Joyce Frieden

The recent Gulf Coast disaster may be a wake-up call for all physicians to establish some kind of emergency backup system for their businesses.

“Physicians don't always think of themselves as running a business, but they're going to think of it now,” Rosemarie Nelson, a Syracuse, N.Y.-based consultant with the Medical Group Management Association, said in an interview.

Michael Ellis, M.D., is hoping that technology might have retained some of his records.

His practice in Chalmette, La., south of New Orleans, is in an area flooded to the rooftops in the aftermath of Hurricane Katrina and the subsequent breakdown of New Orleans' levees.

“Like most physicians, I have billing electronic records, but my office clinical records are paper,” Dr. Ellis, said in an interview shortly after the flood. “I assume all that–and our supplies and equipment–will be unsalvageable.”

Dr. Ellis, an otolaryngologist, said he had backups in place for his billing records, both hard copy and “off campus” (outside computer services), assuming that certain computers weren't damaged or backed up during the flood.

As Ms. Nelson noted, “there is just no way to secure paper records. They're there or they're not. You're not going to copy and store them off-site.”

However, a fully integrated electronic medical record might not have been completely safe for stricken medical communities, either.

Anne L. Shirley, a spokeswoman with the Louisiana State Medical Society, said an undetermined number of records have been destroyed.

Some electronic records weren't able to be accessed as most computer servers have been destroyed, Ms. Shirley said.

The Louisiana State Board of Medical Examiners is located in a hard-hit flood area in New Orleans, and the society's Web site and database were inoperable, even from remote locations, Ms. Shirley said.

“This, as you can imagine, poses a problem with license verification and credentialing for displaced physicians.”

One way to solve backup problems such as these is to have electronic medical records stored in a secure, remote site by a vendor, Ms. Nelson said.

“And, it does not have to be a vendor you bought your software from; there are tons of vendors out there providing remote access.”

Such vendors also can offer Internet-based backups, which “add a whole new sense of security,” she noted. But she also pointed out that if a disaster should occur in a physician's area, the backup disk that was taken home would be as insecure as the records.

Even if they don't use an electronic medical record system (and only about 15% of doctors have them), physicians should consider storing their administrative records–such as financial and scheduling information–off-site, Ms. Nelson suggested.

“You need to think about using off-site backup for your financial applications, scheduling, patient list, and some receivables.

“You still have insurance receivables there, and you're going to need that cash inflow because you're going to have to buy new equipment,” Ms. Nelson pointed out. “So securing your financial records is equally as important.”

Having access to the patient list would be essential, because the physician would need to inform patients that they've set up their practice in a new location or will be reopening on a particular date, she explained.

An advantage of backing up financial information is that it also includes some clinical information, Ms. Nelson said.

“That's because you need to have a diagnosis code to bill the insurance company.”

At press time, Dr. Ellis said he was able to communicate only by e-mail because all the phone prefixes in Louisiana and Mississippi were unreachable.

He was able to reach his practice associate in Birmingham through e-mail.

“Two of my staff communicated that they are in upper Mississippi,” he said. Other physicians e-mailed from Houston and Baton Rouge to let him know their whereabouts.

Dr. Ellis was unable to receive mail. “No one has said what is happening to it, or how we can contact insurers, Medicare, etc., to change our address. “I don't know what patients are doing about getting their prescriptions filled since they can't reach doctors,” he said.

At press time, the Louisiana State Medical Society was working with the state's Department of Health and Hospitals, the Office of Emergency Preparedness, the Department of Homeland Security, and the Federal Emergency Management Agency to contact physicians.

Physicians and others can access information about mail delivery, Medicare eligibility, and insurance claims on Louisiana's medical society's Web site, which is www.lsms.org

“Things in this regard change from minute to minute,” said Ms. Shirley, of the medical society. “I am sure that even more information will become available to us and to our physicians as the days go by.”

FEMA Floodproofing Tips

Here are some general tips from the Federal Emergency Management Agency on flood and hurricane preparation for businesses:

▸ Ask your local emergency management office whether your facility is located in a flood plain. Find out the history of flooding in your area. Determine the elevation of your facility in relation to streams, rivers, and dams.

▸ Learn about community evacuation plans from your local emergency management office.

▸ Establish facility shutdown procedures. Make plans for assisting employees who may need transportation.

▸ Purchase a National Oceanic and Atmospheric Administration weather radio with a warning alarm tone and battery backup. Listen for flood watches and warnings.

▸ Get information about flood insurance from your insurance carrier. Regular property and casualty insurance does not cover flooding.

If a hurricane or other major weather event is being forecast, consider taking these actions ahead of time:

▸ Clear out areas with extensive glass frontage as much as possible. If you have shutters, use them; otherwise, use precut plywood to board up all doors and windows.

▸ Remove outdoor hanging signs.

▸ Bring inside or secure any objects that might become airborne and cause damage in strong winds.

▸ Store as much equipment as high as possible off the floor, especially goods that could be in short supply after the storm.

▸ Move equipment that cannot be stored away from glass and cover it with tarpaulins or heavy plastic.

▸ Place sandbags in spaces where water could enter.

▸ Remove papers from lower drawers of desks and file cabinets and place them in plastic bags or containers on top of the cabinets.

Medical Schools Find Other Locations

Medical schools affected by Hurricane Katrina and its aftermath scrambled to find alternative locations and resources, to ensure that their students and residents would be able to continue practicing medicine.

At press time, most of the students from Tulane University in New Orleans were being housed 180 miles away at Jackson State University in Jackson, Miss. Tulane leadership had set up temporary headquarters in Jackson with the assistance of the University of Mississippi Medical Center.

Paul K. Whelton, M.D., senior vice president for health sciences at Tulane, said the university would establish a more permanent “interim leadership headquarters” in Houston.

“Senior administrative staff are in discussion with their counterparts at Houston-area medical schools about these schools assisting Tulane in continuing to provide medical education for Tulane students in all 4 years of medical education,” the Association of American Medical Colleges reported. A similar plan was being developed for Tulane residents.

In the meantime, the School of Medicine at Louisiana State University, New Orleans, made arrangements to hold classes in Baton Rouge until its facilities were once again suitable for occupation.

“We are closely working with the LSU System Office to arrange appropriate classroom space and accommodations for our students and faculty,” Dean Larry Hollier, M.D., said in a statement.

Charity Hospital in New Orleans will be out of service for an extended period of time, as the city begins a major clean up effort, he said. “We will be expending our bed capacity at Earl K. Long Medical Center [in Baton Rouge], and at University Medical Center in Lafayette … and reassigning our residency staff to those hospitals as well as to some other private hospitals.”

He noted that the university had an online registration available on its Web site at

www.lsuhsc.edu

The University of South Alabama in Mobile reopened in early September, the AAMC reported.

The recent Gulf Coast disaster may be a wake-up call for all physicians to establish some kind of emergency backup system for their businesses.

“Physicians don't always think of themselves as running a business, but they're going to think of it now,” Rosemarie Nelson, a Syracuse, N.Y.-based consultant with the Medical Group Management Association, said in an interview.

Michael Ellis, M.D., is hoping that technology might have retained some of his records.

His practice in Chalmette, La., south of New Orleans, is in an area flooded to the rooftops in the aftermath of Hurricane Katrina and the subsequent breakdown of New Orleans' levees.

“Like most physicians, I have billing electronic records, but my office clinical records are paper,” Dr. Ellis, said in an interview shortly after the flood. “I assume all that–and our supplies and equipment–will be unsalvageable.”

Dr. Ellis, an otolaryngologist, said he had backups in place for his billing records, both hard copy and “off campus” (outside computer services), assuming that certain computers weren't damaged or backed up during the flood.

As Ms. Nelson noted, “there is just no way to secure paper records. They're there or they're not. You're not going to copy and store them off-site.”

However, a fully integrated electronic medical record might not have been completely safe for stricken medical communities, either.

Anne L. Shirley, a spokeswoman with the Louisiana State Medical Society, said an undetermined number of records have been destroyed.

Some electronic records weren't able to be accessed as most computer servers have been destroyed, Ms. Shirley said.

The Louisiana State Board of Medical Examiners is located in a hard-hit flood area in New Orleans, and the society's Web site and database were inoperable, even from remote locations, Ms. Shirley said.

“This, as you can imagine, poses a problem with license verification and credentialing for displaced physicians.”

One way to solve backup problems such as these is to have electronic medical records stored in a secure, remote site by a vendor, Ms. Nelson said.

“And, it does not have to be a vendor you bought your software from; there are tons of vendors out there providing remote access.”

Such vendors also can offer Internet-based backups, which “add a whole new sense of security,” she noted. But she also pointed out that if a disaster should occur in a physician's area, the backup disk that was taken home would be as insecure as the records.

Even if they don't use an electronic medical record system (and only about 15% of doctors have them), physicians should consider storing their administrative records–such as financial and scheduling information–off-site, Ms. Nelson suggested.

“You need to think about using off-site backup for your financial applications, scheduling, patient list, and some receivables.

“You still have insurance receivables there, and you're going to need that cash inflow because you're going to have to buy new equipment,” Ms. Nelson pointed out. “So securing your financial records is equally as important.”

Having access to the patient list would be essential, because the physician would need to inform patients that they've set up their practice in a new location or will be reopening on a particular date, she explained.

An advantage of backing up financial information is that it also includes some clinical information, Ms. Nelson said.

“That's because you need to have a diagnosis code to bill the insurance company.”

At press time, Dr. Ellis said he was able to communicate only by e-mail because all the phone prefixes in Louisiana and Mississippi were unreachable.

He was able to reach his practice associate in Birmingham through e-mail.

“Two of my staff communicated that they are in upper Mississippi,” he said. Other physicians e-mailed from Houston and Baton Rouge to let him know their whereabouts.

Dr. Ellis was unable to receive mail. “No one has said what is happening to it, or how we can contact insurers, Medicare, etc., to change our address. “I don't know what patients are doing about getting their prescriptions filled since they can't reach doctors,” he said.

At press time, the Louisiana State Medical Society was working with the state's Department of Health and Hospitals, the Office of Emergency Preparedness, the Department of Homeland Security, and the Federal Emergency Management Agency to contact physicians.

Physicians and others can access information about mail delivery, Medicare eligibility, and insurance claims on Louisiana's medical society's Web site, which is www.lsms.org

“Things in this regard change from minute to minute,” said Ms. Shirley, of the medical society. “I am sure that even more information will become available to us and to our physicians as the days go by.”

FEMA Floodproofing Tips

Here are some general tips from the Federal Emergency Management Agency on flood and hurricane preparation for businesses:

▸ Ask your local emergency management office whether your facility is located in a flood plain. Find out the history of flooding in your area. Determine the elevation of your facility in relation to streams, rivers, and dams.

▸ Learn about community evacuation plans from your local emergency management office.

▸ Establish facility shutdown procedures. Make plans for assisting employees who may need transportation.

▸ Purchase a National Oceanic and Atmospheric Administration weather radio with a warning alarm tone and battery backup. Listen for flood watches and warnings.

▸ Get information about flood insurance from your insurance carrier. Regular property and casualty insurance does not cover flooding.

If a hurricane or other major weather event is being forecast, consider taking these actions ahead of time:

▸ Clear out areas with extensive glass frontage as much as possible. If you have shutters, use them; otherwise, use precut plywood to board up all doors and windows.

▸ Remove outdoor hanging signs.

▸ Bring inside or secure any objects that might become airborne and cause damage in strong winds.

▸ Store as much equipment as high as possible off the floor, especially goods that could be in short supply after the storm.

▸ Move equipment that cannot be stored away from glass and cover it with tarpaulins or heavy plastic.

▸ Place sandbags in spaces where water could enter.

▸ Remove papers from lower drawers of desks and file cabinets and place them in plastic bags or containers on top of the cabinets.

Medical Schools Find Other Locations

Medical schools affected by Hurricane Katrina and its aftermath scrambled to find alternative locations and resources, to ensure that their students and residents would be able to continue practicing medicine.

At press time, most of the students from Tulane University in New Orleans were being housed 180 miles away at Jackson State University in Jackson, Miss. Tulane leadership had set up temporary headquarters in Jackson with the assistance of the University of Mississippi Medical Center.

Paul K. Whelton, M.D., senior vice president for health sciences at Tulane, said the university would establish a more permanent “interim leadership headquarters” in Houston.

“Senior administrative staff are in discussion with their counterparts at Houston-area medical schools about these schools assisting Tulane in continuing to provide medical education for Tulane students in all 4 years of medical education,” the Association of American Medical Colleges reported. A similar plan was being developed for Tulane residents.

In the meantime, the School of Medicine at Louisiana State University, New Orleans, made arrangements to hold classes in Baton Rouge until its facilities were once again suitable for occupation.

“We are closely working with the LSU System Office to arrange appropriate classroom space and accommodations for our students and faculty,” Dean Larry Hollier, M.D., said in a statement.

Charity Hospital in New Orleans will be out of service for an extended period of time, as the city begins a major clean up effort, he said. “We will be expending our bed capacity at Earl K. Long Medical Center [in Baton Rouge], and at University Medical Center in Lafayette … and reassigning our residency staff to those hospitals as well as to some other private hospitals.”

He noted that the university had an online registration available on its Web site at

www.lsuhsc.edu

The University of South Alabama in Mobile reopened in early September, the AAMC reported.

The recent Gulf Coast disaster may be a wake-up call for all physicians to establish some kind of emergency backup system for their businesses.

“Physicians don't always think of themselves as running a business, but they're going to think of it now,” Rosemarie Nelson, a Syracuse, N.Y.-based consultant with the Medical Group Management Association, said in an interview.

Michael Ellis, M.D., is hoping that technology might have retained some of his records.

His practice in Chalmette, La., south of New Orleans, is in an area flooded to the rooftops in the aftermath of Hurricane Katrina and the subsequent breakdown of New Orleans' levees.

“Like most physicians, I have billing electronic records, but my office clinical records are paper,” Dr. Ellis, said in an interview shortly after the flood. “I assume all that–and our supplies and equipment–will be unsalvageable.”

Dr. Ellis, an otolaryngologist, said he had backups in place for his billing records, both hard copy and “off campus” (outside computer services), assuming that certain computers weren't damaged or backed up during the flood.

As Ms. Nelson noted, “there is just no way to secure paper records. They're there or they're not. You're not going to copy and store them off-site.”

However, a fully integrated electronic medical record might not have been completely safe for stricken medical communities, either.

Anne L. Shirley, a spokeswoman with the Louisiana State Medical Society, said an undetermined number of records have been destroyed.

Some electronic records weren't able to be accessed as most computer servers have been destroyed, Ms. Shirley said.

The Louisiana State Board of Medical Examiners is located in a hard-hit flood area in New Orleans, and the society's Web site and database were inoperable, even from remote locations, Ms. Shirley said.

