Mary Ellen Schneider

Hospitals, health plans, and other health care organizations will soon be able to help physicians obtain health information technology without running afoul of federal fraud laws under regulations issued last month by the Department of Health and Human Services.

In two final regulations published in the Federal Register on Aug. 8, the Centers for Medicare and Medicaid Services and the HHS Office of Inspector General carved out new exceptions to the Stark physician self-referral law and the federal antikickback statute. Under these new exceptions, certain health care entities will be able to donate interoperable electronic health record (EHR) software and training. Hospitals and other health care organizations will also be able to provide hardware, software, and training that are “necessary and used solely” for electronic prescribing.

The regulations did not cap the donations to physicians for electronic prescribing technology, but the government is requiring physicians to share some of the costs of donated EHR technology. Under the rules, physicians will be required to pay 15% of the donor's cost of the EHR technology and services. The regulations go into effect in October (60 days after publication in the Federal Register). The provisions related to EHR arrangements are slated to sunset on Dec. 31, 2013.

The regulations were widely praised by physician organizations and health IT industry groups for breaking down barriers to physician adoption. But Patrick Hope, legislative counsel for the American College of Physicians, said the changes aren't likely to do a whole lot to speed physician adoption of the technologies since few hospitals will be able to afford to donate the expensive technology to physicians.

“They are operating at the margins just as physician offices are,” Mr. Hope said.

ACP officials are urging members of Congress to establish an add-on payment to the Medicare reimbursement for an office visit in an effort to help offset the ongoing costs of an electronic health record system, Mr. Hope said. While the regulations are helpful in removing some barriers, he said, an add-on payment would create a better business case for physician adoption of health IT. The jury is still out as to what impact these regulations will have on physician adoption, said Chantal Worzala, senior associate director for policy at the American Hospital Association. Not all hospitals will have the financial resources to donate health IT services, she said, since only about a third of U.S. hospitals are making a profit.

But the regulations will give hospital administrators more options. “Hospitals really should have flexibility in working with community physicians,” she said.

Although some health plans may be interested in offering electronic prescribing products, Ms. Worzala said, hospitals are likely to want to help physicians acquire more comprehensive EHR systems.

The relaxation of the Stark physician self-referral law and the antikickback statute is a good thing, said Dr. Steven E. Waldren, assistant director of the American Academy of Family Physicians' Center for Health Information Technology, since the changes will allow more health IT resources to flow to physicians. However, he cautioned physicians not to count on getting this support.

This type of support won't be available to all physicians and in some cases may not be appropriate, he said. For example, Dr. Waldren said that some hospital electronic health record systems are not designed for the ambulatory environment and may end up costing physicians more money in the long run. The bottom line is that physicians need to continue to do their “due diligence” in researching systems, he said.

The Medicare Modernization Act of 2003 mandated that the HHS Secretary create exemptions that would allow for certain health care organizations to help furnish physician practices with electronic prescribing technology. The changes were originally outlined in a proposed rule issued last October.

Under the provisions related to electronic prescribing technology, hospitals can donate hardware, software, and services to members of their medical staffs; group practices can donate to physician members; and Medicare prescription drug plan sponsors and Medicare Advantage plans can donate to pharmacies and prescribing physicians. The Stark law exemption and antikickback safe harbors have slightly different definitions of who can donate the comprehensive electronic health record system software and training.

The electronic prescribing safe harbors and exemptions allow organizations to donate hardware, software, Internet connectivity, and training and support services. The provisions for electronic health records are slightly different and do not include hardware. For EHRs, organizations can donate software, which must include an electronic prescribing component. Also, donated information technology and training can include Internet connectivity.

Hospitals, health plans, and other health care organizations will soon be able to help physicians obtain health information technology without running afoul of federal fraud laws under regulations issued last month by the Department of Health and Human Services.

In two final regulations published in the Federal Register on Aug. 8, the Centers for Medicare and Medicaid Services and the HHS Office of Inspector General carved out new exceptions to the Stark physician self-referral law and the federal antikickback statute. Under these new exceptions, certain health care entities will be able to donate interoperable electronic health record (EHR) software and training. Hospitals and other health care organizations will also be able to provide hardware, software, and training that are “necessary and used solely” for electronic prescribing.

The regulations did not cap the donations to physicians for electronic prescribing technology, but the government is requiring physicians to share some of the costs of donated EHR technology. Under the rules, physicians will be required to pay 15% of the donor's cost of the EHR technology and services. The regulations go into effect in October (60 days after publication in the Federal Register). The provisions related to EHR arrangements are slated to sunset on Dec. 31, 2013.

The regulations were widely praised by physician organizations and health IT industry groups for breaking down barriers to physician adoption. But Patrick Hope, legislative counsel for the American College of Physicians, said the changes aren't likely to do a whole lot to speed physician adoption of the technologies since few hospitals will be able to afford to donate the expensive technology to physicians.

“They are operating at the margins just as physician offices are,” Mr. Hope said.

ACP officials are urging members of Congress to establish an add-on payment to the Medicare reimbursement for an office visit in an effort to help offset the ongoing costs of an electronic health record system, Mr. Hope said. While the regulations are helpful in removing some barriers, he said, an add-on payment would create a better business case for physician adoption of health IT. The jury is still out as to what impact these regulations will have on physician adoption, said Chantal Worzala, senior associate director for policy at the American Hospital Association. Not all hospitals will have the financial resources to donate health IT services, she said, since only about a third of U.S. hospitals are making a profit.

But the regulations will give hospital administrators more options. “Hospitals really should have flexibility in working with community physicians,” she said.

Although some health plans may be interested in offering electronic prescribing products, Ms. Worzala said, hospitals are likely to want to help physicians acquire more comprehensive EHR systems.

The relaxation of the Stark physician self-referral law and the antikickback statute is a good thing, said Dr. Steven E. Waldren, assistant director of the American Academy of Family Physicians' Center for Health Information Technology, since the changes will allow more health IT resources to flow to physicians. However, he cautioned physicians not to count on getting this support.

This type of support won't be available to all physicians and in some cases may not be appropriate, he said. For example, Dr. Waldren said that some hospital electronic health record systems are not designed for the ambulatory environment and may end up costing physicians more money in the long run. The bottom line is that physicians need to continue to do their “due diligence” in researching systems, he said.

The Medicare Modernization Act of 2003 mandated that the HHS Secretary create exemptions that would allow for certain health care organizations to help furnish physician practices with electronic prescribing technology. The changes were originally outlined in a proposed rule issued last October.

Under the provisions related to electronic prescribing technology, hospitals can donate hardware, software, and services to members of their medical staffs; group practices can donate to physician members; and Medicare prescription drug plan sponsors and Medicare Advantage plans can donate to pharmacies and prescribing physicians. The Stark law exemption and antikickback safe harbors have slightly different definitions of who can donate the comprehensive electronic health record system software and training.

The electronic prescribing safe harbors and exemptions allow organizations to donate hardware, software, Internet connectivity, and training and support services. The provisions for electronic health records are slightly different and do not include hardware. For EHRs, organizations can donate software, which must include an electronic prescribing component. Also, donated information technology and training can include Internet connectivity.

Hospitals, health plans, and other health care organizations will soon be able to help physicians obtain health information technology without running afoul of federal fraud laws under regulations issued last month by the Department of Health and Human Services.

In two final regulations published in the Federal Register on Aug. 8, the Centers for Medicare and Medicaid Services and the HHS Office of Inspector General carved out new exceptions to the Stark physician self-referral law and the federal antikickback statute. Under these new exceptions, certain health care entities will be able to donate interoperable electronic health record (EHR) software and training. Hospitals and other health care organizations will also be able to provide hardware, software, and training that are “necessary and used solely” for electronic prescribing.

The regulations did not cap the donations to physicians for electronic prescribing technology, but the government is requiring physicians to share some of the costs of donated EHR technology. Under the rules, physicians will be required to pay 15% of the donor's cost of the EHR technology and services. The regulations go into effect in October (60 days after publication in the Federal Register). The provisions related to EHR arrangements are slated to sunset on Dec. 31, 2013.

The regulations were widely praised by physician organizations and health IT industry groups for breaking down barriers to physician adoption. But Patrick Hope, legislative counsel for the American College of Physicians, said the changes aren't likely to do a whole lot to speed physician adoption of the technologies since few hospitals will be able to afford to donate the expensive technology to physicians.

“They are operating at the margins just as physician offices are,” Mr. Hope said.

ACP officials are urging members of Congress to establish an add-on payment to the Medicare reimbursement for an office visit in an effort to help offset the ongoing costs of an electronic health record system, Mr. Hope said. While the regulations are helpful in removing some barriers, he said, an add-on payment would create a better business case for physician adoption of health IT. The jury is still out as to what impact these regulations will have on physician adoption, said Chantal Worzala, senior associate director for policy at the American Hospital Association. Not all hospitals will have the financial resources to donate health IT services, she said, since only about a third of U.S. hospitals are making a profit.

But the regulations will give hospital administrators more options. “Hospitals really should have flexibility in working with community physicians,” she said.

Although some health plans may be interested in offering electronic prescribing products, Ms. Worzala said, hospitals are likely to want to help physicians acquire more comprehensive EHR systems.

The relaxation of the Stark physician self-referral law and the antikickback statute is a good thing, said Dr. Steven E. Waldren, assistant director of the American Academy of Family Physicians' Center for Health Information Technology, since the changes will allow more health IT resources to flow to physicians. However, he cautioned physicians not to count on getting this support.

This type of support won't be available to all physicians and in some cases may not be appropriate, he said. For example, Dr. Waldren said that some hospital electronic health record systems are not designed for the ambulatory environment and may end up costing physicians more money in the long run. The bottom line is that physicians need to continue to do their “due diligence” in researching systems, he said.

The Medicare Modernization Act of 2003 mandated that the HHS Secretary create exemptions that would allow for certain health care organizations to help furnish physician practices with electronic prescribing technology. The changes were originally outlined in a proposed rule issued last October.

Under the provisions related to electronic prescribing technology, hospitals can donate hardware, software, and services to members of their medical staffs; group practices can donate to physician members; and Medicare prescription drug plan sponsors and Medicare Advantage plans can donate to pharmacies and prescribing physicians. The Stark law exemption and antikickback safe harbors have slightly different definitions of who can donate the comprehensive electronic health record system software and training.

The electronic prescribing safe harbors and exemptions allow organizations to donate hardware, software, Internet connectivity, and training and support services. The provisions for electronic health records are slightly different and do not include hardware. For EHRs, organizations can donate software, which must include an electronic prescribing component. Also, donated information technology and training can include Internet connectivity.

Each year, patients in the United States experience at least 1.5 million preventable injuries because of medication errors, according to the findings of an Institute of Medicine analysis.

The report, released in July, estimated that these preventable adverse drug events would add up to about $3.5 billion in additional hospitalization costs this year, excluding the economic burden of lost wages and productivity.

The expert panel convened by the Institute of Medicine (IOM) called on physicians to do their part in reducing medication errors by improving communication with patients about medication safety and adopting electronic prescribing technology.

“Our recommendations boil down to ensuring that consumers are fully informed about how to take medications safely and achieve the desired results, and that health care providers have the tools and data necessary to prescribe, dispense, and administer drugs as safely as possible and to monitor for problems,” J. Lyle Bootman, Ph.D., cochair of the IOM committee and dean of the college of pharmacy at the University of Arizona, Tucson, said in a statement.

The IOM committee set a 2010 deadline for physicians to implement e-prescribing for all prescriptions. Physicians and hospitals should have plans in place by 2008 to implement the necessary technology, the IOM report said. The e-prescribing technology should also be able to provide physicians with real-time clinical decision support tools.

