Colonic diaphragm disease (CDD) is a rare but serious complication of nonsteroidal anti‐inflammatory drug (NSAID) use in which diaphragm‐like strictures develop in the large and/or small intestines. There have been about 100 reported cases of CDD since this finding was first reported in the medical literature in 1989.^1,2 However, given the frequency of NSAID use, providers should consider this diagnosis.

Case Report

An 85-year‐old woman presented to the emergency department (ED) with generalized weakness, occult positive stool, and severe anemia requiring blood transfusions. Eight months prior, she had presented to her primary care physician (PCP) for a routine visit and was found to have anemia. She was referred to gastroenterology by her PCP for an upper endoscopy but refused the referral despite clear warnings of the potential for serious complications. She was started on ferrous sulfate 325 mg po tid at that time. The patient’s hemoglobin (Hbg) levels ranged from 10.8 to 11.2 g/dL prior to her ED presentation, and random fecal occult blood testing had been negative.

In the ED, the patient reported no abdominal pain, nausea emesis or constipation. Her past medical history was significant for compensated diastolic heart failure, paroxysmal atrial fibrillation controlled by medication, and chronic lumbago. The patient had been prescribed NSAIDs for 10 years for the chronic lumbago diagnosis; however, she was inconsistent in taking this medication until more recent years. Surgical history included a hysterectomy and back surgeries in the distant past. She had no symptoms or history of inflammatory bowel disease. The patient’s medications included both the oral and topical forms of diclofenac, conjugated estrogen, nitroglycerin, amlodipine, hydrocodone bitartrate and acetaminophen 5 mg once daily, amiodarone, diazepam, valsartan, furosemide, oxycodone 5 mg nightly prn for severe pain, and ferrous sulfate 325 mg.

Significant laboratory results in the ED included a Hbg level of 8.3 g/dL; a ferritin level of 11.9 ng/mL, and a serum iron level of 12 mg/dL. A computerized tomography scan of the abdomen and pelvis was normal. The patient was admitted, received a blood transfusion, and a gastroenterology consult was obtained for an upper and lower endoscopy. Although copy was normal, the colonoscopy revealed evidence of CDD of the ascending colon.

Colonic Diaphragm Disease

The gross findings seen on this patient’s colonoscopy showed evidence of the development of an internal colonic stricture from the fibrous overgrowth of the diaphragm (Figures A, B, & C). The narrow lumen is exhibited particularly well in Figure A in the upper left image. The external surface of the intestine appears normal.

Presentation and Evaluation

The presenting symptoms of CDD can vary and include abdominal pain, vomiting, lower gastrointestinal bleeding, anemia, and intestinal obstruction/perforation. Evidence seems to suggest a greater association with use of the oxicams (meloxicam, piroxicam) or diclofenac.^1,2 Some researchers have suggested an association with long‐acting NSAID formulations.¹ The use of misoprostol or proton pump inhibitors does not seem to lessen the chance of stricture formulation.² Cox‐2 inhibitors are less likely players in the development of CDD.² Most diaphragms in the large colon have been noted in the cecum, ascending and transverse colon, though descending colonic lesions have been documented as well.¹

The incidence of CDD is higher among women and occurs most often in the seventh decade of life. Correlation with the duration of NSAID use prior to disease onset varies widely, with studies documenting disease onset from 3 months to 5 years after initiating consistent NSAID use.¹ The patient in this case study was prescribed NSAIDs for almost 10 years, although she had poor adherence. One study also notes a possible association of CYP2C9*3 genetic polymorphism with the propensity to develop CDD. This finding is particularly interesting since NSAIDs are principally metabolized by CYP2C9 in the liver. CYP2C9 polymorphisms are thought to induce higher plasma concentrations of NSAIDs over time, which may lead to the formation of colonic diaphragms.²

Endoscopy with biopsy is the diagnostic modality of choice. Use of capsule endoscopy is limited because the capsule may not be able to pass through narrow stricture walls.

Pathology and Histology

The mechanism by which NSAIDs induce the formation of colonic diaphragms may be related to these medications’ effects on mucosal integrity, vasoconstriction, and vascular spasm. These effects may lead to “erosions, ulceration, and diaphragm-like strictures.”³

The primary histologic feature of these strictures is submucosal fibrosis with an intact muscularis propria. Prominent features also include areas of ulceration and granulation.¹ The widened submucosa results in annular constriction of the intestinal lumen with disorganized bundles of smooth muscle, unmyelinated nerve bundles, scattered ganglion cells, and blood vessels. This morphology can resemble a node or mass.⁴ The mucosa is typically normal.⁵ Conditions such as vascular and neuromuscular hamartoma can resemble CDD. Interestingly, the fibrous changes in CDD have been noted apart from NSAID use, leading to speculation that diaphragm formation may be a result of injury and not exclusively a reaction to NSAID use.⁵

Treatment

Recommendations include NSAID withdrawal, endoscopic/fluoroscopic dilatation, and surgical resection. Outcomes with these treatment approaches have been highly variable. For some patients, NSAID withdrawal alone or following resection has resulted in success. However, even with withdrawal of NSAIDs, symptoms may improve, although the histologic findings of CDD may not be reversed.^3,6 In one case report, a colonic stricture persisted endoscopically after NSAID withdrawal but resolved after a 20-week course of prednisone.⁷

Conclusion

Despite NSAID cessation, the patient in this case study presented a month later with an acute bowel obstruction. The bowel obstruction responded to conservative treatment, and the patient declined surgical intervention. The patient was readmitted again 4 months later with an acute bowel obstruction, and underwent an emergent colonic resection. The pathology report was consistent with CDD. In the 3 years since the resection, the patient has had no recurrences and continues to avoid all NSAIDs. She has refused a follow-up postresection colonoscopy.

Colonic diaphragm disease (CDD) is a rare but serious complication of nonsteroidal anti‐inflammatory drug (NSAID) use in which diaphragm‐like strictures develop in the large and/or small intestines. There have been about 100 reported cases of CDD since this finding was first reported in the medical literature in 1989.^1,2 However, given the frequency of NSAID use, providers should consider this diagnosis.

Case Report

An 85-year‐old woman presented to the emergency department (ED) with generalized weakness, occult positive stool, and severe anemia requiring blood transfusions. Eight months prior, she had presented to her primary care physician (PCP) for a routine visit and was found to have anemia. She was referred to gastroenterology by her PCP for an upper endoscopy but refused the referral despite clear warnings of the potential for serious complications. She was started on ferrous sulfate 325 mg po tid at that time. The patient’s hemoglobin (Hbg) levels ranged from 10.8 to 11.2 g/dL prior to her ED presentation, and random fecal occult blood testing had been negative.

In the ED, the patient reported no abdominal pain, nausea emesis or constipation. Her past medical history was significant for compensated diastolic heart failure, paroxysmal atrial fibrillation controlled by medication, and chronic lumbago. The patient had been prescribed NSAIDs for 10 years for the chronic lumbago diagnosis; however, she was inconsistent in taking this medication until more recent years. Surgical history included a hysterectomy and back surgeries in the distant past. She had no symptoms or history of inflammatory bowel disease. The patient’s medications included both the oral and topical forms of diclofenac, conjugated estrogen, nitroglycerin, amlodipine, hydrocodone bitartrate and acetaminophen 5 mg once daily, amiodarone, diazepam, valsartan, furosemide, oxycodone 5 mg nightly prn for severe pain, and ferrous sulfate 325 mg.

Significant laboratory results in the ED included a Hbg level of 8.3 g/dL; a ferritin level of 11.9 ng/mL, and a serum iron level of 12 mg/dL. A computerized tomography scan of the abdomen and pelvis was normal. The patient was admitted, received a blood transfusion, and a gastroenterology consult was obtained for an upper and lower endoscopy. Although copy was normal, the colonoscopy revealed evidence of CDD of the ascending colon.

Colonic Diaphragm Disease

The gross findings seen on this patient’s colonoscopy showed evidence of the development of an internal colonic stricture from the fibrous overgrowth of the diaphragm (Figures A, B, & C). The narrow lumen is exhibited particularly well in Figure A in the upper left image. The external surface of the intestine appears normal.

Presentation and Evaluation

The presenting symptoms of CDD can vary and include abdominal pain, vomiting, lower gastrointestinal bleeding, anemia, and intestinal obstruction/perforation. Evidence seems to suggest a greater association with use of the oxicams (meloxicam, piroxicam) or diclofenac.^1,2 Some researchers have suggested an association with long‐acting NSAID formulations.¹ The use of misoprostol or proton pump inhibitors does not seem to lessen the chance of stricture formulation.² Cox‐2 inhibitors are less likely players in the development of CDD.² Most diaphragms in the large colon have been noted in the cecum, ascending and transverse colon, though descending colonic lesions have been documented as well.¹

The incidence of CDD is higher among women and occurs most often in the seventh decade of life. Correlation with the duration of NSAID use prior to disease onset varies widely, with studies documenting disease onset from 3 months to 5 years after initiating consistent NSAID use.¹ The patient in this case study was prescribed NSAIDs for almost 10 years, although she had poor adherence. One study also notes a possible association of CYP2C9*3 genetic polymorphism with the propensity to develop CDD. This finding is particularly interesting since NSAIDs are principally metabolized by CYP2C9 in the liver. CYP2C9 polymorphisms are thought to induce higher plasma concentrations of NSAIDs over time, which may lead to the formation of colonic diaphragms.²

Endoscopy with biopsy is the diagnostic modality of choice. Use of capsule endoscopy is limited because the capsule may not be able to pass through narrow stricture walls.

Pathology and Histology

The mechanism by which NSAIDs induce the formation of colonic diaphragms may be related to these medications’ effects on mucosal integrity, vasoconstriction, and vascular spasm. These effects may lead to “erosions, ulceration, and diaphragm-like strictures.”³

The primary histologic feature of these strictures is submucosal fibrosis with an intact muscularis propria. Prominent features also include areas of ulceration and granulation.¹ The widened submucosa results in annular constriction of the intestinal lumen with disorganized bundles of smooth muscle, unmyelinated nerve bundles, scattered ganglion cells, and blood vessels. This morphology can resemble a node or mass.⁴ The mucosa is typically normal.⁵ Conditions such as vascular and neuromuscular hamartoma can resemble CDD. Interestingly, the fibrous changes in CDD have been noted apart from NSAID use, leading to speculation that diaphragm formation may be a result of injury and not exclusively a reaction to NSAID use.⁵

Treatment

Recommendations include NSAID withdrawal, endoscopic/fluoroscopic dilatation, and surgical resection. Outcomes with these treatment approaches have been highly variable. For some patients, NSAID withdrawal alone or following resection has resulted in success. However, even with withdrawal of NSAIDs, symptoms may improve, although the histologic findings of CDD may not be reversed.^3,6 In one case report, a colonic stricture persisted endoscopically after NSAID withdrawal but resolved after a 20-week course of prednisone.⁷

Conclusion

Despite NSAID cessation, the patient in this case study presented a month later with an acute bowel obstruction. The bowel obstruction responded to conservative treatment, and the patient declined surgical intervention. The patient was readmitted again 4 months later with an acute bowel obstruction, and underwent an emergent colonic resection. The pathology report was consistent with CDD. In the 3 years since the resection, the patient has had no recurrences and continues to avoid all NSAIDs. She has refused a follow-up postresection colonoscopy.

Colonic diaphragm disease (CDD) is a rare but serious complication of nonsteroidal anti‐inflammatory drug (NSAID) use in which diaphragm‐like strictures develop in the large and/or small intestines. There have been about 100 reported cases of CDD since this finding was first reported in the medical literature in 1989.^1,2 However, given the frequency of NSAID use, providers should consider this diagnosis.

Case Report

An 85-year‐old woman presented to the emergency department (ED) with generalized weakness, occult positive stool, and severe anemia requiring blood transfusions. Eight months prior, she had presented to her primary care physician (PCP) for a routine visit and was found to have anemia. She was referred to gastroenterology by her PCP for an upper endoscopy but refused the referral despite clear warnings of the potential for serious complications. She was started on ferrous sulfate 325 mg po tid at that time. The patient’s hemoglobin (Hbg) levels ranged from 10.8 to 11.2 g/dL prior to her ED presentation, and random fecal occult blood testing had been negative.

In the ED, the patient reported no abdominal pain, nausea emesis or constipation. Her past medical history was significant for compensated diastolic heart failure, paroxysmal atrial fibrillation controlled by medication, and chronic lumbago. The patient had been prescribed NSAIDs for 10 years for the chronic lumbago diagnosis; however, she was inconsistent in taking this medication until more recent years. Surgical history included a hysterectomy and back surgeries in the distant past. She had no symptoms or history of inflammatory bowel disease. The patient’s medications included both the oral and topical forms of diclofenac, conjugated estrogen, nitroglycerin, amlodipine, hydrocodone bitartrate and acetaminophen 5 mg once daily, amiodarone, diazepam, valsartan, furosemide, oxycodone 5 mg nightly prn for severe pain, and ferrous sulfate 325 mg.

Significant laboratory results in the ED included a Hbg level of 8.3 g/dL; a ferritin level of 11.9 ng/mL, and a serum iron level of 12 mg/dL. A computerized tomography scan of the abdomen and pelvis was normal. The patient was admitted, received a blood transfusion, and a gastroenterology consult was obtained for an upper and lower endoscopy. Although copy was normal, the colonoscopy revealed evidence of CDD of the ascending colon.

Colonic Diaphragm Disease

The gross findings seen on this patient’s colonoscopy showed evidence of the development of an internal colonic stricture from the fibrous overgrowth of the diaphragm (Figures A, B, & C). The narrow lumen is exhibited particularly well in Figure A in the upper left image. The external surface of the intestine appears normal.

Presentation and Evaluation

The presenting symptoms of CDD can vary and include abdominal pain, vomiting, lower gastrointestinal bleeding, anemia, and intestinal obstruction/perforation. Evidence seems to suggest a greater association with use of the oxicams (meloxicam, piroxicam) or diclofenac.^1,2 Some researchers have suggested an association with long‐acting NSAID formulations.¹ The use of misoprostol or proton pump inhibitors does not seem to lessen the chance of stricture formulation.² Cox‐2 inhibitors are less likely players in the development of CDD.² Most diaphragms in the large colon have been noted in the cecum, ascending and transverse colon, though descending colonic lesions have been documented as well.¹

The incidence of CDD is higher among women and occurs most often in the seventh decade of life. Correlation with the duration of NSAID use prior to disease onset varies widely, with studies documenting disease onset from 3 months to 5 years after initiating consistent NSAID use.¹ The patient in this case study was prescribed NSAIDs for almost 10 years, although she had poor adherence. One study also notes a possible association of CYP2C9*3 genetic polymorphism with the propensity to develop CDD. This finding is particularly interesting since NSAIDs are principally metabolized by CYP2C9 in the liver. CYP2C9 polymorphisms are thought to induce higher plasma concentrations of NSAIDs over time, which may lead to the formation of colonic diaphragms.²

Endoscopy with biopsy is the diagnostic modality of choice. Use of capsule endoscopy is limited because the capsule may not be able to pass through narrow stricture walls.

