Alicia Ault

NEW ORLEANS – Educating staff to spot triggers for disruptive behavior in long-term care facility residents and to effectively prevent escalation is key to helping head off psychiatric emergencies, Dr. Amita Patel said at the annual meeting of the American Association for Geriatric Psychiatry.

In general, LTC staff–nurse's aides, in particular–are undereducated about dementia and the management of mental illnesses, said Dr. Patel, of the department of psychiatry at Wright State University, Dayton, Ohio. Given that staff members are “overburdened and underpaid,” she said, they often do not have the ability to manage these residents.

Agitated residents who have reached the crisis point are at a higher risk of falls and of injuring themselves and others. Such residents will also tend to be noncompliant, increasing the caregiver's burden, Dr. Patel said. There is already a 50%–70% turnover rate for licensed practical nurses and registered nurses; if they feel more burdened, turnover is likely to increase, she said. In addition, unmanaged psychiatric emergencies expose clinicians and facilities to potentially higher malpractice and workers' compensation premiums.

After she taught staffs at facilities in Ohio about ways to better manage residents, the workers' compensation premiums there went down, Dr. Patel said.

The first step is to prevent stress. The facility's environment is often an issue: Hallways are overcrowded; loud noises emanate from televisions or alarms; lighting is harsh; bathwater is too cold; exit signs act as a beacon for wandering residents seeking a way out. Instead, the environment should be made as soothing as possible, Dr. Patel said.

Alleviating boredom also can help. Activities and exercise are important, especially in the early evenings, when there are often no staff members available to provide activities. Residents may go to bed too early and wake up agitated, she said. Fenced areas can be maintained to allow higher-functioning residents to walk or get outside.

The staff also can make an environment more–or less–hospitable. Administrators should allow time for education on dementia and psychiatric illnesses, so that staff members know what to expect, Dr. Patel said. Staff members can also be taught to become less task oriented. For instance, if a resident is distressed and will not eat, the nurse should not continue shoveling food in just to complete that task, she said. The staff member can walk away and return at another time.

Residents also should be given eye contact, especially if they are hearing or vision impaired. Standing behind an impaired resident and barking out directions can be distressing, Dr. Patel noted.

Validation therapy is useful, particularly in paranoid or delusional residents. If residents are paranoid, don't try to tell them [their fears are] not true, she said. Instead, tell them that the situation will be investigated.

Staff members sometimes have a hard time coping with residents who may be stressed because they are grieving a loss of control or lack of attention from family. The staff can be trained in ways to help residents tolerate some of their distress and also to accept death as a reasonable outcome of living.

If residents do become agitated–exhibiting a change in voice; glaring; perspiring; or becoming restless, irritable and suspicious–“this is the state when you know they eventually are going to escalate,” she said.

At this point, the resident should be given empathetic support, encouraged to breathe, and asked to go to a quiet area. There, an assessment can be made, and–depending on the situation–oral medications might be offered.

An assessment should include an evaluation of what might have caused the episode–environment, a peer interaction, or a drug interaction. A complete blood count, toxicology screen, cognitive screen, and vital signs assessment can all help to get at the root cause. Substance abuse should be suspected if the patient has recently returned from a leave outside the facility, Dr. Patel said.

Once the etiology has been identified, treatment can begin. If the resident calms down, ongoing behavioral interventions and modifications of the environment should be considered. Continued agitation may require sedation or use of a geri-chair. Restraints should be used only as a last resort.

There are no medications approved by the Food and Drug Administration for the management of acute psychiatric emergencies in elderly people, Dr. Patel said. Most often, benzodiazepines are used.

Federal regulations require institutions to document that patients are being given medications for an adequate indication, and that they are given the appropriate dosage for the appropriate duration, Dr. Patel said. Documentation that therapeutic goals are being met must be provided.

The benefits of short-term medication use need to be weighed against the risks of chronic dosing. The benzodiazepines are not well studied in dementia or for long-term use, but are preferred for short-term episodes, despite side effects such as excessive sedation, ataxia, respiratory suppression, and the potential for abuse.

Newer antipsychotics may be useful, especially because several are available as orally disintegrating tablets, including risperidone (Risperdal) and olanzapine (Zyprexa). Residents cannot “cheek” those medications, she noted. Intramuscular olanzapine has been studied in agitated patients with schizophrenia. A 5-mg per injection dose has been recommended for geriatric patients. It should not be used in conjunction with benzodiazepines.

Dr. Patel is a speaker for Eli Lilly & Co., Wyeth Pharmaceuticals, Forest Pharmaceuticals Inc., and Sanofi Aventis.

NEW ORLEANS – Educating staff to spot triggers for disruptive behavior in long-term care facility residents and to effectively prevent escalation is key to helping head off psychiatric emergencies, Dr. Amita Patel said at the annual meeting of the American Association for Geriatric Psychiatry.

In general, LTC staff–nurse's aides, in particular–are undereducated about dementia and the management of mental illnesses, said Dr. Patel, of the department of psychiatry at Wright State University, Dayton, Ohio. Given that staff members are “overburdened and underpaid,” she said, they often do not have the ability to manage these residents.

Agitated residents who have reached the crisis point are at a higher risk of falls and of injuring themselves and others. Such residents will also tend to be noncompliant, increasing the caregiver's burden, Dr. Patel said. There is already a 50%–70% turnover rate for licensed practical nurses and registered nurses; if they feel more burdened, turnover is likely to increase, she said. In addition, unmanaged psychiatric emergencies expose clinicians and facilities to potentially higher malpractice and workers' compensation premiums.

After she taught staffs at facilities in Ohio about ways to better manage residents, the workers' compensation premiums there went down, Dr. Patel said.

The first step is to prevent stress. The facility's environment is often an issue: Hallways are overcrowded; loud noises emanate from televisions or alarms; lighting is harsh; bathwater is too cold; exit signs act as a beacon for wandering residents seeking a way out. Instead, the environment should be made as soothing as possible, Dr. Patel said.

Alleviating boredom also can help. Activities and exercise are important, especially in the early evenings, when there are often no staff members available to provide activities. Residents may go to bed too early and wake up agitated, she said. Fenced areas can be maintained to allow higher-functioning residents to walk or get outside.

The staff also can make an environment more–or less–hospitable. Administrators should allow time for education on dementia and psychiatric illnesses, so that staff members know what to expect, Dr. Patel said. Staff members can also be taught to become less task oriented. For instance, if a resident is distressed and will not eat, the nurse should not continue shoveling food in just to complete that task, she said. The staff member can walk away and return at another time.

Residents also should be given eye contact, especially if they are hearing or vision impaired. Standing behind an impaired resident and barking out directions can be distressing, Dr. Patel noted.

Validation therapy is useful, particularly in paranoid or delusional residents. If residents are paranoid, don't try to tell them [their fears are] not true, she said. Instead, tell them that the situation will be investigated.

Staff members sometimes have a hard time coping with residents who may be stressed because they are grieving a loss of control or lack of attention from family. The staff can be trained in ways to help residents tolerate some of their distress and also to accept death as a reasonable outcome of living.

If residents do become agitated–exhibiting a change in voice; glaring; perspiring; or becoming restless, irritable and suspicious–“this is the state when you know they eventually are going to escalate,” she said.

At this point, the resident should be given empathetic support, encouraged to breathe, and asked to go to a quiet area. There, an assessment can be made, and–depending on the situation–oral medications might be offered.

An assessment should include an evaluation of what might have caused the episode–environment, a peer interaction, or a drug interaction. A complete blood count, toxicology screen, cognitive screen, and vital signs assessment can all help to get at the root cause. Substance abuse should be suspected if the patient has recently returned from a leave outside the facility, Dr. Patel said.

Once the etiology has been identified, treatment can begin. If the resident calms down, ongoing behavioral interventions and modifications of the environment should be considered. Continued agitation may require sedation or use of a geri-chair. Restraints should be used only as a last resort.

There are no medications approved by the Food and Drug Administration for the management of acute psychiatric emergencies in elderly people, Dr. Patel said. Most often, benzodiazepines are used.

Federal regulations require institutions to document that patients are being given medications for an adequate indication, and that they are given the appropriate dosage for the appropriate duration, Dr. Patel said. Documentation that therapeutic goals are being met must be provided.

The benefits of short-term medication use need to be weighed against the risks of chronic dosing. The benzodiazepines are not well studied in dementia or for long-term use, but are preferred for short-term episodes, despite side effects such as excessive sedation, ataxia, respiratory suppression, and the potential for abuse.

Newer antipsychotics may be useful, especially because several are available as orally disintegrating tablets, including risperidone (Risperdal) and olanzapine (Zyprexa). Residents cannot “cheek” those medications, she noted. Intramuscular olanzapine has been studied in agitated patients with schizophrenia. A 5-mg per injection dose has been recommended for geriatric patients. It should not be used in conjunction with benzodiazepines.

Dr. Patel is a speaker for Eli Lilly & Co., Wyeth Pharmaceuticals, Forest Pharmaceuticals Inc., and Sanofi Aventis.

NEW ORLEANS – Educating staff to spot triggers for disruptive behavior in long-term care facility residents and to effectively prevent escalation is key to helping head off psychiatric emergencies, Dr. Amita Patel said at the annual meeting of the American Association for Geriatric Psychiatry.

In general, LTC staff–nurse's aides, in particular–are undereducated about dementia and the management of mental illnesses, said Dr. Patel, of the department of psychiatry at Wright State University, Dayton, Ohio. Given that staff members are “overburdened and underpaid,” she said, they often do not have the ability to manage these residents.

Agitated residents who have reached the crisis point are at a higher risk of falls and of injuring themselves and others. Such residents will also tend to be noncompliant, increasing the caregiver's burden, Dr. Patel said. There is already a 50%–70% turnover rate for licensed practical nurses and registered nurses; if they feel more burdened, turnover is likely to increase, she said. In addition, unmanaged psychiatric emergencies expose clinicians and facilities to potentially higher malpractice and workers' compensation premiums.

After she taught staffs at facilities in Ohio about ways to better manage residents, the workers' compensation premiums there went down, Dr. Patel said.

The first step is to prevent stress. The facility's environment is often an issue: Hallways are overcrowded; loud noises emanate from televisions or alarms; lighting is harsh; bathwater is too cold; exit signs act as a beacon for wandering residents seeking a way out. Instead, the environment should be made as soothing as possible, Dr. Patel said.

Alleviating boredom also can help. Activities and exercise are important, especially in the early evenings, when there are often no staff members available to provide activities. Residents may go to bed too early and wake up agitated, she said. Fenced areas can be maintained to allow higher-functioning residents to walk or get outside.

The staff also can make an environment more–or less–hospitable. Administrators should allow time for education on dementia and psychiatric illnesses, so that staff members know what to expect, Dr. Patel said. Staff members can also be taught to become less task oriented. For instance, if a resident is distressed and will not eat, the nurse should not continue shoveling food in just to complete that task, she said. The staff member can walk away and return at another time.

Residents also should be given eye contact, especially if they are hearing or vision impaired. Standing behind an impaired resident and barking out directions can be distressing, Dr. Patel noted.

Validation therapy is useful, particularly in paranoid or delusional residents. If residents are paranoid, don't try to tell them [their fears are] not true, she said. Instead, tell them that the situation will be investigated.

Staff members sometimes have a hard time coping with residents who may be stressed because they are grieving a loss of control or lack of attention from family. The staff can be trained in ways to help residents tolerate some of their distress and also to accept death as a reasonable outcome of living.

