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FDA warns of endoleaks associated with endovascular grafts for AAA
The Food and Drug Administration has reported an apparent increase in device-related adverse events from the use of endovascular graft repair (EVAR) to treat abdominal aortic aneurysms (AAA).
In a Letter to Health Care Providers issued on Sept. 28, the FDA indicated that “recent information from several sources, including FDA’s Medical Device Reporting system and Annual Clinical Updates to Physicians by the manufacturers, suggests an increase in the occurrence of Type III endoleaks.”
A Type III endoleak is defined by the failure to completely exclude the AAA from blood flow, thereby allowing a systematic arterial pressurization of the aneurysm sac, increasing the risk of rupture, which is a life-threatening event.
The FDA stated that predictors of Type III endoleaks included treatment with early-generation graft materials, the presence of calcified plaque, and inadequate overlap between graft components.
Secondary interventions to treat Type III endoleaks carry their own risk of adverse events.
It is recommended that health care providers should do the following:
- Consider lifelong surveillance of patients who have been treated with EVAR.
- Consider type III endoleaks in the differential diagnosis of patients who present with symptoms of potential aneurysm expansion or rupture.
- Discuss all treatment options in depth with patients before deciding on the best treatment for Type III endoleaks.
- Report any early or late device-related adverse events, including Type IIIa and Type IIIb endoleaks, associated with EVAR, as well as any device-related adverse events that occur as the result of a secondary intervention to treat Type III endoleaks.
These events should be reported to MedWatch, using the FDA’s Safety Information and Adverse Event Reporting Program Online Voluntary Reporting Form. A form also can be requested by calling 800-332-1088.
The FDA stated that it “continues to work with all manufacturers of endovascular graft systems to better understand this issue,” and that the agency would keep the public informed when significant new information becomes available.
The Food and Drug Administration has reported an apparent increase in device-related adverse events from the use of endovascular graft repair (EVAR) to treat abdominal aortic aneurysms (AAA).
In a Letter to Health Care Providers issued on Sept. 28, the FDA indicated that “recent information from several sources, including FDA’s Medical Device Reporting system and Annual Clinical Updates to Physicians by the manufacturers, suggests an increase in the occurrence of Type III endoleaks.”
A Type III endoleak is defined by the failure to completely exclude the AAA from blood flow, thereby allowing a systematic arterial pressurization of the aneurysm sac, increasing the risk of rupture, which is a life-threatening event.
The FDA stated that predictors of Type III endoleaks included treatment with early-generation graft materials, the presence of calcified plaque, and inadequate overlap between graft components.
Secondary interventions to treat Type III endoleaks carry their own risk of adverse events.
It is recommended that health care providers should do the following:
- Consider lifelong surveillance of patients who have been treated with EVAR.
- Consider type III endoleaks in the differential diagnosis of patients who present with symptoms of potential aneurysm expansion or rupture.
- Discuss all treatment options in depth with patients before deciding on the best treatment for Type III endoleaks.
- Report any early or late device-related adverse events, including Type IIIa and Type IIIb endoleaks, associated with EVAR, as well as any device-related adverse events that occur as the result of a secondary intervention to treat Type III endoleaks.
These events should be reported to MedWatch, using the FDA’s Safety Information and Adverse Event Reporting Program Online Voluntary Reporting Form. A form also can be requested by calling 800-332-1088.
The FDA stated that it “continues to work with all manufacturers of endovascular graft systems to better understand this issue,” and that the agency would keep the public informed when significant new information becomes available.
The Food and Drug Administration has reported an apparent increase in device-related adverse events from the use of endovascular graft repair (EVAR) to treat abdominal aortic aneurysms (AAA).
In a Letter to Health Care Providers issued on Sept. 28, the FDA indicated that “recent information from several sources, including FDA’s Medical Device Reporting system and Annual Clinical Updates to Physicians by the manufacturers, suggests an increase in the occurrence of Type III endoleaks.”
A Type III endoleak is defined by the failure to completely exclude the AAA from blood flow, thereby allowing a systematic arterial pressurization of the aneurysm sac, increasing the risk of rupture, which is a life-threatening event.
The FDA stated that predictors of Type III endoleaks included treatment with early-generation graft materials, the presence of calcified plaque, and inadequate overlap between graft components.
Secondary interventions to treat Type III endoleaks carry their own risk of adverse events.
It is recommended that health care providers should do the following:
- Consider lifelong surveillance of patients who have been treated with EVAR.
- Consider type III endoleaks in the differential diagnosis of patients who present with symptoms of potential aneurysm expansion or rupture.
- Discuss all treatment options in depth with patients before deciding on the best treatment for Type III endoleaks.
- Report any early or late device-related adverse events, including Type IIIa and Type IIIb endoleaks, associated with EVAR, as well as any device-related adverse events that occur as the result of a secondary intervention to treat Type III endoleaks.
These events should be reported to MedWatch, using the FDA’s Safety Information and Adverse Event Reporting Program Online Voluntary Reporting Form. A form also can be requested by calling 800-332-1088.
The FDA stated that it “continues to work with all manufacturers of endovascular graft systems to better understand this issue,” and that the agency would keep the public informed when significant new information becomes available.
Key clinical point:
Major finding: FDA monitoring sources have detected an apparent increase in the occurrence of Type III endoleaks following EVAR.
Data source: FDA’s Medical Device Reporting System and the Annual Clinical Updates to Physicians by the manufacturers.
Disclosures: None.
Robot-assisted abdominoperineal resection outperforms open or laparoscopic surgery for rectal cancers
MADRID – The automaton uprising continues: Robot-assisted abdominoperineal resection (APR) can be safely performed in patients with rectal cancers within 5 cm of the anal verge, with surgical results equivalent to those seen with open or laparoscopic APR, investigators say.
Robot-assisted procedures were associated with a significantly lower rate of postoperative complications and with faster functional recovery than either laparoscopic or open surgery in a randomized trial, reported Jianmin Xu, MD, PhD., from Fudan University in Shanghai, China, and colleagues in a scientific poster presented at the European Society for Medical Oncology Congress.
“Retrospective studies have showed that robotic surgery was better than laparoscopic surgery in ensuring radical resection, reducing complications, and promoting recovery. However, there is no clinical trial reported for robotic surgery for rectal cancer. Thus, we conduct this randomized controlled trial to compare the safety and efficacy of robotic, laparoscopic, and open surgery for low rectal cancer,” they wrote.
Dr. Xu and colleagues enrolled 506 patients from 18 to 75 years of age with clinical stage T1 to T3 cancers within 5 cm of the anal verge and no distant metastases and randomly assigned them to resection with either a robot-assisted, laparoscopic, or open APR technique. Three of the 506 patients randomized did not undergo resection, leaving 503 for the per-protocol analysis presented here.
For the primary endpoint of complications rates within 30 days following surgery, the investigators found that patients assigned to robotic-assisted surgery (173 patients) had a total complication rate of 10.4%, compared with 18.8% for 176 patients assigned to laparoscopy (P = .027), and 26% for 154 assigned to open APR (P less than .001). The latter group included four patients assigned to laparoscopy whose procedures were converted to open surgery.
Among patients without complications, robot-assisted procedures were also associated with faster recovery, as measured by days to first flatus, at a median of 1 vs. 2 for laparoscopy and 3 for open procedures (P less than .001 for robots vs. each other surgery type). The robotic surgery was also significantly associated with fewer days to first automatic urination (median 2 vs. 4 for each of the other procedures; P less than .001), and with fewer days to discharge (median 5 vs. 7 for the other procedures; P less than .001).
"These are excellent postoperative complication rates reported, especially for the robotic treatment group, commented Thomas Gruenberger, MD, an oncologic surgeon at Rudolf Hospital in Vienna, in a poster discussion session.
“We all are now favoring laparoscopic surgery for these kinds of patients. The robot is a nice thing to have; however, we cannot use it in every hospital because it’s still quite expensive,” he said.
“We require – and this is a secondary endpoint of the study – long-term follow-up for local and distant outcomes,” he added,
The investigators did not report a funding source. All authors declared having no conflicts of interest. Dr. Gruenberger disclosed research funding, speakers bureau participation, and/or advisory roles with several companies.
MADRID – The automaton uprising continues: Robot-assisted abdominoperineal resection (APR) can be safely performed in patients with rectal cancers within 5 cm of the anal verge, with surgical results equivalent to those seen with open or laparoscopic APR, investigators say.
