Alicia Gallegos

Physicians may finally have some clarity on payment for inpatient administration of 2 chimeric antigen receptor (CAR) T-cell therapies if a proposed rule from the Centers of Medicare & Medicaid Services becomes final.

The agency is seeking to assign ICD-10-PCS codes XW033C3 and XW043C3 to the use of axicabtagene ciloleucel (Yescarta; Kite Pharma, acquired by Gilead in October 2017) and tisagenlecleucel (Kymriah; Novartis) in the inpatient setting for fiscal year 2019. It is also considering the creation of a new Medicare Severity-Diagnosis Related Group (MS-DRG) code for procedures involving the use of CAR T-cell therapy drugs.

Stephanie Farnia, director of health policy and strategic relations for the American Society for Blood and Marrow Transplantation, said the proposal demonstrates that CMS is listening to physicians’ concerns about CAR T payments and working to provide a more reasonable framework. “The primary point of significance is that CAR-T care episodes should be assigned to a specific MS-DRG in FY2019, which will give physicians a clearer sense of inpatient reimbursement in advance,” she said in an interview.

Uncertainty about inpatient payment for administration of the 2 approved CAR T therapies (see p. e126) have been a lingering concern of specialists who use, or are interested in using, the therapies. In April 2018, CMS announced payment rates for outpatient administration of the 2 drugs, settling on $395,380 for axicabtagene ciloleucel and $500,839 for tisagenlecleucel. The two medications have list prices of $373,000 and $475,000, respectively.

However, physicians noted at the time that even if the drugs were first administered in the outpatient setting, inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted for monitoring for serious side effects. In such cases, all payments would then become part of the inpatient stay as per CMS’s 3-day payment window rule.

In the most recent payment proposal, CMS stated that its clinical advisers believe that patients receiving treatment with CAR T-cell therapy would have similar clinical characteristics and comorbidities as patients treated with autologous bone marrow transplant therapy, who are currently assigned to MS-DRG 016 Autologous Bone Marrow Transplant with CC/MCC. Therefore, CMS officials said they would suggest ICD-10-PCS procedure codes XW033C3 and XW043C3 to pre-MDC MS-DRG 016. In addition, the agency is proposing to revise the title of MS-DRG 016 to Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy.

The agency emphasized that it invites public comment on alternative payment approaches for CAR T-cell therapies in the context of the pending, new technology add-on payment applications by the CAR-T drugmakers Novartis and Kite Pharma/Gilead. If approved, the technology add-on payments would provide an additional and separate payment equivalent to up to 50% of the product cost plus the MS-DRG payment received for the episode of care.
 

Shifts and realignments in the face of new developments

The CMS announcement is the latest development in the rapidly growing landscape of CAR T-cell therapies. In 2017, the Food and Drug Administration approved tisagenlecleucel for pediatric acute lymphoblastic leukemia and axicabtagene ciloleucel for relapsed/refractory large B-cell lymphoma in adults, and in May 2018, the agency expanded the indication for tisagenlecleucel to include adults with relapsed/refractory large B-cell lymphoma.

Further advancements are expected for CAR T-cell therapies in 2018, said Cai Xuan, PhD, senior analyst in oncology and hematology for GlobalData, a data analytics and commercial intelligence firm.

For starters, pharmaceutical companies are now working toward next-generation CAR T-cell therapies that can be mass produced, Dr Xuan noted. At a recent American Association for Cancer Research meeting, for example, the biopharmaceutical company Cellectis presented early clinical data in pediatric B-cell acute lymphoblastic leukemia for its off-the-shelf CAR T-cell candidate UCART19. In addition, CRISPR Therapeutics presented preclinical data for one of its off-the-shelf CAR T-cell candidates for multiple myeloma, and the company announced it would apply for approval to start human trials by the end of 2018.

“The trend for 2018 is focused on how to eliminate some of the profitability issues with first-generation CAR Ts because companies realize that manufacturing individualized treatments for each patient is not an ideal business model,” Dr Xuan said in an interview.

More market competition is also in the forecast, particularly from smaller companies, Dr Xuan said. “We are likely to see larger companies acquiring smaller ones once their CAR T technology has matured to a certain point. We have seen it with the Gilead-Kite acquisition and Celgene’s acquisition of Juno Therapeutics. This trend will continue as long as smaller companies are able to develop proprietary next-generation CAR T technologies.”
 

Cost, accessibility, and real-world side effects

The key concerns about the therapies are cost and accessibility, especially for the Medicare population. Cost estimates have put the cost of CAR T-cell therapies as high as $1.5 million per patient and that could make them inaccessible for many.

“There remain unanswered questions about value and cost in older adults,” said Walid F Gellad, MD, codirector for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “There are many life-saving treatments in the medical system that cost much less than this therapy. Presumably, its cost will go down as the indications expand and the experience with creating the CAR T cells improves. At least, one would hope.”

The creation of off-the-shelf, third-party products would help improve accessibility for CAR T-cell therapies and lower cost, said Helen Heslop, MD, director of the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston. “In the longer term, there’re obviously a lot of people looking at how [the treatments] can be made more accessible. These are the first-generation CAR T [products], and I think there’ll be lots of refinements both to make them more effective and safer and also to use a third-party product to bring the cost of goods down.”

Other lingering unknowns about CAR T-cell therapies include how many patients in real-world clinical practice will have serious side effects, compared with those in trials, and the long-term recurrence rates after therapy use, Dr Gellad noted. He recently proposed in an article that government payers reimburse only the cost of manufacturing and some predetermined mark-up for such therapies until confirmatory trials demonstrate clinical benefit (N Engl J Med. 2017;376[21]:2001-4).

The current CAR T-cell therapies are only the beginning, said Dr Richard T Maziarz, MD, a bone marrow transplantation and blood cancer specialist at the Oregon Health and Science University Knight Cancer Institute in Portland. “Genetically engineered cell products are going to explode over the course of the next decade. This is not the end of the line, this is the starting point.”

Disclosures. Dr Maziarz has received consulting fees from Novartis, Juno Therapeutics, and Kite Pharma. Dr Heslop has received consulting fees from Novartis, has conducted research for Cell Medica and holds intellectual property rights/patents from Cell Medica, and has ownership interest in ViraCyte and Marker Therapeutics. Dr Gellad reports grants from Express Scripts.

Physicians may finally have some clarity on payment for inpatient administration of 2 chimeric antigen receptor (CAR) T-cell therapies if a proposed rule from the Centers of Medicare & Medicaid Services becomes final.

The agency is seeking to assign ICD-10-PCS codes XW033C3 and XW043C3 to the use of axicabtagene ciloleucel (Yescarta; Kite Pharma, acquired by Gilead in October 2017) and tisagenlecleucel (Kymriah; Novartis) in the inpatient setting for fiscal year 2019. It is also considering the creation of a new Medicare Severity-Diagnosis Related Group (MS-DRG) code for procedures involving the use of CAR T-cell therapy drugs.

Stephanie Farnia, director of health policy and strategic relations for the American Society for Blood and Marrow Transplantation, said the proposal demonstrates that CMS is listening to physicians’ concerns about CAR T payments and working to provide a more reasonable framework. “The primary point of significance is that CAR-T care episodes should be assigned to a specific MS-DRG in FY2019, which will give physicians a clearer sense of inpatient reimbursement in advance,” she said in an interview.

Uncertainty about inpatient payment for administration of the 2 approved CAR T therapies (see p. e126) have been a lingering concern of specialists who use, or are interested in using, the therapies. In April 2018, CMS announced payment rates for outpatient administration of the 2 drugs, settling on $395,380 for axicabtagene ciloleucel and $500,839 for tisagenlecleucel. The two medications have list prices of $373,000 and $475,000, respectively.

However, physicians noted at the time that even if the drugs were first administered in the outpatient setting, inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted for monitoring for serious side effects. In such cases, all payments would then become part of the inpatient stay as per CMS’s 3-day payment window rule.

In the most recent payment proposal, CMS stated that its clinical advisers believe that patients receiving treatment with CAR T-cell therapy would have similar clinical characteristics and comorbidities as patients treated with autologous bone marrow transplant therapy, who are currently assigned to MS-DRG 016 Autologous Bone Marrow Transplant with CC/MCC. Therefore, CMS officials said they would suggest ICD-10-PCS procedure codes XW033C3 and XW043C3 to pre-MDC MS-DRG 016. In addition, the agency is proposing to revise the title of MS-DRG 016 to Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy.

The agency emphasized that it invites public comment on alternative payment approaches for CAR T-cell therapies in the context of the pending, new technology add-on payment applications by the CAR-T drugmakers Novartis and Kite Pharma/Gilead. If approved, the technology add-on payments would provide an additional and separate payment equivalent to up to 50% of the product cost plus the MS-DRG payment received for the episode of care.
 

Shifts and realignments in the face of new developments

The CMS announcement is the latest development in the rapidly growing landscape of CAR T-cell therapies. In 2017, the Food and Drug Administration approved tisagenlecleucel for pediatric acute lymphoblastic leukemia and axicabtagene ciloleucel for relapsed/refractory large B-cell lymphoma in adults, and in May 2018, the agency expanded the indication for tisagenlecleucel to include adults with relapsed/refractory large B-cell lymphoma.

Further advancements are expected for CAR T-cell therapies in 2018, said Cai Xuan, PhD, senior analyst in oncology and hematology for GlobalData, a data analytics and commercial intelligence firm.

For starters, pharmaceutical companies are now working toward next-generation CAR T-cell therapies that can be mass produced, Dr Xuan noted. At a recent American Association for Cancer Research meeting, for example, the biopharmaceutical company Cellectis presented early clinical data in pediatric B-cell acute lymphoblastic leukemia for its off-the-shelf CAR T-cell candidate UCART19. In addition, CRISPR Therapeutics presented preclinical data for one of its off-the-shelf CAR T-cell candidates for multiple myeloma, and the company announced it would apply for approval to start human trials by the end of 2018.

“The trend for 2018 is focused on how to eliminate some of the profitability issues with first-generation CAR Ts because companies realize that manufacturing individualized treatments for each patient is not an ideal business model,” Dr Xuan said in an interview.

More market competition is also in the forecast, particularly from smaller companies, Dr Xuan said. “We are likely to see larger companies acquiring smaller ones once their CAR T technology has matured to a certain point. We have seen it with the Gilead-Kite acquisition and Celgene’s acquisition of Juno Therapeutics. This trend will continue as long as smaller companies are able to develop proprietary next-generation CAR T technologies.”
 

Cost, accessibility, and real-world side effects

The key concerns about the therapies are cost and accessibility, especially for the Medicare population. Cost estimates have put the cost of CAR T-cell therapies as high as $1.5 million per patient and that could make them inaccessible for many.

“There remain unanswered questions about value and cost in older adults,” said Walid F Gellad, MD, codirector for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “There are many life-saving treatments in the medical system that cost much less than this therapy. Presumably, its cost will go down as the indications expand and the experience with creating the CAR T cells improves. At least, one would hope.”

The creation of off-the-shelf, third-party products would help improve accessibility for CAR T-cell therapies and lower cost, said Helen Heslop, MD, director of the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston. “In the longer term, there’re obviously a lot of people looking at how [the treatments] can be made more accessible. These are the first-generation CAR T [products], and I think there’ll be lots of refinements both to make them more effective and safer and also to use a third-party product to bring the cost of goods down.”

Other lingering unknowns about CAR T-cell therapies include how many patients in real-world clinical practice will have serious side effects, compared with those in trials, and the long-term recurrence rates after therapy use, Dr Gellad noted. He recently proposed in an article that government payers reimburse only the cost of manufacturing and some predetermined mark-up for such therapies until confirmatory trials demonstrate clinical benefit (N Engl J Med. 2017;376[21]:2001-4).

