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Sneak Peek: The Hospital Leader blog
To my next patient:
I often avoid putting my politics on my sleeve, as I don’t want that to get in the way of our relationship. I want you to know that I treat you as a fellow human being, no matter your race, gender, sexual orientation. With the election results, what will change about how I treat you at the bedside? Nothing.
I may know about your criminal past. I see that tattoo underneath your gown. I hear your profanity-filled screed because you won’t get that MRI today. I know you don’t follow the treatment plan, that you are here illegally or that you are a refugee from another country.
I will still care for you no matter what. It’s one of the blessed things we instill in each other in medicine.
I saw someone like you recently: 28 years old, working hard, with two jobs, neither of which provided insurance. She was doing well, without health problems, but then she became fatigued and swollen. She came to the ER after weeks of suffering with what turned out to be failing kidneys. Lupus. She required expensive medications that would aim to reverse her kidney disease. She left the hospital not knowing what would happen next, as there was no way she could afford the treatment. The fates of medicine handed her an unexpected illness, and we had no good way to reassure her of what would come next. I am sorry that more patients without insurance will arrive, instead of the steady decline I had been used to the past few years.
You also remind me of another patient I saw last week. She was sweet in the face, smiling despite her travails, and wore the skimpy gown with pride. She had some fluid just outside her lung that shouldn’t be there: a pleural effusion. We discussed the different possible diagnoses. She had cancer in the past, surgically treated and presumably cured. Was this the cancer back? Was it an infection, easily treated? We couldn’t tell by the exam or the x-ray.
On Tuesday, we took the fluid out. The results trickled in slowly, and initial tests suggested it was benign. We allowed a smile, but final tests were pending. What will turn up? When the final results return? Can we dance in the room with joy? Or will we hold hands, bear the cross, shed a tear, but then lift our heads up and know we will fight for another day, and another day, and not stop fighting until the cancer upon us is gone?
Read the full post at www.hospitalleader.org.
Also on The Hospital Leader blog ...
Post: An open letter to hospital executives about their hospitalist programs
By Leslie Flores, MHA, SFHM
Post: What’s under the hood? A quick look at hospital expenses
By Brad Flansbaum, DO, MPH, MHM
Post: A quick lesson on bundled payments
By John Nelson, MD, MHM
Post: The ABIM Has new plans for MOC and wants your opinion. Give it to ’em!
By Burke Kealey, MD, SFHM
To my next patient:
I often avoid putting my politics on my sleeve, as I don’t want that to get in the way of our relationship. I want you to know that I treat you as a fellow human being, no matter your race, gender, sexual orientation. With the election results, what will change about how I treat you at the bedside? Nothing.
I may know about your criminal past. I see that tattoo underneath your gown. I hear your profanity-filled screed because you won’t get that MRI today. I know you don’t follow the treatment plan, that you are here illegally or that you are a refugee from another country.
I will still care for you no matter what. It’s one of the blessed things we instill in each other in medicine.
I saw someone like you recently: 28 years old, working hard, with two jobs, neither of which provided insurance. She was doing well, without health problems, but then she became fatigued and swollen. She came to the ER after weeks of suffering with what turned out to be failing kidneys. Lupus. She required expensive medications that would aim to reverse her kidney disease. She left the hospital not knowing what would happen next, as there was no way she could afford the treatment. The fates of medicine handed her an unexpected illness, and we had no good way to reassure her of what would come next. I am sorry that more patients without insurance will arrive, instead of the steady decline I had been used to the past few years.
You also remind me of another patient I saw last week. She was sweet in the face, smiling despite her travails, and wore the skimpy gown with pride. She had some fluid just outside her lung that shouldn’t be there: a pleural effusion. We discussed the different possible diagnoses. She had cancer in the past, surgically treated and presumably cured. Was this the cancer back? Was it an infection, easily treated? We couldn’t tell by the exam or the x-ray.
On Tuesday, we took the fluid out. The results trickled in slowly, and initial tests suggested it was benign. We allowed a smile, but final tests were pending. What will turn up? When the final results return? Can we dance in the room with joy? Or will we hold hands, bear the cross, shed a tear, but then lift our heads up and know we will fight for another day, and another day, and not stop fighting until the cancer upon us is gone?
Read the full post at www.hospitalleader.org.
Also on The Hospital Leader blog ...
Post: An open letter to hospital executives about their hospitalist programs
By Leslie Flores, MHA, SFHM
Post: What’s under the hood? A quick look at hospital expenses
By Brad Flansbaum, DO, MPH, MHM
Post: A quick lesson on bundled payments
By John Nelson, MD, MHM
Post: The ABIM Has new plans for MOC and wants your opinion. Give it to ’em!
By Burke Kealey, MD, SFHM
To my next patient:
I often avoid putting my politics on my sleeve, as I don’t want that to get in the way of our relationship. I want you to know that I treat you as a fellow human being, no matter your race, gender, sexual orientation. With the election results, what will change about how I treat you at the bedside? Nothing.
I may know about your criminal past. I see that tattoo underneath your gown. I hear your profanity-filled screed because you won’t get that MRI today. I know you don’t follow the treatment plan, that you are here illegally or that you are a refugee from another country.
I will still care for you no matter what. It’s one of the blessed things we instill in each other in medicine.
I saw someone like you recently: 28 years old, working hard, with two jobs, neither of which provided insurance. She was doing well, without health problems, but then she became fatigued and swollen. She came to the ER after weeks of suffering with what turned out to be failing kidneys. Lupus. She required expensive medications that would aim to reverse her kidney disease. She left the hospital not knowing what would happen next, as there was no way she could afford the treatment. The fates of medicine handed her an unexpected illness, and we had no good way to reassure her of what would come next. I am sorry that more patients without insurance will arrive, instead of the steady decline I had been used to the past few years.
You also remind me of another patient I saw last week. She was sweet in the face, smiling despite her travails, and wore the skimpy gown with pride. She had some fluid just outside her lung that shouldn’t be there: a pleural effusion. We discussed the different possible diagnoses. She had cancer in the past, surgically treated and presumably cured. Was this the cancer back? Was it an infection, easily treated? We couldn’t tell by the exam or the x-ray.
On Tuesday, we took the fluid out. The results trickled in slowly, and initial tests suggested it was benign. We allowed a smile, but final tests were pending. What will turn up? When the final results return? Can we dance in the room with joy? Or will we hold hands, bear the cross, shed a tear, but then lift our heads up and know we will fight for another day, and another day, and not stop fighting until the cancer upon us is gone?
Read the full post at www.hospitalleader.org.
Also on The Hospital Leader blog ...
Post: An open letter to hospital executives about their hospitalist programs
By Leslie Flores, MHA, SFHM
Post: What’s under the hood? A quick look at hospital expenses
By Brad Flansbaum, DO, MPH, MHM
Post: A quick lesson on bundled payments
By John Nelson, MD, MHM
Post: The ABIM Has new plans for MOC and wants your opinion. Give it to ’em!
By Burke Kealey, MD, SFHM
SHM member spotlight
Editor’s note: Each month, SHM puts the spotlight on some of our most active members who are making substantial contributions to hospital medicine.
Visit www.hospitalmedicine.org/getinvolved for more information on how you can help SHM improve the care of hospitalized patients.
Dr. Venkataraman Palabindala, FHM, is a hospitalist at the University of Mississippi Medical Center in Jackson. Dr. Palabindala is an active member of SHM’s IT Committee and has been instrumental in growing the Gulf States Chapter. 
Answer: I was exploring my options during my second year of residency at Greater Baltimore Medical Center as to what my final career path should be. I always loved inpatient medicine, mostly critical care, so I was thinking of completing a pulmonary critical-care fellowship. Completing a hospitalist rotation changed everything about how I saw my future and led me to specialize in hospital medicine.
Once I learned about SHM and the wealth of activities and opportunities membership offered from a few of my attendings, I applied to be part of the Leadership Committee. I attended every meeting and kept my committee work as a top priority. At the time, with little experience in hospital medicine, I knew I might not have as much to contribute as the rest, but my goal was to learn as much as I could. Never once did I feel that my voice was any more or less valuable than those of the rest of the committee members; our committee work was truly a collaborative effort.
As my career in hospital medicine has evolved, so have my contributions to SHM’s committees; I now am a proud member of the IT Committee. We’re currently working on a white paper about hospitalists’ attitudes toward electronic health record (EHR) systems and look forward to sharing more about that next month.
In addition, throughout my time with SHM, I have become a Fellow in Hospital Medicine, attended two “Hill Days” to learn about the policies, and made a concerted effort to be present at as many meetings as possible, especially SHM’s annual meetings. The networking, coupled with the workshops and lectures, is unparalleled. I have missed only one annual meeting, and I feel like I missed a Thanksgiving dinner with my family!
Q: Can you tell us about your role in the revitalization of the Gulf States Chapter and the Chapter Development Program?
A: During my time as a member of the SHM Leadership Committee, I quickly realized that hospitalists in small cities like Dothan, Ala., were not as exposed to networking and education activities as were those in big cities. To unite hospitalists in that area of the country, I founded the Wiregrass Chapter; obtaining 20 signatures to start it was an uphill task. After Dan Dressler, MD, [in Atlanta] and I gave a talk about updates in hospital medicine, the Wiregrass Chapter was awarded the Silver Chapter Award [after its first year in inception], and everything changed. The buzz around the chapter helped it continue to grow.
