Alicia Ault

Psychiatrists in High Demand

The physician search firm Merritt Hawkins & Associates says that from April 2009 to March 2010, requests for psychiatrists jumped 47% over the previous year, and 121% from 3 years ago. The Irving, Tex.–based company said that the increased demand is attributable to the recession and its accompanying rise in stress-related conditions. And as the population ages and more Afghanistan and Iraq war veterans need mental health services, the supply of psychiatrists is dwindling, said Merritt Hawkins. “The shortage of psychiatrists may be a silent one, but it is real nonetheless,” said company president Mark Smith in a statement. The company also reported that more physicians are choosing to work as hospital employees. Four years ago, 23% of physician searches were for positions in hospitals, but in the latest survey, that portion jumped to 51%.

Prescription Narcotic Treatment Up

Almost 10% of substance abuse treatment admissions in 2008 involved prescription narcotic painkiller abuse, quadruple the proportion in 1998, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). The increase touched all age groups, both sexes, and all levels of education and employment. However, slightly more prescription abuse occurred among women and people with higher-than–high school educations, with 13% and 12% of their abuse admissions involving prescription narcotics, respectively. “The nonmedical use of prescription pain relievers is now the second most prevalent form of illicit dug use in the nation,” said the agency's administrator, Pamela S. Hyde, in a statement. It is also the fastest-growing problem, according to the White House Office of National Drug Control Policy. A SAMHSA study released in June found that emergency department visits for nonmedical use of painkillers had doubled between 2004 and 2008.

Millions Get Urgent Mental Care

One in eight (or 12 million) of the nation's 95 million emergency department visits in 2007 was for a mental disorder, substance abuse problem, or both, according to the Agency for Healthcare Research and Quality. Of those 12 million visits, 43% were for depression, 26% for anxiety, and 23% for alcohol-related problems. Two-thirds were for a mental disorder alone, 25% for substance abuse alone, and the remainder for both issues, said the agency. Hospitalizations resulted from 41% of these visits, a rate that's 2.5 times higher than that for emergency department visits not related to mental disorders or substance abuse. The data are in the report “Mental Health and Substance Abuse–Related Emergency Department Visits Among Adults, 2007,” available at

www.hcup-us.ahrq.gov/reports/statbriefs/sb92.pdf

313 Drugs Are in the Pipeline

The Pharmaceutical Research and Manufacturers of America said that there are 313 medications in development to treat mental illness. Of these, 90 (the largest group) are being developed to treat dementias. Two of those–both in phase III testing–are imaging agents intended to be used to diagnose Alzheimer's disease. The next largest category of agents would treat depression, with 71 such products in development. Some 54 drugs are being investigated for schizophrenia, 33 for addiction disorders, 38 for anxiety disorders, 33 for eating disorders (primarily obesity, but also anorexia and bulimia), 21 for sleep disorders, and a handful of drugs for fragile X syndrome and autism. The manufacturers' trade group said that mental illness costs the United States more than $317 billion a year in lost wages, health costs, and disability benefits.

Teen Smoking Leveled Off

The long decline in teen smoking slowed from 2003 to 2009, according to data published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report (2010;59:797-801). The CDC analyzed data from the biennial Youth Risk Behavior Survey for trends from 1991 to 2009, and found that the prevalence of teens who said they'd ever smoked cigarettes declined from 70% in 1991 to 58% in 2003, but had dropped no farther than 46% in 2009. The proportion that had smoked least 1 day of the 30 days before the survey declined from 36% in 1997 to 22% in 2003 and to 19% in 2009. Current frequent smokers dropped from 17% in 1999 to 10% in 2003 and to 7% in 2009. “The slow progress since 2003 tells us that much more needs to be done to reduce youth smoking,” said CDC Director Thomas R. Frieden in a statement.

Bill Seeks Federal Safety Net

A congressional proposal would establish a network of federally qualified behavioral health centers to provide mental health and substance abuse services to low-income Americans. The Community Mental Health and Addictions Safety Net Equity Act (H.R. 5636) was introduced by Rep. Doris Matsui (D-Calif.) and Rep. Eliot Engel (D-N.Y.). It would reimburse the federally qualified centers through Medicaid. “Investing in mental health and addictions treatment can save our economy the many billions we now spend” on emergency department visits, incarceration, and lost productivity, said Rep. Matsui in a statement. The legislation is supported by the National Alliance on Mental Illness and the National Council for Community Behavioral Healthcare, among other organizations.

Psychiatrists in High Demand

The physician search firm Merritt Hawkins & Associates says that from April 2009 to March 2010, requests for psychiatrists jumped 47% over the previous year, and 121% from 3 years ago. The Irving, Tex.–based company said that the increased demand is attributable to the recession and its accompanying rise in stress-related conditions. And as the population ages and more Afghanistan and Iraq war veterans need mental health services, the supply of psychiatrists is dwindling, said Merritt Hawkins. “The shortage of psychiatrists may be a silent one, but it is real nonetheless,” said company president Mark Smith in a statement. The company also reported that more physicians are choosing to work as hospital employees. Four years ago, 23% of physician searches were for positions in hospitals, but in the latest survey, that portion jumped to 51%.

Prescription Narcotic Treatment Up

Almost 10% of substance abuse treatment admissions in 2008 involved prescription narcotic painkiller abuse, quadruple the proportion in 1998, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). The increase touched all age groups, both sexes, and all levels of education and employment. However, slightly more prescription abuse occurred among women and people with higher-than–high school educations, with 13% and 12% of their abuse admissions involving prescription narcotics, respectively. “The nonmedical use of prescription pain relievers is now the second most prevalent form of illicit dug use in the nation,” said the agency's administrator, Pamela S. Hyde, in a statement. It is also the fastest-growing problem, according to the White House Office of National Drug Control Policy. A SAMHSA study released in June found that emergency department visits for nonmedical use of painkillers had doubled between 2004 and 2008.

Millions Get Urgent Mental Care

One in eight (or 12 million) of the nation's 95 million emergency department visits in 2007 was for a mental disorder, substance abuse problem, or both, according to the Agency for Healthcare Research and Quality. Of those 12 million visits, 43% were for depression, 26% for anxiety, and 23% for alcohol-related problems. Two-thirds were for a mental disorder alone, 25% for substance abuse alone, and the remainder for both issues, said the agency. Hospitalizations resulted from 41% of these visits, a rate that's 2.5 times higher than that for emergency department visits not related to mental disorders or substance abuse. The data are in the report “Mental Health and Substance Abuse–Related Emergency Department Visits Among Adults, 2007,” available at

www.hcup-us.ahrq.gov/reports/statbriefs/sb92.pdf

313 Drugs Are in the Pipeline

The Pharmaceutical Research and Manufacturers of America said that there are 313 medications in development to treat mental illness. Of these, 90 (the largest group) are being developed to treat dementias. Two of those–both in phase III testing–are imaging agents intended to be used to diagnose Alzheimer's disease. The next largest category of agents would treat depression, with 71 such products in development. Some 54 drugs are being investigated for schizophrenia, 33 for addiction disorders, 38 for anxiety disorders, 33 for eating disorders (primarily obesity, but also anorexia and bulimia), 21 for sleep disorders, and a handful of drugs for fragile X syndrome and autism. The manufacturers' trade group said that mental illness costs the United States more than $317 billion a year in lost wages, health costs, and disability benefits.

Teen Smoking Leveled Off

The long decline in teen smoking slowed from 2003 to 2009, according to data published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report (2010;59:797-801). The CDC analyzed data from the biennial Youth Risk Behavior Survey for trends from 1991 to 2009, and found that the prevalence of teens who said they'd ever smoked cigarettes declined from 70% in 1991 to 58% in 2003, but had dropped no farther than 46% in 2009. The proportion that had smoked least 1 day of the 30 days before the survey declined from 36% in 1997 to 22% in 2003 and to 19% in 2009. Current frequent smokers dropped from 17% in 1999 to 10% in 2003 and to 7% in 2009. “The slow progress since 2003 tells us that much more needs to be done to reduce youth smoking,” said CDC Director Thomas R. Frieden in a statement.

Bill Seeks Federal Safety Net

A congressional proposal would establish a network of federally qualified behavioral health centers to provide mental health and substance abuse services to low-income Americans. The Community Mental Health and Addictions Safety Net Equity Act (H.R. 5636) was introduced by Rep. Doris Matsui (D-Calif.) and Rep. Eliot Engel (D-N.Y.). It would reimburse the federally qualified centers through Medicaid. “Investing in mental health and addictions treatment can save our economy the many billions we now spend” on emergency department visits, incarceration, and lost productivity, said Rep. Matsui in a statement. The legislation is supported by the National Alliance on Mental Illness and the National Council for Community Behavioral Healthcare, among other organizations.

Psychiatrists in High Demand

The physician search firm Merritt Hawkins & Associates says that from April 2009 to March 2010, requests for psychiatrists jumped 47% over the previous year, and 121% from 3 years ago. The Irving, Tex.–based company said that the increased demand is attributable to the recession and its accompanying rise in stress-related conditions. And as the population ages and more Afghanistan and Iraq war veterans need mental health services, the supply of psychiatrists is dwindling, said Merritt Hawkins. “The shortage of psychiatrists may be a silent one, but it is real nonetheless,” said company president Mark Smith in a statement. The company also reported that more physicians are choosing to work as hospital employees. Four years ago, 23% of physician searches were for positions in hospitals, but in the latest survey, that portion jumped to 51%.