The current CAR T-cell therapies are only the beginning, said Dr Richard T Maziarz, MD, a bone marrow transplantation and blood cancer specialist at the Oregon Health and Science University Knight Cancer Institute in Portland. “Genetically engineered cell products are going to explode over the course of the next decade. This is not the end of the line, this is the starting point.”

Disclosures. Dr Maziarz has received consulting fees from Novartis, Juno Therapeutics, and Kite Pharma. Dr Heslop has received consulting fees from Novartis, has conducted research for Cell Medica and holds intellectual property rights/patents from Cell Medica, and has ownership interest in ViraCyte and Marker Therapeutics. Dr Gellad reports grants from Express Scripts.

Physicians may finally have some clarity on payment for inpatient administration of 2 chimeric antigen receptor (CAR) T-cell therapies if a proposed rule from the Centers of Medicare & Medicaid Services becomes final.

The agency is seeking to assign ICD-10-PCS codes XW033C3 and XW043C3 to the use of axicabtagene ciloleucel (Yescarta; Kite Pharma, acquired by Gilead in October 2017) and tisagenlecleucel (Kymriah; Novartis) in the inpatient setting for fiscal year 2019. It is also considering the creation of a new Medicare Severity-Diagnosis Related Group (MS-DRG) code for procedures involving the use of CAR T-cell therapy drugs.

Stephanie Farnia, director of health policy and strategic relations for the American Society for Blood and Marrow Transplantation, said the proposal demonstrates that CMS is listening to physicians’ concerns about CAR T payments and working to provide a more reasonable framework. “The primary point of significance is that CAR-T care episodes should be assigned to a specific MS-DRG in FY2019, which will give physicians a clearer sense of inpatient reimbursement in advance,” she said in an interview.

Uncertainty about inpatient payment for administration of the 2 approved CAR T therapies (see p. e126) have been a lingering concern of specialists who use, or are interested in using, the therapies. In April 2018, CMS announced payment rates for outpatient administration of the 2 drugs, settling on $395,380 for axicabtagene ciloleucel and $500,839 for tisagenlecleucel. The two medications have list prices of $373,000 and $475,000, respectively.

However, physicians noted at the time that even if the drugs were first administered in the outpatient setting, inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted for monitoring for serious side effects. In such cases, all payments would then become part of the inpatient stay as per CMS’s 3-day payment window rule.

In the most recent payment proposal, CMS stated that its clinical advisers believe that patients receiving treatment with CAR T-cell therapy would have similar clinical characteristics and comorbidities as patients treated with autologous bone marrow transplant therapy, who are currently assigned to MS-DRG 016 Autologous Bone Marrow Transplant with CC/MCC. Therefore, CMS officials said they would suggest ICD-10-PCS procedure codes XW033C3 and XW043C3 to pre-MDC MS-DRG 016. In addition, the agency is proposing to revise the title of MS-DRG 016 to Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy.

The agency emphasized that it invites public comment on alternative payment approaches for CAR T-cell therapies in the context of the pending, new technology add-on payment applications by the CAR-T drugmakers Novartis and Kite Pharma/Gilead. If approved, the technology add-on payments would provide an additional and separate payment equivalent to up to 50% of the product cost plus the MS-DRG payment received for the episode of care.
 

Shifts and realignments in the face of new developments

The CMS announcement is the latest development in the rapidly growing landscape of CAR T-cell therapies. In 2017, the Food and Drug Administration approved tisagenlecleucel for pediatric acute lymphoblastic leukemia and axicabtagene ciloleucel for relapsed/refractory large B-cell lymphoma in adults, and in May 2018, the agency expanded the indication for tisagenlecleucel to include adults with relapsed/refractory large B-cell lymphoma.

Further advancements are expected for CAR T-cell therapies in 2018, said Cai Xuan, PhD, senior analyst in oncology and hematology for GlobalData, a data analytics and commercial intelligence firm.

For starters, pharmaceutical companies are now working toward next-generation CAR T-cell therapies that can be mass produced, Dr Xuan noted. At a recent American Association for Cancer Research meeting, for example, the biopharmaceutical company Cellectis presented early clinical data in pediatric B-cell acute lymphoblastic leukemia for its off-the-shelf CAR T-cell candidate UCART19. In addition, CRISPR Therapeutics presented preclinical data for one of its off-the-shelf CAR T-cell candidates for multiple myeloma, and the company announced it would apply for approval to start human trials by the end of 2018.

“The trend for 2018 is focused on how to eliminate some of the profitability issues with first-generation CAR Ts because companies realize that manufacturing individualized treatments for each patient is not an ideal business model,” Dr Xuan said in an interview.

More market competition is also in the forecast, particularly from smaller companies, Dr Xuan said. “We are likely to see larger companies acquiring smaller ones once their CAR T technology has matured to a certain point. We have seen it with the Gilead-Kite acquisition and Celgene’s acquisition of Juno Therapeutics. This trend will continue as long as smaller companies are able to develop proprietary next-generation CAR T technologies.”
 

Cost, accessibility, and real-world side effects

The key concerns about the therapies are cost and accessibility, especially for the Medicare population. Cost estimates have put the cost of CAR T-cell therapies as high as $1.5 million per patient and that could make them inaccessible for many.

“There remain unanswered questions about value and cost in older adults,” said Walid F Gellad, MD, codirector for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “There are many life-saving treatments in the medical system that cost much less than this therapy. Presumably, its cost will go down as the indications expand and the experience with creating the CAR T cells improves. At least, one would hope.”

The creation of off-the-shelf, third-party products would help improve accessibility for CAR T-cell therapies and lower cost, said Helen Heslop, MD, director of the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston. “In the longer term, there’re obviously a lot of people looking at how [the treatments] can be made more accessible. These are the first-generation CAR T [products], and I think there’ll be lots of refinements both to make them more effective and safer and also to use a third-party product to bring the cost of goods down.”

Other lingering unknowns about CAR T-cell therapies include how many patients in real-world clinical practice will have serious side effects, compared with those in trials, and the long-term recurrence rates after therapy use, Dr Gellad noted. He recently proposed in an article that government payers reimburse only the cost of manufacturing and some predetermined mark-up for such therapies until confirmatory trials demonstrate clinical benefit (N Engl J Med. 2017;376[21]:2001-4).

The current CAR T-cell therapies are only the beginning, said Dr Richard T Maziarz, MD, a bone marrow transplantation and blood cancer specialist at the Oregon Health and Science University Knight Cancer Institute in Portland. “Genetically engineered cell products are going to explode over the course of the next decade. This is not the end of the line, this is the starting point.”

Disclosures. Dr Maziarz has received consulting fees from Novartis, Juno Therapeutics, and Kite Pharma. Dr Heslop has received consulting fees from Novartis, has conducted research for Cell Medica and holds intellectual property rights/patents from Cell Medica, and has ownership interest in ViraCyte and Marker Therapeutics. Dr Gellad reports grants from Express Scripts.

Positive relationships between physicians and nurses not only make for a smoother work environment, they also may reduce medical errors and lower the risk of lawsuits.

A recent study of closed claims by national medical malpractice insurer The Doctors Company found that poor physician oversight is a key contributor to lawsuits against nurses. Investigators analyzed 67 nurse practitioner (NP) claims from January 2011 to December 2016 and compared them with 1,358 claims against primary care physicians during the same time period.

Diagnostic and medication errors were the most common allegations against NPs, the study found, a trend that matched the most frequent allegations against primary care (internal medicine and family medicine) doctors. Top administrative factors that prompted lawsuits against nurses included inadequate physician supervision, failure to adhere to scope of practice, and absence of or deviation from written protocols.

The findings illustrate the importance of effective collaboration between physicians and NPs, said Darrell Ranum, vice president for patient safety and risk management for The Doctors Co. Below, legal experts share six ways to strengthen the physician-nurse relationship and at the same time, reduce liability:
 

1. Foster open dialogue. Cultivating a comfortable environment where nurses and physicians feel at ease sharing concerns and problems is a key step, says Louise B. Andrew, MD, JD, a physician and attorney who specializes in litigation stress management. A common scenario is a nurse who notices an abnormal vital sign but fails to mention it to the supervising physician because they feel they can handle it themselves or because they believe the doctor is too busy or too tired to be bothered, she said. The patient’s condition then worsens, resulting in a poor outcome that could have been avoided with better communication among providers. Delayed/wrong diagnosis accounted for 41% of claims against primary care physicians and 48% of claims against NPs in The Doctors Company study.

2. Stick to the scope. When hiring an NP, make sure their scope of practice is clearly understood by all parties and respect their limitations, said Melanie L. Balestra, a Newport Beach, Calif., attorney and nurse practitioner who represents health providers.

3. Preplan reviews. Early in the doctor-NP relationship, discuss and decide what type of medical cases warrant physician review, Mr. Ranum said. This includes agreeing on the type of patient conditions that will require a physician review and determining the types and percentage of medical records the doctor will evaluate, he said.

“The numbers should be higher at the beginning of the relationship until the physician gains an understanding of the NP’s experience and competence,” Mr. Ranum said. “Setting expectations will open the door to more frequent and more effective communication.”

NPs, meanwhile, should feel confident in requesting the physician’s assistance when a patient’s presentation is complex or a patient has returned with the same complaints, he added.
 

4. Convene regularly. Schedule regular meetings to catch up and discuss patient cases – not just when something goes awry, said Ms. Balestra. During weekly or monthly meetings, physicians, NPs, and other team members can converse in a more relaxed atmosphere and share any concerns or ideas for improvements.

“Have a meeting, whether by phone or in person, just to see how things are going,” she said. “That way, the NP may be able to take some things off the plate for the physician and the physician can see how [he or she] can assist the NP.”

Short huddles at the start of each day also help clinicians and staff prepare for patients and discuss approaches to managing complex conditions or challenging patient personalities, Mr. Ranum said.

“It is often helpful to debrief on patients who were seen during that day and who represent complex conditions,” he said. “Physicians may see opportunities to improve care following the NP’s assessment and diagnosis.”
 

5. Consider noncompliant policy. Create a noncompliant patient policy and work together to address uncooperative patients. Noncompliant patients are a top lawsuit risk, Ms. Balestra said. A noncompliant patient for instance, may provide conflicting information to different health professionals or attempt to blame providers for adverse events, she said.

“Your noncompliant patient is your easiest patient for a lawsuit because they’re not following [instructions] and then something happens, and they say, ‘It’s your fault, you didn’t treat me right.’”

Physician and NPs should be on the same page about noncompliant patients, including taking time to discuss when and how to terminate them from the practice if necessary, she said. Consistent documentation about patients by both physician and NPs is also critical, experts emphasize. Insufficient or lack of documentation led to patient injuries in 17% of cases against primary care doctors and in 19% of cases against NPs in The Doctors Company study.
 

6. Keep patients out of it. When disagreements or grievances occur, discuss the problem in private and ensure all staff members do the same, Dr. Andrew said. Refrain from letting anger or annoyance with another team member carry into patient care or worse, trigger a negative comment about a staff member in front of a patient, she said.

“All it takes is for something to go wrong and a patient or family who has heard such sentiments is tuned into the fact there may be some culpability,” she said. “This is probably a key factor in many a claimant’s decision to seek redress for a bad outcome.”

Instead, address problems or differences as soon as possible and work toward a resolution. It may help to create a conflict resolution policy that outlines behavioral expectations from all team members and suggested solutions when concerns arise.

“We have to put our egos aside,” Ms. Balestra said. “The ultimate goal is the best care of the patient.”

Positive relationships between physicians and nurses not only make for a smoother work environment, they also may reduce medical errors and lower the risk of lawsuits.

A recent study of closed claims by national medical malpractice insurer The Doctors Company found that poor physician oversight is a key contributor to lawsuits against nurses. Investigators analyzed 67 nurse practitioner (NP) claims from January 2011 to December 2016 and compared them with 1,358 claims against primary care physicians during the same time period.