After I moved to Jackson, I applied for a pilot funding project to start a Jackson Chapter, as I realized the Gulf States Chapter was a bit far away. I thought a local chapter would bring all hospitalists in this area together. However, I received a call from Lisa Chester, our chapter liaison at SHM, about being a part of the Gulf States Chapter and serving as a catalyst to revitalize the chapter.
I was thrilled to work with Randy Roth, MD, and Steven Deitelzweig, MD; both are hospitalist leaders in this area. The Chapter Development Program surely helped us to create new goals and develop a realistic timeline. It kept us on track to achieve what we originally set out to do. By creating coupons to encourage membership and arranging more local meetings using this fund, we have been able to experience even more success. We are now recognizing that residents are very excited about SHM meetings and are identifying young leaders to be part of the hospital medicine movement.
Q: How has your participation in HMX – and, more broadly, engagement with SHM – helped you improve your practice?
A: HMX [connect.hospitalmedicine.org] is a great platform for asking questions and exchanging ideas. Being active on HMX has helped me learn important information about performance metrics, observation unit models, EHRs, coding and billing questions, and sometimes even ethical questions.
Although I still have mentors helping me, I know if I post a question on HMX, that I will get many ideas from hospitalists across the nation. I also make it a point to encourage friends every month to download the HMX app on their phones and present it as a valuable resource to my students and residents. As hospitalists, this is our forum with experts available all the time.
To encourage others to use the platform and make myself and fellow committee members accessible to other members, we actively take turns assuming responsibility for maintaining the momentum on HMX by finding intriguing topics of discussion.
Q: As we ring in 2017 after a year of many changes for HM and the health care system in general, what do you see as the biggest HM opportunities this year?
A: We know physician retention and burnout are some of the biggest challenges in hospital medicine. Given the pace at which we are growing as a specialty, I would like to see more time dedicated to addressing and attempting to alleviate these specific issues.
Also, now that hospitalists have left their stamp on inpatient medicine, specialties like critical care, nephrology, cardiology, and ob.gyn. are moving toward this model. We need to do everything we can to integrate them into our pool, move forward together, and learn from each other.
Lastly, mentorship is of paramount importance as we head into the future. We must encourage young hospitalists to mentor students and residents and recruit them to be part of SHM when they return home.
Brett Radler is SHM’s communications specialist.
Editor’s note: Each month, SHM puts the spotlight on some of our most active members who are making substantial contributions to hospital medicine.
Visit www.hospitalmedicine.org/getinvolved for more information on how you can help SHM improve the care of hospitalized patients.
Dr. Venkataraman Palabindala, FHM, is a hospitalist at the University of Mississippi Medical Center in Jackson. Dr. Palabindala is an active member of SHM’s IT Committee and has been instrumental in growing the Gulf States Chapter.
Answer: I was exploring my options during my second year of residency at Greater Baltimore Medical Center as to what my final career path should be. I always loved inpatient medicine, mostly critical care, so I was thinking of completing a pulmonary critical-care fellowship. Completing a hospitalist rotation changed everything about how I saw my future and led me to specialize in hospital medicine.
Once I learned about SHM and the wealth of activities and opportunities membership offered from a few of my attendings, I applied to be part of the Leadership Committee. I attended every meeting and kept my committee work as a top priority. At the time, with little experience in hospital medicine, I knew I might not have as much to contribute as the rest, but my goal was to learn as much as I could. Never once did I feel that my voice was any more or less valuable than those of the rest of the committee members; our committee work was truly a collaborative effort.
As my career in hospital medicine has evolved, so have my contributions to SHM’s committees; I now am a proud member of the IT Committee. We’re currently working on a white paper about hospitalists’ attitudes toward electronic health record (EHR) systems and look forward to sharing more about that next month.
In addition, throughout my time with SHM, I have become a Fellow in Hospital Medicine, attended two “Hill Days” to learn about the policies, and made a concerted effort to be present at as many meetings as possible, especially SHM’s annual meetings. The networking, coupled with the workshops and lectures, is unparalleled. I have missed only one annual meeting, and I feel like I missed a Thanksgiving dinner with my family!
Q: Can you tell us about your role in the revitalization of the Gulf States Chapter and the Chapter Development Program?
A: During my time as a member of the SHM Leadership Committee, I quickly realized that hospitalists in small cities like Dothan, Ala., were not as exposed to networking and education activities as were those in big cities. To unite hospitalists in that area of the country, I founded the Wiregrass Chapter; obtaining 20 signatures to start it was an uphill task. After Dan Dressler, MD, [in Atlanta] and I gave a talk about updates in hospital medicine, the Wiregrass Chapter was awarded the Silver Chapter Award [after its first year in inception], and everything changed. The buzz around the chapter helped it continue to grow.
After I moved to Jackson, I applied for a pilot funding project to start a Jackson Chapter, as I realized the Gulf States Chapter was a bit far away. I thought a local chapter would bring all hospitalists in this area together. However, I received a call from Lisa Chester, our chapter liaison at SHM, about being a part of the Gulf States Chapter and serving as a catalyst to revitalize the chapter.
I was thrilled to work with Randy Roth, MD, and Steven Deitelzweig, MD; both are hospitalist leaders in this area. The Chapter Development Program surely helped us to create new goals and develop a realistic timeline. It kept us on track to achieve what we originally set out to do. By creating coupons to encourage membership and arranging more local meetings using this fund, we have been able to experience even more success. We are now recognizing that residents are very excited about SHM meetings and are identifying young leaders to be part of the hospital medicine movement.
Q: How has your participation in HMX – and, more broadly, engagement with SHM – helped you improve your practice?
A: HMX [connect.hospitalmedicine.org] is a great platform for asking questions and exchanging ideas. Being active on HMX has helped me learn important information about performance metrics, observation unit models, EHRs, coding and billing questions, and sometimes even ethical questions.
Although I still have mentors helping me, I know if I post a question on HMX, that I will get many ideas from hospitalists across the nation. I also make it a point to encourage friends every month to download the HMX app on their phones and present it as a valuable resource to my students and residents. As hospitalists, this is our forum with experts available all the time.
To encourage others to use the platform and make myself and fellow committee members accessible to other members, we actively take turns assuming responsibility for maintaining the momentum on HMX by finding intriguing topics of discussion.
Q: As we ring in 2017 after a year of many changes for HM and the health care system in general, what do you see as the biggest HM opportunities this year?
A: We know physician retention and burnout are some of the biggest challenges in hospital medicine. Given the pace at which we are growing as a specialty, I would like to see more time dedicated to addressing and attempting to alleviate these specific issues.
Also, now that hospitalists have left their stamp on inpatient medicine, specialties like critical care, nephrology, cardiology, and ob.gyn. are moving toward this model. We need to do everything we can to integrate them into our pool, move forward together, and learn from each other.
Lastly, mentorship is of paramount importance as we head into the future. We must encourage young hospitalists to mentor students and residents and recruit them to be part of SHM when they return home.
Brett Radler is SHM’s communications specialist.
Editor’s note: Each month, SHM puts the spotlight on some of our most active members who are making substantial contributions to hospital medicine.
Visit www.hospitalmedicine.org/getinvolved for more information on how you can help SHM improve the care of hospitalized patients.
Dr. Venkataraman Palabindala, FHM, is a hospitalist at the University of Mississippi Medical Center in Jackson. Dr. Palabindala is an active member of SHM’s IT Committee and has been instrumental in growing the Gulf States Chapter.
Answer: I was exploring my options during my second year of residency at Greater Baltimore Medical Center as to what my final career path should be. I always loved inpatient medicine, mostly critical care, so I was thinking of completing a pulmonary critical-care fellowship. Completing a hospitalist rotation changed everything about how I saw my future and led me to specialize in hospital medicine.
Once I learned about SHM and the wealth of activities and opportunities membership offered from a few of my attendings, I applied to be part of the Leadership Committee. I attended every meeting and kept my committee work as a top priority. At the time, with little experience in hospital medicine, I knew I might not have as much to contribute as the rest, but my goal was to learn as much as I could. Never once did I feel that my voice was any more or less valuable than those of the rest of the committee members; our committee work was truly a collaborative effort.
As my career in hospital medicine has evolved, so have my contributions to SHM’s committees; I now am a proud member of the IT Committee. We’re currently working on a white paper about hospitalists’ attitudes toward electronic health record (EHR) systems and look forward to sharing more about that next month.
In addition, throughout my time with SHM, I have become a Fellow in Hospital Medicine, attended two “Hill Days” to learn about the policies, and made a concerted effort to be present at as many meetings as possible, especially SHM’s annual meetings. The networking, coupled with the workshops and lectures, is unparalleled. I have missed only one annual meeting, and I feel like I missed a Thanksgiving dinner with my family!
Q: Can you tell us about your role in the revitalization of the Gulf States Chapter and the Chapter Development Program?