The report, which was written at the request of Congress, underscores for lawmakers the importance of electronic health records (EHRs) in improving safety, said Hedy Cohen, R.N., vice president of the Institute for Safe Medication Practices. There have already been discussions within Congress about how to support the adoption of this technology, she said, and over time, prices for the systems should decrease.

The American Medical Association pointed out that while there is great interest among physicians to adopt health IT, they face a dizzying array of choices, without much basis for objective comparison, and high adoption costs.

Just days before the release of the IOM report, the Certification Commission for Healthcare Information Technology (CCHIT) released the first list of ambulatory EHR products that had been certified as meeting baseline criteria for functionality, interoperability, and security.

“We're encouraged by these first, solid steps to help physicians make purchasing decisions, but there is much more work to be done before the majority of physicians have the capability to do e-prescribing in a comprehensive way that includes safety and security capabilities,” Dr. Cecil B. Wilson, AMA board chair, said in a statement.

And while health IT will help to eliminate some of the errors in prescribing, such as errors from handwriting, it will inevitably introduce new errors to the process, Frances Griffin, a director at the Institute for Healthcare Improvement, said in an interview.

The IOM committee also recommended that physicians do a better job of counseling patients about their medications. Physicians should educate patients and family members by providing information on side effects, contraindications, how to handle adverse reactions, and where to get good information.

And patients should be better informed about their medications at the point of prescribing, at hospital discharge, and at the pharmacy, the report said.

One of the factors that can lead to patients' problems with self-management of medication is the use of free samples, the IOM report noted. Free drug samples can pose problems when a patient is switched to a medication based on the drug's availability rather than on clinical appropriateness. Also, there is generally poor documentation in the medical record when samples are used and adverse events may not be reported, the IOM report noted. The committee recommended that the Agency for Healthcare Research and Quality fund studies evaluating the impact of free samples on overall patient safety as well as on prescribing practice and patient adherence.

Other recommendations from the report include the following suggestions:

▸ Patients or their caregivers should keep an active list of all prescription drugs, over-the-counter drugs, and dietary supplements that they take, why they are taking them, and any known allergies. Physicians should have access to this list.

▸ Government agencies should standardize pharmacy medication information, improve online medication resources, and establish a national drug information telephone help line.

▸ The Food and Drug Administration and the pharmaceutical industry should work together to develop common drug nomenclature with standard abbreviations, acronyms, and terms.

▸ States should attempt to remove barriers to e-prescribing and enact legislation that is consistent with the Medicare Modernization Act's e-prescribing provisions. Under the act, drug plans that participate in the Medicare Part D program were required to support e-prescribing by January 2006. E-prescribing is optional for physicians and pharmacists under the final rule issued by CMS last year.

The IOM report is available online at www.nap.edu

Each year, patients in the United States experience at least 1.5 million preventable injuries because of medication errors, according to the findings of an Institute of Medicine analysis.

The report, released in July, estimated that these preventable adverse drug events would add up to about $3.5 billion in additional hospitalization costs this year, excluding the economic burden of lost wages and productivity.

The expert panel convened by the Institute of Medicine (IOM) called on physicians to do their part in reducing medication errors by improving communication with patients about medication safety and adopting electronic prescribing technology.

“Our recommendations boil down to ensuring that consumers are fully informed about how to take medications safely and achieve the desired results, and that health care providers have the tools and data necessary to prescribe, dispense, and administer drugs as safely as possible and to monitor for problems,” J. Lyle Bootman, Ph.D., cochair of the IOM committee and dean of the college of pharmacy at the University of Arizona, Tucson, said in a statement.

The IOM committee set a 2010 deadline for physicians to implement e-prescribing for all prescriptions. Physicians and hospitals should have plans in place by 2008 to implement the necessary technology, the IOM report said. The e-prescribing technology should also be able to provide physicians with real-time clinical decision support tools.

The report, which was written at the request of Congress, underscores for lawmakers the importance of electronic health records (EHRs) in improving safety, said Hedy Cohen, R.N., vice president of the Institute for Safe Medication Practices. There have already been discussions within Congress about how to support the adoption of this technology, she said, and over time, prices for the systems should decrease.

The American Medical Association pointed out that while there is great interest among physicians to adopt health IT, they face a dizzying array of choices, without much basis for objective comparison, and high adoption costs.

Just days before the release of the IOM report, the Certification Commission for Healthcare Information Technology (CCHIT) released the first list of ambulatory EHR products that had been certified as meeting baseline criteria for functionality, interoperability, and security.

“We're encouraged by these first, solid steps to help physicians make purchasing decisions, but there is much more work to be done before the majority of physicians have the capability to do e-prescribing in a comprehensive way that includes safety and security capabilities,” Dr. Cecil B. Wilson, AMA board chair, said in a statement.

And while health IT will help to eliminate some of the errors in prescribing, such as errors from handwriting, it will inevitably introduce new errors to the process, Frances Griffin, a director at the Institute for Healthcare Improvement, said in an interview.

The IOM committee also recommended that physicians do a better job of counseling patients about their medications. Physicians should educate patients and family members by providing information on side effects, contraindications, how to handle adverse reactions, and where to get good information.

And patients should be better informed about their medications at the point of prescribing, at hospital discharge, and at the pharmacy, the report said.

One of the factors that can lead to patients' problems with self-management of medication is the use of free samples, the IOM report noted. Free drug samples can pose problems when a patient is switched to a medication based on the drug's availability rather than on clinical appropriateness. Also, there is generally poor documentation in the medical record when samples are used and adverse events may not be reported, the IOM report noted. The committee recommended that the Agency for Healthcare Research and Quality fund studies evaluating the impact of free samples on overall patient safety as well as on prescribing practice and patient adherence.

Other recommendations from the report include the following suggestions:

▸ Patients or their caregivers should keep an active list of all prescription drugs, over-the-counter drugs, and dietary supplements that they take, why they are taking them, and any known allergies. Physicians should have access to this list.

▸ Government agencies should standardize pharmacy medication information, improve online medication resources, and establish a national drug information telephone help line.

▸ The Food and Drug Administration and the pharmaceutical industry should work together to develop common drug nomenclature with standard abbreviations, acronyms, and terms.

▸ States should attempt to remove barriers to e-prescribing and enact legislation that is consistent with the Medicare Modernization Act's e-prescribing provisions. Under the act, drug plans that participate in the Medicare Part D program were required to support e-prescribing by January 2006. E-prescribing is optional for physicians and pharmacists under the final rule issued by CMS last year.

The IOM report is available online at www.nap.edu

Each year, patients in the United States experience at least 1.5 million preventable injuries because of medication errors, according to the findings of an Institute of Medicine analysis.

The report, released in July, estimated that these preventable adverse drug events would add up to about $3.5 billion in additional hospitalization costs this year, excluding the economic burden of lost wages and productivity.

The expert panel convened by the Institute of Medicine (IOM) called on physicians to do their part in reducing medication errors by improving communication with patients about medication safety and adopting electronic prescribing technology.

“Our recommendations boil down to ensuring that consumers are fully informed about how to take medications safely and achieve the desired results, and that health care providers have the tools and data necessary to prescribe, dispense, and administer drugs as safely as possible and to monitor for problems,” J. Lyle Bootman, Ph.D., cochair of the IOM committee and dean of the college of pharmacy at the University of Arizona, Tucson, said in a statement.

The IOM committee set a 2010 deadline for physicians to implement e-prescribing for all prescriptions. Physicians and hospitals should have plans in place by 2008 to implement the necessary technology, the IOM report said. The e-prescribing technology should also be able to provide physicians with real-time clinical decision support tools.

The report, which was written at the request of Congress, underscores for lawmakers the importance of electronic health records (EHRs) in improving safety, said Hedy Cohen, R.N., vice president of the Institute for Safe Medication Practices. There have already been discussions within Congress about how to support the adoption of this technology, she said, and over time, prices for the systems should decrease.

The American Medical Association pointed out that while there is great interest among physicians to adopt health IT, they face a dizzying array of choices, without much basis for objective comparison, and high adoption costs.

Just days before the release of the IOM report, the Certification Commission for Healthcare Information Technology (CCHIT) released the first list of ambulatory EHR products that had been certified as meeting baseline criteria for functionality, interoperability, and security.

“We're encouraged by these first, solid steps to help physicians make purchasing decisions, but there is much more work to be done before the majority of physicians have the capability to do e-prescribing in a comprehensive way that includes safety and security capabilities,” Dr. Cecil B. Wilson, AMA board chair, said in a statement.

And while health IT will help to eliminate some of the errors in prescribing, such as errors from handwriting, it will inevitably introduce new errors to the process, Frances Griffin, a director at the Institute for Healthcare Improvement, said in an interview.

The IOM committee also recommended that physicians do a better job of counseling patients about their medications. Physicians should educate patients and family members by providing information on side effects, contraindications, how to handle adverse reactions, and where to get good information.

And patients should be better informed about their medications at the point of prescribing, at hospital discharge, and at the pharmacy, the report said.

One of the factors that can lead to patients' problems with self-management of medication is the use of free samples, the IOM report noted. Free drug samples can pose problems when a patient is switched to a medication based on the drug's availability rather than on clinical appropriateness. Also, there is generally poor documentation in the medical record when samples are used and adverse events may not be reported, the IOM report noted. The committee recommended that the Agency for Healthcare Research and Quality fund studies evaluating the impact of free samples on overall patient safety as well as on prescribing practice and patient adherence.

Other recommendations from the report include the following suggestions:

▸ Patients or their caregivers should keep an active list of all prescription drugs, over-the-counter drugs, and dietary supplements that they take, why they are taking them, and any known allergies. Physicians should have access to this list.

▸ Government agencies should standardize pharmacy medication information, improve online medication resources, and establish a national drug information telephone help line.

▸ The Food and Drug Administration and the pharmaceutical industry should work together to develop common drug nomenclature with standard abbreviations, acronyms, and terms.

▸ States should attempt to remove barriers to e-prescribing and enact legislation that is consistent with the Medicare Modernization Act's e-prescribing provisions. Under the act, drug plans that participate in the Medicare Part D program were required to support e-prescribing by January 2006. E-prescribing is optional for physicians and pharmacists under the final rule issued by CMS last year.

The IOM report is available online at www.nap.edu

Binge Drinking Mapped

The highest rates of underage binge drinking in the United States occurred in the northeast region of North Dakota in 2002–2004, with the lowest rates reported in the District of Columbia's Ward 7, according to a report from the Substance Abuse and Mental Health Services Agency. The report, based on the results of the National Survey on Drug Use and Health, presented rates of binge drinking (consuming five or more drinks on the same occasion) in 340 substate areas among individuals aged 12–20 years. The lowest rate of binge drinking was 10.4% of the 12- to 20-year-old population. The highest rate was 36.1%, according to the SAMHSA report. “We have made real progress in convincing young people to abstain from drug use. Now we need to have the same positive results with alcohol abuse and dependence,” Eric B. Broderick, assistant surgeon general and acting administrator of SAMHSA, said in a statement. “We are working with states and communities to provide information and resources needed to mobilize against underage drinking.” The full report is available at

www.oas.samhsa.gov/substate2k6/substate.pdf

Citizenship Documentation Regs

Officials at the Centers for Medicare and Medicaid Services should ease citizenship documentation requirements for Medicaid recipients and applicants, the National Association of Psychiatric Health Systems said in comments to the agency last month. CMS published an interim final rule that outlined requirements for citizenship documentation in the Federal Register on July 12. NAPHS called on CMS officials to change the phrase “incapacity of mind,” which is used in the regulation, to something that better describes individuals who, “due to a physical or mental condition,” cannot meet the documentation requirements. NAPHS also urged CMS officials to stop the delay in accessing benefits for new Medicaid applicants who have otherwise met eligibility requirements but are waiting for the required citizenship documentation.