Diagnostic and medication errors were the most common allegations against NPs, the study found, a trend that matched the most frequent allegations against primary care (internal medicine and family medicine) doctors. Top administrative factors that prompted lawsuits against nurses included inadequate physician supervision, failure to adhere to scope of practice, and absence of or deviation from written protocols.

The findings illustrate the importance of effective collaboration between physicians and NPs, said Darrell Ranum, vice president for patient safety and risk management for The Doctors Co. Below, legal experts share six ways to strengthen the physician-nurse relationship and at the same time, reduce liability:
 

1. Foster open dialogue. Cultivating a comfortable environment where nurses and physicians feel at ease sharing concerns and problems is a key step, says Louise B. Andrew, MD, JD, a physician and attorney who specializes in litigation stress management. A common scenario is a nurse who notices an abnormal vital sign but fails to mention it to the supervising physician because they feel they can handle it themselves or because they believe the doctor is too busy or too tired to be bothered, she said. The patient’s condition then worsens, resulting in a poor outcome that could have been avoided with better communication among providers. Delayed/wrong diagnosis accounted for 41% of claims against primary care physicians and 48% of claims against NPs in The Doctors Company study.

2. Stick to the scope. When hiring an NP, make sure their scope of practice is clearly understood by all parties and respect their limitations, said Melanie L. Balestra, a Newport Beach, Calif., attorney and nurse practitioner who represents health providers.

3. Preplan reviews. Early in the doctor-NP relationship, discuss and decide what type of medical cases warrant physician review, Mr. Ranum said. This includes agreeing on the type of patient conditions that will require a physician review and determining the types and percentage of medical records the doctor will evaluate, he said.

“The numbers should be higher at the beginning of the relationship until the physician gains an understanding of the NP’s experience and competence,” Mr. Ranum said. “Setting expectations will open the door to more frequent and more effective communication.”

NPs, meanwhile, should feel confident in requesting the physician’s assistance when a patient’s presentation is complex or a patient has returned with the same complaints, he added.
 

4. Convene regularly. Schedule regular meetings to catch up and discuss patient cases – not just when something goes awry, said Ms. Balestra. During weekly or monthly meetings, physicians, NPs, and other team members can converse in a more relaxed atmosphere and share any concerns or ideas for improvements.

“Have a meeting, whether by phone or in person, just to see how things are going,” she said. “That way, the NP may be able to take some things off the plate for the physician and the physician can see how [he or she] can assist the NP.”

Short huddles at the start of each day also help clinicians and staff prepare for patients and discuss approaches to managing complex conditions or challenging patient personalities, Mr. Ranum said.

“It is often helpful to debrief on patients who were seen during that day and who represent complex conditions,” he said. “Physicians may see opportunities to improve care following the NP’s assessment and diagnosis.”
 

5. Consider noncompliant policy. Create a noncompliant patient policy and work together to address uncooperative patients. Noncompliant patients are a top lawsuit risk, Ms. Balestra said. A noncompliant patient for instance, may provide conflicting information to different health professionals or attempt to blame providers for adverse events, she said.

“Your noncompliant patient is your easiest patient for a lawsuit because they’re not following [instructions] and then something happens, and they say, ‘It’s your fault, you didn’t treat me right.’”

Physician and NPs should be on the same page about noncompliant patients, including taking time to discuss when and how to terminate them from the practice if necessary, she said. Consistent documentation about patients by both physician and NPs is also critical, experts emphasize. Insufficient or lack of documentation led to patient injuries in 17% of cases against primary care doctors and in 19% of cases against NPs in The Doctors Company study.
 

6. Keep patients out of it. When disagreements or grievances occur, discuss the problem in private and ensure all staff members do the same, Dr. Andrew said. Refrain from letting anger or annoyance with another team member carry into patient care or worse, trigger a negative comment about a staff member in front of a patient, she said.

“All it takes is for something to go wrong and a patient or family who has heard such sentiments is tuned into the fact there may be some culpability,” she said. “This is probably a key factor in many a claimant’s decision to seek redress for a bad outcome.”

Instead, address problems or differences as soon as possible and work toward a resolution. It may help to create a conflict resolution policy that outlines behavioral expectations from all team members and suggested solutions when concerns arise.

“We have to put our egos aside,” Ms. Balestra said. “The ultimate goal is the best care of the patient.”

Positive relationships between physicians and nurses not only make for a smoother work environment, they also may reduce medical errors and lower the risk of lawsuits.

A recent study of closed claims by national medical malpractice insurer The Doctors Company found that poor physician oversight is a key contributor to lawsuits against nurses. Investigators analyzed 67 nurse practitioner (NP) claims from January 2011 to December 2016 and compared them with 1,358 claims against primary care physicians during the same time period.

Diagnostic and medication errors were the most common allegations against NPs, the study found, a trend that matched the most frequent allegations against primary care (internal medicine and family medicine) doctors. Top administrative factors that prompted lawsuits against nurses included inadequate physician supervision, failure to adhere to scope of practice, and absence of or deviation from written protocols.

The findings illustrate the importance of effective collaboration between physicians and NPs, said Darrell Ranum, vice president for patient safety and risk management for The Doctors Co. Below, legal experts share six ways to strengthen the physician-nurse relationship and at the same time, reduce liability:
 

1. Foster open dialogue. Cultivating a comfortable environment where nurses and physicians feel at ease sharing concerns and problems is a key step, says Louise B. Andrew, MD, JD, a physician and attorney who specializes in litigation stress management. A common scenario is a nurse who notices an abnormal vital sign but fails to mention it to the supervising physician because they feel they can handle it themselves or because they believe the doctor is too busy or too tired to be bothered, she said. The patient’s condition then worsens, resulting in a poor outcome that could have been avoided with better communication among providers. Delayed/wrong diagnosis accounted for 41% of claims against primary care physicians and 48% of claims against NPs in The Doctors Company study.

2. Stick to the scope. When hiring an NP, make sure their scope of practice is clearly understood by all parties and respect their limitations, said Melanie L. Balestra, a Newport Beach, Calif., attorney and nurse practitioner who represents health providers.

3. Preplan reviews. Early in the doctor-NP relationship, discuss and decide what type of medical cases warrant physician review, Mr. Ranum said. This includes agreeing on the type of patient conditions that will require a physician review and determining the types and percentage of medical records the doctor will evaluate, he said.

“The numbers should be higher at the beginning of the relationship until the physician gains an understanding of the NP’s experience and competence,” Mr. Ranum said. “Setting expectations will open the door to more frequent and more effective communication.”

NPs, meanwhile, should feel confident in requesting the physician’s assistance when a patient’s presentation is complex or a patient has returned with the same complaints, he added.
 

4. Convene regularly. Schedule regular meetings to catch up and discuss patient cases – not just when something goes awry, said Ms. Balestra. During weekly or monthly meetings, physicians, NPs, and other team members can converse in a more relaxed atmosphere and share any concerns or ideas for improvements.

“Have a meeting, whether by phone or in person, just to see how things are going,” she said. “That way, the NP may be able to take some things off the plate for the physician and the physician can see how [he or she] can assist the NP.”

Short huddles at the start of each day also help clinicians and staff prepare for patients and discuss approaches to managing complex conditions or challenging patient personalities, Mr. Ranum said.

“It is often helpful to debrief on patients who were seen during that day and who represent complex conditions,” he said. “Physicians may see opportunities to improve care following the NP’s assessment and diagnosis.”
 

5. Consider noncompliant policy. Create a noncompliant patient policy and work together to address uncooperative patients. Noncompliant patients are a top lawsuit risk, Ms. Balestra said. A noncompliant patient for instance, may provide conflicting information to different health professionals or attempt to blame providers for adverse events, she said.

“Your noncompliant patient is your easiest patient for a lawsuit because they’re not following [instructions] and then something happens, and they say, ‘It’s your fault, you didn’t treat me right.’”

Physician and NPs should be on the same page about noncompliant patients, including taking time to discuss when and how to terminate them from the practice if necessary, she said. Consistent documentation about patients by both physician and NPs is also critical, experts emphasize. Insufficient or lack of documentation led to patient injuries in 17% of cases against primary care doctors and in 19% of cases against NPs in The Doctors Company study.
 

6. Keep patients out of it. When disagreements or grievances occur, discuss the problem in private and ensure all staff members do the same, Dr. Andrew said. Refrain from letting anger or annoyance with another team member carry into patient care or worse, trigger a negative comment about a staff member in front of a patient, she said.

“All it takes is for something to go wrong and a patient or family who has heard such sentiments is tuned into the fact there may be some culpability,” she said. “This is probably a key factor in many a claimant’s decision to seek redress for a bad outcome.”

Instead, address problems or differences as soon as possible and work toward a resolution. It may help to create a conflict resolution policy that outlines behavioral expectations from all team members and suggested solutions when concerns arise.

“We have to put our egos aside,” Ms. Balestra said. “The ultimate goal is the best care of the patient.”

A study suggests that delirium in older adults is a postoperative variable that should be included in surgical quality registries, outcome measures, and assessment of hospital performance.

Lead author Julia R. Berian, MD, of the University of Chicago Medical Center and her colleagues wrote, “Postoperative delirium has been associated with mortality, morbidity, prolonged length of stay, and increased costs of care. Furthermore, postoperative delirium may be associated with long-term cognitive and functional decline. However, postoperative delirium has not been incorporated as an outcome measure into major surgical quality registries. Approximately one-third of hospitalized delirium is believed to be preventable, making postoperative delirium an ideal target for surgical quality improvement efforts,” Dr. Berian and her colleagues reported in the Annals of Surgery.

Study authors noted that screening for postoperative delirium in older adults is likely in the best interests of patients. However, they also mentioned that such screening may identify cases of postoperative delirium that were previously unrecognized, resulting in higher rates. In addition, the inclusion of only ACS NSQIP hospitals and the voluntary participation may mean a biased dataset. No one delirium prevention intervention was implemented across the hospitals and so the study doesn’t indicate why some hospitals are more successful than are others. Chart-based identification of patients who have delirium needs further study to assess validity.

Authors concluded that one solution may be to “standardize and consistently employ delirium screening in high-risk patients across hospitals, as has been advocated by a coalition of interdisciplinary experts in geriatric care.”

This project is funded in part by a grant from the John A. Hartford Foundation. The authors declare no conflict of interests.

SOURCE: Berlan JR et al. Ann Surg. 2017 July 24. doi: 10.1097/SLA.0000000000002436

A study suggests that delirium in older adults is a postoperative variable that should be included in surgical quality registries, outcome measures, and assessment of hospital performance.

Lead author Julia R. Berian, MD, of the University of Chicago Medical Center and her colleagues wrote, “Postoperative delirium has been associated with mortality, morbidity, prolonged length of stay, and increased costs of care. Furthermore, postoperative delirium may be associated with long-term cognitive and functional decline. However, postoperative delirium has not been incorporated as an outcome measure into major surgical quality registries. Approximately one-third of hospitalized delirium is believed to be preventable, making postoperative delirium an ideal target for surgical quality improvement efforts,” Dr. Berian and her colleagues reported in the Annals of Surgery.

Study authors noted that screening for postoperative delirium in older adults is likely in the best interests of patients. However, they also mentioned that such screening may identify cases of postoperative delirium that were previously unrecognized, resulting in higher rates. In addition, the inclusion of only ACS NSQIP hospitals and the voluntary participation may mean a biased dataset. No one delirium prevention intervention was implemented across the hospitals and so the study doesn’t indicate why some hospitals are more successful than are others. Chart-based identification of patients who have delirium needs further study to assess validity.

Authors concluded that one solution may be to “standardize and consistently employ delirium screening in high-risk patients across hospitals, as has been advocated by a coalition of interdisciplinary experts in geriatric care.”

