at Virginia Commonwealth University, Richmond.

In this randomized, double-blind, placebo-controlled study, Dr. Essah and colleagues assigned 17 women with PCOS to an oral contraceptive plus 500 mg of metformin three times daily or an oral contraceptive plus a placebo three times daily. Ortho Tri-Cyclen (ethinyl estradiol 35 mcg/norgestimate 0.25 mg) was chosen because it is commonly used in the United States, Dr. Essah said.

All subjects underwent 2-hour oral glucose tolerance testing, frequently sampled intravenous glucose tolerance testing, and brachial artery flow-mediated dilatation at baseline and after 3 months. The subjects' mean age was 24.9, and their mean body mass index was 33.7.

After 3 months, the researchers found no difference between the two groups in weight, BMI, fasting insulin, or fasting glucose measurements. However, the combination oral contraceptive-metformin group experienced a trend toward higher HDL cholesterol (55.6 vs. 47.6 mg/dL) and lower triglyceride levels (86.8 vs. 152.7 mg/dL) compared with the group that took oral contraceptives alone. The combination group also demonstrated a significant increase in acute insulin response to glucose.

The study was funded by the National Institutes of Health. Dr. Essah said she had no financial conflicts of interest.

WASHINGTON — A combination of metformin and the oral contraceptive Ortho Tri-Cyclen improves lipid profiles more than does an oral contraceptive alone in patients with polycystic ovary syndrome, according to preliminary data from a small pilot study.

“Insulin resistance with compensatory hyperinsulinemia plays a critical role in PCOS,” Dr. Paulina Essah said at the annual meeting of the Androgen Excess and PCOS Society. “Traditionally, oral contraceptives have been the treatment for PCOS, but oral contraceptives may worsen or have no effect on insulin sensitivity. There are also very little data on the effects of the combination of metformin and oral contraceptives on insulin resistance and cardiovascular risk,” said Dr. Essah of the division of endocrinology and metabolism at Virginia Commonwealth University, Richmond.

In this randomized, double-blind, placebo-controlled study, Dr. Essah and colleagues assigned 17 women with PCOS to an oral contraceptive plus 500 mg of metformin three times daily or an oral contraceptive plus a placebo three times daily. Ortho Tri-Cyclen (ethinyl estradiol 35 mcg/norgestimate 0.25 mg) was chosen because it is commonly used in the United States, Dr. Essah said.

All subjects underwent 2-hour oral glucose tolerance testing, frequently sampled intravenous glucose tolerance testing, and brachial artery flow-mediated dilatation at baseline and after 3 months. The subjects' mean age was 24.9, and their mean body mass index was 33.7.

After 3 months, the researchers found no difference between the two groups in weight, BMI, fasting insulin, or fasting glucose measurements. However, the combination oral contraceptive-metformin group experienced a trend toward higher HDL cholesterol (55.6 vs. 47.6 mg/dL) and lower triglyceride levels (86.8 vs. 152.7 mg/dL) compared with the group that took oral contraceptives alone. The combination group also demonstrated a significant increase in acute insulin response to glucose.

The study was funded by the National Institutes of Health. Dr. Essah said she had no financial conflicts of interest.

WASHINGTON — A combination of metformin and the oral contraceptive Ortho Tri-Cyclen improves lipid profiles more than does an oral contraceptive alone in patients with polycystic ovary syndrome, according to preliminary data from a small pilot study.

“Insulin resistance with compensatory hyperinsulinemia plays a critical role in PCOS,” Dr. Paulina Essah said at the annual meeting of the Androgen Excess and PCOS Society. “Traditionally, oral contraceptives have been the treatment for PCOS, but oral contraceptives may worsen or have no effect on insulin sensitivity. There are also very little data on the effects of the combination of metformin and oral contraceptives on insulin resistance and cardiovascular risk,” said Dr. Essah of the division of endocrinology and metabolism at Virginia Commonwealth University, Richmond.

In this randomized, double-blind, placebo-controlled study, Dr. Essah and colleagues assigned 17 women with PCOS to an oral contraceptive plus 500 mg of metformin three times daily or an oral contraceptive plus a placebo three times daily. Ortho Tri-Cyclen (ethinyl estradiol 35 mcg/norgestimate 0.25 mg) was chosen because it is commonly used in the United States, Dr. Essah said.

