Joyce Frieden

BALTIMORE – A significant number of medical residents who are referred for professionalism problems have Axis I or Axis II psychopathology.

Dr. Gabrielle S. Hobday, forensic psychiatry fellow at Emory University, Atlanta, and Dr. Glen O. Gabbard, professor of psychiatry at the Baylor College of Medicine, Houston, reviewed records of outpatient psychiatric evaluations of U.S. and Canadian physicians conducted by Dr. Gabbard from 1997 to 2009.

Extracting physicians who were in training at the time of referral, the researchers came up with 18 cases, which they presented in a poster at the annual meeting of the American Academy of Psychiatry and the Law.

Of the residents involved, 83% were male, and 72% were white. Their mean age was 34 years (range 26-47). Among the specialties involved, primary care–including family practice, internal medicine, and pediatrics–was the most common, at 55%.

The reasons residents were referred were grouped into four categories: sexual boundary violations (four residents), non–sexual boundary violations (three residents), disruptive/irresponsible behavior (nine residents), and clinical competence concerns (two residents). Eleven of the 18 subjects had had previous disciplinary measures, such as dismissal from a program or program probation; previous mental health treatment and/or evaluation; or medical board involvement.

Psychiatric diagnoses were common in this group, with 61% meeting criteria for personality disorders or significant personality traits, and 78% having been diagnosed with a non–substance abuse Axis I disorder. Another 16% were diagnosed with a substance abuse disorder, and 50% of the residents in the study had Axis I and II comorbidities.

Deciding whether to refer a physician-in-training for psychiatric help is not always easy, Dr. Hobday said in an interview. “Some people have been under the watchful eye of their program for a year, and things aren't getting any better. … What do we do with this person who's been a resident for 4 years and only has 1 year left?”

Of the 18 trainees in the study, 12 were deemed fit for duty while undergoing concurrent treatment/rehabilitation. Psychiatric treatment, including psychotherapy and/or medication, was recommended in 15 cases.

“In this era of heightened concern about professionalism, great emphasis has been placed on education in medical school and … monitoring in residency,” the authors noted. “However, we also have observed that education is not sufficient to address all of the underlying causes of misconduct.”

The study did not involve outside funding. The authors said they had no conflicts of interest related to the study.

BALTIMORE – A significant number of medical residents who are referred for professionalism problems have Axis I or Axis II psychopathology.

Dr. Gabrielle S. Hobday, forensic psychiatry fellow at Emory University, Atlanta, and Dr. Glen O. Gabbard, professor of psychiatry at the Baylor College of Medicine, Houston, reviewed records of outpatient psychiatric evaluations of U.S. and Canadian physicians conducted by Dr. Gabbard from 1997 to 2009.

Extracting physicians who were in training at the time of referral, the researchers came up with 18 cases, which they presented in a poster at the annual meeting of the American Academy of Psychiatry and the Law.

Of the residents involved, 83% were male, and 72% were white. Their mean age was 34 years (range 26-47). Among the specialties involved, primary care–including family practice, internal medicine, and pediatrics–was the most common, at 55%.

The reasons residents were referred were grouped into four categories: sexual boundary violations (four residents), non–sexual boundary violations (three residents), disruptive/irresponsible behavior (nine residents), and clinical competence concerns (two residents). Eleven of the 18 subjects had had previous disciplinary measures, such as dismissal from a program or program probation; previous mental health treatment and/or evaluation; or medical board involvement.

Psychiatric diagnoses were common in this group, with 61% meeting criteria for personality disorders or significant personality traits, and 78% having been diagnosed with a non–substance abuse Axis I disorder. Another 16% were diagnosed with a substance abuse disorder, and 50% of the residents in the study had Axis I and II comorbidities.

Deciding whether to refer a physician-in-training for psychiatric help is not always easy, Dr. Hobday said in an interview. “Some people have been under the watchful eye of their program for a year, and things aren't getting any better. … What do we do with this person who's been a resident for 4 years and only has 1 year left?”

Of the 18 trainees in the study, 12 were deemed fit for duty while undergoing concurrent treatment/rehabilitation. Psychiatric treatment, including psychotherapy and/or medication, was recommended in 15 cases.

“In this era of heightened concern about professionalism, great emphasis has been placed on education in medical school and … monitoring in residency,” the authors noted. “However, we also have observed that education is not sufficient to address all of the underlying causes of misconduct.”

The study did not involve outside funding. The authors said they had no conflicts of interest related to the study.

BALTIMORE – A significant number of medical residents who are referred for professionalism problems have Axis I or Axis II psychopathology.

Dr. Gabrielle S. Hobday, forensic psychiatry fellow at Emory University, Atlanta, and Dr. Glen O. Gabbard, professor of psychiatry at the Baylor College of Medicine, Houston, reviewed records of outpatient psychiatric evaluations of U.S. and Canadian physicians conducted by Dr. Gabbard from 1997 to 2009.

Extracting physicians who were in training at the time of referral, the researchers came up with 18 cases, which they presented in a poster at the annual meeting of the American Academy of Psychiatry and the Law.

Of the residents involved, 83% were male, and 72% were white. Their mean age was 34 years (range 26-47). Among the specialties involved, primary care–including family practice, internal medicine, and pediatrics–was the most common, at 55%.

The reasons residents were referred were grouped into four categories: sexual boundary violations (four residents), non–sexual boundary violations (three residents), disruptive/irresponsible behavior (nine residents), and clinical competence concerns (two residents). Eleven of the 18 subjects had had previous disciplinary measures, such as dismissal from a program or program probation; previous mental health treatment and/or evaluation; or medical board involvement.

Psychiatric diagnoses were common in this group, with 61% meeting criteria for personality disorders or significant personality traits, and 78% having been diagnosed with a non–substance abuse Axis I disorder. Another 16% were diagnosed with a substance abuse disorder, and 50% of the residents in the study had Axis I and II comorbidities.

Deciding whether to refer a physician-in-training for psychiatric help is not always easy, Dr. Hobday said in an interview. “Some people have been under the watchful eye of their program for a year, and things aren't getting any better. … What do we do with this person who's been a resident for 4 years and only has 1 year left?”

Of the 18 trainees in the study, 12 were deemed fit for duty while undergoing concurrent treatment/rehabilitation. Psychiatric treatment, including psychotherapy and/or medication, was recommended in 15 cases.

“In this era of heightened concern about professionalism, great emphasis has been placed on education in medical school and … monitoring in residency,” the authors noted. “However, we also have observed that education is not sufficient to address all of the underlying causes of misconduct.”

The study did not involve outside funding. The authors said they had no conflicts of interest related to the study.

Numerous speakers at medical meetings fail to disclose financial conflicts, despite explicit requirements for them to do so.

“Disclosures by physicians are largely self-reported, but there is reason to suspect that this may change in the near future,” Dr. Kanu Okike of Brigham and Women's Hospital and Massachusetts General Hospital and colleagues wrote. “Legislation requiring all drug and device manufacturers to publicly disclose payments to physicians is currently pending in the U.S. Congress and has been met with widespread support.”

They analyzed payments made to physicians in 2007 by five makers of total hip and knee prostheses that together account for nearly 95% of the market. Payment listings were found on each company's Web site and included a range of direct and indirect expenditures (N. Engl. J. Med. 2009;361:1466-74).

The authors compared the payments with conflict-of-interest disclosures made by physicians who either presented at or served as board or committee members at the 2008 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS).

A total of 1,347 payments were made to 1,162 physicians during 2007. Overall, 166 physicians received payments from multiple companies, and 282 payments exceeded $100,000. About a quarter of the payments (344) were made to presenters or board or committee members at the AAOS meeting.

In 70% of the 299 cases that could be evaluated for topic relatedness, the payment was directly related to the topic of the meeting presentation. Overall disclosure rate for the payments was 71%, including 79% for directly related payments, 50% for indirectly related payments, and 49% for unrelated payments.

The researchers also surveyed 91 physicians who did not disclose payments; 36 physicians responded to the survey. Reasons for nondisclosure included the payment being unrelated to the presentation topic (39%) and misunderstanding the disclosure requirements (14%). In addition, 11% of respondents said the payment had been disclosed but was inaccurately printed in the program.

The authors noted that the 43 nondisclosed payments relating directly to the presentations totaled $4.3 million.

A limitation of the study included assessing payment relatedness by comparing the presentation topic with the specialty of the companies in question, which “could have underestimated the number of unrelated payments and, consequently, the overall rate of disclosure,” they wrote.

As for their own disclosures, the authors noted that coauthors Dr. Mininder Kocher, Dr. Charles Mehlman, and Dr. Mohit Bhandari have received grants from or consulted for several medical device firms, including several of those mentioned in the study. No other conflicts of interest were reported.

Numerous speakers at medical meetings fail to disclose financial conflicts, despite explicit requirements for them to do so.

“Disclosures by physicians are largely self-reported, but there is reason to suspect that this may change in the near future,” Dr. Kanu Okike of Brigham and Women's Hospital and Massachusetts General Hospital and colleagues wrote. “Legislation requiring all drug and device manufacturers to publicly disclose payments to physicians is currently pending in the U.S. Congress and has been met with widespread support.”

They analyzed payments made to physicians in 2007 by five makers of total hip and knee prostheses that together account for nearly 95% of the market. Payment listings were found on each company's Web site and included a range of direct and indirect expenditures (N. Engl. J. Med. 2009;361:1466-74).

The authors compared the payments with conflict-of-interest disclosures made by physicians who either presented at or served as board or committee members at the 2008 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS).

A total of 1,347 payments were made to 1,162 physicians during 2007. Overall, 166 physicians received payments from multiple companies, and 282 payments exceeded $100,000. About a quarter of the payments (344) were made to presenters or board or committee members at the AAOS meeting.

In 70% of the 299 cases that could be evaluated for topic relatedness, the payment was directly related to the topic of the meeting presentation. Overall disclosure rate for the payments was 71%, including 79% for directly related payments, 50% for indirectly related payments, and 49% for unrelated payments.

The researchers also surveyed 91 physicians who did not disclose payments; 36 physicians responded to the survey. Reasons for nondisclosure included the payment being unrelated to the presentation topic (39%) and misunderstanding the disclosure requirements (14%). In addition, 11% of respondents said the payment had been disclosed but was inaccurately printed in the program.

The authors noted that the 43 nondisclosed payments relating directly to the presentations totaled $4.3 million.

A limitation of the study included assessing payment relatedness by comparing the presentation topic with the specialty of the companies in question, which “could have underestimated the number of unrelated payments and, consequently, the overall rate of disclosure,” they wrote.

As for their own disclosures, the authors noted that coauthors Dr. Mininder Kocher, Dr. Charles Mehlman, and Dr. Mohit Bhandari have received grants from or consulted for several medical device firms, including several of those mentioned in the study. No other conflicts of interest were reported.

Numerous speakers at medical meetings fail to disclose financial conflicts, despite explicit requirements for them to do so.

“Disclosures by physicians are largely self-reported, but there is reason to suspect that this may change in the near future,” Dr. Kanu Okike of Brigham and Women's Hospital and Massachusetts General Hospital and colleagues wrote. “Legislation requiring all drug and device manufacturers to publicly disclose payments to physicians is currently pending in the U.S. Congress and has been met with widespread support.”

They analyzed payments made to physicians in 2007 by five makers of total hip and knee prostheses that together account for nearly 95% of the market. Payment listings were found on each company's Web site and included a range of direct and indirect expenditures (N. Engl. J. Med. 2009;361:1466-74).

The authors compared the payments with conflict-of-interest disclosures made by physicians who either presented at or served as board or committee members at the 2008 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS).

A total of 1,347 payments were made to 1,162 physicians during 2007. Overall, 166 physicians received payments from multiple companies, and 282 payments exceeded $100,000. About a quarter of the payments (344) were made to presenters or board or committee members at the AAOS meeting.

In 70% of the 299 cases that could be evaluated for topic relatedness, the payment was directly related to the topic of the meeting presentation. Overall disclosure rate for the payments was 71%, including 79% for directly related payments, 50% for indirectly related payments, and 49% for unrelated payments.

The researchers also surveyed 91 physicians who did not disclose payments; 36 physicians responded to the survey. Reasons for nondisclosure included the payment being unrelated to the presentation topic (39%) and misunderstanding the disclosure requirements (14%). In addition, 11% of respondents said the payment had been disclosed but was inaccurately printed in the program.

The authors noted that the 43 nondisclosed payments relating directly to the presentations totaled $4.3 million.

A limitation of the study included assessing payment relatedness by comparing the presentation topic with the specialty of the companies in question, which “could have underestimated the number of unrelated payments and, consequently, the overall rate of disclosure,” they wrote.

As for their own disclosures, the authors noted that coauthors Dr. Mininder Kocher, Dr. Charles Mehlman, and Dr. Mohit Bhandari have received grants from or consulted for several medical device firms, including several of those mentioned in the study. No other conflicts of interest were reported.

WASHINGTON – Transitioning as smoothly as possible to the ICD-10 will require a little advanced planning.

Dr. Lee Hilborne, medical director of care coordination at the University of California, Los Angeles, said “the medical community has been very resistant and was fighting approval [of the ICD-10], but at this point they need to [set about] finding a solution” to anticipated problems, he said at a meeting sponsored by the American Health Information Management Association.

Physicians have challenged the adoption of the ICD-10 codes because of concerns about:

▸ Having to hire more certified coders, or recertify current coders.

▸ Needing new computer technology and new billing and collection systems.

▸ Having limited resources for staff training.

▸ Expecting lower reimbursement at first because coding accuracy and productivity will drop in the short term.

