Alicia Ault

CMS Expands Rehab Coverage …

An updated final national coverage decision from the Centers for Medicare and Medicaid Services has expanded the number of people potentially eligible for cardiac rehabilitation. It may allow, for the first time, coverage of some aspects of lifestyle modification programs such as Dr. Dean Ornish's Program for Reversing Heart Disease and the Cardiac Wellness Program of the Mind/Body Medical Institute, Chestnut Hill, Mass. In the past, CMS paid for rehab only for patients with myocardial infarction, coronary artery bypass graft, or stable angina. Now coverage will be available for patients receiving a heart valve, percutaneous transluminal coronary angioplasty or stenting, and heart or heart-lung transplant. Evidence was not sufficient to back payment for rehab for congestive heart failure, said CMS. Under the new policy, CMS will cover programs that include medical evaluation, prescribed exercise, education, cardiac risk factor modification (including nutritional counseling), and counseling for up to 36 sessions. Regional contractors can cover the services beyond 18 weeks, but can't exceed 72 sessions over 36 weeks. To be covered, a rehab program must be under the direct supervision of a physician. Of the 181 comments CMS received, 93 agreed with the agency's decision on expanding covered indications. The agency received 32 comments on the components of rehab programs; of those, 17 said programs like Dr. Ornish's shouldn't be covered because they're more intense and comprehensive than the other services covered and should be under a separate policy.

… But Maintains ECP Policy

In another policy update, CMS said it will not expand indications for external counterpulsation therapy. (Medicare identifies the therapy as “ECP,” but it is also known among providers as enhanced external counterpulsation, or EECP.) Currently, CMS covers ECP for disabling angina (class III or class IV, Canadian Cardiovascular Society Classification or equivalent) that is not amenable to surgical intervention. The agency had been asked to extend coverage to CCSC II angina, heart failure, cardiogenic shock, and acute myocardial infarction, but said that it will not at the current time. ECP, which uses cuffs to gently compress blood vessels, increases diastolic flow and causes systolic unloading. The Prospective Evaluation of EECP in Congestive Heart Failure (PEECH) trial, presented at the American College of Cardiology annual meeting in 2005 and sponsored by a maker of EECP systems, found that a 7-week course of the therapy increased exercise duration, raised quality of life, and improved New York Heart Association class in patients who were on optimal pharmacotherapy. EECP has also been found to be a potentially effective treatment for restless legs syndrome.

ICD Registry Is Official

The national ICD Registry is now the official database for Medicare patients. Launched in June 2005, the registry is a collaboration between the American College of Cardiology and the Heart Rhythm Society. When CMS decided to expand coverage for ICDs last year, the agency required hospitals to begin submitting data to a registry. Initially those submissions were to go to the CMS QNet registry, but now the facilities will be asked to report to the ICD Registry instead. According to the ACC, 1,300 hospitals have been contacted and are all starting to enroll in the registry. “The Medicare aggregate data from the ICD Registry will be made available to the public to better inform patients and physicians on the most appropriate ICD therapy,” said CMS Administrator Mark B. McClellan in a statement.

GAO Report Critical of HRSA

The Health Resources and Services Administration needs to do a better job of making health workforce projections, says a report from the Government Accountability Office. “HRSA has in the past decade published national supply and demand projections for the nurse and pharmacist workforces but no national projections for the physician and dentist workforces,” the GAO said. “We [recommend] HRSA develop a strategy and time frames to regularly update and publish national health professions workforce projections.” In its response, HRSA noted that the GAO focused its criticisms on publications from the agency's national office and did not take into account those from regional workforce centers that are funded by HRSA. The agency also noted it “believe[s] that the legislated goal of providing 'health workforce information and analysis … such as shortages of registered nurses, shortages of pharmacists, and the distribution of health care workers in underserved areas' is broader than what GAO's exclusive focus on supply and demand projections for physicians, nurses, and dentists would allow.”

CMS Expands Rehab Coverage …

An updated final national coverage decision from the Centers for Medicare and Medicaid Services has expanded the number of people potentially eligible for cardiac rehabilitation. It may allow, for the first time, coverage of some aspects of lifestyle modification programs such as Dr. Dean Ornish's Program for Reversing Heart Disease and the Cardiac Wellness Program of the Mind/Body Medical Institute, Chestnut Hill, Mass. In the past, CMS paid for rehab only for patients with myocardial infarction, coronary artery bypass graft, or stable angina. Now coverage will be available for patients receiving a heart valve, percutaneous transluminal coronary angioplasty or stenting, and heart or heart-lung transplant. Evidence was not sufficient to back payment for rehab for congestive heart failure, said CMS. Under the new policy, CMS will cover programs that include medical evaluation, prescribed exercise, education, cardiac risk factor modification (including nutritional counseling), and counseling for up to 36 sessions. Regional contractors can cover the services beyond 18 weeks, but can't exceed 72 sessions over 36 weeks. To be covered, a rehab program must be under the direct supervision of a physician. Of the 181 comments CMS received, 93 agreed with the agency's decision on expanding covered indications. The agency received 32 comments on the components of rehab programs; of those, 17 said programs like Dr. Ornish's shouldn't be covered because they're more intense and comprehensive than the other services covered and should be under a separate policy.

… But Maintains ECP Policy

In another policy update, CMS said it will not expand indications for external counterpulsation therapy. (Medicare identifies the therapy as “ECP,” but it is also known among providers as enhanced external counterpulsation, or EECP.) Currently, CMS covers ECP for disabling angina (class III or class IV, Canadian Cardiovascular Society Classification or equivalent) that is not amenable to surgical intervention. The agency had been asked to extend coverage to CCSC II angina, heart failure, cardiogenic shock, and acute myocardial infarction, but said that it will not at the current time. ECP, which uses cuffs to gently compress blood vessels, increases diastolic flow and causes systolic unloading. The Prospective Evaluation of EECP in Congestive Heart Failure (PEECH) trial, presented at the American College of Cardiology annual meeting in 2005 and sponsored by a maker of EECP systems, found that a 7-week course of the therapy increased exercise duration, raised quality of life, and improved New York Heart Association class in patients who were on optimal pharmacotherapy. EECP has also been found to be a potentially effective treatment for restless legs syndrome.

ICD Registry Is Official

The national ICD Registry is now the official database for Medicare patients. Launched in June 2005, the registry is a collaboration between the American College of Cardiology and the Heart Rhythm Society. When CMS decided to expand coverage for ICDs last year, the agency required hospitals to begin submitting data to a registry. Initially those submissions were to go to the CMS QNet registry, but now the facilities will be asked to report to the ICD Registry instead. According to the ACC, 1,300 hospitals have been contacted and are all starting to enroll in the registry. “The Medicare aggregate data from the ICD Registry will be made available to the public to better inform patients and physicians on the most appropriate ICD therapy,” said CMS Administrator Mark B. McClellan in a statement.

GAO Report Critical of HRSA

The Health Resources and Services Administration needs to do a better job of making health workforce projections, says a report from the Government Accountability Office. “HRSA has in the past decade published national supply and demand projections for the nurse and pharmacist workforces but no national projections for the physician and dentist workforces,” the GAO said. “We [recommend] HRSA develop a strategy and time frames to regularly update and publish national health professions workforce projections.” In its response, HRSA noted that the GAO focused its criticisms on publications from the agency's national office and did not take into account those from regional workforce centers that are funded by HRSA. The agency also noted it “believe[s] that the legislated goal of providing 'health workforce information and analysis … such as shortages of registered nurses, shortages of pharmacists, and the distribution of health care workers in underserved areas' is broader than what GAO's exclusive focus on supply and demand projections for physicians, nurses, and dentists would allow.”

CMS Expands Rehab Coverage …

An updated final national coverage decision from the Centers for Medicare and Medicaid Services has expanded the number of people potentially eligible for cardiac rehabilitation. It may allow, for the first time, coverage of some aspects of lifestyle modification programs such as Dr. Dean Ornish's Program for Reversing Heart Disease and the Cardiac Wellness Program of the Mind/Body Medical Institute, Chestnut Hill, Mass. In the past, CMS paid for rehab only for patients with myocardial infarction, coronary artery bypass graft, or stable angina. Now coverage will be available for patients receiving a heart valve, percutaneous transluminal coronary angioplasty or stenting, and heart or heart-lung transplant. Evidence was not sufficient to back payment for rehab for congestive heart failure, said CMS. Under the new policy, CMS will cover programs that include medical evaluation, prescribed exercise, education, cardiac risk factor modification (including nutritional counseling), and counseling for up to 36 sessions. Regional contractors can cover the services beyond 18 weeks, but can't exceed 72 sessions over 36 weeks. To be covered, a rehab program must be under the direct supervision of a physician. Of the 181 comments CMS received, 93 agreed with the agency's decision on expanding covered indications. The agency received 32 comments on the components of rehab programs; of those, 17 said programs like Dr. Ornish's shouldn't be covered because they're more intense and comprehensive than the other services covered and should be under a separate policy.

… But Maintains ECP Policy

In another policy update, CMS said it will not expand indications for external counterpulsation therapy. (Medicare identifies the therapy as “ECP,” but it is also known among providers as enhanced external counterpulsation, or EECP.) Currently, CMS covers ECP for disabling angina (class III or class IV, Canadian Cardiovascular Society Classification or equivalent) that is not amenable to surgical intervention. The agency had been asked to extend coverage to CCSC II angina, heart failure, cardiogenic shock, and acute myocardial infarction, but said that it will not at the current time. ECP, which uses cuffs to gently compress blood vessels, increases diastolic flow and causes systolic unloading. The Prospective Evaluation of EECP in Congestive Heart Failure (PEECH) trial, presented at the American College of Cardiology annual meeting in 2005 and sponsored by a maker of EECP systems, found that a 7-week course of the therapy increased exercise duration, raised quality of life, and improved New York Heart Association class in patients who were on optimal pharmacotherapy. EECP has also been found to be a potentially effective treatment for restless legs syndrome.

ICD Registry Is Official

The national ICD Registry is now the official database for Medicare patients. Launched in June 2005, the registry is a collaboration between the American College of Cardiology and the Heart Rhythm Society. When CMS decided to expand coverage for ICDs last year, the agency required hospitals to begin submitting data to a registry. Initially those submissions were to go to the CMS QNet registry, but now the facilities will be asked to report to the ICD Registry instead. According to the ACC, 1,300 hospitals have been contacted and are all starting to enroll in the registry. “The Medicare aggregate data from the ICD Registry will be made available to the public to better inform patients and physicians on the most appropriate ICD therapy,” said CMS Administrator Mark B. McClellan in a statement.

GAO Report Critical of HRSA

The Health Resources and Services Administration needs to do a better job of making health workforce projections, says a report from the Government Accountability Office. “HRSA has in the past decade published national supply and demand projections for the nurse and pharmacist workforces but no national projections for the physician and dentist workforces,” the GAO said. “We [recommend] HRSA develop a strategy and time frames to regularly update and publish national health professions workforce projections.” In its response, HRSA noted that the GAO focused its criticisms on publications from the agency's national office and did not take into account those from regional workforce centers that are funded by HRSA. The agency also noted it “believe[s] that the legislated goal of providing 'health workforce information and analysis … such as shortages of registered nurses, shortages of pharmacists, and the distribution of health care workers in underserved areas' is broader than what GAO's exclusive focus on supply and demand projections for physicians, nurses, and dentists would allow.”

New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, seem poised for a post-Katrina recovery that may put them on better footing than before the floods wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

But although Tulane and LSU officials are optimistic, success is far from guaranteed. “The next 6–12 months will be absolutely critical,” said Barbara Beckman, Ph.D., dean of admissions at Tulane.

For now, officials at both schools say that the downsizing at the schools may have a silver lining: It may better prepare the institutions to serve a smaller city with fewer physicians, patients, and hospital beds yet potentially more uncompensated care.

In late February, the U.S. General Accountability Office estimated that only 456 beds were open at three hospitals in the city. That was down from 2,269 before the storm. (See box.) Outside the city, about 1,528 beds of a total 1,814 had reopened.

Since the hurricane last August, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. The LSU faculty were furloughed, but most are not expected to return, Dr. Larry Hollier, chancellor of the Health Sciences Center, said in an interview.

Because LSU is primarily supported by the state, it has more of an uphill battle than does Tulane, which has benefited from its hospital being owned by HCA Inc., Dr. Beckman said.

Physically, 21 of 22 LSU buildings were seriously damaged by the hurricane and subsequent flooding. All of LSU's teaching facilities were under at least 5 feet of water at some point, according to Dr. Hollier.

In the months after the storm, the university was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks. In February, LSU received $50 million in federal hurricane relief money, which was distributed by the state-run Louisiana Recovery Authority to help cover resident and faculty salaries.

“I never had any doubt we would keep it going,” Dr. Hollier said. But his job is far from over.

Initially, all seven of LSU's teaching hospitals were out of commission, leaving many of the school's residents at loose ends. After the storm, LSU moved its residents to hospitals outside the city and across the state, in particular, to Baton Rouge. Some are now back at work in New Orleans.

But just because LSU found positions for its residents doesn't mean the school was going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements, and LSU does not have any with those new facilities. The school sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots, and in April, CMS announced its intention to grant the waiver to LSU and all the schools affected by Katrina in an interim final rule. The waiver, which would let schools receive payments retroactive to the storm for residents at any institution, will become final later in the year.

Tulane sought the same waiver, said Dr. Ronald Amedee, dean of graduate medical education. Before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, Dr. Amedee said.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

On a brighter note, the chaos in New Orleans has not dissuaded future physicians from seeking residencies at city institutions. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

Dr. Amedee said the school attracted top-tier candidates. But they were different from those in years past—many have done charity work in developing countries or with organizations such as Habitat for Humanity, and many are seeking a dual MD and master's degree in public health.

“This is a group of people that came here and did not see water marks on buildings and debris piled up in the street as a negative—they saw it as a positive,” he asserted.

At LSU, 76 of the 172 students in the graduating class decided to stay in-state for training.