Robot-assisted procedures were associated with a significantly lower rate of postoperative complications and with faster functional recovery than either laparoscopic or open surgery in a randomized trial, reported Jianmin Xu, MD, PhD., from Fudan University in Shanghai, China, and colleagues in a scientific poster presented at the European Society for Medical Oncology Congress.
“Retrospective studies have showed that robotic surgery was better than laparoscopic surgery in ensuring radical resection, reducing complications, and promoting recovery. However, there is no clinical trial reported for robotic surgery for rectal cancer. Thus, we conduct this randomized controlled trial to compare the safety and efficacy of robotic, laparoscopic, and open surgery for low rectal cancer,” they wrote.
Dr. Xu and colleagues enrolled 506 patients from 18 to 75 years of age with clinical stage T1 to T3 cancers within 5 cm of the anal verge and no distant metastases and randomly assigned them to resection with either a robot-assisted, laparoscopic, or open APR technique. Three of the 506 patients randomized did not undergo resection, leaving 503 for the per-protocol analysis presented here.
For the primary endpoint of complications rates within 30 days following surgery, the investigators found that patients assigned to robotic-assisted surgery (173 patients) had a total complication rate of 10.4%, compared with 18.8% for 176 patients assigned to laparoscopy (P = .027), and 26% for 154 assigned to open APR (P less than .001). The latter group included four patients assigned to laparoscopy whose procedures were converted to open surgery.
Among patients without complications, robot-assisted procedures were also associated with faster recovery, as measured by days to first flatus, at a median of 1 vs. 2 for laparoscopy and 3 for open procedures (P less than .001 for robots vs. each other surgery type). The robotic surgery was also significantly associated with fewer days to first automatic urination (median 2 vs. 4 for each of the other procedures; P less than .001), and with fewer days to discharge (median 5 vs. 7 for the other procedures; P less than .001).
"These are excellent postoperative complication rates reported, especially for the robotic treatment group, commented Thomas Gruenberger, MD, an oncologic surgeon at Rudolf Hospital in Vienna, in a poster discussion session.
“We all are now favoring laparoscopic surgery for these kinds of patients. The robot is a nice thing to have; however, we cannot use it in every hospital because it’s still quite expensive,” he said.
“We require – and this is a secondary endpoint of the study – long-term follow-up for local and distant outcomes,” he added,
The investigators did not report a funding source. All authors declared having no conflicts of interest. Dr. Gruenberger disclosed research funding, speakers bureau participation, and/or advisory roles with several companies.
MADRID – The automaton uprising continues: Robot-assisted abdominoperineal resection (APR) can be safely performed in patients with rectal cancers within 5 cm of the anal verge, with surgical results equivalent to those seen with open or laparoscopic APR, investigators say.
Robot-assisted procedures were associated with a significantly lower rate of postoperative complications and with faster functional recovery than either laparoscopic or open surgery in a randomized trial, reported Jianmin Xu, MD, PhD., from Fudan University in Shanghai, China, and colleagues in a scientific poster presented at the European Society for Medical Oncology Congress.
“Retrospective studies have showed that robotic surgery was better than laparoscopic surgery in ensuring radical resection, reducing complications, and promoting recovery. However, there is no clinical trial reported for robotic surgery for rectal cancer. Thus, we conduct this randomized controlled trial to compare the safety and efficacy of robotic, laparoscopic, and open surgery for low rectal cancer,” they wrote.
Dr. Xu and colleagues enrolled 506 patients from 18 to 75 years of age with clinical stage T1 to T3 cancers within 5 cm of the anal verge and no distant metastases and randomly assigned them to resection with either a robot-assisted, laparoscopic, or open APR technique. Three of the 506 patients randomized did not undergo resection, leaving 503 for the per-protocol analysis presented here.
For the primary endpoint of complications rates within 30 days following surgery, the investigators found that patients assigned to robotic-assisted surgery (173 patients) had a total complication rate of 10.4%, compared with 18.8% for 176 patients assigned to laparoscopy (P = .027), and 26% for 154 assigned to open APR (P less than .001). The latter group included four patients assigned to laparoscopy whose procedures were converted to open surgery.
Among patients without complications, robot-assisted procedures were also associated with faster recovery, as measured by days to first flatus, at a median of 1 vs. 2 for laparoscopy and 3 for open procedures (P less than .001 for robots vs. each other surgery type). The robotic surgery was also significantly associated with fewer days to first automatic urination (median 2 vs. 4 for each of the other procedures; P less than .001), and with fewer days to discharge (median 5 vs. 7 for the other procedures; P less than .001).
"These are excellent postoperative complication rates reported, especially for the robotic treatment group, commented Thomas Gruenberger, MD, an oncologic surgeon at Rudolf Hospital in Vienna, in a poster discussion session.
“We all are now favoring laparoscopic surgery for these kinds of patients. The robot is a nice thing to have; however, we cannot use it in every hospital because it’s still quite expensive,” he said.
“We require – and this is a secondary endpoint of the study – long-term follow-up for local and distant outcomes,” he added,
The investigators did not report a funding source. All authors declared having no conflicts of interest. Dr. Gruenberger disclosed research funding, speakers bureau participation, and/or advisory roles with several companies.
AT ESMO 2017
Transoral robotic surgery assessed for oral lesions
A single-arm study is being conducted at the Ohio State University Comprehensive Cancer Center, Columbus, to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the da Vinci Robotic Surgical System.
The study started in 2007, and the estimated completion date is December 2020. Investigators hope to enroll 360 adults.
Patients are scheduled for regular postop visits to assess quality of life and other matters. Those unable to return to Ohio State University are contacted by phone or provided with the questionnaire by mail.
A single-arm study is being conducted at the Ohio State University Comprehensive Cancer Center, Columbus, to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the da Vinci Robotic Surgical System.
The study started in 2007, and the estimated completion date is December 2020. Investigators hope to enroll 360 adults.
Patients are scheduled for regular postop visits to assess quality of life and other matters. Those unable to return to Ohio State University are contacted by phone or provided with the questionnaire by mail.
A single-arm study is being conducted at the Ohio State University Comprehensive Cancer Center, Columbus, to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the da Vinci Robotic Surgical System.
The study started in 2007, and the estimated completion date is December 2020. Investigators hope to enroll 360 adults.
Patients are scheduled for regular postop visits to assess quality of life and other matters. Those unable to return to Ohio State University are contacted by phone or provided with the questionnaire by mail.
Robotic surgery technologies have unique learning curves for trainees
Training surgeons to use robotic technology involves learning curves, and a study has found that robotic technologies have unique learning curve profiles that have implications for the time and number of procedures needed to achieve competence.
Giorgio Mazzon, MD, of the Institute of Urology at University College Hospital, London, and his colleagues reviewed the literature on training surgeons in the use of a variety of technologies for urological procedures. They analyzed learning curves for virtual reality robotic simulators, robot-assisted laparoscopic radical prostatectomy (RALP), robot-assisted radical cystectomy (RARC), and robot-assisted partial nephrectomy (RAPN) (Curr Urol Rep. 2017 Sep 23;18:89).
RARC learning curves are more rapid than RALP, but this may be due to the fact that most surgeons practice RALP before learning RARC. It is estimated that it takes 21 procedures for operating time to plateau and 30 patients for proper lymph node yield and positive surgical margins of less than 5% to occur (Eur Urol. 2010 Aug;58[2]:197-202).Safety and competence in RAPN is usually defined by operating times, warm ischemic time, positive surgical margin, and complication rates. It has been reported that RAPN can be safely performed with completion of 25-30 cases (Eur Urol. 2010 Jul;58[1]:127-32).The results of the review “should inform trainers and trainees on what outcomes are expected at a given stage of training,” according to the investigators.
They reported no relevant financial disclosures.
Training surgeons to use robotic technology involves learning curves, and a study has found that robotic technologies have unique learning curve profiles that have implications for the time and number of procedures needed to achieve competence.
Giorgio Mazzon, MD, of the Institute of Urology at University College Hospital, London, and his colleagues reviewed the literature on training surgeons in the use of a variety of technologies for urological procedures. They analyzed learning curves for virtual reality robotic simulators, robot-assisted laparoscopic radical prostatectomy (RALP), robot-assisted radical cystectomy (RARC), and robot-assisted partial nephrectomy (RAPN) (Curr Urol Rep. 2017 Sep 23;18:89).
