Alicia Ault

The true impact isn't known yet, but an administrative change by the Centers for Medicare and Medicaid Services to rules governing the State Children's Health Insurance Program—made on a Friday night during Congress' August recess—may have the effect of dropping children who currently have coverage.

Sen. Jay Rockefeller (D-W.Va.), one of the original coauthors of SCHIP, sent a letter to President George W. Bush chiding the administration for making the change without congressional input.

“Not only do I question the wisdom and legality of this new policy, I also question the process,” wrote Sen. Rockefeller, noting that “a policy change of this magnitude should, at a minimum, be handled through the formal rule-making process, with proper public notice and comment, and not through unilateral subregulatory guidance.”

About 4 million children are eligible for Medicaid or SCHIP currently; some 6 million received benefits in 2006. An estimated 9 million children do not have health insurance.

SCHIP, now entering its 10th year, has been the subject of fierce battles this year, as lawmakers have struggled to come up with financing for the next 5 years that is palatable to both parties. Authorization for SCHIP expires Sept. 30. Before leaving for summer recess, the House and the Senate passed vastly different funding packages.

President Bush said he would veto either bill, saying that he viewed both as a back-door way of expanding government-financed health care at the expense of the private insurance market.

So the Aug. 17 letter from CMS Director for Medicaid and State Operations Dennis G. Smith to state health officials should not have come as a surprise. In the letter, states were told that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. The goal: to ensure that these families aren't opting for SCHIP instead of private insurance.

“Existing regulations … provide that states must have 'reasonable procedures' to prevent substitution of public SCHIP coverage for private coverage,” Mr. Smith wrote.

Many states have had such procedures in place, but the CMS is now requiring that specific processes be implemented. For instance, children will have to be uninsured for at least 1 year before receiving SCHIP benefits. Currently, only Alaska requires a year-long exclusion, said Judy Solomon, a senior fellow with the Center on Budget and Policy Priorities, a Washington-based policy research organization.

Most states impose a 1- to 6-month waiting period, but most also have generous exceptions to those rules.

Under the administrative change, states also will have to prove that they've enrolled at least 95% of children who are below 200% of the federal poverty level, and document that the number of low-income children who are eligible for and covered by private insurance has not dropped by more than 2% in the past 5 years.

States that have already increased their eligibility to 250% or more—18 states—will have to comply with the new requirements within a year or lose some of their federal matching funds.

The CMS said that the requirements should not harm children who currently receive benefits. “We would not expect any effect on current enrollees,” Mr. Smith wrote.

While it's not clear how many children might be dropped, “at the very least, you're going to have thousands of children unable to get coverage,” Ms. Solomon said, noting that the hurdles might be too high for new enrollees.

SCHIP was designed to give states flexibility to meet the needs of their own citizenry, noted Ms. Solomon. For instance, states with a higher cost of living and the ability to shoulder a higher fiscal burden—like New York, New Jersey, and Massachusetts—have increased income eligibility levels.

But the new CMS policy is severely diminishing that flexibility. “This turns back the clock,” Ms. Solomon said.

The House and Senate will meet in conference in September to determine the course of SCHIP over the next 5 years.

The true impact isn't known yet, but an administrative change by the Centers for Medicare and Medicaid Services to rules governing the State Children's Health Insurance Program—made on a Friday night during Congress' August recess—may have the effect of dropping children who currently have coverage.

Sen. Jay Rockefeller (D-W.Va.), one of the original coauthors of SCHIP, sent a letter to President George W. Bush chiding the administration for making the change without congressional input.

“Not only do I question the wisdom and legality of this new policy, I also question the process,” wrote Sen. Rockefeller, noting that “a policy change of this magnitude should, at a minimum, be handled through the formal rule-making process, with proper public notice and comment, and not through unilateral subregulatory guidance.”

About 4 million children are eligible for Medicaid or SCHIP currently; some 6 million received benefits in 2006. An estimated 9 million children do not have health insurance.

SCHIP, now entering its 10th year, has been the subject of fierce battles this year, as lawmakers have struggled to come up with financing for the next 5 years that is palatable to both parties. Authorization for SCHIP expires Sept. 30. Before leaving for summer recess, the House and the Senate passed vastly different funding packages.

President Bush said he would veto either bill, saying that he viewed both as a back-door way of expanding government-financed health care at the expense of the private insurance market.

So the Aug. 17 letter from CMS Director for Medicaid and State Operations Dennis G. Smith to state health officials should not have come as a surprise. In the letter, states were told that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. The goal: to ensure that these families aren't opting for SCHIP instead of private insurance.

“Existing regulations … provide that states must have 'reasonable procedures' to prevent substitution of public SCHIP coverage for private coverage,” Mr. Smith wrote.

Many states have had such procedures in place, but the CMS is now requiring that specific processes be implemented. For instance, children will have to be uninsured for at least 1 year before receiving SCHIP benefits. Currently, only Alaska requires a year-long exclusion, said Judy Solomon, a senior fellow with the Center on Budget and Policy Priorities, a Washington-based policy research organization.

Most states impose a 1- to 6-month waiting period, but most also have generous exceptions to those rules.

Under the administrative change, states also will have to prove that they've enrolled at least 95% of children who are below 200% of the federal poverty level, and document that the number of low-income children who are eligible for and covered by private insurance has not dropped by more than 2% in the past 5 years.

States that have already increased their eligibility to 250% or more—18 states—will have to comply with the new requirements within a year or lose some of their federal matching funds.

The CMS said that the requirements should not harm children who currently receive benefits. “We would not expect any effect on current enrollees,” Mr. Smith wrote.

While it's not clear how many children might be dropped, “at the very least, you're going to have thousands of children unable to get coverage,” Ms. Solomon said, noting that the hurdles might be too high for new enrollees.

SCHIP was designed to give states flexibility to meet the needs of their own citizenry, noted Ms. Solomon. For instance, states with a higher cost of living and the ability to shoulder a higher fiscal burden—like New York, New Jersey, and Massachusetts—have increased income eligibility levels.

But the new CMS policy is severely diminishing that flexibility. “This turns back the clock,” Ms. Solomon said.

The House and Senate will meet in conference in September to determine the course of SCHIP over the next 5 years.

The true impact isn't known yet, but an administrative change by the Centers for Medicare and Medicaid Services to rules governing the State Children's Health Insurance Program—made on a Friday night during Congress' August recess—may have the effect of dropping children who currently have coverage.

Sen. Jay Rockefeller (D-W.Va.), one of the original coauthors of SCHIP, sent a letter to President George W. Bush chiding the administration for making the change without congressional input.

“Not only do I question the wisdom and legality of this new policy, I also question the process,” wrote Sen. Rockefeller, noting that “a policy change of this magnitude should, at a minimum, be handled through the formal rule-making process, with proper public notice and comment, and not through unilateral subregulatory guidance.”

About 4 million children are eligible for Medicaid or SCHIP currently; some 6 million received benefits in 2006. An estimated 9 million children do not have health insurance.

SCHIP, now entering its 10th year, has been the subject of fierce battles this year, as lawmakers have struggled to come up with financing for the next 5 years that is palatable to both parties. Authorization for SCHIP expires Sept. 30. Before leaving for summer recess, the House and the Senate passed vastly different funding packages.

President Bush said he would veto either bill, saying that he viewed both as a back-door way of expanding government-financed health care at the expense of the private insurance market.

So the Aug. 17 letter from CMS Director for Medicaid and State Operations Dennis G. Smith to state health officials should not have come as a surprise. In the letter, states were told that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. The goal: to ensure that these families aren't opting for SCHIP instead of private insurance.

“Existing regulations … provide that states must have 'reasonable procedures' to prevent substitution of public SCHIP coverage for private coverage,” Mr. Smith wrote.

Many states have had such procedures in place, but the CMS is now requiring that specific processes be implemented. For instance, children will have to be uninsured for at least 1 year before receiving SCHIP benefits. Currently, only Alaska requires a year-long exclusion, said Judy Solomon, a senior fellow with the Center on Budget and Policy Priorities, a Washington-based policy research organization.

Most states impose a 1- to 6-month waiting period, but most also have generous exceptions to those rules.

Under the administrative change, states also will have to prove that they've enrolled at least 95% of children who are below 200% of the federal poverty level, and document that the number of low-income children who are eligible for and covered by private insurance has not dropped by more than 2% in the past 5 years.

States that have already increased their eligibility to 250% or more—18 states—will have to comply with the new requirements within a year or lose some of their federal matching funds.

The CMS said that the requirements should not harm children who currently receive benefits. “We would not expect any effect on current enrollees,” Mr. Smith wrote.

While it's not clear how many children might be dropped, “at the very least, you're going to have thousands of children unable to get coverage,” Ms. Solomon said, noting that the hurdles might be too high for new enrollees.

SCHIP was designed to give states flexibility to meet the needs of their own citizenry, noted Ms. Solomon. For instance, states with a higher cost of living and the ability to shoulder a higher fiscal burden—like New York, New Jersey, and Massachusetts—have increased income eligibility levels.

But the new CMS policy is severely diminishing that flexibility. “This turns back the clock,” Ms. Solomon said.

The House and Senate will meet in conference in September to determine the course of SCHIP over the next 5 years.

Two years after Hurricane Katrina, the relatively few open health care facilities and diminished corps of physicians in New Orleans are struggling to serve the needs of a smaller, but just as needy, population. It's a picture that's changed little since this time last year.

Emergency rooms, in particular, bear the brunt of the broken system, as they are one resource that is nearly always available to the uninsured and those with little access to primary care.

It is thought that about 200,000 people now reside in the city, with another 400,000 in the three surrounding parishes (Jefferson, Plaquemines, and St. Bernard). There are some 101,000 uninsured residents and 147,000 Medicaid recipients, according to the Louisiana Department of Health and Hospitals (DHH).

It's still unclear how many of the roughly 3,000 physicians in the area before the storm have returned. In mid-2006, according to Blue Cross and Blue Shield, only half were back. The Louisiana State Board of Medical Examiners said from August 2005 to July 2006, the number of primary care physicians declined from 2,645 to 1,913.

The lack of access has hit hard. An analysis of death notices in the Times-Picayune by Dr. Kevin U. Stephens, Sr., director of the city health department, and associates, showed a 47% mortality increase in the first half of 2006—to 91/100,000, versus 62/100,000 in 2002-2004 (Disaster Med. Public Health Preparedness 2007;1:15-20). The authors studied death notices because of vast gaps in state and city data.

Primary Clinics to Be Medical Homes

In an interview, Dr. Frederick P. Cerise, secretary of the Louisiana Department of Health and Hospitals, said there are 26 primary health care sites in the New Orleans area, including federally qualified health centers, Tulane University and Louisiana State University outpatient clinics, and mobile and nonprofit clinics. The sites will receive $100 million from the federal government over next 3 years as part of a $161 million allocation aimed at improving health care in the area.

The clinics are eagerly awaiting that money, said Dr. Karen DeSalvo, executive director of Tulane University Community Health Center at Covenant House, in an interview. The money will give “a chance to expand upon what's been developing—multiple neighborhood clinics that are turning into medical homes,” said Dr. DeSalvo, also chief of general internal medicine and geriatrics at the university and special assistant to its president for health policy. Dr. DeSalvo that though primary care is improving (the 18 clinics see about 900 patients daily), too many still seek routine care in EDs. “We're trying to find those patients in the ER and get them into our system.”

Inpatient Capacity Still Down

Currently, in New Orleans proper, five hospitals are open; and five more are abandoned or closed, according to the Louisiana Hospital Association.

Louisiana State University, Baton Rouge, is once again operating a level one trauma center in downtown New Orleans at the LSU Interim Hospital (formerly University Hospital).

The now 179-bed Interim Hospital and Tulane Hospital are all that's left of the Medical Center of Louisiana at New Orleans. Before Katrina, that campus also included Charity Hospital, a Veterans Affairs (VA) hospital, and medical office buildings. LSU was able to open Interim Hospital with $64 million in Federal Emergency Management Agency (FEMA) funds. It recently added a 20-bed detox unit (only 5 were staffed at press time), and is in the midst of adding 33 inpatient mental health beds elsewhere in the city, plus a mental health unit in the emergency department.

LSU is one of the main backers of a huge new medical campus within a few blocks of Charity Hospital on a 37-acre parcel that the city said it will take.

According to testimony by Mayor C. Ray Nagin at a field hearing of the U.S. House Committee on Veterans' Affairs in early July, the campus would include 30 public, private, and nonprofit organizations. The state has put aside $38 million for a cancer research institute at the site. The city—along with LSU and Tulane—is trying to convince the VA to rebuild on the campus.

Before Katrina, 75 Tulane physicians had joint VA-Tulane appointments, and 120 Tulane residents received training at the VA, said Dr. Alan Miller, interim senior vice president for health sciences at Tulane, at the hearing. Currently, 40 Tulane doctors provide services and training at VA outpatient clinics, which represents $2.2 million in physician compensation, he said.

The private Ochsner Health System is vying to have the new VA hospital built across the street from its Jefferson Parish campus. At the hearing, Dr. Patrick J. Quinlan, Ochsner's CEO, noted the site “is above sea level and not located in a flood plain.” In the end, however, the VA decided to stay in downtown New Orleans. It has not decided yet whether it will rebuild on the existing shuttered 34-acre site or join together with Charity and University on a new parcel of land. Because the federal government has not agreed to fund a new campus for Charity and University, Gov. Kathleen Blanco signed an executive order allocating an immediate $74.5 million for land acquisition and planning. To come up with the additional $1.2 billion needed, the state will issue a series of bonds.

Some have not given up on Charity. Last year, the state legislature approved a study to see if the first three floors could be refurbished while a new medical campus is put together.