Some physicians subscribe to the theory that the new codes are simply “another strategy to pay physicians less,” Dr. Hilborne said.

The American Medical Association must be a key player in the transition because of its prominent role in the coding process, Dr. Hilborne continued. “The specialty societies will help with specifics,” such as codes that are peculiar to their individual specialties.

The American Psychiatric Association has said that when a new version of the ICD is implemented in the United States, the DSM version in use at that time will be modified to include the new ICD codes.

The deadline for implementing both the new ICD code and the DSM-5 is 2013.

The medical community has been resisting the approval of the ICD-10; now it needs to work to find a solution.

Source DR. HILBORNE

WASHINGTON – Transitioning as smoothly as possible to the ICD-10 will require a little advanced planning.

Dr. Lee Hilborne, medical director of care coordination at the University of California, Los Angeles, said “the medical community has been very resistant and was fighting approval [of the ICD-10], but at this point they need to [set about] finding a solution” to anticipated problems, he said at a meeting sponsored by the American Health Information Management Association.

Physicians have challenged the adoption of the ICD-10 codes because of concerns about:

▸ Having to hire more certified coders, or recertify current coders.

▸ Needing new computer technology and new billing and collection systems.

▸ Having limited resources for staff training.

▸ Expecting lower reimbursement at first because coding accuracy and productivity will drop in the short term.

Some physicians subscribe to the theory that the new codes are simply “another strategy to pay physicians less,” Dr. Hilborne said.

The American Medical Association must be a key player in the transition because of its prominent role in the coding process, Dr. Hilborne continued. “The specialty societies will help with specifics,” such as codes that are peculiar to their individual specialties.

The American Psychiatric Association has said that when a new version of the ICD is implemented in the United States, the DSM version in use at that time will be modified to include the new ICD codes.

The deadline for implementing both the new ICD code and the DSM-5 is 2013.

The medical community has been resisting the approval of the ICD-10; now it needs to work to find a solution.

Source DR. HILBORNE

WASHINGTON – Transitioning as smoothly as possible to the ICD-10 will require a little advanced planning.

Dr. Lee Hilborne, medical director of care coordination at the University of California, Los Angeles, said “the medical community has been very resistant and was fighting approval [of the ICD-10], but at this point they need to [set about] finding a solution” to anticipated problems, he said at a meeting sponsored by the American Health Information Management Association.

Physicians have challenged the adoption of the ICD-10 codes because of concerns about:

▸ Having to hire more certified coders, or recertify current coders.

▸ Needing new computer technology and new billing and collection systems.

▸ Having limited resources for staff training.

▸ Expecting lower reimbursement at first because coding accuracy and productivity will drop in the short term.

Some physicians subscribe to the theory that the new codes are simply “another strategy to pay physicians less,” Dr. Hilborne said.

The American Medical Association must be a key player in the transition because of its prominent role in the coding process, Dr. Hilborne continued. “The specialty societies will help with specifics,” such as codes that are peculiar to their individual specialties.

The American Psychiatric Association has said that when a new version of the ICD is implemented in the United States, the DSM version in use at that time will be modified to include the new ICD codes.

The deadline for implementing both the new ICD code and the DSM-5 is 2013.

The medical community has been resisting the approval of the ICD-10; now it needs to work to find a solution.

Source DR. HILBORNE

NATIONAL HARBOR, MD. — Medicare wants to save money and improve quality of care by reducing the number of patients readmitted to the hospital within 30 days after their initial stay, Dr. Michael Rapp said.

Readmission is a problem within Medicare, said Dr. Rapp, director of the Quality Measurement and Health Assessment Group at the Centers for Medicare and Medicaid Services (CMS). In a recent study, nearly 20% of Medicare fee-for-service patients discharged from the hospital were readmitted within 30 days; 34% were readmitted within 90 days (N. Engl. J. Med. 2009;360:1418–28). The authors estimated the cost to Medicare of those unplanned readmissions at $17.4 billion.

There is “quite a bit of variability” in the 30-day readmission rate, depending on the patient's diagnosis, Dr. Rapp said at the World Health Care Congress Leadership Summit on Hospital Readmissions. For example, 25% of heart failure patients were readmitted within 30 days, compared with 20% of acute myocardial infarction patients and 18% of pneumonia patients.

Part of the problem stems from continuity of care issues, he continued. One study looked at 366 patients discharged from the hospital with a follow-up primary care appointment scheduled within 2 months. The researchers found that 42% of those patients had a medication continuity error, 12% had a work-up error, and 8% had a test follow-up error (J. Gen. Intern. Med. 2003;18:646–51). Subjects with work-up errors were six times more likely to be readmitted than were other subjects, Dr. Rapp noted.

Unplanned rehospitalizations often signal a failure of transition from the hospital to another source of care. Because any hospital admission is a source of revenue for a hospital, reducing the readmission rate means lost revenue for the facility; therefore, other incentives for reducing readmissions need to be worked out, he said.

“One of the ways we've sought to [get hospitals engaged] is by publishing readmission rates,” Dr. Rapp said. “We published them for the first time on the Hospital Compare Web site last July. It got quite a bit of interest.”

Another way the CMS is trying to reduce readmissions is through the Care Transitions Intervention, a way of “coaching” patients during and after discharge. Under a pilot program, the CMS is paying 14 of Medicare's quality improvement organizations to implement this program in some locations. One QIO implementing the program with 130 patients achieved a 7.7% decrease in hospital readmissions, Dr. Rapp said. And 96% of patients said they had a good understanding of how to manage their health after the program was finished, compared with 63% at the start of the program.

Of the 14 communities involved in the pilot program, 9 have seen at least a 2% reduction in readmissions after instituting the program, he added.

Dr. Rapp said the CMS had learned several things from the project:

▸ Community meetings are a catalytic point in the process.

▸ Community recruitment and engagement can take longer than anticipated.

▸ Increased time and resources are required to engage outpatient physicians and specialists.

▸ Patients should be assigned a coach before discharge.

To improve the discharge procedure and reduce hospital readmissions, Dr. Rapp suggested several measures, including creating a collaborative forum that includes patients and families, exchanging quality data routinely, identifying the sickest patients and reviewing the way they get care, and implementing personal health records.

Disclosures: Dr. Rapp reported having no relevant conflicts.

'One of the ways we've sought to [get hospitals engaged] is by publishing readmission rates.'

Source DR. RAPP

NATIONAL HARBOR, MD. — Medicare wants to save money and improve quality of care by reducing the number of patients readmitted to the hospital within 30 days after their initial stay, Dr. Michael Rapp said.

Readmission is a problem within Medicare, said Dr. Rapp, director of the Quality Measurement and Health Assessment Group at the Centers for Medicare and Medicaid Services (CMS). In a recent study, nearly 20% of Medicare fee-for-service patients discharged from the hospital were readmitted within 30 days; 34% were readmitted within 90 days (N. Engl. J. Med. 2009;360:1418–28). The authors estimated the cost to Medicare of those unplanned readmissions at $17.4 billion.

There is “quite a bit of variability” in the 30-day readmission rate, depending on the patient's diagnosis, Dr. Rapp said at the World Health Care Congress Leadership Summit on Hospital Readmissions. For example, 25% of heart failure patients were readmitted within 30 days, compared with 20% of acute myocardial infarction patients and 18% of pneumonia patients.

Part of the problem stems from continuity of care issues, he continued. One study looked at 366 patients discharged from the hospital with a follow-up primary care appointment scheduled within 2 months. The researchers found that 42% of those patients had a medication continuity error, 12% had a work-up error, and 8% had a test follow-up error (J. Gen. Intern. Med. 2003;18:646–51). Subjects with work-up errors were six times more likely to be readmitted than were other subjects, Dr. Rapp noted.

Unplanned rehospitalizations often signal a failure of transition from the hospital to another source of care. Because any hospital admission is a source of revenue for a hospital, reducing the readmission rate means lost revenue for the facility; therefore, other incentives for reducing readmissions need to be worked out, he said.

“One of the ways we've sought to [get hospitals engaged] is by publishing readmission rates,” Dr. Rapp said. “We published them for the first time on the Hospital Compare Web site last July. It got quite a bit of interest.”

Another way the CMS is trying to reduce readmissions is through the Care Transitions Intervention, a way of “coaching” patients during and after discharge. Under a pilot program, the CMS is paying 14 of Medicare's quality improvement organizations to implement this program in some locations. One QIO implementing the program with 130 patients achieved a 7.7% decrease in hospital readmissions, Dr. Rapp said. And 96% of patients said they had a good understanding of how to manage their health after the program was finished, compared with 63% at the start of the program.

Of the 14 communities involved in the pilot program, 9 have seen at least a 2% reduction in readmissions after instituting the program, he added.

Dr. Rapp said the CMS had learned several things from the project:

▸ Community meetings are a catalytic point in the process.

▸ Community recruitment and engagement can take longer than anticipated.

▸ Increased time and resources are required to engage outpatient physicians and specialists.

▸ Patients should be assigned a coach before discharge.

To improve the discharge procedure and reduce hospital readmissions, Dr. Rapp suggested several measures, including creating a collaborative forum that includes patients and families, exchanging quality data routinely, identifying the sickest patients and reviewing the way they get care, and implementing personal health records.

Disclosures: Dr. Rapp reported having no relevant conflicts.

'One of the ways we've sought to [get hospitals engaged] is by publishing readmission rates.'

Source DR. RAPP

NATIONAL HARBOR, MD. — Medicare wants to save money and improve quality of care by reducing the number of patients readmitted to the hospital within 30 days after their initial stay, Dr. Michael Rapp said.

Readmission is a problem within Medicare, said Dr. Rapp, director of the Quality Measurement and Health Assessment Group at the Centers for Medicare and Medicaid Services (CMS). In a recent study, nearly 20% of Medicare fee-for-service patients discharged from the hospital were readmitted within 30 days; 34% were readmitted within 90 days (N. Engl. J. Med. 2009;360:1418–28). The authors estimated the cost to Medicare of those unplanned readmissions at $17.4 billion.

There is “quite a bit of variability” in the 30-day readmission rate, depending on the patient's diagnosis, Dr. Rapp said at the World Health Care Congress Leadership Summit on Hospital Readmissions. For example, 25% of heart failure patients were readmitted within 30 days, compared with 20% of acute myocardial infarction patients and 18% of pneumonia patients.

Part of the problem stems from continuity of care issues, he continued. One study looked at 366 patients discharged from the hospital with a follow-up primary care appointment scheduled within 2 months. The researchers found that 42% of those patients had a medication continuity error, 12% had a work-up error, and 8% had a test follow-up error (J. Gen. Intern. Med. 2003;18:646–51). Subjects with work-up errors were six times more likely to be readmitted than were other subjects, Dr. Rapp noted.

Unplanned rehospitalizations often signal a failure of transition from the hospital to another source of care. Because any hospital admission is a source of revenue for a hospital, reducing the readmission rate means lost revenue for the facility; therefore, other incentives for reducing readmissions need to be worked out, he said.

“One of the ways we've sought to [get hospitals engaged] is by publishing readmission rates,” Dr. Rapp said. “We published them for the first time on the Hospital Compare Web site last July. It got quite a bit of interest.”

Another way the CMS is trying to reduce readmissions is through the Care Transitions Intervention, a way of “coaching” patients during and after discharge. Under a pilot program, the CMS is paying 14 of Medicare's quality improvement organizations to implement this program in some locations. One QIO implementing the program with 130 patients achieved a 7.7% decrease in hospital readmissions, Dr. Rapp said. And 96% of patients said they had a good understanding of how to manage their health after the program was finished, compared with 63% at the start of the program.

Of the 14 communities involved in the pilot program, 9 have seen at least a 2% reduction in readmissions after instituting the program, he added.

Dr. Rapp said the CMS had learned several things from the project:

▸ Community meetings are a catalytic point in the process.

▸ Community recruitment and engagement can take longer than anticipated.

▸ Increased time and resources are required to engage outpatient physicians and specialists.

▸ Patients should be assigned a coach before discharge.

To improve the discharge procedure and reduce hospital readmissions, Dr. Rapp suggested several measures, including creating a collaborative forum that includes patients and families, exchanging quality data routinely, identifying the sickest patients and reviewing the way they get care, and implementing personal health records.

Disclosures: Dr. Rapp reported having no relevant conflicts.

'One of the ways we've sought to [get hospitals engaged] is by publishing readmission rates.'

Source DR. RAPP

NATIONAL HARBOR, MD. — The Society of Hospital Medicine wants to give hospitals a boost when it comes to discharge planning and preventing hospital readmissions.

“The field of hospital medicine has been characterized by some as the worst thing to ever happen to continuity of care,” Dr. Winthrop F. Whitcomb, cofounder and past president of the SHM, said at the World Health Care Congress Leadership Summit on Hospital Readmissions. “We really want to be part of the solution, not just part of the problem.”

To that end, in 2008 the society started Project BOOST (Better Outcomes for Older Adults Through Safe Transitions), a quality improvement initiative aimed at increasing coordination between inpatient and outpatient care and solving problems with the discharge process. “It's a team intervention to bring together hospitalists, other providers, and the hospital itself,” Dr. Whitcomb explained. (See

The project has been implemented in 30 sites nationwide in two phases, with 6 hospitals coming on board in the first phase and the remaining 24 joining in the second phase. Each phase began with a kickoff meeting for all of the new sites, with experts delivering lectures and eliciting discussion on best practices; each site then received a visit from a hospitalist mentor assigned to that particular facility. “The mentor has regular phone calls with the project team to review barriers and [talk about] how things might be done better,” said Dr. Whitcomb, an internist at Mercy Medical Center, Springfield, Mass.