Eating Disorder Prevention

An Internet-based prevention program can help certain college-aged women who are at risk of developing an eating disorder, according to the results of a study sponsored by the National Institutes of Health. The findings, which were published in the August issue of the Archives of General Psychiatry, show that there was no overall drop in the onset of eating disorders among women aged 18–30 years who were at high risk for developing an eating disorder. Participation in the intervention, however, was associated with a decline in the onset of eating disorders among women with baseline behaviors such as self-induced vomiting and laxative use and among women with a baseline body mass index of 25 or more. The intervention included an 8-week cognitive-behavioral intervention called “Student Bodies.” Participants were asked to read materials online, keep an online body image journal, and participate in an online discussion group. “This is the first study to show that eating disorders can be prevented among high-risk groups,” Dr. C. Barr Taylor, the lead study author, said in a statement.

HIV Treatment Adherence

Educational programs can be effective at improving adherence to HIV drug regimens when the programs are one-on-one and provide practical medication management strategies, according to a review of 19 randomized, controlled trials. The literature review, which was published in the Cochrane Library in July, also noted that interventions tended to be successful if they were conducted for longer periods of time, usually 12 weeks or more. Interventions that were performed on a one-on-one basis were successful in improving adherence to medication in 10 out of 15 such studies (67%). In the four studies conducted in group settings, none was successful in improving adherence. The 19 studies reviewed included 2,159 patients. The reviewers did not find evidence to support the use of more “complex psychological constructs” such as self-efficacy, stress management, and motivation.

Drug Code Directory Incomplete

The Department of Health and Human Services' Office of Inspector General has found that the Food and Drug Administration's National Drug Code Directory is incomplete and inaccurate, largely as a result of drug companies' failure to submit required data, though the FDA shares some blame. The NDC Directory is supposed to be a current compendium of marketed drug products. The FDA relies on internal reports and on submissions from pharmaceutical manufacturers, which must report when a new product is introduced or withdrawn. The OIG report is a snapshot of the NDC directory as of February 2005. At that time, there were 123,856 products with unique NDCs. The OIG found that the FDA's listing left off just more than 9,000 drug products. For about 16%, the drug maker either had not submitted required forms or the agency had not appropriately processed them. Listings for about 5,100 products had been held up because the companies had failed to provide needed information. Finally, the OIG found that 34,000 products listed were either no longer marketed or their entries contained erroneous information, mostly because drug makers had not told the FDA that the products were discontinued. In a comment submitted with the report, the FDA acknowledged many of the failures, but also said there was a decrease in the percentage of missing products since 1990.

Binge Drinking Mapped

The highest rates of underage binge drinking in the United States occurred in the northeast region of North Dakota in 2002–2004, with the lowest rates reported in the District of Columbia's Ward 7, according to a report from the Substance Abuse and Mental Health Services Agency. The report, based on the results of the National Survey on Drug Use and Health, presented rates of binge drinking (consuming five or more drinks on the same occasion) in 340 substate areas among individuals aged 12–20 years. The lowest rate of binge drinking was 10.4% of the 12- to 20-year-old population. The highest rate was 36.1%, according to the SAMHSA report. “We have made real progress in convincing young people to abstain from drug use. Now we need to have the same positive results with alcohol abuse and dependence,” Eric B. Broderick, assistant surgeon general and acting administrator of SAMHSA, said in a statement. “We are working with states and communities to provide information and resources needed to mobilize against underage drinking.” The full report is available at

www.oas.samhsa.gov/substate2k6/substate.pdf

Citizenship Documentation Regs

Officials at the Centers for Medicare and Medicaid Services should ease citizenship documentation requirements for Medicaid recipients and applicants, the National Association of Psychiatric Health Systems said in comments to the agency last month. CMS published an interim final rule that outlined requirements for citizenship documentation in the Federal Register on July 12. NAPHS called on CMS officials to change the phrase “incapacity of mind,” which is used in the regulation, to something that better describes individuals who, “due to a physical or mental condition,” cannot meet the documentation requirements. NAPHS also urged CMS officials to stop the delay in accessing benefits for new Medicaid applicants who have otherwise met eligibility requirements but are waiting for the required citizenship documentation.

Eating Disorder Prevention

An Internet-based prevention program can help certain college-aged women who are at risk of developing an eating disorder, according to the results of a study sponsored by the National Institutes of Health. The findings, which were published in the August issue of the Archives of General Psychiatry, show that there was no overall drop in the onset of eating disorders among women aged 18–30 years who were at high risk for developing an eating disorder. Participation in the intervention, however, was associated with a decline in the onset of eating disorders among women with baseline behaviors such as self-induced vomiting and laxative use and among women with a baseline body mass index of 25 or more. The intervention included an 8-week cognitive-behavioral intervention called “Student Bodies.” Participants were asked to read materials online, keep an online body image journal, and participate in an online discussion group. “This is the first study to show that eating disorders can be prevented among high-risk groups,” Dr. C. Barr Taylor, the lead study author, said in a statement.

HIV Treatment Adherence

Educational programs can be effective at improving adherence to HIV drug regimens when the programs are one-on-one and provide practical medication management strategies, according to a review of 19 randomized, controlled trials. The literature review, which was published in the Cochrane Library in July, also noted that interventions tended to be successful if they were conducted for longer periods of time, usually 12 weeks or more. Interventions that were performed on a one-on-one basis were successful in improving adherence to medication in 10 out of 15 such studies (67%). In the four studies conducted in group settings, none was successful in improving adherence. The 19 studies reviewed included 2,159 patients. The reviewers did not find evidence to support the use of more “complex psychological constructs” such as self-efficacy, stress management, and motivation.

Drug Code Directory Incomplete

The Department of Health and Human Services' Office of Inspector General has found that the Food and Drug Administration's National Drug Code Directory is incomplete and inaccurate, largely as a result of drug companies' failure to submit required data, though the FDA shares some blame. The NDC Directory is supposed to be a current compendium of marketed drug products. The FDA relies on internal reports and on submissions from pharmaceutical manufacturers, which must report when a new product is introduced or withdrawn. The OIG report is a snapshot of the NDC directory as of February 2005. At that time, there were 123,856 products with unique NDCs. The OIG found that the FDA's listing left off just more than 9,000 drug products. For about 16%, the drug maker either had not submitted required forms or the agency had not appropriately processed them. Listings for about 5,100 products had been held up because the companies had failed to provide needed information. Finally, the OIG found that 34,000 products listed were either no longer marketed or their entries contained erroneous information, mostly because drug makers had not told the FDA that the products were discontinued. In a comment submitted with the report, the FDA acknowledged many of the failures, but also said there was a decrease in the percentage of missing products since 1990.

Binge Drinking Mapped

The highest rates of underage binge drinking in the United States occurred in the northeast region of North Dakota in 2002–2004, with the lowest rates reported in the District of Columbia's Ward 7, according to a report from the Substance Abuse and Mental Health Services Agency. The report, based on the results of the National Survey on Drug Use and Health, presented rates of binge drinking (consuming five or more drinks on the same occasion) in 340 substate areas among individuals aged 12–20 years. The lowest rate of binge drinking was 10.4% of the 12- to 20-year-old population. The highest rate was 36.1%, according to the SAMHSA report. “We have made real progress in convincing young people to abstain from drug use. Now we need to have the same positive results with alcohol abuse and dependence,” Eric B. Broderick, assistant surgeon general and acting administrator of SAMHSA, said in a statement. “We are working with states and communities to provide information and resources needed to mobilize against underage drinking.” The full report is available at

www.oas.samhsa.gov/substate2k6/substate.pdf

Citizenship Documentation Regs

Officials at the Centers for Medicare and Medicaid Services should ease citizenship documentation requirements for Medicaid recipients and applicants, the National Association of Psychiatric Health Systems said in comments to the agency last month. CMS published an interim final rule that outlined requirements for citizenship documentation in the Federal Register on July 12. NAPHS called on CMS officials to change the phrase “incapacity of mind,” which is used in the regulation, to something that better describes individuals who, “due to a physical or mental condition,” cannot meet the documentation requirements. NAPHS also urged CMS officials to stop the delay in accessing benefits for new Medicaid applicants who have otherwise met eligibility requirements but are waiting for the required citizenship documentation.

Eating Disorder Prevention

An Internet-based prevention program can help certain college-aged women who are at risk of developing an eating disorder, according to the results of a study sponsored by the National Institutes of Health. The findings, which were published in the August issue of the Archives of General Psychiatry, show that there was no overall drop in the onset of eating disorders among women aged 18–30 years who were at high risk for developing an eating disorder. Participation in the intervention, however, was associated with a decline in the onset of eating disorders among women with baseline behaviors such as self-induced vomiting and laxative use and among women with a baseline body mass index of 25 or more. The intervention included an 8-week cognitive-behavioral intervention called “Student Bodies.” Participants were asked to read materials online, keep an online body image journal, and participate in an online discussion group. “This is the first study to show that eating disorders can be prevented among high-risk groups,” Dr. C. Barr Taylor, the lead study author, said in a statement.

HIV Treatment Adherence

Educational programs can be effective at improving adherence to HIV drug regimens when the programs are one-on-one and provide practical medication management strategies, according to a review of 19 randomized, controlled trials. The literature review, which was published in the Cochrane Library in July, also noted that interventions tended to be successful if they were conducted for longer periods of time, usually 12 weeks or more. Interventions that were performed on a one-on-one basis were successful in improving adherence to medication in 10 out of 15 such studies (67%). In the four studies conducted in group settings, none was successful in improving adherence. The 19 studies reviewed included 2,159 patients. The reviewers did not find evidence to support the use of more “complex psychological constructs” such as self-efficacy, stress management, and motivation.

Drug Code Directory Incomplete

The Department of Health and Human Services' Office of Inspector General has found that the Food and Drug Administration's National Drug Code Directory is incomplete and inaccurate, largely as a result of drug companies' failure to submit required data, though the FDA shares some blame. The NDC Directory is supposed to be a current compendium of marketed drug products. The FDA relies on internal reports and on submissions from pharmaceutical manufacturers, which must report when a new product is introduced or withdrawn. The OIG report is a snapshot of the NDC directory as of February 2005. At that time, there were 123,856 products with unique NDCs. The OIG found that the FDA's listing left off just more than 9,000 drug products. For about 16%, the drug maker either had not submitted required forms or the agency had not appropriately processed them. Listings for about 5,100 products had been held up because the companies had failed to provide needed information. Finally, the OIG found that 34,000 products listed were either no longer marketed or their entries contained erroneous information, mostly because drug makers had not told the FDA that the products were discontinued. In a comment submitted with the report, the FDA acknowledged many of the failures, but also said there was a decrease in the percentage of missing products since 1990.

MADRID – A set of newly proposed criteria could bring the diagnosis of Alzheimer's disease into the 21st century by shifting the focus from one based on loss of function toward one that incorporates measurable disease-induced biochemical and structural changes.

For a diagnosis of Alzheimer's disease (AD), the proposed criteria would require presence of an objective confirmed episodic memory disorder plus at least one of the following: a structural abnormality, probably atrophy of the mediotemporal lobe as seen on magnetic resonance imaging; a characteristic biochemical marker obtained from cerebrospinal fluid (CSF); or functional brain impairment as seen on positron emission tomography or single photon emission computed tomography.

The criteria were proposed by the International Working Group on Diagnostic Criteria for Mild Cognitive Impairment/Alzheimer's Disease and were unveiled at the 10th International Conference for Alzheimer's Disease and Related Disorders.

Implementation will require years of testing across all stages of the disease. But the proposed criteria eventually could be a reliable way of distinguishing patients with AD from those with mild cognitive impairment (MCI) and other memory disorders, said Dr. Howard Feldman of the University of British Columbia's Clinic for Alzheimer's Disease and Related Disorders, Vancouver.

“We now diagnose dementia largely based on functional impairments,” Dr. Feldman said. “One of the flaws with this is that it's not clear that function has a real neurobiological correlate, and it's difficult to put everyone on the same plane functionally.”