EDs Feel Ripple Effect

Two years ago, the now-shuttered Charity Hospital ED received 120,000 to 200,000 visits annually. Fewer people are in the city now, but more are sicker or in need of basic care, said Dr. Jim Aiken of the emergency medicine department at LSU, in an interview. “We do a lot of renewing prescriptions and checking blood pressures,” and other primary care interventions. The Interim Hospital sees about 3,500 patients a month. Although things have improved in the last year, the ED admits more patients than before the storm. “We struggle every day with surge capacity,” he said.

Diversion is not uncommon, but the hospitals in the area now at least have a new communications module that lets them track online what's happening at other facilities in the area.

Lack of adequate mental health care, combined with poststorm stress and anxiety, is having the biggest impact on the ED, said Dr. Aiken. It is not unusual for the hospital to be holding 15 psychiatric patients at its 31-bed ED, he said.

Charity also housed a crisis intervention unit where the police could take the mentally ill. With that unit gone, those with psychiatric needs have been spread out.

Before Katrina, there were 578 psychiatric and detox beds in and around New Orleans; that number is now at 236, with only a small portion actually in downtown New Orleans, according to Dr. Cerise. The deteriorated mental health system is “probably the most critical health care issue in this state since the storm,” said Dr. Aiken.

Even the LSU system in Baton Rouge has been affected, said Dr. William “Beau” Clark, president of the Louisiana chapter of the American College of Emergency Physicians. Emergency rooms in that city have absorbed some of New Orleans' outflow, including psychiatric patients who end up boarding in Baton Rouge, he said.

Grants Aim to Recruit, Retain Primary Care Help After Katrina

For more information on the program and to download an application, visit

www.pcrh.dhh.louisiana.gov

Louisiana and the city of New Orleans are struggling to lure physicians and nurses back to the city, and to convince those who have returned to stay despite many uninsured patients and a patchwork system of care.

In April 2006, the federal government declared the greater New Orleans area a health-professional shortage area, making it eligible for federal grants to retain or recruit health professionals, and gave rise to the Greater New Orleans Health Service Corps.

The Louisiana Department of Health and Hospitals, which oversees the Corps, has received $85 million for recruitment and retention, said Gayla Strahan, of the DHH's Bureau of Primary Care and Rural Health and manager of the Service Corps effort. Half goes for recruitment and half for retention.

When the state applied for federal health shortage funds, in mid-2006, there were 405 primary care physicians and 30 psychiatrists in the region, but just 76 primary care doctors and 6 psychiatrists took Medicaid or uninsured patients. Based on the region's then population (about 700,000) and Medicaid enrollment (about 135,000), the DHH determined there was a need for 48 more primary care physicians, 38 more dentists, 10 more psychiatrists, and 33 other mental health professionals (psychologists, licensed clinical social workers, and marriage and family therapists).

The goal is to retain 50 primary care physicians and recruit 48 more by September 2009, when the grant cycle ends, she said. For mental health, the goal is 24 retentions and 43 recruits; for dentists, it is 10 and 30, and for faculty, the aim is to keep 48 current positions and bring in 46 more, including 24 at the medical schools.

The Service Corps also earmarked just over $2 million to retain 5 specialists and bring in 15 more. The applicant has to show there is a dire need, for instance, if there's only one cardiologist who agrees to accept Medicaid.

Applicants must accept Medicare, Medicaid, and the uninsured; work at least 32 hours a week in clinical practice; and be licensed in Louisiana or agree to become licensed before starting. Participants, who have a 3-year obligation, can tailor their own package of incentives up to $110,000, which is paid up front as a lump sum. They can use it for salary, to repay loans, for malpractice premiums, and/or to buy health information technology. Mid-level providers are eligible up to $55,000, registered nurses and nurse faculty up to $40,000, and allied health professionals can receive up to $40,000.

Two years after Hurricane Katrina, the relatively few open health care facilities and diminished corps of physicians in New Orleans are struggling to serve the needs of a smaller, but just as needy, population. It's a picture that's changed little since this time last year.

Emergency rooms, in particular, bear the brunt of the broken system, as they are one resource that is nearly always available to the uninsured and those with little access to primary care.

It is thought that about 200,000 people now reside in the city, with another 400,000 in the three surrounding parishes (Jefferson, Plaquemines, and St. Bernard). There are some 101,000 uninsured residents and 147,000 Medicaid recipients, according to the Louisiana Department of Health and Hospitals (DHH).

It's still unclear how many of the roughly 3,000 physicians in the area before the storm have returned. In mid-2006, according to Blue Cross and Blue Shield, only half were back. The Louisiana State Board of Medical Examiners said from August 2005 to July 2006, the number of primary care physicians declined from 2,645 to 1,913.

The lack of access has hit hard. An analysis of death notices in the Times-Picayune by Dr. Kevin U. Stephens, Sr., director of the city health department, and associates, showed a 47% mortality increase in the first half of 2006—to 91/100,000, versus 62/100,000 in 2002-2004 (Disaster Med. Public Health Preparedness 2007;1:15-20). The authors studied death notices because of vast gaps in state and city data.

Primary Clinics to Be Medical Homes

In an interview, Dr. Frederick P. Cerise, secretary of the Louisiana Department of Health and Hospitals, said there are 26 primary health care sites in the New Orleans area, including federally qualified health centers, Tulane University and Louisiana State University outpatient clinics, and mobile and nonprofit clinics. The sites will receive $100 million from the federal government over next 3 years as part of a $161 million allocation aimed at improving health care in the area.

The clinics are eagerly awaiting that money, said Dr. Karen DeSalvo, executive director of Tulane University Community Health Center at Covenant House, in an interview. The money will give “a chance to expand upon what's been developing—multiple neighborhood clinics that are turning into medical homes,” said Dr. DeSalvo, also chief of general internal medicine and geriatrics at the university and special assistant to its president for health policy. Dr. DeSalvo that though primary care is improving (the 18 clinics see about 900 patients daily), too many still seek routine care in EDs. “We're trying to find those patients in the ER and get them into our system.”

Inpatient Capacity Still Down

Currently, in New Orleans proper, five hospitals are open; and five more are abandoned or closed, according to the Louisiana Hospital Association.

Louisiana State University, Baton Rouge, is once again operating a level one trauma center in downtown New Orleans at the LSU Interim Hospital (formerly University Hospital).

The now 179-bed Interim Hospital and Tulane Hospital are all that's left of the Medical Center of Louisiana at New Orleans. Before Katrina, that campus also included Charity Hospital, a Veterans Affairs (VA) hospital, and medical office buildings. LSU was able to open Interim Hospital with $64 million in Federal Emergency Management Agency (FEMA) funds. It recently added a 20-bed detox unit (only 5 were staffed at press time), and is in the midst of adding 33 inpatient mental health beds elsewhere in the city, plus a mental health unit in the emergency department.

LSU is one of the main backers of a huge new medical campus within a few blocks of Charity Hospital on a 37-acre parcel that the city said it will take.

According to testimony by Mayor C. Ray Nagin at a field hearing of the U.S. House Committee on Veterans' Affairs in early July, the campus would include 30 public, private, and nonprofit organizations. The state has put aside $38 million for a cancer research institute at the site. The city—along with LSU and Tulane—is trying to convince the VA to rebuild on the campus.

Before Katrina, 75 Tulane physicians had joint VA-Tulane appointments, and 120 Tulane residents received training at the VA, said Dr. Alan Miller, interim senior vice president for health sciences at Tulane, at the hearing. Currently, 40 Tulane doctors provide services and training at VA outpatient clinics, which represents $2.2 million in physician compensation, he said.

The private Ochsner Health System is vying to have the new VA hospital built across the street from its Jefferson Parish campus. At the hearing, Dr. Patrick J. Quinlan, Ochsner's CEO, noted the site “is above sea level and not located in a flood plain.” In the end, however, the VA decided to stay in downtown New Orleans. It has not decided yet whether it will rebuild on the existing shuttered 34-acre site or join together with Charity and University on a new parcel of land. Because the federal government has not agreed to fund a new campus for Charity and University, Gov. Kathleen Blanco signed an executive order allocating an immediate $74.5 million for land acquisition and planning. To come up with the additional $1.2 billion needed, the state will issue a series of bonds.

Some have not given up on Charity. Last year, the state legislature approved a study to see if the first three floors could be refurbished while a new medical campus is put together.

EDs Feel Ripple Effect

Two years ago, the now-shuttered Charity Hospital ED received 120,000 to 200,000 visits annually. Fewer people are in the city now, but more are sicker or in need of basic care, said Dr. Jim Aiken of the emergency medicine department at LSU, in an interview. “We do a lot of renewing prescriptions and checking blood pressures,” and other primary care interventions. The Interim Hospital sees about 3,500 patients a month. Although things have improved in the last year, the ED admits more patients than before the storm. “We struggle every day with surge capacity,” he said.

Diversion is not uncommon, but the hospitals in the area now at least have a new communications module that lets them track online what's happening at other facilities in the area.

Lack of adequate mental health care, combined with poststorm stress and anxiety, is having the biggest impact on the ED, said Dr. Aiken. It is not unusual for the hospital to be holding 15 psychiatric patients at its 31-bed ED, he said.

Charity also housed a crisis intervention unit where the police could take the mentally ill. With that unit gone, those with psychiatric needs have been spread out.

Before Katrina, there were 578 psychiatric and detox beds in and around New Orleans; that number is now at 236, with only a small portion actually in downtown New Orleans, according to Dr. Cerise. The deteriorated mental health system is “probably the most critical health care issue in this state since the storm,” said Dr. Aiken.

Even the LSU system in Baton Rouge has been affected, said Dr. William “Beau” Clark, president of the Louisiana chapter of the American College of Emergency Physicians. Emergency rooms in that city have absorbed some of New Orleans' outflow, including psychiatric patients who end up boarding in Baton Rouge, he said.

Grants Aim to Recruit, Retain Primary Care Help After Katrina

For more information on the program and to download an application, visit

www.pcrh.dhh.louisiana.gov

Louisiana and the city of New Orleans are struggling to lure physicians and nurses back to the city, and to convince those who have returned to stay despite many uninsured patients and a patchwork system of care.

In April 2006, the federal government declared the greater New Orleans area a health-professional shortage area, making it eligible for federal grants to retain or recruit health professionals, and gave rise to the Greater New Orleans Health Service Corps.

The Louisiana Department of Health and Hospitals, which oversees the Corps, has received $85 million for recruitment and retention, said Gayla Strahan, of the DHH's Bureau of Primary Care and Rural Health and manager of the Service Corps effort. Half goes for recruitment and half for retention.

When the state applied for federal health shortage funds, in mid-2006, there were 405 primary care physicians and 30 psychiatrists in the region, but just 76 primary care doctors and 6 psychiatrists took Medicaid or uninsured patients. Based on the region's then population (about 700,000) and Medicaid enrollment (about 135,000), the DHH determined there was a need for 48 more primary care physicians, 38 more dentists, 10 more psychiatrists, and 33 other mental health professionals (psychologists, licensed clinical social workers, and marriage and family therapists).

The goal is to retain 50 primary care physicians and recruit 48 more by September 2009, when the grant cycle ends, she said. For mental health, the goal is 24 retentions and 43 recruits; for dentists, it is 10 and 30, and for faculty, the aim is to keep 48 current positions and bring in 46 more, including 24 at the medical schools.

The Service Corps also earmarked just over $2 million to retain 5 specialists and bring in 15 more. The applicant has to show there is a dire need, for instance, if there's only one cardiologist who agrees to accept Medicaid.

Applicants must accept Medicare, Medicaid, and the uninsured; work at least 32 hours a week in clinical practice; and be licensed in Louisiana or agree to become licensed before starting. Participants, who have a 3-year obligation, can tailor their own package of incentives up to $110,000, which is paid up front as a lump sum. They can use it for salary, to repay loans, for malpractice premiums, and/or to buy health information technology. Mid-level providers are eligible up to $55,000, registered nurses and nurse faculty up to $40,000, and allied health professionals can receive up to $40,000.

Two years after Hurricane Katrina, the relatively few open health care facilities and diminished corps of physicians in New Orleans are struggling to serve the needs of a smaller, but just as needy, population. It's a picture that's changed little since this time last year.

Emergency rooms, in particular, bear the brunt of the broken system, as they are one resource that is nearly always available to the uninsured and those with little access to primary care.

It is thought that about 200,000 people now reside in the city, with another 400,000 in the three surrounding parishes (Jefferson, Plaquemines, and St. Bernard). There are some 101,000 uninsured residents and 147,000 Medicaid recipients, according to the Louisiana Department of Health and Hospitals (DHH).

It's still unclear how many of the roughly 3,000 physicians in the area before the storm have returned. In mid-2006, according to Blue Cross and Blue Shield, only half were back. The Louisiana State Board of Medical Examiners said from August 2005 to July 2006, the number of primary care physicians declined from 2,645 to 1,913.

The lack of access has hit hard. An analysis of death notices in the Times-Picayune by Dr. Kevin U. Stephens, Sr., director of the city health department, and associates, showed a 47% mortality increase in the first half of 2006—to 91/100,000, versus 62/100,000 in 2002-2004 (Disaster Med. Public Health Preparedness 2007;1:15-20). The authors studied death notices because of vast gaps in state and city data.

Primary Clinics to Be Medical Homes

In an interview, Dr. Frederick P. Cerise, secretary of the Louisiana Department of Health and Hospitals, said there are 26 primary health care sites in the New Orleans area, including federally qualified health centers, Tulane University and Louisiana State University outpatient clinics, and mobile and nonprofit clinics. The sites will receive $100 million from the federal government over next 3 years as part of a $161 million allocation aimed at improving health care in the area.