All subjects underwent 2-hour oral glucose tolerance testing, frequently sampled intravenous glucose tolerance testing, and brachial artery flow-mediated dilatation at baseline and after 3 months. The subjects' mean age was 24.9, and their mean body mass index was 33.7.

After 3 months, the researchers found no difference between the two groups in weight, BMI, fasting insulin, or fasting glucose measurements. However, the combination oral contraceptive-metformin group experienced a trend toward higher HDL cholesterol (55.6 vs. 47.6 mg/dL) and lower triglyceride levels (86.8 vs. 152.7 mg/dL) compared with the group that took oral contraceptives alone. The combination group also demonstrated a significant increase in acute insulin response to glucose.

The study was funded by the National Institutes of Health. Dr. Essah said she had no financial conflicts of interest.

WASHINGTON — People who are insufficient in vitamin D lose less weight on a low-calorie diet than do those with higher vitamin D levels, a small study has found. But whether or not the low vitamin D level is the cause of less weight loss remains unclear.

“Vitamin D deficiency is closely linked with obesity,” Dr. Shalamar Sibley of the University of Minnesota, Minneapolis, the study's lead author, said at the annual meeting of the Endocrine Society. “But the cause-and-effect nature of this relationship is unclear. This association may be due to sequestration of vitamin D in adipose tissue, and this is a likely contributor. But the other way to look at the question is, is it possible that the lack of vitamin D is promoting obesity or inhibiting weight loss?”

Several small studies have addressed this issue, according to Dr. Sibley.

One study of 60 overweight or obese women comparing a cereal diet with a vegetable diet found that women with higher baseline levels of 25-hydroxyvitamin D lost more weight than did those with lower levels (Br. J. Nutr. 2008;100:269-72).

Another study of 24 overweight women designed to look at the effects of dietary versus supplemental calcium on total energy expenditure with a hypocaloric diet found that women with higher 25-hydroxyvitamin D levels showed increased thermic activity following meal consumption, compared with those with lower vitamin D levels (Obesity 2008;16:1566-72).

To further explore the issue, Dr. Sibley and colleagues recruited 20 women and 18 men with a body mass index of at least 27 kg/m

Participants were screened at baseline to assess usual dietary intake, physical activity, and anthropomorphic and body composition measurements, including height, weight, fat and tissue mass (with dual-energy x-ray absorptiometry), abdominal fat mass distribution (with single-slice CT), and plasma 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D. On average, participants were in the “insufficient” range for vitamin D, but were not outright deficient, Dr. Sibley said.

At the end of the study, women had lost an average of about 4 kg and men about 7 kg. The researchers found levels of both forms of vitamin D at baseline predicted the magnitude of weight loss, after adjustment for sex.

Dr. Sibley added that 1,25-dihydroxyvitamin D “did in fact predict abdominal fat loss in particular, and both forms [of vitamin D] predicted subsequent fat mass loss in abdominal subcutaneous compartments.”

Furthermore, “no significant correlations between baseline BMI, age, or season with baseline vitamin D concentrations or weight loss” were shown, according to Dr. Sibley.

In addition, 1,25-dihydroxyvitamin D levels did not change from baseline to post-weight loss; neither did 25-hydroxyvitamin D levels, she said. Both 1,25-dihydroxy and 25-hydroxyvitamin D levels were closely correlated with each other, both at baseline and after weight loss.

The study's limitations were that it was observational, and that the results could be confounded by the “healthy cohort” effect, she said.

The study was sponsored by the National Institutes of Health, the University of Minnesota, and the Pennock Family Endowment.

Dr. Sibley said he had no relevant conflicts of interest to disclose.

WASHINGTON — People who are insufficient in vitamin D lose less weight on a low-calorie diet than do those with higher vitamin D levels, a small study has found. But whether or not the low vitamin D level is the cause of less weight loss remains unclear.

“Vitamin D deficiency is closely linked with obesity,” Dr. Shalamar Sibley of the University of Minnesota, Minneapolis, the study's lead author, said at the annual meeting of the Endocrine Society. “But the cause-and-effect nature of this relationship is unclear. This association may be due to sequestration of vitamin D in adipose tissue, and this is a likely contributor. But the other way to look at the question is, is it possible that the lack of vitamin D is promoting obesity or inhibiting weight loss?”