“This, as you can imagine, poses a problem with license verification and credentialing for displaced physicians.”

One way to solve backup problems such as these is to have electronic medical records stored in a secure, remote site by a vendor, Ms. Nelson said.

“And, it does not have to be a vendor you bought your software from; there are tons of vendors out there providing remote access.”

Such vendors also can offer Internet-based backups, which “add a whole new sense of security,” she noted. But she also pointed out that if a disaster should occur in a physician's area, the backup disk that was taken home would be as insecure as the records.

Even if they don't use an electronic medical record system (and only about 15% of doctors have them), physicians should consider storing their administrative records–such as financial and scheduling information–off-site, Ms. Nelson suggested.

“You need to think about using off-site backup for your financial applications, scheduling, patient list, and some receivables.

“You still have insurance receivables there, and you're going to need that cash inflow because you're going to have to buy new equipment,” Ms. Nelson pointed out. “So securing your financial records is equally as important.”

Having access to the patient list would be essential, because the physician would need to inform patients that they've set up their practice in a new location or will be reopening on a particular date, she explained.

An advantage of backing up financial information is that it also includes some clinical information, Ms. Nelson said.

“That's because you need to have a diagnosis code to bill the insurance company.”

At press time, Dr. Ellis said he was able to communicate only by e-mail because all the phone prefixes in Louisiana and Mississippi were unreachable.

He was able to reach his practice associate in Birmingham through e-mail.

“Two of my staff communicated that they are in upper Mississippi,” he said. Other physicians e-mailed from Houston and Baton Rouge to let him know their whereabouts.

Dr. Ellis was unable to receive mail. “No one has said what is happening to it, or how we can contact insurers, Medicare, etc., to change our address. “I don't know what patients are doing about getting their prescriptions filled since they can't reach doctors,” he said.

At press time, the Louisiana State Medical Society was working with the state's Department of Health and Hospitals, the Office of Emergency Preparedness, the Department of Homeland Security, and the Federal Emergency Management Agency to contact physicians.

Physicians and others can access information about mail delivery, Medicare eligibility, and insurance claims on Louisiana's medical society's Web site, which is www.lsms.org

“Things in this regard change from minute to minute,” said Ms. Shirley, of the medical society. “I am sure that even more information will become available to us and to our physicians as the days go by.”

FEMA Floodproofing Tips

Here are some general tips from the Federal Emergency Management Agency on flood and hurricane preparation for businesses:

▸ Ask your local emergency management office whether your facility is located in a flood plain. Find out the history of flooding in your area. Determine the elevation of your facility in relation to streams, rivers, and dams.

▸ Learn about community evacuation plans from your local emergency management office.

▸ Establish facility shutdown procedures. Make plans for assisting employees who may need transportation.

▸ Purchase a National Oceanic and Atmospheric Administration weather radio with a warning alarm tone and battery backup. Listen for flood watches and warnings.

▸ Get information about flood insurance from your insurance carrier. Regular property and casualty insurance does not cover flooding.

If a hurricane or other major weather event is being forecast, consider taking these actions ahead of time:

▸ Clear out areas with extensive glass frontage as much as possible. If you have shutters, use them; otherwise, use precut plywood to board up all doors and windows.

▸ Remove outdoor hanging signs.

▸ Bring inside or secure any objects that might become airborne and cause damage in strong winds.

▸ Store as much equipment as high as possible off the floor, especially goods that could be in short supply after the storm.

▸ Move equipment that cannot be stored away from glass and cover it with tarpaulins or heavy plastic.

▸ Place sandbags in spaces where water could enter.

▸ Remove papers from lower drawers of desks and file cabinets and place them in plastic bags or containers on top of the cabinets.

Medical Schools Find Other Locations

Medical schools affected by Hurricane Katrina and its aftermath scrambled to find alternative locations and resources, to ensure that their students and residents would be able to continue practicing medicine.

At press time, most of the students from Tulane University in New Orleans were being housed 180 miles away at Jackson State University in Jackson, Miss. Tulane leadership had set up temporary headquarters in Jackson with the assistance of the University of Mississippi Medical Center.

Paul K. Whelton, M.D., senior vice president for health sciences at Tulane, said the university would establish a more permanent “interim leadership headquarters” in Houston.

“Senior administrative staff are in discussion with their counterparts at Houston-area medical schools about these schools assisting Tulane in continuing to provide medical education for Tulane students in all 4 years of medical education,” the Association of American Medical Colleges reported. A similar plan was being developed for Tulane residents.

In the meantime, the School of Medicine at Louisiana State University, New Orleans, made arrangements to hold classes in Baton Rouge until its facilities were once again suitable for occupation.

“We are closely working with the LSU System Office to arrange appropriate classroom space and accommodations for our students and faculty,” Dean Larry Hollier, M.D., said in a statement.

Charity Hospital in New Orleans will be out of service for an extended period of time, as the city begins a major clean up effort, he said. “We will be expending our bed capacity at Earl K. Long Medical Center [in Baton Rouge], and at University Medical Center in Lafayette … and reassigning our residency staff to those hospitals as well as to some other private hospitals.”

He noted that the university had an online registration available on its Web site at

www.lsuhsc.edu

The University of South Alabama in Mobile reopened in early September, the AAMC reported.

WASHINGTON – More needs to be done to encourage minority patients and providers to participate in clinical drug trials, several speakers said at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

“If you go to the package insert of a lot of drugs currently on the market and look for information on minority participation in clinical trials, what you frequently will see is the phrase, 'No data available,'” said Basil Halliday, founder of BDH Clinical Research Services, a clinical trial consulting firm in Ridgemont, N.C. “It's high time we get rid of that phrase in the package insert.”

One of the most important changes would be a federal mandate to include minority patients in clinical trials as a condition of approval by the Food and Drug Administration. “We also need specific guidance on the degree of representation,” Mr. Halliday said. “I don't want to hear you say that you 'encourage it,' 'support it,' or 'want to see more of it.' You need to give specific numbers because that's the only time the industry will respond. I say mandate, mandate, mandate.”

B. Waine Kong, Ph.D., CEO of the Association of Black Cardiologists, suggested that the FDA establish an Office of Minority Affairs to address issues relating to minorities, including increasing their participation in clinical trials. Several barriers impede minority participation in trials, among them a lack of minority physicians, who are six times more likely to treat minority patients, compared with white physicians, Mr. Halliday said. “As for African American physicians doing clinical trials, it's almost nonexistent.”

Mr. Halliday's company has started the Clinical Research Investigator Support Program to encourage more minority physician participation. “We need to do a better job of creating a pipeline of future physicians, minority scientists, and researchers who are culturally competent and culturally sensitive to the people they're six times more likely to treat,” he said. “We need to involve those people in the process early.”

Minority physicians have a lot of reservations about participating in clinical trials, he continued. “A lot of physicians I have talked to over the years don't know that the pharmaceutical industry had nothing to do with Tuskegee,” Mr. Halliday said, referring to an experiment conducted by the U.S. Public Health Service in which African American men were deliberately left untreated for syphilis.

Dr. Kong noted that minority physicians also face a variety of entry barriers to clinical trials, such as complex, technical forms to fill out and the need for capital investment. Further, many minority physicians are reticent to refer patients to trials being run by other physicians “because of a belief that if they send that patient to another doctor, they may lose that patient. That's not necessarily true.”

On the patient side, minority patients need to be better educated about the benefits of trial participation, such as free, state-of-the-art medical care and better outcomes due to more frequent physician visits, Mr. Halliday said.

He said that his company also has started a minority community outreach and education program with institutional review boards. “It doesn't make sense that the folks sitting on the IRB and approving protocols don't accurately reflect the communities in which they live,” he said. He complimented one board, Essex IRB in Lebanon, N.J., for changing its board makeup to allow for more minority participation.

Mr. Halliday urged the National Institutes of Health to start grant reviewer education programs about minority inclusion in clinical trials. “The same folks, year after year, get money from NIH, but there's no demand on those people to change. We need to hold them accountable for putting minorities in the clinical trial process.”

WASHINGTON – More needs to be done to encourage minority patients and providers to participate in clinical drug trials, several speakers said at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

“If you go to the package insert of a lot of drugs currently on the market and look for information on minority participation in clinical trials, what you frequently will see is the phrase, 'No data available,'” said Basil Halliday, founder of BDH Clinical Research Services, a clinical trial consulting firm in Ridgemont, N.C. “It's high time we get rid of that phrase in the package insert.”

One of the most important changes would be a federal mandate to include minority patients in clinical trials as a condition of approval by the Food and Drug Administration. “We also need specific guidance on the degree of representation,” Mr. Halliday said. “I don't want to hear you say that you 'encourage it,' 'support it,' or 'want to see more of it.' You need to give specific numbers because that's the only time the industry will respond. I say mandate, mandate, mandate.”

B. Waine Kong, Ph.D., CEO of the Association of Black Cardiologists, suggested that the FDA establish an Office of Minority Affairs to address issues relating to minorities, including increasing their participation in clinical trials. Several barriers impede minority participation in trials, among them a lack of minority physicians, who are six times more likely to treat minority patients, compared with white physicians, Mr. Halliday said. “As for African American physicians doing clinical trials, it's almost nonexistent.”

Mr. Halliday's company has started the Clinical Research Investigator Support Program to encourage more minority physician participation. “We need to do a better job of creating a pipeline of future physicians, minority scientists, and researchers who are culturally competent and culturally sensitive to the people they're six times more likely to treat,” he said. “We need to involve those people in the process early.”

Minority physicians have a lot of reservations about participating in clinical trials, he continued. “A lot of physicians I have talked to over the years don't know that the pharmaceutical industry had nothing to do with Tuskegee,” Mr. Halliday said, referring to an experiment conducted by the U.S. Public Health Service in which African American men were deliberately left untreated for syphilis.

Dr. Kong noted that minority physicians also face a variety of entry barriers to clinical trials, such as complex, technical forms to fill out and the need for capital investment. Further, many minority physicians are reticent to refer patients to trials being run by other physicians “because of a belief that if they send that patient to another doctor, they may lose that patient. That's not necessarily true.”

On the patient side, minority patients need to be better educated about the benefits of trial participation, such as free, state-of-the-art medical care and better outcomes due to more frequent physician visits, Mr. Halliday said.

He said that his company also has started a minority community outreach and education program with institutional review boards. “It doesn't make sense that the folks sitting on the IRB and approving protocols don't accurately reflect the communities in which they live,” he said. He complimented one board, Essex IRB in Lebanon, N.J., for changing its board makeup to allow for more minority participation.

Mr. Halliday urged the National Institutes of Health to start grant reviewer education programs about minority inclusion in clinical trials. “The same folks, year after year, get money from NIH, but there's no demand on those people to change. We need to hold them accountable for putting minorities in the clinical trial process.”

WASHINGTON – More needs to be done to encourage minority patients and providers to participate in clinical drug trials, several speakers said at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

“If you go to the package insert of a lot of drugs currently on the market and look for information on minority participation in clinical trials, what you frequently will see is the phrase, 'No data available,'” said Basil Halliday, founder of BDH Clinical Research Services, a clinical trial consulting firm in Ridgemont, N.C. “It's high time we get rid of that phrase in the package insert.”

One of the most important changes would be a federal mandate to include minority patients in clinical trials as a condition of approval by the Food and Drug Administration. “We also need specific guidance on the degree of representation,” Mr. Halliday said. “I don't want to hear you say that you 'encourage it,' 'support it,' or 'want to see more of it.' You need to give specific numbers because that's the only time the industry will respond. I say mandate, mandate, mandate.”

B. Waine Kong, Ph.D., CEO of the Association of Black Cardiologists, suggested that the FDA establish an Office of Minority Affairs to address issues relating to minorities, including increasing their participation in clinical trials. Several barriers impede minority participation in trials, among them a lack of minority physicians, who are six times more likely to treat minority patients, compared with white physicians, Mr. Halliday said. “As for African American physicians doing clinical trials, it's almost nonexistent.”

Mr. Halliday's company has started the Clinical Research Investigator Support Program to encourage more minority physician participation. “We need to do a better job of creating a pipeline of future physicians, minority scientists, and researchers who are culturally competent and culturally sensitive to the people they're six times more likely to treat,” he said. “We need to involve those people in the process early.”

Minority physicians have a lot of reservations about participating in clinical trials, he continued. “A lot of physicians I have talked to over the years don't know that the pharmaceutical industry had nothing to do with Tuskegee,” Mr. Halliday said, referring to an experiment conducted by the U.S. Public Health Service in which African American men were deliberately left untreated for syphilis.

Dr. Kong noted that minority physicians also face a variety of entry barriers to clinical trials, such as complex, technical forms to fill out and the need for capital investment. Further, many minority physicians are reticent to refer patients to trials being run by other physicians “because of a belief that if they send that patient to another doctor, they may lose that patient. That's not necessarily true.”

On the patient side, minority patients need to be better educated about the benefits of trial participation, such as free, state-of-the-art medical care and better outcomes due to more frequent physician visits, Mr. Halliday said.

He said that his company also has started a minority community outreach and education program with institutional review boards. “It doesn't make sense that the folks sitting on the IRB and approving protocols don't accurately reflect the communities in which they live,” he said. He complimented one board, Essex IRB in Lebanon, N.J., for changing its board makeup to allow for more minority participation.

Mr. Halliday urged the National Institutes of Health to start grant reviewer education programs about minority inclusion in clinical trials. “The same folks, year after year, get money from NIH, but there's no demand on those people to change. We need to hold them accountable for putting minorities in the clinical trial process.”

When it comes to tort reform in Texas, physicians there say “so far, so good.”

In 2003, the state enacted a tort reform law similar to that of California, including a $250,000 cap on noneconomic damages. So far, that's been good news for Texas physicians, according to R. Moss Hampton, M.D., head of the Texas Association of Ob.Gyns.

“Everybody here would say it's been a success,” said Dr. Hampton, who practices in Amarillo. He noted that the Texas Medical Liability Trust, the state's largest medical malpractice insurer, has reduced its rates by 17% since the law went into effect.

“That's kind of set the tone for the state, and the state board of insurance is trying to get other carriers to do same thing, with some success,” he said. “And a number of carriers are moving back into the state.”

But “it's obviously early in the process,” Dr. Hampton cautioned. “Everyone told us to expect initially that claims would go down, and [the question is] how soon it would take to start going back up. … We've also seen bills in the legislature trying to erode some of the gains we made, but so far none [has] taken hold.”

Not everyone is pleased with the law. “I have no problems with my malpractice carrier, but this [law] is not the answer,” said Jerry Frankel, M.D., a urologist practicing in McKinney, Tex. “The answer is to totally change the concept of malpractice.”