The clinics are eagerly awaiting that money, said Dr. Karen DeSalvo, executive director of Tulane University Community Health Center at Covenant House, in an interview. The money will give “a chance to expand upon what's been developing—multiple neighborhood clinics that are turning into medical homes,” said Dr. DeSalvo, also chief of general internal medicine and geriatrics at the university and special assistant to its president for health policy. Dr. DeSalvo that though primary care is improving (the 18 clinics see about 900 patients daily), too many still seek routine care in EDs. “We're trying to find those patients in the ER and get them into our system.”

Inpatient Capacity Still Down

Currently, in New Orleans proper, five hospitals are open; and five more are abandoned or closed, according to the Louisiana Hospital Association.

Louisiana State University, Baton Rouge, is once again operating a level one trauma center in downtown New Orleans at the LSU Interim Hospital (formerly University Hospital).

The now 179-bed Interim Hospital and Tulane Hospital are all that's left of the Medical Center of Louisiana at New Orleans. Before Katrina, that campus also included Charity Hospital, a Veterans Affairs (VA) hospital, and medical office buildings. LSU was able to open Interim Hospital with $64 million in Federal Emergency Management Agency (FEMA) funds. It recently added a 20-bed detox unit (only 5 were staffed at press time), and is in the midst of adding 33 inpatient mental health beds elsewhere in the city, plus a mental health unit in the emergency department.

LSU is one of the main backers of a huge new medical campus within a few blocks of Charity Hospital on a 37-acre parcel that the city said it will take.

According to testimony by Mayor C. Ray Nagin at a field hearing of the U.S. House Committee on Veterans' Affairs in early July, the campus would include 30 public, private, and nonprofit organizations. The state has put aside $38 million for a cancer research institute at the site. The city—along with LSU and Tulane—is trying to convince the VA to rebuild on the campus.

Before Katrina, 75 Tulane physicians had joint VA-Tulane appointments, and 120 Tulane residents received training at the VA, said Dr. Alan Miller, interim senior vice president for health sciences at Tulane, at the hearing. Currently, 40 Tulane doctors provide services and training at VA outpatient clinics, which represents $2.2 million in physician compensation, he said.

The private Ochsner Health System is vying to have the new VA hospital built across the street from its Jefferson Parish campus. At the hearing, Dr. Patrick J. Quinlan, Ochsner's CEO, noted the site “is above sea level and not located in a flood plain.” In the end, however, the VA decided to stay in downtown New Orleans. It has not decided yet whether it will rebuild on the existing shuttered 34-acre site or join together with Charity and University on a new parcel of land. Because the federal government has not agreed to fund a new campus for Charity and University, Gov. Kathleen Blanco signed an executive order allocating an immediate $74.5 million for land acquisition and planning. To come up with the additional $1.2 billion needed, the state will issue a series of bonds.

Some have not given up on Charity. Last year, the state legislature approved a study to see if the first three floors could be refurbished while a new medical campus is put together.

EDs Feel Ripple Effect

Two years ago, the now-shuttered Charity Hospital ED received 120,000 to 200,000 visits annually. Fewer people are in the city now, but more are sicker or in need of basic care, said Dr. Jim Aiken of the emergency medicine department at LSU, in an interview. “We do a lot of renewing prescriptions and checking blood pressures,” and other primary care interventions. The Interim Hospital sees about 3,500 patients a month. Although things have improved in the last year, the ED admits more patients than before the storm. “We struggle every day with surge capacity,” he said.

Diversion is not uncommon, but the hospitals in the area now at least have a new communications module that lets them track online what's happening at other facilities in the area.

Lack of adequate mental health care, combined with poststorm stress and anxiety, is having the biggest impact on the ED, said Dr. Aiken. It is not unusual for the hospital to be holding 15 psychiatric patients at its 31-bed ED, he said.

Charity also housed a crisis intervention unit where the police could take the mentally ill. With that unit gone, those with psychiatric needs have been spread out.

Before Katrina, there were 578 psychiatric and detox beds in and around New Orleans; that number is now at 236, with only a small portion actually in downtown New Orleans, according to Dr. Cerise. The deteriorated mental health system is “probably the most critical health care issue in this state since the storm,” said Dr. Aiken.

Even the LSU system in Baton Rouge has been affected, said Dr. William “Beau” Clark, president of the Louisiana chapter of the American College of Emergency Physicians. Emergency rooms in that city have absorbed some of New Orleans' outflow, including psychiatric patients who end up boarding in Baton Rouge, he said.

Grants Aim to Recruit, Retain Primary Care Help After Katrina

For more information on the program and to download an application, visit

www.pcrh.dhh.louisiana.gov

Louisiana and the city of New Orleans are struggling to lure physicians and nurses back to the city, and to convince those who have returned to stay despite many uninsured patients and a patchwork system of care.

In April 2006, the federal government declared the greater New Orleans area a health-professional shortage area, making it eligible for federal grants to retain or recruit health professionals, and gave rise to the Greater New Orleans Health Service Corps.

The Louisiana Department of Health and Hospitals, which oversees the Corps, has received $85 million for recruitment and retention, said Gayla Strahan, of the DHH's Bureau of Primary Care and Rural Health and manager of the Service Corps effort. Half goes for recruitment and half for retention.

When the state applied for federal health shortage funds, in mid-2006, there were 405 primary care physicians and 30 psychiatrists in the region, but just 76 primary care doctors and 6 psychiatrists took Medicaid or uninsured patients. Based on the region's then population (about 700,000) and Medicaid enrollment (about 135,000), the DHH determined there was a need for 48 more primary care physicians, 38 more dentists, 10 more psychiatrists, and 33 other mental health professionals (psychologists, licensed clinical social workers, and marriage and family therapists).

The goal is to retain 50 primary care physicians and recruit 48 more by September 2009, when the grant cycle ends, she said. For mental health, the goal is 24 retentions and 43 recruits; for dentists, it is 10 and 30, and for faculty, the aim is to keep 48 current positions and bring in 46 more, including 24 at the medical schools.

The Service Corps also earmarked just over $2 million to retain 5 specialists and bring in 15 more. The applicant has to show there is a dire need, for instance, if there's only one cardiologist who agrees to accept Medicaid.

Applicants must accept Medicare, Medicaid, and the uninsured; work at least 32 hours a week in clinical practice; and be licensed in Louisiana or agree to become licensed before starting. Participants, who have a 3-year obligation, can tailor their own package of incentives up to $110,000, which is paid up front as a lump sum. They can use it for salary, to repay loans, for malpractice premiums, and/or to buy health information technology. Mid-level providers are eligible up to $55,000, registered nurses and nurse faculty up to $40,000, and allied health professionals can receive up to $40,000.

Cardio Surgery Network Launches

The Cardiothoracic Surgery Investigations Network is getting under way, with the designation of the International Center for Health Outcomes and Innovation Research at Columbia University as the coordinating arm of the new seven-site network. The Columbia center received $23 million from the National Heart, Lung, and Blood Institute to design trials and protocols, to coordinate clinical care, to review data, and to monitor the seven sites: New York-Presbyterian Hospital/Columbia University, New York; Duke University, Durham, N.C.; the Cleveland Clinic; Albert Einstein College of Medicine/Montefiore Medical Center, New York; Emory University, Atlanta; University of Virginia, Charlottesville; and Montreal Heart Institute. The network was established by the National Institutes of Health and the Canadian Institutes of Health Research to promote the use of evidence-based medicine in surgery, and to quickly evaluate major innovations on a large-scale basis. “This cardiothoracic surgery network is important because it will help answer the unanswered questions about which patients may benefit most from heart surgeries and when new technologies are appropriate or not,” said Dr. Eric A. Rose, surgeon-in-chief at New York-Presbyterian and lead investigator for the network, in a statement. NHLBI will award a total of $35 million in grants to the network participants over the next 5 years.

DES Might Be Barred in England

The use of drug-eluting stents could be barred in England and Wales if a draft guidance by the U.K. National Institute for Health and Clinical Excellence is given final approval. NICE makes clinical effectiveness recommendations for the National Health Service. The institute found that drug-eluting stents are not cost effective when compared with bare-metal stents, and said that hospitals participating with the NHS should not implant the devices. Currently, NHS hospitals pay for DES implantation in patients in whom the target artery has an internal diameter smaller than 3 mm or a lesion longer than 15 mm. The guidance was open for public comment through the end of August, and, if approved, would go into effect in January 2008.

Drug Premium About $25 in 2008

The Centers for Medicare and Medicaid Services said that Medicare beneficiaries will pay about $25 a month for their Part D pharmaceutical coverage in 2008. This is about a $3 per month increase over the average premium in 2007, but still 40% lower than what had been projected when the program was established in 2003, according to CMS. The premiums for those who get their benefits through private Medicare Advantage plans will be about $14, according to CMS. The agency said that almost 10 million low-income beneficiaries are having their premiums subsidized by the federal government. Because Part D is sketching out to cost 30% less in the first 10 years than had been estimated, President Bush's 2009 budget will be retooled to reflect the decline, according to CMS.

Small Practices Decline

Some physicians are shying away from practicing in solo and two-physician practices, according to a new report from the Center for Studying Health System Change. Although these small practices are still the most common practice arrangements, researchers saw a shift between 1996–1997 and 2004–2005 from solo and two-person practices to midsized, single-specialty groups of 6–50 physicians. The percentage of physicians who practiced in solo and two-person practices fell from 40.7% in 1996–1997 to 32.5% in 2004–2005. During the same time period, the percentage of physicians practicing in midsized groups rose from 13.1% to 17.6%. The biggest declines in physicians' choosing small practices have come from medical specialists and surgical specialists, whereas the proportion of primary care physicians in small practices has remained steady at about 36%. The report's findings are based on the group's nationally representative Community Tracking Study Physician Survey.

AMA, PhRMA Big Spenders

Halfway through 2007, the American Medical Association and the Pharmaceutical Research and Manufacturers of America were among the bigger spenders when it came to lobbying Capitol Hill for their causes. The AMA spent $10.3 million and PhRMA $10.7 million in the first 6 months of the year, according to lobbying disclosure reports filed with the Senate's public records office. By comparison, the American Heart Association spent $615,790, the American Academy of Family Physicians spent $1.2 million, and the American College of Physicians spent $419,575.

Cardio Surgery Network Launches

The Cardiothoracic Surgery Investigations Network is getting under way, with the designation of the International Center for Health Outcomes and Innovation Research at Columbia University as the coordinating arm of the new seven-site network. The Columbia center received $23 million from the National Heart, Lung, and Blood Institute to design trials and protocols, to coordinate clinical care, to review data, and to monitor the seven sites: New York-Presbyterian Hospital/Columbia University, New York; Duke University, Durham, N.C.; the Cleveland Clinic; Albert Einstein College of Medicine/Montefiore Medical Center, New York; Emory University, Atlanta; University of Virginia, Charlottesville; and Montreal Heart Institute. The network was established by the National Institutes of Health and the Canadian Institutes of Health Research to promote the use of evidence-based medicine in surgery, and to quickly evaluate major innovations on a large-scale basis. “This cardiothoracic surgery network is important because it will help answer the unanswered questions about which patients may benefit most from heart surgeries and when new technologies are appropriate or not,” said Dr. Eric A. Rose, surgeon-in-chief at New York-Presbyterian and lead investigator for the network, in a statement. NHLBI will award a total of $35 million in grants to the network participants over the next 5 years.

DES Might Be Barred in England

The use of drug-eluting stents could be barred in England and Wales if a draft guidance by the U.K. National Institute for Health and Clinical Excellence is given final approval. NICE makes clinical effectiveness recommendations for the National Health Service. The institute found that drug-eluting stents are not cost effective when compared with bare-metal stents, and said that hospitals participating with the NHS should not implant the devices. Currently, NHS hospitals pay for DES implantation in patients in whom the target artery has an internal diameter smaller than 3 mm or a lesion longer than 15 mm. The guidance was open for public comment through the end of August, and, if approved, would go into effect in January 2008.

Drug Premium About $25 in 2008

The Centers for Medicare and Medicaid Services said that Medicare beneficiaries will pay about $25 a month for their Part D pharmaceutical coverage in 2008. This is about a $3 per month increase over the average premium in 2007, but still 40% lower than what had been projected when the program was established in 2003, according to CMS. The premiums for those who get their benefits through private Medicare Advantage plans will be about $14, according to CMS. The agency said that almost 10 million low-income beneficiaries are having their premiums subsidized by the federal government. Because Part D is sketching out to cost 30% less in the first 10 years than had been estimated, President Bush's 2009 budget will be retooled to reflect the decline, according to CMS.

Small Practices Decline

Some physicians are shying away from practicing in solo and two-physician practices, according to a new report from the Center for Studying Health System Change. Although these small practices are still the most common practice arrangements, researchers saw a shift between 1996–1997 and 2004–2005 from solo and two-person practices to midsized, single-specialty groups of 6–50 physicians. The percentage of physicians who practiced in solo and two-person practices fell from 40.7% in 1996–1997 to 32.5% in 2004–2005. During the same time period, the percentage of physicians practicing in midsized groups rose from 13.1% to 17.6%. The biggest declines in physicians' choosing small practices have come from medical specialists and surgical specialists, whereas the proportion of primary care physicians in small practices has remained steady at about 36%. The report's findings are based on the group's nationally representative Community Tracking Study Physician Survey.

AMA, PhRMA Big Spenders

Halfway through 2007, the American Medical Association and the Pharmaceutical Research and Manufacturers of America were among the bigger spenders when it came to lobbying Capitol Hill for their causes. The AMA spent $10.3 million and PhRMA $10.7 million in the first 6 months of the year, according to lobbying disclosure reports filed with the Senate's public records office. By comparison, the American Heart Association spent $615,790, the American Academy of Family Physicians spent $1.2 million, and the American College of Physicians spent $419,575.