If residents do become agitated–exhibiting a change in voice; glaring; perspiring; or becoming restless, irritable and suspicious–“this is the state when you know they eventually are going to escalate,” she said.

At this point, the resident should be given empathetic support, encouraged to breathe, and asked to go to a quiet area. There, an assessment can be made, and–depending on the situation–oral medications might be offered.

An assessment should include an evaluation of what might have caused the episode–environment, a peer interaction, or a drug interaction. A complete blood count, toxicology screen, cognitive screen, and vital signs assessment can all help to get at the root cause. Substance abuse should be suspected if the patient has recently returned from a leave outside the facility, Dr. Patel said.

Once the etiology has been identified, treatment can begin. If the resident calms down, ongoing behavioral interventions and modifications of the environment should be considered. Continued agitation may require sedation or use of a geri-chair. Restraints should be used only as a last resort.

There are no medications approved by the Food and Drug Administration for the management of acute psychiatric emergencies in elderly people, Dr. Patel said. Most often, benzodiazepines are used.

Federal regulations require institutions to document that patients are being given medications for an adequate indication, and that they are given the appropriate dosage for the appropriate duration, Dr. Patel said. Documentation that therapeutic goals are being met must be provided.

The benefits of short-term medication use need to be weighed against the risks of chronic dosing. The benzodiazepines are not well studied in dementia or for long-term use, but are preferred for short-term episodes, despite side effects such as excessive sedation, ataxia, respiratory suppression, and the potential for abuse.

Newer antipsychotics may be useful, especially because several are available as orally disintegrating tablets, including risperidone (Risperdal) and olanzapine (Zyprexa). Residents cannot “cheek” those medications, she noted. Intramuscular olanzapine has been studied in agitated patients with schizophrenia. A 5-mg per injection dose has been recommended for geriatric patients. It should not be used in conjunction with benzodiazepines.

Dr. Patel is a speaker for Eli Lilly & Co., Wyeth Pharmaceuticals, Forest Pharmaceuticals Inc., and Sanofi Aventis.

BALTIMORE — Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, in an effort to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recommendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

PQRI is a hot topic among physicians. According to a Department of Health and Human Services spokeswoman, more than 600 people attended the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008.

Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. The STS supports the PQRI effort, but “we feel that it must go farther, and we feel that can be accomplished through the use of registries.”

This year, PQRI is structured to collect data on processes, not outcomes, he said. Registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement, Dr. Rich said.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance). Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, he said. And input standards should be established to ensure that the data cover all patients, not just a random sample, Dr. Rich said. Finally, registries should be subject to validation and an audit mechanism.

The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons. The ABNS envisions using the measures to teach neurosurgery residents how to collect outcomes data and to use the data for quality improvement, for neurosurgeons to prepare for board certification, and as part of the maintenance of certification process.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

More than 5,000 physicians completed a PIM in 2006, and 5,000 more are currently working on PIMs, Dr. Cary Sennett, ABIM senior vice president of strategy and clinical analytics, said at the forum.

Aetna, UnitedHealthcare, Humana, and several regional Blue Cross and Blue Shield plans have recognized PIMs as fulfilling quality improvement criteria, said Dr. Sennett, who added that ABIM supported the PQRI effort.

The American College of Physicians was due to make a statement at the forum, but a representative on the conference call said the ACP was not yet ready to share its thoughts on registries and PQRI.

BALTIMORE — Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, in an effort to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recommendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

PQRI is a hot topic among physicians. According to a Department of Health and Human Services spokeswoman, more than 600 people attended the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008.

Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. The STS supports the PQRI effort, but “we feel that it must go farther, and we feel that can be accomplished through the use of registries.”

This year, PQRI is structured to collect data on processes, not outcomes, he said. Registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement, Dr. Rich said.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance). Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, he said. And input standards should be established to ensure that the data cover all patients, not just a random sample, Dr. Rich said. Finally, registries should be subject to validation and an audit mechanism.

The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons. The ABNS envisions using the measures to teach neurosurgery residents how to collect outcomes data and to use the data for quality improvement, for neurosurgeons to prepare for board certification, and as part of the maintenance of certification process.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

More than 5,000 physicians completed a PIM in 2006, and 5,000 more are currently working on PIMs, Dr. Cary Sennett, ABIM senior vice president of strategy and clinical analytics, said at the forum.

Aetna, UnitedHealthcare, Humana, and several regional Blue Cross and Blue Shield plans have recognized PIMs as fulfilling quality improvement criteria, said Dr. Sennett, who added that ABIM supported the PQRI effort.

The American College of Physicians was due to make a statement at the forum, but a representative on the conference call said the ACP was not yet ready to share its thoughts on registries and PQRI.

BALTIMORE — Outcomes registries, not claims data, should be the base for the Physician Quality Reporting Initiative next year, physicians and their representatives said at a forum held in May by the Centers for Medicare and Medicaid Services.

CMS officials said they are gathering comments on how to evolve from claims-based information to a registry model, in an effort to prevent duplicative efforts to collect data and to encourage quality improvement. The agency's final recommendations will be published in the Federal Register in mid-August as a proposed set of 2008 reportable measures, agency officials said.

PQRI is a hot topic among physicians. According to a Department of Health and Human Services spokeswoman, more than 600 people attended the forum via conference call. The initiative was mandated as part of the Tax Relief and Health Care Act of 2006. Beginning in July, physicians can take part in the initiative by reporting on specialty-specific measures. This year, CMS has listed 74 measures (posted at www.cms.hhs.gov/PQRI

To participate, physicians submit data on those measures through December on at least 80% of their cases. Those who participate will get a bonus lump-sum payout of 1.5% of claims submitted, some time in mid-2008.

Many physicians already report on such measures to specialty societies.

The longest-running registry is maintained by the Society of Thoracic Surgeons. The 17-year-old registry contains more than 3 million records, Dr. Jeffrey Rich of the STS said at the forum. The STS supports the PQRI effort, but “we feel that it must go farther, and we feel that can be accomplished through the use of registries.”

This year, PQRI is structured to collect data on processes, not outcomes, he said. Registries allow for the collection of clinical data on patient outcomes, which is more useful for quality improvement, Dr. Rich said.

STS suggested that outcomes measures should be vetted through groups such as the American Medical Association's Physician Consortium for Performance Improvement and the AQA (formerly the Ambulatory Care Quality Alliance). Measures that cut across disciplines should be harmonized, preferably by the National Quality Forum, he said. And input standards should be established to ensure that the data cover all patients, not just a random sample, Dr. Rich said. Finally, registries should be subject to validation and an audit mechanism.

The American Board of Neurological Surgery has developed 15 procedure-specific outcomes measures that are available online, said Dr. Robert Harbaugh of the American Association of Neurological Surgeons. The ABNS envisions using the measures to teach neurosurgery residents how to collect outcomes data and to use the data for quality improvement, for neurosurgeons to prepare for board certification, and as part of the maintenance of certification process.

In 2006, the American Board of Internal Medicine began requiring internists to begin using Practice Improvement Modules (PIMs) in order to maintain certification. With PIMs, physicians enter medical data about patients, and then receive reports back from ABIM, which they are supposed to analyze and use to develop a self-improvement plan.

More than 5,000 physicians completed a PIM in 2006, and 5,000 more are currently working on PIMs, Dr. Cary Sennett, ABIM senior vice president of strategy and clinical analytics, said at the forum.

Aetna, UnitedHealthcare, Humana, and several regional Blue Cross and Blue Shield plans have recognized PIMs as fulfilling quality improvement criteria, said Dr. Sennett, who added that ABIM supported the PQRI effort.

The American College of Physicians was due to make a statement at the forum, but a representative on the conference call said the ACP was not yet ready to share its thoughts on registries and PQRI.

WASHINGTON — A retrospective look at the Surveillance, Epidemiology, and End Results database indicates that too few nodes are being evaluated in some patients with pancreatic cancer, which may result in understaging, Dr. Mark Slidell said at a symposium sponsored by the Society of Surgical Oncology.

In the analysis of more than 4,000 patients, those who did not have any nodes examined were 44% more likely to die during follow-up, Dr. Slidell said. Several investigators have suggested that extended lymphadenectomy should be performed routinely, but that has not been conclusively shown to improve outcomes in previous studies, he said.

In addition, the data showed that the lymph node ratio—total number of positive nodes divided by the total number of examined nodes—is an important predictor of survival, said Dr. Slidell, a resident at Georgetown University, Washington. He and his colleagues at Johns Hopkins University in Baltimore had hypothesized that the ratio of metastatic to examined nodes may be more important for staging and survival than the number of nodes harvested alone.

But data on this measure, the lymph node (LN) ratio, are limited, with most previous studies performed at single institutions and academic centers.

He and his colleagues identified 4,005 patients (2,042 men and 1,963 women) in the National Cancer Institute's SEER database who had resection for pancreatic adenocarcinoma between 1988 and 2003. The patients' median age was 66, and most had tumors that were larger than 2 cm.

The database included standard demographic information and tumor size, grade, LN involvement, total number of LNs examined, and the number of positive nodes. The authors calculated the LN ratio by dividing the total number of positive nodes by the total number of examined nodes.

The median tumor size was 3 cm. Most patients who had surgery had a pancreatectomy.

The median number of nodes examined was seven. Most patients had fewer than 12 nodes examined, and 390 patients (10.1%) had 0 nodes examined. Of the 3,478 patients who did have nodes examined, 1,507 (43.3%) had no metastases and were classified as N0, and 56% (1,971) had metastatic disease (classified as N1).

The mean number of nodes examined in the negative group was 8, while the mean in the node-positive group was 11.

Overall, median survival was 13 months and the 5-year survival rate was 17%.

With multivariate analysis, the prognostic factors related to survival included tumor stage, tumor grade, a tumor size of greater than 2 cm, the number of nodes examined, the LN ratio, and N1 disease.

Patients with zero nodes examined were at highest risk of disease-specific death, as they were 44% more likely to die during follow-up, Dr. Slidell said.

Dr. Slidell and his colleagues also evaluated whether a greater number of positive nodes was associated with decreased survival. N0 patients had significantly better survival than N1 patients, but within the group of patients with N1 disease, an increasing number of positive nodes was not significantly associated with poorer survival; however, it was associated with a nonsignificant trend toward decreased survival, said Dr. Slidell.

N1 disease also increased the risk of disease-specific death, as did a higher LN ratio. Five-year survival for N1 disease was 7%, compared with 18% for N0 disease.

LN ratio proved to be even more important. For a ratio of 0, the median survival was 17 months, for ratios of 0–0.2 it was 15 months, and for 0.2–0.4 it was 12 months. Median survival declined to 10 months for ratios greater than 0.4.

The LN ratio appears to be a better predictor of survival, and should be considered for use as a potential stratification method in future clinical studies, he said.

WASHINGTON — A retrospective look at the Surveillance, Epidemiology, and End Results database indicates that too few nodes are being evaluated in some patients with pancreatic cancer, which may result in understaging, Dr. Mark Slidell said at a symposium sponsored by the Society of Surgical Oncology.

In the analysis of more than 4,000 patients, those who did not have any nodes examined were 44% more likely to die during follow-up, Dr. Slidell said. Several investigators have suggested that extended lymphadenectomy should be performed routinely, but that has not been conclusively shown to improve outcomes in previous studies, he said.

In addition, the data showed that the lymph node ratio—total number of positive nodes divided by the total number of examined nodes—is an important predictor of survival, said Dr. Slidell, a resident at Georgetown University, Washington. He and his colleagues at Johns Hopkins University in Baltimore had hypothesized that the ratio of metastatic to examined nodes may be more important for staging and survival than the number of nodes harvested alone.

