ACS Surgery News

For patients with Clostridium difficile infections, undetectable peripheral eosinophils at admission were a significant predictor of severe outcomes, even in the absence of hypotension and tachycardia, researchers wrote in JAMA Surgery.

CDC/Jennifer Hulsey

“In animal models, peripheral eosinopenia is a biologically plausible predictive factor for adverse outcomes, and human data from this study indicate that this frequent addition to an admission complete blood cell count is an inexpensive, widely available risk index in the treatment of C. difficile infection,” wrote Audrey S. Kulaylat, MD, of Penn State University, Hershey, and her associates.

In their cohort study of 2,065 patients admitted to two tertiary referral centers with C. difficile infection, undetectable eosinophil counts at hospital admission were associated with significantly increased odds of in-hospital mortality in both a training dataset (odds ratio, 2.01; 95% confidence interval, 1.08-3.73; P = .03) and a validation dataset (OR, 2.26; 95% CI, 1.33-3.83; P = .002). Undetectable eosinophil counts also were associated with elevated odds of severe disease requiring intensive care, vasopressor use, and emergency total colectomy. Besides eosinopenia, significant predictors of mortality included having more comorbidities and lower systolic blood pressure at admission. Strikingly, when patients had no initial hypotension or tachycardia, an undetectable eosinophil count was the only identifiable predictor of in-hospital death (OR, 5.76; 95% CI, 1.99-16.64). An elevated white blood cell count was not a significant predictor of mortality in this subgroup.

Dr. Kulaylat and her associates are studying the microbiome in C. difficile infection. Their work has identified a host immune reaction marked by an “exaggerated inflammasome response” and peripheral eosinopenia, they explained. Two recent murine models have produced similar results.

Admission eosinophil counts “allow for an immediate assessment of mortality risk at admission that is inexpensive and part of a differential for a standard complete blood count available at any hospital,” they concluded. They are now prospectively evaluating a prognostic score for C. difficile infection that includes eosinopenia and other easily discernible admission factors. The National Institutes of Health supported the work. The researchers reported having no conflicts of interest.
 

SOURCE: Kulaylat AS et al. JAMA Surg. 2018 Sep 12. doi: 10.1001/jamasurg.2018.3174.
 

For patients with Clostridium difficile infections, undetectable peripheral eosinophils at admission were a significant predictor of severe outcomes, even in the absence of hypotension and tachycardia, researchers wrote in JAMA Surgery.

CDC/Jennifer Hulsey

“In animal models, peripheral eosinopenia is a biologically plausible predictive factor for adverse outcomes, and human data from this study indicate that this frequent addition to an admission complete blood cell count is an inexpensive, widely available risk index in the treatment of C. difficile infection,” wrote Audrey S. Kulaylat, MD, of Penn State University, Hershey, and her associates.

In their cohort study of 2,065 patients admitted to two tertiary referral centers with C. difficile infection, undetectable eosinophil counts at hospital admission were associated with significantly increased odds of in-hospital mortality in both a training dataset (odds ratio, 2.01; 95% confidence interval, 1.08-3.73; P = .03) and a validation dataset (OR, 2.26; 95% CI, 1.33-3.83; P = .002). Undetectable eosinophil counts also were associated with elevated odds of severe disease requiring intensive care, vasopressor use, and emergency total colectomy. Besides eosinopenia, significant predictors of mortality included having more comorbidities and lower systolic blood pressure at admission. Strikingly, when patients had no initial hypotension or tachycardia, an undetectable eosinophil count was the only identifiable predictor of in-hospital death (OR, 5.76; 95% CI, 1.99-16.64). An elevated white blood cell count was not a significant predictor of mortality in this subgroup.

Dr. Kulaylat and her associates are studying the microbiome in C. difficile infection. Their work has identified a host immune reaction marked by an “exaggerated inflammasome response” and peripheral eosinopenia, they explained. Two recent murine models have produced similar results.

Admission eosinophil counts “allow for an immediate assessment of mortality risk at admission that is inexpensive and part of a differential for a standard complete blood count available at any hospital,” they concluded. They are now prospectively evaluating a prognostic score for C. difficile infection that includes eosinopenia and other easily discernible admission factors. The National Institutes of Health supported the work. The researchers reported having no conflicts of interest.
 

SOURCE: Kulaylat AS et al. JAMA Surg. 2018 Sep 12. doi: 10.1001/jamasurg.2018.3174.
 

For patients with Clostridium difficile infections, undetectable peripheral eosinophils at admission were a significant predictor of severe outcomes, even in the absence of hypotension and tachycardia, researchers wrote in JAMA Surgery.

CDC/Jennifer Hulsey

“In animal models, peripheral eosinopenia is a biologically plausible predictive factor for adverse outcomes, and human data from this study indicate that this frequent addition to an admission complete blood cell count is an inexpensive, widely available risk index in the treatment of C. difficile infection,” wrote Audrey S. Kulaylat, MD, of Penn State University, Hershey, and her associates.

In their cohort study of 2,065 patients admitted to two tertiary referral centers with C. difficile infection, undetectable eosinophil counts at hospital admission were associated with significantly increased odds of in-hospital mortality in both a training dataset (odds ratio, 2.01; 95% confidence interval, 1.08-3.73; P = .03) and a validation dataset (OR, 2.26; 95% CI, 1.33-3.83; P = .002). Undetectable eosinophil counts also were associated with elevated odds of severe disease requiring intensive care, vasopressor use, and emergency total colectomy. Besides eosinopenia, significant predictors of mortality included having more comorbidities and lower systolic blood pressure at admission. Strikingly, when patients had no initial hypotension or tachycardia, an undetectable eosinophil count was the only identifiable predictor of in-hospital death (OR, 5.76; 95% CI, 1.99-16.64). An elevated white blood cell count was not a significant predictor of mortality in this subgroup.

Dr. Kulaylat and her associates are studying the microbiome in C. difficile infection. Their work has identified a host immune reaction marked by an “exaggerated inflammasome response” and peripheral eosinopenia, they explained. Two recent murine models have produced similar results.

Admission eosinophil counts “allow for an immediate assessment of mortality risk at admission that is inexpensive and part of a differential for a standard complete blood count available at any hospital,” they concluded. They are now prospectively evaluating a prognostic score for C. difficile infection that includes eosinopenia and other easily discernible admission factors. The National Institutes of Health supported the work. The researchers reported having no conflicts of interest.
 

SOURCE: Kulaylat AS et al. JAMA Surg. 2018 Sep 12. doi: 10.1001/jamasurg.2018.3174.
 

Despite concerns that resident involvement in operations might pose a risk to the patient, the inclusion of general surgery residents in high-risk surgery cases does not negatively impact outcomes, according to a database study of more than 25,000 patients.

Adrienne N. Cobb, MD, of Loyola University Medical Center, Maywood, Ill., and her colleagues used the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database (2005-2012) to identify all patients undergoing any of six high-risk procedures on an elective basis.

Dr. Cobb and her colleagues compared outcomes for 25,363 patients who had procedures with and without resident participation: 4,018 and 21,345 patients, respectively. They also evaluated selected outcomes by postgraduate year (PGY). Junior residents were considered as PGY 1-2, senior residents were considered PGY 3, 4, and 5, and participants were considered fellows if they were PGY 6 or higher, according to their report published in the Journal of Surgical Research.

The six procedures assessed were esophagectomy (1,233 patients), open abdominal aortic aneurysm repair (162), laparoscopic paraesophageal resection with Nissen fundoplication (2,316), pancreaticoduodenectomy (Whipple, 10,309), abdominoperineal resection (2,003), and hepatectomy (9,329).

The primary outcome of the study was 30-day mortality with the exposure being resident involvement. Secondary outcomes that had complications included superficial and deep surgical site infection, wound disruption, bleeding requiring transfusion, return to the operating room, pneumonia, unplanned reintubation, pulmonary embolism, acute renal failure, stroke, MI, sepsis, urinary tract infection (UTI), and deep vein thrombosis, operative time, and length of stay.

In both univariate and multivariate analysis, there were no significant differences in mortality between patients who did or did not have procedures in which resident participation at any level of training was involved.

Overall, resident participation did increase the odds of a prolonged operative time (odds ratio, 1.5; 95% confidence interval, 1.1-2.1). Only abdominal perineal resection showed an increased odds risk of having a prolonged operation when residents were involved (OR, 4.3; 95% CI, 1.1-4.8). With regard to these results, the authors commented: “We assert that the additional time spent with trainees in the OR is integral to the production of confident and competent surgeons and does not lead to poorer outcomes for patients. It may, however, lead to increasing costs for the hospital and the patient.”

When risk-adjusted odds were calculated for all the other secondary outcomes and postoperative outcomes tested, UTI was the only one to show a negative impact when residents were involved (OR, 2.3; 95% CI, 1.1-4.8).

The study limitations include the age of the data and the limited number of procedures evaluated, and thus might not be generalizable to a more modern era and other procedures, according to the authors.

“Apart from UTI rates, resident participation did not significantly increase patient morbidity or mortality. Residents should continue to be given active and engaging roles in the OR, even in the most challenging cases,” Dr. Cobb and her colleagues concluded.

The study was funded by the National Institutes of Health. The authors reported that they had no disclosures.

mlesney@mdedge.com

SOURCE: Cobb AN et al. J Surg Res. 2018 Dec; 232:308-17.

Despite concerns that resident involvement in operations might pose a risk to the patient, the inclusion of general surgery residents in high-risk surgery cases does not negatively impact outcomes, according to a database study of more than 25,000 patients.

Adrienne N. Cobb, MD, of Loyola University Medical Center, Maywood, Ill., and her colleagues used the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database (2005-2012) to identify all patients undergoing any of six high-risk procedures on an elective basis.

Dr. Cobb and her colleagues compared outcomes for 25,363 patients who had procedures with and without resident participation: 4,018 and 21,345 patients, respectively. They also evaluated selected outcomes by postgraduate year (PGY). Junior residents were considered as PGY 1-2, senior residents were considered PGY 3, 4, and 5, and participants were considered fellows if they were PGY 6 or higher, according to their report published in the Journal of Surgical Research.

The six procedures assessed were esophagectomy (1,233 patients), open abdominal aortic aneurysm repair (162), laparoscopic paraesophageal resection with Nissen fundoplication (2,316), pancreaticoduodenectomy (Whipple, 10,309), abdominoperineal resection (2,003), and hepatectomy (9,329).

The primary outcome of the study was 30-day mortality with the exposure being resident involvement. Secondary outcomes that had complications included superficial and deep surgical site infection, wound disruption, bleeding requiring transfusion, return to the operating room, pneumonia, unplanned reintubation, pulmonary embolism, acute renal failure, stroke, MI, sepsis, urinary tract infection (UTI), and deep vein thrombosis, operative time, and length of stay.

In both univariate and multivariate analysis, there were no significant differences in mortality between patients who did or did not have procedures in which resident participation at any level of training was involved.

Overall, resident participation did increase the odds of a prolonged operative time (odds ratio, 1.5; 95% confidence interval, 1.1-2.1). Only abdominal perineal resection showed an increased odds risk of having a prolonged operation when residents were involved (OR, 4.3; 95% CI, 1.1-4.8). With regard to these results, the authors commented: “We assert that the additional time spent with trainees in the OR is integral to the production of confident and competent surgeons and does not lead to poorer outcomes for patients. It may, however, lead to increasing costs for the hospital and the patient.”

When risk-adjusted odds were calculated for all the other secondary outcomes and postoperative outcomes tested, UTI was the only one to show a negative impact when residents were involved (OR, 2.3; 95% CI, 1.1-4.8).

The study limitations include the age of the data and the limited number of procedures evaluated, and thus might not be generalizable to a more modern era and other procedures, according to the authors.

“Apart from UTI rates, resident participation did not significantly increase patient morbidity or mortality. Residents should continue to be given active and engaging roles in the OR, even in the most challenging cases,” Dr. Cobb and her colleagues concluded.

The study was funded by the National Institutes of Health. The authors reported that they had no disclosures.

mlesney@mdedge.com

SOURCE: Cobb AN et al. J Surg Res. 2018 Dec; 232:308-17.

Despite concerns that resident involvement in operations might pose a risk to the patient, the inclusion of general surgery residents in high-risk surgery cases does not negatively impact outcomes, according to a database study of more than 25,000 patients.

Adrienne N. Cobb, MD, of Loyola University Medical Center, Maywood, Ill., and her colleagues used the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database (2005-2012) to identify all patients undergoing any of six high-risk procedures on an elective basis.

Dr. Cobb and her colleagues compared outcomes for 25,363 patients who had procedures with and without resident participation: 4,018 and 21,345 patients, respectively. They also evaluated selected outcomes by postgraduate year (PGY). Junior residents were considered as PGY 1-2, senior residents were considered PGY 3, 4, and 5, and participants were considered fellows if they were PGY 6 or higher, according to their report published in the Journal of Surgical Research.

The six procedures assessed were esophagectomy (1,233 patients), open abdominal aortic aneurysm repair (162), laparoscopic paraesophageal resection with Nissen fundoplication (2,316), pancreaticoduodenectomy (Whipple, 10,309), abdominoperineal resection (2,003), and hepatectomy (9,329).

The primary outcome of the study was 30-day mortality with the exposure being resident involvement. Secondary outcomes that had complications included superficial and deep surgical site infection, wound disruption, bleeding requiring transfusion, return to the operating room, pneumonia, unplanned reintubation, pulmonary embolism, acute renal failure, stroke, MI, sepsis, urinary tract infection (UTI), and deep vein thrombosis, operative time, and length of stay.

In both univariate and multivariate analysis, there were no significant differences in mortality between patients who did or did not have procedures in which resident participation at any level of training was involved.

Overall, resident participation did increase the odds of a prolonged operative time (odds ratio, 1.5; 95% confidence interval, 1.1-2.1). Only abdominal perineal resection showed an increased odds risk of having a prolonged operation when residents were involved (OR, 4.3; 95% CI, 1.1-4.8). With regard to these results, the authors commented: “We assert that the additional time spent with trainees in the OR is integral to the production of confident and competent surgeons and does not lead to poorer outcomes for patients. It may, however, lead to increasing costs for the hospital and the patient.”

When risk-adjusted odds were calculated for all the other secondary outcomes and postoperative outcomes tested, UTI was the only one to show a negative impact when residents were involved (OR, 2.3; 95% CI, 1.1-4.8).

The study limitations include the age of the data and the limited number of procedures evaluated, and thus might not be generalizable to a more modern era and other procedures, according to the authors.

“Apart from UTI rates, resident participation did not significantly increase patient morbidity or mortality. Residents should continue to be given active and engaging roles in the OR, even in the most challenging cases,” Dr. Cobb and her colleagues concluded.

The study was funded by the National Institutes of Health. The authors reported that they had no disclosures.

mlesney@mdedge.com

SOURCE: Cobb AN et al. J Surg Res. 2018 Dec; 232:308-17.

Obesity carries a significant risk of hernia formation and recurrence after repair, and combining repair techniques with bariatric surgery can improve outcomes and lower the rate of complication for select patients, according to recent guidelines released by the American Society for Metabolic and Bariatric Surgery and the American Hernia Society.

Emanuele Lo Menzo, MD, of the Bariatric and Metabolic Institute at Cleveland Clinic Florida in Weston, and his colleagues issued a statement, published in the journal Surgery for Obesity and Related Diseases, based on available evidence from scientific literature on the impact of obesity on hernia surgery and what effect treating obesity has on improving hernia repair outcomes.

