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Telephone calls improve long-term follow-up after hernia repair
Follow-up telephone calls can significantly improve the collection of long-term patient-reported outcomes following ventral hernia repair, according to a study published online in the Oct. 20 edition of the Journal of the American College of Surgeons.
Nishant Ganesh Kumar, a medical student, and his colleagues at Vanderbilt University, Nashville, Tenn., wrote that while ventral hernia repair is one of the most common surgical procedures in the world, reliable long-term, prospective data on outcomes has been extremely difficult to collect.
In this Plan-Do-Study-Act (PDSA) prospective study, 99 patients who had undergone ventral hernia repair were followed up by telephone, in addition to the usual email communication, 1 year after their procedure. The calls were initially made between 1:00 p.m. and 3:00 p.m. in the first phase of the study, then changed to after 3:00 p.m. in the second phase.
Compared to the long-term completion rate of 16.3% prior to the intervention – where follow-up was largely through physical clinical visits – researchers saw a completion rate of 35.7% with the telephone calls between 1:00 p.m. and 3:00 p.m., and a 55.1% completion rate after changing the call time to after 3:00 p.m. The mean participation rate was 45.4%.
Once contact was made, all the patients completed the full patient-reported outcomes assessment, although the researchers did note that some seem to experience fatigue during questioning that required the interviewers to gently steer them back to the questions.
“The advantage of making phone calls was severalfold, including clarification of survey questions to help patients with providing more insightful responses, allaying concerns of patients, and personalizing long-term follow-up, a crucial aspect missing through automated surveys,” the authors wrote.
In addition to changing the time in which the calls were made, the researchers also changed how the survey was introduced to the patients, such as referring to the survey as “follow-up,” which seemed to improve patient participation.
“Further, it was observed that during conversations with the patient, highlighting relevant features of their medical and surgical history, such as the date of the surgery, the surgeon who operated on them, and their disease progression since surgery helped in developing a rapport with the patient and increased the chances of their participation,” they reported. “With these approaches, the participation rate after the second PDSA cycle increased to 55.1%.”
The data analyses in the study were supported by the Americas Hernia Society Quality Collaborative. There were no disclosures relevant to the study.
Follow-up telephone calls can significantly improve the collection of long-term patient-reported outcomes following ventral hernia repair, according to a study published online in the Oct. 20 edition of the Journal of the American College of Surgeons.
Nishant Ganesh Kumar, a medical student, and his colleagues at Vanderbilt University, Nashville, Tenn., wrote that while ventral hernia repair is one of the most common surgical procedures in the world, reliable long-term, prospective data on outcomes has been extremely difficult to collect.
In this Plan-Do-Study-Act (PDSA) prospective study, 99 patients who had undergone ventral hernia repair were followed up by telephone, in addition to the usual email communication, 1 year after their procedure. The calls were initially made between 1:00 p.m. and 3:00 p.m. in the first phase of the study, then changed to after 3:00 p.m. in the second phase.
Compared to the long-term completion rate of 16.3% prior to the intervention – where follow-up was largely through physical clinical visits – researchers saw a completion rate of 35.7% with the telephone calls between 1:00 p.m. and 3:00 p.m., and a 55.1% completion rate after changing the call time to after 3:00 p.m. The mean participation rate was 45.4%.
Once contact was made, all the patients completed the full patient-reported outcomes assessment, although the researchers did note that some seem to experience fatigue during questioning that required the interviewers to gently steer them back to the questions.
“The advantage of making phone calls was severalfold, including clarification of survey questions to help patients with providing more insightful responses, allaying concerns of patients, and personalizing long-term follow-up, a crucial aspect missing through automated surveys,” the authors wrote.
In addition to changing the time in which the calls were made, the researchers also changed how the survey was introduced to the patients, such as referring to the survey as “follow-up,” which seemed to improve patient participation.
“Further, it was observed that during conversations with the patient, highlighting relevant features of their medical and surgical history, such as the date of the surgery, the surgeon who operated on them, and their disease progression since surgery helped in developing a rapport with the patient and increased the chances of their participation,” they reported. “With these approaches, the participation rate after the second PDSA cycle increased to 55.1%.”
The data analyses in the study were supported by the Americas Hernia Society Quality Collaborative. There were no disclosures relevant to the study.
Follow-up telephone calls can significantly improve the collection of long-term patient-reported outcomes following ventral hernia repair, according to a study published online in the Oct. 20 edition of the Journal of the American College of Surgeons.
Nishant Ganesh Kumar, a medical student, and his colleagues at Vanderbilt University, Nashville, Tenn., wrote that while ventral hernia repair is one of the most common surgical procedures in the world, reliable long-term, prospective data on outcomes has been extremely difficult to collect.
In this Plan-Do-Study-Act (PDSA) prospective study, 99 patients who had undergone ventral hernia repair were followed up by telephone, in addition to the usual email communication, 1 year after their procedure. The calls were initially made between 1:00 p.m. and 3:00 p.m. in the first phase of the study, then changed to after 3:00 p.m. in the second phase.
Compared to the long-term completion rate of 16.3% prior to the intervention – where follow-up was largely through physical clinical visits – researchers saw a completion rate of 35.7% with the telephone calls between 1:00 p.m. and 3:00 p.m., and a 55.1% completion rate after changing the call time to after 3:00 p.m. The mean participation rate was 45.4%.
Once contact was made, all the patients completed the full patient-reported outcomes assessment, although the researchers did note that some seem to experience fatigue during questioning that required the interviewers to gently steer them back to the questions.
“The advantage of making phone calls was severalfold, including clarification of survey questions to help patients with providing more insightful responses, allaying concerns of patients, and personalizing long-term follow-up, a crucial aspect missing through automated surveys,” the authors wrote.
In addition to changing the time in which the calls were made, the researchers also changed how the survey was introduced to the patients, such as referring to the survey as “follow-up,” which seemed to improve patient participation.
“Further, it was observed that during conversations with the patient, highlighting relevant features of their medical and surgical history, such as the date of the surgery, the surgeon who operated on them, and their disease progression since surgery helped in developing a rapport with the patient and increased the chances of their participation,” they reported. “With these approaches, the participation rate after the second PDSA cycle increased to 55.1%.”
The data analyses in the study were supported by the Americas Hernia Society Quality Collaborative. There were no disclosures relevant to the study.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Key clinical point: Follow-up telephone calls can significantly improve the collection of long-term patient-reported outcomes following ventral hernia repair.
Major finding: Compared to the long-term completion rate of 16.3% prior to the intervention, a telephone call follow-up increased the mean participation rate to 45.4%.
Data source: Prospective cohort study of 99 patients who underwent ventral hernia repair.
Disclosures: The data analyses in the study were supported by the Americas Hernia Society Quality Collaborative. There were no disclosures relevant to the study.
Adding respiratory rate to triage criteria improves accurate staging of chest trauma patients
WASHINGTON – Adding respiratory rate and suspected blunt chest injury to a trauma assessment in the field significantly improved the appropriate triaging of level III trauma patients.
When the assessment specifically evaluated for tachypnea in the setting of blunt chest injury, undertriaging improved by 1.2%, John Yonge, MD, said at the annual clinical congress of the American College of Surgeons.
“When we applied this new criteria to our 10-year study, we identified 661 patients who should have been activated as a level I or level II,” but instead were assessed as less critically injured, Dr. Yonge said in an interview. This initial misstep significantly extended the time before patients could have critical surgical procedures and was related to higher mortality among them.
Dr. Yonge, a surgical fellow at Oregon Health & Science University, Portland, and his mentor Martin Schreiber, MD, conducted the retrospective study of 7,880 trauma patients admitted at level III activation from 2004 to 2014. The OHSU trauma system has three activation levels.
• Level I activations are reserved for the most critically injured patients; attending trauma surgeon and anesthesiologist presence is mandatory.
• Level II activations capture moderate to severe injuries; trauma surgeon and respiratory therapist presence is mandated.
• Level III activations are designed to capture patients who do not require an immediate lifesaving intervention; the presence of the trauma surgery chief resident and attending emergency medicine physician is mandatory.
Patients were considered undertriaged if they were admitted as level III activations, but then required a critical intervention (chest tube placement, intubation, needle thoracostomy, or intracranial pressure monitoring) in the emergency department or ultimately met level I or II activation criteria.
Among all the level III patients, 466 (6%) were undertriaged: 390 were undertriaged based on the existing level I or II activation criteria, and 76 were considered undertriaged based on the need for a critical intervention.
Most of the undertriaged patients (65%) met criteria for level I activation; the rest should have been triaged as level II patients. Compared with appropriately staged level III patients, mortality among the undertriaged patients was significantly higher (3.2% vs. 0.6%). Undertriaged patients also experienced longer delays before initiation of major emergency surgery: a mean of 147 minutes, compared with 106 minutes for appropriately triaged level I patients and 62 minutes for appropriately triaged level II patients.
Dr. Yonge then looked for clinical measures that would improve triage. Tachypnea (respiratory rate of more than 20 breaths per minute) in the field stood out as a significant factor. Tachypneic patients who had a suspected chest injury were 70% more likely to be undertriaged than were those with a normal respiratory rate. Tachypnea was significantly associated with a diagnosis of flail chest, emergency department intubation, and chest tube placement.
The team then constructed a new triage criterion for patients with suspected chest injury – tachypnea combined with suspected blunt thoracic injury. By applying that model to their study population of level III patients, they determined that the level III undertriage rate would be reduced by 1.2%.
Tying the physiologic marker of tachypnea to a suspected clinical diagnosis is a key factor, Dr. Yonge noted. “Just adding tachypnea doesn’t help us. In fact, it would overwhelm us, because a trauma patient could very well be tachypneic because he’s experiencing panic. But tying it to a suspected clinical diagnosis gives us a meaningful result.”
He confirmed this linkage with an additional analysis. “We looked to see how severely injured these patients were and found that 71% of them had an Abbreviated Injury Score (AIS) to the chest of 3 or more, indicating a severe chest injury. Only 29% had an AIS of 2 or less. So this proves that respiratory rate is a valid triage criterion and can be used to identify patients who need a higher level of trauma care.”
The challenge now, Dr. Yonge said, is incorporating the marker into clinical practice. “It doesn’t matter how many statistics you do, if you can’t educate the prehospital providers in this, it’s useless. They are the crux of the trauma system.”
Although national guidelines do recommend assessing respiratory rate as part of field triage, it often isn’t recorded or is only estimated, Dr. Yonge said. That’s one reason he used the 20-breaths-per-minute cutoff rate. “It doesn’t even take a full minute to assess this, but it can make a big improvement in care.”
Neither he nor Dr. Schreiber had any financial disclosures.
[email protected]
On Twitter @alz_gal
WASHINGTON – Adding respiratory rate and suspected blunt chest injury to a trauma assessment in the field significantly improved the appropriate triaging of level III trauma patients.
When the assessment specifically evaluated for tachypnea in the setting of blunt chest injury, undertriaging improved by 1.2%, John Yonge, MD, said at the annual clinical congress of the American College of Surgeons.
“When we applied this new criteria to our 10-year study, we identified 661 patients who should have been activated as a level I or level II,” but instead were assessed as less critically injured, Dr. Yonge said in an interview. This initial misstep significantly extended the time before patients could have critical surgical procedures and was related to higher mortality among them.
Dr. Yonge, a surgical fellow at Oregon Health & Science University, Portland, and his mentor Martin Schreiber, MD, conducted the retrospective study of 7,880 trauma patients admitted at level III activation from 2004 to 2014. The OHSU trauma system has three activation levels.
• Level I activations are reserved for the most critically injured patients; attending trauma surgeon and anesthesiologist presence is mandatory.
• Level II activations capture moderate to severe injuries; trauma surgeon and respiratory therapist presence is mandated.
• Level III activations are designed to capture patients who do not require an immediate lifesaving intervention; the presence of the trauma surgery chief resident and attending emergency medicine physician is mandatory.
Patients were considered undertriaged if they were admitted as level III activations, but then required a critical intervention (chest tube placement, intubation, needle thoracostomy, or intracranial pressure monitoring) in the emergency department or ultimately met level I or II activation criteria.
Among all the level III patients, 466 (6%) were undertriaged: 390 were undertriaged based on the existing level I or II activation criteria, and 76 were considered undertriaged based on the need for a critical intervention.
Most of the undertriaged patients (65%) met criteria for level I activation; the rest should have been triaged as level II patients. Compared with appropriately staged level III patients, mortality among the undertriaged patients was significantly higher (3.2% vs. 0.6%). Undertriaged patients also experienced longer delays before initiation of major emergency surgery: a mean of 147 minutes, compared with 106 minutes for appropriately triaged level I patients and 62 minutes for appropriately triaged level II patients.
Dr. Yonge then looked for clinical measures that would improve triage. Tachypnea (respiratory rate of more than 20 breaths per minute) in the field stood out as a significant factor. Tachypneic patients who had a suspected chest injury were 70% more likely to be undertriaged than were those with a normal respiratory rate. Tachypnea was significantly associated with a diagnosis of flail chest, emergency department intubation, and chest tube placement.