Tulane moved all 155 of its first- and second-year students to Baylor College of Medicine in Houston, where they are taking classes from the 150–200 faculty still on the Tulane payroll.

The third- and fourth-year students are taking electives in Louisiana, Texas, and elsewhere. Tulane aims to reopen its medical school in July.

Most LSU students were relocated to the school's main Baton Rouge campus, but the schools of public health and graduate studies returned to New Orleans in January.

Dr. Hollier said he expected the medical and nursing students to start attending classes in the city in July, and medical school applications are on par with previous years.

At Tulane, about 8,000 students have applied for 155 positions. “I've got an overfilled class,” said Dr. Beckman, but “what's different this year is the enthusiasm level. I wouldn't be anywhere else, and I think that's what the students feel.”

ELSEVIER GLOBAL MEDICAL NEWS

New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, seem poised for a post-Katrina recovery that may put them on better footing than before the floods wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

But although Tulane and LSU officials are optimistic, success is far from guaranteed. “The next 6–12 months will be absolutely critical,” said Barbara Beckman, Ph.D., dean of admissions at Tulane.

For now, officials at both schools say that the downsizing at the schools may have a silver lining: It may better prepare the institutions to serve a smaller city with fewer physicians, patients, and hospital beds yet potentially more uncompensated care.

In late February, the U.S. General Accountability Office estimated that only 456 beds were open at three hospitals in the city. That was down from 2,269 before the storm. (See box.) Outside the city, about 1,528 beds of a total 1,814 had reopened.

Since the hurricane last August, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. The LSU faculty were furloughed, but most are not expected to return, Dr. Larry Hollier, chancellor of the Health Sciences Center, said in an interview.

Because LSU is primarily supported by the state, it has more of an uphill battle than does Tulane, which has benefited from its hospital being owned by HCA Inc., Dr. Beckman said.

Physically, 21 of 22 LSU buildings were seriously damaged by the hurricane and subsequent flooding. All of LSU's teaching facilities were under at least 5 feet of water at some point, according to Dr. Hollier.

In the months after the storm, the university was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks. In February, LSU received $50 million in federal hurricane relief money, which was distributed by the state-run Louisiana Recovery Authority to help cover resident and faculty salaries.

“I never had any doubt we would keep it going,” Dr. Hollier said. But his job is far from over.

Initially, all seven of LSU's teaching hospitals were out of commission, leaving many of the school's residents at loose ends. After the storm, LSU moved its residents to hospitals outside the city and across the state, in particular, to Baton Rouge. Some are now back at work in New Orleans.

But just because LSU found positions for its residents doesn't mean the school was going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements, and LSU does not have any with those new facilities. The school sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots, and in April, CMS announced its intention to grant the waiver to LSU and all the schools affected by Katrina in an interim final rule. The waiver, which would let schools receive payments retroactive to the storm for residents at any institution, will become final later in the year.

Tulane sought the same waiver, said Dr. Ronald Amedee, dean of graduate medical education. Before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, Dr. Amedee said.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

On a brighter note, the chaos in New Orleans has not dissuaded future physicians from seeking residencies at city institutions. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

Dr. Amedee said the school attracted top-tier candidates. But they were different from those in years past—many have done charity work in developing countries or with organizations such as Habitat for Humanity, and many are seeking a dual MD and master's degree in public health.

“This is a group of people that came here and did not see water marks on buildings and debris piled up in the street as a negative—they saw it as a positive,” he asserted.

At LSU, 76 of the 172 students in the graduating class decided to stay in-state for training.

Tulane moved all 155 of its first- and second-year students to Baylor College of Medicine in Houston, where they are taking classes from the 150–200 faculty still on the Tulane payroll.

The third- and fourth-year students are taking electives in Louisiana, Texas, and elsewhere. Tulane aims to reopen its medical school in July.

Most LSU students were relocated to the school's main Baton Rouge campus, but the schools of public health and graduate studies returned to New Orleans in January.

Dr. Hollier said he expected the medical and nursing students to start attending classes in the city in July, and medical school applications are on par with previous years.

At Tulane, about 8,000 students have applied for 155 positions. “I've got an overfilled class,” said Dr. Beckman, but “what's different this year is the enthusiasm level. I wouldn't be anywhere else, and I think that's what the students feel.”

ELSEVIER GLOBAL MEDICAL NEWS

New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, seem poised for a post-Katrina recovery that may put them on better footing than before the floods wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

But although Tulane and LSU officials are optimistic, success is far from guaranteed. “The next 6–12 months will be absolutely critical,” said Barbara Beckman, Ph.D., dean of admissions at Tulane.

For now, officials at both schools say that the downsizing at the schools may have a silver lining: It may better prepare the institutions to serve a smaller city with fewer physicians, patients, and hospital beds yet potentially more uncompensated care.

In late February, the U.S. General Accountability Office estimated that only 456 beds were open at three hospitals in the city. That was down from 2,269 before the storm. (See box.) Outside the city, about 1,528 beds of a total 1,814 had reopened.

Since the hurricane last August, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. The LSU faculty were furloughed, but most are not expected to return, Dr. Larry Hollier, chancellor of the Health Sciences Center, said in an interview.

Because LSU is primarily supported by the state, it has more of an uphill battle than does Tulane, which has benefited from its hospital being owned by HCA Inc., Dr. Beckman said.

Physically, 21 of 22 LSU buildings were seriously damaged by the hurricane and subsequent flooding. All of LSU's teaching facilities were under at least 5 feet of water at some point, according to Dr. Hollier.

In the months after the storm, the university was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks. In February, LSU received $50 million in federal hurricane relief money, which was distributed by the state-run Louisiana Recovery Authority to help cover resident and faculty salaries.

“I never had any doubt we would keep it going,” Dr. Hollier said. But his job is far from over.

Initially, all seven of LSU's teaching hospitals were out of commission, leaving many of the school's residents at loose ends. After the storm, LSU moved its residents to hospitals outside the city and across the state, in particular, to Baton Rouge. Some are now back at work in New Orleans.

But just because LSU found positions for its residents doesn't mean the school was going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements, and LSU does not have any with those new facilities. The school sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots, and in April, CMS announced its intention to grant the waiver to LSU and all the schools affected by Katrina in an interim final rule. The waiver, which would let schools receive payments retroactive to the storm for residents at any institution, will become final later in the year.

Tulane sought the same waiver, said Dr. Ronald Amedee, dean of graduate medical education. Before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, Dr. Amedee said.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

On a brighter note, the chaos in New Orleans has not dissuaded future physicians from seeking residencies at city institutions. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

Dr. Amedee said the school attracted top-tier candidates. But they were different from those in years past—many have done charity work in developing countries or with organizations such as Habitat for Humanity, and many are seeking a dual MD and master's degree in public health.

“This is a group of people that came here and did not see water marks on buildings and debris piled up in the street as a negative—they saw it as a positive,” he asserted.

At LSU, 76 of the 172 students in the graduating class decided to stay in-state for training.

Tulane moved all 155 of its first- and second-year students to Baylor College of Medicine in Houston, where they are taking classes from the 150–200 faculty still on the Tulane payroll.

The third- and fourth-year students are taking electives in Louisiana, Texas, and elsewhere. Tulane aims to reopen its medical school in July.

Most LSU students were relocated to the school's main Baton Rouge campus, but the schools of public health and graduate studies returned to New Orleans in January.

Dr. Hollier said he expected the medical and nursing students to start attending classes in the city in July, and medical school applications are on par with previous years.

At Tulane, about 8,000 students have applied for 155 positions. “I've got an overfilled class,” said Dr. Beckman, but “what's different this year is the enthusiasm level. I wouldn't be anywhere else, and I think that's what the students feel.”

ELSEVIER GLOBAL MEDICAL NEWS

Downsizing may put New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, on sounder financial footing than they were before the floods of Hurricane Katrina wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

While closure of several hospitals and clinics affiliated with those schools is of concern now, Dr. Larry Hollier, chancellor of the LSU Health Sciences Center predicted that a new primary care system under consideration eventually could better serve the city's charity care needs. Louisiana had the second highest number of uninsured individuals in the nation in 2005. Access and payment issues, however, continue to be a concern in the interim.

In late February, the federal Government Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. (See box.) Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Just two of the city's nine hospitals are fully reopened. A third, Tulane University Hospital and Clinic, has opened 62 of its 237 beds. Before the storm, 90 clinics, including 70 that were operated by the state, provided care for the uninsured. Now just 10 are open, and most are operating at 50% or less capacity, according to the U.S. Government Accountability Office.

Hurricane Katrina accelerated a long-simmering debate about what to do with the city's two main charity care facilities—University and Charity hospitals, both owned by the state and operated by Louisiana State University. Charity Hospital is housed in a 21-story facility built in 1939, but has been in continuous operation since 1736. University Hospital was built in the 1960s.

Together they had 500 beds; Charity was the central service site for the uninsured, but was deteriorating before Katrina, said Dr. Larry Hollier, chancellor of the LSU Health Sciences Center, in an interview.

LSU has said that it will not reopen Charity, but that it will reopen University on a phased-in basis, with 100 beds in July, 200 by November, and 250 by January. An LSU-hired consultant estimated that it would take $117 million to repair University and $257 million to get Charity back in operation. However, the Federal Emergency Management Agency—which is slated to pay for the hospitals' recovery because they are in a federal disaster area—had much lower estimates: $12 million for University and $24 million for Charity, according to the GAO report.

Without Charity, Tulane University Hospital is seeing more uninsured patients these days—about 30% of its patient visits. “That's a huge increase” from before the hurricane, said Dr. Ronald Amedee, dean of graduate medical education at Tulane.

Dr. Hollier, his LSU colleagues, and state government officials are proposing to build a new hospital in conjunction with the Department of Veterans Affairs, which also lost its 206-bed facility.

“We need more third-party payers,” said Dr. Hollier in an interview, noting that Louisiana pays for most of the charity care in a state where 23% of the population is uninsured.

So far, Congress has approved $75 million in planning funds, and the Bush Administration set aside $600 million for new construction in the hurricane relief package. But the joint hospital plan still needs to be approved and fully funded by Congress. The soonest that could happen is the end of the year, Dr. Hollier said.

“Everybody understands the urgency of this to the city,” Dr. Hollier said. But under the new post-Katrina system, he added, “I think there will be better access for the uninsured.”

Under a plan being advanced by LSU, the state would open more primary care clinics around the city. But it's not yet clear who will pay for those clinics, Dr. Hollier said.

And with so many neighborhoods still sitting empty, no one knows where those clinics would be built or whether there will be anyone to serve in those areas.

With all seven of LSU's teaching hospitals initially out of commission, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU now has 50 residents—a substantial increase from the 8 who served there before the storm.

Dr. Ronald Amedee, dean of graduate medical education at Tulane, said that before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, most were transferred elsewhere.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

But just because Tulane and LSU found positions for its residents doesn't mean the schools are going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements. The schools sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver, which would let schools receive payments retroactive to the storm for residents at any institution and will become final later in the year.

Since the hurricane, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. LSU faculty members were furloughed, but most are not expected to return, according to Dr. Hollier.

Primarily supported by the state, LSU has more of an uphill financial battle than does Tulane, which has benefited from its hospital being owned by HCA Inc.

In the months after the storm, LSU was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks. In February, LSU received $50 million in federal hurricane relief money, which was distributed by the state-run Louisiana Recovery Authority to help cover resident and faculty salaries.

On a bright note, the medical schools and residency programs are experiencing intense interest. At LSU, 76 of the 172 students in their graduating medical school class decided to stay in-state for residency. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

“This is one of the most successful matches we've had in decades,” Dr. Amedee said. “We really hit it big.”

Tulane aims to reopen its medical school in July. About 8,000 students have applied for 155 positions. The school attracted top-tier candidates. But they were different than those in years past—many have done charity work in developing countries or with organizations like Habitat for Humanity, and many are seeking a dual master's degree in public health and an MD degree.

“I've got an overfilled class,” said Barbara Beckman, Ph.D., dean of admissions at the Tulane Medical School, noting that Tulane always has a large number of applicants, but “what's different this year is the enthusiasm level.” Added Dr. Beckman, “I wouldn't be anywhere else, and I think that's what the students feel.”

ELSEVIER GLOBAL MEDICAL NEWS

Downsizing may put New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, on sounder financial footing than they were before the floods of Hurricane Katrina wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

While closure of several hospitals and clinics affiliated with those schools is of concern now, Dr. Larry Hollier, chancellor of the LSU Health Sciences Center predicted that a new primary care system under consideration eventually could better serve the city's charity care needs. Louisiana had the second highest number of uninsured individuals in the nation in 2005. Access and payment issues, however, continue to be a concern in the interim.

In late February, the federal Government Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. (See box.) Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Just two of the city's nine hospitals are fully reopened. A third, Tulane University Hospital and Clinic, has opened 62 of its 237 beds. Before the storm, 90 clinics, including 70 that were operated by the state, provided care for the uninsured. Now just 10 are open, and most are operating at 50% or less capacity, according to the U.S. Government Accountability Office.

Hurricane Katrina accelerated a long-simmering debate about what to do with the city's two main charity care facilities—University and Charity hospitals, both owned by the state and operated by Louisiana State University. Charity Hospital is housed in a 21-story facility built in 1939, but has been in continuous operation since 1736. University Hospital was built in the 1960s.

Together they had 500 beds; Charity was the central service site for the uninsured, but was deteriorating before Katrina, said Dr. Larry Hollier, chancellor of the LSU Health Sciences Center, in an interview.

LSU has said that it will not reopen Charity, but that it will reopen University on a phased-in basis, with 100 beds in July, 200 by November, and 250 by January. An LSU-hired consultant estimated that it would take $117 million to repair University and $257 million to get Charity back in operation. However, the Federal Emergency Management Agency—which is slated to pay for the hospitals' recovery because they are in a federal disaster area—had much lower estimates: $12 million for University and $24 million for Charity, according to the GAO report.