However, recent advances regarding the clinical, structural, pathologic, and biochemical hallmarks of dementia can serve as the basis for a much more targeted diagnostic method, he said. “It's time to package these into a new set of criteria that work in mild, moderate, and advanced stages of the disease as well as in the prodromal stage.” The cornerstone of the proposed criteria is the requirement for an episodic memory disorder, which must be gradual, progressive, and of at least 6 months' duration.

Tests of delayed recall are the best at distinguishing cognitively normal patients from those with MCI who will progress to AD, Dr. Feldman said. “It's imperative that we have a test that will allow for controlled encoding, a very important dimension of the impaired episodic memory in Alzheimer's.” These types of tests, including the delayed recall and double memory tests, differentiate between the memory storage or encoding problems, which are characteristic of AD, and problems involving memory retrieval.

The medial temporal structural assessment could either be done qualitatively, on the hippocampus, choroidal fissure, or temporal horn, or quantitatively on hippocampus, entorhinal cortex, or parahippocampal gyrus. “Studies suggest good sensitivity and specificity for AD and normal patients, and good discrimination of those who will progress from MCI.”

The proposed biochemical criterion would involve CSF measures of amyloid β1–42, total tau, or phospho tau. Finally, the functional brain scanning criterion on PET would show diminished glucose metabolism in the bilateral temporoparietal regions and posterior cingulate.

More research will be necessary to further hone each criterion, Dr. Feldman said. “We need to deal with the extent of abnormality each one would measure, and find cutoff points and specific instruments for each.”

Funding for Imaging Studies in Dementia

The Alzheimer's Disease Neuroimaging Initiative–a 5-year study looking at imaging technology to improve early diagnosis and gauge the effectiveness of treatments–got a $2.1 million boost last month from the Alzheimer's Association.

Officials at the association had previously granted $1 million to help fund this $60 million public-private initiative launched by the National Institute on Aging in 2004.

The project is aimed at testing whether serial magnetic resonance imaging, positron emission tomography, biologic markers, and clinical and neuropsychological assessments can be used together to measure the progression of mild Alzheimer's disease and mild cognitive impairment.

Researchers also will evaluate the use of PET scans with Pittsburgh Compound B (PIB). “PET/PIB technology will be a valuable addition to the study,” Dr. Samuel Gandy, chair of the Alzheimer's Association's Medical and Scientific Advisory Council, said in a statement. Patients are currently being recruited for the study. For more information, check

www.nia.nih.gov/Alzheimers/ResearchInformation/ClinicalTrials/ADNI.htm

MADRID – A set of newly proposed criteria could bring the diagnosis of Alzheimer's disease into the 21st century by shifting the focus from one based on loss of function toward one that incorporates measurable disease-induced biochemical and structural changes.

For a diagnosis of Alzheimer's disease (AD), the proposed criteria would require presence of an objective confirmed episodic memory disorder plus at least one of the following: a structural abnormality, probably atrophy of the mediotemporal lobe as seen on magnetic resonance imaging; a characteristic biochemical marker obtained from cerebrospinal fluid (CSF); or functional brain impairment as seen on positron emission tomography or single photon emission computed tomography.

The criteria were proposed by the International Working Group on Diagnostic Criteria for Mild Cognitive Impairment/Alzheimer's Disease and were unveiled at the 10th International Conference for Alzheimer's Disease and Related Disorders.

Implementation will require years of testing across all stages of the disease. But the proposed criteria eventually could be a reliable way of distinguishing patients with AD from those with mild cognitive impairment (MCI) and other memory disorders, said Dr. Howard Feldman of the University of British Columbia's Clinic for Alzheimer's Disease and Related Disorders, Vancouver.

“We now diagnose dementia largely based on functional impairments,” Dr. Feldman said. “One of the flaws with this is that it's not clear that function has a real neurobiological correlate, and it's difficult to put everyone on the same plane functionally.”

However, recent advances regarding the clinical, structural, pathologic, and biochemical hallmarks of dementia can serve as the basis for a much more targeted diagnostic method, he said. “It's time to package these into a new set of criteria that work in mild, moderate, and advanced stages of the disease as well as in the prodromal stage.” The cornerstone of the proposed criteria is the requirement for an episodic memory disorder, which must be gradual, progressive, and of at least 6 months' duration.

Tests of delayed recall are the best at distinguishing cognitively normal patients from those with MCI who will progress to AD, Dr. Feldman said. “It's imperative that we have a test that will allow for controlled encoding, a very important dimension of the impaired episodic memory in Alzheimer's.” These types of tests, including the delayed recall and double memory tests, differentiate between the memory storage or encoding problems, which are characteristic of AD, and problems involving memory retrieval.

The medial temporal structural assessment could either be done qualitatively, on the hippocampus, choroidal fissure, or temporal horn, or quantitatively on hippocampus, entorhinal cortex, or parahippocampal gyrus. “Studies suggest good sensitivity and specificity for AD and normal patients, and good discrimination of those who will progress from MCI.”

The proposed biochemical criterion would involve CSF measures of amyloid β1–42, total tau, or phospho tau. Finally, the functional brain scanning criterion on PET would show diminished glucose metabolism in the bilateral temporoparietal regions and posterior cingulate.

More research will be necessary to further hone each criterion, Dr. Feldman said. “We need to deal with the extent of abnormality each one would measure, and find cutoff points and specific instruments for each.”

Funding for Imaging Studies in Dementia

The Alzheimer's Disease Neuroimaging Initiative–a 5-year study looking at imaging technology to improve early diagnosis and gauge the effectiveness of treatments–got a $2.1 million boost last month from the Alzheimer's Association.

Officials at the association had previously granted $1 million to help fund this $60 million public-private initiative launched by the National Institute on Aging in 2004.

The project is aimed at testing whether serial magnetic resonance imaging, positron emission tomography, biologic markers, and clinical and neuropsychological assessments can be used together to measure the progression of mild Alzheimer's disease and mild cognitive impairment.

Researchers also will evaluate the use of PET scans with Pittsburgh Compound B (PIB). “PET/PIB technology will be a valuable addition to the study,” Dr. Samuel Gandy, chair of the Alzheimer's Association's Medical and Scientific Advisory Council, said in a statement. Patients are currently being recruited for the study. For more information, check

www.nia.nih.gov/Alzheimers/ResearchInformation/ClinicalTrials/ADNI.htm

MADRID – A set of newly proposed criteria could bring the diagnosis of Alzheimer's disease into the 21st century by shifting the focus from one based on loss of function toward one that incorporates measurable disease-induced biochemical and structural changes.

For a diagnosis of Alzheimer's disease (AD), the proposed criteria would require presence of an objective confirmed episodic memory disorder plus at least one of the following: a structural abnormality, probably atrophy of the mediotemporal lobe as seen on magnetic resonance imaging; a characteristic biochemical marker obtained from cerebrospinal fluid (CSF); or functional brain impairment as seen on positron emission tomography or single photon emission computed tomography.

The criteria were proposed by the International Working Group on Diagnostic Criteria for Mild Cognitive Impairment/Alzheimer's Disease and were unveiled at the 10th International Conference for Alzheimer's Disease and Related Disorders.

Implementation will require years of testing across all stages of the disease. But the proposed criteria eventually could be a reliable way of distinguishing patients with AD from those with mild cognitive impairment (MCI) and other memory disorders, said Dr. Howard Feldman of the University of British Columbia's Clinic for Alzheimer's Disease and Related Disorders, Vancouver.

“We now diagnose dementia largely based on functional impairments,” Dr. Feldman said. “One of the flaws with this is that it's not clear that function has a real neurobiological correlate, and it's difficult to put everyone on the same plane functionally.”

However, recent advances regarding the clinical, structural, pathologic, and biochemical hallmarks of dementia can serve as the basis for a much more targeted diagnostic method, he said. “It's time to package these into a new set of criteria that work in mild, moderate, and advanced stages of the disease as well as in the prodromal stage.” The cornerstone of the proposed criteria is the requirement for an episodic memory disorder, which must be gradual, progressive, and of at least 6 months' duration.

Tests of delayed recall are the best at distinguishing cognitively normal patients from those with MCI who will progress to AD, Dr. Feldman said. “It's imperative that we have a test that will allow for controlled encoding, a very important dimension of the impaired episodic memory in Alzheimer's.” These types of tests, including the delayed recall and double memory tests, differentiate between the memory storage or encoding problems, which are characteristic of AD, and problems involving memory retrieval.

The medial temporal structural assessment could either be done qualitatively, on the hippocampus, choroidal fissure, or temporal horn, or quantitatively on hippocampus, entorhinal cortex, or parahippocampal gyrus. “Studies suggest good sensitivity and specificity for AD and normal patients, and good discrimination of those who will progress from MCI.”

The proposed biochemical criterion would involve CSF measures of amyloid β1–42, total tau, or phospho tau. Finally, the functional brain scanning criterion on PET would show diminished glucose metabolism in the bilateral temporoparietal regions and posterior cingulate.

More research will be necessary to further hone each criterion, Dr. Feldman said. “We need to deal with the extent of abnormality each one would measure, and find cutoff points and specific instruments for each.”

Funding for Imaging Studies in Dementia

The Alzheimer's Disease Neuroimaging Initiative–a 5-year study looking at imaging technology to improve early diagnosis and gauge the effectiveness of treatments–got a $2.1 million boost last month from the Alzheimer's Association.

Officials at the association had previously granted $1 million to help fund this $60 million public-private initiative launched by the National Institute on Aging in 2004.

The project is aimed at testing whether serial magnetic resonance imaging, positron emission tomography, biologic markers, and clinical and neuropsychological assessments can be used together to measure the progression of mild Alzheimer's disease and mild cognitive impairment.

Researchers also will evaluate the use of PET scans with Pittsburgh Compound B (PIB). “PET/PIB technology will be a valuable addition to the study,” Dr. Samuel Gandy, chair of the Alzheimer's Association's Medical and Scientific Advisory Council, said in a statement. Patients are currently being recruited for the study. For more information, check

www.nia.nih.gov/Alzheimers/ResearchInformation/ClinicalTrials/ADNI.htm

Two Democratic senators are aiming to move patient safety to the center of the medical liability debate.

Sen. Hillary Rodham Clinton (D-N.Y.) and Sen. Barack Obama (D-Ill.) have introduced legislation that would provide grant funding for physicians, hospitals, and health systems to routinely report medical errors to a national database. In cases in which patients were harmed, the hospitals and physicians involved would disclose the error and offer to enter into confidential negotiations on compensation. Any disclosures and apologies from physicians would be considered confidential under the bill.

“For too long, our health care system has discouraged the kind of communication needed to find and correct the conditions that lead to medical errors,” Sen. Clinton said in a statement. “Our bill puts patient safety first and creates an avenue for doctors and patients to find solutions outside of the courtroom.”

The two senators recently touted the benefits of the bill, the National Medical Error Disclosure and Compensation Act (S. 1784), in a perspective published in the New England Journal of Medicine.

In addition, medical liability insurers who participate in the program would be required to put a portion of any savings realized toward reducing physician premiums. For health care providers who participate, a portion of the savings must be used for activities that reduce medical errors and improve patient safety.

But some physician leaders are skeptical that the bill will gain any traction in an election year. The legislation was introduced last September and was referred to the Senate Committee on Health, Education, Labor, and Pensions. Dr. Joseph Flood, chairman of the government affairs committee for the American College of Rheumatology, said the focus on patient safety is important but that the approach outlined in the bill could have unintended consequences. The bill is unlikely to be effective as long as it requires the reporting of errors without providing an environment in which physicians will not be unduly punished, he said.