RARC learning curves are more rapid than RALP, but this may be due to the fact that most surgeons practice RALP before learning RARC. It is estimated that it takes 21 procedures for operating time to plateau and 30 patients for proper lymph node yield and positive surgical margins of less than 5% to occur (Eur Urol. 2010 Aug;58[2]:197-202).Safety and competence in RAPN is usually defined by operating times, warm ischemic time, positive surgical margin, and complication rates. It has been reported that RAPN can be safely performed with completion of 25-30 cases (Eur Urol. 2010 Jul;58[1]:127-32).The results of the review “should inform trainers and trainees on what outcomes are expected at a given stage of training,” according to the investigators.
They reported no relevant financial disclosures.
Training surgeons to use robotic technology involves learning curves, and a study has found that robotic technologies have unique learning curve profiles that have implications for the time and number of procedures needed to achieve competence.
Giorgio Mazzon, MD, of the Institute of Urology at University College Hospital, London, and his colleagues reviewed the literature on training surgeons in the use of a variety of technologies for urological procedures. They analyzed learning curves for virtual reality robotic simulators, robot-assisted laparoscopic radical prostatectomy (RALP), robot-assisted radical cystectomy (RARC), and robot-assisted partial nephrectomy (RAPN) (Curr Urol Rep. 2017 Sep 23;18:89).
RARC learning curves are more rapid than RALP, but this may be due to the fact that most surgeons practice RALP before learning RARC. It is estimated that it takes 21 procedures for operating time to plateau and 30 patients for proper lymph node yield and positive surgical margins of less than 5% to occur (Eur Urol. 2010 Aug;58[2]:197-202).Safety and competence in RAPN is usually defined by operating times, warm ischemic time, positive surgical margin, and complication rates. It has been reported that RAPN can be safely performed with completion of 25-30 cases (Eur Urol. 2010 Jul;58[1]:127-32).The results of the review “should inform trainers and trainees on what outcomes are expected at a given stage of training,” according to the investigators.
They reported no relevant financial disclosures.
FROM CURRENT UROLOGY REPORTS
Key clinical point:
Major finding: For virtual reality training programs, recommendations for achieving safety and competence is between 4 and 12 hours of training in a simulator.
Data source: Review of studies of learning curves in robotic urological surgery.
Disclosures: The researchers reported no financial disclosures.
Swedish study finds low risk of developing psoriasis in bariatric surgery patients
Obese patients who undergo bariatric surgery have a lower risk of later developing psoriasis, according to results of nonrandomized, longitudinal intervention trial.
Cristina Maglio, MD, of the University of Gothenburg, Sweden, and her associates found that over a 26-year follow-up period, the adjusted hazard ratio (HR) of developing psoriasis was 0.65 (95% confidence interval [CI], 0.47-0.89; P = .008) for patients who underwent bariatric surgery, compared with those who received conventional, nonsurgical obesity treatments. Psoriasis developed in 3.6% of 1,991 patients in the surgery group during follow-up and in 5.1% of 2,018 control patients during follow-up.
Conversely, the difference in the risk of developing psoriatic arthritis (PsA), experienced by up to one-third of patients with psoriasis, was not statistically significant (HR, 0.77; 95% CI, 0.43-1.37; P = .287). PsA developed in 1% of subjects from the surgery group and 1.3% from the control group.
To understand how surgery affected the development of psoriasis or psoriatic arthritis, the researchers conducted a trial with a control group and surgery group. In the control group, 2,018 patients received standard obesity treatments that included recommendations on eating behavior, food selection, and physical activity. The 1,991 patients in the surgery group underwent gastric banding (375), vertical banded gastroplasty (1,354), or gastric bypass (262). At the start of the study, patients were evaluated for baseline measurements, then again at 6 months. After the 6-month mark, patients were reevaluated at 1, 2, 3, 4, 6, 8, 10, 15, and 20 years, respectively. All study participants, regardless of trial group, were examined and presented patient health questionnaires at each follow-up. The endpoint for this study was the first diagnosis of either psoriasis or PsA. Body mass index decreased significantly in the surgery group, compared with virtually no change in the control group.
Vertical banded gastroplasty was found to significantly lower the incidence of psoriasis, compared with usual treatment. But using gastric banding as a reference, vertical banded gastroplasty (HR, 0.80; 95% CI, 0.46-1.39; P = .418) and gastric bypass (HR, 0.71; 95% CI, 0.29-1.71; P = 0.439) were found to have similar effects on the prevention of psoriasis.
The researchers also identified several risk factors that significantly increased the risk of developing psoriasis. Smoking (HR, 1.75; 95% CI, 1.26-2.42; P = .001), a known risk factor in the development of psoriasis, and the length of time a patient had been obese (HR, 1.28; 95% CI, 1.05-1.55; P = .014) were found to be independently associated with an increased risk of psoriasis.
As part of their risk analysis, Dr. Maglio and her colleagues analyzed the interactions of baseline risk factors such as BMI and obesity duration with the bariatric surgery. This analysis found no significant interactions between baseline risk factors and bariatric surgery. It did reveal that patients who were older at baseline evaluation had slightly better responses to bariatric surgery with lower incidences of psoriasis, compared with younger patients, but the differences were not statistically significant.
“The preventive role of bariatric surgery on the risk of psoriasis has been recently highlighted by a retrospective Danish study (JAMA Surg. 2017 Apr 1;152[4]:344-9),” noted Dr. Maglio and her colleagues. “However, we lent strength to the previous results by confirming this association in a large prospective intervention trial designed to examine the effect of bariatric surgery on obesity-related comorbidities in comparison with usual obesity care.
This study was funded in part by the National Institutes of Diabetes and Digestive and Kidney Diseases, the Swedish Rheumatism association, the Swedish Research Council, the University of Gothenburg, and the Swedish federal government. Dr. Anna Rudin reported that part of her salary at Sahlgrenska University is supported by a grant from AstraZeneca. Dr. Lena M.S. Carlsson has received lecture fees from AstraZeneca, Johnson & Johnson, and Merck Sharp and Dohme. Dr. Maglio and Dr. Markku Peltonen had no relevant financial disclosures.
SOURCE: Maglio et al. Obesity. 2017. Dec; 25[12]:2068-73.
Obese patients who undergo bariatric surgery have a lower risk of later developing psoriasis, according to results of nonrandomized, longitudinal intervention trial.
Cristina Maglio, MD, of the University of Gothenburg, Sweden, and her associates found that over a 26-year follow-up period, the adjusted hazard ratio (HR) of developing psoriasis was 0.65 (95% confidence interval [CI], 0.47-0.89; P = .008) for patients who underwent bariatric surgery, compared with those who received conventional, nonsurgical obesity treatments. Psoriasis developed in 3.6% of 1,991 patients in the surgery group during follow-up and in 5.1% of 2,018 control patients during follow-up.
Conversely, the difference in the risk of developing psoriatic arthritis (PsA), experienced by up to one-third of patients with psoriasis, was not statistically significant (HR, 0.77; 95% CI, 0.43-1.37; P = .287). PsA developed in 1% of subjects from the surgery group and 1.3% from the control group.
To understand how surgery affected the development of psoriasis or psoriatic arthritis, the researchers conducted a trial with a control group and surgery group. In the control group, 2,018 patients received standard obesity treatments that included recommendations on eating behavior, food selection, and physical activity. The 1,991 patients in the surgery group underwent gastric banding (375), vertical banded gastroplasty (1,354), or gastric bypass (262). At the start of the study, patients were evaluated for baseline measurements, then again at 6 months. After the 6-month mark, patients were reevaluated at 1, 2, 3, 4, 6, 8, 10, 15, and 20 years, respectively. All study participants, regardless of trial group, were examined and presented patient health questionnaires at each follow-up. The endpoint for this study was the first diagnosis of either psoriasis or PsA. Body mass index decreased significantly in the surgery group, compared with virtually no change in the control group.
Vertical banded gastroplasty was found to significantly lower the incidence of psoriasis, compared with usual treatment. But using gastric banding as a reference, vertical banded gastroplasty (HR, 0.80; 95% CI, 0.46-1.39; P = .418) and gastric bypass (HR, 0.71; 95% CI, 0.29-1.71; P = 0.439) were found to have similar effects on the prevention of psoriasis.
The researchers also identified several risk factors that significantly increased the risk of developing psoriasis. Smoking (HR, 1.75; 95% CI, 1.26-2.42; P = .001), a known risk factor in the development of psoriasis, and the length of time a patient had been obese (HR, 1.28; 95% CI, 1.05-1.55; P = .014) were found to be independently associated with an increased risk of psoriasis.
As part of their risk analysis, Dr. Maglio and her colleagues analyzed the interactions of baseline risk factors such as BMI and obesity duration with the bariatric surgery. This analysis found no significant interactions between baseline risk factors and bariatric surgery. It did reveal that patients who were older at baseline evaluation had slightly better responses to bariatric surgery with lower incidences of psoriasis, compared with younger patients, but the differences were not statistically significant.