A: During my time as a member of the SHM Leadership Committee, I quickly realized that hospitalists in small cities like Dothan, Ala., were not as exposed to networking and education activities as were those in big cities. To unite hospitalists in that area of the country, I founded the Wiregrass Chapter; obtaining 20 signatures to start it was an uphill task. After Dan Dressler, MD, [in Atlanta] and I gave a talk about updates in hospital medicine, the Wiregrass Chapter was awarded the Silver Chapter Award [after its first year in inception], and everything changed. The buzz around the chapter helped it continue to grow.
After I moved to Jackson, I applied for a pilot funding project to start a Jackson Chapter, as I realized the Gulf States Chapter was a bit far away. I thought a local chapter would bring all hospitalists in this area together. However, I received a call from Lisa Chester, our chapter liaison at SHM, about being a part of the Gulf States Chapter and serving as a catalyst to revitalize the chapter.
I was thrilled to work with Randy Roth, MD, and Steven Deitelzweig, MD; both are hospitalist leaders in this area. The Chapter Development Program surely helped us to create new goals and develop a realistic timeline. It kept us on track to achieve what we originally set out to do. By creating coupons to encourage membership and arranging more local meetings using this fund, we have been able to experience even more success. We are now recognizing that residents are very excited about SHM meetings and are identifying young leaders to be part of the hospital medicine movement.
Q: How has your participation in HMX – and, more broadly, engagement with SHM – helped you improve your practice?
A: HMX [connect.hospitalmedicine.org] is a great platform for asking questions and exchanging ideas. Being active on HMX has helped me learn important information about performance metrics, observation unit models, EHRs, coding and billing questions, and sometimes even ethical questions.
Although I still have mentors helping me, I know if I post a question on HMX, that I will get many ideas from hospitalists across the nation. I also make it a point to encourage friends every month to download the HMX app on their phones and present it as a valuable resource to my students and residents. As hospitalists, this is our forum with experts available all the time.
To encourage others to use the platform and make myself and fellow committee members accessible to other members, we actively take turns assuming responsibility for maintaining the momentum on HMX by finding intriguing topics of discussion.
Q: As we ring in 2017 after a year of many changes for HM and the health care system in general, what do you see as the biggest HM opportunities this year?
A: We know physician retention and burnout are some of the biggest challenges in hospital medicine. Given the pace at which we are growing as a specialty, I would like to see more time dedicated to addressing and attempting to alleviate these specific issues.
Also, now that hospitalists have left their stamp on inpatient medicine, specialties like critical care, nephrology, cardiology, and ob.gyn. are moving toward this model. We need to do everything we can to integrate them into our pool, move forward together, and learn from each other.
Lastly, mentorship is of paramount importance as we head into the future. We must encourage young hospitalists to mentor students and residents and recruit them to be part of SHM when they return home.
Brett Radler is SHM’s communications specialist.
Add-on fenfluramine reduces seizure frequency in Dravet syndrome
HOUSTON – Low-dose fenfluramine was found to reduce seizures significantly among a small cohort with Dravet syndrome without the appearance of valvular abnormalities or pulmonary hypertension, according to a prospective study presented at a poster session of the annual meeting of the American Epilepsy Society.
Six of nine Dravet syndrome (DS) patients (66%) had at least a 50% reduction in major motor seizure frequency for at least 90% of the period during which they took fenfluramine. Five of the nine DS patients (56%) experienced a reduction in major motor seizure frequency of 75% or more for at least 60% of the median 1.9 years they were on fenfluramine.
According to lead author An-Sofie Schoonjans, MD, and her collaborators, the results suggest that “low-dose fenfluramine provides significant improvement in seizure frequency while being generally well tolerated in DS patients.”
The study criteria included patients aged 6 months to 50 years who had a DS diagnosis; enrollees ranged in age from 1.2 to 29.8 years when starting fenfluramine. Though criteria allowed enrollment of patients with and without a mutation in the SCN1A gene, all participants did have a de novo mutation of the SCN1A gene, according to Dr. Schoonjans of the department of pediatric neurology at Antwerp (Belgium) University Hospital and her colleagues. They wrote that mutations in the gene, which encodes the alpha subunit of type 1 voltage-gated sodium channels, are found in about 80% of DS patients.
During the 3-month run-in period that began the study, patients had a median seizure frequency of 15 seizures per month. Patients remained on their baseline antiepilepsy regimen during the run-in period and throughout the study, with fenfluramine used as add-on therapy. At baseline, all patients were taking valproic acid and at least one other antiepileptic medication; three patients were taking four medications and one was taking five medications. Three patients also had vagal nerve stimulators with stable settings.
Throughout the study period, patients or their caregivers kept a seizure diary, recording major motor seizures. Those keeping the diary were instructed to record all tonic-clonic, tonic, atonic, and myoclonic seizures lasting more than 30 seconds.
Three months after beginning treatment, the study population’s median seizure frequency fell to 2.0 per month (–84%). Frequency fell further during the first year, to 1.0 per month (–79%; a smaller percent reduction because data were not available for this time period for the patient with the highest seizure frequency). For the total treatment period, the median seizure frequency was 1.9 per month (–76%). The reduction in seizure frequency was statistically significant at all time points (P less than .05; compared with baseline).
Fenfluramine was generally well-tolerated. Five patients experienced somnolence, and four had loss of appetite.
To track cardiovascular safety, all patients had echocardiographs at baseline and every 3 months during the first year of treatment. Echocardiographs were performed every 6 months during the second year, and annually thereafter. One patient had systolic dysfunction characterized by a reduced ejection fraction (53%) and fractional shortening (26%), findings of “no clinical significance,” according to Dr. Schoonjans and her colleagues.
Fenfluramine was part of an oral weight loss drug combination, along with phentermine. The combo, known as “fen-phen,” was associated with increased rates of pulmonary hypertension and valve disease, particularly aortic valve thickening and regurgitation. It was withdrawn from the market in 1997. Though pulmonary hypertension would frequently resolve after discontinuing fen-phen, not all patients with valvulopathy experienced resolution, and case reports of patients with the aortic valve thickening typically seen with fenfluramine are still surfacing many years after the drug’s discontinuation (e.g., Tex Heart Inst J. 2011;38[5]:581-3).
Fenfluramine was typically given at doses up to 60 mg when used with phentermine for weight loss. The dosing for Dravet syndrome patients in this study was much lower and weight based, ranging from 0.1 to 1.0 mg/kg per day, with a maximum permitted dose of 20 mg/day.
Fenfluramine is a serotonin releaser, and serotonin is known to modulate the action of voltage-gated sodium channels. However, the exact mechanism by which the drug reduces seizure frequency is not known. Clinical trials are underway in the United States for both DS and Lennox Gastaut epilepsy, and fenfluramine has been granted orphan drug status in the United States and Europe, according to an announcement from Zogenix, the drug’s manufacturer.
The study was funded by Zogenix, which holds a Royal Decree to dispense the drug under the study conditions in Belgium, where the study took place. Zogenix also funded writing and editorial assistance for the poster presentation.
[email protected]
On Twitter @karioakes
HOUSTON – Low-dose fenfluramine was found to reduce seizures significantly among a small cohort with Dravet syndrome without the appearance of valvular abnormalities or pulmonary hypertension, according to a prospective study presented at a poster session of the annual meeting of the American Epilepsy Society.
Six of nine Dravet syndrome (DS) patients (66%) had at least a 50% reduction in major motor seizure frequency for at least 90% of the period during which they took fenfluramine. Five of the nine DS patients (56%) experienced a reduction in major motor seizure frequency of 75% or more for at least 60% of the median 1.9 years they were on fenfluramine.
According to lead author An-Sofie Schoonjans, MD, and her collaborators, the results suggest that “low-dose fenfluramine provides significant improvement in seizure frequency while being generally well tolerated in DS patients.”
The study criteria included patients aged 6 months to 50 years who had a DS diagnosis; enrollees ranged in age from 1.2 to 29.8 years when starting fenfluramine. Though criteria allowed enrollment of patients with and without a mutation in the SCN1A gene, all participants did have a de novo mutation of the SCN1A gene, according to Dr. Schoonjans of the department of pediatric neurology at Antwerp (Belgium) University Hospital and her colleagues. They wrote that mutations in the gene, which encodes the alpha subunit of type 1 voltage-gated sodium channels, are found in about 80% of DS patients.
During the 3-month run-in period that began the study, patients had a median seizure frequency of 15 seizures per month. Patients remained on their baseline antiepilepsy regimen during the run-in period and throughout the study, with fenfluramine used as add-on therapy. At baseline, all patients were taking valproic acid and at least one other antiepileptic medication; three patients were taking four medications and one was taking five medications. Three patients also had vagal nerve stimulators with stable settings.
Throughout the study period, patients or their caregivers kept a seizure diary, recording major motor seizures. Those keeping the diary were instructed to record all tonic-clonic, tonic, atonic, and myoclonic seizures lasting more than 30 seconds.
Three months after beginning treatment, the study population’s median seizure frequency fell to 2.0 per month (–84%). Frequency fell further during the first year, to 1.0 per month (–79%; a smaller percent reduction because data were not available for this time period for the patient with the highest seizure frequency). For the total treatment period, the median seizure frequency was 1.9 per month (–76%). The reduction in seizure frequency was statistically significant at all time points (P less than .05; compared with baseline).