Dr. Larry S. Fields, president of the American Academy of Family Physicians, said that Sen. Clinton and Sen. Obama had their chance to vote for comprehensive liability reform back in May when the Senate defeated a motion to consider S. 22. That bill would have capped noneconomic damages at $250,000 and allowed courts to restrict the payment of attorney contingency fees. Sen. Clinton voted against the motion, and Sen. Obama did not vote.

As long as medical liability reform remains a partisan issue, it will be difficult to pass meaningful reform, Dr. Fields said.

Two Democratic senators are aiming to move patient safety to the center of the medical liability debate.

Sen. Hillary Rodham Clinton (D-N.Y.) and Sen. Barack Obama (D-Ill.) have introduced legislation that would provide grant funding for physicians, hospitals, and health systems to routinely report medical errors to a national database. In cases in which patients were harmed, the hospitals and physicians involved would disclose the error and offer to enter into confidential negotiations on compensation. Any disclosures and apologies from physicians would be considered confidential under the bill.

“For too long, our health care system has discouraged the kind of communication needed to find and correct the conditions that lead to medical errors,” Sen. Clinton said in a statement. “Our bill puts patient safety first and creates an avenue for doctors and patients to find solutions outside of the courtroom.”

The two senators recently touted the benefits of the bill, the National Medical Error Disclosure and Compensation Act (S. 1784), in a perspective published in the New England Journal of Medicine.

In addition, medical liability insurers who participate in the program would be required to put a portion of any savings realized toward reducing physician premiums. For health care providers who participate, a portion of the savings must be used for activities that reduce medical errors and improve patient safety.

But some physician leaders are skeptical that the bill will gain any traction in an election year. The legislation was introduced last September and was referred to the Senate Committee on Health, Education, Labor, and Pensions. Dr. Joseph Flood, chairman of the government affairs committee for the American College of Rheumatology, said the focus on patient safety is important but that the approach outlined in the bill could have unintended consequences. The bill is unlikely to be effective as long as it requires the reporting of errors without providing an environment in which physicians will not be unduly punished, he said.

Dr. Larry S. Fields, president of the American Academy of Family Physicians, said that Sen. Clinton and Sen. Obama had their chance to vote for comprehensive liability reform back in May when the Senate defeated a motion to consider S. 22. That bill would have capped noneconomic damages at $250,000 and allowed courts to restrict the payment of attorney contingency fees. Sen. Clinton voted against the motion, and Sen. Obama did not vote.

As long as medical liability reform remains a partisan issue, it will be difficult to pass meaningful reform, Dr. Fields said.

Two Democratic senators are aiming to move patient safety to the center of the medical liability debate.

Sen. Hillary Rodham Clinton (D-N.Y.) and Sen. Barack Obama (D-Ill.) have introduced legislation that would provide grant funding for physicians, hospitals, and health systems to routinely report medical errors to a national database. In cases in which patients were harmed, the hospitals and physicians involved would disclose the error and offer to enter into confidential negotiations on compensation. Any disclosures and apologies from physicians would be considered confidential under the bill.

“For too long, our health care system has discouraged the kind of communication needed to find and correct the conditions that lead to medical errors,” Sen. Clinton said in a statement. “Our bill puts patient safety first and creates an avenue for doctors and patients to find solutions outside of the courtroom.”

The two senators recently touted the benefits of the bill, the National Medical Error Disclosure and Compensation Act (S. 1784), in a perspective published in the New England Journal of Medicine.

In addition, medical liability insurers who participate in the program would be required to put a portion of any savings realized toward reducing physician premiums. For health care providers who participate, a portion of the savings must be used for activities that reduce medical errors and improve patient safety.

But some physician leaders are skeptical that the bill will gain any traction in an election year. The legislation was introduced last September and was referred to the Senate Committee on Health, Education, Labor, and Pensions. Dr. Joseph Flood, chairman of the government affairs committee for the American College of Rheumatology, said the focus on patient safety is important but that the approach outlined in the bill could have unintended consequences. The bill is unlikely to be effective as long as it requires the reporting of errors without providing an environment in which physicians will not be unduly punished, he said.

Dr. Larry S. Fields, president of the American Academy of Family Physicians, said that Sen. Clinton and Sen. Obama had their chance to vote for comprehensive liability reform back in May when the Senate defeated a motion to consider S. 22. That bill would have capped noneconomic damages at $250,000 and allowed courts to restrict the payment of attorney contingency fees. Sen. Clinton voted against the motion, and Sen. Obama did not vote.

As long as medical liability reform remains a partisan issue, it will be difficult to pass meaningful reform, Dr. Fields said.

Nationwide use of performance measures related to just two clinical areas—coronary artery bypass graft surgery and pneumonia—could have saved hospitals as much as $1 billion in 2004.

That conclusion is part of an analysis from Premier Inc., an alliance of not-for-profit hospitals and health care systems. Officials at Premier also estimated that use of the same performance measures would have improved quality of care in hospitals resulting in about 3,000 fewer deaths, 6,000 fewer complications, 6,000 fewer readmissions, and 500,000 fewer days in the hospital nationwide over 1 year.

The analysis is an extrapolation of the first-year results of a Medicare pay-for-performance demonstration project that involved more than 250 Premier member hospitals in 38 states around the country. As part of the demonstration project, which began in October 2003, Premier collected data on the use of quality indicators for five clinical conditions—myocardial infarction, coronary artery bypass graft (CABG), pneumonia, heart failure, and hip and knee replacement.

The Centers for Medicare and Medicaid Services offered incentive payments to hospitals based on their performance on the quality indicators. The 3-year project is still ongoing but the first-year results showed improvements in all clinical categories.

As part of its national analysis, Premier concentrated on two high-volume diagnoses—pneumonia and CABG—and extrapolated outcomes for the use of seven pneumonia measures and four CABG measures. The predictions on cost savings and quality improvement are based on all pneumonia and CABG patients receiving 76% or more of the recommended performance measures.

“Improving patient care in these two clinical areas … can be proven statistically to reduce costs, save a noticeable number of lives, to reduce complications of care, to reduce readmissions, and to shorten length of stay,” Richard A. Norling, president and CEO of Premier, said during a teleconference to announce the results of the analysis.

For pneumonia patients, Premier officials estimated the impact of oxygenation assessment, pneumococcal vaccination, blood culture before first antibiotic, adult smoking cessation counseling, initial antibiotic selection, initial antibiotic within 4 hours of hospitalization, and influenza vaccination.

For CABG patients, Premier calculated the effect of aspirin prescribed at discharge, prophylactic antibiotic selection for surgical patients, prophylactic antibiotic within 1 hour prior to surgical incision, and prophylactic antibiotic discontinued within 24 hours after the end of surgery.

For more information on the Premier analysis of the impact of performance measures, go to www.premierinc.com/p4p/press

Nationwide use of performance measures related to just two clinical areas—coronary artery bypass graft surgery and pneumonia—could have saved hospitals as much as $1 billion in 2004.

That conclusion is part of an analysis from Premier Inc., an alliance of not-for-profit hospitals and health care systems. Officials at Premier also estimated that use of the same performance measures would have improved quality of care in hospitals resulting in about 3,000 fewer deaths, 6,000 fewer complications, 6,000 fewer readmissions, and 500,000 fewer days in the hospital nationwide over 1 year.

The analysis is an extrapolation of the first-year results of a Medicare pay-for-performance demonstration project that involved more than 250 Premier member hospitals in 38 states around the country. As part of the demonstration project, which began in October 2003, Premier collected data on the use of quality indicators for five clinical conditions—myocardial infarction, coronary artery bypass graft (CABG), pneumonia, heart failure, and hip and knee replacement.

The Centers for Medicare and Medicaid Services offered incentive payments to hospitals based on their performance on the quality indicators. The 3-year project is still ongoing but the first-year results showed improvements in all clinical categories.

As part of its national analysis, Premier concentrated on two high-volume diagnoses—pneumonia and CABG—and extrapolated outcomes for the use of seven pneumonia measures and four CABG measures. The predictions on cost savings and quality improvement are based on all pneumonia and CABG patients receiving 76% or more of the recommended performance measures.

“Improving patient care in these two clinical areas … can be proven statistically to reduce costs, save a noticeable number of lives, to reduce complications of care, to reduce readmissions, and to shorten length of stay,” Richard A. Norling, president and CEO of Premier, said during a teleconference to announce the results of the analysis.

For pneumonia patients, Premier officials estimated the impact of oxygenation assessment, pneumococcal vaccination, blood culture before first antibiotic, adult smoking cessation counseling, initial antibiotic selection, initial antibiotic within 4 hours of hospitalization, and influenza vaccination.

For CABG patients, Premier calculated the effect of aspirin prescribed at discharge, prophylactic antibiotic selection for surgical patients, prophylactic antibiotic within 1 hour prior to surgical incision, and prophylactic antibiotic discontinued within 24 hours after the end of surgery.

For more information on the Premier analysis of the impact of performance measures, go to www.premierinc.com/p4p/press

Nationwide use of performance measures related to just two clinical areas—coronary artery bypass graft surgery and pneumonia—could have saved hospitals as much as $1 billion in 2004.

That conclusion is part of an analysis from Premier Inc., an alliance of not-for-profit hospitals and health care systems. Officials at Premier also estimated that use of the same performance measures would have improved quality of care in hospitals resulting in about 3,000 fewer deaths, 6,000 fewer complications, 6,000 fewer readmissions, and 500,000 fewer days in the hospital nationwide over 1 year.

The analysis is an extrapolation of the first-year results of a Medicare pay-for-performance demonstration project that involved more than 250 Premier member hospitals in 38 states around the country. As part of the demonstration project, which began in October 2003, Premier collected data on the use of quality indicators for five clinical conditions—myocardial infarction, coronary artery bypass graft (CABG), pneumonia, heart failure, and hip and knee replacement.

The Centers for Medicare and Medicaid Services offered incentive payments to hospitals based on their performance on the quality indicators. The 3-year project is still ongoing but the first-year results showed improvements in all clinical categories.

As part of its national analysis, Premier concentrated on two high-volume diagnoses—pneumonia and CABG—and extrapolated outcomes for the use of seven pneumonia measures and four CABG measures. The predictions on cost savings and quality improvement are based on all pneumonia and CABG patients receiving 76% or more of the recommended performance measures.

“Improving patient care in these two clinical areas … can be proven statistically to reduce costs, save a noticeable number of lives, to reduce complications of care, to reduce readmissions, and to shorten length of stay,” Richard A. Norling, president and CEO of Premier, said during a teleconference to announce the results of the analysis.

For pneumonia patients, Premier officials estimated the impact of oxygenation assessment, pneumococcal vaccination, blood culture before first antibiotic, adult smoking cessation counseling, initial antibiotic selection, initial antibiotic within 4 hours of hospitalization, and influenza vaccination.

For CABG patients, Premier calculated the effect of aspirin prescribed at discharge, prophylactic antibiotic selection for surgical patients, prophylactic antibiotic within 1 hour prior to surgical incision, and prophylactic antibiotic discontinued within 24 hours after the end of surgery.

For more information on the Premier analysis of the impact of performance measures, go to www.premierinc.com/p4p/press

Unless Congress intervenes by the end of the year, physicians are scheduled to face a 5.1% cut in Medicare payments starting Jan. 1, 2007.

Officials at the Centers for Medicare and Medicaid Services published the proposed physician fee schedule changes in the Aug. 22 issue of the Federal Register; the final regulation is expected in the fall. The proposed cut, which comes on the heels of years of pay freezes and minor increases, is likely to force some physicians to stop accepting new Medicare patients, several physicians told this newspaper.

About 45% of physicians surveyed by the American Medical Association in February and March of this year reported that they would either decrease or stop seeing new Medicare patients if Medicare payments were reduced by 5% in 2007. The AMA surveyed more than 8,000 physicians, including both members and nonmembers.