The team then constructed a new triage criterion for patients with suspected chest injury – tachypnea combined with suspected blunt thoracic injury. By applying that model to their study population of level III patients, they determined that the level III undertriage rate would be reduced by 1.2%.
Tying the physiologic marker of tachypnea to a suspected clinical diagnosis is a key factor, Dr. Yonge noted. “Just adding tachypnea doesn’t help us. In fact, it would overwhelm us, because a trauma patient could very well be tachypneic because he’s experiencing panic. But tying it to a suspected clinical diagnosis gives us a meaningful result.”
He confirmed this linkage with an additional analysis. “We looked to see how severely injured these patients were and found that 71% of them had an Abbreviated Injury Score (AIS) to the chest of 3 or more, indicating a severe chest injury. Only 29% had an AIS of 2 or less. So this proves that respiratory rate is a valid triage criterion and can be used to identify patients who need a higher level of trauma care.”
The challenge now, Dr. Yonge said, is incorporating the marker into clinical practice. “It doesn’t matter how many statistics you do, if you can’t educate the prehospital providers in this, it’s useless. They are the crux of the trauma system.”
Although national guidelines do recommend assessing respiratory rate as part of field triage, it often isn’t recorded or is only estimated, Dr. Yonge said. That’s one reason he used the 20-breaths-per-minute cutoff rate. “It doesn’t even take a full minute to assess this, but it can make a big improvement in care.”
Neither he nor Dr. Schreiber had any financial disclosures.
[email protected]
On Twitter @alz_gal
WASHINGTON – Adding respiratory rate and suspected blunt chest injury to a trauma assessment in the field significantly improved the appropriate triaging of level III trauma patients.
When the assessment specifically evaluated for tachypnea in the setting of blunt chest injury, undertriaging improved by 1.2%, John Yonge, MD, said at the annual clinical congress of the American College of Surgeons.
“When we applied this new criteria to our 10-year study, we identified 661 patients who should have been activated as a level I or level II,” but instead were assessed as less critically injured, Dr. Yonge said in an interview. This initial misstep significantly extended the time before patients could have critical surgical procedures and was related to higher mortality among them.
Dr. Yonge, a surgical fellow at Oregon Health & Science University, Portland, and his mentor Martin Schreiber, MD, conducted the retrospective study of 7,880 trauma patients admitted at level III activation from 2004 to 2014. The OHSU trauma system has three activation levels.
• Level I activations are reserved for the most critically injured patients; attending trauma surgeon and anesthesiologist presence is mandatory.
• Level II activations capture moderate to severe injuries; trauma surgeon and respiratory therapist presence is mandated.
• Level III activations are designed to capture patients who do not require an immediate lifesaving intervention; the presence of the trauma surgery chief resident and attending emergency medicine physician is mandatory.
Patients were considered undertriaged if they were admitted as level III activations, but then required a critical intervention (chest tube placement, intubation, needle thoracostomy, or intracranial pressure monitoring) in the emergency department or ultimately met level I or II activation criteria.
Among all the level III patients, 466 (6%) were undertriaged: 390 were undertriaged based on the existing level I or II activation criteria, and 76 were considered undertriaged based on the need for a critical intervention.
Most of the undertriaged patients (65%) met criteria for level I activation; the rest should have been triaged as level II patients. Compared with appropriately staged level III patients, mortality among the undertriaged patients was significantly higher (3.2% vs. 0.6%). Undertriaged patients also experienced longer delays before initiation of major emergency surgery: a mean of 147 minutes, compared with 106 minutes for appropriately triaged level I patients and 62 minutes for appropriately triaged level II patients.
Dr. Yonge then looked for clinical measures that would improve triage. Tachypnea (respiratory rate of more than 20 breaths per minute) in the field stood out as a significant factor. Tachypneic patients who had a suspected chest injury were 70% more likely to be undertriaged than were those with a normal respiratory rate. Tachypnea was significantly associated with a diagnosis of flail chest, emergency department intubation, and chest tube placement.
The team then constructed a new triage criterion for patients with suspected chest injury – tachypnea combined with suspected blunt thoracic injury. By applying that model to their study population of level III patients, they determined that the level III undertriage rate would be reduced by 1.2%.
Tying the physiologic marker of tachypnea to a suspected clinical diagnosis is a key factor, Dr. Yonge noted. “Just adding tachypnea doesn’t help us. In fact, it would overwhelm us, because a trauma patient could very well be tachypneic because he’s experiencing panic. But tying it to a suspected clinical diagnosis gives us a meaningful result.”
He confirmed this linkage with an additional analysis. “We looked to see how severely injured these patients were and found that 71% of them had an Abbreviated Injury Score (AIS) to the chest of 3 or more, indicating a severe chest injury. Only 29% had an AIS of 2 or less. So this proves that respiratory rate is a valid triage criterion and can be used to identify patients who need a higher level of trauma care.”
The challenge now, Dr. Yonge said, is incorporating the marker into clinical practice. “It doesn’t matter how many statistics you do, if you can’t educate the prehospital providers in this, it’s useless. They are the crux of the trauma system.”
Although national guidelines do recommend assessing respiratory rate as part of field triage, it often isn’t recorded or is only estimated, Dr. Yonge said. That’s one reason he used the 20-breaths-per-minute cutoff rate. “It doesn’t even take a full minute to assess this, but it can make a big improvement in care.”
Neither he nor Dr. Schreiber had any financial disclosures.
[email protected]
On Twitter @alz_gal
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: Adding a triage assessment criterion of tachypnea plus suspected chest injury improved undertriage of chest trauma patients by 1.2%.
Data source: The retrospective database study comprising 7,880 patients.
Disclosures: Neither Dr. Yonge nor Dr. Schreiber had any financial disclosures.
Four-part ‘safety bundle’ targets gynecologic surgery infections
In a new consensus safety bundle designed to reduce the frequency of infections related to gynecologic surgery, an expert panel is calling for preoperative evaluation of infection risk in every patient and surgical timeouts in every case.
The bundle, from the Council on Patient Safety in Women & Mother’s Health Care, seeks to compile existing guidelines and evidence-based recommendations in a way that can be easily implemented with whatever resources an individual institution has available.
The safety bundle covers four domains:
1. Readiness (every facility). The statement calls for standardized preoperative and postoperative care instructions and clearly defined roles for each surgical team member.
Standards should also be established regarding skin preparation, use of prophylactic antibiotics (terminate them within 24 hours after surgery completion unless medical indications are present), and temperature, such as ambient operating room temperature.
“Although the effect of temperature maintenance on surgical site infection is not definitive,” the consensus statement says, “there is no denying other benefits of normothermia; foremost among these is overall patient satisfaction and comfort.”
2. Recognition and prevention (every patient). Every patient should undergo a preoperative evaluation of infection risk based on blood glucose level, body mass index, immunodeficiency, methicillin-resistant Staphylococcus aureus (MRSA) status, nutritional status, and smoking status.
3. Response (every case). Develop “timeouts” during operations, as mandated by the Joint Commission, to address antibiotic dosage and timing, and reassess risk for infection following the procedure based on the length of surgery and blood loss.
4. Reporting and systems learning (every facility). Develop “huddles” – brief team meetings of less than 15 minutes – for high-risk patients. Surgeons and hospital officials should also create a system to report and analyze data about surgical site infections and share physician-specific infection data with all surgeons as part of ongoing professional practice evaluation.
The statement appeared in Obstetrics & Gynecology (2017;129:50-61) and was published concurrently in Anesthesia & Analgesia, the Journal of Obstetric, Gynecologic & Neonatal Nursing, and the AANA Journal.
The authors reported having no potential conflicts of interest.
In a new consensus safety bundle designed to reduce the frequency of infections related to gynecologic surgery, an expert panel is calling for preoperative evaluation of infection risk in every patient and surgical timeouts in every case.
The bundle, from the Council on Patient Safety in Women & Mother’s Health Care, seeks to compile existing guidelines and evidence-based recommendations in a way that can be easily implemented with whatever resources an individual institution has available.
The safety bundle covers four domains:
1. Readiness (every facility). The statement calls for standardized preoperative and postoperative care instructions and clearly defined roles for each surgical team member.
Standards should also be established regarding skin preparation, use of prophylactic antibiotics (terminate them within 24 hours after surgery completion unless medical indications are present), and temperature, such as ambient operating room temperature.
“Although the effect of temperature maintenance on surgical site infection is not definitive,” the consensus statement says, “there is no denying other benefits of normothermia; foremost among these is overall patient satisfaction and comfort.”
2. Recognition and prevention (every patient). Every patient should undergo a preoperative evaluation of infection risk based on blood glucose level, body mass index, immunodeficiency, methicillin-resistant Staphylococcus aureus (MRSA) status, nutritional status, and smoking status.
3. Response (every case). Develop “timeouts” during operations, as mandated by the Joint Commission, to address antibiotic dosage and timing, and reassess risk for infection following the procedure based on the length of surgery and blood loss.
4. Reporting and systems learning (every facility). Develop “huddles” – brief team meetings of less than 15 minutes – for high-risk patients. Surgeons and hospital officials should also create a system to report and analyze data about surgical site infections and share physician-specific infection data with all surgeons as part of ongoing professional practice evaluation.
The statement appeared in Obstetrics & Gynecology (2017;129:50-61) and was published concurrently in Anesthesia & Analgesia, the Journal of Obstetric, Gynecologic & Neonatal Nursing, and the AANA Journal.
The authors reported having no potential conflicts of interest.
In a new consensus safety bundle designed to reduce the frequency of infections related to gynecologic surgery, an expert panel is calling for preoperative evaluation of infection risk in every patient and surgical timeouts in every case.
The bundle, from the Council on Patient Safety in Women & Mother’s Health Care, seeks to compile existing guidelines and evidence-based recommendations in a way that can be easily implemented with whatever resources an individual institution has available.
The safety bundle covers four domains:
1. Readiness (every facility). The statement calls for standardized preoperative and postoperative care instructions and clearly defined roles for each surgical team member.
Standards should also be established regarding skin preparation, use of prophylactic antibiotics (terminate them within 24 hours after surgery completion unless medical indications are present), and temperature, such as ambient operating room temperature.
“Although the effect of temperature maintenance on surgical site infection is not definitive,” the consensus statement says, “there is no denying other benefits of normothermia; foremost among these is overall patient satisfaction and comfort.”
2. Recognition and prevention (every patient). Every patient should undergo a preoperative evaluation of infection risk based on blood glucose level, body mass index, immunodeficiency, methicillin-resistant Staphylococcus aureus (MRSA) status, nutritional status, and smoking status.
3. Response (every case). Develop “timeouts” during operations, as mandated by the Joint Commission, to address antibiotic dosage and timing, and reassess risk for infection following the procedure based on the length of surgery and blood loss.
4. Reporting and systems learning (every facility). Develop “huddles” – brief team meetings of less than 15 minutes – for high-risk patients. Surgeons and hospital officials should also create a system to report and analyze data about surgical site infections and share physician-specific infection data with all surgeons as part of ongoing professional practice evaluation.
The statement appeared in Obstetrics & Gynecology (2017;129:50-61) and was published concurrently in Anesthesia & Analgesia, the Journal of Obstetric, Gynecologic & Neonatal Nursing, and the AANA Journal.
The authors reported having no potential conflicts of interest.
FROM OBSTETRICS & GYNECOLOGY
Trump administration to focus on ACA reform, tort reform
Look for three things from the Trump administration: significant changes to the Affordable Care Act, few changes to MACRA’s Quality Payment Program, and a conservative swing in the courts.
Republicans have had their sights on the Affordable Care Act since its passage in 2010; with majorities in both the House and the Senate, the question is not if, but when President Obama’s signature piece of legislation will be dismantled.
President-elect Donald Trump ran on the promise of ACA repeal. Health policy priorities on his transition website focus on greater use of health savings accounts, the ability to purchase insurance across state lines, and the reestablishment of high-risk pools.
Health policy experts differ in how they see ACA reform coming about, with some predicting a quick repeal coupled with an immediate legislative replacement, while others envision repeal with more time to craft replacement legislation. Reform also could come as a series of smaller bills rather than one comprehensive package.
Using budget reconciliation would not allow for full ACA repeal since only provisions that involve revenue generation or spending could be altered. However, since budget reconciliation bills cannot be filibustered, only a simple majority is needed for Senate passage. With their razor-thin majority – 51 seats – Republicans will need some support from outside of their own party.
“Twenty-some Democrats, many in very-deep ‘red states’ including North Dakota, are up for reelection in 2018,” Ms. Turner said. “They saw what happened to the candidates who supported Obamacare in 2016 – many of them went down. It happened with Evan Bayh in Indiana, who was running again to reclaim the Senate seat he left in 2010. And the Republican candidate [Todd Young] reminded the voters over and over that Evan Bayh voted for Obamacare. Same thing happened in Wisconsin with [Republican] Sen. Ron Johnson being challenged by Russ Feingold, who also was in the Senate when Obamacare passed. Feingold went down to defeat again. I think the lot of Democratic senators are going to be looking at what happened to those people and think ‘Maybe I better participate in coming up with a more sensible solution.’ ”
More importantly, the GOP may be looking for bipartisan support, especially since the ACA passed on a strict party-line vote. To that end, it could make more sense to delay reform efforts until a broader coalition can be formed and simultaneous repeal/replace package could be brought to both the House and the Senate floors.