Several small studies have addressed this issue, according to Dr. Sibley.

One study of 60 overweight or obese women comparing a cereal diet with a vegetable diet found that women with higher baseline levels of 25-hydroxyvitamin D lost more weight than did those with lower levels (Br. J. Nutr. 2008;100:269-72).

Another study of 24 overweight women designed to look at the effects of dietary versus supplemental calcium on total energy expenditure with a hypocaloric diet found that women with higher 25-hydroxyvitamin D levels showed increased thermic activity following meal consumption, compared with those with lower vitamin D levels (Obesity 2008;16:1566-72).

To further explore the issue, Dr. Sibley and colleagues recruited 20 women and 18 men with a body mass index of at least 27 kg/m

Participants were screened at baseline to assess usual dietary intake, physical activity, and anthropomorphic and body composition measurements, including height, weight, fat and tissue mass (with dual-energy x-ray absorptiometry), abdominal fat mass distribution (with single-slice CT), and plasma 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D. On average, participants were in the “insufficient” range for vitamin D, but were not outright deficient, Dr. Sibley said.

At the end of the study, women had lost an average of about 4 kg and men about 7 kg. The researchers found levels of both forms of vitamin D at baseline predicted the magnitude of weight loss, after adjustment for sex.

Dr. Sibley added that 1,25-dihydroxyvitamin D “did in fact predict abdominal fat loss in particular, and both forms [of vitamin D] predicted subsequent fat mass loss in abdominal subcutaneous compartments.”

Furthermore, “no significant correlations between baseline BMI, age, or season with baseline vitamin D concentrations or weight loss” were shown, according to Dr. Sibley.

In addition, 1,25-dihydroxyvitamin D levels did not change from baseline to post-weight loss; neither did 25-hydroxyvitamin D levels, she said. Both 1,25-dihydroxy and 25-hydroxyvitamin D levels were closely correlated with each other, both at baseline and after weight loss.

The study's limitations were that it was observational, and that the results could be confounded by the “healthy cohort” effect, she said.

The study was sponsored by the National Institutes of Health, the University of Minnesota, and the Pennock Family Endowment.

Dr. Sibley said he had no relevant conflicts of interest to disclose.

WASHINGTON — People who are insufficient in vitamin D lose less weight on a low-calorie diet than do those with higher vitamin D levels, a small study has found. But whether or not the low vitamin D level is the cause of less weight loss remains unclear.

“Vitamin D deficiency is closely linked with obesity,” Dr. Shalamar Sibley of the University of Minnesota, Minneapolis, the study's lead author, said at the annual meeting of the Endocrine Society. “But the cause-and-effect nature of this relationship is unclear. This association may be due to sequestration of vitamin D in adipose tissue, and this is a likely contributor. But the other way to look at the question is, is it possible that the lack of vitamin D is promoting obesity or inhibiting weight loss?”

Several small studies have addressed this issue, according to Dr. Sibley.

One study of 60 overweight or obese women comparing a cereal diet with a vegetable diet found that women with higher baseline levels of 25-hydroxyvitamin D lost more weight than did those with lower levels (Br. J. Nutr. 2008;100:269-72).

Another study of 24 overweight women designed to look at the effects of dietary versus supplemental calcium on total energy expenditure with a hypocaloric diet found that women with higher 25-hydroxyvitamin D levels showed increased thermic activity following meal consumption, compared with those with lower vitamin D levels (Obesity 2008;16:1566-72).

To further explore the issue, Dr. Sibley and colleagues recruited 20 women and 18 men with a body mass index of at least 27 kg/m

Participants were screened at baseline to assess usual dietary intake, physical activity, and anthropomorphic and body composition measurements, including height, weight, fat and tissue mass (with dual-energy x-ray absorptiometry), abdominal fat mass distribution (with single-slice CT), and plasma 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D. On average, participants were in the “insufficient” range for vitamin D, but were not outright deficient, Dr. Sibley said.

At the end of the study, women had lost an average of about 4 kg and men about 7 kg. The researchers found levels of both forms of vitamin D at baseline predicted the magnitude of weight loss, after adjustment for sex.