Pathology and Histology

The mechanism by which NSAIDs induce the formation of colonic diaphragms may be related to these medications’ effects on mucosal integrity, vasoconstriction, and vascular spasm. These effects may lead to “erosions, ulceration, and diaphragm-like strictures.”³

The primary histologic feature of these strictures is submucosal fibrosis with an intact muscularis propria. Prominent features also include areas of ulceration and granulation.¹ The widened submucosa results in annular constriction of the intestinal lumen with disorganized bundles of smooth muscle, unmyelinated nerve bundles, scattered ganglion cells, and blood vessels. This morphology can resemble a node or mass.⁴ The mucosa is typically normal.⁵ Conditions such as vascular and neuromuscular hamartoma can resemble CDD. Interestingly, the fibrous changes in CDD have been noted apart from NSAID use, leading to speculation that diaphragm formation may be a result of injury and not exclusively a reaction to NSAID use.⁵

Treatment

Recommendations include NSAID withdrawal, endoscopic/fluoroscopic dilatation, and surgical resection. Outcomes with these treatment approaches have been highly variable. For some patients, NSAID withdrawal alone or following resection has resulted in success. However, even with withdrawal of NSAIDs, symptoms may improve, although the histologic findings of CDD may not be reversed.^3,6 In one case report, a colonic stricture persisted endoscopically after NSAID withdrawal but resolved after a 20-week course of prednisone.⁷

Conclusion

Despite NSAID cessation, the patient in this case study presented a month later with an acute bowel obstruction. The bowel obstruction responded to conservative treatment, and the patient declined surgical intervention. The patient was readmitted again 4 months later with an acute bowel obstruction, and underwent an emergent colonic resection. The pathology report was consistent with CDD. In the 3 years since the resection, the patient has had no recurrences and continues to avoid all NSAIDs. She has refused a follow-up postresection colonoscopy.

Warfarin tablets

WASHINGTON, DC—An analysis of real-world data suggests elderly patients with non-valvular atrial fibrillation (NVAF) have a lower risk of stroke or systemic embolism and a lower risk of major bleeding if they receive apixaban rather than warfarin.

The study also indicates that elderly NVAF patients who receive dabigatran have a similar risk of stroke/systemic embolism as those on warfarin, but the risk of major bleeding is lower with dabigatran.

And rivaroxaban poses a lower risk of stroke/systemic embolism than warfarin but a higher risk of major bleeding.

However, the researchers who conducted this analysis stressed that it cannot be used as stand-alone evidence to validate the efficacy and/or safety of any of the drugs studied.

The results of the analysis were presented at the American College of Cardiology’s 66th Annual Scientific Session (abstract 1134M-13).

The researchers also presented data on the financial costs of major bleeding associated with apixaban, dabigatran, rivaroxaban, and warfarin (abstract 1189-085/085).

The research was conducted by employees from Bristol-Myers Squibb Company and Pfizer Inc., the companies marketing apixaban, as well as other researchers who have relationships with the companies.

The team evaluated medical and pharmacy claims from the US Medicare fee-for-service database. They looked at NVAF patients age 65 and older who were newly prescribed apixaban, dabigatran, rivaroxaban, or warfarin between January 1, 2013, and December 31, 2014.

The researchers compared each of the direct oral anticoagulants to warfarin using 1:1 propensity score matching methodology to balance select demographic and clinical characteristics between the groups.

The team used Cox proportional hazards models to estimate the hazard ratio (HR) of stroke/systemic embolism and major bleeding.

Results

In a comparison of apixaban and warfarin (20,803 patients in each treatment group), apixaban was associated with a significantly lower risk of stroke or systemic embolism than warfarin (HR: 0.40, 95% CI: 0.31-0.53; P<0.0001).

Apixaban was also associated with a significantly lower risk of major bleeding than warfarin (HR: 0.51, 95% CI: 0.44-0.58; P<0.0001). The cost of major bleeding per patient per month was $286 with apixaban and $537 with warfarin (P<0.0001).

In a comparison of dabigatran and warfarin (16,731 patients in each treatment group), the risk of stroke or systemic embolism was similar between the cohorts (HR: 0.94, 95% CI: 0.74-1.21; P=0.647).

However, the risk of major bleeding was significantly lower with dabigatran than with warfarin (HR: 0.79, 95% CI: 0.69-0.91; P=0.001). The cost of major bleeding per patient per month was $367 with dabigatran and $452 with warfarin (P=0.032).

In a comparison of rivaroxaban and warfarin (52,476 patients in each group), rivaroxaban was associated with a significantly lower risk of stroke or systemic embolism than warfarin (HR: 0.72, 95% CI: 0.63-0.83; P<0.0001).

However, the risk of major bleeding was significantly higher with rivaroxaban than with warfarin (HR: 1.17, 95% CI: 1.10-1.26; P<0.0001). The cost of major bleeding per patient per month was $524 with rivaroxaban and $500 with warfarin (P=0.154).

Limitations

The researchers noted that this analysis has several limitations. For instance, information on laboratory results and time in therapeutic range were not available. Diagnoses were identified through ICD-9 codes, and drug prescriptions were identified through prescription claims.

Propensity score matching was used to mimic randomization by balancing pre-defined demographic and clinical characteristics at baseline for both treatment cohorts. However, unobserved confounders (such as laboratory values and patient preferences) may exist.

As with any real-world data analysis, missing values, coding errors, and a lack of clinical accuracy may have introduced bias.

The researchers stressed that, due to such limitations, real-world data analyses cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment. However, these analyses add to information provided by randomized clinical trials.

“Studies such as this large US Medicare database analysis supplement pivotal trials by broadening and deepening our scientific knowledge of how patients respond to direct oral anticoagulants in everyday clinical practice,” said Alpesh Amin, MD, principal investigator and professor of medicine at the University of California, Irvine.

“Given the diversity of patients with non-valvular atrial fibrillation, analyses of real-world data provide further information that adds to data generated in randomized clinical trials.”

Warfarin tablets

WASHINGTON, DC—An analysis of real-world data suggests elderly patients with non-valvular atrial fibrillation (NVAF) have a lower risk of stroke or systemic embolism and a lower risk of major bleeding if they receive apixaban rather than warfarin.

The study also indicates that elderly NVAF patients who receive dabigatran have a similar risk of stroke/systemic embolism as those on warfarin, but the risk of major bleeding is lower with dabigatran.

And rivaroxaban poses a lower risk of stroke/systemic embolism than warfarin but a higher risk of major bleeding.

However, the researchers who conducted this analysis stressed that it cannot be used as stand-alone evidence to validate the efficacy and/or safety of any of the drugs studied.

The results of the analysis were presented at the American College of Cardiology’s 66th Annual Scientific Session (abstract 1134M-13).

The researchers also presented data on the financial costs of major bleeding associated with apixaban, dabigatran, rivaroxaban, and warfarin (abstract 1189-085/085).

The research was conducted by employees from Bristol-Myers Squibb Company and Pfizer Inc., the companies marketing apixaban, as well as other researchers who have relationships with the companies.

The team evaluated medical and pharmacy claims from the US Medicare fee-for-service database. They looked at NVAF patients age 65 and older who were newly prescribed apixaban, dabigatran, rivaroxaban, or warfarin between January 1, 2013, and December 31, 2014.

The researchers compared each of the direct oral anticoagulants to warfarin using 1:1 propensity score matching methodology to balance select demographic and clinical characteristics between the groups.

The team used Cox proportional hazards models to estimate the hazard ratio (HR) of stroke/systemic embolism and major bleeding.

Results

In a comparison of apixaban and warfarin (20,803 patients in each treatment group), apixaban was associated with a significantly lower risk of stroke or systemic embolism than warfarin (HR: 0.40, 95% CI: 0.31-0.53; P<0.0001).

Apixaban was also associated with a significantly lower risk of major bleeding than warfarin (HR: 0.51, 95% CI: 0.44-0.58; P<0.0001). The cost of major bleeding per patient per month was $286 with apixaban and $537 with warfarin (P<0.0001).

In a comparison of dabigatran and warfarin (16,731 patients in each treatment group), the risk of stroke or systemic embolism was similar between the cohorts (HR: 0.94, 95% CI: 0.74-1.21; P=0.647).

However, the risk of major bleeding was significantly lower with dabigatran than with warfarin (HR: 0.79, 95% CI: 0.69-0.91; P=0.001). The cost of major bleeding per patient per month was $367 with dabigatran and $452 with warfarin (P=0.032).

In a comparison of rivaroxaban and warfarin (52,476 patients in each group), rivaroxaban was associated with a significantly lower risk of stroke or systemic embolism than warfarin (HR: 0.72, 95% CI: 0.63-0.83; P<0.0001).

However, the risk of major bleeding was significantly higher with rivaroxaban than with warfarin (HR: 1.17, 95% CI: 1.10-1.26; P<0.0001). The cost of major bleeding per patient per month was $524 with rivaroxaban and $500 with warfarin (P=0.154).

Limitations

The researchers noted that this analysis has several limitations. For instance, information on laboratory results and time in therapeutic range were not available. Diagnoses were identified through ICD-9 codes, and drug prescriptions were identified through prescription claims.

Propensity score matching was used to mimic randomization by balancing pre-defined demographic and clinical characteristics at baseline for both treatment cohorts. However, unobserved confounders (such as laboratory values and patient preferences) may exist.

As with any real-world data analysis, missing values, coding errors, and a lack of clinical accuracy may have introduced bias.

The researchers stressed that, due to such limitations, real-world data analyses cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment. However, these analyses add to information provided by randomized clinical trials.

“Studies such as this large US Medicare database analysis supplement pivotal trials by broadening and deepening our scientific knowledge of how patients respond to direct oral anticoagulants in everyday clinical practice,” said Alpesh Amin, MD, principal investigator and professor of medicine at the University of California, Irvine.

“Given the diversity of patients with non-valvular atrial fibrillation, analyses of real-world data provide further information that adds to data generated in randomized clinical trials.”

Warfarin tablets

WASHINGTON, DC—An analysis of real-world data suggests elderly patients with non-valvular atrial fibrillation (NVAF) have a lower risk of stroke or systemic embolism and a lower risk of major bleeding if they receive apixaban rather than warfarin.

The study also indicates that elderly NVAF patients who receive dabigatran have a similar risk of stroke/systemic embolism as those on warfarin, but the risk of major bleeding is lower with dabigatran.

And rivaroxaban poses a lower risk of stroke/systemic embolism than warfarin but a higher risk of major bleeding.

However, the researchers who conducted this analysis stressed that it cannot be used as stand-alone evidence to validate the efficacy and/or safety of any of the drugs studied.

The results of the analysis were presented at the American College of Cardiology’s 66th Annual Scientific Session (abstract 1134M-13).

The researchers also presented data on the financial costs of major bleeding associated with apixaban, dabigatran, rivaroxaban, and warfarin (abstract 1189-085/085).

The research was conducted by employees from Bristol-Myers Squibb Company and Pfizer Inc., the companies marketing apixaban, as well as other researchers who have relationships with the companies.

The team evaluated medical and pharmacy claims from the US Medicare fee-for-service database. They looked at NVAF patients age 65 and older who were newly prescribed apixaban, dabigatran, rivaroxaban, or warfarin between January 1, 2013, and December 31, 2014.

The researchers compared each of the direct oral anticoagulants to warfarin using 1:1 propensity score matching methodology to balance select demographic and clinical characteristics between the groups.

The team used Cox proportional hazards models to estimate the hazard ratio (HR) of stroke/systemic embolism and major bleeding.

Results

In a comparison of apixaban and warfarin (20,803 patients in each treatment group), apixaban was associated with a significantly lower risk of stroke or systemic embolism than warfarin (HR: 0.40, 95% CI: 0.31-0.53; P<0.0001).

Apixaban was also associated with a significantly lower risk of major bleeding than warfarin (HR: 0.51, 95% CI: 0.44-0.58; P<0.0001). The cost of major bleeding per patient per month was $286 with apixaban and $537 with warfarin (P<0.0001).

In a comparison of dabigatran and warfarin (16,731 patients in each treatment group), the risk of stroke or systemic embolism was similar between the cohorts (HR: 0.94, 95% CI: 0.74-1.21; P=0.647).

However, the risk of major bleeding was significantly lower with dabigatran than with warfarin (HR: 0.79, 95% CI: 0.69-0.91; P=0.001). The cost of major bleeding per patient per month was $367 with dabigatran and $452 with warfarin (P=0.032).

In a comparison of rivaroxaban and warfarin (52,476 patients in each group), rivaroxaban was associated with a significantly lower risk of stroke or systemic embolism than warfarin (HR: 0.72, 95% CI: 0.63-0.83; P<0.0001).

However, the risk of major bleeding was significantly higher with rivaroxaban than with warfarin (HR: 1.17, 95% CI: 1.10-1.26; P<0.0001). The cost of major bleeding per patient per month was $524 with rivaroxaban and $500 with warfarin (P=0.154).

Limitations

The researchers noted that this analysis has several limitations. For instance, information on laboratory results and time in therapeutic range were not available. Diagnoses were identified through ICD-9 codes, and drug prescriptions were identified through prescription claims.

Propensity score matching was used to mimic randomization by balancing pre-defined demographic and clinical characteristics at baseline for both treatment cohorts. However, unobserved confounders (such as laboratory values and patient preferences) may exist.

As with any real-world data analysis, missing values, coding errors, and a lack of clinical accuracy may have introduced bias.

The researchers stressed that, due to such limitations, real-world data analyses cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment. However, these analyses add to information provided by randomized clinical trials.

“Studies such as this large US Medicare database analysis supplement pivotal trials by broadening and deepening our scientific knowledge of how patients respond to direct oral anticoagulants in everyday clinical practice,” said Alpesh Amin, MD, principal investigator and professor of medicine at the University of California, Irvine.

“Given the diversity of patients with non-valvular atrial fibrillation, analyses of real-world data provide further information that adds to data generated in randomized clinical trials.”

Ingelheim Pharmaceuticals

WASHINGTON, DC—Results from the RE-CIRCUIT trial suggest that uninterrupted dabigatran poses a lower risk of major bleeding than uninterrupted warfarin in patients with non-valvular atrial fibrillation (NVAF) who are undergoing catheter ablation.

Patients who received dabigatran also had fewer serious and severe adverse events (AEs).

The incidence of minor bleeding was similar between the treatment groups, and the incidence of AEs leading to treatment discontinuation was higher with dabigatran.

These results were presented at the American College of Cardiology’s 66th Annual Scientific Session and simultaneously published in NEJM.

This study was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc.

The RE-CIRCUIT trial enrolled 704 patients with paroxysmal or persistent NVAF, and 635 of them ultimately underwent catheter ablation with uninterrupted anticoagulation.

The patients were randomized to receive dabigatran at 150 mg twice daily or warfarin (with a target international normalized ratio [INR] of 2.0–3.0) in a 1:1 ratio and remained on this treatment for the duration of the trial.

The mean adherence to dabigatran was 97.6%, and patients receiving warfarin were within the guideline-defined target INR range 66% of the time. The majority of patients in both groups (86.1% in the dabigatran group and 84.3% in the warfarin group) received study treatment for at least 8 weeks after ablation.