In the new Congress, Senate Republicans might face some of the same obstructionist tactics they used during the Obama administration, which could complicate efforts to get bipartisan support.
“When you have people like Sen. [Bernie] Sanders (I-Vt.) and Sen. [Elizabeth] Warren (D-Mass.) saying they are going to adapt a scorched earth approach going forward, they and their followers don’t have any intention of doing anything that would in any way appear to cooperate with the Republicans,” Dr. Wilensky said. “Of course, there are other Democrats, especially some of the ones who will be up in 2018, who might not be quite so adamant.”
“Repeal without a clear idea of what the replacement would be would really throw that market into chaos, where right now we are at a place where the markets are relatively stable,” Dr. Collins said in an interview.“The best way to think about the ACA, and particularly on the marketplaces and what repeal means, is this image of the three-legged stool. The individual market is the seat and the legs include consumer protections, particularly guaranteed issue; the individual requirement to have insurance; and the subsidies to make that coverage affordable – Medicaid expansion is part of that as well. If you start to remove any one of those legs, the market becomes extremely unstable.”
Repealing the individual mandate is problematic as it goes hand in hand with the ban on coverage denial because of preexisting conditions, something President-elect Trump has signaled he is looking to maintain, Ms. Turner said, adding that free market solutions with appropriate incentives could be a different way to encourage healthy people to get coverage to help generate premium revenue to cover patients with preexisting conditions.
While the ACA will be in the crosshairs, experts expect MACRA to remain more or less intact, maybe with some minor tweaks, at least early on.
While the Medicare Access and CHIP Reauthorization Act of 2015 passed with overwhelming support from both parties, “the [implementing regulations] are just a nightmare and I think the Trump administration is going to have to take a look at them,” Ms. Turner said. She added that physicians are weary of the ever-growing federal administrative hassles. “You do not want doctors to leave private practice in droves, and they are looking at this cost of compliance.”
“I think that [MACRA] is just way too much of an in-the-weeds policy thing for the Trump administration to have addressed yet,” Ms. Turner continued. “But this certainly is going to have to be on the agenda because they are going to hear from a lot of doctors that this is not acceptable.”
Mr. Trump also has called for Medicaid reform, with block grants to the states.
“Everyone keeps talking about a block grant, but that is a clumsy way of doing it,” Ms. Turner said, suggesting the program be even more refined to cover people in different baskets, including dual-eligibles, healthy adults that were part of the ACA Medicaid expansion, mothers and infants, and disabled individuals. “A capitated allotment [allows the government to provide more support to] the people who need it.”
Dr. Wilensky suggested that the Trump administration could revisit the 1332 waiver process, another provision of the ACA.
“The current administration has taken a very-rigid view on that you have to keep savings from Medicaid and the ACA separate and any changes have to be budget neutral to each, which is an extremely rigid set of requirements,” she said. Instead “Medicaid and ACA savings could count together and it just needs to be budget neutral over a 3- or 5-year period. That would then allow states to come in and request a lot of flexibility that the current administration hasn’t been inclined to give them.”
Likewise, the Children’s Health Insurance Plan (CHIP) is up for reauthorization. While the program remains relatively popular, it could be due for some reforms as well. Dr. Wilensky said it might be time for the program to go away, though doing that would face resistance from congressional Democrats.
Likewise, Ms. Turner suggested it could be time to fold CHIP into another program like Medicaid.
“Does it really make sense for a mother who is overwhelmed, maybe even with two jobs, to have her kids on a different health insurance program than she’s on?” Ms. Turner said. “It just adds to the burden and the paperwork. Would it make more sense to blend some of these programs together, making sure the people get the health coverage they need, but without all these artificial silos that really make it much more difficult for the user at the other end. I think they are going to take a look at that.”
Whether the ACA is amended or repealed may affect some – but not all – of the ACA-related cases lingering in the courts.
Zubik v. Burwell for instance, may become irrelevant if President-elect Trump eliminates the ACA’s birth control mandate or its accommodation clause. Zubik centers on an exception to the birth control mandate for organizations that oppose coverage for contraceptives but are not exempted entities, such as churches. The plaintiffs argue that the government’s opt-out process makes them complicit in offering contraception coverage indirectly.
The Trump administration could choose to broaden the mandate’s exemption to include the religious organizations, thus satisfying the plaintiffs, said Timothy S. Jost, a health law professor at Washington and Lee University in Lexington, Va., who added that the case would become moot if the ACA is repealed wholesale.
“Millions of women [currently] get access to birth control without cost sharing through the Affordable Care Act,” he said in an interview. “That’s an issue [the new administration] is going to have to confront.”
In March, U.S. Supreme Court justices requested that both sides provide new briefs that outlined how contraception could be provided without requiring notice on the part of the suing employers. Then, in light of the briefs, the high court vacated the lower court rulings related to Zubik and remanded the case to the four appeals courts that had originally ruled on the issue.
If the case makes its way back to the Supreme Court, the ultimate ruling will largely depend on the makeup of the court at the time, said Eric D. Fader, a New York–based health law attorney.
“As long as we have a 4-4 Supreme Court, everything is up in the air,” Mr. Fader said in an interview. “As soon as that ninth slot is filled, I think we’re going to see some decisions that are going to be in line with traditional Republican conservative positions.”
However, a set of ACA-related cases that involve payments to insurers will continue litigating, regardless of actions by the new administration, analysts said. A half-dozen health insurers have sued the Health & Human Services department over alleged underpayments under the ACA’s risk corridor program.
“Even if you do away with the ACA, these cases all pertain to conduct that has already occurred, so they’re not going to be automatically moot,” Mr. Fader said in an interview. “They may struggle along for a while.”
The cases stem from the ACA’s risk corridor program, which requires HHS to collect funds from excessively profitable insurers that offer qualified health plans under the exchanges, while paying out funds to QHP insurers that have excessive losses. Collections from profitable insurers under the program fell short in 2014 and again in 2015, resulting in HHS paying about 12 cents on the dollar in payments to insurers.
The plaintiffs allege they’ve been shortchanged and that the government must reimburse them full payments for 2014. The Department of Justice (DOJ) argues the cases are premature because the full amount owed under the program is not due until 2016, after the program runs its course.
The Trump administration may surrender another ACA-linked challenge that questions billions in payments made to insurers, Mr. Jost said in an interview. In House v. Burwell, the House of Representatives accuses HHS of wrongly spending billions to repay insurers for health insurance provided to certain low-income patients under the ACA. The House claims HHS is illegally spending monies that Congress never appropriated. HHS argues that other statutory provisions of the ACA authorize expenditures for cost-sharing reimbursements. In May, the U.S. District Court for the District of Columbia decided in favor of the House, ruling that Congress never appropriated money for the payments and that no public money can be spent without an appropriation.
There is speculation that the Trump administration may not pursue an appeal, Mr. Jost said. “I think they better think long and hard about that because I don’t know why any president would want court precedent saying one house of Congress can sue the president whenever it disagrees,” he said. “If the Trump administration would give in on the lawsuit or the House would win … there would be some very large losses and some very large premium increases next year. There could be some very significant disruption of insurance markets.”
Again, if the ACA is repealed, the case may become irrelevant, Mr. Fader said. “If you get rid of the ACA and eliminate the cost sharing structure, than House v. Burwell is going to just be moot.”
“We have seen a substantial uptick in antitrust enforcement activity in health care over the last several years,” he said in an interview. “The Trump administration has said that one of its themes is reducing the regulatory burden on businesses. People will be watching to see if that means an attempt to back off of some of the more-aggressive antitrust enforcement activities in health care and other industries.”
The Obama administration is currently fighting to block two mega-mergers among four of the largest health insurers in the nation. The DOJ filed legal challenges earlier this year seeking to ban Anthem’s proposed acquisition of Cigna and Aetna’s proposed acquisition of Humana. The lawsuits allege the mergers – valued at $54 billion and $37 billion respectively – would negatively affect doctors, patients, and employers by limiting price competition, reducing benefits, and lowering quality of care. A majority of physician associations and patient groups oppose the mergers. But experts said the new administration could drop the challenges.
Similarly, the Trump administration could be more lax in its enforcement of the Stark Law. “You could certainly say if the administration is committed to reducing regulatory burden, one thing the administration might push forward is reducing some of the enforcement with respect to technical violations of Stark,” Mr. Horton said, noting that the Senate recently questioned if the government is going too far in regulating physician relationships under Stark. “If your theme is ‘Let’s cut back on regulation,’ that would be an area that you would think the administration would look at.”
Meanwhile, stronger medical malpractice reforms could be on the horizon in light of a Republican-controlled Congress. Tort reform advocates have a good chance at passing federal medical liability reforms that were left out of the ACA’s passage in 2010, said Dennis A. Cardoza, public affairs director and cochair of the federal public affairs practice at a national health law firm.
Earlier versions of the ACA included amendments that mandated lawsuits go through a state or federal alternative dispute resolution system prior to being filed in court. Another provision that failed would have provided federal grants to states that created special health courts for medical malpractice claims. The amendment would have allowed states to create expert panels, administrative health care tribunals, or a combination of the two.
“There’s much stronger support for tort reform among the Republicans in Congress,” Mr. Cardoza said in an interview. “There’s a shot [now]. If the reforms don’t go too far where they would penalize injured patients, I think they could get additional support and be well received by the Congress.”
Tougher abortion restrictions are likely under the Trump administration, experts said. President-elect Trump has said he is committed to nominating a ninth Supreme Court justice who opposes Roe v. Wade.
Vice President-elect Mike Pence, who is considered a strong voice for the religious right, will likely influence who Mr. Trump nominates for the high court, said Rep-elect Raskin, who added that if ever there was time that abortion rights are in jeopardy, it’s now.
“This really puts the Republicans to the test,” he said in an interview. “For decades now, they have been calling for the overruling of Roe v. Wade. The religious right will never forgive them if it doesn’t happen now. [Republicans] control the House, the Senate, and the White House. They have it within their reach to create a five-justice majority on the court.”
[email protected]
[email protected]
On Twitter @legal_med
Look for three things from the Trump administration: significant changes to the Affordable Care Act, few changes to MACRA’s Quality Payment Program, and a conservative swing in the courts.
Republicans have had their sights on the Affordable Care Act since its passage in 2010; with majorities in both the House and the Senate, the question is not if, but when President Obama’s signature piece of legislation will be dismantled.
President-elect Donald Trump ran on the promise of ACA repeal. Health policy priorities on his transition website focus on greater use of health savings accounts, the ability to purchase insurance across state lines, and the reestablishment of high-risk pools.
Health policy experts differ in how they see ACA reform coming about, with some predicting a quick repeal coupled with an immediate legislative replacement, while others envision repeal with more time to craft replacement legislation. Reform also could come as a series of smaller bills rather than one comprehensive package.
Using budget reconciliation would not allow for full ACA repeal since only provisions that involve revenue generation or spending could be altered. However, since budget reconciliation bills cannot be filibustered, only a simple majority is needed for Senate passage. With their razor-thin majority – 51 seats – Republicans will need some support from outside of their own party.
“Twenty-some Democrats, many in very-deep ‘red states’ including North Dakota, are up for reelection in 2018,” Ms. Turner said. “They saw what happened to the candidates who supported Obamacare in 2016 – many of them went down. It happened with Evan Bayh in Indiana, who was running again to reclaim the Senate seat he left in 2010. And the Republican candidate [Todd Young] reminded the voters over and over that Evan Bayh voted for Obamacare. Same thing happened in Wisconsin with [Republican] Sen. Ron Johnson being challenged by Russ Feingold, who also was in the Senate when Obamacare passed. Feingold went down to defeat again. I think the lot of Democratic senators are going to be looking at what happened to those people and think ‘Maybe I better participate in coming up with a more sensible solution.’ ”
More importantly, the GOP may be looking for bipartisan support, especially since the ACA passed on a strict party-line vote. To that end, it could make more sense to delay reform efforts until a broader coalition can be formed and simultaneous repeal/replace package could be brought to both the House and the Senate floors.
In the new Congress, Senate Republicans might face some of the same obstructionist tactics they used during the Obama administration, which could complicate efforts to get bipartisan support.
“When you have people like Sen. [Bernie] Sanders (I-Vt.) and Sen. [Elizabeth] Warren (D-Mass.) saying they are going to adapt a scorched earth approach going forward, they and their followers don’t have any intention of doing anything that would in any way appear to cooperate with the Republicans,” Dr. Wilensky said. “Of course, there are other Democrats, especially some of the ones who will be up in 2018, who might not be quite so adamant.”
“Repeal without a clear idea of what the replacement would be would really throw that market into chaos, where right now we are at a place where the markets are relatively stable,” Dr. Collins said in an interview.“The best way to think about the ACA, and particularly on the marketplaces and what repeal means, is this image of the three-legged stool. The individual market is the seat and the legs include consumer protections, particularly guaranteed issue; the individual requirement to have insurance; and the subsidies to make that coverage affordable – Medicaid expansion is part of that as well. If you start to remove any one of those legs, the market becomes extremely unstable.”
