Joyce Frieden

Washington — Exenatide helps increase weight loss in obese nondiabetic patients who also are following a diet and exercise program, recent study results suggest.

Dr. Michael Trautmann, a researcher at Eli Lilly & Co., and his colleagues conducted a double-blind, placebo-controlled study of 152 patients with a mean body mass index of 39.6 kg/m

As is typical with obesity studies, 35% of patients originally enrolled did not complete the study, Dr. Trautmann said.

Patients were randomized to receive placebo or 10 mcg exenatide twice daily. Lifestyle modification—comprising a balanced, calorie-restricted diet; moderate increase in physical activity, with a target of 150 minutes per week; and counseling sessions at 4-week intervals—was prescribed for all participants, Dr. Trautmann said at the annual meeting of the Endocrine Society.

The study's primary end point was change in body weight. Secondary end points included changes in glucose tolerance, physical activity, and dietary behavior. After 24 weeks, a significantly higher percentage of exenatide-treated patients had lost at least 5% of their body weight, compared with patients on placebo (31% vs. 17%), Dr. Trautmann said. All of the patients who had lost 10% or more of their body weight were in the exenatide group.

The average weight loss in the placebo group was 1.6 kg. In the exenatide group, the average weight loss was 5.1 kg, “a highly significant difference,” he said.

In subgroup analysis, “due to the small sample size, one cannot conclude too much from these results, but the trend indicates that in patients with mild obesity—with a BMI of less than 35 kg/m

Among patients with impaired glucose tolerance at baseline, three-quarters who were on exenatide normalized their glucose levels, compared with slightly more than half of the patients on placebo, he said. “Clearly, weight loss is known to improve glucose tolerance.”

Side effects with exenatide included mild to moderate nausea, which was experienced by 25% of those in the exenatide group, compared with 4% of those on placebo. The nausea rate in the exenatide group was lower than has been seen in type 2 diabetes patients who are taking exenatide, he said.

No hypoglycemia occurred among patients on exenatide, “again confirming the strict glucose dependence of the insulin secretion induction by GLP-1 receptor agonists,” Dr. Trautmann said.

The study was sponsored by Eli Lilly and Amylin Pharmaceuticals.

All of the patients who had lost at least 10% of their body weight were in the exenatide treatment group.

Source DR. TRAUTMANN

Washington — Exenatide helps increase weight loss in obese nondiabetic patients who also are following a diet and exercise program, recent study results suggest.

Dr. Michael Trautmann, a researcher at Eli Lilly & Co., and his colleagues conducted a double-blind, placebo-controlled study of 152 patients with a mean body mass index of 39.6 kg/m

As is typical with obesity studies, 35% of patients originally enrolled did not complete the study, Dr. Trautmann said.

Patients were randomized to receive placebo or 10 mcg exenatide twice daily. Lifestyle modification—comprising a balanced, calorie-restricted diet; moderate increase in physical activity, with a target of 150 minutes per week; and counseling sessions at 4-week intervals—was prescribed for all participants, Dr. Trautmann said at the annual meeting of the Endocrine Society.

The study's primary end point was change in body weight. Secondary end points included changes in glucose tolerance, physical activity, and dietary behavior. After 24 weeks, a significantly higher percentage of exenatide-treated patients had lost at least 5% of their body weight, compared with patients on placebo (31% vs. 17%), Dr. Trautmann said. All of the patients who had lost 10% or more of their body weight were in the exenatide group.

The average weight loss in the placebo group was 1.6 kg. In the exenatide group, the average weight loss was 5.1 kg, “a highly significant difference,” he said.

In subgroup analysis, “due to the small sample size, one cannot conclude too much from these results, but the trend indicates that in patients with mild obesity—with a BMI of less than 35 kg/m

Among patients with impaired glucose tolerance at baseline, three-quarters who were on exenatide normalized their glucose levels, compared with slightly more than half of the patients on placebo, he said. “Clearly, weight loss is known to improve glucose tolerance.”

Side effects with exenatide included mild to moderate nausea, which was experienced by 25% of those in the exenatide group, compared with 4% of those on placebo. The nausea rate in the exenatide group was lower than has been seen in type 2 diabetes patients who are taking exenatide, he said.

No hypoglycemia occurred among patients on exenatide, “again confirming the strict glucose dependence of the insulin secretion induction by GLP-1 receptor agonists,” Dr. Trautmann said.

The study was sponsored by Eli Lilly and Amylin Pharmaceuticals.

All of the patients who had lost at least 10% of their body weight were in the exenatide treatment group.

Source DR. TRAUTMANN

Washington — Exenatide helps increase weight loss in obese nondiabetic patients who also are following a diet and exercise program, recent study results suggest.

Dr. Michael Trautmann, a researcher at Eli Lilly & Co., and his colleagues conducted a double-blind, placebo-controlled study of 152 patients with a mean body mass index of 39.6 kg/m

As is typical with obesity studies, 35% of patients originally enrolled did not complete the study, Dr. Trautmann said.

Patients were randomized to receive placebo or 10 mcg exenatide twice daily. Lifestyle modification—comprising a balanced, calorie-restricted diet; moderate increase in physical activity, with a target of 150 minutes per week; and counseling sessions at 4-week intervals—was prescribed for all participants, Dr. Trautmann said at the annual meeting of the Endocrine Society.

The study's primary end point was change in body weight. Secondary end points included changes in glucose tolerance, physical activity, and dietary behavior. After 24 weeks, a significantly higher percentage of exenatide-treated patients had lost at least 5% of their body weight, compared with patients on placebo (31% vs. 17%), Dr. Trautmann said. All of the patients who had lost 10% or more of their body weight were in the exenatide group.

The average weight loss in the placebo group was 1.6 kg. In the exenatide group, the average weight loss was 5.1 kg, “a highly significant difference,” he said.

In subgroup analysis, “due to the small sample size, one cannot conclude too much from these results, but the trend indicates that in patients with mild obesity—with a BMI of less than 35 kg/m

Among patients with impaired glucose tolerance at baseline, three-quarters who were on exenatide normalized their glucose levels, compared with slightly more than half of the patients on placebo, he said. “Clearly, weight loss is known to improve glucose tolerance.”