Without Charity, Tulane University Hospital is seeing more uninsured patients these days—about 30% of its patient visits. “That's a huge increase” from before the hurricane, said Dr. Ronald Amedee, dean of graduate medical education at Tulane.

Dr. Hollier, his LSU colleagues, and state government officials are proposing to build a new hospital in conjunction with the Department of Veterans Affairs, which also lost its 206-bed facility.

“We need more third-party payers,” said Dr. Hollier in an interview, noting that Louisiana pays for most of the charity care in a state where 23% of the population is uninsured.

So far, Congress has approved $75 million in planning funds, and the Bush Administration set aside $600 million for new construction in the hurricane relief package. But the joint hospital plan still needs to be approved and fully funded by Congress. The soonest that could happen is the end of the year, Dr. Hollier said.

“Everybody understands the urgency of this to the city,” Dr. Hollier said. But under the new post-Katrina system, he added, “I think there will be better access for the uninsured.”

Under a plan being advanced by LSU, the state would open more primary care clinics around the city. But it's not yet clear who will pay for those clinics, Dr. Hollier said.

And with so many neighborhoods still sitting empty, no one knows where those clinics would be built or whether there will be anyone to serve in those areas.

With all seven of LSU's teaching hospitals initially out of commission, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU now has 50 residents—a substantial increase from the 8 who served there before the storm.

Dr. Ronald Amedee, dean of graduate medical education at Tulane, said that before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, most were transferred elsewhere.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

But just because Tulane and LSU found positions for its residents doesn't mean the schools are going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements. The schools sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver, which would let schools receive payments retroactive to the storm for residents at any institution and will become final later in the year.

Since the hurricane, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. LSU faculty members were furloughed, but most are not expected to return, according to Dr. Hollier.

Primarily supported by the state, LSU has more of an uphill financial battle than does Tulane, which has benefited from its hospital being owned by HCA Inc.

In the months after the storm, LSU was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks. In February, LSU received $50 million in federal hurricane relief money, which was distributed by the state-run Louisiana Recovery Authority to help cover resident and faculty salaries.

On a bright note, the medical schools and residency programs are experiencing intense interest. At LSU, 76 of the 172 students in their graduating medical school class decided to stay in-state for residency. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

“This is one of the most successful matches we've had in decades,” Dr. Amedee said. “We really hit it big.”

Tulane aims to reopen its medical school in July. About 8,000 students have applied for 155 positions. The school attracted top-tier candidates. But they were different than those in years past—many have done charity work in developing countries or with organizations like Habitat for Humanity, and many are seeking a dual master's degree in public health and an MD degree.

“I've got an overfilled class,” said Barbara Beckman, Ph.D., dean of admissions at the Tulane Medical School, noting that Tulane always has a large number of applicants, but “what's different this year is the enthusiasm level.” Added Dr. Beckman, “I wouldn't be anywhere else, and I think that's what the students feel.”

ELSEVIER GLOBAL MEDICAL NEWS

Downsizing may put New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, on sounder financial footing than they were before the floods of Hurricane Katrina wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

While closure of several hospitals and clinics affiliated with those schools is of concern now, Dr. Larry Hollier, chancellor of the LSU Health Sciences Center predicted that a new primary care system under consideration eventually could better serve the city's charity care needs. Louisiana had the second highest number of uninsured individuals in the nation in 2005. Access and payment issues, however, continue to be a concern in the interim.

In late February, the federal Government Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. (See box.) Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Just two of the city's nine hospitals are fully reopened. A third, Tulane University Hospital and Clinic, has opened 62 of its 237 beds. Before the storm, 90 clinics, including 70 that were operated by the state, provided care for the uninsured. Now just 10 are open, and most are operating at 50% or less capacity, according to the U.S. Government Accountability Office.

Hurricane Katrina accelerated a long-simmering debate about what to do with the city's two main charity care facilities—University and Charity hospitals, both owned by the state and operated by Louisiana State University. Charity Hospital is housed in a 21-story facility built in 1939, but has been in continuous operation since 1736. University Hospital was built in the 1960s.

Together they had 500 beds; Charity was the central service site for the uninsured, but was deteriorating before Katrina, said Dr. Larry Hollier, chancellor of the LSU Health Sciences Center, in an interview.

LSU has said that it will not reopen Charity, but that it will reopen University on a phased-in basis, with 100 beds in July, 200 by November, and 250 by January. An LSU-hired consultant estimated that it would take $117 million to repair University and $257 million to get Charity back in operation. However, the Federal Emergency Management Agency—which is slated to pay for the hospitals' recovery because they are in a federal disaster area—had much lower estimates: $12 million for University and $24 million for Charity, according to the GAO report.

Without Charity, Tulane University Hospital is seeing more uninsured patients these days—about 30% of its patient visits. “That's a huge increase” from before the hurricane, said Dr. Ronald Amedee, dean of graduate medical education at Tulane.

Dr. Hollier, his LSU colleagues, and state government officials are proposing to build a new hospital in conjunction with the Department of Veterans Affairs, which also lost its 206-bed facility.

“We need more third-party payers,” said Dr. Hollier in an interview, noting that Louisiana pays for most of the charity care in a state where 23% of the population is uninsured.

So far, Congress has approved $75 million in planning funds, and the Bush Administration set aside $600 million for new construction in the hurricane relief package. But the joint hospital plan still needs to be approved and fully funded by Congress. The soonest that could happen is the end of the year, Dr. Hollier said.

“Everybody understands the urgency of this to the city,” Dr. Hollier said. But under the new post-Katrina system, he added, “I think there will be better access for the uninsured.”

Under a plan being advanced by LSU, the state would open more primary care clinics around the city. But it's not yet clear who will pay for those clinics, Dr. Hollier said.

And with so many neighborhoods still sitting empty, no one knows where those clinics would be built or whether there will be anyone to serve in those areas.

With all seven of LSU's teaching hospitals initially out of commission, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU now has 50 residents—a substantial increase from the 8 who served there before the storm.

Dr. Ronald Amedee, dean of graduate medical education at Tulane, said that before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, most were transferred elsewhere.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

But just because Tulane and LSU found positions for its residents doesn't mean the schools are going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements. The schools sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver, which would let schools receive payments retroactive to the storm for residents at any institution and will become final later in the year.

Since the hurricane, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. LSU faculty members were furloughed, but most are not expected to return, according to Dr. Hollier.

Primarily supported by the state, LSU has more of an uphill financial battle than does Tulane, which has benefited from its hospital being owned by HCA Inc.

In the months after the storm, LSU was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks. In February, LSU received $50 million in federal hurricane relief money, which was distributed by the state-run Louisiana Recovery Authority to help cover resident and faculty salaries.

On a bright note, the medical schools and residency programs are experiencing intense interest. At LSU, 76 of the 172 students in their graduating medical school class decided to stay in-state for residency. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

“This is one of the most successful matches we've had in decades,” Dr. Amedee said. “We really hit it big.”

Tulane aims to reopen its medical school in July. About 8,000 students have applied for 155 positions. The school attracted top-tier candidates. But they were different than those in years past—many have done charity work in developing countries or with organizations like Habitat for Humanity, and many are seeking a dual master's degree in public health and an MD degree.

“I've got an overfilled class,” said Barbara Beckman, Ph.D., dean of admissions at the Tulane Medical School, noting that Tulane always has a large number of applicants, but “what's different this year is the enthusiasm level.” Added Dr. Beckman, “I wouldn't be anywhere else, and I think that's what the students feel.”

ELSEVIER GLOBAL MEDICAL NEWS

Physicians as well as patient and industry representatives say a congressionally imposed reduction in Medicare reimbursement for intravenous immunoglobulin—when combined with several other factors—is having a devastating impact on access to the therapy, leading to more infections and serious illnesses.

The payment scheme went into effect for physician offices in 2005 and for hospitals beginning in January, and was partly a reaction by the Centers for Medicare and Medicaid Services to rising intravenous immunoglobulin (IVIG) use, said Bruce Kruger, director of practice and policy for the American Academy of Allergy, Asthma, and Immunology (AAAAI).

The immune therapy is approved for primary immunodeficiency, idiopathic thrombocytopenic purpura, Kawasaki disease, chronic lymphocytic leukemia, pediatric HIV infection, and allogeneic bone marrow transplantation.

There also has been increasing off-label use for infectious diseases; neurologic diseases such as myasthenia gravis, multiple sclerosis, and polymyositis; hematologic diseases, allergies, and transplantation.

About 17% of the 50,000 people who receive IVIG for primary immune therapy are Medicare eligible and have been the first to start experiencing access issues, said Marcia Boyle, president of the Immune Deficiency Foundation (IDF). Ms. Boyle and Mr. Kruger said that private insurers are following Medicare's lead and also are starting to cut IVIG payments.

At the same time, supplies of the hard-to-make therapy—it takes up to a year to create—have tightened, partly because of rising demand.

From 2000 to 2005, manufacturers increased supplies by 60%, but it still was not enough, Julie Birkhofer, executive director, North America, of the Plasma Protein Therapeutics Association (PPTA), said in an interview.

Another problem: Much of the supply is tied up in physician offices, and they have stopped offering infusions because of the decreased payments.

In a study commissioned by the IVIG Summit Group (which includes the PPTA, the IDF, several medical association, and individual physicians), the Lewin Group found that physicians are losing an average $400 per infusion, and that the losses pile up with increasing infusions. At 10 infusions, a physician would tally a $3,100 loss, according to Lewin.

The IDF and others say that patients have begun migrating to hospitals as physicians shut down infusion services, but that hospitals also are curbing IVIG infusions as the lower reimbursement hits them.

An IDF-funded study presented as a poster at the AAAAI's annual meeting in early March found that 39% of the 202 patients with primary immune deficiencies surveyed said they had problems in getting their IVIG therapy from June 2004 to June 2005, including postponed infusions, increased intervals between infusions, and being switched to a less-tolerated product.

The physician's office is considered a safer environment than a hospital for an immune-compromised patient. Infusions, usually given monthly, generally cost $5,000.

CMS has been reimbursing physicians for the average sales price plus 6%, and in 2006, added a $69-per-infusion payment to cover administrative costs. In 2005, CMS was paying hospitals 83% of the average wholesale price, which was a slightly higher reimbursement. But in 2006, hospitals also were moved to the average sales price plus 6% rate, which Lewin estimated as a 9% shortfall between the acquisition cost and the Medicare payment, said Ms. Birkhofer. Hospitals were also given an additional $75 for administration.

The PPTA, the AAAAI, and others are seeking an add-on payment for the product and to assign Health Care Common Procedure Codes to each brand of IVIG. Currently, all 10 available brands are bundled under one code, which gives physicians an incentive to prescribe the lowest-cost IVIG, said Ms. Birkhofer. That can affect patient access and care because not every patient can tolerate the same brand of IVIG, she said.

PPTA has received a legal opinion that CMS can adjust the payment through a rule or some other administrative mechanism.

Mr. Kruger said a payment add-on may be an interim solution, but long term, the demand issue should be addressed. “We're not so naïve to think that all therapy that was being provided was appropriate and necessary,” he said.

AAAAI's Primary Immunodeficiency Committee has assembled a review of evidence supporting IVIG use in various conditions. The panel reviewed 80 indications, said Dr. Jordan S. Orange of the University of Pennsylvania, Philadelphia, and lead author of the review (J. Allergy Clin. Immunol. 2006;117:S525–53).

The paper aims “to emphasize the importance of selecting patients for immunoglobulin very carefully,” said Dr. Orange. “Pushing the boundaries of indications is going to lead to increased usage of a scarce product,” and those uses may not always be effective, he said.

Dr. Orange helped design and analyze a new unpublished AAAAI/Immune Deficiency Foundation survey of specialists who treat primary immune deficiency. One of the questions asked members about the impact of the CMS reimbursement. Ninety-five percent said the current policy represented some risk to their patients, Dr. Orange said.

Physicians as well as patient and industry representatives say a congressionally imposed reduction in Medicare reimbursement for intravenous immunoglobulin—when combined with several other factors—is having a devastating impact on access to the therapy, leading to more infections and serious illnesses.

The payment scheme went into effect for physician offices in 2005 and for hospitals beginning in January, and was partly a reaction by the Centers for Medicare and Medicaid Services to rising intravenous immunoglobulin (IVIG) use, said Bruce Kruger, director of practice and policy for the American Academy of Allergy, Asthma, and Immunology (AAAAI).

The immune therapy is approved for primary immunodeficiency, idiopathic thrombocytopenic purpura, Kawasaki disease, chronic lymphocytic leukemia, pediatric HIV infection, and allogeneic bone marrow transplantation.

There also has been increasing off-label use for infectious diseases; neurologic diseases such as myasthenia gravis, multiple sclerosis, and polymyositis; hematologic diseases, allergies, and transplantation.

About 17% of the 50,000 people who receive IVIG for primary immune therapy are Medicare eligible and have been the first to start experiencing access issues, said Marcia Boyle, president of the Immune Deficiency Foundation (IDF). Ms. Boyle and Mr. Kruger said that private insurers are following Medicare's lead and also are starting to cut IVIG payments.

At the same time, supplies of the hard-to-make therapy—it takes up to a year to create—have tightened, partly because of rising demand.

From 2000 to 2005, manufacturers increased supplies by 60%, but it still was not enough, Julie Birkhofer, executive director, North America, of the Plasma Protein Therapeutics Association (PPTA), said in an interview.

Another problem: Much of the supply is tied up in physician offices, and they have stopped offering infusions because of the decreased payments.

In a study commissioned by the IVIG Summit Group (which includes the PPTA, the IDF, several medical association, and individual physicians), the Lewin Group found that physicians are losing an average $400 per infusion, and that the losses pile up with increasing infusions. At 10 infusions, a physician would tally a $3,100 loss, according to Lewin.

The IDF and others say that patients have begun migrating to hospitals as physicians shut down infusion services, but that hospitals also are curbing IVIG infusions as the lower reimbursement hits them.