“The preventive role of bariatric surgery on the risk of psoriasis has been recently highlighted by a retrospective Danish study (JAMA Surg. 2017 Apr 1;152[4]:344-9),” noted Dr. Maglio and her colleagues. “However, we lent strength to the previous results by confirming this association in a large prospective intervention trial designed to examine the effect of bariatric surgery on obesity-related comorbidities in comparison with usual obesity care.
This study was funded in part by the National Institutes of Diabetes and Digestive and Kidney Diseases, the Swedish Rheumatism association, the Swedish Research Council, the University of Gothenburg, and the Swedish federal government. Dr. Anna Rudin reported that part of her salary at Sahlgrenska University is supported by a grant from AstraZeneca. Dr. Lena M.S. Carlsson has received lecture fees from AstraZeneca, Johnson & Johnson, and Merck Sharp and Dohme. Dr. Maglio and Dr. Markku Peltonen had no relevant financial disclosures.
SOURCE: Maglio et al. Obesity. 2017. Dec; 25[12]:2068-73.
Obese patients who undergo bariatric surgery have a lower risk of later developing psoriasis, according to results of nonrandomized, longitudinal intervention trial.
Cristina Maglio, MD, of the University of Gothenburg, Sweden, and her associates found that over a 26-year follow-up period, the adjusted hazard ratio (HR) of developing psoriasis was 0.65 (95% confidence interval [CI], 0.47-0.89; P = .008) for patients who underwent bariatric surgery, compared with those who received conventional, nonsurgical obesity treatments. Psoriasis developed in 3.6% of 1,991 patients in the surgery group during follow-up and in 5.1% of 2,018 control patients during follow-up.
Conversely, the difference in the risk of developing psoriatic arthritis (PsA), experienced by up to one-third of patients with psoriasis, was not statistically significant (HR, 0.77; 95% CI, 0.43-1.37; P = .287). PsA developed in 1% of subjects from the surgery group and 1.3% from the control group.
To understand how surgery affected the development of psoriasis or psoriatic arthritis, the researchers conducted a trial with a control group and surgery group. In the control group, 2,018 patients received standard obesity treatments that included recommendations on eating behavior, food selection, and physical activity. The 1,991 patients in the surgery group underwent gastric banding (375), vertical banded gastroplasty (1,354), or gastric bypass (262). At the start of the study, patients were evaluated for baseline measurements, then again at 6 months. After the 6-month mark, patients were reevaluated at 1, 2, 3, 4, 6, 8, 10, 15, and 20 years, respectively. All study participants, regardless of trial group, were examined and presented patient health questionnaires at each follow-up. The endpoint for this study was the first diagnosis of either psoriasis or PsA. Body mass index decreased significantly in the surgery group, compared with virtually no change in the control group.
Vertical banded gastroplasty was found to significantly lower the incidence of psoriasis, compared with usual treatment. But using gastric banding as a reference, vertical banded gastroplasty (HR, 0.80; 95% CI, 0.46-1.39; P = .418) and gastric bypass (HR, 0.71; 95% CI, 0.29-1.71; P = 0.439) were found to have similar effects on the prevention of psoriasis.
The researchers also identified several risk factors that significantly increased the risk of developing psoriasis. Smoking (HR, 1.75; 95% CI, 1.26-2.42; P = .001), a known risk factor in the development of psoriasis, and the length of time a patient had been obese (HR, 1.28; 95% CI, 1.05-1.55; P = .014) were found to be independently associated with an increased risk of psoriasis.
As part of their risk analysis, Dr. Maglio and her colleagues analyzed the interactions of baseline risk factors such as BMI and obesity duration with the bariatric surgery. This analysis found no significant interactions between baseline risk factors and bariatric surgery. It did reveal that patients who were older at baseline evaluation had slightly better responses to bariatric surgery with lower incidences of psoriasis, compared with younger patients, but the differences were not statistically significant.
“The preventive role of bariatric surgery on the risk of psoriasis has been recently highlighted by a retrospective Danish study (JAMA Surg. 2017 Apr 1;152[4]:344-9),” noted Dr. Maglio and her colleagues. “However, we lent strength to the previous results by confirming this association in a large prospective intervention trial designed to examine the effect of bariatric surgery on obesity-related comorbidities in comparison with usual obesity care.
This study was funded in part by the National Institutes of Diabetes and Digestive and Kidney Diseases, the Swedish Rheumatism association, the Swedish Research Council, the University of Gothenburg, and the Swedish federal government. Dr. Anna Rudin reported that part of her salary at Sahlgrenska University is supported by a grant from AstraZeneca. Dr. Lena M.S. Carlsson has received lecture fees from AstraZeneca, Johnson & Johnson, and Merck Sharp and Dohme. Dr. Maglio and Dr. Markku Peltonen had no relevant financial disclosures.
SOURCE: Maglio et al. Obesity. 2017. Dec; 25[12]:2068-73.
FROM OBESITY
Key clinical point:
Major finding: Obese patients who underwent bariatric surgery had a lower incidence of psoriasis over a 26-year period (HR, 0.65; 95% CI: 0.47-0.89; P = .008), compared with usual care.
Study details: Swedish Obese Subjects study, a longitudinal, nonrandomized intervention trial comprising 1,991 surgery group patients and 2,018 control patients.
Disclosures: This study was funded in part by the National Institutes of Diabetes and Digestive and Kidney Diseases, the Swedish Rheumatism association, the Swedish Research Council, the University of Gothenburg, and the Swedish federal government. Dr. Anna Rudin reported that part of her salary at Sahlgrenska University is supported by a grant from AstraZeneca. Dr. Lena M.S. Carlsson has received lecture fees from AstraZeneca, Johnson & Johnson, and Merck Sharp and Dohme. Dr. Maglio and Dr. Markku Peltonen had no relevant financial disclosures.
Source: Maglio et al. Obesity. 2017. Dec; 25[12]:2068-2073.
Long-term specialist care reduces post-RYGB anemia risk
Patients who underwent Roux-en-Y gastric bypass surgery (RYGB) without long-term bariatric specialist follow-up experienced a significantly higher rate of anemia at 10 years than did patients who had such specialist follow-up, according to findings from a database review.
Among 74 patients available for analysis – 58 men and 16 women with a mean age of 51 years who underwent RYGB at a single Veterans Affairs medical center between 2002 and 2006 – the mean rate of preoperative anemia was 20% (15 patients). The rate increased to 28% (21 patients) at 1 year, 31% (23 patients) at 5 years, and 47% (35 patients) at 10 years, according to a research letter by Gao Linda Chen, MD, and her colleagues in the surgical service of the VA Palo Alto (Calif.) Health Care System (JAMA Surg. 2017. Sep 20. doi: 10.1001/jamasurg.2017.3158).
Among 58 patients with no bariatric specialist follow-up after 5 years, the anemia rate increased from 22% (13 patients) before surgery to 57% (33 patients) at 10 years, while the corresponding rates for those with specialty follow-up were 19% (3 patients) and 13% (2 patients). After adjustment for preoperative anemia, those without specialist follow-up had significantly higher odds of anemia at 10 years (odds ratio, 6.1).
“Long-term complications of RYGB, such as anemia, may go unrecognized by nonbariatric specialists,” the investigators wrote, noting that the high rates of anemia at 10 years “may reflect a mixed vitamin and mineral deficiency, because patients had normocytic anemia.
“Our study suggests that follow-up with bariatric specialists more than 5 years after surgery, rather than with specialists with no bariatric expertise, can decrease long-term anemia risk,” they continued. “This finding may demonstrate the bariatric specialist’s specific understanding of the long-term risk for nutritional deficiency after RYGB and the importance of vitamin and mineral supplementation.”
The findings suggest a bariatric team approach with planning for long-term follow-up. “We implemented a hub-and-spoke model for bariatric care, including health care specialist education, in which the bariatric team communicates regularly with the patient’s primary care clinician before and after surgery.”
Although the study is limited by small sample size, the findings nevertheless underscore that “long-term follow-up should be an integral part of bariatric programs, and additional studies are needed to identify potential barriers to successful follow-up,” they concluded.
The authors reported having no disclosures.
Patients who underwent Roux-en-Y gastric bypass surgery (RYGB) without long-term bariatric specialist follow-up experienced a significantly higher rate of anemia at 10 years than did patients who had such specialist follow-up, according to findings from a database review.