Repealing the individual mandate is problematic as it goes hand in hand with the ban on coverage denial because of preexisting conditions, something President-elect Trump has signaled he is looking to maintain, Ms. Turner said, adding that free market solutions with appropriate incentives could be a different way to encourage healthy people to get coverage to help generate premium revenue to cover patients with preexisting conditions.
While the ACA will be in the crosshairs, experts expect MACRA to remain more or less intact, maybe with some minor tweaks, at least early on.
While the Medicare Access and CHIP Reauthorization Act of 2015 passed with overwhelming support from both parties, “the [implementing regulations] are just a nightmare and I think the Trump administration is going to have to take a look at them,” Ms. Turner said. She added that physicians are weary of the ever-growing federal administrative hassles. “You do not want doctors to leave private practice in droves, and they are looking at this cost of compliance.”
“I think that [MACRA] is just way too much of an in-the-weeds policy thing for the Trump administration to have addressed yet,” Ms. Turner continued. “But this certainly is going to have to be on the agenda because they are going to hear from a lot of doctors that this is not acceptable.”
Mr. Trump also has called for Medicaid reform, with block grants to the states.
“Everyone keeps talking about a block grant, but that is a clumsy way of doing it,” Ms. Turner said, suggesting the program be even more refined to cover people in different baskets, including dual-eligibles, healthy adults that were part of the ACA Medicaid expansion, mothers and infants, and disabled individuals. “A capitated allotment [allows the government to provide more support to] the people who need it.”
Dr. Wilensky suggested that the Trump administration could revisit the 1332 waiver process, another provision of the ACA.
“The current administration has taken a very-rigid view on that you have to keep savings from Medicaid and the ACA separate and any changes have to be budget neutral to each, which is an extremely rigid set of requirements,” she said. Instead “Medicaid and ACA savings could count together and it just needs to be budget neutral over a 3- or 5-year period. That would then allow states to come in and request a lot of flexibility that the current administration hasn’t been inclined to give them.”
Likewise, the Children’s Health Insurance Plan (CHIP) is up for reauthorization. While the program remains relatively popular, it could be due for some reforms as well. Dr. Wilensky said it might be time for the program to go away, though doing that would face resistance from congressional Democrats.
Likewise, Ms. Turner suggested it could be time to fold CHIP into another program like Medicaid.
“Does it really make sense for a mother who is overwhelmed, maybe even with two jobs, to have her kids on a different health insurance program than she’s on?” Ms. Turner said. “It just adds to the burden and the paperwork. Would it make more sense to blend some of these programs together, making sure the people get the health coverage they need, but without all these artificial silos that really make it much more difficult for the user at the other end. I think they are going to take a look at that.”
Whether the ACA is amended or repealed may affect some – but not all – of the ACA-related cases lingering in the courts.
Zubik v. Burwell for instance, may become irrelevant if President-elect Trump eliminates the ACA’s birth control mandate or its accommodation clause. Zubik centers on an exception to the birth control mandate for organizations that oppose coverage for contraceptives but are not exempted entities, such as churches. The plaintiffs argue that the government’s opt-out process makes them complicit in offering contraception coverage indirectly.
The Trump administration could choose to broaden the mandate’s exemption to include the religious organizations, thus satisfying the plaintiffs, said Timothy S. Jost, a health law professor at Washington and Lee University in Lexington, Va., who added that the case would become moot if the ACA is repealed wholesale.
“Millions of women [currently] get access to birth control without cost sharing through the Affordable Care Act,” he said in an interview. “That’s an issue [the new administration] is going to have to confront.”
In March, U.S. Supreme Court justices requested that both sides provide new briefs that outlined how contraception could be provided without requiring notice on the part of the suing employers. Then, in light of the briefs, the high court vacated the lower court rulings related to Zubik and remanded the case to the four appeals courts that had originally ruled on the issue.
If the case makes its way back to the Supreme Court, the ultimate ruling will largely depend on the makeup of the court at the time, said Eric D. Fader, a New York–based health law attorney.
“As long as we have a 4-4 Supreme Court, everything is up in the air,” Mr. Fader said in an interview. “As soon as that ninth slot is filled, I think we’re going to see some decisions that are going to be in line with traditional Republican conservative positions.”
However, a set of ACA-related cases that involve payments to insurers will continue litigating, regardless of actions by the new administration, analysts said. A half-dozen health insurers have sued the Health & Human Services department over alleged underpayments under the ACA’s risk corridor program.
“Even if you do away with the ACA, these cases all pertain to conduct that has already occurred, so they’re not going to be automatically moot,” Mr. Fader said in an interview. “They may struggle along for a while.”
The cases stem from the ACA’s risk corridor program, which requires HHS to collect funds from excessively profitable insurers that offer qualified health plans under the exchanges, while paying out funds to QHP insurers that have excessive losses. Collections from profitable insurers under the program fell short in 2014 and again in 2015, resulting in HHS paying about 12 cents on the dollar in payments to insurers.
The plaintiffs allege they’ve been shortchanged and that the government must reimburse them full payments for 2014. The Department of Justice (DOJ) argues the cases are premature because the full amount owed under the program is not due until 2016, after the program runs its course.
The Trump administration may surrender another ACA-linked challenge that questions billions in payments made to insurers, Mr. Jost said in an interview. In House v. Burwell, the House of Representatives accuses HHS of wrongly spending billions to repay insurers for health insurance provided to certain low-income patients under the ACA. The House claims HHS is illegally spending monies that Congress never appropriated. HHS argues that other statutory provisions of the ACA authorize expenditures for cost-sharing reimbursements. In May, the U.S. District Court for the District of Columbia decided in favor of the House, ruling that Congress never appropriated money for the payments and that no public money can be spent without an appropriation.
There is speculation that the Trump administration may not pursue an appeal, Mr. Jost said. “I think they better think long and hard about that because I don’t know why any president would want court precedent saying one house of Congress can sue the president whenever it disagrees,” he said. “If the Trump administration would give in on the lawsuit or the House would win … there would be some very large losses and some very large premium increases next year. There could be some very significant disruption of insurance markets.”
Again, if the ACA is repealed, the case may become irrelevant, Mr. Fader said. “If you get rid of the ACA and eliminate the cost sharing structure, than House v. Burwell is going to just be moot.”
“We have seen a substantial uptick in antitrust enforcement activity in health care over the last several years,” he said in an interview. “The Trump administration has said that one of its themes is reducing the regulatory burden on businesses. People will be watching to see if that means an attempt to back off of some of the more-aggressive antitrust enforcement activities in health care and other industries.”
The Obama administration is currently fighting to block two mega-mergers among four of the largest health insurers in the nation. The DOJ filed legal challenges earlier this year seeking to ban Anthem’s proposed acquisition of Cigna and Aetna’s proposed acquisition of Humana. The lawsuits allege the mergers – valued at $54 billion and $37 billion respectively – would negatively affect doctors, patients, and employers by limiting price competition, reducing benefits, and lowering quality of care. A majority of physician associations and patient groups oppose the mergers. But experts said the new administration could drop the challenges.
Similarly, the Trump administration could be more lax in its enforcement of the Stark Law. “You could certainly say if the administration is committed to reducing regulatory burden, one thing the administration might push forward is reducing some of the enforcement with respect to technical violations of Stark,” Mr. Horton said, noting that the Senate recently questioned if the government is going too far in regulating physician relationships under Stark. “If your theme is ‘Let’s cut back on regulation,’ that would be an area that you would think the administration would look at.”
Meanwhile, stronger medical malpractice reforms could be on the horizon in light of a Republican-controlled Congress. Tort reform advocates have a good chance at passing federal medical liability reforms that were left out of the ACA’s passage in 2010, said Dennis A. Cardoza, public affairs director and cochair of the federal public affairs practice at a national health law firm.
Earlier versions of the ACA included amendments that mandated lawsuits go through a state or federal alternative dispute resolution system prior to being filed in court. Another provision that failed would have provided federal grants to states that created special health courts for medical malpractice claims. The amendment would have allowed states to create expert panels, administrative health care tribunals, or a combination of the two.
“There’s much stronger support for tort reform among the Republicans in Congress,” Mr. Cardoza said in an interview. “There’s a shot [now]. If the reforms don’t go too far where they would penalize injured patients, I think they could get additional support and be well received by the Congress.”
Tougher abortion restrictions are likely under the Trump administration, experts said. President-elect Trump has said he is committed to nominating a ninth Supreme Court justice who opposes Roe v. Wade.
Vice President-elect Mike Pence, who is considered a strong voice for the religious right, will likely influence who Mr. Trump nominates for the high court, said Rep-elect Raskin, who added that if ever there was time that abortion rights are in jeopardy, it’s now.
“This really puts the Republicans to the test,” he said in an interview. “For decades now, they have been calling for the overruling of Roe v. Wade. The religious right will never forgive them if it doesn’t happen now. [Republicans] control the House, the Senate, and the White House. They have it within their reach to create a five-justice majority on the court.”
[email protected]
[email protected]
On Twitter @legal_med
Look for three things from the Trump administration: significant changes to the Affordable Care Act, few changes to MACRA’s Quality Payment Program, and a conservative swing in the courts.
Republicans have had their sights on the Affordable Care Act since its passage in 2010; with majorities in both the House and the Senate, the question is not if, but when President Obama’s signature piece of legislation will be dismantled.
President-elect Donald Trump ran on the promise of ACA repeal. Health policy priorities on his transition website focus on greater use of health savings accounts, the ability to purchase insurance across state lines, and the reestablishment of high-risk pools.
Health policy experts differ in how they see ACA reform coming about, with some predicting a quick repeal coupled with an immediate legislative replacement, while others envision repeal with more time to craft replacement legislation. Reform also could come as a series of smaller bills rather than one comprehensive package.
Using budget reconciliation would not allow for full ACA repeal since only provisions that involve revenue generation or spending could be altered. However, since budget reconciliation bills cannot be filibustered, only a simple majority is needed for Senate passage. With their razor-thin majority – 51 seats – Republicans will need some support from outside of their own party.
“Twenty-some Democrats, many in very-deep ‘red states’ including North Dakota, are up for reelection in 2018,” Ms. Turner said. “They saw what happened to the candidates who supported Obamacare in 2016 – many of them went down. It happened with Evan Bayh in Indiana, who was running again to reclaim the Senate seat he left in 2010. And the Republican candidate [Todd Young] reminded the voters over and over that Evan Bayh voted for Obamacare. Same thing happened in Wisconsin with [Republican] Sen. Ron Johnson being challenged by Russ Feingold, who also was in the Senate when Obamacare passed. Feingold went down to defeat again. I think the lot of Democratic senators are going to be looking at what happened to those people and think ‘Maybe I better participate in coming up with a more sensible solution.’ ”
More importantly, the GOP may be looking for bipartisan support, especially since the ACA passed on a strict party-line vote. To that end, it could make more sense to delay reform efforts until a broader coalition can be formed and simultaneous repeal/replace package could be brought to both the House and the Senate floors.
In the new Congress, Senate Republicans might face some of the same obstructionist tactics they used during the Obama administration, which could complicate efforts to get bipartisan support.
“When you have people like Sen. [Bernie] Sanders (I-Vt.) and Sen. [Elizabeth] Warren (D-Mass.) saying they are going to adapt a scorched earth approach going forward, they and their followers don’t have any intention of doing anything that would in any way appear to cooperate with the Republicans,” Dr. Wilensky said. “Of course, there are other Democrats, especially some of the ones who will be up in 2018, who might not be quite so adamant.”
“Repeal without a clear idea of what the replacement would be would really throw that market into chaos, where right now we are at a place where the markets are relatively stable,” Dr. Collins said in an interview.“The best way to think about the ACA, and particularly on the marketplaces and what repeal means, is this image of the three-legged stool. The individual market is the seat and the legs include consumer protections, particularly guaranteed issue; the individual requirement to have insurance; and the subsidies to make that coverage affordable – Medicaid expansion is part of that as well. If you start to remove any one of those legs, the market becomes extremely unstable.”
Repealing the individual mandate is problematic as it goes hand in hand with the ban on coverage denial because of preexisting conditions, something President-elect Trump has signaled he is looking to maintain, Ms. Turner said, adding that free market solutions with appropriate incentives could be a different way to encourage healthy people to get coverage to help generate premium revenue to cover patients with preexisting conditions.
While the ACA will be in the crosshairs, experts expect MACRA to remain more or less intact, maybe with some minor tweaks, at least early on.
While the Medicare Access and CHIP Reauthorization Act of 2015 passed with overwhelming support from both parties, “the [implementing regulations] are just a nightmare and I think the Trump administration is going to have to take a look at them,” Ms. Turner said. She added that physicians are weary of the ever-growing federal administrative hassles. “You do not want doctors to leave private practice in droves, and they are looking at this cost of compliance.”