An IDF-funded study presented as a poster at the AAAAI's annual meeting in early March found that 39% of the 202 patients with primary immune deficiencies surveyed said they had problems in getting their IVIG therapy from June 2004 to June 2005, including postponed infusions, increased intervals between infusions, and being switched to a less-tolerated product.

The physician's office is considered a safer environment than a hospital for an immune-compromised patient. Infusions, usually given monthly, generally cost $5,000.

CMS has been reimbursing physicians for the average sales price plus 6%, and in 2006, added a $69-per-infusion payment to cover administrative costs. In 2005, CMS was paying hospitals 83% of the average wholesale price, which was a slightly higher reimbursement. But in 2006, hospitals also were moved to the average sales price plus 6% rate, which Lewin estimated as a 9% shortfall between the acquisition cost and the Medicare payment, said Ms. Birkhofer. Hospitals were also given an additional $75 for administration.

The PPTA, the AAAAI, and others are seeking an add-on payment for the product and to assign Health Care Common Procedure Codes to each brand of IVIG. Currently, all 10 available brands are bundled under one code, which gives physicians an incentive to prescribe the lowest-cost IVIG, said Ms. Birkhofer. That can affect patient access and care because not every patient can tolerate the same brand of IVIG, she said.

PPTA has received a legal opinion that CMS can adjust the payment through a rule or some other administrative mechanism.

Mr. Kruger said a payment add-on may be an interim solution, but long term, the demand issue should be addressed. “We're not so naïve to think that all therapy that was being provided was appropriate and necessary,” he said.

AAAAI's Primary Immunodeficiency Committee has assembled a review of evidence supporting IVIG use in various conditions. The panel reviewed 80 indications, said Dr. Jordan S. Orange of the University of Pennsylvania, Philadelphia, and lead author of the review (J. Allergy Clin. Immunol. 2006;117:S525–53).

The paper aims “to emphasize the importance of selecting patients for immunoglobulin very carefully,” said Dr. Orange. “Pushing the boundaries of indications is going to lead to increased usage of a scarce product,” and those uses may not always be effective, he said.

Dr. Orange helped design and analyze a new unpublished AAAAI/Immune Deficiency Foundation survey of specialists who treat primary immune deficiency. One of the questions asked members about the impact of the CMS reimbursement. Ninety-five percent said the current policy represented some risk to their patients, Dr. Orange said.

Physicians as well as patient and industry representatives say a congressionally imposed reduction in Medicare reimbursement for intravenous immunoglobulin—when combined with several other factors—is having a devastating impact on access to the therapy, leading to more infections and serious illnesses.

The payment scheme went into effect for physician offices in 2005 and for hospitals beginning in January, and was partly a reaction by the Centers for Medicare and Medicaid Services to rising intravenous immunoglobulin (IVIG) use, said Bruce Kruger, director of practice and policy for the American Academy of Allergy, Asthma, and Immunology (AAAAI).

The immune therapy is approved for primary immunodeficiency, idiopathic thrombocytopenic purpura, Kawasaki disease, chronic lymphocytic leukemia, pediatric HIV infection, and allogeneic bone marrow transplantation.

There also has been increasing off-label use for infectious diseases; neurologic diseases such as myasthenia gravis, multiple sclerosis, and polymyositis; hematologic diseases, allergies, and transplantation.

About 17% of the 50,000 people who receive IVIG for primary immune therapy are Medicare eligible and have been the first to start experiencing access issues, said Marcia Boyle, president of the Immune Deficiency Foundation (IDF). Ms. Boyle and Mr. Kruger said that private insurers are following Medicare's lead and also are starting to cut IVIG payments.

At the same time, supplies of the hard-to-make therapy—it takes up to a year to create—have tightened, partly because of rising demand.

From 2000 to 2005, manufacturers increased supplies by 60%, but it still was not enough, Julie Birkhofer, executive director, North America, of the Plasma Protein Therapeutics Association (PPTA), said in an interview.

Another problem: Much of the supply is tied up in physician offices, and they have stopped offering infusions because of the decreased payments.

In a study commissioned by the IVIG Summit Group (which includes the PPTA, the IDF, several medical association, and individual physicians), the Lewin Group found that physicians are losing an average $400 per infusion, and that the losses pile up with increasing infusions. At 10 infusions, a physician would tally a $3,100 loss, according to Lewin.

The IDF and others say that patients have begun migrating to hospitals as physicians shut down infusion services, but that hospitals also are curbing IVIG infusions as the lower reimbursement hits them.

An IDF-funded study presented as a poster at the AAAAI's annual meeting in early March found that 39% of the 202 patients with primary immune deficiencies surveyed said they had problems in getting their IVIG therapy from June 2004 to June 2005, including postponed infusions, increased intervals between infusions, and being switched to a less-tolerated product.

The physician's office is considered a safer environment than a hospital for an immune-compromised patient. Infusions, usually given monthly, generally cost $5,000.

CMS has been reimbursing physicians for the average sales price plus 6%, and in 2006, added a $69-per-infusion payment to cover administrative costs. In 2005, CMS was paying hospitals 83% of the average wholesale price, which was a slightly higher reimbursement. But in 2006, hospitals also were moved to the average sales price plus 6% rate, which Lewin estimated as a 9% shortfall between the acquisition cost and the Medicare payment, said Ms. Birkhofer. Hospitals were also given an additional $75 for administration.

The PPTA, the AAAAI, and others are seeking an add-on payment for the product and to assign Health Care Common Procedure Codes to each brand of IVIG. Currently, all 10 available brands are bundled under one code, which gives physicians an incentive to prescribe the lowest-cost IVIG, said Ms. Birkhofer. That can affect patient access and care because not every patient can tolerate the same brand of IVIG, she said.

PPTA has received a legal opinion that CMS can adjust the payment through a rule or some other administrative mechanism.

Mr. Kruger said a payment add-on may be an interim solution, but long term, the demand issue should be addressed. “We're not so naïve to think that all therapy that was being provided was appropriate and necessary,” he said.

AAAAI's Primary Immunodeficiency Committee has assembled a review of evidence supporting IVIG use in various conditions. The panel reviewed 80 indications, said Dr. Jordan S. Orange of the University of Pennsylvania, Philadelphia, and lead author of the review (J. Allergy Clin. Immunol. 2006;117:S525–53).

The paper aims “to emphasize the importance of selecting patients for immunoglobulin very carefully,” said Dr. Orange. “Pushing the boundaries of indications is going to lead to increased usage of a scarce product,” and those uses may not always be effective, he said.

Dr. Orange helped design and analyze a new unpublished AAAAI/Immune Deficiency Foundation survey of specialists who treat primary immune deficiency. One of the questions asked members about the impact of the CMS reimbursement. Ninety-five percent said the current policy represented some risk to their patients, Dr. Orange said.

New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, seem poised for a post-Katrina recovery that may put them on better footing than before the floods wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

Tulane and LSU officials are optimistic, but success is far from guaranteed.

“The next 6–12 months will be absolutely critical,” said Barbara Beckman, Ph.D., dean of admissions at Tulane.

For now, officials at both schools say the downsizing may have a silver lining: It may better prepare the institutions to serve a smaller city with fewer physicians, patients, and hospital beds.

In late February, the U.S. General Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Since the hurricane, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. The LSU faculty were furloughed, but most are not expected to return, Dr. Larry Hollier, chancellor of the Health Sciences Center, said in an interview.

Because it is primarily supported by the state, LSU has more of an uphill battle than does Tulane, which has benefited from its hospital being owned by HCA Inc., Dr. Beckman said. Physically, 21 of 22 LSU buildings were seriously damaged by the hurricane and subsequent flooding. All of LSU's teaching facilities were under at least 5 feet of water at some point, Dr. Hollier said.

In the months after the storm, the university was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cuts.

In February, LSU received $50 million in federal hurricane relief money, which was used to help cover resident and faculty salaries. “I never had any doubt that we would keep it going,” Dr. Hollier said.

After the storm, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU has 50 residents–a substantial increase from the 8 before the storm.

But just because LSU found positions for its residents doesn't mean the school was going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements, and LSU does not have any with those new facilities. The school sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver to LSU and all the schools affected by Katrina in an interim final rule. The waiver, which would let schools receive payments retroactive to the storm for residents at any institution, will become final later in the year. Tulane sought the same waiver, said Dr. Ronald Amedee, dean of graduate medical education. Before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, Dr. Amedee said. LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

On a bright note, the chaos in New Orleans has not dissuaded future physicians from seeking residencies at city institutions. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class. “This is one of the most successful matches we've had in decades,” Dr. Amedee said. He said the school attracted top-tier candidates. But they were different than those in years past–many have done charity work in developing countries or with organizations like Habitat for Humanity, and many are seeking a dual master's degree in public health and an MD degree. “This is a group of people that came here and did not see water marks on buildings and debris piled up in the street as a negative–they saw it as a positive,” Dr. Amedee said.

New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, seem poised for a post-Katrina recovery that may put them on better footing than before the floods wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

Tulane and LSU officials are optimistic, but success is far from guaranteed.

“The next 6–12 months will be absolutely critical,” said Barbara Beckman, Ph.D., dean of admissions at Tulane.

For now, officials at both schools say the downsizing may have a silver lining: It may better prepare the institutions to serve a smaller city with fewer physicians, patients, and hospital beds.

In late February, the U.S. General Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Since the hurricane, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. The LSU faculty were furloughed, but most are not expected to return, Dr. Larry Hollier, chancellor of the Health Sciences Center, said in an interview.

Because it is primarily supported by the state, LSU has more of an uphill battle than does Tulane, which has benefited from its hospital being owned by HCA Inc., Dr. Beckman said. Physically, 21 of 22 LSU buildings were seriously damaged by the hurricane and subsequent flooding. All of LSU's teaching facilities were under at least 5 feet of water at some point, Dr. Hollier said.

In the months after the storm, the university was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cuts.

In February, LSU received $50 million in federal hurricane relief money, which was used to help cover resident and faculty salaries. “I never had any doubt that we would keep it going,” Dr. Hollier said.

After the storm, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU has 50 residents–a substantial increase from the 8 before the storm.

But just because LSU found positions for its residents doesn't mean the school was going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements, and LSU does not have any with those new facilities. The school sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver to LSU and all the schools affected by Katrina in an interim final rule. The waiver, which would let schools receive payments retroactive to the storm for residents at any institution, will become final later in the year. Tulane sought the same waiver, said Dr. Ronald Amedee, dean of graduate medical education. Before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, Dr. Amedee said. LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

On a bright note, the chaos in New Orleans has not dissuaded future physicians from seeking residencies at city institutions. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class. “This is one of the most successful matches we've had in decades,” Dr. Amedee said. He said the school attracted top-tier candidates. But they were different than those in years past–many have done charity work in developing countries or with organizations like Habitat for Humanity, and many are seeking a dual master's degree in public health and an MD degree. “This is a group of people that came here and did not see water marks on buildings and debris piled up in the street as a negative–they saw it as a positive,” Dr. Amedee said.

New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, seem poised for a post-Katrina recovery that may put them on better footing than before the floods wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

Tulane and LSU officials are optimistic, but success is far from guaranteed.

“The next 6–12 months will be absolutely critical,” said Barbara Beckman, Ph.D., dean of admissions at Tulane.

For now, officials at both schools say the downsizing may have a silver lining: It may better prepare the institutions to serve a smaller city with fewer physicians, patients, and hospital beds.

In late February, the U.S. General Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Since the hurricane, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. The LSU faculty were furloughed, but most are not expected to return, Dr. Larry Hollier, chancellor of the Health Sciences Center, said in an interview.

Because it is primarily supported by the state, LSU has more of an uphill battle than does Tulane, which has benefited from its hospital being owned by HCA Inc., Dr. Beckman said. Physically, 21 of 22 LSU buildings were seriously damaged by the hurricane and subsequent flooding. All of LSU's teaching facilities were under at least 5 feet of water at some point, Dr. Hollier said.

In the months after the storm, the university was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cuts.

In February, LSU received $50 million in federal hurricane relief money, which was used to help cover resident and faculty salaries. “I never had any doubt that we would keep it going,” Dr. Hollier said.

After the storm, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU has 50 residents–a substantial increase from the 8 before the storm.

But just because LSU found positions for its residents doesn't mean the school was going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements, and LSU does not have any with those new facilities. The school sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver to LSU and all the schools affected by Katrina in an interim final rule. The waiver, which would let schools receive payments retroactive to the storm for residents at any institution, will become final later in the year. Tulane sought the same waiver, said Dr. Ronald Amedee, dean of graduate medical education. Before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, Dr. Amedee said. LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

On a bright note, the chaos in New Orleans has not dissuaded future physicians from seeking residencies at city institutions. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class. “This is one of the most successful matches we've had in decades,” Dr. Amedee said. He said the school attracted top-tier candidates. But they were different than those in years past–many have done charity work in developing countries or with organizations like Habitat for Humanity, and many are seeking a dual master's degree in public health and an MD degree. “This is a group of people that came here and did not see water marks on buildings and debris piled up in the street as a negative–they saw it as a positive,” Dr. Amedee said.

Medicare might not pay for implantation of the Charité artificial spinal disk if a proposed coverage decision becomes final in May.

According to the Centers for Medicare and Medicaid Services proposal, the evidence is not adequate to conclude that disk replacement with the Charité “is reasonable and necessary.”

CMS is accepting comments through April and will make a final decision May 6. The agency said it found few data in patients older than 65 and that the results of the pivotal Charité study “are unconvincing as a demonstration of net health benefit.”

Several specialty societies—including the North American Spine Society, the Scoliosis Research Society, and the Spine Arthroplasty Society—have commented, mostly saying that the jury is still out on older patients. The American Association of Neurological Surgeons and the Congress of Neurological Surgeons said the surgeon should decide what is best, adding that not enough data on patients older than 60 years existed “to demonstrate that this procedure is inappropriate for elderly patients.”