In addition to the mentoring component, the project identifies a hospitalist on staff at each site who will be part of the team, he said. “We want to help hospitalists realize their potential as change agents.”

One of the project's goals is to reduce the rate of readmissions to the hospital, he continued, noting that a recent study found that one in five Medicare patients who were admitted to the hospital were rehospitalized within 30 days at a cost to Medicare of $17.4 billion. Half of the readmitted patients never saw their outpatient physician before they were readmitted.

The Project BOOST toolkit includes Web-based tools and a listserv. In addition to those resources, the medical literature gives several clues as to what methods work well for coordinating the transition from inpatient to outpatient, Dr. Whitcomb said. These include multidisciplinary rounds, assessing and enhancing patients' understanding of their condition and treatment, a proactive approach to assessing patients' problems, patient-friendly discharge information including a reconciled medication list, and good communication. “BOOST gets everybody talking to each other, which doesn't necessarily happen if you don't go out of your way to make that happen,” he said.

To make sure patients understand their discharge instructions, project teams use the “teach back” method, in which patients teach back to providers what the discharge instructions are. There is also a discharge form that patients must fill out, which explains the reason for their hospital stay and their discharge instructions, including what to do and who to call if certain medical problems arise.

The team also calls high-risk patients within 72 hours of discharge to assess how they're doing, and makes sure they have defined appointments with their primary care physicians. Figuring out which patients are at high risk of readmission can be tricky, so the program team uses the “7 Ps” test:

▸ Principal diagnosis.

▸ Problem medications.

▸ Polypharmacy.

▸ Poor health literacy.

▸ Patient support lacking in the community.

▸ Psychiatric issues.

▸ Prior hospitalizations.

The “7 Ps” are “a way for the site to prioritize which patients get more intensive application of the BOOST toolkit,” Dr. Whitcomb said.

Hospitals participating in the project thus far say that some parts of Project BOOST are easier to implement than others, said Dr. Luke O. Hansen, an analyst for the project. Among the parts they find easy: improving communication, standardizing discharge information, and tracking length of stay, readmission rates, and satisfaction with the program.

Some of the more difficult issues include bridging silos between different parts of the hospital, dealing with the required changes in workflow and culture, arranging expedited follow-up appointments, and finding resources to make follow-up phone calls. “There is no 'one-size-fits-all' approach” to the program, said Dr. Hansen, of Northwestern University, Chicago. “Each hospital is a unique climate that will facilitate change [for] some elements and create barriers around others.”

One difficulty that can crop up is getting nonmedicine specialists, such as surgeons, to go along with the program. “Physician extenders tend to help the surgeon a lot,” Dr. Whitcomb said. “If a surgeon is in [an] operating room all day, is that surgeon really going to come out and spend 45 minutes on a good discharge? That is much more likely to happen if the surgeon uses a physician extender.”

Another option for helping surgeons participate in the project is to “talk to a hospitalist about comanaging more of the nonmedicine cases—not just doing the discharge paperwork, but also [helping with medical issues such as] glycemic control and delirium prevention,” he continued.

Next steps for the project include collecting and analyzing data, incorporating lessons learned, and expanding the number of sites, Dr. Hansen said, noting that project analysts hope to have preliminary results on hospital readmissions by the end of 2010. The project is currently adding another 15 sites in Michigan in partnership with that state's Blue Cross Blue Shield carrier, he added.

Disclosures: Funding for Project BOOST is being provided in part by the John A. Hartford Foundation. Dr. Whitcomb and Dr. Hansen did not disclose any conflicts of interest related to their presentations.

NATIONAL HARBOR, MD. — The Society of Hospital Medicine wants to give hospitals a boost when it comes to discharge planning and preventing hospital readmissions.

“The field of hospital medicine has been characterized by some as the worst thing to ever happen to continuity of care,” Dr. Winthrop F. Whitcomb, cofounder and past president of the SHM, said at the World Health Care Congress Leadership Summit on Hospital Readmissions. “We really want to be part of the solution, not just part of the problem.”

To that end, in 2008 the society started Project BOOST (Better Outcomes for Older Adults Through Safe Transitions), a quality improvement initiative aimed at increasing coordination between inpatient and outpatient care and solving problems with the discharge process. “It's a team intervention to bring together hospitalists, other providers, and the hospital itself,” Dr. Whitcomb explained. (See

The project has been implemented in 30 sites nationwide in two phases, with 6 hospitals coming on board in the first phase and the remaining 24 joining in the second phase. Each phase began with a kickoff meeting for all of the new sites, with experts delivering lectures and eliciting discussion on best practices; each site then received a visit from a hospitalist mentor assigned to that particular facility. “The mentor has regular phone calls with the project team to review barriers and [talk about] how things might be done better,” said Dr. Whitcomb, an internist at Mercy Medical Center, Springfield, Mass.

In addition to the mentoring component, the project identifies a hospitalist on staff at each site who will be part of the team, he said. “We want to help hospitalists realize their potential as change agents.”

One of the project's goals is to reduce the rate of readmissions to the hospital, he continued, noting that a recent study found that one in five Medicare patients who were admitted to the hospital were rehospitalized within 30 days at a cost to Medicare of $17.4 billion. Half of the readmitted patients never saw their outpatient physician before they were readmitted.

The Project BOOST toolkit includes Web-based tools and a listserv. In addition to those resources, the medical literature gives several clues as to what methods work well for coordinating the transition from inpatient to outpatient, Dr. Whitcomb said. These include multidisciplinary rounds, assessing and enhancing patients' understanding of their condition and treatment, a proactive approach to assessing patients' problems, patient-friendly discharge information including a reconciled medication list, and good communication. “BOOST gets everybody talking to each other, which doesn't necessarily happen if you don't go out of your way to make that happen,” he said.

To make sure patients understand their discharge instructions, project teams use the “teach back” method, in which patients teach back to providers what the discharge instructions are. There is also a discharge form that patients must fill out, which explains the reason for their hospital stay and their discharge instructions, including what to do and who to call if certain medical problems arise.

The team also calls high-risk patients within 72 hours of discharge to assess how they're doing, and makes sure they have defined appointments with their primary care physicians. Figuring out which patients are at high risk of readmission can be tricky, so the program team uses the “7 Ps” test:

▸ Principal diagnosis.

▸ Problem medications.

▸ Polypharmacy.

▸ Poor health literacy.

▸ Patient support lacking in the community.

▸ Psychiatric issues.

▸ Prior hospitalizations.

The “7 Ps” are “a way for the site to prioritize which patients get more intensive application of the BOOST toolkit,” Dr. Whitcomb said.

Hospitals participating in the project thus far say that some parts of Project BOOST are easier to implement than others, said Dr. Luke O. Hansen, an analyst for the project. Among the parts they find easy: improving communication, standardizing discharge information, and tracking length of stay, readmission rates, and satisfaction with the program.

Some of the more difficult issues include bridging silos between different parts of the hospital, dealing with the required changes in workflow and culture, arranging expedited follow-up appointments, and finding resources to make follow-up phone calls. “There is no 'one-size-fits-all' approach” to the program, said Dr. Hansen, of Northwestern University, Chicago. “Each hospital is a unique climate that will facilitate change [for] some elements and create barriers around others.”

One difficulty that can crop up is getting nonmedicine specialists, such as surgeons, to go along with the program. “Physician extenders tend to help the surgeon a lot,” Dr. Whitcomb said. “If a surgeon is in [an] operating room all day, is that surgeon really going to come out and spend 45 minutes on a good discharge? That is much more likely to happen if the surgeon uses a physician extender.”

Another option for helping surgeons participate in the project is to “talk to a hospitalist about comanaging more of the nonmedicine cases—not just doing the discharge paperwork, but also [helping with medical issues such as] glycemic control and delirium prevention,” he continued.

Next steps for the project include collecting and analyzing data, incorporating lessons learned, and expanding the number of sites, Dr. Hansen said, noting that project analysts hope to have preliminary results on hospital readmissions by the end of 2010. The project is currently adding another 15 sites in Michigan in partnership with that state's Blue Cross Blue Shield carrier, he added.

Disclosures: Funding for Project BOOST is being provided in part by the John A. Hartford Foundation. Dr. Whitcomb and Dr. Hansen did not disclose any conflicts of interest related to their presentations.

NATIONAL HARBOR, MD. — The Society of Hospital Medicine wants to give hospitals a boost when it comes to discharge planning and preventing hospital readmissions.

“The field of hospital medicine has been characterized by some as the worst thing to ever happen to continuity of care,” Dr. Winthrop F. Whitcomb, cofounder and past president of the SHM, said at the World Health Care Congress Leadership Summit on Hospital Readmissions. “We really want to be part of the solution, not just part of the problem.”

To that end, in 2008 the society started Project BOOST (Better Outcomes for Older Adults Through Safe Transitions), a quality improvement initiative aimed at increasing coordination between inpatient and outpatient care and solving problems with the discharge process. “It's a team intervention to bring together hospitalists, other providers, and the hospital itself,” Dr. Whitcomb explained. (See

The project has been implemented in 30 sites nationwide in two phases, with 6 hospitals coming on board in the first phase and the remaining 24 joining in the second phase. Each phase began with a kickoff meeting for all of the new sites, with experts delivering lectures and eliciting discussion on best practices; each site then received a visit from a hospitalist mentor assigned to that particular facility. “The mentor has regular phone calls with the project team to review barriers and [talk about] how things might be done better,” said Dr. Whitcomb, an internist at Mercy Medical Center, Springfield, Mass.

In addition to the mentoring component, the project identifies a hospitalist on staff at each site who will be part of the team, he said. “We want to help hospitalists realize their potential as change agents.”

One of the project's goals is to reduce the rate of readmissions to the hospital, he continued, noting that a recent study found that one in five Medicare patients who were admitted to the hospital were rehospitalized within 30 days at a cost to Medicare of $17.4 billion. Half of the readmitted patients never saw their outpatient physician before they were readmitted.

The Project BOOST toolkit includes Web-based tools and a listserv. In addition to those resources, the medical literature gives several clues as to what methods work well for coordinating the transition from inpatient to outpatient, Dr. Whitcomb said. These include multidisciplinary rounds, assessing and enhancing patients' understanding of their condition and treatment, a proactive approach to assessing patients' problems, patient-friendly discharge information including a reconciled medication list, and good communication. “BOOST gets everybody talking to each other, which doesn't necessarily happen if you don't go out of your way to make that happen,” he said.

To make sure patients understand their discharge instructions, project teams use the “teach back” method, in which patients teach back to providers what the discharge instructions are. There is also a discharge form that patients must fill out, which explains the reason for their hospital stay and their discharge instructions, including what to do and who to call if certain medical problems arise.

The team also calls high-risk patients within 72 hours of discharge to assess how they're doing, and makes sure they have defined appointments with their primary care physicians. Figuring out which patients are at high risk of readmission can be tricky, so the program team uses the “7 Ps” test:

▸ Principal diagnosis.

▸ Problem medications.

▸ Polypharmacy.

▸ Poor health literacy.

▸ Patient support lacking in the community.

▸ Psychiatric issues.

▸ Prior hospitalizations.

The “7 Ps” are “a way for the site to prioritize which patients get more intensive application of the BOOST toolkit,” Dr. Whitcomb said.

Hospitals participating in the project thus far say that some parts of Project BOOST are easier to implement than others, said Dr. Luke O. Hansen, an analyst for the project. Among the parts they find easy: improving communication, standardizing discharge information, and tracking length of stay, readmission rates, and satisfaction with the program.

Some of the more difficult issues include bridging silos between different parts of the hospital, dealing with the required changes in workflow and culture, arranging expedited follow-up appointments, and finding resources to make follow-up phone calls. “There is no 'one-size-fits-all' approach” to the program, said Dr. Hansen, of Northwestern University, Chicago. “Each hospital is a unique climate that will facilitate change [for] some elements and create barriers around others.”

One difficulty that can crop up is getting nonmedicine specialists, such as surgeons, to go along with the program. “Physician extenders tend to help the surgeon a lot,” Dr. Whitcomb said. “If a surgeon is in [an] operating room all day, is that surgeon really going to come out and spend 45 minutes on a good discharge? That is much more likely to happen if the surgeon uses a physician extender.”

Another option for helping surgeons participate in the project is to “talk to a hospitalist about comanaging more of the nonmedicine cases—not just doing the discharge paperwork, but also [helping with medical issues such as] glycemic control and delirium prevention,” he continued.

Next steps for the project include collecting and analyzing data, incorporating lessons learned, and expanding the number of sites, Dr. Hansen said, noting that project analysts hope to have preliminary results on hospital readmissions by the end of 2010. The project is currently adding another 15 sites in Michigan in partnership with that state's Blue Cross Blue Shield carrier, he added.

Disclosures: Funding for Project BOOST is being provided in part by the John A. Hartford Foundation. Dr. Whitcomb and Dr. Hansen did not disclose any conflicts of interest related to their presentations.

Physicians in Montana may legally assist terminally ill patients in hastening death, according to a ruling by the Montana Supreme Court.

The decision in the case of Baxter v. State of Montana concerned Robert Baxter, a retired truck driver from Billings, Mont., who was terminally ill with lymphocytic leukemia with diffuse lymphadenopathy. As a result of the disease and its treatment, Mr. Baxter suffered from symptoms including “infections, chronic fatigue and weakness, anemia, night sweats, nausea, massively swollen glands, significant ongoing digestive problems, and generalized pain and discomfort,” according to the decision.