But data on this measure, the lymph node (LN) ratio, are limited, with most previous studies performed at single institutions and academic centers.

He and his colleagues identified 4,005 patients (2,042 men and 1,963 women) in the National Cancer Institute's SEER database who had resection for pancreatic adenocarcinoma between 1988 and 2003. The patients' median age was 66, and most had tumors that were larger than 2 cm.

The database included standard demographic information and tumor size, grade, LN involvement, total number of LNs examined, and the number of positive nodes. The authors calculated the LN ratio by dividing the total number of positive nodes by the total number of examined nodes.

The median tumor size was 3 cm. Most patients who had surgery had a pancreatectomy.

The median number of nodes examined was seven. Most patients had fewer than 12 nodes examined, and 390 patients (10.1%) had 0 nodes examined. Of the 3,478 patients who did have nodes examined, 1,507 (43.3%) had no metastases and were classified as N0, and 56% (1,971) had metastatic disease (classified as N1).

The mean number of nodes examined in the negative group was 8, while the mean in the node-positive group was 11.

Overall, median survival was 13 months and the 5-year survival rate was 17%.

With multivariate analysis, the prognostic factors related to survival included tumor stage, tumor grade, a tumor size of greater than 2 cm, the number of nodes examined, the LN ratio, and N1 disease.

Patients with zero nodes examined were at highest risk of disease-specific death, as they were 44% more likely to die during follow-up, Dr. Slidell said.

Dr. Slidell and his colleagues also evaluated whether a greater number of positive nodes was associated with decreased survival. N0 patients had significantly better survival than N1 patients, but within the group of patients with N1 disease, an increasing number of positive nodes was not significantly associated with poorer survival; however, it was associated with a nonsignificant trend toward decreased survival, said Dr. Slidell.

N1 disease also increased the risk of disease-specific death, as did a higher LN ratio. Five-year survival for N1 disease was 7%, compared with 18% for N0 disease.

LN ratio proved to be even more important. For a ratio of 0, the median survival was 17 months, for ratios of 0–0.2 it was 15 months, and for 0.2–0.4 it was 12 months. Median survival declined to 10 months for ratios greater than 0.4.

The LN ratio appears to be a better predictor of survival, and should be considered for use as a potential stratification method in future clinical studies, he said.

WASHINGTON — A retrospective look at the Surveillance, Epidemiology, and End Results database indicates that too few nodes are being evaluated in some patients with pancreatic cancer, which may result in understaging, Dr. Mark Slidell said at a symposium sponsored by the Society of Surgical Oncology.

In the analysis of more than 4,000 patients, those who did not have any nodes examined were 44% more likely to die during follow-up, Dr. Slidell said. Several investigators have suggested that extended lymphadenectomy should be performed routinely, but that has not been conclusively shown to improve outcomes in previous studies, he said.

In addition, the data showed that the lymph node ratio—total number of positive nodes divided by the total number of examined nodes—is an important predictor of survival, said Dr. Slidell, a resident at Georgetown University, Washington. He and his colleagues at Johns Hopkins University in Baltimore had hypothesized that the ratio of metastatic to examined nodes may be more important for staging and survival than the number of nodes harvested alone.

But data on this measure, the lymph node (LN) ratio, are limited, with most previous studies performed at single institutions and academic centers.

He and his colleagues identified 4,005 patients (2,042 men and 1,963 women) in the National Cancer Institute's SEER database who had resection for pancreatic adenocarcinoma between 1988 and 2003. The patients' median age was 66, and most had tumors that were larger than 2 cm.

The database included standard demographic information and tumor size, grade, LN involvement, total number of LNs examined, and the number of positive nodes. The authors calculated the LN ratio by dividing the total number of positive nodes by the total number of examined nodes.

The median tumor size was 3 cm. Most patients who had surgery had a pancreatectomy.

The median number of nodes examined was seven. Most patients had fewer than 12 nodes examined, and 390 patients (10.1%) had 0 nodes examined. Of the 3,478 patients who did have nodes examined, 1,507 (43.3%) had no metastases and were classified as N0, and 56% (1,971) had metastatic disease (classified as N1).

The mean number of nodes examined in the negative group was 8, while the mean in the node-positive group was 11.

Overall, median survival was 13 months and the 5-year survival rate was 17%.

With multivariate analysis, the prognostic factors related to survival included tumor stage, tumor grade, a tumor size of greater than 2 cm, the number of nodes examined, the LN ratio, and N1 disease.

Patients with zero nodes examined were at highest risk of disease-specific death, as they were 44% more likely to die during follow-up, Dr. Slidell said.

Dr. Slidell and his colleagues also evaluated whether a greater number of positive nodes was associated with decreased survival. N0 patients had significantly better survival than N1 patients, but within the group of patients with N1 disease, an increasing number of positive nodes was not significantly associated with poorer survival; however, it was associated with a nonsignificant trend toward decreased survival, said Dr. Slidell.

N1 disease also increased the risk of disease-specific death, as did a higher LN ratio. Five-year survival for N1 disease was 7%, compared with 18% for N0 disease.

LN ratio proved to be even more important. For a ratio of 0, the median survival was 17 months, for ratios of 0–0.2 it was 15 months, and for 0.2–0.4 it was 12 months. Median survival declined to 10 months for ratios greater than 0.4.

The LN ratio appears to be a better predictor of survival, and should be considered for use as a potential stratification method in future clinical studies, he said.

WASHINGTON — Endoscopic mucosal resection seems to be safe and effective for Barrett's esophagus with high-grade dysplasia or intramucosal adenocarcinoma, and may help patients avoid an esophagectomy, according to a small study presented at a symposium sponsored by the Society of Surgical Oncology.

The procedure has been used to remove focal dysplastic lesions arising in Barrett's endothelium. Although that is successful initially, over time the rates of recurrence increase significantly, said Dr. Andrew Ross of the University of Chicago. This is not surprising, because most Barrett's dysplasias are microscopic and multifocal, so removing just a single focus probably is not very effective, he said.

Clinicians in Europe have shifted to using esophageal mucosal resection (EMR) to completely remove entire segments of Barrett's esophagus, resulting in high remission rates out to 18 months, Dr. Ross said.

Aiming to replicate the European results, he and his colleagues reviewed a prospectively collected database on all patients undergoing EMR for high-grade dysplasia (HGD) or intramucosal adenocarcinoma (IA) at the University of Chicago over a 5-year period.

There were 46 procedures in 26 patients (21 men and 5 women), with a median age of 65.5 years. Of these patients, 15 had HGD, 8 had IA, and 3 had a combination of the two. Half of the patients had short-segment and half had long-segment Barrett's. The median length in the long-segment Barrett's was 5.1 cm.

All patients underwent endoscopic ultrasound to rule out adenopathy and submucosal invasion. The EMRs were performed with a single-channel upper endoscope, but the surgical techniques evolved over time. Argon plasma coagulation was applied to resection margins. Surveillance endoscopy with a 4-quadrant biopsy every 1–2 cm was performed at 6-month intervals. All patients were maintained on twice-daily proton pump inhibitors.

Of the 26 patients, 16 have completed the protocol so far; 8 are awaiting the first follow-up endoscopy. There has been complete eradication—defined as normal-appearing squamous epithelium in surveillance endoscopy—in 11 patients who have been followed for a mean of 16 months. Two patients had residual HGD or IA, two had residual Barrett's with low-grade dysplasia, and one had residual Barrett's alone.

One patient was removed from the study because a submucosal invasion was discovered after the first EMR, and another died of unrelated causes. Most of the patients went home right after the EMR session.

The primary complication thus far has been esophageal stricture, affecting 7 (30%) of the 26 patients. Most saw a resolution of any dysphasia after one or two sessions of balloon dilation, but two patients had to have 10 dilations, Dr. Ross said. The strictures are probably occurring because the endoscopists found it more effective to do the total resection in one session—thus eliminating the scar tissue that resulted from doing the procedure in two sessions. Resection results are better, but strictures have increased.

Dr. Ross and his colleagues were also able to compare pre-EMR and post-EMR histopathology. The EMR removes large tissue specimens. There was histopathologic concordance in 70% of cases, but two patients were upstaged and six were downstaged according to the post-EMR histopathology, he said.

“It's a little bit concerning in that we rely heavily as endoscopists on the pinch biopsy specimens in the management, treatment, work-up, etc., of patients with Barrett's,” Dr. Ross said.

Post-EMR histopathology revealed that HGD and IA were buried under normal-appearing squamous epithelium in nine patients, he said. “If you're doing surveillance endoscopy and you biopsied normal-appearing tissue, you may have missed cancerous lesions beneath the muscosa.”

Compared with the standard biopsy protocol, EMR appears to provide more accurate histopathologic diagnosis and tumor staging, and it is a safe and effective alternative for eradicating HGD and IA in Barrett's, Dr. Ross said.

Stricture formation is a risk, especially with longer segments, he said.

“These preliminary data are encouraging,” he said, adding that larger studies with longer follow-up are needed before widespread adoption of the technique.

He also noted the need for technological advances. “This is a difficult procedure to perform because our instruments are rudimentary and difficult to utilize.”

Dr. Ross has no conflict of interests to disclose.

Barrett's esophagus with high-grade dysplasia is shown before the procedure.

The same lesion is shown immediately after endoscopic mucosal resection. Photos courtesy Dr. Andrew Ross

WASHINGTON — Endoscopic mucosal resection seems to be safe and effective for Barrett's esophagus with high-grade dysplasia or intramucosal adenocarcinoma, and may help patients avoid an esophagectomy, according to a small study presented at a symposium sponsored by the Society of Surgical Oncology.

The procedure has been used to remove focal dysplastic lesions arising in Barrett's endothelium. Although that is successful initially, over time the rates of recurrence increase significantly, said Dr. Andrew Ross of the University of Chicago. This is not surprising, because most Barrett's dysplasias are microscopic and multifocal, so removing just a single focus probably is not very effective, he said.

Clinicians in Europe have shifted to using esophageal mucosal resection (EMR) to completely remove entire segments of Barrett's esophagus, resulting in high remission rates out to 18 months, Dr. Ross said.

Aiming to replicate the European results, he and his colleagues reviewed a prospectively collected database on all patients undergoing EMR for high-grade dysplasia (HGD) or intramucosal adenocarcinoma (IA) at the University of Chicago over a 5-year period.

There were 46 procedures in 26 patients (21 men and 5 women), with a median age of 65.5 years. Of these patients, 15 had HGD, 8 had IA, and 3 had a combination of the two. Half of the patients had short-segment and half had long-segment Barrett's. The median length in the long-segment Barrett's was 5.1 cm.

All patients underwent endoscopic ultrasound to rule out adenopathy and submucosal invasion. The EMRs were performed with a single-channel upper endoscope, but the surgical techniques evolved over time. Argon plasma coagulation was applied to resection margins. Surveillance endoscopy with a 4-quadrant biopsy every 1–2 cm was performed at 6-month intervals. All patients were maintained on twice-daily proton pump inhibitors.

Of the 26 patients, 16 have completed the protocol so far; 8 are awaiting the first follow-up endoscopy. There has been complete eradication—defined as normal-appearing squamous epithelium in surveillance endoscopy—in 11 patients who have been followed for a mean of 16 months. Two patients had residual HGD or IA, two had residual Barrett's with low-grade dysplasia, and one had residual Barrett's alone.