The authors noted abdominal wall hernia in obese patients is “a significant and increasingly common challenge for surgeons” and cited recent data from the American College of Surgeons National Surgical Quality Improvement Program that shows 60% of ventral hernia repairs (VHR) are performed on patients with body mass indexes (BMIs) above 30 kg/m². Overall, they noted that general surgeons perform approximately 350,000 conventional hernia repairs (CHR) and 800,000 incisional hernia (IH) repairs each year.

The literature on the impact of obesity on hernia repair outcomes and the feasibility of a combined operation to address each problem has significant gaps, leaving surgeons to decide on a correct course based on individual patient needs. The guideline offers some recommendations, and notes areas that remain understudied. First, “in patients with severe obesity and [ventral hernia] and both being amenable to laparoscopic repair, combined hernia repair and [metabolic/bariatric surgery] may be safe and associated with good short-term outcomes and low risk of infection.” But the use of synthetic mesh in these patients is not well studied and so the guideline passes on a recommendation of mesh. For those obese patients with symptomatic abdominal wall hernias (AWHs) not amenable to laparoscopy, the guideline notes that metabolic/bariatric surgery first may be the best option.
 

Risk of hernia in obese patients

Studies suggest there is an increased risk of primary and IH among patients with BMIs greater than 25 kg/m², with one study finding an 18.2% complication rate after single-incision laparoscopic surgery for patients with BMIs of 40 kg/m² or higher^, compared with a 3.5% complication rate among patients at a normal body weight. Severe BMI also is a risk factor for developing surgical site infection (SSI), which can cause recurrence, the authors said. Evidence from multiple studies further supports BMI as a risk factor for hernia recurrence, and intra-abdominal pressure from obesity increases the risk of developing an AWH.

“While most authors attribute the increased risk for AWH formation in the setting of obesity to BMI alone, others have suggested that abdominal circumference and elevated visceral fat may play a more significant role,” the authors wrote.

However, Dr. Lo Menzo and his colleagues admitted the actual rate of IH is difficult to calculate because some patients may not seek treatment for minimally symptomatic hernias. Patients with higher BMIs may not be aware of or seek treatment for common symptoms of IH such as groin bulge, or when they do seek treatment, it can present with symptoms such as incarceration or strangulation, they said. Patients with higher BMIs also are more likely to be offered “watchful waiting” because of higher complication rates in this patient population, which may contribute to incarceration or strangulation symptoms in these patients, they added.
 

Complications and recurrence

There is no one recommended repair technique or ideal BMI for hernia repair in obese patients, the authors wrote. One study found laparoscopic VHRs had a complication rate of 1.2% and reoccurrence rate of 5.5% at mean 25-month follow-up in patients with BMIs of 38 kg/m² or greater, while a different study with a similar design found a 3.8% reoccurrence rate at 18-month follow-up. Degree of obesity can affect complication rate: One study showed that 73% of all complications after laparoscopic VHR occurred in the group of patients with BMIs of 30 kg/m² or greater; a different study of laparoscopic VHR had an 8.3% hernia reoccurrence rate in patients with BMIs of 40 kg/m₂ or greater_, compared with patients at a normal weight (2.9%), with time to hernia reoccurrence being shorter in the higher-BMI group. A study of obese patients undergoing retromuscular open repair had a wound complication rate of 16% and a reoccurrence rate of 6%, with another study of patients undergoing umbilical hernia repair showing similar rates of complication and reoccurrence.

Panniculectomy

Among patients who underwent IH repair with panniculectomy, the authors found a 40% complication rate and a 10% reoccurrence rate in patients with BMIs of 40 kg/m² or greater who received a partial underlay mesh placement hernia repair, while a different study found an increased risk of surgical site occurrences but not SSI in patients with BMIs of 34.3 kg/m² or greater who underwent open ventral incisional hernia repair with panniculectomy. A third study found BMIs were not linked to a 55% complication rate in patients who underwent open ventral IH repair with and without mesh.

Simultaneous surgery

The authors noted that studies have shown that performing laparoscopic hernia repair and metabolic and bariatric surgery simultaneously is safe and has good short-term results. Specifically, patients who underwent the surgery with synthetic mesh had a low rate of infection or reoccurrence. Patients who underwent simultaneous weight-loss surgery and VHR had an elevated risk of SSI but no increased rate of 30-day mortality or morbidity, according to results from a large-scale registry. However, the authors noted patients with severe obesity may not be good candidates for simultaneous metabolic and bariatric surgery [MBS] and VHR, such as in patients with “large abdominal wall defects, loss of abdominal domain, extensive intestinal adhesive disease, poor quality skin (i.e., attenuated skin, prior skin graft, or ulcerated skin), incarcerated hernias containing bowel, hernias with previous synthetic mesh, hernias with chronic infection, or patients who have already undergone MBS with altered anatomy that is still intact.”

Preop weight loss

There is mixed data on the effect of weight loss prior to VHR through interventions such as very-low-calorie diets, pharmacotherapy, intragastric balloon therapy, and MBS as a first-stage procedure prior to VHR. Many patients treating their obesity with very-low-calorie diets lose approximately 10%-20% of their initial body weight and keep the weight off for at least 18 months, while one study showed patients who underwent intragastric balloon therapy lost approximately 10% of their body weight over 6 months; however, other studies have questioned the efficacy of this therapy, compared with a structured weight loss program or bariatric surgery. The authors also noted the difficulty of coordinating VHR after weight-loss surgery, lack of support from insurers, and they cited reports that cautioned bariatric surgeons to not leave hernias untreated during MBS. There is no current evidence pharmacotherapy through Food and Drug Administration–approved weight-loss drugs prior to hernia repair yield the weight-loss results needed for these patients to improve hernia outcomes, they added.

“Ultimately, there are various appropriate treatment modalities for each patient, and surgeons must use their judgment in selecting from among the different feasible options,” Dr. Lo Menzo and his colleagues wrote in the guidelines.

The authors report no relevant conflicts of interest.

SOURCE: Lo Menzo E et al. Surg Obes Relat Dis. 2018 Jul 19. doi: 10.1016/j.soard.2018.07.005.

Obesity carries a significant risk of hernia formation and recurrence after repair, and combining repair techniques with bariatric surgery can improve outcomes and lower the rate of complication for select patients, according to recent guidelines released by the American Society for Metabolic and Bariatric Surgery and the American Hernia Society.

Emanuele Lo Menzo, MD, of the Bariatric and Metabolic Institute at Cleveland Clinic Florida in Weston, and his colleagues issued a statement, published in the journal Surgery for Obesity and Related Diseases, based on available evidence from scientific literature on the impact of obesity on hernia surgery and what effect treating obesity has on improving hernia repair outcomes.

The authors noted abdominal wall hernia in obese patients is “a significant and increasingly common challenge for surgeons” and cited recent data from the American College of Surgeons National Surgical Quality Improvement Program that shows 60% of ventral hernia repairs (VHR) are performed on patients with body mass indexes (BMIs) above 30 kg/m². Overall, they noted that general surgeons perform approximately 350,000 conventional hernia repairs (CHR) and 800,000 incisional hernia (IH) repairs each year.

The literature on the impact of obesity on hernia repair outcomes and the feasibility of a combined operation to address each problem has significant gaps, leaving surgeons to decide on a correct course based on individual patient needs. The guideline offers some recommendations, and notes areas that remain understudied. First, “in patients with severe obesity and [ventral hernia] and both being amenable to laparoscopic repair, combined hernia repair and [metabolic/bariatric surgery] may be safe and associated with good short-term outcomes and low risk of infection.” But the use of synthetic mesh in these patients is not well studied and so the guideline passes on a recommendation of mesh. For those obese patients with symptomatic abdominal wall hernias (AWHs) not amenable to laparoscopy, the guideline notes that metabolic/bariatric surgery first may be the best option.
 

Risk of hernia in obese patients

Studies suggest there is an increased risk of primary and IH among patients with BMIs greater than 25 kg/m², with one study finding an 18.2% complication rate after single-incision laparoscopic surgery for patients with BMIs of 40 kg/m² or higher^, compared with a 3.5% complication rate among patients at a normal body weight. Severe BMI also is a risk factor for developing surgical site infection (SSI), which can cause recurrence, the authors said. Evidence from multiple studies further supports BMI as a risk factor for hernia recurrence, and intra-abdominal pressure from obesity increases the risk of developing an AWH.

“While most authors attribute the increased risk for AWH formation in the setting of obesity to BMI alone, others have suggested that abdominal circumference and elevated visceral fat may play a more significant role,” the authors wrote.

However, Dr. Lo Menzo and his colleagues admitted the actual rate of IH is difficult to calculate because some patients may not seek treatment for minimally symptomatic hernias. Patients with higher BMIs may not be aware of or seek treatment for common symptoms of IH such as groin bulge, or when they do seek treatment, it can present with symptoms such as incarceration or strangulation, they said. Patients with higher BMIs also are more likely to be offered “watchful waiting” because of higher complication rates in this patient population, which may contribute to incarceration or strangulation symptoms in these patients, they added.
 

Complications and recurrence

There is no one recommended repair technique or ideal BMI for hernia repair in obese patients, the authors wrote. One study found laparoscopic VHRs had a complication rate of 1.2% and reoccurrence rate of 5.5% at mean 25-month follow-up in patients with BMIs of 38 kg/m² or greater, while a different study with a similar design found a 3.8% reoccurrence rate at 18-month follow-up. Degree of obesity can affect complication rate: One study showed that 73% of all complications after laparoscopic VHR occurred in the group of patients with BMIs of 30 kg/m² or greater; a different study of laparoscopic VHR had an 8.3% hernia reoccurrence rate in patients with BMIs of 40 kg/m₂ or greater_, compared with patients at a normal weight (2.9%), with time to hernia reoccurrence being shorter in the higher-BMI group. A study of obese patients undergoing retromuscular open repair had a wound complication rate of 16% and a reoccurrence rate of 6%, with another study of patients undergoing umbilical hernia repair showing similar rates of complication and reoccurrence.

Panniculectomy

Among patients who underwent IH repair with panniculectomy, the authors found a 40% complication rate and a 10% reoccurrence rate in patients with BMIs of 40 kg/m² or greater who received a partial underlay mesh placement hernia repair, while a different study found an increased risk of surgical site occurrences but not SSI in patients with BMIs of 34.3 kg/m² or greater who underwent open ventral incisional hernia repair with panniculectomy. A third study found BMIs were not linked to a 55% complication rate in patients who underwent open ventral IH repair with and without mesh.

Simultaneous surgery

The authors noted that studies have shown that performing laparoscopic hernia repair and metabolic and bariatric surgery simultaneously is safe and has good short-term results. Specifically, patients who underwent the surgery with synthetic mesh had a low rate of infection or reoccurrence. Patients who underwent simultaneous weight-loss surgery and VHR had an elevated risk of SSI but no increased rate of 30-day mortality or morbidity, according to results from a large-scale registry. However, the authors noted patients with severe obesity may not be good candidates for simultaneous metabolic and bariatric surgery [MBS] and VHR, such as in patients with “large abdominal wall defects, loss of abdominal domain, extensive intestinal adhesive disease, poor quality skin (i.e., attenuated skin, prior skin graft, or ulcerated skin), incarcerated hernias containing bowel, hernias with previous synthetic mesh, hernias with chronic infection, or patients who have already undergone MBS with altered anatomy that is still intact.”

Preop weight loss

There is mixed data on the effect of weight loss prior to VHR through interventions such as very-low-calorie diets, pharmacotherapy, intragastric balloon therapy, and MBS as a first-stage procedure prior to VHR. Many patients treating their obesity with very-low-calorie diets lose approximately 10%-20% of their initial body weight and keep the weight off for at least 18 months, while one study showed patients who underwent intragastric balloon therapy lost approximately 10% of their body weight over 6 months; however, other studies have questioned the efficacy of this therapy, compared with a structured weight loss program or bariatric surgery. The authors also noted the difficulty of coordinating VHR after weight-loss surgery, lack of support from insurers, and they cited reports that cautioned bariatric surgeons to not leave hernias untreated during MBS. There is no current evidence pharmacotherapy through Food and Drug Administration–approved weight-loss drugs prior to hernia repair yield the weight-loss results needed for these patients to improve hernia outcomes, they added.

“Ultimately, there are various appropriate treatment modalities for each patient, and surgeons must use their judgment in selecting from among the different feasible options,” Dr. Lo Menzo and his colleagues wrote in the guidelines.

The authors report no relevant conflicts of interest.

SOURCE: Lo Menzo E et al. Surg Obes Relat Dis. 2018 Jul 19. doi: 10.1016/j.soard.2018.07.005.

Obesity carries a significant risk of hernia formation and recurrence after repair, and combining repair techniques with bariatric surgery can improve outcomes and lower the rate of complication for select patients, according to recent guidelines released by the American Society for Metabolic and Bariatric Surgery and the American Hernia Society.

Emanuele Lo Menzo, MD, of the Bariatric and Metabolic Institute at Cleveland Clinic Florida in Weston, and his colleagues issued a statement, published in the journal Surgery for Obesity and Related Diseases, based on available evidence from scientific literature on the impact of obesity on hernia surgery and what effect treating obesity has on improving hernia repair outcomes.

The authors noted abdominal wall hernia in obese patients is “a significant and increasingly common challenge for surgeons” and cited recent data from the American College of Surgeons National Surgical Quality Improvement Program that shows 60% of ventral hernia repairs (VHR) are performed on patients with body mass indexes (BMIs) above 30 kg/m². Overall, they noted that general surgeons perform approximately 350,000 conventional hernia repairs (CHR) and 800,000 incisional hernia (IH) repairs each year.

The literature on the impact of obesity on hernia repair outcomes and the feasibility of a combined operation to address each problem has significant gaps, leaving surgeons to decide on a correct course based on individual patient needs. The guideline offers some recommendations, and notes areas that remain understudied. First, “in patients with severe obesity and [ventral hernia] and both being amenable to laparoscopic repair, combined hernia repair and [metabolic/bariatric surgery] may be safe and associated with good short-term outcomes and low risk of infection.” But the use of synthetic mesh in these patients is not well studied and so the guideline passes on a recommendation of mesh. For those obese patients with symptomatic abdominal wall hernias (AWHs) not amenable to laparoscopy, the guideline notes that metabolic/bariatric surgery first may be the best option.
 

Risk of hernia in obese patients

Studies suggest there is an increased risk of primary and IH among patients with BMIs greater than 25 kg/m², with one study finding an 18.2% complication rate after single-incision laparoscopic surgery for patients with BMIs of 40 kg/m² or higher^, compared with a 3.5% complication rate among patients at a normal body weight. Severe BMI also is a risk factor for developing surgical site infection (SSI), which can cause recurrence, the authors said. Evidence from multiple studies further supports BMI as a risk factor for hernia recurrence, and intra-abdominal pressure from obesity increases the risk of developing an AWH.

“While most authors attribute the increased risk for AWH formation in the setting of obesity to BMI alone, others have suggested that abdominal circumference and elevated visceral fat may play a more significant role,” the authors wrote.

However, Dr. Lo Menzo and his colleagues admitted the actual rate of IH is difficult to calculate because some patients may not seek treatment for minimally symptomatic hernias. Patients with higher BMIs may not be aware of or seek treatment for common symptoms of IH such as groin bulge, or when they do seek treatment, it can present with symptoms such as incarceration or strangulation, they said. Patients with higher BMIs also are more likely to be offered “watchful waiting” because of higher complication rates in this patient population, which may contribute to incarceration or strangulation symptoms in these patients, they added.
 