Side effects with exenatide included mild to moderate nausea, which was experienced by 25% of those in the exenatide group, compared with 4% of those on placebo. The nausea rate in the exenatide group was lower than has been seen in type 2 diabetes patients who are taking exenatide, he said.

No hypoglycemia occurred among patients on exenatide, “again confirming the strict glucose dependence of the insulin secretion induction by GLP-1 receptor agonists,” Dr. Trautmann said.

The study was sponsored by Eli Lilly and Amylin Pharmaceuticals.

All of the patients who had lost at least 10% of their body weight were in the exenatide treatment group.

Source DR. TRAUTMANN

WASHINGTON — Electronic health records systems should be precertified to comply with Recovery Act requirements even before the government issues its final certification rules, a federal advisory panel recommends.

Since the final rules may not go into effect until next year, “the suggestion is to establish something called preliminary certification based on the assumption that vendors would be willing to take a reasonable risk that what has been proposed in the regulatory process is probably pretty close to what is going to come out the other side,” Paul Egerman, cochair of the certification/adoption workgroup of the Health and Human Services Department's Health Information Technology (HIT) Policy Committee, said at a meeting of the committee.

That way, vendors could start certifying based on the proposed criteria, “and when the regulatory process is completed, hopefully there's only a very small adjustment that we can tack on” before the software becomes HHS-certified, he added.

Whether and when HHS will adopt its committee's recommendation is uncertain at this point, according to Dr. David Blumenthal, the committee's chair and national HIT coordinator at HHS.

“We'll have to do this in a deliberate way that includes public comment and takes the necessary steps within the department and in the federal government generally,” he said during a conference call. “I think the rule-making process we have to go through will make it very difficult to react in that time frame.”

Under the Recovery Act, formally known as the American Recovery and Reinvestment Act, $19 billion has been set aside to encourage HIT adoption, including electronic health records. The money includes $44,000 in financial incentives for each physician who purchases a certified EHR system and makes “meaningful use” of it by 2011; physicians who adopt EHRs later will also get an incentive, but the amount will diminish gradually over several years and disappear completely after 2014. Providers who have not adopted EHRs by 2015 will see reductions in their Medicare reimbursement.

Currently, only the Certification Commission for Health Information Technology (CCHIT) can certify an EHR; however, certification/adoption workgroup members emphasized the need for more than one certifying organization and recommended that any certifying groups be distinct from those that set the certification criteria.

To help physicians and hospitals get ready to implement EHRs, the Obama administration is making $598 million in Recovery Act funds available now to establish 70 HIT “extension centers” that will provide hospitals and clinicians with hands-on technical assistance in the selection, acquisition, implementation, and meaningful use of certified EHRs. The extension center grants will be awarded on a rolling basis, with the first being issued in fiscal year 2010, which begins on Oct. 1. Another $564 million is also being made available in fiscal 2010 to states and state-designated groups to implement health information exchange.

In other business at the meeting, the committee also refined its proposed definition of certification. The new definition reads, “HHS certification means that a system is able to support the achievement of privacy and interoperability, and that the system is able to support the achievement of the meaningful use results that the government expects.”

The workgroup on the definition of meaningful use outlined its plans, which include a meeting to address gaps in meaningful use criteria. Specifically, the group will meet in October to hear from specialist physicians about how to make the criteria relevant to them. They also want to address the needs of smaller practices and hospitals, and of safety net providers.

WASHINGTON — Electronic health records systems should be precertified to comply with Recovery Act requirements even before the government issues its final certification rules, a federal advisory panel recommends.

Since the final rules may not go into effect until next year, “the suggestion is to establish something called preliminary certification based on the assumption that vendors would be willing to take a reasonable risk that what has been proposed in the regulatory process is probably pretty close to what is going to come out the other side,” Paul Egerman, cochair of the certification/adoption workgroup of the Health and Human Services Department's Health Information Technology (HIT) Policy Committee, said at a meeting of the committee.

That way, vendors could start certifying based on the proposed criteria, “and when the regulatory process is completed, hopefully there's only a very small adjustment that we can tack on” before the software becomes HHS-certified, he added.

Whether and when HHS will adopt its committee's recommendation is uncertain at this point, according to Dr. David Blumenthal, the committee's chair and national HIT coordinator at HHS.

“We'll have to do this in a deliberate way that includes public comment and takes the necessary steps within the department and in the federal government generally,” he said during a conference call. “I think the rule-making process we have to go through will make it very difficult to react in that time frame.”

Under the Recovery Act, formally known as the American Recovery and Reinvestment Act, $19 billion has been set aside to encourage HIT adoption, including electronic health records. The money includes $44,000 in financial incentives for each physician who purchases a certified EHR system and makes “meaningful use” of it by 2011; physicians who adopt EHRs later will also get an incentive, but the amount will diminish gradually over several years and disappear completely after 2014. Providers who have not adopted EHRs by 2015 will see reductions in their Medicare reimbursement.

Currently, only the Certification Commission for Health Information Technology (CCHIT) can certify an EHR; however, certification/adoption workgroup members emphasized the need for more than one certifying organization and recommended that any certifying groups be distinct from those that set the certification criteria.

To help physicians and hospitals get ready to implement EHRs, the Obama administration is making $598 million in Recovery Act funds available now to establish 70 HIT “extension centers” that will provide hospitals and clinicians with hands-on technical assistance in the selection, acquisition, implementation, and meaningful use of certified EHRs. The extension center grants will be awarded on a rolling basis, with the first being issued in fiscal year 2010, which begins on Oct. 1. Another $564 million is also being made available in fiscal 2010 to states and state-designated groups to implement health information exchange.

In other business at the meeting, the committee also refined its proposed definition of certification. The new definition reads, “HHS certification means that a system is able to support the achievement of privacy and interoperability, and that the system is able to support the achievement of the meaningful use results that the government expects.”

The workgroup on the definition of meaningful use outlined its plans, which include a meeting to address gaps in meaningful use criteria. Specifically, the group will meet in October to hear from specialist physicians about how to make the criteria relevant to them. They also want to address the needs of smaller practices and hospitals, and of safety net providers.

WASHINGTON — Electronic health records systems should be precertified to comply with Recovery Act requirements even before the government issues its final certification rules, a federal advisory panel recommends.