Prescription Narcotic Treatment Up

Almost 10% of substance abuse treatment admissions in 2008 involved prescription narcotic painkiller abuse, quadruple the proportion in 1998, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). The increase touched all age groups, both sexes, and all levels of education and employment. However, slightly more prescription abuse occurred among women and people with higher-than–high school educations, with 13% and 12% of their abuse admissions involving prescription narcotics, respectively. “The nonmedical use of prescription pain relievers is now the second most prevalent form of illicit dug use in the nation,” said the agency's administrator, Pamela S. Hyde, in a statement. It is also the fastest-growing problem, according to the White House Office of National Drug Control Policy. A SAMHSA study released in June found that emergency department visits for nonmedical use of painkillers had doubled between 2004 and 2008.

Millions Get Urgent Mental Care

One in eight (or 12 million) of the nation's 95 million emergency department visits in 2007 was for a mental disorder, substance abuse problem, or both, according to the Agency for Healthcare Research and Quality. Of those 12 million visits, 43% were for depression, 26% for anxiety, and 23% for alcohol-related problems. Two-thirds were for a mental disorder alone, 25% for substance abuse alone, and the remainder for both issues, said the agency. Hospitalizations resulted from 41% of these visits, a rate that's 2.5 times higher than that for emergency department visits not related to mental disorders or substance abuse. The data are in the report “Mental Health and Substance Abuse–Related Emergency Department Visits Among Adults, 2007,” available at

www.hcup-us.ahrq.gov/reports/statbriefs/sb92.pdf

313 Drugs Are in the Pipeline

The Pharmaceutical Research and Manufacturers of America said that there are 313 medications in development to treat mental illness. Of these, 90 (the largest group) are being developed to treat dementias. Two of those–both in phase III testing–are imaging agents intended to be used to diagnose Alzheimer's disease. The next largest category of agents would treat depression, with 71 such products in development. Some 54 drugs are being investigated for schizophrenia, 33 for addiction disorders, 38 for anxiety disorders, 33 for eating disorders (primarily obesity, but also anorexia and bulimia), 21 for sleep disorders, and a handful of drugs for fragile X syndrome and autism. The manufacturers' trade group said that mental illness costs the United States more than $317 billion a year in lost wages, health costs, and disability benefits.

Teen Smoking Leveled Off

The long decline in teen smoking slowed from 2003 to 2009, according to data published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report (2010;59:797-801). The CDC analyzed data from the biennial Youth Risk Behavior Survey for trends from 1991 to 2009, and found that the prevalence of teens who said they'd ever smoked cigarettes declined from 70% in 1991 to 58% in 2003, but had dropped no farther than 46% in 2009. The proportion that had smoked least 1 day of the 30 days before the survey declined from 36% in 1997 to 22% in 2003 and to 19% in 2009. Current frequent smokers dropped from 17% in 1999 to 10% in 2003 and to 7% in 2009. “The slow progress since 2003 tells us that much more needs to be done to reduce youth smoking,” said CDC Director Thomas R. Frieden in a statement.

Bill Seeks Federal Safety Net

A congressional proposal would establish a network of federally qualified behavioral health centers to provide mental health and substance abuse services to low-income Americans. The Community Mental Health and Addictions Safety Net Equity Act (H.R. 5636) was introduced by Rep. Doris Matsui (D-Calif.) and Rep. Eliot Engel (D-N.Y.). It would reimburse the federally qualified centers through Medicaid. “Investing in mental health and addictions treatment can save our economy the many billions we now spend” on emergency department visits, incarceration, and lost productivity, said Rep. Matsui in a statement. The legislation is supported by the National Alliance on Mental Illness and the National Council for Community Behavioral Healthcare, among other organizations.

WASHINGTON – The federal government is seeking to track acute and long-term health effects in individuals working to clean up the BP oil spill in the Gulf of Mexico and is enlisting health care providers to assist, the director of the National Institute for Occupational Safety and Health (NIOSH) testified at a hearing.

Dr. John Howard said at the June 16 hearing that the agency he leads had begun enrolling workers in what could end up becoming a formal registry. NIOSH is eager to have a full list of anyone involved in the clean-up, he said, noting that no such list was compiled for volunteers and others who helped at Ground Zero in the wake of Sept. 11, 2001. The lack of such a list made it difficult to go back and correlate either acute or long-term health complaints with exposure, he said.

NIOSH is “trying to keep all health care professionals alerted to our rostering effort,” so that all workers who are potentially exposed to any hazards are included in the database, Dr. Howard said. He called on Gulf region physicians to refer to NIOSH any patients they might see who have worked on the clean-up effort.

NIOSH employees have gone into the field and to BP-operated training centers to ask workers to complete a simple one-page questionnaire. The questionnaire seeks demographic data, whether the worker is a contractor, BP employee, or volunteer. It includes specific questions relating to the type of work being done, duration of the work, and whether the person smokes or has been vaccinated for tetanus. Federal officials hope to post the questionnaire online shortly, and are asking physicians who encounter workers to direct them to NIOSH to complete the survey.

So far, 13,000 workers have completed forms, said Dr. Howard, but he estimates that at least another 15,000-20,000 people are working on the clean-up. NIOSH asked for but has yet to receive a full list of BP workers involved, Dr. Howard said. “It's a simple request,” he said to reporters after the hearing. Dr. Howard expressed consternation that the oil company had yet to respond.

Clean-up workers will receive the most significant exposure to toxic substances, he said, adding that they would be the best group to study to determine long-term risks. Currently, there are few data on long-term health effects of exposures to oil and to the chemicals, such as dispersants, being used in the clean-up, Dr. Howard said.

The federal government also is attempting to track exposures in the general population. The American Association of Poison Control Centers has directed its 60 local centers in all 50 states to code any calls related to the oil spill so that the Centers for Disease Control and Prevention can track them, said Dr. Howard. As of May 27, there were 93 calls, mostly from Louisiana and Mississippi. In all, 34 callers had been exposed to oil and reported symptoms, including cough, nausea, headache, eye irritation, chest pain, and dizziness, according to data on the CDC's Web site.

Health issues are also being tracked through BioSense, an existing network of health facilities that track health changes in real time and report back to the CDC. There are 86 participating facilities in the five Gulf states. So far, there have been some spikes in skin irritation and asthma in two states; investigations are continuing.

State health departments in Alabama, Florida, Louisiana, and Mississippi are also soliciting reports and tracking illnesses. At press time, the Louisiana Department of Health and Hospitals reported 109 spill-related illnesses–74 from workers and 35 from the public. In all, 33 were reported through poison control centers; 43 through emergency departments; and others from urgent care centers, clinics, physician offices, and a hotline. Most of the complaints were of odors or inhalation issues. There were nine hospitalizations, all in workers.

Many lawmakers at the hearing said they were concerned that both workers and residents of the Gulf states were being given confusing messages about health and safety and where to report exposures or problems. In addition to the state health departments, the CDC, NIOSH, and BP are also taking exposure reports.

Dr. Howard said that was one reason he was pushing BP to correlate its list with NIOSH. He also said that he supports a centralized Web site for all the spill-related data.

The Environmental Protection Agency is also monitoring the air, water, and soil and issuing reports on its Web site; the Food and Drug Administration is tracking seafood safety.

WASHINGTON – The federal government is seeking to track acute and long-term health effects in individuals working to clean up the BP oil spill in the Gulf of Mexico and is enlisting health care providers to assist, the director of the National Institute for Occupational Safety and Health (NIOSH) testified at a hearing.

Dr. John Howard said at the June 16 hearing that the agency he leads had begun enrolling workers in what could end up becoming a formal registry. NIOSH is eager to have a full list of anyone involved in the clean-up, he said, noting that no such list was compiled for volunteers and others who helped at Ground Zero in the wake of Sept. 11, 2001. The lack of such a list made it difficult to go back and correlate either acute or long-term health complaints with exposure, he said.

NIOSH is “trying to keep all health care professionals alerted to our rostering effort,” so that all workers who are potentially exposed to any hazards are included in the database, Dr. Howard said. He called on Gulf region physicians to refer to NIOSH any patients they might see who have worked on the clean-up effort.

NIOSH employees have gone into the field and to BP-operated training centers to ask workers to complete a simple one-page questionnaire. The questionnaire seeks demographic data, whether the worker is a contractor, BP employee, or volunteer. It includes specific questions relating to the type of work being done, duration of the work, and whether the person smokes or has been vaccinated for tetanus. Federal officials hope to post the questionnaire online shortly, and are asking physicians who encounter workers to direct them to NIOSH to complete the survey.

So far, 13,000 workers have completed forms, said Dr. Howard, but he estimates that at least another 15,000-20,000 people are working on the clean-up. NIOSH asked for but has yet to receive a full list of BP workers involved, Dr. Howard said. “It's a simple request,” he said to reporters after the hearing. Dr. Howard expressed consternation that the oil company had yet to respond.

Clean-up workers will receive the most significant exposure to toxic substances, he said, adding that they would be the best group to study to determine long-term risks. Currently, there are few data on long-term health effects of exposures to oil and to the chemicals, such as dispersants, being used in the clean-up, Dr. Howard said.

The federal government also is attempting to track exposures in the general population. The American Association of Poison Control Centers has directed its 60 local centers in all 50 states to code any calls related to the oil spill so that the Centers for Disease Control and Prevention can track them, said Dr. Howard. As of May 27, there were 93 calls, mostly from Louisiana and Mississippi. In all, 34 callers had been exposed to oil and reported symptoms, including cough, nausea, headache, eye irritation, chest pain, and dizziness, according to data on the CDC's Web site.

Health issues are also being tracked through BioSense, an existing network of health facilities that track health changes in real time and report back to the CDC. There are 86 participating facilities in the five Gulf states. So far, there have been some spikes in skin irritation and asthma in two states; investigations are continuing.