Among 74 patients available for analysis – 58 men and 16 women with a mean age of 51 years who underwent RYGB at a single Veterans Affairs medical center between 2002 and 2006 – the mean rate of preoperative anemia was 20% (15 patients). The rate increased to 28% (21 patients) at 1 year, 31% (23 patients) at 5 years, and 47% (35 patients) at 10 years, according to a research letter by Gao Linda Chen, MD, and her colleagues in the surgical service of the VA Palo Alto (Calif.) Health Care System (JAMA Surg. 2017. Sep 20. doi: 10.1001/jamasurg.2017.3158).
Among 58 patients with no bariatric specialist follow-up after 5 years, the anemia rate increased from 22% (13 patients) before surgery to 57% (33 patients) at 10 years, while the corresponding rates for those with specialty follow-up were 19% (3 patients) and 13% (2 patients). After adjustment for preoperative anemia, those without specialist follow-up had significantly higher odds of anemia at 10 years (odds ratio, 6.1).
“Long-term complications of RYGB, such as anemia, may go unrecognized by nonbariatric specialists,” the investigators wrote, noting that the high rates of anemia at 10 years “may reflect a mixed vitamin and mineral deficiency, because patients had normocytic anemia.
“Our study suggests that follow-up with bariatric specialists more than 5 years after surgery, rather than with specialists with no bariatric expertise, can decrease long-term anemia risk,” they continued. “This finding may demonstrate the bariatric specialist’s specific understanding of the long-term risk for nutritional deficiency after RYGB and the importance of vitamin and mineral supplementation.”
The findings suggest a bariatric team approach with planning for long-term follow-up. “We implemented a hub-and-spoke model for bariatric care, including health care specialist education, in which the bariatric team communicates regularly with the patient’s primary care clinician before and after surgery.”
Although the study is limited by small sample size, the findings nevertheless underscore that “long-term follow-up should be an integral part of bariatric programs, and additional studies are needed to identify potential barriers to successful follow-up,” they concluded.
The authors reported having no disclosures.
Patients who underwent Roux-en-Y gastric bypass surgery (RYGB) without long-term bariatric specialist follow-up experienced a significantly higher rate of anemia at 10 years than did patients who had such specialist follow-up, according to findings from a database review.
Among 74 patients available for analysis – 58 men and 16 women with a mean age of 51 years who underwent RYGB at a single Veterans Affairs medical center between 2002 and 2006 – the mean rate of preoperative anemia was 20% (15 patients). The rate increased to 28% (21 patients) at 1 year, 31% (23 patients) at 5 years, and 47% (35 patients) at 10 years, according to a research letter by Gao Linda Chen, MD, and her colleagues in the surgical service of the VA Palo Alto (Calif.) Health Care System (JAMA Surg. 2017. Sep 20. doi: 10.1001/jamasurg.2017.3158).
Among 58 patients with no bariatric specialist follow-up after 5 years, the anemia rate increased from 22% (13 patients) before surgery to 57% (33 patients) at 10 years, while the corresponding rates for those with specialty follow-up were 19% (3 patients) and 13% (2 patients). After adjustment for preoperative anemia, those without specialist follow-up had significantly higher odds of anemia at 10 years (odds ratio, 6.1).
“Long-term complications of RYGB, such as anemia, may go unrecognized by nonbariatric specialists,” the investigators wrote, noting that the high rates of anemia at 10 years “may reflect a mixed vitamin and mineral deficiency, because patients had normocytic anemia.
“Our study suggests that follow-up with bariatric specialists more than 5 years after surgery, rather than with specialists with no bariatric expertise, can decrease long-term anemia risk,” they continued. “This finding may demonstrate the bariatric specialist’s specific understanding of the long-term risk for nutritional deficiency after RYGB and the importance of vitamin and mineral supplementation.”
The findings suggest a bariatric team approach with planning for long-term follow-up. “We implemented a hub-and-spoke model for bariatric care, including health care specialist education, in which the bariatric team communicates regularly with the patient’s primary care clinician before and after surgery.”
Although the study is limited by small sample size, the findings nevertheless underscore that “long-term follow-up should be an integral part of bariatric programs, and additional studies are needed to identify potential barriers to successful follow-up,” they concluded.
The authors reported having no disclosures.
FROM JAMA SURGERY
Key clinical point:
Major finding: RYGB patients without specialist follow-up had significantly higher odds of anemia at 10 years (adjusted odds ratio, 6.1).
Data source: A retrospective review of 74 patients from a prospective 10-year database.
Disclosures: The authors reported having no disclosures.
Proposed MACRA participation threshold gets mixed reviews
Proposed changes to the Quality Payment Program (QPP) – the value-based payment program established by the Medicare Access and CHIP Reauthorization Act (MACRA) – are drawing mixed reactions from physicians.
A key component of the proposed update to the QPP is an expansion of the exemption threshold for the Merit-based Incentive Payment System (MIPS). Currently, physicians are exempt from MIPS if they bill $30,000 or less in Medicare Part B charges or have 100 or fewer Medicare patients. The proposal would increase the number of exempt physicians by raising the threshold to $90,000 or less in Part B charges or 200 or fewer Medicare patients.
Eligible clinicians and group practices that fall below the threshold can still voluntarily submit data, but they will not be scored for their participation in MIPS and will not be eligible for bonuses or face penalties for not meeting goals.
The expanded threshold proposal drew praise from the American Medical Association for exempting many small and rural practices from the requirements, but they also called on the agency to move more quickly in notifying physicians if they fall into the exempt category.
The American College of Surgeons expressed support for the changes to the threshold, adding that going forward the threshold should “be maintained at numbers no lower than that proposed for the 2018 performance period so that providers may have certainty of the criteria and their participation responsibilities from year to year.”
The American College of Cardiology supported the expansion of the low-volume threshold and encouraged the agency to review the levels annually.
But the Association of American Physicians & Surgeons suggested the volume threshold didn’t go far enough. “We ask that CMS consider a further widening of the threshold to all practices with 18 or fewer clinicians,” the group said in its comments on the proposal. “A threshold in terms of billing amounts and the number of patients creates an unhelpful incentive for physicians to turn away Medicare patients in order to qualify for the exemption.”
The group argued that larger practices can better absorb the cost of complying with MACRA regulations and basing participation on billing could create uncertainty due to fluctuations in billing from year-to-year.
Opt in option?
Several other groups sought a pathway for exempt physicians to opt into the program and take advantage of bonuses, especially those who had already prepared for the program based on the lower initial threshold.
“By raising the low-volume threshold and not offering an opt-in ability, CMS is further and needlessly delaying practices from payment based on value over volume, as well as the intent behind the establishment of virtual groups,” the American Academy of Family Physicians wrote in comments to the CMS.
The American Gastroenterological Association voiced its support for expanding the exclusion threshold and supported the idea of an opt-in, but called on the CMS to hold harmless those practices that opted in. “Clinicians and groups opting-in to the QPP should not be subject to negative payment adjustments,” AGA said in its comments to the CMS.
The American Academy of Dermatology Association supports the proposed low-volume threshold and called upon the CMS to allow those who want to participate to create a path to opt into MIPS.
The Endocrine Society supports the expansion of the threshold, but called on the CMS to provide a pathway for those who want to participate if they are otherwise excluded.
The American Osteopathic Association also called for a pathway for exempted physicians to opt in. And they cited two negative effects of expanding the threshold to a wider group of physicians. “First, it will result in wasted resources from practices that prepared for MIPS participation and are now unable to participate,” the association said in comments to the CMS. “Second, it will have the effect of dividing all practices into two levels: those that are incentivized to provide value-based care, and a significant number that are not eligible for such incentives.”
Individuals vs. groups
The American Congress of Obstetricians and Gynecologists (ACOG) supports the proposed threshold for individuals, but suggested changes for groups. “ACOG continues to believe that the threshold should only apply to individual clinicians and that CMS should develop a new, separate definition if the agency believes that groups should also have a low-volume threshold,” ACOG said in comments to the CMS. “Setting the low-volume threshold at both the individual and group level introduces unnecessary complexity into the program because other exclusions for MIPS only apply to individual clinicians.”
The Medical Group Management Association (MGMA), while supporting the general goal of reducing burden on small and solo practices, suggested it needed to be tweaked for the group setting.
“MGMA continues to question CMS’ application of the same threshold at both the clinician and group practice level,” the association said in its comments to the CMS. “This approach significantly disadvantages groups of clinicians who, in the aggregate, rarely care for Medicare patients, but include one or two members that actively participate in the program. MGMA urges CMS to extend its own logic behind setting a group practice equivalent for the non-patient-facing definition by exempting group practices when 75% or more of the national provider identifiers who bill under the group’s tax identification number meet the threshold on an individual basis.”