Results

The study’s primary endpoint was the incidence of major bleeding events, as defined by the International Society on Thrombosis and Hemostasis, during the ablation procedure and up to 2 months after.

There was a significantly lower incidence of major bleeding with uninterrupted dabigatran than with uninterrupted warfarin—1.6% (n=5) and 6.9% (n=22), respectively (P<0.001).

Major bleeding events (in the dabigatran and warfarin groups, respectively) included pericardial tamponade (1 and 6),  pericardial effusion (1 and 0), groin bleeds (2 in both), groin hematomas (0 and 8), gastrointestinal bleeds (1 and 2), intracranial bleeds (0 and 2), pseudoaneurysm (0 and 1), and hematomas (0 and 2).

The incidence of minor bleeding was similar between the treatment groups—18.6% (n=59) in the dabigatran group and 17.0% (n=54) in the warfarin group.

The incidence of serious AEs was 18.6% in the dabigatran group and 22.2% in the warfarin group. The most frequent serious AEs were atrial flutter (5.9% and 5.6%, respectively), atrial fibrillation (1.8% and 3.8%, respectively), and cardiac tamponade (0.3% and 1.2%, respectively).

The incidence of severe AEs was 3.3% in the dabigatran group and 6.2% in the warfarin group. The incidence of AEs leading to treatment discontinuation was 5.6% and 2.4%, respectively.

There were no cases of stroke, systemic embolism, or transient ischemic attack in the dabigatran group. However, there was a transient ischemic attack in the warfarin group.

“These results are exciting news for the medical community,” said study investigator Hugh Calkins, MD, of Johns Hopkins Hospital in Baltimore, Maryland.

“During an ablation procedure, patients are at risk of potential major complications, including stroke and bleeding. Therefore, anticoagulation management at the time of AFib ablation is critically important. In RE-CIRCUIT, we have seen that uninterrupted anticoagulation with dabigatran showed significantly lower major bleeding complications than warfarin in atrial fibrillation patients undergoing cardiac ablation.”

Ingelheim Pharmaceuticals

WASHINGTON, DC—Results from the RE-CIRCUIT trial suggest that uninterrupted dabigatran poses a lower risk of major bleeding than uninterrupted warfarin in patients with non-valvular atrial fibrillation (NVAF) who are undergoing catheter ablation.

Patients who received dabigatran also had fewer serious and severe adverse events (AEs).

The incidence of minor bleeding was similar between the treatment groups, and the incidence of AEs leading to treatment discontinuation was higher with dabigatran.

These results were presented at the American College of Cardiology’s 66th Annual Scientific Session and simultaneously published in NEJM.

This study was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc.

The RE-CIRCUIT trial enrolled 704 patients with paroxysmal or persistent NVAF, and 635 of them ultimately underwent catheter ablation with uninterrupted anticoagulation.

The patients were randomized to receive dabigatran at 150 mg twice daily or warfarin (with a target international normalized ratio [INR] of 2.0–3.0) in a 1:1 ratio and remained on this treatment for the duration of the trial.

The mean adherence to dabigatran was 97.6%, and patients receiving warfarin were within the guideline-defined target INR range 66% of the time. The majority of patients in both groups (86.1% in the dabigatran group and 84.3% in the warfarin group) received study treatment for at least 8 weeks after ablation.

Results

The study’s primary endpoint was the incidence of major bleeding events, as defined by the International Society on Thrombosis and Hemostasis, during the ablation procedure and up to 2 months after.

There was a significantly lower incidence of major bleeding with uninterrupted dabigatran than with uninterrupted warfarin—1.6% (n=5) and 6.9% (n=22), respectively (P<0.001).

Major bleeding events (in the dabigatran and warfarin groups, respectively) included pericardial tamponade (1 and 6),  pericardial effusion (1 and 0), groin bleeds (2 in both), groin hematomas (0 and 8), gastrointestinal bleeds (1 and 2), intracranial bleeds (0 and 2), pseudoaneurysm (0 and 1), and hematomas (0 and 2).

The incidence of minor bleeding was similar between the treatment groups—18.6% (n=59) in the dabigatran group and 17.0% (n=54) in the warfarin group.

The incidence of serious AEs was 18.6% in the dabigatran group and 22.2% in the warfarin group. The most frequent serious AEs were atrial flutter (5.9% and 5.6%, respectively), atrial fibrillation (1.8% and 3.8%, respectively), and cardiac tamponade (0.3% and 1.2%, respectively).

The incidence of severe AEs was 3.3% in the dabigatran group and 6.2% in the warfarin group. The incidence of AEs leading to treatment discontinuation was 5.6% and 2.4%, respectively.

There were no cases of stroke, systemic embolism, or transient ischemic attack in the dabigatran group. However, there was a transient ischemic attack in the warfarin group.

“These results are exciting news for the medical community,” said study investigator Hugh Calkins, MD, of Johns Hopkins Hospital in Baltimore, Maryland.

“During an ablation procedure, patients are at risk of potential major complications, including stroke and bleeding. Therefore, anticoagulation management at the time of AFib ablation is critically important. In RE-CIRCUIT, we have seen that uninterrupted anticoagulation with dabigatran showed significantly lower major bleeding complications than warfarin in atrial fibrillation patients undergoing cardiac ablation.”

Ingelheim Pharmaceuticals

WASHINGTON, DC—Results from the RE-CIRCUIT trial suggest that uninterrupted dabigatran poses a lower risk of major bleeding than uninterrupted warfarin in patients with non-valvular atrial fibrillation (NVAF) who are undergoing catheter ablation.

Patients who received dabigatran also had fewer serious and severe adverse events (AEs).

The incidence of minor bleeding was similar between the treatment groups, and the incidence of AEs leading to treatment discontinuation was higher with dabigatran.

These results were presented at the American College of Cardiology’s 66th Annual Scientific Session and simultaneously published in NEJM.

This study was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc.

The RE-CIRCUIT trial enrolled 704 patients with paroxysmal or persistent NVAF, and 635 of them ultimately underwent catheter ablation with uninterrupted anticoagulation.

The patients were randomized to receive dabigatran at 150 mg twice daily or warfarin (with a target international normalized ratio [INR] of 2.0–3.0) in a 1:1 ratio and remained on this treatment for the duration of the trial.

The mean adherence to dabigatran was 97.6%, and patients receiving warfarin were within the guideline-defined target INR range 66% of the time. The majority of patients in both groups (86.1% in the dabigatran group and 84.3% in the warfarin group) received study treatment for at least 8 weeks after ablation.

Results

The study’s primary endpoint was the incidence of major bleeding events, as defined by the International Society on Thrombosis and Hemostasis, during the ablation procedure and up to 2 months after.

There was a significantly lower incidence of major bleeding with uninterrupted dabigatran than with uninterrupted warfarin—1.6% (n=5) and 6.9% (n=22), respectively (P<0.001).

Major bleeding events (in the dabigatran and warfarin groups, respectively) included pericardial tamponade (1 and 6),  pericardial effusion (1 and 0), groin bleeds (2 in both), groin hematomas (0 and 8), gastrointestinal bleeds (1 and 2), intracranial bleeds (0 and 2), pseudoaneurysm (0 and 1), and hematomas (0 and 2).

The incidence of minor bleeding was similar between the treatment groups—18.6% (n=59) in the dabigatran group and 17.0% (n=54) in the warfarin group.

The incidence of serious AEs was 18.6% in the dabigatran group and 22.2% in the warfarin group. The most frequent serious AEs were atrial flutter (5.9% and 5.6%, respectively), atrial fibrillation (1.8% and 3.8%, respectively), and cardiac tamponade (0.3% and 1.2%, respectively).

The incidence of severe AEs was 3.3% in the dabigatran group and 6.2% in the warfarin group. The incidence of AEs leading to treatment discontinuation was 5.6% and 2.4%, respectively.

There were no cases of stroke, systemic embolism, or transient ischemic attack in the dabigatran group. However, there was a transient ischemic attack in the warfarin group.

“These results are exciting news for the medical community,” said study investigator Hugh Calkins, MD, of Johns Hopkins Hospital in Baltimore, Maryland.

“During an ablation procedure, patients are at risk of potential major complications, including stroke and bleeding. Therefore, anticoagulation management at the time of AFib ablation is critically important. In RE-CIRCUIT, we have seen that uninterrupted anticoagulation with dabigatran showed significantly lower major bleeding complications than warfarin in atrial fibrillation patients undergoing cardiac ablation.”

The American College of Surgeons (ACS), in collaboration with the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality, Baltimore, MD, has launched the AHRQ (Agency for Healthcare Research and Quality) Safety Program for Enhanced Recovery after Surgery (ERAS). This new surgical quality improvement program is funded and guided by AHRQ.

The AHRQ Safety Program for ERAS will support hospitals in implementing perioperative evidence-based protocols to meaningfully improve clinical outcomes, reduce health care utilization, and improve the patient experience. This program aims to enroll at least 750 hospitals throughout the five-year contract. Hospitals within the U.S., Puerto Rico, and the District of Columbia are eligible to participate across five service lines: colorectal, orthopaedic, bariatric, gynecology, and emergency general surgery.

Participating hospitals will have access to the international leaders in ERAS, including representatives of surgery, anesthesiology, and nursing; prototype ERAS protocols developed for five procedures based on up-to-date evidence review; literature to support protocols; tools and educational materials to facilitate implementation; quality improvement specialist support; and coaching calls to support hospital work.

Program enrollment will begin in spring 2017. For more information, contact [email protected].

The American College of Surgeons (ACS), in collaboration with the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality, Baltimore, MD, has launched the AHRQ (Agency for Healthcare Research and Quality) Safety Program for Enhanced Recovery after Surgery (ERAS). This new surgical quality improvement program is funded and guided by AHRQ.

The AHRQ Safety Program for ERAS will support hospitals in implementing perioperative evidence-based protocols to meaningfully improve clinical outcomes, reduce health care utilization, and improve the patient experience. This program aims to enroll at least 750 hospitals throughout the five-year contract. Hospitals within the U.S., Puerto Rico, and the District of Columbia are eligible to participate across five service lines: colorectal, orthopaedic, bariatric, gynecology, and emergency general surgery.

Participating hospitals will have access to the international leaders in ERAS, including representatives of surgery, anesthesiology, and nursing; prototype ERAS protocols developed for five procedures based on up-to-date evidence review; literature to support protocols; tools and educational materials to facilitate implementation; quality improvement specialist support; and coaching calls to support hospital work.

Program enrollment will begin in spring 2017. For more information, contact [email protected].

The American College of Surgeons (ACS), in collaboration with the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality, Baltimore, MD, has launched the AHRQ (Agency for Healthcare Research and Quality) Safety Program for Enhanced Recovery after Surgery (ERAS). This new surgical quality improvement program is funded and guided by AHRQ.

The AHRQ Safety Program for ERAS will support hospitals in implementing perioperative evidence-based protocols to meaningfully improve clinical outcomes, reduce health care utilization, and improve the patient experience. This program aims to enroll at least 750 hospitals throughout the five-year contract. Hospitals within the U.S., Puerto Rico, and the District of Columbia are eligible to participate across five service lines: colorectal, orthopaedic, bariatric, gynecology, and emergency general surgery.

Participating hospitals will have access to the international leaders in ERAS, including representatives of surgery, anesthesiology, and nursing; prototype ERAS protocols developed for five procedures based on up-to-date evidence review; literature to support protocols; tools and educational materials to facilitate implementation; quality improvement specialist support; and coaching calls to support hospital work.

Program enrollment will begin in spring 2017. For more information, contact [email protected].

The Surgical History Group (SHG) of the American College of Surgeons (ACS) has unveiled the inaugural issue of the Bulletin of the Surgical History Group: Papers from the 2016 Poster Competition. This publication is a compendium of articles based on abstracts that medical students and residents submitted for the SHG’s poster competition at Clinical Congress 2016 in Washington, DC.

The SHG sponsors a poster competition at the annual Clinical Congress, featuring the scholarly work of students and residents. Submissions cover a range of surgical history topics.

More than 40 abstracts were submitted for presentation at Clinical Congress 2016 in Washington, DC. A panel of judges led by J. Patrick O’Leary, MD, FACS, and Patrick Greiffenstein, MD, FACS, Chair and Co-Chair, respectively, of the Poster Competition Committee, selected 21 posters for the program and chose two posters among the high-quality entries for top prizes. The SHG decided that the students’ and residents’ scholarship deserved wider distribution in a more permanent format than posters. All participants were invited to submit their work in written form for this collection of articles available for the study and enjoyment of both Fellows and the public interested in the history of surgery.

The e-bulletin can be accessed on the SHG website at facs.org/about-acs/archives/shg.

The Surgical History Group (SHG) of the American College of Surgeons (ACS) has unveiled the inaugural issue of the Bulletin of the Surgical History Group: Papers from the 2016 Poster Competition. This publication is a compendium of articles based on abstracts that medical students and residents submitted for the SHG’s poster competition at Clinical Congress 2016 in Washington, DC.

The SHG sponsors a poster competition at the annual Clinical Congress, featuring the scholarly work of students and residents. Submissions cover a range of surgical history topics.

More than 40 abstracts were submitted for presentation at Clinical Congress 2016 in Washington, DC. A panel of judges led by J. Patrick O’Leary, MD, FACS, and Patrick Greiffenstein, MD, FACS, Chair and Co-Chair, respectively, of the Poster Competition Committee, selected 21 posters for the program and chose two posters among the high-quality entries for top prizes. The SHG decided that the students’ and residents’ scholarship deserved wider distribution in a more permanent format than posters. All participants were invited to submit their work in written form for this collection of articles available for the study and enjoyment of both Fellows and the public interested in the history of surgery.

The e-bulletin can be accessed on the SHG website at facs.org/about-acs/archives/shg.

The Surgical History Group (SHG) of the American College of Surgeons (ACS) has unveiled the inaugural issue of the Bulletin of the Surgical History Group: Papers from the 2016 Poster Competition. This publication is a compendium of articles based on abstracts that medical students and residents submitted for the SHG’s poster competition at Clinical Congress 2016 in Washington, DC.

The SHG sponsors a poster competition at the annual Clinical Congress, featuring the scholarly work of students and residents. Submissions cover a range of surgical history topics.

More than 40 abstracts were submitted for presentation at Clinical Congress 2016 in Washington, DC. A panel of judges led by J. Patrick O’Leary, MD, FACS, and Patrick Greiffenstein, MD, FACS, Chair and Co-Chair, respectively, of the Poster Competition Committee, selected 21 posters for the program and chose two posters among the high-quality entries for top prizes. The SHG decided that the students’ and residents’ scholarship deserved wider distribution in a more permanent format than posters. All participants were invited to submit their work in written form for this collection of articles available for the study and enjoyment of both Fellows and the public interested in the history of surgery.

The e-bulletin can be accessed on the SHG website at facs.org/about-acs/archives/shg.

With a new administration and Congress in place, as well as many exciting internal changes, the American College of Surgeons (ACS) is looking forward to an exciting year ahead.