State health departments in Alabama, Florida, Louisiana, and Mississippi are also soliciting reports and tracking illnesses. At press time, the Louisiana Department of Health and Hospitals reported 109 spill-related illnesses–74 from workers and 35 from the public. In all, 33 were reported through poison control centers; 43 through emergency departments; and others from urgent care centers, clinics, physician offices, and a hotline. Most of the complaints were of odors or inhalation issues. There were nine hospitalizations, all in workers.

Many lawmakers at the hearing said they were concerned that both workers and residents of the Gulf states were being given confusing messages about health and safety and where to report exposures or problems. In addition to the state health departments, the CDC, NIOSH, and BP are also taking exposure reports.

Dr. Howard said that was one reason he was pushing BP to correlate its list with NIOSH. He also said that he supports a centralized Web site for all the spill-related data.

The Environmental Protection Agency is also monitoring the air, water, and soil and issuing reports on its Web site; the Food and Drug Administration is tracking seafood safety.

WASHINGTON – The federal government is seeking to track acute and long-term health effects in individuals working to clean up the BP oil spill in the Gulf of Mexico and is enlisting health care providers to assist, the director of the National Institute for Occupational Safety and Health (NIOSH) testified at a hearing.

Dr. John Howard said at the June 16 hearing that the agency he leads had begun enrolling workers in what could end up becoming a formal registry. NIOSH is eager to have a full list of anyone involved in the clean-up, he said, noting that no such list was compiled for volunteers and others who helped at Ground Zero in the wake of Sept. 11, 2001. The lack of such a list made it difficult to go back and correlate either acute or long-term health complaints with exposure, he said.

NIOSH is “trying to keep all health care professionals alerted to our rostering effort,” so that all workers who are potentially exposed to any hazards are included in the database, Dr. Howard said. He called on Gulf region physicians to refer to NIOSH any patients they might see who have worked on the clean-up effort.

NIOSH employees have gone into the field and to BP-operated training centers to ask workers to complete a simple one-page questionnaire. The questionnaire seeks demographic data, whether the worker is a contractor, BP employee, or volunteer. It includes specific questions relating to the type of work being done, duration of the work, and whether the person smokes or has been vaccinated for tetanus. Federal officials hope to post the questionnaire online shortly, and are asking physicians who encounter workers to direct them to NIOSH to complete the survey.

So far, 13,000 workers have completed forms, said Dr. Howard, but he estimates that at least another 15,000-20,000 people are working on the clean-up. NIOSH asked for but has yet to receive a full list of BP workers involved, Dr. Howard said. “It's a simple request,” he said to reporters after the hearing. Dr. Howard expressed consternation that the oil company had yet to respond.

Clean-up workers will receive the most significant exposure to toxic substances, he said, adding that they would be the best group to study to determine long-term risks. Currently, there are few data on long-term health effects of exposures to oil and to the chemicals, such as dispersants, being used in the clean-up, Dr. Howard said.

The federal government also is attempting to track exposures in the general population. The American Association of Poison Control Centers has directed its 60 local centers in all 50 states to code any calls related to the oil spill so that the Centers for Disease Control and Prevention can track them, said Dr. Howard. As of May 27, there were 93 calls, mostly from Louisiana and Mississippi. In all, 34 callers had been exposed to oil and reported symptoms, including cough, nausea, headache, eye irritation, chest pain, and dizziness, according to data on the CDC's Web site.

Health issues are also being tracked through BioSense, an existing network of health facilities that track health changes in real time and report back to the CDC. There are 86 participating facilities in the five Gulf states. So far, there have been some spikes in skin irritation and asthma in two states; investigations are continuing.

State health departments in Alabama, Florida, Louisiana, and Mississippi are also soliciting reports and tracking illnesses. At press time, the Louisiana Department of Health and Hospitals reported 109 spill-related illnesses–74 from workers and 35 from the public. In all, 33 were reported through poison control centers; 43 through emergency departments; and others from urgent care centers, clinics, physician offices, and a hotline. Most of the complaints were of odors or inhalation issues. There were nine hospitalizations, all in workers.

Many lawmakers at the hearing said they were concerned that both workers and residents of the Gulf states were being given confusing messages about health and safety and where to report exposures or problems. In addition to the state health departments, the CDC, NIOSH, and BP are also taking exposure reports.

Dr. Howard said that was one reason he was pushing BP to correlate its list with NIOSH. He also said that he supports a centralized Web site for all the spill-related data.

The Environmental Protection Agency is also monitoring the air, water, and soil and issuing reports on its Web site; the Food and Drug Administration is tracking seafood safety.

The federal government published regulations that will allow for temporary certification of electronic health records—the first step in helping physicians and other providers get the software and hardware required to be eligible for bonus payments under federal health programs.

According to the Office of the National Coordinator for Health Information Technology (ONC), the rule “establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify [electronic health record] technology.”

“We hope that all [health information technology] stakeholders view this rule as the federal government's commitment to reduce uncertainty in the health IT marketplace and advance the successful implementation of EHR incentive programs,” Dr. David Blumenthal, national coordinator for health information technology, said in a statement.

Certification means that the EHR package has been tested and includes the required capabilities to meet the “meaningful use” standards issued by ONC. Hospitals and physicians will have the assurance that the certified EHRs can help them improve the quality of care and qualify for bonus payments under Medicare or Medicaid.

By purchasing certified EHR technology, hospitals and eligible professionals will be able to make EHR purchasing decisions knowing that the technology will allow them to become meaningful users of electronic health records, qualify for the payment incentives, and begin to use EHRs in a way that will improve quality and efficiency in our health care system, Dr. Blumenthal said.

This rule is for a temporary program. A final rule on permanent certification of EHRs will be issued in the fall.

For more information about the temporary certification program and rule, please visit http://healthit.hhs.gov/certification

The federal government published regulations that will allow for temporary certification of electronic health records—the first step in helping physicians and other providers get the software and hardware required to be eligible for bonus payments under federal health programs.

According to the Office of the National Coordinator for Health Information Technology (ONC), the rule “establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify [electronic health record] technology.”

“We hope that all [health information technology] stakeholders view this rule as the federal government's commitment to reduce uncertainty in the health IT marketplace and advance the successful implementation of EHR incentive programs,” Dr. David Blumenthal, national coordinator for health information technology, said in a statement.

Certification means that the EHR package has been tested and includes the required capabilities to meet the “meaningful use” standards issued by ONC. Hospitals and physicians will have the assurance that the certified EHRs can help them improve the quality of care and qualify for bonus payments under Medicare or Medicaid.

By purchasing certified EHR technology, hospitals and eligible professionals will be able to make EHR purchasing decisions knowing that the technology will allow them to become meaningful users of electronic health records, qualify for the payment incentives, and begin to use EHRs in a way that will improve quality and efficiency in our health care system, Dr. Blumenthal said.

This rule is for a temporary program. A final rule on permanent certification of EHRs will be issued in the fall.

For more information about the temporary certification program and rule, please visit http://healthit.hhs.gov/certification

The federal government published regulations that will allow for temporary certification of electronic health records—the first step in helping physicians and other providers get the software and hardware required to be eligible for bonus payments under federal health programs.

According to the Office of the National Coordinator for Health Information Technology (ONC), the rule “establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify [electronic health record] technology.”

“We hope that all [health information technology] stakeholders view this rule as the federal government's commitment to reduce uncertainty in the health IT marketplace and advance the successful implementation of EHR incentive programs,” Dr. David Blumenthal, national coordinator for health information technology, said in a statement.

Certification means that the EHR package has been tested and includes the required capabilities to meet the “meaningful use” standards issued by ONC. Hospitals and physicians will have the assurance that the certified EHRs can help them improve the quality of care and qualify for bonus payments under Medicare or Medicaid.

By purchasing certified EHR technology, hospitals and eligible professionals will be able to make EHR purchasing decisions knowing that the technology will allow them to become meaningful users of electronic health records, qualify for the payment incentives, and begin to use EHRs in a way that will improve quality and efficiency in our health care system, Dr. Blumenthal said.

This rule is for a temporary program. A final rule on permanent certification of EHRs will be issued in the fall.

For more information about the temporary certification program and rule, please visit http://healthit.hhs.gov/certification

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty, according to an article published online.

The 16-member ACGME task force that wrote the standards will review public comments and make any modifications considered necessary before July 2011, when the new standards will go into effect.

The original ACGME standards, established in 2003, have been the subject of much consternation in the medical community, with opinions differing over whether they have been too restrictive or too loose to properly protect patients and ensure a good quality of life for residents.

According to the latest report, written by Dr. Thomas J. Nasca, Dr. Susan H. Day, and Dr. E. Stephen Amis Jr. on behalf of the ACGME task force, the 2003 standards had the following three “problematic” elements, as identified by the educational community and the public:

▸ The limits on duty hours may have created a shift mentality among residents, which tends to conflict with the duty to serve patients.

▸ Many academic programs began focusing on meeting the duty hour restrictions, perhaps at the expense of education.

▸ The 80-hour work week, with up to 24 hours of continuous duty, was seen by many as compromising patient safety.

In 2008, the Institute of Medicine took a hard look at the ACGME standards and, among other things, recommended that no residents should exceed 16 hours of continuous duty.

The ACGME convened the task force to consider the IOM recommendations. One of the biggest challenges, according to the authors, was to reconcile the IOM's suggestion for an across-the-board restriction on duty hours with the continuing plea from academic programs that duty hours needed to be tailored to each specialty (N. Engl. J. Med. 2010 [doi:10.1056/NEJMsb1005800]).