Fenfluramine was generally well-tolerated. Five patients experienced somnolence, and four had loss of appetite.
To track cardiovascular safety, all patients had echocardiographs at baseline and every 3 months during the first year of treatment. Echocardiographs were performed every 6 months during the second year, and annually thereafter. One patient had systolic dysfunction characterized by a reduced ejection fraction (53%) and fractional shortening (26%), findings of “no clinical significance,” according to Dr. Schoonjans and her colleagues.
Fenfluramine was part of an oral weight loss drug combination, along with phentermine. The combo, known as “fen-phen,” was associated with increased rates of pulmonary hypertension and valve disease, particularly aortic valve thickening and regurgitation. It was withdrawn from the market in 1997. Though pulmonary hypertension would frequently resolve after discontinuing fen-phen, not all patients with valvulopathy experienced resolution, and case reports of patients with the aortic valve thickening typically seen with fenfluramine are still surfacing many years after the drug’s discontinuation (e.g., Tex Heart Inst J. 2011;38[5]:581-3).
Fenfluramine was typically given at doses up to 60 mg when used with phentermine for weight loss. The dosing for Dravet syndrome patients in this study was much lower and weight based, ranging from 0.1 to 1.0 mg/kg per day, with a maximum permitted dose of 20 mg/day.
Fenfluramine is a serotonin releaser, and serotonin is known to modulate the action of voltage-gated sodium channels. However, the exact mechanism by which the drug reduces seizure frequency is not known. Clinical trials are underway in the United States for both DS and Lennox Gastaut epilepsy, and fenfluramine has been granted orphan drug status in the United States and Europe, according to an announcement from Zogenix, the drug’s manufacturer.
The study was funded by Zogenix, which holds a Royal Decree to dispense the drug under the study conditions in Belgium, where the study took place. Zogenix also funded writing and editorial assistance for the poster presentation.
[email protected]
On Twitter @karioakes
HOUSTON – Low-dose fenfluramine was found to reduce seizures significantly among a small cohort with Dravet syndrome without the appearance of valvular abnormalities or pulmonary hypertension, according to a prospective study presented at a poster session of the annual meeting of the American Epilepsy Society.
Six of nine Dravet syndrome (DS) patients (66%) had at least a 50% reduction in major motor seizure frequency for at least 90% of the period during which they took fenfluramine. Five of the nine DS patients (56%) experienced a reduction in major motor seizure frequency of 75% or more for at least 60% of the median 1.9 years they were on fenfluramine.
According to lead author An-Sofie Schoonjans, MD, and her collaborators, the results suggest that “low-dose fenfluramine provides significant improvement in seizure frequency while being generally well tolerated in DS patients.”
The study criteria included patients aged 6 months to 50 years who had a DS diagnosis; enrollees ranged in age from 1.2 to 29.8 years when starting fenfluramine. Though criteria allowed enrollment of patients with and without a mutation in the SCN1A gene, all participants did have a de novo mutation of the SCN1A gene, according to Dr. Schoonjans of the department of pediatric neurology at Antwerp (Belgium) University Hospital and her colleagues. They wrote that mutations in the gene, which encodes the alpha subunit of type 1 voltage-gated sodium channels, are found in about 80% of DS patients.
During the 3-month run-in period that began the study, patients had a median seizure frequency of 15 seizures per month. Patients remained on their baseline antiepilepsy regimen during the run-in period and throughout the study, with fenfluramine used as add-on therapy. At baseline, all patients were taking valproic acid and at least one other antiepileptic medication; three patients were taking four medications and one was taking five medications. Three patients also had vagal nerve stimulators with stable settings.
Throughout the study period, patients or their caregivers kept a seizure diary, recording major motor seizures. Those keeping the diary were instructed to record all tonic-clonic, tonic, atonic, and myoclonic seizures lasting more than 30 seconds.
Three months after beginning treatment, the study population’s median seizure frequency fell to 2.0 per month (–84%). Frequency fell further during the first year, to 1.0 per month (–79%; a smaller percent reduction because data were not available for this time period for the patient with the highest seizure frequency). For the total treatment period, the median seizure frequency was 1.9 per month (–76%). The reduction in seizure frequency was statistically significant at all time points (P less than .05; compared with baseline).
Fenfluramine was generally well-tolerated. Five patients experienced somnolence, and four had loss of appetite.
To track cardiovascular safety, all patients had echocardiographs at baseline and every 3 months during the first year of treatment. Echocardiographs were performed every 6 months during the second year, and annually thereafter. One patient had systolic dysfunction characterized by a reduced ejection fraction (53%) and fractional shortening (26%), findings of “no clinical significance,” according to Dr. Schoonjans and her colleagues.
Fenfluramine was part of an oral weight loss drug combination, along with phentermine. The combo, known as “fen-phen,” was associated with increased rates of pulmonary hypertension and valve disease, particularly aortic valve thickening and regurgitation. It was withdrawn from the market in 1997. Though pulmonary hypertension would frequently resolve after discontinuing fen-phen, not all patients with valvulopathy experienced resolution, and case reports of patients with the aortic valve thickening typically seen with fenfluramine are still surfacing many years after the drug’s discontinuation (e.g., Tex Heart Inst J. 2011;38[5]:581-3).
Fenfluramine was typically given at doses up to 60 mg when used with phentermine for weight loss. The dosing for Dravet syndrome patients in this study was much lower and weight based, ranging from 0.1 to 1.0 mg/kg per day, with a maximum permitted dose of 20 mg/day.
Fenfluramine is a serotonin releaser, and serotonin is known to modulate the action of voltage-gated sodium channels. However, the exact mechanism by which the drug reduces seizure frequency is not known. Clinical trials are underway in the United States for both DS and Lennox Gastaut epilepsy, and fenfluramine has been granted orphan drug status in the United States and Europe, according to an announcement from Zogenix, the drug’s manufacturer.
The study was funded by Zogenix, which holds a Royal Decree to dispense the drug under the study conditions in Belgium, where the study took place. Zogenix also funded writing and editorial assistance for the poster presentation.
[email protected]
On Twitter @karioakes
AT AES 2016
Key clinical point:
Major finding: Six of nine patients (66%) had a reduction in seizure frequency of at least 50% for at least 90% of the time they were taking fenfluramine.
Data source: Prospective cohort study of nine patients with Dravet syndrome who took fenfluramine as add-on therapy for a median 1.9 years.
Disclosures: The study was funded by Zogenix, which funded editorial and writing support for the poster presentation.
FDA eases mental health warnings in smoking cessation drugs’ labels
Labels on two smoking cessation treatments will offer less severe warnings for mental health risk potentials in people with no history of psychiatric disorders, the Food and Drug Administration has announced.
Varenicline (Chantix) will no longer include a boxed warning for serious mental health side effects. The label for bupropion (Zyban) will still include a boxed warning, but language describing the potential for serious psychiatric adverse events will no longer appear within it. Updates will also be made to both labels to describe side effects on mood, behavior, or thinking.
In addition, varenicline’s label will reflect trial data showing its superior efficacy, compared with oral bupropion or nicotine patch. Although a patient medication guide will still be included with each prescription, the risk evaluation and mitigation strategy that prompted the guide will no longer be in place.
Earlier this year, two FDA advisory committees voted in favor of updating varenicline’s label, based on data from a randomized, controlled trial of more than 8,000 smokers, half of whom had a history of psychiatric disorders.
The trial showed no clinically significant difference in risk of adverse events across the smoking cessation treatments varenicline, bupropion, nicotine patch, or placebo study arms, although the risk was higher in the psychiatric cohorts in each.
Overall, 2% of those without a history of mental illness experienced neuropsychiatric adverse events, compared with between 5% and 7% of those with such a history.
The trial was cosponsored by Pfizer, maker of Chantix, and GlaxoSmithKline, maker of Zyban.
The FDA approved varenicline for smoking cessation in 2006 and approved bupropion, which also is indicated to treat depression and seasonal affective disorder, in 1997. After numerous postmarketing reports of increased incidents of psychiatric disorders occurring in smokers who used either drug, the agency added the boxed warning to each in 2009.
FDA officials advised clinicians to guard against changes in mental health status in smokers using these therapies. However, “the results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines,” they noted.
On Twitter @whitneymcknight
Labels on two smoking cessation treatments will offer less severe warnings for mental health risk potentials in people with no history of psychiatric disorders, the Food and Drug Administration has announced.
Varenicline (Chantix) will no longer include a boxed warning for serious mental health side effects. The label for bupropion (Zyban) will still include a boxed warning, but language describing the potential for serious psychiatric adverse events will no longer appear within it. Updates will also be made to both labels to describe side effects on mood, behavior, or thinking.
In addition, varenicline’s label will reflect trial data showing its superior efficacy, compared with oral bupropion or nicotine patch. Although a patient medication guide will still be included with each prescription, the risk evaluation and mitigation strategy that prompted the guide will no longer be in place.
Earlier this year, two FDA advisory committees voted in favor of updating varenicline’s label, based on data from a randomized, controlled trial of more than 8,000 smokers, half of whom had a history of psychiatric disorders.