Instead of the current system, Dr. Frankel supports a no-fault liability system, in which injured patients are reimbursed based on a set formula. “The way the system works now, only a tiny percentage of people get compensation, and 70% of money goes to lawyers and the court system,” he said. “But if you leave the lawyers out and the courts out, 100% of compensation would go to victims of bad outcomes.”

Using caps to compensate patients who have been harmed is not a fair approach, Dr. Frankel said. “The trouble with caps is, we do have nightmares. One woman had a bilateral mastectomy, and she had benign disease. She got $100,000. If this had happened to my wife, a trillion dollars wouldn't be enough.”

To make sure that bad physicians are appropriately disciplined, there should be a separate system to monitor them, Dr. Frankel said. He said the reason malpractice premiums had been going up does not appear to be related to lawsuits. “Maybe 1% of people who are injured get some kind of compensation, and nobody's shown that the number of injuries is growing or the number of bad doctors is increasing.” Instead, he said, “all that happens is when the stock market goes bad, premiums go up.”

Not so, according to Donald J. Zuk, president and CEO of SCPIE, a medical malpractice insurer that left the Texas market in 2002. “Insurers cannot raise premiums to cover past losses,” he said at a conference sponsored by the American Enterprise Institute, in Washington. Rather, “premiums are tied to estimates of future paid losses.”

Mr. Zuk said that his company left the Texas market because of losses from lawsuits. In 1999, for instance, the company's loss ratio in the state was 177%–it paid out 77% more in claims than it had taken in premiums. The loss ratio increased over the next 2 years to 228% in 2001; by 2004 it had dropped to 139%, still well over the amount it had taken in.

Despite the new law, Mr. Zuk said his company has no plans to reenter the Texas market. “We're out of Texas for the immediate future because it's just too dangerous.”

When it comes to tort reform in Texas, physicians there say “so far, so good.”

In 2003, the state enacted a tort reform law similar to that of California, including a $250,000 cap on noneconomic damages. So far, that's been good news for Texas physicians, according to R. Moss Hampton, M.D., head of the Texas Association of Ob.Gyns.

“Everybody here would say it's been a success,” said Dr. Hampton, who practices in Amarillo. He noted that the Texas Medical Liability Trust, the state's largest medical malpractice insurer, has reduced its rates by 17% since the law went into effect.

“That's kind of set the tone for the state, and the state board of insurance is trying to get other carriers to do same thing, with some success,” he said. “And a number of carriers are moving back into the state.”

But “it's obviously early in the process,” Dr. Hampton cautioned. “Everyone told us to expect initially that claims would go down, and [the question is] how soon it would take to start going back up. … We've also seen bills in the legislature trying to erode some of the gains we made, but so far none [has] taken hold.”

Not everyone is pleased with the law. “I have no problems with my malpractice carrier, but this [law] is not the answer,” said Jerry Frankel, M.D., a urologist practicing in McKinney, Tex. “The answer is to totally change the concept of malpractice.”

Instead of the current system, Dr. Frankel supports a no-fault liability system, in which injured patients are reimbursed based on a set formula. “The way the system works now, only a tiny percentage of people get compensation, and 70% of money goes to lawyers and the court system,” he said. “But if you leave the lawyers out and the courts out, 100% of compensation would go to victims of bad outcomes.”

Using caps to compensate patients who have been harmed is not a fair approach, Dr. Frankel said. “The trouble with caps is, we do have nightmares. One woman had a bilateral mastectomy, and she had benign disease. She got $100,000. If this had happened to my wife, a trillion dollars wouldn't be enough.”

To make sure that bad physicians are appropriately disciplined, there should be a separate system to monitor them, Dr. Frankel said. He said the reason malpractice premiums had been going up does not appear to be related to lawsuits. “Maybe 1% of people who are injured get some kind of compensation, and nobody's shown that the number of injuries is growing or the number of bad doctors is increasing.” Instead, he said, “all that happens is when the stock market goes bad, premiums go up.”

Not so, according to Donald J. Zuk, president and CEO of SCPIE, a medical malpractice insurer that left the Texas market in 2002. “Insurers cannot raise premiums to cover past losses,” he said at a conference sponsored by the American Enterprise Institute, in Washington. Rather, “premiums are tied to estimates of future paid losses.”

Mr. Zuk said that his company left the Texas market because of losses from lawsuits. In 1999, for instance, the company's loss ratio in the state was 177%–it paid out 77% more in claims than it had taken in premiums. The loss ratio increased over the next 2 years to 228% in 2001; by 2004 it had dropped to 139%, still well over the amount it had taken in.

Despite the new law, Mr. Zuk said his company has no plans to reenter the Texas market. “We're out of Texas for the immediate future because it's just too dangerous.”

When it comes to tort reform in Texas, physicians there say “so far, so good.”

In 2003, the state enacted a tort reform law similar to that of California, including a $250,000 cap on noneconomic damages. So far, that's been good news for Texas physicians, according to R. Moss Hampton, M.D., head of the Texas Association of Ob.Gyns.

“Everybody here would say it's been a success,” said Dr. Hampton, who practices in Amarillo. He noted that the Texas Medical Liability Trust, the state's largest medical malpractice insurer, has reduced its rates by 17% since the law went into effect.

“That's kind of set the tone for the state, and the state board of insurance is trying to get other carriers to do same thing, with some success,” he said. “And a number of carriers are moving back into the state.”

But “it's obviously early in the process,” Dr. Hampton cautioned. “Everyone told us to expect initially that claims would go down, and [the question is] how soon it would take to start going back up. … We've also seen bills in the legislature trying to erode some of the gains we made, but so far none [has] taken hold.”

Not everyone is pleased with the law. “I have no problems with my malpractice carrier, but this [law] is not the answer,” said Jerry Frankel, M.D., a urologist practicing in McKinney, Tex. “The answer is to totally change the concept of malpractice.”

Instead of the current system, Dr. Frankel supports a no-fault liability system, in which injured patients are reimbursed based on a set formula. “The way the system works now, only a tiny percentage of people get compensation, and 70% of money goes to lawyers and the court system,” he said. “But if you leave the lawyers out and the courts out, 100% of compensation would go to victims of bad outcomes.”

Using caps to compensate patients who have been harmed is not a fair approach, Dr. Frankel said. “The trouble with caps is, we do have nightmares. One woman had a bilateral mastectomy, and she had benign disease. She got $100,000. If this had happened to my wife, a trillion dollars wouldn't be enough.”

To make sure that bad physicians are appropriately disciplined, there should be a separate system to monitor them, Dr. Frankel said. He said the reason malpractice premiums had been going up does not appear to be related to lawsuits. “Maybe 1% of people who are injured get some kind of compensation, and nobody's shown that the number of injuries is growing or the number of bad doctors is increasing.” Instead, he said, “all that happens is when the stock market goes bad, premiums go up.”

Not so, according to Donald J. Zuk, president and CEO of SCPIE, a medical malpractice insurer that left the Texas market in 2002. “Insurers cannot raise premiums to cover past losses,” he said at a conference sponsored by the American Enterprise Institute, in Washington. Rather, “premiums are tied to estimates of future paid losses.”

Mr. Zuk said that his company left the Texas market because of losses from lawsuits. In 1999, for instance, the company's loss ratio in the state was 177%–it paid out 77% more in claims than it had taken in premiums. The loss ratio increased over the next 2 years to 228% in 2001; by 2004 it had dropped to 139%, still well over the amount it had taken in.

Despite the new law, Mr. Zuk said his company has no plans to reenter the Texas market. “We're out of Texas for the immediate future because it's just too dangerous.”

Psychiatric Residents Increasing

The number of psychiatric residents is increasing modestly, according to a resident census conducted by the American Psychiatric Association. As of Aug. 30, the total number of psychiatric residents had increased 1.6% over the previous year. U.S. medical graduates increased 4%, and women residents were up 5.5%, the census showed. Psychosomatic medicine, a new psychiatric subspecialty, had 60% female fellows. The top three most popular subspecialties were child and adolescent psychiatry, addiction psychiatry, and forensic psychiatry; all subspecialties had increasing numbers of fellows except for geriatric psychiatry. Geographically, the highest concentration of residents was in New York state, followed by California.

Data on Youth Suicide Attempts

About 900,000 children aged 12–17 planned to commit suicide during their worst or most recent episode of major depression, according to data from the Substance Abuse and Mental Health Services Administration. Of those who planned suicide, 712,000 attempted it. The report, which was compiled using data from the 2004 National Survey on Drug Use and Health, defined a “major depressive episode” as a period of at least 2 weeks in which a person experienced a depressed mood or loss of interest or pleasure in daily activities, and had at least five of nine symptoms of depression listed in the DSM-IV. “Suicide is a preventable tragedy,” said Charles Curie, the SAMHSA administrator. “It is a thief that sets no boundaries and seeks victims of all ages.”

Public Health Unpreparedness

Many local public health agencies are ill-prepared to learn about and respond to naturally occurring outbreaks of deadly infectious diseases or acts of bioterrorism, a test by the RAND Corporation has found. To conduct the test, researchers posed as local physicians who were reporting fictitious cases of botulism, anthrax, smallpox, bubonic plague, and other diseases to 19 public health agencies in 18 states nationwide. (Agency directors agreed in advance to participate in the test, but did not tell their staff members.) In one case, after listening to a description of the classic symptoms of bubonic plague, a public health worker advised the caller not to worry because no similar cases had been reported. Another caller who reported a botulism case was told: “You're right; it does sound like botulism. I wouldn't worry too much if I were you.” The article appears in the Aug. 30 online edition of Health Affairs.

Drug Abuse Counseling Protocol

SAMHSA has issued a new Treatment Improvement Protocol designed to help substance abuse counselors working with clients in the criminal justice system. The guidelines, known as TIP 44, provide information on screening, assessments, treatment services, and follow-up services for people in various criminal justice settings. For example, they note that in the pretrial setting, treatment professionals need to be careful not to coerce clients into waiving due process rights. The guidelines also explain that in-prison drug abuse treatment followed by community-based continuing care has been credited with reducing short-term recidivism and relapse rates. The guidelines are available online at

www.samhsa.gov/news/newsreleases/TIP%2044-CJA.pdf

Part B Premiums on the Rise

Medicare Part B monthly premiums will be $88.50 in 2006, an increase of $10.30 from the current $78.20 premium, the Centers for Medicare and Medicaid Services reported. The agency cited continued rapid growth in the intensity and use of Part B services as the main reason for the increase. “This growth is seen in physician office visits, lab tests, minor procedures, and physician-administered drugs. It also includes rapid growth in hospital outpatient services,” CMS said in a statement. They also said that “part of the premium increase is necessary to increase assets that, for accounting purposes, are held in the Part B trust fund.” Though premiums are rising, most Medicare beneficiaries will see significantly lower out-of-pocket health care costs in 2006 because of the savings in drug costs from the new Medicare prescription drug benefit, the agency contends.

Employer Health Coverage Declines

The percentage of businesses offering health insurance to employees has declined over the past 5 years as the cost of providing insurance benefits outpaces inflation and wage growth, according to the 2005 Annual Employer Health Benefits Survey released by the Kaiser Family Foundation and Health Research and Educational Trust. The survey found that three of five firms (60%) offered coverage to workers in 2005, a decrease from 69% in 2000 and 66% in 2003. “The drop stems almost entirely from fewer small businesses offering health benefits, as nearly all businesses (98%) with 200 or more workers offer such benefits,” the news release stated. The survey found that 20% of employers that offer health insurance currently provide a high-deductible health plan option. Very large companies–those with 5,000 or more employees–are significantly more likely than smaller ones to offer a high-deductible plan option, with 33% offering such an option in 2005. High-deductible health plans are defined in the survey as plans with at least a $1,000 deductible for single coverage or at least a $2,000 deductible for family coverage. In the meantime, relatively few workers are enrolled in “consumer-driven” plans, despite their growing availability.

Psychiatric Residents Increasing

The number of psychiatric residents is increasing modestly, according to a resident census conducted by the American Psychiatric Association. As of Aug. 30, the total number of psychiatric residents had increased 1.6% over the previous year. U.S. medical graduates increased 4%, and women residents were up 5.5%, the census showed. Psychosomatic medicine, a new psychiatric subspecialty, had 60% female fellows. The top three most popular subspecialties were child and adolescent psychiatry, addiction psychiatry, and forensic psychiatry; all subspecialties had increasing numbers of fellows except for geriatric psychiatry. Geographically, the highest concentration of residents was in New York state, followed by California.

Data on Youth Suicide Attempts

About 900,000 children aged 12–17 planned to commit suicide during their worst or most recent episode of major depression, according to data from the Substance Abuse and Mental Health Services Administration. Of those who planned suicide, 712,000 attempted it. The report, which was compiled using data from the 2004 National Survey on Drug Use and Health, defined a “major depressive episode” as a period of at least 2 weeks in which a person experienced a depressed mood or loss of interest or pleasure in daily activities, and had at least five of nine symptoms of depression listed in the DSM-IV. “Suicide is a preventable tragedy,” said Charles Curie, the SAMHSA administrator. “It is a thief that sets no boundaries and seeks victims of all ages.”

Public Health Unpreparedness

Many local public health agencies are ill-prepared to learn about and respond to naturally occurring outbreaks of deadly infectious diseases or acts of bioterrorism, a test by the RAND Corporation has found. To conduct the test, researchers posed as local physicians who were reporting fictitious cases of botulism, anthrax, smallpox, bubonic plague, and other diseases to 19 public health agencies in 18 states nationwide. (Agency directors agreed in advance to participate in the test, but did not tell their staff members.) In one case, after listening to a description of the classic symptoms of bubonic plague, a public health worker advised the caller not to worry because no similar cases had been reported. Another caller who reported a botulism case was told: “You're right; it does sound like botulism. I wouldn't worry too much if I were you.” The article appears in the Aug. 30 online edition of Health Affairs.

Drug Abuse Counseling Protocol

SAMHSA has issued a new Treatment Improvement Protocol designed to help substance abuse counselors working with clients in the criminal justice system. The guidelines, known as TIP 44, provide information on screening, assessments, treatment services, and follow-up services for people in various criminal justice settings. For example, they note that in the pretrial setting, treatment professionals need to be careful not to coerce clients into waiving due process rights. The guidelines also explain that in-prison drug abuse treatment followed by community-based continuing care has been credited with reducing short-term recidivism and relapse rates. The guidelines are available online at

www.samhsa.gov/news/newsreleases/TIP%2044-CJA.pdf

Part B Premiums on the Rise

Medicare Part B monthly premiums will be $88.50 in 2006, an increase of $10.30 from the current $78.20 premium, the Centers for Medicare and Medicaid Services reported. The agency cited continued rapid growth in the intensity and use of Part B services as the main reason for the increase. “This growth is seen in physician office visits, lab tests, minor procedures, and physician-administered drugs. It also includes rapid growth in hospital outpatient services,” CMS said in a statement. They also said that “part of the premium increase is necessary to increase assets that, for accounting purposes, are held in the Part B trust fund.” Though premiums are rising, most Medicare beneficiaries will see significantly lower out-of-pocket health care costs in 2006 because of the savings in drug costs from the new Medicare prescription drug benefit, the agency contends.