One patient was removed from the study because a submucosal invasion was discovered after the first EMR, and another died of unrelated causes. Most of the patients went home right after the EMR session.

The primary complication thus far has been esophageal stricture, affecting 7 (30%) of the 26 patients. Most saw a resolution of any dysphasia after one or two sessions of balloon dilation, but two patients had to have 10 dilations, Dr. Ross said. The strictures are probably occurring because the endoscopists found it more effective to do the total resection in one session—thus eliminating the scar tissue that resulted from doing the procedure in two sessions. Resection results are better, but strictures have increased.

Dr. Ross and his colleagues were also able to compare pre-EMR and post-EMR histopathology. The EMR removes large tissue specimens. There was histopathologic concordance in 70% of cases, but two patients were upstaged and six were downstaged according to the post-EMR histopathology, he said.

“It's a little bit concerning in that we rely heavily as endoscopists on the pinch biopsy specimens in the management, treatment, work-up, etc., of patients with Barrett's,” Dr. Ross said.

Post-EMR histopathology revealed that HGD and IA were buried under normal-appearing squamous epithelium in nine patients, he said. “If you're doing surveillance endoscopy and you biopsied normal-appearing tissue, you may have missed cancerous lesions beneath the muscosa.”

Compared with the standard biopsy protocol, EMR appears to provide more accurate histopathologic diagnosis and tumor staging, and it is a safe and effective alternative for eradicating HGD and IA in Barrett's, Dr. Ross said.

Stricture formation is a risk, especially with longer segments, he said.

“These preliminary data are encouraging,” he said, adding that larger studies with longer follow-up are needed before widespread adoption of the technique.

He also noted the need for technological advances. “This is a difficult procedure to perform because our instruments are rudimentary and difficult to utilize.”

Dr. Ross has no conflict of interests to disclose.

Barrett's esophagus with high-grade dysplasia is shown before the procedure.

The same lesion is shown immediately after endoscopic mucosal resection. Photos courtesy Dr. Andrew Ross

WASHINGTON — Endoscopic mucosal resection seems to be safe and effective for Barrett's esophagus with high-grade dysplasia or intramucosal adenocarcinoma, and may help patients avoid an esophagectomy, according to a small study presented at a symposium sponsored by the Society of Surgical Oncology.

The procedure has been used to remove focal dysplastic lesions arising in Barrett's endothelium. Although that is successful initially, over time the rates of recurrence increase significantly, said Dr. Andrew Ross of the University of Chicago. This is not surprising, because most Barrett's dysplasias are microscopic and multifocal, so removing just a single focus probably is not very effective, he said.

Clinicians in Europe have shifted to using esophageal mucosal resection (EMR) to completely remove entire segments of Barrett's esophagus, resulting in high remission rates out to 18 months, Dr. Ross said.

Aiming to replicate the European results, he and his colleagues reviewed a prospectively collected database on all patients undergoing EMR for high-grade dysplasia (HGD) or intramucosal adenocarcinoma (IA) at the University of Chicago over a 5-year period.

There were 46 procedures in 26 patients (21 men and 5 women), with a median age of 65.5 years. Of these patients, 15 had HGD, 8 had IA, and 3 had a combination of the two. Half of the patients had short-segment and half had long-segment Barrett's. The median length in the long-segment Barrett's was 5.1 cm.

All patients underwent endoscopic ultrasound to rule out adenopathy and submucosal invasion. The EMRs were performed with a single-channel upper endoscope, but the surgical techniques evolved over time. Argon plasma coagulation was applied to resection margins. Surveillance endoscopy with a 4-quadrant biopsy every 1–2 cm was performed at 6-month intervals. All patients were maintained on twice-daily proton pump inhibitors.

Of the 26 patients, 16 have completed the protocol so far; 8 are awaiting the first follow-up endoscopy. There has been complete eradication—defined as normal-appearing squamous epithelium in surveillance endoscopy—in 11 patients who have been followed for a mean of 16 months. Two patients had residual HGD or IA, two had residual Barrett's with low-grade dysplasia, and one had residual Barrett's alone.

One patient was removed from the study because a submucosal invasion was discovered after the first EMR, and another died of unrelated causes. Most of the patients went home right after the EMR session.

The primary complication thus far has been esophageal stricture, affecting 7 (30%) of the 26 patients. Most saw a resolution of any dysphasia after one or two sessions of balloon dilation, but two patients had to have 10 dilations, Dr. Ross said. The strictures are probably occurring because the endoscopists found it more effective to do the total resection in one session—thus eliminating the scar tissue that resulted from doing the procedure in two sessions. Resection results are better, but strictures have increased.

Dr. Ross and his colleagues were also able to compare pre-EMR and post-EMR histopathology. The EMR removes large tissue specimens. There was histopathologic concordance in 70% of cases, but two patients were upstaged and six were downstaged according to the post-EMR histopathology, he said.

“It's a little bit concerning in that we rely heavily as endoscopists on the pinch biopsy specimens in the management, treatment, work-up, etc., of patients with Barrett's,” Dr. Ross said.

Post-EMR histopathology revealed that HGD and IA were buried under normal-appearing squamous epithelium in nine patients, he said. “If you're doing surveillance endoscopy and you biopsied normal-appearing tissue, you may have missed cancerous lesions beneath the muscosa.”

Compared with the standard biopsy protocol, EMR appears to provide more accurate histopathologic diagnosis and tumor staging, and it is a safe and effective alternative for eradicating HGD and IA in Barrett's, Dr. Ross said.

Stricture formation is a risk, especially with longer segments, he said.

“These preliminary data are encouraging,” he said, adding that larger studies with longer follow-up are needed before widespread adoption of the technique.

He also noted the need for technological advances. “This is a difficult procedure to perform because our instruments are rudimentary and difficult to utilize.”

Dr. Ross has no conflict of interests to disclose.

Barrett's esophagus with high-grade dysplasia is shown before the procedure.

The same lesion is shown immediately after endoscopic mucosal resection. Photos courtesy Dr. Andrew Ross

WASHINGTON — Dermatologists are not very knowledgeable about the training requirements and scope of practice of nurse-practitioners and physician assistants, according to a poster presented at the annual meeting of the American Academy of Dermatology.

The poster presented results of a survey given to 150 participants at a forum on physician extenders held at last year's annual AAD meeting. A total of 83 surveys (55%) were returned, according to Dr. Marianna Blyumin and her colleagues at Massachusetts General Hospital, Boston.

Forty percent of the respondents were female, 83% held a medical degree, and 82% were board-certified dermatologists. Almost all practiced in the United States.

Specifically, the survey questioned physicians about extenders' scope of practice, pay, how scope of practice is determined (by state or federal authorities), whether they practice independently of the physician, and how much training was required for nurse-practitioners.

None of those polled answered all of the questions correctly; on average, 44% of answers were correct. Knowledge was not influenced by age, gender, board certification, practice location, or whether the respondent had worked with the non- physician practitioners in the past, according to the authors.

On average, physicians rated their past experiences with NPs as neutral and their experiences with PAs as positive.

Interestingly, more than 50% of the physicians said they viewed both NPs and PAs as potential partners in the future. A smaller number (20%-30%) said they viewed them as subordinates, and a few reported viewing extenders as potential competition.

Despite limited knowledge of these extenders currently, the larger view of them as future partners was encouraging, concluded the authors.

WASHINGTON — Dermatologists are not very knowledgeable about the training requirements and scope of practice of nurse-practitioners and physician assistants, according to a poster presented at the annual meeting of the American Academy of Dermatology.

The poster presented results of a survey given to 150 participants at a forum on physician extenders held at last year's annual AAD meeting. A total of 83 surveys (55%) were returned, according to Dr. Marianna Blyumin and her colleagues at Massachusetts General Hospital, Boston.

Forty percent of the respondents were female, 83% held a medical degree, and 82% were board-certified dermatologists. Almost all practiced in the United States.

Specifically, the survey questioned physicians about extenders' scope of practice, pay, how scope of practice is determined (by state or federal authorities), whether they practice independently of the physician, and how much training was required for nurse-practitioners.

None of those polled answered all of the questions correctly; on average, 44% of answers were correct. Knowledge was not influenced by age, gender, board certification, practice location, or whether the respondent had worked with the non- physician practitioners in the past, according to the authors.

On average, physicians rated their past experiences with NPs as neutral and their experiences with PAs as positive.

Interestingly, more than 50% of the physicians said they viewed both NPs and PAs as potential partners in the future. A smaller number (20%-30%) said they viewed them as subordinates, and a few reported viewing extenders as potential competition.

Despite limited knowledge of these extenders currently, the larger view of them as future partners was encouraging, concluded the authors.

WASHINGTON — Dermatologists are not very knowledgeable about the training requirements and scope of practice of nurse-practitioners and physician assistants, according to a poster presented at the annual meeting of the American Academy of Dermatology.

The poster presented results of a survey given to 150 participants at a forum on physician extenders held at last year's annual AAD meeting. A total of 83 surveys (55%) were returned, according to Dr. Marianna Blyumin and her colleagues at Massachusetts General Hospital, Boston.

Forty percent of the respondents were female, 83% held a medical degree, and 82% were board-certified dermatologists. Almost all practiced in the United States.

Specifically, the survey questioned physicians about extenders' scope of practice, pay, how scope of practice is determined (by state or federal authorities), whether they practice independently of the physician, and how much training was required for nurse-practitioners.

None of those polled answered all of the questions correctly; on average, 44% of answers were correct. Knowledge was not influenced by age, gender, board certification, practice location, or whether the respondent had worked with the non- physician practitioners in the past, according to the authors.

On average, physicians rated their past experiences with NPs as neutral and their experiences with PAs as positive.

Interestingly, more than 50% of the physicians said they viewed both NPs and PAs as potential partners in the future. A smaller number (20%-30%) said they viewed them as subordinates, and a few reported viewing extenders as potential competition.

Despite limited knowledge of these extenders currently, the larger view of them as future partners was encouraging, concluded the authors.

Starting in April 2008, retailers and suppliers in 10 metropolitan areas that sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

"The final rule we are announcing today is focused on improving both service delivery and the quality of care, while getting savings for beneficiaries and taxpayers," Ms. Norwalk said in a statement.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

Bidding will probably be open until late June. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

The new process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. CMS outlined its intentions in a proposed rule in August 2006. It also gathered data from two pilot studies that ran from 1999 to 2002 in San Antonio and in Polk County, Fla., Ms. Norwalk said. After incorporating public comments and experience from the pilot, CMS published the final rule in the Federal Register.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The locations were selected because they are 10 of the largest Metropolitan Statistical Areas in the United States and because each area had high costs and/or high utilization of DME items in the 10 focus categories. Although New York, Los Angeles, and Chicago are among the largest Metropolitan Statistical Areas and have high costs and utilization, CMS decided to exclude those areas initially to simplify the process, Ms. Norwalk said.

The 10 categories include: oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays).

In most CBAs, only nine categories will be subject to bidding in 2008. All 10 will be covered in the Miami and the San Juan areas.

Since 60% of diabetic supplies are delivered through mail-order, CMS decided to require those suppliers to be subject to competitive bidding. Thus, patients with diabetes will continue to have the option of mail-order and it should be less costly, according to CMS. Payment for supplies obtained at a pharmacy or elsewhere will still be covered under the old Medicare fee schedule, even in the 10 CBAs, the agency said.

Blood glucose monitors are not subject to competitive bidding.