“I think that [MACRA] is just way too much of an in-the-weeds policy thing for the Trump administration to have addressed yet,” Ms. Turner continued. “But this certainly is going to have to be on the agenda because they are going to hear from a lot of doctors that this is not acceptable.”
Mr. Trump also has called for Medicaid reform, with block grants to the states.
“Everyone keeps talking about a block grant, but that is a clumsy way of doing it,” Ms. Turner said, suggesting the program be even more refined to cover people in different baskets, including dual-eligibles, healthy adults that were part of the ACA Medicaid expansion, mothers and infants, and disabled individuals. “A capitated allotment [allows the government to provide more support to] the people who need it.”
Dr. Wilensky suggested that the Trump administration could revisit the 1332 waiver process, another provision of the ACA.
“The current administration has taken a very-rigid view on that you have to keep savings from Medicaid and the ACA separate and any changes have to be budget neutral to each, which is an extremely rigid set of requirements,” she said. Instead “Medicaid and ACA savings could count together and it just needs to be budget neutral over a 3- or 5-year period. That would then allow states to come in and request a lot of flexibility that the current administration hasn’t been inclined to give them.”
Likewise, the Children’s Health Insurance Plan (CHIP) is up for reauthorization. While the program remains relatively popular, it could be due for some reforms as well. Dr. Wilensky said it might be time for the program to go away, though doing that would face resistance from congressional Democrats.
Likewise, Ms. Turner suggested it could be time to fold CHIP into another program like Medicaid.
“Does it really make sense for a mother who is overwhelmed, maybe even with two jobs, to have her kids on a different health insurance program than she’s on?” Ms. Turner said. “It just adds to the burden and the paperwork. Would it make more sense to blend some of these programs together, making sure the people get the health coverage they need, but without all these artificial silos that really make it much more difficult for the user at the other end. I think they are going to take a look at that.”
Whether the ACA is amended or repealed may affect some – but not all – of the ACA-related cases lingering in the courts.
Zubik v. Burwell for instance, may become irrelevant if President-elect Trump eliminates the ACA’s birth control mandate or its accommodation clause. Zubik centers on an exception to the birth control mandate for organizations that oppose coverage for contraceptives but are not exempted entities, such as churches. The plaintiffs argue that the government’s opt-out process makes them complicit in offering contraception coverage indirectly.
The Trump administration could choose to broaden the mandate’s exemption to include the religious organizations, thus satisfying the plaintiffs, said Timothy S. Jost, a health law professor at Washington and Lee University in Lexington, Va., who added that the case would become moot if the ACA is repealed wholesale.
“Millions of women [currently] get access to birth control without cost sharing through the Affordable Care Act,” he said in an interview. “That’s an issue [the new administration] is going to have to confront.”
In March, U.S. Supreme Court justices requested that both sides provide new briefs that outlined how contraception could be provided without requiring notice on the part of the suing employers. Then, in light of the briefs, the high court vacated the lower court rulings related to Zubik and remanded the case to the four appeals courts that had originally ruled on the issue.
If the case makes its way back to the Supreme Court, the ultimate ruling will largely depend on the makeup of the court at the time, said Eric D. Fader, a New York–based health law attorney.
“As long as we have a 4-4 Supreme Court, everything is up in the air,” Mr. Fader said in an interview. “As soon as that ninth slot is filled, I think we’re going to see some decisions that are going to be in line with traditional Republican conservative positions.”
However, a set of ACA-related cases that involve payments to insurers will continue litigating, regardless of actions by the new administration, analysts said. A half-dozen health insurers have sued the Health & Human Services department over alleged underpayments under the ACA’s risk corridor program.
“Even if you do away with the ACA, these cases all pertain to conduct that has already occurred, so they’re not going to be automatically moot,” Mr. Fader said in an interview. “They may struggle along for a while.”
The cases stem from the ACA’s risk corridor program, which requires HHS to collect funds from excessively profitable insurers that offer qualified health plans under the exchanges, while paying out funds to QHP insurers that have excessive losses. Collections from profitable insurers under the program fell short in 2014 and again in 2015, resulting in HHS paying about 12 cents on the dollar in payments to insurers.
The plaintiffs allege they’ve been shortchanged and that the government must reimburse them full payments for 2014. The Department of Justice (DOJ) argues the cases are premature because the full amount owed under the program is not due until 2016, after the program runs its course.
The Trump administration may surrender another ACA-linked challenge that questions billions in payments made to insurers, Mr. Jost said in an interview. In House v. Burwell, the House of Representatives accuses HHS of wrongly spending billions to repay insurers for health insurance provided to certain low-income patients under the ACA. The House claims HHS is illegally spending monies that Congress never appropriated. HHS argues that other statutory provisions of the ACA authorize expenditures for cost-sharing reimbursements. In May, the U.S. District Court for the District of Columbia decided in favor of the House, ruling that Congress never appropriated money for the payments and that no public money can be spent without an appropriation.
There is speculation that the Trump administration may not pursue an appeal, Mr. Jost said. “I think they better think long and hard about that because I don’t know why any president would want court precedent saying one house of Congress can sue the president whenever it disagrees,” he said. “If the Trump administration would give in on the lawsuit or the House would win … there would be some very large losses and some very large premium increases next year. There could be some very significant disruption of insurance markets.”
Again, if the ACA is repealed, the case may become irrelevant, Mr. Fader said. “If you get rid of the ACA and eliminate the cost sharing structure, than House v. Burwell is going to just be moot.”
“We have seen a substantial uptick in antitrust enforcement activity in health care over the last several years,” he said in an interview. “The Trump administration has said that one of its themes is reducing the regulatory burden on businesses. People will be watching to see if that means an attempt to back off of some of the more-aggressive antitrust enforcement activities in health care and other industries.”
The Obama administration is currently fighting to block two mega-mergers among four of the largest health insurers in the nation. The DOJ filed legal challenges earlier this year seeking to ban Anthem’s proposed acquisition of Cigna and Aetna’s proposed acquisition of Humana. The lawsuits allege the mergers – valued at $54 billion and $37 billion respectively – would negatively affect doctors, patients, and employers by limiting price competition, reducing benefits, and lowering quality of care. A majority of physician associations and patient groups oppose the mergers. But experts said the new administration could drop the challenges.
Similarly, the Trump administration could be more lax in its enforcement of the Stark Law. “You could certainly say if the administration is committed to reducing regulatory burden, one thing the administration might push forward is reducing some of the enforcement with respect to technical violations of Stark,” Mr. Horton said, noting that the Senate recently questioned if the government is going too far in regulating physician relationships under Stark. “If your theme is ‘Let’s cut back on regulation,’ that would be an area that you would think the administration would look at.”
Meanwhile, stronger medical malpractice reforms could be on the horizon in light of a Republican-controlled Congress. Tort reform advocates have a good chance at passing federal medical liability reforms that were left out of the ACA’s passage in 2010, said Dennis A. Cardoza, public affairs director and cochair of the federal public affairs practice at a national health law firm.
Earlier versions of the ACA included amendments that mandated lawsuits go through a state or federal alternative dispute resolution system prior to being filed in court. Another provision that failed would have provided federal grants to states that created special health courts for medical malpractice claims. The amendment would have allowed states to create expert panels, administrative health care tribunals, or a combination of the two.
“There’s much stronger support for tort reform among the Republicans in Congress,” Mr. Cardoza said in an interview. “There’s a shot [now]. If the reforms don’t go too far where they would penalize injured patients, I think they could get additional support and be well received by the Congress.”
Tougher abortion restrictions are likely under the Trump administration, experts said. President-elect Trump has said he is committed to nominating a ninth Supreme Court justice who opposes Roe v. Wade.
Vice President-elect Mike Pence, who is considered a strong voice for the religious right, will likely influence who Mr. Trump nominates for the high court, said Rep-elect Raskin, who added that if ever there was time that abortion rights are in jeopardy, it’s now.
“This really puts the Republicans to the test,” he said in an interview. “For decades now, they have been calling for the overruling of Roe v. Wade. The religious right will never forgive them if it doesn’t happen now. [Republicans] control the House, the Senate, and the White House. They have it within their reach to create a five-justice majority on the court.”
[email protected]
[email protected]
On Twitter @legal_med
Light and heavy mesh deliver similar outcomes and QOL for lap inguinal repair
WASHINGTON – The weight of mesh used in laparoscopic inguinal hernia repairs was not a significant factor in postoperative outcomes and quality of life, in a large, long-term study.
“There are approximately 700,000 inguinal hernia repairs annually,” said Steve Groene, MD, of the Carolinas Medical Center, Charlotte, N.C. “The goal of our study was to utilize a large sample size of long-term follow-up and compare surgical and quality of life outcomes between light-weight and heavy-weight mesh in laparoscopic inguinal hernia repairs.”
The rates of postoperative complications such as surgical infection, urinary retention, and recurrence in the two groups were similar. Although the LW mesh group had a significantly higher rate of hematoma and seroma, that difference vanished with a multivariate analysis that accounted for confounding factors such as smoking, elective vs. emergent surgery, and surgical technique, Dr. Groene said at the annual clinical congress of the American College of Surgeons.
Quality of life (QOL) was measured with the Carolina Comfort Scale before surgery and at the 2-week, 1-month, 6-month, 12-month, 24-month, and 36-month follow-ups. The investigators looked at pain, movement limitation, and mesh sensation for outcomes and symptoms. There were no other statistically significant differences in QOL between the groups at any of the follow-up time points.
When asked during the discussion about the experience of the investigators in getting patients to continue through a 36-month follow-up, Dr. Groene said that “at 1 month, we were about 60%, [and] at 1 year about 40%; having about 40%-42% of people following up at 1 month is very good.”
Dr. Groene concluded that surgeons should continue to use the type of mesh they feel most comfortable with for laparoscopic inguinal hernia repair and expect to have similar outcomes.
He reported having no relevant financial disclosures.
WASHINGTON – The weight of mesh used in laparoscopic inguinal hernia repairs was not a significant factor in postoperative outcomes and quality of life, in a large, long-term study.
“There are approximately 700,000 inguinal hernia repairs annually,” said Steve Groene, MD, of the Carolinas Medical Center, Charlotte, N.C. “The goal of our study was to utilize a large sample size of long-term follow-up and compare surgical and quality of life outcomes between light-weight and heavy-weight mesh in laparoscopic inguinal hernia repairs.”
The rates of postoperative complications such as surgical infection, urinary retention, and recurrence in the two groups were similar. Although the LW mesh group had a significantly higher rate of hematoma and seroma, that difference vanished with a multivariate analysis that accounted for confounding factors such as smoking, elective vs. emergent surgery, and surgical technique, Dr. Groene said at the annual clinical congress of the American College of Surgeons.
Quality of life (QOL) was measured with the Carolina Comfort Scale before surgery and at the 2-week, 1-month, 6-month, 12-month, 24-month, and 36-month follow-ups. The investigators looked at pain, movement limitation, and mesh sensation for outcomes and symptoms. There were no other statistically significant differences in QOL between the groups at any of the follow-up time points.
When asked during the discussion about the experience of the investigators in getting patients to continue through a 36-month follow-up, Dr. Groene said that “at 1 month, we were about 60%, [and] at 1 year about 40%; having about 40%-42% of people following up at 1 month is very good.”
Dr. Groene concluded that surgeons should continue to use the type of mesh they feel most comfortable with for laparoscopic inguinal hernia repair and expect to have similar outcomes.
He reported having no relevant financial disclosures.
WASHINGTON – The weight of mesh used in laparoscopic inguinal hernia repairs was not a significant factor in postoperative outcomes and quality of life, in a large, long-term study.
“There are approximately 700,000 inguinal hernia repairs annually,” said Steve Groene, MD, of the Carolinas Medical Center, Charlotte, N.C. “The goal of our study was to utilize a large sample size of long-term follow-up and compare surgical and quality of life outcomes between light-weight and heavy-weight mesh in laparoscopic inguinal hernia repairs.”
The rates of postoperative complications such as surgical infection, urinary retention, and recurrence in the two groups were similar. Although the LW mesh group had a significantly higher rate of hematoma and seroma, that difference vanished with a multivariate analysis that accounted for confounding factors such as smoking, elective vs. emergent surgery, and surgical technique, Dr. Groene said at the annual clinical congress of the American College of Surgeons.
Quality of life (QOL) was measured with the Carolina Comfort Scale before surgery and at the 2-week, 1-month, 6-month, 12-month, 24-month, and 36-month follow-ups. The investigators looked at pain, movement limitation, and mesh sensation for outcomes and symptoms. There were no other statistically significant differences in QOL between the groups at any of the follow-up time points.
When asked during the discussion about the experience of the investigators in getting patients to continue through a 36-month follow-up, Dr. Groene said that “at 1 month, we were about 60%, [and] at 1 year about 40%; having about 40%-42% of people following up at 1 month is very good.”
Dr. Groene concluded that surgeons should continue to use the type of mesh they feel most comfortable with for laparoscopic inguinal hernia repair and expect to have similar outcomes.
He reported having no relevant financial disclosures.
FROM ACS CLINICAL CONGRESS
Key clinical point:
Major finding: For laparoscopic inguinal hernia repair, mesh weight was not a significant factor in postoperative complications or quality of life, as measured by the Carolinas Comfort Scale.