Since the final rules may not go into effect until next year, “the suggestion is to establish something called preliminary certification based on the assumption that vendors would be willing to take a reasonable risk that what has been proposed in the regulatory process is probably pretty close to what is going to come out the other side,” Paul Egerman, cochair of the certification/adoption workgroup of the Health and Human Services Department's Health Information Technology (HIT) Policy Committee, said at a meeting of the committee.

That way, vendors could start certifying based on the proposed criteria, “and when the regulatory process is completed, hopefully there's only a very small adjustment that we can tack on” before the software becomes HHS-certified, he added.

Whether and when HHS will adopt its committee's recommendation is uncertain at this point, according to Dr. David Blumenthal, the committee's chair and national HIT coordinator at HHS.

“We'll have to do this in a deliberate way that includes public comment and takes the necessary steps within the department and in the federal government generally,” he said during a conference call. “I think the rule-making process we have to go through will make it very difficult to react in that time frame.”

Under the Recovery Act, formally known as the American Recovery and Reinvestment Act, $19 billion has been set aside to encourage HIT adoption, including electronic health records. The money includes $44,000 in financial incentives for each physician who purchases a certified EHR system and makes “meaningful use” of it by 2011; physicians who adopt EHRs later will also get an incentive, but the amount will diminish gradually over several years and disappear completely after 2014. Providers who have not adopted EHRs by 2015 will see reductions in their Medicare reimbursement.

Currently, only the Certification Commission for Health Information Technology (CCHIT) can certify an EHR; however, certification/adoption workgroup members emphasized the need for more than one certifying organization and recommended that any certifying groups be distinct from those that set the certification criteria.

To help physicians and hospitals get ready to implement EHRs, the Obama administration is making $598 million in Recovery Act funds available now to establish 70 HIT “extension centers” that will provide hospitals and clinicians with hands-on technical assistance in the selection, acquisition, implementation, and meaningful use of certified EHRs. The extension center grants will be awarded on a rolling basis, with the first being issued in fiscal year 2010, which begins on Oct. 1. Another $564 million is also being made available in fiscal 2010 to states and state-designated groups to implement health information exchange.

In other business at the meeting, the committee also refined its proposed definition of certification. The new definition reads, “HHS certification means that a system is able to support the achievement of privacy and interoperability, and that the system is able to support the achievement of the meaningful use results that the government expects.”

The workgroup on the definition of meaningful use outlined its plans, which include a meeting to address gaps in meaningful use criteria. Specifically, the group will meet in October to hear from specialist physicians about how to make the criteria relevant to them. They also want to address the needs of smaller practices and hospitals, and of safety net providers.

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.

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 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 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 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.”

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. “The Red Flags Rule is really about fraud protection, and HIPAA is more about data security,” said Naomi Lefkowitz of the division of privacy and identity protection at the Federal Trade Commission.

Mary Ellen Schneider contributed to this story.

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.

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 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 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 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.”

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. “The Red Flags Rule is really about fraud protection, and HIPAA is more about data security,” said Naomi Lefkowitz of the division of privacy and identity protection at the Federal Trade Commission.

Mary Ellen Schneider contributed to this story.

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.

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 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 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 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.”

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. “The Red Flags Rule is really about fraud protection, and HIPAA is more about data security,” said Naomi Lefkowitz of the division of privacy and identity protection at the Federal Trade Commission.

Mary Ellen Schneider contributed to this story.

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 (formally known as the American Recovery and Reinvestment Act of 2009), $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, a 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 out the medical liability system here.”

The standards and certification sub-committee 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. “That was not at all what was intended,” he replied. “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.”

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 (formally known as the American Recovery and Reinvestment Act of 2009), $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, a 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 out the medical liability system here.”

The standards and certification sub-committee 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. “That was not at all what was intended,” he replied. “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.”

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 (formally known as the American Recovery and Reinvestment Act of 2009), $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, a 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 out the medical liability system here.”

The standards and certification sub-committee 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. “That was not at all what was intended,” he replied. “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.”

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

WASHINGTON — Electronic health records systems should be precertified to comply with Recovery Act requirements even before the government issues its final certification rules, a federal advisory panel recommends.

Since the final rules may not go into effect until next year, “the suggestion is to establish something called preliminary certification based on the assumption that vendors would be willing to take a reasonable risk that what has been proposed in the regulatory process is probably pretty close to what is going to come out the other side,” Paul Egerman, cochair of the certification/adoption workgroup of the Health and Human Services Department's Health Information Technology (HIT) Policy Committee, said at a meeting of the committee.

That way, vendors could start certifying based on the proposed criteria, “and when the regulatory process is completed, hopefully there's only a very small adjustment that we can tack on” before the software becomes HHS-certified, he added.

Whether and when HHS will adopt its committee's recommendation is uncertain at this point, according to Dr. David Blumenthal, the committee's chair and national HIT coordinator at HHS.

“We'll have to do this in a deliberate way that includes public comment and takes the necessary steps within the department and in the federal government generally,” he said during a conference call. “I think the rule-making process we have to go through will make it very difficult to react in that time frame.”

Under the Recovery Act, formally known as the American Recovery and Reinvestment Act, $19 billion has been set aside to encourage HIT adoption, including electronic health records. The money includes $44,000 in financial incentives for each physician who purchases a certified EHR system and makes “meaningful use” of it by 2011; physicians who adopt EHRs later will also get an incentive, but the amount will diminish gradually over several years and disappear completely after 2014. Providers who have not adopted EHRs by 2015 will see reductions in their Medicare reimbursement.

Currently, only the Certification Commission for Health Information Technology can certify EHRs; however, certification/adoption workgroup members emphasized the need for more than one certifying organization and recommended that any certifying groups be distinct from those that set the certification criteria.

To help physicians and hospitals get ready to implement EHRs, the Obama administration is making $598 million in Recovery Act funds available now to establish 70 HIT “extension centers” that will provide hospitals and clinicians with hands-on technical assistance in the selection, acquisition, implementation, and meaningful use of certified EHRs. The extension center grants will be awarded on a rolling basis, with the first being issued in fiscal year 2010, which begins on Oct. 1. Another $564 million is also being made available in fiscal 2010 to states and state-designated groups to implement health information exchange.

HHS also will provide assistance to health care providers through the HIT Research Center, which will disseminate relevant information on effective practices and help the extension centers collaborate with one another and share best practices on EHR use.