This project is funded in part by a grant from the John A. Hartford Foundation. The authors declare no conflict of interests.

SOURCE: Berlan JR et al. Ann Surg. 2017 July 24. doi: 10.1097/SLA.0000000000002436

A study suggests that delirium in older adults is a postoperative variable that should be included in surgical quality registries, outcome measures, and assessment of hospital performance.

Lead author Julia R. Berian, MD, of the University of Chicago Medical Center and her colleagues wrote, “Postoperative delirium has been associated with mortality, morbidity, prolonged length of stay, and increased costs of care. Furthermore, postoperative delirium may be associated with long-term cognitive and functional decline. However, postoperative delirium has not been incorporated as an outcome measure into major surgical quality registries. Approximately one-third of hospitalized delirium is believed to be preventable, making postoperative delirium an ideal target for surgical quality improvement efforts,” Dr. Berian and her colleagues reported in the Annals of Surgery.

Study authors noted that screening for postoperative delirium in older adults is likely in the best interests of patients. However, they also mentioned that such screening may identify cases of postoperative delirium that were previously unrecognized, resulting in higher rates. In addition, the inclusion of only ACS NSQIP hospitals and the voluntary participation may mean a biased dataset. No one delirium prevention intervention was implemented across the hospitals and so the study doesn’t indicate why some hospitals are more successful than are others. Chart-based identification of patients who have delirium needs further study to assess validity.

Authors concluded that one solution may be to “standardize and consistently employ delirium screening in high-risk patients across hospitals, as has been advocated by a coalition of interdisciplinary experts in geriatric care.”

This project is funded in part by a grant from the John A. Hartford Foundation. The authors declare no conflict of interests.

SOURCE: Berlan JR et al. Ann Surg. 2017 July 24. doi: 10.1097/SLA.0000000000002436

Physicians may finally have some clarity on payment for inpatient administration of two chimeric antigen receptor–T-cell therapies if a proposed rule from the Centers of Medicare & Medicaid Services becomes final.

The agency is seeking to assign ICD-10-PCS codes XW033C3 and XW043C3 to the use of axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) in the inpatient setting for fiscal year 2019. The agency is also considering the creation of a new Medicare Severity–Diagnosis Related Group (MS-DRG) code for procedures involving the use of chimeric antigen receptor (CAR) T-cell therapy drugs. The proposal was published in May in the Federal Register.

The proposal demonstrates that CMS is listening to physicians’ concerns about CAR T payments and working to provide a more reasonable framework, said Stephanie Farnia, director of health policy and strategic relations for the American Society for Blood and Marrow Transplantation.

“The primary point of significance is that CAR-T care episodes should be assigned to a specific MS-DRG in FY2019, which will give physicians a clearer sense of inpatient reimbursement in advance,” she said in an interview.

Uncertainty about inpatient payment for administration of the two approved CAR-T therapies have been a lingering concern of specialists using, or interested in using, the therapies. In April 2018, CMS announced payment rates for outpatient administration of the two drugs, settling on $395,380 for axicabtagene ciloleucel and $500,839 for tisagenlecleucel. The two medications have list prices of $373,000 and $475,000, respectively.

However, physicians noted that even if the drugs are first administered in the outpatient setting, inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted in order to be monitored for serious side effects. In such cases, all payments will become part of the inpatient stay per CMS’ 3-day payment window rule.

In outlining the most recent payment proposal, CMS stated that its clinical advisers believe that patients receiving treatment with CAR T-cell therapy would have similar clinical characteristics and comorbidities as patients treated with autologous bone marrow transplant therapy, who are currently assigned to MS-DRG 016 “Autologous Bone Marrow Transplant with CC/MCC”. Therefore, CMS officials said they are suggesting ICD-10-PCS procedure codes XW033C3 and XW043C3 to pre-MDC MS-DRG 016. Additionally, the agency is proposing to revise the title of MS-DRG 016 from “Autologous Bone Marrow Transplant with CC/MCC” to “Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy.”

However, the agency emphasized that it invites public comment on alternative payment approaches for CAR T-cell therapies in the context of the pending, new technology add-on payment applications by the CAR-T drugmakers Novartis Pharmaceuticals and Kite Pharma. If approved in the final rule, the technology add-on payments would provide an additional and separate payment equivalent to up to 50% of the product cost plus the MS-DRG payment received for the episode of care.

Other items in the proposed rule include approximate base payments for hematopoietic stem cell transplantation for fiscal 2019, which starts Oct. 1, 2018. The approximate per unit payment is $5,498, which translates to a total base payment of $64,790 for allogeneic bone marrow transplant (MS-DRG 014) for instance. In an American Society for Blood and Marrow Transplantation blog, Ms. Farnia outlined the approximate base weights and estimated reimbursements calculated from the rule.

CMS did not make any changes to the payment model for allogeneic hematopoietic cell transplantation despite continued requests by physicians for donor acquisition charges. Ms. Farnia encourages doctors to express to CMS the importance of such reimbursement during the comment period.

Public comments on the inpatient payment proposal are due by June 25, 2018, and can be submitted at https://www.regulations.gov. Additionally, CMS will convene a meeting of the Medicare Evidence Development & Coverage Advisory Committee on August 22, 2018, to consider whether to issue a national coverage policy for CAR T-cell therapies that would set consistent parameters for patient access.

Physicians may finally have some clarity on payment for inpatient administration of two chimeric antigen receptor–T-cell therapies if a proposed rule from the Centers of Medicare & Medicaid Services becomes final.

The agency is seeking to assign ICD-10-PCS codes XW033C3 and XW043C3 to the use of axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) in the inpatient setting for fiscal year 2019. The agency is also considering the creation of a new Medicare Severity–Diagnosis Related Group (MS-DRG) code for procedures involving the use of chimeric antigen receptor (CAR) T-cell therapy drugs. The proposal was published in May in the Federal Register.

The proposal demonstrates that CMS is listening to physicians’ concerns about CAR T payments and working to provide a more reasonable framework, said Stephanie Farnia, director of health policy and strategic relations for the American Society for Blood and Marrow Transplantation.

“The primary point of significance is that CAR-T care episodes should be assigned to a specific MS-DRG in FY2019, which will give physicians a clearer sense of inpatient reimbursement in advance,” she said in an interview.

Uncertainty about inpatient payment for administration of the two approved CAR-T therapies have been a lingering concern of specialists using, or interested in using, the therapies. In April 2018, CMS announced payment rates for outpatient administration of the two drugs, settling on $395,380 for axicabtagene ciloleucel and $500,839 for tisagenlecleucel. The two medications have list prices of $373,000 and $475,000, respectively.

However, physicians noted that even if the drugs are first administered in the outpatient setting, inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted in order to be monitored for serious side effects. In such cases, all payments will become part of the inpatient stay per CMS’ 3-day payment window rule.

In outlining the most recent payment proposal, CMS stated that its clinical advisers believe that patients receiving treatment with CAR T-cell therapy would have similar clinical characteristics and comorbidities as patients treated with autologous bone marrow transplant therapy, who are currently assigned to MS-DRG 016 “Autologous Bone Marrow Transplant with CC/MCC”. Therefore, CMS officials said they are suggesting ICD-10-PCS procedure codes XW033C3 and XW043C3 to pre-MDC MS-DRG 016. Additionally, the agency is proposing to revise the title of MS-DRG 016 from “Autologous Bone Marrow Transplant with CC/MCC” to “Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy.”

However, the agency emphasized that it invites public comment on alternative payment approaches for CAR T-cell therapies in the context of the pending, new technology add-on payment applications by the CAR-T drugmakers Novartis Pharmaceuticals and Kite Pharma. If approved in the final rule, the technology add-on payments would provide an additional and separate payment equivalent to up to 50% of the product cost plus the MS-DRG payment received for the episode of care.

Other items in the proposed rule include approximate base payments for hematopoietic stem cell transplantation for fiscal 2019, which starts Oct. 1, 2018. The approximate per unit payment is $5,498, which translates to a total base payment of $64,790 for allogeneic bone marrow transplant (MS-DRG 014) for instance. In an American Society for Blood and Marrow Transplantation blog, Ms. Farnia outlined the approximate base weights and estimated reimbursements calculated from the rule.

CMS did not make any changes to the payment model for allogeneic hematopoietic cell transplantation despite continued requests by physicians for donor acquisition charges. Ms. Farnia encourages doctors to express to CMS the importance of such reimbursement during the comment period.

Public comments on the inpatient payment proposal are due by June 25, 2018, and can be submitted at https://www.regulations.gov. Additionally, CMS will convene a meeting of the Medicare Evidence Development & Coverage Advisory Committee on August 22, 2018, to consider whether to issue a national coverage policy for CAR T-cell therapies that would set consistent parameters for patient access.

Physicians may finally have some clarity on payment for inpatient administration of two chimeric antigen receptor–T-cell therapies if a proposed rule from the Centers of Medicare & Medicaid Services becomes final.

The agency is seeking to assign ICD-10-PCS codes XW033C3 and XW043C3 to the use of axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) in the inpatient setting for fiscal year 2019. The agency is also considering the creation of a new Medicare Severity–Diagnosis Related Group (MS-DRG) code for procedures involving the use of chimeric antigen receptor (CAR) T-cell therapy drugs. The proposal was published in May in the Federal Register.

The proposal demonstrates that CMS is listening to physicians’ concerns about CAR T payments and working to provide a more reasonable framework, said Stephanie Farnia, director of health policy and strategic relations for the American Society for Blood and Marrow Transplantation.

“The primary point of significance is that CAR-T care episodes should be assigned to a specific MS-DRG in FY2019, which will give physicians a clearer sense of inpatient reimbursement in advance,” she said in an interview.

Uncertainty about inpatient payment for administration of the two approved CAR-T therapies have been a lingering concern of specialists using, or interested in using, the therapies. In April 2018, CMS announced payment rates for outpatient administration of the two drugs, settling on $395,380 for axicabtagene ciloleucel and $500,839 for tisagenlecleucel. The two medications have list prices of $373,000 and $475,000, respectively.

However, physicians noted that even if the drugs are first administered in the outpatient setting, inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted in order to be monitored for serious side effects. In such cases, all payments will become part of the inpatient stay per CMS’ 3-day payment window rule.

In outlining the most recent payment proposal, CMS stated that its clinical advisers believe that patients receiving treatment with CAR T-cell therapy would have similar clinical characteristics and comorbidities as patients treated with autologous bone marrow transplant therapy, who are currently assigned to MS-DRG 016 “Autologous Bone Marrow Transplant with CC/MCC”. Therefore, CMS officials said they are suggesting ICD-10-PCS procedure codes XW033C3 and XW043C3 to pre-MDC MS-DRG 016. Additionally, the agency is proposing to revise the title of MS-DRG 016 from “Autologous Bone Marrow Transplant with CC/MCC” to “Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy.”

However, the agency emphasized that it invites public comment on alternative payment approaches for CAR T-cell therapies in the context of the pending, new technology add-on payment applications by the CAR-T drugmakers Novartis Pharmaceuticals and Kite Pharma. If approved in the final rule, the technology add-on payments would provide an additional and separate payment equivalent to up to 50% of the product cost plus the MS-DRG payment received for the episode of care.

Other items in the proposed rule include approximate base payments for hematopoietic stem cell transplantation for fiscal 2019, which starts Oct. 1, 2018. The approximate per unit payment is $5,498, which translates to a total base payment of $64,790 for allogeneic bone marrow transplant (MS-DRG 014) for instance. In an American Society for Blood and Marrow Transplantation blog, Ms. Farnia outlined the approximate base weights and estimated reimbursements calculated from the rule.