The court said further, “The symptoms were expected to increase in frequency and intensity as the chemotherapy lost its effectiveness. There was no cure for Mr. Baxter's disease and no prospect of recovery. Mr. Baxter wanted the option of ingesting a lethal dose of medication prescribed by his physician and self-administered at the time of Mr. Baxter's own choosing.”

Mr. Baxter, along with four physicians and Compassion & Choices, a group that advocates for aid in dying, filed suit in Montana's district court for the first judicial district, challenging the constitutionality of Montana homicide statutes being applied to physicians who provide aid in dying to mentally competent, terminally ill patients. Mr. Baxter's attorneys contended that the right to die with dignity was constitutional under Montana law.

The district court ruled in favor of Mr. Baxter, but the state appealed the ruling to the Montana Supreme Court. On Dec. 31, 2009, that court also ruled in favor of Mr. Baxter, by a vote of 5-2, although it declined to comment on whether aid in dying complied with the Montana constitution. Mr. Baxter had died in December 2008.

“This court is guided by the judicial principle that we should decline to rule on the constitutionality of a legislative act if we are able to decide the case without reaching constitutional questions,” Justice W. William Leaphart wrote. “We find nothing in Montana Supreme Court precedent or Montana statutes indicating that physician aid in dying is against public policy. … Furthermore, the Montana Rights of the Terminally Ill Act indicates legislative respect for a patient's autonomous right to decide if and how he will receive medical treatment at the end of his life. … We therefore hold that under [Montana law], a terminally ill patient's consent to physician aid in dying constitutes a statutory defense to a charge of homicide against the aiding physician when no other consent exceptions apply.”

Justice James Rice, one of the two dissenting judges, argued that under current Montana law, a physician can be prosecuted for helping a patient commit suicide—if the patient survives, the crime falls under the category of aiding suicide; if the patient dies, the crime is regarded as a homicide.

“It is also very clear that a patient's consent to the physician's efforts is of no consequence whatsoever under these statutes,” he wrote. “In my view, the Court's conclusion is without support, without clear reason, and without moral force.”

In the wake of the court ruling—which cannot be appealed—opinions vary as to whether more Montana physicians will now provide aid in dying to terminally ill patients. Chicago health care attorney Miles J. Zaremski, who wrote a “friend of the court” brief in support of Mr. Baxter in the Montana case, said that even though the decision came out in their favor of the plaintiff, physicians in Montana will be reluctant to aid terminally ill patients in dying until legal protocols for the procedure have been established.

“In Montana, if the patient gives the doctor consent to provide aid in dying, the physician can escape homicide laws,” said Mr. Zaremski, who is also a former president of the American College of Legal Medicine. “Well, how was that consent given? Were there witnesses to it? Did you wait 10 days? I think you need protocols and standards in place.”

Oregon and Washington, the only states with aid-in-dying statutes, have protocols written into their laws, he noted.

Kathryn Tucker, legal director of Compassion & Choices, noted that another aid-in-dying case with which her group is involved is being litigated in Connecticut. Ms. Tucker disagreed with the idea that Montana physicians would not immediately feel freer to provide aid in dying to terminally ill patients in the wake of the state supreme court decision.

“Montana physicians can feel safe that in providing aid in dying they don't run risk of criminal prosecution,” she said. “We know aid in dying happens in every state, even where the legality is unclear. In Montana, this [decision] brings clarity to this issue.”

Ms. Tucker added that most medical care “is not governed by statute; it's governed by the standard of care and best practices. So most physicians will approach aid in dying in Montana as something regulated by the standard of care. I think what's going to happen with Montana [is that this case] will move aid in dying into normal medical practice that's governed by the standard of care and we'll get away from the notion that there needs to be elaborate statutes.”

As to whether other states will adopt aid-in-dying statutes, Mr. Zaremski made the analogy that “gay marriage and rights for gay couples was an unknown and foreign concept, and now it's inching forward bit by bit, so maybe someday aid in dying will be the norm and not the exception.”

Physicians in Montana may legally assist terminally ill patients in hastening death, according to a ruling by the Montana Supreme Court.

The decision in the case of Baxter v. State of Montana concerned Robert Baxter, a retired truck driver from Billings, Mont., who was terminally ill with lymphocytic leukemia with diffuse lymphadenopathy. As a result of the disease and its treatment, Mr. Baxter suffered from symptoms including “infections, chronic fatigue and weakness, anemia, night sweats, nausea, massively swollen glands, significant ongoing digestive problems, and generalized pain and discomfort,” according to the decision.

The court said further, “The symptoms were expected to increase in frequency and intensity as the chemotherapy lost its effectiveness. There was no cure for Mr. Baxter's disease and no prospect of recovery. Mr. Baxter wanted the option of ingesting a lethal dose of medication prescribed by his physician and self-administered at the time of Mr. Baxter's own choosing.”

Mr. Baxter, along with four physicians and Compassion & Choices, a group that advocates for aid in dying, filed suit in Montana's district court for the first judicial district, challenging the constitutionality of Montana homicide statutes being applied to physicians who provide aid in dying to mentally competent, terminally ill patients. Mr. Baxter's attorneys contended that the right to die with dignity was constitutional under Montana law.

The district court ruled in favor of Mr. Baxter, but the state appealed the ruling to the Montana Supreme Court. On Dec. 31, 2009, that court also ruled in favor of Mr. Baxter, by a vote of 5-2, although it declined to comment on whether aid in dying complied with the Montana constitution. Mr. Baxter had died in December 2008.

“This court is guided by the judicial principle that we should decline to rule on the constitutionality of a legislative act if we are able to decide the case without reaching constitutional questions,” Justice W. William Leaphart wrote. “We find nothing in Montana Supreme Court precedent or Montana statutes indicating that physician aid in dying is against public policy. … Furthermore, the Montana Rights of the Terminally Ill Act indicates legislative respect for a patient's autonomous right to decide if and how he will receive medical treatment at the end of his life. … We therefore hold that under [Montana law], a terminally ill patient's consent to physician aid in dying constitutes a statutory defense to a charge of homicide against the aiding physician when no other consent exceptions apply.”

Justice James Rice, one of the two dissenting judges, argued that under current Montana law, a physician can be prosecuted for helping a patient commit suicide—if the patient survives, the crime falls under the category of aiding suicide; if the patient dies, the crime is regarded as a homicide.

“It is also very clear that a patient's consent to the physician's efforts is of no consequence whatsoever under these statutes,” he wrote. “In my view, the Court's conclusion is without support, without clear reason, and without moral force.”

In the wake of the court ruling—which cannot be appealed—opinions vary as to whether more Montana physicians will now provide aid in dying to terminally ill patients. Chicago health care attorney Miles J. Zaremski, who wrote a “friend of the court” brief in support of Mr. Baxter in the Montana case, said that even though the decision came out in their favor of the plaintiff, physicians in Montana will be reluctant to aid terminally ill patients in dying until legal protocols for the procedure have been established.

“In Montana, if the patient gives the doctor consent to provide aid in dying, the physician can escape homicide laws,” said Mr. Zaremski, who is also a former president of the American College of Legal Medicine. “Well, how was that consent given? Were there witnesses to it? Did you wait 10 days? I think you need protocols and standards in place.”

Oregon and Washington, the only states with aid-in-dying statutes, have protocols written into their laws, he noted.

Kathryn Tucker, legal director of Compassion & Choices, noted that another aid-in-dying case with which her group is involved is being litigated in Connecticut. Ms. Tucker disagreed with the idea that Montana physicians would not immediately feel freer to provide aid in dying to terminally ill patients in the wake of the state supreme court decision.

“Montana physicians can feel safe that in providing aid in dying they don't run risk of criminal prosecution,” she said. “We know aid in dying happens in every state, even where the legality is unclear. In Montana, this [decision] brings clarity to this issue.”

Ms. Tucker added that most medical care “is not governed by statute; it's governed by the standard of care and best practices. So most physicians will approach aid in dying in Montana as something regulated by the standard of care. I think what's going to happen with Montana [is that this case] will move aid in dying into normal medical practice that's governed by the standard of care and we'll get away from the notion that there needs to be elaborate statutes.”

As to whether other states will adopt aid-in-dying statutes, Mr. Zaremski made the analogy that “gay marriage and rights for gay couples was an unknown and foreign concept, and now it's inching forward bit by bit, so maybe someday aid in dying will be the norm and not the exception.”

Physicians in Montana may legally assist terminally ill patients in hastening death, according to a ruling by the Montana Supreme Court.

The decision in the case of Baxter v. State of Montana concerned Robert Baxter, a retired truck driver from Billings, Mont., who was terminally ill with lymphocytic leukemia with diffuse lymphadenopathy. As a result of the disease and its treatment, Mr. Baxter suffered from symptoms including “infections, chronic fatigue and weakness, anemia, night sweats, nausea, massively swollen glands, significant ongoing digestive problems, and generalized pain and discomfort,” according to the decision.

The court said further, “The symptoms were expected to increase in frequency and intensity as the chemotherapy lost its effectiveness. There was no cure for Mr. Baxter's disease and no prospect of recovery. Mr. Baxter wanted the option of ingesting a lethal dose of medication prescribed by his physician and self-administered at the time of Mr. Baxter's own choosing.”

Mr. Baxter, along with four physicians and Compassion & Choices, a group that advocates for aid in dying, filed suit in Montana's district court for the first judicial district, challenging the constitutionality of Montana homicide statutes being applied to physicians who provide aid in dying to mentally competent, terminally ill patients. Mr. Baxter's attorneys contended that the right to die with dignity was constitutional under Montana law.

The district court ruled in favor of Mr. Baxter, but the state appealed the ruling to the Montana Supreme Court. On Dec. 31, 2009, that court also ruled in favor of Mr. Baxter, by a vote of 5-2, although it declined to comment on whether aid in dying complied with the Montana constitution. Mr. Baxter had died in December 2008.

“This court is guided by the judicial principle that we should decline to rule on the constitutionality of a legislative act if we are able to decide the case without reaching constitutional questions,” Justice W. William Leaphart wrote. “We find nothing in Montana Supreme Court precedent or Montana statutes indicating that physician aid in dying is against public policy. … Furthermore, the Montana Rights of the Terminally Ill Act indicates legislative respect for a patient's autonomous right to decide if and how he will receive medical treatment at the end of his life. … We therefore hold that under [Montana law], a terminally ill patient's consent to physician aid in dying constitutes a statutory defense to a charge of homicide against the aiding physician when no other consent exceptions apply.”

Justice James Rice, one of the two dissenting judges, argued that under current Montana law, a physician can be prosecuted for helping a patient commit suicide—if the patient survives, the crime falls under the category of aiding suicide; if the patient dies, the crime is regarded as a homicide.

“It is also very clear that a patient's consent to the physician's efforts is of no consequence whatsoever under these statutes,” he wrote. “In my view, the Court's conclusion is without support, without clear reason, and without moral force.”

In the wake of the court ruling—which cannot be appealed—opinions vary as to whether more Montana physicians will now provide aid in dying to terminally ill patients. Chicago health care attorney Miles J. Zaremski, who wrote a “friend of the court” brief in support of Mr. Baxter in the Montana case, said that even though the decision came out in their favor of the plaintiff, physicians in Montana will be reluctant to aid terminally ill patients in dying until legal protocols for the procedure have been established.

“In Montana, if the patient gives the doctor consent to provide aid in dying, the physician can escape homicide laws,” said Mr. Zaremski, who is also a former president of the American College of Legal Medicine. “Well, how was that consent given? Were there witnesses to it? Did you wait 10 days? I think you need protocols and standards in place.”

Oregon and Washington, the only states with aid-in-dying statutes, have protocols written into their laws, he noted.

Kathryn Tucker, legal director of Compassion & Choices, noted that another aid-in-dying case with which her group is involved is being litigated in Connecticut. Ms. Tucker disagreed with the idea that Montana physicians would not immediately feel freer to provide aid in dying to terminally ill patients in the wake of the state supreme court decision.

“Montana physicians can feel safe that in providing aid in dying they don't run risk of criminal prosecution,” she said. “We know aid in dying happens in every state, even where the legality is unclear. In Montana, this [decision] brings clarity to this issue.”

Ms. Tucker added that most medical care “is not governed by statute; it's governed by the standard of care and best practices. So most physicians will approach aid in dying in Montana as something regulated by the standard of care. I think what's going to happen with Montana [is that this case] will move aid in dying into normal medical practice that's governed by the standard of care and we'll get away from the notion that there needs to be elaborate statutes.”

As to whether other states will adopt aid-in-dying statutes, Mr. Zaremski made the analogy that “gay marriage and rights for gay couples was an unknown and foreign concept, and now it's inching forward bit by bit, so maybe someday aid in dying will be the norm and not the exception.”

Dr. Howard Steinman knows how to deal with unhappy patients: Have a blast.

"BLAST" is the acronym that Dr. Steinman, director of dermatologic and skin cancer surgery at Texas A&M College of Medicine in College Station, uses to outline steps dermatologists can take when dealing with an upset patient.

He outlined the BLAST method at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation:

- Believe. Believing is the "cornerstone" of the process, according to Dr. Steinman. "Express belief, even if the patient is exaggerating, lying, emotional or irrational, or incorrect," he said. "The patient believes you have harmed or wronged them; belittle or trivialize their belief at your peril."

- Listen. Stop the mind and mouth and listen to what the patient is saying - let them vent, said Dr. Steinman, who is also an associate professor of medicine at Texas A&M. Give them a "magic minute" to get out all their grievances. "Do not mentally react and start preparing your rebuttal," he added. "Pause, relax, clear your head, and stay calm." That means not getting upset with patients who are rude or angry, or who swear, threaten, or repeat their complaints more than once.