The trial showed no clinically significant difference in risk of adverse events across the smoking cessation treatments varenicline, bupropion, nicotine patch, or placebo study arms, although the risk was higher in the psychiatric cohorts in each.
Overall, 2% of those without a history of mental illness experienced neuropsychiatric adverse events, compared with between 5% and 7% of those with such a history.
The trial was cosponsored by Pfizer, maker of Chantix, and GlaxoSmithKline, maker of Zyban.
The FDA approved varenicline for smoking cessation in 2006 and approved bupropion, which also is indicated to treat depression and seasonal affective disorder, in 1997. After numerous postmarketing reports of increased incidents of psychiatric disorders occurring in smokers who used either drug, the agency added the boxed warning to each in 2009.
FDA officials advised clinicians to guard against changes in mental health status in smokers using these therapies. However, “the results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines,” they noted.
On Twitter @whitneymcknight
Labels on two smoking cessation treatments will offer less severe warnings for mental health risk potentials in people with no history of psychiatric disorders, the Food and Drug Administration has announced.
Varenicline (Chantix) will no longer include a boxed warning for serious mental health side effects. The label for bupropion (Zyban) will still include a boxed warning, but language describing the potential for serious psychiatric adverse events will no longer appear within it. Updates will also be made to both labels to describe side effects on mood, behavior, or thinking.
In addition, varenicline’s label will reflect trial data showing its superior efficacy, compared with oral bupropion or nicotine patch. Although a patient medication guide will still be included with each prescription, the risk evaluation and mitigation strategy that prompted the guide will no longer be in place.
Earlier this year, two FDA advisory committees voted in favor of updating varenicline’s label, based on data from a randomized, controlled trial of more than 8,000 smokers, half of whom had a history of psychiatric disorders.
The trial showed no clinically significant difference in risk of adverse events across the smoking cessation treatments varenicline, bupropion, nicotine patch, or placebo study arms, although the risk was higher in the psychiatric cohorts in each.
Overall, 2% of those without a history of mental illness experienced neuropsychiatric adverse events, compared with between 5% and 7% of those with such a history.
The trial was cosponsored by Pfizer, maker of Chantix, and GlaxoSmithKline, maker of Zyban.
The FDA approved varenicline for smoking cessation in 2006 and approved bupropion, which also is indicated to treat depression and seasonal affective disorder, in 1997. After numerous postmarketing reports of increased incidents of psychiatric disorders occurring in smokers who used either drug, the agency added the boxed warning to each in 2009.
FDA officials advised clinicians to guard against changes in mental health status in smokers using these therapies. However, “the results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines,” they noted.
On Twitter @whitneymcknight
Severe postoperative pain following thoracotomy predicts persistent pain months later
Patients who suffer from severe pain in the days immediately following an open thoracotomy are significantly more likely to still be experiencing pain from the procedure 6 months later, according to a study published in the Journal of Clinical Anesthesia.
“A recognized cause of persistent postsurgical pain is poorly controlled immediate postoperative pain,” wrote the authors, led by Gopinath Niraj, MD, of the University Hospitals of Leicester (England) NHS Trust. “Open thoracotomy can induce significant pain during the immediate postoperative period. Patients undergoing thoracotomy also have one of the greatest incidences of chronic postoperative pain and disability among all the surgical procedures.”
Dr. Niraj and his coinvestigators conducted an audit on 504 patients who underwent open thoracotomy at a single center between May 2010 and April 2012. The audit consisted of a questionnaire composed of 15 questions, which asked yes/no questions about the existence of and location of postoperative pain, and numerical questions regarding the severity of pain. Scores of 7 or higher on a 10-point scale indicated “severe pain,” according to the investigators (J Clin Anesth. 2017;36:174-7). Subjects were evaluated at 72 hours and at 6 months after the operation.
Of the 504 patients, there were 364 survivors, of which 306 received questionnaires. Of those 306, 133 (43%) reported at least five incidents of severe pain within 72 hours of undergoing the operation. Within this group, 109 (82%) reported feeling some amount of persistent pain 6 months later. Chronic post-thoracotomy pain was considered severe in 10% of those subjects, while 24% reported it as moderate and 48% said it was mild.
A total of 289 of the 306 subjects (95%) received an epidural analgesic in the 72 hours after thoracotomy. In terms of satisfaction with pain management, patients were overall positive; 36.3% rated it “excellent,” 43.8% called it “good,” while only 15.8% said it was “fair” and 3.8% said it was “poor.”
“Our audit has some limitations,” the authors noted. “The retrospective project relied on patient self-report and recall.”
Dr. Niraj and his coauthors did not report any financial conflicts. No funding sources for this study were disclosed.
Patients who suffer from severe pain in the days immediately following an open thoracotomy are significantly more likely to still be experiencing pain from the procedure 6 months later, according to a study published in the Journal of Clinical Anesthesia.
“A recognized cause of persistent postsurgical pain is poorly controlled immediate postoperative pain,” wrote the authors, led by Gopinath Niraj, MD, of the University Hospitals of Leicester (England) NHS Trust. “Open thoracotomy can induce significant pain during the immediate postoperative period. Patients undergoing thoracotomy also have one of the greatest incidences of chronic postoperative pain and disability among all the surgical procedures.”
Dr. Niraj and his coinvestigators conducted an audit on 504 patients who underwent open thoracotomy at a single center between May 2010 and April 2012. The audit consisted of a questionnaire composed of 15 questions, which asked yes/no questions about the existence of and location of postoperative pain, and numerical questions regarding the severity of pain. Scores of 7 or higher on a 10-point scale indicated “severe pain,” according to the investigators (J Clin Anesth. 2017;36:174-7). Subjects were evaluated at 72 hours and at 6 months after the operation.
Of the 504 patients, there were 364 survivors, of which 306 received questionnaires. Of those 306, 133 (43%) reported at least five incidents of severe pain within 72 hours of undergoing the operation. Within this group, 109 (82%) reported feeling some amount of persistent pain 6 months later. Chronic post-thoracotomy pain was considered severe in 10% of those subjects, while 24% reported it as moderate and 48% said it was mild.
A total of 289 of the 306 subjects (95%) received an epidural analgesic in the 72 hours after thoracotomy. In terms of satisfaction with pain management, patients were overall positive; 36.3% rated it “excellent,” 43.8% called it “good,” while only 15.8% said it was “fair” and 3.8% said it was “poor.”
“Our audit has some limitations,” the authors noted. “The retrospective project relied on patient self-report and recall.”
Dr. Niraj and his coauthors did not report any financial conflicts. No funding sources for this study were disclosed.
Patients who suffer from severe pain in the days immediately following an open thoracotomy are significantly more likely to still be experiencing pain from the procedure 6 months later, according to a study published in the Journal of Clinical Anesthesia.
“A recognized cause of persistent postsurgical pain is poorly controlled immediate postoperative pain,” wrote the authors, led by Gopinath Niraj, MD, of the University Hospitals of Leicester (England) NHS Trust. “Open thoracotomy can induce significant pain during the immediate postoperative period. Patients undergoing thoracotomy also have one of the greatest incidences of chronic postoperative pain and disability among all the surgical procedures.”
Dr. Niraj and his coinvestigators conducted an audit on 504 patients who underwent open thoracotomy at a single center between May 2010 and April 2012. The audit consisted of a questionnaire composed of 15 questions, which asked yes/no questions about the existence of and location of postoperative pain, and numerical questions regarding the severity of pain. Scores of 7 or higher on a 10-point scale indicated “severe pain,” according to the investigators (J Clin Anesth. 2017;36:174-7). Subjects were evaluated at 72 hours and at 6 months after the operation.
Of the 504 patients, there were 364 survivors, of which 306 received questionnaires. Of those 306, 133 (43%) reported at least five incidents of severe pain within 72 hours of undergoing the operation. Within this group, 109 (82%) reported feeling some amount of persistent pain 6 months later. Chronic post-thoracotomy pain was considered severe in 10% of those subjects, while 24% reported it as moderate and 48% said it was mild.
A total of 289 of the 306 subjects (95%) received an epidural analgesic in the 72 hours after thoracotomy. In terms of satisfaction with pain management, patients were overall positive; 36.3% rated it “excellent,” 43.8% called it “good,” while only 15.8% said it was “fair” and 3.8% said it was “poor.”
“Our audit has some limitations,” the authors noted. “The retrospective project relied on patient self-report and recall.”
Dr. Niraj and his coauthors did not report any financial conflicts. No funding sources for this study were disclosed.
FROM THE JOURNAL OF CLINICAL ANESTHESIA
Key clinical point:
Major finding: 133 of 306 patients were in severe pain 72 hours after thoracotomy; of these, 109 (82%) still had pain 6 months later.
Data source: Retrospective, single-center study of 504 thoracotomy patients between May 2010 and April 2012.
Disclosures: Authors reported no financial disclosures nor funding source.
CMS nixes Part B drug payment demonstration
A controversial demonstration project that would have tested new methods to pay for the drugs administered in medical offices has been canceled by the Centers for Medicare & Medicaid Services.