Complications and recurrence

There is no one recommended repair technique or ideal BMI for hernia repair in obese patients, the authors wrote. One study found laparoscopic VHRs had a complication rate of 1.2% and reoccurrence rate of 5.5% at mean 25-month follow-up in patients with BMIs of 38 kg/m² or greater, while a different study with a similar design found a 3.8% reoccurrence rate at 18-month follow-up. Degree of obesity can affect complication rate: One study showed that 73% of all complications after laparoscopic VHR occurred in the group of patients with BMIs of 30 kg/m² or greater; a different study of laparoscopic VHR had an 8.3% hernia reoccurrence rate in patients with BMIs of 40 kg/m₂ or greater_, compared with patients at a normal weight (2.9%), with time to hernia reoccurrence being shorter in the higher-BMI group. A study of obese patients undergoing retromuscular open repair had a wound complication rate of 16% and a reoccurrence rate of 6%, with another study of patients undergoing umbilical hernia repair showing similar rates of complication and reoccurrence.

Panniculectomy

Among patients who underwent IH repair with panniculectomy, the authors found a 40% complication rate and a 10% reoccurrence rate in patients with BMIs of 40 kg/m² or greater who received a partial underlay mesh placement hernia repair, while a different study found an increased risk of surgical site occurrences but not SSI in patients with BMIs of 34.3 kg/m² or greater who underwent open ventral incisional hernia repair with panniculectomy. A third study found BMIs were not linked to a 55% complication rate in patients who underwent open ventral IH repair with and without mesh.

Simultaneous surgery

The authors noted that studies have shown that performing laparoscopic hernia repair and metabolic and bariatric surgery simultaneously is safe and has good short-term results. Specifically, patients who underwent the surgery with synthetic mesh had a low rate of infection or reoccurrence. Patients who underwent simultaneous weight-loss surgery and VHR had an elevated risk of SSI but no increased rate of 30-day mortality or morbidity, according to results from a large-scale registry. However, the authors noted patients with severe obesity may not be good candidates for simultaneous metabolic and bariatric surgery [MBS] and VHR, such as in patients with “large abdominal wall defects, loss of abdominal domain, extensive intestinal adhesive disease, poor quality skin (i.e., attenuated skin, prior skin graft, or ulcerated skin), incarcerated hernias containing bowel, hernias with previous synthetic mesh, hernias with chronic infection, or patients who have already undergone MBS with altered anatomy that is still intact.”

Preop weight loss

There is mixed data on the effect of weight loss prior to VHR through interventions such as very-low-calorie diets, pharmacotherapy, intragastric balloon therapy, and MBS as a first-stage procedure prior to VHR. Many patients treating their obesity with very-low-calorie diets lose approximately 10%-20% of their initial body weight and keep the weight off for at least 18 months, while one study showed patients who underwent intragastric balloon therapy lost approximately 10% of their body weight over 6 months; however, other studies have questioned the efficacy of this therapy, compared with a structured weight loss program or bariatric surgery. The authors also noted the difficulty of coordinating VHR after weight-loss surgery, lack of support from insurers, and they cited reports that cautioned bariatric surgeons to not leave hernias untreated during MBS. There is no current evidence pharmacotherapy through Food and Drug Administration–approved weight-loss drugs prior to hernia repair yield the weight-loss results needed for these patients to improve hernia outcomes, they added.

“Ultimately, there are various appropriate treatment modalities for each patient, and surgeons must use their judgment in selecting from among the different feasible options,” Dr. Lo Menzo and his colleagues wrote in the guidelines.

The authors report no relevant conflicts of interest.

SOURCE: Lo Menzo E et al. Surg Obes Relat Dis. 2018 Jul 19. doi: 10.1016/j.soard.2018.07.005.

Leaders in the House and the Senate have agreed to a final legislative package to address the opioid crisis.

Alicia Ault/MDedge News

The consensus legislation, called the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (H.R. 6), combines a House bill of the same name passed in June with the Opioid Crisis Response Act (S. 2680), passed by the Senate by a 99-1 vote on Sept. 17.

A number of provisions would affect medical practice directly, by:

• Allowing Medicare to pay clinicians to provide substance-use disorder treatment via telemedicine.
• Adding to the Welcome to Medicare exam as well as the annual physical a review of beneficiary’s opioid prescriptions, screening for potential abuse, and referral to appropriate treatment services, if necessary.
• Requiring controlled substance prescriptions covered by Part D to be transmitted electronically beginning Jan. 1, 2021.
• Allowing physicians who recently graduated in good standing from an accredited school and who have appropriate training to prescribe medication-assisted therapy.
• Requiring CMS to notify prescribers if they are identified as statistical outliers when it comes to prescribing opioids, as compared with their peers.

“The bill will make a real difference in Medicare, a program in which one in three beneficiaries is prescribed an opioid,” Senate Finance Committee Chairman Orrin Hatch (R-Utah) said Sept .17 during Senate floor debate.

“It will empower patients through information on pain treatment alternatives. It will expand treatment options for patients suffering from addiction, including through increased access to care via telehealth,” he said. “The bill also increases the ability to track opioid prescriptions to prevent misuse and diversion, while also ensuring that beneficiaries promptly get the medications they need.”

The bill also requires the Food and Drug Administration to issue guidance on expedited pathways for approval of new nonaddictive pain treatments and on the appropriate use of pain endpoints across agency divisions as well as clarification on requirements on how opioid-sparing data is to be used on labels.

The combined legislation also clarifies the FDA’s authority to require drug manufacturers to package opioids in three- and seven-supply blister packs, as well as requiring manufacturers to provide patients with simple and safe options to dispose of unused opioids.

The combined bill addresses one of the criticisms of the Senate-passed version.

Sen. Edward Markey (D-Mass.) noted the absence of a provision that would have given nurse practitioners and physician assistants permanent prescribing authority for medication-assisted therapies.

“This is a missed opportunity to build upon our commitment to treatment,” he said on the Senate floor.

The final version of H.R. 6 that will be voted on by both chambers includes the House-passed provision.

At press time, votes on the combined bill had not been scheduled.

Sen. Margaret Wood Hassan (D-N.H.) warned the Congress not to get complacent.

“This legislation is a vital next step in our efforts to combat this crisis,” she said. “The biggest mistake anyone could make is thinking that our efforts are anywhere close to being done.”

A section-by-section summary of the bill can be found here.
 

gtwachtman@mdedge.com

Leaders in the House and the Senate have agreed to a final legislative package to address the opioid crisis.

Alicia Ault/MDedge News

The consensus legislation, called the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (H.R. 6), combines a House bill of the same name passed in June with the Opioid Crisis Response Act (S. 2680), passed by the Senate by a 99-1 vote on Sept. 17.

A number of provisions would affect medical practice directly, by:

• Allowing Medicare to pay clinicians to provide substance-use disorder treatment via telemedicine.
• Adding to the Welcome to Medicare exam as well as the annual physical a review of beneficiary’s opioid prescriptions, screening for potential abuse, and referral to appropriate treatment services, if necessary.
• Requiring controlled substance prescriptions covered by Part D to be transmitted electronically beginning Jan. 1, 2021.
• Allowing physicians who recently graduated in good standing from an accredited school and who have appropriate training to prescribe medication-assisted therapy.
• Requiring CMS to notify prescribers if they are identified as statistical outliers when it comes to prescribing opioids, as compared with their peers.

“The bill will make a real difference in Medicare, a program in which one in three beneficiaries is prescribed an opioid,” Senate Finance Committee Chairman Orrin Hatch (R-Utah) said Sept .17 during Senate floor debate.

“It will empower patients through information on pain treatment alternatives. It will expand treatment options for patients suffering from addiction, including through increased access to care via telehealth,” he said. “The bill also increases the ability to track opioid prescriptions to prevent misuse and diversion, while also ensuring that beneficiaries promptly get the medications they need.”

The bill also requires the Food and Drug Administration to issue guidance on expedited pathways for approval of new nonaddictive pain treatments and on the appropriate use of pain endpoints across agency divisions as well as clarification on requirements on how opioid-sparing data is to be used on labels.

The combined legislation also clarifies the FDA’s authority to require drug manufacturers to package opioids in three- and seven-supply blister packs, as well as requiring manufacturers to provide patients with simple and safe options to dispose of unused opioids.

The combined bill addresses one of the criticisms of the Senate-passed version.

Sen. Edward Markey (D-Mass.) noted the absence of a provision that would have given nurse practitioners and physician assistants permanent prescribing authority for medication-assisted therapies.

“This is a missed opportunity to build upon our commitment to treatment,” he said on the Senate floor.

The final version of H.R. 6 that will be voted on by both chambers includes the House-passed provision.

At press time, votes on the combined bill had not been scheduled.

Sen. Margaret Wood Hassan (D-N.H.) warned the Congress not to get complacent.

“This legislation is a vital next step in our efforts to combat this crisis,” she said. “The biggest mistake anyone could make is thinking that our efforts are anywhere close to being done.”

A section-by-section summary of the bill can be found here.
 

gtwachtman@mdedge.com

Leaders in the House and the Senate have agreed to a final legislative package to address the opioid crisis.

Alicia Ault/MDedge News

The consensus legislation, called the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (H.R. 6), combines a House bill of the same name passed in June with the Opioid Crisis Response Act (S. 2680), passed by the Senate by a 99-1 vote on Sept. 17.

A number of provisions would affect medical practice directly, by:

• Allowing Medicare to pay clinicians to provide substance-use disorder treatment via telemedicine.
• Adding to the Welcome to Medicare exam as well as the annual physical a review of beneficiary’s opioid prescriptions, screening for potential abuse, and referral to appropriate treatment services, if necessary.
• Requiring controlled substance prescriptions covered by Part D to be transmitted electronically beginning Jan. 1, 2021.
• Allowing physicians who recently graduated in good standing from an accredited school and who have appropriate training to prescribe medication-assisted therapy.
• Requiring CMS to notify prescribers if they are identified as statistical outliers when it comes to prescribing opioids, as compared with their peers.

“The bill will make a real difference in Medicare, a program in which one in three beneficiaries is prescribed an opioid,” Senate Finance Committee Chairman Orrin Hatch (R-Utah) said Sept .17 during Senate floor debate.

“It will empower patients through information on pain treatment alternatives. It will expand treatment options for patients suffering from addiction, including through increased access to care via telehealth,” he said. “The bill also increases the ability to track opioid prescriptions to prevent misuse and diversion, while also ensuring that beneficiaries promptly get the medications they need.”

The bill also requires the Food and Drug Administration to issue guidance on expedited pathways for approval of new nonaddictive pain treatments and on the appropriate use of pain endpoints across agency divisions as well as clarification on requirements on how opioid-sparing data is to be used on labels.

The combined legislation also clarifies the FDA’s authority to require drug manufacturers to package opioids in three- and seven-supply blister packs, as well as requiring manufacturers to provide patients with simple and safe options to dispose of unused opioids.

The combined bill addresses one of the criticisms of the Senate-passed version.

Sen. Edward Markey (D-Mass.) noted the absence of a provision that would have given nurse practitioners and physician assistants permanent prescribing authority for medication-assisted therapies.

“This is a missed opportunity to build upon our commitment to treatment,” he said on the Senate floor.

The final version of H.R. 6 that will be voted on by both chambers includes the House-passed provision.

At press time, votes on the combined bill had not been scheduled.

Sen. Margaret Wood Hassan (D-N.H.) warned the Congress not to get complacent.

“This legislation is a vital next step in our efforts to combat this crisis,” she said. “The biggest mistake anyone could make is thinking that our efforts are anywhere close to being done.”

A section-by-section summary of the bill can be found here.
 

gtwachtman@mdedge.com

ST. LOUIS – Compared with ibuprofen, opioid pain medication offered little benefit for pain control after venous ablation surgery, in the experience of one surgical center.

BackyardProduction/Thinkstock

Sharing study results at a poster session at the annual meeting of the Midwestern Vascular Surgery Society, Jana Sacco, MD, and her colleagues found that patients who received opioid prescriptions after venous ablations did not have significantly different postsurgical pain than did those who received ibuprofen alone.

The study, conducted against the national backdrop of greater scrutiny of postsurgical opioid prescribing, was the first to look at post–venous ablation pain management strategies, said Dr. Sacco, a resident physician at Henry Ford Hospital, Detroit. Venous ablation surgery can improve quality of life for patients with varicose veins, but best practices for managing postprocedure discomfort had not been clear; some patients receive opioid pain medications, while others are directed to use ibuprofen as needed for pain control.

The retrospective, single-center study assessed pre- and postoperative pain for patients undergoing venous ablation procedures over a 2-year period, said Dr. Sacco.

Patients who were prescribed opioids were compared with patients who were simply asked to take ibuprofen for pain control.

Comparing preoperative to postoperative pain scores, Dr. Sacco and her colleagues defined a change of 2-3 points on a 0-10 Likert scale as “good” improvement; a change of 1 point was defined as “mild” improvement, and no change or worsening was defined as no improvement.

Of the 268 patients for whom postoperative follow-up data were available, 142 received opioid prescriptions, while 126 did not.

Across the entire group of patients studied, those who had moderate to severe preoperative pain had significant improvement in pain after their procedures.

Whether patients received opioid pain medication after their venous ablation was not correlated with the degree of improvement in postprocedure pain scores. Of those who saw no improvement, 30 patients (45%) received opioids and 36 (55%) did not. Of the 89 patients who saw mild postprocedure improvement in pain, 35 (40%) were not discharged on opioids, and of 65 patients who had good improvement in postprocedure pain, 44% were not discharged on opioids (P = .7 for difference across groups).

When Dr. Sacco and her fellow researchers examined such patient characteristics as sex, race, body mass index, smoking status, and CEAP venous severity classification, they did not see any significant differences in pain scores. Similarly, neither the type of procedure (radiofrequency or laser ablation) nor information on whether compression treatment was used was associated with a difference in pain scores.

Dr. Sacco and her coauthors noted that the study was limited by its retrospective nature and the fact that patients were all drawn from a single institution. Additionally, the investigators were only able to ascertain whether opioids had been prescribed, not whether – or how much – medication was actually taken by patients.

“Most patients report an improvement in symptoms after undergoing vein ablation procedures,” reported Dr. Sacco and her colleagues, and most patients also do well with nonopioid pain control regimens. “Overprescribing opioids exposes patients to the risk of narcotic overdose and chronic opioid use and should be used with caution for patients undergoing vein ablation surgery,” they wrote.

Dr. Sacco reported no outside sources of funding and no conflicts of interest.
 

koakes@mdedge.com

ST. LOUIS – Compared with ibuprofen, opioid pain medication offered little benefit for pain control after venous ablation surgery, in the experience of one surgical center.

BackyardProduction/Thinkstock

Sharing study results at a poster session at the annual meeting of the Midwestern Vascular Surgery Society, Jana Sacco, MD, and her colleagues found that patients who received opioid prescriptions after venous ablations did not have significantly different postsurgical pain than did those who received ibuprofen alone.

The study, conducted against the national backdrop of greater scrutiny of postsurgical opioid prescribing, was the first to look at post–venous ablation pain management strategies, said Dr. Sacco, a resident physician at Henry Ford Hospital, Detroit. Venous ablation surgery can improve quality of life for patients with varicose veins, but best practices for managing postprocedure discomfort had not been clear; some patients receive opioid pain medications, while others are directed to use ibuprofen as needed for pain control.

The retrospective, single-center study assessed pre- and postoperative pain for patients undergoing venous ablation procedures over a 2-year period, said Dr. Sacco.

Patients who were prescribed opioids were compared with patients who were simply asked to take ibuprofen for pain control.