Quality improvement

Making certain that surgeons have the tools they need to measure and evaluate their performance is a key mission of the College. To this end, we have initiated the database integration system, which will bring together under a single platform the ACS National Surgical Quality Improvement Program (ACS NSQIP®), National Cancer Database, National Trauma Data Bank, and Surgeon Specific Registry (SSRTM). This project, which is being implemented incrementally, will make it easier for surgeons to meet American Board of Surgery (ABS) Maintenance of Certification requirements and Medicare payment mandates.

Advocacy

The Medicare Access and CHIP Reauthorization Act (MACRA), enacted in 2015, repealed the flawed sustainable growth rate (SGR) methodology that was used for many years to calculate Medicare physician reimbursement. Replacing the SGR is the Quality Payment Program (QPP), which advances a longstanding policy goal of basing payment on value rather than on volume.

Surgeons can participate in the QPP through one of two pathways—the Merit-Based Incentive Payment System (MIPS) or the Advanced Alternative Payment Models (APMs). MIPS is the default QPP pathway most physicians will use initially. The College has taken a number of steps to ensure that surgeons are able to comply with MIPS’ reporting requirements and performance measures. For example, we have created an online Resource Center (https://www.facs.org/advocacy/qpp) for surgeons seeking information about the QPP. In addition, we are working with health policy experts at Brandeis University, Waltham, MA, and Brigham and Women’s Hospital, Boston, to propose surgical APMs.

We anticipate that the new presidential administration and Republican-controlled Congress will leave QPP untouched—at least for a while. However, we also speculate that they will attempt to repeal at least some provisions in the Affordable Care Act (ACA). The ACS intends to play an active role in what is certain to be a highly charged debate—just as we did when the ACA was under consideration. As we enter this discussion, we will advocate for the policies that we believe will have the greatest benefit toward ensuring that all surgical patients have access to necessary services. We will not be swayed by politics but rather, will promote our enduring principles for health care reform: quality improvement and patient safety, patient access to surgical care, reduction of health care costs, and medical liability reform.

Education

Surgical education and training have been at the heart of the College’s mission since the organization’s inception. We believe the ACS’ education and training programs are the cornerstones of excellence, transform possibilities into realities, and instill the joy of lifelong learning.

Of particular concern in recent years have been reports that a significant percentage of general surgeon residency graduates leave training feeling insecure about their ability to perform advanced procedures and to manage a practice. In response, the College launched the Transition to Practice in General Surgery program, which provides opportunities for recently graduated residents to engage in a period of mentored practice.

In addition, the College has been working with other stakeholders, including the ABS, the Accreditation Council for Graduate Medical Education, the Association of Program Directors in Surgery, and the Residency Review Committee for Surgery, to develop a road map to secure the future of general surgery. Concepts discussed in these meetings include the following:

• Medical student boot camps
• Further training after five years of general surgery residency
• Modification to duty-hour requirements
• Competency-based education and skills assessment
• Guidelines for self-assessment during residency
• A faculty development requirement
• Career-long record keeping, starting in medical school

Today’s residents are tomorrow’s surgeons. Given the aging population that will be seeking their services, it is imperative that the House of Surgery take responsibility for ensuring that graduates of general surgery training programs have the full range of skills and the confidence necessary to care for these vulnerable patients.

Member services and communication

Our Member Services area continues to develop programs that are designed to encourage surgeon engagement and well-being.

The 2017 Leadership & Advocacy Summit, May 6-9 in Washington, DC, will address such topics as team building, managing critical situations, burnout, common mistakes in leadership, and domestic volunteerism. During the advocacy portion of the meeting, members will have opportunities to flex their leadership muscle and advocate on their patients’ behalf.

The College recognizes that surgeons need to be mentally, emotionally, and physically healthy to provide optimal care to their patients. With this thought in mind, the ACS invites all active, dues-paying members to use the Physician Well-Being Index. This validated screening tool provides an opportunity for surgeons to better understand their overall well-being and identify areas of risk compared to physicians across the nation. Access to local and national resources will also be targeted to surgeons based on their results. Access the ACS Surgeon Well-Being page to learn more about the tool.

Furthermore, the College has continued to make its communications vehicles more interactive and user-friendly. The ACS Communities are thriving, allowing members to share their common concerns and interests in a protected environment. We also are working to have all of our major publications, including the Bulletin and the Journal of the American College of Surgeons, moved to fully digital platforms.

I am proud of the strides the College is making and look forward to an exciting and productive year. As always, please let us know how we can better serve you and your patients.

Dr. Hoyt is the Executive Director of the American College of Surgeons.

With a new administration and Congress in place, as well as many exciting internal changes, the American College of Surgeons (ACS) is looking forward to an exciting year ahead.

Quality improvement

Making certain that surgeons have the tools they need to measure and evaluate their performance is a key mission of the College. To this end, we have initiated the database integration system, which will bring together under a single platform the ACS National Surgical Quality Improvement Program (ACS NSQIP®), National Cancer Database, National Trauma Data Bank, and Surgeon Specific Registry (SSRTM). This project, which is being implemented incrementally, will make it easier for surgeons to meet American Board of Surgery (ABS) Maintenance of Certification requirements and Medicare payment mandates.

Advocacy

The Medicare Access and CHIP Reauthorization Act (MACRA), enacted in 2015, repealed the flawed sustainable growth rate (SGR) methodology that was used for many years to calculate Medicare physician reimbursement. Replacing the SGR is the Quality Payment Program (QPP), which advances a longstanding policy goal of basing payment on value rather than on volume.

Surgeons can participate in the QPP through one of two pathways—the Merit-Based Incentive Payment System (MIPS) or the Advanced Alternative Payment Models (APMs). MIPS is the default QPP pathway most physicians will use initially. The College has taken a number of steps to ensure that surgeons are able to comply with MIPS’ reporting requirements and performance measures. For example, we have created an online Resource Center (https://www.facs.org/advocacy/qpp) for surgeons seeking information about the QPP. In addition, we are working with health policy experts at Brandeis University, Waltham, MA, and Brigham and Women’s Hospital, Boston, to propose surgical APMs.

We anticipate that the new presidential administration and Republican-controlled Congress will leave QPP untouched—at least for a while. However, we also speculate that they will attempt to repeal at least some provisions in the Affordable Care Act (ACA). The ACS intends to play an active role in what is certain to be a highly charged debate—just as we did when the ACA was under consideration. As we enter this discussion, we will advocate for the policies that we believe will have the greatest benefit toward ensuring that all surgical patients have access to necessary services. We will not be swayed by politics but rather, will promote our enduring principles for health care reform: quality improvement and patient safety, patient access to surgical care, reduction of health care costs, and medical liability reform.

Education

Surgical education and training have been at the heart of the College’s mission since the organization’s inception. We believe the ACS’ education and training programs are the cornerstones of excellence, transform possibilities into realities, and instill the joy of lifelong learning.

Of particular concern in recent years have been reports that a significant percentage of general surgeon residency graduates leave training feeling insecure about their ability to perform advanced procedures and to manage a practice. In response, the College launched the Transition to Practice in General Surgery program, which provides opportunities for recently graduated residents to engage in a period of mentored practice.

In addition, the College has been working with other stakeholders, including the ABS, the Accreditation Council for Graduate Medical Education, the Association of Program Directors in Surgery, and the Residency Review Committee for Surgery, to develop a road map to secure the future of general surgery. Concepts discussed in these meetings include the following:

• Medical student boot camps
• Further training after five years of general surgery residency
• Modification to duty-hour requirements
• Competency-based education and skills assessment
• Guidelines for self-assessment during residency
• A faculty development requirement
• Career-long record keeping, starting in medical school

Today’s residents are tomorrow’s surgeons. Given the aging population that will be seeking their services, it is imperative that the House of Surgery take responsibility for ensuring that graduates of general surgery training programs have the full range of skills and the confidence necessary to care for these vulnerable patients.

Member services and communication

Our Member Services area continues to develop programs that are designed to encourage surgeon engagement and well-being.

The 2017 Leadership & Advocacy Summit, May 6-9 in Washington, DC, will address such topics as team building, managing critical situations, burnout, common mistakes in leadership, and domestic volunteerism. During the advocacy portion of the meeting, members will have opportunities to flex their leadership muscle and advocate on their patients’ behalf.

The College recognizes that surgeons need to be mentally, emotionally, and physically healthy to provide optimal care to their patients. With this thought in mind, the ACS invites all active, dues-paying members to use the Physician Well-Being Index. This validated screening tool provides an opportunity for surgeons to better understand their overall well-being and identify areas of risk compared to physicians across the nation. Access to local and national resources will also be targeted to surgeons based on their results. Access the ACS Surgeon Well-Being page to learn more about the tool.

Furthermore, the College has continued to make its communications vehicles more interactive and user-friendly. The ACS Communities are thriving, allowing members to share their common concerns and interests in a protected environment. We also are working to have all of our major publications, including the Bulletin and the Journal of the American College of Surgeons, moved to fully digital platforms.

I am proud of the strides the College is making and look forward to an exciting and productive year. As always, please let us know how we can better serve you and your patients.

Dr. Hoyt is the Executive Director of the American College of Surgeons.

With a new administration and Congress in place, as well as many exciting internal changes, the American College of Surgeons (ACS) is looking forward to an exciting year ahead.

Quality improvement

Making certain that surgeons have the tools they need to measure and evaluate their performance is a key mission of the College. To this end, we have initiated the database integration system, which will bring together under a single platform the ACS National Surgical Quality Improvement Program (ACS NSQIP®), National Cancer Database, National Trauma Data Bank, and Surgeon Specific Registry (SSRTM). This project, which is being implemented incrementally, will make it easier for surgeons to meet American Board of Surgery (ABS) Maintenance of Certification requirements and Medicare payment mandates.

Advocacy

The Medicare Access and CHIP Reauthorization Act (MACRA), enacted in 2015, repealed the flawed sustainable growth rate (SGR) methodology that was used for many years to calculate Medicare physician reimbursement. Replacing the SGR is the Quality Payment Program (QPP), which advances a longstanding policy goal of basing payment on value rather than on volume.

Surgeons can participate in the QPP through one of two pathways—the Merit-Based Incentive Payment System (MIPS) or the Advanced Alternative Payment Models (APMs). MIPS is the default QPP pathway most physicians will use initially. The College has taken a number of steps to ensure that surgeons are able to comply with MIPS’ reporting requirements and performance measures. For example, we have created an online Resource Center (https://www.facs.org/advocacy/qpp) for surgeons seeking information about the QPP. In addition, we are working with health policy experts at Brandeis University, Waltham, MA, and Brigham and Women’s Hospital, Boston, to propose surgical APMs.

We anticipate that the new presidential administration and Republican-controlled Congress will leave QPP untouched—at least for a while. However, we also speculate that they will attempt to repeal at least some provisions in the Affordable Care Act (ACA). The ACS intends to play an active role in what is certain to be a highly charged debate—just as we did when the ACA was under consideration. As we enter this discussion, we will advocate for the policies that we believe will have the greatest benefit toward ensuring that all surgical patients have access to necessary services. We will not be swayed by politics but rather, will promote our enduring principles for health care reform: quality improvement and patient safety, patient access to surgical care, reduction of health care costs, and medical liability reform.

Education

Surgical education and training have been at the heart of the College’s mission since the organization’s inception. We believe the ACS’ education and training programs are the cornerstones of excellence, transform possibilities into realities, and instill the joy of lifelong learning.

Of particular concern in recent years have been reports that a significant percentage of general surgeon residency graduates leave training feeling insecure about their ability to perform advanced procedures and to manage a practice. In response, the College launched the Transition to Practice in General Surgery program, which provides opportunities for recently graduated residents to engage in a period of mentored practice.

In addition, the College has been working with other stakeholders, including the ABS, the Accreditation Council for Graduate Medical Education, the Association of Program Directors in Surgery, and the Residency Review Committee for Surgery, to develop a road map to secure the future of general surgery. Concepts discussed in these meetings include the following:

• Medical student boot camps
• Further training after five years of general surgery residency
• Modification to duty-hour requirements
• Competency-based education and skills assessment
• Guidelines for self-assessment during residency
• A faculty development requirement
• Career-long record keeping, starting in medical school

Today’s residents are tomorrow’s surgeons. Given the aging population that will be seeking their services, it is imperative that the House of Surgery take responsibility for ensuring that graduates of general surgery training programs have the full range of skills and the confidence necessary to care for these vulnerable patients.

Member services and communication

Our Member Services area continues to develop programs that are designed to encourage surgeon engagement and well-being.

The 2017 Leadership & Advocacy Summit, May 6-9 in Washington, DC, will address such topics as team building, managing critical situations, burnout, common mistakes in leadership, and domestic volunteerism. During the advocacy portion of the meeting, members will have opportunities to flex their leadership muscle and advocate on their patients’ behalf.

The College recognizes that surgeons need to be mentally, emotionally, and physically healthy to provide optimal care to their patients. With this thought in mind, the ACS invites all active, dues-paying members to use the Physician Well-Being Index. This validated screening tool provides an opportunity for surgeons to better understand their overall well-being and identify areas of risk compared to physicians across the nation. Access to local and national resources will also be targeted to surgeons based on their results. Access the ACS Surgeon Well-Being page to learn more about the tool.

Furthermore, the College has continued to make its communications vehicles more interactive and user-friendly. The ACS Communities are thriving, allowing members to share their common concerns and interests in a protected environment. We also are working to have all of our major publications, including the Bulletin and the Journal of the American College of Surgeons, moved to fully digital platforms.

I am proud of the strides the College is making and look forward to an exciting and productive year. As always, please let us know how we can better serve you and your patients.

Dr. Hoyt is the Executive Director of the American College of Surgeons.

To provide a more comprehensive look at the American College of Surgeons (ACS) quality improvement efforts, the College has announced that the ACS National Surgical Quality Improvement Program (ACS NSQIP®) Annual Conference will now be the 2017 ACS Quality and Safety Conference. The meeting will take place July 21-24 at the New York Hilton Midtown, NY.

The annual ACS NSQIP conference has grown rapidly in recent years – the 2016 conference in San Diego, CA, drew nearly 1,500 surgeon champions, surgical clinical reviewers (SCRs), and other quality improvement professionals. The ACS Quality and Safety Conference will build on that success, featuring leaders in surgery as speakers and various presentations focused on ACS NSQIP, while offering expanded content on the following ACS Quality Programs:

• ACS NSQIP Pediatric

• Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program

• Children’s Surgery Verification™ Quality Improvement Program

• Surgeon Specific Registry
 

Achieving quality

The theme of the expanded conference, Achieving Quality: Present and Future, will serve as the basis of the meeting’s proceedings. To achieve the goal of improving quality, presenters and organizers are striving to accomplish the following objectives:

Provide a forum to share the most up-to-date knowledge pertaining to local, national, and international quality improvement initiatives in surgery.

Present methods used to analyze clinical registry data and demonstrate practical ways to use the data.

Assist hospitals in analyzing, managing, and interpreting data by providing education on proven methods that will empower hospitals to make a positive impact on patient care.

Enhance the learning experience by offering breakout sessions that educate attendees on topic areas of interest to them, with consideration of their level of experience in ACS quality improvement programs.
 

Conference highlights

In addition to talks from surgical leaders, the 2017 ACS Quality and Safety Conference will offer other notable events.