Data source: A prospective study of 1,270 laparoscopic inguinal hernia repair patients from a hernia-specific database.
Disclosures: Dr. Groene reported having no relevant financial disclosures.
Risk models for hernia recurrence don’t hold up to external validation
Five common variable selection strategies failed to produce a statistical model that accurately predicted ventral hernia recurrence in an investigation published in the Journal of Surgical Research.
The finding matters because those five techniques – expert opinion and various multivariate regression and bootstrapping strategies – have been widely used in previous studies to create risk scores for ventral hernia recurrence. The new study calls the value of existing scoring systems into question (J Surg Res. 2016 Nov;206[1]:159-67. doi: 10.1016/j.jss.2016.07.042).
The lack of external validation in many studies leads to medical findings that often can’t be confirmed by subsequent studies. It’s a problem that has contributed to skepticism about research results in both the medical community and the general public, they said.
“This study demonstrates the importance of true external validation on an external data set. Simply splitting a data set and validating [internally] does not appear to be an adequate assessment of predictive accuracy. … We recommend that future researchers consider using and presenting the results of multiple variable selection strategies [and] focus on presenting predictive accuracy on external data sets to validate their model,” the team concluded.
The original goal of the project was to identify the best predictors of ventral hernia recurrence since suggestions from past studies have varied. The team first used a prospective database of 790 ventral hernia repair patients to identify predictors of recurrence. Of that group, 526 patients – 173 (32.9%) of whom had a recurrence after a median follow-up of 20 months – were used to identify risk variables using expert opinion, selective stepwise regression, liberal stepwise regression, and bootstrapping with both restrictive and liberal internal resampling.
The team used the remaining 264 patients to confirm the findings. As in previous studies, internal validation worked: all five models had a Harrell’s C-statistic of about 0.76, which is considered reasonable, Dr. Holihan and her associates reported.
However, when the investigators applied their models to a second database of 1,225 patients followed for a median of 9 months – with 155 recurrences (12.7%) – they were not much better at predicting recurrence than a coin toss, with C-statistic values of about 0.56.
Some variables made the cut with all five selection techniques, including hernia type, wound class, and albumin levels, which are related to how well the wound heals. Other variables were significant in some selection strategies but not others, including smoking status, open versus laparoscopic approach, and mesh use.
At least for now, clinical intuition remains important for assessing rerupture risk, they said.
The National Institutes of Health funded the work. Author disclosures were not reported.
Five common variable selection strategies failed to produce a statistical model that accurately predicted ventral hernia recurrence in an investigation published in the Journal of Surgical Research.
The finding matters because those five techniques – expert opinion and various multivariate regression and bootstrapping strategies – have been widely used in previous studies to create risk scores for ventral hernia recurrence. The new study calls the value of existing scoring systems into question (J Surg Res. 2016 Nov;206[1]:159-67. doi: 10.1016/j.jss.2016.07.042).
The lack of external validation in many studies leads to medical findings that often can’t be confirmed by subsequent studies. It’s a problem that has contributed to skepticism about research results in both the medical community and the general public, they said.
“This study demonstrates the importance of true external validation on an external data set. Simply splitting a data set and validating [internally] does not appear to be an adequate assessment of predictive accuracy. … We recommend that future researchers consider using and presenting the results of multiple variable selection strategies [and] focus on presenting predictive accuracy on external data sets to validate their model,” the team concluded.
The original goal of the project was to identify the best predictors of ventral hernia recurrence since suggestions from past studies have varied. The team first used a prospective database of 790 ventral hernia repair patients to identify predictors of recurrence. Of that group, 526 patients – 173 (32.9%) of whom had a recurrence after a median follow-up of 20 months – were used to identify risk variables using expert opinion, selective stepwise regression, liberal stepwise regression, and bootstrapping with both restrictive and liberal internal resampling.
The team used the remaining 264 patients to confirm the findings. As in previous studies, internal validation worked: all five models had a Harrell’s C-statistic of about 0.76, which is considered reasonable, Dr. Holihan and her associates reported.
However, when the investigators applied their models to a second database of 1,225 patients followed for a median of 9 months – with 155 recurrences (12.7%) – they were not much better at predicting recurrence than a coin toss, with C-statistic values of about 0.56.
Some variables made the cut with all five selection techniques, including hernia type, wound class, and albumin levels, which are related to how well the wound heals. Other variables were significant in some selection strategies but not others, including smoking status, open versus laparoscopic approach, and mesh use.
At least for now, clinical intuition remains important for assessing rerupture risk, they said.
The National Institutes of Health funded the work. Author disclosures were not reported.
Five common variable selection strategies failed to produce a statistical model that accurately predicted ventral hernia recurrence in an investigation published in the Journal of Surgical Research.
The finding matters because those five techniques – expert opinion and various multivariate regression and bootstrapping strategies – have been widely used in previous studies to create risk scores for ventral hernia recurrence. The new study calls the value of existing scoring systems into question (J Surg Res. 2016 Nov;206[1]:159-67. doi: 10.1016/j.jss.2016.07.042).
The lack of external validation in many studies leads to medical findings that often can’t be confirmed by subsequent studies. It’s a problem that has contributed to skepticism about research results in both the medical community and the general public, they said.
“This study demonstrates the importance of true external validation on an external data set. Simply splitting a data set and validating [internally] does not appear to be an adequate assessment of predictive accuracy. … We recommend that future researchers consider using and presenting the results of multiple variable selection strategies [and] focus on presenting predictive accuracy on external data sets to validate their model,” the team concluded.
The original goal of the project was to identify the best predictors of ventral hernia recurrence since suggestions from past studies have varied. The team first used a prospective database of 790 ventral hernia repair patients to identify predictors of recurrence. Of that group, 526 patients – 173 (32.9%) of whom had a recurrence after a median follow-up of 20 months – were used to identify risk variables using expert opinion, selective stepwise regression, liberal stepwise regression, and bootstrapping with both restrictive and liberal internal resampling.
The team used the remaining 264 patients to confirm the findings. As in previous studies, internal validation worked: all five models had a Harrell’s C-statistic of about 0.76, which is considered reasonable, Dr. Holihan and her associates reported.
However, when the investigators applied their models to a second database of 1,225 patients followed for a median of 9 months – with 155 recurrences (12.7%) – they were not much better at predicting recurrence than a coin toss, with C-statistic values of about 0.56.
Some variables made the cut with all five selection techniques, including hernia type, wound class, and albumin levels, which are related to how well the wound heals. Other variables were significant in some selection strategies but not others, including smoking status, open versus laparoscopic approach, and mesh use.
At least for now, clinical intuition remains important for assessing rerupture risk, they said.
The National Institutes of Health funded the work. Author disclosures were not reported.
FROM THE JOURNAL OF SURGICAL RESEARCH
Key clinical point:
Major finding: Risk models developed from the five strategies weren’t much better at predicting recurrence than a coin toss, with C-statistic values of about 0.56.
Data source: Analysis of two datasets containing a total of 2,015 ventral hernia repair patients.
Disclosures: The National Institutes of Health funded the work. Author disclosures were not reported.
Do fellowship programs help prepare general surgery residents for board exams?
WASHINGTON – Pass rates on the general surgery board exams were significantly higher for programs in which residents trained alongside surgical fellows, according to a retrospective study presented at the annual clinical congress of the American College of Surgeons.
The study adds another perspective to the ongoing debate about the impact of fellowships on general surgery residency and residency programs. Mohammed J. Al Fayyadh, MD, of the University of Texas Health Science Center at San Antonio and his associates investigated the impact of fellowships on program pass rates for general surgery boards. They reviewed American Board of Surgery exam data for the classes of 2010-2014, which included 242 programs (a total of 5,191 resident examinees), of which 148 had fellows participating (3,767 resident examinees).
The findings suggest that having fellows in a program has a positive impact on the pass rates of those taking the ABS general surgery exam. Pass rates were significantly higher for general surgery programs with fellows. This trend held for all measures studied: Qualifying (written) exam (88% vs. 86%), certifying (oral) exam (83% vs. 80%), and combined exams (74% vs. 69%). Differences between the groups were statistically significant.
The pass rates tended to be higher in programs with higher Fel:Res ratios. For example, programs with a 1.5:1 Fel:Res ratio had the highest pass rates for the qualifying, certifying, and combined exams.
The impact of subspecialty fellowships on general surgery residencies has been the subject of research and debate in recent years. Some studies have suggested that subspecialty training for fellows has meant that general surgery residents have less opportunity to operate in areas such as trauma (“Trauma operative training declining for general surgery residents,” ACS Surgery News, Oct. 4, 2016) and vascular surgery (Ann Vasc Surg. 2016;33;98-102).
Taken in this context, it is possible that the programs with more fellows simply recruit more competitive residents who tend to do better on exams. However, this could also reflect more resources in fellowship programs that are available to all trainees or better mentorship opportunities, said Dr. Al Fayyadh. He concluded that more research is needed to tease out the impact of fellowship programs on general surgery resident education.
Dr. Al Fayyadh had no disclosures.
WASHINGTON – Pass rates on the general surgery board exams were significantly higher for programs in which residents trained alongside surgical fellows, according to a retrospective study presented at the annual clinical congress of the American College of Surgeons.
The study adds another perspective to the ongoing debate about the impact of fellowships on general surgery residency and residency programs. Mohammed J. Al Fayyadh, MD, of the University of Texas Health Science Center at San Antonio and his associates investigated the impact of fellowships on program pass rates for general surgery boards. They reviewed American Board of Surgery exam data for the classes of 2010-2014, which included 242 programs (a total of 5,191 resident examinees), of which 148 had fellows participating (3,767 resident examinees).
The findings suggest that having fellows in a program has a positive impact on the pass rates of those taking the ABS general surgery exam. Pass rates were significantly higher for general surgery programs with fellows. This trend held for all measures studied: Qualifying (written) exam (88% vs. 86%), certifying (oral) exam (83% vs. 80%), and combined exams (74% vs. 69%). Differences between the groups were statistically significant.
The pass rates tended to be higher in programs with higher Fel:Res ratios. For example, programs with a 1.5:1 Fel:Res ratio had the highest pass rates for the qualifying, certifying, and combined exams.
The impact of subspecialty fellowships on general surgery residencies has been the subject of research and debate in recent years. Some studies have suggested that subspecialty training for fellows has meant that general surgery residents have less opportunity to operate in areas such as trauma (“Trauma operative training declining for general surgery residents,” ACS Surgery News, Oct. 4, 2016) and vascular surgery (Ann Vasc Surg. 2016;33;98-102).
Taken in this context, it is possible that the programs with more fellows simply recruit more competitive residents who tend to do better on exams. However, this could also reflect more resources in fellowship programs that are available to all trainees or better mentorship opportunities, said Dr. Al Fayyadh. He concluded that more research is needed to tease out the impact of fellowship programs on general surgery resident education.
Dr. Al Fayyadh had no disclosures.
WASHINGTON – Pass rates on the general surgery board exams were significantly higher for programs in which residents trained alongside surgical fellows, according to a retrospective study presented at the annual clinical congress of the American College of Surgeons.
The study adds another perspective to the ongoing debate about the impact of fellowships on general surgery residency and residency programs. Mohammed J. Al Fayyadh, MD, of the University of Texas Health Science Center at San Antonio and his associates investigated the impact of fellowships on program pass rates for general surgery boards. They reviewed American Board of Surgery exam data for the classes of 2010-2014, which included 242 programs (a total of 5,191 resident examinees), of which 148 had fellows participating (3,767 resident examinees).
The findings suggest that having fellows in a program has a positive impact on the pass rates of those taking the ABS general surgery exam. Pass rates were significantly higher for general surgery programs with fellows. This trend held for all measures studied: Qualifying (written) exam (88% vs. 86%), certifying (oral) exam (83% vs. 80%), and combined exams (74% vs. 69%). Differences between the groups were statistically significant.
The pass rates tended to be higher in programs with higher Fel:Res ratios. For example, programs with a 1.5:1 Fel:Res ratio had the highest pass rates for the qualifying, certifying, and combined exams.
The impact of subspecialty fellowships on general surgery residencies has been the subject of research and debate in recent years. Some studies have suggested that subspecialty training for fellows has meant that general surgery residents have less opportunity to operate in areas such as trauma (“Trauma operative training declining for general surgery residents,” ACS Surgery News, Oct. 4, 2016) and vascular surgery (Ann Vasc Surg. 2016;33;98-102).
Taken in this context, it is possible that the programs with more fellows simply recruit more competitive residents who tend to do better on exams. However, this could also reflect more resources in fellowship programs that are available to all trainees or better mentorship opportunities, said Dr. Al Fayyadh. He concluded that more research is needed to tease out the impact of fellowship programs on general surgery resident education.
Dr. Al Fayyadh had no disclosures.
AT THE ACS CLINICAL CONGRESS
Senate sends 21st Century Cures bill to president
With little debate and less dissent, the Senate passed the 21st Century Cures bill and sent it to President Obama for his promised signature.