CMS did not make any changes to the payment model for allogeneic hematopoietic cell transplantation despite continued requests by physicians for donor acquisition charges. Ms. Farnia encourages doctors to express to CMS the importance of such reimbursement during the comment period.

Public comments on the inpatient payment proposal are due by June 25, 2018, and can be submitted at https://www.regulations.gov. Additionally, CMS will convene a meeting of the Medicare Evidence Development & Coverage Advisory Committee on August 22, 2018, to consider whether to issue a national coverage policy for CAR T-cell therapies that would set consistent parameters for patient access.

In a study of anesthesia medical malpractice cases involving gastrointestinal endoscopies, endoscopic retrograde cholangiopancreatography (ERCP) was the procedure that most often resulted in payouts to plaintiffs.

Lead author Alexander B. Stone, MD, of Brigham and Women’s Hospital, Boston, and his colleagues examined 58 malpractice cases involving anesthesia providers between January 2007 and December 2016 from the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System, a database representing about 30% of annual malpractice cases in the United States. Of these cases, 48% were associated with esophagogastroduodenoscopy, 19% involved ERCP, 14% resulted from colonoscopies, 14% stemmed from combined esophagogastroduodenoscopy and colonoscopy, and 5% involved endoscopic ultrasound. Investigators found that 91% of ERCP cases resulted in a payment to plaintiffs, compared with 37.5% of colonoscopy cases, 25% of combined esophagogastroduodenoscopy/colonoscopy cases, 21% of esophagogastroduodenoscopy cases, and 0% of endoscopic ultrasound cases, according to the study published in the April 24 Journal of Clinical Anesthesia.

Of all 58 claims, the mean payment was $99,754. When restricted to only claims that resulted in payment (22 cases), the mean payment rose to $275,510, and the median payment was $7,170. No significant difference existed in the percentage of cases that resulted in payment between high-, middle-, and low-severity cases.

The most common contributing factors to the alleged anesthesiology-related adverse events were lack of technical skill, clinical judgment errors, communication mishaps, and documentation problems. Within the technical skill category, technical problems from a known complication, poor technique, and failure to resuscitate were frequent contributing factors. Within the clinical judgment category, failure to monitor the physiological status of the patient was the most common subcategory noted.

Oversedation was another possible contributing factor in 62.5% of the cases, investigators found. For the purposes of this study, oversedation was defined as unexpected changes in the physiological state of the patient and/or unplanned intubation for a patient undergoing monitored anesthesia care. But the authors concluded that oversedation alone did not lead to liability for anesthesia providers practicing in the endoscopy suite; rather, it was allegations of technical and clinical judgment failures, such as the inability to recognize acute clinical deterioration or manage difficulty, that most often resulted in settlements to plaintiffs. The analysis also suggested that even when adverse events occured in the endoscopy suite, anesthesiologists were less likely to be found liable when highly trained and well-equipped anesthesia providers were readily available.

The authors concluded that it is critical to have a well-prepared anesthesia provider when medically complex patients are undergoing endoscopic procedures.

The authors had no disclosures.

SOURCE: Stone AB et al. J Clin Anesth. 2018 Apr 24;48:15-20.

* This story was updated on June 7, 2018.

In a study of anesthesia medical malpractice cases involving gastrointestinal endoscopies, endoscopic retrograde cholangiopancreatography (ERCP) was the procedure that most often resulted in payouts to plaintiffs.

Lead author Alexander B. Stone, MD, of Brigham and Women’s Hospital, Boston, and his colleagues examined 58 malpractice cases involving anesthesia providers between January 2007 and December 2016 from the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System, a database representing about 30% of annual malpractice cases in the United States. Of these cases, 48% were associated with esophagogastroduodenoscopy, 19% involved ERCP, 14% resulted from colonoscopies, 14% stemmed from combined esophagogastroduodenoscopy and colonoscopy, and 5% involved endoscopic ultrasound. Investigators found that 91% of ERCP cases resulted in a payment to plaintiffs, compared with 37.5% of colonoscopy cases, 25% of combined esophagogastroduodenoscopy/colonoscopy cases, 21% of esophagogastroduodenoscopy cases, and 0% of endoscopic ultrasound cases, according to the study published in the April 24 Journal of Clinical Anesthesia.

Of all 58 claims, the mean payment was $99,754. When restricted to only claims that resulted in payment (22 cases), the mean payment rose to $275,510, and the median payment was $7,170. No significant difference existed in the percentage of cases that resulted in payment between high-, middle-, and low-severity cases.

The most common contributing factors to the alleged anesthesiology-related adverse events were lack of technical skill, clinical judgment errors, communication mishaps, and documentation problems. Within the technical skill category, technical problems from a known complication, poor technique, and failure to resuscitate were frequent contributing factors. Within the clinical judgment category, failure to monitor the physiological status of the patient was the most common subcategory noted.

Oversedation was another possible contributing factor in 62.5% of the cases, investigators found. For the purposes of this study, oversedation was defined as unexpected changes in the physiological state of the patient and/or unplanned intubation for a patient undergoing monitored anesthesia care. But the authors concluded that oversedation alone did not lead to liability for anesthesia providers practicing in the endoscopy suite; rather, it was allegations of technical and clinical judgment failures, such as the inability to recognize acute clinical deterioration or manage difficulty, that most often resulted in settlements to plaintiffs. The analysis also suggested that even when adverse events occured in the endoscopy suite, anesthesiologists were less likely to be found liable when highly trained and well-equipped anesthesia providers were readily available.

The authors concluded that it is critical to have a well-prepared anesthesia provider when medically complex patients are undergoing endoscopic procedures.

The authors had no disclosures.

SOURCE: Stone AB et al. J Clin Anesth. 2018 Apr 24;48:15-20.

* This story was updated on June 7, 2018.

In a study of anesthesia medical malpractice cases involving gastrointestinal endoscopies, endoscopic retrograde cholangiopancreatography (ERCP) was the procedure that most often resulted in payouts to plaintiffs.

Lead author Alexander B. Stone, MD, of Brigham and Women’s Hospital, Boston, and his colleagues examined 58 malpractice cases involving anesthesia providers between January 2007 and December 2016 from the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System, a database representing about 30% of annual malpractice cases in the United States. Of these cases, 48% were associated with esophagogastroduodenoscopy, 19% involved ERCP, 14% resulted from colonoscopies, 14% stemmed from combined esophagogastroduodenoscopy and colonoscopy, and 5% involved endoscopic ultrasound. Investigators found that 91% of ERCP cases resulted in a payment to plaintiffs, compared with 37.5% of colonoscopy cases, 25% of combined esophagogastroduodenoscopy/colonoscopy cases, 21% of esophagogastroduodenoscopy cases, and 0% of endoscopic ultrasound cases, according to the study published in the April 24 Journal of Clinical Anesthesia.

Of all 58 claims, the mean payment was $99,754. When restricted to only claims that resulted in payment (22 cases), the mean payment rose to $275,510, and the median payment was $7,170. No significant difference existed in the percentage of cases that resulted in payment between high-, middle-, and low-severity cases.

The most common contributing factors to the alleged anesthesiology-related adverse events were lack of technical skill, clinical judgment errors, communication mishaps, and documentation problems. Within the technical skill category, technical problems from a known complication, poor technique, and failure to resuscitate were frequent contributing factors. Within the clinical judgment category, failure to monitor the physiological status of the patient was the most common subcategory noted.

Oversedation was another possible contributing factor in 62.5% of the cases, investigators found. For the purposes of this study, oversedation was defined as unexpected changes in the physiological state of the patient and/or unplanned intubation for a patient undergoing monitored anesthesia care. But the authors concluded that oversedation alone did not lead to liability for anesthesia providers practicing in the endoscopy suite; rather, it was allegations of technical and clinical judgment failures, such as the inability to recognize acute clinical deterioration or manage difficulty, that most often resulted in settlements to plaintiffs. The analysis also suggested that even when adverse events occured in the endoscopy suite, anesthesiologists were less likely to be found liable when highly trained and well-equipped anesthesia providers were readily available.

The authors concluded that it is critical to have a well-prepared anesthesia provider when medically complex patients are undergoing endoscopic procedures.

The authors had no disclosures.

SOURCE: Stone AB et al. J Clin Anesth. 2018 Apr 24;48:15-20.

* This story was updated on June 7, 2018.

A group of oncologists is urging the Food and Drug Administration to review a new, flat-pricing strategy for all doses of ibrutinib (Imbruvica), calling the shift potentially dangerous for patients.

Pharmacyclics, an AbbVie company based in Sunnyvale, Calif., recently introduced a new, single-tablet formulation of ibrutinib in varying strengths (140 mg, 280 mg, 420 mg, and 560 mg) and set a flat price across all doses. At the same time, they removed the drug’s original 140-mg capsules – which cost about a third of the new, flat-rate price – from the market. The drug company says the new, single-tablet formulations give patients a convenient, once-a-day dosing regimen that could improve therapy adherence.

Ibrutinib is approved to treat a number of hematologic cancers, including mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom macroglobulinemia, and marginal zone lymphoma.

But in an April letter published in the Cancer Letter, nine physicians from cancer centers across the country expressed concern that the new dosage and pricing scheme could compromise patient safety and limit doctors’ dosage decisions.

“While the prescribing information is complex, prescribers and patients have had the flexibility of taking anywhere from one to four 140-mg capsules, readily permitting dose reduction to all but the lowest labeled dose [70 mg],” the authors wrote. “However, the new formulation and its associated marketing scheme [YOU&i] greatly impact the ability of the prescriber and patient to follow the prescribing information, resulting in the potential for a greatly enhanced risk of toxicities relative to that observed in the clinical trials which utilized multiples of the 140-mg capsules.”

The problems stem from a cancer drug that often requires dosage adjustments, the authors noted. The specific dosage for an ibrutinib patient depends on the indication, prior toxicities, concomitant medications, occurrence of ibrutinib intolerance, and current hepatic function. Because of such diverse criteria, dosage modifications are made frequently.

The new pricing system makes it harder for physicians to adjust the dose without running afoul of insurers and potentially affecting access for patients.

A group of oncologists is urging the Food and Drug Administration to review a new, flat-pricing strategy for all doses of ibrutinib (Imbruvica), calling the shift potentially dangerous for patients.

Pharmacyclics, an AbbVie company based in Sunnyvale, Calif., recently introduced a new, single-tablet formulation of ibrutinib in varying strengths (140 mg, 280 mg, 420 mg, and 560 mg) and set a flat price across all doses. At the same time, they removed the drug’s original 140-mg capsules – which cost about a third of the new, flat-rate price – from the market. The drug company says the new, single-tablet formulations give patients a convenient, once-a-day dosing regimen that could improve therapy adherence.

Ibrutinib is approved to treat a number of hematologic cancers, including mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom macroglobulinemia, and marginal zone lymphoma.

But in an April letter published in the Cancer Letter, nine physicians from cancer centers across the country expressed concern that the new dosage and pricing scheme could compromise patient safety and limit doctors’ dosage decisions.

“While the prescribing information is complex, prescribers and patients have had the flexibility of taking anywhere from one to four 140-mg capsules, readily permitting dose reduction to all but the lowest labeled dose [70 mg],” the authors wrote. “However, the new formulation and its associated marketing scheme [YOU&i] greatly impact the ability of the prescriber and patient to follow the prescribing information, resulting in the potential for a greatly enhanced risk of toxicities relative to that observed in the clinical trials which utilized multiples of the 140-mg capsules.”

The problems stem from a cancer drug that often requires dosage adjustments, the authors noted. The specific dosage for an ibrutinib patient depends on the indication, prior toxicities, concomitant medications, occurrence of ibrutinib intolerance, and current hepatic function. Because of such diverse criteria, dosage modifications are made frequently.

The new pricing system makes it harder for physicians to adjust the dose without running afoul of insurers and potentially affecting access for patients.