That trend has already begun in some communities. Dr. Michael McAdoo, a family physician in Milan, Tenn., who works in a four-physician practice, stopped taking new Medicare patients about 3 years ago. “We saw this coming,” he said.

Now, with potentially deeper cuts on the horizon, he is considering stopping his hospital coverage and has begun limiting the number of Medicare patients he sees each day. In Milan, a town of about 10,000, there is only one physician in the community who is still accepting new Medicare patients. “I anticipate this will probably get worse,” Dr. McAdoo said.

Over time, there will likely be access-to-care problems in rheumatology as well, said Dr. Michael Schweitz, vice president of the Coalition of State Rheumatology Organizations and a rheumatologist in West Palm Beach, Fla. He has already started to hear about physicians who are not accepting new Medicare patients, though the practice is not widespread, he said.

And for physicians who care for a large number of Medicare patients and aren't willing to limit access, the cut will mean a significant drop in their take-home pay, Dr. Schweitz said. The cuts are especially tough on general internists and other primary care physicians who already face difficulty in recruiting young physicians to their practices, said Dr. Yul Ejnes, an internist in Cranston, R.I., and chair of the board of governors of the American College of Physicians. Many physicians have been willing to continue to see Medicare patients despite the falling reimbursement rates, Dr. Ejnes said, but lawmakers can't count on that indefinitely.

In his practice, about 20%–30% of his patients are Medicare beneficiaries, so Dr. Ejnes said he expects to see an impact on his bottom line due to the projected cuts. The impact could be greater if private insurance companies that tie their payment rates to Medicare choose to lower their payments at the same time.

The cuts are also likely to result in access issues beyond Medicare beneficiaries, he said. For example, if a physician has to cut back on staff because of Medicare payment cuts, that will affect all patients. And if a physician chooses to retire early, that affects thousands of patients who have to seek care elsewhere. “The impact is on the system as a whole,” Dr. Ejnes said.

The proposed cut comes just a few weeks after CMS officials announced plans to change the way Medicare pays for evaluation and management services, with physicians who provide more cognitive services getting a bigger piece of the Medicare pie. But those increases to primary care physicians are likely to be nearly wiped out by the projected payment cuts based on the sustainable growth rate (SGR) formula.

And the latest SGR cut compounds the problem for specialties in which physicians are expected to experience cuts based on the proposed changes to the way Medicare pays for evaluation and management services. For example, Medicare payments to cardiologists could drop by about 7% next year, due to the 5.1% proposed fee schedule cut plus a proposed 1% decrease in work and practice expense relative value units for 2007, and a 1% decrease based on the implementation of imaging provisions in the Deficit Reduction Act of 2005 (DRA). The impact will vary among individual cardiologists based on the mix of services provided, according to the American College of Cardiology.

The AMA called on Congress to stop the proposed 2007 payment cut and begin to reimburse physicians based on the actual cost of providing care. AMA officials estimate that without a change to the current payment formula, Medicare payments will be cut 37% over the next 9 years, while at the same time practice costs will rise 22%.

Medicare physician payment rates are set annually based on a statutory formula. That formula adjusts the Medicare Economic Index based on how actual medical expenditures compare to a target rate—the SGR. The SGR is based in part on medical inflation, the projected growth in the domestic economy, and projected changes in the number of Medicare beneficiaries.

While there has been legislation introduced in Congress this year aimed at changing the formula that calculates physician payments under Medicare, a permanent fix to the payment problem is unlikely this year, said Dr. Larry Fields, president of the American Academy of Family Physicians.

The AAFP is pushing for a positive update of between 2% and 5% for 2007 and real engagement to permanently fix the problem next year, he said. Officials at the AAFP have commissioned a health care consulting firm, the Lewin Group, to examine alternative payment mechanisms that would not involve the use of the SGR formula, he said. They hope to use that information to work with Congress on a permanent solution next year, Dr. Fields said.

In addition to the 5.1% payment cut, the CMS proposal also seeks to expand coverage for some preventive services. For example, the proposed rule would implement the provisions of the DRA that call for making abdominal aortic aneurysm screening a Medicare-covered preventive service. The benefit would include a one-time ultrasound screening for beneficiaries who seek the “Welcome to Medicare” physical, along with education, counseling, and referral services.

The CMS proposed rule would also implement other provisions of the DRA which call for exempting colorectal cancer screening from the Part B Medicare deductible.

Unless Congress intervenes by the end of the year, physicians are scheduled to face a 5.1% cut in Medicare payments starting Jan. 1, 2007.

Officials at the Centers for Medicare and Medicaid Services published the proposed physician fee schedule changes in the Aug. 22 issue of the Federal Register; the final regulation is expected in the fall. The proposed cut, which comes on the heels of years of pay freezes and minor increases, is likely to force some physicians to stop accepting new Medicare patients, several physicians told this newspaper.

About 45% of physicians surveyed by the American Medical Association in February and March of this year reported that they would either decrease or stop seeing new Medicare patients if Medicare payments were reduced by 5% in 2007. The AMA surveyed more than 8,000 physicians, including both members and nonmembers.

That trend has already begun in some communities. Dr. Michael McAdoo, a family physician in Milan, Tenn., who works in a four-physician practice, stopped taking new Medicare patients about 3 years ago. “We saw this coming,” he said.

Now, with potentially deeper cuts on the horizon, he is considering stopping his hospital coverage and has begun limiting the number of Medicare patients he sees each day. In Milan, a town of about 10,000, there is only one physician in the community who is still accepting new Medicare patients. “I anticipate this will probably get worse,” Dr. McAdoo said.

Over time, there will likely be access-to-care problems in rheumatology as well, said Dr. Michael Schweitz, vice president of the Coalition of State Rheumatology Organizations and a rheumatologist in West Palm Beach, Fla. He has already started to hear about physicians who are not accepting new Medicare patients, though the practice is not widespread, he said.

And for physicians who care for a large number of Medicare patients and aren't willing to limit access, the cut will mean a significant drop in their take-home pay, Dr. Schweitz said. The cuts are especially tough on general internists and other primary care physicians who already face difficulty in recruiting young physicians to their practices, said Dr. Yul Ejnes, an internist in Cranston, R.I., and chair of the board of governors of the American College of Physicians. Many physicians have been willing to continue to see Medicare patients despite the falling reimbursement rates, Dr. Ejnes said, but lawmakers can't count on that indefinitely.

In his practice, about 20%–30% of his patients are Medicare beneficiaries, so Dr. Ejnes said he expects to see an impact on his bottom line due to the projected cuts. The impact could be greater if private insurance companies that tie their payment rates to Medicare choose to lower their payments at the same time.

The cuts are also likely to result in access issues beyond Medicare beneficiaries, he said. For example, if a physician has to cut back on staff because of Medicare payment cuts, that will affect all patients. And if a physician chooses to retire early, that affects thousands of patients who have to seek care elsewhere. “The impact is on the system as a whole,” Dr. Ejnes said.

The proposed cut comes just a few weeks after CMS officials announced plans to change the way Medicare pays for evaluation and management services, with physicians who provide more cognitive services getting a bigger piece of the Medicare pie. But those increases to primary care physicians are likely to be nearly wiped out by the projected payment cuts based on the sustainable growth rate (SGR) formula.

And the latest SGR cut compounds the problem for specialties in which physicians are expected to experience cuts based on the proposed changes to the way Medicare pays for evaluation and management services. For example, Medicare payments to cardiologists could drop by about 7% next year, due to the 5.1% proposed fee schedule cut plus a proposed 1% decrease in work and practice expense relative value units for 2007, and a 1% decrease based on the implementation of imaging provisions in the Deficit Reduction Act of 2005 (DRA). The impact will vary among individual cardiologists based on the mix of services provided, according to the American College of Cardiology.

The AMA called on Congress to stop the proposed 2007 payment cut and begin to reimburse physicians based on the actual cost of providing care. AMA officials estimate that without a change to the current payment formula, Medicare payments will be cut 37% over the next 9 years, while at the same time practice costs will rise 22%.

Medicare physician payment rates are set annually based on a statutory formula. That formula adjusts the Medicare Economic Index based on how actual medical expenditures compare to a target rate—the SGR. The SGR is based in part on medical inflation, the projected growth in the domestic economy, and projected changes in the number of Medicare beneficiaries.

While there has been legislation introduced in Congress this year aimed at changing the formula that calculates physician payments under Medicare, a permanent fix to the payment problem is unlikely this year, said Dr. Larry Fields, president of the American Academy of Family Physicians.

The AAFP is pushing for a positive update of between 2% and 5% for 2007 and real engagement to permanently fix the problem next year, he said. Officials at the AAFP have commissioned a health care consulting firm, the Lewin Group, to examine alternative payment mechanisms that would not involve the use of the SGR formula, he said. They hope to use that information to work with Congress on a permanent solution next year, Dr. Fields said.

In addition to the 5.1% payment cut, the CMS proposal also seeks to expand coverage for some preventive services. For example, the proposed rule would implement the provisions of the DRA that call for making abdominal aortic aneurysm screening a Medicare-covered preventive service. The benefit would include a one-time ultrasound screening for beneficiaries who seek the “Welcome to Medicare” physical, along with education, counseling, and referral services.

The CMS proposed rule would also implement other provisions of the DRA which call for exempting colorectal cancer screening from the Part B Medicare deductible.

Unless Congress intervenes by the end of the year, physicians are scheduled to face a 5.1% cut in Medicare payments starting Jan. 1, 2007.

Officials at the Centers for Medicare and Medicaid Services published the proposed physician fee schedule changes in the Aug. 22 issue of the Federal Register; the final regulation is expected in the fall. The proposed cut, which comes on the heels of years of pay freezes and minor increases, is likely to force some physicians to stop accepting new Medicare patients, several physicians told this newspaper.

About 45% of physicians surveyed by the American Medical Association in February and March of this year reported that they would either decrease or stop seeing new Medicare patients if Medicare payments were reduced by 5% in 2007. The AMA surveyed more than 8,000 physicians, including both members and nonmembers.

That trend has already begun in some communities. Dr. Michael McAdoo, a family physician in Milan, Tenn., who works in a four-physician practice, stopped taking new Medicare patients about 3 years ago. “We saw this coming,” he said.

Now, with potentially deeper cuts on the horizon, he is considering stopping his hospital coverage and has begun limiting the number of Medicare patients he sees each day. In Milan, a town of about 10,000, there is only one physician in the community who is still accepting new Medicare patients. “I anticipate this will probably get worse,” Dr. McAdoo said.

Over time, there will likely be access-to-care problems in rheumatology as well, said Dr. Michael Schweitz, vice president of the Coalition of State Rheumatology Organizations and a rheumatologist in West Palm Beach, Fla. He has already started to hear about physicians who are not accepting new Medicare patients, though the practice is not widespread, he said.

And for physicians who care for a large number of Medicare patients and aren't willing to limit access, the cut will mean a significant drop in their take-home pay, Dr. Schweitz said. The cuts are especially tough on general internists and other primary care physicians who already face difficulty in recruiting young physicians to their practices, said Dr. Yul Ejnes, an internist in Cranston, R.I., and chair of the board of governors of the American College of Physicians. Many physicians have been willing to continue to see Medicare patients despite the falling reimbursement rates, Dr. Ejnes said, but lawmakers can't count on that indefinitely.

In his practice, about 20%–30% of his patients are Medicare beneficiaries, so Dr. Ejnes said he expects to see an impact on his bottom line due to the projected cuts. The impact could be greater if private insurance companies that tie their payment rates to Medicare choose to lower their payments at the same time.

The cuts are also likely to result in access issues beyond Medicare beneficiaries, he said. For example, if a physician has to cut back on staff because of Medicare payment cuts, that will affect all patients. And if a physician chooses to retire early, that affects thousands of patients who have to seek care elsewhere. “The impact is on the system as a whole,” Dr. Ejnes said.