The legislation passed the House by an overwhelming 392-26 vote on Nov. 30. Key provisions of the bill (H.R. 34) include:
• Food and Drug Administration reforms, including expedited review for certain medical devices, streamlined review for drug/device combinations, and increased patient involvement in the drug approval process, with $500 million to implement the reforms.
• $4.8 billion over 10 years for key biomedical research efforts including the BRAIN Initiative, the Cancer Moonshot, and the Precision Medicine Initiative.
• $1 billion in grants to states over a 2-year period to help supplement opioid abuse prevention and treatment activities.
• Provisions to improve the interoperability of EHRs.
• Provisions to improve treatment of serious mental illness.
“This bipartisan legislation – which [Senate] Majority Leader Mitch McConnell [R-Ky.] has called ‘the most important legislation Congress will pass this year’ – will help us take advantage of the breathtaking advances in biomedical research and bring those innovations to doctors’ offices and patients’ medicine cabinets around the county,” Sen. Lamar Alexander (R-Tenn.), chair of the Senate Health, Education, Labor, and Pensions Committee, said in a statement.
“The most important prescription drug-related crisis facing our country right now is the skyrocketing price of prescription drugs. This bill does not even deal with that issue,” Sen. Sanders said on the Senate floor. “How can we talk about a bill dealing with the pharmaceutical industry without addressing the elephant in the room, which is the fact that we pay the highest prices in the world for medicine?”
In his weekly address on Dec. 3, President Obama promised to “sign [the bill] as soon as it reaches my desk.”
Gregory Twachtman contributed to this report.
[email protected]
On Twitter @denisefulton
With little debate and less dissent, the Senate passed the 21st Century Cures bill and sent it to President Obama for his promised signature.
The legislation passed the House by an overwhelming 392-26 vote on Nov. 30. Key provisions of the bill (H.R. 34) include:
• Food and Drug Administration reforms, including expedited review for certain medical devices, streamlined review for drug/device combinations, and increased patient involvement in the drug approval process, with $500 million to implement the reforms.
• $4.8 billion over 10 years for key biomedical research efforts including the BRAIN Initiative, the Cancer Moonshot, and the Precision Medicine Initiative.
• $1 billion in grants to states over a 2-year period to help supplement opioid abuse prevention and treatment activities.
• Provisions to improve the interoperability of EHRs.
• Provisions to improve treatment of serious mental illness.
“This bipartisan legislation – which [Senate] Majority Leader Mitch McConnell [R-Ky.] has called ‘the most important legislation Congress will pass this year’ – will help us take advantage of the breathtaking advances in biomedical research and bring those innovations to doctors’ offices and patients’ medicine cabinets around the county,” Sen. Lamar Alexander (R-Tenn.), chair of the Senate Health, Education, Labor, and Pensions Committee, said in a statement.
“The most important prescription drug-related crisis facing our country right now is the skyrocketing price of prescription drugs. This bill does not even deal with that issue,” Sen. Sanders said on the Senate floor. “How can we talk about a bill dealing with the pharmaceutical industry without addressing the elephant in the room, which is the fact that we pay the highest prices in the world for medicine?”
In his weekly address on Dec. 3, President Obama promised to “sign [the bill] as soon as it reaches my desk.”
Gregory Twachtman contributed to this report.
[email protected]
On Twitter @denisefulton
With little debate and less dissent, the Senate passed the 21st Century Cures bill and sent it to President Obama for his promised signature.
The legislation passed the House by an overwhelming 392-26 vote on Nov. 30. Key provisions of the bill (H.R. 34) include:
• Food and Drug Administration reforms, including expedited review for certain medical devices, streamlined review for drug/device combinations, and increased patient involvement in the drug approval process, with $500 million to implement the reforms.
• $4.8 billion over 10 years for key biomedical research efforts including the BRAIN Initiative, the Cancer Moonshot, and the Precision Medicine Initiative.
• $1 billion in grants to states over a 2-year period to help supplement opioid abuse prevention and treatment activities.
• Provisions to improve the interoperability of EHRs.
• Provisions to improve treatment of serious mental illness.
“This bipartisan legislation – which [Senate] Majority Leader Mitch McConnell [R-Ky.] has called ‘the most important legislation Congress will pass this year’ – will help us take advantage of the breathtaking advances in biomedical research and bring those innovations to doctors’ offices and patients’ medicine cabinets around the county,” Sen. Lamar Alexander (R-Tenn.), chair of the Senate Health, Education, Labor, and Pensions Committee, said in a statement.
“The most important prescription drug-related crisis facing our country right now is the skyrocketing price of prescription drugs. This bill does not even deal with that issue,” Sen. Sanders said on the Senate floor. “How can we talk about a bill dealing with the pharmaceutical industry without addressing the elephant in the room, which is the fact that we pay the highest prices in the world for medicine?”
In his weekly address on Dec. 3, President Obama promised to “sign [the bill] as soon as it reaches my desk.”
Gregory Twachtman contributed to this report.
[email protected]
On Twitter @denisefulton
Skin cancer a concern in pediatric solid organ transplant recipients
As survival rates among pediatric organ transplant recipients increase, so do the rates of cutaneous malignancies later in life for this population, who are at a greater risk for skin cancers that include nonmelanoma skin cancers (NMSCs), melanoma, Kaposi sarcoma, and anogenital carcinoma, according to the authors of a literature review.
In studies, skin cancers account for 13%-55% of all cancers in pediatric organ transplant recipients (POTRs), according to Alexander L. Fogel of Stanford (Calif.) University and his coauthors. The review article provides an update on this topic, as well as information on the prevention and management of skin cancers in this population, and the differences between this group and adult organ transplant recipients (AOTRs).
NMSC is the most common type of skin cancer in the pediatric group – and the second most common type of malignancy (NMSCs are the most common type of cancer affecting adult organ transplant recipients). NMSCs typically appear an average of 12-18 years post transplantation in this population (at an average age of 26-34 years). Length of posttransplantation follow-up, sunlight exposure, fair skin, and Northern European ancestry are among the factors associated with increased risk. This type of cancer involves the lip nearly twice as often as in adult recipients: 23% vs. 12%. The pediatric cohort also experiences more nonmelanoma cancer spreading to the lymph nodes than do adults: 9% vs. 6%.
Among pediatric transplant recipients, squamous cell carcinomas appear 2.8 times more often than basal cell carcinomas, “a trend that is opposite that observed in the nontransplant population,” the authors wrote.
In one study, anogenital carcinomas accounted for 4% of posttransplant cancers in this cohort, at an average of 12 years after the transplant, at a mean age of 27 years.
Some data indicate that in adult transplant recipients, there is an association between the human papillomavirus, and anal and genital warts and posttransplant anogenital cancer, but there are little data looking at this association in the pediatric group, the authors noted.
Although melanoma and Kaposi sarcoma are also found in this cohort at rates greater than in the general population, and are associated with high mortality rates, the data are too few to draw conclusions, the authors wrote.
In 2014, 1,795 pediatric solid organ transplants were performed, accounting for 6% of all such transplants. The absolute number of pediatric transplants has remained fairly stable over 5 years, yet very little pediatric-specific literature exists for prevention and management of skin cancers post transplantation, the authors pointed out.
Changing immunosuppressive medications used in transplantation may be effective in reducing skin cancer risk, they said, noting that including rapamycin inhibitors in combination therapy has been shown to reduce the risk of developing skin cancers in some transplant patients by more than half.
The authors emphasized that regular sunscreen use and dermatologic checkups are also essential in this population, and that “the importance of regular dermatologic evaluation should be stressed to patients and their families.”
Mr. Fogel’s coauthors were Mari Miyar, MD, of the department of dermatology, Kaiser Permanente, San Jose, Calif., and Joyce Teng, MD, of the departments of dermatology and pediatrics, Stanford. The authors had no disclosures listed, and no funding source for the review was listed.
This article was updated 12/8/16.
[email protected]
On Twitter @whitneymcknight
As survival rates among pediatric organ transplant recipients increase, so do the rates of cutaneous malignancies later in life for this population, who are at a greater risk for skin cancers that include nonmelanoma skin cancers (NMSCs), melanoma, Kaposi sarcoma, and anogenital carcinoma, according to the authors of a literature review.
In studies, skin cancers account for 13%-55% of all cancers in pediatric organ transplant recipients (POTRs), according to Alexander L. Fogel of Stanford (Calif.) University and his coauthors. The review article provides an update on this topic, as well as information on the prevention and management of skin cancers in this population, and the differences between this group and adult organ transplant recipients (AOTRs).
NMSC is the most common type of skin cancer in the pediatric group – and the second most common type of malignancy (NMSCs are the most common type of cancer affecting adult organ transplant recipients). NMSCs typically appear an average of 12-18 years post transplantation in this population (at an average age of 26-34 years). Length of posttransplantation follow-up, sunlight exposure, fair skin, and Northern European ancestry are among the factors associated with increased risk. This type of cancer involves the lip nearly twice as often as in adult recipients: 23% vs. 12%. The pediatric cohort also experiences more nonmelanoma cancer spreading to the lymph nodes than do adults: 9% vs. 6%.
Among pediatric transplant recipients, squamous cell carcinomas appear 2.8 times more often than basal cell carcinomas, “a trend that is opposite that observed in the nontransplant population,” the authors wrote.
In one study, anogenital carcinomas accounted for 4% of posttransplant cancers in this cohort, at an average of 12 years after the transplant, at a mean age of 27 years.
Some data indicate that in adult transplant recipients, there is an association between the human papillomavirus, and anal and genital warts and posttransplant anogenital cancer, but there are little data looking at this association in the pediatric group, the authors noted.
Although melanoma and Kaposi sarcoma are also found in this cohort at rates greater than in the general population, and are associated with high mortality rates, the data are too few to draw conclusions, the authors wrote.
In 2014, 1,795 pediatric solid organ transplants were performed, accounting for 6% of all such transplants. The absolute number of pediatric transplants has remained fairly stable over 5 years, yet very little pediatric-specific literature exists for prevention and management of skin cancers post transplantation, the authors pointed out.
Changing immunosuppressive medications used in transplantation may be effective in reducing skin cancer risk, they said, noting that including rapamycin inhibitors in combination therapy has been shown to reduce the risk of developing skin cancers in some transplant patients by more than half.
The authors emphasized that regular sunscreen use and dermatologic checkups are also essential in this population, and that “the importance of regular dermatologic evaluation should be stressed to patients and their families.”
Mr. Fogel’s coauthors were Mari Miyar, MD, of the department of dermatology, Kaiser Permanente, San Jose, Calif., and Joyce Teng, MD, of the departments of dermatology and pediatrics, Stanford. The authors had no disclosures listed, and no funding source for the review was listed.
This article was updated 12/8/16.
[email protected]
On Twitter @whitneymcknight
As survival rates among pediatric organ transplant recipients increase, so do the rates of cutaneous malignancies later in life for this population, who are at a greater risk for skin cancers that include nonmelanoma skin cancers (NMSCs), melanoma, Kaposi sarcoma, and anogenital carcinoma, according to the authors of a literature review.
In studies, skin cancers account for 13%-55% of all cancers in pediatric organ transplant recipients (POTRs), according to Alexander L. Fogel of Stanford (Calif.) University and his coauthors. The review article provides an update on this topic, as well as information on the prevention and management of skin cancers in this population, and the differences between this group and adult organ transplant recipients (AOTRs).
NMSC is the most common type of skin cancer in the pediatric group – and the second most common type of malignancy (NMSCs are the most common type of cancer affecting adult organ transplant recipients). NMSCs typically appear an average of 12-18 years post transplantation in this population (at an average age of 26-34 years). Length of posttransplantation follow-up, sunlight exposure, fair skin, and Northern European ancestry are among the factors associated with increased risk. This type of cancer involves the lip nearly twice as often as in adult recipients: 23% vs. 12%. The pediatric cohort also experiences more nonmelanoma cancer spreading to the lymph nodes than do adults: 9% vs. 6%.
Among pediatric transplant recipients, squamous cell carcinomas appear 2.8 times more often than basal cell carcinomas, “a trend that is opposite that observed in the nontransplant population,” the authors wrote.
In one study, anogenital carcinomas accounted for 4% of posttransplant cancers in this cohort, at an average of 12 years after the transplant, at a mean age of 27 years.
Some data indicate that in adult transplant recipients, there is an association between the human papillomavirus, and anal and genital warts and posttransplant anogenital cancer, but there are little data looking at this association in the pediatric group, the authors noted.
Although melanoma and Kaposi sarcoma are also found in this cohort at rates greater than in the general population, and are associated with high mortality rates, the data are too few to draw conclusions, the authors wrote.
In 2014, 1,795 pediatric solid organ transplants were performed, accounting for 6% of all such transplants. The absolute number of pediatric transplants has remained fairly stable over 5 years, yet very little pediatric-specific literature exists for prevention and management of skin cancers post transplantation, the authors pointed out.
Changing immunosuppressive medications used in transplantation may be effective in reducing skin cancer risk, they said, noting that including rapamycin inhibitors in combination therapy has been shown to reduce the risk of developing skin cancers in some transplant patients by more than half.