A group of oncologists is urging the Food and Drug Administration to review a new, flat-pricing strategy for all doses of ibrutinib (Imbruvica), calling the shift potentially dangerous for patients.

Pharmacyclics, an AbbVie company based in Sunnyvale, Calif., recently introduced a new, single-tablet formulation of ibrutinib in varying strengths (140 mg, 280 mg, 420 mg, and 560 mg) and set a flat price across all doses. At the same time, they removed the drug’s original 140-mg capsules – which cost about a third of the new, flat-rate price – from the market. The drug company says the new, single-tablet formulations give patients a convenient, once-a-day dosing regimen that could improve therapy adherence.

Ibrutinib is approved to treat a number of hematologic cancers, including mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom macroglobulinemia, and marginal zone lymphoma.

But in an April letter published in the Cancer Letter, nine physicians from cancer centers across the country expressed concern that the new dosage and pricing scheme could compromise patient safety and limit doctors’ dosage decisions.

“While the prescribing information is complex, prescribers and patients have had the flexibility of taking anywhere from one to four 140-mg capsules, readily permitting dose reduction to all but the lowest labeled dose [70 mg],” the authors wrote. “However, the new formulation and its associated marketing scheme [YOU&i] greatly impact the ability of the prescriber and patient to follow the prescribing information, resulting in the potential for a greatly enhanced risk of toxicities relative to that observed in the clinical trials which utilized multiples of the 140-mg capsules.”

The problems stem from a cancer drug that often requires dosage adjustments, the authors noted. The specific dosage for an ibrutinib patient depends on the indication, prior toxicities, concomitant medications, occurrence of ibrutinib intolerance, and current hepatic function. Because of such diverse criteria, dosage modifications are made frequently.

The new pricing system makes it harder for physicians to adjust the dose without running afoul of insurers and potentially affecting access for patients.

Officials at the Centers for Medicare & Medicaid Services announced reimbursement rates for outpatient administration of two chimeric antigen receptor (CAR) T-cell therapies, settling on a fee that is roughly the wholesale acquisition cost plus 6%.

The agency will pay $395,380 to those who administer axicabtagene ciloleucel (Yescarta) on an outpatient basis and $500,839 for outpatient use of tisagenlecleucel (Kymriah), a similar CAR T-cell therapy for cancer patients. The two drugs have list prices of $373,000 and $475,000, respectively.

Courtesy Novartis

Although CMS set the Medicare Part B copayment for axicabtagene ciloleucel at $79,076, the agency later clarified that out-of-pocket expenses for Medicare patients are capped at around $1,340 in 2018 – the amount of the inpatient hospital deductible.

The Medicare rate is a first step to being able to use and get paid for CAR T-cell therapies, said Richard T. Maziarz, MD, a bone marrow transplantation and blood cancer specialist at the Oregon Health and Science University Knight Cancer Institute in Portland. However, the rate is not as straight forward as it sounds, he pointed out.

“This is big news,” Dr. Maziarz said in an interview. “This allows us to start to deliver these therapies, but there is a risk: If we give this in the outpatient setting and someone ends up needing hospitalization, we may end up not being reimbursed for the drug product.”

That’s because of CMS’s 3-day payment window rule, Dr. Maziarz explained: If medical treatment is provided in an outpatient setting and the patient needs inpatient care within 72 hours, all payments prior to that 72-hour window become part of the inpatient stay, according to the rule. Inpatient reimbursement varies depending on treatment, previous patient comorbidities, and complications during their stay. Analysts say that inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted so doctors can monitor them for serious side effects.

“If I have a drug that costs me $373,000, what happens if I admit the patient?” Dr. Maziarz said. “I don’t get $373,000; I get between $8,000 and $18,000. So if we give this and someone gets sick in 48 hours, then we may be at risk for losing.”

On the inpatient side, Medicare payment for CAR T-cell therapy is currently bundled into the payment for the inpatient stay, rather than being paid separately. The drug manufacturers – Gilead Sciences and Novartis AG – have requested that CMS set a separate “new technology add-on payment,” but the agency has not yet issued a decision.

Courtesy Dr. Richard Maziarz

“The trend for 2018 is very much focusing on how to eliminate some of the profitability issues with first-generation CAR Ts because companies realize that manufacturing individualized treatments for each patient is not an ideal business model,” Dr. Xuan said in an interview.

More market competition is also in the forecast, particularly from smaller companies, Dr. Xuan said.

“What we are likely to see in the future is larger companies acquiring smaller ones once their CAR T technology has matured to a certain point,” she said. “We have seen it with the Gilead-Kite acquisition, as well as Celgene’s acquisition of Juno Therapeutics, and this trend will continue as long as smaller companies are able to develop proprietary next-generation CAR T technologies.”

Cost and accessibility remain key concerns with the therapies, especially for the Medicare population. Cost estimates have put the cost of CAR T-cell therapies as high as $1.5 million per patient.

“There remain unanswered questions about value and cost in older adults,” said Walid F. Gellad, MD, codirector for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “There are many life-saving treatments in the medical system that cost much less than this therapy. Presumably, its cost will go down as the indications expand and the experience with creating the CAR T cells improves. At least, one would hope.”

Time will tell how reimbursement plays out during clinical practice, but one thing is for certain: The current CAR T-cell therapies are only the beginning, Dr. Maziarz said.

“Genetically-engineered cell products are going to explode over the next decade,” he said. “This is not the end of the line, this is the starting point.”

Dr. Maziarz has received consulting fees from Novartis, Juno Therapeutics, and Kite Pharma. Dr. Heslop has received consulting fees from Novartis, has conducted research for Cell Medica and holds intellectual property rights/patents from Cell Medica, and has ownership interest in ViraCyte and Marker Therapeutics. Dr. Gellad reports grants from Express Scripts.

Officials at the Centers for Medicare & Medicaid Services announced reimbursement rates for outpatient administration of two chimeric antigen receptor (CAR) T-cell therapies, settling on a fee that is roughly the wholesale acquisition cost plus 6%.

The agency will pay $395,380 to those who administer axicabtagene ciloleucel (Yescarta) on an outpatient basis and $500,839 for outpatient use of tisagenlecleucel (Kymriah), a similar CAR T-cell therapy for cancer patients. The two drugs have list prices of $373,000 and $475,000, respectively.

Courtesy Novartis

Although CMS set the Medicare Part B copayment for axicabtagene ciloleucel at $79,076, the agency later clarified that out-of-pocket expenses for Medicare patients are capped at around $1,340 in 2018 – the amount of the inpatient hospital deductible.

The Medicare rate is a first step to being able to use and get paid for CAR T-cell therapies, said Richard T. Maziarz, MD, a bone marrow transplantation and blood cancer specialist at the Oregon Health and Science University Knight Cancer Institute in Portland. However, the rate is not as straight forward as it sounds, he pointed out.

“This is big news,” Dr. Maziarz said in an interview. “This allows us to start to deliver these therapies, but there is a risk: If we give this in the outpatient setting and someone ends up needing hospitalization, we may end up not being reimbursed for the drug product.”

That’s because of CMS’s 3-day payment window rule, Dr. Maziarz explained: If medical treatment is provided in an outpatient setting and the patient needs inpatient care within 72 hours, all payments prior to that 72-hour window become part of the inpatient stay, according to the rule. Inpatient reimbursement varies depending on treatment, previous patient comorbidities, and complications during their stay. Analysts say that inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted so doctors can monitor them for serious side effects.

“If I have a drug that costs me $373,000, what happens if I admit the patient?” Dr. Maziarz said. “I don’t get $373,000; I get between $8,000 and $18,000. So if we give this and someone gets sick in 48 hours, then we may be at risk for losing.”

On the inpatient side, Medicare payment for CAR T-cell therapy is currently bundled into the payment for the inpatient stay, rather than being paid separately. The drug manufacturers – Gilead Sciences and Novartis AG – have requested that CMS set a separate “new technology add-on payment,” but the agency has not yet issued a decision.

Courtesy Dr. Richard Maziarz

“The trend for 2018 is very much focusing on how to eliminate some of the profitability issues with first-generation CAR Ts because companies realize that manufacturing individualized treatments for each patient is not an ideal business model,” Dr. Xuan said in an interview.

More market competition is also in the forecast, particularly from smaller companies, Dr. Xuan said.

“What we are likely to see in the future is larger companies acquiring smaller ones once their CAR T technology has matured to a certain point,” she said. “We have seen it with the Gilead-Kite acquisition, as well as Celgene’s acquisition of Juno Therapeutics, and this trend will continue as long as smaller companies are able to develop proprietary next-generation CAR T technologies.”

Cost and accessibility remain key concerns with the therapies, especially for the Medicare population. Cost estimates have put the cost of CAR T-cell therapies as high as $1.5 million per patient.

“There remain unanswered questions about value and cost in older adults,” said Walid F. Gellad, MD, codirector for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “There are many life-saving treatments in the medical system that cost much less than this therapy. Presumably, its cost will go down as the indications expand and the experience with creating the CAR T cells improves. At least, one would hope.”

Time will tell how reimbursement plays out during clinical practice, but one thing is for certain: The current CAR T-cell therapies are only the beginning, Dr. Maziarz said.

“Genetically-engineered cell products are going to explode over the next decade,” he said. “This is not the end of the line, this is the starting point.”

Dr. Maziarz has received consulting fees from Novartis, Juno Therapeutics, and Kite Pharma. Dr. Heslop has received consulting fees from Novartis, has conducted research for Cell Medica and holds intellectual property rights/patents from Cell Medica, and has ownership interest in ViraCyte and Marker Therapeutics. Dr. Gellad reports grants from Express Scripts.

Officials at the Centers for Medicare & Medicaid Services announced reimbursement rates for outpatient administration of two chimeric antigen receptor (CAR) T-cell therapies, settling on a fee that is roughly the wholesale acquisition cost plus 6%.

The agency will pay $395,380 to those who administer axicabtagene ciloleucel (Yescarta) on an outpatient basis and $500,839 for outpatient use of tisagenlecleucel (Kymriah), a similar CAR T-cell therapy for cancer patients. The two drugs have list prices of $373,000 and $475,000, respectively.

Courtesy Novartis

Although CMS set the Medicare Part B copayment for axicabtagene ciloleucel at $79,076, the agency later clarified that out-of-pocket expenses for Medicare patients are capped at around $1,340 in 2018 – the amount of the inpatient hospital deductible.

The Medicare rate is a first step to being able to use and get paid for CAR T-cell therapies, said Richard T. Maziarz, MD, a bone marrow transplantation and blood cancer specialist at the Oregon Health and Science University Knight Cancer Institute in Portland. However, the rate is not as straight forward as it sounds, he pointed out.

“This is big news,” Dr. Maziarz said in an interview. “This allows us to start to deliver these therapies, but there is a risk: If we give this in the outpatient setting and someone ends up needing hospitalization, we may end up not being reimbursed for the drug product.”

That’s because of CMS’s 3-day payment window rule, Dr. Maziarz explained: If medical treatment is provided in an outpatient setting and the patient needs inpatient care within 72 hours, all payments prior to that 72-hour window become part of the inpatient stay, according to the rule. Inpatient reimbursement varies depending on treatment, previous patient comorbidities, and complications during their stay. Analysts say that inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted so doctors can monitor them for serious side effects.

“If I have a drug that costs me $373,000, what happens if I admit the patient?” Dr. Maziarz said. “I don’t get $373,000; I get between $8,000 and $18,000. So if we give this and someone gets sick in 48 hours, then we may be at risk for losing.”

On the inpatient side, Medicare payment for CAR T-cell therapy is currently bundled into the payment for the inpatient stay, rather than being paid separately. The drug manufacturers – Gilead Sciences and Novartis AG – have requested that CMS set a separate “new technology add-on payment,” but the agency has not yet issued a decision.