The Charité was approved by the Food and Drug Administration last November, but it has not been widely adopted and is rarely being paid for by insurers. So far, 176 procedures have been covered by insurers; Medicare has paid for a few cases as well, said Dr. Richard Toselli, worldwide vice president for research and development at DePuy Spine Inc. of Raynham, Mass., manufacturer of the Charité disk.

The disk is indicated for 18- to 60-year-old patients with degenerative disk disease at one level, either L4/L5 or L5/S1. It has not been studied in patients older than age 60.

CMS began its coverage review at the request of Dr. Richard Deyo, an internist and professor of medicine and health services at the University of Washington, Seattle. In an interview, Dr. Deyo said he was concerned about the safety of the Charité in older patients partly because osteopenia and osteoporosis are contraindications.

Dr. Deyo also said the Charité had shown in trials only that it was not inferior to a type of fusion—Bagby and Kuslich (BAK) cages with iliac crest bone graft—a procedure he called “largely discredited.”

The disk is not intended to be implanted in patients older than age 65, so Medicare's proposal did not come as a great surprise, Dr. Toselli said in an interview.

DePuy Spine is hoping that Medicare will pay for Charité implantation in its disabled beneficiaries, he said. Medicare has 42 million beneficiaries; about 6.5 million are younger than age 65 and disabled.

A split coverage decision would not be unprecedented. A CMS spokesman said the agency has in the past covered procedures or therapies for subgroups of the Medicare population, or has imposed restrictions on the prescribing or use of a device or therapy.

In its Charité proposal, however, CMS said the data did not seem to support using the disk in the disabled, either.

Medicare might not pay for implantation of the Charité artificial spinal disk if a proposed coverage decision becomes final in May.

According to the Centers for Medicare and Medicaid Services proposal, the evidence is not adequate to conclude that disk replacement with the Charité “is reasonable and necessary.”

CMS is accepting comments through April and will make a final decision May 6. The agency said it found few data in patients older than 65 and that the results of the pivotal Charité study “are unconvincing as a demonstration of net health benefit.”

Several specialty societies—including the North American Spine Society, the Scoliosis Research Society, and the Spine Arthroplasty Society—have commented, mostly saying that the jury is still out on older patients. The American Association of Neurological Surgeons and the Congress of Neurological Surgeons said the surgeon should decide what is best, adding that not enough data on patients older than 60 years existed “to demonstrate that this procedure is inappropriate for elderly patients.”

The Charité was approved by the Food and Drug Administration last November, but it has not been widely adopted and is rarely being paid for by insurers. So far, 176 procedures have been covered by insurers; Medicare has paid for a few cases as well, said Dr. Richard Toselli, worldwide vice president for research and development at DePuy Spine Inc. of Raynham, Mass., manufacturer of the Charité disk.

The disk is indicated for 18- to 60-year-old patients with degenerative disk disease at one level, either L4/L5 or L5/S1. It has not been studied in patients older than age 60.

CMS began its coverage review at the request of Dr. Richard Deyo, an internist and professor of medicine and health services at the University of Washington, Seattle. In an interview, Dr. Deyo said he was concerned about the safety of the Charité in older patients partly because osteopenia and osteoporosis are contraindications.

Dr. Deyo also said the Charité had shown in trials only that it was not inferior to a type of fusion—Bagby and Kuslich (BAK) cages with iliac crest bone graft—a procedure he called “largely discredited.”

The disk is not intended to be implanted in patients older than age 65, so Medicare's proposal did not come as a great surprise, Dr. Toselli said in an interview.

DePuy Spine is hoping that Medicare will pay for Charité implantation in its disabled beneficiaries, he said. Medicare has 42 million beneficiaries; about 6.5 million are younger than age 65 and disabled.

A split coverage decision would not be unprecedented. A CMS spokesman said the agency has in the past covered procedures or therapies for subgroups of the Medicare population, or has imposed restrictions on the prescribing or use of a device or therapy.

In its Charité proposal, however, CMS said the data did not seem to support using the disk in the disabled, either.

Medicare might not pay for implantation of the Charité artificial spinal disk if a proposed coverage decision becomes final in May.

According to the Centers for Medicare and Medicaid Services proposal, the evidence is not adequate to conclude that disk replacement with the Charité “is reasonable and necessary.”

CMS is accepting comments through April and will make a final decision May 6. The agency said it found few data in patients older than 65 and that the results of the pivotal Charité study “are unconvincing as a demonstration of net health benefit.”

Several specialty societies—including the North American Spine Society, the Scoliosis Research Society, and the Spine Arthroplasty Society—have commented, mostly saying that the jury is still out on older patients. The American Association of Neurological Surgeons and the Congress of Neurological Surgeons said the surgeon should decide what is best, adding that not enough data on patients older than 60 years existed “to demonstrate that this procedure is inappropriate for elderly patients.”

The Charité was approved by the Food and Drug Administration last November, but it has not been widely adopted and is rarely being paid for by insurers. So far, 176 procedures have been covered by insurers; Medicare has paid for a few cases as well, said Dr. Richard Toselli, worldwide vice president for research and development at DePuy Spine Inc. of Raynham, Mass., manufacturer of the Charité disk.

The disk is indicated for 18- to 60-year-old patients with degenerative disk disease at one level, either L4/L5 or L5/S1. It has not been studied in patients older than age 60.

CMS began its coverage review at the request of Dr. Richard Deyo, an internist and professor of medicine and health services at the University of Washington, Seattle. In an interview, Dr. Deyo said he was concerned about the safety of the Charité in older patients partly because osteopenia and osteoporosis are contraindications.

Dr. Deyo also said the Charité had shown in trials only that it was not inferior to a type of fusion—Bagby and Kuslich (BAK) cages with iliac crest bone graft—a procedure he called “largely discredited.”

The disk is not intended to be implanted in patients older than age 65, so Medicare's proposal did not come as a great surprise, Dr. Toselli said in an interview.

DePuy Spine is hoping that Medicare will pay for Charité implantation in its disabled beneficiaries, he said. Medicare has 42 million beneficiaries; about 6.5 million are younger than age 65 and disabled.

A split coverage decision would not be unprecedented. A CMS spokesman said the agency has in the past covered procedures or therapies for subgroups of the Medicare population, or has imposed restrictions on the prescribing or use of a device or therapy.

In its Charité proposal, however, CMS said the data did not seem to support using the disk in the disabled, either.

Downsizing may put New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, on sounder financial footing than they were before the floods of Hurricane Katrina wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

Closure of several hospitals and clinics affiliated with those schools is of concern now, but Dr. Larry Hollier, chancellor of the LSU Health Sciences Center predicted that a new primary care system under consideration eventually could better serve the city's charity care needs. Louisiana had the second highest number of uninsured individuals in the nation in 2005. Access and payment issues, however, continue to be a concern in the interim.

In late February, the federal Government Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. (See box.) Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Just two of the city's nine hospitals are fully reopened. A third, Tulane University Hospital and Clinic, has opened 62 of its 237 beds. Before the storm, 90 clinics, including 70 that were operated by the state, provided care for the uninsured. Now just 10 are open, and most are operating at 50% or less capacity, according to the U.S. Government Accountability Office

Hurricane Katrina accelerated a long-simmering debate about what to do with the city's main charity care facilities—University and Charity hospitals, both owned by the state and operated by Louisiana State University. Charity Hospital is housed in a 21-story facility built in 1939, but has been in continuous operation since 1736. University Hospital was built in the 1960s. Together they had 500 beds; Charity was the central service site for the uninsured, but was deteriorating before Katrina, said Dr. Larry Hollier, chancellor of the LSU Health Sciences Center, in an interview.

LSU has said that it will not reopen Charity, but that it will reopen University on a phased-in basis, with 100 beds in July, 200 by November, and 250 by January. An LSU-hired consultant estimated that it would take $117 million to repair University and $257 million to get Charity back in operation. But the Federal Emergency Management Agency—which is slated to pay for the hospitals' recovery because they are in a federal disaster area—had much lower estimates: $12 million for University and $24 million for Charity, according to the GAO report.

Without Charity, the uninsured are migrating to private hospitals. Tulane University Hospital is seeing more uninsured patients these days—about 30% of its patient visits. “That's a huge increase” from before the hurricane, said Dr. Ronald Amedee, dean of graduate medical education at Tulane.

Dr. Hollier, his LSU colleagues, and state government officials are proposing to build a new hospital in conjunction with the Department of Veterans Affairs, which also lost its 206-bed facility. “We need more third-party payers,” he said in an interview, noting that Louisiana pays for most of the charity care in a state where 23% of the population is uninsured.

So far, Congress has approved $75 million in planning funds, and the Bush Administration set aside $600 million for new construction in the hurricane relief package. But the joint hospital plan still needs to be approved and fully funded by Congress. The soonest that could happen is the end of the year, Dr. Hollier said.

“Everybody understands the urgency of this to the city,” Dr. Hollier said. But under the new post-Katrina system, “I think there will be better access for the uninsured.” Under a plan being advanced by LSU, the state would open more primary care clinics around the city. But it's not yet clear who will pay for those clinics, he said. And with so many neighborhoods still sitting empty, no one knows where those clinics would be built or whether there will be anyone to serve in those areas.

With all seven of LSU's teaching hospitals initially out of commission, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU now has 50 residents—a substantial increase from the 8 who served there before the storm.

Dr. Ronald Amedee, dean of graduate medical education at Tulane, said that before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, he said.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

But just because Tulane and LSU found positions for its residents doesn't mean the schools are going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements. The schools sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver, which would let schools receive payments retroactive to the storm for residents at any institution and will become final later in the year.

Since the hurricane, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. LSU faculty members were furloughed, but most are not expected to return, according to Dr. Hollier.

Primarily supported by the state, LSU has more of an uphill financial battle than does Tulane, which has benefited from its hospital being owned by HCA Inc.

In the months after the storm, LSU was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks. In February, LSU received $50 million in federal hurricane relief, distributed by the state-run Louisiana Recovery Authority to help cover resident and faculty salaries.

On a bright note, the medical schools and residency programs are experiencing intense interest. At LSU, 76 of the 172 students in their graduating medical school class decided to stay in-state for residency. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

“This is one of the most successful matches we've had in decades,” Dr. Amedee said. “We really hit it big.”

Tulane aims to reopen its medical school in July. Tulane had moved all 155 of its first- and second-year students to Baylor College of Medicine in Houston, where they are taking classes from the 150–200 faculty still on the Tulane payroll. The third and fourth years are taking electives in Louisiana, Texas, and elsewhere.

Dr. Hollier said he expected LSU medical and nursing students to start attending classes in the city in July; medical school applications are on par with previous years.

At Tulane, about 8,000 students have applied for 155 positions. The school attracted top-tier candidates. But they were different than those in years past—many have done charity work in developing countries or with organizations like Habitat for Humanity, and many are seeking a dual master's degree in public health and an MD degree.

“This is a group of people that came here and did not see water marks on buildings and debris piled up in the street as a negative—they saw it as a positive,” Dr. Amedee said.

“I've got an overfilled class,” said Barbara Beckman, Ph.D., dean of admissions at the Tulane Medical School, noting that Tulane always has a large number of applicants, but “what's different this year is the enthusiasm level.”

Dr. Beckman added: “I wouldn't be anywhere else, and I think that's what the students feel.”

ELSEVIER GLOBAL MEDICAL NEWS

Downsizing may put New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, on sounder financial footing than they were before the floods of Hurricane Katrina wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

Closure of several hospitals and clinics affiliated with those schools is of concern now, but Dr. Larry Hollier, chancellor of the LSU Health Sciences Center predicted that a new primary care system under consideration eventually could better serve the city's charity care needs. Louisiana had the second highest number of uninsured individuals in the nation in 2005. Access and payment issues, however, continue to be a concern in the interim.

In late February, the federal Government Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. (See box.) Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Just two of the city's nine hospitals are fully reopened. A third, Tulane University Hospital and Clinic, has opened 62 of its 237 beds. Before the storm, 90 clinics, including 70 that were operated by the state, provided care for the uninsured. Now just 10 are open, and most are operating at 50% or less capacity, according to the U.S. Government Accountability Office

Hurricane Katrina accelerated a long-simmering debate about what to do with the city's main charity care facilities—University and Charity hospitals, both owned by the state and operated by Louisiana State University. Charity Hospital is housed in a 21-story facility built in 1939, but has been in continuous operation since 1736. University Hospital was built in the 1960s. Together they had 500 beds; Charity was the central service site for the uninsured, but was deteriorating before Katrina, said Dr. Larry Hollier, chancellor of the LSU Health Sciences Center, in an interview.

LSU has said that it will not reopen Charity, but that it will reopen University on a phased-in basis, with 100 beds in July, 200 by November, and 250 by January. An LSU-hired consultant estimated that it would take $117 million to repair University and $257 million to get Charity back in operation. But the Federal Emergency Management Agency—which is slated to pay for the hospitals' recovery because they are in a federal disaster area—had much lower estimates: $12 million for University and $24 million for Charity, according to the GAO report.

Without Charity, the uninsured are migrating to private hospitals. Tulane University Hospital is seeing more uninsured patients these days—about 30% of its patient visits. “That's a huge increase” from before the hurricane, said Dr. Ronald Amedee, dean of graduate medical education at Tulane.

Dr. Hollier, his LSU colleagues, and state government officials are proposing to build a new hospital in conjunction with the Department of Veterans Affairs, which also lost its 206-bed facility. “We need more third-party payers,” he said in an interview, noting that Louisiana pays for most of the charity care in a state where 23% of the population is uninsured.

So far, Congress has approved $75 million in planning funds, and the Bush Administration set aside $600 million for new construction in the hurricane relief package. But the joint hospital plan still needs to be approved and fully funded by Congress. The soonest that could happen is the end of the year, Dr. Hollier said.

“Everybody understands the urgency of this to the city,” Dr. Hollier said. But under the new post-Katrina system, “I think there will be better access for the uninsured.” Under a plan being advanced by LSU, the state would open more primary care clinics around the city. But it's not yet clear who will pay for those clinics, he said. And with so many neighborhoods still sitting empty, no one knows where those clinics would be built or whether there will be anyone to serve in those areas.