The agency received considerable backlash from physicians, Congress, and others when the demonstration project was announced in March 2016.
The agency said it received “a great deal of support from some” for the proposed demonstration. However, “a number of stakeholders expressed strong concerns about the model. While CMS was working to address these concerns, the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time.”
The demonstration project was designed to test new methods to “improve how Medicare Part B pays for prescription drugs and supports physicians and other clinicians in delivering high quality care,” according to a fact sheet published in March.
Under the project, medical practices would have been divided into two groups. A control group would continue to be paid for Part B drugs at the current rate of 106% of average sales price (ASP), while the other would have been paid at 102.5% of ASP plus a flat fee of $16.80 per drug payment. Starting in January 2017, each group would have been further subdivided with a portion of each being subjected to value-based purchasing tools.
One key criticism of the demonstration project centered on the proposed randomization of practices, which was based on primary care service areas (clusters of zip codes with similar Part B medical care patterns). That randomization scheme could have caused different payment levels – and patient out-of-pocket spending – for geographically close areas. Further, participation in the demonstration project would have been mandatory, with no mechanism to opt out.
“This is a model for how Washington should, but often doesn’t, work,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “We are grateful that CMS came to the right decision after listening to stakeholders.”
An analysis of the proposed demonstration project by Avalere found that specialists would likely see a decrease in their drug payments under the proposal, while primary care doctors would likely see an increase, and that 7 of the 10 drugs most affected by this proposal were drugs used to treat cancer.
A controversial demonstration project that would have tested new methods to pay for the drugs administered in medical offices has been canceled by the Centers for Medicare & Medicaid Services.
The agency received considerable backlash from physicians, Congress, and others when the demonstration project was announced in March 2016.
The agency said it received “a great deal of support from some” for the proposed demonstration. However, “a number of stakeholders expressed strong concerns about the model. While CMS was working to address these concerns, the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time.”
The demonstration project was designed to test new methods to “improve how Medicare Part B pays for prescription drugs and supports physicians and other clinicians in delivering high quality care,” according to a fact sheet published in March.
Under the project, medical practices would have been divided into two groups. A control group would continue to be paid for Part B drugs at the current rate of 106% of average sales price (ASP), while the other would have been paid at 102.5% of ASP plus a flat fee of $16.80 per drug payment. Starting in January 2017, each group would have been further subdivided with a portion of each being subjected to value-based purchasing tools.
One key criticism of the demonstration project centered on the proposed randomization of practices, which was based on primary care service areas (clusters of zip codes with similar Part B medical care patterns). That randomization scheme could have caused different payment levels – and patient out-of-pocket spending – for geographically close areas. Further, participation in the demonstration project would have been mandatory, with no mechanism to opt out.
“This is a model for how Washington should, but often doesn’t, work,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “We are grateful that CMS came to the right decision after listening to stakeholders.”
An analysis of the proposed demonstration project by Avalere found that specialists would likely see a decrease in their drug payments under the proposal, while primary care doctors would likely see an increase, and that 7 of the 10 drugs most affected by this proposal were drugs used to treat cancer.
A controversial demonstration project that would have tested new methods to pay for the drugs administered in medical offices has been canceled by the Centers for Medicare & Medicaid Services.
The agency received considerable backlash from physicians, Congress, and others when the demonstration project was announced in March 2016.
The agency said it received “a great deal of support from some” for the proposed demonstration. However, “a number of stakeholders expressed strong concerns about the model. While CMS was working to address these concerns, the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time.”
The demonstration project was designed to test new methods to “improve how Medicare Part B pays for prescription drugs and supports physicians and other clinicians in delivering high quality care,” according to a fact sheet published in March.
Under the project, medical practices would have been divided into two groups. A control group would continue to be paid for Part B drugs at the current rate of 106% of average sales price (ASP), while the other would have been paid at 102.5% of ASP plus a flat fee of $16.80 per drug payment. Starting in January 2017, each group would have been further subdivided with a portion of each being subjected to value-based purchasing tools.
One key criticism of the demonstration project centered on the proposed randomization of practices, which was based on primary care service areas (clusters of zip codes with similar Part B medical care patterns). That randomization scheme could have caused different payment levels – and patient out-of-pocket spending – for geographically close areas. Further, participation in the demonstration project would have been mandatory, with no mechanism to opt out.
“This is a model for how Washington should, but often doesn’t, work,” American Medical Association President Andrew W. Gurman, MD, said in a statement. “We are grateful that CMS came to the right decision after listening to stakeholders.”
An analysis of the proposed demonstration project by Avalere found that specialists would likely see a decrease in their drug payments under the proposal, while primary care doctors would likely see an increase, and that 7 of the 10 drugs most affected by this proposal were drugs used to treat cancer.
Should you continue to participate in Medicare?
Since writing about the new MACRA bureaucracy, and the Morton’s Choice facing private practitioners between Scylla (the Merit-based Incentive Payment System) and Charybdis (the still largely undefined Alternate Payment Models), a question I’ve been hearing with increasing frequency is whether it wouldn’t be better to simply opt out of Medicare participation entirely.
It is easy to see why more and more physicians are asking that question. Although the incoming administration has promised significant (but largely unspecified) changes to the health care system – as I wrote last month – reimbursements continue to decrease, onerous regulations continue to increase, and there is no evidence to suggest that either of those trends will change anytime soon. That leaves many physicians wondering whether their continued participation with Medicare (and Medicaid, for those who accept it) is ultimately worth it. 
It is difficult to assign a firm answer to the basic question of whether or not opting out is a good idea. As usual, it will depend upon your unique circumstances, as well as the size and composition of your practice. This is not a decision to make lightly, or hastily – particularly if a significant percentage of your patients have federal or state health care coverage.
You will need to carefully consider the pros and cons involved, beginning with the fact that once you pull the trigger, there’s no going back for at least 2 years. (If you are opting out for the very first time, you do have 90 days to change your mind and opt back in.) And you must create a physician-patient agreement covering your treatment and billing guidelines, and make sure all of your Medicare/Medicaid patients sign it.
The obvious benefit of opting out is the freedom to do and bill what and how you wish. Once liberated from CMS compliance restrictions, you can spend your time treating patients, rather than catering to and being controlled by the government. The physician-patient relationship regains its proper priority; you can work directly with your patients in structuring their care plans and pursuing the best treatment options. Physicians with small, relatively young patient populations often find the prospect of charting their own course particularly attractive.
Not only that, but some commercial carriers require Medicare participation in order to maintain credentialing with them. So if you opt out of federal and state participation, you will also need to opt out of commercial plans with that requirement. Hospital admitting privileges may also be contingent on Medicare participation; be sure to check your hospitals’ bylaws.
Another challenge is pushback from patients. While few patients like dealing with insurance claims, fewer still are willing to pay for their care themselves. When drafting a physician-patient agreement, it must be made very clear that you are not going to bill Medicare or Medicaid for services rendered, and that patients cannot do so either. Inevitably, a substantial percentage of your Medicare/Medicaid-covered patients will choose to switch to a participating physician.
If you do decide to opt out, here is how you do it:
1. Notify your patients that you will be opting out by a specific date, which should be the first day of a calendar quarter.
2. File an affidavit (available at CMS.gov) with your local Medicare carrier at least 30 days before your opt-out date.
3. Draft and post a fee schedule.
4. Draft a private contract to be signed by all Medicare beneficiaries, covering all services that would normally be covered by Medicare. Be sure to run it past your attorney.
5. Install procedures to ensure that your office never files a Medicare claim, and never provides information to enable a patient to file a Medicare claim. The two exceptions – for emergency care, and for covered services that Medicare would deem unnecessary – should be used sparingly, and with caution.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Since writing about the new MACRA bureaucracy, and the Morton’s Choice facing private practitioners between Scylla (the Merit-based Incentive Payment System) and Charybdis (the still largely undefined Alternate Payment Models), a question I’ve been hearing with increasing frequency is whether it wouldn’t be better to simply opt out of Medicare participation entirely.
It is easy to see why more and more physicians are asking that question. Although the incoming administration has promised significant (but largely unspecified) changes to the health care system – as I wrote last month – reimbursements continue to decrease, onerous regulations continue to increase, and there is no evidence to suggest that either of those trends will change anytime soon. That leaves many physicians wondering whether their continued participation with Medicare (and Medicaid, for those who accept it) is ultimately worth it.
It is difficult to assign a firm answer to the basic question of whether or not opting out is a good idea. As usual, it will depend upon your unique circumstances, as well as the size and composition of your practice. This is not a decision to make lightly, or hastily – particularly if a significant percentage of your patients have federal or state health care coverage.
You will need to carefully consider the pros and cons involved, beginning with the fact that once you pull the trigger, there’s no going back for at least 2 years. (If you are opting out for the very first time, you do have 90 days to change your mind and opt back in.) And you must create a physician-patient agreement covering your treatment and billing guidelines, and make sure all of your Medicare/Medicaid patients sign it.
The obvious benefit of opting out is the freedom to do and bill what and how you wish. Once liberated from CMS compliance restrictions, you can spend your time treating patients, rather than catering to and being controlled by the government. The physician-patient relationship regains its proper priority; you can work directly with your patients in structuring their care plans and pursuing the best treatment options. Physicians with small, relatively young patient populations often find the prospect of charting their own course particularly attractive.