Committee member Dr. Neil Calman, a family physician and president of the Institute for Family Health in Bronx, N.Y., said the committee needed to do a better job of convincing health care consumers that exchanging health information is a good idea.

“People are worried about privacy and security because we haven't really sold them on what the benefits are of this [information] exchange to them,” he said. “Is [the information] relevant to this individual provider who I'm seeing right now? Do they need to see everything or do I only want to share a part of it? I think that's a big part of what we need to be pushing in order to move this forward.”

WASHINGTON — Electronic health records systems should be precertified to comply with Recovery Act requirements even before the government issues its final certification rules, a federal advisory panel recommends.

Since the final rules may not go into effect until next year, “the suggestion is to establish something called preliminary certification based on the assumption that vendors would be willing to take a reasonable risk that what has been proposed in the regulatory process is probably pretty close to what is going to come out the other side,” Paul Egerman, cochair of the certification/adoption workgroup of the Health and Human Services Department's Health Information Technology (HIT) Policy Committee, said at a meeting of the committee.

That way, vendors could start certifying based on the proposed criteria, “and when the regulatory process is completed, hopefully there's only a very small adjustment that we can tack on” before the software becomes HHS-certified, he added.

Whether and when HHS will adopt its committee's recommendation is uncertain at this point, according to Dr. David Blumenthal, the committee's chair and national HIT coordinator at HHS.

“We'll have to do this in a deliberate way that includes public comment and takes the necessary steps within the department and in the federal government generally,” he said during a conference call. “I think the rule-making process we have to go through will make it very difficult to react in that time frame.”

Under the Recovery Act, formally known as the American Recovery and Reinvestment Act, $19 billion has been set aside to encourage HIT adoption, including electronic health records. The money includes $44,000 in financial incentives for each physician who purchases a certified EHR system and makes “meaningful use” of it by 2011; physicians who adopt EHRs later will also get an incentive, but the amount will diminish gradually over several years and disappear completely after 2014. Providers who have not adopted EHRs by 2015 will see reductions in their Medicare reimbursement.

Currently, only the Certification Commission for Health Information Technology can certify EHRs; however, certification/adoption workgroup members emphasized the need for more than one certifying organization and recommended that any certifying groups be distinct from those that set the certification criteria.

To help physicians and hospitals get ready to implement EHRs, the Obama administration is making $598 million in Recovery Act funds available now to establish 70 HIT “extension centers” that will provide hospitals and clinicians with hands-on technical assistance in the selection, acquisition, implementation, and meaningful use of certified EHRs. The extension center grants will be awarded on a rolling basis, with the first being issued in fiscal year 2010, which begins on Oct. 1. Another $564 million is also being made available in fiscal 2010 to states and state-designated groups to implement health information exchange.

HHS also will provide assistance to health care providers through the HIT Research Center, which will disseminate relevant information on effective practices and help the extension centers collaborate with one another and share best practices on EHR use.

Committee member Dr. Neil Calman, a family physician and president of the Institute for Family Health in Bronx, N.Y., said the committee needed to do a better job of convincing health care consumers that exchanging health information is a good idea.

“People are worried about privacy and security because we haven't really sold them on what the benefits are of this [information] exchange to them,” he said. “Is [the information] relevant to this individual provider who I'm seeing right now? Do they need to see everything or do I only want to share a part of it? I think that's a big part of what we need to be pushing in order to move this forward.”

WASHINGTON — Electronic health records systems should be precertified to comply with Recovery Act requirements even before the government issues its final certification rules, a federal advisory panel recommends.

Since the final rules may not go into effect until next year, “the suggestion is to establish something called preliminary certification based on the assumption that vendors would be willing to take a reasonable risk that what has been proposed in the regulatory process is probably pretty close to what is going to come out the other side,” Paul Egerman, cochair of the certification/adoption workgroup of the Health and Human Services Department's Health Information Technology (HIT) Policy Committee, said at a meeting of the committee.

That way, vendors could start certifying based on the proposed criteria, “and when the regulatory process is completed, hopefully there's only a very small adjustment that we can tack on” before the software becomes HHS-certified, he added.

Whether and when HHS will adopt its committee's recommendation is uncertain at this point, according to Dr. David Blumenthal, the committee's chair and national HIT coordinator at HHS.

“We'll have to do this in a deliberate way that includes public comment and takes the necessary steps within the department and in the federal government generally,” he said during a conference call. “I think the rule-making process we have to go through will make it very difficult to react in that time frame.”

Under the Recovery Act, formally known as the American Recovery and Reinvestment Act, $19 billion has been set aside to encourage HIT adoption, including electronic health records. The money includes $44,000 in financial incentives for each physician who purchases a certified EHR system and makes “meaningful use” of it by 2011; physicians who adopt EHRs later will also get an incentive, but the amount will diminish gradually over several years and disappear completely after 2014. Providers who have not adopted EHRs by 2015 will see reductions in their Medicare reimbursement.

Currently, only the Certification Commission for Health Information Technology can certify EHRs; however, certification/adoption workgroup members emphasized the need for more than one certifying organization and recommended that any certifying groups be distinct from those that set the certification criteria.

To help physicians and hospitals get ready to implement EHRs, the Obama administration is making $598 million in Recovery Act funds available now to establish 70 HIT “extension centers” that will provide hospitals and clinicians with hands-on technical assistance in the selection, acquisition, implementation, and meaningful use of certified EHRs. The extension center grants will be awarded on a rolling basis, with the first being issued in fiscal year 2010, which begins on Oct. 1. Another $564 million is also being made available in fiscal 2010 to states and state-designated groups to implement health information exchange.

HHS also will provide assistance to health care providers through the HIT Research Center, which will disseminate relevant information on effective practices and help the extension centers collaborate with one another and share best practices on EHR use.

Committee member Dr. Neil Calman, a family physician and president of the Institute for Family Health in Bronx, N.Y., said the committee needed to do a better job of convincing health care consumers that exchanging health information is a good idea.

“People are worried about privacy and security because we haven't really sold them on what the benefits are of this [information] exchange to them,” he said. “Is [the information] relevant to this individual provider who I'm seeing right now? Do they need to see everything or do I only want to share a part of it? I think that's a big part of what we need to be pushing in order to move this forward.”

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:

▸ No identification.

▸ Photo ID that doesn't match patient.

▸ Documents that appear to be altered or forged.

