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Elective open conversion after failed EVAR safer than emergent

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Emergency open conversion after failed endovascular aortic aneurysm repair shows significantly higher mortality and morbidity, compared with elective conversion, according to the results of a retrospective, observational study of 31 patients at a single institution.

The primary endpoints of the study were 30-day and in-hospital mortality. Secondary endpoints included moderate to severe complications, secondary interventions, length of ICU stay, and length of hospital stay (LOS), according to I. Ben Abdallah, MD, of the Hôpital Européen Georges Pompidou and his colleagues.

During the study period, a total of 338 patients received EVAR at the institution. Of these, 31 patients underwent open conversion (19 elective, 12 emergent) after EVAR between August 2008 and September 2016. The median time from the index EVAR to the open conversion was 35 months, with the most common indications for intervention being endoleaks (24 patients, 77%), stent graft infection (3, 10%), thrombosis (3, 10%) and kinking (1, 3%). Stents removed were manufactured by various device makers, according to the report (Eur J Vasc Endovasc Surg. 2017;53:831-6).

The patient population had a mean age of 73 years and comprised 84% men. The two groups, elective and emergent, were highly similar in numerous comorbidities, with the only significant difference between them being a greater incidence of chronic renal disease among the emergent group, as compared with the elective (42% vs. 5%).

Overall in-hospital mortality was 10%, and significantly greater in emergent vs. elective conversion (25% vs. 0%). Renal and pulmonary complications were significantly higher in the emergency group (42% vs. 5% and 42% vs. 0%, respectively). There was no significant difference between elective and emergent hospital stay (14 days vs. 20 days), but ICU stay was significantly shorter for elective conversion (2 days vs. 7 days).

There were no late complications or death seen in either group after a mean follow-up of 18 months.

“In this series, open conversion seems to be significantly safer and more effective when performed electively with no mortality, a lower incidence of morbidity (renal and pulmonary), and shorter ICU stay. These results underline that close surveillance, allowing planned elective open conversion, is the key to better outcomes after failed EVAR,” the researchers concluded.

The authors reported that they had no conflicts of interest, and the study received no outside funding.

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Emergency open conversion after failed endovascular aortic aneurysm repair shows significantly higher mortality and morbidity, compared with elective conversion, according to the results of a retrospective, observational study of 31 patients at a single institution.

The primary endpoints of the study were 30-day and in-hospital mortality. Secondary endpoints included moderate to severe complications, secondary interventions, length of ICU stay, and length of hospital stay (LOS), according to I. Ben Abdallah, MD, of the Hôpital Européen Georges Pompidou and his colleagues.

During the study period, a total of 338 patients received EVAR at the institution. Of these, 31 patients underwent open conversion (19 elective, 12 emergent) after EVAR between August 2008 and September 2016. The median time from the index EVAR to the open conversion was 35 months, with the most common indications for intervention being endoleaks (24 patients, 77%), stent graft infection (3, 10%), thrombosis (3, 10%) and kinking (1, 3%). Stents removed were manufactured by various device makers, according to the report (Eur J Vasc Endovasc Surg. 2017;53:831-6).

The patient population had a mean age of 73 years and comprised 84% men. The two groups, elective and emergent, were highly similar in numerous comorbidities, with the only significant difference between them being a greater incidence of chronic renal disease among the emergent group, as compared with the elective (42% vs. 5%).

Overall in-hospital mortality was 10%, and significantly greater in emergent vs. elective conversion (25% vs. 0%). Renal and pulmonary complications were significantly higher in the emergency group (42% vs. 5% and 42% vs. 0%, respectively). There was no significant difference between elective and emergent hospital stay (14 days vs. 20 days), but ICU stay was significantly shorter for elective conversion (2 days vs. 7 days).

There were no late complications or death seen in either group after a mean follow-up of 18 months.

“In this series, open conversion seems to be significantly safer and more effective when performed electively with no mortality, a lower incidence of morbidity (renal and pulmonary), and shorter ICU stay. These results underline that close surveillance, allowing planned elective open conversion, is the key to better outcomes after failed EVAR,” the researchers concluded.

The authors reported that they had no conflicts of interest, and the study received no outside funding.

 

Emergency open conversion after failed endovascular aortic aneurysm repair shows significantly higher mortality and morbidity, compared with elective conversion, according to the results of a retrospective, observational study of 31 patients at a single institution.

The primary endpoints of the study were 30-day and in-hospital mortality. Secondary endpoints included moderate to severe complications, secondary interventions, length of ICU stay, and length of hospital stay (LOS), according to I. Ben Abdallah, MD, of the Hôpital Européen Georges Pompidou and his colleagues.

During the study period, a total of 338 patients received EVAR at the institution. Of these, 31 patients underwent open conversion (19 elective, 12 emergent) after EVAR between August 2008 and September 2016. The median time from the index EVAR to the open conversion was 35 months, with the most common indications for intervention being endoleaks (24 patients, 77%), stent graft infection (3, 10%), thrombosis (3, 10%) and kinking (1, 3%). Stents removed were manufactured by various device makers, according to the report (Eur J Vasc Endovasc Surg. 2017;53:831-6).

The patient population had a mean age of 73 years and comprised 84% men. The two groups, elective and emergent, were highly similar in numerous comorbidities, with the only significant difference between them being a greater incidence of chronic renal disease among the emergent group, as compared with the elective (42% vs. 5%).

Overall in-hospital mortality was 10%, and significantly greater in emergent vs. elective conversion (25% vs. 0%). Renal and pulmonary complications were significantly higher in the emergency group (42% vs. 5% and 42% vs. 0%, respectively). There was no significant difference between elective and emergent hospital stay (14 days vs. 20 days), but ICU stay was significantly shorter for elective conversion (2 days vs. 7 days).

There were no late complications or death seen in either group after a mean follow-up of 18 months.

“In this series, open conversion seems to be significantly safer and more effective when performed electively with no mortality, a lower incidence of morbidity (renal and pulmonary), and shorter ICU stay. These results underline that close surveillance, allowing planned elective open conversion, is the key to better outcomes after failed EVAR,” the researchers concluded.

The authors reported that they had no conflicts of interest, and the study received no outside funding.

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FROM THE EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY

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Key clinical point: Elective open conversion should be performed before an emergency repair is needed.

Major finding: Overall in-hospital mortality was 10% and significantly greater in emergent vs. elective conversion (25% vs. 0%).

Data source: A retrospective database analysis of 31 patients undergoing EVAR open conversion at a single institution.

Disclosures: The authors reported that they had no conflicts of interest, and the study received no outside funding.

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Tips and tricks for appealing an audit

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CHICAGO – The question is not if a physician will face a Medicare or Medicaid billing audit, but when, according to Abby Pendleton, a New York–based health law attorney. That’s why it pays to know how to handle an audit before one probe disrupts your practice. At a recent American Bar Association meeting, Ms. Pendleton and H. Rusty Comley, a Jackson, Mississippi–based health law attorney, offered answers to top audit questions and provided guidance on how physicians can successfully appeal an audit.

When should you appeal?

There are a number of factors to consider when deciding whether to appeal audit findings. For starters, consider the cost of the payback amount and the basis of the findings.

Abby Pendleton
If the amount of money is nominal, the audit involves a one-time mistake and the decision is not really disputable, a doctor may just want to pay the audit request, Mr. Comley said in an interview.

“In other words, the provider would spend more money and time to appeal the audit than to pay the audit, and the issue or mistake is not likely repeated in past or future claims,” it might make sense to just pay, he said.

H. Rusty Comley
On the other hand, if the findings are arguable, the monetary amount is significant, and/or the audit could affect more than just one billing, the doctor may want to consider appealing. Paying a small monetary amount could become problematic when the audit issue or “mistake” may have been repeated or will be repeated, Mr. Comley cautioned, adding that paying without dispute could create a precedent for future audits.

If the basis of the findings stem from an interpretation of a local coverage decision that the physician disagrees with, he or she may also want to appeal, Ms. Pendleton added.

“If you don’t fight it, there’s an argument that, ‘Well, guess what? You had that issue going back 6 years for all these other claims, and now we get into the [Medicare] 60 day overpayment identification [rule],’ ” she said at the meeting. “If a physician is [not] aware of payments they’re not entitled to, even if they think they were right on the front end, but they later become aware, they have 60 days to refund it or its a false claim. Those are considerations that really need to be looked at.”
 

What should you expect from an appeal?

Expect to go through more than one appeals process step to succeed. There are five stages to the appeals process .

“At the redetermination stage, I don’t see a whole lot of movement in terms of great success at that first stage,” Ms. Pendleton said. “So, don’t think, ‘If we get to that first level of appeal, we’re expecting to win.’ If you look at the statistics, it’s not really that realistic.”

Although a provider has 120 days to file an appeal, it’s smarter to file within the first 30 days, Ms. Pendleton advised. If an appeal is filed within 30 days, the government cannot recoup it’s demand from a doctor’s current Medicare payments.

Expect a lengthy time frame for a final outcome. Under federal law, once an appeal gets to the administrative law judge (ALJ) stage (the third stage), the appellant should receive a hearing decision within 90 days. However, because of heavy case backlogs, physicians typically don’t get a hearing for 3 years, Ms. Pendleton said.

“The problem is, your MAC [Medicare administrative contractor] can start taking your money after the [second] stage,” she said. “If it’s a huge dollar amount, you’re probably going to have to enter into a payment plan [with the government]. You will eventually get your money back, if you win, three to four years later.”

Note that physicians generally experience a higher degree of success at the ALJ stage, so it may be worth continuing the appeal through this stage, she noted.

Overall, more than one-third of audit findings are reversed in providers’ favor during the appeals process. Of 170,482 Medicare appeal decisions in 2015, 37% were made in favor of the health provider, an increase from 23% in 2014, according to 2015 Medicare data and 2014 reports.

The cost to appeal varies significantly between Medicaid and Medicare and depends largely on the complexity of the audit, Mr. Comley said. A Medicaid audit appeal, through an ALJ hearing and written appeal to a court, may cost between $20,000 to $60,000 depending on the circumstances, he said. By contrast, a Medicare appeal resolved in the first stage of appeal may only cost a few thousand dollars for a relatively simple audit.

“Of course, the costs will rise at each level of the Medicare appeal process, especially in the third stage involving the ALJ telephonic hearing, but, in most cases, the Medicare appeal costs will still be below a similar Medicaid appeal,” he said.
 

What strategies can help you win?

 

 

Consider reaching out to your congressional representative or senators, Mr. Comley advised. Particularly if the issue involves a medical treatment decision or a medically necessary determination, it may be helpful to copy “your favorite Congressman or senator’s office” on correspondence with the MAC. Clearly state your argument against the findings and how/why the medical decision was made. Legislators will often get involved and could help your appeal, Mr. Comley said.

Further, don’t just review the claims that auditors denied. Also evaluate the claims they have approved in the past, he added.

“In almost every case I’ve been involved in, they’ll approve claims that, on the other hand, they deny,” Mr. Comley said. “Under most legal standards, that’s a good way to win – it’s called arbitrary and capricious.”

Find the best experts to back your case, Ms. Pendleton advised. Consider including expert opinions in written responses to the government that support the services provided and/or have medical experts ready to testify during hearings. If the government based its findings on statistics or cited statistics in its review, involve a statistical expert who can argue against the government’s conclusion.

If the case is significant enough, consider skipping steps in the appeals process to get the case before a federal court sooner. Appellants can escalate their appeal through the process at nearly every stage if the government fails to respond within a timely manner. At the second stage, for example, if the qualified independent contractor does not issue a decision within 60 days, an appellant generally has the right to escalate the case to an administrative law judge. If the ALJ does not issue a decision within 90 days, the appeal can generally be escalated to the Appeals Council level, and, if the council does not issue a decision within 90 days, appellants can seek judicial review.