Expansion goes too far
But the AMGA, which represents group practices, called the new threshold “counterproductive” in its comment letter and suggested that the CMS should be lowering the threshold, not raising it.
AMGA noted that eligible clinicians who do not meet the threshold, but who are providing high-value care as defined by the QPP, are “forced to leave higher reimbursement rates on the table; these could be considerable over time.”
In addition, AMGA said that expanding the exemption decreases the money available for those who are required to participate. The CMS estimates in the proposed rule that in payment year 2019, $1.333 billion would be paid to top performers (including $500 million in exceptional performance bonus payments), but under the newest proposal, that number drops to $673 million (including $500 million in exceptional performance bonus payments). This will translate to a 0.3% bump in payment in 2020.
“The effect of eliminating of two-thirds of eligible clinicians from the MIPS formula is to financially undermine participating clinicians,” AMGA said in comments to the CMS. “They effectively lose by winning.”
Proposed changes to the Quality Payment Program (QPP) – the value-based payment program established by the Medicare Access and CHIP Reauthorization Act (MACRA) – are drawing mixed reactions from physicians.
A key component of the proposed update to the QPP is an expansion of the exemption threshold for the Merit-based Incentive Payment System (MIPS). Currently, physicians are exempt from MIPS if they bill $30,000 or less in Medicare Part B charges or have 100 or fewer Medicare patients. The proposal would increase the number of exempt physicians by raising the threshold to $90,000 or less in Part B charges or 200 or fewer Medicare patients.
Eligible clinicians and group practices that fall below the threshold can still voluntarily submit data, but they will not be scored for their participation in MIPS and will not be eligible for bonuses or face penalties for not meeting goals.
The expanded threshold proposal drew praise from the American Medical Association for exempting many small and rural practices from the requirements, but they also called on the agency to move more quickly in notifying physicians if they fall into the exempt category.
The American College of Surgeons expressed support for the changes to the threshold, adding that going forward the threshold should “be maintained at numbers no lower than that proposed for the 2018 performance period so that providers may have certainty of the criteria and their participation responsibilities from year to year.”
The American College of Cardiology supported the expansion of the low-volume threshold and encouraged the agency to review the levels annually.
But the Association of American Physicians & Surgeons suggested the volume threshold didn’t go far enough. “We ask that CMS consider a further widening of the threshold to all practices with 18 or fewer clinicians,” the group said in its comments on the proposal. “A threshold in terms of billing amounts and the number of patients creates an unhelpful incentive for physicians to turn away Medicare patients in order to qualify for the exemption.”
The group argued that larger practices can better absorb the cost of complying with MACRA regulations and basing participation on billing could create uncertainty due to fluctuations in billing from year-to-year.
Opt in option?
Several other groups sought a pathway for exempt physicians to opt into the program and take advantage of bonuses, especially those who had already prepared for the program based on the lower initial threshold.
“By raising the low-volume threshold and not offering an opt-in ability, CMS is further and needlessly delaying practices from payment based on value over volume, as well as the intent behind the establishment of virtual groups,” the American Academy of Family Physicians wrote in comments to the CMS.
The American Gastroenterological Association voiced its support for expanding the exclusion threshold and supported the idea of an opt-in, but called on the CMS to hold harmless those practices that opted in. “Clinicians and groups opting-in to the QPP should not be subject to negative payment adjustments,” AGA said in its comments to the CMS.
The American Academy of Dermatology Association supports the proposed low-volume threshold and called upon the CMS to allow those who want to participate to create a path to opt into MIPS.
The Endocrine Society supports the expansion of the threshold, but called on the CMS to provide a pathway for those who want to participate if they are otherwise excluded.
The American Osteopathic Association also called for a pathway for exempted physicians to opt in. And they cited two negative effects of expanding the threshold to a wider group of physicians. “First, it will result in wasted resources from practices that prepared for MIPS participation and are now unable to participate,” the association said in comments to the CMS. “Second, it will have the effect of dividing all practices into two levels: those that are incentivized to provide value-based care, and a significant number that are not eligible for such incentives.”
Individuals vs. groups
The American Congress of Obstetricians and Gynecologists (ACOG) supports the proposed threshold for individuals, but suggested changes for groups. “ACOG continues to believe that the threshold should only apply to individual clinicians and that CMS should develop a new, separate definition if the agency believes that groups should also have a low-volume threshold,” ACOG said in comments to the CMS. “Setting the low-volume threshold at both the individual and group level introduces unnecessary complexity into the program because other exclusions for MIPS only apply to individual clinicians.”
The Medical Group Management Association (MGMA), while supporting the general goal of reducing burden on small and solo practices, suggested it needed to be tweaked for the group setting.
“MGMA continues to question CMS’ application of the same threshold at both the clinician and group practice level,” the association said in its comments to the CMS. “This approach significantly disadvantages groups of clinicians who, in the aggregate, rarely care for Medicare patients, but include one or two members that actively participate in the program. MGMA urges CMS to extend its own logic behind setting a group practice equivalent for the non-patient-facing definition by exempting group practices when 75% or more of the national provider identifiers who bill under the group’s tax identification number meet the threshold on an individual basis.”
Expansion goes too far
But the AMGA, which represents group practices, called the new threshold “counterproductive” in its comment letter and suggested that the CMS should be lowering the threshold, not raising it.
AMGA noted that eligible clinicians who do not meet the threshold, but who are providing high-value care as defined by the QPP, are “forced to leave higher reimbursement rates on the table; these could be considerable over time.”
In addition, AMGA said that expanding the exemption decreases the money available for those who are required to participate. The CMS estimates in the proposed rule that in payment year 2019, $1.333 billion would be paid to top performers (including $500 million in exceptional performance bonus payments), but under the newest proposal, that number drops to $673 million (including $500 million in exceptional performance bonus payments). This will translate to a 0.3% bump in payment in 2020.
“The effect of eliminating of two-thirds of eligible clinicians from the MIPS formula is to financially undermine participating clinicians,” AMGA said in comments to the CMS. “They effectively lose by winning.”
Proposed changes to the Quality Payment Program (QPP) – the value-based payment program established by the Medicare Access and CHIP Reauthorization Act (MACRA) – are drawing mixed reactions from physicians.
A key component of the proposed update to the QPP is an expansion of the exemption threshold for the Merit-based Incentive Payment System (MIPS). Currently, physicians are exempt from MIPS if they bill $30,000 or less in Medicare Part B charges or have 100 or fewer Medicare patients. The proposal would increase the number of exempt physicians by raising the threshold to $90,000 or less in Part B charges or 200 or fewer Medicare patients.
Eligible clinicians and group practices that fall below the threshold can still voluntarily submit data, but they will not be scored for their participation in MIPS and will not be eligible for bonuses or face penalties for not meeting goals.
The expanded threshold proposal drew praise from the American Medical Association for exempting many small and rural practices from the requirements, but they also called on the agency to move more quickly in notifying physicians if they fall into the exempt category.
The American College of Surgeons expressed support for the changes to the threshold, adding that going forward the threshold should “be maintained at numbers no lower than that proposed for the 2018 performance period so that providers may have certainty of the criteria and their participation responsibilities from year to year.”
The American College of Cardiology supported the expansion of the low-volume threshold and encouraged the agency to review the levels annually.
But the Association of American Physicians & Surgeons suggested the volume threshold didn’t go far enough. “We ask that CMS consider a further widening of the threshold to all practices with 18 or fewer clinicians,” the group said in its comments on the proposal. “A threshold in terms of billing amounts and the number of patients creates an unhelpful incentive for physicians to turn away Medicare patients in order to qualify for the exemption.”
The group argued that larger practices can better absorb the cost of complying with MACRA regulations and basing participation on billing could create uncertainty due to fluctuations in billing from year-to-year.
Opt in option?
Several other groups sought a pathway for exempt physicians to opt into the program and take advantage of bonuses, especially those who had already prepared for the program based on the lower initial threshold.
“By raising the low-volume threshold and not offering an opt-in ability, CMS is further and needlessly delaying practices from payment based on value over volume, as well as the intent behind the establishment of virtual groups,” the American Academy of Family Physicians wrote in comments to the CMS.
The American Gastroenterological Association voiced its support for expanding the exclusion threshold and supported the idea of an opt-in, but called on the CMS to hold harmless those practices that opted in. “Clinicians and groups opting-in to the QPP should not be subject to negative payment adjustments,” AGA said in its comments to the CMS.