Keynote speaker Blake Haxton, a member of the 2016 U.S. Paralympic Team in rowing, will share his unique insight with attendees. Mr. Haxton contracted necrotizing fasciitis in March 2009, in his senior year of high school. The infection led to heart, lung, kidney, and liver failure, as well as the loss of both legs; however, after an intensive rehabilitation regimen, he was able to attend and graduate from college and law school.

Another conference highlight will be abstract competitions in four categories: Medical Student and Surgical Resident Abstract Competition, SCR Abstract Competition, Clinical Abstract Competition, and Abstract Poster Competition.

Clifford Y. Ko, MD, MS, MSHS, FACS, FASCRS, Director, ACS Division of Research and Optimal Patient Care, which oversees all ACS Quality Programs, is enthusiastic about the newly expanded ACS Quality and Safety Conference. “We are excited to have multiple quality programs of the American College of Surgeons coming together for this conference so that we can all learn how to get better, become more efficient, and provide high-value care in all types of settings,” Dr. Ko said. “This is the first time we’ve put together a conference like this, which we hope will be the first of many.”

More information about the 2017 ACS Quality and Safety Conference can be found at facs.org/quality-programs/quality-safety-conference.

To provide a more comprehensive look at the American College of Surgeons (ACS) quality improvement efforts, the College has announced that the ACS National Surgical Quality Improvement Program (ACS NSQIP®) Annual Conference will now be the 2017 ACS Quality and Safety Conference. The meeting will take place July 21-24 at the New York Hilton Midtown, NY.

The annual ACS NSQIP conference has grown rapidly in recent years – the 2016 conference in San Diego, CA, drew nearly 1,500 surgeon champions, surgical clinical reviewers (SCRs), and other quality improvement professionals. The ACS Quality and Safety Conference will build on that success, featuring leaders in surgery as speakers and various presentations focused on ACS NSQIP, while offering expanded content on the following ACS Quality Programs:

• ACS NSQIP Pediatric

• Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program

• Children’s Surgery Verification™ Quality Improvement Program

• Surgeon Specific Registry
 

Achieving quality

The theme of the expanded conference, Achieving Quality: Present and Future, will serve as the basis of the meeting’s proceedings. To achieve the goal of improving quality, presenters and organizers are striving to accomplish the following objectives:

Provide a forum to share the most up-to-date knowledge pertaining to local, national, and international quality improvement initiatives in surgery.

Present methods used to analyze clinical registry data and demonstrate practical ways to use the data.

Assist hospitals in analyzing, managing, and interpreting data by providing education on proven methods that will empower hospitals to make a positive impact on patient care.

Enhance the learning experience by offering breakout sessions that educate attendees on topic areas of interest to them, with consideration of their level of experience in ACS quality improvement programs.
 

Conference highlights

In addition to talks from surgical leaders, the 2017 ACS Quality and Safety Conference will offer other notable events.

Keynote speaker Blake Haxton, a member of the 2016 U.S. Paralympic Team in rowing, will share his unique insight with attendees. Mr. Haxton contracted necrotizing fasciitis in March 2009, in his senior year of high school. The infection led to heart, lung, kidney, and liver failure, as well as the loss of both legs; however, after an intensive rehabilitation regimen, he was able to attend and graduate from college and law school.

Another conference highlight will be abstract competitions in four categories: Medical Student and Surgical Resident Abstract Competition, SCR Abstract Competition, Clinical Abstract Competition, and Abstract Poster Competition.

Clifford Y. Ko, MD, MS, MSHS, FACS, FASCRS, Director, ACS Division of Research and Optimal Patient Care, which oversees all ACS Quality Programs, is enthusiastic about the newly expanded ACS Quality and Safety Conference. “We are excited to have multiple quality programs of the American College of Surgeons coming together for this conference so that we can all learn how to get better, become more efficient, and provide high-value care in all types of settings,” Dr. Ko said. “This is the first time we’ve put together a conference like this, which we hope will be the first of many.”

More information about the 2017 ACS Quality and Safety Conference can be found at facs.org/quality-programs/quality-safety-conference.

To provide a more comprehensive look at the American College of Surgeons (ACS) quality improvement efforts, the College has announced that the ACS National Surgical Quality Improvement Program (ACS NSQIP®) Annual Conference will now be the 2017 ACS Quality and Safety Conference. The meeting will take place July 21-24 at the New York Hilton Midtown, NY.

The annual ACS NSQIP conference has grown rapidly in recent years – the 2016 conference in San Diego, CA, drew nearly 1,500 surgeon champions, surgical clinical reviewers (SCRs), and other quality improvement professionals. The ACS Quality and Safety Conference will build on that success, featuring leaders in surgery as speakers and various presentations focused on ACS NSQIP, while offering expanded content on the following ACS Quality Programs:

• ACS NSQIP Pediatric

• Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program

• Children’s Surgery Verification™ Quality Improvement Program

• Surgeon Specific Registry
 

Achieving quality

The theme of the expanded conference, Achieving Quality: Present and Future, will serve as the basis of the meeting’s proceedings. To achieve the goal of improving quality, presenters and organizers are striving to accomplish the following objectives:

Provide a forum to share the most up-to-date knowledge pertaining to local, national, and international quality improvement initiatives in surgery.

Present methods used to analyze clinical registry data and demonstrate practical ways to use the data.

Assist hospitals in analyzing, managing, and interpreting data by providing education on proven methods that will empower hospitals to make a positive impact on patient care.

Enhance the learning experience by offering breakout sessions that educate attendees on topic areas of interest to them, with consideration of their level of experience in ACS quality improvement programs.
 

Conference highlights

In addition to talks from surgical leaders, the 2017 ACS Quality and Safety Conference will offer other notable events.

Keynote speaker Blake Haxton, a member of the 2016 U.S. Paralympic Team in rowing, will share his unique insight with attendees. Mr. Haxton contracted necrotizing fasciitis in March 2009, in his senior year of high school. The infection led to heart, lung, kidney, and liver failure, as well as the loss of both legs; however, after an intensive rehabilitation regimen, he was able to attend and graduate from college and law school.

Another conference highlight will be abstract competitions in four categories: Medical Student and Surgical Resident Abstract Competition, SCR Abstract Competition, Clinical Abstract Competition, and Abstract Poster Competition.

Clifford Y. Ko, MD, MS, MSHS, FACS, FASCRS, Director, ACS Division of Research and Optimal Patient Care, which oversees all ACS Quality Programs, is enthusiastic about the newly expanded ACS Quality and Safety Conference. “We are excited to have multiple quality programs of the American College of Surgeons coming together for this conference so that we can all learn how to get better, become more efficient, and provide high-value care in all types of settings,” Dr. Ko said. “This is the first time we’ve put together a conference like this, which we hope will be the first of many.”

More information about the 2017 ACS Quality and Safety Conference can be found at facs.org/quality-programs/quality-safety-conference.

The American Medical Association (AMA) Interim House of Delegates (HOD) meeting took place November 12–15, 2016, in Orlando, FL. A total of 530 state medical society and specialty society delegates, including the six members of the American College of Surgeons’ (ACS) delegation, debated the policy implications of 32 reports and 101 resolutions. Occurring within a week of the national elections, a central focus of the meeting was the uncertainty about the future of the Affordable Care Act (ACA). On the other hand, the Stop the Bleed® program received an enthusiastic reception.

ACS delegation sponsors Stop the Bleed skills course

AMA meetings provide an opportunity for the ACS delegates to share College initiatives with physician leaders from a breadth of geographic locations, specialties, and career stages. In this spirit, ACS delegates, all of whom are Stop the Bleed instructors, along with Leonard J. Weireter, MD, FACS, Vice-Chair, ACS Committee on Trauma, presented the skills course to 125 practicing physicians, residents, and medical student delegates. Through four half-hour sessions, participants refreshed their hands-on skills in bleeding control and became advocates for bringing the course back to their communities. Course success was recognized before the entire HOD.

Surgical Caucus focuses on mass casualty readiness

The Surgical Caucus sponsored a one-hour educational session, The Hartford Consensus: Strategies to Enhance Survival in Active Shooter and Intentional Mass Casualty Events. Dr. Weireter shared an overview of the Hartford Consensus recommendations for effective response to active shooter and mass casualty events and highlighted the value of the Stop the Bleed course in improving survival of casualties from these events.

Orlando trauma surgeon Michael Cheatham, MD, FACS, gave a synopsis of the Orlando Regional Medical Center response to the Pulse nightclub shooting in June 2016. In addition to conducting relevant readiness drills, he emphasized the importance of including casualty family assistance and post-event hospital staff counseling in mass casualty plans.

At this meeting, the AMA endorsed recommendations from a 2015 call to action by eight health professional organizations and the American Bar Association to reduce the public health consequences of firearm-related injury.

U.S. elections put health care system in spotlight

Five resolutions covering a spectrum of opinions about AMA engagement in ACA reform were discussed. The five proposals were consolidated into one adopted resolution, which calls for the AMA, in collaboration with state and specialty medical societies, to actively discuss the future of health care reform with the new presidential administration and Congress. AMA executive vice-president James Madera, MD, sent a letter to congressional leaders on January 3 emphasizing the AMA’s interest in proposals that “make coverage more affordable, provide greater choice, and increase the number of those insured.”

The ACS delegation focused on the ACS Health Care Reform General Principles, which promote a systems-based approach to health care quality and safety, patient access to surgical care, reduction of health care costs, and medical liability reform.

Maintenance of Certification

General disaffection with Maintenance of Certification (MOC) requirements persists in multiple specialties, with particular concerns related to its use in credentialing and privileging decisions. The HOD adopted a policy that directs the AMA to increase efforts to ensure that MOC does not become a requirement for insurance panel participation, state medical licensure, and medical staff membership (initial and ongoing).

Medical student and resident training

Delegates agreed with a need for formal leadership training during medical school. The AMA now advocates for the creation of leadership programs that emphasize experiential learning of skills necessary to lead inter-professional teams. Delegates also recognized the importance of having training program policies that support residents who are breastfeeding. As a result, the AMA will now work with appropriate professional regulatory organizations to put policies for protected times and locations for breastfeeding into program requirements.

Surgeon management of patients with perioperative pain

A resolution intended to reduce perioperative opioid consumption was introduced, calling for hospitals to adopt practices for perioperative pain management, which include services dedicated to acute pain management. This proposal generated a great deal of concern among surgical and anesthesiology delegates. The HOD appreciated that surgeons are trained to manage the perioperative pain of their patients and may consult for additional services as needed. Thus, existing AMA efforts to promote appropriate clinical use of opioid analgesics were reaffirmed in lieu of the resolution.

Next meeting

The next meeting of the AMA HOD is scheduled for June 10–14 in Chicago. This meeting will be the first since the inauguration of President Donald Trump, and the ACS delegates anticipate that national health care policy will again dominate the discussion. ACS members with suggestions for potential resolutions should forward them to Jon Sutton at [email protected].

ACS Delegation at the AMA HOD

• John H. Armstrong, MD, FACS (Delegation Chair), acute care surgery, Ocala, FL

• Brian J. Gavitt, MD, MPH (also Young Physicians Section delegate), general surgery, Cincinnati, OH

• Jacob Moalem, MD, FACS (also Young Physicians Section delegate), general surgery, Rochester, NY

• Leigh A. Neumayer, MD, FACS, general surgery, Tucson, AZ; Vice-Chair, ACS Board of Regents

• Naveen F. Sangji, MD, general surgery resident, Boston, MA

• Patricia L. Turner, MD, FACS, general surgery, Chicago, IL; Director, ACS Division of Member Services; Chair, AMA Council on Medical Education
 

Dr. Armstrong is a member of the American College of Surgeons (ACS) Health Policy and Advocacy Group, and Past-Chair, ACS Professional Association political action committee (ACSPA-SurgeonsPAC).

Mr. Sutton is Manager, State Affairs, ACS Division of Advocacy and Health Policy, Washington, DC.

The American Medical Association (AMA) Interim House of Delegates (HOD) meeting took place November 12–15, 2016, in Orlando, FL. A total of 530 state medical society and specialty society delegates, including the six members of the American College of Surgeons’ (ACS) delegation, debated the policy implications of 32 reports and 101 resolutions. Occurring within a week of the national elections, a central focus of the meeting was the uncertainty about the future of the Affordable Care Act (ACA). On the other hand, the Stop the Bleed® program received an enthusiastic reception.

ACS delegation sponsors Stop the Bleed skills course

AMA meetings provide an opportunity for the ACS delegates to share College initiatives with physician leaders from a breadth of geographic locations, specialties, and career stages. In this spirit, ACS delegates, all of whom are Stop the Bleed instructors, along with Leonard J. Weireter, MD, FACS, Vice-Chair, ACS Committee on Trauma, presented the skills course to 125 practicing physicians, residents, and medical student delegates. Through four half-hour sessions, participants refreshed their hands-on skills in bleeding control and became advocates for bringing the course back to their communities. Course success was recognized before the entire HOD.

Surgical Caucus focuses on mass casualty readiness

The Surgical Caucus sponsored a one-hour educational session, The Hartford Consensus: Strategies to Enhance Survival in Active Shooter and Intentional Mass Casualty Events. Dr. Weireter shared an overview of the Hartford Consensus recommendations for effective response to active shooter and mass casualty events and highlighted the value of the Stop the Bleed course in improving survival of casualties from these events.

Orlando trauma surgeon Michael Cheatham, MD, FACS, gave a synopsis of the Orlando Regional Medical Center response to the Pulse nightclub shooting in June 2016. In addition to conducting relevant readiness drills, he emphasized the importance of including casualty family assistance and post-event hospital staff counseling in mass casualty plans.

At this meeting, the AMA endorsed recommendations from a 2015 call to action by eight health professional organizations and the American Bar Association to reduce the public health consequences of firearm-related injury.

U.S. elections put health care system in spotlight

Five resolutions covering a spectrum of opinions about AMA engagement in ACA reform were discussed. The five proposals were consolidated into one adopted resolution, which calls for the AMA, in collaboration with state and specialty medical societies, to actively discuss the future of health care reform with the new presidential administration and Congress. AMA executive vice-president James Madera, MD, sent a letter to congressional leaders on January 3 emphasizing the AMA’s interest in proposals that “make coverage more affordable, provide greater choice, and increase the number of those insured.”

The ACS delegation focused on the ACS Health Care Reform General Principles, which promote a systems-based approach to health care quality and safety, patient access to surgical care, reduction of health care costs, and medical liability reform.

Maintenance of Certification

General disaffection with Maintenance of Certification (MOC) requirements persists in multiple specialties, with particular concerns related to its use in credentialing and privileging decisions. The HOD adopted a policy that directs the AMA to increase efforts to ensure that MOC does not become a requirement for insurance panel participation, state medical licensure, and medical staff membership (initial and ongoing).

Medical student and resident training

Delegates agreed with a need for formal leadership training during medical school. The AMA now advocates for the creation of leadership programs that emphasize experiential learning of skills necessary to lead inter-professional teams. Delegates also recognized the importance of having training program policies that support residents who are breastfeeding. As a result, the AMA will now work with appropriate professional regulatory organizations to put policies for protected times and locations for breastfeeding into program requirements.