After the patient has finished talking, restate the patient's concerns in a relaxed tone: "What I hear you saying is that you expected all of the lines and redness to be gone by now." The statement may need to be rephrased or repeated or until the patient is satisfied, Dr. Steinman said. Phrasing the statement in terms of an expectation is helpful, especially if the patient's expectation is not appropriate or accurate. He added that although physicians should listen and clarify, they should never try to defend or justify. "The patient doesn't care," Dr. Steinman said. "They want solutions, not excuses."

- Apologize. Making an apology does not mean acceptance of legal responsibility, he noted. Instead, just apologize for what the patient is experiencing and for their unmet expectations. "Apologize even if you did nothing wrong," said Dr. Steinman. "The patient feels they have a legitimate complaint and expects an apology. A sincere apology will diffuse much of the patient's fear, frustration, and anger." Examples of apologies might include, "I'm sorry the Botox treatment caused your eyelid to droop," or "I'm sorry the laser treatment did not remove all of your brown spots, but sometimes several treatments are required."

One patient of Dr. Steinman's experienced significant crusting and prolonged erythema after a filler injection to the glabella. "At my initial session when she noted the complication, I apologized and reassured her I would make every effort to make it right for her," he said in an interview. "Her upset abated at that point; she eventually completely healed, and all follow-up visits went smoothly."

- Satisfy. This means solving the patient's concerns. Explain their options, the time frame for improvement, and whether the problem can be completely solved, Dr. Steinman said. Be sure to make yourself available to the patient in the form of more visits or phone calls.

- Thank. Wrap up by thanking the patient for the second chance; for giving you the information that something occurred that upset them; for staying in your practice; and for not damaging your reputation.

As for whether to discharge unhappy patients, Dr. Steinman said he would consider doing so only after several calls or office visits attempting to solve the problem did not work, or if the patient was "persistently abusive to my staff; persistently unhappy about perceived deficiencies in how they were treated by myself or my staff; were upset over fees and the issue could not be resolved; or if they had acceptable results and were still not satisfied, and I couldn't find a way to satisfy their concerns." He added that he "would not discharge a patient if they had experienced a serious side effect or complication from a procedure, even if they were abusive or unhappy. But I might not agree to perform any new cosmetic services."

"When dealing with upset patients, we often become anxious, defensive, or angry. BLAST is very effective for defusing, redirecting, and correcting these situations, whether they are related to the family, the social arena, or business. It also gives the doctor a mental framework that will give him greater confidence and less anxiety when having to deal with an unhappy patient. Rather than wanting to avoid a confrontation, I simply say to myself, 'This is going to be a BLAST as I enter the room," he concluded.

Dr. Steinman had no relevant conflicts of interest. SDEF and this news organization are owned by Elsevier.

Dr. Howard Steinman knows how to deal with unhappy patients: Have a blast.

"BLAST" is the acronym that Dr. Steinman, director of dermatologic and skin cancer surgery at Texas A&M College of Medicine in College Station, uses to outline steps dermatologists can take when dealing with an upset patient.

He outlined the BLAST method at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation:

- Believe. Believing is the "cornerstone" of the process, according to Dr. Steinman. "Express belief, even if the patient is exaggerating, lying, emotional or irrational, or incorrect," he said. "The patient believes you have harmed or wronged them; belittle or trivialize their belief at your peril."

- Listen. Stop the mind and mouth and listen to what the patient is saying - let them vent, said Dr. Steinman, who is also an associate professor of medicine at Texas A&M. Give them a "magic minute" to get out all their grievances. "Do not mentally react and start preparing your rebuttal," he added. "Pause, relax, clear your head, and stay calm." That means not getting upset with patients who are rude or angry, or who swear, threaten, or repeat their complaints more than once.

After the patient has finished talking, restate the patient's concerns in a relaxed tone: "What I hear you saying is that you expected all of the lines and redness to be gone by now." The statement may need to be rephrased or repeated or until the patient is satisfied, Dr. Steinman said. Phrasing the statement in terms of an expectation is helpful, especially if the patient's expectation is not appropriate or accurate. He added that although physicians should listen and clarify, they should never try to defend or justify. "The patient doesn't care," Dr. Steinman said. "They want solutions, not excuses."

- Apologize. Making an apology does not mean acceptance of legal responsibility, he noted. Instead, just apologize for what the patient is experiencing and for their unmet expectations. "Apologize even if you did nothing wrong," said Dr. Steinman. "The patient feels they have a legitimate complaint and expects an apology. A sincere apology will diffuse much of the patient's fear, frustration, and anger." Examples of apologies might include, "I'm sorry the Botox treatment caused your eyelid to droop," or "I'm sorry the laser treatment did not remove all of your brown spots, but sometimes several treatments are required."

One patient of Dr. Steinman's experienced significant crusting and prolonged erythema after a filler injection to the glabella. "At my initial session when she noted the complication, I apologized and reassured her I would make every effort to make it right for her," he said in an interview. "Her upset abated at that point; she eventually completely healed, and all follow-up visits went smoothly."

- Satisfy. This means solving the patient's concerns. Explain their options, the time frame for improvement, and whether the problem can be completely solved, Dr. Steinman said. Be sure to make yourself available to the patient in the form of more visits or phone calls.

- Thank. Wrap up by thanking the patient for the second chance; for giving you the information that something occurred that upset them; for staying in your practice; and for not damaging your reputation.

As for whether to discharge unhappy patients, Dr. Steinman said he would consider doing so only after several calls or office visits attempting to solve the problem did not work, or if the patient was "persistently abusive to my staff; persistently unhappy about perceived deficiencies in how they were treated by myself or my staff; were upset over fees and the issue could not be resolved; or if they had acceptable results and were still not satisfied, and I couldn't find a way to satisfy their concerns." He added that he "would not discharge a patient if they had experienced a serious side effect or complication from a procedure, even if they were abusive or unhappy. But I might not agree to perform any new cosmetic services."

"When dealing with upset patients, we often become anxious, defensive, or angry. BLAST is very effective for defusing, redirecting, and correcting these situations, whether they are related to the family, the social arena, or business. It also gives the doctor a mental framework that will give him greater confidence and less anxiety when having to deal with an unhappy patient. Rather than wanting to avoid a confrontation, I simply say to myself, 'This is going to be a BLAST as I enter the room," he concluded.

Dr. Steinman had no relevant conflicts of interest. SDEF and this news organization are owned by Elsevier.

Dr. Howard Steinman knows how to deal with unhappy patients: Have a blast.

"BLAST" is the acronym that Dr. Steinman, director of dermatologic and skin cancer surgery at Texas A&M College of Medicine in College Station, uses to outline steps dermatologists can take when dealing with an upset patient.

He outlined the BLAST method at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation:

- Believe. Believing is the "cornerstone" of the process, according to Dr. Steinman. "Express belief, even if the patient is exaggerating, lying, emotional or irrational, or incorrect," he said. "The patient believes you have harmed or wronged them; belittle or trivialize their belief at your peril."

- Listen. Stop the mind and mouth and listen to what the patient is saying - let them vent, said Dr. Steinman, who is also an associate professor of medicine at Texas A&M. Give them a "magic minute" to get out all their grievances. "Do not mentally react and start preparing your rebuttal," he added. "Pause, relax, clear your head, and stay calm." That means not getting upset with patients who are rude or angry, or who swear, threaten, or repeat their complaints more than once.

After the patient has finished talking, restate the patient's concerns in a relaxed tone: "What I hear you saying is that you expected all of the lines and redness to be gone by now." The statement may need to be rephrased or repeated or until the patient is satisfied, Dr. Steinman said. Phrasing the statement in terms of an expectation is helpful, especially if the patient's expectation is not appropriate or accurate. He added that although physicians should listen and clarify, they should never try to defend or justify. "The patient doesn't care," Dr. Steinman said. "They want solutions, not excuses."

- Apologize. Making an apology does not mean acceptance of legal responsibility, he noted. Instead, just apologize for what the patient is experiencing and for their unmet expectations. "Apologize even if you did nothing wrong," said Dr. Steinman. "The patient feels they have a legitimate complaint and expects an apology. A sincere apology will diffuse much of the patient's fear, frustration, and anger." Examples of apologies might include, "I'm sorry the Botox treatment caused your eyelid to droop," or "I'm sorry the laser treatment did not remove all of your brown spots, but sometimes several treatments are required."

One patient of Dr. Steinman's experienced significant crusting and prolonged erythema after a filler injection to the glabella. "At my initial session when she noted the complication, I apologized and reassured her I would make every effort to make it right for her," he said in an interview. "Her upset abated at that point; she eventually completely healed, and all follow-up visits went smoothly."

- Satisfy. This means solving the patient's concerns. Explain their options, the time frame for improvement, and whether the problem can be completely solved, Dr. Steinman said. Be sure to make yourself available to the patient in the form of more visits or phone calls.

- Thank. Wrap up by thanking the patient for the second chance; for giving you the information that something occurred that upset them; for staying in your practice; and for not damaging your reputation.

As for whether to discharge unhappy patients, Dr. Steinman said he would consider doing so only after several calls or office visits attempting to solve the problem did not work, or if the patient was "persistently abusive to my staff; persistently unhappy about perceived deficiencies in how they were treated by myself or my staff; were upset over fees and the issue could not be resolved; or if they had acceptable results and were still not satisfied, and I couldn't find a way to satisfy their concerns." He added that he "would not discharge a patient if they had experienced a serious side effect or complication from a procedure, even if they were abusive or unhappy. But I might not agree to perform any new cosmetic services."

"When dealing with upset patients, we often become anxious, defensive, or angry. BLAST is very effective for defusing, redirecting, and correcting these situations, whether they are related to the family, the social arena, or business. It also gives the doctor a mental framework that will give him greater confidence and less anxiety when having to deal with an unhappy patient. Rather than wanting to avoid a confrontation, I simply say to myself, 'This is going to be a BLAST as I enter the room," he concluded.

Dr. Steinman had no relevant conflicts of interest. SDEF and this news organization are owned by Elsevier.

Physicians in Montana may legally assist terminally ill patients in hastening death, according to a ruling by the Montana Supreme Court.

The decision in the case of Baxter v. State of Montana concerned Robert Baxter, a retired truck driver from Billings, Mont., who was terminally ill with lymphocytic leukemia with diffuse lymphadenopathy. As a result of the disease and its treatment, Mr. Baxter suffered from symptoms including “infections, chronic fatigue and weakness, anemia, night sweats, nausea, massively swollen glands, significant ongoing digestive problems, and generalized pain and discomfort,” according to the decision.

The court said further, “The symptoms were expected to increase in frequency and intensity as the chemotherapy lost its effectiveness. There was no cure for Mr. Baxter's disease and no prospect of recovery. Mr. Baxter wanted the option of ingesting a lethal dose of medication prescribed by his physician and self-administered at the time of Mr. Baxter's own choosing.”

Mr. Baxter, along with four physicians and Compassion & Choices, a pro-aid-in-dying group, filed suit in Montana's district court for the first judicial district, challenging the constitutionality of Montana homicide statutes being applied to physicians who provide aid in dying to mentally competent, terminally ill patients. Mr. Baxter's attorneys contended that the right to die with dignity was constitutional under Montana law.

The district court ruled in favor of Mr. Baxter, but the state appealed the ruling to the Montana Supreme Court. On Dec. 31, 2009, that court also ruled in favor of Mr. Baxter, by a vote of 5-2, although it declined to comment on whether aid in dying complied with the Montana constitution. Mr. Baxter had died in December 2008.

“This court is guided by the judicial principle that we should decline to rule on the constitutionality of a legislative act if we are able to decide the case without reaching constitutional questions,” wrote Justice W. William Leaphart. “We find nothing in Montana Supreme Court precedent or Montana statutes indicating that physician aid in dying is against public policy. … Furthermore, the Montana Rights of the Terminally Ill Act indicates legislative respect for a patient's autonomous right to decide if and how he will receive medical treatment at the end of his life. … We therefore hold that under [Montana law], a terminally ill patient's consent to physician aid in dying constitutes a statutory defense to a charge of homicide against the aiding physician when no other consent exceptions apply.”

Justice James Rice, one of the two dissenting judges, argued that under current Montana law, a physician can be prosecuted for helping a patient commit suicide—if the patient survives, the crime falls under the category of aiding suicide; if the patient dies, the crime is regarded as a homicide.

“Importantly, it is also very clear that a patient's consent to the physician's efforts is of no consequence whatsoever under these statutes,” he wrote. “[The majority] ignores expressed intent, parses statutes, and churns reasons to avoid the clear policy of the State and reach an untenable conclusion: that it is against public policy for a physician to assist in a suicide if the patient happens to live after taking the medication; but that the very same act, with the very same intent, is not against public policy if the patient dies. In my view, the Court's conclusion is without support, without clear reason, and without moral force.”

In the wake of the court ruling—which cannot be appealed—opinions vary as to whether more Montana physicians will now provide aid in dying to terminally ill patients. Chicago health care attorney Miles J. Zaremski, who wrote a “friend of the court” brief in support of Mr. Baxter in the Montana case, said that even though the decision came out in their favor of them plaintiff, physicians in Montana will be reluctant to aid terminally ill patients in dying until legal protocols for the procedure have been established.

“In Montana, if the patient gives the doctor consent to provide aid in dying, the physician can escape homicide laws,” said Mr. Zaremski, who is also a former president of the American College of Legal Medicine. “Well, how was that consent given? Were there witnesses to it? Did you wait 10 days? I think you need protocols and standards in place.”