Comparing preoperative to postoperative pain scores, Dr. Sacco and her colleagues defined a change of 2-3 points on a 0-10 Likert scale as “good” improvement; a change of 1 point was defined as “mild” improvement, and no change or worsening was defined as no improvement.

Of the 268 patients for whom postoperative follow-up data were available, 142 received opioid prescriptions, while 126 did not.

Across the entire group of patients studied, those who had moderate to severe preoperative pain had significant improvement in pain after their procedures.

Whether patients received opioid pain medication after their venous ablation was not correlated with the degree of improvement in postprocedure pain scores. Of those who saw no improvement, 30 patients (45%) received opioids and 36 (55%) did not. Of the 89 patients who saw mild postprocedure improvement in pain, 35 (40%) were not discharged on opioids, and of 65 patients who had good improvement in postprocedure pain, 44% were not discharged on opioids (P = .7 for difference across groups).

When Dr. Sacco and her fellow researchers examined such patient characteristics as sex, race, body mass index, smoking status, and CEAP venous severity classification, they did not see any significant differences in pain scores. Similarly, neither the type of procedure (radiofrequency or laser ablation) nor information on whether compression treatment was used was associated with a difference in pain scores.

Dr. Sacco and her coauthors noted that the study was limited by its retrospective nature and the fact that patients were all drawn from a single institution. Additionally, the investigators were only able to ascertain whether opioids had been prescribed, not whether – or how much – medication was actually taken by patients.

“Most patients report an improvement in symptoms after undergoing vein ablation procedures,” reported Dr. Sacco and her colleagues, and most patients also do well with nonopioid pain control regimens. “Overprescribing opioids exposes patients to the risk of narcotic overdose and chronic opioid use and should be used with caution for patients undergoing vein ablation surgery,” they wrote.

Dr. Sacco reported no outside sources of funding and no conflicts of interest.
 

koakes@mdedge.com

ST. LOUIS – Compared with ibuprofen, opioid pain medication offered little benefit for pain control after venous ablation surgery, in the experience of one surgical center.

BackyardProduction/Thinkstock

Sharing study results at a poster session at the annual meeting of the Midwestern Vascular Surgery Society, Jana Sacco, MD, and her colleagues found that patients who received opioid prescriptions after venous ablations did not have significantly different postsurgical pain than did those who received ibuprofen alone.

The study, conducted against the national backdrop of greater scrutiny of postsurgical opioid prescribing, was the first to look at post–venous ablation pain management strategies, said Dr. Sacco, a resident physician at Henry Ford Hospital, Detroit. Venous ablation surgery can improve quality of life for patients with varicose veins, but best practices for managing postprocedure discomfort had not been clear; some patients receive opioid pain medications, while others are directed to use ibuprofen as needed for pain control.

The retrospective, single-center study assessed pre- and postoperative pain for patients undergoing venous ablation procedures over a 2-year period, said Dr. Sacco.

Patients who were prescribed opioids were compared with patients who were simply asked to take ibuprofen for pain control.

Comparing preoperative to postoperative pain scores, Dr. Sacco and her colleagues defined a change of 2-3 points on a 0-10 Likert scale as “good” improvement; a change of 1 point was defined as “mild” improvement, and no change or worsening was defined as no improvement.

Of the 268 patients for whom postoperative follow-up data were available, 142 received opioid prescriptions, while 126 did not.

Across the entire group of patients studied, those who had moderate to severe preoperative pain had significant improvement in pain after their procedures.

Whether patients received opioid pain medication after their venous ablation was not correlated with the degree of improvement in postprocedure pain scores. Of those who saw no improvement, 30 patients (45%) received opioids and 36 (55%) did not. Of the 89 patients who saw mild postprocedure improvement in pain, 35 (40%) were not discharged on opioids, and of 65 patients who had good improvement in postprocedure pain, 44% were not discharged on opioids (P = .7 for difference across groups).

When Dr. Sacco and her fellow researchers examined such patient characteristics as sex, race, body mass index, smoking status, and CEAP venous severity classification, they did not see any significant differences in pain scores. Similarly, neither the type of procedure (radiofrequency or laser ablation) nor information on whether compression treatment was used was associated with a difference in pain scores.

Dr. Sacco and her coauthors noted that the study was limited by its retrospective nature and the fact that patients were all drawn from a single institution. Additionally, the investigators were only able to ascertain whether opioids had been prescribed, not whether – or how much – medication was actually taken by patients.

“Most patients report an improvement in symptoms after undergoing vein ablation procedures,” reported Dr. Sacco and her colleagues, and most patients also do well with nonopioid pain control regimens. “Overprescribing opioids exposes patients to the risk of narcotic overdose and chronic opioid use and should be used with caution for patients undergoing vein ablation surgery,” they wrote.

Dr. Sacco reported no outside sources of funding and no conflicts of interest.
 

koakes@mdedge.com

ST. LOUIS – Many vascular surgery trainees felt unprepared to take the Registered Physician in Vascular Interpretation (RPVI) exam, according to a recent survey. However, trainees in a program without a structured noninvasive vascular laboratory (NIVL) curriculum felt particularly unprepared, said Daisy Chou, MD.

Kari Oakes/MDedge News

“There is wide variation in NIVL experience amongst vascular surgery training programs,” noted Dr. Chou, a vascular surgery fellow at the Ohio State University, Columbus. She presented survey results at the annual meeting of the Midwestern Vascular Surgical Society. The survey constructed by Dr. Chou and her colleagues went out to trainees in both 0+5 and 5+2 vascular surgery training programs in September, 2017, in 114 unique programs.

Eventually, trainees from just over half of the programs responded (N = 61 programs, 53.5%), said Dr. Chou. Using responses from individual trainees, the authors grouped programs into one of two categories: those whose trainees felt well prepared for the RPVI, and those whose trainees felt unprepared for the RPVI.

In addition to a yes/no question about preparedness, the survey also asked whether training programs had a structured curriculum; respondents were asked to identify specific NIVL-related training activities. The survey asked about individual didactic components, as well as whether the trainee spent individual time with an attending physician and hands-on time with vascular technologists. Respondents were asked about the amount of time, measured in half days per week, spent in the vascular laboratory.

Finally, the survey asked whether trainees took a pre-RPVI exam review course, and whether they passed the RPVI exam on their first attempt.

Overall, 34 of the programs with respondents (55.7%) had structured curricula; the same number included lectures. Twenty programs (32.8%) provided video content, and 29 (47.5%) used textbooks. Just 18 programs (29.5%) assigned articles.

One-on-one time spent with an attending physician and focused on NIVL techniques was reported for 32 programs (52.5%). More programs (n = 37; 60.7%) provided trainees hands-on experience with vascular technologists.

Most programs (n = 32; 52.5%) had trainees spending less than one half day per week in the vascular laboratory, according to survey respondents.

In terms of preparedness, respondents for over half of the programs did not respond to the question asking whether they felt prepared for the RPVI, presumably because they had not yet taken the exam. This, acknowledged Dr. Chou, was a significant limitation of the survey. There was a timing problem: Trainees were surveyed at the start of the 2017-2018 academic year, but the RPVI exam isn’t usually taken until the end of the final year of training, with review courses taken not long before that.

Of the 32 programs with trainees who reported taking the RPVI exam, 18 had trainees who felt unprepared, and 14 program had trainees who felt well prepared. About a quarter of programs (N = 15; 24.6%) had trainees who took a review course prior to taking the exam.

Dr. Chou and her colleagues then examined the survey responses another way, seeing what differentiated the programs whose trainees felt well prepared from those with trainees who felt unprepared.

Statistically, the clear standout was whether the program had a structured curriculum: The 14 programs with a structured curriculum all had students who reported feeling well prepared. Just one-third of the 18 programs with unprepared students had a structured curriculum, which was a significant difference (P = .0001).

Also, programs that assigned articles and those that gave formal lectures were more likely to have students who felt prepared to sit for the RPVI exam (P = .002 and .004, respectively). A higher number of programs that gave trainees hands-on time with vascular technologists had trainees who felt prepared, but the difference wasn’t quite statistically significant (P = .05).

Having taken a review course prior to the exam was associated with feeling well prepared (P = .03).

Dr. Chou and her colleagues performed a logistic regression analysis to arrive at the educational components associated with the highest odds for trainees feeling well prepared. Lectures and articles came out on top in this analysis (odds ratios for feeling well prepared, 15.88 and 15.97, respectively). Hands-on time with vascular technologists had an odds ratio of 5.12 for feeling prepared.

Taking a review course boosted preparedness as well, with an odds ratio of 11.85 for feeling well prepared for the RPVI exam. This created a bit of a conundrum for the investigators, said Dr. Chou: “All well prepared programs had a structured NIVL curriculum, but most of their trainees still took an RPVI review course, so it’s unclear if the structured curriculum or the review course is responsible for trainees feeling well prepared for the RPVI exam,” she said.

An important caveat to the analysis of survey results, said Dr. Chou, is that “It’s unknown how these results will translate into pass rates.

“Vascular surgery leadership should not leave NIVL education to review courses,” said Dr. Chou. The ultimate goal, she said, should be to achieve expertise in the service of providing better patient care. To this end, Dr. Chou and her coauthors recommend that a structured NIVL curriculum be incorporated into vascular surgery training, and that the program include time spent with vascular technologists, a formal lecture-based component, and structured reading, as is provided by a journal club.

Dr. Chou reported no conflicts of interest, and no external sources of funding.

koakes@mdedge.com

ST. LOUIS – Many vascular surgery trainees felt unprepared to take the Registered Physician in Vascular Interpretation (RPVI) exam, according to a recent survey. However, trainees in a program without a structured noninvasive vascular laboratory (NIVL) curriculum felt particularly unprepared, said Daisy Chou, MD.

Kari Oakes/MDedge News

“There is wide variation in NIVL experience amongst vascular surgery training programs,” noted Dr. Chou, a vascular surgery fellow at the Ohio State University, Columbus. She presented survey results at the annual meeting of the Midwestern Vascular Surgical Society. The survey constructed by Dr. Chou and her colleagues went out to trainees in both 0+5 and 5+2 vascular surgery training programs in September, 2017, in 114 unique programs.

Eventually, trainees from just over half of the programs responded (N = 61 programs, 53.5%), said Dr. Chou. Using responses from individual trainees, the authors grouped programs into one of two categories: those whose trainees felt well prepared for the RPVI, and those whose trainees felt unprepared for the RPVI.

In addition to a yes/no question about preparedness, the survey also asked whether training programs had a structured curriculum; respondents were asked to identify specific NIVL-related training activities. The survey asked about individual didactic components, as well as whether the trainee spent individual time with an attending physician and hands-on time with vascular technologists. Respondents were asked about the amount of time, measured in half days per week, spent in the vascular laboratory.

Finally, the survey asked whether trainees took a pre-RPVI exam review course, and whether they passed the RPVI exam on their first attempt.

Overall, 34 of the programs with respondents (55.7%) had structured curricula; the same number included lectures. Twenty programs (32.8%) provided video content, and 29 (47.5%) used textbooks. Just 18 programs (29.5%) assigned articles.

One-on-one time spent with an attending physician and focused on NIVL techniques was reported for 32 programs (52.5%). More programs (n = 37; 60.7%) provided trainees hands-on experience with vascular technologists.

Most programs (n = 32; 52.5%) had trainees spending less than one half day per week in the vascular laboratory, according to survey respondents.

In terms of preparedness, respondents for over half of the programs did not respond to the question asking whether they felt prepared for the RPVI, presumably because they had not yet taken the exam. This, acknowledged Dr. Chou, was a significant limitation of the survey. There was a timing problem: Trainees were surveyed at the start of the 2017-2018 academic year, but the RPVI exam isn’t usually taken until the end of the final year of training, with review courses taken not long before that.

Of the 32 programs with trainees who reported taking the RPVI exam, 18 had trainees who felt unprepared, and 14 program had trainees who felt well prepared. About a quarter of programs (N = 15; 24.6%) had trainees who took a review course prior to taking the exam.

Dr. Chou and her colleagues then examined the survey responses another way, seeing what differentiated the programs whose trainees felt well prepared from those with trainees who felt unprepared.

Statistically, the clear standout was whether the program had a structured curriculum: The 14 programs with a structured curriculum all had students who reported feeling well prepared. Just one-third of the 18 programs with unprepared students had a structured curriculum, which was a significant difference (P = .0001).

Also, programs that assigned articles and those that gave formal lectures were more likely to have students who felt prepared to sit for the RPVI exam (P = .002 and .004, respectively). A higher number of programs that gave trainees hands-on time with vascular technologists had trainees who felt prepared, but the difference wasn’t quite statistically significant (P = .05).

Having taken a review course prior to the exam was associated with feeling well prepared (P = .03).

Dr. Chou and her colleagues performed a logistic regression analysis to arrive at the educational components associated with the highest odds for trainees feeling well prepared. Lectures and articles came out on top in this analysis (odds ratios for feeling well prepared, 15.88 and 15.97, respectively). Hands-on time with vascular technologists had an odds ratio of 5.12 for feeling prepared.

Taking a review course boosted preparedness as well, with an odds ratio of 11.85 for feeling well prepared for the RPVI exam. This created a bit of a conundrum for the investigators, said Dr. Chou: “All well prepared programs had a structured NIVL curriculum, but most of their trainees still took an RPVI review course, so it’s unclear if the structured curriculum or the review course is responsible for trainees feeling well prepared for the RPVI exam,” she said.

An important caveat to the analysis of survey results, said Dr. Chou, is that “It’s unknown how these results will translate into pass rates.

“Vascular surgery leadership should not leave NIVL education to review courses,” said Dr. Chou. The ultimate goal, she said, should be to achieve expertise in the service of providing better patient care. To this end, Dr. Chou and her coauthors recommend that a structured NIVL curriculum be incorporated into vascular surgery training, and that the program include time spent with vascular technologists, a formal lecture-based component, and structured reading, as is provided by a journal club.

Dr. Chou reported no conflicts of interest, and no external sources of funding.

koakes@mdedge.com

ST. LOUIS – Many vascular surgery trainees felt unprepared to take the Registered Physician in Vascular Interpretation (RPVI) exam, according to a recent survey. However, trainees in a program without a structured noninvasive vascular laboratory (NIVL) curriculum felt particularly unprepared, said Daisy Chou, MD.

Kari Oakes/MDedge News

“There is wide variation in NIVL experience amongst vascular surgery training programs,” noted Dr. Chou, a vascular surgery fellow at the Ohio State University, Columbus. She presented survey results at the annual meeting of the Midwestern Vascular Surgical Society. The survey constructed by Dr. Chou and her colleagues went out to trainees in both 0+5 and 5+2 vascular surgery training programs in September, 2017, in 114 unique programs.

Eventually, trainees from just over half of the programs responded (N = 61 programs, 53.5%), said Dr. Chou. Using responses from individual trainees, the authors grouped programs into one of two categories: those whose trainees felt well prepared for the RPVI, and those whose trainees felt unprepared for the RPVI.

In addition to a yes/no question about preparedness, the survey also asked whether training programs had a structured curriculum; respondents were asked to identify specific NIVL-related training activities. The survey asked about individual didactic components, as well as whether the trainee spent individual time with an attending physician and hands-on time with vascular technologists. Respondents were asked about the amount of time, measured in half days per week, spent in the vascular laboratory.

Finally, the survey asked whether trainees took a pre-RPVI exam review course, and whether they passed the RPVI exam on their first attempt.

Overall, 34 of the programs with respondents (55.7%) had structured curricula; the same number included lectures. Twenty programs (32.8%) provided video content, and 29 (47.5%) used textbooks. Just 18 programs (29.5%) assigned articles.