It may be worth it to have your day in court sooner, Ms. Pendleton said.

“It might be an option for providers if you have a large audit with a lot at stake,” she said. “Escalate it through. Get it to federal court and argue it.”

The 5 steps of the Medicare appeals process

There are five stages of the Medicare audit appeals process, according to the Centers for Medicare & Medicaid Services. They include:

1. Redetermination by the Fiscal Intermediary. A redetermination is an examination of a claim by a Medicare administrative contractor (MAC) separate from the personnel who made the initial claim determination. The appellant has 120 days from the date of initial claim determination receipt to file an appeal.

2. Reconsideration by a Qualified Independent Contractor (QIC). A QIC is an independent contractor who didn’t take part in the level 1 decision. The QIC will review the request for a reconsideration and make a decision. An appellant must file a request for reconsideration within 180 days of Medicare redetermination notice or remittance advice receipt.

3. Administrative Law Judge (ALJ) hearing. Appellants present their case to an ALJ who will review the facts of the appeal and listen to testimony before making a decision. An ALJ hearing is usually held by phone or video conference. Appellants can ask the ALJ to make a decision without a hearing. The ALJ may also issue a decision without holding a hearing if evidence in the record supports a decision that’s fully in the appellant’s favor.

4. Medicare Appeals Council review. If you disagree with the ALJ decision or wish to escalate the appeal because the ALJ ruling time frame has passed, a request for a Medicare Appeals Council review can be made. A request for a Medicare Appeals Council review must be made within 60 days of receipt of the ALJ’s decision or after the ALJ ruling time frame expires.

5. Judicial review in U.S. District Court. A party may file an action in federal district court within 60 calendar days after the date receiving notice of the Medicare Appeals Council’s decision or after a council notice that it is not able to reach a decision. To get a judicial review in federal district court, the case amount must meet a minimum dollar amount ($1,560 in 2017).

Each state has its own Medicaid appeals process. Contact your state’s Medicaid office to find out how to appeal a Medicaid audit finding.

 

Body

Dr. Michael E. Nelson, FCCP
Michael E. Nelson, MD, FCCP, comments: The most effective way to handle an audit is not to be involved in one. This requires an appropriate knowledge of coding and billing tempered with a strong dose of honesty. While CMS rules for coding and billing can occasionally be confusing, they are not intended to “trick” physicians into making errors. Rather, either through lack of understanding, poor documentation, or dishonesty (upcoding), mistakes can be made. Unfortunately, the physician is considered guilty until proven otherwise. The 37% success rate of appeals argues that this is true more often than not. As noted in the article, a CMS audit can be a very anxiety-provoking, time-consuming, and expensive process that one should avoid at all costs. The key to doing this and improving the physician success rate if one is audited is through education of the providers and advocating to amend poorly written CMS policy. Dishonesty will have to correct itself.  
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Body

Dr. Michael E. Nelson, FCCP
Michael E. Nelson, MD, FCCP, comments: The most effective way to handle an audit is not to be involved in one. This requires an appropriate knowledge of coding and billing tempered with a strong dose of honesty. While CMS rules for coding and billing can occasionally be confusing, they are not intended to “trick” physicians into making errors. Rather, either through lack of understanding, poor documentation, or dishonesty (upcoding), mistakes can be made. Unfortunately, the physician is considered guilty until proven otherwise. The 37% success rate of appeals argues that this is true more often than not. As noted in the article, a CMS audit can be a very anxiety-provoking, time-consuming, and expensive process that one should avoid at all costs. The key to doing this and improving the physician success rate if one is audited is through education of the providers and advocating to amend poorly written CMS policy. Dishonesty will have to correct itself.  
Body

Dr. Michael E. Nelson, FCCP
Michael E. Nelson, MD, FCCP, comments: The most effective way to handle an audit is not to be involved in one. This requires an appropriate knowledge of coding and billing tempered with a strong dose of honesty. While CMS rules for coding and billing can occasionally be confusing, they are not intended to “trick” physicians into making errors. Rather, either through lack of understanding, poor documentation, or dishonesty (upcoding), mistakes can be made. Unfortunately, the physician is considered guilty until proven otherwise. The 37% success rate of appeals argues that this is true more often than not. As noted in the article, a CMS audit can be a very anxiety-provoking, time-consuming, and expensive process that one should avoid at all costs. The key to doing this and improving the physician success rate if one is audited is through education of the providers and advocating to amend poorly written CMS policy. Dishonesty will have to correct itself.  

 

CHICAGO – The question is not if a physician will face a Medicare or Medicaid billing audit, but when, according to Abby Pendleton, a New York–based health law attorney. That’s why it pays to know how to handle an audit before one probe disrupts your practice. At a recent American Bar Association meeting, Ms. Pendleton and H. Rusty Comley, a Jackson, Mississippi–based health law attorney, offered answers to top audit questions and provided guidance on how physicians can successfully appeal an audit.

When should you appeal?

There are a number of factors to consider when deciding whether to appeal audit findings. For starters, consider the cost of the payback amount and the basis of the findings.

Abby Pendleton
If the amount of money is nominal, the audit involves a one-time mistake and the decision is not really disputable, a doctor may just want to pay the audit request, Mr. Comley said in an interview.

“In other words, the provider would spend more money and time to appeal the audit than to pay the audit, and the issue or mistake is not likely repeated in past or future claims,” it might make sense to just pay, he said.

H. Rusty Comley
On the other hand, if the findings are arguable, the monetary amount is significant, and/or the audit could affect more than just one billing, the doctor may want to consider appealing. Paying a small monetary amount could become problematic when the audit issue or “mistake” may have been repeated or will be repeated, Mr. Comley cautioned, adding that paying without dispute could create a precedent for future audits.

If the basis of the findings stem from an interpretation of a local coverage decision that the physician disagrees with, he or she may also want to appeal, Ms. Pendleton added.

“If you don’t fight it, there’s an argument that, ‘Well, guess what? You had that issue going back 6 years for all these other claims, and now we get into the [Medicare] 60 day overpayment identification [rule],’ ” she said at the meeting. “If a physician is [not] aware of payments they’re not entitled to, even if they think they were right on the front end, but they later become aware, they have 60 days to refund it or its a false claim. Those are considerations that really need to be looked at.”
 

What should you expect from an appeal?

Expect to go through more than one appeals process step to succeed. There are five stages to the appeals process .

“At the redetermination stage, I don’t see a whole lot of movement in terms of great success at that first stage,” Ms. Pendleton said. “So, don’t think, ‘If we get to that first level of appeal, we’re expecting to win.’ If you look at the statistics, it’s not really that realistic.”

Although a provider has 120 days to file an appeal, it’s smarter to file within the first 30 days, Ms. Pendleton advised. If an appeal is filed within 30 days, the government cannot recoup it’s demand from a doctor’s current Medicare payments.

Expect a lengthy time frame for a final outcome. Under federal law, once an appeal gets to the administrative law judge (ALJ) stage (the third stage), the appellant should receive a hearing decision within 90 days. However, because of heavy case backlogs, physicians typically don’t get a hearing for 3 years, Ms. Pendleton said.

“The problem is, your MAC [Medicare administrative contractor] can start taking your money after the [second] stage,” she said. “If it’s a huge dollar amount, you’re probably going to have to enter into a payment plan [with the government]. You will eventually get your money back, if you win, three to four years later.”

Note that physicians generally experience a higher degree of success at the ALJ stage, so it may be worth continuing the appeal through this stage, she noted.

Overall, more than one-third of audit findings are reversed in providers’ favor during the appeals process. Of 170,482 Medicare appeal decisions in 2015, 37% were made in favor of the health provider, an increase from 23% in 2014, according to 2015 Medicare data and 2014 reports.

The cost to appeal varies significantly between Medicaid and Medicare and depends largely on the complexity of the audit, Mr. Comley said. A Medicaid audit appeal, through an ALJ hearing and written appeal to a court, may cost between $20,000 to $60,000 depending on the circumstances, he said. By contrast, a Medicare appeal resolved in the first stage of appeal may only cost a few thousand dollars for a relatively simple audit.

“Of course, the costs will rise at each level of the Medicare appeal process, especially in the third stage involving the ALJ telephonic hearing, but, in most cases, the Medicare appeal costs will still be below a similar Medicaid appeal,” he said.
 

What strategies can help you win?

 

 

Consider reaching out to your congressional representative or senators, Mr. Comley advised. Particularly if the issue involves a medical treatment decision or a medically necessary determination, it may be helpful to copy “your favorite Congressman or senator’s office” on correspondence with the MAC. Clearly state your argument against the findings and how/why the medical decision was made. Legislators will often get involved and could help your appeal, Mr. Comley said.

Further, don’t just review the claims that auditors denied. Also evaluate the claims they have approved in the past, he added.

“In almost every case I’ve been involved in, they’ll approve claims that, on the other hand, they deny,” Mr. Comley said. “Under most legal standards, that’s a good way to win – it’s called arbitrary and capricious.”

Find the best experts to back your case, Ms. Pendleton advised. Consider including expert opinions in written responses to the government that support the services provided and/or have medical experts ready to testify during hearings. If the government based its findings on statistics or cited statistics in its review, involve a statistical expert who can argue against the government’s conclusion.

If the case is significant enough, consider skipping steps in the appeals process to get the case before a federal court sooner. Appellants can escalate their appeal through the process at nearly every stage if the government fails to respond within a timely manner. At the second stage, for example, if the qualified independent contractor does not issue a decision within 60 days, an appellant generally has the right to escalate the case to an administrative law judge. If the ALJ does not issue a decision within 90 days, the appeal can generally be escalated to the Appeals Council level, and, if the council does not issue a decision within 90 days, appellants can seek judicial review.

It may be worth it to have your day in court sooner, Ms. Pendleton said.

“It might be an option for providers if you have a large audit with a lot at stake,” she said. “Escalate it through. Get it to federal court and argue it.”

The 5 steps of the Medicare appeals process

There are five stages of the Medicare audit appeals process, according to the Centers for Medicare & Medicaid Services. They include:

1. Redetermination by the Fiscal Intermediary. A redetermination is an examination of a claim by a Medicare administrative contractor (MAC) separate from the personnel who made the initial claim determination. The appellant has 120 days from the date of initial claim determination receipt to file an appeal.

2. Reconsideration by a Qualified Independent Contractor (QIC). A QIC is an independent contractor who didn’t take part in the level 1 decision. The QIC will review the request for a reconsideration and make a decision. An appellant must file a request for reconsideration within 180 days of Medicare redetermination notice or remittance advice receipt.

3. Administrative Law Judge (ALJ) hearing. Appellants present their case to an ALJ who will review the facts of the appeal and listen to testimony before making a decision. An ALJ hearing is usually held by phone or video conference. Appellants can ask the ALJ to make a decision without a hearing. The ALJ may also issue a decision without holding a hearing if evidence in the record supports a decision that’s fully in the appellant’s favor.

4. Medicare Appeals Council review. If you disagree with the ALJ decision or wish to escalate the appeal because the ALJ ruling time frame has passed, a request for a Medicare Appeals Council review can be made. A request for a Medicare Appeals Council review must be made within 60 days of receipt of the ALJ’s decision or after the ALJ ruling time frame expires.

5. Judicial review in U.S. District Court. A party may file an action in federal district court within 60 calendar days after the date receiving notice of the Medicare Appeals Council’s decision or after a council notice that it is not able to reach a decision. To get a judicial review in federal district court, the case amount must meet a minimum dollar amount ($1,560 in 2017).

Each state has its own Medicaid appeals process. Contact your state’s Medicaid office to find out how to appeal a Medicaid audit finding.