With all seven of LSU's teaching hospitals initially out of commission, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU now has 50 residents—a substantial increase from the 8 who served there before the storm.

Dr. Ronald Amedee, dean of graduate medical education at Tulane, said that before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, he said.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

But just because Tulane and LSU found positions for its residents doesn't mean the schools are going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements. The schools sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver, which would let schools receive payments retroactive to the storm for residents at any institution and will become final later in the year.

Since the hurricane, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. LSU faculty members were furloughed, but most are not expected to return, according to Dr. Hollier.

Primarily supported by the state, LSU has more of an uphill financial battle than does Tulane, which has benefited from its hospital being owned by HCA Inc.

In the months after the storm, LSU was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks. In February, LSU received $50 million in federal hurricane relief, distributed by the state-run Louisiana Recovery Authority to help cover resident and faculty salaries.

On a bright note, the medical schools and residency programs are experiencing intense interest. At LSU, 76 of the 172 students in their graduating medical school class decided to stay in-state for residency. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

“This is one of the most successful matches we've had in decades,” Dr. Amedee said. “We really hit it big.”

Tulane aims to reopen its medical school in July. Tulane had moved all 155 of its first- and second-year students to Baylor College of Medicine in Houston, where they are taking classes from the 150–200 faculty still on the Tulane payroll. The third and fourth years are taking electives in Louisiana, Texas, and elsewhere.

Dr. Hollier said he expected LSU medical and nursing students to start attending classes in the city in July; medical school applications are on par with previous years.

At Tulane, about 8,000 students have applied for 155 positions. The school attracted top-tier candidates. But they were different than those in years past—many have done charity work in developing countries or with organizations like Habitat for Humanity, and many are seeking a dual master's degree in public health and an MD degree.

“This is a group of people that came here and did not see water marks on buildings and debris piled up in the street as a negative—they saw it as a positive,” Dr. Amedee said.

“I've got an overfilled class,” said Barbara Beckman, Ph.D., dean of admissions at the Tulane Medical School, noting that Tulane always has a large number of applicants, but “what's different this year is the enthusiasm level.”

Dr. Beckman added: “I wouldn't be anywhere else, and I think that's what the students feel.”

ELSEVIER GLOBAL MEDICAL NEWS

Downsizing may put New Orleans' two medical schools, Tulane University and Louisiana State University Health Sciences Center, on sounder financial footing than they were before the floods of Hurricane Katrina wiped out much of their infrastructure and dispersed their faculty, residents, and student bodies.

Closure of several hospitals and clinics affiliated with those schools is of concern now, but Dr. Larry Hollier, chancellor of the LSU Health Sciences Center predicted that a new primary care system under consideration eventually could better serve the city's charity care needs. Louisiana had the second highest number of uninsured individuals in the nation in 2005. Access and payment issues, however, continue to be a concern in the interim.

In late February, the federal Government Accountability Office estimated that only 456 beds were open at three hospitals in the city, down from 2,269 before the storm. (See box.) Outside the city, about 1,528 beds out of a total 1,814 had reopened.

Just two of the city's nine hospitals are fully reopened. A third, Tulane University Hospital and Clinic, has opened 62 of its 237 beds. Before the storm, 90 clinics, including 70 that were operated by the state, provided care for the uninsured. Now just 10 are open, and most are operating at 50% or less capacity, according to the U.S. Government Accountability Office

Hurricane Katrina accelerated a long-simmering debate about what to do with the city's main charity care facilities—University and Charity hospitals, both owned by the state and operated by Louisiana State University. Charity Hospital is housed in a 21-story facility built in 1939, but has been in continuous operation since 1736. University Hospital was built in the 1960s. Together they had 500 beds; Charity was the central service site for the uninsured, but was deteriorating before Katrina, said Dr. Larry Hollier, chancellor of the LSU Health Sciences Center, in an interview.

LSU has said that it will not reopen Charity, but that it will reopen University on a phased-in basis, with 100 beds in July, 200 by November, and 250 by January. An LSU-hired consultant estimated that it would take $117 million to repair University and $257 million to get Charity back in operation. But the Federal Emergency Management Agency—which is slated to pay for the hospitals' recovery because they are in a federal disaster area—had much lower estimates: $12 million for University and $24 million for Charity, according to the GAO report.

Without Charity, the uninsured are migrating to private hospitals. Tulane University Hospital is seeing more uninsured patients these days—about 30% of its patient visits. “That's a huge increase” from before the hurricane, said Dr. Ronald Amedee, dean of graduate medical education at Tulane.

Dr. Hollier, his LSU colleagues, and state government officials are proposing to build a new hospital in conjunction with the Department of Veterans Affairs, which also lost its 206-bed facility. “We need more third-party payers,” he said in an interview, noting that Louisiana pays for most of the charity care in a state where 23% of the population is uninsured.

So far, Congress has approved $75 million in planning funds, and the Bush Administration set aside $600 million for new construction in the hurricane relief package. But the joint hospital plan still needs to be approved and fully funded by Congress. The soonest that could happen is the end of the year, Dr. Hollier said.

“Everybody understands the urgency of this to the city,” Dr. Hollier said. But under the new post-Katrina system, “I think there will be better access for the uninsured.” Under a plan being advanced by LSU, the state would open more primary care clinics around the city. But it's not yet clear who will pay for those clinics, he said. And with so many neighborhoods still sitting empty, no one knows where those clinics would be built or whether there will be anyone to serve in those areas.

With all seven of LSU's teaching hospitals initially out of commission, LSU moved its residents to hospitals outside the city and across the state, in particular to Baton Rouge. Some are now back at work in New Orleans. At Touro Infirmary, which is down to 250 beds (from 345), LSU now has 50 residents—a substantial increase from the 8 who served there before the storm.

Dr. Ronald Amedee, dean of graduate medical education at Tulane, said that before the storm, the school had 46 fully accredited programs and 521 residents and fellows in the city. With the evacuation and closures, 217 were transferred to Texas Medical Center, 200 to other sites in Louisiana, and 110 to facilities across the United States. Before the storm, Tulane had agreements with 13 institutions; residents are now at 91 different hospitals, he said.

LSU had 802 residents at 12 teaching hospitals around the state before the storm. Most were moved to other hospitals in Louisiana, and 100 have been granted permanent transfers.

But just because Tulane and LSU found positions for its residents doesn't mean the schools are going to be paid for their salaries and upkeep. Under the federal graduate medical education program, schools are required to have affiliation agreements. The schools sought a waiver from the Centers for Medicare and Medicaid Services to receive payment for those new slots.

In April, CMS announced its intention to grant the waiver, which would let schools receive payments retroactive to the storm for residents at any institution and will become final later in the year.

Since the hurricane, 132 medical faculty members at Tulane and 270 at LSU have lost their jobs. LSU faculty members were furloughed, but most are not expected to return, according to Dr. Hollier.

Primarily supported by the state, LSU has more of an uphill financial battle than does Tulane, which has benefited from its hospital being owned by HCA Inc.

In the months after the storm, LSU was losing $13 million a month, and at the end of 2005, it was facing a $50 million deficit even after $63 million in cutbacks. In February, LSU received $50 million in federal hurricane relief, distributed by the state-run Louisiana Recovery Authority to help cover resident and faculty salaries.

On a bright note, the medical schools and residency programs are experiencing intense interest. At LSU, 76 of the 172 students in their graduating medical school class decided to stay in-state for residency. Tulane's 70 residency slots were easily filled; 20 are from the medical school's 2006 graduating class.

“This is one of the most successful matches we've had in decades,” Dr. Amedee said. “We really hit it big.”

Tulane aims to reopen its medical school in July. Tulane had moved all 155 of its first- and second-year students to Baylor College of Medicine in Houston, where they are taking classes from the 150–200 faculty still on the Tulane payroll. The third and fourth years are taking electives in Louisiana, Texas, and elsewhere.

Dr. Hollier said he expected LSU medical and nursing students to start attending classes in the city in July; medical school applications are on par with previous years.

At Tulane, about 8,000 students have applied for 155 positions. The school attracted top-tier candidates. But they were different than those in years past—many have done charity work in developing countries or with organizations like Habitat for Humanity, and many are seeking a dual master's degree in public health and an MD degree.

“This is a group of people that came here and did not see water marks on buildings and debris piled up in the street as a negative—they saw it as a positive,” Dr. Amedee said.

“I've got an overfilled class,” said Barbara Beckman, Ph.D., dean of admissions at the Tulane Medical School, noting that Tulane always has a large number of applicants, but “what's different this year is the enthusiasm level.”

Dr. Beckman added: “I wouldn't be anywhere else, and I think that's what the students feel.”

ELSEVIER GLOBAL MEDICAL NEWS

Physicians as well as patient and industry representatives say that a congressionally imposed reduction in Medicare reimbursement for intravenous immunoglobulin—when combined with several other factors—is having a devastating impact on access to the therapy, leading to more infections and serious illnesses among patients.

The payment scheme went into effect for physician offices in 2005 and for hospitals starting in January, and was partly a reaction by the Centers for Medicare and Medicaid Services to rising intravenous immunoglobulin (IVIG) use, Bruce Kruger, director of practice and policy for the American Academy of Allergy, Asthma, and Immunology (AAAAI), said in an interview.

The immune therapy is approved for primary immunodeficiency, idiopathic thrombocytopenic purpura, Kawasaki disease, chronic lymphocytic leukemia, pediatric HIV infection, and allogeneic bone marrow transplantation. There has been growing off-label use for infectious diseases; neurologic diseases such as myasthenia gravis, multiple sclerosis, and polymyositis; hematologic diseases, allergies, and transplantation.

About 17% of the 50,000 people who receive IVIG for primary immune therapy are Medicare eligible and have been the first to start experiencing access issues, said Marcia Boyle, president of the Immune Deficiency Foundation (IDF). Ms. Boyle and Mr. Kruger said that private insurers are following Medicare's lead and also are starting to cut IVIG payments.

At the same time, supplies of the hard-to-make therapy—it takes up to a year to create—have tightened, partly because of rising demand. From 2000 to 2005, manufacturers increased supplies by 60%, but it still was not enough, Julie Birkhofer, executive director, North America, of the Plasma Protein Therapeutics Association (PPTA), said in an interview.

Another problem: Much of the supply is tied up in physician offices, and they have stopped offering infusions because of the decreased payments. In a study commissioned by the IVIG Summit Group (which includes the PPTA, the IDF, several medical association, and individual physicians), the Lewin Group found that physicians are losing an average $400 per infusion, and that the losses pile up with increasing infusions. At 10 infusions, a physician would tally a $3,100 loss, according to Lewin.

The IDF and others say that patients have begun migrating to hospitals as physicians shut down infusion services, but that hospitals also are curbing IVIG infusions as the lower reimbursement hits them.

An IDF-funded study presented as a poster at the AAAAI's annual meeting in March found that 39% of the 202 patients with primary immune deficiencies surveyed said they had problems in getting their IVIG therapy from June 2004 to June 2005, including postponed infusions, increased intervals between infusions, and being switched to a less-tolerated product.

The physician's office is considered a safer environment than a hospital for an immune-compromised patient. Infusions, usually given monthly, generally cost $5,000. CMS has been reimbursing physicians for the average sales price plus 6%, and in 2006, added a $69-per-infusion payment to cover administrative costs.

In 2005, CMS was paying hospitals 83% of the average wholesale price, which was a slightly higher reimbursement. But in 2006, hospitals also were moved to the average sales price plus 6% rate, which Lewin estimated as a 9% shortfall between the acquisition cost and the Medicare payment, said Ms. Birkhofer. Hospitals were also given an additional $75 for administration.

The PPTA, the AAAAI, and others are seeking an add-on payment for the product and to assign Health Care Common Procedure Codes to each brand of IVIG. Currently, all 10 available brands are bundled under one code, which gives physicians an incentive to prescribe the lowest-cost IVIG, said Ms. Birkhofer. That can affect patient access and care because not every patient can tolerate the same brand of IVIG, she said.

PPTA has received a legal opinion that CMS can adjust the payment through a rule or some other administrative mechanism.

Mr. Kruger said a payment add-on may be an interim solution, but long term, the demand issue should be addressed. “We're not so naïve to think that all therapy that was being provided was appropriate and necessary,” he said.

AAAAI's Primary Immunodeficiency Committee has assembled a review of evidence supporting IVIG use in various conditions. The panel reviewed 80 indications, said Dr. Jordan S. Orange of the University of Pennsylvania, Philadelphia, and lead author of the review (J. Allergy Clin. Immunol. 2006;117:S525–53).

The paper aims “to emphasize the importance of selecting patients for immunoglobulin very carefully,” Dr. Orange said. “Pushing the boundaries of indications is going to lead to increased usage of a scarce product,” and those uses may not always be effective, he said.

But he also agreed that reimbursement is an issue. Dr. Orange helped design and analyze a new unpublished AAAAI/Immune Deficiency Foundation survey of specialists who treat primary immune deficiency. One of the questions asked members about the impact of the CMS reimbursement. Overall, 95% said that the current policy represented some risk to their patients, Dr. Orange said.

Physicians as well as patient and industry representatives say that a congressionally imposed reduction in Medicare reimbursement for intravenous immunoglobulin—when combined with several other factors—is having a devastating impact on access to the therapy, leading to more infections and serious illnesses among patients.

The payment scheme went into effect for physician offices in 2005 and for hospitals starting in January, and was partly a reaction by the Centers for Medicare and Medicaid Services to rising intravenous immunoglobulin (IVIG) use, Bruce Kruger, director of practice and policy for the American Academy of Allergy, Asthma, and Immunology (AAAAI), said in an interview.

The immune therapy is approved for primary immunodeficiency, idiopathic thrombocytopenic purpura, Kawasaki disease, chronic lymphocytic leukemia, pediatric HIV infection, and allogeneic bone marrow transplantation. There has been growing off-label use for infectious diseases; neurologic diseases such as myasthenia gravis, multiple sclerosis, and polymyositis; hematologic diseases, allergies, and transplantation.