One-on-one time spent with an attending physician and focused on NIVL techniques was reported for 32 programs (52.5%). More programs (n = 37; 60.7%) provided trainees hands-on experience with vascular technologists.

Most programs (n = 32; 52.5%) had trainees spending less than one half day per week in the vascular laboratory, according to survey respondents.

In terms of preparedness, respondents for over half of the programs did not respond to the question asking whether they felt prepared for the RPVI, presumably because they had not yet taken the exam. This, acknowledged Dr. Chou, was a significant limitation of the survey. There was a timing problem: Trainees were surveyed at the start of the 2017-2018 academic year, but the RPVI exam isn’t usually taken until the end of the final year of training, with review courses taken not long before that.

Of the 32 programs with trainees who reported taking the RPVI exam, 18 had trainees who felt unprepared, and 14 program had trainees who felt well prepared. About a quarter of programs (N = 15; 24.6%) had trainees who took a review course prior to taking the exam.

Dr. Chou and her colleagues then examined the survey responses another way, seeing what differentiated the programs whose trainees felt well prepared from those with trainees who felt unprepared.

Statistically, the clear standout was whether the program had a structured curriculum: The 14 programs with a structured curriculum all had students who reported feeling well prepared. Just one-third of the 18 programs with unprepared students had a structured curriculum, which was a significant difference (P = .0001).

Also, programs that assigned articles and those that gave formal lectures were more likely to have students who felt prepared to sit for the RPVI exam (P = .002 and .004, respectively). A higher number of programs that gave trainees hands-on time with vascular technologists had trainees who felt prepared, but the difference wasn’t quite statistically significant (P = .05).

Having taken a review course prior to the exam was associated with feeling well prepared (P = .03).

Dr. Chou and her colleagues performed a logistic regression analysis to arrive at the educational components associated with the highest odds for trainees feeling well prepared. Lectures and articles came out on top in this analysis (odds ratios for feeling well prepared, 15.88 and 15.97, respectively). Hands-on time with vascular technologists had an odds ratio of 5.12 for feeling prepared.

Taking a review course boosted preparedness as well, with an odds ratio of 11.85 for feeling well prepared for the RPVI exam. This created a bit of a conundrum for the investigators, said Dr. Chou: “All well prepared programs had a structured NIVL curriculum, but most of their trainees still took an RPVI review course, so it’s unclear if the structured curriculum or the review course is responsible for trainees feeling well prepared for the RPVI exam,” she said.

An important caveat to the analysis of survey results, said Dr. Chou, is that “It’s unknown how these results will translate into pass rates.

“Vascular surgery leadership should not leave NIVL education to review courses,” said Dr. Chou. The ultimate goal, she said, should be to achieve expertise in the service of providing better patient care. To this end, Dr. Chou and her coauthors recommend that a structured NIVL curriculum be incorporated into vascular surgery training, and that the program include time spent with vascular technologists, a formal lecture-based component, and structured reading, as is provided by a journal club.

Dr. Chou reported no conflicts of interest, and no external sources of funding.

koakes@mdedge.com

A proposed rule from the White House would make it harder for legal immigrants to get green cards if they have received certain kinds of public assistance – including Medicaid, food stamps, and housing subsidies. Green cards allow them to live and work permanently in the United States.

“Those seeking to immigrate to the United States must show they can support themselves financially,” Homeland Security Secretary Kirstjen Nielsen said in a statement.

The proposal, announced Sept. 22, marks a new frontier in the administration’s long-term effort to curb immigration, both legal and illegal. It already has spurred intense criticism from Democrats, anti-poverty activists, health care organizations, and immigrants’ rights advocates, who call its restrictions unprecedented.

“We are operating in an overall climate of tremendous fear and anxiety as a result of the administration’s overall approach to immigration enforcement and immigration policy,” said Mark Greenberg, a senior fellow at the Migration Policy Institute, which studies migration and refugee policies at local, national, and international levels. He is also a former Obama administration official.

But what effect would this proposal have?

It’s a complicated question, touching upon vast government programs, with billions of dollars at stake. While the implications aren’t all immediately clear, Kaiser Health News breaks down some of the key elements.
 

1. First thing first: What is the White House proposing?

The Trump administration wants to redefine a status known as “public charge” – a category used to determine whether someone seeking permanent resident status is “likely to become primarily dependent on the government for subsistence.”

In the past, people have been at risk of being defined a “public charge” if they took cash welfare – known as Temporary Assistance for Needy Families, or Supplemental Security Income – or federal help paying for long-term care. (Immigrants must be in the country legally for 5 years before being eligible for TANF or SSI.)

And that “public charge” designation could undermine their applications for permanent residence.

The new rule would expand the list to include some health insurance, food, and housing programs. Specifically, it would penalize green-card applicants for using Medicaid, a federal-state health plan for low-income people. (Penalties would not apply for using Medicaid in certain emergencies or for some Medicaid services provided through schools and disability programs.)

Using food stamps, Section 8 rental assistance, and federal housing vouchers also would count against applicants. Enrollment in a Medicare Part D program subsidy to help low-income people buy prescription drugs would work against them, too.

The proposal “is definitely a dramatic change from how public charge works today,” said Kelly Whitener, an associate professor at Georgetown University’s Center for Children and Families who specializes in pediatric health benefits and managed-care systems.

A leaked version of the rule from March suggested officials then were also considering penalizing those who receive subsidies to buy health insurance on the Affordable Care Act marketplaces. But that idea was not in the proposal. The marketplace subsidies are aimed at people at a generally higher income bracket than the beneficiaries targeted in the Trump plan, Whitener noted.

“They’re really homing in on low-income immigrants,” she added.

Nielsen said the proposed rule is “intended to promote immigrant self-sufficiency and protect finite resources.”
 

2. Is this as unprecedented as critics say?

Yes.

Public charge is an old idea. In the 1990s, lawmakers expanded it to consider explicitly whether people had received cash-based welfare.

But including programs like Medicaid and food stamps, which are much wider in scope, is a significant change. It would more likely hit working people – the majority of people on Medicaid are themselves employed, and almost 80% live in families with at least one working member, according to data compiled by the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

Children who are American citizens but whose parents are immigrants could be more likely to suffer repercussions, said some experts. When parents opt out of public assistance for fear of their own legal status, their kids are less likely to be enrolled in programs such as the Children’s Health Insurance Program, or CHIP, for which they would qualify.

To be clear, receiving public aid wouldn’t necessarily stop people from getting a green card. But it would tilt the odds against them.

“Another piece is the enormous discretion the administration will have under its proposal in making judgments about who gets admitted to the country and who gets a green card,” said the Migration Policy Institute’s Greenberg.
 

3. When will the policy shift take effect?

This is an early step in the complex federal rule-making process. And a lot could still change.

Once the proposed rule appears in the Federal Register, a 60-day countdown starts, during which anyone can weigh in with comments.

A final rule likely wouldn’t take effect until 2019.

And DHS is still seeking input on some details. For instance, it hasn’t decided whether CHIP would be counted as one of the “public charge” eligible programs.

In the interim, people who had received public benefits before the rule took effect would not be penalized for doing so.
 

4. Already, though, the proposal is having effects

DHS estimates that 2.5% of eligible immigrants would drop out of public benefits programs because of this change – which would tally about $1.5 billion worth of federal money per year. But others expect a much larger impact.

“The chilling effects will be vastly greater than the individuals directly affected,” Greenberg said. “There’s considerable reason to believe that [the White House estimate] may be a significant understatement.”

In the proposed rule, DHS notes that the changes could result in “worse health outcomes,” “increased use of emergency rooms,” “increased prevalence of communicable diseases,” “increased rates of poverty,” and other concerns.

Given the complexity of these programs and the proposed rule – and the high stakes at play – low-income immigrants would be much more likely to avoid public benefits altogether, immigration experts said. Millions of immigrants are likely to be affected directly or indirectly, according to the Center for Law and Social Policy, a D.C.-based nonprofit organization.

That could have stark health implications.

Take free vaccines, for which children are often eligible and which would not be subject to the public charge rule. Families afraid of jeopardizing a green card could still be more likely to opt out of that service, Whitener said.

Already, she added, there are reports of people declining federal assistance – even though nothing has yet happened.

“The fear factor cannot be underestimated,” she said.
 

5. Will people sue?

Legal action is likely.

Officials such as California Attorney General Xavier Becerra, who has frequently clashed with the White House, are weighing challenges to the rule.

“The Trump Administration’s proposal punishes hard-working immigrant families – even targeting children who are citizens – for utilizing programs that provide basic nutrition and healthcare. This is an assault on our families and our communities,” Becerra said in a statement.

But these actions depend on the final shape of the regulation, which could change through the rule-making process.

“They are likely to receive a very large number of sharply critical comments, and there is no way to know what changes they might make as a result,” Greenberg said.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

A proposed rule from the White House would make it harder for legal immigrants to get green cards if they have received certain kinds of public assistance – including Medicaid, food stamps, and housing subsidies. Green cards allow them to live and work permanently in the United States.

“Those seeking to immigrate to the United States must show they can support themselves financially,” Homeland Security Secretary Kirstjen Nielsen said in a statement.

The proposal, announced Sept. 22, marks a new frontier in the administration’s long-term effort to curb immigration, both legal and illegal. It already has spurred intense criticism from Democrats, anti-poverty activists, health care organizations, and immigrants’ rights advocates, who call its restrictions unprecedented.

“We are operating in an overall climate of tremendous fear and anxiety as a result of the administration’s overall approach to immigration enforcement and immigration policy,” said Mark Greenberg, a senior fellow at the Migration Policy Institute, which studies migration and refugee policies at local, national, and international levels. He is also a former Obama administration official.

But what effect would this proposal have?

It’s a complicated question, touching upon vast government programs, with billions of dollars at stake. While the implications aren’t all immediately clear, Kaiser Health News breaks down some of the key elements.
 

1. First thing first: What is the White House proposing?

The Trump administration wants to redefine a status known as “public charge” – a category used to determine whether someone seeking permanent resident status is “likely to become primarily dependent on the government for subsistence.”

In the past, people have been at risk of being defined a “public charge” if they took cash welfare – known as Temporary Assistance for Needy Families, or Supplemental Security Income – or federal help paying for long-term care. (Immigrants must be in the country legally for 5 years before being eligible for TANF or SSI.)

And that “public charge” designation could undermine their applications for permanent residence.

The new rule would expand the list to include some health insurance, food, and housing programs. Specifically, it would penalize green-card applicants for using Medicaid, a federal-state health plan for low-income people. (Penalties would not apply for using Medicaid in certain emergencies or for some Medicaid services provided through schools and disability programs.)

Using food stamps, Section 8 rental assistance, and federal housing vouchers also would count against applicants. Enrollment in a Medicare Part D program subsidy to help low-income people buy prescription drugs would work against them, too.

The proposal “is definitely a dramatic change from how public charge works today,” said Kelly Whitener, an associate professor at Georgetown University’s Center for Children and Families who specializes in pediatric health benefits and managed-care systems.

A leaked version of the rule from March suggested officials then were also considering penalizing those who receive subsidies to buy health insurance on the Affordable Care Act marketplaces. But that idea was not in the proposal. The marketplace subsidies are aimed at people at a generally higher income bracket than the beneficiaries targeted in the Trump plan, Whitener noted.

“They’re really homing in on low-income immigrants,” she added.

Nielsen said the proposed rule is “intended to promote immigrant self-sufficiency and protect finite resources.”
 

2. Is this as unprecedented as critics say?

Yes.

Public charge is an old idea. In the 1990s, lawmakers expanded it to consider explicitly whether people had received cash-based welfare.

But including programs like Medicaid and food stamps, which are much wider in scope, is a significant change. It would more likely hit working people – the majority of people on Medicaid are themselves employed, and almost 80% live in families with at least one working member, according to data compiled by the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

Children who are American citizens but whose parents are immigrants could be more likely to suffer repercussions, said some experts. When parents opt out of public assistance for fear of their own legal status, their kids are less likely to be enrolled in programs such as the Children’s Health Insurance Program, or CHIP, for which they would qualify.

To be clear, receiving public aid wouldn’t necessarily stop people from getting a green card. But it would tilt the odds against them.

“Another piece is the enormous discretion the administration will have under its proposal in making judgments about who gets admitted to the country and who gets a green card,” said the Migration Policy Institute’s Greenberg.
 

3. When will the policy shift take effect?

This is an early step in the complex federal rule-making process. And a lot could still change.

Once the proposed rule appears in the Federal Register, a 60-day countdown starts, during which anyone can weigh in with comments.

A final rule likely wouldn’t take effect until 2019.

And DHS is still seeking input on some details. For instance, it hasn’t decided whether CHIP would be counted as one of the “public charge” eligible programs.

In the interim, people who had received public benefits before the rule took effect would not be penalized for doing so.
 

4. Already, though, the proposal is having effects

DHS estimates that 2.5% of eligible immigrants would drop out of public benefits programs because of this change – which would tally about $1.5 billion worth of federal money per year. But others expect a much larger impact.

“The chilling effects will be vastly greater than the individuals directly affected,” Greenberg said. “There’s considerable reason to believe that [the White House estimate] may be a significant understatement.”

In the proposed rule, DHS notes that the changes could result in “worse health outcomes,” “increased use of emergency rooms,” “increased prevalence of communicable diseases,” “increased rates of poverty,” and other concerns.

Given the complexity of these programs and the proposed rule – and the high stakes at play – low-income immigrants would be much more likely to avoid public benefits altogether, immigration experts said. Millions of immigrants are likely to be affected directly or indirectly, according to the Center for Law and Social Policy, a D.C.-based nonprofit organization.

That could have stark health implications.

Take free vaccines, for which children are often eligible and which would not be subject to the public charge rule. Families afraid of jeopardizing a green card could still be more likely to opt out of that service, Whitener said.

Already, she added, there are reports of people declining federal assistance – even though nothing has yet happened.

“The fear factor cannot be underestimated,” she said.
 

5. Will people sue?

Legal action is likely.

Officials such as California Attorney General Xavier Becerra, who has frequently clashed with the White House, are weighing challenges to the rule.

“The Trump Administration’s proposal punishes hard-working immigrant families – even targeting children who are citizens – for utilizing programs that provide basic nutrition and healthcare. This is an assault on our families and our communities,” Becerra said in a statement.

But these actions depend on the final shape of the regulation, which could change through the rule-making process.

“They are likely to receive a very large number of sharply critical comments, and there is no way to know what changes they might make as a result,” Greenberg said.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

A proposed rule from the White House would make it harder for legal immigrants to get green cards if they have received certain kinds of public assistance – including Medicaid, food stamps, and housing subsidies. Green cards allow them to live and work permanently in the United States.

“Those seeking to immigrate to the United States must show they can support themselves financially,” Homeland Security Secretary Kirstjen Nielsen said in a statement.

The proposal, announced Sept. 22, marks a new frontier in the administration’s long-term effort to curb immigration, both legal and illegal. It already has spurred intense criticism from Democrats, anti-poverty activists, health care organizations, and immigrants’ rights advocates, who call its restrictions unprecedented.

“We are operating in an overall climate of tremendous fear and anxiety as a result of the administration’s overall approach to immigration enforcement and immigration policy,” said Mark Greenberg, a senior fellow at the Migration Policy Institute, which studies migration and refugee policies at local, national, and international levels. He is also a former Obama administration official.

But what effect would this proposal have?

It’s a complicated question, touching upon vast government programs, with billions of dollars at stake. While the implications aren’t all immediately clear, Kaiser Health News breaks down some of the key elements.
 