▸ Insurance information that cannot be verified.

▸ 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.

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 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 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.”

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.

Mary Ellen Schneider contributed to this report.

'Many of usneed to re-think our standard registration procedures and beef them up.' MS. KING

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:

▸ No identification.

▸ Photo ID that doesn't match patient.

▸ Documents that appear to be altered or forged.

▸ Insurance information that cannot be verified.

▸ 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.

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 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 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.”

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.

Mary Ellen Schneider contributed to this report.

'Many of usneed to re-think our standard registration procedures and beef them up.' MS. KING

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:

▸ No identification.

▸ Photo ID that doesn't match patient.

▸ Documents that appear to be altered or forged.

▸ Insurance information that cannot be verified.

▸ 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.

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 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 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.”

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.

Mary Ellen Schneider contributed to this report.

'Many of usneed to re-think our standard registration procedures and beef them up.' MS. KING

WASHINGTON — Exenatide helps increase weight loss in obese nondiabetic patients who also are following a diet and exercise program, recent study results suggest.

Dr. Michael Trautmann, a researcher at Eli Lilly & Co., and his colleagues conducted a double-blind, placebo-controlled study of 152 patients with a mean body mass index of 39.6 kg/m

As is typical with obesity studies, 35% of patients enrolled did not complete the study, Dr. Trautmann said.

Patients were randomized to receive placebo or 10 mcg exenatide twice daily. Lifestyle modification—consisting of a balanced, calorie-restricted diet; moderate increase in physical activity, with a target of 150 minutes per week; and counseling sessions at 4-week intervals—was prescribed for all participants, Dr. Trautmann said at the annual meeting of the Endocrine Society.

The study's primary end point was change in body weight. Secondary end points included changes in glucose tolerance, physical activity, and dietary behavior.

After 24 weeks, a significantly higher percentage of exenatide-treated patients had lost at least 5% of their body weight, compared with patients on placebo (31% vs. 17%), Dr. Trautmann said. All of the patients who had lost 10% or more of their body weight were in the exenatide group.

Average weight loss in the placebo group was 1.6 kg. In the exenatide group, the average loss was 5.1 kg, “a highly significant difference,” he said.

In subgroup analysis, “due to the small sample size, one cannot conclude too much from these results, but the trend indicates that in patients with mild obesity—with a BMI of less than 35 kg/m

Among patients with impaired glucose tolerance at baseline, three-quarters who were on exenatide normalized their glucose levels, compared with slightly more than half of the patients on placebo, he said. “Clearly, weight loss is known to improve glucose tolerance.”

The study was sponsored by Eli Lilly and Amylin Pharmaceuticals.

All of the patients who had lost 10% or more of their body weight were in the exenatide group.

Source DR. TRAUTMANN

WASHINGTON — Exenatide helps increase weight loss in obese nondiabetic patients who also are following a diet and exercise program, recent study results suggest.

Dr. Michael Trautmann, a researcher at Eli Lilly & Co., and his colleagues conducted a double-blind, placebo-controlled study of 152 patients with a mean body mass index of 39.6 kg/m

As is typical with obesity studies, 35% of patients enrolled did not complete the study, Dr. Trautmann said.

Patients were randomized to receive placebo or 10 mcg exenatide twice daily. Lifestyle modification—consisting of a balanced, calorie-restricted diet; moderate increase in physical activity, with a target of 150 minutes per week; and counseling sessions at 4-week intervals—was prescribed for all participants, Dr. Trautmann said at the annual meeting of the Endocrine Society.

The study's primary end point was change in body weight. Secondary end points included changes in glucose tolerance, physical activity, and dietary behavior.

After 24 weeks, a significantly higher percentage of exenatide-treated patients had lost at least 5% of their body weight, compared with patients on placebo (31% vs. 17%), Dr. Trautmann said. All of the patients who had lost 10% or more of their body weight were in the exenatide group.

Average weight loss in the placebo group was 1.6 kg. In the exenatide group, the average loss was 5.1 kg, “a highly significant difference,” he said.

In subgroup analysis, “due to the small sample size, one cannot conclude too much from these results, but the trend indicates that in patients with mild obesity—with a BMI of less than 35 kg/m

Among patients with impaired glucose tolerance at baseline, three-quarters who were on exenatide normalized their glucose levels, compared with slightly more than half of the patients on placebo, he said. “Clearly, weight loss is known to improve glucose tolerance.”

The study was sponsored by Eli Lilly and Amylin Pharmaceuticals.

All of the patients who had lost 10% or more of their body weight were in the exenatide group.

Source DR. TRAUTMANN

WASHINGTON — Exenatide helps increase weight loss in obese nondiabetic patients who also are following a diet and exercise program, recent study results suggest.

Dr. Michael Trautmann, a researcher at Eli Lilly & Co., and his colleagues conducted a double-blind, placebo-controlled study of 152 patients with a mean body mass index of 39.6 kg/m

As is typical with obesity studies, 35% of patients enrolled did not complete the study, Dr. Trautmann said.

Patients were randomized to receive placebo or 10 mcg exenatide twice daily. Lifestyle modification—consisting of a balanced, calorie-restricted diet; moderate increase in physical activity, with a target of 150 minutes per week; and counseling sessions at 4-week intervals—was prescribed for all participants, Dr. Trautmann said at the annual meeting of the Endocrine Society.

The study's primary end point was change in body weight. Secondary end points included changes in glucose tolerance, physical activity, and dietary behavior.

After 24 weeks, a significantly higher percentage of exenatide-treated patients had lost at least 5% of their body weight, compared with patients on placebo (31% vs. 17%), Dr. Trautmann said. All of the patients who had lost 10% or more of their body weight were in the exenatide group.

Average weight loss in the placebo group was 1.6 kg. In the exenatide group, the average loss was 5.1 kg, “a highly significant difference,” he said.

In subgroup analysis, “due to the small sample size, one cannot conclude too much from these results, but the trend indicates that in patients with mild obesity—with a BMI of less than 35 kg/m

Among patients with impaired glucose tolerance at baseline, three-quarters who were on exenatide normalized their glucose levels, compared with slightly more than half of the patients on placebo, he said. “Clearly, weight loss is known to improve glucose tolerance.”

The study was sponsored by Eli Lilly and Amylin Pharmaceuticals.