About 17% of the 50,000 people who receive IVIG for primary immune therapy are Medicare eligible and have been the first to start experiencing access issues, said Marcia Boyle, president of the Immune Deficiency Foundation (IDF). Ms. Boyle and Mr. Kruger said that private insurers are following Medicare's lead and also are starting to cut IVIG payments.

At the same time, supplies of the hard-to-make therapy—it takes up to a year to create—have tightened, partly because of rising demand. From 2000 to 2005, manufacturers increased supplies by 60%, but it still was not enough, Julie Birkhofer, executive director, North America, of the Plasma Protein Therapeutics Association (PPTA), said in an interview.

Another problem: Much of the supply is tied up in physician offices, and they have stopped offering infusions because of the decreased payments. In a study commissioned by the IVIG Summit Group (which includes the PPTA, the IDF, several medical association, and individual physicians), the Lewin Group found that physicians are losing an average $400 per infusion, and that the losses pile up with increasing infusions. At 10 infusions, a physician would tally a $3,100 loss, according to Lewin.

The IDF and others say that patients have begun migrating to hospitals as physicians shut down infusion services, but that hospitals also are curbing IVIG infusions as the lower reimbursement hits them.

An IDF-funded study presented as a poster at the AAAAI's annual meeting in March found that 39% of the 202 patients with primary immune deficiencies surveyed said they had problems in getting their IVIG therapy from June 2004 to June 2005, including postponed infusions, increased intervals between infusions, and being switched to a less-tolerated product.

The physician's office is considered a safer environment than a hospital for an immune-compromised patient. Infusions, usually given monthly, generally cost $5,000. CMS has been reimbursing physicians for the average sales price plus 6%, and in 2006, added a $69-per-infusion payment to cover administrative costs.

In 2005, CMS was paying hospitals 83% of the average wholesale price, which was a slightly higher reimbursement. But in 2006, hospitals also were moved to the average sales price plus 6% rate, which Lewin estimated as a 9% shortfall between the acquisition cost and the Medicare payment, said Ms. Birkhofer. Hospitals were also given an additional $75 for administration.

The PPTA, the AAAAI, and others are seeking an add-on payment for the product and to assign Health Care Common Procedure Codes to each brand of IVIG. Currently, all 10 available brands are bundled under one code, which gives physicians an incentive to prescribe the lowest-cost IVIG, said Ms. Birkhofer. That can affect patient access and care because not every patient can tolerate the same brand of IVIG, she said.

PPTA has received a legal opinion that CMS can adjust the payment through a rule or some other administrative mechanism.

Mr. Kruger said a payment add-on may be an interim solution, but long term, the demand issue should be addressed. “We're not so naïve to think that all therapy that was being provided was appropriate and necessary,” he said.

AAAAI's Primary Immunodeficiency Committee has assembled a review of evidence supporting IVIG use in various conditions. The panel reviewed 80 indications, said Dr. Jordan S. Orange of the University of Pennsylvania, Philadelphia, and lead author of the review (J. Allergy Clin. Immunol. 2006;117:S525–53).

The paper aims “to emphasize the importance of selecting patients for immunoglobulin very carefully,” Dr. Orange said. “Pushing the boundaries of indications is going to lead to increased usage of a scarce product,” and those uses may not always be effective, he said.

But he also agreed that reimbursement is an issue. Dr. Orange helped design and analyze a new unpublished AAAAI/Immune Deficiency Foundation survey of specialists who treat primary immune deficiency. One of the questions asked members about the impact of the CMS reimbursement. Overall, 95% said that the current policy represented some risk to their patients, Dr. Orange said.

Physicians as well as patient and industry representatives say that a congressionally imposed reduction in Medicare reimbursement for intravenous immunoglobulin—when combined with several other factors—is having a devastating impact on access to the therapy, leading to more infections and serious illnesses among patients.

The payment scheme went into effect for physician offices in 2005 and for hospitals starting in January, and was partly a reaction by the Centers for Medicare and Medicaid Services to rising intravenous immunoglobulin (IVIG) use, Bruce Kruger, director of practice and policy for the American Academy of Allergy, Asthma, and Immunology (AAAAI), said in an interview.

The immune therapy is approved for primary immunodeficiency, idiopathic thrombocytopenic purpura, Kawasaki disease, chronic lymphocytic leukemia, pediatric HIV infection, and allogeneic bone marrow transplantation. There has been growing off-label use for infectious diseases; neurologic diseases such as myasthenia gravis, multiple sclerosis, and polymyositis; hematologic diseases, allergies, and transplantation.

About 17% of the 50,000 people who receive IVIG for primary immune therapy are Medicare eligible and have been the first to start experiencing access issues, said Marcia Boyle, president of the Immune Deficiency Foundation (IDF). Ms. Boyle and Mr. Kruger said that private insurers are following Medicare's lead and also are starting to cut IVIG payments.

At the same time, supplies of the hard-to-make therapy—it takes up to a year to create—have tightened, partly because of rising demand. From 2000 to 2005, manufacturers increased supplies by 60%, but it still was not enough, Julie Birkhofer, executive director, North America, of the Plasma Protein Therapeutics Association (PPTA), said in an interview.

Another problem: Much of the supply is tied up in physician offices, and they have stopped offering infusions because of the decreased payments. In a study commissioned by the IVIG Summit Group (which includes the PPTA, the IDF, several medical association, and individual physicians), the Lewin Group found that physicians are losing an average $400 per infusion, and that the losses pile up with increasing infusions. At 10 infusions, a physician would tally a $3,100 loss, according to Lewin.

The IDF and others say that patients have begun migrating to hospitals as physicians shut down infusion services, but that hospitals also are curbing IVIG infusions as the lower reimbursement hits them.

An IDF-funded study presented as a poster at the AAAAI's annual meeting in March found that 39% of the 202 patients with primary immune deficiencies surveyed said they had problems in getting their IVIG therapy from June 2004 to June 2005, including postponed infusions, increased intervals between infusions, and being switched to a less-tolerated product.

The physician's office is considered a safer environment than a hospital for an immune-compromised patient. Infusions, usually given monthly, generally cost $5,000. CMS has been reimbursing physicians for the average sales price plus 6%, and in 2006, added a $69-per-infusion payment to cover administrative costs.

In 2005, CMS was paying hospitals 83% of the average wholesale price, which was a slightly higher reimbursement. But in 2006, hospitals also were moved to the average sales price plus 6% rate, which Lewin estimated as a 9% shortfall between the acquisition cost and the Medicare payment, said Ms. Birkhofer. Hospitals were also given an additional $75 for administration.

The PPTA, the AAAAI, and others are seeking an add-on payment for the product and to assign Health Care Common Procedure Codes to each brand of IVIG. Currently, all 10 available brands are bundled under one code, which gives physicians an incentive to prescribe the lowest-cost IVIG, said Ms. Birkhofer. That can affect patient access and care because not every patient can tolerate the same brand of IVIG, she said.

PPTA has received a legal opinion that CMS can adjust the payment through a rule or some other administrative mechanism.

Mr. Kruger said a payment add-on may be an interim solution, but long term, the demand issue should be addressed. “We're not so naïve to think that all therapy that was being provided was appropriate and necessary,” he said.

AAAAI's Primary Immunodeficiency Committee has assembled a review of evidence supporting IVIG use in various conditions. The panel reviewed 80 indications, said Dr. Jordan S. Orange of the University of Pennsylvania, Philadelphia, and lead author of the review (J. Allergy Clin. Immunol. 2006;117:S525–53).

The paper aims “to emphasize the importance of selecting patients for immunoglobulin very carefully,” Dr. Orange said. “Pushing the boundaries of indications is going to lead to increased usage of a scarce product,” and those uses may not always be effective, he said.

But he also agreed that reimbursement is an issue. Dr. Orange helped design and analyze a new unpublished AAAAI/Immune Deficiency Foundation survey of specialists who treat primary immune deficiency. One of the questions asked members about the impact of the CMS reimbursement. Overall, 95% said that the current policy represented some risk to their patients, Dr. Orange said.

ROCKVILLE, MD. — The Food and Drug Administration's Anti-Infective Advisory Committee unanimously supported the approval of daptomycin (Cubicin) for Staphylococcus aureus bacteremia, but was not as certain that the drug was safe and effective for infective endocarditis.

And despite the 9–0 vote on bacteremia, the panel had reservations. “I was shocked at how low the overall cure rate was,” said Dr. Jan Patterson, a committee member and professor of medicine at the University of Texas, San Antonio. “Nonetheless, it was as good as current therapy.”

By a narrow 5–4 margin, the panel voted to approve daptomycin for infective endocarditis (IE). Those in favor of approval said that since the drug was already being used off label—Cubist Pharmaceuticals estimated that 25% of off-label use is for S. aureus bacteremia—that physicians should get better guidance.

Daptomycin was approved in 2003 for complicated skin and skin structure infections. Most physicians have been prescribing it at 4 mg/kg, but daptomycin was tested at 6 mg/kg for bacteremia and IE.

Panelists who voted against approval of daptomycin for IE said there were too few patients in that arm to draw a conclusion.

The FDA usually follows the advice of its advisory panels. In fact, within a few weeks of the meeting, the agency told Cubist that daptomycin was approvable, pending negotiations over the drug's label.

Cubist presented data from a 44-site, 236-patient trial, conducted during 2002–2005. Patients were randomized to daptomycin 6 mg/kg IV every 24 hours or vancomycin 1 g IV every 12 hours plus gentamicin 1 mg/kg every 8 hours for 4 days, or antistaphylococcus penicillin 2 g every 4 hours, plus the gentamicin regimen. The intent-to-treat population was 120 patients in the daptomycin arm and 115 in the comparator arms. Patients had to have a positive blood culture within 2 days of enrollment.

The investigators judged success or failure at the end of therapy. Success was defined as being clinically cured or improved, having a negative blood culture, and not receiving a potentially effective nonstudy antibiotic. Cure was assessed by a blinded independent adjudication panel 6 weeks after end of therapy.

The panel determined that the overall success rate, which included bacteremia and endocarditis, was 44% (53 of 120) for daptomycin and 42% (48 of 115) for the comparator group. The daptomycin and comparator success rates were higher for uncomplicated (56% and 55%) than for complicated bacteremia (43% for both).

The cure rate was not as high for IE, which was confirmed in a subset of the patients. For right-sided IE, 8 of 19 daptomycin patients with were cured, compared with 7 of 16 in the comparator arm. For left-sided IE, 1 of 19 daptomycin patients were cured, compared with 2 of 9 in the comparator arm.

FDA reviewers and panel members were concerned about what they viewed as rising minimum inhibitory concentrations (MICs) of daptomycin. Peter Coderre, a microbiologist in the FDA's division of anti-infective and ophthalmology products, said breakpoints have not yet been established for intermediate and resistant isolates. According to the company, seven patients had high minimum inhibitory concentrations; only one was successfully cured. Mr. Coderre also noted that there have been eight reports of resistance to daptomycin since it was introduced last spring.

“The fact that you'll get resistance is no surprise,” Dr. John Bradley, a panelist, and director of the infectious diseases division at Children's Hospital and Health Center in San Diego. “But in these seriously ill patients, the consequences are huge.”

Panel members were not as concerned about safety. Skeletal muscle is most often affected. Current labeling advises physicians to monitor creatine phosphokinase levels weekly and to consider discontinuing statins. In the trial, patients were monitored three times a week.

ROCKVILLE, MD. — The Food and Drug Administration's Anti-Infective Advisory Committee unanimously supported the approval of daptomycin (Cubicin) for Staphylococcus aureus bacteremia, but was not as certain that the drug was safe and effective for infective endocarditis.

And despite the 9–0 vote on bacteremia, the panel had reservations. “I was shocked at how low the overall cure rate was,” said Dr. Jan Patterson, a committee member and professor of medicine at the University of Texas, San Antonio. “Nonetheless, it was as good as current therapy.”

By a narrow 5–4 margin, the panel voted to approve daptomycin for infective endocarditis (IE). Those in favor of approval said that since the drug was already being used off label—Cubist Pharmaceuticals estimated that 25% of off-label use is for S. aureus bacteremia—that physicians should get better guidance.

Daptomycin was approved in 2003 for complicated skin and skin structure infections. Most physicians have been prescribing it at 4 mg/kg, but daptomycin was tested at 6 mg/kg for bacteremia and IE.

Panelists who voted against approval of daptomycin for IE said there were too few patients in that arm to draw a conclusion.

The FDA usually follows the advice of its advisory panels. In fact, within a few weeks of the meeting, the agency told Cubist that daptomycin was approvable, pending negotiations over the drug's label.

Cubist presented data from a 44-site, 236-patient trial, conducted during 2002–2005. Patients were randomized to daptomycin 6 mg/kg IV every 24 hours or vancomycin 1 g IV every 12 hours plus gentamicin 1 mg/kg every 8 hours for 4 days, or antistaphylococcus penicillin 2 g every 4 hours, plus the gentamicin regimen. The intent-to-treat population was 120 patients in the daptomycin arm and 115 in the comparator arms. Patients had to have a positive blood culture within 2 days of enrollment.

The investigators judged success or failure at the end of therapy. Success was defined as being clinically cured or improved, having a negative blood culture, and not receiving a potentially effective nonstudy antibiotic. Cure was assessed by a blinded independent adjudication panel 6 weeks after end of therapy.

The panel determined that the overall success rate, which included bacteremia and endocarditis, was 44% (53 of 120) for daptomycin and 42% (48 of 115) for the comparator group. The daptomycin and comparator success rates were higher for uncomplicated (56% and 55%) than for complicated bacteremia (43% for both).

The cure rate was not as high for IE, which was confirmed in a subset of the patients. For right-sided IE, 8 of 19 daptomycin patients with were cured, compared with 7 of 16 in the comparator arm. For left-sided IE, 1 of 19 daptomycin patients were cured, compared with 2 of 9 in the comparator arm.