1. First thing first: What is the White House proposing?

The Trump administration wants to redefine a status known as “public charge” – a category used to determine whether someone seeking permanent resident status is “likely to become primarily dependent on the government for subsistence.”

In the past, people have been at risk of being defined a “public charge” if they took cash welfare – known as Temporary Assistance for Needy Families, or Supplemental Security Income – or federal help paying for long-term care. (Immigrants must be in the country legally for 5 years before being eligible for TANF or SSI.)

And that “public charge” designation could undermine their applications for permanent residence.

The new rule would expand the list to include some health insurance, food, and housing programs. Specifically, it would penalize green-card applicants for using Medicaid, a federal-state health plan for low-income people. (Penalties would not apply for using Medicaid in certain emergencies or for some Medicaid services provided through schools and disability programs.)

Using food stamps, Section 8 rental assistance, and federal housing vouchers also would count against applicants. Enrollment in a Medicare Part D program subsidy to help low-income people buy prescription drugs would work against them, too.

The proposal “is definitely a dramatic change from how public charge works today,” said Kelly Whitener, an associate professor at Georgetown University’s Center for Children and Families who specializes in pediatric health benefits and managed-care systems.

A leaked version of the rule from March suggested officials then were also considering penalizing those who receive subsidies to buy health insurance on the Affordable Care Act marketplaces. But that idea was not in the proposal. The marketplace subsidies are aimed at people at a generally higher income bracket than the beneficiaries targeted in the Trump plan, Whitener noted.

“They’re really homing in on low-income immigrants,” she added.

Nielsen said the proposed rule is “intended to promote immigrant self-sufficiency and protect finite resources.”
 

2. Is this as unprecedented as critics say?

Yes.

Public charge is an old idea. In the 1990s, lawmakers expanded it to consider explicitly whether people had received cash-based welfare.

But including programs like Medicaid and food stamps, which are much wider in scope, is a significant change. It would more likely hit working people – the majority of people on Medicaid are themselves employed, and almost 80% live in families with at least one working member, according to data compiled by the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

Children who are American citizens but whose parents are immigrants could be more likely to suffer repercussions, said some experts. When parents opt out of public assistance for fear of their own legal status, their kids are less likely to be enrolled in programs such as the Children’s Health Insurance Program, or CHIP, for which they would qualify.

To be clear, receiving public aid wouldn’t necessarily stop people from getting a green card. But it would tilt the odds against them.

“Another piece is the enormous discretion the administration will have under its proposal in making judgments about who gets admitted to the country and who gets a green card,” said the Migration Policy Institute’s Greenberg.
 

3. When will the policy shift take effect?

This is an early step in the complex federal rule-making process. And a lot could still change.

Once the proposed rule appears in the Federal Register, a 60-day countdown starts, during which anyone can weigh in with comments.

A final rule likely wouldn’t take effect until 2019.

And DHS is still seeking input on some details. For instance, it hasn’t decided whether CHIP would be counted as one of the “public charge” eligible programs.

In the interim, people who had received public benefits before the rule took effect would not be penalized for doing so.
 

4. Already, though, the proposal is having effects

DHS estimates that 2.5% of eligible immigrants would drop out of public benefits programs because of this change – which would tally about $1.5 billion worth of federal money per year. But others expect a much larger impact.

“The chilling effects will be vastly greater than the individuals directly affected,” Greenberg said. “There’s considerable reason to believe that [the White House estimate] may be a significant understatement.”

In the proposed rule, DHS notes that the changes could result in “worse health outcomes,” “increased use of emergency rooms,” “increased prevalence of communicable diseases,” “increased rates of poverty,” and other concerns.

Given the complexity of these programs and the proposed rule – and the high stakes at play – low-income immigrants would be much more likely to avoid public benefits altogether, immigration experts said. Millions of immigrants are likely to be affected directly or indirectly, according to the Center for Law and Social Policy, a D.C.-based nonprofit organization.

That could have stark health implications.

Take free vaccines, for which children are often eligible and which would not be subject to the public charge rule. Families afraid of jeopardizing a green card could still be more likely to opt out of that service, Whitener said.

Already, she added, there are reports of people declining federal assistance – even though nothing has yet happened.

“The fear factor cannot be underestimated,” she said.
 

5. Will people sue?

Legal action is likely.

Officials such as California Attorney General Xavier Becerra, who has frequently clashed with the White House, are weighing challenges to the rule.

“The Trump Administration’s proposal punishes hard-working immigrant families – even targeting children who are citizens – for utilizing programs that provide basic nutrition and healthcare. This is an assault on our families and our communities,” Becerra said in a statement.

But these actions depend on the final shape of the regulation, which could change through the rule-making process.

“They are likely to receive a very large number of sharply critical comments, and there is no way to know what changes they might make as a result,” Greenberg said.
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation.

Longer-term outcomes of treating uncomplicated acute appendicitis with antibiotics suggest it is a feasible alternative to appendectomy.

copyright decade3d/Thinkstock

Researchers have presented the 5-year follow-up data from the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotic therapy in 530 patients.

They found that 39.1% (100) of the 257 patients randomized to antibiotic therapy – 3 days of intravenous ertapenem followed by 7 days of oral levofloxacin and metronidazole – experienced a recurrence of appendicitis within 5 years and subsequently had surgery.

However the authors noted that seven of these patients were later found not to have appendicitis, so the true success rate for antibiotic treatment was actually 63.7%.

Seventy of the patients who experienced a recurrence underwent surgery in the first year after randomization, 17 in the second year, 3 in the third year, 5 in the fourth year, and the remaining 5 patients in the fifth year, the authors wrote in an article published in JAMA.

However the overall complication rate was similar in patients who were randomized to undergo appendectomy and in those who were initially randomized to the antibiotic group but later experienced a recurrence and underwent surgery.

“No patient initially treated with antibiotics, who ultimately developed recurrent appendicitis, had any complications related to the delay in surgery,” wrote Paulina Salminen, MD, from Turku (Finland) University Hospital and coauthors. “Nearly two-thirds of all patients who initially presented with uncomplicated appendicitis were successfully treated with antibiotics alone, and those who ultimately developed recurrent disease did not experience any adverse outcomes related to the delay in appendectomy.”

Of the 100 patients randomized to antibiotics who underwent appendectomy after a recurrence, 15 were operated on when they were first hospitalized at study admission.

The authors commented that the study design allowed for surgeons to exercise their clinical judgment in choosing when to perform an appendectomy on patients in the antibiotic group, because antibiotics alone was not considered acceptable treatment for appendicitis.

“This led to some patients undergoing appendectomy who did not have appendicitis or who might have been successfully treated with antibiotics or an another course of antibiotics,” they wrote. “Future studies should investigate protocols for further imaging or antibiotic treatment for patients who develop recurrent appendicitis after they were initially treated with antibiotics.”

In the recurrence group, the majority were found to have uncomplicated appendicitis, but complicated appendicitis was seen in two patients between 2 and 5 years after the index admission.

There was a significant 17.9% higher complication rate in the appendectomy group, compared with the antibiotic group – 24.4% versus 6.5% – at 5 years and two patients in the appendectomy group had severe complications requiring reoperation.

They suggested that the higher complication rate with surgery, which was mostly attributable to infections, could be reduced by the use of laparoscopic appendectomy, which is also associated with faster recovery.

The median length of hospital stay was 3 days for both the appendectomy group and the antibiotics-only group, but patients randomized to appendectomy took a median of 22 days of sick leave, compared with 11 days for those randomized to antibiotics (P less than .001).

In the absence of standard protocol on treating appendicitis with antibiotics, the authors noted that they took a conservative approach, using broad-spectrum antibiotics and keeping patients in hospital for 3 days for observation.

“The success of antibiotic treatment for appendicitis calls into question prior beliefs that appendicitis inevitably results in serious intra-abdominal infection if appendectomy is not performed.”

The study was supported by the Mary and Georg C. Ehrnrooth Foundation, the EVO Foundation, and Turku University. One author declared lecture fees from three pharmaceutical companies but no other conflicts of interest were declared.

SOURCE: Salminen P et al. JAMA 2018;320:1259-65. doi: 10.1001/jama.2018.13201.

Longer-term outcomes of treating uncomplicated acute appendicitis with antibiotics suggest it is a feasible alternative to appendectomy.

copyright decade3d/Thinkstock

Researchers have presented the 5-year follow-up data from the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotic therapy in 530 patients.

They found that 39.1% (100) of the 257 patients randomized to antibiotic therapy – 3 days of intravenous ertapenem followed by 7 days of oral levofloxacin and metronidazole – experienced a recurrence of appendicitis within 5 years and subsequently had surgery.

However the authors noted that seven of these patients were later found not to have appendicitis, so the true success rate for antibiotic treatment was actually 63.7%.

Seventy of the patients who experienced a recurrence underwent surgery in the first year after randomization, 17 in the second year, 3 in the third year, 5 in the fourth year, and the remaining 5 patients in the fifth year, the authors wrote in an article published in JAMA.

However the overall complication rate was similar in patients who were randomized to undergo appendectomy and in those who were initially randomized to the antibiotic group but later experienced a recurrence and underwent surgery.

“No patient initially treated with antibiotics, who ultimately developed recurrent appendicitis, had any complications related to the delay in surgery,” wrote Paulina Salminen, MD, from Turku (Finland) University Hospital and coauthors. “Nearly two-thirds of all patients who initially presented with uncomplicated appendicitis were successfully treated with antibiotics alone, and those who ultimately developed recurrent disease did not experience any adverse outcomes related to the delay in appendectomy.”

Of the 100 patients randomized to antibiotics who underwent appendectomy after a recurrence, 15 were operated on when they were first hospitalized at study admission.

The authors commented that the study design allowed for surgeons to exercise their clinical judgment in choosing when to perform an appendectomy on patients in the antibiotic group, because antibiotics alone was not considered acceptable treatment for appendicitis.

“This led to some patients undergoing appendectomy who did not have appendicitis or who might have been successfully treated with antibiotics or an another course of antibiotics,” they wrote. “Future studies should investigate protocols for further imaging or antibiotic treatment for patients who develop recurrent appendicitis after they were initially treated with antibiotics.”

In the recurrence group, the majority were found to have uncomplicated appendicitis, but complicated appendicitis was seen in two patients between 2 and 5 years after the index admission.

There was a significant 17.9% higher complication rate in the appendectomy group, compared with the antibiotic group – 24.4% versus 6.5% – at 5 years and two patients in the appendectomy group had severe complications requiring reoperation.

They suggested that the higher complication rate with surgery, which was mostly attributable to infections, could be reduced by the use of laparoscopic appendectomy, which is also associated with faster recovery.

The median length of hospital stay was 3 days for both the appendectomy group and the antibiotics-only group, but patients randomized to appendectomy took a median of 22 days of sick leave, compared with 11 days for those randomized to antibiotics (P less than .001).

In the absence of standard protocol on treating appendicitis with antibiotics, the authors noted that they took a conservative approach, using broad-spectrum antibiotics and keeping patients in hospital for 3 days for observation.

“The success of antibiotic treatment for appendicitis calls into question prior beliefs that appendicitis inevitably results in serious intra-abdominal infection if appendectomy is not performed.”

The study was supported by the Mary and Georg C. Ehrnrooth Foundation, the EVO Foundation, and Turku University. One author declared lecture fees from three pharmaceutical companies but no other conflicts of interest were declared.

SOURCE: Salminen P et al. JAMA 2018;320:1259-65. doi: 10.1001/jama.2018.13201.

Longer-term outcomes of treating uncomplicated acute appendicitis with antibiotics suggest it is a feasible alternative to appendectomy.

copyright decade3d/Thinkstock

Researchers have presented the 5-year follow-up data from the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotic therapy in 530 patients.

They found that 39.1% (100) of the 257 patients randomized to antibiotic therapy – 3 days of intravenous ertapenem followed by 7 days of oral levofloxacin and metronidazole – experienced a recurrence of appendicitis within 5 years and subsequently had surgery.

However the authors noted that seven of these patients were later found not to have appendicitis, so the true success rate for antibiotic treatment was actually 63.7%.

Seventy of the patients who experienced a recurrence underwent surgery in the first year after randomization, 17 in the second year, 3 in the third year, 5 in the fourth year, and the remaining 5 patients in the fifth year, the authors wrote in an article published in JAMA.

However the overall complication rate was similar in patients who were randomized to undergo appendectomy and in those who were initially randomized to the antibiotic group but later experienced a recurrence and underwent surgery.

“No patient initially treated with antibiotics, who ultimately developed recurrent appendicitis, had any complications related to the delay in surgery,” wrote Paulina Salminen, MD, from Turku (Finland) University Hospital and coauthors. “Nearly two-thirds of all patients who initially presented with uncomplicated appendicitis were successfully treated with antibiotics alone, and those who ultimately developed recurrent disease did not experience any adverse outcomes related to the delay in appendectomy.”

Of the 100 patients randomized to antibiotics who underwent appendectomy after a recurrence, 15 were operated on when they were first hospitalized at study admission.

The authors commented that the study design allowed for surgeons to exercise their clinical judgment in choosing when to perform an appendectomy on patients in the antibiotic group, because antibiotics alone was not considered acceptable treatment for appendicitis.

“This led to some patients undergoing appendectomy who did not have appendicitis or who might have been successfully treated with antibiotics or an another course of antibiotics,” they wrote. “Future studies should investigate protocols for further imaging or antibiotic treatment for patients who develop recurrent appendicitis after they were initially treated with antibiotics.”

In the recurrence group, the majority were found to have uncomplicated appendicitis, but complicated appendicitis was seen in two patients between 2 and 5 years after the index admission.

There was a significant 17.9% higher complication rate in the appendectomy group, compared with the antibiotic group – 24.4% versus 6.5% – at 5 years and two patients in the appendectomy group had severe complications requiring reoperation.

They suggested that the higher complication rate with surgery, which was mostly attributable to infections, could be reduced by the use of laparoscopic appendectomy, which is also associated with faster recovery.

The median length of hospital stay was 3 days for both the appendectomy group and the antibiotics-only group, but patients randomized to appendectomy took a median of 22 days of sick leave, compared with 11 days for those randomized to antibiotics (P less than .001).

In the absence of standard protocol on treating appendicitis with antibiotics, the authors noted that they took a conservative approach, using broad-spectrum antibiotics and keeping patients in hospital for 3 days for observation.

“The success of antibiotic treatment for appendicitis calls into question prior beliefs that appendicitis inevitably results in serious intra-abdominal infection if appendectomy is not performed.”

The study was supported by the Mary and Georg C. Ehrnrooth Foundation, the EVO Foundation, and Turku University. One author declared lecture fees from three pharmaceutical companies but no other conflicts of interest were declared.

SOURCE: Salminen P et al. JAMA 2018;320:1259-65. doi: 10.1001/jama.2018.13201.

LAS VEGAS – Up to 22% of opioid abusers also abuse gabapentin, taking high doses of the antiepileptic for its psychoactive effects, or to potentiate the effect of opioids.

ah_designs/Getty Images

The drug – the 10th most commonly prescribed in the United States – is increasingly implicated in overdose deaths. In response, several states have recently reclassified the antiepileptic as a Schedule V controlled substance. Other states have declined to go that far, but have added gabapentin (Neurontin and others) to the drugs that must be reported to state prescription monitoring programs.

“Gabapentin and pregabalin [Lyrica] are versatile and important drugs that are widely prescribed and used off label for a number of conditions from seizure disorder to fibromyalgia,” said Joseph Pergolizzi Jr., MD, who discussed the issue during the annual PAINWeek. “Abuse patterns differ somewhat from abuse patterns with prescription opioids. People who misuse gabapentinoids tend to already use other drugs inappropriately. It’s rare to find a person who only takes them recreationally, but it is increasingly common to find polydrug abusers who take gabapentinoids.”