Oregon and Washington, the only states with aid-in-dying statutes, have protocols written into their laws, he noted. As to who would write the Montana protocols, “I think the legislature should, with input from the medical community,” he said.

Kathryn Tucker, legal director of Compassion & Choices, noted that another aid-in-dying case with which her group is involved is being litigated in Connecticut. Ms. Tucker disagreed with the idea that Montana physicians would not immediately feel freer to provide aid in dying to terminally ill patients in the wake of the state supreme court decision.

“Montana physicians can feel safe that in providing aid in dying they don't run risk of criminal prosecution,” she said. “We know aid in dying happens in every state, even where the legality is unclear. In Montana, this [decision] brings clarity to this issue.”

Ms. Tucker added that most medical care “is not governed by statute; it's governed by the standard of care and best practices. So most physicians will approach aid in dying in Montana as something regulated by the standard of care. I think what's going to happen with Montana … [is that this case] will move aid in dying into normal medical practice that's governed by the standard of care and we'll get away from the notion that there need to be elaborate statutes.”

As to whether other states will adopt aid-in-dying statutes, “It's almost like gay marriage,” Mr. Zaremski said. “Gay marriage and rights for gay couples was an unknown and foreign concept, and now it's inching forward bit by bit, so maybe someday aid in dying will be the norm and not the exception.”

Physicians in Montana may legally assist terminally ill patients in hastening death, according to a ruling by the Montana Supreme Court.

The decision in the case of Baxter v. State of Montana concerned Robert Baxter, a retired truck driver from Billings, Mont., who was terminally ill with lymphocytic leukemia with diffuse lymphadenopathy. As a result of the disease and its treatment, Mr. Baxter suffered from symptoms including “infections, chronic fatigue and weakness, anemia, night sweats, nausea, massively swollen glands, significant ongoing digestive problems, and generalized pain and discomfort,” according to the decision.

The court said further, “The symptoms were expected to increase in frequency and intensity as the chemotherapy lost its effectiveness. There was no cure for Mr. Baxter's disease and no prospect of recovery. Mr. Baxter wanted the option of ingesting a lethal dose of medication prescribed by his physician and self-administered at the time of Mr. Baxter's own choosing.”

Mr. Baxter, along with four physicians and Compassion & Choices, a pro-aid-in-dying group, filed suit in Montana's district court for the first judicial district, challenging the constitutionality of Montana homicide statutes being applied to physicians who provide aid in dying to mentally competent, terminally ill patients. Mr. Baxter's attorneys contended that the right to die with dignity was constitutional under Montana law.

The district court ruled in favor of Mr. Baxter, but the state appealed the ruling to the Montana Supreme Court. On Dec. 31, 2009, that court also ruled in favor of Mr. Baxter, by a vote of 5-2, although it declined to comment on whether aid in dying complied with the Montana constitution. Mr. Baxter had died in December 2008.

“This court is guided by the judicial principle that we should decline to rule on the constitutionality of a legislative act if we are able to decide the case without reaching constitutional questions,” wrote Justice W. William Leaphart. “We find nothing in Montana Supreme Court precedent or Montana statutes indicating that physician aid in dying is against public policy. … Furthermore, the Montana Rights of the Terminally Ill Act indicates legislative respect for a patient's autonomous right to decide if and how he will receive medical treatment at the end of his life. … We therefore hold that under [Montana law], a terminally ill patient's consent to physician aid in dying constitutes a statutory defense to a charge of homicide against the aiding physician when no other consent exceptions apply.”

Justice James Rice, one of the two dissenting judges, argued that under current Montana law, a physician can be prosecuted for helping a patient commit suicide—if the patient survives, the crime falls under the category of aiding suicide; if the patient dies, the crime is regarded as a homicide.

“Importantly, it is also very clear that a patient's consent to the physician's efforts is of no consequence whatsoever under these statutes,” he wrote. “[The majority] ignores expressed intent, parses statutes, and churns reasons to avoid the clear policy of the State and reach an untenable conclusion: that it is against public policy for a physician to assist in a suicide if the patient happens to live after taking the medication; but that the very same act, with the very same intent, is not against public policy if the patient dies. In my view, the Court's conclusion is without support, without clear reason, and without moral force.”

In the wake of the court ruling—which cannot be appealed—opinions vary as to whether more Montana physicians will now provide aid in dying to terminally ill patients. Chicago health care attorney Miles J. Zaremski, who wrote a “friend of the court” brief in support of Mr. Baxter in the Montana case, said that even though the decision came out in their favor of them plaintiff, physicians in Montana will be reluctant to aid terminally ill patients in dying until legal protocols for the procedure have been established.

“In Montana, if the patient gives the doctor consent to provide aid in dying, the physician can escape homicide laws,” said Mr. Zaremski, who is also a former president of the American College of Legal Medicine. “Well, how was that consent given? Were there witnesses to it? Did you wait 10 days? I think you need protocols and standards in place.”

Oregon and Washington, the only states with aid-in-dying statutes, have protocols written into their laws, he noted. As to who would write the Montana protocols, “I think the legislature should, with input from the medical community,” he said.

Kathryn Tucker, legal director of Compassion & Choices, noted that another aid-in-dying case with which her group is involved is being litigated in Connecticut. Ms. Tucker disagreed with the idea that Montana physicians would not immediately feel freer to provide aid in dying to terminally ill patients in the wake of the state supreme court decision.

“Montana physicians can feel safe that in providing aid in dying they don't run risk of criminal prosecution,” she said. “We know aid in dying happens in every state, even where the legality is unclear. In Montana, this [decision] brings clarity to this issue.”

Ms. Tucker added that most medical care “is not governed by statute; it's governed by the standard of care and best practices. So most physicians will approach aid in dying in Montana as something regulated by the standard of care. I think what's going to happen with Montana … [is that this case] will move aid in dying into normal medical practice that's governed by the standard of care and we'll get away from the notion that there need to be elaborate statutes.”

As to whether other states will adopt aid-in-dying statutes, “It's almost like gay marriage,” Mr. Zaremski said. “Gay marriage and rights for gay couples was an unknown and foreign concept, and now it's inching forward bit by bit, so maybe someday aid in dying will be the norm and not the exception.”

Physicians in Montana may legally assist terminally ill patients in hastening death, according to a ruling by the Montana Supreme Court.

The decision in the case of Baxter v. State of Montana concerned Robert Baxter, a retired truck driver from Billings, Mont., who was terminally ill with lymphocytic leukemia with diffuse lymphadenopathy. As a result of the disease and its treatment, Mr. Baxter suffered from symptoms including “infections, chronic fatigue and weakness, anemia, night sweats, nausea, massively swollen glands, significant ongoing digestive problems, and generalized pain and discomfort,” according to the decision.

The court said further, “The symptoms were expected to increase in frequency and intensity as the chemotherapy lost its effectiveness. There was no cure for Mr. Baxter's disease and no prospect of recovery. Mr. Baxter wanted the option of ingesting a lethal dose of medication prescribed by his physician and self-administered at the time of Mr. Baxter's own choosing.”

Mr. Baxter, along with four physicians and Compassion & Choices, a pro-aid-in-dying group, filed suit in Montana's district court for the first judicial district, challenging the constitutionality of Montana homicide statutes being applied to physicians who provide aid in dying to mentally competent, terminally ill patients. Mr. Baxter's attorneys contended that the right to die with dignity was constitutional under Montana law.

The district court ruled in favor of Mr. Baxter, but the state appealed the ruling to the Montana Supreme Court. On Dec. 31, 2009, that court also ruled in favor of Mr. Baxter, by a vote of 5-2, although it declined to comment on whether aid in dying complied with the Montana constitution. Mr. Baxter had died in December 2008.

“This court is guided by the judicial principle that we should decline to rule on the constitutionality of a legislative act if we are able to decide the case without reaching constitutional questions,” wrote Justice W. William Leaphart. “We find nothing in Montana Supreme Court precedent or Montana statutes indicating that physician aid in dying is against public policy. … Furthermore, the Montana Rights of the Terminally Ill Act indicates legislative respect for a patient's autonomous right to decide if and how he will receive medical treatment at the end of his life. … We therefore hold that under [Montana law], a terminally ill patient's consent to physician aid in dying constitutes a statutory defense to a charge of homicide against the aiding physician when no other consent exceptions apply.”

Justice James Rice, one of the two dissenting judges, argued that under current Montana law, a physician can be prosecuted for helping a patient commit suicide—if the patient survives, the crime falls under the category of aiding suicide; if the patient dies, the crime is regarded as a homicide.

“Importantly, it is also very clear that a patient's consent to the physician's efforts is of no consequence whatsoever under these statutes,” he wrote. “[The majority] ignores expressed intent, parses statutes, and churns reasons to avoid the clear policy of the State and reach an untenable conclusion: that it is against public policy for a physician to assist in a suicide if the patient happens to live after taking the medication; but that the very same act, with the very same intent, is not against public policy if the patient dies. In my view, the Court's conclusion is without support, without clear reason, and without moral force.”

In the wake of the court ruling—which cannot be appealed—opinions vary as to whether more Montana physicians will now provide aid in dying to terminally ill patients. Chicago health care attorney Miles J. Zaremski, who wrote a “friend of the court” brief in support of Mr. Baxter in the Montana case, said that even though the decision came out in their favor of them plaintiff, physicians in Montana will be reluctant to aid terminally ill patients in dying until legal protocols for the procedure have been established.

“In Montana, if the patient gives the doctor consent to provide aid in dying, the physician can escape homicide laws,” said Mr. Zaremski, who is also a former president of the American College of Legal Medicine. “Well, how was that consent given? Were there witnesses to it? Did you wait 10 days? I think you need protocols and standards in place.”

Oregon and Washington, the only states with aid-in-dying statutes, have protocols written into their laws, he noted. As to who would write the Montana protocols, “I think the legislature should, with input from the medical community,” he said.

Kathryn Tucker, legal director of Compassion & Choices, noted that another aid-in-dying case with which her group is involved is being litigated in Connecticut. Ms. Tucker disagreed with the idea that Montana physicians would not immediately feel freer to provide aid in dying to terminally ill patients in the wake of the state supreme court decision.

“Montana physicians can feel safe that in providing aid in dying they don't run risk of criminal prosecution,” she said. “We know aid in dying happens in every state, even where the legality is unclear. In Montana, this [decision] brings clarity to this issue.”

Ms. Tucker added that most medical care “is not governed by statute; it's governed by the standard of care and best practices. So most physicians will approach aid in dying in Montana as something regulated by the standard of care. I think what's going to happen with Montana … [is that this case] will move aid in dying into normal medical practice that's governed by the standard of care and we'll get away from the notion that there need to be elaborate statutes.”

As to whether other states will adopt aid-in-dying statutes, “It's almost like gay marriage,” Mr. Zaremski said. “Gay marriage and rights for gay couples was an unknown and foreign concept, and now it's inching forward bit by bit, so maybe someday aid in dying will be the norm and not the exception.”

The U.K. medical journal the Lancet has taken the unusual step of withdrawing an article it published—a study of 12 children with behavioral disorders that developed following administration of vaccines or the onset of measles or otitis media.

“Following the judgment of the U.K. General Medical Council [GMC] Fitness to Practise Panel on Jan. 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al. are incorrect, contrary to the findings of an earlier investigation,” the Lancet editors said in a statement. “In particular, the claims in the original paper that children were 'consecutively referred' and that investigations were 'approved' by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.”

The Wakefield study involved 12 children described in the journal as having been consecutively referred to the pediatric gastroenterology department at the Royal Free Hospital and School of Medicine in London (Lancet 1998;351:637-41). All had a history of a pervasive developmental disorder with loss of acquired skills. They also had intestinal symptoms, including diarrhea, abdominal pain, bloating, and food intolerance. “Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent,” the authors wrote.

The researchers took histories, including details of immunizations and exposure to infectious diseases as well as developmental histories.

They also performed a battery of tests, including colonoscopy with multiple biopsies, cerebral MRI, and EEG. Lab tests were performed to rule out known causes of childhood neurodegenerative disorders.

No subjects were found to have neurological abnormalities on clinical examination; all MRI scans, EEGs, and cerebrospinal-fluid profiles were normal, and none of the boys had fragile X syndrome.

Early development milestones had been achieved by 11 of 12 children, with the exception of one girl found to have coarctation of the aorta and who progressed rapidly after that condition was corrected at 14 months.

Behavioral diagnoses for the children included autism (9), possible postviral or vaccinal encephalitis (2) and disintegrative psychosis (1).

In eight children, parents or physicians linked the onset of behavioral problems to receiving the MMR vaccine. Five children had immediate adverse vaccine reactions including rash, fever, delirium, and in three cases, convulsions.

One subject had received monovalent measles vaccine at 15 months, after which his development slowed. He later received a dose of the MMR vaccine at age 4 years 5 months, a day after which his mother described “striking deterioration in his behavior that she did link with the immunization,” the researchers noted.

On endoscopy, the caecum was seen in all cases, and the ileum in all but two. Four cases showed the “red halo” sign around swollen caecal lymphoid follicles, an early endoscopic feature of Crohn's disease. The researchers said the “most striking and consistent feature” was lymphoid nodular hyperplasia of the terminal ileum in 10 subjects.

The researchers noted that “intestinal and behavioral pathologies may have occurred together by chance, reflecting a selection bias in a self-referred group; however, the uniformity of the intestinal pathological changes and the fact that previous studies have found intestinal dysfunction in children with autistic spectrum disorders suggests that the connection is real and reflects a unique disease process.”