Dr. Sibley added that 1,25-dihydroxyvitamin D “did in fact predict abdominal fat loss in particular, and both forms [of vitamin D] predicted subsequent fat mass loss in abdominal subcutaneous compartments.”

Furthermore, “no significant correlations between baseline BMI, age, or season with baseline vitamin D concentrations or weight loss” were shown, according to Dr. Sibley.

In addition, 1,25-dihydroxyvitamin D levels did not change from baseline to post-weight loss; neither did 25-hydroxyvitamin D levels, she said. Both 1,25-dihydroxy and 25-hydroxyvitamin D levels were closely correlated with each other, both at baseline and after weight loss.

The study's limitations were that it was observational, and that the results could be confounded by the “healthy cohort” effect, she said.

The study was sponsored by the National Institutes of Health, the University of Minnesota, and the Pennock Family Endowment.

Dr. Sibley said he had no relevant conflicts of interest to disclose.

WASHINGTON — The upcoming ICD-10 diagnosis and procedure coding system is more complicated than was its predecessor, ICD-9, but it will allow for a greater level of clinical detail and will be better able to keep up with advances in technology, according to several speakers at a meeting sponsored by the American Health Information Management Association.

“ICD-9 badly needs to be replaced,” said Nelly Leon-Chisen, director of coding and classification at the American Hospital Association. “It's 30 years old, and the terminology and classification of some conditions are obsolete.”

There are two parts to ICD-10, formally known as the International Classification of Diseases, 10th revision, which goes into effect in the United States on Oct. 1, 2013: ICD-10-CM, which is the clinical modification of the World Health Organization's ICD-10 diagnostic coding system; and ICD-10-PCS, an inpatient procedural coding system developed under contract to the Centers for Medicare and Medicaid Services.

ICD-10 “will have better data for evaluating and improving quality of care. It will provide codes for a more complete picture,” she added, noting that the new code set will allow health officials to be “better able to track and respond to global health threats.”

Because ICD-10 can more precisely document diagnoses and procedures, it will bring better justification of medical necessity for billing purposes, “but not from day 1,” said Ms. Leon-Chisen. “It will take a little while” for people to adjust to the new codes. The new system also may reduce opportunities for fraud.

Ms. Leon-Chisen outlined a few basic differences between the two diagnosis codes:

▸ ICD-9 codes contain 3–5 characters, whereas ICD-10 contains 3–7 characters.

▸ In ICD-9 codes, the first character can be alphabetic or numeric, but in ICD-10, the first character is always alphabetic.

▸ ICD-10 codes can include the use of a placeholder “x,” whereas ICD-9 codes cannot.

She also gave an example, showing the differences between the two revisions. Under the ICD-9 coding system, a patient with a pressure ulcer on the right buttock might receive a diagnosis code of 707.05, “pressure ulcer, buttock.” Under ICD-10, the same patient would get L89.111, “decubitus ulcer of right buttock limited to breakdown of the skin.” A pressure ulcer on the left buttock or a more severe one including necrosis of the bone would get a different ICD-10 code.

Sue Bowman, director of coding policy and compliance for the American Health Information Management Association, noted that ICD-10-PCS can have even more complexities. For example, under ICD-9, there is only one code for artery repair; under ICD-10-PCS, there are 276 codes. However, “once you work with it, you're struck by the logic of the system,” she said. “It's really not that difficult.” Under the ICD-10 code structure, each character has a specific meaning.

Ms. Bowman pointed out some of the differences between procedure codes under the two revisions. For example, ICD-9 procedure codes have 3–4 characters, whereas ICD-10-PCS codes always have 7 characters. Also, all ICD-9 procedure code characters are numeric, whereas ICD-10-PCS code characters can each be alphabetic or numeric.

As an example of the difference in procedure codes, she cited the ICD-9 code 17.43 for “percutaneous robotic assisted procedure,” versus 8E093CZ, the ICD-10-PCS code for “robotic assisted procedure of head and neck region, percutaneous approach.”

One issue that Medicare officials and others dealing with ICD-10 are wrangling with, Ms. Bowman noted, is when—or whether—both ICD-9 and ICD-10 should be “frozen”—that is, when no more new codes should be added to either code set so that they will be stable while people are making the changeover.