To qualify to bid, suppliers have to be accredited by 1 of 10 agencies certified by CMS. Those include the Joint Commission on Accreditation of Healthcare Organizations, the Board of Orthotist/Prosthetist Certification, and the Accreditation Commission for Health Care Inc.

Generally, bidders also have to be in good standing with Medicare, have an active National Supplier Clearinghouse number, and agree to service an entire bidding area, regardless of where a beneficiary may be located.

Of the winning contract slots, 30% are set aside for small suppliers—those with gross revenue of $3.5 million or less per year.

A list of the accrediting bodies, bidding criteria, and other details can be found online at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Starting in April 2008, retailers and suppliers in 10 metropolitan areas that sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

"The final rule we are announcing today is focused on improving both service delivery and the quality of care, while getting savings for beneficiaries and taxpayers," Ms. Norwalk said in a statement.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

Bidding will probably be open until late June. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

The new process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. CMS outlined its intentions in a proposed rule in August 2006. It also gathered data from two pilot studies that ran from 1999 to 2002 in San Antonio and in Polk County, Fla., Ms. Norwalk said. After incorporating public comments and experience from the pilot, CMS published the final rule in the Federal Register.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The locations were selected because they are 10 of the largest Metropolitan Statistical Areas in the United States and because each area had high costs and/or high utilization of DME items in the 10 focus categories. Although New York, Los Angeles, and Chicago are among the largest Metropolitan Statistical Areas and have high costs and utilization, CMS decided to exclude those areas initially to simplify the process, Ms. Norwalk said.

The 10 categories include: oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays).

In most CBAs, only nine categories will be subject to bidding in 2008. All 10 will be covered in the Miami and the San Juan areas.

Since 60% of diabetic supplies are delivered through mail-order, CMS decided to require those suppliers to be subject to competitive bidding. Thus, patients with diabetes will continue to have the option of mail-order and it should be less costly, according to CMS. Payment for supplies obtained at a pharmacy or elsewhere will still be covered under the old Medicare fee schedule, even in the 10 CBAs, the agency said.

Blood glucose monitors are not subject to competitive bidding.

To qualify to bid, suppliers have to be accredited by 1 of 10 agencies certified by CMS. Those include the Joint Commission on Accreditation of Healthcare Organizations, the Board of Orthotist/Prosthetist Certification, and the Accreditation Commission for Health Care Inc.

Generally, bidders also have to be in good standing with Medicare, have an active National Supplier Clearinghouse number, and agree to service an entire bidding area, regardless of where a beneficiary may be located.

Of the winning contract slots, 30% are set aside for small suppliers—those with gross revenue of $3.5 million or less per year.

A list of the accrediting bodies, bidding criteria, and other details can be found online at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Starting in April 2008, retailers and suppliers in 10 metropolitan areas that sell certain durable medical equipment will have to become accredited and enter a competitive bidding process, according to a final rule issued by the Centers for Medicare and Medicaid Services.

Unlike other entities, physicians may opt out of competitive bidding and accreditation, but they will still have to accept a single payment for the durable medical equipment (DME) item instead of a fee schedule-based payment, Acting CMS Administrator Leslie Norwalk said in a briefing with reporters.

The new competitive bidding program was developed to reduce Medicare's substantial DME expenditures and to decrease the out-of-pocket burden for beneficiaries, who are liable for copayments of 20%.

"The final rule we are announcing today is focused on improving both service delivery and the quality of care, while getting savings for beneficiaries and taxpayers," Ms. Norwalk said in a statement.

She estimated that Medicare could shave $1 billion a year off its DME tab by the time the program is fully implemented in 2010.

The final rule will apply initially only to 10 categories of supplies and only to suppliers in 10 competitive bidding areas (CBA) that have been established by CMS. Physicians, hospitals, and other entities that sell DME, prosthetics, orthotics, and certain other supplies will be required to submit bids to CMS proposing charges for the items.

Bidding will probably be open until late June. CMS will evaluate the bids and then, probably in December, the agency will award contracts to a certain number of bidders in each CBA, Ms. Norwalk said in the briefing.

Beginning in April 2008, Medicare will pay a single amount for each item in those areas instead of basing payments on a fee schedule, as it has in the past.

CMS will expand the program to 70 bidding areas in 2009, and to more CBAs, and to cover more DME items after that, Ms. Norwalk said.

The new process was required by the Medicare Prescription Drug Improvement and Modernization Act of 2003. CMS outlined its intentions in a proposed rule in August 2006. It also gathered data from two pilot studies that ran from 1999 to 2002 in San Antonio and in Polk County, Fla., Ms. Norwalk said. After incorporating public comments and experience from the pilot, CMS published the final rule in the Federal Register.

Suppliers in the following 10 areas will be the first subject to the new requirements: Charlotte-Gastonia-Concord, N.C./S.C.; Cincinnati-Middletown, Ohio/Ky./Ind.; Cleveland-Elyria-Mentor, Ohio; Dallas-Fort Worth-Arlington, Tex.; Kansas City, Mo./Kans.; Miami-Fort Lauderdale-Miami Beach, Fla.; Orlando-Kissimmee, Fla.; Pittsburgh; Riverside-San Bernardino-Ontario, Calif.; and San Juan-Caguas-Guaynabo, Puerto Rico.

The locations were selected because they are 10 of the largest Metropolitan Statistical Areas in the United States and because each area had high costs and/or high utilization of DME items in the 10 focus categories. Although New York, Los Angeles, and Chicago are among the largest Metropolitan Statistical Areas and have high costs and utilization, CMS decided to exclude those areas initially to simplify the process, Ms. Norwalk said.

The 10 categories include: oxygen supplies and equipment; standard power wheelchairs, scooters, and accessories; complex rehabilitative power wheelchairs and accessories; mail-order diabetes supplies; enteral nutrients, equipment, and supplies; continuous positive airway pressure (CPAP) devices; respiratory assist devices and supplies and accessories; hospital beds and accessories; negative pressure wound therapy pumps and supplies and accessories; walkers and related accessories; and support surfaces (group 2 and 3 mattresses and overlays).

In most CBAs, only nine categories will be subject to bidding in 2008. All 10 will be covered in the Miami and the San Juan areas.

Since 60% of diabetic supplies are delivered through mail-order, CMS decided to require those suppliers to be subject to competitive bidding. Thus, patients with diabetes will continue to have the option of mail-order and it should be less costly, according to CMS. Payment for supplies obtained at a pharmacy or elsewhere will still be covered under the old Medicare fee schedule, even in the 10 CBAs, the agency said.

Blood glucose monitors are not subject to competitive bidding.

To qualify to bid, suppliers have to be accredited by 1 of 10 agencies certified by CMS. Those include the Joint Commission on Accreditation of Healthcare Organizations, the Board of Orthotist/Prosthetist Certification, and the Accreditation Commission for Health Care Inc.

Generally, bidders also have to be in good standing with Medicare, have an active National Supplier Clearinghouse number, and agree to service an entire bidding area, regardless of where a beneficiary may be located.

Of the winning contract slots, 30% are set aside for small suppliers—those with gross revenue of $3.5 million or less per year.

A list of the accrediting bodies, bidding criteria, and other details can be found online at www.cms.hhs.gov/CompetitiveAcqforDMEPOS

Mich. Derm Faces Jail Time

A Michigan dermatologist has been found guilty of defrauding Medicare and a Blue Cross Blue Shield plan. Dr. Robert W. Stokes of Grand Rapids, Mich., faces up to 10 years in prison for his conviction on 31 counts of health care fraud. The U.S. Attorney for the Western District of Michigan alleged that Dr. Stokes was upcoding surgical procedures and then billing for follow-up visits for post-operative infections that did not exist. Dr. Stokes came to the attention of federal authorities through patient complaints and audits conducted by Medicare and Blue Cross Blue Shield of Michigan. The Health and Human Services Department's Office of Inspector General and the Federal Bureau of Investigation conducted the inquiry into Dr. Stokes' billing practices and estimated that he fraudulently charged at least $500,000. Dr. Stokes has agreed to cease the practice of medicine, but has not been sentenced yet. His attorney, Mark Kriger of LaRene and Kriger in Detroit, said in an interview that his client had no fraudulent intent and will appeal the conviction.

Medicis Settles With Feds

Medicis Pharmaceutical Corp. of Scottsdale, Ariz. has agreed to pay the U.S. government $9.8 million to settle allegations that it illegally promoted Loprox (ciclopirox) as a diaper rash treatment. Loprox is not approved by the Food and Drug Administration for skin disorders in children under age 10 years. The settlement is the result of a whistle-blower complaint by four former Medicis sales representatives, who, as a result, will get a portion of the settlement. They alleged that from 2001 to 2004, Medicis representatives targeted pediatricians in an attempt to get them to prescribe Loprox for diaper rash. The case was jointly investigated by the FDA and the Kansas Attorney General's office. Medicis says "the alleged off-label promotion" was by its former pediatric sales division, which it divested in 2004. "Medicis confronted this situation head on and fully cooperated with the government, consistent with the company's strong commitment to compliance and integrity," said company general counsel Jason Hanson in a statement.

Top Ten Questions on Injectables

Safety is a top concern about the use of injectable treatments among women aged 25 years and older, according to a survey by Harris Interactive commissioned by the National Women's Health Resource Center (NWHRC) and Allergan Inc. About 1,300 women were queried by Harris in early April. After safety, respondents' next nine questions were about cost, whether results would look natural, duration of treatment and length of the procedure, insurance coverage, whether there would be pain, scarring, bruising or other side effects, and finally, if facial expressions would still be possible after treatment. The survey is part of a joint Allergan-NWHRC campaign to educate women on injectable treatments; fuller results will be released later this summer. The not-for-profit, independent NWHRC develops and distributes objective women's health information based on the latest advances in medical research and practice, according to its Web site.

IVIG Pay, Access Issues Confirmed

Two new reports from HHS confirm that Medicare payments for intravenous immune globulin (IVIG) are severely lagging behind price increases from manufacturers, making it difficult for hospitals and physicians to offer the therapy. In an April report, the HHS Inspector General found that in the third quarter of 2006, 56% of hospitals and 59% of physicians bought IVIG at prices below the Medicare reimbursement amount, which means they were able to marginally profit on the therapy. But that means that 44% of hospitals and 41% of physicians paid more for IVIG than Medicare reimbursed, said Marcia Boyle, president of the Immune Deficiency Foundation, in an interview. Further, the Inspector General found that a majority of physicians and hospitals were underpaid by Medicare relative to IVIG price for the first half-quarters of the year. Medicare acknowledged that the market was fragile, due to tight supplies and price increases and that physicians in hospitals would face the same crisis this year that they did last.

Debridement Restrictions Lifted

The American Academy of Family Physicians said it has succeeded in its drive to remove restrictive language from a Medicare carrier's draft local coverage determination on wound care. The restriction would have affected physicians in Texas, Delaware, Maryland, and Virginia. Last December, AAFP questioned TrailBlazer Health Enterprises' proposed debridement limits of three times for one wound. AAFP said that although repetitive debridement of one wound is uncommon, sometimes, serial debridement is the only option. TrailBlazer removed the restrictions from its final policy, released in April.

Juries Side With MDs

Juries in malpractice cases sympathize more with physicians and less with their patients, according to an extensive review of studies involving malpractice cases from 1989 to 2006. Philip Peters, of the University of Missouri-Columbia School of Law, found that plaintiffs rarely win weak cases, although they have more success in cases viewed as a "toss-up" and better outcomes in cases with strong evidence of medical negligence. Mr. Peters, whose study appeared in the May edition of the Michigan Law Review, said that several factors systemically favor medical defendants in the courtroom, including the defendant's superior resources, physicians' social standing, social norms against "profiting" by injury, and the jury's willingness to give physicians the benefit of the doubt when evidence conflicts.