Despite consistent gastrointestinal findings, behavioral changes in these children were not consistent, the authors wrote. “In some cases the onset and course of behavioral regression was precipitous, with children losing all communication skills over a few weeks to months.”

They added that their study “did not prove an association between measles, mumps, and rubella vaccine and the syndrome described…. If there is a causal link between measles, mumps, and rubella vaccine and this syndrome, a rising incidence might be anticipated after the introduction of this vaccine in the [United Kingdom] in 1988. Published evidence is inadequate to show whether there is a change in incidence or a link with measles, mumps, and rubella vaccine.”

According to its report, the GMC panel found that in 1996, Dr. Wakefield was involved in advising Richard Barr, an attorney acting on behalf of people alleged to have suffered harm caused by the administration of the MMR vaccine, “as to the research that would be required to establish that the vaccine was causing injury.” The panel found that “[Dr. Wakefield's] involvement in the MMR litigation … had ethical implications and should have been disclosed.”

Similarly, it found that Dr. Wakefield should have disclosed that he received 50,000 pounds ($78,000) in funding for the study from the Legal Aid Board—from a grant that Mr. Barr applied for. In helping Mr. Barr apply for the money, Dr. Wakefield did not disclose to the Legal Aid Board that some of the items that money was being requested for, such as MRI studies, were already being paid for by Britain's National Health Service, the board found.

Regarding the Lancet paper, the panel found that Dr. Wakefield's describing the referral process as “routine” when some of the patients were actually specifically selected for the study “was irresponsible and misleading and contrary to [his] duty as a senior author.”

The panel also noted that four of the children in the study lacked a history of gastrointestinal symptoms, thereby making them unlikely “routine referrals” to the hospital's gastroenterology department, and that Dr. Wakefield should have disclosed to the Lancet that in 1997, he filed for a patent on a new MMR vaccine.

In the case of one of the children in the study, the panel also found that Dr. Wakefield “ordered the neurophysiological investigations without having requisite paediatric qualifications and writing an incorrect diagnosis on the investigation form.”

The panel also noted that Dr. Wakefield paid some children who were guests at his son's birthday party £5 ($8) to have their blood taken as part of the study; it noted that this showed “a callous disregard for the distress and pain that [Dr. Wakefield] knew or ought to have known the children involved might suffer.”

In addition to its statement on the withdrawal of the article, the Lancet's editors also released a 2004 comment from the Royal Free and University College Medical School and the Royal Free Hampstead NHS Trust stating that they were “entirely satisfied that the investigations performed on the children reported in the Lancet paper had been subjected to appropriate and rigorous ethical scrutiny. Because the nature of the condition affecting child behavior and gastroenterological symptoms was unknown and required elucidation, the investigation of these children was properly submitted to and fully discussed by the Ethical Practices Committee at the Royal Free Hampstead in 1996…. The clinical management and investigation of these children was performed at the Free by a dedicated team of consultant pediatric gastroenterologists, in full consultation with and agreement of the parents of the affected children” (Lancet 2004;363:824).

Does The Lancet's withdrawal of the paper help vaccination advocates? “I think the retraction is far too little far too late,” Dr. Paul Offit, chief of the division of infectious diseases and the director of the Vaccine Education Center at the Children's Hospital of Philadelphia, said in an interview.

“The Lancet published a hypothesis that was unsupported and has since been disproven by careful scientific study. But there is no undoing the harm of that original paper. Many parents abandoned the MMR vaccine. As a consequence, hundreds of children were hospitalized and four were killed by measles. This retraction will do nothing to change that,” Dr. Offit continued.

The Lancet and this news organization are both owned by Elsevier.

The U.K. medical journal the Lancet has taken the unusual step of withdrawing an article it published—a study of 12 children with behavioral disorders that developed following administration of vaccines or the onset of measles or otitis media.

“Following the judgment of the U.K. General Medical Council [GMC] Fitness to Practise Panel on Jan. 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al. are incorrect, contrary to the findings of an earlier investigation,” the Lancet editors said in a statement. “In particular, the claims in the original paper that children were 'consecutively referred' and that investigations were 'approved' by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.”

The Wakefield study involved 12 children described in the journal as having been consecutively referred to the pediatric gastroenterology department at the Royal Free Hospital and School of Medicine in London (Lancet 1998;351:637-41). All had a history of a pervasive developmental disorder with loss of acquired skills. They also had intestinal symptoms, including diarrhea, abdominal pain, bloating, and food intolerance. “Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent,” the authors wrote.

The researchers took histories, including details of immunizations and exposure to infectious diseases as well as developmental histories.

They also performed a battery of tests, including colonoscopy with multiple biopsies, cerebral MRI, and EEG. Lab tests were performed to rule out known causes of childhood neurodegenerative disorders.

No subjects were found to have neurological abnormalities on clinical examination; all MRI scans, EEGs, and cerebrospinal-fluid profiles were normal, and none of the boys had fragile X syndrome.

Early development milestones had been achieved by 11 of 12 children, with the exception of one girl found to have coarctation of the aorta and who progressed rapidly after that condition was corrected at 14 months.

Behavioral diagnoses for the children included autism (9), possible postviral or vaccinal encephalitis (2) and disintegrative psychosis (1).

In eight children, parents or physicians linked the onset of behavioral problems to receiving the MMR vaccine. Five children had immediate adverse vaccine reactions including rash, fever, delirium, and in three cases, convulsions.

One subject had received monovalent measles vaccine at 15 months, after which his development slowed. He later received a dose of the MMR vaccine at age 4 years 5 months, a day after which his mother described “striking deterioration in his behavior that she did link with the immunization,” the researchers noted.

On endoscopy, the caecum was seen in all cases, and the ileum in all but two. Four cases showed the “red halo” sign around swollen caecal lymphoid follicles, an early endoscopic feature of Crohn's disease. The researchers said the “most striking and consistent feature” was lymphoid nodular hyperplasia of the terminal ileum in 10 subjects.

The researchers noted that “intestinal and behavioral pathologies may have occurred together by chance, reflecting a selection bias in a self-referred group; however, the uniformity of the intestinal pathological changes and the fact that previous studies have found intestinal dysfunction in children with autistic spectrum disorders suggests that the connection is real and reflects a unique disease process.”

Despite consistent gastrointestinal findings, behavioral changes in these children were not consistent, the authors wrote. “In some cases the onset and course of behavioral regression was precipitous, with children losing all communication skills over a few weeks to months.”

They added that their study “did not prove an association between measles, mumps, and rubella vaccine and the syndrome described…. If there is a causal link between measles, mumps, and rubella vaccine and this syndrome, a rising incidence might be anticipated after the introduction of this vaccine in the [United Kingdom] in 1988. Published evidence is inadequate to show whether there is a change in incidence or a link with measles, mumps, and rubella vaccine.”

According to its report, the GMC panel found that in 1996, Dr. Wakefield was involved in advising Richard Barr, an attorney acting on behalf of people alleged to have suffered harm caused by the administration of the MMR vaccine, “as to the research that would be required to establish that the vaccine was causing injury.” The panel found that “[Dr. Wakefield's] involvement in the MMR litigation … had ethical implications and should have been disclosed.”

Similarly, it found that Dr. Wakefield should have disclosed that he received 50,000 pounds ($78,000) in funding for the study from the Legal Aid Board—from a grant that Mr. Barr applied for. In helping Mr. Barr apply for the money, Dr. Wakefield did not disclose to the Legal Aid Board that some of the items that money was being requested for, such as MRI studies, were already being paid for by Britain's National Health Service, the board found.

Regarding the Lancet paper, the panel found that Dr. Wakefield's describing the referral process as “routine” when some of the patients were actually specifically selected for the study “was irresponsible and misleading and contrary to [his] duty as a senior author.”

The panel also noted that four of the children in the study lacked a history of gastrointestinal symptoms, thereby making them unlikely “routine referrals” to the hospital's gastroenterology department, and that Dr. Wakefield should have disclosed to the Lancet that in 1997, he filed for a patent on a new MMR vaccine.

In the case of one of the children in the study, the panel also found that Dr. Wakefield “ordered the neurophysiological investigations without having requisite paediatric qualifications and writing an incorrect diagnosis on the investigation form.”

The panel also noted that Dr. Wakefield paid some children who were guests at his son's birthday party £5 ($8) to have their blood taken as part of the study; it noted that this showed “a callous disregard for the distress and pain that [Dr. Wakefield] knew or ought to have known the children involved might suffer.”

In addition to its statement on the withdrawal of the article, the Lancet's editors also released a 2004 comment from the Royal Free and University College Medical School and the Royal Free Hampstead NHS Trust stating that they were “entirely satisfied that the investigations performed on the children reported in the Lancet paper had been subjected to appropriate and rigorous ethical scrutiny. Because the nature of the condition affecting child behavior and gastroenterological symptoms was unknown and required elucidation, the investigation of these children was properly submitted to and fully discussed by the Ethical Practices Committee at the Royal Free Hampstead in 1996…. The clinical management and investigation of these children was performed at the Free by a dedicated team of consultant pediatric gastroenterologists, in full consultation with and agreement of the parents of the affected children” (Lancet 2004;363:824).

Does The Lancet's withdrawal of the paper help vaccination advocates? “I think the retraction is far too little far too late,” Dr. Paul Offit, chief of the division of infectious diseases and the director of the Vaccine Education Center at the Children's Hospital of Philadelphia, said in an interview.

“The Lancet published a hypothesis that was unsupported and has since been disproven by careful scientific study. But there is no undoing the harm of that original paper. Many parents abandoned the MMR vaccine. As a consequence, hundreds of children were hospitalized and four were killed by measles. This retraction will do nothing to change that,” Dr. Offit continued.

The Lancet and this news organization are both owned by Elsevier.

The U.K. medical journal the Lancet has taken the unusual step of withdrawing an article it published—a study of 12 children with behavioral disorders that developed following administration of vaccines or the onset of measles or otitis media.

“Following the judgment of the U.K. General Medical Council [GMC] Fitness to Practise Panel on Jan. 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al. are incorrect, contrary to the findings of an earlier investigation,” the Lancet editors said in a statement. “In particular, the claims in the original paper that children were 'consecutively referred' and that investigations were 'approved' by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.”

The Wakefield study involved 12 children described in the journal as having been consecutively referred to the pediatric gastroenterology department at the Royal Free Hospital and School of Medicine in London (Lancet 1998;351:637-41). All had a history of a pervasive developmental disorder with loss of acquired skills. They also had intestinal symptoms, including diarrhea, abdominal pain, bloating, and food intolerance. “Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent,” the authors wrote.

The researchers took histories, including details of immunizations and exposure to infectious diseases as well as developmental histories.

They also performed a battery of tests, including colonoscopy with multiple biopsies, cerebral MRI, and EEG. Lab tests were performed to rule out known causes of childhood neurodegenerative disorders.

No subjects were found to have neurological abnormalities on clinical examination; all MRI scans, EEGs, and cerebrospinal-fluid profiles were normal, and none of the boys had fragile X syndrome.

Early development milestones had been achieved by 11 of 12 children, with the exception of one girl found to have coarctation of the aorta and who progressed rapidly after that condition was corrected at 14 months.

Behavioral diagnoses for the children included autism (9), possible postviral or vaccinal encephalitis (2) and disintegrative psychosis (1).

In eight children, parents or physicians linked the onset of behavioral problems to receiving the MMR vaccine. Five children had immediate adverse vaccine reactions including rash, fever, delirium, and in three cases, convulsions.

One subject had received monovalent measles vaccine at 15 months, after which his development slowed. He later received a dose of the MMR vaccine at age 4 years 5 months, a day after which his mother described “striking deterioration in his behavior that she did link with the immunization,” the researchers noted.

On endoscopy, the caecum was seen in all cases, and the ileum in all but two. Four cases showed the “red halo” sign around swollen caecal lymphoid follicles, an early endoscopic feature of Crohn's disease. The researchers said the “most striking and consistent feature” was lymphoid nodular hyperplasia of the terminal ileum in 10 subjects.

The researchers noted that “intestinal and behavioral pathologies may have occurred together by chance, reflecting a selection bias in a self-referred group; however, the uniformity of the intestinal pathological changes and the fact that previous studies have found intestinal dysfunction in children with autistic spectrum disorders suggests that the connection is real and reflects a unique disease process.”

Despite consistent gastrointestinal findings, behavioral changes in these children were not consistent, the authors wrote. “In some cases the onset and course of behavioral regression was precipitous, with children losing all communication skills over a few weeks to months.”

They added that their study “did not prove an association between measles, mumps, and rubella vaccine and the syndrome described…. If there is a causal link between measles, mumps, and rubella vaccine and this syndrome, a rising incidence might be anticipated after the introduction of this vaccine in the [United Kingdom] in 1988. Published evidence is inadequate to show whether there is a change in incidence or a link with measles, mumps, and rubella vaccine.”

According to its report, the GMC panel found that in 1996, Dr. Wakefield was involved in advising Richard Barr, an attorney acting on behalf of people alleged to have suffered harm caused by the administration of the MMR vaccine, “as to the research that would be required to establish that the vaccine was causing injury.” The panel found that “[Dr. Wakefield's] involvement in the MMR litigation … had ethical implications and should have been disclosed.”

Similarly, it found that Dr. Wakefield should have disclosed that he received 50,000 pounds ($78,000) in funding for the study from the Legal Aid Board—from a grant that Mr. Barr applied for. In helping Mr. Barr apply for the money, Dr. Wakefield did not disclose to the Legal Aid Board that some of the items that money was being requested for, such as MRI studies, were already being paid for by Britain's National Health Service, the board found.