Cardio Surgery Network Launches

The Cardiothoracic Surgery Investigations Network is getting under way, with the designation of the International Center for Health Outcomes and Innovation Research at Columbia University as the coordinating arm of the new seven-site network. The Columbia center received $23 million from the National Heart, Lung, and Blood Institute to design trials and protocols, to coordinate clinical care, to review data, and to monitor the seven sites: New York-Presbyterian Hospital/Columbia University, New York; Duke University, Durham, N.C.; the Cleveland Clinic; Albert Einstein College of Medicine/Montefiore Medical Center, New York; Emory University, Atlanta; University of Virginia, Charlottesville; and Montreal Heart Institute. The network was established by the National Institutes of Health and the Canadian Institutes of Health Research to promote the use of evidence-based medicine in surgery, and to quickly evaluate major innovations on a large-scale basis. “This cardiothoracic surgery network is important because it will help answer the unanswered questions about which patients may benefit most from heart surgeries and when new technologies are appropriate or not,” said Dr. Eric A. Rose, surgeon-in-chief at New York-Presbyterian and lead investigator for the network, in a statement. NHLBI will award a total of $35 million in grants to the network participants over the next 5 years.

DES Might Be Barred in England

The use of drug-eluting stents could be barred in England and Wales if a draft guidance by the U.K. National Institute for Health and Clinical Excellence is given final approval. NICE makes clinical effectiveness recommendations for the National Health Service. The institute found that drug-eluting stents are not cost effective when compared with bare-metal stents, and said that hospitals participating with the NHS should not implant the devices. Currently, NHS hospitals pay for DES implantation in patients in whom the target artery has an internal diameter smaller than 3 mm or a lesion longer than 15 mm. The guidance was open for public comment through the end of August, and, if approved, would go into effect in January 2008.

Drug Premium About $25 in 2008

The Centers for Medicare and Medicaid Services said that Medicare beneficiaries will pay about $25 a month for their Part D pharmaceutical coverage in 2008. This is about a $3 per month increase over the average premium in 2007, but still 40% lower than what had been projected when the program was established in 2003, according to CMS. The premiums for those who get their benefits through private Medicare Advantage plans will be about $14, according to CMS. The agency said that almost 10 million low-income beneficiaries are having their premiums subsidized by the federal government. Because Part D is sketching out to cost 30% less in the first 10 years than had been estimated, President Bush's 2009 budget will be retooled to reflect the decline, according to CMS.

Small Practices Decline

Some physicians are shying away from practicing in solo and two-physician practices, according to a new report from the Center for Studying Health System Change. Although these small practices are still the most common practice arrangements, researchers saw a shift between 1996–1997 and 2004–2005 from solo and two-person practices to midsized, single-specialty groups of 6–50 physicians. The percentage of physicians who practiced in solo and two-person practices fell from 40.7% in 1996–1997 to 32.5% in 2004–2005. During the same time period, the percentage of physicians practicing in midsized groups rose from 13.1% to 17.6%. The biggest declines in physicians' choosing small practices have come from medical specialists and surgical specialists, whereas the proportion of primary care physicians in small practices has remained steady at about 36%. The report's findings are based on the group's nationally representative Community Tracking Study Physician Survey.

AMA, PhRMA Big Spenders

Halfway through 2007, the American Medical Association and the Pharmaceutical Research and Manufacturers of America were among the bigger spenders when it came to lobbying Capitol Hill for their causes. The AMA spent $10.3 million and PhRMA $10.7 million in the first 6 months of the year, according to lobbying disclosure reports filed with the Senate's public records office. By comparison, the American Heart Association spent $615,790, the American Academy of Family Physicians spent $1.2 million, and the American College of Physicians spent $419,575.

The U.S. House Committee on Energy and Commerce is looking into whether the Food and Drug Administration may have been too lenient in its treatment of Cordis Corp. after the agency warned the company in 2004 about manufacturing violations relating to its Cypher sirolimus-eluting coronary stent.

In letters sent to FDA Commissioner Dr. Andrew von Eschenbach and to Johnson & Johnson CEO William Weldon in August, the congressional committee said it was seeking all documentation relating to FDA inspections of six Cordis facilities in 2003.

Following those inspections, the agency sent a warning letter to Cordis, a Johnson & Johnson subsidiary, in April 2004 citing violations in good manufacturing practice regulations. The FDA found “systemic violations in the quality management system employed to ensure the safety and effectiveness of your drug-eluting stents that recurred at several of your facilities,” wrote the agency in its warning letter.

“Despite these numerous violations, however, Cordis was allowed to continue marketing Cypher stents,” wrote Committee Chairman Rep. John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chairman Rep. Bart Stupak (D-Mich.).

Companies are legally entitled to continue manufacturing a drug or device after a issuance of warning letter. If there is a public health threat, the agency will seek a voluntary recall. Otherwise, until the violations cited in a warning letter are resolved, a manufacturer can't receive approval of other new or pending applications for drugs or devices. For Cordis, that hold lasted from April 2004 until June 2007.

In an interview, Ira Loss, an analyst who follows the medical device and pharmaceutical sectors for Washington Analysis Corp., noted that Cordis lost ground to competitors that had carotid stents approved while its carotid device was on hold. He said it was not clear why the Energy and Commerce panel would be pursuing an action against Cordis now.

The first half of 2007 has been a dismal one for drug-eluting stents. When compared with the second quarter of 2006, U.S. sales of Cypher dropped 41% in the second quarter of 2007, to $210 million, reported Johnson & Johnson. Sales outside the United States dropped 30%, to $240 million.

The U.S. House Committee on Energy and Commerce is looking into whether the Food and Drug Administration may have been too lenient in its treatment of Cordis Corp. after the agency warned the company in 2004 about manufacturing violations relating to its Cypher sirolimus-eluting coronary stent.

In letters sent to FDA Commissioner Dr. Andrew von Eschenbach and to Johnson & Johnson CEO William Weldon in August, the congressional committee said it was seeking all documentation relating to FDA inspections of six Cordis facilities in 2003.

Following those inspections, the agency sent a warning letter to Cordis, a Johnson & Johnson subsidiary, in April 2004 citing violations in good manufacturing practice regulations. The FDA found “systemic violations in the quality management system employed to ensure the safety and effectiveness of your drug-eluting stents that recurred at several of your facilities,” wrote the agency in its warning letter.

“Despite these numerous violations, however, Cordis was allowed to continue marketing Cypher stents,” wrote Committee Chairman Rep. John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chairman Rep. Bart Stupak (D-Mich.).

Companies are legally entitled to continue manufacturing a drug or device after a issuance of warning letter. If there is a public health threat, the agency will seek a voluntary recall. Otherwise, until the violations cited in a warning letter are resolved, a manufacturer can't receive approval of other new or pending applications for drugs or devices. For Cordis, that hold lasted from April 2004 until June 2007.

In an interview, Ira Loss, an analyst who follows the medical device and pharmaceutical sectors for Washington Analysis Corp., noted that Cordis lost ground to competitors that had carotid stents approved while its carotid device was on hold. He said it was not clear why the Energy and Commerce panel would be pursuing an action against Cordis now.

The first half of 2007 has been a dismal one for drug-eluting stents. When compared with the second quarter of 2006, U.S. sales of Cypher dropped 41% in the second quarter of 2007, to $210 million, reported Johnson & Johnson. Sales outside the United States dropped 30%, to $240 million.

The U.S. House Committee on Energy and Commerce is looking into whether the Food and Drug Administration may have been too lenient in its treatment of Cordis Corp. after the agency warned the company in 2004 about manufacturing violations relating to its Cypher sirolimus-eluting coronary stent.

In letters sent to FDA Commissioner Dr. Andrew von Eschenbach and to Johnson & Johnson CEO William Weldon in August, the congressional committee said it was seeking all documentation relating to FDA inspections of six Cordis facilities in 2003.

Following those inspections, the agency sent a warning letter to Cordis, a Johnson & Johnson subsidiary, in April 2004 citing violations in good manufacturing practice regulations. The FDA found “systemic violations in the quality management system employed to ensure the safety and effectiveness of your drug-eluting stents that recurred at several of your facilities,” wrote the agency in its warning letter.

“Despite these numerous violations, however, Cordis was allowed to continue marketing Cypher stents,” wrote Committee Chairman Rep. John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chairman Rep. Bart Stupak (D-Mich.).

Companies are legally entitled to continue manufacturing a drug or device after a issuance of warning letter. If there is a public health threat, the agency will seek a voluntary recall. Otherwise, until the violations cited in a warning letter are resolved, a manufacturer can't receive approval of other new or pending applications for drugs or devices. For Cordis, that hold lasted from April 2004 until June 2007.

In an interview, Ira Loss, an analyst who follows the medical device and pharmaceutical sectors for Washington Analysis Corp., noted that Cordis lost ground to competitors that had carotid stents approved while its carotid device was on hold. He said it was not clear why the Energy and Commerce panel would be pursuing an action against Cordis now.

The first half of 2007 has been a dismal one for drug-eluting stents. When compared with the second quarter of 2006, U.S. sales of Cypher dropped 41% in the second quarter of 2007, to $210 million, reported Johnson & Johnson. Sales outside the United States dropped 30%, to $240 million.

The true impact isn't known yet, but an administrative change by the Centers for Medicare and Medicaid Services to rules governing the State Children's Health Insurance Program—made on a Friday night during Congress' August recess—may have the effect of dropping children who currently have coverage.

Sen. Jay Rockefeller (D-W.Va.), one of the original coauthors of SCHIP, sent a letter to President George W. Bush chiding the administration for making the change without congressional input.

“Not only do I question the wisdom and legality of this new policy, I also question the process,” wrote Sen. Rockefeller, noting that “a policy change of this magnitude should, at a minimum, be handled through the formal rule-making process, with proper public notice and comment.”

About 4 million children are eligible for Medicaid or SCHIP currently; some 6 million received benefits in 2006. An estimated 9 million children do not have health insurance.

SCHIP, now entering its 10th year, has been the subject of fierce battles this year, as lawmakers have struggled to come up with financing for the next 5 years. Authorization for SCHIP expires Sept. 30. Before leaving for summer recess, the House and the Senate passed very different packages.

President Bush said he would veto either bill, saying that he viewed both as a back-door way of expanding government-financed health care at the expense of the private insurance market.

So, the Aug. 17 letter from CMS Director for Medicaid and State Operations Dennis G. Smith to state health officials should not have come as a surprise. In the letter, states were told that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. The goal: to ensure that these families aren't opting for SCHIP instead of private insurance.

CMS is now requiring that, for example, children be uninsured for at least 1 year before receiving SCHIP benefits. In addition, states also will have to document that the number of low-income children who are eligible for and covered by private insurance has not dropped by more than 2% in the past 5 years.

The House and Senate will meet in conference in September to determine the course of SCHIP over the next 5 years.

The true impact isn't known yet, but an administrative change by the Centers for Medicare and Medicaid Services to rules governing the State Children's Health Insurance Program—made on a Friday night during Congress' August recess—may have the effect of dropping children who currently have coverage.

Sen. Jay Rockefeller (D-W.Va.), one of the original coauthors of SCHIP, sent a letter to President George W. Bush chiding the administration for making the change without congressional input.

“Not only do I question the wisdom and legality of this new policy, I also question the process,” wrote Sen. Rockefeller, noting that “a policy change of this magnitude should, at a minimum, be handled through the formal rule-making process, with proper public notice and comment.”

About 4 million children are eligible for Medicaid or SCHIP currently; some 6 million received benefits in 2006. An estimated 9 million children do not have health insurance.

SCHIP, now entering its 10th year, has been the subject of fierce battles this year, as lawmakers have struggled to come up with financing for the next 5 years. Authorization for SCHIP expires Sept. 30. Before leaving for summer recess, the House and the Senate passed very different packages.

President Bush said he would veto either bill, saying that he viewed both as a back-door way of expanding government-financed health care at the expense of the private insurance market.

So, the Aug. 17 letter from CMS Director for Medicaid and State Operations Dennis G. Smith to state health officials should not have come as a surprise. In the letter, states were told that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. The goal: to ensure that these families aren't opting for SCHIP instead of private insurance.

CMS is now requiring that, for example, children be uninsured for at least 1 year before receiving SCHIP benefits. In addition, states also will have to document that the number of low-income children who are eligible for and covered by private insurance has not dropped by more than 2% in the past 5 years.

The House and Senate will meet in conference in September to determine the course of SCHIP over the next 5 years.

The true impact isn't known yet, but an administrative change by the Centers for Medicare and Medicaid Services to rules governing the State Children's Health Insurance Program—made on a Friday night during Congress' August recess—may have the effect of dropping children who currently have coverage.

Sen. Jay Rockefeller (D-W.Va.), one of the original coauthors of SCHIP, sent a letter to President George W. Bush chiding the administration for making the change without congressional input.

“Not only do I question the wisdom and legality of this new policy, I also question the process,” wrote Sen. Rockefeller, noting that “a policy change of this magnitude should, at a minimum, be handled through the formal rule-making process, with proper public notice and comment.”

About 4 million children are eligible for Medicaid or SCHIP currently; some 6 million received benefits in 2006. An estimated 9 million children do not have health insurance.

SCHIP, now entering its 10th year, has been the subject of fierce battles this year, as lawmakers have struggled to come up with financing for the next 5 years. Authorization for SCHIP expires Sept. 30. Before leaving for summer recess, the House and the Senate passed very different packages.

President Bush said he would veto either bill, saying that he viewed both as a back-door way of expanding government-financed health care at the expense of the private insurance market.

So, the Aug. 17 letter from CMS Director for Medicaid and State Operations Dennis G. Smith to state health officials should not have come as a surprise. In the letter, states were told that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. The goal: to ensure that these families aren't opting for SCHIP instead of private insurance.

CMS is now requiring that, for example, children be uninsured for at least 1 year before receiving SCHIP benefits. In addition, states also will have to document that the number of low-income children who are eligible for and covered by private insurance has not dropped by more than 2% in the past 5 years.