Mich. Derm Faces Jail Time

A Michigan dermatologist has been found guilty of defrauding Medicare and a Blue Cross Blue Shield plan. Dr. Robert W. Stokes of Grand Rapids, Mich., faces up to 10 years in prison for his conviction on 31 counts of health care fraud. The U.S. Attorney for the Western District of Michigan alleged that Dr. Stokes was upcoding surgical procedures and then billing for follow-up visits for post-operative infections that did not exist. Dr. Stokes came to the attention of federal authorities through patient complaints and audits conducted by Medicare and Blue Cross Blue Shield of Michigan. The Health and Human Services Department's Office of Inspector General and the Federal Bureau of Investigation conducted the inquiry into Dr. Stokes' billing practices and estimated that he fraudulently charged at least $500,000. Dr. Stokes has agreed to cease the practice of medicine, but has not been sentenced yet. His attorney, Mark Kriger of LaRene and Kriger in Detroit, said in an interview that his client had no fraudulent intent and will appeal the conviction.

Medicis Settles With Feds

Medicis Pharmaceutical Corp. of Scottsdale, Ariz. has agreed to pay the U.S. government $9.8 million to settle allegations that it illegally promoted Loprox (ciclopirox) as a diaper rash treatment. Loprox is not approved by the Food and Drug Administration for skin disorders in children under age 10 years. The settlement is the result of a whistle-blower complaint by four former Medicis sales representatives, who, as a result, will get a portion of the settlement. They alleged that from 2001 to 2004, Medicis representatives targeted pediatricians in an attempt to get them to prescribe Loprox for diaper rash. The case was jointly investigated by the FDA and the Kansas Attorney General's office. Medicis says "the alleged off-label promotion" was by its former pediatric sales division, which it divested in 2004. "Medicis confronted this situation head on and fully cooperated with the government, consistent with the company's strong commitment to compliance and integrity," said company general counsel Jason Hanson in a statement.

Top Ten Questions on Injectables

Safety is a top concern about the use of injectable treatments among women aged 25 years and older, according to a survey by Harris Interactive commissioned by the National Women's Health Resource Center (NWHRC) and Allergan Inc. About 1,300 women were queried by Harris in early April. After safety, respondents' next nine questions were about cost, whether results would look natural, duration of treatment and length of the procedure, insurance coverage, whether there would be pain, scarring, bruising or other side effects, and finally, if facial expressions would still be possible after treatment. The survey is part of a joint Allergan-NWHRC campaign to educate women on injectable treatments; fuller results will be released later this summer. The not-for-profit, independent NWHRC develops and distributes objective women's health information based on the latest advances in medical research and practice, according to its Web site.

IVIG Pay, Access Issues Confirmed

Two new reports from HHS confirm that Medicare payments for intravenous immune globulin (IVIG) are severely lagging behind price increases from manufacturers, making it difficult for hospitals and physicians to offer the therapy. In an April report, the HHS Inspector General found that in the third quarter of 2006, 56% of hospitals and 59% of physicians bought IVIG at prices below the Medicare reimbursement amount, which means they were able to marginally profit on the therapy. But that means that 44% of hospitals and 41% of physicians paid more for IVIG than Medicare reimbursed, said Marcia Boyle, president of the Immune Deficiency Foundation, in an interview. Further, the Inspector General found that a majority of physicians and hospitals were underpaid by Medicare relative to IVIG price for the first half-quarters of the year. Medicare acknowledged that the market was fragile, due to tight supplies and price increases and that physicians in hospitals would face the same crisis this year that they did last.

Debridement Restrictions Lifted

The American Academy of Family Physicians said it has succeeded in its drive to remove restrictive language from a Medicare carrier's draft local coverage determination on wound care. The restriction would have affected physicians in Texas, Delaware, Maryland, and Virginia. Last December, AAFP questioned TrailBlazer Health Enterprises' proposed debridement limits of three times for one wound. AAFP said that although repetitive debridement of one wound is uncommon, sometimes, serial debridement is the only option. TrailBlazer removed the restrictions from its final policy, released in April.

Juries Side With MDs

Juries in malpractice cases sympathize more with physicians and less with their patients, according to an extensive review of studies involving malpractice cases from 1989 to 2006. Philip Peters, of the University of Missouri-Columbia School of Law, found that plaintiffs rarely win weak cases, although they have more success in cases viewed as a "toss-up" and better outcomes in cases with strong evidence of medical negligence. Mr. Peters, whose study appeared in the May edition of the Michigan Law Review, said that several factors systemically favor medical defendants in the courtroom, including the defendant's superior resources, physicians' social standing, social norms against "profiting" by injury, and the jury's willingness to give physicians the benefit of the doubt when evidence conflicts.

Mich. Derm Faces Jail Time

A Michigan dermatologist has been found guilty of defrauding Medicare and a Blue Cross Blue Shield plan. Dr. Robert W. Stokes of Grand Rapids, Mich., faces up to 10 years in prison for his conviction on 31 counts of health care fraud. The U.S. Attorney for the Western District of Michigan alleged that Dr. Stokes was upcoding surgical procedures and then billing for follow-up visits for post-operative infections that did not exist. Dr. Stokes came to the attention of federal authorities through patient complaints and audits conducted by Medicare and Blue Cross Blue Shield of Michigan. The Health and Human Services Department's Office of Inspector General and the Federal Bureau of Investigation conducted the inquiry into Dr. Stokes' billing practices and estimated that he fraudulently charged at least $500,000. Dr. Stokes has agreed to cease the practice of medicine, but has not been sentenced yet. His attorney, Mark Kriger of LaRene and Kriger in Detroit, said in an interview that his client had no fraudulent intent and will appeal the conviction.

Medicis Settles With Feds

Medicis Pharmaceutical Corp. of Scottsdale, Ariz. has agreed to pay the U.S. government $9.8 million to settle allegations that it illegally promoted Loprox (ciclopirox) as a diaper rash treatment. Loprox is not approved by the Food and Drug Administration for skin disorders in children under age 10 years. The settlement is the result of a whistle-blower complaint by four former Medicis sales representatives, who, as a result, will get a portion of the settlement. They alleged that from 2001 to 2004, Medicis representatives targeted pediatricians in an attempt to get them to prescribe Loprox for diaper rash. The case was jointly investigated by the FDA and the Kansas Attorney General's office. Medicis says "the alleged off-label promotion" was by its former pediatric sales division, which it divested in 2004. "Medicis confronted this situation head on and fully cooperated with the government, consistent with the company's strong commitment to compliance and integrity," said company general counsel Jason Hanson in a statement.

Top Ten Questions on Injectables

Safety is a top concern about the use of injectable treatments among women aged 25 years and older, according to a survey by Harris Interactive commissioned by the National Women's Health Resource Center (NWHRC) and Allergan Inc. About 1,300 women were queried by Harris in early April. After safety, respondents' next nine questions were about cost, whether results would look natural, duration of treatment and length of the procedure, insurance coverage, whether there would be pain, scarring, bruising or other side effects, and finally, if facial expressions would still be possible after treatment. The survey is part of a joint Allergan-NWHRC campaign to educate women on injectable treatments; fuller results will be released later this summer. The not-for-profit, independent NWHRC develops and distributes objective women's health information based on the latest advances in medical research and practice, according to its Web site.

IVIG Pay, Access Issues Confirmed

Two new reports from HHS confirm that Medicare payments for intravenous immune globulin (IVIG) are severely lagging behind price increases from manufacturers, making it difficult for hospitals and physicians to offer the therapy. In an April report, the HHS Inspector General found that in the third quarter of 2006, 56% of hospitals and 59% of physicians bought IVIG at prices below the Medicare reimbursement amount, which means they were able to marginally profit on the therapy. But that means that 44% of hospitals and 41% of physicians paid more for IVIG than Medicare reimbursed, said Marcia Boyle, president of the Immune Deficiency Foundation, in an interview. Further, the Inspector General found that a majority of physicians and hospitals were underpaid by Medicare relative to IVIG price for the first half-quarters of the year. Medicare acknowledged that the market was fragile, due to tight supplies and price increases and that physicians in hospitals would face the same crisis this year that they did last.

Debridement Restrictions Lifted

The American Academy of Family Physicians said it has succeeded in its drive to remove restrictive language from a Medicare carrier's draft local coverage determination on wound care. The restriction would have affected physicians in Texas, Delaware, Maryland, and Virginia. Last December, AAFP questioned TrailBlazer Health Enterprises' proposed debridement limits of three times for one wound. AAFP said that although repetitive debridement of one wound is uncommon, sometimes, serial debridement is the only option. TrailBlazer removed the restrictions from its final policy, released in April.

Juries Side With MDs

Juries in malpractice cases sympathize more with physicians and less with their patients, according to an extensive review of studies involving malpractice cases from 1989 to 2006. Philip Peters, of the University of Missouri-Columbia School of Law, found that plaintiffs rarely win weak cases, although they have more success in cases viewed as a "toss-up" and better outcomes in cases with strong evidence of medical negligence. Mr. Peters, whose study appeared in the May edition of the Michigan Law Review, said that several factors systemically favor medical defendants in the courtroom, including the defendant's superior resources, physicians' social standing, social norms against "profiting" by injury, and the jury's willingness to give physicians the benefit of the doubt when evidence conflicts.

The full Senate has approved a 5-year reauthorization of the Medical Device User Fee Modernization Act as part of a legislative package that included reauthorization of the Prescription Drug User Fee Act.

MDUFMA is due to expire Sept. 30. The law governs how much manufacturers are expected to pay for review of their products and also sets out review timetables that the agency must meet.

The medical device industry was largely happy with the bill as passed.

“The agreement provides additional resources to [the Food and Drug Administration] to hire additional reviewers providing patients with access to safe, lifesaving medical devices in a timely manner,” AdvaMed President and CEO Stephen J. Ubl said in a statement.

“The agreement also provides manufacturers with a more predictable fee schedule with regard to user fee rates,” he said.

The device user fee portion of the bill is largely the result of an agreement hammered out earlier this year by the FDA and the industry.

In a briefing with reporters unveiling the specifics of the agreement, Dr. Jeffrey Shuren, the FDA's assistant director for policy, touted its “aggressive performance goals.”

Under current law, in fiscal year 2007, the FDA is required to make a decision on 90% of premarket approval applications (PMAs) within 320 days, and on 50% within 180 days.

With the new proposal, 60% of PMAs will be reviewed within 180 days, and 90% within 295 days in fiscal year 2008.

This year, 90% of priority PMAs are required to be reviewed within 300 days, and 80% of 510(k)s within 90 days. Under the new proposal, in fiscal year 2008, 90% of priority PMAs will be reviewed within 280 days, and 50% within 180 days. Ninety percent of 510(k)s will be reviewed within 90 days, and almost all—98%–-within 150 days.

Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said that the current law had expedited the division's review of devices for blood testing and transfusion, and for cellular therapies and tissues. Before the program, it took an average of 123 days to review an application; in 2006, the average was about 55 days, Dr. Goodman told reporters.

The agency also is proposing to streamline its review of diagnostic imaging devices and said it would publish draft guidance on the issue by October 2008. The FDA would also make more use of private, outside inspectors.