Employer Health Coverage Declines

The percentage of businesses offering health insurance to employees has declined over the past 5 years as the cost of providing insurance benefits outpaces inflation and wage growth, according to the 2005 Annual Employer Health Benefits Survey released by the Kaiser Family Foundation and Health Research and Educational Trust. The survey found that three of five firms (60%) offered coverage to workers in 2005, a decrease from 69% in 2000 and 66% in 2003. “The drop stems almost entirely from fewer small businesses offering health benefits, as nearly all businesses (98%) with 200 or more workers offer such benefits,” the news release stated. The survey found that 20% of employers that offer health insurance currently provide a high-deductible health plan option. Very large companies–those with 5,000 or more employees–are significantly more likely than smaller ones to offer a high-deductible plan option, with 33% offering such an option in 2005. High-deductible health plans are defined in the survey as plans with at least a $1,000 deductible for single coverage or at least a $2,000 deductible for family coverage. In the meantime, relatively few workers are enrolled in “consumer-driven” plans, despite their growing availability.

Psychiatric Residents Increasing

The number of psychiatric residents is increasing modestly, according to a resident census conducted by the American Psychiatric Association. As of Aug. 30, the total number of psychiatric residents had increased 1.6% over the previous year. U.S. medical graduates increased 4%, and women residents were up 5.5%, the census showed. Psychosomatic medicine, a new psychiatric subspecialty, had 60% female fellows. The top three most popular subspecialties were child and adolescent psychiatry, addiction psychiatry, and forensic psychiatry; all subspecialties had increasing numbers of fellows except for geriatric psychiatry. Geographically, the highest concentration of residents was in New York state, followed by California.

Data on Youth Suicide Attempts

About 900,000 children aged 12–17 planned to commit suicide during their worst or most recent episode of major depression, according to data from the Substance Abuse and Mental Health Services Administration. Of those who planned suicide, 712,000 attempted it. The report, which was compiled using data from the 2004 National Survey on Drug Use and Health, defined a “major depressive episode” as a period of at least 2 weeks in which a person experienced a depressed mood or loss of interest or pleasure in daily activities, and had at least five of nine symptoms of depression listed in the DSM-IV. “Suicide is a preventable tragedy,” said Charles Curie, the SAMHSA administrator. “It is a thief that sets no boundaries and seeks victims of all ages.”

Public Health Unpreparedness

Many local public health agencies are ill-prepared to learn about and respond to naturally occurring outbreaks of deadly infectious diseases or acts of bioterrorism, a test by the RAND Corporation has found. To conduct the test, researchers posed as local physicians who were reporting fictitious cases of botulism, anthrax, smallpox, bubonic plague, and other diseases to 19 public health agencies in 18 states nationwide. (Agency directors agreed in advance to participate in the test, but did not tell their staff members.) In one case, after listening to a description of the classic symptoms of bubonic plague, a public health worker advised the caller not to worry because no similar cases had been reported. Another caller who reported a botulism case was told: “You're right; it does sound like botulism. I wouldn't worry too much if I were you.” The article appears in the Aug. 30 online edition of Health Affairs.

Drug Abuse Counseling Protocol

SAMHSA has issued a new Treatment Improvement Protocol designed to help substance abuse counselors working with clients in the criminal justice system. The guidelines, known as TIP 44, provide information on screening, assessments, treatment services, and follow-up services for people in various criminal justice settings. For example, they note that in the pretrial setting, treatment professionals need to be careful not to coerce clients into waiving due process rights. The guidelines also explain that in-prison drug abuse treatment followed by community-based continuing care has been credited with reducing short-term recidivism and relapse rates. The guidelines are available online at

www.samhsa.gov/news/newsreleases/TIP%2044-CJA.pdf

Part B Premiums on the Rise

Medicare Part B monthly premiums will be $88.50 in 2006, an increase of $10.30 from the current $78.20 premium, the Centers for Medicare and Medicaid Services reported. The agency cited continued rapid growth in the intensity and use of Part B services as the main reason for the increase. “This growth is seen in physician office visits, lab tests, minor procedures, and physician-administered drugs. It also includes rapid growth in hospital outpatient services,” CMS said in a statement. They also said that “part of the premium increase is necessary to increase assets that, for accounting purposes, are held in the Part B trust fund.” Though premiums are rising, most Medicare beneficiaries will see significantly lower out-of-pocket health care costs in 2006 because of the savings in drug costs from the new Medicare prescription drug benefit, the agency contends.

Employer Health Coverage Declines

The percentage of businesses offering health insurance to employees has declined over the past 5 years as the cost of providing insurance benefits outpaces inflation and wage growth, according to the 2005 Annual Employer Health Benefits Survey released by the Kaiser Family Foundation and Health Research and Educational Trust. The survey found that three of five firms (60%) offered coverage to workers in 2005, a decrease from 69% in 2000 and 66% in 2003. “The drop stems almost entirely from fewer small businesses offering health benefits, as nearly all businesses (98%) with 200 or more workers offer such benefits,” the news release stated. The survey found that 20% of employers that offer health insurance currently provide a high-deductible health plan option. Very large companies–those with 5,000 or more employees–are significantly more likely than smaller ones to offer a high-deductible plan option, with 33% offering such an option in 2005. High-deductible health plans are defined in the survey as plans with at least a $1,000 deductible for single coverage or at least a $2,000 deductible for family coverage. In the meantime, relatively few workers are enrolled in “consumer-driven” plans, despite their growing availability.

New voluntary guidelines for direct-to-consumer prescription drug advertising released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups who say they don't go far enough.

“While I wish the PhRMA guidelines would have gone further and proposed a moratorium on DTC [direct to consumer] advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure,” Senate Majority Leader Bill Frist, M.D. (R-Tenn.), said in a statement. Sidney Wolfe, M.D. director of the Public Citizen Health Research Group, called the PhRMA announcement “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.” The guidelines were released in August at an American Legislative Exchange Council meeting in Dallas. They call for pharmaceutical manufacturers to educate physicians and other health care providers about new drugs before advertising them to consumers.

“The centerpiece is the notion that the companies are committing an appropriate amount of time to educate health care professionals about new medications and new indications … to make sure physicians and other providers know about the medicines and benefits before,” direct-to-consumer advertising campaigns are undertaken, Billy Tauzin, CEO of PhRMA and a former congressman from Louisiana, said at a press conference sponsored by PhRMA.

The length of time the companies will take to educate physicians will depend on several factors, including whether the drug is a life-saving one and how complex the risk-benefit profile is, Mr. Tauzin said.

Other provisions of the voluntary guidelines, which 23 companies have signed onto, include:

▸ DTC ads should be balanced, and discuss both the benefits and risks of the medication. The information should be presented in “clear, understandable language, without distraction from the content.”

▸ Ads should be targeted to avoid audiences that are not age-appropriate. For example, Karen Katen, president of Pfizer Human Health, said that her company would not run a television advertisement for Viagra (sildenafil) during the Super Bowl, when young children may be watching.

▸ Companies should submit new DTC print and television advertisements to the FDA before releasing them. PhRMA board chair Bill Weldon said this does not mean that companies would submit an ad to the FDA on Tuesday and then run it on Wednesday. “The intent is to make sure that FDA has been able to comment on any programs prior to advertising,” said Mr. Weldon, who is also chairman and CEO of Johnson & Johnson.

▸ Ads that identify a product by name should include the product's indications as well as its risks and benefits. This means no more ads that just give the name of the medication and tell what it's for, Mr. Tauzin said.

PhRMA also will convene an independent board in about a year to get outside opinion on whether the companies are following the guidelines. The panel will include experts in health care, broadcasting, and other relevant disciplines.

The voluntary guidelines are available at www.phrma.org/publications/policy//admin/2005-08-02.1194.pdf

New voluntary guidelines for direct-to-consumer prescription drug advertising released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups who say they don't go far enough.

“While I wish the PhRMA guidelines would have gone further and proposed a moratorium on DTC [direct to consumer] advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure,” Senate Majority Leader Bill Frist, M.D. (R-Tenn.), said in a statement. Sidney Wolfe, M.D. director of the Public Citizen Health Research Group, called the PhRMA announcement “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.” The guidelines were released in August at an American Legislative Exchange Council meeting in Dallas. They call for pharmaceutical manufacturers to educate physicians and other health care providers about new drugs before advertising them to consumers.

“The centerpiece is the notion that the companies are committing an appropriate amount of time to educate health care professionals about new medications and new indications … to make sure physicians and other providers know about the medicines and benefits before,” direct-to-consumer advertising campaigns are undertaken, Billy Tauzin, CEO of PhRMA and a former congressman from Louisiana, said at a press conference sponsored by PhRMA.

The length of time the companies will take to educate physicians will depend on several factors, including whether the drug is a life-saving one and how complex the risk-benefit profile is, Mr. Tauzin said.

Other provisions of the voluntary guidelines, which 23 companies have signed onto, include:

▸ DTC ads should be balanced, and discuss both the benefits and risks of the medication. The information should be presented in “clear, understandable language, without distraction from the content.”

▸ Ads should be targeted to avoid audiences that are not age-appropriate. For example, Karen Katen, president of Pfizer Human Health, said that her company would not run a television advertisement for Viagra (sildenafil) during the Super Bowl, when young children may be watching.

▸ Companies should submit new DTC print and television advertisements to the FDA before releasing them. PhRMA board chair Bill Weldon said this does not mean that companies would submit an ad to the FDA on Tuesday and then run it on Wednesday. “The intent is to make sure that FDA has been able to comment on any programs prior to advertising,” said Mr. Weldon, who is also chairman and CEO of Johnson & Johnson.

▸ Ads that identify a product by name should include the product's indications as well as its risks and benefits. This means no more ads that just give the name of the medication and tell what it's for, Mr. Tauzin said.

PhRMA also will convene an independent board in about a year to get outside opinion on whether the companies are following the guidelines. The panel will include experts in health care, broadcasting, and other relevant disciplines.

The voluntary guidelines are available at www.phrma.org/publications/policy//admin/2005-08-02.1194.pdf

New voluntary guidelines for direct-to-consumer prescription drug advertising released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups who say they don't go far enough.

“While I wish the PhRMA guidelines would have gone further and proposed a moratorium on DTC [direct to consumer] advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure,” Senate Majority Leader Bill Frist, M.D. (R-Tenn.), said in a statement. Sidney Wolfe, M.D. director of the Public Citizen Health Research Group, called the PhRMA announcement “a meaningless attempt to fool people into believing the guidelines are stronger than they really are.” The guidelines were released in August at an American Legislative Exchange Council meeting in Dallas. They call for pharmaceutical manufacturers to educate physicians and other health care providers about new drugs before advertising them to consumers.

“The centerpiece is the notion that the companies are committing an appropriate amount of time to educate health care professionals about new medications and new indications … to make sure physicians and other providers know about the medicines and benefits before,” direct-to-consumer advertising campaigns are undertaken, Billy Tauzin, CEO of PhRMA and a former congressman from Louisiana, said at a press conference sponsored by PhRMA.

The length of time the companies will take to educate physicians will depend on several factors, including whether the drug is a life-saving one and how complex the risk-benefit profile is, Mr. Tauzin said.

Other provisions of the voluntary guidelines, which 23 companies have signed onto, include:

▸ DTC ads should be balanced, and discuss both the benefits and risks of the medication. The information should be presented in “clear, understandable language, without distraction from the content.”

▸ Ads should be targeted to avoid audiences that are not age-appropriate. For example, Karen Katen, president of Pfizer Human Health, said that her company would not run a television advertisement for Viagra (sildenafil) during the Super Bowl, when young children may be watching.

▸ Companies should submit new DTC print and television advertisements to the FDA before releasing them. PhRMA board chair Bill Weldon said this does not mean that companies would submit an ad to the FDA on Tuesday and then run it on Wednesday. “The intent is to make sure that FDA has been able to comment on any programs prior to advertising,” said Mr. Weldon, who is also chairman and CEO of Johnson & Johnson.

▸ Ads that identify a product by name should include the product's indications as well as its risks and benefits. This means no more ads that just give the name of the medication and tell what it's for, Mr. Tauzin said.

PhRMA also will convene an independent board in about a year to get outside opinion on whether the companies are following the guidelines. The panel will include experts in health care, broadcasting, and other relevant disciplines.

The voluntary guidelines are available at www.phrma.org/publications/policy//admin/2005-08-02.1194.pdf

When a patient with obstructive sleep apnea can't tolerate using a continuous positive airway pressure device, what's the next step?

“The option people end up thinking about when CPAP fails is typically surgery,” said Kent Moore, M.D., D.D.S., president of the Academy of Dental Sleep Medicine. But there is another alternative.

“There is strong level 1 data showing that oral appliance therapy can be more effective than soft palate surgery,” said Dr. Moore, an oral/maxillofacial surgeon in private practice in Charlotte, N.C.

For example, one prospective randomized trial compared dental appliances with uvulopalatopharyngoplasty in 95 men with sleep apnea. The men who used dental appliances had a success rate (a 50% or greater reduction in the apnea index) of 95%, which was significantly higher than the 70% success rate for the patients who underwent surgery (Chest 2002;121:674–7).

Dr. Moore emphasized that most professionals encourage patients with sleep apnea to start out by trying CPAP, which is recognized as effective first-line treatment for patients with sleep apnea.

“But a lot of folks just simply can't tolerate CPAP for numerous reasons,” he said. “One reason is that [the required] airway pressures are not easily tolerated in folks with milder forms of apnea. Another issue is sleeping with the device attached to the head or face–simple comfort issues prevent a lot of patients from tolerating it. And there is also the claustrophobia issue.”

Several types of dental appliances are currently on the market for treating sleep apnea. One type that is widely used is a variation on the Herbst appliance, which is designed to help stimulate jaw growth in children. “Dentists have adopted that effect for sleep apnea, because you're advancing the mandible, which expands the airway at the base of the tongue,” Dr. Moore explained. “An oral appliance has several effects: It expands the airway, lowers soft tissue compliance, and makes the airway stiffer. The combined effect has a huge benefit for a large number of patients with sleep apnea.”

Like other medical devices, apnea appliances do have side effects. For example, the mandibular repositioning devices can cause temporomandibular joint syndrome, and they also can change the position of the teeth. “Shifting of the teeth is the bigger of the two issues, but even the orthodontists in our practice group say, 'Get over it–people aren't going to die from malocclusion,'” Dr. Moore said.