The House and Senate will meet in conference in September to determine the course of SCHIP over the next 5 years.

Men Heavier Alcohol Users

As has been previously shown, males are more likely than females to report heavy alcohol use and binge alcohol use, the National Survey on Drug Use and Health found. In 2004–2005, 57% of males aged 12 years or older reported past-month alcohol use, compared with 45% of females. Binge alcohol use was reported by 31% of males, compared with only 15% of females. Similarly, 10% of males, compared with only 3% of females, reported heavy alcohol use (defined as five or more drinks on the same occasion on 5 or more days in the past month). Alcohol dependence or abuse was highest in 18- to 25-year-old men (22%), and in American Indian or Alaskan Native men (19%). Men living in households with incomes less than $20,000 also had higher levels of dependence or abuse. The survey is published by the Substance Abuse and Mental Health Services Administration.

Torture Resolution Criticized

At its annual meeting, the American Psychological Association resolved that although psychologists can attend or participate in interrogations, they should not plan, design, assist, or participate in sessions that involve 19 techniques that group deemed “unethical,” including waterboarding, sexual humiliation, sleep deprivation, hooding, the use of dogs, the exploitation of phobias, the use of psychotropic drugs, and threats of harm or death. Some members have been fighting for years to get the organization to completely bar participation in abusive interrogations. The American Civil Liberties Union called on the group to do so before the meeting, which was heavily protested. The group's ethics director, Stephen Behnke, Ph.D., said in a statement that the organization had a “long-standing position that torture and other forms of inhuman and degrading treatment are unethical,” and that the new resolution “adds specificity to that prohibition.” The psychologists called on the U.S. government to prohibit the 19 techniques. After the meeting, popular author and association member Mary Pipher, Ph.D., returned a presidential citation she earned in 2006, saying that the resolution was a “terrible mistake.”

Beefing Up School Mental Health

Lawmakers in the House and Senate have introduced legislation to funnel grants to schools to increase their ability to respond to students' mental health needs. Rep. Grace Napolitano's (D-Calif.) Mental Health in Schools Act of 2007 (H.R. 3430) is the companion to S. 1332, introduced in May by Senators Ted Kennedy (D-Mass.), Michael Enzi (R-Wyo.), Pete Domenici (R-N.M.), and Christopher Dodd (D-Conn.). Rep. Napolitano's bill has 65 cosponsors. Neither the House nor Senate version has advanced to committee yet. Both bills would direct the Department of Health and Human Services to award grants to establish comprehensive mental health programs in schools.

Drug Premium About $25 in 2008

The Centers for Medicare and Medicaid Services said Medicare beneficiaries will pay about $25 a month for their Part D prescription drug coverage in 2008. This is an approximate $3 per month increase over the average premium in 2007, but is still 40% lower than what had been projected when the program was established in 2003, according to CMS. The premiums for those who get their benefits through private Medicare Advantage plans will be about $14, according to CMS. The agency said that almost 10 million low-income beneficiaries are having their premiums subsidized by the federal government. Because Part D is sketching out to cost 30% less in the first 10 years than had been estimated, President Bush's 2009 budget will be retooled to reflect the decline, according to CMS.

Small Practices Decline

Physicians are shying away from solo and two-physician practices, according to a new report from the Center for Studying Health System Change. Although these small practices are still the most common practice arrangements, between 1996–1997 and 2004–2005 researchers saw a shift from solo and two-person practices to midsized, single-specialty groups of 6–50 physicians. The percentage of physicians who practiced in solo and two-person practices fell from 41% in 1996–1997 to 33% in 2004–2005. During the same period, the percentage of physicians practicing in midsized groups rose from 13% to 18%. The biggest declines in physicians choosing small practices have come from medical specialists and surgical specialists, whereas the proportion of primary care physicians in small practices has remained steady at about 36%. The report's findings are based on the Center for Studying Health System Change's nationally representative Community Tracking Study Physician Survey.

GAO Finds Medicaid Decline

A law requiring most U.S. citizens applying for Medicaid coverage to document their citizenship has caused eligible citizens to lose Medicaid coverage, and the law costs far more to administer than it saves, according to two government analyses. The law went into effect on July 1, 2006, and affects 30 million children and 16 million parents currently enrolled in Medicaid, as well as millions of new applicants. The first analysis, from the Government Accountability Office, found that half the states are reporting declines in Medicaid coverage because of the requirement, and many of those losing coverage appear to be U.S. citizens. The second analysis, produced by the House Committee on Oversight and Government Reform, found that for every $100 spent by federal taxpayers to implement the documentation requirements in six states, only 14 cents in Medicaid savings can be documented.

Men Heavier Alcohol Users

As has been previously shown, males are more likely than females to report heavy alcohol use and binge alcohol use, the National Survey on Drug Use and Health found. In 2004–2005, 57% of males aged 12 years or older reported past-month alcohol use, compared with 45% of females. Binge alcohol use was reported by 31% of males, compared with only 15% of females. Similarly, 10% of males, compared with only 3% of females, reported heavy alcohol use (defined as five or more drinks on the same occasion on 5 or more days in the past month). Alcohol dependence or abuse was highest in 18- to 25-year-old men (22%), and in American Indian or Alaskan Native men (19%). Men living in households with incomes less than $20,000 also had higher levels of dependence or abuse. The survey is published by the Substance Abuse and Mental Health Services Administration.

Torture Resolution Criticized

At its annual meeting, the American Psychological Association resolved that although psychologists can attend or participate in interrogations, they should not plan, design, assist, or participate in sessions that involve 19 techniques that group deemed “unethical,” including waterboarding, sexual humiliation, sleep deprivation, hooding, the use of dogs, the exploitation of phobias, the use of psychotropic drugs, and threats of harm or death. Some members have been fighting for years to get the organization to completely bar participation in abusive interrogations. The American Civil Liberties Union called on the group to do so before the meeting, which was heavily protested. The group's ethics director, Stephen Behnke, Ph.D., said in a statement that the organization had a “long-standing position that torture and other forms of inhuman and degrading treatment are unethical,” and that the new resolution “adds specificity to that prohibition.” The psychologists called on the U.S. government to prohibit the 19 techniques. After the meeting, popular author and association member Mary Pipher, Ph.D., returned a presidential citation she earned in 2006, saying that the resolution was a “terrible mistake.”

Beefing Up School Mental Health

Lawmakers in the House and Senate have introduced legislation to funnel grants to schools to increase their ability to respond to students' mental health needs. Rep. Grace Napolitano's (D-Calif.) Mental Health in Schools Act of 2007 (H.R. 3430) is the companion to S. 1332, introduced in May by Senators Ted Kennedy (D-Mass.), Michael Enzi (R-Wyo.), Pete Domenici (R-N.M.), and Christopher Dodd (D-Conn.). Rep. Napolitano's bill has 65 cosponsors. Neither the House nor Senate version has advanced to committee yet. Both bills would direct the Department of Health and Human Services to award grants to establish comprehensive mental health programs in schools.

Drug Premium About $25 in 2008

The Centers for Medicare and Medicaid Services said Medicare beneficiaries will pay about $25 a month for their Part D prescription drug coverage in 2008. This is an approximate $3 per month increase over the average premium in 2007, but is still 40% lower than what had been projected when the program was established in 2003, according to CMS. The premiums for those who get their benefits through private Medicare Advantage plans will be about $14, according to CMS. The agency said that almost 10 million low-income beneficiaries are having their premiums subsidized by the federal government. Because Part D is sketching out to cost 30% less in the first 10 years than had been estimated, President Bush's 2009 budget will be retooled to reflect the decline, according to CMS.

Small Practices Decline

Physicians are shying away from solo and two-physician practices, according to a new report from the Center for Studying Health System Change. Although these small practices are still the most common practice arrangements, between 1996–1997 and 2004–2005 researchers saw a shift from solo and two-person practices to midsized, single-specialty groups of 6–50 physicians. The percentage of physicians who practiced in solo and two-person practices fell from 41% in 1996–1997 to 33% in 2004–2005. During the same period, the percentage of physicians practicing in midsized groups rose from 13% to 18%. The biggest declines in physicians choosing small practices have come from medical specialists and surgical specialists, whereas the proportion of primary care physicians in small practices has remained steady at about 36%. The report's findings are based on the Center for Studying Health System Change's nationally representative Community Tracking Study Physician Survey.

GAO Finds Medicaid Decline

A law requiring most U.S. citizens applying for Medicaid coverage to document their citizenship has caused eligible citizens to lose Medicaid coverage, and the law costs far more to administer than it saves, according to two government analyses. The law went into effect on July 1, 2006, and affects 30 million children and 16 million parents currently enrolled in Medicaid, as well as millions of new applicants. The first analysis, from the Government Accountability Office, found that half the states are reporting declines in Medicaid coverage because of the requirement, and many of those losing coverage appear to be U.S. citizens. The second analysis, produced by the House Committee on Oversight and Government Reform, found that for every $100 spent by federal taxpayers to implement the documentation requirements in six states, only 14 cents in Medicaid savings can be documented.

Men Heavier Alcohol Users

As has been previously shown, males are more likely than females to report heavy alcohol use and binge alcohol use, the National Survey on Drug Use and Health found. In 2004–2005, 57% of males aged 12 years or older reported past-month alcohol use, compared with 45% of females. Binge alcohol use was reported by 31% of males, compared with only 15% of females. Similarly, 10% of males, compared with only 3% of females, reported heavy alcohol use (defined as five or more drinks on the same occasion on 5 or more days in the past month). Alcohol dependence or abuse was highest in 18- to 25-year-old men (22%), and in American Indian or Alaskan Native men (19%). Men living in households with incomes less than $20,000 also had higher levels of dependence or abuse. The survey is published by the Substance Abuse and Mental Health Services Administration.

Torture Resolution Criticized

At its annual meeting, the American Psychological Association resolved that although psychologists can attend or participate in interrogations, they should not plan, design, assist, or participate in sessions that involve 19 techniques that group deemed “unethical,” including waterboarding, sexual humiliation, sleep deprivation, hooding, the use of dogs, the exploitation of phobias, the use of psychotropic drugs, and threats of harm or death. Some members have been fighting for years to get the organization to completely bar participation in abusive interrogations. The American Civil Liberties Union called on the group to do so before the meeting, which was heavily protested. The group's ethics director, Stephen Behnke, Ph.D., said in a statement that the organization had a “long-standing position that torture and other forms of inhuman and degrading treatment are unethical,” and that the new resolution “adds specificity to that prohibition.” The psychologists called on the U.S. government to prohibit the 19 techniques. After the meeting, popular author and association member Mary Pipher, Ph.D., returned a presidential citation she earned in 2006, saying that the resolution was a “terrible mistake.”

Beefing Up School Mental Health

Lawmakers in the House and Senate have introduced legislation to funnel grants to schools to increase their ability to respond to students' mental health needs. Rep. Grace Napolitano's (D-Calif.) Mental Health in Schools Act of 2007 (H.R. 3430) is the companion to S. 1332, introduced in May by Senators Ted Kennedy (D-Mass.), Michael Enzi (R-Wyo.), Pete Domenici (R-N.M.), and Christopher Dodd (D-Conn.). Rep. Napolitano's bill has 65 cosponsors. Neither the House nor Senate version has advanced to committee yet. Both bills would direct the Department of Health and Human Services to award grants to establish comprehensive mental health programs in schools.

Drug Premium About $25 in 2008

The Centers for Medicare and Medicaid Services said Medicare beneficiaries will pay about $25 a month for their Part D prescription drug coverage in 2008. This is an approximate $3 per month increase over the average premium in 2007, but is still 40% lower than what had been projected when the program was established in 2003, according to CMS. The premiums for those who get their benefits through private Medicare Advantage plans will be about $14, according to CMS. The agency said that almost 10 million low-income beneficiaries are having their premiums subsidized by the federal government. Because Part D is sketching out to cost 30% less in the first 10 years than had been estimated, President Bush's 2009 budget will be retooled to reflect the decline, according to CMS.

Small Practices Decline

Physicians are shying away from solo and two-physician practices, according to a new report from the Center for Studying Health System Change. Although these small practices are still the most common practice arrangements, between 1996–1997 and 2004–2005 researchers saw a shift from solo and two-person practices to midsized, single-specialty groups of 6–50 physicians. The percentage of physicians who practiced in solo and two-person practices fell from 41% in 1996–1997 to 33% in 2004–2005. During the same period, the percentage of physicians practicing in midsized groups rose from 13% to 18%. The biggest declines in physicians choosing small practices have come from medical specialists and surgical specialists, whereas the proportion of primary care physicians in small practices has remained steady at about 36%. The report's findings are based on the Center for Studying Health System Change's nationally representative Community Tracking Study Physician Survey.

GAO Finds Medicaid Decline

A law requiring most U.S. citizens applying for Medicaid coverage to document their citizenship has caused eligible citizens to lose Medicaid coverage, and the law costs far more to administer than it saves, according to two government analyses. The law went into effect on July 1, 2006, and affects 30 million children and 16 million parents currently enrolled in Medicaid, as well as millions of new applicants. The first analysis, from the Government Accountability Office, found that half the states are reporting declines in Medicaid coverage because of the requirement, and many of those losing coverage appear to be U.S. citizens. The second analysis, produced by the House Committee on Oversight and Government Reform, found that for every $100 spent by federal taxpayers to implement the documentation requirements in six states, only 14 cents in Medicaid savings can be documented.

CHICAGO – A proposed definition and diagnostic criteria aim to help physicians deal with the growing number of patients presenting with refractory migraine, Dr. Elliott A. Schulman said at the annual meeting of the American Headache Society.

“[Refractory migraine] is out there, we just haven't defined it,” said Dr. Schulman, noting that the incidence is probably 10%–50% of cases seen in practice. By setting a definition, he said, patients who need greater care can be identified early, a standard of care can be established, the epidemiology can be further studied and clarified, and candidates for novel treatment approaches can be identified for clinical trials.