For surgery, in particular, it would be difficult—and contrary to learning—to have a resident leave in the midst of a procedure because his or her duty hours had been reached.

The ACGME panel also had to weigh whether there was sufficient evidence to show that working more than 16 hours or up to 30 hours continuously led to more medical errors, as has been suggested by many critics of the duty hour standards.

According to the ACGME panel, the data thus far indicate only that first-year residents are more prone to mistakes as a result of sleep deprivation. Therefore, the task force urged a new paradigm for the first year of residency, whereby residents cannot be on duty for longer than 16 hours continuously and should have 10 hours off and 8 hours free of duty between their scheduled duty periods. First-year residents are not allowed to moonlight, and they must have direct, in-house, attending-level supervision.

All residents are allowed to work up to an additional 4 hours to facilitate patient handoffs—an area of concern for patient safety.

The panel decided not to tailor duty hours to specialties “because studies have not shown that the safety effect of current standards varies with specialty,” said the authors.

The IOM had also criticized the ACGME for not properly enforcing the duty hours. The task force said that enforcement is an “inherent” challenge, partly because there are some 9,000 accredited programs.

However, the ACGME is now undertaking annual site visits and analyzing whether institutions can comply. Eventually, the organization will give each institution a report on its compliance status and recommendations for resolving problems. The reports will be made available to the public, said the authors.

Wake Up Doctor, a coalition of public interest and patient safety groups that has been pushing the ACGME to further restrict resident hours, said that the new standards don't go far enough. The group gave the ACGME an “F” for failing to comply with the IOM recommendation that continuous duty be restricted to 16 hours for all residents.

The coalition also gave a failing grade to the ACGME's plans for better monitoring compliance with the standards. However, the recommendation for greater supervision of first-year residents got higher marks.

The revised standards represent an important step, but “I think the acid test will be in the details,” said Helen Haskell, founder and president of Mothers Against Medical Error, and a coalition member, in a statement. “We need to be sure that residents of all levels have sufficient backup and reasonable limits on their workloads.”

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty, according to an article published online.

The 16-member ACGME task force that wrote the standards will review public comments and make any modifications considered necessary before July 2011, when the new standards will go into effect.

The original ACGME standards, established in 2003, have been the subject of much consternation in the medical community, with opinions differing over whether they have been too restrictive or too loose to properly protect patients and ensure a good quality of life for residents.

According to the latest report, written by Dr. Thomas J. Nasca, Dr. Susan H. Day, and Dr. E. Stephen Amis Jr. on behalf of the ACGME task force, the 2003 standards had the following three “problematic” elements, as identified by the educational community and the public:

▸ The limits on duty hours may have created a shift mentality among residents, which tends to conflict with the duty to serve patients.

▸ Many academic programs began focusing on meeting the duty hour restrictions, perhaps at the expense of education.

▸ The 80-hour work week, with up to 24 hours of continuous duty, was seen by many as compromising patient safety.

In 2008, the Institute of Medicine took a hard look at the ACGME standards and, among other things, recommended that no residents should exceed 16 hours of continuous duty.

The ACGME convened the task force to consider the IOM recommendations. One of the biggest challenges, according to the authors, was to reconcile the IOM's suggestion for an across-the-board restriction on duty hours with the continuing plea from academic programs that duty hours needed to be tailored to each specialty (N. Engl. J. Med. 2010 [doi:10.1056/NEJMsb1005800]).

For surgery, in particular, it would be difficult—and contrary to learning—to have a resident leave in the midst of a procedure because his or her duty hours had been reached.

The ACGME panel also had to weigh whether there was sufficient evidence to show that working more than 16 hours or up to 30 hours continuously led to more medical errors, as has been suggested by many critics of the duty hour standards.

According to the ACGME panel, the data thus far indicate only that first-year residents are more prone to mistakes as a result of sleep deprivation. Therefore, the task force urged a new paradigm for the first year of residency, whereby residents cannot be on duty for longer than 16 hours continuously and should have 10 hours off and 8 hours free of duty between their scheduled duty periods. First-year residents are not allowed to moonlight, and they must have direct, in-house, attending-level supervision.

All residents are allowed to work up to an additional 4 hours to facilitate patient handoffs—an area of concern for patient safety.

The panel decided not to tailor duty hours to specialties “because studies have not shown that the safety effect of current standards varies with specialty,” said the authors.

The IOM had also criticized the ACGME for not properly enforcing the duty hours. The task force said that enforcement is an “inherent” challenge, partly because there are some 9,000 accredited programs.

However, the ACGME is now undertaking annual site visits and analyzing whether institutions can comply. Eventually, the organization will give each institution a report on its compliance status and recommendations for resolving problems. The reports will be made available to the public, said the authors.

Wake Up Doctor, a coalition of public interest and patient safety groups that has been pushing the ACGME to further restrict resident hours, said that the new standards don't go far enough. The group gave the ACGME an “F” for failing to comply with the IOM recommendation that continuous duty be restricted to 16 hours for all residents.

The coalition also gave a failing grade to the ACGME's plans for better monitoring compliance with the standards. However, the recommendation for greater supervision of first-year residents got higher marks.

The revised standards represent an important step, but “I think the acid test will be in the details,” said Helen Haskell, founder and president of Mothers Against Medical Error, and a coalition member, in a statement. “We need to be sure that residents of all levels have sufficient backup and reasonable limits on their workloads.”

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty, according to an article published online.

The 16-member ACGME task force that wrote the standards will review public comments and make any modifications considered necessary before July 2011, when the new standards will go into effect.

The original ACGME standards, established in 2003, have been the subject of much consternation in the medical community, with opinions differing over whether they have been too restrictive or too loose to properly protect patients and ensure a good quality of life for residents.

According to the latest report, written by Dr. Thomas J. Nasca, Dr. Susan H. Day, and Dr. E. Stephen Amis Jr. on behalf of the ACGME task force, the 2003 standards had the following three “problematic” elements, as identified by the educational community and the public:

▸ The limits on duty hours may have created a shift mentality among residents, which tends to conflict with the duty to serve patients.

▸ Many academic programs began focusing on meeting the duty hour restrictions, perhaps at the expense of education.

▸ The 80-hour work week, with up to 24 hours of continuous duty, was seen by many as compromising patient safety.

In 2008, the Institute of Medicine took a hard look at the ACGME standards and, among other things, recommended that no residents should exceed 16 hours of continuous duty.

The ACGME convened the task force to consider the IOM recommendations. One of the biggest challenges, according to the authors, was to reconcile the IOM's suggestion for an across-the-board restriction on duty hours with the continuing plea from academic programs that duty hours needed to be tailored to each specialty (N. Engl. J. Med. 2010 [doi:10.1056/NEJMsb1005800]).

For surgery, in particular, it would be difficult—and contrary to learning—to have a resident leave in the midst of a procedure because his or her duty hours had been reached.

The ACGME panel also had to weigh whether there was sufficient evidence to show that working more than 16 hours or up to 30 hours continuously led to more medical errors, as has been suggested by many critics of the duty hour standards.

According to the ACGME panel, the data thus far indicate only that first-year residents are more prone to mistakes as a result of sleep deprivation. Therefore, the task force urged a new paradigm for the first year of residency, whereby residents cannot be on duty for longer than 16 hours continuously and should have 10 hours off and 8 hours free of duty between their scheduled duty periods. First-year residents are not allowed to moonlight, and they must have direct, in-house, attending-level supervision.

All residents are allowed to work up to an additional 4 hours to facilitate patient handoffs—an area of concern for patient safety.

The panel decided not to tailor duty hours to specialties “because studies have not shown that the safety effect of current standards varies with specialty,” said the authors.

The IOM had also criticized the ACGME for not properly enforcing the duty hours. The task force said that enforcement is an “inherent” challenge, partly because there are some 9,000 accredited programs.

However, the ACGME is now undertaking annual site visits and analyzing whether institutions can comply. Eventually, the organization will give each institution a report on its compliance status and recommendations for resolving problems. The reports will be made available to the public, said the authors.

Wake Up Doctor, a coalition of public interest and patient safety groups that has been pushing the ACGME to further restrict resident hours, said that the new standards don't go far enough. The group gave the ACGME an “F” for failing to comply with the IOM recommendation that continuous duty be restricted to 16 hours for all residents.

The coalition also gave a failing grade to the ACGME's plans for better monitoring compliance with the standards. However, the recommendation for greater supervision of first-year residents got higher marks.

The revised standards represent an important step, but “I think the acid test will be in the details,” said Helen Haskell, founder and president of Mothers Against Medical Error, and a coalition member, in a statement. “We need to be sure that residents of all levels have sufficient backup and reasonable limits on their workloads.”

WASHINGTON — A group of 19 health systems is taking the first steps toward becoming accountable care organizations, joining together to share best practices, coordinate care, and improve quality.

The health systems—which include Geisinger Health System, Baystate Health, and Bon Secours Health System—are all members of Premier Inc., a nonprofit health purchasing and quality improvement alliance. Premier will provide the expertise and databases necessary for the systems to build the accountable care organizations (ACOs).

According to Premier, members of the ACO Implementation Collaborative may be ready in 2012 to start contracting with the Centers for Medicare and Medicaid Services under the shared savings program mandated under the health reform law (Affordable Care Act). ACOs have been envisioned as the backbone of the new health care system, but they were not clearly defined in the law President Obama signed in March.