Courtesy Dr. Richard Maziarz

“The trend for 2018 is very much focusing on how to eliminate some of the profitability issues with first-generation CAR Ts because companies realize that manufacturing individualized treatments for each patient is not an ideal business model,” Dr. Xuan said in an interview.

More market competition is also in the forecast, particularly from smaller companies, Dr. Xuan said.

“What we are likely to see in the future is larger companies acquiring smaller ones once their CAR T technology has matured to a certain point,” she said. “We have seen it with the Gilead-Kite acquisition, as well as Celgene’s acquisition of Juno Therapeutics, and this trend will continue as long as smaller companies are able to develop proprietary next-generation CAR T technologies.”

Cost and accessibility remain key concerns with the therapies, especially for the Medicare population. Cost estimates have put the cost of CAR T-cell therapies as high as $1.5 million per patient.

“There remain unanswered questions about value and cost in older adults,” said Walid F. Gellad, MD, codirector for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “There are many life-saving treatments in the medical system that cost much less than this therapy. Presumably, its cost will go down as the indications expand and the experience with creating the CAR T cells improves. At least, one would hope.”

Time will tell how reimbursement plays out during clinical practice, but one thing is for certain: The current CAR T-cell therapies are only the beginning, Dr. Maziarz said.

“Genetically-engineered cell products are going to explode over the next decade,” he said. “This is not the end of the line, this is the starting point.”

Dr. Maziarz has received consulting fees from Novartis, Juno Therapeutics, and Kite Pharma. Dr. Heslop has received consulting fees from Novartis, has conducted research for Cell Medica and holds intellectual property rights/patents from Cell Medica, and has ownership interest in ViraCyte and Marker Therapeutics. Dr. Gellad reports grants from Express Scripts.

Nearly a quarter of public speakers at meetings of a Food and Drug Administration advisory committee had conflicts of interest, about 20% of which are undisclosed, a study finds.

Matthew S. McCoy, PhD., of the University of Pennsylvania, Philadelphia, and his colleagues analyzed the public speakers at 15 meetings of the FDA Anesthetic and Analgesic Drug Products Advisory Committee from September 2009 to April 2017 related to the approval of drug products. (The committee advises the FDA on anesthesiology and pain management drug products.)

Investigators evaluated meeting transcripts to learn whether speakers reported chronic pain; had received the drug under review; reported an organization affiliation; reported a conflict of interest; and expressed support, opposition or were neutral with respect to drug approval. Of the 112 speakers studied, about 20% disclosed a conflict of interest, 5% had an undisclosed financial association with the sponsor that existed prior to the meeting and 13% had an undisclosed financial association of indeterminate date,the researchers reported in JAMA Internal Medicine on April 23.

Of those 112 speakers, 20 reported having experienced chronic pain and 11 reported receiving the drug under review. Overall, about 70% of speakers (76 out of 112) supported drug approval, the study found. Speakers who disclosed a conflict of interest were significantly more likely to support drug approval. When financial associations of indeterminate date were classified as conflicts of interest, speakers with a conflict were more than eight times as likely to support drug approval.

Dr. McCoy and his colleagues noted that the findings raise concerns about pro–sponsor bias among speakers at advisory committee meetings. They propose that the FDA should require – rather than only encourage – speakers to disclose conflicts of interest at all of the agency’s advisory committee meetings.

SOURCE: McCoy MS et al. JAMA Intern Med. 2018 Apr 23. doi:10.1001/jamainternmed.2018.1324

Nearly a quarter of public speakers at meetings of a Food and Drug Administration advisory committee had conflicts of interest, about 20% of which are undisclosed, a study finds.

Matthew S. McCoy, PhD., of the University of Pennsylvania, Philadelphia, and his colleagues analyzed the public speakers at 15 meetings of the FDA Anesthetic and Analgesic Drug Products Advisory Committee from September 2009 to April 2017 related to the approval of drug products. (The committee advises the FDA on anesthesiology and pain management drug products.)

Investigators evaluated meeting transcripts to learn whether speakers reported chronic pain; had received the drug under review; reported an organization affiliation; reported a conflict of interest; and expressed support, opposition or were neutral with respect to drug approval. Of the 112 speakers studied, about 20% disclosed a conflict of interest, 5% had an undisclosed financial association with the sponsor that existed prior to the meeting and 13% had an undisclosed financial association of indeterminate date,the researchers reported in JAMA Internal Medicine on April 23.

Of those 112 speakers, 20 reported having experienced chronic pain and 11 reported receiving the drug under review. Overall, about 70% of speakers (76 out of 112) supported drug approval, the study found. Speakers who disclosed a conflict of interest were significantly more likely to support drug approval. When financial associations of indeterminate date were classified as conflicts of interest, speakers with a conflict were more than eight times as likely to support drug approval.

Dr. McCoy and his colleagues noted that the findings raise concerns about pro–sponsor bias among speakers at advisory committee meetings. They propose that the FDA should require – rather than only encourage – speakers to disclose conflicts of interest at all of the agency’s advisory committee meetings.

SOURCE: McCoy MS et al. JAMA Intern Med. 2018 Apr 23. doi:10.1001/jamainternmed.2018.1324

Nearly a quarter of public speakers at meetings of a Food and Drug Administration advisory committee had conflicts of interest, about 20% of which are undisclosed, a study finds.

Matthew S. McCoy, PhD., of the University of Pennsylvania, Philadelphia, and his colleagues analyzed the public speakers at 15 meetings of the FDA Anesthetic and Analgesic Drug Products Advisory Committee from September 2009 to April 2017 related to the approval of drug products. (The committee advises the FDA on anesthesiology and pain management drug products.)

Investigators evaluated meeting transcripts to learn whether speakers reported chronic pain; had received the drug under review; reported an organization affiliation; reported a conflict of interest; and expressed support, opposition or were neutral with respect to drug approval. Of the 112 speakers studied, about 20% disclosed a conflict of interest, 5% had an undisclosed financial association with the sponsor that existed prior to the meeting and 13% had an undisclosed financial association of indeterminate date,the researchers reported in JAMA Internal Medicine on April 23.

Of those 112 speakers, 20 reported having experienced chronic pain and 11 reported receiving the drug under review. Overall, about 70% of speakers (76 out of 112) supported drug approval, the study found. Speakers who disclosed a conflict of interest were significantly more likely to support drug approval. When financial associations of indeterminate date were classified as conflicts of interest, speakers with a conflict were more than eight times as likely to support drug approval.

Dr. McCoy and his colleagues noted that the findings raise concerns about pro–sponsor bias among speakers at advisory committee meetings. They propose that the FDA should require – rather than only encourage – speakers to disclose conflicts of interest at all of the agency’s advisory committee meetings.

SOURCE: McCoy MS et al. JAMA Intern Med. 2018 Apr 23. doi:10.1001/jamainternmed.2018.1324

A new study highlights a marked delay between completion of clinical trials and when the results reach practicing clinicians.

The study, published online in JAMA Oncology, found that even for the most pressing findings, the median publication of final clinical data is nearly 1 year.

Lindor Qunaj of Brown University, Providence, R.I., and colleagues measured the time frame between when eight large pharmaceutical companies issued press releases announcing completed phase 3 oncology clinical trials and the public sharing of the results either on ClinicalTrials.gov or a peer-reviewed biomedical journal. Collectively, the eight companies accounted for 72% of all oncology sales in 2015. The press releases were posted between January 2011 and June 2016. Investigators found the median time from press release to publication of data was 300 days.

Clinical trials with negative results had median delays of more than 100 days longer than positive results, the investigators found. Of the 100 press releases studied, only 31% included the magnitude of study findings. Most press releases (66%) reported outcomes of studies involving drugs already approved by the Food and Drug Administration for some indication. Press releases regarding preapproval drugs were less likely to contain quantitative reports of effect sizes. The majority of final clinical results (90%) were either posted, published, or both, within 2 years. No difference existed in the median delay between trials studying approved drugs compared with unapproved drugs.

Mr. Qunaj and associates noted that their analysis emphasizes the ongoing criticism of the speed at which pharmaceutical companies publish findings from clinical trials. The authors suggested that pharmaceutical companies, publishers, and journals work to minimize such delays. For instance, they might consider preprinting, the practice of publishing “draft” findings prior to, or in tandem with, peer review. Through preprints, companies could post all relevant study data, including measured outcomes and toxic effects, as well as study protocol, Mr. Qunaj and associates wrote. In addition, the authors suggested that publishers continue to consider innovative efforts to “responsibly accelerate the peer review process, or to further shorten the time between manuscript acceptance and data availability.”

“We do foresee possible objections from pharmaceutical companies, scientific journals, and medical societies,” the authors wrote. “Embargoed, timed data releases are a potent tool for marketing study findings and drawing traffic to the journal or meeting where the results are presented. However, these interests are narrow, while the needs of science more generally, and the patients with the conditions that these companies have studied, matter more.”

A coauthor, Peter Bach, MD, received personal fees and grants from numerous sources. No other disclosures were reported.

SOURCE: Qunaj L et al. JAMA Oncol. 2018 Apr 12. doi:10.1001/jamaoncol.2018.0264.

A new study highlights a marked delay between completion of clinical trials and when the results reach practicing clinicians.

The study, published online in JAMA Oncology, found that even for the most pressing findings, the median publication of final clinical data is nearly 1 year.

Lindor Qunaj of Brown University, Providence, R.I., and colleagues measured the time frame between when eight large pharmaceutical companies issued press releases announcing completed phase 3 oncology clinical trials and the public sharing of the results either on ClinicalTrials.gov or a peer-reviewed biomedical journal. Collectively, the eight companies accounted for 72% of all oncology sales in 2015. The press releases were posted between January 2011 and June 2016. Investigators found the median time from press release to publication of data was 300 days.

Clinical trials with negative results had median delays of more than 100 days longer than positive results, the investigators found. Of the 100 press releases studied, only 31% included the magnitude of study findings. Most press releases (66%) reported outcomes of studies involving drugs already approved by the Food and Drug Administration for some indication. Press releases regarding preapproval drugs were less likely to contain quantitative reports of effect sizes. The majority of final clinical results (90%) were either posted, published, or both, within 2 years. No difference existed in the median delay between trials studying approved drugs compared with unapproved drugs.

Mr. Qunaj and associates noted that their analysis emphasizes the ongoing criticism of the speed at which pharmaceutical companies publish findings from clinical trials. The authors suggested that pharmaceutical companies, publishers, and journals work to minimize such delays. For instance, they might consider preprinting, the practice of publishing “draft” findings prior to, or in tandem with, peer review. Through preprints, companies could post all relevant study data, including measured outcomes and toxic effects, as well as study protocol, Mr. Qunaj and associates wrote. In addition, the authors suggested that publishers continue to consider innovative efforts to “responsibly accelerate the peer review process, or to further shorten the time between manuscript acceptance and data availability.”

“We do foresee possible objections from pharmaceutical companies, scientific journals, and medical societies,” the authors wrote. “Embargoed, timed data releases are a potent tool for marketing study findings and drawing traffic to the journal or meeting where the results are presented. However, these interests are narrow, while the needs of science more generally, and the patients with the conditions that these companies have studied, matter more.”

A coauthor, Peter Bach, MD, received personal fees and grants from numerous sources. No other disclosures were reported.

SOURCE: Qunaj L et al. JAMA Oncol. 2018 Apr 12. doi:10.1001/jamaoncol.2018.0264.

A new study highlights a marked delay between completion of clinical trials and when the results reach practicing clinicians.

The study, published online in JAMA Oncology, found that even for the most pressing findings, the median publication of final clinical data is nearly 1 year.