 

 

CHICAGO – The question is not if a physician will face a Medicare or Medicaid billing audit, but when, according to Abby Pendleton, a New York–based health law attorney. That’s why it pays to know how to handle an audit before one probe disrupts your practice. At a recent American Bar Association meeting, Ms. Pendleton and H. Rusty Comley, a Jackson, Mississippi–based health law attorney, offered answers to top audit questions and provided guidance on how physicians can successfully appeal an audit.

When should you appeal?

There are a number of factors to consider when deciding whether to appeal audit findings. For starters, consider the cost of the payback amount and the basis of the findings.

Abby Pendleton
If the amount of money is nominal, the audit involves a one-time mistake and the decision is not really disputable, a doctor may just want to pay the audit request, Mr. Comley said in an interview.

“In other words, the provider would spend more money and time to appeal the audit than to pay the audit, and the issue or mistake is not likely repeated in past or future claims,” it might make sense to just pay, he said.

H. Rusty Comley
On the other hand, if the findings are arguable, the monetary amount is significant, and/or the audit could affect more than just one billing, the doctor may want to consider appealing. Paying a small monetary amount could become problematic when the audit issue or “mistake” may have been repeated or will be repeated, Mr. Comley cautioned, adding that paying without dispute could create a precedent for future audits.

If the basis of the findings stem from an interpretation of a local coverage decision that the physician disagrees with, he or she may also want to appeal, Ms. Pendleton added.

“If you don’t fight it, there’s an argument that, ‘Well, guess what? You had that issue going back 6 years for all these other claims, and now we get into the [Medicare] 60 day overpayment identification [rule],’ ” she said at the meeting. “If a physician is [not] aware of payments they’re not entitled to, even if they think they were right on the front end, but they later become aware, they have 60 days to refund it or its a false claim. Those are considerations that really need to be looked at.”
 

What should you expect from an appeal?

Expect to go through more than one appeals process step to succeed. There are five stages to the appeals process .

“At the redetermination stage, I don’t see a whole lot of movement in terms of great success at that first stage,” Ms. Pendleton said. “So, don’t think, ‘If we get to that first level of appeal, we’re expecting to win.’ If you look at the statistics, it’s not really that realistic.”

Although a provider has 120 days to file an appeal, it’s smarter to file within the first 30 days, Ms. Pendleton advised. If an appeal is filed within 30 days, the government cannot recoup it’s demand from a doctor’s current Medicare payments.

Expect a lengthy time frame for a final outcome. Under federal law, once an appeal gets to the administrative law judge (ALJ) stage (the third stage), the appellant should receive a hearing decision within 90 days. However, because of heavy case backlogs, physicians typically don’t get a hearing for 3 years, Ms. Pendleton said.

“The problem is, your MAC [Medicare administrative contractor] can start taking your money after the [second] stage,” she said. “If it’s a huge dollar amount, you’re probably going to have to enter into a payment plan [with the government]. You will eventually get your money back, if you win, three to four years later.”

Note that physicians generally experience a higher degree of success at the ALJ stage, so it may be worth continuing the appeal through this stage, she noted.

Overall, more than one-third of audit findings are reversed in providers’ favor during the appeals process. Of 170,482 Medicare appeal decisions in 2015, 37% were made in favor of the health provider, an increase from 23% in 2014, according to 2015 Medicare data and 2014 reports.

The cost to appeal varies significantly between Medicaid and Medicare and depends largely on the complexity of the audit, Mr. Comley said. A Medicaid audit appeal, through an ALJ hearing and written appeal to a court, may cost between $20,000 to $60,000 depending on the circumstances, he said. By contrast, a Medicare appeal resolved in the first stage of appeal may only cost a few thousand dollars for a relatively simple audit.

“Of course, the costs will rise at each level of the Medicare appeal process, especially in the third stage involving the ALJ telephonic hearing, but, in most cases, the Medicare appeal costs will still be below a similar Medicaid appeal,” he said.
 

What strategies can help you win?

 

 

Consider reaching out to your congressional representative or senators, Mr. Comley advised. Particularly if the issue involves a medical treatment decision or a medically necessary determination, it may be helpful to copy “your favorite Congressman or senator’s office” on correspondence with the MAC. Clearly state your argument against the findings and how/why the medical decision was made. Legislators will often get involved and could help your appeal, Mr. Comley said.

Further, don’t just review the claims that auditors denied. Also evaluate the claims they have approved in the past, he added.

“In almost every case I’ve been involved in, they’ll approve claims that, on the other hand, they deny,” Mr. Comley said. “Under most legal standards, that’s a good way to win – it’s called arbitrary and capricious.”

Find the best experts to back your case, Ms. Pendleton advised. Consider including expert opinions in written responses to the government that support the services provided and/or have medical experts ready to testify during hearings. If the government based its findings on statistics or cited statistics in its review, involve a statistical expert who can argue against the government’s conclusion.

If the case is significant enough, consider skipping steps in the appeals process to get the case before a federal court sooner. Appellants can escalate their appeal through the process at nearly every stage if the government fails to respond within a timely manner. At the second stage, for example, if the qualified independent contractor does not issue a decision within 60 days, an appellant generally has the right to escalate the case to an administrative law judge. If the ALJ does not issue a decision within 90 days, the appeal can generally be escalated to the Appeals Council level, and, if the council does not issue a decision within 90 days, appellants can seek judicial review.

It may be worth it to have your day in court sooner, Ms. Pendleton said.

“It might be an option for providers if you have a large audit with a lot at stake,” she said. “Escalate it through. Get it to federal court and argue it.”

The 5 steps of the Medicare appeals process

There are five stages of the Medicare audit appeals process, according to the Centers for Medicare & Medicaid Services. They include:

1. Redetermination by the Fiscal Intermediary. A redetermination is an examination of a claim by a Medicare administrative contractor (MAC) separate from the personnel who made the initial claim determination. The appellant has 120 days from the date of initial claim determination receipt to file an appeal.

2. Reconsideration by a Qualified Independent Contractor (QIC). A QIC is an independent contractor who didn’t take part in the level 1 decision. The QIC will review the request for a reconsideration and make a decision. An appellant must file a request for reconsideration within 180 days of Medicare redetermination notice or remittance advice receipt.

3. Administrative Law Judge (ALJ) hearing. Appellants present their case to an ALJ who will review the facts of the appeal and listen to testimony before making a decision. An ALJ hearing is usually held by phone or video conference. Appellants can ask the ALJ to make a decision without a hearing. The ALJ may also issue a decision without holding a hearing if evidence in the record supports a decision that’s fully in the appellant’s favor.

4. Medicare Appeals Council review. If you disagree with the ALJ decision or wish to escalate the appeal because the ALJ ruling time frame has passed, a request for a Medicare Appeals Council review can be made. A request for a Medicare Appeals Council review must be made within 60 days of receipt of the ALJ’s decision or after the ALJ ruling time frame expires.

5. Judicial review in U.S. District Court. A party may file an action in federal district court within 60 calendar days after the date receiving notice of the Medicare Appeals Council’s decision or after a council notice that it is not able to reach a decision. To get a judicial review in federal district court, the case amount must meet a minimum dollar amount ($1,560 in 2017).

Each state has its own Medicaid appeals process. Contact your state’s Medicaid office to find out how to appeal a Medicaid audit finding.

 

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VA cohort study: Individualize SSI prophylaxis based on patient factors

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The combined use of vancomycin and a beta-lactam antibiotic for prophylaxis against surgical site infections is associated with both benefits and harms, according to findings from a national propensity-score–adjusted retrospective cohort study.

For example, the combination treatment reduced surgical site infections (SSIs) 30 days after cardiac surgical procedures but increased the risk of postoperative acute kidney injury (AKI) in some patients, Westyn Branch-Elliman, MD, of the VA Boston Healthcare System and her colleagues reported online July 10 in PLOS Medicine.

Janice Haney Carr/CDC
Magnified 20,000X, this colorized scanning electron micrograph depicts a grouping of MRSA bacteria.
Of 70,101 cardiac, orthopedic joint replacement, vascular, colorectal, and hysterectomy procedures performed between Oct. 1, 2008, and Sept. 30, 2013, in a multicenter, national VA cohort, 52,504 involved use of beta-lactam–only prophylaxis, 5,089 involved vancomycin-only prophylaxis, and 12,508 involved prophylaxis with a combination of the two. There were 2,466 surgical site infections at 109 medical centers.

Among cardiac surgery patients, the incidence of surgical site infections was significantly lower for the 6,953 patients treated with both drugs vs. the 12,834 treated with a single agent (0.95% vs. 1.48%), the investigators found (PLOS Med. 2017 Jul 10. doi: 10.1371/journal.pmed.1002340).

SSI benefit with combination therapy

“After controlling for age, diabetes, ASA [American Society of Anesthesiologists] score, mupirocin administration, current smoking status, and preoperative MRSA [methicillin-resistant Staphylococcus aureus] colonization status, receipt of combination antimicrobial prophylaxis was associated with reduced SSI risk following cardiac surgical procedures (adjusted risk ratio, 0.61),” they wrote, noting that, when combination therapy was compared with either of the agents alone, the associations were similar and that no association between SSI reduction and the combination regimen was seen for the other types of surgical procedures assessed.

Secondary analyses showed that, among the cardiac patients, differences in the rates of SSIs were seen based on MRSA status in patients undergoing cardiac surgery. Among MRSA-colonized patients, SSIs occurred in 8 of 346 patients (2.3%) who received combination prophylaxis vs. 4 of 100 patients (4%) who received vancomycin alone (aRR, 0.53), and, among MRSA-negative and MRSA-unknown cardiac surgery patients, SSIs occurred in 58 of 6,607 patients (0.88%) receiving combination prophylaxis and 146 of 10,215 patients (1.4%) receiving a beta-lactam alone (aRR, 0.60).

“Among MRSA-colonized patients undergoing cardiac surgery, the associated absolute risk reduction for SSI was approximately triple that of the absolute risk reduction in MRSA-negative or -unknown patients, with a [number needed to treat] to prevent 1 SSI of 53 for the MRSA-colonized group, compared with 176 for the MRSA-negative or -unknown groups,” they wrote.

The incidence of Clostridium difficile infection was similar in both exposure groups (0.72% and 0.81% with combination and single agent prophylaxis, respectively).

Higher AKI risk with combination therapy

“In contrast, combination versus single prophylaxis was associated with higher relative risk of AKI in the 7-day postoperative period after adjusting for prophylaxis regimen duration, age, diabetes, ASA score, and smoking,” they said.

The rate of AKI was 23.75% among patients receiving combination prophylaxis, compared with 20.79% and 13.93% among those receiving vancomycin alone and a beta-lactam alone, respectively.

Significant associations between absolute risk of AKI and receipt of combination regimens were seen across all types of procedures, the investigators said.

“Overall, the NNH [number needed to harm] to cause one episode of AKI in cardiac surgery patients receiving combination therapy was 22, and, for stage 3 AKI, 167. The NNH associated with one additional episode of any postoperative AKI after receipt of combination therapy was 76 following orthopedic procedures and 25 following vascular surgical procedures,” they said.

The optimal approach for preventing SSIs is unclear. Although the multidisciplinary Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery recommend single agent prophylaxis most often, with a beta-lactam antibiotic, for most surgical procedures, the use of vancomycin alone is a consideration in MRSA-colonized patients and in centers with a high MRSA incidence, and combination prophylaxis with a beta-lactam plus vancomycin is increasing. However, the relative risks and benefit of this strategy have not been carefully studied, the investigators said.