At the briefing, Sen. Max Baucus (D-Mont.), Rep. Earl Pomeroy (D-N.D.), and Rep. Charles Boustany (R-La.) praised the Premier effort, saying that it would help speed transformation of the health care system into one that values quality over quantity. Sen. Baucus said that the ACOs in the Premier alliance “put the new and innovative ideas in the health care reform law into practice to improve health care quality while reducing inefficient and wasteful spending.” Rep. Boustany, who is a cardiovascular surgeon, added that the reform law did not go far enough to align incentives among health providers or to foster care coordination.

The Premier alliance will address some of these issues, he said, but it still is not clear if the ACO model can work in rural areas where there may be great distances between facilities and disparate missions from urban or suburban counterparts.

According to Premier president and CEO Susan S. DeVore, all members of the ACO collaborative will build the “critical components of accountable care,” including a patient-centered foundation; medical homes that deliver primary care and wellness; incentives to reward coordination, efficiency, and productivity; tight integration among specialists, ancillary providers, and hospitals; reimbursement models that reward value over volume; and health information technology systems that can be used to coordinate care across networks.

The 19 systems already have some of these elements in place and can pursue accountability for a portion of their population, according to Premier. These hospitals and health systems have been participating in Premier's QUEST: High-Performing Hospitals collaborative. QUEST is a 3-year information and quality improvement sharing initiative involving 200 hospitals in 31 states. In the first year, hospitals reduced the cost of care by an average $343 per patient. The facilities delivered care according to evidence-based quality measures 86% of the time, according to Premier.

The ACO Implementation Collaborative aims to build on that success. The first step is to define value. According to Premier, the agreed-upon definition so far is to optimize patient outcomes, the patient care experience, and the total cost of care.

Dr. Nicholas Wolter, CEO of the Billings Clinic, which is part of the ACO collaborative, said although ACOs may seem to be a fad, much as managed care was in the early 1990s, more is known now about patient safety and delivering high-quality care. “In the ACO, patients are partners working with their care team to manage and improve their health. This is the real goal of health reform—the highest quality care at a more cost-effective price for patients and taxpayers.”

To watch a video interview of Dr. Wolter, go to http://www.youtube.com/watch?v=2OzuMyovRss

Members of the Premier Collaborative to Date

Aria Health, Philadelphia

AtlantiCare, Egg Harbor Township, N.J.

Baystate Health, Springfield, Mass.

Billings Clinic, Mont.

Bon Secours Health System Inc., Greenville, S.C., and Richmond, Va.

CaroMont Health, Gastonia, N.C.

Fairview Health Services, Minneapolis

Geisinger Health System, Danville, Pa.

Heartland Health, St. Joseph, Mo.

Methodist Medical Center of Illinois, Peoria

North Shore-LIJ Health System, Long Island, N.Y.

Presbyterian Healthcare Services, Albuquerque

Saint Francis Health System, Tulsa, Okla.

Southcoast Hospitals Group, Fall River, Mass.

SSM Health Care, St. Louis

Summa Health System, Akron, Ohio

Texas Health Resources, Arlington, Tex.

University Hospitals, Cleveland

WASHINGTON — A group of 19 health systems is taking the first steps toward becoming accountable care organizations, joining together to share best practices, coordinate care, and improve quality.

The health systems—which include Geisinger Health System, Baystate Health, and Bon Secours Health System—are all members of Premier Inc., a nonprofit health purchasing and quality improvement alliance. Premier will provide the expertise and databases necessary for the systems to build the accountable care organizations (ACOs).

According to Premier, members of the ACO Implementation Collaborative may be ready in 2012 to start contracting with the Centers for Medicare and Medicaid Services under the shared savings program mandated under the health reform law (Affordable Care Act). ACOs have been envisioned as the backbone of the new health care system, but they were not clearly defined in the law President Obama signed in March.

At the briefing, Sen. Max Baucus (D-Mont.), Rep. Earl Pomeroy (D-N.D.), and Rep. Charles Boustany (R-La.) praised the Premier effort, saying that it would help speed transformation of the health care system into one that values quality over quantity. Sen. Baucus said that the ACOs in the Premier alliance “put the new and innovative ideas in the health care reform law into practice to improve health care quality while reducing inefficient and wasteful spending.” Rep. Boustany, who is a cardiovascular surgeon, added that the reform law did not go far enough to align incentives among health providers or to foster care coordination.

The Premier alliance will address some of these issues, he said, but it still is not clear if the ACO model can work in rural areas where there may be great distances between facilities and disparate missions from urban or suburban counterparts.

According to Premier president and CEO Susan S. DeVore, all members of the ACO collaborative will build the “critical components of accountable care,” including a patient-centered foundation; medical homes that deliver primary care and wellness; incentives to reward coordination, efficiency, and productivity; tight integration among specialists, ancillary providers, and hospitals; reimbursement models that reward value over volume; and health information technology systems that can be used to coordinate care across networks.

The 19 systems already have some of these elements in place and can pursue accountability for a portion of their population, according to Premier. These hospitals and health systems have been participating in Premier's QUEST: High-Performing Hospitals collaborative. QUEST is a 3-year information and quality improvement sharing initiative involving 200 hospitals in 31 states. In the first year, hospitals reduced the cost of care by an average $343 per patient. The facilities delivered care according to evidence-based quality measures 86% of the time, according to Premier.

The ACO Implementation Collaborative aims to build on that success. The first step is to define value. According to Premier, the agreed-upon definition so far is to optimize patient outcomes, the patient care experience, and the total cost of care.

Dr. Nicholas Wolter, CEO of the Billings Clinic, which is part of the ACO collaborative, said although ACOs may seem to be a fad, much as managed care was in the early 1990s, more is known now about patient safety and delivering high-quality care. “In the ACO, patients are partners working with their care team to manage and improve their health. This is the real goal of health reform—the highest quality care at a more cost-effective price for patients and taxpayers.”

To watch a video interview of Dr. Wolter, go to http://www.youtube.com/watch?v=2OzuMyovRss

Members of the Premier Collaborative to Date

Aria Health, Philadelphia

AtlantiCare, Egg Harbor Township, N.J.

Baystate Health, Springfield, Mass.

Billings Clinic, Mont.

Bon Secours Health System Inc., Greenville, S.C., and Richmond, Va.

CaroMont Health, Gastonia, N.C.

Fairview Health Services, Minneapolis

Geisinger Health System, Danville, Pa.

Heartland Health, St. Joseph, Mo.

Methodist Medical Center of Illinois, Peoria

North Shore-LIJ Health System, Long Island, N.Y.

Presbyterian Healthcare Services, Albuquerque

Saint Francis Health System, Tulsa, Okla.

Southcoast Hospitals Group, Fall River, Mass.

SSM Health Care, St. Louis

Summa Health System, Akron, Ohio

Texas Health Resources, Arlington, Tex.

University Hospitals, Cleveland

WASHINGTON — A group of 19 health systems is taking the first steps toward becoming accountable care organizations, joining together to share best practices, coordinate care, and improve quality.

The health systems—which include Geisinger Health System, Baystate Health, and Bon Secours Health System—are all members of Premier Inc., a nonprofit health purchasing and quality improvement alliance. Premier will provide the expertise and databases necessary for the systems to build the accountable care organizations (ACOs).

According to Premier, members of the ACO Implementation Collaborative may be ready in 2012 to start contracting with the Centers for Medicare and Medicaid Services under the shared savings program mandated under the health reform law (Affordable Care Act). ACOs have been envisioned as the backbone of the new health care system, but they were not clearly defined in the law President Obama signed in March.

At the briefing, Sen. Max Baucus (D-Mont.), Rep. Earl Pomeroy (D-N.D.), and Rep. Charles Boustany (R-La.) praised the Premier effort, saying that it would help speed transformation of the health care system into one that values quality over quantity. Sen. Baucus said that the ACOs in the Premier alliance “put the new and innovative ideas in the health care reform law into practice to improve health care quality while reducing inefficient and wasteful spending.” Rep. Boustany, who is a cardiovascular surgeon, added that the reform law did not go far enough to align incentives among health providers or to foster care coordination.

The Premier alliance will address some of these issues, he said, but it still is not clear if the ACO model can work in rural areas where there may be great distances between facilities and disparate missions from urban or suburban counterparts.

According to Premier president and CEO Susan S. DeVore, all members of the ACO collaborative will build the “critical components of accountable care,” including a patient-centered foundation; medical homes that deliver primary care and wellness; incentives to reward coordination, efficiency, and productivity; tight integration among specialists, ancillary providers, and hospitals; reimbursement models that reward value over volume; and health information technology systems that can be used to coordinate care across networks.

The 19 systems already have some of these elements in place and can pursue accountability for a portion of their population, according to Premier. These hospitals and health systems have been participating in Premier's QUEST: High-Performing Hospitals collaborative. QUEST is a 3-year information and quality improvement sharing initiative involving 200 hospitals in 31 states. In the first year, hospitals reduced the cost of care by an average $343 per patient. The facilities delivered care according to evidence-based quality measures 86% of the time, according to Premier.

The ACO Implementation Collaborative aims to build on that success. The first step is to define value. According to Premier, the agreed-upon definition so far is to optimize patient outcomes, the patient care experience, and the total cost of care.

Dr. Nicholas Wolter, CEO of the Billings Clinic, which is part of the ACO collaborative, said although ACOs may seem to be a fad, much as managed care was in the early 1990s, more is known now about patient safety and delivering high-quality care. “In the ACO, patients are partners working with their care team to manage and improve their health. This is the real goal of health reform—the highest quality care at a more cost-effective price for patients and taxpayers.”