The authors emphasized that regular sunscreen use and dermatologic checkups are also essential in this population, and that “the importance of regular dermatologic evaluation should be stressed to patients and their families.”
Mr. Fogel’s coauthors were Mari Miyar, MD, of the department of dermatology, Kaiser Permanente, San Jose, Calif., and Joyce Teng, MD, of the departments of dermatology and pediatrics, Stanford. The authors had no disclosures listed, and no funding source for the review was listed.
This article was updated 12/8/16.
[email protected]
On Twitter @whitneymcknight
FROM PEDIATRIC DERMATOLOGY
Key clinical point:
Major finding: Pediatric solid organ transplant recipients experience skin cancer rates between 13% and 55%.
Data source: A literature review of malignancies among pediatric organ transplant recipients.
Disclosures: The authors listed no disclosures, and no funding source for the review was listed.
New-onset pain rare after Essure placement
ORLANDO – While some women report new-onset pelvic pain after placement of an Essure sterilization device, results of a retrospective study suggest this pain is actually associated with placement of the device in about 1% of cases.
Among 1,430 women who had an Essure micro-insert (Bayer) placed at a tertiary care hospital in Canada from June 2002 to June 2013, 62 secondary surgeries were performed, including some for removal of fallopian tubes and removal of the device.
In total, 27 patients reported new-onset pelvic pain after Essure placement and another 11 reported worsening of previous pain. Upon further workup, 15 of the 27 women in the new-onset pain group had another possible explanation for their pain, including surgical or pathology findings of endometriosis or adenomyosis. The investigators concluded there was a link between the pain and the device in just 12 (0.8%) of the women.
Among these dozen patients, the investigators linked the pain in eight women to perforation or migration of the Essure device. Investigators found no other obvious cause for the new-onset pain in the remaining four patients and attributed it to the Essure device.
Set realistic expectations, take a comprehensive pain history, and reassure women when they report post-Essure placement pain, James Robinson, MD, a minimally invasive gynecologic surgeon at Medstar Washington Hospital in Washington, D.C., advised at the meeting, which was sponsored by AAGL.
Dr. Robinson pointed out that there is no standardized approach to managing women with complaints of pain or guidelines on how best to remove the device. Imaging to confirm proper placement and to rule out other sources of pelvic pain, followed by medical or surgical management as warranted, can be effective strategies.
“There is less science here – it’s more the art of medicine, I think,” he said.
Dr. Robinson filled in as a presenter for one of the study coauthors, John A. Thiel, MD, of the University of Saskatchewan, Saskatoon, who was unable to attend the conference.
The study by Dr. Thiel and his colleagues suggests a thorough examination will typically reveal other reasons for pelvic pain and rules out the Essure device as the cause, Dr. Robinson said. The full findings of the study are published in the Journal of Minimally Invasive Gynecology (2016 Nov-Dec;23[7]:1158-1162).
Does removal help?
In a recently published case series of 29 women who had their Essure device removed laparoscopically because of pain, 23 reported relief following excision (Contraception. 2016 Aug;94[2]:190-2).
“Again, a subset had misplaced inserts or had another condition such as endometriosis,” Dr. Robinson said.
The majority of women whose pain resolved with removal of the devices reported their pain early on, so there is an important takeaway from this,” Dr. Robinson said. “We need to listen to our patients when they report pain shortly after device placement … and respond to that.”
Dr. Robinson advised physicians to be ready to surgically remove the device if that is warranted. “I think a lot of people doing these procedures are not comfortable taking their patient back to the operating room or don’t know who to send them to,” he said. “If you are going to place the device, you should be able to take it out or know someone who can.”
The bigger picture
Even though the Essure device is not frequently the cause of pelvic pain, physicians needs to be aware that some patients are likely to assume that it is.
Dr. Robinson pointed to a case in which a woman who had the Essure micro-insert placed 7 years earlier presented with a complaint of a bilateral tingling sensation over the course of 6 months. Online research led her to suspect Essure as the cause of her symptoms. However, on further investigation, it turned out she had relatively high levels of lead in her system from leaky pipes in her home. “It wasn’t an Essure issue,” he said. “But because it’s out there, people will jump to the conclusion that the foreign body is likely the cause of their problem.”
Ob.gyns. should become familiar with websites such as essureproblems.webs.com, which chronicle problems patients have reported with the device, he said.
When talking to patients, start with informed consent and listen to their concerns, Dr. Robinson advised. As part of the counseling about Essure permanent birth control, discuss the risks and benefits of alternatives, such as laparoscopic tubal ligation, long-acting reversible contraception, and vasectomy.
“I took the time to listen to the FDA hearing in Sept 2015 and … it moved me to listen to those patients, and I’ve been a huge advocate of Essure sterilization. I felt for a while I would never do another tubal ligation,” Dr. Robinson said. “But when you listen to patients who have real complaints, what sticks out in your mind is so many of these people are upset because no one took them seriously and listened to them.”
ORLANDO – While some women report new-onset pelvic pain after placement of an Essure sterilization device, results of a retrospective study suggest this pain is actually associated with placement of the device in about 1% of cases.
Among 1,430 women who had an Essure micro-insert (Bayer) placed at a tertiary care hospital in Canada from June 2002 to June 2013, 62 secondary surgeries were performed, including some for removal of fallopian tubes and removal of the device.
In total, 27 patients reported new-onset pelvic pain after Essure placement and another 11 reported worsening of previous pain. Upon further workup, 15 of the 27 women in the new-onset pain group had another possible explanation for their pain, including surgical or pathology findings of endometriosis or adenomyosis. The investigators concluded there was a link between the pain and the device in just 12 (0.8%) of the women.
Among these dozen patients, the investigators linked the pain in eight women to perforation or migration of the Essure device. Investigators found no other obvious cause for the new-onset pain in the remaining four patients and attributed it to the Essure device.
Set realistic expectations, take a comprehensive pain history, and reassure women when they report post-Essure placement pain, James Robinson, MD, a minimally invasive gynecologic surgeon at Medstar Washington Hospital in Washington, D.C., advised at the meeting, which was sponsored by AAGL.
Dr. Robinson pointed out that there is no standardized approach to managing women with complaints of pain or guidelines on how best to remove the device. Imaging to confirm proper placement and to rule out other sources of pelvic pain, followed by medical or surgical management as warranted, can be effective strategies.
“There is less science here – it’s more the art of medicine, I think,” he said.
Dr. Robinson filled in as a presenter for one of the study coauthors, John A. Thiel, MD, of the University of Saskatchewan, Saskatoon, who was unable to attend the conference.
The study by Dr. Thiel and his colleagues suggests a thorough examination will typically reveal other reasons for pelvic pain and rules out the Essure device as the cause, Dr. Robinson said. The full findings of the study are published in the Journal of Minimally Invasive Gynecology (2016 Nov-Dec;23[7]:1158-1162).
Does removal help?
In a recently published case series of 29 women who had their Essure device removed laparoscopically because of pain, 23 reported relief following excision (Contraception. 2016 Aug;94[2]:190-2).
“Again, a subset had misplaced inserts or had another condition such as endometriosis,” Dr. Robinson said.
The majority of women whose pain resolved with removal of the devices reported their pain early on, so there is an important takeaway from this,” Dr. Robinson said. “We need to listen to our patients when they report pain shortly after device placement … and respond to that.”
Dr. Robinson advised physicians to be ready to surgically remove the device if that is warranted. “I think a lot of people doing these procedures are not comfortable taking their patient back to the operating room or don’t know who to send them to,” he said. “If you are going to place the device, you should be able to take it out or know someone who can.”
The bigger picture
Even though the Essure device is not frequently the cause of pelvic pain, physicians needs to be aware that some patients are likely to assume that it is.
Dr. Robinson pointed to a case in which a woman who had the Essure micro-insert placed 7 years earlier presented with a complaint of a bilateral tingling sensation over the course of 6 months. Online research led her to suspect Essure as the cause of her symptoms. However, on further investigation, it turned out she had relatively high levels of lead in her system from leaky pipes in her home. “It wasn’t an Essure issue,” he said. “But because it’s out there, people will jump to the conclusion that the foreign body is likely the cause of their problem.”
Ob.gyns. should become familiar with websites such as essureproblems.webs.com, which chronicle problems patients have reported with the device, he said.
When talking to patients, start with informed consent and listen to their concerns, Dr. Robinson advised. As part of the counseling about Essure permanent birth control, discuss the risks and benefits of alternatives, such as laparoscopic tubal ligation, long-acting reversible contraception, and vasectomy.
“I took the time to listen to the FDA hearing in Sept 2015 and … it moved me to listen to those patients, and I’ve been a huge advocate of Essure sterilization. I felt for a while I would never do another tubal ligation,” Dr. Robinson said. “But when you listen to patients who have real complaints, what sticks out in your mind is so many of these people are upset because no one took them seriously and listened to them.”
ORLANDO – While some women report new-onset pelvic pain after placement of an Essure sterilization device, results of a retrospective study suggest this pain is actually associated with placement of the device in about 1% of cases.
Among 1,430 women who had an Essure micro-insert (Bayer) placed at a tertiary care hospital in Canada from June 2002 to June 2013, 62 secondary surgeries were performed, including some for removal of fallopian tubes and removal of the device.
In total, 27 patients reported new-onset pelvic pain after Essure placement and another 11 reported worsening of previous pain. Upon further workup, 15 of the 27 women in the new-onset pain group had another possible explanation for their pain, including surgical or pathology findings of endometriosis or adenomyosis. The investigators concluded there was a link between the pain and the device in just 12 (0.8%) of the women.
Among these dozen patients, the investigators linked the pain in eight women to perforation or migration of the Essure device. Investigators found no other obvious cause for the new-onset pain in the remaining four patients and attributed it to the Essure device.
Set realistic expectations, take a comprehensive pain history, and reassure women when they report post-Essure placement pain, James Robinson, MD, a minimally invasive gynecologic surgeon at Medstar Washington Hospital in Washington, D.C., advised at the meeting, which was sponsored by AAGL.
Dr. Robinson pointed out that there is no standardized approach to managing women with complaints of pain or guidelines on how best to remove the device. Imaging to confirm proper placement and to rule out other sources of pelvic pain, followed by medical or surgical management as warranted, can be effective strategies.
“There is less science here – it’s more the art of medicine, I think,” he said.
Dr. Robinson filled in as a presenter for one of the study coauthors, John A. Thiel, MD, of the University of Saskatchewan, Saskatoon, who was unable to attend the conference.
The study by Dr. Thiel and his colleagues suggests a thorough examination will typically reveal other reasons for pelvic pain and rules out the Essure device as the cause, Dr. Robinson said. The full findings of the study are published in the Journal of Minimally Invasive Gynecology (2016 Nov-Dec;23[7]:1158-1162).
Does removal help?
In a recently published case series of 29 women who had their Essure device removed laparoscopically because of pain, 23 reported relief following excision (Contraception. 2016 Aug;94[2]:190-2).
“Again, a subset had misplaced inserts or had another condition such as endometriosis,” Dr. Robinson said.
The majority of women whose pain resolved with removal of the devices reported their pain early on, so there is an important takeaway from this,” Dr. Robinson said. “We need to listen to our patients when they report pain shortly after device placement … and respond to that.”
Dr. Robinson advised physicians to be ready to surgically remove the device if that is warranted. “I think a lot of people doing these procedures are not comfortable taking their patient back to the operating room or don’t know who to send them to,” he said. “If you are going to place the device, you should be able to take it out or know someone who can.”
The bigger picture
Even though the Essure device is not frequently the cause of pelvic pain, physicians needs to be aware that some patients are likely to assume that it is.
Dr. Robinson pointed to a case in which a woman who had the Essure micro-insert placed 7 years earlier presented with a complaint of a bilateral tingling sensation over the course of 6 months. Online research led her to suspect Essure as the cause of her symptoms. However, on further investigation, it turned out she had relatively high levels of lead in her system from leaky pipes in her home. “It wasn’t an Essure issue,” he said. “But because it’s out there, people will jump to the conclusion that the foreign body is likely the cause of their problem.”
Ob.gyns. should become familiar with websites such as essureproblems.webs.com, which chronicle problems patients have reported with the device, he said.
When talking to patients, start with informed consent and listen to their concerns, Dr. Robinson advised. As part of the counseling about Essure permanent birth control, discuss the risks and benefits of alternatives, such as laparoscopic tubal ligation, long-acting reversible contraception, and vasectomy.
“I took the time to listen to the FDA hearing in Sept 2015 and … it moved me to listen to those patients, and I’ve been a huge advocate of Essure sterilization. I felt for a while I would never do another tubal ligation,” Dr. Robinson said. “But when you listen to patients who have real complaints, what sticks out in your mind is so many of these people are upset because no one took them seriously and listened to them.”
Key clinical point:
Major finding: Of 1,430 women who had the Essure inserts placed, just 12 had new-onset pain that was found to be related to the device.
Data source: Retrospective cohort study of 1,430 women treated at a tertiary care hospital in Canada.
Disclosures: Dr. Robinson reported having no financial disclosures.