Surgeon management of patients with perioperative pain

A resolution intended to reduce perioperative opioid consumption was introduced, calling for hospitals to adopt practices for perioperative pain management, which include services dedicated to acute pain management. This proposal generated a great deal of concern among surgical and anesthesiology delegates. The HOD appreciated that surgeons are trained to manage the perioperative pain of their patients and may consult for additional services as needed. Thus, existing AMA efforts to promote appropriate clinical use of opioid analgesics were reaffirmed in lieu of the resolution.

Next meeting

The next meeting of the AMA HOD is scheduled for June 10–14 in Chicago. This meeting will be the first since the inauguration of President Donald Trump, and the ACS delegates anticipate that national health care policy will again dominate the discussion. ACS members with suggestions for potential resolutions should forward them to Jon Sutton at [email protected].

ACS Delegation at the AMA HOD

• John H. Armstrong, MD, FACS (Delegation Chair), acute care surgery, Ocala, FL

• Brian J. Gavitt, MD, MPH (also Young Physicians Section delegate), general surgery, Cincinnati, OH

• Jacob Moalem, MD, FACS (also Young Physicians Section delegate), general surgery, Rochester, NY

• Leigh A. Neumayer, MD, FACS, general surgery, Tucson, AZ; Vice-Chair, ACS Board of Regents

• Naveen F. Sangji, MD, general surgery resident, Boston, MA

• Patricia L. Turner, MD, FACS, general surgery, Chicago, IL; Director, ACS Division of Member Services; Chair, AMA Council on Medical Education
 

Dr. Armstrong is a member of the American College of Surgeons (ACS) Health Policy and Advocacy Group, and Past-Chair, ACS Professional Association political action committee (ACSPA-SurgeonsPAC).

Mr. Sutton is Manager, State Affairs, ACS Division of Advocacy and Health Policy, Washington, DC.

The American Medical Association (AMA) Interim House of Delegates (HOD) meeting took place November 12–15, 2016, in Orlando, FL. A total of 530 state medical society and specialty society delegates, including the six members of the American College of Surgeons’ (ACS) delegation, debated the policy implications of 32 reports and 101 resolutions. Occurring within a week of the national elections, a central focus of the meeting was the uncertainty about the future of the Affordable Care Act (ACA). On the other hand, the Stop the Bleed® program received an enthusiastic reception.

ACS delegation sponsors Stop the Bleed skills course

AMA meetings provide an opportunity for the ACS delegates to share College initiatives with physician leaders from a breadth of geographic locations, specialties, and career stages. In this spirit, ACS delegates, all of whom are Stop the Bleed instructors, along with Leonard J. Weireter, MD, FACS, Vice-Chair, ACS Committee on Trauma, presented the skills course to 125 practicing physicians, residents, and medical student delegates. Through four half-hour sessions, participants refreshed their hands-on skills in bleeding control and became advocates for bringing the course back to their communities. Course success was recognized before the entire HOD.

Surgical Caucus focuses on mass casualty readiness

The Surgical Caucus sponsored a one-hour educational session, The Hartford Consensus: Strategies to Enhance Survival in Active Shooter and Intentional Mass Casualty Events. Dr. Weireter shared an overview of the Hartford Consensus recommendations for effective response to active shooter and mass casualty events and highlighted the value of the Stop the Bleed course in improving survival of casualties from these events.

Orlando trauma surgeon Michael Cheatham, MD, FACS, gave a synopsis of the Orlando Regional Medical Center response to the Pulse nightclub shooting in June 2016. In addition to conducting relevant readiness drills, he emphasized the importance of including casualty family assistance and post-event hospital staff counseling in mass casualty plans.

At this meeting, the AMA endorsed recommendations from a 2015 call to action by eight health professional organizations and the American Bar Association to reduce the public health consequences of firearm-related injury.

U.S. elections put health care system in spotlight

Five resolutions covering a spectrum of opinions about AMA engagement in ACA reform were discussed. The five proposals were consolidated into one adopted resolution, which calls for the AMA, in collaboration with state and specialty medical societies, to actively discuss the future of health care reform with the new presidential administration and Congress. AMA executive vice-president James Madera, MD, sent a letter to congressional leaders on January 3 emphasizing the AMA’s interest in proposals that “make coverage more affordable, provide greater choice, and increase the number of those insured.”

The ACS delegation focused on the ACS Health Care Reform General Principles, which promote a systems-based approach to health care quality and safety, patient access to surgical care, reduction of health care costs, and medical liability reform.

Maintenance of Certification

General disaffection with Maintenance of Certification (MOC) requirements persists in multiple specialties, with particular concerns related to its use in credentialing and privileging decisions. The HOD adopted a policy that directs the AMA to increase efforts to ensure that MOC does not become a requirement for insurance panel participation, state medical licensure, and medical staff membership (initial and ongoing).

Medical student and resident training

Delegates agreed with a need for formal leadership training during medical school. The AMA now advocates for the creation of leadership programs that emphasize experiential learning of skills necessary to lead inter-professional teams. Delegates also recognized the importance of having training program policies that support residents who are breastfeeding. As a result, the AMA will now work with appropriate professional regulatory organizations to put policies for protected times and locations for breastfeeding into program requirements.

Surgeon management of patients with perioperative pain

A resolution intended to reduce perioperative opioid consumption was introduced, calling for hospitals to adopt practices for perioperative pain management, which include services dedicated to acute pain management. This proposal generated a great deal of concern among surgical and anesthesiology delegates. The HOD appreciated that surgeons are trained to manage the perioperative pain of their patients and may consult for additional services as needed. Thus, existing AMA efforts to promote appropriate clinical use of opioid analgesics were reaffirmed in lieu of the resolution.

Next meeting

The next meeting of the AMA HOD is scheduled for June 10–14 in Chicago. This meeting will be the first since the inauguration of President Donald Trump, and the ACS delegates anticipate that national health care policy will again dominate the discussion. ACS members with suggestions for potential resolutions should forward them to Jon Sutton at [email protected].

ACS Delegation at the AMA HOD

• John H. Armstrong, MD, FACS (Delegation Chair), acute care surgery, Ocala, FL

• Brian J. Gavitt, MD, MPH (also Young Physicians Section delegate), general surgery, Cincinnati, OH

• Jacob Moalem, MD, FACS (also Young Physicians Section delegate), general surgery, Rochester, NY

• Leigh A. Neumayer, MD, FACS, general surgery, Tucson, AZ; Vice-Chair, ACS Board of Regents

• Naveen F. Sangji, MD, general surgery resident, Boston, MA

• Patricia L. Turner, MD, FACS, general surgery, Chicago, IL; Director, ACS Division of Member Services; Chair, AMA Council on Medical Education
 

Dr. Armstrong is a member of the American College of Surgeons (ACS) Health Policy and Advocacy Group, and Past-Chair, ACS Professional Association political action committee (ACSPA-SurgeonsPAC).

Mr. Sutton is Manager, State Affairs, ACS Division of Advocacy and Health Policy, Washington, DC.

I am sure that even though Theodor Billroth and Johannes Brahms were close friends, Billroth never listened to music in his operating room. I’m pretty sure because the Victrola was invented around 1906 and the first commercial radio broadcast was in 1920. So unless Billroth hired a Viennese string quartet to play in his amphitheater, it is likely the operating room was a pretty quiet place.

Radios were the size of a small refrigerator into the 1940s when Bell Laboratories’ invention of the transistor technology permitted small units to play tinny music through speakers about 2 inches across. So, I would guess that Alfred Blalock didn’t listen to Elvis Presley or Buddy Holly during his pioneering days at Hopkins.  

By the late 1960s high-quality, recorded music was available on 8-track tapes invented by the Lear Jet Corporation. Music at that point was literally available everywhere and the OR became a theater once more for some surgeons. Cassette tapes followed, and Johnny Paycheck echoed in the heart room where I trained in Dallas – usually at high volume. When Apple changed the world with the iPod in 2001 and then the Internet streaming services emerged, it became possible to take out a gall bladder accompanied by Vladimir Horowitz or Madonna. And it happens routinely.  

As I write this, I am listening to a jazz streaming station. Music is one of the most important elements of my life. Yet, my operating room has had music on only one occasion since I became an attending surgeon. I love music too much for it to be in my OR. It not only relaxes me, which may not be entirely a good thing in surgery, but it engages my intellect, taking up needed CPU time which might be useful in avoiding catastrophe for the patient before me.

Not long ago this subject was the focus of a discussion thread on the ACS Communities. Many reported that they never listen to music in the OR, others said it was essential to their performance, and still others took a middle ground. Everyone said the music shouldn’t be loud; however, I can recall visiting a number of operating rooms in which loud was the standard volume setting. Most respondents spoke in terms of what they needed and like. Several felt that as captain of the SS Operating Room they had the final say of whether, what, and when music would be played.

I noted in the conversation justification, defensiveness, authoritarianism mixed with personal insight that is so characteristic of many surgeons. Of course, there isn’t a “right” answer here any more than there is in a number of OR traditions.  The evidence is all over the place except when it comes to volume. There, it is clear that loud music causes or exacerbates communications errors due to inability of the OR team to hear one another or distraction of the team from their primary task.

Music affects everyone in the OR. It represents one of many operating room components that hold the potential of both betterment of care or endangerment of the patient. To say that music in the OR is wrong is like saying propellers on aircraft are somehow wrong. Among the most serious injuries at general aviation airports is individuals walking into a spinning propeller; however, without the propeller the plane can’t fly and deliver its benefits enjoyed at large. The problem isn’t that propellers are evil. It is that they are invisible to the victim who ignores their dangers.

My point is that music is an example of the need for us to be aware of the primary and secondary effects of even the small things we do in the OR because innocuous as they seem, they have potential dangers. The Council on Surgical and Perioperative Care of which the ACS is a member, has more data and resources on their homepage (cspsteam.org) for those interested in the subject on distractions in the OR.  

So, what I’ve learned through listening to the music of my colleagues opinions is that when it comes to music, we need to be aware of the spinning propeller of noise pollution in the OR. Many invisible dangers inhabit the OR. Take a moment and listen for them.

Dr. Hughes is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, and Co-Editor of ACS Surgery News.

I am sure that even though Theodor Billroth and Johannes Brahms were close friends, Billroth never listened to music in his operating room. I’m pretty sure because the Victrola was invented around 1906 and the first commercial radio broadcast was in 1920. So unless Billroth hired a Viennese string quartet to play in his amphitheater, it is likely the operating room was a pretty quiet place.

Radios were the size of a small refrigerator into the 1940s when Bell Laboratories’ invention of the transistor technology permitted small units to play tinny music through speakers about 2 inches across. So, I would guess that Alfred Blalock didn’t listen to Elvis Presley or Buddy Holly during his pioneering days at Hopkins.  

By the late 1960s high-quality, recorded music was available on 8-track tapes invented by the Lear Jet Corporation. Music at that point was literally available everywhere and the OR became a theater once more for some surgeons. Cassette tapes followed, and Johnny Paycheck echoed in the heart room where I trained in Dallas – usually at high volume. When Apple changed the world with the iPod in 2001 and then the Internet streaming services emerged, it became possible to take out a gall bladder accompanied by Vladimir Horowitz or Madonna. And it happens routinely.  

As I write this, I am listening to a jazz streaming station. Music is one of the most important elements of my life. Yet, my operating room has had music on only one occasion since I became an attending surgeon. I love music too much for it to be in my OR. It not only relaxes me, which may not be entirely a good thing in surgery, but it engages my intellect, taking up needed CPU time which might be useful in avoiding catastrophe for the patient before me.

Not long ago this subject was the focus of a discussion thread on the ACS Communities. Many reported that they never listen to music in the OR, others said it was essential to their performance, and still others took a middle ground. Everyone said the music shouldn’t be loud; however, I can recall visiting a number of operating rooms in which loud was the standard volume setting. Most respondents spoke in terms of what they needed and like. Several felt that as captain of the SS Operating Room they had the final say of whether, what, and when music would be played.

I noted in the conversation justification, defensiveness, authoritarianism mixed with personal insight that is so characteristic of many surgeons. Of course, there isn’t a “right” answer here any more than there is in a number of OR traditions.  The evidence is all over the place except when it comes to volume. There, it is clear that loud music causes or exacerbates communications errors due to inability of the OR team to hear one another or distraction of the team from their primary task.

Music affects everyone in the OR. It represents one of many operating room components that hold the potential of both betterment of care or endangerment of the patient. To say that music in the OR is wrong is like saying propellers on aircraft are somehow wrong. Among the most serious injuries at general aviation airports is individuals walking into a spinning propeller; however, without the propeller the plane can’t fly and deliver its benefits enjoyed at large. The problem isn’t that propellers are evil. It is that they are invisible to the victim who ignores their dangers.

My point is that music is an example of the need for us to be aware of the primary and secondary effects of even the small things we do in the OR because innocuous as they seem, they have potential dangers. The Council on Surgical and Perioperative Care of which the ACS is a member, has more data and resources on their homepage (cspsteam.org) for those interested in the subject on distractions in the OR.  

So, what I’ve learned through listening to the music of my colleagues opinions is that when it comes to music, we need to be aware of the spinning propeller of noise pollution in the OR. Many invisible dangers inhabit the OR. Take a moment and listen for them.

Dr. Hughes is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, and Co-Editor of ACS Surgery News.

I am sure that even though Theodor Billroth and Johannes Brahms were close friends, Billroth never listened to music in his operating room. I’m pretty sure because the Victrola was invented around 1906 and the first commercial radio broadcast was in 1920. So unless Billroth hired a Viennese string quartet to play in his amphitheater, it is likely the operating room was a pretty quiet place.

Radios were the size of a small refrigerator into the 1940s when Bell Laboratories’ invention of the transistor technology permitted small units to play tinny music through speakers about 2 inches across. So, I would guess that Alfred Blalock didn’t listen to Elvis Presley or Buddy Holly during his pioneering days at Hopkins.  

By the late 1960s high-quality, recorded music was available on 8-track tapes invented by the Lear Jet Corporation. Music at that point was literally available everywhere and the OR became a theater once more for some surgeons. Cassette tapes followed, and Johnny Paycheck echoed in the heart room where I trained in Dallas – usually at high volume. When Apple changed the world with the iPod in 2001 and then the Internet streaming services emerged, it became possible to take out a gall bladder accompanied by Vladimir Horowitz or Madonna. And it happens routinely.  

As I write this, I am listening to a jazz streaming station. Music is one of the most important elements of my life. Yet, my operating room has had music on only one occasion since I became an attending surgeon. I love music too much for it to be in my OR. It not only relaxes me, which may not be entirely a good thing in surgery, but it engages my intellect, taking up needed CPU time which might be useful in avoiding catastrophe for the patient before me.

Not long ago this subject was the focus of a discussion thread on the ACS Communities. Many reported that they never listen to music in the OR, others said it was essential to their performance, and still others took a middle ground. Everyone said the music shouldn’t be loud; however, I can recall visiting a number of operating rooms in which loud was the standard volume setting. Most respondents spoke in terms of what they needed and like. Several felt that as captain of the SS Operating Room they had the final say of whether, what, and when music would be played.