The proposed cut comes just a few weeks after CMS officials announced plans to change the way Medicare pays for evaluation and management services, with physicians who provide more cognitive services getting a bigger piece of the Medicare pie. But those increases to primary care physicians are likely to be nearly wiped out by the projected payment cuts based on the sustainable growth rate (SGR) formula.

And the latest SGR cut compounds the problem for specialties in which physicians are expected to experience cuts based on the proposed changes to the way Medicare pays for evaluation and management services. For example, Medicare payments to cardiologists could drop by about 7% next year, due to the 5.1% proposed fee schedule cut plus a proposed 1% decrease in work and practice expense relative value units for 2007, and a 1% decrease based on the implementation of imaging provisions in the Deficit Reduction Act of 2005 (DRA). The impact will vary among individual cardiologists based on the mix of services provided, according to the American College of Cardiology.

The AMA called on Congress to stop the proposed 2007 payment cut and begin to reimburse physicians based on the actual cost of providing care. AMA officials estimate that without a change to the current payment formula, Medicare payments will be cut 37% over the next 9 years, while at the same time practice costs will rise 22%.

Medicare physician payment rates are set annually based on a statutory formula. That formula adjusts the Medicare Economic Index based on how actual medical expenditures compare to a target rate—the SGR. The SGR is based in part on medical inflation, the projected growth in the domestic economy, and projected changes in the number of Medicare beneficiaries.

While there has been legislation introduced in Congress this year aimed at changing the formula that calculates physician payments under Medicare, a permanent fix to the payment problem is unlikely this year, said Dr. Larry Fields, president of the American Academy of Family Physicians.

The AAFP is pushing for a positive update of between 2% and 5% for 2007 and real engagement to permanently fix the problem next year, he said. Officials at the AAFP have commissioned a health care consulting firm, the Lewin Group, to examine alternative payment mechanisms that would not involve the use of the SGR formula, he said. They hope to use that information to work with Congress on a permanent solution next year, Dr. Fields said.

In addition to the 5.1% payment cut, the CMS proposal also seeks to expand coverage for some preventive services. For example, the proposed rule would implement the provisions of the DRA that call for making abdominal aortic aneurysm screening a Medicare-covered preventive service. The benefit would include a one-time ultrasound screening for beneficiaries who seek the “Welcome to Medicare” physical, along with education, counseling, and referral services.

The CMS proposed rule would also implement other provisions of the DRA which call for exempting colorectal cancer screening from the Part B Medicare deductible.

LOS ANGELES — Both seniors and adolescents can be good candidates for Roux-en-Y gastric bypass surgery, according to new research presented at the annual Digestive Disease Week.

In a retrospective analysis of 167 surgical cases at the Mayo Clinic in Rochester, Minn., involving patients aged 60 or older and adolescents aged 12–18 years, researchers found a significant decrease in obesity-related mortality after gastric bypass surgery, and limited morbidity and mortality overall.

The researchers analyzed cases from the Mayo Clinic's 20-year bariatric surgery database and obtained morbidity and mortality rates from medical records. They also sent a questionnaire to all surviving patients.

The older patients had higher rates of adverse events and reported having experienced less dramatic results both in decreases in body mass index (BMI) and self-assessed declines in obesity-related health conditions.

The 155 older patients—aged 60–76 years—had a 6% mortality after 5 years of follow-up, and another 14% had had serious morbidities that delayed their discharge from the hospital follwing surgery, such as wound infections, bowel obstructions, or cardiovascular events.

Patients reported about a 50% reversal in obesity-related comorbidities, and the average BMI was reduced from 46 to 33 kg/m

Mortality for older patients in this study (0.7%) is significantly lower than the rate in a previous report about Medicare patients who underwent gastric bypass surgery, Dr. Sarr said. That study reported a 30-day mortality of nearly 5% in patients aged 65 and older (JAMA 2005;294:1903–8).

“That is just not our experience at the Mayo Clinic,” he said.

But he added that mortality and morbidity post surgery can be high at surgical centers that perform a low volume of these operations, while high-volume centers carry a much lower risk.

Among 12 adolescent patients aged 12–18 years who underwent the surgery, there were no serious adverse events and no deaths after 3 years of follow-up. The overall morbidity was about 10%, Dr. Sarr said.

The adolescent patients had an average drop in BMI of 55 to 36, and patients reported experiencing an 82% reduction in obesity-related diseases.

The need for the surgery in the adolescent population is clear, he said, so the debate now centers on the appropriate operation in this group. For example, some surgeons favor using a gastric band, which can be adjusted or removed, instead of traditional Roux-en-Y gastric bypass surgery. Dr. Sarr said he expects to see more research in this population in the next 3–4 years.

LOS ANGELES — Both seniors and adolescents can be good candidates for Roux-en-Y gastric bypass surgery, according to new research presented at the annual Digestive Disease Week.

In a retrospective analysis of 167 surgical cases at the Mayo Clinic in Rochester, Minn., involving patients aged 60 or older and adolescents aged 12–18 years, researchers found a significant decrease in obesity-related mortality after gastric bypass surgery, and limited morbidity and mortality overall.

The researchers analyzed cases from the Mayo Clinic's 20-year bariatric surgery database and obtained morbidity and mortality rates from medical records. They also sent a questionnaire to all surviving patients.

The older patients had higher rates of adverse events and reported having experienced less dramatic results both in decreases in body mass index (BMI) and self-assessed declines in obesity-related health conditions.

The 155 older patients—aged 60–76 years—had a 6% mortality after 5 years of follow-up, and another 14% had had serious morbidities that delayed their discharge from the hospital follwing surgery, such as wound infections, bowel obstructions, or cardiovascular events.

Patients reported about a 50% reversal in obesity-related comorbidities, and the average BMI was reduced from 46 to 33 kg/m

Mortality for older patients in this study (0.7%) is significantly lower than the rate in a previous report about Medicare patients who underwent gastric bypass surgery, Dr. Sarr said. That study reported a 30-day mortality of nearly 5% in patients aged 65 and older (JAMA 2005;294:1903–8).

“That is just not our experience at the Mayo Clinic,” he said.

But he added that mortality and morbidity post surgery can be high at surgical centers that perform a low volume of these operations, while high-volume centers carry a much lower risk.

Among 12 adolescent patients aged 12–18 years who underwent the surgery, there were no serious adverse events and no deaths after 3 years of follow-up. The overall morbidity was about 10%, Dr. Sarr said.

The adolescent patients had an average drop in BMI of 55 to 36, and patients reported experiencing an 82% reduction in obesity-related diseases.

The need for the surgery in the adolescent population is clear, he said, so the debate now centers on the appropriate operation in this group. For example, some surgeons favor using a gastric band, which can be adjusted or removed, instead of traditional Roux-en-Y gastric bypass surgery. Dr. Sarr said he expects to see more research in this population in the next 3–4 years.

LOS ANGELES — Both seniors and adolescents can be good candidates for Roux-en-Y gastric bypass surgery, according to new research presented at the annual Digestive Disease Week.

In a retrospective analysis of 167 surgical cases at the Mayo Clinic in Rochester, Minn., involving patients aged 60 or older and adolescents aged 12–18 years, researchers found a significant decrease in obesity-related mortality after gastric bypass surgery, and limited morbidity and mortality overall.

The researchers analyzed cases from the Mayo Clinic's 20-year bariatric surgery database and obtained morbidity and mortality rates from medical records. They also sent a questionnaire to all surviving patients.

The older patients had higher rates of adverse events and reported having experienced less dramatic results both in decreases in body mass index (BMI) and self-assessed declines in obesity-related health conditions.

The 155 older patients—aged 60–76 years—had a 6% mortality after 5 years of follow-up, and another 14% had had serious morbidities that delayed their discharge from the hospital follwing surgery, such as wound infections, bowel obstructions, or cardiovascular events.

Patients reported about a 50% reversal in obesity-related comorbidities, and the average BMI was reduced from 46 to 33 kg/m

Mortality for older patients in this study (0.7%) is significantly lower than the rate in a previous report about Medicare patients who underwent gastric bypass surgery, Dr. Sarr said. That study reported a 30-day mortality of nearly 5% in patients aged 65 and older (JAMA 2005;294:1903–8).

“That is just not our experience at the Mayo Clinic,” he said.

But he added that mortality and morbidity post surgery can be high at surgical centers that perform a low volume of these operations, while high-volume centers carry a much lower risk.

Among 12 adolescent patients aged 12–18 years who underwent the surgery, there were no serious adverse events and no deaths after 3 years of follow-up. The overall morbidity was about 10%, Dr. Sarr said.

The adolescent patients had an average drop in BMI of 55 to 36, and patients reported experiencing an 82% reduction in obesity-related diseases.

The need for the surgery in the adolescent population is clear, he said, so the debate now centers on the appropriate operation in this group. For example, some surgeons favor using a gastric band, which can be adjusted or removed, instead of traditional Roux-en-Y gastric bypass surgery. Dr. Sarr said he expects to see more research in this population in the next 3–4 years.

Providing telephone counseling and targeted educational materials to the siblings of recently diagnosed melanoma patients can help improve the rate and quality of skin self-screening, according to the results of new research.

In a randomized controlled trial that included 494 siblings of melanoma patients, those who received the study intervention were more likely to examine all of their moles, including those on the back, compared with siblings who had received usual care (odds ratio 1.76).

Those receiving targeted education also were more likely to compare all of their moles to see if one stood out (odds ratio 2.20).

Alan C. Geller, R.N., of Boston University, and his colleagues contacted 667 siblings of recently diagnosed melanoma patients. Of this group, 494 consented to participate in the study and completed a baseline survey. The siblings were randomized to receive either the study intervention or usual care, which in the study was a suggestion by the dermatologist that siblings be screened for melanoma. A total of 314 siblings completed the 12-month survey (Cancer 2006;107:806–14).

The intervention included a motivational telephone session with a health educator, tailored print materials at various points in the first 6 months, three additional telephone counseling sessions, and information about free screening programs.

The calls and materials were customized to the particular needs or concerns of the siblings. Study participants who said they had difficulty checking for moles on their back, for example, were given information on how to include that as part of their self-exam.

The researchers assessed the efficacy of the intervention by whether the siblings had a skin cancer screening exam by a dermatologist within 12 months of completing the baseline survey, whether they conducted a personal skin self-exam within 12 months, and whether they had always or often used sunscreen with SPF 15 or more during the past summer when spending more than 15 minutes in the sun.

Although the siblings in the intervention arm showed greater improvement in self-screening, both arms showed similar results in terms of obtaining an exam from a dermatologist within a year and routinely using sunscreen.

At baseline, about 28% of participants in both groups had been to a dermatologist for an exam in the last year. That figure rose to about 68% after 12 months. About 56% of participants in both groups reported routinely using sunscreen at baseline and that figure rose to 66% for the usual-care group and 67% for the intervention group after 12 months.

Dr. June K. Robinson of Chicago, editor of the Archives of Dermatology, praised the study. Teaching skin self-examination to those who recognize their personal risk can help to improve the performance and quality of the exam, she said in an interview.

The lesson for clinicians making a diagnosis of melanoma is to ask patients to inform their first-degree relatives so they can be examined by a dermatologist. “One of the most important motivators for the patient is for the physician to tell them to do something,” Dr. Robinson said.

Teaching skin self-examination to those who recognize their personal risk can improve the quality of the exam. DR. ROBINSON

ELSEVIER GLOBAL MEDICAL NEWS

Providing telephone counseling and targeted educational materials to the siblings of recently diagnosed melanoma patients can help improve the rate and quality of skin self-screening, according to the results of new research.

In a randomized controlled trial that included 494 siblings of melanoma patients, those who received the study intervention were more likely to examine all of their moles, including those on the back, compared with siblings who had received usual care (odds ratio 1.76).

Those receiving targeted education also were more likely to compare all of their moles to see if one stood out (odds ratio 2.20).