Thus, the investigators used a propensity-adjusted, log-binomial regression model stratified by type of surgical procedure among the cases identified in the Veterans Affairs cohort to assess the association between SSIs and receipt of combination prophylaxis versus single agent prophylaxis.

Though limited by the observational study design and by factors such as a predominantly male and slightly older and more rural population, the findings suggest that “clinicians may need to individualize prophylaxis strategy based on patient-specific factors that influence the risk-versus-benefit equation,” they said, concluding that “future studies are needed to evaluate the utility of MRSA screening protocols for optimizing and individualizing surgical prophylaxis regimen.”

This study was funded by Veterans Affairs Health Services Research and Development. Dr. Branch-Elliman reported having no disclosures. One other author, Eli Perencevich, MD, received an investigator initiated Grant from Merck Pharmaceuticals in 2013.

 

 

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The combined use of vancomycin and a beta-lactam antibiotic for prophylaxis against surgical site infections is associated with both benefits and harms, according to findings from a national propensity-score–adjusted retrospective cohort study.

For example, the combination treatment reduced surgical site infections (SSIs) 30 days after cardiac surgical procedures but increased the risk of postoperative acute kidney injury (AKI) in some patients, Westyn Branch-Elliman, MD, of the VA Boston Healthcare System and her colleagues reported online July 10 in PLOS Medicine.

Janice Haney Carr/CDC
Magnified 20,000X, this colorized scanning electron micrograph depicts a grouping of MRSA bacteria.
Of 70,101 cardiac, orthopedic joint replacement, vascular, colorectal, and hysterectomy procedures performed between Oct. 1, 2008, and Sept. 30, 2013, in a multicenter, national VA cohort, 52,504 involved use of beta-lactam–only prophylaxis, 5,089 involved vancomycin-only prophylaxis, and 12,508 involved prophylaxis with a combination of the two. There were 2,466 surgical site infections at 109 medical centers.

Among cardiac surgery patients, the incidence of surgical site infections was significantly lower for the 6,953 patients treated with both drugs vs. the 12,834 treated with a single agent (0.95% vs. 1.48%), the investigators found (PLOS Med. 2017 Jul 10. doi: 10.1371/journal.pmed.1002340).

SSI benefit with combination therapy

“After controlling for age, diabetes, ASA [American Society of Anesthesiologists] score, mupirocin administration, current smoking status, and preoperative MRSA [methicillin-resistant Staphylococcus aureus] colonization status, receipt of combination antimicrobial prophylaxis was associated with reduced SSI risk following cardiac surgical procedures (adjusted risk ratio, 0.61),” they wrote, noting that, when combination therapy was compared with either of the agents alone, the associations were similar and that no association between SSI reduction and the combination regimen was seen for the other types of surgical procedures assessed.

Secondary analyses showed that, among the cardiac patients, differences in the rates of SSIs were seen based on MRSA status in patients undergoing cardiac surgery. Among MRSA-colonized patients, SSIs occurred in 8 of 346 patients (2.3%) who received combination prophylaxis vs. 4 of 100 patients (4%) who received vancomycin alone (aRR, 0.53), and, among MRSA-negative and MRSA-unknown cardiac surgery patients, SSIs occurred in 58 of 6,607 patients (0.88%) receiving combination prophylaxis and 146 of 10,215 patients (1.4%) receiving a beta-lactam alone (aRR, 0.60).

“Among MRSA-colonized patients undergoing cardiac surgery, the associated absolute risk reduction for SSI was approximately triple that of the absolute risk reduction in MRSA-negative or -unknown patients, with a [number needed to treat] to prevent 1 SSI of 53 for the MRSA-colonized group, compared with 176 for the MRSA-negative or -unknown groups,” they wrote.

The incidence of Clostridium difficile infection was similar in both exposure groups (0.72% and 0.81% with combination and single agent prophylaxis, respectively).

Higher AKI risk with combination therapy

“In contrast, combination versus single prophylaxis was associated with higher relative risk of AKI in the 7-day postoperative period after adjusting for prophylaxis regimen duration, age, diabetes, ASA score, and smoking,” they said.

The rate of AKI was 23.75% among patients receiving combination prophylaxis, compared with 20.79% and 13.93% among those receiving vancomycin alone and a beta-lactam alone, respectively.

Significant associations between absolute risk of AKI and receipt of combination regimens were seen across all types of procedures, the investigators said.

“Overall, the NNH [number needed to harm] to cause one episode of AKI in cardiac surgery patients receiving combination therapy was 22, and, for stage 3 AKI, 167. The NNH associated with one additional episode of any postoperative AKI after receipt of combination therapy was 76 following orthopedic procedures and 25 following vascular surgical procedures,” they said.

The optimal approach for preventing SSIs is unclear. Although the multidisciplinary Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery recommend single agent prophylaxis most often, with a beta-lactam antibiotic, for most surgical procedures, the use of vancomycin alone is a consideration in MRSA-colonized patients and in centers with a high MRSA incidence, and combination prophylaxis with a beta-lactam plus vancomycin is increasing. However, the relative risks and benefit of this strategy have not been carefully studied, the investigators said.

Thus, the investigators used a propensity-adjusted, log-binomial regression model stratified by type of surgical procedure among the cases identified in the Veterans Affairs cohort to assess the association between SSIs and receipt of combination prophylaxis versus single agent prophylaxis.

Though limited by the observational study design and by factors such as a predominantly male and slightly older and more rural population, the findings suggest that “clinicians may need to individualize prophylaxis strategy based on patient-specific factors that influence the risk-versus-benefit equation,” they said, concluding that “future studies are needed to evaluate the utility of MRSA screening protocols for optimizing and individualizing surgical prophylaxis regimen.”

This study was funded by Veterans Affairs Health Services Research and Development. Dr. Branch-Elliman reported having no disclosures. One other author, Eli Perencevich, MD, received an investigator initiated Grant from Merck Pharmaceuticals in 2013.

 

 

 

The combined use of vancomycin and a beta-lactam antibiotic for prophylaxis against surgical site infections is associated with both benefits and harms, according to findings from a national propensity-score–adjusted retrospective cohort study.

For example, the combination treatment reduced surgical site infections (SSIs) 30 days after cardiac surgical procedures but increased the risk of postoperative acute kidney injury (AKI) in some patients, Westyn Branch-Elliman, MD, of the VA Boston Healthcare System and her colleagues reported online July 10 in PLOS Medicine.

Janice Haney Carr/CDC
Magnified 20,000X, this colorized scanning electron micrograph depicts a grouping of MRSA bacteria.
Of 70,101 cardiac, orthopedic joint replacement, vascular, colorectal, and hysterectomy procedures performed between Oct. 1, 2008, and Sept. 30, 2013, in a multicenter, national VA cohort, 52,504 involved use of beta-lactam–only prophylaxis, 5,089 involved vancomycin-only prophylaxis, and 12,508 involved prophylaxis with a combination of the two. There were 2,466 surgical site infections at 109 medical centers.

Among cardiac surgery patients, the incidence of surgical site infections was significantly lower for the 6,953 patients treated with both drugs vs. the 12,834 treated with a single agent (0.95% vs. 1.48%), the investigators found (PLOS Med. 2017 Jul 10. doi: 10.1371/journal.pmed.1002340).

SSI benefit with combination therapy

“After controlling for age, diabetes, ASA [American Society of Anesthesiologists] score, mupirocin administration, current smoking status, and preoperative MRSA [methicillin-resistant Staphylococcus aureus] colonization status, receipt of combination antimicrobial prophylaxis was associated with reduced SSI risk following cardiac surgical procedures (adjusted risk ratio, 0.61),” they wrote, noting that, when combination therapy was compared with either of the agents alone, the associations were similar and that no association between SSI reduction and the combination regimen was seen for the other types of surgical procedures assessed.

Secondary analyses showed that, among the cardiac patients, differences in the rates of SSIs were seen based on MRSA status in patients undergoing cardiac surgery. Among MRSA-colonized patients, SSIs occurred in 8 of 346 patients (2.3%) who received combination prophylaxis vs. 4 of 100 patients (4%) who received vancomycin alone (aRR, 0.53), and, among MRSA-negative and MRSA-unknown cardiac surgery patients, SSIs occurred in 58 of 6,607 patients (0.88%) receiving combination prophylaxis and 146 of 10,215 patients (1.4%) receiving a beta-lactam alone (aRR, 0.60).

“Among MRSA-colonized patients undergoing cardiac surgery, the associated absolute risk reduction for SSI was approximately triple that of the absolute risk reduction in MRSA-negative or -unknown patients, with a [number needed to treat] to prevent 1 SSI of 53 for the MRSA-colonized group, compared with 176 for the MRSA-negative or -unknown groups,” they wrote.

The incidence of Clostridium difficile infection was similar in both exposure groups (0.72% and 0.81% with combination and single agent prophylaxis, respectively).

Higher AKI risk with combination therapy

“In contrast, combination versus single prophylaxis was associated with higher relative risk of AKI in the 7-day postoperative period after adjusting for prophylaxis regimen duration, age, diabetes, ASA score, and smoking,” they said.

The rate of AKI was 23.75% among patients receiving combination prophylaxis, compared with 20.79% and 13.93% among those receiving vancomycin alone and a beta-lactam alone, respectively.

Significant associations between absolute risk of AKI and receipt of combination regimens were seen across all types of procedures, the investigators said.

“Overall, the NNH [number needed to harm] to cause one episode of AKI in cardiac surgery patients receiving combination therapy was 22, and, for stage 3 AKI, 167. The NNH associated with one additional episode of any postoperative AKI after receipt of combination therapy was 76 following orthopedic procedures and 25 following vascular surgical procedures,” they said.

The optimal approach for preventing SSIs is unclear. Although the multidisciplinary Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery recommend single agent prophylaxis most often, with a beta-lactam antibiotic, for most surgical procedures, the use of vancomycin alone is a consideration in MRSA-colonized patients and in centers with a high MRSA incidence, and combination prophylaxis with a beta-lactam plus vancomycin is increasing. However, the relative risks and benefit of this strategy have not been carefully studied, the investigators said.

Thus, the investigators used a propensity-adjusted, log-binomial regression model stratified by type of surgical procedure among the cases identified in the Veterans Affairs cohort to assess the association between SSIs and receipt of combination prophylaxis versus single agent prophylaxis.

Though limited by the observational study design and by factors such as a predominantly male and slightly older and more rural population, the findings suggest that “clinicians may need to individualize prophylaxis strategy based on patient-specific factors that influence the risk-versus-benefit equation,” they said, concluding that “future studies are needed to evaluate the utility of MRSA screening protocols for optimizing and individualizing surgical prophylaxis regimen.”

This study was funded by Veterans Affairs Health Services Research and Development. Dr. Branch-Elliman reported having no disclosures. One other author, Eli Perencevich, MD, received an investigator initiated Grant from Merck Pharmaceuticals in 2013.

 

 

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Key clinical point: Combination vancomycin/beta-lactam prophylaxis against surgical site infections is associated with both benefits and harms.

Major finding: The SSI incidence was 0.95% vs. 1.48% with combination vs. single agent–therapy in cardiac surgery patients. Acute kidney injuries occurred in 23.75% of all surgery patients receiving combination prophylaxis, compared with 20.79% and 13.93% with vancomycin or a beta-lactam, respectively.

Data source: A retrospective cohort study of more than 70,000 surgical procedures.

Disclosures: This study was funded by Veterans Affairs Health Services Research and Development. Dr. Branch-Elliman reported having no disclosures. One other author, Eli Perencevich, MD, received an investigator initiated grant from Merck Pharmaceuticals in 2013.

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Multiple factors predict surgical site infection risk after lower extremity revascularization

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Patient, operative, and hospital factors were found to be significant predictors of the risk of surgical site infection in patients who underwent open lower extremity bypass procedures, according to the results of a retrospective data analysis.