All of the patients who had lost 10% or more of their body weight were in the exenatide group.

Source DR. TRAUTMANN

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 S. Collins said at the annual meeting of the Endocrine Society.

Dr. Collins, the former head of the National Human Genome Research Institute who was recently nominated by President Obama to serve as director of the National Institutes of Health, 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. “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.”

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.”

With such a pipeline, 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.”

During a question-and-answer session, Dr. Collins was asked whether he would list his priorities for NIH “as a private citizen,” because the meeting took place before his nomination for the top job. He cited the importance of harnessing new technologies. “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, Dr. Collins 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.”

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 S. Collins said at the annual meeting of the Endocrine Society.

Dr. Collins, the former head of the National Human Genome Research Institute who was recently nominated by President Obama to serve as director of the National Institutes of Health, 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. “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.”

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.”

With such a pipeline, 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.”

During a question-and-answer session, Dr. Collins was asked whether he would list his priorities for NIH “as a private citizen,” because the meeting took place before his nomination for the top job. He cited the importance of harnessing new technologies. “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, Dr. Collins 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.”

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 S. Collins said at the annual meeting of the Endocrine Society.

Dr. Collins, the former head of the National Human Genome Research Institute who was recently nominated by President Obama to serve as director of the National Institutes of Health, 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. “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.”

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.”

With such a pipeline, 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.”

During a question-and-answer session, Dr. Collins was asked whether he would list his priorities for NIH “as a private citizen,” because the meeting took place before his nomination for the top job. He cited the importance of harnessing new technologies. “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, Dr. Collins 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.”

WASHINGTON – Quality improvement must be an integral part of any health reform plan, according to one expert.

Although there have been many improvements in medical care over the past few years, “with the miracles have come burdens,” Dr. Donald Berwick, president and CEO of the Institute for Healthcare Improvement, said at the annual meeting of the American Health Lawyers Association. “Miracles and hazards come hand in hand.”

Improving the quality of health care doesn't necessarily mean spending more money; in fact, the opposite is often true, Dr. Berwick said. “England spends 8%-8.5% [of its gross domestic product] on health care–about half of what we do–and has equally fine care.” And the Dartmouth Atlas Project has found that regions of the United States that spend the most on health care–areas with more hospital beds per capita and more specialists, and where more procedures are done–often have worse care outcomes.

“They have higher mortality and the same functional status among patients” as do those in lower spending areas, he said. “Doctors in these areas report more problems with continuity [of care], and patients are less satisfied.”

The biggest predictor of quality of care by far, however, is race, Dr. Berwick continued. “If you are black, that is the biggest count against you for health status; that's not true in the rest of the developed world.” A black male child born in inner-city Baltimore this year, for instance, has an 8-year-lower life expectancy than does a white child, he said. Using a strictly market-based approach won't solve quality problems, according to Dr. Berwick. “I simply do not think markets will work in health care,” he said. “But I think there is a way out, and it has to do with leadership.”

The health care system has to allow for the fact that people see what they expect to see and interpret the world accordingly, which can lead to errors in the operating room and other health care settings, Dr. Berwick said. “If we wish to be safe, we have to engineer dikes around human frailty. And it can be done. It's done in airplane cockpits and in nuclear power plants.”

He added that a well-engineered system “does not beat up on the workforce; it does not yell at the nurse for making a mistake; it does not blame [people] for being human.” Instead, “it's the design of work that determines the outcomes of work.”

For example, Dr. Berwick said, a big problem in hospitals has been central venous line infections. “We know now that if you adhere strictly to science, if you follow every single one of these five steps [good hand hygiene, maximal barrier precautions upon insertion, chlorhexidine skin antisepsis, optimal catheter site selection, and daily review of line necessity with prompt removal of unnecessary lines], you can … essentially abolish central venous line infections.”

These infections still occur in hospitals “because we haven't put in the reliable systems that make it go right every single time,” he said

Hospital governance boards must get involved to help make these changes happen, he added. “Think about it this way. If it's true that your hospital could abolish central venous line infections–and it can–and a patient tomorrow morning gets a central venous line infection, the board caused it. I know of no other way to think about it.”

Many health care organizations and communities working on quality improvement are using the goal of “triple aim”: better experience of care, a healthier population (through reductions in smoking, obesity, and other health problems), and reduction of per capita costs. The Institute for Healthcare Improvement “[has] about 40 or 50 organizations that have said, 'I want to achieve the triple aim for my organization,'” Dr. Berwick said. Grand Junction, Colo., and Green Bay, Wisc., are two of the communities working to achieve the triple aim in health care.

WASHINGTON – Quality improvement must be an integral part of any health reform plan, according to one expert.

Although there have been many improvements in medical care over the past few years, “with the miracles have come burdens,” Dr. Donald Berwick, president and CEO of the Institute for Healthcare Improvement, said at the annual meeting of the American Health Lawyers Association. “Miracles and hazards come hand in hand.”

Improving the quality of health care doesn't necessarily mean spending more money; in fact, the opposite is often true, Dr. Berwick said. “England spends 8%-8.5% [of its gross domestic product] on health care–about half of what we do–and has equally fine care.” And the Dartmouth Atlas Project has found that regions of the United States that spend the most on health care–areas with more hospital beds per capita and more specialists, and where more procedures are done–often have worse care outcomes.

“They have higher mortality and the same functional status among patients” as do those in lower spending areas, he said. “Doctors in these areas report more problems with continuity [of care], and patients are less satisfied.”

The biggest predictor of quality of care by far, however, is race, Dr. Berwick continued. “If you are black, that is the biggest count against you for health status; that's not true in the rest of the developed world.” A black male child born in inner-city Baltimore this year, for instance, has an 8-year-lower life expectancy than does a white child, he said. Using a strictly market-based approach won't solve quality problems, according to Dr. Berwick. “I simply do not think markets will work in health care,” he said. “But I think there is a way out, and it has to do with leadership.”

The health care system has to allow for the fact that people see what they expect to see and interpret the world accordingly, which can lead to errors in the operating room and other health care settings, Dr. Berwick said. “If we wish to be safe, we have to engineer dikes around human frailty. And it can be done. It's done in airplane cockpits and in nuclear power plants.”

He added that a well-engineered system “does not beat up on the workforce; it does not yell at the nurse for making a mistake; it does not blame [people] for being human.” Instead, “it's the design of work that determines the outcomes of work.”