ICD-10 will bring better justification of medical necessity for billing purposes.

Source MS. LEON-CHISEN

ICD-10 Resources

Sue Bowman of the American Health Information Management Association recommended the following resources for more information on ICD-10:

American Health Information Management Association

www.ahima.org/icd10

American Hospital Association's ICD-10 Resource Center

www.ahacentraloffice.com/ahacentraloffice_app/ICD-10/ICD-10.jsp

Centers for Medicare and Medicaid Services

www.cms.hhs.gov/ICD10

National Center for Health Statistics/CDC

www.cdc.gov/nchs/about/otheract/icd9/abticd10.htm

WASHINGTON — The upcoming ICD-10 diagnosis and procedure coding system is more complicated than was its predecessor, ICD-9, but it will allow for a greater level of clinical detail and will be better able to keep up with advances in technology, according to several speakers at a meeting sponsored by the American Health Information Management Association.

“ICD-9 badly needs to be replaced,” said Nelly Leon-Chisen, director of coding and classification at the American Hospital Association. “It's 30 years old, and the terminology and classification of some conditions are obsolete.”

There are two parts to ICD-10, formally known as the International Classification of Diseases, 10th revision, which goes into effect in the United States on Oct. 1, 2013: ICD-10-CM, which is the clinical modification of the World Health Organization's ICD-10 diagnostic coding system; and ICD-10-PCS, an inpatient procedural coding system developed under contract to the Centers for Medicare and Medicaid Services.

ICD-10 “will have better data for evaluating and improving quality of care. It will provide codes for a more complete picture,” she added, noting that the new code set will allow health officials to be “better able to track and respond to global health threats.”

Because ICD-10 can more precisely document diagnoses and procedures, it will bring better justification of medical necessity for billing purposes, “but not from day 1,” said Ms. Leon-Chisen. “It will take a little while” for people to adjust to the new codes. The new system also may reduce opportunities for fraud.

Ms. Leon-Chisen outlined a few basic differences between the two diagnosis codes:

▸ ICD-9 codes contain 3–5 characters, whereas ICD-10 contains 3–7 characters.

▸ In ICD-9 codes, the first character can be alphabetic or numeric, but in ICD-10, the first character is always alphabetic.

▸ ICD-10 codes can include the use of a placeholder “x,” whereas ICD-9 codes cannot.

She also gave an example, showing the differences between the two revisions. Under the ICD-9 coding system, a patient with a pressure ulcer on the right buttock might receive a diagnosis code of 707.05, “pressure ulcer, buttock.” Under ICD-10, the same patient would get L89.111, “decubitus ulcer of right buttock limited to breakdown of the skin.” A pressure ulcer on the left buttock or a more severe one including necrosis of the bone would get a different ICD-10 code.

Sue Bowman, director of coding policy and compliance for the American Health Information Management Association, noted that ICD-10-PCS can have even more complexities. For example, under ICD-9, there is only one code for artery repair; under ICD-10-PCS, there are 276 codes. However, “once you work with it, you're struck by the logic of the system,” she said. “It's really not that difficult.” Under the ICD-10 code structure, each character has a specific meaning.

Ms. Bowman pointed out some of the differences between procedure codes under the two revisions. For example, ICD-9 procedure codes have 3–4 characters, whereas ICD-10-PCS codes always have 7 characters. Also, all ICD-9 procedure code characters are numeric, whereas ICD-10-PCS code characters can each be alphabetic or numeric.

As an example of the difference in procedure codes, she cited the ICD-9 code 17.43 for “percutaneous robotic assisted procedure,” versus 8E093CZ, the ICD-10-PCS code for “robotic assisted procedure of head and neck region, percutaneous approach.”

One issue that Medicare officials and others dealing with ICD-10 are wrangling with, Ms. Bowman noted, is when—or whether—both ICD-9 and ICD-10 should be “frozen”—that is, when no more new codes should be added to either code set so that they will be stable while people are making the changeover.

ICD-10 will bring better justification of medical necessity for billing purposes.