The study assessed the outcomes of 3,033 patients who underwent elective or urgent open LEB procedures between January 2012 and June 2015 using data from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium Vascular Intervention Collaborative (BMC2 VIC), a statewide cardiovascular consortium of 35 hospitals, according to Frank M. Davis, MD, and his colleagues at the University of Michigan, Ann Arbor.

Demographic information, medical history, laboratory test results before and after the procedure, procedural indication, procedural urgency, technical details of procedures, and associated complications were assessed for each patient. Women comprised 31% of patients, the average patient age was 66 years, and 83% of the population was white (J Vasc Surg. 2017 Jun;65[6]:1769-78).

Among all of the patients treated, 320 developed SSIs and 2,713 did not. The procedural indications included one or more of the following: claudication (72%), rest pain (50.5%), ulcer/gangrene (32.4%), or acute limb ischemia (15.1%). Antibiotics were appropriately administered to 97% of the patients, according to the researchers, “demonstrating high compliance across the BMC2 VIC.”

  • Patient factors: As indicated by previous studies, obesity (odds ratio, 1.78), dialysis dependence (OR, 4.33), and hypertension (OR, 4.29) conferred a significant increased risk of SSI after LEB, according to Dr. Davis and his colleagues. In addition, however, they found that previous vascular surgery (OR, 1.57), previous percutaneous coronary intervention (OR, 1.47), use of antiplatelet medication (OR, 4.29), and low Peripheral Artery Questionnaire symptom severity (OR, 1.48) were significant independent predictors of SSI.
  • Operative factors: Prolonged procedural length (OR, 2.95), iodine-only antiseptic skin preparation (OR, 1.73), and high peak intraoperative glucose (defined as a peak glucose greater than 180 mg/dL; OR, 1.99) were significant independent predictors of SSI. However, concomitant stent placement was found to be significantly predictive (OR, .38), “perhaps due to improvement in regional and subcutaneous vascular flow after the intervention,” the researchers suggested.
  • Hospital factors: Larger overall hospital size (OR, 2.22) and major teaching center (OR, 1.66) were associated with increased risk of SSI. “Interestingly, we did not find an association with SSI and the hospital annual volume or the hospital urgent/emergent procedure rate,” the researchers added.

SSIs were not found to be significantly associated with a difference in 30-day mortality. However, they were significantly associated with an increased rate of several postoperative morbidities, including transfusion, lymph leak, major amputation, and open surgical bypass revision at or within 30 days of the index operation, according to Dr. Davis and his colleagues.

“Although some factors, such as patients comorbidities, are not modifiable, others represent areas for quality improvement in at-risk patients,” the researchers indicated. “Diligence should be devoted to decreasing operative length, controlling intraoperative glucose levels, and avoiding iodine-only skin preparation to decrease the rate of SSIs and its numerous associate morbidities in vascular surgery patients.”

In discussing the issue of antiplatelet medication being an indicator of increased risk, the authors pointed out that it was a hitherto unreported factor in the vascular literature, and of concern because, “as expected, a high percentage of patients (78.7%) were taking antiplatelet medication at the time of their LEB.”

Because the association of antiplatelet medication with SSIs was independent of the need for operative transfusion or the need for repeat intervention, the researchers speculated that “all antiplatelet agents have the theoretical potential to diminish activation-dependent platelet immune functions.” They referred to previous studies showing that clopidogrel was associated with significantly higher clinical rates of infection, particularly pneumonia.

Limitations cited for the study were the retrospective nature of the database analysis, the possibility of confounders not assessed in the data, and the fact that outcomes were limited to 30-day events, which would not take into account longer-term graft failure or mortality.

The authors reported having no conflicts of interest with regard to the study.

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Patient, operative, and hospital factors were found to be significant predictors of the risk of surgical site infection in patients who underwent open lower extremity bypass procedures, according to the results of a retrospective data analysis.

The study assessed the outcomes of 3,033 patients who underwent elective or urgent open LEB procedures between January 2012 and June 2015 using data from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium Vascular Intervention Collaborative (BMC2 VIC), a statewide cardiovascular consortium of 35 hospitals, according to Frank M. Davis, MD, and his colleagues at the University of Michigan, Ann Arbor.

Demographic information, medical history, laboratory test results before and after the procedure, procedural indication, procedural urgency, technical details of procedures, and associated complications were assessed for each patient. Women comprised 31% of patients, the average patient age was 66 years, and 83% of the population was white (J Vasc Surg. 2017 Jun;65[6]:1769-78).

Among all of the patients treated, 320 developed SSIs and 2,713 did not. The procedural indications included one or more of the following: claudication (72%), rest pain (50.5%), ulcer/gangrene (32.4%), or acute limb ischemia (15.1%). Antibiotics were appropriately administered to 97% of the patients, according to the researchers, “demonstrating high compliance across the BMC2 VIC.”

  • Patient factors: As indicated by previous studies, obesity (odds ratio, 1.78), dialysis dependence (OR, 4.33), and hypertension (OR, 4.29) conferred a significant increased risk of SSI after LEB, according to Dr. Davis and his colleagues. In addition, however, they found that previous vascular surgery (OR, 1.57), previous percutaneous coronary intervention (OR, 1.47), use of antiplatelet medication (OR, 4.29), and low Peripheral Artery Questionnaire symptom severity (OR, 1.48) were significant independent predictors of SSI.
  • Operative factors: Prolonged procedural length (OR, 2.95), iodine-only antiseptic skin preparation (OR, 1.73), and high peak intraoperative glucose (defined as a peak glucose greater than 180 mg/dL; OR, 1.99) were significant independent predictors of SSI. However, concomitant stent placement was found to be significantly predictive (OR, .38), “perhaps due to improvement in regional and subcutaneous vascular flow after the intervention,” the researchers suggested.
  • Hospital factors: Larger overall hospital size (OR, 2.22) and major teaching center (OR, 1.66) were associated with increased risk of SSI. “Interestingly, we did not find an association with SSI and the hospital annual volume or the hospital urgent/emergent procedure rate,” the researchers added.

SSIs were not found to be significantly associated with a difference in 30-day mortality. However, they were significantly associated with an increased rate of several postoperative morbidities, including transfusion, lymph leak, major amputation, and open surgical bypass revision at or within 30 days of the index operation, according to Dr. Davis and his colleagues.

“Although some factors, such as patients comorbidities, are not modifiable, others represent areas for quality improvement in at-risk patients,” the researchers indicated. “Diligence should be devoted to decreasing operative length, controlling intraoperative glucose levels, and avoiding iodine-only skin preparation to decrease the rate of SSIs and its numerous associate morbidities in vascular surgery patients.”

In discussing the issue of antiplatelet medication being an indicator of increased risk, the authors pointed out that it was a hitherto unreported factor in the vascular literature, and of concern because, “as expected, a high percentage of patients (78.7%) were taking antiplatelet medication at the time of their LEB.”

Because the association of antiplatelet medication with SSIs was independent of the need for operative transfusion or the need for repeat intervention, the researchers speculated that “all antiplatelet agents have the theoretical potential to diminish activation-dependent platelet immune functions.” They referred to previous studies showing that clopidogrel was associated with significantly higher clinical rates of infection, particularly pneumonia.

Limitations cited for the study were the retrospective nature of the database analysis, the possibility of confounders not assessed in the data, and the fact that outcomes were limited to 30-day events, which would not take into account longer-term graft failure or mortality.

The authors reported having no conflicts of interest with regard to the study.

 

Patient, operative, and hospital factors were found to be significant predictors of the risk of surgical site infection in patients who underwent open lower extremity bypass procedures, according to the results of a retrospective data analysis.

The study assessed the outcomes of 3,033 patients who underwent elective or urgent open LEB procedures between January 2012 and June 2015 using data from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium Vascular Intervention Collaborative (BMC2 VIC), a statewide cardiovascular consortium of 35 hospitals, according to Frank M. Davis, MD, and his colleagues at the University of Michigan, Ann Arbor.

Demographic information, medical history, laboratory test results before and after the procedure, procedural indication, procedural urgency, technical details of procedures, and associated complications were assessed for each patient. Women comprised 31% of patients, the average patient age was 66 years, and 83% of the population was white (J Vasc Surg. 2017 Jun;65[6]:1769-78).

Among all of the patients treated, 320 developed SSIs and 2,713 did not. The procedural indications included one or more of the following: claudication (72%), rest pain (50.5%), ulcer/gangrene (32.4%), or acute limb ischemia (15.1%). Antibiotics were appropriately administered to 97% of the patients, according to the researchers, “demonstrating high compliance across the BMC2 VIC.”

  • Patient factors: As indicated by previous studies, obesity (odds ratio, 1.78), dialysis dependence (OR, 4.33), and hypertension (OR, 4.29) conferred a significant increased risk of SSI after LEB, according to Dr. Davis and his colleagues. In addition, however, they found that previous vascular surgery (OR, 1.57), previous percutaneous coronary intervention (OR, 1.47), use of antiplatelet medication (OR, 4.29), and low Peripheral Artery Questionnaire symptom severity (OR, 1.48) were significant independent predictors of SSI.
  • Operative factors: Prolonged procedural length (OR, 2.95), iodine-only antiseptic skin preparation (OR, 1.73), and high peak intraoperative glucose (defined as a peak glucose greater than 180 mg/dL; OR, 1.99) were significant independent predictors of SSI. However, concomitant stent placement was found to be significantly predictive (OR, .38), “perhaps due to improvement in regional and subcutaneous vascular flow after the intervention,” the researchers suggested.
  • Hospital factors: Larger overall hospital size (OR, 2.22) and major teaching center (OR, 1.66) were associated with increased risk of SSI. “Interestingly, we did not find an association with SSI and the hospital annual volume or the hospital urgent/emergent procedure rate,” the researchers added.

SSIs were not found to be significantly associated with a difference in 30-day mortality. However, they were significantly associated with an increased rate of several postoperative morbidities, including transfusion, lymph leak, major amputation, and open surgical bypass revision at or within 30 days of the index operation, according to Dr. Davis and his colleagues.

“Although some factors, such as patients comorbidities, are not modifiable, others represent areas for quality improvement in at-risk patients,” the researchers indicated. “Diligence should be devoted to decreasing operative length, controlling intraoperative glucose levels, and avoiding iodine-only skin preparation to decrease the rate of SSIs and its numerous associate morbidities in vascular surgery patients.”

In discussing the issue of antiplatelet medication being an indicator of increased risk, the authors pointed out that it was a hitherto unreported factor in the vascular literature, and of concern because, “as expected, a high percentage of patients (78.7%) were taking antiplatelet medication at the time of their LEB.”

Because the association of antiplatelet medication with SSIs was independent of the need for operative transfusion or the need for repeat intervention, the researchers speculated that “all antiplatelet agents have the theoretical potential to diminish activation-dependent platelet immune functions.” They referred to previous studies showing that clopidogrel was associated with significantly higher clinical rates of infection, particularly pneumonia.

Limitations cited for the study were the retrospective nature of the database analysis, the possibility of confounders not assessed in the data, and the fact that outcomes were limited to 30-day events, which would not take into account longer-term graft failure or mortality.

The authors reported having no conflicts of interest with regard to the study.

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Key clinical point: Procedural length, preoperative antiplatelet medication, peak intraoperative glucose, and iodine-based skin preparation were among the factors that increased the risk of SSIs.

Major finding: SSIs occurred in 10.6% of lower extremity bypasses.

Data source: A retrospective analysis of 3,033 elective or urgent open LEB procedures performed over a 3.5-year period in a statewide cardiovascular consortium of 35 hospitals.