Alan C. Geller, R.N., of Boston University, and his colleagues contacted 667 siblings of recently diagnosed melanoma patients. Of this group, 494 consented to participate in the study and completed a baseline survey. The siblings were randomized to receive either the study intervention or usual care, which in the study was a suggestion by the dermatologist that siblings be screened for melanoma. A total of 314 siblings completed the 12-month survey (Cancer 2006;107:806–14).

The intervention included a motivational telephone session with a health educator, tailored print materials at various points in the first 6 months, three additional telephone counseling sessions, and information about free screening programs.

The calls and materials were customized to the particular needs or concerns of the siblings. Study participants who said they had difficulty checking for moles on their back, for example, were given information on how to include that as part of their self-exam.

The researchers assessed the efficacy of the intervention by whether the siblings had a skin cancer screening exam by a dermatologist within 12 months of completing the baseline survey, whether they conducted a personal skin self-exam within 12 months, and whether they had always or often used sunscreen with SPF 15 or more during the past summer when spending more than 15 minutes in the sun.

Although the siblings in the intervention arm showed greater improvement in self-screening, both arms showed similar results in terms of obtaining an exam from a dermatologist within a year and routinely using sunscreen.

At baseline, about 28% of participants in both groups had been to a dermatologist for an exam in the last year. That figure rose to about 68% after 12 months. About 56% of participants in both groups reported routinely using sunscreen at baseline and that figure rose to 66% for the usual-care group and 67% for the intervention group after 12 months.

Dr. June K. Robinson of Chicago, editor of the Archives of Dermatology, praised the study. Teaching skin self-examination to those who recognize their personal risk can help to improve the performance and quality of the exam, she said in an interview.

The lesson for clinicians making a diagnosis of melanoma is to ask patients to inform their first-degree relatives so they can be examined by a dermatologist. “One of the most important motivators for the patient is for the physician to tell them to do something,” Dr. Robinson said.

Teaching skin self-examination to those who recognize their personal risk can improve the quality of the exam. DR. ROBINSON

ELSEVIER GLOBAL MEDICAL NEWS

Providing telephone counseling and targeted educational materials to the siblings of recently diagnosed melanoma patients can help improve the rate and quality of skin self-screening, according to the results of new research.

In a randomized controlled trial that included 494 siblings of melanoma patients, those who received the study intervention were more likely to examine all of their moles, including those on the back, compared with siblings who had received usual care (odds ratio 1.76).

Those receiving targeted education also were more likely to compare all of their moles to see if one stood out (odds ratio 2.20).

Alan C. Geller, R.N., of Boston University, and his colleagues contacted 667 siblings of recently diagnosed melanoma patients. Of this group, 494 consented to participate in the study and completed a baseline survey. The siblings were randomized to receive either the study intervention or usual care, which in the study was a suggestion by the dermatologist that siblings be screened for melanoma. A total of 314 siblings completed the 12-month survey (Cancer 2006;107:806–14).

The intervention included a motivational telephone session with a health educator, tailored print materials at various points in the first 6 months, three additional telephone counseling sessions, and information about free screening programs.

The calls and materials were customized to the particular needs or concerns of the siblings. Study participants who said they had difficulty checking for moles on their back, for example, were given information on how to include that as part of their self-exam.

The researchers assessed the efficacy of the intervention by whether the siblings had a skin cancer screening exam by a dermatologist within 12 months of completing the baseline survey, whether they conducted a personal skin self-exam within 12 months, and whether they had always or often used sunscreen with SPF 15 or more during the past summer when spending more than 15 minutes in the sun.

Although the siblings in the intervention arm showed greater improvement in self-screening, both arms showed similar results in terms of obtaining an exam from a dermatologist within a year and routinely using sunscreen.

At baseline, about 28% of participants in both groups had been to a dermatologist for an exam in the last year. That figure rose to about 68% after 12 months. About 56% of participants in both groups reported routinely using sunscreen at baseline and that figure rose to 66% for the usual-care group and 67% for the intervention group after 12 months.

Dr. June K. Robinson of Chicago, editor of the Archives of Dermatology, praised the study. Teaching skin self-examination to those who recognize their personal risk can help to improve the performance and quality of the exam, she said in an interview.

The lesson for clinicians making a diagnosis of melanoma is to ask patients to inform their first-degree relatives so they can be examined by a dermatologist. “One of the most important motivators for the patient is for the physician to tell them to do something,” Dr. Robinson said.

Teaching skin self-examination to those who recognize their personal risk can improve the quality of the exam. DR. ROBINSON

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — A 0.45-mg daily dose of synthetic conjugated estrogens-A improves moderate to severe menopausal vasomotor symptoms, compared with placebo, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The results indicate that postmenopausal women who start estrogen therapy at a low dose may be able to gain the efficacy of higher-dose treatments while having minimal side effects, Dr. James A. Simon of George Washington University in Washington and Dr. Sam S. Miller of the SAM Clinical Research Center in San Antonio wrote in a poster presented at the ACOG meeting.

At week 12 of therapy, nearly 38% of patients taking synthetic conjugated estrogens-A (SCE-A) reported no moderate to severe vasomotor symptoms vs. 7.8% of patients taking placebo, according to the researchers. In addition, the 0.45-mg daily dose of SCE-A reduced the mean weekly frequency of moderate to severe vasomotor symptoms by 67.8 from a baseline of 95.9 at 12 weeks, compared with a mean drop of 42.9 among placebo patients from the same baseline score.

The multicenter, double-blind trial included postmenopausal women, with or without a uterus, who had experienced at least 60 moderate to severe vasomotor symptoms per week. A total of 104 patients were randomized to receive either the 0.45-mg dose of SCE-A or placebo daily for 12 weeks. Approximately 91% of the patients taking SCE-A and 67% of the patients taking placebo completed the full 12 weeks of the study.

The subjects were asked to keep a daily diary of the frequency and severity of their symptoms. Patients also had vital signs, body weight, and adverse events evaluated during six office visits. The investigators assessed the safety and tolerability of the treatment through standard laboratory evaluations at screening and at week 12 of the study.

The research was supported by Duramed Research Inc. of Bala Cynwyd, Pa., which markets SCE-A under the trade name Cenestin. Duramed is a wholly owned subsidiary of Barr Pharmaceuticals.

Cenestin 0.45 mg was approved by the Food and Drug Administration in 2004 for the treatment of moderate to severe vasomotor symptoms.

The patients recruited for the study were healthy women ages 30–80 years who had experienced spontaneous amenorrhea for 12 months prior to screening or who had a bilateral oophorectomy, with or without hysterectomy, at least 6 weeks before screening.

Patients taking SCE-A had a greater reduction in frequency of symptoms starting at week 2 and reaching statistical significance from week 3 on. The drug also resulted in greater reduction in severity of symptoms at week 2, reaching statistical significance from week 5 on.

Nearly 38% of patients taking the estrogens reported no moderate to severe vasomotor symptoms at week 12. DR. SIMON

WASHINGTON — A 0.45-mg daily dose of synthetic conjugated estrogens-A improves moderate to severe menopausal vasomotor symptoms, compared with placebo, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The results indicate that postmenopausal women who start estrogen therapy at a low dose may be able to gain the efficacy of higher-dose treatments while having minimal side effects, Dr. James A. Simon of George Washington University in Washington and Dr. Sam S. Miller of the SAM Clinical Research Center in San Antonio wrote in a poster presented at the ACOG meeting.

At week 12 of therapy, nearly 38% of patients taking synthetic conjugated estrogens-A (SCE-A) reported no moderate to severe vasomotor symptoms vs. 7.8% of patients taking placebo, according to the researchers. In addition, the 0.45-mg daily dose of SCE-A reduced the mean weekly frequency of moderate to severe vasomotor symptoms by 67.8 from a baseline of 95.9 at 12 weeks, compared with a mean drop of 42.9 among placebo patients from the same baseline score.

The multicenter, double-blind trial included postmenopausal women, with or without a uterus, who had experienced at least 60 moderate to severe vasomotor symptoms per week. A total of 104 patients were randomized to receive either the 0.45-mg dose of SCE-A or placebo daily for 12 weeks. Approximately 91% of the patients taking SCE-A and 67% of the patients taking placebo completed the full 12 weeks of the study.

The subjects were asked to keep a daily diary of the frequency and severity of their symptoms. Patients also had vital signs, body weight, and adverse events evaluated during six office visits. The investigators assessed the safety and tolerability of the treatment through standard laboratory evaluations at screening and at week 12 of the study.

The research was supported by Duramed Research Inc. of Bala Cynwyd, Pa., which markets SCE-A under the trade name Cenestin. Duramed is a wholly owned subsidiary of Barr Pharmaceuticals.

Cenestin 0.45 mg was approved by the Food and Drug Administration in 2004 for the treatment of moderate to severe vasomotor symptoms.

The patients recruited for the study were healthy women ages 30–80 years who had experienced spontaneous amenorrhea for 12 months prior to screening or who had a bilateral oophorectomy, with or without hysterectomy, at least 6 weeks before screening.

Patients taking SCE-A had a greater reduction in frequency of symptoms starting at week 2 and reaching statistical significance from week 3 on. The drug also resulted in greater reduction in severity of symptoms at week 2, reaching statistical significance from week 5 on.

Nearly 38% of patients taking the estrogens reported no moderate to severe vasomotor symptoms at week 12. DR. SIMON

WASHINGTON — A 0.45-mg daily dose of synthetic conjugated estrogens-A improves moderate to severe menopausal vasomotor symptoms, compared with placebo, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The results indicate that postmenopausal women who start estrogen therapy at a low dose may be able to gain the efficacy of higher-dose treatments while having minimal side effects, Dr. James A. Simon of George Washington University in Washington and Dr. Sam S. Miller of the SAM Clinical Research Center in San Antonio wrote in a poster presented at the ACOG meeting.

At week 12 of therapy, nearly 38% of patients taking synthetic conjugated estrogens-A (SCE-A) reported no moderate to severe vasomotor symptoms vs. 7.8% of patients taking placebo, according to the researchers. In addition, the 0.45-mg daily dose of SCE-A reduced the mean weekly frequency of moderate to severe vasomotor symptoms by 67.8 from a baseline of 95.9 at 12 weeks, compared with a mean drop of 42.9 among placebo patients from the same baseline score.

The multicenter, double-blind trial included postmenopausal women, with or without a uterus, who had experienced at least 60 moderate to severe vasomotor symptoms per week. A total of 104 patients were randomized to receive either the 0.45-mg dose of SCE-A or placebo daily for 12 weeks. Approximately 91% of the patients taking SCE-A and 67% of the patients taking placebo completed the full 12 weeks of the study.

The subjects were asked to keep a daily diary of the frequency and severity of their symptoms. Patients also had vital signs, body weight, and adverse events evaluated during six office visits. The investigators assessed the safety and tolerability of the treatment through standard laboratory evaluations at screening and at week 12 of the study.

The research was supported by Duramed Research Inc. of Bala Cynwyd, Pa., which markets SCE-A under the trade name Cenestin. Duramed is a wholly owned subsidiary of Barr Pharmaceuticals.

Cenestin 0.45 mg was approved by the Food and Drug Administration in 2004 for the treatment of moderate to severe vasomotor symptoms.

The patients recruited for the study were healthy women ages 30–80 years who had experienced spontaneous amenorrhea for 12 months prior to screening or who had a bilateral oophorectomy, with or without hysterectomy, at least 6 weeks before screening.

Patients taking SCE-A had a greater reduction in frequency of symptoms starting at week 2 and reaching statistical significance from week 3 on. The drug also resulted in greater reduction in severity of symptoms at week 2, reaching statistical significance from week 5 on.

Nearly 38% of patients taking the estrogens reported no moderate to severe vasomotor symptoms at week 12. DR. SIMON