To watch a video interview of Dr. Wolter, go to http://www.youtube.com/watch?v=2OzuMyovRss

Members of the Premier Collaborative to Date

Aria Health, Philadelphia

AtlantiCare, Egg Harbor Township, N.J.

Baystate Health, Springfield, Mass.

Billings Clinic, Mont.

Bon Secours Health System Inc., Greenville, S.C., and Richmond, Va.

CaroMont Health, Gastonia, N.C.

Fairview Health Services, Minneapolis

Geisinger Health System, Danville, Pa.

Heartland Health, St. Joseph, Mo.

Methodist Medical Center of Illinois, Peoria

North Shore-LIJ Health System, Long Island, N.Y.

Presbyterian Healthcare Services, Albuquerque

Saint Francis Health System, Tulsa, Okla.

Southcoast Hospitals Group, Fall River, Mass.

SSM Health Care, St. Louis

Summa Health System, Akron, Ohio

Texas Health Resources, Arlington, Tex.

University Hospitals, Cleveland

COLLEGE PARK, MD. — The Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 7-1 to recommend approval of the platelet inhibitor ticagrelor to treat non–ST elevation myocardial infarction and ST-elevation myocardial infarction in patients intended to receive primary coronary intervention or who would be managed medically.

The panel did not directly address other indications being sought by ticagrelor's maker, AstraZeneca, including in unstable angina and after a coronary artery bypass graft (CABG). But in an interview after the meeting, FDA official Robert Temple said that the panel had basically covered all the populations that would be considered under the rubric of acute coronary syndrome. As the agency weighs approval, it will decide whether to grant specific indications, said Dr. Temple, who is head of the office reviewing ticagrelor (Brilinta).

According to the company, ticagrelor is the first reversibly binding oral adenosine diphosphate receptor antagonist. It selectively inhibits P2Y12, a key target receptor for ADP.

FDA committee member Mori J. Krantz was the lone panelist who voted against approval. He said that he was concerned about data from the pivotal PLATO (A Study of Platelet Inhibition and Patient Outcomes) study showing that patients in the United States did not fare as well as those in overseas sites.

“That it went in the opposite direction is a little discomforting,” said Dr. Krantz of the University of Colorado, Denver.

Committee chairman Sanjay Kaul voted in favor of approval, but said, “I am concerned, however, about the data going in the wrong direction in the United States.” He urged the FDA to require a postapproval study that would include a substantial number of Americans and look in particular at unstable angina.

The FDA generally follows its panels' advice.

The PLATO data was first presented at the European Society of Cardiology in 2009 and published online in the New England Journal of Medicine in August 2009. The randomized, double-blind trial compared ticagrelor to clopidogrel in all-comer ACS patients. The study enrolled 18,624 patients at 862 centers in 43 countries.

AstraZeneca said that PLATO proved that ticagrelor was superior to clopidogrel, with a 16% reduction in relative risk for the primary composite end point of cardiovascular death, myocardial infarction, or stroke. The company claimed there was no difference in major bleeding as defined by the trial, but acknowledged that there was a slightly higher number of patients with intracranial hemorrhage, including fatal hemorrhage.

The FDA reviewers said they also found a higher rate of bleeding after CABG.

But the main concern—and the primary reason for the panel meeting—was why there were more cardiovascular events in Americans. AstraZeneca said that a post hoc analysis determined that Americans were taking higher doses of aspirin, which led to more heart attacks, strokes, and deaths.

After lengthy debate, the committee said the difference could not be attributed to chance alone or to the aspirin dosages. Differences in clinical practice in the United States were the more likely explanation, said a number of panelists.

Members of FDA advisory panels have been cleared of conflicts related to the topic under discussion. The agency is due to make a decision on the application for approval by Sept. 18.

COLLEGE PARK, MD. — The Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 7-1 to recommend approval of the platelet inhibitor ticagrelor to treat non–ST elevation myocardial infarction and ST-elevation myocardial infarction in patients intended to receive primary coronary intervention or who would be managed medically.

The panel did not directly address other indications being sought by ticagrelor's maker, AstraZeneca, including in unstable angina and after a coronary artery bypass graft (CABG). But in an interview after the meeting, FDA official Robert Temple said that the panel had basically covered all the populations that would be considered under the rubric of acute coronary syndrome. As the agency weighs approval, it will decide whether to grant specific indications, said Dr. Temple, who is head of the office reviewing ticagrelor (Brilinta).

According to the company, ticagrelor is the first reversibly binding oral adenosine diphosphate receptor antagonist. It selectively inhibits P2Y12, a key target receptor for ADP.

FDA committee member Mori J. Krantz was the lone panelist who voted against approval. He said that he was concerned about data from the pivotal PLATO (A Study of Platelet Inhibition and Patient Outcomes) study showing that patients in the United States did not fare as well as those in overseas sites.

“That it went in the opposite direction is a little discomforting,” said Dr. Krantz of the University of Colorado, Denver.

Committee chairman Sanjay Kaul voted in favor of approval, but said, “I am concerned, however, about the data going in the wrong direction in the United States.” He urged the FDA to require a postapproval study that would include a substantial number of Americans and look in particular at unstable angina.

The FDA generally follows its panels' advice.

The PLATO data was first presented at the European Society of Cardiology in 2009 and published online in the New England Journal of Medicine in August 2009. The randomized, double-blind trial compared ticagrelor to clopidogrel in all-comer ACS patients. The study enrolled 18,624 patients at 862 centers in 43 countries.

AstraZeneca said that PLATO proved that ticagrelor was superior to clopidogrel, with a 16% reduction in relative risk for the primary composite end point of cardiovascular death, myocardial infarction, or stroke. The company claimed there was no difference in major bleeding as defined by the trial, but acknowledged that there was a slightly higher number of patients with intracranial hemorrhage, including fatal hemorrhage.

The FDA reviewers said they also found a higher rate of bleeding after CABG.

But the main concern—and the primary reason for the panel meeting—was why there were more cardiovascular events in Americans. AstraZeneca said that a post hoc analysis determined that Americans were taking higher doses of aspirin, which led to more heart attacks, strokes, and deaths.

After lengthy debate, the committee said the difference could not be attributed to chance alone or to the aspirin dosages. Differences in clinical practice in the United States were the more likely explanation, said a number of panelists.

Members of FDA advisory panels have been cleared of conflicts related to the topic under discussion. The agency is due to make a decision on the application for approval by Sept. 18.

COLLEGE PARK, MD. — The Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 7-1 to recommend approval of the platelet inhibitor ticagrelor to treat non–ST elevation myocardial infarction and ST-elevation myocardial infarction in patients intended to receive primary coronary intervention or who would be managed medically.

The panel did not directly address other indications being sought by ticagrelor's maker, AstraZeneca, including in unstable angina and after a coronary artery bypass graft (CABG). But in an interview after the meeting, FDA official Robert Temple said that the panel had basically covered all the populations that would be considered under the rubric of acute coronary syndrome. As the agency weighs approval, it will decide whether to grant specific indications, said Dr. Temple, who is head of the office reviewing ticagrelor (Brilinta).

According to the company, ticagrelor is the first reversibly binding oral adenosine diphosphate receptor antagonist. It selectively inhibits P2Y12, a key target receptor for ADP.

FDA committee member Mori J. Krantz was the lone panelist who voted against approval. He said that he was concerned about data from the pivotal PLATO (A Study of Platelet Inhibition and Patient Outcomes) study showing that patients in the United States did not fare as well as those in overseas sites.

“That it went in the opposite direction is a little discomforting,” said Dr. Krantz of the University of Colorado, Denver.

Committee chairman Sanjay Kaul voted in favor of approval, but said, “I am concerned, however, about the data going in the wrong direction in the United States.” He urged the FDA to require a postapproval study that would include a substantial number of Americans and look in particular at unstable angina.

The FDA generally follows its panels' advice.

The PLATO data was first presented at the European Society of Cardiology in 2009 and published online in the New England Journal of Medicine in August 2009. The randomized, double-blind trial compared ticagrelor to clopidogrel in all-comer ACS patients. The study enrolled 18,624 patients at 862 centers in 43 countries.

AstraZeneca said that PLATO proved that ticagrelor was superior to clopidogrel, with a 16% reduction in relative risk for the primary composite end point of cardiovascular death, myocardial infarction, or stroke. The company claimed there was no difference in major bleeding as defined by the trial, but acknowledged that there was a slightly higher number of patients with intracranial hemorrhage, including fatal hemorrhage.

The FDA reviewers said they also found a higher rate of bleeding after CABG.

But the main concern—and the primary reason for the panel meeting—was why there were more cardiovascular events in Americans. AstraZeneca said that a post hoc analysis determined that Americans were taking higher doses of aspirin, which led to more heart attacks, strokes, and deaths.

After lengthy debate, the committee said the difference could not be attributed to chance alone or to the aspirin dosages. Differences in clinical practice in the United States were the more likely explanation, said a number of panelists.

Members of FDA advisory panels have been cleared of conflicts related to the topic under discussion. The agency is due to make a decision on the application for approval by Sept. 18.

The Food and Drug Administration on July 29 warned physicians and patients that children exposed to a mist form of estradiol might experience hormonally fueled side effects such as breast enlargement.

The topical estrogen, Evamist, is sprayed on the skin on the inside of the forearm.

The FDA said that, since Evamist was approved in 2007, the agency has received eight reports in children aged 3-5 years who had been exposed to the drug through skin contact. The girls experienced premature puberty, including development of breast buds and breast mass, while the boys reported effects consistent with gynecomastia, the agency said in a safety announcement.

These effects occurred several weeks to several months after the adult relative had started Evamist therapy. In some cases, symptoms resolved after the estrogen was discontinued or when the child’s exposure was minimized.