Disclosures: The authors reported having no conflicts of interest with regard to the study.

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Better bariatric surgery outcomes with lower preoperative BMI

Results confirm benefits of BMI below 30 after bariatric surgery
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Delaying bariatric surgery until body mass index is highly elevated may reduce the likelihood of achieving a BMI of less than 30 within a year, according to a paper published online July 26 in JAMA Surgery.

A retrospective study using prospectively gathered clinical data of 27,320 adults who underwent bariatric surgery in Michigan showed around one in three (36%) achieved a BMI below 30 within a year after surgery (JAMA Surgery 2017, July 26. doi: 10.1001/jamasurg.2017.2348). But obese patients with a body mass index of less than 40 kg/m2 before undergoing bariatric surgery are significantly more likely to achieve a postoperative BMI of under 30.

Individuals who had a preoperative BMI of less than 40 had a 12-fold higher chance of getting their BMI below 30, compared to those whose preoperative BMI was 40 or above (95% confidence interval 1.71-14.16, P less than .001). Only 8.5% of individuals with a BMI at or above 50 achieved a postoperative BMI below 30.

Dr. Oliver A. Varban
“It is important to note that EWL [excess weight loss] percentage may appear exaggerated in relation to actual mass lost in patients with lower initial BMI in these studies,” wrote Oliver A. Varban, MD, FACS, of the University of Michigan Health Systems, and his coauthors. “However, it also highlights the advantages of early surgical management of obesity in that smaller amounts of weight loss are required to achieve the desired effect.”

The likelihood of getting below 30 within a year was eightfold higher in patients who had a sleeve gastrectomy, 21 times greater in those who underwent Roux-en-Y bypass, and 82 times higher in those who had a duodenal switch, compared with patients who had adjustable gastric banding (P less than .001).

The researchers also compared other outcomes in individuals whose BMI dropped below 30 and in those who did not achieve this degree of weight loss. The analysis showed that those with a BMI below 30 after 1 year had at least a twofold greater chance of discontinuing cholesterol-lowering medications, insulin, diabetes medications, antihypertensives, and CPAP for sleep apnea, compared with those whose BMI remained at 30 or above. They were also more than three times more likely to report being ‘very satisfied’ with the outcomes of surgery.

The authors noted that the cohort’s mean BMI was 48, which was above the established threshold for bariatric surgery, namely a BMI of 40, or 35 with weight-related comorbidities.

“Our results suggest that patients with morbid obesity should be targeted for surgery when their BMI is still less than 40, as these patients are more likely to achieve a target BMI that results in substantial reduction in weight-related comorbidities,” the authors wrote.

However, they stressed that their findings should not be taken as a reason to exclude patients with a BMI above 40 from surgery, pointing out that even for patients with higher preoperative BMIs, bariatric surgery offered substantial health and quality of life benefits.

They also acknowledged that 1-year weight data was available for around 50% of patients in the registry, which may have led to selection bias.

“Policies and practice patterns that delay or incentivize patients to pursue bariatric surgery only once the BMI is highly elevated can result in inferior outcomes,” the investigators concluded.

Blue Cross Blue Shield of Michigan/Blue Care Network funded the study. Three authors had received salary support from Blue Cross Blue Shield. No other conflicts of interest were declared.
Body

 

The authors’ conclusion that bariatric surgery should be more liberally applied to patients with less severe obesity is consistent with multiple reports of improved control of type 2 diabetes, if not remission, among lower-BMI patient populations following MBS [metabolic and bariatric surgery]. However, these reports generally do not refute the importance of weight loss in achieving important clinical benefit among patients with obesity-related comorbid disease.

One strength of the present study is that it is a clinical database. However, 50% attrition of the follow-up weight loss data at 1 year is potentially problematic.
 

Bruce M. Wolfe, MD, FACS, and Elizaveta Walker, MPH, are in the division of bariatric surgery, department of surgery, at Oregon Health & Science University, Portland. These comments are taken from an accompanying editorial (JAMA Surgery 2017 Jul 26. doi: 10.1001/jamasurg.2017.2349). No conflicts of interest were declared.

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The authors’ conclusion that bariatric surgery should be more liberally applied to patients with less severe obesity is consistent with multiple reports of improved control of type 2 diabetes, if not remission, among lower-BMI patient populations following MBS [metabolic and bariatric surgery]. However, these reports generally do not refute the importance of weight loss in achieving important clinical benefit among patients with obesity-related comorbid disease.

One strength of the present study is that it is a clinical database. However, 50% attrition of the follow-up weight loss data at 1 year is potentially problematic.
 

Bruce M. Wolfe, MD, FACS, and Elizaveta Walker, MPH, are in the division of bariatric surgery, department of surgery, at Oregon Health & Science University, Portland. These comments are taken from an accompanying editorial (JAMA Surgery 2017 Jul 26. doi: 10.1001/jamasurg.2017.2349). No conflicts of interest were declared.

Body

 

The authors’ conclusion that bariatric surgery should be more liberally applied to patients with less severe obesity is consistent with multiple reports of improved control of type 2 diabetes, if not remission, among lower-BMI patient populations following MBS [metabolic and bariatric surgery]. However, these reports generally do not refute the importance of weight loss in achieving important clinical benefit among patients with obesity-related comorbid disease.

One strength of the present study is that it is a clinical database. However, 50% attrition of the follow-up weight loss data at 1 year is potentially problematic.
 

Bruce M. Wolfe, MD, FACS, and Elizaveta Walker, MPH, are in the division of bariatric surgery, department of surgery, at Oregon Health & Science University, Portland. These comments are taken from an accompanying editorial (JAMA Surgery 2017 Jul 26. doi: 10.1001/jamasurg.2017.2349). No conflicts of interest were declared.

Title
Results confirm benefits of BMI below 30 after bariatric surgery
Results confirm benefits of BMI below 30 after bariatric surgery

 

Delaying bariatric surgery until body mass index is highly elevated may reduce the likelihood of achieving a BMI of less than 30 within a year, according to a paper published online July 26 in JAMA Surgery.

A retrospective study using prospectively gathered clinical data of 27,320 adults who underwent bariatric surgery in Michigan showed around one in three (36%) achieved a BMI below 30 within a year after surgery (JAMA Surgery 2017, July 26. doi: 10.1001/jamasurg.2017.2348). But obese patients with a body mass index of less than 40 kg/m2 before undergoing bariatric surgery are significantly more likely to achieve a postoperative BMI of under 30.

Individuals who had a preoperative BMI of less than 40 had a 12-fold higher chance of getting their BMI below 30, compared to those whose preoperative BMI was 40 or above (95% confidence interval 1.71-14.16, P less than .001). Only 8.5% of individuals with a BMI at or above 50 achieved a postoperative BMI below 30.

Dr. Oliver A. Varban
“It is important to note that EWL [excess weight loss] percentage may appear exaggerated in relation to actual mass lost in patients with lower initial BMI in these studies,” wrote Oliver A. Varban, MD, FACS, of the University of Michigan Health Systems, and his coauthors. “However, it also highlights the advantages of early surgical management of obesity in that smaller amounts of weight loss are required to achieve the desired effect.”

The likelihood of getting below 30 within a year was eightfold higher in patients who had a sleeve gastrectomy, 21 times greater in those who underwent Roux-en-Y bypass, and 82 times higher in those who had a duodenal switch, compared with patients who had adjustable gastric banding (P less than .001).

The researchers also compared other outcomes in individuals whose BMI dropped below 30 and in those who did not achieve this degree of weight loss. The analysis showed that those with a BMI below 30 after 1 year had at least a twofold greater chance of discontinuing cholesterol-lowering medications, insulin, diabetes medications, antihypertensives, and CPAP for sleep apnea, compared with those whose BMI remained at 30 or above. They were also more than three times more likely to report being ‘very satisfied’ with the outcomes of surgery.

The authors noted that the cohort’s mean BMI was 48, which was above the established threshold for bariatric surgery, namely a BMI of 40, or 35 with weight-related comorbidities.

“Our results suggest that patients with morbid obesity should be targeted for surgery when their BMI is still less than 40, as these patients are more likely to achieve a target BMI that results in substantial reduction in weight-related comorbidities,” the authors wrote.

However, they stressed that their findings should not be taken as a reason to exclude patients with a BMI above 40 from surgery, pointing out that even for patients with higher preoperative BMIs, bariatric surgery offered substantial health and quality of life benefits.

They also acknowledged that 1-year weight data was available for around 50% of patients in the registry, which may have led to selection bias.

“Policies and practice patterns that delay or incentivize patients to pursue bariatric surgery only once the BMI is highly elevated can result in inferior outcomes,” the investigators concluded.

Blue Cross Blue Shield of Michigan/Blue Care Network funded the study. Three authors had received salary support from Blue Cross Blue Shield. No other conflicts of interest were declared.

 

Delaying bariatric surgery until body mass index is highly elevated may reduce the likelihood of achieving a BMI of less than 30 within a year, according to a paper published online July 26 in JAMA Surgery.

A retrospective study using prospectively gathered clinical data of 27,320 adults who underwent bariatric surgery in Michigan showed around one in three (36%) achieved a BMI below 30 within a year after surgery (JAMA Surgery 2017, July 26. doi: 10.1001/jamasurg.2017.2348). But obese patients with a body mass index of less than 40 kg/m2 before undergoing bariatric surgery are significantly more likely to achieve a postoperative BMI of under 30.

Individuals who had a preoperative BMI of less than 40 had a 12-fold higher chance of getting their BMI below 30, compared to those whose preoperative BMI was 40 or above (95% confidence interval 1.71-14.16, P less than .001). Only 8.5% of individuals with a BMI at or above 50 achieved a postoperative BMI below 30.

Dr. Oliver A. Varban
“It is important to note that EWL [excess weight loss] percentage may appear exaggerated in relation to actual mass lost in patients with lower initial BMI in these studies,” wrote Oliver A. Varban, MD, FACS, of the University of Michigan Health Systems, and his coauthors. “However, it also highlights the advantages of early surgical management of obesity in that smaller amounts of weight loss are required to achieve the desired effect.”

The likelihood of getting below 30 within a year was eightfold higher in patients who had a sleeve gastrectomy, 21 times greater in those who underwent Roux-en-Y bypass, and 82 times higher in those who had a duodenal switch, compared with patients who had adjustable gastric banding (P less than .001).

The researchers also compared other outcomes in individuals whose BMI dropped below 30 and in those who did not achieve this degree of weight loss. The analysis showed that those with a BMI below 30 after 1 year had at least a twofold greater chance of discontinuing cholesterol-lowering medications, insulin, diabetes medications, antihypertensives, and CPAP for sleep apnea, compared with those whose BMI remained at 30 or above. They were also more than three times more likely to report being ‘very satisfied’ with the outcomes of surgery.

The authors noted that the cohort’s mean BMI was 48, which was above the established threshold for bariatric surgery, namely a BMI of 40, or 35 with weight-related comorbidities.

“Our results suggest that patients with morbid obesity should be targeted for surgery when their BMI is still less than 40, as these patients are more likely to achieve a target BMI that results in substantial reduction in weight-related comorbidities,” the authors wrote.

However, they stressed that their findings should not be taken as a reason to exclude patients with a BMI above 40 from surgery, pointing out that even for patients with higher preoperative BMIs, bariatric surgery offered substantial health and quality of life benefits.

They also acknowledged that 1-year weight data was available for around 50% of patients in the registry, which may have led to selection bias.

“Policies and practice patterns that delay or incentivize patients to pursue bariatric surgery only once the BMI is highly elevated can result in inferior outcomes,” the investigators concluded.