For patients who don't have the teeth or bone structure needed to anchor the mandibular devices, tongue-retaining appliances can be used to pull the tongue forward and expand the airway at the base of the tongue. “You'd be shocked at the number of people who have insurance … and their teeth–usually the upper teeth–are gone,” said R. Neal Aguillard, M.D., medical director of the sleep disorders center at Methodist Hospital, Memphis.

Only certain patients are good candidates for dental appliances, which can cost anywhere from several hundred to several thousand dollars for the device and the required dental visits.

“Dental appliances may be an appropriate first line of treatment in patients with milder degrees of sleep apnea,” said Carl E. Hunt, M.D., director of the National Center on Sleep Disorders Research at the National Heart, Lung, and Blood Institute, in Bethesda, Md. “This has to be very individualized.”

Dr. Aguillard agreed. “Unless the patient has really severe apnea, I'll mention it as an option,” he said. “If the patient has claustrophobia and can't stand having anything on [his] face, I'm going to be first opting for an oral appliance.”

To determine whether a dental appliance will work in a particular patient, the dentist must do a thorough examination, including special x-ray studies, Dr. Aguillard explained.

“The reason people have apnea varies from one person to another,” he said. “Sometimes the problem may be in the nose, sometimes it's the roof of the mouth, sometimes it may be the tongue, sometimes the jaw, and sometimes the tonsils and adenoids. Sometimes more than one place is blocking off and keeping air from getting into the windpipe. So x-rays are important, because they can give you an idea of whether repositioning the jaw will actually do something.”

A barrier to wider use of dental appliance treatment for sleep apnea is widespread unfamiliarity with the approach in the general medical profession, according to Dr. Moore. “It's a real frustration for us right now as a profession,” he said. “Physicians themselves are not getting the word on it, and the general public is getting even less.”

Dr. Hunt agreed. “Many times today, the primary care physician refers the patient for a sleep study and gets a report back, and it's up to [the patient] to coordinate treatment.”

Ins and Outs of Sleep Apnea Appliances

When choosing an appliance to treat sleep apnea, the options are many and varied, Dr. Moore said.

Custom-made adjustable appliances require several visits for evaluation, fitting, and follow-up. The initial evaluation includes tests to assess the ability of the upper airway to expand when the jaw is moved forward. After the appliance has been made and fitted, the patient can come in at any time for adjustments, but it's especially important for the patient to visit after the symptoms have improved.

“Once that point has been achieved, a repeat portable monitoring test is ordered … to assess results of titration,” he continued. “Following this, the patient is sent back to the sleep physician for possible repeat polysomnography.”

In addition, “the patient needs to be followed for the length of time that they continue with use of the appliance–possibly every 6 months to 1 year–in order to monitor for changes in occlusion, TMJ problems, or other problems with the appliance,” Dr. Moore noted.

In contrast to adjustable appliances, there are devices that are not custom made, known as “boil and bite.” These “one-position appliances” are not adjustable after the initial fitting. “Some of these can be effective, and they are generally less expensive than custom-made appliances, which will cost more because they are uniquely patient-specific,” he said.

Costs can range from several hundred to several thousand dollars, which includes the appliance as well as visits for evaluation and fitting. Health insurers typically will cover these costs if the patient has sleep apnea that has been documented by polysomnography, Dr. Moore said.

When a patient with obstructive sleep apnea can't tolerate using a continuous positive airway pressure device, what's the next step?

“The option people end up thinking about when CPAP fails is typically surgery,” said Kent Moore, M.D., D.D.S., president of the Academy of Dental Sleep Medicine. But there is another alternative.

“There is strong level 1 data showing that oral appliance therapy can be more effective than soft palate surgery,” said Dr. Moore, an oral/maxillofacial surgeon in private practice in Charlotte, N.C.

For example, one prospective randomized trial compared dental appliances with uvulopalatopharyngoplasty in 95 men with sleep apnea. The men who used dental appliances had a success rate (a 50% or greater reduction in the apnea index) of 95%, which was significantly higher than the 70% success rate for the patients who underwent surgery (Chest 2002;121:674–7).

Dr. Moore emphasized that most professionals encourage patients with sleep apnea to start out by trying CPAP, which is recognized as effective first-line treatment for patients with sleep apnea.

“But a lot of folks just simply can't tolerate CPAP for numerous reasons,” he said. “One reason is that [the required] airway pressures are not easily tolerated in folks with milder forms of apnea. Another issue is sleeping with the device attached to the head or face–simple comfort issues prevent a lot of patients from tolerating it. And there is also the claustrophobia issue.”

Several types of dental appliances are currently on the market for treating sleep apnea. One type that is widely used is a variation on the Herbst appliance, which is designed to help stimulate jaw growth in children. “Dentists have adopted that effect for sleep apnea, because you're advancing the mandible, which expands the airway at the base of the tongue,” Dr. Moore explained. “An oral appliance has several effects: It expands the airway, lowers soft tissue compliance, and makes the airway stiffer. The combined effect has a huge benefit for a large number of patients with sleep apnea.”

Like other medical devices, apnea appliances do have side effects. For example, the mandibular repositioning devices can cause temporomandibular joint syndrome, and they also can change the position of the teeth. “Shifting of the teeth is the bigger of the two issues, but even the orthodontists in our practice group say, 'Get over it–people aren't going to die from malocclusion,'” Dr. Moore said.

For patients who don't have the teeth or bone structure needed to anchor the mandibular devices, tongue-retaining appliances can be used to pull the tongue forward and expand the airway at the base of the tongue. “You'd be shocked at the number of people who have insurance … and their teeth–usually the upper teeth–are gone,” said R. Neal Aguillard, M.D., medical director of the sleep disorders center at Methodist Hospital, Memphis.

Only certain patients are good candidates for dental appliances, which can cost anywhere from several hundred to several thousand dollars for the device and the required dental visits.

“Dental appliances may be an appropriate first line of treatment in patients with milder degrees of sleep apnea,” said Carl E. Hunt, M.D., director of the National Center on Sleep Disorders Research at the National Heart, Lung, and Blood Institute, in Bethesda, Md. “This has to be very individualized.”

Dr. Aguillard agreed. “Unless the patient has really severe apnea, I'll mention it as an option,” he said. “If the patient has claustrophobia and can't stand having anything on [his] face, I'm going to be first opting for an oral appliance.”

To determine whether a dental appliance will work in a particular patient, the dentist must do a thorough examination, including special x-ray studies, Dr. Aguillard explained.

“The reason people have apnea varies from one person to another,” he said. “Sometimes the problem may be in the nose, sometimes it's the roof of the mouth, sometimes it may be the tongue, sometimes the jaw, and sometimes the tonsils and adenoids. Sometimes more than one place is blocking off and keeping air from getting into the windpipe. So x-rays are important, because they can give you an idea of whether repositioning the jaw will actually do something.”

A barrier to wider use of dental appliance treatment for sleep apnea is widespread unfamiliarity with the approach in the general medical profession, according to Dr. Moore. “It's a real frustration for us right now as a profession,” he said. “Physicians themselves are not getting the word on it, and the general public is getting even less.”

Dr. Hunt agreed. “Many times today, the primary care physician refers the patient for a sleep study and gets a report back, and it's up to [the patient] to coordinate treatment.”

Ins and Outs of Sleep Apnea Appliances

When choosing an appliance to treat sleep apnea, the options are many and varied, Dr. Moore said.

Custom-made adjustable appliances require several visits for evaluation, fitting, and follow-up. The initial evaluation includes tests to assess the ability of the upper airway to expand when the jaw is moved forward. After the appliance has been made and fitted, the patient can come in at any time for adjustments, but it's especially important for the patient to visit after the symptoms have improved.

“Once that point has been achieved, a repeat portable monitoring test is ordered … to assess results of titration,” he continued. “Following this, the patient is sent back to the sleep physician for possible repeat polysomnography.”

In addition, “the patient needs to be followed for the length of time that they continue with use of the appliance–possibly every 6 months to 1 year–in order to monitor for changes in occlusion, TMJ problems, or other problems with the appliance,” Dr. Moore noted.

In contrast to adjustable appliances, there are devices that are not custom made, known as “boil and bite.” These “one-position appliances” are not adjustable after the initial fitting. “Some of these can be effective, and they are generally less expensive than custom-made appliances, which will cost more because they are uniquely patient-specific,” he said.

Costs can range from several hundred to several thousand dollars, which includes the appliance as well as visits for evaluation and fitting. Health insurers typically will cover these costs if the patient has sleep apnea that has been documented by polysomnography, Dr. Moore said.

When a patient with obstructive sleep apnea can't tolerate using a continuous positive airway pressure device, what's the next step?

“The option people end up thinking about when CPAP fails is typically surgery,” said Kent Moore, M.D., D.D.S., president of the Academy of Dental Sleep Medicine. But there is another alternative.

“There is strong level 1 data showing that oral appliance therapy can be more effective than soft palate surgery,” said Dr. Moore, an oral/maxillofacial surgeon in private practice in Charlotte, N.C.

For example, one prospective randomized trial compared dental appliances with uvulopalatopharyngoplasty in 95 men with sleep apnea. The men who used dental appliances had a success rate (a 50% or greater reduction in the apnea index) of 95%, which was significantly higher than the 70% success rate for the patients who underwent surgery (Chest 2002;121:674–7).

Dr. Moore emphasized that most professionals encourage patients with sleep apnea to start out by trying CPAP, which is recognized as effective first-line treatment for patients with sleep apnea.

“But a lot of folks just simply can't tolerate CPAP for numerous reasons,” he said. “One reason is that [the required] airway pressures are not easily tolerated in folks with milder forms of apnea. Another issue is sleeping with the device attached to the head or face–simple comfort issues prevent a lot of patients from tolerating it. And there is also the claustrophobia issue.”

Several types of dental appliances are currently on the market for treating sleep apnea. One type that is widely used is a variation on the Herbst appliance, which is designed to help stimulate jaw growth in children. “Dentists have adopted that effect for sleep apnea, because you're advancing the mandible, which expands the airway at the base of the tongue,” Dr. Moore explained. “An oral appliance has several effects: It expands the airway, lowers soft tissue compliance, and makes the airway stiffer. The combined effect has a huge benefit for a large number of patients with sleep apnea.”

Like other medical devices, apnea appliances do have side effects. For example, the mandibular repositioning devices can cause temporomandibular joint syndrome, and they also can change the position of the teeth. “Shifting of the teeth is the bigger of the two issues, but even the orthodontists in our practice group say, 'Get over it–people aren't going to die from malocclusion,'” Dr. Moore said.

For patients who don't have the teeth or bone structure needed to anchor the mandibular devices, tongue-retaining appliances can be used to pull the tongue forward and expand the airway at the base of the tongue. “You'd be shocked at the number of people who have insurance … and their teeth–usually the upper teeth–are gone,” said R. Neal Aguillard, M.D., medical director of the sleep disorders center at Methodist Hospital, Memphis.

Only certain patients are good candidates for dental appliances, which can cost anywhere from several hundred to several thousand dollars for the device and the required dental visits.

“Dental appliances may be an appropriate first line of treatment in patients with milder degrees of sleep apnea,” said Carl E. Hunt, M.D., director of the National Center on Sleep Disorders Research at the National Heart, Lung, and Blood Institute, in Bethesda, Md. “This has to be very individualized.”

Dr. Aguillard agreed. “Unless the patient has really severe apnea, I'll mention it as an option,” he said. “If the patient has claustrophobia and can't stand having anything on [his] face, I'm going to be first opting for an oral appliance.”

To determine whether a dental appliance will work in a particular patient, the dentist must do a thorough examination, including special x-ray studies, Dr. Aguillard explained.

“The reason people have apnea varies from one person to another,” he said. “Sometimes the problem may be in the nose, sometimes it's the roof of the mouth, sometimes it may be the tongue, sometimes the jaw, and sometimes the tonsils and adenoids. Sometimes more than one place is blocking off and keeping air from getting into the windpipe. So x-rays are important, because they can give you an idea of whether repositioning the jaw will actually do something.”

A barrier to wider use of dental appliance treatment for sleep apnea is widespread unfamiliarity with the approach in the general medical profession, according to Dr. Moore. “It's a real frustration for us right now as a profession,” he said. “Physicians themselves are not getting the word on it, and the general public is getting even less.”

Dr. Hunt agreed. “Many times today, the primary care physician refers the patient for a sleep study and gets a report back, and it's up to [the patient] to coordinate treatment.”

Ins and Outs of Sleep Apnea Appliances

When choosing an appliance to treat sleep apnea, the options are many and varied, Dr. Moore said.

Custom-made adjustable appliances require several visits for evaluation, fitting, and follow-up. The initial evaluation includes tests to assess the ability of the upper airway to expand when the jaw is moved forward. After the appliance has been made and fitted, the patient can come in at any time for adjustments, but it's especially important for the patient to visit after the symptoms have improved.

“Once that point has been achieved, a repeat portable monitoring test is ordered … to assess results of titration,” he continued. “Following this, the patient is sent back to the sleep physician for possible repeat polysomnography.”

In addition, “the patient needs to be followed for the length of time that they continue with use of the appliance–possibly every 6 months to 1 year–in order to monitor for changes in occlusion, TMJ problems, or other problems with the appliance,” Dr. Moore noted.

In contrast to adjustable appliances, there are devices that are not custom made, known as “boil and bite.” These “one-position appliances” are not adjustable after the initial fitting. “Some of these can be effective, and they are generally less expensive than custom-made appliances, which will cost more because they are uniquely patient-specific,” he said.

Costs can range from several hundred to several thousand dollars, which includes the appliance as well as visits for evaluation and fitting. Health insurers typically will cover these costs if the patient has sleep apnea that has been documented by polysomnography, Dr. Moore said.

A planned vote in Congress on $10 billion in cuts to Medicaid and other changes to the program has become another casualty of Hurricane Katrina.

“There's no doubt that Hurricane Katrina has made it necessary to provide additional resources for the Medicaid program, and we're going to do that apart from reconciliation in the Katrina relief package that's being put together,” Sen. Chuck Grassley (R-Iowa), chair of the Senate Finance Committee, said when announcing an indefinite delay.

“There's broad agreement that some changes need to be made in order to preserve and sustain this vital health care program for the poor and disabled,” he said.

“It's important to understand that the Medicaid reform effort is about fixing loopholes and stopping abusive spending so that more money is available to help states reach those in need both in the short- and long-term.”

In the House of Representatives, 113 Democratic members signed a letter to House Speaker J. Dennis Hastert (R-Ill.) urging him to abandon the proposed spending cuts.