For example, Dr. Berwick said, a big problem in hospitals has been central venous line infections. “We know now that if you adhere strictly to science, if you follow every single one of these five steps [good hand hygiene, maximal barrier precautions upon insertion, chlorhexidine skin antisepsis, optimal catheter site selection, and daily review of line necessity with prompt removal of unnecessary lines], you can … essentially abolish central venous line infections.”

These infections still occur in hospitals “because we haven't put in the reliable systems that make it go right every single time,” he said

Hospital governance boards must get involved to help make these changes happen, he added. “Think about it this way. If it's true that your hospital could abolish central venous line infections–and it can–and a patient tomorrow morning gets a central venous line infection, the board caused it. I know of no other way to think about it.”

Many health care organizations and communities working on quality improvement are using the goal of “triple aim”: better experience of care, a healthier population (through reductions in smoking, obesity, and other health problems), and reduction of per capita costs. The Institute for Healthcare Improvement “[has] about 40 or 50 organizations that have said, 'I want to achieve the triple aim for my organization,'” Dr. Berwick said. Grand Junction, Colo., and Green Bay, Wisc., are two of the communities working to achieve the triple aim in health care.

WASHINGTON – Quality improvement must be an integral part of any health reform plan, according to one expert.

Although there have been many improvements in medical care over the past few years, “with the miracles have come burdens,” Dr. Donald Berwick, president and CEO of the Institute for Healthcare Improvement, said at the annual meeting of the American Health Lawyers Association. “Miracles and hazards come hand in hand.”

Improving the quality of health care doesn't necessarily mean spending more money; in fact, the opposite is often true, Dr. Berwick said. “England spends 8%-8.5% [of its gross domestic product] on health care–about half of what we do–and has equally fine care.” And the Dartmouth Atlas Project has found that regions of the United States that spend the most on health care–areas with more hospital beds per capita and more specialists, and where more procedures are done–often have worse care outcomes.

“They have higher mortality and the same functional status among patients” as do those in lower spending areas, he said. “Doctors in these areas report more problems with continuity [of care], and patients are less satisfied.”

The biggest predictor of quality of care by far, however, is race, Dr. Berwick continued. “If you are black, that is the biggest count against you for health status; that's not true in the rest of the developed world.” A black male child born in inner-city Baltimore this year, for instance, has an 8-year-lower life expectancy than does a white child, he said. Using a strictly market-based approach won't solve quality problems, according to Dr. Berwick. “I simply do not think markets will work in health care,” he said. “But I think there is a way out, and it has to do with leadership.”

The health care system has to allow for the fact that people see what they expect to see and interpret the world accordingly, which can lead to errors in the operating room and other health care settings, Dr. Berwick said. “If we wish to be safe, we have to engineer dikes around human frailty. And it can be done. It's done in airplane cockpits and in nuclear power plants.”

He added that a well-engineered system “does not beat up on the workforce; it does not yell at the nurse for making a mistake; it does not blame [people] for being human.” Instead, “it's the design of work that determines the outcomes of work.”

For example, Dr. Berwick said, a big problem in hospitals has been central venous line infections. “We know now that if you adhere strictly to science, if you follow every single one of these five steps [good hand hygiene, maximal barrier precautions upon insertion, chlorhexidine skin antisepsis, optimal catheter site selection, and daily review of line necessity with prompt removal of unnecessary lines], you can … essentially abolish central venous line infections.”

These infections still occur in hospitals “because we haven't put in the reliable systems that make it go right every single time,” he said

Hospital governance boards must get involved to help make these changes happen, he added. “Think about it this way. If it's true that your hospital could abolish central venous line infections–and it can–and a patient tomorrow morning gets a central venous line infection, the board caused it. I know of no other way to think about it.”

Many health care organizations and communities working on quality improvement are using the goal of “triple aim”: better experience of care, a healthier population (through reductions in smoking, obesity, and other health problems), and reduction of per capita costs. The Institute for Healthcare Improvement “[has] about 40 or 50 organizations that have said, 'I want to achieve the triple aim for my organization,'” Dr. Berwick said. Grand Junction, Colo., and Green Bay, Wisc., are two of the communities working to achieve the triple aim in health care.

TAMPA, FLA. — Anywhere from 12% to 45% of hospital admissions of children for dehydration could be prevented, according to results from a study of 85 such admissions.

Dr. Vineeta Mittal and Dr. Glenn Flores of the University of Texas Southwestern Medical Center and Children's Medical Center, Dallas, performed a cross-sectional survey of parents, primary care providers, and inpatient attending physicians involved in care of pediatric patients admitted for dehydration. The study included patients admitted to an urban hospital over a 20-month period. The study, part of a larger study of 560 children admitted for avoidable hospitalization conditions, was presented in a poster at a pediatric hospital medicine meeting.

The researchers asked each patient's parent or guardian these questions:

▸ Could hospitalization have been prevented? If so, how?

▸ Did the parent speak to the primary care provider, or take the child to visit a primary care provider, prior to admission?

▸ Did the family have good access to care, or were there financial barriers or difficulties in obtaining medication?

▸ Was the parent satisfied with the child's regular provider (if there was one)?

The investigators also asked the primary care physician and the inpatient attending physician for each patient if and how the hospitalization could have been avoided.

The researchers found that, depending on who did the assessment, 12%-45% of hospitalizations for dehydration could have been avoided. Many of the admissions could have been prevented if parents had had better information about their child's condition and about the proper use of oral rehydration solution therapy, they said.

Overall, all three sources—parents, the primary care physician, and the inpatient attending physician—assessed a particular hospitalization as being avoidable 12% of the time, and any one of the three sources said it was avoidable 45% of the time. When it was broken down by who did the assessment, parents said the hospitalization could have been avoided 25% of the time, compared with 33% of the time for primary care providers and 19% of the time for the inpatient attending physicians.

In one case cited by the researchers, the parent said the hospitalization could have been avoided “if they had explained it to me better in the [primary care] clinic,” the primary care physician said it could have been avoided “with more appropriate care,” and the inpatient attending physician said it could not have been avoided because it was a “rapid onset, too severe.”