To address the problem, the society's Refractory Headache Special Interest Section was formed in 2000. In April 2006, the section surveyed all AHS members on a proposed definition of refractory migraine, whether it should be added to the International Classification of Headache Disorders, and for information on some of the best practices used.

Two hundred-twenty members responded, for a response rate of 18%, said Dr. Schulman, a neurologist at Lankenau Hospital, Wynnewood, Pa. More than half the respondents believed that refractory migraine should be defined as occurring more than 15 days a month, that it should be associated with disability, and that a definition should include inadequate response to multiple abortive and preventive medications. Almost 60% said a refractory migraine definition should be added to the ICHD.

The criteria proposed for refractory migraine and refractory chronic migraine, which were unveiled at the AHS meeting, were based on the survey results, a literature review, and collaborative discussions, Dr. Schulman said.

The section proposed the following criteria:

▸ The primary diagnosis is ICHD-II migraine or chronic migraine.

▸ The headaches cause significant interference with function of quality of life despite modification of triggers, lifestyle factors, and adequate trials of acute and preventive medicines with established efficacy. This would include failed adequate trials of preventive medicines, alone or in combination, from two of four drug classes: β-blockers, anticonvulsants, tricyclic antidepressants, and calcium channel blockers, as well as failed adequate trials of abortive medicines, including both a triptan and an intranasal or injectable dihydroergotamine (DHE); and either nonsteroidal anti-inflammatory drugs or combination analgesics.

▸ An adequate trial is defined as an appropriate dose administered typically for at least 2 months or the maximum-tolerated dose.

▸ The following modifiers would be included: with or without medication overuse, as defined by ICHD-II; with significant disability, as defined by a Migraine Disability Assessment Questionnaire score of 11 or higher.

The criteria “are intended to stimulate discussion leading to a consensus on the definition of refractory migraine and refractory chronic migraine for research and clinical purposes,” said Dr. Schulman.

Dr. Morris Levin of Dartmouth University, Hanover, N.H., discussed at least four different options for how refractory migraine could be added to the ICHD classification system: as a new diagnostic chapter; as a subdivision to each current headache chapter; as a modifier to the primary diagnosis, as is done with the DSM-IV used for psychiatric disorders; or as an “axis II” diagnosis, again, as is used in the DSM-IV.

In weighing the pros and cons, Dr. Levin noted that the first option would make for a huge new chapter, which might be impractical. Adding subsections to the primary headache diagnosis is logical but would create new language and many new diagnoses, he said.

The addition of a modifier would least affect the rest of the ICHD, but would add another layer to each patient's diagnosis, said Dr. Levin.

Finally, adding another axis would change the overall ICHD format.

Even so, he said, it is worth trying at least one approach and then field testing it, as that would help provide data and validity to the ICHD classification committee.

Dr. Schulman disclosed that he has received grants, honoraria, advisory board and consultation fees from Merck & Co. and Pfizer Inc., and his institution receives direct pharmaceutical industry support. Dr. Levin has received grants, honoraria, and other fees for consultation and advisory board participation from Elan Pharmaceuticals Inc., Allergan Inc., AstraZeneca, Merck, Pfizer, and Ortho-McNeil Inc. His institution also receives direct pharmaceutical industry support.

CHICAGO – A proposed definition and diagnostic criteria aim to help physicians deal with the growing number of patients presenting with refractory migraine, Dr. Elliott A. Schulman said at the annual meeting of the American Headache Society.

“[Refractory migraine] is out there, we just haven't defined it,” said Dr. Schulman, noting that the incidence is probably 10%–50% of cases seen in practice. By setting a definition, he said, patients who need greater care can be identified early, a standard of care can be established, the epidemiology can be further studied and clarified, and candidates for novel treatment approaches can be identified for clinical trials.

To address the problem, the society's Refractory Headache Special Interest Section was formed in 2000. In April 2006, the section surveyed all AHS members on a proposed definition of refractory migraine, whether it should be added to the International Classification of Headache Disorders, and for information on some of the best practices used.

Two hundred-twenty members responded, for a response rate of 18%, said Dr. Schulman, a neurologist at Lankenau Hospital, Wynnewood, Pa. More than half the respondents believed that refractory migraine should be defined as occurring more than 15 days a month, that it should be associated with disability, and that a definition should include inadequate response to multiple abortive and preventive medications. Almost 60% said a refractory migraine definition should be added to the ICHD.

The criteria proposed for refractory migraine and refractory chronic migraine, which were unveiled at the AHS meeting, were based on the survey results, a literature review, and collaborative discussions, Dr. Schulman said.

The section proposed the following criteria:

▸ The primary diagnosis is ICHD-II migraine or chronic migraine.

▸ The headaches cause significant interference with function of quality of life despite modification of triggers, lifestyle factors, and adequate trials of acute and preventive medicines with established efficacy. This would include failed adequate trials of preventive medicines, alone or in combination, from two of four drug classes: β-blockers, anticonvulsants, tricyclic antidepressants, and calcium channel blockers, as well as failed adequate trials of abortive medicines, including both a triptan and an intranasal or injectable dihydroergotamine (DHE); and either nonsteroidal anti-inflammatory drugs or combination analgesics.

▸ An adequate trial is defined as an appropriate dose administered typically for at least 2 months or the maximum-tolerated dose.

▸ The following modifiers would be included: with or without medication overuse, as defined by ICHD-II; with significant disability, as defined by a Migraine Disability Assessment Questionnaire score of 11 or higher.

The criteria “are intended to stimulate discussion leading to a consensus on the definition of refractory migraine and refractory chronic migraine for research and clinical purposes,” said Dr. Schulman.

Dr. Morris Levin of Dartmouth University, Hanover, N.H., discussed at least four different options for how refractory migraine could be added to the ICHD classification system: as a new diagnostic chapter; as a subdivision to each current headache chapter; as a modifier to the primary diagnosis, as is done with the DSM-IV used for psychiatric disorders; or as an “axis II” diagnosis, again, as is used in the DSM-IV.

In weighing the pros and cons, Dr. Levin noted that the first option would make for a huge new chapter, which might be impractical. Adding subsections to the primary headache diagnosis is logical but would create new language and many new diagnoses, he said.

The addition of a modifier would least affect the rest of the ICHD, but would add another layer to each patient's diagnosis, said Dr. Levin.

Finally, adding another axis would change the overall ICHD format.

Even so, he said, it is worth trying at least one approach and then field testing it, as that would help provide data and validity to the ICHD classification committee.

Dr. Schulman disclosed that he has received grants, honoraria, advisory board and consultation fees from Merck & Co. and Pfizer Inc., and his institution receives direct pharmaceutical industry support. Dr. Levin has received grants, honoraria, and other fees for consultation and advisory board participation from Elan Pharmaceuticals Inc., Allergan Inc., AstraZeneca, Merck, Pfizer, and Ortho-McNeil Inc. His institution also receives direct pharmaceutical industry support.

CHICAGO – A proposed definition and diagnostic criteria aim to help physicians deal with the growing number of patients presenting with refractory migraine, Dr. Elliott A. Schulman said at the annual meeting of the American Headache Society.

“[Refractory migraine] is out there, we just haven't defined it,” said Dr. Schulman, noting that the incidence is probably 10%–50% of cases seen in practice. By setting a definition, he said, patients who need greater care can be identified early, a standard of care can be established, the epidemiology can be further studied and clarified, and candidates for novel treatment approaches can be identified for clinical trials.

To address the problem, the society's Refractory Headache Special Interest Section was formed in 2000. In April 2006, the section surveyed all AHS members on a proposed definition of refractory migraine, whether it should be added to the International Classification of Headache Disorders, and for information on some of the best practices used.

Two hundred-twenty members responded, for a response rate of 18%, said Dr. Schulman, a neurologist at Lankenau Hospital, Wynnewood, Pa. More than half the respondents believed that refractory migraine should be defined as occurring more than 15 days a month, that it should be associated with disability, and that a definition should include inadequate response to multiple abortive and preventive medications. Almost 60% said a refractory migraine definition should be added to the ICHD.

The criteria proposed for refractory migraine and refractory chronic migraine, which were unveiled at the AHS meeting, were based on the survey results, a literature review, and collaborative discussions, Dr. Schulman said.

The section proposed the following criteria:

▸ The primary diagnosis is ICHD-II migraine or chronic migraine.

▸ The headaches cause significant interference with function of quality of life despite modification of triggers, lifestyle factors, and adequate trials of acute and preventive medicines with established efficacy. This would include failed adequate trials of preventive medicines, alone or in combination, from two of four drug classes: β-blockers, anticonvulsants, tricyclic antidepressants, and calcium channel blockers, as well as failed adequate trials of abortive medicines, including both a triptan and an intranasal or injectable dihydroergotamine (DHE); and either nonsteroidal anti-inflammatory drugs or combination analgesics.

▸ An adequate trial is defined as an appropriate dose administered typically for at least 2 months or the maximum-tolerated dose.

▸ The following modifiers would be included: with or without medication overuse, as defined by ICHD-II; with significant disability, as defined by a Migraine Disability Assessment Questionnaire score of 11 or higher.

The criteria “are intended to stimulate discussion leading to a consensus on the definition of refractory migraine and refractory chronic migraine for research and clinical purposes,” said Dr. Schulman.

Dr. Morris Levin of Dartmouth University, Hanover, N.H., discussed at least four different options for how refractory migraine could be added to the ICHD classification system: as a new diagnostic chapter; as a subdivision to each current headache chapter; as a modifier to the primary diagnosis, as is done with the DSM-IV used for psychiatric disorders; or as an “axis II” diagnosis, again, as is used in the DSM-IV.

In weighing the pros and cons, Dr. Levin noted that the first option would make for a huge new chapter, which might be impractical. Adding subsections to the primary headache diagnosis is logical but would create new language and many new diagnoses, he said.

The addition of a modifier would least affect the rest of the ICHD, but would add another layer to each patient's diagnosis, said Dr. Levin.

Finally, adding another axis would change the overall ICHD format.

Even so, he said, it is worth trying at least one approach and then field testing it, as that would help provide data and validity to the ICHD classification committee.

Dr. Schulman disclosed that he has received grants, honoraria, advisory board and consultation fees from Merck & Co. and Pfizer Inc., and his institution receives direct pharmaceutical industry support. Dr. Levin has received grants, honoraria, and other fees for consultation and advisory board participation from Elan Pharmaceuticals Inc., Allergan Inc., AstraZeneca, Merck, Pfizer, and Ortho-McNeil Inc. His institution also receives direct pharmaceutical industry support.

Starting next year, federal health programs will cover any procedure performed at an ambulatory surgery center, with few but defined exclusions, according to final regulations released by the Centers for Medicare and Medicaid Services.

The payment formula for such procedures, to be phased in over 4 years, was also set by the regulations.

Previously, CMS covered approximately 2,600 procedures when they were performed at an ASC; now, an additional 790 procedures will be eligible in 2008. According to Dr. Charles Mabry, chairman of the American College of Surgeons' health policy steering committee and a member of the general surgery coding and reimbursement committee, as new procedures receive CPT codes, they, too will be covered, unless they are specifically excluded.

CMS will not pay for a procedure if it falls within these exclusion criteria:

▸ It poses a significant safety risk to the beneficiary.

▸ It would result in the patient's requiring active monitoring or an overnight stay.

▸ It directly involves major blood vessels.

▸ It requires major or prolonged invasion of body cavities.

▸ It results in extensive blood loss.

▸ It is emergent or life threatening.

▸ It requires systemic thrombolysis.

▸ It can be reported only with an unlisted code.

The change means that more patients will likely be able to have procedures done in an ASC, said Dr. Mabry, who is also a shareholder in an ambulatory surgery center in Pine Bluff, Ark.

The question now: “Is the payment rate the right rate?” he said. (See box.)

CMS also decided to limit payment for procedures performed in an ASC that are done in a physician's office more than half the time. “CMS does not want to create inappropriate payment incentives for procedures to be performed in ASCs if the physician's office is the most efficient setting for providing high quality care,” according to the agency.

FASA, the advocacy arm of the Foundation for Ambulatory Surgery in America, objected to this proposal and also to CMS's list of exclusions, arguing that the agency should pay for any procedure that is not covered under the inpatient system.

Under the new rule, Medicare will make separate payments for ancillary services, such as radiology, and for some drugs and biologicals considered integral to a surgical procedure.

The agency will also make adjustments for procedures that have high device costs—that is, when the cost of the device accounts for more than half the median cost of the procedure.

Those high device-cost procedures include placement of neurostimulators, pulse generators, or pacemakers.

The adjustment is already in effect under CMS's hospital outpatient payment system.

Payment Proposals for 2008: More Increases Than Cuts

CMS is accepting comments on the 2008 proposals until mid-September. The final regulations will be published in November.

In addition to setting the formula for how ambulatory surgery centers will be paid going forward, CMS has also issued proposals on how the formula will guide payments to ASCs in 2008, and on how much hospital outpatient departments will receive in 2008.

In 2008, the federal health agency has proposed that ASCs would be paid at 65% of hospital outpatient rates, a slight increase over an earlier proposal of 62%.

Medicare and Medicaid expect to pay $3 billion in 2008 to about 4,600 participating ASCs, according to CMS.

In the proposed pay rates, orthopedic procedures would receive the greatest increases, whereas gastrointestinal procedures would be cut. An upper GI endoscopy with biopsy (CPT code 43239) would be cut by 13%, from $446 in 2007 to $387 in 2008. A small-bowel endoscopy with biopsy (CPT code 44361) would be cut by about 11%.

The American Gastroenterological Association said in a statement that it “intends to aggressively fight the [proposed] rule's implementation, through congressional action, if necessary.”