The agency also said that it had received exposure reports in two spayed female dogs that had licked the Evamist users’ forearm. One animal experienced mammary/nipple enlargement, vulvar swelling, and liver failure, and the other had vaginal prolapse and elevated estrogen levels.

The FDA is working with Evamist maker Ther-Rx to identify factors contributing to the exposures.

The Food and Drug Administration on July 29 warned physicians and patients that children exposed to a mist form of estradiol might experience hormonally fueled side effects such as breast enlargement.

The topical estrogen, Evamist, is sprayed on the skin on the inside of the forearm.

The FDA said that, since Evamist was approved in 2007, the agency has received eight reports in children aged 3-5 years who had been exposed to the drug through skin contact. The girls experienced premature puberty, including development of breast buds and breast mass, while the boys reported effects consistent with gynecomastia, the agency said in a safety announcement.

These effects occurred several weeks to several months after the adult relative had started Evamist therapy. In some cases, symptoms resolved after the estrogen was discontinued or when the child’s exposure was minimized.

The agency also said that it had received exposure reports in two spayed female dogs that had licked the Evamist users’ forearm. One animal experienced mammary/nipple enlargement, vulvar swelling, and liver failure, and the other had vaginal prolapse and elevated estrogen levels.

The FDA is working with Evamist maker Ther-Rx to identify factors contributing to the exposures.

The Food and Drug Administration on July 29 warned physicians and patients that children exposed to a mist form of estradiol might experience hormonally fueled side effects such as breast enlargement.

The topical estrogen, Evamist, is sprayed on the skin on the inside of the forearm.

The FDA said that, since Evamist was approved in 2007, the agency has received eight reports in children aged 3-5 years who had been exposed to the drug through skin contact. The girls experienced premature puberty, including development of breast buds and breast mass, while the boys reported effects consistent with gynecomastia, the agency said in a safety announcement.

These effects occurred several weeks to several months after the adult relative had started Evamist therapy. In some cases, symptoms resolved after the estrogen was discontinued or when the child’s exposure was minimized.

The agency also said that it had received exposure reports in two spayed female dogs that had licked the Evamist users’ forearm. One animal experienced mammary/nipple enlargement, vulvar swelling, and liver failure, and the other had vaginal prolapse and elevated estrogen levels.

The FDA is working with Evamist maker Ther-Rx to identify factors contributing to the exposures.

The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.

Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.

The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.

The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug's label about the increased potential for developing eosinophilic pneumonia. The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.

Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing. The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician.

The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.

Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.

The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.

The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug's label about the increased potential for developing eosinophilic pneumonia. The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.

Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing. The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician.

The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.

Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.

The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.

The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug's label about the increased potential for developing eosinophilic pneumonia. The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.

Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing. The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician.

WASHINGTON – Direct-to-consumer genetic tests are deceptively marketed and often give misleading results that are of little or no practical use, said the U.S. Government Accountability Office in a report released on July 22 at a hearing of the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations.

Subcommittee chairman Rep. Bart Stupak (D-Mich.) called on the three genetic testing companies in attendance to stop marketing their products to consumers until the Food and Drug Administration or National Institutes of Health can establish standards for how the testing should be conducted and how results should be shared with consumers.

Currently, the tests are being sold without FDA approval. But Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said that the agency has been trying to assess how to regulate the products. A genetic test is subject to FDA oversight if it is a medical device being used in the diagnosis of disease or to cure, mitigate, treat, or prevent disease.

The agency has basically hung back on enforcing the rule of the law on the DTC tests but now is clamping down, said Dr. Shuren. In May, the FDA told Pathway Genomics that it had to get approval for its genetic health report, which it was going to sell at Walgreen's stores. Pathway is no longer marketing directly to consumers.

Pathway's agreement with Walgreen's "lit a fire" at FDA, said Dr. Shuren. "We thought at this point, it's time to take action," he said.

In June, the FDA sent similar warnings to four other companies: Knome Inc., Navigenics Inc., deCODE genetics, and 23andMe and, on July 19, the agency warned 15 more companies.

The GAO investigated companies selling DTC tests in 2006 but was asked by the subcommittee to revisit the market in the wake of reports that companies were more "reputable." The agency bought 10 tests each from four companies – 23andMe, deCODE genetics, Pathway Genomics, and Navigenics – using five volunteer DNA donors. Each volunteer used his or her own information when submitting one test, and submitted fictitious information for the second test. Each kit cost between $300 and $1,000.

All five donors received conflicting results. A total of 68% of the time the donors received a different prediction for the same disease being tested, according to Gregory Kutz, managing director of the GAO's Forensic Audits and Special Investigations. In one case, a donor with a pacemaker implanted for 13 years to treat atrial fibrillation was told he was at a lower risk for developing the condition.

"These results show that these tests aren't ready for prime time," said Mr. Kutz. And yet, the market for the tests is at about $1 billion a year and growing some 20%-30% a year, he said.

The GAO also made undercover calls to 15 companies, including the 4 from which the agency bought test kits, asking about test reliability, privacy policies, and to inquire about supplements that some of the testing firms were selling. Four of the companies claimed that "a consumer's DNA could be used to create personalized supplements that would cure diseases," said the GAO in its report.

Two companies claimed they could predict at which sports a child would excel, and two companies offered to help a consumer secretly test her fiancé's DNA and "surprise" him with the results. Mr. Kutz said this practice is restricted in 33 states.

Many of the House members in attendance said they believed the tests should not be marketed to consumers. Rep. Parker Griffith (R-Ala.) said, "This is all bogus," adding, "this is nothing more than the snake oil salesman revisited in a high-tech community and in a high-tech way."

Representatives from 23andMe, Navigenics, and Pathway Genomics all defended their products at the hearing, but added that they agreed that more regulation of the industry was needed.

WASHINGTON – Direct-to-consumer genetic tests are deceptively marketed and often give misleading results that are of little or no practical use, said the U.S. Government Accountability Office in a report released on July 22 at a hearing of the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations.

Subcommittee chairman Rep. Bart Stupak (D-Mich.) called on the three genetic testing companies in attendance to stop marketing their products to consumers until the Food and Drug Administration or National Institutes of Health can establish standards for how the testing should be conducted and how results should be shared with consumers.

Currently, the tests are being sold without FDA approval. But Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said that the agency has been trying to assess how to regulate the products. A genetic test is subject to FDA oversight if it is a medical device being used in the diagnosis of disease or to cure, mitigate, treat, or prevent disease.

The agency has basically hung back on enforcing the rule of the law on the DTC tests but now is clamping down, said Dr. Shuren. In May, the FDA told Pathway Genomics that it had to get approval for its genetic health report, which it was going to sell at Walgreen's stores. Pathway is no longer marketing directly to consumers.

Pathway's agreement with Walgreen's "lit a fire" at FDA, said Dr. Shuren. "We thought at this point, it's time to take action," he said.

In June, the FDA sent similar warnings to four other companies: Knome Inc., Navigenics Inc., deCODE genetics, and 23andMe and, on July 19, the agency warned 15 more companies.

The GAO investigated companies selling DTC tests in 2006 but was asked by the subcommittee to revisit the market in the wake of reports that companies were more "reputable." The agency bought 10 tests each from four companies – 23andMe, deCODE genetics, Pathway Genomics, and Navigenics – using five volunteer DNA donors. Each volunteer used his or her own information when submitting one test, and submitted fictitious information for the second test. Each kit cost between $300 and $1,000.

All five donors received conflicting results. A total of 68% of the time the donors received a different prediction for the same disease being tested, according to Gregory Kutz, managing director of the GAO's Forensic Audits and Special Investigations. In one case, a donor with a pacemaker implanted for 13 years to treat atrial fibrillation was told he was at a lower risk for developing the condition.

"These results show that these tests aren't ready for prime time," said Mr. Kutz. And yet, the market for the tests is at about $1 billion a year and growing some 20%-30% a year, he said.

The GAO also made undercover calls to 15 companies, including the 4 from which the agency bought test kits, asking about test reliability, privacy policies, and to inquire about supplements that some of the testing firms were selling. Four of the companies claimed that "a consumer's DNA could be used to create personalized supplements that would cure diseases," said the GAO in its report.

Two companies claimed they could predict at which sports a child would excel, and two companies offered to help a consumer secretly test her fiancé's DNA and "surprise" him with the results. Mr. Kutz said this practice is restricted in 33 states.

Many of the House members in attendance said they believed the tests should not be marketed to consumers. Rep. Parker Griffith (R-Ala.) said, "This is all bogus," adding, "this is nothing more than the snake oil salesman revisited in a high-tech community and in a high-tech way."

Representatives from 23andMe, Navigenics, and Pathway Genomics all defended their products at the hearing, but added that they agreed that more regulation of the industry was needed.

WASHINGTON – Direct-to-consumer genetic tests are deceptively marketed and often give misleading results that are of little or no practical use, said the U.S. Government Accountability Office in a report released on July 22 at a hearing of the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations.

Subcommittee chairman Rep. Bart Stupak (D-Mich.) called on the three genetic testing companies in attendance to stop marketing their products to consumers until the Food and Drug Administration or National Institutes of Health can establish standards for how the testing should be conducted and how results should be shared with consumers.

Currently, the tests are being sold without FDA approval. But Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said that the agency has been trying to assess how to regulate the products. A genetic test is subject to FDA oversight if it is a medical device being used in the diagnosis of disease or to cure, mitigate, treat, or prevent disease.