In general, “pediatricians need to provide more in-depth education to parents about how to keep children hydrated,” Dr. Mittal said in an interview. “Even reinforcing that as little as 1 teaspoon [of fluid] every 10 minutes is okay may help reduce emergency department visits and hospitalizations.”

Also, having a short-stay unit at the hospital would help, she said. “A lot of these kids don't need to be in the hospital and stay there for days.” Just getting them rehydrated and watching them for a few hours before sending them home would probably be enough in many cases.

Another big barrier to preventing a hospital admission was a lack of health insurance. “If the parents had had insurance, they would have gone to or called their primary care physician for advice,” Dr. Mittal said.

She declared no conflicts of interest.

A related video with Dr. Mittal is at www.youtube.com/HospitalistNews

Many of the admissions could have been prevented if parents had had better information.

Source DR. MITTAL

TAMPA, FLA. — Anywhere from 12% to 45% of hospital admissions of children for dehydration could be prevented, according to results from a study of 85 such admissions.

Dr. Vineeta Mittal and Dr. Glenn Flores of the University of Texas Southwestern Medical Center and Children's Medical Center, Dallas, performed a cross-sectional survey of parents, primary care providers, and inpatient attending physicians involved in care of pediatric patients admitted for dehydration. The study included patients admitted to an urban hospital over a 20-month period. The study, part of a larger study of 560 children admitted for avoidable hospitalization conditions, was presented in a poster at a pediatric hospital medicine meeting.

The researchers asked each patient's parent or guardian these questions:

▸ Could hospitalization have been prevented? If so, how?

▸ Did the parent speak to the primary care provider, or take the child to visit a primary care provider, prior to admission?

▸ Did the family have good access to care, or were there financial barriers or difficulties in obtaining medication?

▸ Was the parent satisfied with the child's regular provider (if there was one)?

The investigators also asked the primary care physician and the inpatient attending physician for each patient if and how the hospitalization could have been avoided.

The researchers found that, depending on who did the assessment, 12%-45% of hospitalizations for dehydration could have been avoided. Many of the admissions could have been prevented if parents had had better information about their child's condition and about the proper use of oral rehydration solution therapy, they said.

Overall, all three sources—parents, the primary care physician, and the inpatient attending physician—assessed a particular hospitalization as being avoidable 12% of the time, and any one of the three sources said it was avoidable 45% of the time. When it was broken down by who did the assessment, parents said the hospitalization could have been avoided 25% of the time, compared with 33% of the time for primary care providers and 19% of the time for the inpatient attending physicians.

In one case cited by the researchers, the parent said the hospitalization could have been avoided “if they had explained it to me better in the [primary care] clinic,” the primary care physician said it could have been avoided “with more appropriate care,” and the inpatient attending physician said it could not have been avoided because it was a “rapid onset, too severe.”

In general, “pediatricians need to provide more in-depth education to parents about how to keep children hydrated,” Dr. Mittal said in an interview. “Even reinforcing that as little as 1 teaspoon [of fluid] every 10 minutes is okay may help reduce emergency department visits and hospitalizations.”

Also, having a short-stay unit at the hospital would help, she said. “A lot of these kids don't need to be in the hospital and stay there for days.” Just getting them rehydrated and watching them for a few hours before sending them home would probably be enough in many cases.

Another big barrier to preventing a hospital admission was a lack of health insurance. “If the parents had had insurance, they would have gone to or called their primary care physician for advice,” Dr. Mittal said.

She declared no conflicts of interest.

A related video with Dr. Mittal is at www.youtube.com/HospitalistNews

Many of the admissions could have been prevented if parents had had better information.

Source DR. MITTAL

TAMPA, FLA. — Anywhere from 12% to 45% of hospital admissions of children for dehydration could be prevented, according to results from a study of 85 such admissions.

Dr. Vineeta Mittal and Dr. Glenn Flores of the University of Texas Southwestern Medical Center and Children's Medical Center, Dallas, performed a cross-sectional survey of parents, primary care providers, and inpatient attending physicians involved in care of pediatric patients admitted for dehydration. The study included patients admitted to an urban hospital over a 20-month period. The study, part of a larger study of 560 children admitted for avoidable hospitalization conditions, was presented in a poster at a pediatric hospital medicine meeting.

The researchers asked each patient's parent or guardian these questions:

▸ Could hospitalization have been prevented? If so, how?

▸ Did the parent speak to the primary care provider, or take the child to visit a primary care provider, prior to admission?

▸ Did the family have good access to care, or were there financial barriers or difficulties in obtaining medication?

▸ Was the parent satisfied with the child's regular provider (if there was one)?

The investigators also asked the primary care physician and the inpatient attending physician for each patient if and how the hospitalization could have been avoided.

The researchers found that, depending on who did the assessment, 12%-45% of hospitalizations for dehydration could have been avoided. Many of the admissions could have been prevented if parents had had better information about their child's condition and about the proper use of oral rehydration solution therapy, they said.

Overall, all three sources—parents, the primary care physician, and the inpatient attending physician—assessed a particular hospitalization as being avoidable 12% of the time, and any one of the three sources said it was avoidable 45% of the time. When it was broken down by who did the assessment, parents said the hospitalization could have been avoided 25% of the time, compared with 33% of the time for primary care providers and 19% of the time for the inpatient attending physicians.

In one case cited by the researchers, the parent said the hospitalization could have been avoided “if they had explained it to me better in the [primary care] clinic,” the primary care physician said it could have been avoided “with more appropriate care,” and the inpatient attending physician said it could not have been avoided because it was a “rapid onset, too severe.”

In general, “pediatricians need to provide more in-depth education to parents about how to keep children hydrated,” Dr. Mittal said in an interview. “Even reinforcing that as little as 1 teaspoon [of fluid] every 10 minutes is okay may help reduce emergency department visits and hospitalizations.”

Also, having a short-stay unit at the hospital would help, she said. “A lot of these kids don't need to be in the hospital and stay there for days.” Just getting them rehydrated and watching them for a few hours before sending them home would probably be enough in many cases.

Another big barrier to preventing a hospital admission was a lack of health insurance. “If the parents had had insurance, they would have gone to or called their primary care physician for advice,” Dr. Mittal said.

She declared no conflicts of interest.

A related video with Dr. Mittal is at www.youtube.com/HospitalistNews

Many of the admissions could have been prevented if parents had had better information.

Source DR. MITTAL