The group argued that by setting a uniform rate of 65%, an ASC will not be able to cover the costs of many procedures, including luminal stents for gastrointestinal cancers and endoscopic ultrasound. ASC payments should be tied to the hospital outpatient market basket factor, not the consumer price index, as CMS is proposing, according to the AGA.

The agency also issued its proposal for hospital outpatient payments, which is partially driven by the desire to keep beneficiary copays at 20%. In 2008, the overall copay will be about 26%, but for most procedures, beneficiaries will be liable for only 20%.

Hospitals will receive $35 billion under the proposed rule in 2008, about a 10% increase over 2007. CMS said “the current rate of growth of expenditures is of great concern,” because of its effect on taxpayers and beneficiaries whose premiums fund 25% of Medicare Part B expenses.

Procedures involving the implantation of cardiac devices are mostly slated for increases: from 5% for bare-metal stents to 14% for drug-eluting stents, and 3%–20% for defibrillators.

Payment for the implantation of neurologic devices would also increase under the proposal. For instance, implantation of a neurostimulator would rise from $11,500 in 2007 to $12,500 in 2008.

Hospitals will get an automatic 2% cut in fees in 2009 if they don't report on 10 quality measures in 2008, including five measures on how well emergency departments handle MI; two surgical care measures (the selection and timing of antibiotic prophylaxis); one heart failure measure (ACE inhibitor or angiotensin receptor blocker given); one on community-acquired pneumonia (empiric antibiotic); and a diabetes measure (poor hemoglobin A_1c control).

Starting next year, federal health programs will cover any procedure performed at an ambulatory surgery center, with few but defined exclusions, according to final regulations released by the Centers for Medicare and Medicaid Services.

The payment formula for such procedures, to be phased in over 4 years, was also set by the regulations.

Previously, CMS covered approximately 2,600 procedures when they were performed at an ASC; now, an additional 790 procedures will be eligible in 2008. According to Dr. Charles Mabry, chairman of the American College of Surgeons' health policy steering committee and a member of the general surgery coding and reimbursement committee, as new procedures receive CPT codes, they, too will be covered, unless they are specifically excluded.

CMS will not pay for a procedure if it falls within these exclusion criteria:

▸ It poses a significant safety risk to the beneficiary.

▸ It would result in the patient's requiring active monitoring or an overnight stay.

▸ It directly involves major blood vessels.

▸ It requires major or prolonged invasion of body cavities.

▸ It results in extensive blood loss.

▸ It is emergent or life threatening.

▸ It requires systemic thrombolysis.

▸ It can be reported only with an unlisted code.

The change means that more patients will likely be able to have procedures done in an ASC, said Dr. Mabry, who is also a shareholder in an ambulatory surgery center in Pine Bluff, Ark.

The question now: “Is the payment rate the right rate?” he said. (See box.)

CMS also decided to limit payment for procedures performed in an ASC that are done in a physician's office more than half the time. “CMS does not want to create inappropriate payment incentives for procedures to be performed in ASCs if the physician's office is the most efficient setting for providing high quality care,” according to the agency.

FASA, the advocacy arm of the Foundation for Ambulatory Surgery in America, objected to this proposal and also to CMS's list of exclusions, arguing that the agency should pay for any procedure that is not covered under the inpatient system.

Under the new rule, Medicare will make separate payments for ancillary services, such as radiology, and for some drugs and biologicals considered integral to a surgical procedure.

The agency will also make adjustments for procedures that have high device costs—that is, when the cost of the device accounts for more than half the median cost of the procedure.

Those high device-cost procedures include placement of neurostimulators, pulse generators, or pacemakers.

The adjustment is already in effect under CMS's hospital outpatient payment system.

Payment Proposals for 2008: More Increases Than Cuts

CMS is accepting comments on the 2008 proposals until mid-September. The final regulations will be published in November.

In addition to setting the formula for how ambulatory surgery centers will be paid going forward, CMS has also issued proposals on how the formula will guide payments to ASCs in 2008, and on how much hospital outpatient departments will receive in 2008.

In 2008, the federal health agency has proposed that ASCs would be paid at 65% of hospital outpatient rates, a slight increase over an earlier proposal of 62%.

Medicare and Medicaid expect to pay $3 billion in 2008 to about 4,600 participating ASCs, according to CMS.

In the proposed pay rates, orthopedic procedures would receive the greatest increases, whereas gastrointestinal procedures would be cut. An upper GI endoscopy with biopsy (CPT code 43239) would be cut by 13%, from $446 in 2007 to $387 in 2008. A small-bowel endoscopy with biopsy (CPT code 44361) would be cut by about 11%.

The American Gastroenterological Association said in a statement that it “intends to aggressively fight the [proposed] rule's implementation, through congressional action, if necessary.”

The group argued that by setting a uniform rate of 65%, an ASC will not be able to cover the costs of many procedures, including luminal stents for gastrointestinal cancers and endoscopic ultrasound. ASC payments should be tied to the hospital outpatient market basket factor, not the consumer price index, as CMS is proposing, according to the AGA.

The agency also issued its proposal for hospital outpatient payments, which is partially driven by the desire to keep beneficiary copays at 20%. In 2008, the overall copay will be about 26%, but for most procedures, beneficiaries will be liable for only 20%.

Hospitals will receive $35 billion under the proposed rule in 2008, about a 10% increase over 2007. CMS said “the current rate of growth of expenditures is of great concern,” because of its effect on taxpayers and beneficiaries whose premiums fund 25% of Medicare Part B expenses.

Procedures involving the implantation of cardiac devices are mostly slated for increases: from 5% for bare-metal stents to 14% for drug-eluting stents, and 3%–20% for defibrillators.

Payment for the implantation of neurologic devices would also increase under the proposal. For instance, implantation of a neurostimulator would rise from $11,500 in 2007 to $12,500 in 2008.

Hospitals will get an automatic 2% cut in fees in 2009 if they don't report on 10 quality measures in 2008, including five measures on how well emergency departments handle MI; two surgical care measures (the selection and timing of antibiotic prophylaxis); one heart failure measure (ACE inhibitor or angiotensin receptor blocker given); one on community-acquired pneumonia (empiric antibiotic); and a diabetes measure (poor hemoglobin A_1c control).

Starting next year, federal health programs will cover any procedure performed at an ambulatory surgery center, with few but defined exclusions, according to final regulations released by the Centers for Medicare and Medicaid Services.

The payment formula for such procedures, to be phased in over 4 years, was also set by the regulations.

Previously, CMS covered approximately 2,600 procedures when they were performed at an ASC; now, an additional 790 procedures will be eligible in 2008. According to Dr. Charles Mabry, chairman of the American College of Surgeons' health policy steering committee and a member of the general surgery coding and reimbursement committee, as new procedures receive CPT codes, they, too will be covered, unless they are specifically excluded.

CMS will not pay for a procedure if it falls within these exclusion criteria:

▸ It poses a significant safety risk to the beneficiary.

▸ It would result in the patient's requiring active monitoring or an overnight stay.

▸ It directly involves major blood vessels.

▸ It requires major or prolonged invasion of body cavities.

▸ It results in extensive blood loss.

▸ It is emergent or life threatening.

▸ It requires systemic thrombolysis.

▸ It can be reported only with an unlisted code.

The change means that more patients will likely be able to have procedures done in an ASC, said Dr. Mabry, who is also a shareholder in an ambulatory surgery center in Pine Bluff, Ark.

The question now: “Is the payment rate the right rate?” he said. (See box.)

CMS also decided to limit payment for procedures performed in an ASC that are done in a physician's office more than half the time. “CMS does not want to create inappropriate payment incentives for procedures to be performed in ASCs if the physician's office is the most efficient setting for providing high quality care,” according to the agency.

FASA, the advocacy arm of the Foundation for Ambulatory Surgery in America, objected to this proposal and also to CMS's list of exclusions, arguing that the agency should pay for any procedure that is not covered under the inpatient system.

Under the new rule, Medicare will make separate payments for ancillary services, such as radiology, and for some drugs and biologicals considered integral to a surgical procedure.

The agency will also make adjustments for procedures that have high device costs—that is, when the cost of the device accounts for more than half the median cost of the procedure.

Those high device-cost procedures include placement of neurostimulators, pulse generators, or pacemakers.

The adjustment is already in effect under CMS's hospital outpatient payment system.

Payment Proposals for 2008: More Increases Than Cuts

CMS is accepting comments on the 2008 proposals until mid-September. The final regulations will be published in November.

In addition to setting the formula for how ambulatory surgery centers will be paid going forward, CMS has also issued proposals on how the formula will guide payments to ASCs in 2008, and on how much hospital outpatient departments will receive in 2008.

In 2008, the federal health agency has proposed that ASCs would be paid at 65% of hospital outpatient rates, a slight increase over an earlier proposal of 62%.

Medicare and Medicaid expect to pay $3 billion in 2008 to about 4,600 participating ASCs, according to CMS.

In the proposed pay rates, orthopedic procedures would receive the greatest increases, whereas gastrointestinal procedures would be cut. An upper GI endoscopy with biopsy (CPT code 43239) would be cut by 13%, from $446 in 2007 to $387 in 2008. A small-bowel endoscopy with biopsy (CPT code 44361) would be cut by about 11%.

The American Gastroenterological Association said in a statement that it “intends to aggressively fight the [proposed] rule's implementation, through congressional action, if necessary.”

The group argued that by setting a uniform rate of 65%, an ASC will not be able to cover the costs of many procedures, including luminal stents for gastrointestinal cancers and endoscopic ultrasound. ASC payments should be tied to the hospital outpatient market basket factor, not the consumer price index, as CMS is proposing, according to the AGA.

The agency also issued its proposal for hospital outpatient payments, which is partially driven by the desire to keep beneficiary copays at 20%. In 2008, the overall copay will be about 26%, but for most procedures, beneficiaries will be liable for only 20%.

Hospitals will receive $35 billion under the proposed rule in 2008, about a 10% increase over 2007. CMS said “the current rate of growth of expenditures is of great concern,” because of its effect on taxpayers and beneficiaries whose premiums fund 25% of Medicare Part B expenses.

Procedures involving the implantation of cardiac devices are mostly slated for increases: from 5% for bare-metal stents to 14% for drug-eluting stents, and 3%–20% for defibrillators.

Payment for the implantation of neurologic devices would also increase under the proposal. For instance, implantation of a neurostimulator would rise from $11,500 in 2007 to $12,500 in 2008.

Hospitals will get an automatic 2% cut in fees in 2009 if they don't report on 10 quality measures in 2008, including five measures on how well emergency departments handle MI; two surgical care measures (the selection and timing of antibiotic prophylaxis); one heart failure measure (ACE inhibitor or angiotensin receptor blocker given); one on community-acquired pneumonia (empiric antibiotic); and a diabetes measure (poor hemoglobin A_1c control).

WASHINGTON — Patients who are sicker, who are taking warfarin, and whose polyps are removed by snare with cautery are at higher risk for complications following screening or surveillance colonoscopy, according to an analysis presented at the annual Digestive Disease Week.

Overall, the incidence of serious complications after screening was 2.2 of every 1,000 exams, and it was 1.7/1,000 for potential related events, according to Dr. Cynthia Ko of the University of Washington, Seattle.

Dr. Ko and her colleagues prospectively assessed colonoscopies performed on 18,271 patients aged 40 years and older who were referred for average risk screening, surveillance of prior polyps or cancer, a family history of polyps or cancer, or follow-up after another diagnostic procedure, such as a positive result on a fecal occult blood test.

Patients were excluded if they had a history of recent gastrointestinal bleeding or of inflammatory bowel disease, or had an incomplete colonoscopy because of poor bowel preparation.

The researchers identified the study patients through the Clinical Outcomes Research Initiative, a database maintained by the Oregon Health and Science University, Portland. Participating practices include academic, Veterans Affairs, and community endoscopy practices that agree to generate electronic medical record reports for endoscopic procedures.

Currently, complication rates for surveillance and screening aren't well defined, Dr. Ko said. Perforation rates vary from 0.01% to 0.2%, and postpolypectomy syndrome incidence varies from 0.4% to 1%, she said.

In the Washington study, patients were queried at 7 and 30 days after colonoscopy about new symptoms, physician visits, hospitalizations, and unplanned surgeries.

Related events included colon perforation, GI bleeding, diverticulitis, and postpolypectomy syndrome. Potentially related complications included cardiac and neurologic events.

The 18,271 patients came from 19 sites and received colonoscopies from 89 endoscopists. The patients were referred because they were at risk (42%), they needed surveillance (27%), they had a family history (17%), or they had to have follow-up on a previous diagnostic test (14%).

Related complication rates were 1.3/1,000 for GI bleeding requiring hospitalization, 0.8/1,000 for GI bleeding requiring transfusion, 0.9/1,000 for diverticulitis, 0.3/1,000 for diverticulitis requiring hospitalization, 0.1/1,000 for postpolypectomy syndrome, and 0.2/1,000 for perforation.

The authors also calculated an overall complication rate of 2.2/1,000, which included GI bleeding with transfusion, diverticulitis with hospitalization, perforation, or postpolypectomy syndrome. The serious complication rate was 1.4/1,000; serious complications included GI bleeding with hospitalization, diverticulitis with hospitalization, perforation, or postpolypectomy syndrome.

Potentially related events included angina or myocardial infarction (0.6/1,000), stroke or transient ischemic attack (0.4/1,000), and other events, including hospitalization for intravenous catheter site infections, abdominal pain, arrythmia, gallstones, kidney stones, and drug reactions (0.7/1,000).

Complications were more common in patients undergoing a surveillance or follow-up exam, and for those who were older. There were no complications among the 40- to 49-year-olds, compared with 4.4/1,000 among patients aged 80 and older.