Not only that, but some commercial carriers require Medicare participation in order to maintain credentialing with them. So if you opt out of federal and state participation, you will also need to opt out of commercial plans with that requirement. Hospital admitting privileges may also be contingent on Medicare participation; be sure to check your hospitals’ bylaws.
Another challenge is pushback from patients. While few patients like dealing with insurance claims, fewer still are willing to pay for their care themselves. When drafting a physician-patient agreement, it must be made very clear that you are not going to bill Medicare or Medicaid for services rendered, and that patients cannot do so either. Inevitably, a substantial percentage of your Medicare/Medicaid-covered patients will choose to switch to a participating physician.
If you do decide to opt out, here is how you do it:
1. Notify your patients that you will be opting out by a specific date, which should be the first day of a calendar quarter.
2. File an affidavit (available at CMS.gov) with your local Medicare carrier at least 30 days before your opt-out date.
3. Draft and post a fee schedule.
4. Draft a private contract to be signed by all Medicare beneficiaries, covering all services that would normally be covered by Medicare. Be sure to run it past your attorney.
5. Install procedures to ensure that your office never files a Medicare claim, and never provides information to enable a patient to file a Medicare claim. The two exceptions – for emergency care, and for covered services that Medicare would deem unnecessary – should be used sparingly, and with caution.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Since writing about the new MACRA bureaucracy, and the Morton’s Choice facing private practitioners between Scylla (the Merit-based Incentive Payment System) and Charybdis (the still largely undefined Alternate Payment Models), a question I’ve been hearing with increasing frequency is whether it wouldn’t be better to simply opt out of Medicare participation entirely.
It is easy to see why more and more physicians are asking that question. Although the incoming administration has promised significant (but largely unspecified) changes to the health care system – as I wrote last month – reimbursements continue to decrease, onerous regulations continue to increase, and there is no evidence to suggest that either of those trends will change anytime soon. That leaves many physicians wondering whether their continued participation with Medicare (and Medicaid, for those who accept it) is ultimately worth it.
It is difficult to assign a firm answer to the basic question of whether or not opting out is a good idea. As usual, it will depend upon your unique circumstances, as well as the size and composition of your practice. This is not a decision to make lightly, or hastily – particularly if a significant percentage of your patients have federal or state health care coverage.
You will need to carefully consider the pros and cons involved, beginning with the fact that once you pull the trigger, there’s no going back for at least 2 years. (If you are opting out for the very first time, you do have 90 days to change your mind and opt back in.) And you must create a physician-patient agreement covering your treatment and billing guidelines, and make sure all of your Medicare/Medicaid patients sign it.
The obvious benefit of opting out is the freedom to do and bill what and how you wish. Once liberated from CMS compliance restrictions, you can spend your time treating patients, rather than catering to and being controlled by the government. The physician-patient relationship regains its proper priority; you can work directly with your patients in structuring their care plans and pursuing the best treatment options. Physicians with small, relatively young patient populations often find the prospect of charting their own course particularly attractive.
Not only that, but some commercial carriers require Medicare participation in order to maintain credentialing with them. So if you opt out of federal and state participation, you will also need to opt out of commercial plans with that requirement. Hospital admitting privileges may also be contingent on Medicare participation; be sure to check your hospitals’ bylaws.
Another challenge is pushback from patients. While few patients like dealing with insurance claims, fewer still are willing to pay for their care themselves. When drafting a physician-patient agreement, it must be made very clear that you are not going to bill Medicare or Medicaid for services rendered, and that patients cannot do so either. Inevitably, a substantial percentage of your Medicare/Medicaid-covered patients will choose to switch to a participating physician.
If you do decide to opt out, here is how you do it:
1. Notify your patients that you will be opting out by a specific date, which should be the first day of a calendar quarter.
2. File an affidavit (available at CMS.gov) with your local Medicare carrier at least 30 days before your opt-out date.
3. Draft and post a fee schedule.
4. Draft a private contract to be signed by all Medicare beneficiaries, covering all services that would normally be covered by Medicare. Be sure to run it past your attorney.
5. Install procedures to ensure that your office never files a Medicare claim, and never provides information to enable a patient to file a Medicare claim. The two exceptions – for emergency care, and for covered services that Medicare would deem unnecessary – should be used sparingly, and with caution.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
FDA approves rucaparib for BRCA-positive advanced ovarian cancer
The Food and Drug Administration has granted accelerated approval to rucaparib for the treatment of women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a germline or somatic BRCA gene mutation. The FDA also approved the FoundationFocus CDxBRCA companion diagnostic for use with rucaparib to detect BRCA1 and BRCA2 gene mutations in the tumor tissue.
Approval of rucaparib (Rubraca), a poly ADP-ribose polymerase (PARP) inhibitor, was based on an objective response rate (ORR) of 54%, and a median duration of response of 9.2 months, in a pooled analysis of two, single-arm clinical trials, the FDA said in a statement.
All 106 patients in the two trials had BRCA-mutated advanced ovarian cancer and had been treated with two or more chemotherapy regimens. They received rucaparib 600 mg orally twice daily. BRCA gene mutations were confirmed in 96% of participants with available tumor tissue using the FoundationFocus CDxBRCA companion diagnostic. ORR was similar for patients with a BRCA1 gene mutation or BRCA2 gene mutation.
Patients should be monitored for hematologic toxicity at baseline and monthly thereafter, and use of rucaparib should be discontinued if MDS/AML is confirmed, the FDA said on its website.
Rucaparib is marketed by Clovis Oncology. The FoundationFocus CDxBRCA companion diagnostic is marketed by Foundation Medicine.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has granted accelerated approval to rucaparib for the treatment of women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a germline or somatic BRCA gene mutation. The FDA also approved the FoundationFocus CDxBRCA companion diagnostic for use with rucaparib to detect BRCA1 and BRCA2 gene mutations in the tumor tissue.
Approval of rucaparib (Rubraca), a poly ADP-ribose polymerase (PARP) inhibitor, was based on an objective response rate (ORR) of 54%, and a median duration of response of 9.2 months, in a pooled analysis of two, single-arm clinical trials, the FDA said in a statement.
All 106 patients in the two trials had BRCA-mutated advanced ovarian cancer and had been treated with two or more chemotherapy regimens. They received rucaparib 600 mg orally twice daily. BRCA gene mutations were confirmed in 96% of participants with available tumor tissue using the FoundationFocus CDxBRCA companion diagnostic. ORR was similar for patients with a BRCA1 gene mutation or BRCA2 gene mutation.
Patients should be monitored for hematologic toxicity at baseline and monthly thereafter, and use of rucaparib should be discontinued if MDS/AML is confirmed, the FDA said on its website.
Rucaparib is marketed by Clovis Oncology. The FoundationFocus CDxBRCA companion diagnostic is marketed by Foundation Medicine.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has granted accelerated approval to rucaparib for the treatment of women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a germline or somatic BRCA gene mutation. The FDA also approved the FoundationFocus CDxBRCA companion diagnostic for use with rucaparib to detect BRCA1 and BRCA2 gene mutations in the tumor tissue.
Approval of rucaparib (Rubraca), a poly ADP-ribose polymerase (PARP) inhibitor, was based on an objective response rate (ORR) of 54%, and a median duration of response of 9.2 months, in a pooled analysis of two, single-arm clinical trials, the FDA said in a statement.
All 106 patients in the two trials had BRCA-mutated advanced ovarian cancer and had been treated with two or more chemotherapy regimens. They received rucaparib 600 mg orally twice daily. BRCA gene mutations were confirmed in 96% of participants with available tumor tissue using the FoundationFocus CDxBRCA companion diagnostic. ORR was similar for patients with a BRCA1 gene mutation or BRCA2 gene mutation.
Patients should be monitored for hematologic toxicity at baseline and monthly thereafter, and use of rucaparib should be discontinued if MDS/AML is confirmed, the FDA said on its website.
Rucaparib is marketed by Clovis Oncology. The FoundationFocus CDxBRCA companion diagnostic is marketed by Foundation Medicine.
[email protected]
On Twitter @nikolaideslaura
SLND after neoadjuvant chemo is feasible, but more study needed
SAN ANTONIO – Sentinel lymph node detection after neoadjuvant chemotherapy (NAC) is a safe and feasible strategy for preventing unnecessary systematic lymphadenectomy in patients with operable breast cancer and no clinical signs of cancer in the axillary lymph nodes prior to NAC, according to findings from the French prospective multicenter GANEA 2 trial.
However, further study is needed to assess the clinical impact of the 12% false negative rate associated with sentinel lymph node detection (SLND) in the current study, according to Jean-Marc Classe, MD, who reported the findings at the San Antonio Breast Cancer Symposium.
SLND was feasible in that it was achieved in 570 of 590 women (97%) with large operable breast tumors and negative findings on axillary sonography with fine needle cytology who were enrolled in the study, said Dr. Classe of Institut Cancerologie de l’Ouest Rene Gauducheau, Nantes, France.