Currently, manufacturers have to go through a lengthy process to use third-party reviewers.

Under the new proposal, they'd only have to give 30 days' notice, and they would be allowed to use the reviewers for a larger number of inspections.

The FDA estimated that it will require $220 million to review devices in fiscal year 2008, of which it plans to raise about $49 million from user fees. Over the 5 years of the program, it will need $1.2 billion, of which $287 million will come from industry.

In the past 5 years, the agency has had to go back to manufacturers to seek supplemental increases when there was a shortfall—which occurred when there were fewer new device applications than had been anticipated.

If the new legislation becomes law, fees will be fixed for each year of the program. Half the fees will come from applications—for new devices, supplements, manufacturing modifications, and classification information—and half from two new fees: one for manufacturing establishments and single-device reprocessors, and a periodic annual report fee. About 425 devices are subject to annual reporting requirements.

The House is still weighing prescription drug and medical device user fee reauthorizations.

Both the House and the Senate must move quickly to avoid layoffs and interruptions at the FDA, which has become heavily dependent on industry user fees to finance its work.

Senate Reauthorizes Prescription Drug User Fee Act; House Still in Early Phases

After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.

Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews. The current PDUFA law expires Sept. 30.

Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.

At least one amendment to the original legislation (S. 1082) was passed that would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

PDUFA would allow the FDA to collect $393 million in drug user fees in 2008, including a $30 million increase for postapproval drug safety programs.

The bill would also require drug makers to publish a registry of all late-phase II, and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would fund another 5 years of the Best Pharmaceuticals for Children Act. Companies that conduct pediatric studies of their products are eligible for additional patent life under the law, which expires Oct. 1. The new 5-year program will extend a drug's patent life by 3 months (instead of 6 offered under the previous law) if sales of the product are more than $1 billion and by 6 months if sales are less than $1 billion.

Under the Best Pharmaceuticals for Children Act, the Government Accountability Office found that drug sponsors have initiated pediatric drug studies for most of the on-patent drugs for which the FDA has requested studies. About 87% of drugs studied had labeling changes, often because the pediatric drug studies found that children might have been exposed to ineffective drugs or dosing; overdosing; or previously unknown side effects.

The Senate vote was hailed by the brand name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy, as it secured a promise from a group of Senators to markup legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The Generic Pharmaceutical Association also praised a group of senators who secured passage of an amendment requiring the FDA to move forward on generic drug applications even though a brand name company has filed a citizen's petition questioning the generic. In the past, the FDA has not been able to consider approval of a generic until the petition was resolved—and, filing a petition has become a common strategy used by the brand name industry, according to the GPhA.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.

The full Senate has approved a 5-year reauthorization of the Medical Device User Fee Modernization Act as part of a legislative package that included reauthorization of the Prescription Drug User Fee Act.

MDUFMA is due to expire Sept. 30. The law governs how much manufacturers are expected to pay for review of their products and also sets out review timetables that the agency must meet.

The medical device industry was largely happy with the bill as passed.

“The agreement provides additional resources to [the Food and Drug Administration] to hire additional reviewers providing patients with access to safe, lifesaving medical devices in a timely manner,” AdvaMed President and CEO Stephen J. Ubl said in a statement.

“The agreement also provides manufacturers with a more predictable fee schedule with regard to user fee rates,” he said.

The device user fee portion of the bill is largely the result of an agreement hammered out earlier this year by the FDA and the industry.

In a briefing with reporters unveiling the specifics of the agreement, Dr. Jeffrey Shuren, the FDA's assistant director for policy, touted its “aggressive performance goals.”

Under current law, in fiscal year 2007, the FDA is required to make a decision on 90% of premarket approval applications (PMAs) within 320 days, and on 50% within 180 days.

With the new proposal, 60% of PMAs will be reviewed within 180 days, and 90% within 295 days in fiscal year 2008.

This year, 90% of priority PMAs are required to be reviewed within 300 days, and 80% of 510(k)s within 90 days. Under the new proposal, in fiscal year 2008, 90% of priority PMAs will be reviewed within 280 days, and 50% within 180 days. Ninety percent of 510(k)s will be reviewed within 90 days, and almost all—98%–-within 150 days.

Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said that the current law had expedited the division's review of devices for blood testing and transfusion, and for cellular therapies and tissues. Before the program, it took an average of 123 days to review an application; in 2006, the average was about 55 days, Dr. Goodman told reporters.

The agency also is proposing to streamline its review of diagnostic imaging devices and said it would publish draft guidance on the issue by October 2008. The FDA would also make more use of private, outside inspectors.

Currently, manufacturers have to go through a lengthy process to use third-party reviewers.

Under the new proposal, they'd only have to give 30 days' notice, and they would be allowed to use the reviewers for a larger number of inspections.

The FDA estimated that it will require $220 million to review devices in fiscal year 2008, of which it plans to raise about $49 million from user fees. Over the 5 years of the program, it will need $1.2 billion, of which $287 million will come from industry.

In the past 5 years, the agency has had to go back to manufacturers to seek supplemental increases when there was a shortfall—which occurred when there were fewer new device applications than had been anticipated.

If the new legislation becomes law, fees will be fixed for each year of the program. Half the fees will come from applications—for new devices, supplements, manufacturing modifications, and classification information—and half from two new fees: one for manufacturing establishments and single-device reprocessors, and a periodic annual report fee. About 425 devices are subject to annual reporting requirements.

The House is still weighing prescription drug and medical device user fee reauthorizations.

Both the House and the Senate must move quickly to avoid layoffs and interruptions at the FDA, which has become heavily dependent on industry user fees to finance its work.

Senate Reauthorizes Prescription Drug User Fee Act; House Still in Early Phases

After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.

Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews. The current PDUFA law expires Sept. 30.

Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.

At least one amendment to the original legislation (S. 1082) was passed that would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

PDUFA would allow the FDA to collect $393 million in drug user fees in 2008, including a $30 million increase for postapproval drug safety programs.

The bill would also require drug makers to publish a registry of all late-phase II, and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would fund another 5 years of the Best Pharmaceuticals for Children Act. Companies that conduct pediatric studies of their products are eligible for additional patent life under the law, which expires Oct. 1. The new 5-year program will extend a drug's patent life by 3 months (instead of 6 offered under the previous law) if sales of the product are more than $1 billion and by 6 months if sales are less than $1 billion.

Under the Best Pharmaceuticals for Children Act, the Government Accountability Office found that drug sponsors have initiated pediatric drug studies for most of the on-patent drugs for which the FDA has requested studies. About 87% of drugs studied had labeling changes, often because the pediatric drug studies found that children might have been exposed to ineffective drugs or dosing; overdosing; or previously unknown side effects.

The Senate vote was hailed by the brand name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy, as it secured a promise from a group of Senators to markup legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The Generic Pharmaceutical Association also praised a group of senators who secured passage of an amendment requiring the FDA to move forward on generic drug applications even though a brand name company has filed a citizen's petition questioning the generic. In the past, the FDA has not been able to consider approval of a generic until the petition was resolved—and, filing a petition has become a common strategy used by the brand name industry, according to the GPhA.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.

The full Senate has approved a 5-year reauthorization of the Medical Device User Fee Modernization Act as part of a legislative package that included reauthorization of the Prescription Drug User Fee Act.

MDUFMA is due to expire Sept. 30. The law governs how much manufacturers are expected to pay for review of their products and also sets out review timetables that the agency must meet.

The medical device industry was largely happy with the bill as passed.

“The agreement provides additional resources to [the Food and Drug Administration] to hire additional reviewers providing patients with access to safe, lifesaving medical devices in a timely manner,” AdvaMed President and CEO Stephen J. Ubl said in a statement.

“The agreement also provides manufacturers with a more predictable fee schedule with regard to user fee rates,” he said.

The device user fee portion of the bill is largely the result of an agreement hammered out earlier this year by the FDA and the industry.

In a briefing with reporters unveiling the specifics of the agreement, Dr. Jeffrey Shuren, the FDA's assistant director for policy, touted its “aggressive performance goals.”

Under current law, in fiscal year 2007, the FDA is required to make a decision on 90% of premarket approval applications (PMAs) within 320 days, and on 50% within 180 days.

With the new proposal, 60% of PMAs will be reviewed within 180 days, and 90% within 295 days in fiscal year 2008.

This year, 90% of priority PMAs are required to be reviewed within 300 days, and 80% of 510(k)s within 90 days. Under the new proposal, in fiscal year 2008, 90% of priority PMAs will be reviewed within 280 days, and 50% within 180 days. Ninety percent of 510(k)s will be reviewed within 90 days, and almost all—98%–-within 150 days.

Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said that the current law had expedited the division's review of devices for blood testing and transfusion, and for cellular therapies and tissues. Before the program, it took an average of 123 days to review an application; in 2006, the average was about 55 days, Dr. Goodman told reporters.

The agency also is proposing to streamline its review of diagnostic imaging devices and said it would publish draft guidance on the issue by October 2008. The FDA would also make more use of private, outside inspectors.

Currently, manufacturers have to go through a lengthy process to use third-party reviewers.

Under the new proposal, they'd only have to give 30 days' notice, and they would be allowed to use the reviewers for a larger number of inspections.

The FDA estimated that it will require $220 million to review devices in fiscal year 2008, of which it plans to raise about $49 million from user fees. Over the 5 years of the program, it will need $1.2 billion, of which $287 million will come from industry.

In the past 5 years, the agency has had to go back to manufacturers to seek supplemental increases when there was a shortfall—which occurred when there were fewer new device applications than had been anticipated.

If the new legislation becomes law, fees will be fixed for each year of the program. Half the fees will come from applications—for new devices, supplements, manufacturing modifications, and classification information—and half from two new fees: one for manufacturing establishments and single-device reprocessors, and a periodic annual report fee. About 425 devices are subject to annual reporting requirements.

The House is still weighing prescription drug and medical device user fee reauthorizations.

Both the House and the Senate must move quickly to avoid layoffs and interruptions at the FDA, which has become heavily dependent on industry user fees to finance its work.

Senate Reauthorizes Prescription Drug User Fee Act; House Still in Early Phases

After some last-minute wrangling over drug reimportation and regulation of advertising, the Senate voted 93–1 to fund another 5 years of the Prescription Drug User Fee Act.

Among other issues, PDUFA governs how much pharmaceutical manufacturers pay to have their products reviewed by the Food and Drug Administration, and how quickly the agency must complete those reviews. The current PDUFA law expires Sept. 30.

Some have criticized the program, saying that it lets a regulated industry have too much power over its regulators. But the FDA has become increasingly dependent on user fees to fund its work.

At least one amendment to the original legislation (S. 1082) was passed that would give the agency more teeth. Senators voted 64–30 to approve Sen. Chuck Grassley's (R-Iowa) amendment to increase fines—from $10,000 to $250,000—for companies that don't comply with FDA directives on label changes, postapproval studies, and communicating new information about safety.

The penalties would double every 30 days, but would be capped at $2 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” said Sen. Grassley in a statement.

Drug safety has been a significant focus of the legislation as it has made its way through the Senate.

Sen. Edward Kennedy (D-Mass.) and Sen. Michael Enzi (R-Wy.) had been hoping to attach proposals for improved drug safety to the PDUFA reauthorization, but most of their suggestions were defeated or watered down in a committee vote in mid-April.

The centerpiece of their proposals was to require a risk evaluation and mitigation strategy (REMS) plan for all new chemical entities and biologics. Instead, the Senate Health, Education, Labor, and Pensions committee voted to give the FDA authority to determine when a new drug should have a REMS. That provision made it into the legislation that passed the full Senate. The panel also voted to require the FDA to set up a public-private partnership for routine surveillance of postmarketing drug safety, which also was part of the final bill.