Referring to areas affected by the hurricane, the letter noted, “The health care safety net in these states will be strained to the breaking point by these events. Many of the victims of this tragedy will be left without health care coverage for months if not longer, just when they need it the most. … And they deserve our help.”

A planned vote in Congress on $10 billion in cuts to Medicaid and other changes to the program has become another casualty of Hurricane Katrina.

“There's no doubt that Hurricane Katrina has made it necessary to provide additional resources for the Medicaid program, and we're going to do that apart from reconciliation in the Katrina relief package that's being put together,” Sen. Chuck Grassley (R-Iowa), chair of the Senate Finance Committee, said when announcing an indefinite delay.

“There's broad agreement that some changes need to be made in order to preserve and sustain this vital health care program for the poor and disabled,” he said.

“It's important to understand that the Medicaid reform effort is about fixing loopholes and stopping abusive spending so that more money is available to help states reach those in need both in the short- and long-term.”

In the House of Representatives, 113 Democratic members signed a letter to House Speaker J. Dennis Hastert (R-Ill.) urging him to abandon the proposed spending cuts.

Referring to areas affected by the hurricane, the letter noted, “The health care safety net in these states will be strained to the breaking point by these events. Many of the victims of this tragedy will be left without health care coverage for months if not longer, just when they need it the most. … And they deserve our help.”

A planned vote in Congress on $10 billion in cuts to Medicaid and other changes to the program has become another casualty of Hurricane Katrina.

“There's no doubt that Hurricane Katrina has made it necessary to provide additional resources for the Medicaid program, and we're going to do that apart from reconciliation in the Katrina relief package that's being put together,” Sen. Chuck Grassley (R-Iowa), chair of the Senate Finance Committee, said when announcing an indefinite delay.

“There's broad agreement that some changes need to be made in order to preserve and sustain this vital health care program for the poor and disabled,” he said.

“It's important to understand that the Medicaid reform effort is about fixing loopholes and stopping abusive spending so that more money is available to help states reach those in need both in the short- and long-term.”

In the House of Representatives, 113 Democratic members signed a letter to House Speaker J. Dennis Hastert (R-Ill.) urging him to abandon the proposed spending cuts.

Referring to areas affected by the hurricane, the letter noted, “The health care safety net in these states will be strained to the breaking point by these events. Many of the victims of this tragedy will be left without health care coverage for months if not longer, just when they need it the most. … And they deserve our help.”

WASHINGTON — The Centers for Medicare and Medicaid Services has revised its rules for reimbursement for power wheelchairs and scooters.

This interim final rule is a critical step in ensuring that people with Medicare have access to appropriate technology to assist them with mobility, CMS Administrator Mark McClellan, M.D., said in a statement.

The rule is part of a comprehensive strategy to help Medicare beneficiaries get the mobility assistance equipment they need while avoiding unnecessary administrative burdens and inappropriate Medicare spending.

Physicians and other providers criticized the old reimbursement criteria as too burdensome, because they required physicians to provide a certificate of medical necessity before the wheelchair could be covered.

But CMS officials were wary of loosening coverage requirements because of a rash of fraudulent wheelchair and scooter claims. The fraud reached such a high level that CMS launched its Operator Wheeler Dealer campaign to stop it.

Under the new regulations, the medical necessity certificate has been eliminated, but in its place, the agency is requiring certain clinical documentation items from the patient's medical record, along with a written prescription—given within 30 days of the evaluation—issued to the supplier. And the rules continue to require that physicians must conduct a face-to-face examination of the patient before they can prescribe a mobility device.

Medicare already pays for this evaluation visit. However, because of the additional documentation required under the new regulations, Medicare is authorizing an additional payment to physicians for preparing the paperwork.

Physicians must include a special billing code on the office visit claim in order to receive this extra payment.

The agency also is removing the requirement that only certain specialists—physiatrists, orthopedic surgeons, neurologists, and rheumatologists—are allowed to prescribe power scooters. Instead, all physicians and treating practitioners will be able to prescribe scooters and power wheelchairs.

The Power Mobility Coalition (PMC), a group of mobility-device manufacturers, expressed concern that the new rules would make it tougher for physicians to comply.

The PMC agrees with CMS that the treating physician is in the best position to assess the need for power mobility devices, but is concerned that, in order to fully succeed, CMS and its contractors will have to conduct a comprehensive review of the benefit for physicians, the organization said in a statement. Physicians may not be fully aware of the analytical standard that will be applied to claims, let alone which of the 49 new product codes most appropriately meets beneficiary needs.

The PMC also has concerns over the 30-day time frame for submission of a [mobility device] claim after a physician face-to-face visit, the statement continued. Given the extensive documentation requirement, suppliers, especially those in rural areas, may find the 30-day time frame too tight to obtain and submit all relevant parts of the medical record, as well as the necessary supporting documentation.

The new rules, which were published in the Aug. 26 Federal Register, will take effect Oct. 25. CMS will accept comments on the rules until Nov. 25, and a final rule will be published at a later date, according to the agency.

The interim final rule and accompanying fact sheet can be found online at www.cms.hhs.gov/coverage/wheelchairs.asp

WASHINGTON — The Centers for Medicare and Medicaid Services has revised its rules for reimbursement for power wheelchairs and scooters.

This interim final rule is a critical step in ensuring that people with Medicare have access to appropriate technology to assist them with mobility, CMS Administrator Mark McClellan, M.D., said in a statement.

The rule is part of a comprehensive strategy to help Medicare beneficiaries get the mobility assistance equipment they need while avoiding unnecessary administrative burdens and inappropriate Medicare spending.

Physicians and other providers criticized the old reimbursement criteria as too burdensome, because they required physicians to provide a certificate of medical necessity before the wheelchair could be covered.

But CMS officials were wary of loosening coverage requirements because of a rash of fraudulent wheelchair and scooter claims. The fraud reached such a high level that CMS launched its Operator Wheeler Dealer campaign to stop it.

Under the new regulations, the medical necessity certificate has been eliminated, but in its place, the agency is requiring certain clinical documentation items from the patient's medical record, along with a written prescription—given within 30 days of the evaluation—issued to the supplier. And the rules continue to require that physicians must conduct a face-to-face examination of the patient before they can prescribe a mobility device.

Medicare already pays for this evaluation visit. However, because of the additional documentation required under the new regulations, Medicare is authorizing an additional payment to physicians for preparing the paperwork.

Physicians must include a special billing code on the office visit claim in order to receive this extra payment.

The agency also is removing the requirement that only certain specialists—physiatrists, orthopedic surgeons, neurologists, and rheumatologists—are allowed to prescribe power scooters. Instead, all physicians and treating practitioners will be able to prescribe scooters and power wheelchairs.

The Power Mobility Coalition (PMC), a group of mobility-device manufacturers, expressed concern that the new rules would make it tougher for physicians to comply.

The PMC agrees with CMS that the treating physician is in the best position to assess the need for power mobility devices, but is concerned that, in order to fully succeed, CMS and its contractors will have to conduct a comprehensive review of the benefit for physicians, the organization said in a statement. Physicians may not be fully aware of the analytical standard that will be applied to claims, let alone which of the 49 new product codes most appropriately meets beneficiary needs.

The PMC also has concerns over the 30-day time frame for submission of a [mobility device] claim after a physician face-to-face visit, the statement continued. Given the extensive documentation requirement, suppliers, especially those in rural areas, may find the 30-day time frame too tight to obtain and submit all relevant parts of the medical record, as well as the necessary supporting documentation.

The new rules, which were published in the Aug. 26 Federal Register, will take effect Oct. 25. CMS will accept comments on the rules until Nov. 25, and a final rule will be published at a later date, according to the agency.

The interim final rule and accompanying fact sheet can be found online at www.cms.hhs.gov/coverage/wheelchairs.asp

WASHINGTON — The Centers for Medicare and Medicaid Services has revised its rules for reimbursement for power wheelchairs and scooters.

This interim final rule is a critical step in ensuring that people with Medicare have access to appropriate technology to assist them with mobility, CMS Administrator Mark McClellan, M.D., said in a statement.

The rule is part of a comprehensive strategy to help Medicare beneficiaries get the mobility assistance equipment they need while avoiding unnecessary administrative burdens and inappropriate Medicare spending.

Physicians and other providers criticized the old reimbursement criteria as too burdensome, because they required physicians to provide a certificate of medical necessity before the wheelchair could be covered.

But CMS officials were wary of loosening coverage requirements because of a rash of fraudulent wheelchair and scooter claims. The fraud reached such a high level that CMS launched its Operator Wheeler Dealer campaign to stop it.

Under the new regulations, the medical necessity certificate has been eliminated, but in its place, the agency is requiring certain clinical documentation items from the patient's medical record, along with a written prescription—given within 30 days of the evaluation—issued to the supplier. And the rules continue to require that physicians must conduct a face-to-face examination of the patient before they can prescribe a mobility device.

Medicare already pays for this evaluation visit. However, because of the additional documentation required under the new regulations, Medicare is authorizing an additional payment to physicians for preparing the paperwork.

Physicians must include a special billing code on the office visit claim in order to receive this extra payment.

The agency also is removing the requirement that only certain specialists—physiatrists, orthopedic surgeons, neurologists, and rheumatologists—are allowed to prescribe power scooters. Instead, all physicians and treating practitioners will be able to prescribe scooters and power wheelchairs.

The Power Mobility Coalition (PMC), a group of mobility-device manufacturers, expressed concern that the new rules would make it tougher for physicians to comply.

The PMC agrees with CMS that the treating physician is in the best position to assess the need for power mobility devices, but is concerned that, in order to fully succeed, CMS and its contractors will have to conduct a comprehensive review of the benefit for physicians, the organization said in a statement. Physicians may not be fully aware of the analytical standard that will be applied to claims, let alone which of the 49 new product codes most appropriately meets beneficiary needs.

The PMC also has concerns over the 30-day time frame for submission of a [mobility device] claim after a physician face-to-face visit, the statement continued. Given the extensive documentation requirement, suppliers, especially those in rural areas, may find the 30-day time frame too tight to obtain and submit all relevant parts of the medical record, as well as the necessary supporting documentation.

The new rules, which were published in the Aug. 26 Federal Register, will take effect Oct. 25. CMS will accept comments on the rules until Nov. 25, and a final rule will be published at a later date, according to the agency.

The interim final rule and accompanying fact sheet can be found online at www.cms.hhs.gov/coverage/wheelchairs.asp

Medicare's decision to increase payment for stroke patients who receive tissue plasminogen activator likely will result in more stroke centers, but experts are divided over whether it will mean better care for patients.

“It's a great step forward,” said William Barsan, M.D., professor and chair of emergency medicine at the University of Michigan, Ann Arbor. “This has been something in the works for a long time. We identified this as an issue that needed to be addressed soon after TPA was released.”

Currently, the Centers for Medicare and Medicaid Services (CMS) pays hospitals the same amount—about $5,700—under its diagnosis-related group (DRG) payment system for treating a stroke patient, regardless of whether TPA is used. But under a proposed regulation issued in August, CMS would develop a new DRG called “acute ischemic stroke with use of thrombolytic agents.”

Although TPA costs about $2,000 per dose, the new DRG would pay hospitals about $6,000 more for these patients. That's because patients who receive TPA generally are sicker overall than other stroke patients, and often require more intensive treatment and longer hospital stays, according to a CMS spokeswoman.

That logic is further explained in the proposed regulation. The regulation's authors wrote that when they reviewed average charges for stroke patients, “we noted that the average standardized charges for all patients in DRG 14 ['Intracranial Hemorrhage or Cerebral Infarction'] were $18,997, but that the subset of 2,085 cases in which TPA was used had average standardized charges of $35,128.” As a result, “we are changing the structure of stroke DRGs not to award higher payment for a specific drug, but to recognize the need for better overall care for this group of patients.”

In addition to getting TPA to more patients, this change also will save CMS money if it goes through, said Joseph Broderick, M.D., professor and chair of neurology at the University of Cincinnati. “If you can keep patients out of rehabilitation and nursing homes because you improve things on the front end, you save Medicare and the health system money,” Dr. Broderick said.

But Jerome Hoffman, M.D., professor of medicine and emergency medicine at the University of California, Los Angeles, is not so sure that giving more stroke patients TPA is a good idea. “There is not good evidence that TPA is beneficial in patients with stroke,” he said. “It probably helps a few people and hurts a few people, and the balance is really unclear.”

Aside from the issue of which patients should receive TPA, the increased payment will encourage hospitals to put more money into treating stroke patients, according to Dr. Broderick.

“A lot of hospitals have not seen a reason why they should put more resources into [treating] strokes when, in essence, these kinds of patients are going to cost them money.”

Now that they're being paid more for these patients, “more administrators will say, 'Why don't we have a stroke center? Why don't we have more patients who are treated with TPA?'” he said. “If they are going to get paid almost twice as much money, that's an incentive to see why the system is not working, why someone isn't taking the initiative.”

But new financial incentives for hospitals may have little impact on what some experts say is fundamentally a clinical obstacle.

It's not that hospitals don't want to provide patients with proper care, said Dr. Barsan, but it takes a lot of effort to make TPA treatment work efficiently, especially because there is only a 3-hour window for administration once the stroke has occurred.

The 3-hour window is a big issue, Dr. Hoffman concurred. “Many people who are having a stroke wake up with symptoms, so it's hard to tell when they were last normal,” he said.

“So most people are outside the 3-hour window.”

A survey Dr. Barsan and colleagues performed of more than 1,100 emergency physicians found that while 60% of respondents said they were “very likely” or “likely” to use TPA in an ideal setting with an appropriate patient and access to the proper equipment and personnel, another 24% of respondents said they would be unlikely to use the drug, and 16% said they were “uncertain” about the matter (Ann. Emerg. Med. 2005;46:56–60).

Of this combined group, nearly two-thirds said they were concerned about a possible brain hemorrhage, another 23% listed lack of benefit from the drug, and 12% said they would not use it for both reasons.

Then there are the practical issues. “Ideally, you would have a 'door-to-needle' time of 60 minutes,” Dr. Barsan said. This would require first rapidly identifying the patient when he or she arrives in the emergency department, then doing an exam and determining that the patient did have a stroke, and finally sending the patient for a CT scan to make sure it is not a hemorrhagic stroke, he said.

In the end, if the drug is used within strict guidelines, “I don't think it will matter all that much in terms of harm or benefit to patients,” Dr. Hoffman added.

“But when you put monetary or legal incentives on people to use it, and they use it a lot more because they think they're supposed to, it could be harmful.”

Medicare's decision to increase payment for stroke patients who receive tissue plasminogen activator likely will result in more stroke centers, but experts are divided over whether it will mean better care for patients.