Blue Cross Blue Shield of Michigan/Blue Care Network funded the study. Three authors had received salary support from Blue Cross Blue Shield. No other conflicts of interest were declared.
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Key clinical point: A BMI below 40 prior to undergoing bariatric surgery gives patients a significantly better chance of achieving a 1-year postoperative BMI under 30.

Major finding: Obese patients with a BMI less than 40 before undergoing bariatric surgery are more than 12 times more likely to achieve a postoperative BMI of under 30.

Data source: A retrospective study using prospectively gathered clinical data of 27, 320 adults who underwent bariatric surgery.

Disclosures: Blue Cross Blue Shield of Michigan/Blue Care Network funded the study. Three authors had received salary support from Blue Cross Blue Shield. No other conflicts of interest were declared.

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First Senate vote to repeal and replace ACA fails

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Senate Republicans’ first attempt to repeal and replace the Affordable Care Act failed July 25 as nine Republican senators crossed the aisle to vote against a measure that had no chance of passing.

The process started with a dramatic appearance by Sen. John McCain (R-Ariz.), recovering from surgery to diagnose glioblastoma, who returned to Washington to cast a key vote that would allow debate to move forward. The Senate split 50-50 on that vote, with Sen. Susan Collins (R-Maine) and Sen. Lisa Murkowski (R-Alaska) crossing the aisle to vote with all the chamber’s Democrats against the motion to proceed. Vice President Mike Pence cast the tie-breaking vote in favor of beginning debate.

designer491/Thinkstock
The bill under consideration was the Obamacare Repeal Reconciliation Act, which aimed to repeal the ACA by the end of 2019.

However, the first amendment voted on would have replaced that language with the most recent version of the Senate GOP repeal-and-replace plan, the Better Care Reconciliation Act, with two additional provisions. One was from Sen. Ted Cruz (R-Tex.) and would allow insurers to offer more limited health insurance plans along side plans that cover the ACA’s essential benefits package. A second provision from Sen. Rob Portman (R-Ohio) would have added an additional $100 billion to the state stability fund to help low-income individuals whose Medicaid coverage was repealed.

The amendment was dead on arrival, as it would have needed 60 votes to pass. Throughout the repeal-and-replace effort, the 48 Senate Democrats have been firm in voting against any action. While much of the repeal-and-replace effort to date has relied on the budget reconciliation process, which requires a simple majority for passage, this legislation did not qualify and needed a supermajority of 60 votes for passage.

The nine GOP senators voting against the amendment included Collins, Murkowski, Bob Corker (Tenn.), Tom Cotton (Ark.), Lindsey Graham (S.C.), Dena Heller (Nev.), Mike Lee (Utah), Jerry Moran (Kan.), and Rand Paul (Ky.).

Earlier in the day, just after voting in favor of action on this legislation, Sen. McCain pleaded with his colleagues to return to regular order and write a bill that has bipartisan support. He criticized congressional Democrats for forcing the ACA through without bipartisan support 7 years ago and congressional Republicans for doing the exact same thing now with their repeal-and-replace efforts.

“Why don’t we try the old way of legislating in the Senate, the way our rules and customs encourage us to act,” Sen. McCain asked. “Let the Health, Education, Labor, and Pensions Committee under Chairman Alexander and Ranking Member Murray hold hearings, try to report a bill out of committee with contributions from both sides. Then bring it to the floor for amendment and debate and see if we can pass something that will be imperfect, full of compromises, and not very pleasing to implacable partisans on either side but that might provide workable solutions to problems Americans are struggling with today.”

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Senate Republicans’ first attempt to repeal and replace the Affordable Care Act failed July 25 as nine Republican senators crossed the aisle to vote against a measure that had no chance of passing.

The process started with a dramatic appearance by Sen. John McCain (R-Ariz.), recovering from surgery to diagnose glioblastoma, who returned to Washington to cast a key vote that would allow debate to move forward. The Senate split 50-50 on that vote, with Sen. Susan Collins (R-Maine) and Sen. Lisa Murkowski (R-Alaska) crossing the aisle to vote with all the chamber’s Democrats against the motion to proceed. Vice President Mike Pence cast the tie-breaking vote in favor of beginning debate.

designer491/Thinkstock
The bill under consideration was the Obamacare Repeal Reconciliation Act, which aimed to repeal the ACA by the end of 2019.

However, the first amendment voted on would have replaced that language with the most recent version of the Senate GOP repeal-and-replace plan, the Better Care Reconciliation Act, with two additional provisions. One was from Sen. Ted Cruz (R-Tex.) and would allow insurers to offer more limited health insurance plans along side plans that cover the ACA’s essential benefits package. A second provision from Sen. Rob Portman (R-Ohio) would have added an additional $100 billion to the state stability fund to help low-income individuals whose Medicaid coverage was repealed.

The amendment was dead on arrival, as it would have needed 60 votes to pass. Throughout the repeal-and-replace effort, the 48 Senate Democrats have been firm in voting against any action. While much of the repeal-and-replace effort to date has relied on the budget reconciliation process, which requires a simple majority for passage, this legislation did not qualify and needed a supermajority of 60 votes for passage.

The nine GOP senators voting against the amendment included Collins, Murkowski, Bob Corker (Tenn.), Tom Cotton (Ark.), Lindsey Graham (S.C.), Dena Heller (Nev.), Mike Lee (Utah), Jerry Moran (Kan.), and Rand Paul (Ky.).

Earlier in the day, just after voting in favor of action on this legislation, Sen. McCain pleaded with his colleagues to return to regular order and write a bill that has bipartisan support. He criticized congressional Democrats for forcing the ACA through without bipartisan support 7 years ago and congressional Republicans for doing the exact same thing now with their repeal-and-replace efforts.

“Why don’t we try the old way of legislating in the Senate, the way our rules and customs encourage us to act,” Sen. McCain asked. “Let the Health, Education, Labor, and Pensions Committee under Chairman Alexander and Ranking Member Murray hold hearings, try to report a bill out of committee with contributions from both sides. Then bring it to the floor for amendment and debate and see if we can pass something that will be imperfect, full of compromises, and not very pleasing to implacable partisans on either side but that might provide workable solutions to problems Americans are struggling with today.”

 

Senate Republicans’ first attempt to repeal and replace the Affordable Care Act failed July 25 as nine Republican senators crossed the aisle to vote against a measure that had no chance of passing.

The process started with a dramatic appearance by Sen. John McCain (R-Ariz.), recovering from surgery to diagnose glioblastoma, who returned to Washington to cast a key vote that would allow debate to move forward. The Senate split 50-50 on that vote, with Sen. Susan Collins (R-Maine) and Sen. Lisa Murkowski (R-Alaska) crossing the aisle to vote with all the chamber’s Democrats against the motion to proceed. Vice President Mike Pence cast the tie-breaking vote in favor of beginning debate.

designer491/Thinkstock
The bill under consideration was the Obamacare Repeal Reconciliation Act, which aimed to repeal the ACA by the end of 2019.

However, the first amendment voted on would have replaced that language with the most recent version of the Senate GOP repeal-and-replace plan, the Better Care Reconciliation Act, with two additional provisions. One was from Sen. Ted Cruz (R-Tex.) and would allow insurers to offer more limited health insurance plans along side plans that cover the ACA’s essential benefits package. A second provision from Sen. Rob Portman (R-Ohio) would have added an additional $100 billion to the state stability fund to help low-income individuals whose Medicaid coverage was repealed.

The amendment was dead on arrival, as it would have needed 60 votes to pass. Throughout the repeal-and-replace effort, the 48 Senate Democrats have been firm in voting against any action. While much of the repeal-and-replace effort to date has relied on the budget reconciliation process, which requires a simple majority for passage, this legislation did not qualify and needed a supermajority of 60 votes for passage.

The nine GOP senators voting against the amendment included Collins, Murkowski, Bob Corker (Tenn.), Tom Cotton (Ark.), Lindsey Graham (S.C.), Dena Heller (Nev.), Mike Lee (Utah), Jerry Moran (Kan.), and Rand Paul (Ky.).

Earlier in the day, just after voting in favor of action on this legislation, Sen. McCain pleaded with his colleagues to return to regular order and write a bill that has bipartisan support. He criticized congressional Democrats for forcing the ACA through without bipartisan support 7 years ago and congressional Republicans for doing the exact same thing now with their repeal-and-replace efforts.

“Why don’t we try the old way of legislating in the Senate, the way our rules and customs encourage us to act,” Sen. McCain asked. “Let the Health, Education, Labor, and Pensions Committee under Chairman Alexander and Ranking Member Murray hold hearings, try to report a bill out of committee with contributions from both sides. Then bring it to the floor for amendment and debate and see if we can pass something that will be imperfect, full of compromises, and not very pleasing to implacable partisans on either side but that might provide workable solutions to problems Americans are struggling with today.”

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Multidisciplinary bundle drives drop in colorectal SSIs

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NEW YORK – Facing an “unacceptably high” rate of surgical site infections associated with colorectal surgery at their community hospital, surgeons searched for solutions. They created a perioperative bundle of interventions that ultimately dropped their infection rates enough to achieve the highest ranking in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP).

“The Centers for Disease Control and Prevention recommends we use a robust surveillance program to monitor surgical site infection data. The system gives us feedback, and that will [help us] reduce surgical site infection (SSI) risk,” said Christopher Wolff, MD, a PGY4 resident at the Cleveland Clinic Akron General Hospital. “NSQIP and the National Healthcare Safety Network from the CDC are two programs that do just that.”

Fuse/Thinkstock
SSIs are the most common cause of health care–associated infections, accounting for 31% of the total. SSIs cause many downstream effects, including adverse clinical outcomes, decreased patient satisfaction, readmission penalties, and more. They also can be costly, Dr. Wolff said. “A surgical complication can cost upward of $11,000. ... In 2013, our own internal review of our outcomes found an unacceptably high rate of SSIs with colorectal surgery,” Dr. Wolff said in a presentation of the study, a Resident Abstract Competition Winner, at the American College of Surgeons Quality and Safety Conference. “So we developed a bundled protocol. We wanted to create a multidisciplinary bundle that would follow the patient through their care in our hospital … from the presurgical area through to recovery on the floor.”

The effort paid off, with the number of SSIs going from 16 cases in 2013 to 10 cases in 2014 and then 5 cases in 2015. Since the bundle was implemented in the last quarter of 2014, “we’ve seen a consistent downtrend since that point in our total infections, and we kept that in the background of a consistent number of cases.

“We have good outcomes by incidence, but that is not the whole story,” Dr. Wolff said. “With respect to colorectal infections, we are now performing in the ‘exemplary’ category, compared with our peers” according to the ACS NSQIP data. In addition, “we are performing at or below the SIR [standardized infection ratio] or expected number consistently since the implementation.”

The bundle addresses actions in five domains: preoperative, anesthesia, operating room, post–anesthesia care unit, and postoperative floor interventions. Preoperative elements include patient education, use of chlorhexidine wipes before surgery, and antibiotics noted on the chart, for example. Additional features include prewarming preoperatively and maintaining normothermia, requiring all surgeons scrub traditionally instead of “foaming,” use of wound protectors in the OR, and close monitoring of blood glucose in diabetics postoperatively. “There also is education of floor nurses on how to take care of these patients specifically,” Dr. Wolff noted.

To identify these areas for improvement, Dr. Wolff and his colleagues initially reviewed the literature to find individual and bundle elements demonstrated to improve outcomes. Then, a surgeon group “think tank” discussed the possibilities. However, reaching agreement was not easy, Dr. Wolff said. “They had a hard time agreeing on best practices, even within our own specialty. We did finally come to a consensus.

“We took those bundled protocols through to other areas and said ‘here are the things we want you to work on, things we want you to improve.’ That did not necessarily go over so well,” Dr. Wolff said. Because of resistance from their colleagues, they changed strategies. “We brought other people to the table and changed our work groups from being surgeons only to [being] a multidisciplinary team.”