Regarding the Lancet paper, the panel found that Dr. Wakefield's describing the referral process as “routine” when some of the patients were actually specifically selected for the study “was irresponsible and misleading and contrary to [his] duty as a senior author.”

The panel also noted that four of the children in the study lacked a history of gastrointestinal symptoms, thereby making them unlikely “routine referrals” to the hospital's gastroenterology department, and that Dr. Wakefield should have disclosed to the Lancet that in 1997, he filed for a patent on a new MMR vaccine.

In the case of one of the children in the study, the panel also found that Dr. Wakefield “ordered the neurophysiological investigations without having requisite paediatric qualifications and writing an incorrect diagnosis on the investigation form.”

The panel also noted that Dr. Wakefield paid some children who were guests at his son's birthday party £5 ($8) to have their blood taken as part of the study; it noted that this showed “a callous disregard for the distress and pain that [Dr. Wakefield] knew or ought to have known the children involved might suffer.”

In addition to its statement on the withdrawal of the article, the Lancet's editors also released a 2004 comment from the Royal Free and University College Medical School and the Royal Free Hampstead NHS Trust stating that they were “entirely satisfied that the investigations performed on the children reported in the Lancet paper had been subjected to appropriate and rigorous ethical scrutiny. Because the nature of the condition affecting child behavior and gastroenterological symptoms was unknown and required elucidation, the investigation of these children was properly submitted to and fully discussed by the Ethical Practices Committee at the Royal Free Hampstead in 1996…. The clinical management and investigation of these children was performed at the Free by a dedicated team of consultant pediatric gastroenterologists, in full consultation with and agreement of the parents of the affected children” (Lancet 2004;363:824).

Does The Lancet's withdrawal of the paper help vaccination advocates? “I think the retraction is far too little far too late,” Dr. Paul Offit, chief of the division of infectious diseases and the director of the Vaccine Education Center at the Children's Hospital of Philadelphia, said in an interview.

“The Lancet published a hypothesis that was unsupported and has since been disproven by careful scientific study. But there is no undoing the harm of that original paper. Many parents abandoned the MMR vaccine. As a consequence, hundreds of children were hospitalized and four were killed by measles. This retraction will do nothing to change that,” Dr. Offit continued.

The Lancet and this news organization are both owned by Elsevier.

Tobacco Act Takes a Hit

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www.fda.gov/medicaldevices

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The American Diabetes Association has named Dr. Kenneth Moritsugu to the board of directors of its research foundation, which raises funds for diabetes research. Dr. Moritsugu is the chairman of the Johnson & Johnson Diabetes Institute and vice president for global strategic affairs of the Johnson & Johnson family of diabetes companies. Prior to his current corporate position, he served in the U.S. Public Health Service commissioned corps for 37 years, including a stint as acting surgeon general in 2002. Dr. Moritsugu has worked as a consultant on health professions and systems across the United States as well as in Kuwait, Saudi Arabia, Nigeria, Germany, and Mexico. He was diagnosed with latent type 1 diabetes in 2000 and is an advocate for diabetes prevention and health literacy.

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Most Medicare beneficiaries are able to get timely appointments when they need one, according to an annual survey conducted by the Medicare Payment Advisory Commission. In fact, Medicare beneficiaries report better physician access than the privately insured population, according to the findings, which were based on a poll of 4,000 Medicare beneficiaries and 4,000 privately insured individuals ages 50-64 years. Of note, both groups reported that finding a new primary care physician was more difficult than finding a new specialist. In related news, MedPAC voted last month to request that Congress approve a 1% increase in the Medicare physician payment rate for 2011. In addition, the commission pushed for a budget-neutral payment increase specifically for primary care services.

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The Agency for Healthcare Research and Quality reports that 1 in 13 American adults who needed to see a specialist in 2007 said that getting access was a “big problem.” The data come from the Medical Expenditure Panel Survey. The agency said that respondents were not asked why they had access problems. But the survey report added that access problems can be due to a lack of health insurance, specialists' nonparticipation in a patient's health plan, and long waits for appointments. The survey found that 16% of adults without primary care physicians had problems accessing specialists, compared with 6% of those who had a usual source of primary care. Nonelderly uninsured adults had the most difficulty getting in to see a specialist, followed by nonelderly adults with public health coverage and those with private insurance. More data are available in the agency's report, “Variations in Perceived Need and Access to Specialty Care Among Adults in the U.S. Civilian Noninstitutionalized Population, 2007,” available at

www.meps.ahrq.gov/mepsweb/data_files/publications/st274/stat274.pdf

Tobacco Act Takes a Hit

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FDA Names New Device Chief

The Food and Drug Administration has named a new permanent head of the Center for Devices and Radiological Health. Dr. Jeffrey Shuren, who has been acting director since early September, will now direct the center. He replaces Dr. Daniel Schultz, who resigned last year after critics claimed he was too cozy with medical device makers. In a statement, the head of the device industry trade group Advanced Medical Technology Association (AdvaMed) applauded Dr. Shuren's appointment and said that he has already shown effective leadership skills. “His more than 10 years experience at FDA, in various high-level policy and planning positions within the commissioner's office, will serve him well as he takes control of an organization that oversees such a wide range of life-saving and life-enhancing products,” said AdvaMed CEO Stephen J. Ubl. The Center for Devices and Radiological Health also unveiled its strategic plan for 2010, with four priority areas: effectively regulating products throughout their development and marketing, enhancing communication and transparency, strengthening the center's workforce and workplace, and spurring innovation and addressing unmet public health needs. The strategic plan is available at

www.fda.gov/medicaldevices

Moritsugu Joins ADA Research Board

The American Diabetes Association has named Dr. Kenneth Moritsugu to the board of directors of its research foundation, which raises funds for diabetes research. Dr. Moritsugu is the chairman of the Johnson & Johnson Diabetes Institute and vice president for global strategic affairs of the Johnson & Johnson family of diabetes companies. Prior to his current corporate position, he served in the U.S. Public Health Service commissioned corps for 37 years, including a stint as acting surgeon general in 2002. Dr. Moritsugu has worked as a consultant on health professions and systems across the United States as well as in Kuwait, Saudi Arabia, Nigeria, Germany, and Mexico. He was diagnosed with latent type 1 diabetes in 2000 and is an advocate for diabetes prevention and health literacy.

'Extraordinary' Drug Price Hikes

The Government Accountability Office said that 416 brand-name pharmaceutical products had “extraordinary” price increases from 2000 to 2008. While this represents only 0.5% of all brand-name products, most of the increases ranged from 100% to 499%, the GAO said in a report released in early January (GAO-10-201). More than half of those products were in three therapeutic classes: central nervous system, anti-infective, and cardiovascular. One possible reason for the price inflation, said the agency: The drugs are bought from wholesalers, repackaged, and resold at higher prices to physicians or hospitals. But increases also were driven by a lack of generic or other therapeutic alternatives for various drugs, the GAO said. The Pharmaceutical Research and Manufacturers of America (PhRMA) industry group said that the report “focuses only on a small number of selected brand medicines rather than the entire prescription drug market.” PhRMA Senior Vice President Ken Johnson commented that national data show a decline in retail drug spending in 2008.

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Most Medicare beneficiaries are able to get timely appointments when they need one, according to an annual survey conducted by the Medicare Payment Advisory Commission. In fact, Medicare beneficiaries report better physician access than the privately insured population, according to the findings, which were based on a poll of 4,000 Medicare beneficiaries and 4,000 privately insured individuals ages 50-64 years. Of note, both groups reported that finding a new primary care physician was more difficult than finding a new specialist. In related news, MedPAC voted last month to request that Congress approve a 1% increase in the Medicare physician payment rate for 2011. In addition, the commission pushed for a budget-neutral payment increase specifically for primary care services.

Access to Specialists a Problem

The Agency for Healthcare Research and Quality reports that 1 in 13 American adults who needed to see a specialist in 2007 said that getting access was a “big problem.” The data come from the Medical Expenditure Panel Survey. The agency said that respondents were not asked why they had access problems. But the survey report added that access problems can be due to a lack of health insurance, specialists' nonparticipation in a patient's health plan, and long waits for appointments. The survey found that 16% of adults without primary care physicians had problems accessing specialists, compared with 6% of those who had a usual source of primary care. Nonelderly uninsured adults had the most difficulty getting in to see a specialist, followed by nonelderly adults with public health coverage and those with private insurance. More data are available in the agency's report, “Variations in Perceived Need and Access to Specialty Care Among Adults in the U.S. Civilian Noninstitutionalized Population, 2007,” available at

www.meps.ahrq.gov/mepsweb/data_files/publications/st274/stat274.pdf

Tobacco Act Takes a Hit

A federal district court has struck down parts of the Family Smoking Prevention and Tobacco Control Act of 2009, saying that some of the landmark law violates tobacco makers' free speech rights. The U.S. District Court for the Western District of Kentucky ruled it unconstitutional for government to ban color and images in tobacco advertising. However, the court upheld provisions of the law requiring large, strongly worded warnings on tobacco packaging, prohibiting companies from making health claims about tobacco products without Food and Drug Administration review, and banning tobacco-branded events and merchandise, such as T-shirts. American Thoracic Society president Dr. J.R. Curtis said in a statement that the society is still “confident that the FDA will exercise its new authority to reduce tobacco use in the U.S. by stopping the efforts of big tobacco to market its dangerous products to minors, and by giving current smokers more motivation to stop smoking.”

FDA Names New Device Chief

The Food and Drug Administration has named a new permanent head of the Center for Devices and Radiological Health. Dr. Jeffrey Shuren, who has been acting director since early September, will now direct the center. He replaces Dr. Daniel Schultz, who resigned last year after critics claimed he was too cozy with medical device makers. In a statement, the head of the device industry trade group Advanced Medical Technology Association (AdvaMed) applauded Dr. Shuren's appointment and said that he has already shown effective leadership skills. “His more than 10 years experience at FDA, in various high-level policy and planning positions within the commissioner's office, will serve him well as he takes control of an organization that oversees such a wide range of life-saving and life-enhancing products,” said AdvaMed CEO Stephen J. Ubl. The Center for Devices and Radiological Health also unveiled its strategic plan for 2010, with four priority areas: effectively regulating products throughout their development and marketing, enhancing communication and transparency, strengthening the center's workforce and workplace, and spurring innovation and addressing unmet public health needs. The strategic plan is available at

www.fda.gov/medicaldevices

Moritsugu Joins ADA Research Board

The American Diabetes Association has named Dr. Kenneth Moritsugu to the board of directors of its research foundation, which raises funds for diabetes research. Dr. Moritsugu is the chairman of the Johnson & Johnson Diabetes Institute and vice president for global strategic affairs of the Johnson & Johnson family of diabetes companies. Prior to his current corporate position, he served in the U.S. Public Health Service commissioned corps for 37 years, including a stint as acting surgeon general in 2002. Dr. Moritsugu has worked as a consultant on health professions and systems across the United States as well as in Kuwait, Saudi Arabia, Nigeria, Germany, and Mexico. He was diagnosed with latent type 1 diabetes in 2000 and is an advocate for diabetes prevention and health literacy.

'Extraordinary' Drug Price Hikes

The Government Accountability Office said that 416 brand-name pharmaceutical products had “extraordinary” price increases from 2000 to 2008. While this represents only 0.5% of all brand-name products, most of the increases ranged from 100% to 499%, the GAO said in a report released in early January (GAO-10-201). More than half of those products were in three therapeutic classes: central nervous system, anti-infective, and cardiovascular. One possible reason for the price inflation, said the agency: The drugs are bought from wholesalers, repackaged, and resold at higher prices to physicians or hospitals. But increases also were driven by a lack of generic or other therapeutic alternatives for various drugs, the GAO said. The Pharmaceutical Research and Manufacturers of America (PhRMA) industry group said that the report “focuses only on a small number of selected brand medicines rather than the entire prescription drug market.” PhRMA Senior Vice President Ken Johnson commented that national data show a decline in retail drug spending in 2008.

MedPAC Pushes for Pay Increases

Most Medicare beneficiaries are able to get timely appointments when they need one, according to an annual survey conducted by the Medicare Payment Advisory Commission. In fact, Medicare beneficiaries report better physician access than the privately insured population, according to the findings, which were based on a poll of 4,000 Medicare beneficiaries and 4,000 privately insured individuals ages 50-64 years. Of note, both groups reported that finding a new primary care physician was more difficult than finding a new specialist. In related news, MedPAC voted last month to request that Congress approve a 1% increase in the Medicare physician payment rate for 2011. In addition, the commission pushed for a budget-neutral payment increase specifically for primary care services.

Access to Specialists a Problem

The Agency for Healthcare Research and Quality reports that 1 in 13 American adults who needed to see a specialist in 2007 said that getting access was a “big problem.” The data come from the Medical Expenditure Panel Survey. The agency said that respondents were not asked why they had access problems. But the survey report added that access problems can be due to a lack of health insurance, specialists' nonparticipation in a patient's health plan, and long waits for appointments. The survey found that 16% of adults without primary care physicians had problems accessing specialists, compared with 6% of those who had a usual source of primary care. Nonelderly uninsured adults had the most difficulty getting in to see a specialist, followed by nonelderly adults with public health coverage and those with private insurance. More data are available in the agency's report, “Variations in Perceived Need and Access to Specialty Care Among Adults in the U.S. Civilian Noninstitutionalized Population, 2007,” available at

www.meps.ahrq.gov/mepsweb/data_files/publications/st274/stat274.pdf