“It's a great step forward,” said William Barsan, M.D., professor and chair of emergency medicine at the University of Michigan, Ann Arbor. “This has been something in the works for a long time. We identified this as an issue that needed to be addressed soon after TPA was released.”

Currently, the Centers for Medicare and Medicaid Services (CMS) pays hospitals the same amount—about $5,700—under its diagnosis-related group (DRG) payment system for treating a stroke patient, regardless of whether TPA is used. But under a proposed regulation issued in August, CMS would develop a new DRG called “acute ischemic stroke with use of thrombolytic agents.”

Although TPA costs about $2,000 per dose, the new DRG would pay hospitals about $6,000 more for these patients. That's because patients who receive TPA generally are sicker overall than other stroke patients, and often require more intensive treatment and longer hospital stays, according to a CMS spokeswoman.

That logic is further explained in the proposed regulation. The regulation's authors wrote that when they reviewed average charges for stroke patients, “we noted that the average standardized charges for all patients in DRG 14 ['Intracranial Hemorrhage or Cerebral Infarction'] were $18,997, but that the subset of 2,085 cases in which TPA was used had average standardized charges of $35,128.” As a result, “we are changing the structure of stroke DRGs not to award higher payment for a specific drug, but to recognize the need for better overall care for this group of patients.”

In addition to getting TPA to more patients, this change also will save CMS money if it goes through, said Joseph Broderick, M.D., professor and chair of neurology at the University of Cincinnati. “If you can keep patients out of rehabilitation and nursing homes because you improve things on the front end, you save Medicare and the health system money,” Dr. Broderick said.

But Jerome Hoffman, M.D., professor of medicine and emergency medicine at the University of California, Los Angeles, is not so sure that giving more stroke patients TPA is a good idea. “There is not good evidence that TPA is beneficial in patients with stroke,” he said. “It probably helps a few people and hurts a few people, and the balance is really unclear.”

Aside from the issue of which patients should receive TPA, the increased payment will encourage hospitals to put more money into treating stroke patients, according to Dr. Broderick.

“A lot of hospitals have not seen a reason why they should put more resources into [treating] strokes when, in essence, these kinds of patients are going to cost them money.”

Now that they're being paid more for these patients, “more administrators will say, 'Why don't we have a stroke center? Why don't we have more patients who are treated with TPA?'” he said. “If they are going to get paid almost twice as much money, that's an incentive to see why the system is not working, why someone isn't taking the initiative.”

But new financial incentives for hospitals may have little impact on what some experts say is fundamentally a clinical obstacle.

It's not that hospitals don't want to provide patients with proper care, said Dr. Barsan, but it takes a lot of effort to make TPA treatment work efficiently, especially because there is only a 3-hour window for administration once the stroke has occurred.

The 3-hour window is a big issue, Dr. Hoffman concurred. “Many people who are having a stroke wake up with symptoms, so it's hard to tell when they were last normal,” he said.

“So most people are outside the 3-hour window.”

A survey Dr. Barsan and colleagues performed of more than 1,100 emergency physicians found that while 60% of respondents said they were “very likely” or “likely” to use TPA in an ideal setting with an appropriate patient and access to the proper equipment and personnel, another 24% of respondents said they would be unlikely to use the drug, and 16% said they were “uncertain” about the matter (Ann. Emerg. Med. 2005;46:56–60).

Of this combined group, nearly two-thirds said they were concerned about a possible brain hemorrhage, another 23% listed lack of benefit from the drug, and 12% said they would not use it for both reasons.

Then there are the practical issues. “Ideally, you would have a 'door-to-needle' time of 60 minutes,” Dr. Barsan said. This would require first rapidly identifying the patient when he or she arrives in the emergency department, then doing an exam and determining that the patient did have a stroke, and finally sending the patient for a CT scan to make sure it is not a hemorrhagic stroke, he said.

In the end, if the drug is used within strict guidelines, “I don't think it will matter all that much in terms of harm or benefit to patients,” Dr. Hoffman added.

“But when you put monetary or legal incentives on people to use it, and they use it a lot more because they think they're supposed to, it could be harmful.”

Medicare's decision to increase payment for stroke patients who receive tissue plasminogen activator likely will result in more stroke centers, but experts are divided over whether it will mean better care for patients.

“It's a great step forward,” said William Barsan, M.D., professor and chair of emergency medicine at the University of Michigan, Ann Arbor. “This has been something in the works for a long time. We identified this as an issue that needed to be addressed soon after TPA was released.”

Currently, the Centers for Medicare and Medicaid Services (CMS) pays hospitals the same amount—about $5,700—under its diagnosis-related group (DRG) payment system for treating a stroke patient, regardless of whether TPA is used. But under a proposed regulation issued in August, CMS would develop a new DRG called “acute ischemic stroke with use of thrombolytic agents.”

Although TPA costs about $2,000 per dose, the new DRG would pay hospitals about $6,000 more for these patients. That's because patients who receive TPA generally are sicker overall than other stroke patients, and often require more intensive treatment and longer hospital stays, according to a CMS spokeswoman.

That logic is further explained in the proposed regulation. The regulation's authors wrote that when they reviewed average charges for stroke patients, “we noted that the average standardized charges for all patients in DRG 14 ['Intracranial Hemorrhage or Cerebral Infarction'] were $18,997, but that the subset of 2,085 cases in which TPA was used had average standardized charges of $35,128.” As a result, “we are changing the structure of stroke DRGs not to award higher payment for a specific drug, but to recognize the need for better overall care for this group of patients.”

In addition to getting TPA to more patients, this change also will save CMS money if it goes through, said Joseph Broderick, M.D., professor and chair of neurology at the University of Cincinnati. “If you can keep patients out of rehabilitation and nursing homes because you improve things on the front end, you save Medicare and the health system money,” Dr. Broderick said.

But Jerome Hoffman, M.D., professor of medicine and emergency medicine at the University of California, Los Angeles, is not so sure that giving more stroke patients TPA is a good idea. “There is not good evidence that TPA is beneficial in patients with stroke,” he said. “It probably helps a few people and hurts a few people, and the balance is really unclear.”

Aside from the issue of which patients should receive TPA, the increased payment will encourage hospitals to put more money into treating stroke patients, according to Dr. Broderick.

“A lot of hospitals have not seen a reason why they should put more resources into [treating] strokes when, in essence, these kinds of patients are going to cost them money.”

Now that they're being paid more for these patients, “more administrators will say, 'Why don't we have a stroke center? Why don't we have more patients who are treated with TPA?'” he said. “If they are going to get paid almost twice as much money, that's an incentive to see why the system is not working, why someone isn't taking the initiative.”

But new financial incentives for hospitals may have little impact on what some experts say is fundamentally a clinical obstacle.

It's not that hospitals don't want to provide patients with proper care, said Dr. Barsan, but it takes a lot of effort to make TPA treatment work efficiently, especially because there is only a 3-hour window for administration once the stroke has occurred.

The 3-hour window is a big issue, Dr. Hoffman concurred. “Many people who are having a stroke wake up with symptoms, so it's hard to tell when they were last normal,” he said.

“So most people are outside the 3-hour window.”

A survey Dr. Barsan and colleagues performed of more than 1,100 emergency physicians found that while 60% of respondents said they were “very likely” or “likely” to use TPA in an ideal setting with an appropriate patient and access to the proper equipment and personnel, another 24% of respondents said they would be unlikely to use the drug, and 16% said they were “uncertain” about the matter (Ann. Emerg. Med. 2005;46:56–60).

Of this combined group, nearly two-thirds said they were concerned about a possible brain hemorrhage, another 23% listed lack of benefit from the drug, and 12% said they would not use it for both reasons.

Then there are the practical issues. “Ideally, you would have a 'door-to-needle' time of 60 minutes,” Dr. Barsan said. This would require first rapidly identifying the patient when he or she arrives in the emergency department, then doing an exam and determining that the patient did have a stroke, and finally sending the patient for a CT scan to make sure it is not a hemorrhagic stroke, he said.

In the end, if the drug is used within strict guidelines, “I don't think it will matter all that much in terms of harm or benefit to patients,” Dr. Hoffman added.

“But when you put monetary or legal incentives on people to use it, and they use it a lot more because they think they're supposed to, it could be harmful.”

The recent disaster in New Orleans may be a wake-up call for all physicians to establish some kind of emergency backup system for their businesses.

"Physicians don't always think of themselves as running a business, but they're going to think of it now," Rosemarie Nelson, a Syracuse, N.Y.-based consultant with the Medical Group Management Association, said in an interview.

Otolaryngologist Michael Ellis, M.D., hopes that technology might have retained some of his records. His practice in Chalmette, La., south of New Orleans, is in an area flooded to the rooftops in the aftermath of Hurricane Katrina and the subsequent breakdown of New Orleans' levees.

"Like most physicians, I have billing electronic records, but my office clinical records are paper. I assume all that—and our supplies and equipment—will be unsalvageable," he said in an interview shortly following the flood.

Dr. Ellis said that he had backups in place for his billing records, both hard copy and "off campus," (outside computer services) assuming that certain computers weren't damaged or backed up during the flood.

As Ms. Nelson noted, "there is just no way to secure paper records. They're there or they're not. You're not going to copy and store them off-site."

However, a fully integrated electronic medical record might not have been completely safe for stricken medical communities, either.

Anne L. Shirley, a spokeswoman with the Louisiana State Medical Society, said an undetermined number of records have been destroyed.

Some electronic records weren't able to be accessed as most computer servers have been destroyed, Ms. Shirley said. The Louisiana State Board of Medical Examiners is located in a hard-hit flood area in New Orleans, and the society's Web site and database were inoperable, even from remote locations, Ms. Shirley said. "This, as you can imagine, poses a problem with license verification and credentialing for displaced physicians."

One way to solve backup problems such as these is to have electronic medical records stored in a secure, remote site by a vendor, Ms. Nelson said. "And, it does not have to be a vendor you bought your software from; there are tons of vendors out there providing remote access."

Such vendors also can offer Internet-based backups, which "add a whole new sense of security," she noted. "When something happens in an area or region, that [backup disk] you took home is as insecure as your records."

Even if they don't use an electronic medical record system (and only about 15% of doctors have them), physicians should consider storing their administrative records, such as financial and scheduling information off-site, Ms. Nelson said.

"You need to think about using off-site backup for your financial applications, scheduling, patient list, and some receivables. You still have insurance receivables there, and you're going to need that cash inflow because you're going to have to buy new equipment. So securing your financial records is equally as important." The patient list will be essential when you need to inform patients that you've set up your practice in a new location or will be reopening on a particular date, she added.

An advantage of backing up financial information is that it also includes some clinical information, Ms. Nelson said. "That's because you need to have a diagnosis code to bill the insurance company."

At press time, Dr. Ellis was able to communicate only by e-mail because all the phone prefixes in Louisiana and Mississippi were unreachable.

He could reach his practice associate in Birmingham via e-mail. "Two of my staff communicated that they are in upper Mississippi," he said. Other physicians e-mailed from Houston and Baton Rouge to let him know their whereabouts.

At press time, the Louisiana State Medical Society was working with the state's Department of Health and Hospitals, the Office of Emergency Preparedness, the Department of Homeland Security, and the Federal Emergency Management Agency to contact physicians.

FEMA Floodproofing Tips

Here are some general tips from the Federal Emergency Management Agency on flood and hurricane preparation for businesses:

▸ Ask your local emergency management office whether your facility is located in a flood plain. Find out the history of flooding in your area. Determine the elevation of your facility in relation to streams, rivers, and dams.

▸ Learn about community evacuation plans from your local emergency management office.

▸ Establish facility shutdown procedures. Make plans for assisting employees who may need transportation.

▸ Purchase a National Oceanic and Atmospheric Administration weather radio with a warning alarm tone and battery backup. Listen for flood watches and warnings.

▸ Get information about flood insurance from your insurance carrier. Regular property and casualty insurance does not cover flooding.

If a hurricane or another kind of major weather event is being forecast, consider taking these actions ahead of time:

▸ Clear out areas with extensive glass frontage as much as possible. If you have shutters, use them; otherwise, use precut plywood to board up doors and windows.

▸ Remove outdoor hanging signs.

▸ Bring inside or secure any objects that might become airborne and cause damage in strong winds.

▸ Store as much equipment as high as possible off the floor, especially goods that could be in short supply after the storm.

▸ Move equipment that cannot be stored away from glass and cover it with tarpaulins or heavy plastic.

▸ Place sandbags in spaces where water could enter.

▸ Remove papers from lower drawers of desks and file cabinets and place them in plastic bags or containers on top of the cabinets.

Medical Schools' Alternative Locations

Medical schools affected by Hurricane Katrina and its aftermath scrambled to find alternative locations and resources, to ensure that their students and residents would be able to continue practicing medicine.

At press time, most of the students from Tulane University in New Orleans were being housed 180 miles away at Jackson State University in Jackson, Miss. Tulane leadership had set up temporary headquarters in Jackson with the assistance of the University of Mississippi Medical Center.

Paul K. Whelton, M.D., senior vice president for health sciences at Tulane, said the university would establish a more permanent "interim leadership headquarters" in Houston.

"Senior administrative staff are in discussion with their counterparts at Houston-area medical schools about these schools assisting Tulane in continuing to provide medical education for Tulane students in all 4 years of medical education," the Association of American Medical Colleges reported. A similar plan was being developed for Tulane residents.

In the meantime, the School of Medicine at Louisiana State University, New Orleans, made arrangements to hold classes in Baton Rouge until its facilities were once again suitable for occupation.

"We are closely working with the LSU System Office to arrange appropriate classroom space and accommodations for our students and faculty," Dean Larry Hollier, M.D., said in a statement.

Charity Hospital in New Orleans will be out of service for an extended period of time, as the city begins a major clean up effort, he said. "We will be expending our bed capacity at Earl K. Long Medical Center [in Baton Rouge], and at University Medical Center in Lafayette … and reassigning our residency staff to those hospitals as well as to some other private hospitals."

He noted that the university had an online registration available on its Web site at

www.lsuhsc.edu

The University of South Alabama in Mobile reopened in early September, the AAMC reported.

How to Volunteer

The federal government is seeking volunteers from the health care and relief professions listed below to deploy to the Gulf region. Deployment may last 14 days or longer and may include 12-hour shifts under austere conditions, according to the Health and Human Services department.