FDA reviewers and panel members were concerned about what they viewed as rising minimum inhibitory concentrations (MICs) of daptomycin. Peter Coderre, a microbiologist in the FDA's division of anti-infective and ophthalmology products, said breakpoints have not yet been established for intermediate and resistant isolates. According to the company, seven patients had high minimum inhibitory concentrations; only one was successfully cured. Mr. Coderre also noted that there have been eight reports of resistance to daptomycin since it was introduced last spring.

“The fact that you'll get resistance is no surprise,” Dr. John Bradley, a panelist, and director of the infectious diseases division at Children's Hospital and Health Center in San Diego. “But in these seriously ill patients, the consequences are huge.”

Panel members were not as concerned about safety. Skeletal muscle is most often affected. Current labeling advises physicians to monitor creatine phosphokinase levels weekly and to consider discontinuing statins. In the trial, patients were monitored three times a week.

ROCKVILLE, MD. — The Food and Drug Administration's Anti-Infective Advisory Committee unanimously supported the approval of daptomycin (Cubicin) for Staphylococcus aureus bacteremia, but was not as certain that the drug was safe and effective for infective endocarditis.

And despite the 9–0 vote on bacteremia, the panel had reservations. “I was shocked at how low the overall cure rate was,” said Dr. Jan Patterson, a committee member and professor of medicine at the University of Texas, San Antonio. “Nonetheless, it was as good as current therapy.”

By a narrow 5–4 margin, the panel voted to approve daptomycin for infective endocarditis (IE). Those in favor of approval said that since the drug was already being used off label—Cubist Pharmaceuticals estimated that 25% of off-label use is for S. aureus bacteremia—that physicians should get better guidance.

Daptomycin was approved in 2003 for complicated skin and skin structure infections. Most physicians have been prescribing it at 4 mg/kg, but daptomycin was tested at 6 mg/kg for bacteremia and IE.

Panelists who voted against approval of daptomycin for IE said there were too few patients in that arm to draw a conclusion.

The FDA usually follows the advice of its advisory panels. In fact, within a few weeks of the meeting, the agency told Cubist that daptomycin was approvable, pending negotiations over the drug's label.

Cubist presented data from a 44-site, 236-patient trial, conducted during 2002–2005. Patients were randomized to daptomycin 6 mg/kg IV every 24 hours or vancomycin 1 g IV every 12 hours plus gentamicin 1 mg/kg every 8 hours for 4 days, or antistaphylococcus penicillin 2 g every 4 hours, plus the gentamicin regimen. The intent-to-treat population was 120 patients in the daptomycin arm and 115 in the comparator arms. Patients had to have a positive blood culture within 2 days of enrollment.

The investigators judged success or failure at the end of therapy. Success was defined as being clinically cured or improved, having a negative blood culture, and not receiving a potentially effective nonstudy antibiotic. Cure was assessed by a blinded independent adjudication panel 6 weeks after end of therapy.

The panel determined that the overall success rate, which included bacteremia and endocarditis, was 44% (53 of 120) for daptomycin and 42% (48 of 115) for the comparator group. The daptomycin and comparator success rates were higher for uncomplicated (56% and 55%) than for complicated bacteremia (43% for both).

The cure rate was not as high for IE, which was confirmed in a subset of the patients. For right-sided IE, 8 of 19 daptomycin patients with were cured, compared with 7 of 16 in the comparator arm. For left-sided IE, 1 of 19 daptomycin patients were cured, compared with 2 of 9 in the comparator arm.

FDA reviewers and panel members were concerned about what they viewed as rising minimum inhibitory concentrations (MICs) of daptomycin. Peter Coderre, a microbiologist in the FDA's division of anti-infective and ophthalmology products, said breakpoints have not yet been established for intermediate and resistant isolates. According to the company, seven patients had high minimum inhibitory concentrations; only one was successfully cured. Mr. Coderre also noted that there have been eight reports of resistance to daptomycin since it was introduced last spring.

“The fact that you'll get resistance is no surprise,” Dr. John Bradley, a panelist, and director of the infectious diseases division at Children's Hospital and Health Center in San Diego. “But in these seriously ill patients, the consequences are huge.”

Panel members were not as concerned about safety. Skeletal muscle is most often affected. Current labeling advises physicians to monitor creatine phosphokinase levels weekly and to consider discontinuing statins. In the trial, patients were monitored three times a week.

BALTIMORE — Preoperative screening to identify potential cardiac complications is often unnecessary and may not help a surgeon to map out how to reduce risk during an elective procedure, said Dr. Richard Lange at a cardiovascular conference sponsored by Johns Hopkins University, Baltimore.

There are many reasons to focus on patients who are at highest risk for complications. Nuclear stress testing alone costs about $10 billion each year, said Dr. Lange, chief of clinical cardiology at Johns Hopkins. There are 27 million people who undergo noncardiac surgeries each year in the United States, but only 8 million have coronary artery disease or risk factors, and 50,000 will have a perioperative myocardial infarction, he said.

Patients undergoing low- or intermediate-risk procedures aren't likely to need stress testing, he said. Endoscopic, superficial, cataract, and breast procedures are considered low risk, with a less than 1% complication rate. Procedures with an intermediate risk (1%–5% complication rate) include carotid endarterectomy, as well as head and neck, intraperitoneal, intrathoracic, orthopedic, and prostate procedures.

The highest-risk procedures—with complications occurring in more than 5%—include emergent major operations, especially in elderly patients, in the aorta or other major vessels, in peripheral vasculature, and in procedures with large fluid shifts or blood loss, Dr. Lange said.

Usually, older patients and those who have rhythm disorders, abnormal ECGs, a low functional capacity, or uncontrolled hypertension are considered to be at risk for cardiac complications. But none of these is an independent risk factor, he said.

However, six predictors have been identified as independent risk factors: a high-risk surgical procedure; a history of ischemic heart disease; a history of heart failure; a history of transient ischemic attack or stroke; insulin therapy; and a preoperative serum creatinine level greater than 2 mg/dL (Circulation 1999;100:1043–49). According to this Revised Cardiac Risk Index, the focus for work-ups should be on patients who have more than three of these risk factors.

Not all tests provide valuable information, either. A 2003 metaanalysis of the predictive ability of noninvasive tests found varying sensitivity and specificity results (Heart 2003;89:1327–34). Perfusion imaging, for instance, had a high sensitivity, but low specificity. Dobutamine stress echocardiography had an 85% sensitivity and 70% specificity. Tests should provide a high positive predictive value, and—more importantly—should give the clinician information beyond what can be determined by the clinical risk factors, Dr. Lange said. And tests should lead to a strategy that reduces the risk of perioperative MI.

If a diagnostic test seems warranted and indicates increased risk, it's not always advisable to perform coronary revascularization, he said. Several studies have shown that patients who had a percutaneous coronary intervention (PCI) or coronary bypass artery graft (CABG) to minimize risk actually ended up in worse condition. The Coronary Artery Revascularization Prophylaxis trial found that high-risk patients who received a PCI or CABG followed by vascular surgery did no better than those who were given medical therapy (N. Engl. J. Med. 2004;351:2795–804). And, Dr. Lange said, there was a 9% rate of death or myocardial infarction during the revascularization procedure.

Stenting before noncardiac surgery may put patients at even higher risk, he said, citing three trials showing increased major bleeding, cardiac events, and death if the follow-on procedure was done within a few weeks.

Drug-eluting stents may put patients at higher risk because of delayed endothelialization and increased risk of subacute and late thrombosis. The evidence suggests that noncardiac surgery should be done a minimum of 3–6 months after drug-eluting stent placement, he said.

BALTIMORE — Preoperative screening to identify potential cardiac complications is often unnecessary and may not help a surgeon to map out how to reduce risk during an elective procedure, said Dr. Richard Lange at a cardiovascular conference sponsored by Johns Hopkins University, Baltimore.

There are many reasons to focus on patients who are at highest risk for complications. Nuclear stress testing alone costs about $10 billion each year, said Dr. Lange, chief of clinical cardiology at Johns Hopkins. There are 27 million people who undergo noncardiac surgeries each year in the United States, but only 8 million have coronary artery disease or risk factors, and 50,000 will have a perioperative myocardial infarction, he said.

Patients undergoing low- or intermediate-risk procedures aren't likely to need stress testing, he said. Endoscopic, superficial, cataract, and breast procedures are considered low risk, with a less than 1% complication rate. Procedures with an intermediate risk (1%–5% complication rate) include carotid endarterectomy, as well as head and neck, intraperitoneal, intrathoracic, orthopedic, and prostate procedures.

The highest-risk procedures—with complications occurring in more than 5%—include emergent major operations, especially in elderly patients, in the aorta or other major vessels, in peripheral vasculature, and in procedures with large fluid shifts or blood loss, Dr. Lange said.

Usually, older patients and those who have rhythm disorders, abnormal ECGs, a low functional capacity, or uncontrolled hypertension are considered to be at risk for cardiac complications. But none of these is an independent risk factor, he said.

However, six predictors have been identified as independent risk factors: a high-risk surgical procedure; a history of ischemic heart disease; a history of heart failure; a history of transient ischemic attack or stroke; insulin therapy; and a preoperative serum creatinine level greater than 2 mg/dL (Circulation 1999;100:1043–49). According to this Revised Cardiac Risk Index, the focus for work-ups should be on patients who have more than three of these risk factors.

Not all tests provide valuable information, either. A 2003 metaanalysis of the predictive ability of noninvasive tests found varying sensitivity and specificity results (Heart 2003;89:1327–34). Perfusion imaging, for instance, had a high sensitivity, but low specificity. Dobutamine stress echocardiography had an 85% sensitivity and 70% specificity. Tests should provide a high positive predictive value, and—more importantly—should give the clinician information beyond what can be determined by the clinical risk factors, Dr. Lange said. And tests should lead to a strategy that reduces the risk of perioperative MI.

If a diagnostic test seems warranted and indicates increased risk, it's not always advisable to perform coronary revascularization, he said. Several studies have shown that patients who had a percutaneous coronary intervention (PCI) or coronary bypass artery graft (CABG) to minimize risk actually ended up in worse condition. The Coronary Artery Revascularization Prophylaxis trial found that high-risk patients who received a PCI or CABG followed by vascular surgery did no better than those who were given medical therapy (N. Engl. J. Med. 2004;351:2795–804). And, Dr. Lange said, there was a 9% rate of death or myocardial infarction during the revascularization procedure.

Stenting before noncardiac surgery may put patients at even higher risk, he said, citing three trials showing increased major bleeding, cardiac events, and death if the follow-on procedure was done within a few weeks.

Drug-eluting stents may put patients at higher risk because of delayed endothelialization and increased risk of subacute and late thrombosis. The evidence suggests that noncardiac surgery should be done a minimum of 3–6 months after drug-eluting stent placement, he said.

BALTIMORE — Preoperative screening to identify potential cardiac complications is often unnecessary and may not help a surgeon to map out how to reduce risk during an elective procedure, said Dr. Richard Lange at a cardiovascular conference sponsored by Johns Hopkins University, Baltimore.

There are many reasons to focus on patients who are at highest risk for complications. Nuclear stress testing alone costs about $10 billion each year, said Dr. Lange, chief of clinical cardiology at Johns Hopkins. There are 27 million people who undergo noncardiac surgeries each year in the United States, but only 8 million have coronary artery disease or risk factors, and 50,000 will have a perioperative myocardial infarction, he said.

Patients undergoing low- or intermediate-risk procedures aren't likely to need stress testing, he said. Endoscopic, superficial, cataract, and breast procedures are considered low risk, with a less than 1% complication rate. Procedures with an intermediate risk (1%–5% complication rate) include carotid endarterectomy, as well as head and neck, intraperitoneal, intrathoracic, orthopedic, and prostate procedures.

The highest-risk procedures—with complications occurring in more than 5%—include emergent major operations, especially in elderly patients, in the aorta or other major vessels, in peripheral vasculature, and in procedures with large fluid shifts or blood loss, Dr. Lange said.

Usually, older patients and those who have rhythm disorders, abnormal ECGs, a low functional capacity, or uncontrolled hypertension are considered to be at risk for cardiac complications. But none of these is an independent risk factor, he said.

However, six predictors have been identified as independent risk factors: a high-risk surgical procedure; a history of ischemic heart disease; a history of heart failure; a history of transient ischemic attack or stroke; insulin therapy; and a preoperative serum creatinine level greater than 2 mg/dL (Circulation 1999;100:1043–49). According to this Revised Cardiac Risk Index, the focus for work-ups should be on patients who have more than three of these risk factors.

Not all tests provide valuable information, either. A 2003 metaanalysis of the predictive ability of noninvasive tests found varying sensitivity and specificity results (Heart 2003;89:1327–34). Perfusion imaging, for instance, had a high sensitivity, but low specificity. Dobutamine stress echocardiography had an 85% sensitivity and 70% specificity. Tests should provide a high positive predictive value, and—more importantly—should give the clinician information beyond what can be determined by the clinical risk factors, Dr. Lange said. And tests should lead to a strategy that reduces the risk of perioperative MI.

If a diagnostic test seems warranted and indicates increased risk, it's not always advisable to perform coronary revascularization, he said. Several studies have shown that patients who had a percutaneous coronary intervention (PCI) or coronary bypass artery graft (CABG) to minimize risk actually ended up in worse condition. The Coronary Artery Revascularization Prophylaxis trial found that high-risk patients who received a PCI or CABG followed by vascular surgery did no better than those who were given medical therapy (N. Engl. J. Med. 2004;351:2795–804). And, Dr. Lange said, there was a 9% rate of death or myocardial infarction during the revascularization procedure.

Stenting before noncardiac surgery may put patients at even higher risk, he said, citing three trials showing increased major bleeding, cardiac events, and death if the follow-on procedure was done within a few weeks.

Drug-eluting stents may put patients at higher risk because of delayed endothelialization and increased risk of subacute and late thrombosis. The evidence suggests that noncardiac surgery should be done a minimum of 3–6 months after drug-eluting stent placement, he said.