The American Academy of Dermatology Association supports the proposed low-volume threshold and called upon the CMS to allow those who want to participate to create a path to opt into MIPS.
The Endocrine Society supports the expansion of the threshold, but called on the CMS to provide a pathway for those who want to participate if they are otherwise excluded.
The American Osteopathic Association also called for a pathway for exempted physicians to opt in. And they cited two negative effects of expanding the threshold to a wider group of physicians. “First, it will result in wasted resources from practices that prepared for MIPS participation and are now unable to participate,” the association said in comments to the CMS. “Second, it will have the effect of dividing all practices into two levels: those that are incentivized to provide value-based care, and a significant number that are not eligible for such incentives.”
Individuals vs. groups
The American Congress of Obstetricians and Gynecologists (ACOG) supports the proposed threshold for individuals, but suggested changes for groups. “ACOG continues to believe that the threshold should only apply to individual clinicians and that CMS should develop a new, separate definition if the agency believes that groups should also have a low-volume threshold,” ACOG said in comments to the CMS. “Setting the low-volume threshold at both the individual and group level introduces unnecessary complexity into the program because other exclusions for MIPS only apply to individual clinicians.”
The Medical Group Management Association (MGMA), while supporting the general goal of reducing burden on small and solo practices, suggested it needed to be tweaked for the group setting.
“MGMA continues to question CMS’ application of the same threshold at both the clinician and group practice level,” the association said in its comments to the CMS. “This approach significantly disadvantages groups of clinicians who, in the aggregate, rarely care for Medicare patients, but include one or two members that actively participate in the program. MGMA urges CMS to extend its own logic behind setting a group practice equivalent for the non-patient-facing definition by exempting group practices when 75% or more of the national provider identifiers who bill under the group’s tax identification number meet the threshold on an individual basis.”
Expansion goes too far
But the AMGA, which represents group practices, called the new threshold “counterproductive” in its comment letter and suggested that the CMS should be lowering the threshold, not raising it.
AMGA noted that eligible clinicians who do not meet the threshold, but who are providing high-value care as defined by the QPP, are “forced to leave higher reimbursement rates on the table; these could be considerable over time.”
In addition, AMGA said that expanding the exemption decreases the money available for those who are required to participate. The CMS estimates in the proposed rule that in payment year 2019, $1.333 billion would be paid to top performers (including $500 million in exceptional performance bonus payments), but under the newest proposal, that number drops to $673 million (including $500 million in exceptional performance bonus payments). This will translate to a 0.3% bump in payment in 2020.
“The effect of eliminating of two-thirds of eligible clinicians from the MIPS formula is to financially undermine participating clinicians,” AMGA said in comments to the CMS. “They effectively lose by winning.”
Robot-assisted prostatectomy providing better outcomes
Robot-assisted radical prostatectomy shows better early postoperative outcomes than does laparoscopic radical prostatectomy, but the differences between the two surgical approaches disappeared by the 6-month follow-up.
Dr. Hiroyuki Koike and his colleagues at Wakayama (Japan) Medical University Hospital conducted a study of two groups of patients treated for localized prostate cancer. One group of 229 patients underwent laparoscopic radical prostatectomy (LRP) between July 2007 and July 2013. The other group of 115 patients had robot-assisted radical prostatectomy (RARP) between December 2012 and August 2014 (J Robot Surg. 2017;11[3]:325-31).
The patients were given health-related quality of life self-assessment surveys prior to surgery and at 3, 6, and 12 months post surgery. In addition, a generic questionnaire, the eight-item Short-Form Health Survey, was used to assess a physical component summary (PCS) and a mental component summary (MCS). The Expanded Prostate Cancer Index of Prostate, which covers four domains – urinary, sexual, bowel, and hormonal – was used as a disease-specific measure, and the response rates for both LRP and RARP at each follow-up interval were over 80%.
“The RARP group showed significantly better scores in urinary summary and all urinary subscales at postoperative 3-month follow-up. However, these differences disappeared at postoperative 6 and 12-month follow-up,” the investigators wrote. For the urinary summary score, LRP significantly underperformed, compared with RARP, with scores of 63.3 vs. 75.8, respectively, after 3 months. In addition, the bowel function score was superior for RARP, compared with LRP, at 96.9 vs. 92.9, respectively. Sexual function results were similar, with RARP and LRP scores of 2.8 vs. 0.
The general measures of the PCS and MCS also favored RARP. At the 3-month follow-up, PCS (51.3 vs. 48.1) and MCS (50 vs. 47.8) scores were higher for RARP, compared with LRP.
“It is unclear why our superiority of urinary function in RARP was observed only in early period. However, we can speculate several reasons for better urinary function in RARP group. First, we were able to treat the apex area more delicately with RARP. Second, some of the new techniques which we employed after the introduction of RARP could influence the urinary continence recovery,” the investigators wrote.
The authors had no relevant financial disclosures.
Robot-assisted radical prostatectomy shows better early postoperative outcomes than does laparoscopic radical prostatectomy, but the differences between the two surgical approaches disappeared by the 6-month follow-up.
Dr. Hiroyuki Koike and his colleagues at Wakayama (Japan) Medical University Hospital conducted a study of two groups of patients treated for localized prostate cancer. One group of 229 patients underwent laparoscopic radical prostatectomy (LRP) between July 2007 and July 2013. The other group of 115 patients had robot-assisted radical prostatectomy (RARP) between December 2012 and August 2014 (J Robot Surg. 2017;11[3]:325-31).
The patients were given health-related quality of life self-assessment surveys prior to surgery and at 3, 6, and 12 months post surgery. In addition, a generic questionnaire, the eight-item Short-Form Health Survey, was used to assess a physical component summary (PCS) and a mental component summary (MCS). The Expanded Prostate Cancer Index of Prostate, which covers four domains – urinary, sexual, bowel, and hormonal – was used as a disease-specific measure, and the response rates for both LRP and RARP at each follow-up interval were over 80%.
“The RARP group showed significantly better scores in urinary summary and all urinary subscales at postoperative 3-month follow-up. However, these differences disappeared at postoperative 6 and 12-month follow-up,” the investigators wrote. For the urinary summary score, LRP significantly underperformed, compared with RARP, with scores of 63.3 vs. 75.8, respectively, after 3 months. In addition, the bowel function score was superior for RARP, compared with LRP, at 96.9 vs. 92.9, respectively. Sexual function results were similar, with RARP and LRP scores of 2.8 vs. 0.
The general measures of the PCS and MCS also favored RARP. At the 3-month follow-up, PCS (51.3 vs. 48.1) and MCS (50 vs. 47.8) scores were higher for RARP, compared with LRP.
“It is unclear why our superiority of urinary function in RARP was observed only in early period. However, we can speculate several reasons for better urinary function in RARP group. First, we were able to treat the apex area more delicately with RARP. Second, some of the new techniques which we employed after the introduction of RARP could influence the urinary continence recovery,” the investigators wrote.
The authors had no relevant financial disclosures.
Robot-assisted radical prostatectomy shows better early postoperative outcomes than does laparoscopic radical prostatectomy, but the differences between the two surgical approaches disappeared by the 6-month follow-up.
Dr. Hiroyuki Koike and his colleagues at Wakayama (Japan) Medical University Hospital conducted a study of two groups of patients treated for localized prostate cancer. One group of 229 patients underwent laparoscopic radical prostatectomy (LRP) between July 2007 and July 2013. The other group of 115 patients had robot-assisted radical prostatectomy (RARP) between December 2012 and August 2014 (J Robot Surg. 2017;11[3]:325-31).
The patients were given health-related quality of life self-assessment surveys prior to surgery and at 3, 6, and 12 months post surgery. In addition, a generic questionnaire, the eight-item Short-Form Health Survey, was used to assess a physical component summary (PCS) and a mental component summary (MCS). The Expanded Prostate Cancer Index of Prostate, which covers four domains – urinary, sexual, bowel, and hormonal – was used as a disease-specific measure, and the response rates for both LRP and RARP at each follow-up interval were over 80%.
“The RARP group showed significantly better scores in urinary summary and all urinary subscales at postoperative 3-month follow-up. However, these differences disappeared at postoperative 6 and 12-month follow-up,” the investigators wrote. For the urinary summary score, LRP significantly underperformed, compared with RARP, with scores of 63.3 vs. 75.8, respectively, after 3 months. In addition, the bowel function score was superior for RARP, compared with LRP, at 96.9 vs. 92.9, respectively. Sexual function results were similar, with RARP and LRP scores of 2.8 vs. 0.