Volunteers will be unpaid, but will receive travel reimbursement, a per diem, and coverage under the Federal Tort Claims Act for liability coverage and workman's compensation, HHS said in a statement. To volunteer, visit

http://volunteer.ccrf.hhs.gov

Administration/finance officers

Chaplains

Clinical physicians

Coroners

Dental forensics

Dentists

Dieticians

EMTs

Environmental health

Epidemiologists

Facility managers

Housekeepers

IT/communications officers

Laboratory technicians

Licensed practical nurses

Medical clerks

Medical examiners

Medical record/health information managers

Mental health workers

Morticians

Mortuary assistants

Nursing assistants/nursing support technicians

Nursing staff directors

Paramedics

Patient transporters/volunteers

Pharmacists

Psychologists

Physician's assistants or nurse-practitioners

Physician chiefs of staff

Radiologic technicians

Respiratory therapists

Registered nurses

Safety officers

Security officers

Social workers

Substance abuse counselors

Supply managers

Veterinarians

The recent disaster in New Orleans may be a wake-up call for all physicians to establish some kind of emergency backup system for their businesses.

"Physicians don't always think of themselves as running a business, but they're going to think of it now," Rosemarie Nelson, a Syracuse, N.Y.-based consultant with the Medical Group Management Association, said in an interview.

Otolaryngologist Michael Ellis, M.D., hopes that technology might have retained some of his records. His practice in Chalmette, La., south of New Orleans, is in an area flooded to the rooftops in the aftermath of Hurricane Katrina and the subsequent breakdown of New Orleans' levees.

"Like most physicians, I have billing electronic records, but my office clinical records are paper. I assume all that—and our supplies and equipment—will be unsalvageable," he said in an interview shortly following the flood.

Dr. Ellis said that he had backups in place for his billing records, both hard copy and "off campus," (outside computer services) assuming that certain computers weren't damaged or backed up during the flood.

As Ms. Nelson noted, "there is just no way to secure paper records. They're there or they're not. You're not going to copy and store them off-site."

However, a fully integrated electronic medical record might not have been completely safe for stricken medical communities, either.

Anne L. Shirley, a spokeswoman with the Louisiana State Medical Society, said an undetermined number of records have been destroyed.

Some electronic records weren't able to be accessed as most computer servers have been destroyed, Ms. Shirley said. The Louisiana State Board of Medical Examiners is located in a hard-hit flood area in New Orleans, and the society's Web site and database were inoperable, even from remote locations, Ms. Shirley said. "This, as you can imagine, poses a problem with license verification and credentialing for displaced physicians."

One way to solve backup problems such as these is to have electronic medical records stored in a secure, remote site by a vendor, Ms. Nelson said. "And, it does not have to be a vendor you bought your software from; there are tons of vendors out there providing remote access."

Such vendors also can offer Internet-based backups, which "add a whole new sense of security," she noted. "When something happens in an area or region, that [backup disk] you took home is as insecure as your records."

Even if they don't use an electronic medical record system (and only about 15% of doctors have them), physicians should consider storing their administrative records, such as financial and scheduling information off-site, Ms. Nelson said.

"You need to think about using off-site backup for your financial applications, scheduling, patient list, and some receivables. You still have insurance receivables there, and you're going to need that cash inflow because you're going to have to buy new equipment. So securing your financial records is equally as important." The patient list will be essential when you need to inform patients that you've set up your practice in a new location or will be reopening on a particular date, she added.

An advantage of backing up financial information is that it also includes some clinical information, Ms. Nelson said. "That's because you need to have a diagnosis code to bill the insurance company."

At press time, Dr. Ellis was able to communicate only by e-mail because all the phone prefixes in Louisiana and Mississippi were unreachable.

He could reach his practice associate in Birmingham via e-mail. "Two of my staff communicated that they are in upper Mississippi," he said. Other physicians e-mailed from Houston and Baton Rouge to let him know their whereabouts.

At press time, the Louisiana State Medical Society was working with the state's Department of Health and Hospitals, the Office of Emergency Preparedness, the Department of Homeland Security, and the Federal Emergency Management Agency to contact physicians.

FEMA Floodproofing Tips

Here are some general tips from the Federal Emergency Management Agency on flood and hurricane preparation for businesses:

▸ Ask your local emergency management office whether your facility is located in a flood plain. Find out the history of flooding in your area. Determine the elevation of your facility in relation to streams, rivers, and dams.

▸ Learn about community evacuation plans from your local emergency management office.

▸ Establish facility shutdown procedures. Make plans for assisting employees who may need transportation.

▸ Purchase a National Oceanic and Atmospheric Administration weather radio with a warning alarm tone and battery backup. Listen for flood watches and warnings.

▸ Get information about flood insurance from your insurance carrier. Regular property and casualty insurance does not cover flooding.

If a hurricane or another kind of major weather event is being forecast, consider taking these actions ahead of time:

▸ Clear out areas with extensive glass frontage as much as possible. If you have shutters, use them; otherwise, use precut plywood to board up doors and windows.

▸ Remove outdoor hanging signs.

▸ Bring inside or secure any objects that might become airborne and cause damage in strong winds.

▸ Store as much equipment as high as possible off the floor, especially goods that could be in short supply after the storm.

▸ Move equipment that cannot be stored away from glass and cover it with tarpaulins or heavy plastic.

▸ Place sandbags in spaces where water could enter.

▸ Remove papers from lower drawers of desks and file cabinets and place them in plastic bags or containers on top of the cabinets.

Medical Schools' Alternative Locations

Medical schools affected by Hurricane Katrina and its aftermath scrambled to find alternative locations and resources, to ensure that their students and residents would be able to continue practicing medicine.

At press time, most of the students from Tulane University in New Orleans were being housed 180 miles away at Jackson State University in Jackson, Miss. Tulane leadership had set up temporary headquarters in Jackson with the assistance of the University of Mississippi Medical Center.

Paul K. Whelton, M.D., senior vice president for health sciences at Tulane, said the university would establish a more permanent "interim leadership headquarters" in Houston.

"Senior administrative staff are in discussion with their counterparts at Houston-area medical schools about these schools assisting Tulane in continuing to provide medical education for Tulane students in all 4 years of medical education," the Association of American Medical Colleges reported. A similar plan was being developed for Tulane residents.

In the meantime, the School of Medicine at Louisiana State University, New Orleans, made arrangements to hold classes in Baton Rouge until its facilities were once again suitable for occupation.

"We are closely working with the LSU System Office to arrange appropriate classroom space and accommodations for our students and faculty," Dean Larry Hollier, M.D., said in a statement.

Charity Hospital in New Orleans will be out of service for an extended period of time, as the city begins a major clean up effort, he said. "We will be expending our bed capacity at Earl K. Long Medical Center [in Baton Rouge], and at University Medical Center in Lafayette … and reassigning our residency staff to those hospitals as well as to some other private hospitals."

He noted that the university had an online registration available on its Web site at

www.lsuhsc.edu

The University of South Alabama in Mobile reopened in early September, the AAMC reported.

How to Volunteer

The federal government is seeking volunteers from the health care and relief professions listed below to deploy to the Gulf region. Deployment may last 14 days or longer and may include 12-hour shifts under austere conditions, according to the Health and Human Services department.

Volunteers will be unpaid, but will receive travel reimbursement, a per diem, and coverage under the Federal Tort Claims Act for liability coverage and workman's compensation, HHS said in a statement. To volunteer, visit

http://volunteer.ccrf.hhs.gov

Administration/finance officers

Chaplains

Clinical physicians

Coroners

Dental forensics

Dentists

Dieticians

EMTs

Environmental health

Epidemiologists

Facility managers

Housekeepers

IT/communications officers

Laboratory technicians

Licensed practical nurses

Medical clerks

Medical examiners

Medical record/health information managers

Mental health workers

Morticians

Mortuary assistants

Nursing assistants/nursing support technicians

Nursing staff directors

Paramedics

Patient transporters/volunteers

Pharmacists

Psychologists

Physician's assistants or nurse-practitioners

Physician chiefs of staff

Radiologic technicians

Respiratory therapists

Registered nurses

Safety officers

Security officers

Social workers

Substance abuse counselors

Supply managers

Veterinarians

The recent disaster in New Orleans may be a wake-up call for all physicians to establish some kind of emergency backup system for their businesses.

"Physicians don't always think of themselves as running a business, but they're going to think of it now," Rosemarie Nelson, a Syracuse, N.Y.-based consultant with the Medical Group Management Association, said in an interview.

Otolaryngologist Michael Ellis, M.D., hopes that technology might have retained some of his records. His practice in Chalmette, La., south of New Orleans, is in an area flooded to the rooftops in the aftermath of Hurricane Katrina and the subsequent breakdown of New Orleans' levees.

"Like most physicians, I have billing electronic records, but my office clinical records are paper. I assume all that—and our supplies and equipment—will be unsalvageable," he said in an interview shortly following the flood.

Dr. Ellis said that he had backups in place for his billing records, both hard copy and "off campus," (outside computer services) assuming that certain computers weren't damaged or backed up during the flood.

As Ms. Nelson noted, "there is just no way to secure paper records. They're there or they're not. You're not going to copy and store them off-site."

However, a fully integrated electronic medical record might not have been completely safe for stricken medical communities, either.

Anne L. Shirley, a spokeswoman with the Louisiana State Medical Society, said an undetermined number of records have been destroyed.

Some electronic records weren't able to be accessed as most computer servers have been destroyed, Ms. Shirley said. The Louisiana State Board of Medical Examiners is located in a hard-hit flood area in New Orleans, and the society's Web site and database were inoperable, even from remote locations, Ms. Shirley said. "This, as you can imagine, poses a problem with license verification and credentialing for displaced physicians."

One way to solve backup problems such as these is to have electronic medical records stored in a secure, remote site by a vendor, Ms. Nelson said. "And, it does not have to be a vendor you bought your software from; there are tons of vendors out there providing remote access."

Such vendors also can offer Internet-based backups, which "add a whole new sense of security," she noted. "When something happens in an area or region, that [backup disk] you took home is as insecure as your records."

Even if they don't use an electronic medical record system (and only about 15% of doctors have them), physicians should consider storing their administrative records, such as financial and scheduling information off-site, Ms. Nelson said.

"You need to think about using off-site backup for your financial applications, scheduling, patient list, and some receivables. You still have insurance receivables there, and you're going to need that cash inflow because you're going to have to buy new equipment. So securing your financial records is equally as important." The patient list will be essential when you need to inform patients that you've set up your practice in a new location or will be reopening on a particular date, she added.

An advantage of backing up financial information is that it also includes some clinical information, Ms. Nelson said. "That's because you need to have a diagnosis code to bill the insurance company."

At press time, Dr. Ellis was able to communicate only by e-mail because all the phone prefixes in Louisiana and Mississippi were unreachable.

He could reach his practice associate in Birmingham via e-mail. "Two of my staff communicated that they are in upper Mississippi," he said. Other physicians e-mailed from Houston and Baton Rouge to let him know their whereabouts.

At press time, the Louisiana State Medical Society was working with the state's Department of Health and Hospitals, the Office of Emergency Preparedness, the Department of Homeland Security, and the Federal Emergency Management Agency to contact physicians.

FEMA Floodproofing Tips

Here are some general tips from the Federal Emergency Management Agency on flood and hurricane preparation for businesses:

▸ Ask your local emergency management office whether your facility is located in a flood plain. Find out the history of flooding in your area. Determine the elevation of your facility in relation to streams, rivers, and dams.

▸ Learn about community evacuation plans from your local emergency management office.

▸ Establish facility shutdown procedures. Make plans for assisting employees who may need transportation.

▸ Purchase a National Oceanic and Atmospheric Administration weather radio with a warning alarm tone and battery backup. Listen for flood watches and warnings.

▸ Get information about flood insurance from your insurance carrier. Regular property and casualty insurance does not cover flooding.

If a hurricane or another kind of major weather event is being forecast, consider taking these actions ahead of time:

▸ Clear out areas with extensive glass frontage as much as possible. If you have shutters, use them; otherwise, use precut plywood to board up doors and windows.

▸ Remove outdoor hanging signs.

▸ Bring inside or secure any objects that might become airborne and cause damage in strong winds.

▸ Store as much equipment as high as possible off the floor, especially goods that could be in short supply after the storm.

▸ Move equipment that cannot be stored away from glass and cover it with tarpaulins or heavy plastic.

▸ Place sandbags in spaces where water could enter.

▸ Remove papers from lower drawers of desks and file cabinets and place them in plastic bags or containers on top of the cabinets.

Medical Schools' Alternative Locations

Medical schools affected by Hurricane Katrina and its aftermath scrambled to find alternative locations and resources, to ensure that their students and residents would be able to continue practicing medicine.

At press time, most of the students from Tulane University in New Orleans were being housed 180 miles away at Jackson State University in Jackson, Miss. Tulane leadership had set up temporary headquarters in Jackson with the assistance of the University of Mississippi Medical Center.

Paul K. Whelton, M.D., senior vice president for health sciences at Tulane, said the university would establish a more permanent "interim leadership headquarters" in Houston.

"Senior administrative staff are in discussion with their counterparts at Houston-area medical schools about these schools assisting Tulane in continuing to provide medical education for Tulane students in all 4 years of medical education," the Association of American Medical Colleges reported. A similar plan was being developed for Tulane residents.

In the meantime, the School of Medicine at Louisiana State University, New Orleans, made arrangements to hold classes in Baton Rouge until its facilities were once again suitable for occupation.

"We are closely working with the LSU System Office to arrange appropriate classroom space and accommodations for our students and faculty," Dean Larry Hollier, M.D., said in a statement.

Charity Hospital in New Orleans will be out of service for an extended period of time, as the city begins a major clean up effort, he said. "We will be expending our bed capacity at Earl K. Long Medical Center [in Baton Rouge], and at University Medical Center in Lafayette … and reassigning our residency staff to those hospitals as well as to some other private hospitals."

He noted that the university had an online registration available on its Web site at

www.lsuhsc.edu

The University of South Alabama in Mobile reopened in early September, the AAMC reported.

How to Volunteer

The federal government is seeking volunteers from the health care and relief professions listed below to deploy to the Gulf region. Deployment may last 14 days or longer and may include 12-hour shifts under austere conditions, according to the Health and Human Services department.

Volunteers will be unpaid, but will receive travel reimbursement, a per diem, and coverage under the Federal Tort Claims Act for liability coverage and workman's compensation, HHS said in a statement. To volunteer, visit

http://volunteer.ccrf.hhs.gov

Administration/finance officers

Chaplains

Clinical physicians

Coroners

Dental forensics

Dentists

Dieticians

EMTs

Environmental health

Epidemiologists

Facility managers

Housekeepers

IT/communications officers

Laboratory technicians

Licensed practical nurses

Medical clerks

Medical examiners

Medical record/health information managers

Mental health workers

Morticians

Mortuary assistants

Nursing assistants/nursing support technicians

Nursing staff directors

Paramedics

Patient transporters/volunteers

Pharmacists

Psychologists

Physician's assistants or nurse-practitioners

Physician chiefs of staff

Radiologic technicians

Respiratory therapists

Registered nurses

Safety officers

Security officers

Social workers

Substance abuse counselors

Supply managers

Veterinarians