The agency has basically hung back on enforcing the rule of the law on the DTC tests but now is clamping down, said Dr. Shuren. In May, the FDA told Pathway Genomics that it had to get approval for its genetic health report, which it was going to sell at Walgreen's stores. Pathway is no longer marketing directly to consumers.

Pathway's agreement with Walgreen's "lit a fire" at FDA, said Dr. Shuren. "We thought at this point, it's time to take action," he said.

In June, the FDA sent similar warnings to four other companies: Knome Inc., Navigenics Inc., deCODE genetics, and 23andMe and, on July 19, the agency warned 15 more companies.

The GAO investigated companies selling DTC tests in 2006 but was asked by the subcommittee to revisit the market in the wake of reports that companies were more "reputable." The agency bought 10 tests each from four companies – 23andMe, deCODE genetics, Pathway Genomics, and Navigenics – using five volunteer DNA donors. Each volunteer used his or her own information when submitting one test, and submitted fictitious information for the second test. Each kit cost between $300 and $1,000.

All five donors received conflicting results. A total of 68% of the time the donors received a different prediction for the same disease being tested, according to Gregory Kutz, managing director of the GAO's Forensic Audits and Special Investigations. In one case, a donor with a pacemaker implanted for 13 years to treat atrial fibrillation was told he was at a lower risk for developing the condition.

"These results show that these tests aren't ready for prime time," said Mr. Kutz. And yet, the market for the tests is at about $1 billion a year and growing some 20%-30% a year, he said.

The GAO also made undercover calls to 15 companies, including the 4 from which the agency bought test kits, asking about test reliability, privacy policies, and to inquire about supplements that some of the testing firms were selling. Four of the companies claimed that "a consumer's DNA could be used to create personalized supplements that would cure diseases," said the GAO in its report.

Two companies claimed they could predict at which sports a child would excel, and two companies offered to help a consumer secretly test her fiancé's DNA and "surprise" him with the results. Mr. Kutz said this practice is restricted in 33 states.

Many of the House members in attendance said they believed the tests should not be marketed to consumers. Rep. Parker Griffith (R-Ala.) said, "This is all bogus," adding, "this is nothing more than the snake oil salesman revisited in a high-tech community and in a high-tech way."

Representatives from 23andMe, Navigenics, and Pathway Genomics all defended their products at the hearing, but added that they agreed that more regulation of the industry was needed.

President Obama on July 7 announced the recess appointment of Dr. Donald Berwick to be the Administrator of the Centers for Medicare and Medicaid Services (CMS), bypassing what looked like a lengthy fight to have the nominee confirmed by the Senate.

In making the appointment, the President said in a statement, “It’s unfortunate that, at a time when our nation is facing enormous challenges, many in Congress have decided to delay critical nominations for political purposes.”

The White House announced President Obama’s intention to make the recess appointment on its blog on July 6. White House spokesman Dan Pfeiffer wrote that the move was necessary because, “Many Republicans in Congress have made it clear in recent weeks that they were going to stall the nomination as long as they could, solely to score political points.”

Dr. Berwick, a pediatrician who is a nationally known leader in health care quality, is supported by many health care and consumer groups, Mr. Pfeiffer noted. Dr. Berwick is president and CEO of the Cambridge, Mass.-based Institute for Healthcare Improvement.

The American Hospital Association (AHA) and others leaped to support Dr. Berwick.

“Don has dedicated his career to engaging hospitals, doctors, nurses and other health care providers to improve patient care,” AHA President Rich Umbdenstock said in a statement. “A physician and innovator in health care quality, his knowledge of the health care system makes him the right choice.”

Sen. John Kerry (D-Mass.) also issued a statement, chiding Republicans for their “lockstep stalling” of Dr. Berwick’s nomination, and praising him for his assistance in overhauling the Massachusetts health care system.

“He’s first rate all the way, and throughout Massachusetts’ landmark health reform, Don was there, helping lead our state to the highest rate of health care coverage in the nation,” according to Sen. Kerry.

Senate Minority Leader Mitch McConnell (R-Ky.), however, was scathing in his reaction to the appointment, calling Dr. Berwick “one of the most prominent advocates of rationed health care.”

“Democrats haven’t scheduled so much as a committee hearing for Donald Berwick but the mere possibility of allowing the American people the opportunity to hear what he intends to do with their health care is evidently reason enough for this Administration to sneak him through without public scrutiny,” Sen. McConnell said in a statement.

Under the Constitution, the President nominates individuals to serve in high-level government positions; those individuals must then be confirmed by the Senate. However, the Constitution also allows the President to make such appointments without Senate confirmation if Congress is in recess, as it currently is for the Independence Day holiday.

While the purpose of a recess appointment is to ensure the continuity of the government, over the years, such appointments have been used to evade political battles

Until Dr. Berwick’s appointment, CMS was without a permanent administrator since 2006.

President Obama on July 7 announced the recess appointment of Dr. Donald Berwick to be the Administrator of the Centers for Medicare and Medicaid Services (CMS), bypassing what looked like a lengthy fight to have the nominee confirmed by the Senate.

In making the appointment, the President said in a statement, “It’s unfortunate that, at a time when our nation is facing enormous challenges, many in Congress have decided to delay critical nominations for political purposes.”

The White House announced President Obama’s intention to make the recess appointment on its blog on July 6. White House spokesman Dan Pfeiffer wrote that the move was necessary because, “Many Republicans in Congress have made it clear in recent weeks that they were going to stall the nomination as long as they could, solely to score political points.”

Dr. Berwick, a pediatrician who is a nationally known leader in health care quality, is supported by many health care and consumer groups, Mr. Pfeiffer noted. Dr. Berwick is president and CEO of the Cambridge, Mass.-based Institute for Healthcare Improvement.

The American Hospital Association (AHA) and others leaped to support Dr. Berwick.

“Don has dedicated his career to engaging hospitals, doctors, nurses and other health care providers to improve patient care,” AHA President Rich Umbdenstock said in a statement. “A physician and innovator in health care quality, his knowledge of the health care system makes him the right choice.”

Sen. John Kerry (D-Mass.) also issued a statement, chiding Republicans for their “lockstep stalling” of Dr. Berwick’s nomination, and praising him for his assistance in overhauling the Massachusetts health care system.

“He’s first rate all the way, and throughout Massachusetts’ landmark health reform, Don was there, helping lead our state to the highest rate of health care coverage in the nation,” according to Sen. Kerry.

Senate Minority Leader Mitch McConnell (R-Ky.), however, was scathing in his reaction to the appointment, calling Dr. Berwick “one of the most prominent advocates of rationed health care.”

“Democrats haven’t scheduled so much as a committee hearing for Donald Berwick but the mere possibility of allowing the American people the opportunity to hear what he intends to do with their health care is evidently reason enough for this Administration to sneak him through without public scrutiny,” Sen. McConnell said in a statement.

Under the Constitution, the President nominates individuals to serve in high-level government positions; those individuals must then be confirmed by the Senate. However, the Constitution also allows the President to make such appointments without Senate confirmation if Congress is in recess, as it currently is for the Independence Day holiday.

While the purpose of a recess appointment is to ensure the continuity of the government, over the years, such appointments have been used to evade political battles

Until Dr. Berwick’s appointment, CMS was without a permanent administrator since 2006.

President Obama on July 7 announced the recess appointment of Dr. Donald Berwick to be the Administrator of the Centers for Medicare and Medicaid Services (CMS), bypassing what looked like a lengthy fight to have the nominee confirmed by the Senate.

In making the appointment, the President said in a statement, “It’s unfortunate that, at a time when our nation is facing enormous challenges, many in Congress have decided to delay critical nominations for political purposes.”

The White House announced President Obama’s intention to make the recess appointment on its blog on July 6. White House spokesman Dan Pfeiffer wrote that the move was necessary because, “Many Republicans in Congress have made it clear in recent weeks that they were going to stall the nomination as long as they could, solely to score political points.”

Dr. Berwick, a pediatrician who is a nationally known leader in health care quality, is supported by many health care and consumer groups, Mr. Pfeiffer noted. Dr. Berwick is president and CEO of the Cambridge, Mass.-based Institute for Healthcare Improvement.

The American Hospital Association (AHA) and others leaped to support Dr. Berwick.

“Don has dedicated his career to engaging hospitals, doctors, nurses and other health care providers to improve patient care,” AHA President Rich Umbdenstock said in a statement. “A physician and innovator in health care quality, his knowledge of the health care system makes him the right choice.”

Sen. John Kerry (D-Mass.) also issued a statement, chiding Republicans for their “lockstep stalling” of Dr. Berwick’s nomination, and praising him for his assistance in overhauling the Massachusetts health care system.

“He’s first rate all the way, and throughout Massachusetts’ landmark health reform, Don was there, helping lead our state to the highest rate of health care coverage in the nation,” according to Sen. Kerry.

Senate Minority Leader Mitch McConnell (R-Ky.), however, was scathing in his reaction to the appointment, calling Dr. Berwick “one of the most prominent advocates of rationed health care.”

“Democrats haven’t scheduled so much as a committee hearing for Donald Berwick but the mere possibility of allowing the American people the opportunity to hear what he intends to do with their health care is evidently reason enough for this Administration to sneak him through without public scrutiny,” Sen. McConnell said in a statement.

Under the Constitution, the President nominates individuals to serve in high-level government positions; those individuals must then be confirmed by the Senate. However, the Constitution also allows the President to make such appointments without Senate confirmation if Congress is in recess, as it currently is for the Independence Day holiday.

While the purpose of a recess appointment is to ensure the continuity of the government, over the years, such appointments have been used to evade political battles

Until Dr. Berwick’s appointment, CMS was without a permanent administrator since 2006.