Source MS. LEON-CHISEN

ICD-10 Resources

Sue Bowman of the American Health Information Management Association recommended the following resources for more information on ICD-10:

American Health Information Management Association

www.ahima.org/icd10

American Hospital Association's ICD-10 Resource Center

www.ahacentraloffice.com/ahacentraloffice_app/ICD-10/ICD-10.jsp

Centers for Medicare and Medicaid Services

www.cms.hhs.gov/ICD10

National Center for Health Statistics/CDC

www.cdc.gov/nchs/about/otheract/icd9/abticd10.htm

WASHINGTON — The upcoming ICD-10 diagnosis and procedure coding system is more complicated than was its predecessor, ICD-9, but it will allow for a greater level of clinical detail and will be better able to keep up with advances in technology, according to several speakers at a meeting sponsored by the American Health Information Management Association.

“ICD-9 badly needs to be replaced,” said Nelly Leon-Chisen, director of coding and classification at the American Hospital Association. “It's 30 years old, and the terminology and classification of some conditions are obsolete.”

There are two parts to ICD-10, formally known as the International Classification of Diseases, 10th revision, which goes into effect in the United States on Oct. 1, 2013: ICD-10-CM, which is the clinical modification of the World Health Organization's ICD-10 diagnostic coding system; and ICD-10-PCS, an inpatient procedural coding system developed under contract to the Centers for Medicare and Medicaid Services.

ICD-10 “will have better data for evaluating and improving quality of care. It will provide codes for a more complete picture,” she added, noting that the new code set will allow health officials to be “better able to track and respond to global health threats.”

Because ICD-10 can more precisely document diagnoses and procedures, it will bring better justification of medical necessity for billing purposes, “but not from day 1,” said Ms. Leon-Chisen. “It will take a little while” for people to adjust to the new codes. The new system also may reduce opportunities for fraud.

Ms. Leon-Chisen outlined a few basic differences between the two diagnosis codes:

▸ ICD-9 codes contain 3–5 characters, whereas ICD-10 contains 3–7 characters.

▸ In ICD-9 codes, the first character can be alphabetic or numeric, but in ICD-10, the first character is always alphabetic.

▸ ICD-10 codes can include the use of a placeholder “x,” whereas ICD-9 codes cannot.

She also gave an example, showing the differences between the two revisions. Under the ICD-9 coding system, a patient with a pressure ulcer on the right buttock might receive a diagnosis code of 707.05, “pressure ulcer, buttock.” Under ICD-10, the same patient would get L89.111, “decubitus ulcer of right buttock limited to breakdown of the skin.” A pressure ulcer on the left buttock or a more severe one including necrosis of the bone would get a different ICD-10 code.

Sue Bowman, director of coding policy and compliance for the American Health Information Management Association, noted that ICD-10-PCS can have even more complexities. For example, under ICD-9, there is only one code for artery repair; under ICD-10-PCS, there are 276 codes. However, “once you work with it, you're struck by the logic of the system,” she said. “It's really not that difficult.” Under the ICD-10 code structure, each character has a specific meaning.

Ms. Bowman pointed out some of the differences between procedure codes under the two revisions. For example, ICD-9 procedure codes have 3–4 characters, whereas ICD-10-PCS codes always have 7 characters. Also, all ICD-9 procedure code characters are numeric, whereas ICD-10-PCS code characters can each be alphabetic or numeric.

As an example of the difference in procedure codes, she cited the ICD-9 code 17.43 for “percutaneous robotic assisted procedure,” versus 8E093CZ, the ICD-10-PCS code for “robotic assisted procedure of head and neck region, percutaneous approach.”

One issue that Medicare officials and others dealing with ICD-10 are wrangling with, Ms. Bowman noted, is when—or whether—both ICD-9 and ICD-10 should be “frozen”—that is, when no more new codes should be added to either code set so that they will be stable while people are making the changeover.

ICD-10 will bring better justification of medical necessity for billing purposes.

Source MS. LEON-CHISEN

ICD-10 Resources

Sue Bowman of the American Health Information Management Association recommended the following resources for more information on ICD-10:

American Health Information Management Association

www.ahima.org/icd10

American Hospital Association's ICD-10 Resource Center

www.ahacentraloffice.com/ahacentraloffice_app/ICD-10/ICD-10.jsp

Centers for Medicare and Medicaid Services

www.cms.hhs.gov/ICD10

National Center for Health Statistics/CDC

www.cdc.gov/nchs/about/otheract/icd9/abticd10.htm