I noted in the conversation justification, defensiveness, authoritarianism mixed with personal insight that is so characteristic of many surgeons. Of course, there isn’t a “right” answer here any more than there is in a number of OR traditions.  The evidence is all over the place except when it comes to volume. There, it is clear that loud music causes or exacerbates communications errors due to inability of the OR team to hear one another or distraction of the team from their primary task.

Music affects everyone in the OR. It represents one of many operating room components that hold the potential of both betterment of care or endangerment of the patient. To say that music in the OR is wrong is like saying propellers on aircraft are somehow wrong. Among the most serious injuries at general aviation airports is individuals walking into a spinning propeller; however, without the propeller the plane can’t fly and deliver its benefits enjoyed at large. The problem isn’t that propellers are evil. It is that they are invisible to the victim who ignores their dangers.

My point is that music is an example of the need for us to be aware of the primary and secondary effects of even the small things we do in the OR because innocuous as they seem, they have potential dangers. The Council on Surgical and Perioperative Care of which the ACS is a member, has more data and resources on their homepage (cspsteam.org) for those interested in the subject on distractions in the OR.  

So, what I’ve learned through listening to the music of my colleagues opinions is that when it comes to music, we need to be aware of the spinning propeller of noise pollution in the OR. Many invisible dangers inhabit the OR. Take a moment and listen for them.

Dr. Hughes is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, and Co-Editor of ACS Surgery News.

MACRA is now a fact of life.

Implementation of the Medicare Access and CHIP Reauthorization Act (MACRA), the historic Medicare reform law that replaced the Sustainable Growth Rate (SGR) formula in 2015, began in January 2017. Patrick V. Bailey, MD, FACS, Medical Director, Advocacy, in the American College of Surgeons (ACS) Division of Advocacy and Health Policy (DAHP) office in Washington DC has, for the past several years, been involved with ensuring that the policy implemented takes into account the interests of surgeons and their patients. He has seen MACRA develop from its beginnings. Dr. Bailey, a pediatric surgeon, has deep knowledge about the program, both from the policy perspective and as a surgeon. We asked Dr. Bailey to share with us his insights on what surgeons can expect and what surgeons can do to avoid penalties.



1) Many surgeons are overwhelmed by the perceived complexity of the new MACRA law. What do you say to those who have so far tuned out much of the information they have been given?



A few thoughts. First, we really do understand that the concerns about the complexity are real. Some of those very real feelings come out of a basic aversion to change. Some come from the overall stress and uncertainty surrounding the constant changes in our health care system that have been ongoing for years. And some are the result of the continuously expanding administrative burden. We get it.

Is MACRA exactly what we surgeons would wish for? No, but those of us who have worked in the policy process feel our efforts had a positive impact on how this legislation played out. More importantly, we are absolutely confident that, for 2017, ALL surgeons can avoid a penalty.

From a pragmatic perspective, the implementation of MACRA is going forward, and burying one’s head in the sand will not make it go away. Therefore, it is imperative that surgeons devote some time to understanding the new Quality Payment Program, or QPP, which is the operationalization of the MACRA law. Even a very limited time investment will pay dividends in the Medicare payment they receive in 2019, based on their performance in 2017.

So, if you have avoided dealing with this up until now, I urge you to set aside an hour or so to look at the materials that the ACS has prepared. The reporting requirements may look much less daunting once you become familiar with them.

Again, I am confident that surgeons can and will be successful (as defined by either avoiding a penalty or receiving a small positive rate update), if they take some time to acquire some basic knowledge about the program, make an assessment of their individual practice situation, determine the best course for their individual situation, and take the necessary actions to meet the requirements for the choices they have made.

Fortunately, there is still more than ample time to get started and ACS has developed resources for Fellows to assist them in educating themselves about the program and making their individual choices about their level of participation.



2) With all the talk of change to the Affordable Care Act (ACA), how likely is it that all of this will simply “go away”?



The ACA and MACRA are separate and different pieces of legislation from a temporal, process, policy, and political perspective. In fact, despite the fact that the ACS and other medical specialty groups specifically advocated for language repealing the SGR be included in the ACA in 2010, that did not occur. Therefore, the efforts directed at repealing the SGR took another 5 years and ultimately culminated in the passage of MACRA in 2015.

Many will recall the contentious process and political repercussions that resulted in the passage of the ACA. In contrast, leaders from both political parties worked cooperatively on the SGR repeal legislation we now know as MACRA. This resulted in the MACRA legislation being passed in a very bipartisan manner with only 37 of the 435 members of the House and 8 of the 100 members of the Senate voting against the law.

Accordingly, while we believe there will be a need for some specific, targeted legislative “fixes” and regulatory relief actions from CMS (Centers for Medicare and Medicaid Services) to address faults in the QPP (and the ACS will continue our efforts in this direction), it is highly unlikely that MACRA will be repealed or that it will change significantly in the near-term future.



3) What is the starting point for surgeons who want to learn more and begin the process of determining how best to participate?



There is a relatively straightforward process, which revolves around a series of questions and individual decisions.

First, surgeons should determine if all their Merit-based Incentive Payment System (MIPS) data will be reported by their institution or group via a group reporting option (GPRO). For those surgeons, whose data are so reported, they are done and there is nothing further for them to do.

If their data are not reported for them via a GPRO, then they should determine if CMS has notified them that they are exempt from participating in MIPS due to the low volume threshold. If you see 100 or fewer Medicare patients annually or one submits $30,000 or less in Medicare claims, you are not eligible for MIPS incentives or subject to its penalties.

However, this is not a determination that individual Fellows can make on their own based on data they may have on hand based on prior calendar or fiscal years. Instead, CMS makes the determination based on a specific period and notifies individual providers who are so exempted. It is also our understanding that a website, where one can check whether they have been excluded based on the low volume threshold, is forthcoming from CMS. When this website becomes available, ACS will make sure Fellows are informed.

If your data are not reported via a GPRO and you do not receive notification from CMS that you are exempt based on the low-volume threshold, then you have choices to make – having choices is a good thing.

For those who want to compete for positive updates in their Medicare payment rates in 2019 based on their reporting in 2017, I recommend they first visit facs.org/qpp where we have made available a variety of resources in print, video, and PowerPoint formats to assist Fellows in making their plans for participating for either a full or partial year. The update received will depend on performance and not on the amount of data submitted or the time of participation. That said, for those who plan to fully engage, participation over a longer period of time provides more opportunity for improvement and, thus, increases the potential for better performance.



4) What about surgeons who simply want to avoid a penalty and forgo any chance for a positive update?



If your goal for 2017 is to simply avoid a penalty, CMS only requires data be submitted for only one of the three components of MIPS that will be reported this year. Here again for 2017, you have a choice to submit:

A) The required base score measures for your EHR (now known as Advancing Care Information) OR

B) Participation in one Improvement Activity for 90 days, which is reported by simple attestation OR

C) Submit one Quality measure on one patient, which may be reported by a registry, a qualified clinical data registry (QCDR), an EHR or, traditional claims

One very important point to note is that one is NOT required to have a certified EHR to avoid a penalty for 2017. I believe this point alone has been the source of a lot of misunderstanding and anxiety about the QPP and MIPS.

Another key point is that, by simply engaging in one Improvement Activity (such as Maintenance of Certification Part IV, registering with your state’s prescription drug monitoring program, or use of the ACS’ Surgical Risk Calculator) and attesting to having done so with the ACS Surgeon Specific Registry (SSR) or the CMS web portal, one can avoid a penalty.

Alternatively, using the SSR to submit one Quality measure on one patient will also suffice to prevent one from receiving a penalty in 2019 based on their 2017 performance.

It is relatively easy to avoid any negative financial implications of MIPS in 2017, but it does require some effort, albeit minimal. It is also important for Fellows to remember that, since MIPS is essentially a tournament model, those who choose not to participate will take the penalty that provides the funds used to reward those who do participate. I think most surgeons will want to participate, even if only at the minimal levels outlined above, in order to avoid “paying for” another provider’s positive update.



5) What are the consequences of not participating at the minimal levels you just described and choosing to submit no data?



That question is perhaps best addressed in the form of a comparison between 2016 and 2017.

In 2016, if one did not report any PQRS (Physician Quality Reporting System) data and did not participate in the electronic health record meaningful use program, their lack of participation would result in a 10% negative payment adjustment in 2018. In 2017, if one chooses not to submit the minimal amount of data for either the ACI, Improvement Activity, or Quality components as discussed previously, that lack of participation will lead to a 4% negative payment adjustment in 2019.

In effect, those who have never participated and continue to not do so will see a 6% increase in their Medicare reimbursement in 2019 compared to what they receive in 2018.

However, we DO NOT recommend this option because, in future years, the negative payment adjustments will gradually increase to 9%. Accordingly, we encourage Fellows to use 2017 as a period to learn and get familiar and more comfortable with the reporting of data so that they will be better prepared to be successful in those future years when the stakes are higher.



6) You have mentioned the resources ACS has prepared to assist Fellows with this transition. Can you be more specific about what is available?



The ACS one-stop shop is the Quality Payment Program Resource Center found at www.facs.org/qpp.

Fellows who attended the Clinical Congress in Washington last October likely received a copy of the MACRA Quality Payment Manual which was developed to help educate Fellows about the QPP. That manual has subsequently been totally revamped and updated to reflect the changes to the QPP as reflected in the final rule. We highly encourage Fellows to obtain and read the latest version – it is available as individual sections or as the complete publication on the facs.org/qpp webpage.

Also available on the QPP webpage is the second generation of the video series we first created last fall. There are now a total of 6 videos with a run time for the entire series of approximately 30 minutes. The videos cover a wide spectrum of topics including the historical background and context of MACRA, an introduction to MIPS, and three individual videos dedicated to MIPS components: Quality, Advancing Care Information and Improvement Activity, and a video outlining the options for participation in 2017.

The PowerPoint presentations seen in the videos are also available, as are links to specific CMS web pages and more information on ACS’ efforts to develop advanced alternative payment models (APMs) for surgeons.

We will continue to update the website throughout the year in our ongoing efforts to refine the resources to be the most useful to Fellows.

I would encourage all Fellows to visit the website, watch the videos, and read the manual. I realize time is a precious commodity, but with a total time investment of 60-90 minutes, one can acquire an operational knowledge of the QPP and make a determination as to how they wish to participate.

Again, no Fellow should settle for accepting a penalty in 2019 based on what they do this year. With the multiple options available, it is simply too easy to avoid and to do so would effectively serve to put their money in someone else’s pocket. For those who feel more prepared (that is, they have previously reported PQRS data and have a 2014 or 2015 edition EHR) and wish to seek a positive rate update, investment of more time will obviously be required. However, in addition to the small positive payment update they will likely receive, probably the most substantial benefit to be derived is their preparation for future years when the incentives and penalties increase to +/- 9%.

Finally, ACS “has your back” on coping with MACRA and as always, ACS staff in Chicago and Washington are available to assist Fellows with their preparation, to answer questions about the program and the reporting requirements, or to provide general or specific direction in their efforts to navigate the QPP.
 

[email protected]

MACRA is now a fact of life.

Implementation of the Medicare Access and CHIP Reauthorization Act (MACRA), the historic Medicare reform law that replaced the Sustainable Growth Rate (SGR) formula in 2015, began in January 2017. Patrick V. Bailey, MD, FACS, Medical Director, Advocacy, in the American College of Surgeons (ACS) Division of Advocacy and Health Policy (DAHP) office in Washington DC has, for the past several years, been involved with ensuring that the policy implemented takes into account the interests of surgeons and their patients. He has seen MACRA develop from its beginnings. Dr. Bailey, a pediatric surgeon, has deep knowledge about the program, both from the policy perspective and as a surgeon. We asked Dr. Bailey to share with us his insights on what surgeons can expect and what surgeons can do to avoid penalties.



1) Many surgeons are overwhelmed by the perceived complexity of the new MACRA law. What do you say to those who have so far tuned out much of the information they have been given?



A few thoughts. First, we really do understand that the concerns about the complexity are real. Some of those very real feelings come out of a basic aversion to change. Some come from the overall stress and uncertainty surrounding the constant changes in our health care system that have been ongoing for years. And some are the result of the continuously expanding administrative burden. We get it.

Is MACRA exactly what we surgeons would wish for? No, but those of us who have worked in the policy process feel our efforts had a positive impact on how this legislation played out. More importantly, we are absolutely confident that, for 2017, ALL surgeons can avoid a penalty.

From a pragmatic perspective, the implementation of MACRA is going forward, and burying one’s head in the sand will not make it go away. Therefore, it is imperative that surgeons devote some time to understanding the new Quality Payment Program, or QPP, which is the operationalization of the MACRA law. Even a very limited time investment will pay dividends in the Medicare payment they receive in 2019, based on their performance in 2017.

So, if you have avoided dealing with this up until now, I urge you to set aside an hour or so to look at the materials that the ACS has prepared. The reporting requirements may look much less daunting once you become familiar with them.

Again, I am confident that surgeons can and will be successful (as defined by either avoiding a penalty or receiving a small positive rate update), if they take some time to acquire some basic knowledge about the program, make an assessment of their individual practice situation, determine the best course for their individual situation, and take the necessary actions to meet the requirements for the choices they have made.

Fortunately, there is still more than ample time to get started and ACS has developed resources for Fellows to assist them in educating themselves about the program and making their individual choices about their level of participation.



2) With all the talk of change to the Affordable Care Act (ACA), how likely is it that all of this will simply “go away”?



The ACA and MACRA are separate and different pieces of legislation from a temporal, process, policy, and political perspective. In fact, despite the fact that the ACS and other medical specialty groups specifically advocated for language repealing the SGR be included in the ACA in 2010, that did not occur. Therefore, the efforts directed at repealing the SGR took another 5 years and ultimately culminated in the passage of MACRA in 2015.

Many will recall the contentious process and political repercussions that resulted in the passage of the ACA. In contrast, leaders from both political parties worked cooperatively on the SGR repeal legislation we now know as MACRA. This resulted in the MACRA legislation being passed in a very bipartisan manner with only 37 of the 435 members of the House and 8 of the 100 members of the Senate voting against the law.

Accordingly, while we believe there will be a need for some specific, targeted legislative “fixes” and regulatory relief actions from CMS (Centers for Medicare and Medicaid Services) to address faults in the QPP (and the ACS will continue our efforts in this direction), it is highly unlikely that MACRA will be repealed or that it will change significantly in the near-term future.



3) What is the starting point for surgeons who want to learn more and begin the process of determining how best to participate?



There is a relatively straightforward process, which revolves around a series of questions and individual decisions.

First, surgeons should determine if all their Merit-based Incentive Payment System (MIPS) data will be reported by their institution or group via a group reporting option (GPRO). For those surgeons, whose data are so reported, they are done and there is nothing further for them to do.

If their data are not reported for them via a GPRO, then they should determine if CMS has notified them that they are exempt from participating in MIPS due to the low volume threshold. If you see 100 or fewer Medicare patients annually or one submits $30,000 or less in Medicare claims, you are not eligible for MIPS incentives or subject to its penalties.