Using a multivariate analysis, the authors determined that there was a threefold increase in complications in patients who were American Society of Anesthesiologists class III, compared with class I or II patients; a fivefold increase in patients who took warfarin, compared with those who used aspirin or NSAIDs; and a fivefold increase for a polyp removed with cautery. If more than one polyp was removed, there was a 13-fold increase in complications, Dr. Ko said. There was no difference among the sites, and the endoscopist's case volume did not influence the findings, she said.

She cautioned against applying the results to all physicians because the study included only gastroenterologists.

The study was supported by the National Institutes of Health and the Centers for Disease Control and Prevention, said Dr. Ko, who had no disclosures.

WASHINGTON — Patients who are sicker, who are taking warfarin, and whose polyps are removed by snare with cautery are at higher risk for complications following screening or surveillance colonoscopy, according to an analysis presented at the annual Digestive Disease Week.

Overall, the incidence of serious complications after screening was 2.2 of every 1,000 exams, and it was 1.7/1,000 for potential related events, according to Dr. Cynthia Ko of the University of Washington, Seattle.

Dr. Ko and her colleagues prospectively assessed colonoscopies performed on 18,271 patients aged 40 years and older who were referred for average risk screening, surveillance of prior polyps or cancer, a family history of polyps or cancer, or follow-up after another diagnostic procedure, such as a positive result on a fecal occult blood test.

Patients were excluded if they had a history of recent gastrointestinal bleeding or of inflammatory bowel disease, or had an incomplete colonoscopy because of poor bowel preparation.

The researchers identified the study patients through the Clinical Outcomes Research Initiative, a database maintained by the Oregon Health and Science University, Portland. Participating practices include academic, Veterans Affairs, and community endoscopy practices that agree to generate electronic medical record reports for endoscopic procedures.

Currently, complication rates for surveillance and screening aren't well defined, Dr. Ko said. Perforation rates vary from 0.01% to 0.2%, and postpolypectomy syndrome incidence varies from 0.4% to 1%, she said.

In the Washington study, patients were queried at 7 and 30 days after colonoscopy about new symptoms, physician visits, hospitalizations, and unplanned surgeries.

Related events included colon perforation, GI bleeding, diverticulitis, and postpolypectomy syndrome. Potentially related complications included cardiac and neurologic events.

The 18,271 patients came from 19 sites and received colonoscopies from 89 endoscopists. The patients were referred because they were at risk (42%), they needed surveillance (27%), they had a family history (17%), or they had to have follow-up on a previous diagnostic test (14%).

Related complication rates were 1.3/1,000 for GI bleeding requiring hospitalization, 0.8/1,000 for GI bleeding requiring transfusion, 0.9/1,000 for diverticulitis, 0.3/1,000 for diverticulitis requiring hospitalization, 0.1/1,000 for postpolypectomy syndrome, and 0.2/1,000 for perforation.

The authors also calculated an overall complication rate of 2.2/1,000, which included GI bleeding with transfusion, diverticulitis with hospitalization, perforation, or postpolypectomy syndrome. The serious complication rate was 1.4/1,000; serious complications included GI bleeding with hospitalization, diverticulitis with hospitalization, perforation, or postpolypectomy syndrome.

Potentially related events included angina or myocardial infarction (0.6/1,000), stroke or transient ischemic attack (0.4/1,000), and other events, including hospitalization for intravenous catheter site infections, abdominal pain, arrythmia, gallstones, kidney stones, and drug reactions (0.7/1,000).

Complications were more common in patients undergoing a surveillance or follow-up exam, and for those who were older. There were no complications among the 40- to 49-year-olds, compared with 4.4/1,000 among patients aged 80 and older.

Using a multivariate analysis, the authors determined that there was a threefold increase in complications in patients who were American Society of Anesthesiologists class III, compared with class I or II patients; a fivefold increase in patients who took warfarin, compared with those who used aspirin or NSAIDs; and a fivefold increase for a polyp removed with cautery. If more than one polyp was removed, there was a 13-fold increase in complications, Dr. Ko said. There was no difference among the sites, and the endoscopist's case volume did not influence the findings, she said.

She cautioned against applying the results to all physicians because the study included only gastroenterologists.

The study was supported by the National Institutes of Health and the Centers for Disease Control and Prevention, said Dr. Ko, who had no disclosures.

WASHINGTON — Patients who are sicker, who are taking warfarin, and whose polyps are removed by snare with cautery are at higher risk for complications following screening or surveillance colonoscopy, according to an analysis presented at the annual Digestive Disease Week.

Overall, the incidence of serious complications after screening was 2.2 of every 1,000 exams, and it was 1.7/1,000 for potential related events, according to Dr. Cynthia Ko of the University of Washington, Seattle.

Dr. Ko and her colleagues prospectively assessed colonoscopies performed on 18,271 patients aged 40 years and older who were referred for average risk screening, surveillance of prior polyps or cancer, a family history of polyps or cancer, or follow-up after another diagnostic procedure, such as a positive result on a fecal occult blood test.

Patients were excluded if they had a history of recent gastrointestinal bleeding or of inflammatory bowel disease, or had an incomplete colonoscopy because of poor bowel preparation.

The researchers identified the study patients through the Clinical Outcomes Research Initiative, a database maintained by the Oregon Health and Science University, Portland. Participating practices include academic, Veterans Affairs, and community endoscopy practices that agree to generate electronic medical record reports for endoscopic procedures.

Currently, complication rates for surveillance and screening aren't well defined, Dr. Ko said. Perforation rates vary from 0.01% to 0.2%, and postpolypectomy syndrome incidence varies from 0.4% to 1%, she said.

In the Washington study, patients were queried at 7 and 30 days after colonoscopy about new symptoms, physician visits, hospitalizations, and unplanned surgeries.

Related events included colon perforation, GI bleeding, diverticulitis, and postpolypectomy syndrome. Potentially related complications included cardiac and neurologic events.

The 18,271 patients came from 19 sites and received colonoscopies from 89 endoscopists. The patients were referred because they were at risk (42%), they needed surveillance (27%), they had a family history (17%), or they had to have follow-up on a previous diagnostic test (14%).

Related complication rates were 1.3/1,000 for GI bleeding requiring hospitalization, 0.8/1,000 for GI bleeding requiring transfusion, 0.9/1,000 for diverticulitis, 0.3/1,000 for diverticulitis requiring hospitalization, 0.1/1,000 for postpolypectomy syndrome, and 0.2/1,000 for perforation.

The authors also calculated an overall complication rate of 2.2/1,000, which included GI bleeding with transfusion, diverticulitis with hospitalization, perforation, or postpolypectomy syndrome. The serious complication rate was 1.4/1,000; serious complications included GI bleeding with hospitalization, diverticulitis with hospitalization, perforation, or postpolypectomy syndrome.

Potentially related events included angina or myocardial infarction (0.6/1,000), stroke or transient ischemic attack (0.4/1,000), and other events, including hospitalization for intravenous catheter site infections, abdominal pain, arrythmia, gallstones, kidney stones, and drug reactions (0.7/1,000).

Complications were more common in patients undergoing a surveillance or follow-up exam, and for those who were older. There were no complications among the 40- to 49-year-olds, compared with 4.4/1,000 among patients aged 80 and older.

Using a multivariate analysis, the authors determined that there was a threefold increase in complications in patients who were American Society of Anesthesiologists class III, compared with class I or II patients; a fivefold increase in patients who took warfarin, compared with those who used aspirin or NSAIDs; and a fivefold increase for a polyp removed with cautery. If more than one polyp was removed, there was a 13-fold increase in complications, Dr. Ko said. There was no difference among the sites, and the endoscopist's case volume did not influence the findings, she said.

She cautioned against applying the results to all physicians because the study included only gastroenterologists.

The study was supported by the National Institutes of Health and the Centers for Disease Control and Prevention, said Dr. Ko, who had no disclosures.

Starting next year, federal health programs will cover any procedure performed at an ambulatory surgery center, with few but defined exclusions, according to final regulations released by the Centers for Medicare and Medicaid Services.

The payment formula for such procedures, to be phased in over 4 years, was also set by the regulations.

Previously, CMS covered approximately 2,600 procedures when they were performed at an ASC; now, an additional 790 procedures will be eligible in 2008. According to Dr. Charles Mabry, chairman of the American College of Surgeons' health policy steering committee and a member of the general surgery coding and reimbursement committee, as new procedures receive CPT codes, they too will be covered, unless they are specifically excluded.

CMS will not pay for a procedure if it falls within the following exclusion criteria:

▸ It poses a significant safety risk to the beneficiary.

▸ It would result in the patient's requiring active monitoring or an overnight stay.

▸ It directly involves major blood vessels.

▸ It requires major or prolonged invasion of body cavities.

▸ It results in extensive blood loss.

▸ It is emergent or life threatening.

▸ It requires systemic thrombolysis.

▸ It can be reported only with an unlisted code.

The change means that more patients will likely be able to have procedures done in an ASC, said Dr. Mabry, who is also a shareholder in an ambulatory surgery center in Pine Bluff, Ark.

CMS also decided to limit payment for procedures performed in an ASC that are done in a physician's office more than half the time. "CMS does not want to create inappropriate payment incentives for procedures to be performed in ASCs if the physician's office is the most efficient setting for providing high quality care," according to the agency.

FASA, the advocacy arm of the Foundation for Ambulatory Surgery in America, objected to this proposal and also to CMS's list of exclusions, arguing that the agency should pay for any procedure that is not covered under the inpatient system.

Medicare will make separate payments for ancillary services, such as radiology, and for some drugs and biologicals considered integral to a procedure. The agency will also make adjustments for procedures that have high device costs (that is, when the cost of the device accounts for more than half the median cost of the procedure). Those high device-cost procedures include placement of neurostimulators, pulse generators, or pacemakers.

The adjustment is already in effect under CMS's hospital outpatient payment system.

Starting next year, federal health programs will cover any procedure performed at an ambulatory surgery center, with few but defined exclusions, according to final regulations released by the Centers for Medicare and Medicaid Services.

The payment formula for such procedures, to be phased in over 4 years, was also set by the regulations.

Previously, CMS covered approximately 2,600 procedures when they were performed at an ASC; now, an additional 790 procedures will be eligible in 2008. According to Dr. Charles Mabry, chairman of the American College of Surgeons' health policy steering committee and a member of the general surgery coding and reimbursement committee, as new procedures receive CPT codes, they too will be covered, unless they are specifically excluded.

CMS will not pay for a procedure if it falls within the following exclusion criteria:

▸ It poses a significant safety risk to the beneficiary.

▸ It would result in the patient's requiring active monitoring or an overnight stay.

▸ It directly involves major blood vessels.

▸ It requires major or prolonged invasion of body cavities.

▸ It results in extensive blood loss.

▸ It is emergent or life threatening.

▸ It requires systemic thrombolysis.

▸ It can be reported only with an unlisted code.

The change means that more patients will likely be able to have procedures done in an ASC, said Dr. Mabry, who is also a shareholder in an ambulatory surgery center in Pine Bluff, Ark.

CMS also decided to limit payment for procedures performed in an ASC that are done in a physician's office more than half the time. "CMS does not want to create inappropriate payment incentives for procedures to be performed in ASCs if the physician's office is the most efficient setting for providing high quality care," according to the agency.

FASA, the advocacy arm of the Foundation for Ambulatory Surgery in America, objected to this proposal and also to CMS's list of exclusions, arguing that the agency should pay for any procedure that is not covered under the inpatient system.

Medicare will make separate payments for ancillary services, such as radiology, and for some drugs and biologicals considered integral to a procedure. The agency will also make adjustments for procedures that have high device costs (that is, when the cost of the device accounts for more than half the median cost of the procedure). Those high device-cost procedures include placement of neurostimulators, pulse generators, or pacemakers.

The adjustment is already in effect under CMS's hospital outpatient payment system.

Starting next year, federal health programs will cover any procedure performed at an ambulatory surgery center, with few but defined exclusions, according to final regulations released by the Centers for Medicare and Medicaid Services.

The payment formula for such procedures, to be phased in over 4 years, was also set by the regulations.

Previously, CMS covered approximately 2,600 procedures when they were performed at an ASC; now, an additional 790 procedures will be eligible in 2008. According to Dr. Charles Mabry, chairman of the American College of Surgeons' health policy steering committee and a member of the general surgery coding and reimbursement committee, as new procedures receive CPT codes, they too will be covered, unless they are specifically excluded.

CMS will not pay for a procedure if it falls within the following exclusion criteria:

▸ It poses a significant safety risk to the beneficiary.

▸ It would result in the patient's requiring active monitoring or an overnight stay.

▸ It directly involves major blood vessels.

▸ It requires major or prolonged invasion of body cavities.

▸ It results in extensive blood loss.

▸ It is emergent or life threatening.

▸ It requires systemic thrombolysis.

▸ It can be reported only with an unlisted code.

The change means that more patients will likely be able to have procedures done in an ASC, said Dr. Mabry, who is also a shareholder in an ambulatory surgery center in Pine Bluff, Ark.

CMS also decided to limit payment for procedures performed in an ASC that are done in a physician's office more than half the time. "CMS does not want to create inappropriate payment incentives for procedures to be performed in ASCs if the physician's office is the most efficient setting for providing high quality care," according to the agency.

FASA, the advocacy arm of the Foundation for Ambulatory Surgery in America, objected to this proposal and also to CMS's list of exclusions, arguing that the agency should pay for any procedure that is not covered under the inpatient system.

Medicare will make separate payments for ancillary services, such as radiology, and for some drugs and biologicals considered integral to a procedure. The agency will also make adjustments for procedures that have high device costs (that is, when the cost of the device accounts for more than half the median cost of the procedure). Those high device-cost procedures include placement of neurostimulators, pulse generators, or pacemakers.

The adjustment is already in effect under CMS's hospital outpatient payment system.