PDUFA would allow the FDA to collect $393 million in drug user fees in 2008, including a $30 million increase for postapproval drug safety programs.

The bill would also require drug makers to publish a registry of all late-phase II, and all phase III and IV trials, and to make all trial results available in a public database.

Finally, PDUFA would fund another 5 years of the Best Pharmaceuticals for Children Act. Companies that conduct pediatric studies of their products are eligible for additional patent life under the law, which expires Oct. 1. The new 5-year program will extend a drug's patent life by 3 months (instead of 6 offered under the previous law) if sales of the product are more than $1 billion and by 6 months if sales are less than $1 billion.

Under the Best Pharmaceuticals for Children Act, the Government Accountability Office found that drug sponsors have initiated pediatric drug studies for most of the on-patent drugs for which the FDA has requested studies. About 87% of drugs studied had labeling changes, often because the pediatric drug studies found that children might have been exposed to ineffective drugs or dosing; overdosing; or previously unknown side effects.

The Senate vote was hailed by the brand name and generic pharmaceutical industries.

“The significant increases in user fees will provide the FDA the resources necessary to improve and modernize its already strong drug safety monitoring system,” PhRMA President and CEO Billy Tauzin said in a statement.

The generic industry was happy, as it secured a promise from a group of Senators to markup legislation authorizing generic copies of biologic drugs by mid-June, with a goal of incorporating it into the final House-Senate agreement on the PDUFA law.

The Generic Pharmaceutical Association also praised a group of senators who secured passage of an amendment requiring the FDA to move forward on generic drug applications even though a brand name company has filed a citizen's petition questioning the generic. In the past, the FDA has not been able to consider approval of a generic until the petition was resolved—and, filing a petition has become a common strategy used by the brand name industry, according to the GPhA.

The PDUFA legislation still has far to go before it becomes law. The House is still in the early phases of work.

WASHINGTON — Food and Drug Administration officials said in March that they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts. The projects, including a pilot project to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.

In a September 2006 report that lambasted FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch.

“I think 5 years is too late to find out what a drug is doing,” said Dr. Robert Temple, associate director for medical policy at the FDA.

The FDA's Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to pull together all available data at 1, 2, and 3 years after launch. Officials will look at the Adverse Events Reporting System database, ongoing postmarketing studies, and other data to see how much can be learned about each particular drug at each time point, said Dr. Temple. He would not disclose which drugs are part of the pilot.

The FDA also plans to publish a newsletter on its Web site that will provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology.

He promised a full accounting but noted that the agency will not disclose any proprietary information.

The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel pharmaceutical manufacturers to fulfill their commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington and Burling in Washington said that most companies comply with FDA requests because “industry is terrified of FDA.” Mr. Hutt said FDA had all the enforcement power it needed already. He argued that the agency did, however, need more funding outside of the user fees it collects.

FDA critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for fiscal 2007.

She also noted that as of fiscal 2006, companies had 1,632 pending postmarketing commitments. The number of studies being requested is on the rise, said Ms. Pendergast, noting that the average was 1.5 per approved drug before 2003 and 5 per approved drug in 2003–2004. In the most recent report to Congress (fiscal 2006), 63% of those studies had not been started, she said. The agency needs a better hammer to get those studies done, said Ms. Pendergast.

WASHINGTON — Food and Drug Administration officials said in March that they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts. The projects, including a pilot project to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.

In a September 2006 report that lambasted FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch.

“I think 5 years is too late to find out what a drug is doing,” said Dr. Robert Temple, associate director for medical policy at the FDA.

The FDA's Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to pull together all available data at 1, 2, and 3 years after launch. Officials will look at the Adverse Events Reporting System database, ongoing postmarketing studies, and other data to see how much can be learned about each particular drug at each time point, said Dr. Temple. He would not disclose which drugs are part of the pilot.

The FDA also plans to publish a newsletter on its Web site that will provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology.

He promised a full accounting but noted that the agency will not disclose any proprietary information.

The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel pharmaceutical manufacturers to fulfill their commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington and Burling in Washington said that most companies comply with FDA requests because “industry is terrified of FDA.” Mr. Hutt said FDA had all the enforcement power it needed already. He argued that the agency did, however, need more funding outside of the user fees it collects.

FDA critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for fiscal 2007.

She also noted that as of fiscal 2006, companies had 1,632 pending postmarketing commitments. The number of studies being requested is on the rise, said Ms. Pendergast, noting that the average was 1.5 per approved drug before 2003 and 5 per approved drug in 2003–2004. In the most recent report to Congress (fiscal 2006), 63% of those studies had not been started, she said. The agency needs a better hammer to get those studies done, said Ms. Pendergast.

WASHINGTON — Food and Drug Administration officials said in March that they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts. The projects, including a pilot project to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.

In a September 2006 report that lambasted FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch.

“I think 5 years is too late to find out what a drug is doing,” said Dr. Robert Temple, associate director for medical policy at the FDA.

The FDA's Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to pull together all available data at 1, 2, and 3 years after launch. Officials will look at the Adverse Events Reporting System database, ongoing postmarketing studies, and other data to see how much can be learned about each particular drug at each time point, said Dr. Temple. He would not disclose which drugs are part of the pilot.

The FDA also plans to publish a newsletter on its Web site that will provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology.

He promised a full accounting but noted that the agency will not disclose any proprietary information.

The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel pharmaceutical manufacturers to fulfill their commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington and Burling in Washington said that most companies comply with FDA requests because “industry is terrified of FDA.” Mr. Hutt said FDA had all the enforcement power it needed already. He argued that the agency did, however, need more funding outside of the user fees it collects.

FDA critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for fiscal 2007.

She also noted that as of fiscal 2006, companies had 1,632 pending postmarketing commitments. The number of studies being requested is on the rise, said Ms. Pendergast, noting that the average was 1.5 per approved drug before 2003 and 5 per approved drug in 2003–2004. In the most recent report to Congress (fiscal 2006), 63% of those studies had not been started, she said. The agency needs a better hammer to get those studies done, said Ms. Pendergast.

Physicians and other health care providers who fail to comply with the May 23 deadline to acquire and start using National Provider Identifiers will not be penalized if they can show they deployed a “contingency plan,” the Centers for Medicare and Medicaid Services announced.

“Covered entities that have been making a good faith effort to comply with the NPI provisions may, for up to 12 months, implement contingency plans that could include accepting legacy provider numbers on HIPAA transactions in order to maintain operations and cash flows,” said CMS Acting Administrator Leslie Norwalk in a statement.

The agency decided to create this grace period “after it became apparent that many covered entities would not be able to fully comply with the NPI standard” by the original deadline, Ms. Norwalk said. The new compliance guideline can be downloaded from the agency's Web site (http://www.cms.hhs.gov/NationalProvIdentStand

According to Dr. Joseph S. Eastern, a Belleville, N.J., dermatologist who lectures widely on practice management issues, one poorly understood aspect of the NPI transition is the “taxonomies,” or supplemental codes that categorize the scope of your office's clinical services. For more on taxonomy codes, visit http://codelists.wpc-edi.com/mambo_taxonomy_2.asp

To ensure a smooth transition for your practice, CMS lists seven steps:

1. Apply for an NPI at https://nppes.cms.hhs.gov.

2. Update your practice software, including billing applications, to incorporate your NPI.

3. Share your NPI with other providers, health plans, clearinghouses, and anyone else who may need it for billing purposes.

4. Communicate with all your health plans and clearinghouses; make sure they are all prepared for the NPI transition.

5. Test your systems to make sure they can process claims and any other HIPAA-related transactions with the NPI.

6. Educate your staff thoroughly on the NPI transition.

7. Implement use of your NPI in all your business practices.

Be sure to ask your software vendors to upgrade your system so that it incorporates your NPI, Dr. Eastern said.

Physicians and other health care providers who fail to comply with the May 23 deadline to acquire and start using National Provider Identifiers will not be penalized if they can show they deployed a “contingency plan,” the Centers for Medicare and Medicaid Services announced.

“Covered entities that have been making a good faith effort to comply with the NPI provisions may, for up to 12 months, implement contingency plans that could include accepting legacy provider numbers on HIPAA transactions in order to maintain operations and cash flows,” said CMS Acting Administrator Leslie Norwalk in a statement.

The agency decided to create this grace period “after it became apparent that many covered entities would not be able to fully comply with the NPI standard” by the original deadline, Ms. Norwalk said. The new compliance guideline can be downloaded from the agency's Web site (http://www.cms.hhs.gov/NationalProvIdentStand

According to Dr. Joseph S. Eastern, a Belleville, N.J., dermatologist who lectures widely on practice management issues, one poorly understood aspect of the NPI transition is the “taxonomies,” or supplemental codes that categorize the scope of your office's clinical services. For more on taxonomy codes, visit http://codelists.wpc-edi.com/mambo_taxonomy_2.asp

To ensure a smooth transition for your practice, CMS lists seven steps:

1. Apply for an NPI at https://nppes.cms.hhs.gov.

2. Update your practice software, including billing applications, to incorporate your NPI.

3. Share your NPI with other providers, health plans, clearinghouses, and anyone else who may need it for billing purposes.

4. Communicate with all your health plans and clearinghouses; make sure they are all prepared for the NPI transition.

5. Test your systems to make sure they can process claims and any other HIPAA-related transactions with the NPI.

6. Educate your staff thoroughly on the NPI transition.

7. Implement use of your NPI in all your business practices.

Be sure to ask your software vendors to upgrade your system so that it incorporates your NPI, Dr. Eastern said.

Physicians and other health care providers who fail to comply with the May 23 deadline to acquire and start using National Provider Identifiers will not be penalized if they can show they deployed a “contingency plan,” the Centers for Medicare and Medicaid Services announced.

“Covered entities that have been making a good faith effort to comply with the NPI provisions may, for up to 12 months, implement contingency plans that could include accepting legacy provider numbers on HIPAA transactions in order to maintain operations and cash flows,” said CMS Acting Administrator Leslie Norwalk in a statement.

The agency decided to create this grace period “after it became apparent that many covered entities would not be able to fully comply with the NPI standard” by the original deadline, Ms. Norwalk said. The new compliance guideline can be downloaded from the agency's Web site (http://www.cms.hhs.gov/NationalProvIdentStand

According to Dr. Joseph S. Eastern, a Belleville, N.J., dermatologist who lectures widely on practice management issues, one poorly understood aspect of the NPI transition is the “taxonomies,” or supplemental codes that categorize the scope of your office's clinical services. For more on taxonomy codes, visit http://codelists.wpc-edi.com/mambo_taxonomy_2.asp

To ensure a smooth transition for your practice, CMS lists seven steps:

1. Apply for an NPI at https://nppes.cms.hhs.gov.

2. Update your practice software, including billing applications, to incorporate your NPI.

3. Share your NPI with other providers, health plans, clearinghouses, and anyone else who may need it for billing purposes.

4. Communicate with all your health plans and clearinghouses; make sure they are all prepared for the NPI transition.

5. Test your systems to make sure they can process claims and any other HIPAA-related transactions with the NPI.

6. Educate your staff thoroughly on the NPI transition.

7. Implement use of your NPI in all your business practices.

Be sure to ask your software vendors to upgrade your system so that it incorporates your NPI, Dr. Eastern said.