Gabapentin abuse appears to be more common in Europe than in the United States, where it’s just beginning to emerge, Dr. Pergolizzi said. And the picture is more nuanced than it might first appear: Many of those who are misusing the drug are using it as a “do-it-yourself” opioid withdrawal aid, he said in an interview.

At the meeting, he presented a literature review comprising 46 papers on pregabalin abuse and 263 on gabapentin abuse. Several important themes arose from these papers, said Dr. Pergolizzi, cofounder and chief operating officer of NEMA Research Inc., Naples, Fla.:

• Gabapentin and pregabalin are being prescribed off label for numerous conditions, including bipolar disorder, neuropathic pain, diabetic neuropathy, complex regional pain syndrome, attention deficit disorder, restless leg syndrome, trigeminal neuralgia, periodic limb movement disorder of sleep, migraine, drug and alcohol withdrawal seizures, chronic low back pain, and even menopausal symptoms.
• About a one-third of users experience withdrawal symptoms with sudden discontinuation. Symptoms include disorientation, anxiety, insomnia, heart palpitations, diaphoresis, and abdominal cramps.
• Risk factors for abuse are emerging. These include opioid use disorders, mental illnesses, and a history of taking supratherapeutic doses of the drugs. Age and sex don’t seem to be a consistent risk factor for abuse.
• Abusers can obtain nonprescription gabapentinoids more easily each year, including street sales and online orders, Dr. Pergolizzi said. “A Google search conducted in July for ‘buy gabapentin without a prescription’ yielded 4.48 million results and ‘buy pregabalin without a prescription,’ 622,000. A similar search conducted in September 2017 yielded 1.19 million and 352,000 results, respectively.”
• Few urine drug assays screen for gabapentinoids, which makes them easy to conceal in random drug testing.

Reports of gabapentin-involved drug overdoses and even deaths have recently emerged in the United States, particularly in the opioid abuse-plagued Appalachian states. An article in May in Drug and Alcohol Dependence examined the prevalence of gabapentin in postmortem toxicology in drug overdose deaths in four Appalachian states in 2015 (Drug Alcohol Depend. 2018;186:80-5). Rates were 4% in eastern Tennessee, 15% in West Virginia, 20% in North Carolina, and 41% in Kentucky.

Three states have now added gabapentin to their list of Schedule V controlled substances: Kentucky in 2017, West Virginia this May, and Tennessee in July.

Ohio, Minnesota, Virginia, and Massachusetts have taken a different tack to controlling dispensing. In those states, all pharmacies, prescribers, and wholesalers must report all dispensing and sales of gabapentin to their prescription monitoring databases.

Dr. Pergolizzi disclosed financial relationships with numerous pharmaceutical companies.

msullivan@mdedge.com

SOURCE: Pergolizzi J et al. PAINWeek 2018, Poster 55.

LAS VEGAS – Up to 22% of opioid abusers also abuse gabapentin, taking high doses of the antiepileptic for its psychoactive effects, or to potentiate the effect of opioids.

ah_designs/Getty Images

The drug – the 10th most commonly prescribed in the United States – is increasingly implicated in overdose deaths. In response, several states have recently reclassified the antiepileptic as a Schedule V controlled substance. Other states have declined to go that far, but have added gabapentin (Neurontin and others) to the drugs that must be reported to state prescription monitoring programs.

“Gabapentin and pregabalin [Lyrica] are versatile and important drugs that are widely prescribed and used off label for a number of conditions from seizure disorder to fibromyalgia,” said Joseph Pergolizzi Jr., MD, who discussed the issue during the annual PAINWeek. “Abuse patterns differ somewhat from abuse patterns with prescription opioids. People who misuse gabapentinoids tend to already use other drugs inappropriately. It’s rare to find a person who only takes them recreationally, but it is increasingly common to find polydrug abusers who take gabapentinoids.”

Gabapentin abuse appears to be more common in Europe than in the United States, where it’s just beginning to emerge, Dr. Pergolizzi said. And the picture is more nuanced than it might first appear: Many of those who are misusing the drug are using it as a “do-it-yourself” opioid withdrawal aid, he said in an interview.

At the meeting, he presented a literature review comprising 46 papers on pregabalin abuse and 263 on gabapentin abuse. Several important themes arose from these papers, said Dr. Pergolizzi, cofounder and chief operating officer of NEMA Research Inc., Naples, Fla.:

• Gabapentin and pregabalin are being prescribed off label for numerous conditions, including bipolar disorder, neuropathic pain, diabetic neuropathy, complex regional pain syndrome, attention deficit disorder, restless leg syndrome, trigeminal neuralgia, periodic limb movement disorder of sleep, migraine, drug and alcohol withdrawal seizures, chronic low back pain, and even menopausal symptoms.
• About a one-third of users experience withdrawal symptoms with sudden discontinuation. Symptoms include disorientation, anxiety, insomnia, heart palpitations, diaphoresis, and abdominal cramps.
• Risk factors for abuse are emerging. These include opioid use disorders, mental illnesses, and a history of taking supratherapeutic doses of the drugs. Age and sex don’t seem to be a consistent risk factor for abuse.
• Abusers can obtain nonprescription gabapentinoids more easily each year, including street sales and online orders, Dr. Pergolizzi said. “A Google search conducted in July for ‘buy gabapentin without a prescription’ yielded 4.48 million results and ‘buy pregabalin without a prescription,’ 622,000. A similar search conducted in September 2017 yielded 1.19 million and 352,000 results, respectively.”
• Few urine drug assays screen for gabapentinoids, which makes them easy to conceal in random drug testing.

Reports of gabapentin-involved drug overdoses and even deaths have recently emerged in the United States, particularly in the opioid abuse-plagued Appalachian states. An article in May in Drug and Alcohol Dependence examined the prevalence of gabapentin in postmortem toxicology in drug overdose deaths in four Appalachian states in 2015 (Drug Alcohol Depend. 2018;186:80-5). Rates were 4% in eastern Tennessee, 15% in West Virginia, 20% in North Carolina, and 41% in Kentucky.

Three states have now added gabapentin to their list of Schedule V controlled substances: Kentucky in 2017, West Virginia this May, and Tennessee in July.

Ohio, Minnesota, Virginia, and Massachusetts have taken a different tack to controlling dispensing. In those states, all pharmacies, prescribers, and wholesalers must report all dispensing and sales of gabapentin to their prescription monitoring databases.

Dr. Pergolizzi disclosed financial relationships with numerous pharmaceutical companies.

msullivan@mdedge.com

SOURCE: Pergolizzi J et al. PAINWeek 2018, Poster 55.

LAS VEGAS – Up to 22% of opioid abusers also abuse gabapentin, taking high doses of the antiepileptic for its psychoactive effects, or to potentiate the effect of opioids.

ah_designs/Getty Images

The drug – the 10th most commonly prescribed in the United States – is increasingly implicated in overdose deaths. In response, several states have recently reclassified the antiepileptic as a Schedule V controlled substance. Other states have declined to go that far, but have added gabapentin (Neurontin and others) to the drugs that must be reported to state prescription monitoring programs.

“Gabapentin and pregabalin [Lyrica] are versatile and important drugs that are widely prescribed and used off label for a number of conditions from seizure disorder to fibromyalgia,” said Joseph Pergolizzi Jr., MD, who discussed the issue during the annual PAINWeek. “Abuse patterns differ somewhat from abuse patterns with prescription opioids. People who misuse gabapentinoids tend to already use other drugs inappropriately. It’s rare to find a person who only takes them recreationally, but it is increasingly common to find polydrug abusers who take gabapentinoids.”

Gabapentin abuse appears to be more common in Europe than in the United States, where it’s just beginning to emerge, Dr. Pergolizzi said. And the picture is more nuanced than it might first appear: Many of those who are misusing the drug are using it as a “do-it-yourself” opioid withdrawal aid, he said in an interview.

At the meeting, he presented a literature review comprising 46 papers on pregabalin abuse and 263 on gabapentin abuse. Several important themes arose from these papers, said Dr. Pergolizzi, cofounder and chief operating officer of NEMA Research Inc., Naples, Fla.:

• Gabapentin and pregabalin are being prescribed off label for numerous conditions, including bipolar disorder, neuropathic pain, diabetic neuropathy, complex regional pain syndrome, attention deficit disorder, restless leg syndrome, trigeminal neuralgia, periodic limb movement disorder of sleep, migraine, drug and alcohol withdrawal seizures, chronic low back pain, and even menopausal symptoms.
• About a one-third of users experience withdrawal symptoms with sudden discontinuation. Symptoms include disorientation, anxiety, insomnia, heart palpitations, diaphoresis, and abdominal cramps.
• Risk factors for abuse are emerging. These include opioid use disorders, mental illnesses, and a history of taking supratherapeutic doses of the drugs. Age and sex don’t seem to be a consistent risk factor for abuse.
• Abusers can obtain nonprescription gabapentinoids more easily each year, including street sales and online orders, Dr. Pergolizzi said. “A Google search conducted in July for ‘buy gabapentin without a prescription’ yielded 4.48 million results and ‘buy pregabalin without a prescription,’ 622,000. A similar search conducted in September 2017 yielded 1.19 million and 352,000 results, respectively.”
• Few urine drug assays screen for gabapentinoids, which makes them easy to conceal in random drug testing.

Reports of gabapentin-involved drug overdoses and even deaths have recently emerged in the United States, particularly in the opioid abuse-plagued Appalachian states. An article in May in Drug and Alcohol Dependence examined the prevalence of gabapentin in postmortem toxicology in drug overdose deaths in four Appalachian states in 2015 (Drug Alcohol Depend. 2018;186:80-5). Rates were 4% in eastern Tennessee, 15% in West Virginia, 20% in North Carolina, and 41% in Kentucky.

Three states have now added gabapentin to their list of Schedule V controlled substances: Kentucky in 2017, West Virginia this May, and Tennessee in July.

Ohio, Minnesota, Virginia, and Massachusetts have taken a different tack to controlling dispensing. In those states, all pharmacies, prescribers, and wholesalers must report all dispensing and sales of gabapentin to their prescription monitoring databases.

Dr. Pergolizzi disclosed financial relationships with numerous pharmaceutical companies.

msullivan@mdedge.com

SOURCE: Pergolizzi J et al. PAINWeek 2018, Poster 55.

This article was produced in collaboration with the Houston Chronicle.

The Trump administration on Sept. 17 proposed eliminating a decade-old regulation that puts hospitals at risk of losing their Medicare funding if too many of their patients die or suffer organ failure after receiving transplants.

The rule the government is proposing to scrap is the same one that led the Centers for Medicare & Medicaid Services to cut off funding in August for heart transplants at Baylor St. Luke’s Medical Center in Houston after an investigation by ProPublica and the Houston Chronicle revealed an outsized number of patient deaths and complications in recent years.

The proposal was unveiled Sept. 17 as part of the White House’s push to “cut the red tape” and do away with “burdensome regulation” that officials said put paperwork ahead of patients. In a speech announcing the proposed changes, CMS Administrator Seema Verma said the agency’s existing policies have “put lives in danger.”

“We are proposing to remove those inefficiencies to reduce the amount of time patients have to wait, so that they can begin healing,” Ms. Verma said.

The proposal, now subject to public comment and revision before it is finalized, surprised many transplant physicians who have long called for relaxed federal oversight. They’ve argued that the rules requiring that hospitals meet certain survival thresholds for transplants discourage them from taking on risky patients or accepting less-than-perfect organs, lengthening the time patients spend on the waiting list.

Some experts, however, said the proposal would not help patients because it would weaken the government’s authority to hold transplant programs accountable if they fail to provide safe patient care. The regulation was put in place in 2007 after a series of scandals at transplant programs revealed lax federal oversight. Several transplant programs had compiled abysmal patient survival statistics for years while continuing to receive Medicare funding.

Even though it has the authority to do so, Medicare rarely terminates programs for poor outcomes. It is far more common for the government to force underperforming programs into systems-improvement agreements, in which hospitals agree to make certain changes and be subject to stepped-up oversight.

Medicare bypassed that process and cut off funding for heart transplants at St. Luke’s in August after the hospital’s 1-year patient survival rate fell below national norms from 2014 to mid-2016. A few St. Luke’s cardiologists grew so concerned that they started sending some of their patients to other hospitals for transplants.

St. Luke’s has appealed its Medicare termination, saying, “we do not believe CMS’ recent decisions reflect our ongoing progress and accomplishments to improve the quality of our care.” A spokeswoman said officials are still reviewing the Medicare proposal and declined to comment.

In a statement to reporters Sept. 21, CMS said it would continue to monitoring transplant programs and is strengthening its process for inspecting transplant programs to ensure they provide safe, quality care.

“CMS will continue to collect the data on each transplant program’s performance with regards to patient and graft survival,” the agency said in the statement. “These data, rather than being a stand-alone measure, will be used as a component of the survey process to further inform and direct the survey.”

If the proposed regulatory change had been in place previously, it’s not clear whether St. Luke’s would have faced punitive action from Medicare.

“I am probably in the minority in the transplant community, but I think, based on what is proposed, this is a bad idea,” said Laura J. Aguiar, an Arizona-based transplant consultant who has spent years helping programs improve their outcomes to stave off Medicare penalties. “I have been around long enough to remember that there were very valid reasons why CMS, in the George W. Bush administration, took the steps they took in implementing all of this.”

Since the rules were put in place 11 years ago, the percentage of patients who survive at least 1 year after receiving heart, kidney, lung, and other organ transplants has increased nationally. But some experts say those gains have come at a cost.

Jesse D. Schold, PhD, a researcher in quantitative health sciences at the Cleveland Clinic, has spent years chronicling what he calls the “unintended consequences” of holding transplant programs accountable for poor outcomes. Even though CMS relies on data that has been adjusted to ensure that programs aren’t punished for treating sicker patients or accepting riskier donor organs, Dr. Schold said the rules have created a perception that programs need to turn away some ailing patients and reject less-than-ideal organs in order to meet outcome targets.

As a result, Dr. Schold said, some potentially viable donor organs are discarded while thousands of patients die on waiting lists each year. Dr. Schold said he was surprised to learn a study he coauthored was among the research cited by CMS as justification for the policy change, which he said would be a “significant net positive” for patients.

“I don’t want anything to in any way imply that I’m a fan of the current administration,” Dr. Schold said, referencing the Trump administration’s aggressive and often controversial efforts to slash regulations. “However, in this case, I think it is something that is beneficial.”

Joel Adler, MD, a liver surgeon at the University of Wisconsin–Madison, whose research also was cited by CMS, said a major weakness of the current regulation is that it focuses only on the survival of patients fortunate enough to have received a transplant. Medicare, he said, does not take into account the percentage of patients who die awaiting a transplant. That can discourage programs from accepting organs for patients who might be less likely to survive afterward.

Despite identifying problems with the current rules, Dr. Adler and his coauthor did not propose eliminating Medicare’s standards, but they instead suggested ways to improve outcome measures and create incentives for programs to perform more, not fewer, transplants.

“Should we get rid of (the regulation) entirely?” Dr. Adler asked. “I don’t know. I suspect we’ll swing back to somewhere in the middle, because there has to be some mechanism of capturing things when they are really, really bad. That has to exist.”

Medicare isn’t the only organization that oversees transplant centers. The United Network for Organ Sharing, a federal contractor that operates the national waiting list for organs, can put programs on probation or even revoke their good standing for continued poor results, though it rarely takes such actions. Similarly, another federal contractor, the Scientific Registry of Transplant Recipients, analyzes transplant outcomes and publicly reports which centers have mortality rates that are higher than expected based on the characteristics of their patients.