Cancer cells were detected by SLND in 139 subjects after NAC and surgery, and all of those patients underwent axillary lymph node dissection. Another 418 had no sentinel node involvement after NAC and surgery, and had adequate follow-up; among those, overall 3-year survival was 97.8% and 3-year disease-free survival was 94.8%,
“In this group of patients ... we found only one axillary relapse,” he said.
These rates are comparable to historical survival rates among those without axillary involvement who undergo axillary lymph node dissection rather than sentinel lymph node detection, and the findings suggest that women with no clinical signs of axillary involvement could be spared systematic lymphadenectomy, he said.
“The standard surgical treatment after neoadjuvant chemotherapy is breast cancer surgery and lymphadenectomy level 1 and 2, but since the [National Surgical Adjuvant Breast and Bowel Project] B-27 trial, we all know that after neoadjuvant chemotherapy there are not any involved nodes in 50%-58% of patients,” he said, adding that about half of all lymphadenectomies in these patients are therefore unnecessary.
That percentage increases to more than 70% in “the very specific situation of patients treated for HER2+ breast cancer with cytologically proved axillary metastases after neoadjuvant chemotherapy,” he said.
“So we know that there is a place for sentinel lymph node biopsy after neoadjuvant chemotherapy in order to avoid unnecessary lymphadenectomy,” he said.
However, the high false negative rate associated with SLND in this and in prior studies, including the first GANEA trial, remains a concern. In fact, the most recent guidelines stated that the proof was too weak to strongly recommend sentinel lymph node biopsy after NAC, he noted.
The GANEA 2 trial was performed in response to a call in those guidelines for additional studies to assess the long-term risks of this strategy.
Study subjects included patients with FIGO stage T1-T3 infiltrating breast cancer who were enrolled from 15 French institutions between July 2010 and February 2014. Those with inflammatory cancer, local relapse, contraindications for NAC, or interrupted NAC due to progressive disease were excluded.
Follow-up included a medical visit with clinical assessment every 6 months and annual mammography.
The findings suggest that in patients with no proof of node involvement before treatment, SLND “seems to be safe within the limits of the short-term follow-up of this study,” Dr. Classe said, noting that given the concerns about the false negative rate and the uncertainty about the clinical impact of that, this approach “is not proved to be a safe procedure outside of trials.”
The strategy will be further evaluated, with a focus on eliminating false negative results, in the GANEA 3 trial, he said.
Dr. Classe reported having no disclosures.
SAN ANTONIO – Sentinel lymph node detection after neoadjuvant chemotherapy (NAC) is a safe and feasible strategy for preventing unnecessary systematic lymphadenectomy in patients with operable breast cancer and no clinical signs of cancer in the axillary lymph nodes prior to NAC, according to findings from the French prospective multicenter GANEA 2 trial.
However, further study is needed to assess the clinical impact of the 12% false negative rate associated with sentinel lymph node detection (SLND) in the current study, according to Jean-Marc Classe, MD, who reported the findings at the San Antonio Breast Cancer Symposium.
SLND was feasible in that it was achieved in 570 of 590 women (97%) with large operable breast tumors and negative findings on axillary sonography with fine needle cytology who were enrolled in the study, said Dr. Classe of Institut Cancerologie de l’Ouest Rene Gauducheau, Nantes, France.
Cancer cells were detected by SLND in 139 subjects after NAC and surgery, and all of those patients underwent axillary lymph node dissection. Another 418 had no sentinel node involvement after NAC and surgery, and had adequate follow-up; among those, overall 3-year survival was 97.8% and 3-year disease-free survival was 94.8%,
“In this group of patients ... we found only one axillary relapse,” he said.
These rates are comparable to historical survival rates among those without axillary involvement who undergo axillary lymph node dissection rather than sentinel lymph node detection, and the findings suggest that women with no clinical signs of axillary involvement could be spared systematic lymphadenectomy, he said.
“The standard surgical treatment after neoadjuvant chemotherapy is breast cancer surgery and lymphadenectomy level 1 and 2, but since the [National Surgical Adjuvant Breast and Bowel Project] B-27 trial, we all know that after neoadjuvant chemotherapy there are not any involved nodes in 50%-58% of patients,” he said, adding that about half of all lymphadenectomies in these patients are therefore unnecessary.
That percentage increases to more than 70% in “the very specific situation of patients treated for HER2+ breast cancer with cytologically proved axillary metastases after neoadjuvant chemotherapy,” he said.
“So we know that there is a place for sentinel lymph node biopsy after neoadjuvant chemotherapy in order to avoid unnecessary lymphadenectomy,” he said.
However, the high false negative rate associated with SLND in this and in prior studies, including the first GANEA trial, remains a concern. In fact, the most recent guidelines stated that the proof was too weak to strongly recommend sentinel lymph node biopsy after NAC, he noted.
The GANEA 2 trial was performed in response to a call in those guidelines for additional studies to assess the long-term risks of this strategy.
Study subjects included patients with FIGO stage T1-T3 infiltrating breast cancer who were enrolled from 15 French institutions between July 2010 and February 2014. Those with inflammatory cancer, local relapse, contraindications for NAC, or interrupted NAC due to progressive disease were excluded.
Follow-up included a medical visit with clinical assessment every 6 months and annual mammography.
The findings suggest that in patients with no proof of node involvement before treatment, SLND “seems to be safe within the limits of the short-term follow-up of this study,” Dr. Classe said, noting that given the concerns about the false negative rate and the uncertainty about the clinical impact of that, this approach “is not proved to be a safe procedure outside of trials.”
The strategy will be further evaluated, with a focus on eliminating false negative results, in the GANEA 3 trial, he said.
Dr. Classe reported having no disclosures.
SAN ANTONIO – Sentinel lymph node detection after neoadjuvant chemotherapy (NAC) is a safe and feasible strategy for preventing unnecessary systematic lymphadenectomy in patients with operable breast cancer and no clinical signs of cancer in the axillary lymph nodes prior to NAC, according to findings from the French prospective multicenter GANEA 2 trial.
However, further study is needed to assess the clinical impact of the 12% false negative rate associated with sentinel lymph node detection (SLND) in the current study, according to Jean-Marc Classe, MD, who reported the findings at the San Antonio Breast Cancer Symposium.
SLND was feasible in that it was achieved in 570 of 590 women (97%) with large operable breast tumors and negative findings on axillary sonography with fine needle cytology who were enrolled in the study, said Dr. Classe of Institut Cancerologie de l’Ouest Rene Gauducheau, Nantes, France.
Cancer cells were detected by SLND in 139 subjects after NAC and surgery, and all of those patients underwent axillary lymph node dissection. Another 418 had no sentinel node involvement after NAC and surgery, and had adequate follow-up; among those, overall 3-year survival was 97.8% and 3-year disease-free survival was 94.8%,
“In this group of patients ... we found only one axillary relapse,” he said.
These rates are comparable to historical survival rates among those without axillary involvement who undergo axillary lymph node dissection rather than sentinel lymph node detection, and the findings suggest that women with no clinical signs of axillary involvement could be spared systematic lymphadenectomy, he said.
“The standard surgical treatment after neoadjuvant chemotherapy is breast cancer surgery and lymphadenectomy level 1 and 2, but since the [National Surgical Adjuvant Breast and Bowel Project] B-27 trial, we all know that after neoadjuvant chemotherapy there are not any involved nodes in 50%-58% of patients,” he said, adding that about half of all lymphadenectomies in these patients are therefore unnecessary.
That percentage increases to more than 70% in “the very specific situation of patients treated for HER2+ breast cancer with cytologically proved axillary metastases after neoadjuvant chemotherapy,” he said.
“So we know that there is a place for sentinel lymph node biopsy after neoadjuvant chemotherapy in order to avoid unnecessary lymphadenectomy,” he said.
However, the high false negative rate associated with SLND in this and in prior studies, including the first GANEA trial, remains a concern. In fact, the most recent guidelines stated that the proof was too weak to strongly recommend sentinel lymph node biopsy after NAC, he noted.
The GANEA 2 trial was performed in response to a call in those guidelines for additional studies to assess the long-term risks of this strategy.
Study subjects included patients with FIGO stage T1-T3 infiltrating breast cancer who were enrolled from 15 French institutions between July 2010 and February 2014. Those with inflammatory cancer, local relapse, contraindications for NAC, or interrupted NAC due to progressive disease were excluded.
Follow-up included a medical visit with clinical assessment every 6 months and annual mammography.
The findings suggest that in patients with no proof of node involvement before treatment, SLND “seems to be safe within the limits of the short-term follow-up of this study,” Dr. Classe said, noting that given the concerns about the false negative rate and the uncertainty about the clinical impact of that, this approach “is not proved to be a safe procedure outside of trials.”
The strategy will be further evaluated, with a focus on eliminating false negative results, in the GANEA 3 trial, he said.
Dr. Classe reported having no disclosures.
AT SABCS 2016
Key clinical point:
Major finding: Overall 3-year survival was 97.8% and 3-year disease-free survival was 94.8% in 418 breast cancer patients who had no sentinel node involvement after NAC and surgery.
Data source: The prospective multicenter GANEA 2 trial of 590 patients.
Disclosures: Dr. Classe reported having no disclosures.