Lindor Qunaj of Brown University, Providence, R.I., and colleagues measured the time frame between when eight large pharmaceutical companies issued press releases announcing completed phase 3 oncology clinical trials and the public sharing of the results either on ClinicalTrials.gov or a peer-reviewed biomedical journal. Collectively, the eight companies accounted for 72% of all oncology sales in 2015. The press releases were posted between January 2011 and June 2016. Investigators found the median time from press release to publication of data was 300 days.

Clinical trials with negative results had median delays of more than 100 days longer than positive results, the investigators found. Of the 100 press releases studied, only 31% included the magnitude of study findings. Most press releases (66%) reported outcomes of studies involving drugs already approved by the Food and Drug Administration for some indication. Press releases regarding preapproval drugs were less likely to contain quantitative reports of effect sizes. The majority of final clinical results (90%) were either posted, published, or both, within 2 years. No difference existed in the median delay between trials studying approved drugs compared with unapproved drugs.

Mr. Qunaj and associates noted that their analysis emphasizes the ongoing criticism of the speed at which pharmaceutical companies publish findings from clinical trials. The authors suggested that pharmaceutical companies, publishers, and journals work to minimize such delays. For instance, they might consider preprinting, the practice of publishing “draft” findings prior to, or in tandem with, peer review. Through preprints, companies could post all relevant study data, including measured outcomes and toxic effects, as well as study protocol, Mr. Qunaj and associates wrote. In addition, the authors suggested that publishers continue to consider innovative efforts to “responsibly accelerate the peer review process, or to further shorten the time between manuscript acceptance and data availability.”

“We do foresee possible objections from pharmaceutical companies, scientific journals, and medical societies,” the authors wrote. “Embargoed, timed data releases are a potent tool for marketing study findings and drawing traffic to the journal or meeting where the results are presented. However, these interests are narrow, while the needs of science more generally, and the patients with the conditions that these companies have studied, matter more.”

A coauthor, Peter Bach, MD, received personal fees and grants from numerous sources. No other disclosures were reported.

SOURCE: Qunaj L et al. JAMA Oncol. 2018 Apr 12. doi:10.1001/jamaoncol.2018.0264.

Obstetrician-gynecologists have a central role in helping pregnant patients maintain employment by writing appropriate notes to employers and informing patients of their rights, according to a new committee opinion by the American College of Obstetricians and Gynecologists.

The opinion, released March 28, outlines key considerations for ob.gyns. in assisting pregnant patients with employment maintenance and helping protect them from employment discrimination. The most common employment issues that pregnant women face include pregnancy-related discrimination, work accommodations that allow continued employment, job-protected leave, and wage replacement while on leave, according to the opinion. After delivery, top employment concerns involve lactation, and accommodations and leave for recovery, bonding, and caring for the infant.

“It’s important that ob.gyns. discuss workplace expectations with their working pregnant patient,” Yasser El-Sayed, MD, vice chair of the ACOG’s committee on obstetric practice said in a statement. “Some women may be unaware of attendant risks to pregnancy at their job, while others may be unaware that their ob.gyn. can offer both support and potential solutions or resources, whether in the form of slight modifications or a formal medical note detailing the need for an accommodation to protect the patient’s health.”

To address these issues, ACOG recommends that ob.gyns. reassure patients that working during pregnancy is generally safe. In the case of high-risk or complicated pregnancy, ob.gyns. should inform patients that work accommodations often can allow for continued safe employment. Appropriately drafted notes by physicians to employers are key, the opinion stresses.

“By writing appropriate notes to employers, obstetrician-gynecologists and other obstetric care providers can be instrumental in obtaining accommodations for their patients who are able to continue working,” the authors wrote. “Accommodations that allow a woman to keep working are the most reliable way to guarantee pay, benefits, and job protection.”

Because the way in which medical certification paperwork is written can greatly affect whether employers comply with medical suggestions, physicians should familiarize themselves with the most effective ways to write such notes, according to ACOG. The recent opinion provides an overview of the necessary structure and contents of medical notes to optimize their effects. The opinion highlights the work of Pregnant@Work, an online note-writing resource developed by the University of California’s Hastings Center for WorkLife Law, San Francisco, that assists health providers in writing legally appropriate work accommodations letters.

Also important for ob.gyns. is knowing the relevant state and federal protections for pregnant patients and new mothers who work or take medical leave. In some instances, it may be necessary for women to consult with a legal counselor in cases in which discrimination has occurred, accommodations are denied, or complex legal questions arise, according to the opinion.

The ACOG opinion is timely because more women than ever before are a part of the workforce, said Rebecca Jackson, MD, a member of ACOG’s committee on obstetric practice and a coauthor of the opinion. Dr. Jackson recently participated in a multidisciplinary work group that addressed legal issues around employment accommodations for pregnant women. Dr. Jackson said she approached ACOG about creating formal guidance on the subject after hearing about the many employment challenges pregnant women experience and how the way physician notes are written can greatly influence accommodations.

“As health care providers responsible for caring for women, it’s essential our guidance addresses the key considerations for maintaining women’s health – this often includes work environments, particularly for pregnant and immediately postpartum women who may have specific health care needs requiring adjustments or accommodations,” Dr. Jackson said in an interview. “Obstetric care providers must be equipped with the necessary and relevant guidance to appropriately support their patients or refer them to additional resources, like legal assistance. This guidance is an important component in building that knowledge among women’s health care providers and ensuring more women can access the care and treatment they need when they need it without compromising their careers or income.”

Obstetrician-gynecologists have a central role in helping pregnant patients maintain employment by writing appropriate notes to employers and informing patients of their rights, according to a new committee opinion by the American College of Obstetricians and Gynecologists.

The opinion, released March 28, outlines key considerations for ob.gyns. in assisting pregnant patients with employment maintenance and helping protect them from employment discrimination. The most common employment issues that pregnant women face include pregnancy-related discrimination, work accommodations that allow continued employment, job-protected leave, and wage replacement while on leave, according to the opinion. After delivery, top employment concerns involve lactation, and accommodations and leave for recovery, bonding, and caring for the infant.

“It’s important that ob.gyns. discuss workplace expectations with their working pregnant patient,” Yasser El-Sayed, MD, vice chair of the ACOG’s committee on obstetric practice said in a statement. “Some women may be unaware of attendant risks to pregnancy at their job, while others may be unaware that their ob.gyn. can offer both support and potential solutions or resources, whether in the form of slight modifications or a formal medical note detailing the need for an accommodation to protect the patient’s health.”

To address these issues, ACOG recommends that ob.gyns. reassure patients that working during pregnancy is generally safe. In the case of high-risk or complicated pregnancy, ob.gyns. should inform patients that work accommodations often can allow for continued safe employment. Appropriately drafted notes by physicians to employers are key, the opinion stresses.

“By writing appropriate notes to employers, obstetrician-gynecologists and other obstetric care providers can be instrumental in obtaining accommodations for their patients who are able to continue working,” the authors wrote. “Accommodations that allow a woman to keep working are the most reliable way to guarantee pay, benefits, and job protection.”

Because the way in which medical certification paperwork is written can greatly affect whether employers comply with medical suggestions, physicians should familiarize themselves with the most effective ways to write such notes, according to ACOG. The recent opinion provides an overview of the necessary structure and contents of medical notes to optimize their effects. The opinion highlights the work of Pregnant@Work, an online note-writing resource developed by the University of California’s Hastings Center for WorkLife Law, San Francisco, that assists health providers in writing legally appropriate work accommodations letters.

Also important for ob.gyns. is knowing the relevant state and federal protections for pregnant patients and new mothers who work or take medical leave. In some instances, it may be necessary for women to consult with a legal counselor in cases in which discrimination has occurred, accommodations are denied, or complex legal questions arise, according to the opinion.

The ACOG opinion is timely because more women than ever before are a part of the workforce, said Rebecca Jackson, MD, a member of ACOG’s committee on obstetric practice and a coauthor of the opinion. Dr. Jackson recently participated in a multidisciplinary work group that addressed legal issues around employment accommodations for pregnant women. Dr. Jackson said she approached ACOG about creating formal guidance on the subject after hearing about the many employment challenges pregnant women experience and how the way physician notes are written can greatly influence accommodations.

“As health care providers responsible for caring for women, it’s essential our guidance addresses the key considerations for maintaining women’s health – this often includes work environments, particularly for pregnant and immediately postpartum women who may have specific health care needs requiring adjustments or accommodations,” Dr. Jackson said in an interview. “Obstetric care providers must be equipped with the necessary and relevant guidance to appropriately support their patients or refer them to additional resources, like legal assistance. This guidance is an important component in building that knowledge among women’s health care providers and ensuring more women can access the care and treatment they need when they need it without compromising their careers or income.”

Obstetrician-gynecologists have a central role in helping pregnant patients maintain employment by writing appropriate notes to employers and informing patients of their rights, according to a new committee opinion by the American College of Obstetricians and Gynecologists.

The opinion, released March 28, outlines key considerations for ob.gyns. in assisting pregnant patients with employment maintenance and helping protect them from employment discrimination. The most common employment issues that pregnant women face include pregnancy-related discrimination, work accommodations that allow continued employment, job-protected leave, and wage replacement while on leave, according to the opinion. After delivery, top employment concerns involve lactation, and accommodations and leave for recovery, bonding, and caring for the infant.

“It’s important that ob.gyns. discuss workplace expectations with their working pregnant patient,” Yasser El-Sayed, MD, vice chair of the ACOG’s committee on obstetric practice said in a statement. “Some women may be unaware of attendant risks to pregnancy at their job, while others may be unaware that their ob.gyn. can offer both support and potential solutions or resources, whether in the form of slight modifications or a formal medical note detailing the need for an accommodation to protect the patient’s health.”

To address these issues, ACOG recommends that ob.gyns. reassure patients that working during pregnancy is generally safe. In the case of high-risk or complicated pregnancy, ob.gyns. should inform patients that work accommodations often can allow for continued safe employment. Appropriately drafted notes by physicians to employers are key, the opinion stresses.

“By writing appropriate notes to employers, obstetrician-gynecologists and other obstetric care providers can be instrumental in obtaining accommodations for their patients who are able to continue working,” the authors wrote. “Accommodations that allow a woman to keep working are the most reliable way to guarantee pay, benefits, and job protection.”

Because the way in which medical certification paperwork is written can greatly affect whether employers comply with medical suggestions, physicians should familiarize themselves with the most effective ways to write such notes, according to ACOG. The recent opinion provides an overview of the necessary structure and contents of medical notes to optimize their effects. The opinion highlights the work of Pregnant@Work, an online note-writing resource developed by the University of California’s Hastings Center for WorkLife Law, San Francisco, that assists health providers in writing legally appropriate work accommodations letters.

Also important for ob.gyns. is knowing the relevant state and federal protections for pregnant patients and new mothers who work or take medical leave. In some instances, it may be necessary for women to consult with a legal counselor in cases in which discrimination has occurred, accommodations are denied, or complex legal questions arise, according to the opinion.

The ACOG opinion is timely because more women than ever before are a part of the workforce, said Rebecca Jackson, MD, a member of ACOG’s committee on obstetric practice and a coauthor of the opinion. Dr. Jackson recently participated in a multidisciplinary work group that addressed legal issues around employment accommodations for pregnant women. Dr. Jackson said she approached ACOG about creating formal guidance on the subject after hearing about the many employment challenges pregnant women experience and how the way physician notes are written can greatly influence accommodations.

“As health care providers responsible for caring for women, it’s essential our guidance addresses the key considerations for maintaining women’s health – this often includes work environments, particularly for pregnant and immediately postpartum women who may have specific health care needs requiring adjustments or accommodations,” Dr. Jackson said in an interview. “Obstetric care providers must be equipped with the necessary and relevant guidance to appropriately support their patients or refer them to additional resources, like legal assistance. This guidance is an important component in building that knowledge among women’s health care providers and ensuring more women can access the care and treatment they need when they need it without compromising their careers or income.”