Even if the proposal is approved, it would not mean CMS would stop regulating transplant programs. Last year, for example, CMS cut off funding to the Medical University Hospital in Charleston, South Carolina, after the program failed to perform the minimum number of heart transplants required by CMS to maintain certification. That provision, also added during the reforms of 2007, would not be affected by the changes proposed Sept. 17.

The Charleston hospital, South Carolina’s only heart transplant program, made necessary changes and regained Medicare certification this year.

Alexander Aussi, a San Antonio–based consultant who specializes in helping transplant programs satisfy regulatory requirements, said he understands the desire to reduce the number of rules and regulations that transplant centers must follow. But he said he fears that the CMS proposal would return the transplant field to an earlier era when “some programs were cowboyish about their outcomes.”

“I cannot tell you in good conscience that if you remove those guidelines and metrics … that you’re going to have better outcomes,” Mr. Aussi said. “On the contrary, I believe you’re going to have a lot of transplant programs reversing course.”

Ms. Aguiar, the Arizona-based consultant, shares those concerns. Even without strict CMS oversight, she said, many transplant programs will continue providing high-quality care; but some won’t.

“There will be others that will take the removal of these requirements as a blessing to go back to the bad old days,” she said, “and it is patients who will end up paying the price for it.”
 

Mike Hixenbaugh is an investigative reporter at the Houston Chronicle. Email him at mike.hixenbaugh@chron.com and follow him on Twitter at @Mike_Hixenbaugh. Charles Ornstein is a senior editor at ProPublica, overseeing the Local Reporting Network. Follow him on Twitter at @charlesornstein.

This article was produced in collaboration with the Houston Chronicle.

The Trump administration on Sept. 17 proposed eliminating a decade-old regulation that puts hospitals at risk of losing their Medicare funding if too many of their patients die or suffer organ failure after receiving transplants.

The rule the government is proposing to scrap is the same one that led the Centers for Medicare & Medicaid Services to cut off funding in August for heart transplants at Baylor St. Luke’s Medical Center in Houston after an investigation by ProPublica and the Houston Chronicle revealed an outsized number of patient deaths and complications in recent years.

The proposal was unveiled Sept. 17 as part of the White House’s push to “cut the red tape” and do away with “burdensome regulation” that officials said put paperwork ahead of patients. In a speech announcing the proposed changes, CMS Administrator Seema Verma said the agency’s existing policies have “put lives in danger.”

“We are proposing to remove those inefficiencies to reduce the amount of time patients have to wait, so that they can begin healing,” Ms. Verma said.

The proposal, now subject to public comment and revision before it is finalized, surprised many transplant physicians who have long called for relaxed federal oversight. They’ve argued that the rules requiring that hospitals meet certain survival thresholds for transplants discourage them from taking on risky patients or accepting less-than-perfect organs, lengthening the time patients spend on the waiting list.

Some experts, however, said the proposal would not help patients because it would weaken the government’s authority to hold transplant programs accountable if they fail to provide safe patient care. The regulation was put in place in 2007 after a series of scandals at transplant programs revealed lax federal oversight. Several transplant programs had compiled abysmal patient survival statistics for years while continuing to receive Medicare funding.

Even though it has the authority to do so, Medicare rarely terminates programs for poor outcomes. It is far more common for the government to force underperforming programs into systems-improvement agreements, in which hospitals agree to make certain changes and be subject to stepped-up oversight.

Medicare bypassed that process and cut off funding for heart transplants at St. Luke’s in August after the hospital’s 1-year patient survival rate fell below national norms from 2014 to mid-2016. A few St. Luke’s cardiologists grew so concerned that they started sending some of their patients to other hospitals for transplants.

St. Luke’s has appealed its Medicare termination, saying, “we do not believe CMS’ recent decisions reflect our ongoing progress and accomplishments to improve the quality of our care.” A spokeswoman said officials are still reviewing the Medicare proposal and declined to comment.

In a statement to reporters Sept. 21, CMS said it would continue to monitoring transplant programs and is strengthening its process for inspecting transplant programs to ensure they provide safe, quality care.

“CMS will continue to collect the data on each transplant program’s performance with regards to patient and graft survival,” the agency said in the statement. “These data, rather than being a stand-alone measure, will be used as a component of the survey process to further inform and direct the survey.”

If the proposed regulatory change had been in place previously, it’s not clear whether St. Luke’s would have faced punitive action from Medicare.

“I am probably in the minority in the transplant community, but I think, based on what is proposed, this is a bad idea,” said Laura J. Aguiar, an Arizona-based transplant consultant who has spent years helping programs improve their outcomes to stave off Medicare penalties. “I have been around long enough to remember that there were very valid reasons why CMS, in the George W. Bush administration, took the steps they took in implementing all of this.”

Since the rules were put in place 11 years ago, the percentage of patients who survive at least 1 year after receiving heart, kidney, lung, and other organ transplants has increased nationally. But some experts say those gains have come at a cost.

Jesse D. Schold, PhD, a researcher in quantitative health sciences at the Cleveland Clinic, has spent years chronicling what he calls the “unintended consequences” of holding transplant programs accountable for poor outcomes. Even though CMS relies on data that has been adjusted to ensure that programs aren’t punished for treating sicker patients or accepting riskier donor organs, Dr. Schold said the rules have created a perception that programs need to turn away some ailing patients and reject less-than-ideal organs in order to meet outcome targets.

As a result, Dr. Schold said, some potentially viable donor organs are discarded while thousands of patients die on waiting lists each year. Dr. Schold said he was surprised to learn a study he coauthored was among the research cited by CMS as justification for the policy change, which he said would be a “significant net positive” for patients.

“I don’t want anything to in any way imply that I’m a fan of the current administration,” Dr. Schold said, referencing the Trump administration’s aggressive and often controversial efforts to slash regulations. “However, in this case, I think it is something that is beneficial.”

Joel Adler, MD, a liver surgeon at the University of Wisconsin–Madison, whose research also was cited by CMS, said a major weakness of the current regulation is that it focuses only on the survival of patients fortunate enough to have received a transplant. Medicare, he said, does not take into account the percentage of patients who die awaiting a transplant. That can discourage programs from accepting organs for patients who might be less likely to survive afterward.

Despite identifying problems with the current rules, Dr. Adler and his coauthor did not propose eliminating Medicare’s standards, but they instead suggested ways to improve outcome measures and create incentives for programs to perform more, not fewer, transplants.

“Should we get rid of (the regulation) entirely?” Dr. Adler asked. “I don’t know. I suspect we’ll swing back to somewhere in the middle, because there has to be some mechanism of capturing things when they are really, really bad. That has to exist.”

Medicare isn’t the only organization that oversees transplant centers. The United Network for Organ Sharing, a federal contractor that operates the national waiting list for organs, can put programs on probation or even revoke their good standing for continued poor results, though it rarely takes such actions. Similarly, another federal contractor, the Scientific Registry of Transplant Recipients, analyzes transplant outcomes and publicly reports which centers have mortality rates that are higher than expected based on the characteristics of their patients.

Even if the proposal is approved, it would not mean CMS would stop regulating transplant programs. Last year, for example, CMS cut off funding to the Medical University Hospital in Charleston, South Carolina, after the program failed to perform the minimum number of heart transplants required by CMS to maintain certification. That provision, also added during the reforms of 2007, would not be affected by the changes proposed Sept. 17.

The Charleston hospital, South Carolina’s only heart transplant program, made necessary changes and regained Medicare certification this year.

Alexander Aussi, a San Antonio–based consultant who specializes in helping transplant programs satisfy regulatory requirements, said he understands the desire to reduce the number of rules and regulations that transplant centers must follow. But he said he fears that the CMS proposal would return the transplant field to an earlier era when “some programs were cowboyish about their outcomes.”

“I cannot tell you in good conscience that if you remove those guidelines and metrics … that you’re going to have better outcomes,” Mr. Aussi said. “On the contrary, I believe you’re going to have a lot of transplant programs reversing course.”

Ms. Aguiar, the Arizona-based consultant, shares those concerns. Even without strict CMS oversight, she said, many transplant programs will continue providing high-quality care; but some won’t.

“There will be others that will take the removal of these requirements as a blessing to go back to the bad old days,” she said, “and it is patients who will end up paying the price for it.”
 

Mike Hixenbaugh is an investigative reporter at the Houston Chronicle. Email him at mike.hixenbaugh@chron.com and follow him on Twitter at @Mike_Hixenbaugh. Charles Ornstein is a senior editor at ProPublica, overseeing the Local Reporting Network. Follow him on Twitter at @charlesornstein.

This article was produced in collaboration with the Houston Chronicle.

The Trump administration on Sept. 17 proposed eliminating a decade-old regulation that puts hospitals at risk of losing their Medicare funding if too many of their patients die or suffer organ failure after receiving transplants.

The rule the government is proposing to scrap is the same one that led the Centers for Medicare & Medicaid Services to cut off funding in August for heart transplants at Baylor St. Luke’s Medical Center in Houston after an investigation by ProPublica and the Houston Chronicle revealed an outsized number of patient deaths and complications in recent years.

The proposal was unveiled Sept. 17 as part of the White House’s push to “cut the red tape” and do away with “burdensome regulation” that officials said put paperwork ahead of patients. In a speech announcing the proposed changes, CMS Administrator Seema Verma said the agency’s existing policies have “put lives in danger.”

“We are proposing to remove those inefficiencies to reduce the amount of time patients have to wait, so that they can begin healing,” Ms. Verma said.

The proposal, now subject to public comment and revision before it is finalized, surprised many transplant physicians who have long called for relaxed federal oversight. They’ve argued that the rules requiring that hospitals meet certain survival thresholds for transplants discourage them from taking on risky patients or accepting less-than-perfect organs, lengthening the time patients spend on the waiting list.

Some experts, however, said the proposal would not help patients because it would weaken the government’s authority to hold transplant programs accountable if they fail to provide safe patient care. The regulation was put in place in 2007 after a series of scandals at transplant programs revealed lax federal oversight. Several transplant programs had compiled abysmal patient survival statistics for years while continuing to receive Medicare funding.

Even though it has the authority to do so, Medicare rarely terminates programs for poor outcomes. It is far more common for the government to force underperforming programs into systems-improvement agreements, in which hospitals agree to make certain changes and be subject to stepped-up oversight.

Medicare bypassed that process and cut off funding for heart transplants at St. Luke’s in August after the hospital’s 1-year patient survival rate fell below national norms from 2014 to mid-2016. A few St. Luke’s cardiologists grew so concerned that they started sending some of their patients to other hospitals for transplants.

St. Luke’s has appealed its Medicare termination, saying, “we do not believe CMS’ recent decisions reflect our ongoing progress and accomplishments to improve the quality of our care.” A spokeswoman said officials are still reviewing the Medicare proposal and declined to comment.

In a statement to reporters Sept. 21, CMS said it would continue to monitoring transplant programs and is strengthening its process for inspecting transplant programs to ensure they provide safe, quality care.

“CMS will continue to collect the data on each transplant program’s performance with regards to patient and graft survival,” the agency said in the statement. “These data, rather than being a stand-alone measure, will be used as a component of the survey process to further inform and direct the survey.”

If the proposed regulatory change had been in place previously, it’s not clear whether St. Luke’s would have faced punitive action from Medicare.

“I am probably in the minority in the transplant community, but I think, based on what is proposed, this is a bad idea,” said Laura J. Aguiar, an Arizona-based transplant consultant who has spent years helping programs improve their outcomes to stave off Medicare penalties. “I have been around long enough to remember that there were very valid reasons why CMS, in the George W. Bush administration, took the steps they took in implementing all of this.”

Since the rules were put in place 11 years ago, the percentage of patients who survive at least 1 year after receiving heart, kidney, lung, and other organ transplants has increased nationally. But some experts say those gains have come at a cost.

Jesse D. Schold, PhD, a researcher in quantitative health sciences at the Cleveland Clinic, has spent years chronicling what he calls the “unintended consequences” of holding transplant programs accountable for poor outcomes. Even though CMS relies on data that has been adjusted to ensure that programs aren’t punished for treating sicker patients or accepting riskier donor organs, Dr. Schold said the rules have created a perception that programs need to turn away some ailing patients and reject less-than-ideal organs in order to meet outcome targets.

As a result, Dr. Schold said, some potentially viable donor organs are discarded while thousands of patients die on waiting lists each year. Dr. Schold said he was surprised to learn a study he coauthored was among the research cited by CMS as justification for the policy change, which he said would be a “significant net positive” for patients.

“I don’t want anything to in any way imply that I’m a fan of the current administration,” Dr. Schold said, referencing the Trump administration’s aggressive and often controversial efforts to slash regulations. “However, in this case, I think it is something that is beneficial.”

Joel Adler, MD, a liver surgeon at the University of Wisconsin–Madison, whose research also was cited by CMS, said a major weakness of the current regulation is that it focuses only on the survival of patients fortunate enough to have received a transplant. Medicare, he said, does not take into account the percentage of patients who die awaiting a transplant. That can discourage programs from accepting organs for patients who might be less likely to survive afterward.

Despite identifying problems with the current rules, Dr. Adler and his coauthor did not propose eliminating Medicare’s standards, but they instead suggested ways to improve outcome measures and create incentives for programs to perform more, not fewer, transplants.

“Should we get rid of (the regulation) entirely?” Dr. Adler asked. “I don’t know. I suspect we’ll swing back to somewhere in the middle, because there has to be some mechanism of capturing things when they are really, really bad. That has to exist.”

Medicare isn’t the only organization that oversees transplant centers. The United Network for Organ Sharing, a federal contractor that operates the national waiting list for organs, can put programs on probation or even revoke their good standing for continued poor results, though it rarely takes such actions. Similarly, another federal contractor, the Scientific Registry of Transplant Recipients, analyzes transplant outcomes and publicly reports which centers have mortality rates that are higher than expected based on the characteristics of their patients.

Even if the proposal is approved, it would not mean CMS would stop regulating transplant programs. Last year, for example, CMS cut off funding to the Medical University Hospital in Charleston, South Carolina, after the program failed to perform the minimum number of heart transplants required by CMS to maintain certification. That provision, also added during the reforms of 2007, would not be affected by the changes proposed Sept. 17.

The Charleston hospital, South Carolina’s only heart transplant program, made necessary changes and regained Medicare certification this year.

Alexander Aussi, a San Antonio–based consultant who specializes in helping transplant programs satisfy regulatory requirements, said he understands the desire to reduce the number of rules and regulations that transplant centers must follow. But he said he fears that the CMS proposal would return the transplant field to an earlier era when “some programs were cowboyish about their outcomes.”

“I cannot tell you in good conscience that if you remove those guidelines and metrics … that you’re going to have better outcomes,” Mr. Aussi said. “On the contrary, I believe you’re going to have a lot of transplant programs reversing course.”

Ms. Aguiar, the Arizona-based consultant, shares those concerns. Even without strict CMS oversight, she said, many transplant programs will continue providing high-quality care; but some won’t.

“There will be others that will take the removal of these requirements as a blessing to go back to the bad old days,” she said, “and it is patients who will end up paying the price for it.”
 

Mike Hixenbaugh is an investigative reporter at the Houston Chronicle. Email him at mike.hixenbaugh@chron.com and follow him on Twitter at @Mike_Hixenbaugh. Charles Ornstein is a senior editor at ProPublica, overseeing the Local Reporting Network. Follow him on Twitter at @charlesornstein.