The general measures of the PCS and MCS also favored RARP. At the 3-month follow-up, PCS (51.3 vs. 48.1) and MCS (50 vs. 47.8) scores were higher for RARP, compared with LRP.
“It is unclear why our superiority of urinary function in RARP was observed only in early period. However, we can speculate several reasons for better urinary function in RARP group. First, we were able to treat the apex area more delicately with RARP. Second, some of the new techniques which we employed after the introduction of RARP could influence the urinary continence recovery,” the investigators wrote.
The authors had no relevant financial disclosures.
FROM JOURNAL OF ROBOTIC SURGERY
Key clinical point:
Major finding: Quality-of-life score for robotic-assisted radical prostatectomy was higher in all urinary categories after 3 months.
Data source: Postop survey results from patients with localized prostate cancer who underwent laparoscopic radical prostatectomy (n = 229) or robot-assisted radical prostatectomy (n = 115).
Disclosures: The investigators had no financial disclosures to report.
Peer-to-peer learning about robotic surgery is happening on social media
Social media is now being used by surgeons for interaction among peers, informal learning, exchange of technical information, and diffusion of ideas.
A study has examined posting and membership data from a closed Facebook page, the “Robotic Surgery Collaboration,” created by surgeons who practice robotic-assisted procedures. Overall, the findings show exponential growth in membership in January 2015 through August 2016, some signs of stagnating engagement, and use of the platform for peer-to-peer learning and discussion.
“The growth in this group over time suggests that surgeons found it useful for engaging in informal interactions and learning vicariously from one another, but also reveals that not all users were actively engaged in these interactions each month and that growth in active membership differed from growth in overall group membership (as evident in the stagnating growth of active members, despite continued growth in total members),” the investigators concluded. Read the full study at Ann Surg. 2017 Aug 29. doi: 10.1097/SLA.0000000000002479. (Epub ahead of print).
Social media is now being used by surgeons for interaction among peers, informal learning, exchange of technical information, and diffusion of ideas.
A study has examined posting and membership data from a closed Facebook page, the “Robotic Surgery Collaboration,” created by surgeons who practice robotic-assisted procedures. Overall, the findings show exponential growth in membership in January 2015 through August 2016, some signs of stagnating engagement, and use of the platform for peer-to-peer learning and discussion.
“The growth in this group over time suggests that surgeons found it useful for engaging in informal interactions and learning vicariously from one another, but also reveals that not all users were actively engaged in these interactions each month and that growth in active membership differed from growth in overall group membership (as evident in the stagnating growth of active members, despite continued growth in total members),” the investigators concluded. Read the full study at Ann Surg. 2017 Aug 29. doi: 10.1097/SLA.0000000000002479. (Epub ahead of print).
Social media is now being used by surgeons for interaction among peers, informal learning, exchange of technical information, and diffusion of ideas.
A study has examined posting and membership data from a closed Facebook page, the “Robotic Surgery Collaboration,” created by surgeons who practice robotic-assisted procedures. Overall, the findings show exponential growth in membership in January 2015 through August 2016, some signs of stagnating engagement, and use of the platform for peer-to-peer learning and discussion.
“The growth in this group over time suggests that surgeons found it useful for engaging in informal interactions and learning vicariously from one another, but also reveals that not all users were actively engaged in these interactions each month and that growth in active membership differed from growth in overall group membership (as evident in the stagnating growth of active members, despite continued growth in total members),” the investigators concluded. Read the full study at Ann Surg. 2017 Aug 29. doi: 10.1097/SLA.0000000000002479. (Epub ahead of print).
ACS weighs in on surgeon workforce bill
ACS weighs in on surgeon workforce bill
The American College of Surgeons (ACS) submitted a statement for the record (available at facs.org/~/media/files/email/091417_workforce.ashx) September 14 to the U.S. House Committee on Energy and Commerce regarding its hearing on Supporting Tomorrow’s Health Providers: Examining Workforce Programs under the Public Health Service Act. The statement emphasizes that building a solid foundation of accurate and actionable workforce data is critical to making rational, informed decisions for building an optimal health care workforce. The ACS reiterates its support for the Ensuring Access to General Surgery Act of 2017 (H.R. 2906/ S.1351), sponsored by Reps. Larry Bucshon, MD, FACS (R-IN), and Ami Bera, MD (D-CA), and Sens. Charles Grassley (R-IA) and Brian Schatz (D-HI). This legislation would direct the Secretary of the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration, to conduct a study to define and identify general surgery workforce shortage areas. Additionally, it would grant the Secretary the authority to provide a general surgery shortage area designation.
The ACS maintains that a shortage of general surgeons is a critical component of the nation’s health care workforce crisis. Consequently, the ACS is urging policymakers to recognize through the designation of a formal surgical shortage area that only surgeons are uniquely trained and qualified to provide certain necessary, lifesaving procedures. Surgeons play a pivotal role in the community-based health care system, but unlike other key community providers, surgery has no official shortage area designation.
The ACS encourages Fellows to contact their members of Congress through SurgeonsVoice (member login required) at www.surgeonsvoice.org to urge them to sign on in support of this legislation. For more information about surgical workforce shortage legislation, contact Carrie Zlatos, ACS Senior Congressional Lobbyist, at [email protected] or 202-672-1508.
ACS weighs in on surgeon workforce bill
The American College of Surgeons (ACS) submitted a statement for the record (available at facs.org/~/media/files/email/091417_workforce.ashx) September 14 to the U.S. House Committee on Energy and Commerce regarding its hearing on Supporting Tomorrow’s Health Providers: Examining Workforce Programs under the Public Health Service Act. The statement emphasizes that building a solid foundation of accurate and actionable workforce data is critical to making rational, informed decisions for building an optimal health care workforce. The ACS reiterates its support for the Ensuring Access to General Surgery Act of 2017 (H.R. 2906/ S.1351), sponsored by Reps. Larry Bucshon, MD, FACS (R-IN), and Ami Bera, MD (D-CA), and Sens. Charles Grassley (R-IA) and Brian Schatz (D-HI). This legislation would direct the Secretary of the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration, to conduct a study to define and identify general surgery workforce shortage areas. Additionally, it would grant the Secretary the authority to provide a general surgery shortage area designation.
The ACS maintains that a shortage of general surgeons is a critical component of the nation’s health care workforce crisis. Consequently, the ACS is urging policymakers to recognize through the designation of a formal surgical shortage area that only surgeons are uniquely trained and qualified to provide certain necessary, lifesaving procedures. Surgeons play a pivotal role in the community-based health care system, but unlike other key community providers, surgery has no official shortage area designation.
The ACS encourages Fellows to contact their members of Congress through SurgeonsVoice (member login required) at www.surgeonsvoice.org to urge them to sign on in support of this legislation. For more information about surgical workforce shortage legislation, contact Carrie Zlatos, ACS Senior Congressional Lobbyist, at [email protected] or 202-672-1508.
ACS weighs in on surgeon workforce bill
The American College of Surgeons (ACS) submitted a statement for the record (available at facs.org/~/media/files/email/091417_workforce.ashx) September 14 to the U.S. House Committee on Energy and Commerce regarding its hearing on Supporting Tomorrow’s Health Providers: Examining Workforce Programs under the Public Health Service Act. The statement emphasizes that building a solid foundation of accurate and actionable workforce data is critical to making rational, informed decisions for building an optimal health care workforce. The ACS reiterates its support for the Ensuring Access to General Surgery Act of 2017 (H.R. 2906/ S.1351), sponsored by Reps. Larry Bucshon, MD, FACS (R-IN), and Ami Bera, MD (D-CA), and Sens. Charles Grassley (R-IA) and Brian Schatz (D-HI). This legislation would direct the Secretary of the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration, to conduct a study to define and identify general surgery workforce shortage areas. Additionally, it would grant the Secretary the authority to provide a general surgery shortage area designation.
The ACS maintains that a shortage of general surgeons is a critical component of the nation’s health care workforce crisis. Consequently, the ACS is urging policymakers to recognize through the designation of a formal surgical shortage area that only surgeons are uniquely trained and qualified to provide certain necessary, lifesaving procedures. Surgeons play a pivotal role in the community-based health care system, but unlike other key community providers, surgery has no official shortage area designation.
The ACS encourages Fellows to contact their members of Congress through SurgeonsVoice (member login required) at www.surgeonsvoice.org to urge them to sign on in support of this legislation. For more information about surgical workforce shortage legislation, contact Carrie Zlatos, ACS Senior Congressional Lobbyist, at [email protected] or 202-672-1508.