However, this is not a determination that individual Fellows can make on their own based on data they may have on hand based on prior calendar or fiscal years. Instead, CMS makes the determination based on a specific period and notifies individual providers who are so exempted. It is also our understanding that a website, where one can check whether they have been excluded based on the low volume threshold, is forthcoming from CMS. When this website becomes available, ACS will make sure Fellows are informed.

If your data are not reported via a GPRO and you do not receive notification from CMS that you are exempt based on the low-volume threshold, then you have choices to make – having choices is a good thing.

For those who want to compete for positive updates in their Medicare payment rates in 2019 based on their reporting in 2017, I recommend they first visit facs.org/qpp where we have made available a variety of resources in print, video, and PowerPoint formats to assist Fellows in making their plans for participating for either a full or partial year. The update received will depend on performance and not on the amount of data submitted or the time of participation. That said, for those who plan to fully engage, participation over a longer period of time provides more opportunity for improvement and, thus, increases the potential for better performance.



4) What about surgeons who simply want to avoid a penalty and forgo any chance for a positive update?



If your goal for 2017 is to simply avoid a penalty, CMS only requires data be submitted for only one of the three components of MIPS that will be reported this year. Here again for 2017, you have a choice to submit:

A) The required base score measures for your EHR (now known as Advancing Care Information) OR

B) Participation in one Improvement Activity for 90 days, which is reported by simple attestation OR

C) Submit one Quality measure on one patient, which may be reported by a registry, a qualified clinical data registry (QCDR), an EHR or, traditional claims

One very important point to note is that one is NOT required to have a certified EHR to avoid a penalty for 2017. I believe this point alone has been the source of a lot of misunderstanding and anxiety about the QPP and MIPS.

Another key point is that, by simply engaging in one Improvement Activity (such as Maintenance of Certification Part IV, registering with your state’s prescription drug monitoring program, or use of the ACS’ Surgical Risk Calculator) and attesting to having done so with the ACS Surgeon Specific Registry (SSR) or the CMS web portal, one can avoid a penalty.

Alternatively, using the SSR to submit one Quality measure on one patient will also suffice to prevent one from receiving a penalty in 2019 based on their 2017 performance.

It is relatively easy to avoid any negative financial implications of MIPS in 2017, but it does require some effort, albeit minimal. It is also important for Fellows to remember that, since MIPS is essentially a tournament model, those who choose not to participate will take the penalty that provides the funds used to reward those who do participate. I think most surgeons will want to participate, even if only at the minimal levels outlined above, in order to avoid “paying for” another provider’s positive update.



5) What are the consequences of not participating at the minimal levels you just described and choosing to submit no data?



That question is perhaps best addressed in the form of a comparison between 2016 and 2017.

In 2016, if one did not report any PQRS (Physician Quality Reporting System) data and did not participate in the electronic health record meaningful use program, their lack of participation would result in a 10% negative payment adjustment in 2018. In 2017, if one chooses not to submit the minimal amount of data for either the ACI, Improvement Activity, or Quality components as discussed previously, that lack of participation will lead to a 4% negative payment adjustment in 2019.

In effect, those who have never participated and continue to not do so will see a 6% increase in their Medicare reimbursement in 2019 compared to what they receive in 2018.

However, we DO NOT recommend this option because, in future years, the negative payment adjustments will gradually increase to 9%. Accordingly, we encourage Fellows to use 2017 as a period to learn and get familiar and more comfortable with the reporting of data so that they will be better prepared to be successful in those future years when the stakes are higher.



6) You have mentioned the resources ACS has prepared to assist Fellows with this transition. Can you be more specific about what is available?



The ACS one-stop shop is the Quality Payment Program Resource Center found at www.facs.org/qpp.

Fellows who attended the Clinical Congress in Washington last October likely received a copy of the MACRA Quality Payment Manual which was developed to help educate Fellows about the QPP. That manual has subsequently been totally revamped and updated to reflect the changes to the QPP as reflected in the final rule. We highly encourage Fellows to obtain and read the latest version – it is available as individual sections or as the complete publication on the facs.org/qpp webpage.

Also available on the QPP webpage is the second generation of the video series we first created last fall. There are now a total of 6 videos with a run time for the entire series of approximately 30 minutes. The videos cover a wide spectrum of topics including the historical background and context of MACRA, an introduction to MIPS, and three individual videos dedicated to MIPS components: Quality, Advancing Care Information and Improvement Activity, and a video outlining the options for participation in 2017.

The PowerPoint presentations seen in the videos are also available, as are links to specific CMS web pages and more information on ACS’ efforts to develop advanced alternative payment models (APMs) for surgeons.

We will continue to update the website throughout the year in our ongoing efforts to refine the resources to be the most useful to Fellows.

I would encourage all Fellows to visit the website, watch the videos, and read the manual. I realize time is a precious commodity, but with a total time investment of 60-90 minutes, one can acquire an operational knowledge of the QPP and make a determination as to how they wish to participate.

Again, no Fellow should settle for accepting a penalty in 2019 based on what they do this year. With the multiple options available, it is simply too easy to avoid and to do so would effectively serve to put their money in someone else’s pocket. For those who feel more prepared (that is, they have previously reported PQRS data and have a 2014 or 2015 edition EHR) and wish to seek a positive rate update, investment of more time will obviously be required. However, in addition to the small positive payment update they will likely receive, probably the most substantial benefit to be derived is their preparation for future years when the incentives and penalties increase to +/- 9%.

Finally, ACS “has your back” on coping with MACRA and as always, ACS staff in Chicago and Washington are available to assist Fellows with their preparation, to answer questions about the program and the reporting requirements, or to provide general or specific direction in their efforts to navigate the QPP.
 

[email protected]

MACRA is now a fact of life.

Implementation of the Medicare Access and CHIP Reauthorization Act (MACRA), the historic Medicare reform law that replaced the Sustainable Growth Rate (SGR) formula in 2015, began in January 2017. Patrick V. Bailey, MD, FACS, Medical Director, Advocacy, in the American College of Surgeons (ACS) Division of Advocacy and Health Policy (DAHP) office in Washington DC has, for the past several years, been involved with ensuring that the policy implemented takes into account the interests of surgeons and their patients. He has seen MACRA develop from its beginnings. Dr. Bailey, a pediatric surgeon, has deep knowledge about the program, both from the policy perspective and as a surgeon. We asked Dr. Bailey to share with us his insights on what surgeons can expect and what surgeons can do to avoid penalties.



1) Many surgeons are overwhelmed by the perceived complexity of the new MACRA law. What do you say to those who have so far tuned out much of the information they have been given?



A few thoughts. First, we really do understand that the concerns about the complexity are real. Some of those very real feelings come out of a basic aversion to change. Some come from the overall stress and uncertainty surrounding the constant changes in our health care system that have been ongoing for years. And some are the result of the continuously expanding administrative burden. We get it.

Is MACRA exactly what we surgeons would wish for? No, but those of us who have worked in the policy process feel our efforts had a positive impact on how this legislation played out. More importantly, we are absolutely confident that, for 2017, ALL surgeons can avoid a penalty.

From a pragmatic perspective, the implementation of MACRA is going forward, and burying one’s head in the sand will not make it go away. Therefore, it is imperative that surgeons devote some time to understanding the new Quality Payment Program, or QPP, which is the operationalization of the MACRA law. Even a very limited time investment will pay dividends in the Medicare payment they receive in 2019, based on their performance in 2017.

So, if you have avoided dealing with this up until now, I urge you to set aside an hour or so to look at the materials that the ACS has prepared. The reporting requirements may look much less daunting once you become familiar with them.

Again, I am confident that surgeons can and will be successful (as defined by either avoiding a penalty or receiving a small positive rate update), if they take some time to acquire some basic knowledge about the program, make an assessment of their individual practice situation, determine the best course for their individual situation, and take the necessary actions to meet the requirements for the choices they have made.

Fortunately, there is still more than ample time to get started and ACS has developed resources for Fellows to assist them in educating themselves about the program and making their individual choices about their level of participation.



2) With all the talk of change to the Affordable Care Act (ACA), how likely is it that all of this will simply “go away”?



The ACA and MACRA are separate and different pieces of legislation from a temporal, process, policy, and political perspective. In fact, despite the fact that the ACS and other medical specialty groups specifically advocated for language repealing the SGR be included in the ACA in 2010, that did not occur. Therefore, the efforts directed at repealing the SGR took another 5 years and ultimately culminated in the passage of MACRA in 2015.

Many will recall the contentious process and political repercussions that resulted in the passage of the ACA. In contrast, leaders from both political parties worked cooperatively on the SGR repeal legislation we now know as MACRA. This resulted in the MACRA legislation being passed in a very bipartisan manner with only 37 of the 435 members of the House and 8 of the 100 members of the Senate voting against the law.

Accordingly, while we believe there will be a need for some specific, targeted legislative “fixes” and regulatory relief actions from CMS (Centers for Medicare and Medicaid Services) to address faults in the QPP (and the ACS will continue our efforts in this direction), it is highly unlikely that MACRA will be repealed or that it will change significantly in the near-term future.



3) What is the starting point for surgeons who want to learn more and begin the process of determining how best to participate?



There is a relatively straightforward process, which revolves around a series of questions and individual decisions.

First, surgeons should determine if all their Merit-based Incentive Payment System (MIPS) data will be reported by their institution or group via a group reporting option (GPRO). For those surgeons, whose data are so reported, they are done and there is nothing further for them to do.

If their data are not reported for them via a GPRO, then they should determine if CMS has notified them that they are exempt from participating in MIPS due to the low volume threshold. If you see 100 or fewer Medicare patients annually or one submits $30,000 or less in Medicare claims, you are not eligible for MIPS incentives or subject to its penalties.

However, this is not a determination that individual Fellows can make on their own based on data they may have on hand based on prior calendar or fiscal years. Instead, CMS makes the determination based on a specific period and notifies individual providers who are so exempted. It is also our understanding that a website, where one can check whether they have been excluded based on the low volume threshold, is forthcoming from CMS. When this website becomes available, ACS will make sure Fellows are informed.

If your data are not reported via a GPRO and you do not receive notification from CMS that you are exempt based on the low-volume threshold, then you have choices to make – having choices is a good thing.

For those who want to compete for positive updates in their Medicare payment rates in 2019 based on their reporting in 2017, I recommend they first visit facs.org/qpp where we have made available a variety of resources in print, video, and PowerPoint formats to assist Fellows in making their plans for participating for either a full or partial year. The update received will depend on performance and not on the amount of data submitted or the time of participation. That said, for those who plan to fully engage, participation over a longer period of time provides more opportunity for improvement and, thus, increases the potential for better performance.



4) What about surgeons who simply want to avoid a penalty and forgo any chance for a positive update?



If your goal for 2017 is to simply avoid a penalty, CMS only requires data be submitted for only one of the three components of MIPS that will be reported this year. Here again for 2017, you have a choice to submit:

A) The required base score measures for your EHR (now known as Advancing Care Information) OR

B) Participation in one Improvement Activity for 90 days, which is reported by simple attestation OR

C) Submit one Quality measure on one patient, which may be reported by a registry, a qualified clinical data registry (QCDR), an EHR or, traditional claims

One very important point to note is that one is NOT required to have a certified EHR to avoid a penalty for 2017. I believe this point alone has been the source of a lot of misunderstanding and anxiety about the QPP and MIPS.

Another key point is that, by simply engaging in one Improvement Activity (such as Maintenance of Certification Part IV, registering with your state’s prescription drug monitoring program, or use of the ACS’ Surgical Risk Calculator) and attesting to having done so with the ACS Surgeon Specific Registry (SSR) or the CMS web portal, one can avoid a penalty.

Alternatively, using the SSR to submit one Quality measure on one patient will also suffice to prevent one from receiving a penalty in 2019 based on their 2017 performance.

It is relatively easy to avoid any negative financial implications of MIPS in 2017, but it does require some effort, albeit minimal. It is also important for Fellows to remember that, since MIPS is essentially a tournament model, those who choose not to participate will take the penalty that provides the funds used to reward those who do participate. I think most surgeons will want to participate, even if only at the minimal levels outlined above, in order to avoid “paying for” another provider’s positive update.



5) What are the consequences of not participating at the minimal levels you just described and choosing to submit no data?



That question is perhaps best addressed in the form of a comparison between 2016 and 2017.

In 2016, if one did not report any PQRS (Physician Quality Reporting System) data and did not participate in the electronic health record meaningful use program, their lack of participation would result in a 10% negative payment adjustment in 2018. In 2017, if one chooses not to submit the minimal amount of data for either the ACI, Improvement Activity, or Quality components as discussed previously, that lack of participation will lead to a 4% negative payment adjustment in 2019.

In effect, those who have never participated and continue to not do so will see a 6% increase in their Medicare reimbursement in 2019 compared to what they receive in 2018.

However, we DO NOT recommend this option because, in future years, the negative payment adjustments will gradually increase to 9%. Accordingly, we encourage Fellows to use 2017 as a period to learn and get familiar and more comfortable with the reporting of data so that they will be better prepared to be successful in those future years when the stakes are higher.



6) You have mentioned the resources ACS has prepared to assist Fellows with this transition. Can you be more specific about what is available?



The ACS one-stop shop is the Quality Payment Program Resource Center found at www.facs.org/qpp.

Fellows who attended the Clinical Congress in Washington last October likely received a copy of the MACRA Quality Payment Manual which was developed to help educate Fellows about the QPP. That manual has subsequently been totally revamped and updated to reflect the changes to the QPP as reflected in the final rule. We highly encourage Fellows to obtain and read the latest version – it is available as individual sections or as the complete publication on the facs.org/qpp webpage.

Also available on the QPP webpage is the second generation of the video series we first created last fall. There are now a total of 6 videos with a run time for the entire series of approximately 30 minutes. The videos cover a wide spectrum of topics including the historical background and context of MACRA, an introduction to MIPS, and three individual videos dedicated to MIPS components: Quality, Advancing Care Information and Improvement Activity, and a video outlining the options for participation in 2017.

The PowerPoint presentations seen in the videos are also available, as are links to specific CMS web pages and more information on ACS’ efforts to develop advanced alternative payment models (APMs) for surgeons.

We will continue to update the website throughout the year in our ongoing efforts to refine the resources to be the most useful to Fellows.

I would encourage all Fellows to visit the website, watch the videos, and read the manual. I realize time is a precious commodity, but with a total time investment of 60-90 minutes, one can acquire an operational knowledge of the QPP and make a determination as to how they wish to participate.

Again, no Fellow should settle for accepting a penalty in 2019 based on what they do this year. With the multiple options available, it is simply too easy to avoid and to do so would effectively serve to put their money in someone else’s pocket. For those who feel more prepared (that is, they have previously reported PQRS data and have a 2014 or 2015 edition EHR) and wish to seek a positive rate update, investment of more time will obviously be required. However, in addition to the small positive payment update they will likely receive, probably the most substantial benefit to be derived is their preparation for future years when the incentives and penalties increase to +/- 9%.

Finally, ACS “has your back” on coping with MACRA and as always, ACS staff in Chicago and Washington are available to assist Fellows with their preparation, to answer questions about the program and the reporting requirements, or to provide general or specific direction in their efforts to navigate the QPP.
 

[email protected]