The process took months and months of deliberation. It’s important to have a champion behind the project, said Dr. Wolff. “I have to thank my chairman, Mark C. Horattas, MD, FACS, who had the vision to see this through.

“We implemented tried-and-true measures to reduce surgical site infections. We did so in a team manner and had multidisciplinary buy-in, and that created a culture change in our program over time,” Dr. Wolff said.

This study also shows, Dr. Wolff added, that “a successful multidisciplinary quality improvement program can be implemented in a community hospital setting.”

Going forward, continuous monitoring will identify any areas that need improvement over time. The preoperative bundle also will be integrated into an Enhanced Recovery After Surgery protocol.

The Akron Hospital is now ranked by ACS NSQIP in the top 10% of hospitals for their colorectal SSI rate. “It’s nice to meet someone in the first decile,” session moderator Timothy D. Jackson, MD, FACS, of the University of Toronto said after Dr. Wolff’s presentation. “I’ve never done that before, and I took notes for what to do at my hospital.”

 

 

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NEW YORK – Facing an “unacceptably high” rate of surgical site infections associated with colorectal surgery at their community hospital, surgeons searched for solutions. They created a perioperative bundle of interventions that ultimately dropped their infection rates enough to achieve the highest ranking in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP).

“The Centers for Disease Control and Prevention recommends we use a robust surveillance program to monitor surgical site infection data. The system gives us feedback, and that will [help us] reduce surgical site infection (SSI) risk,” said Christopher Wolff, MD, a PGY4 resident at the Cleveland Clinic Akron General Hospital. “NSQIP and the National Healthcare Safety Network from the CDC are two programs that do just that.”

Fuse/Thinkstock
SSIs are the most common cause of health care–associated infections, accounting for 31% of the total. SSIs cause many downstream effects, including adverse clinical outcomes, decreased patient satisfaction, readmission penalties, and more. They also can be costly, Dr. Wolff said. “A surgical complication can cost upward of $11,000. ... In 2013, our own internal review of our outcomes found an unacceptably high rate of SSIs with colorectal surgery,” Dr. Wolff said in a presentation of the study, a Resident Abstract Competition Winner, at the American College of Surgeons Quality and Safety Conference. “So we developed a bundled protocol. We wanted to create a multidisciplinary bundle that would follow the patient through their care in our hospital … from the presurgical area through to recovery on the floor.”

The effort paid off, with the number of SSIs going from 16 cases in 2013 to 10 cases in 2014 and then 5 cases in 2015. Since the bundle was implemented in the last quarter of 2014, “we’ve seen a consistent downtrend since that point in our total infections, and we kept that in the background of a consistent number of cases.

“We have good outcomes by incidence, but that is not the whole story,” Dr. Wolff said. “With respect to colorectal infections, we are now performing in the ‘exemplary’ category, compared with our peers” according to the ACS NSQIP data. In addition, “we are performing at or below the SIR [standardized infection ratio] or expected number consistently since the implementation.”

The bundle addresses actions in five domains: preoperative, anesthesia, operating room, post–anesthesia care unit, and postoperative floor interventions. Preoperative elements include patient education, use of chlorhexidine wipes before surgery, and antibiotics noted on the chart, for example. Additional features include prewarming preoperatively and maintaining normothermia, requiring all surgeons scrub traditionally instead of “foaming,” use of wound protectors in the OR, and close monitoring of blood glucose in diabetics postoperatively. “There also is education of floor nurses on how to take care of these patients specifically,” Dr. Wolff noted.

To identify these areas for improvement, Dr. Wolff and his colleagues initially reviewed the literature to find individual and bundle elements demonstrated to improve outcomes. Then, a surgeon group “think tank” discussed the possibilities. However, reaching agreement was not easy, Dr. Wolff said. “They had a hard time agreeing on best practices, even within our own specialty. We did finally come to a consensus.

“We took those bundled protocols through to other areas and said ‘here are the things we want you to work on, things we want you to improve.’ That did not necessarily go over so well,” Dr. Wolff said. Because of resistance from their colleagues, they changed strategies. “We brought other people to the table and changed our work groups from being surgeons only to [being] a multidisciplinary team.”

The process took months and months of deliberation. It’s important to have a champion behind the project, said Dr. Wolff. “I have to thank my chairman, Mark C. Horattas, MD, FACS, who had the vision to see this through.

“We implemented tried-and-true measures to reduce surgical site infections. We did so in a team manner and had multidisciplinary buy-in, and that created a culture change in our program over time,” Dr. Wolff said.

This study also shows, Dr. Wolff added, that “a successful multidisciplinary quality improvement program can be implemented in a community hospital setting.”

Going forward, continuous monitoring will identify any areas that need improvement over time. The preoperative bundle also will be integrated into an Enhanced Recovery After Surgery protocol.

The Akron Hospital is now ranked by ACS NSQIP in the top 10% of hospitals for their colorectal SSI rate. “It’s nice to meet someone in the first decile,” session moderator Timothy D. Jackson, MD, FACS, of the University of Toronto said after Dr. Wolff’s presentation. “I’ve never done that before, and I took notes for what to do at my hospital.”

 

 

 

NEW YORK – Facing an “unacceptably high” rate of surgical site infections associated with colorectal surgery at their community hospital, surgeons searched for solutions. They created a perioperative bundle of interventions that ultimately dropped their infection rates enough to achieve the highest ranking in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP).

“The Centers for Disease Control and Prevention recommends we use a robust surveillance program to monitor surgical site infection data. The system gives us feedback, and that will [help us] reduce surgical site infection (SSI) risk,” said Christopher Wolff, MD, a PGY4 resident at the Cleveland Clinic Akron General Hospital. “NSQIP and the National Healthcare Safety Network from the CDC are two programs that do just that.”

Fuse/Thinkstock
SSIs are the most common cause of health care–associated infections, accounting for 31% of the total. SSIs cause many downstream effects, including adverse clinical outcomes, decreased patient satisfaction, readmission penalties, and more. They also can be costly, Dr. Wolff said. “A surgical complication can cost upward of $11,000. ... In 2013, our own internal review of our outcomes found an unacceptably high rate of SSIs with colorectal surgery,” Dr. Wolff said in a presentation of the study, a Resident Abstract Competition Winner, at the American College of Surgeons Quality and Safety Conference. “So we developed a bundled protocol. We wanted to create a multidisciplinary bundle that would follow the patient through their care in our hospital … from the presurgical area through to recovery on the floor.”

The effort paid off, with the number of SSIs going from 16 cases in 2013 to 10 cases in 2014 and then 5 cases in 2015. Since the bundle was implemented in the last quarter of 2014, “we’ve seen a consistent downtrend since that point in our total infections, and we kept that in the background of a consistent number of cases.

“We have good outcomes by incidence, but that is not the whole story,” Dr. Wolff said. “With respect to colorectal infections, we are now performing in the ‘exemplary’ category, compared with our peers” according to the ACS NSQIP data. In addition, “we are performing at or below the SIR [standardized infection ratio] or expected number consistently since the implementation.”

The bundle addresses actions in five domains: preoperative, anesthesia, operating room, post–anesthesia care unit, and postoperative floor interventions. Preoperative elements include patient education, use of chlorhexidine wipes before surgery, and antibiotics noted on the chart, for example. Additional features include prewarming preoperatively and maintaining normothermia, requiring all surgeons scrub traditionally instead of “foaming,” use of wound protectors in the OR, and close monitoring of blood glucose in diabetics postoperatively. “There also is education of floor nurses on how to take care of these patients specifically,” Dr. Wolff noted.

To identify these areas for improvement, Dr. Wolff and his colleagues initially reviewed the literature to find individual and bundle elements demonstrated to improve outcomes. Then, a surgeon group “think tank” discussed the possibilities. However, reaching agreement was not easy, Dr. Wolff said. “They had a hard time agreeing on best practices, even within our own specialty. We did finally come to a consensus.

“We took those bundled protocols through to other areas and said ‘here are the things we want you to work on, things we want you to improve.’ That did not necessarily go over so well,” Dr. Wolff said. Because of resistance from their colleagues, they changed strategies. “We brought other people to the table and changed our work groups from being surgeons only to [being] a multidisciplinary team.”

The process took months and months of deliberation. It’s important to have a champion behind the project, said Dr. Wolff. “I have to thank my chairman, Mark C. Horattas, MD, FACS, who had the vision to see this through.

“We implemented tried-and-true measures to reduce surgical site infections. We did so in a team manner and had multidisciplinary buy-in, and that created a culture change in our program over time,” Dr. Wolff said.

This study also shows, Dr. Wolff added, that “a successful multidisciplinary quality improvement program can be implemented in a community hospital setting.”

Going forward, continuous monitoring will identify any areas that need improvement over time. The preoperative bundle also will be integrated into an Enhanced Recovery After Surgery protocol.

The Akron Hospital is now ranked by ACS NSQIP in the top 10% of hospitals for their colorectal SSI rate. “It’s nice to meet someone in the first decile,” session moderator Timothy D. Jackson, MD, FACS, of the University of Toronto said after Dr. Wolff’s presentation. “I’ve never done that before, and I took notes for what to do at my hospital.”

 

 

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Key clinical point: A multidisciplinary team initiative successfully reduced surgical site infections after colorectal surgery in a community hospital.

Major finding: The number of annual SSIs dropped from 16 in the calendar year before the intervention to 5 afterward.

Data source: Comparison of SSI rates before and after a bundled intervention in late 2014.

Disclosures: Dr. Wolff had no relevant financial disclosures.

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Surgeons can take steps to reduce excess opioids

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NEW YORK – Surgeons prescribe approximately 10% of the 280 million schedule II prescriptions written every year. Because patients report taking on average 20%-30% of their opioid pills, a large amount of these drugs end up being diverted to nonpatients and contributing to the opioid epidemic in the United States, said Jonah J. Stulberg, MD.

”You can’t turn on the television, pick up the newspaper, do anything on social media without seeing a lot of headlines about the tragedies occurring because of opioid abuse,” said Dr. Stulberg, assistant professor of surgery at Northwestern University in Chicago.

The majority of opioid abusers are obtaining the drugs through diversion, he said. “So the prescriptions we’re writing and the excess pills we have available, they do make a difference. They’re making it down the pipeline.”

Some practical steps

There are practical actions surgeons can take to try to reduce the sheer volume of prescription opioids that end up in the hands of people for whom they are not intended, Dr. Stulberg said at the American College of Surgeons Quality and Safety Conference.

Sign up for a prescription monitoring program, he suggested. These programs are now available in 49 states (Missouri is the exception). “It’s really easy to create an account as a provider.” Just search online for your state’s prescription monitoring program and enter your contact information, he said. The state will then ask you for some basic information.

Take it one step further and integrate your prescription monitoring program into your electronic medical records, Dr. Stulberg said. “We’re starting to integrate it in all hospitals in Illinois. That means when the surgeon or the nurse providers look up the patient, they will know if the patient got two other prescriptions in the last 2 weeks.” He added, “You can ask if they need more pills before adding to the surplus.”

Another practical strategy is to give patients better access to opioid disposal. Find out where the nearest drug return receptacle or kiosk is located – a pharmacy, police station, or elsewhere – and inform your patients. “We put opioid retrieval boxes in our clinic. When patients are educated about this, they bring [excess pills] back.”

Minimizing opioid prescribing in surgery

“This is not a problem of one individual specialty,” Dr. Stulberg said. “We have a problem of culture, a problem of mindset. So we need to approach solving this problem, in my opinion, from that perspective.”

Start with setting patient expectations in the preoperative period. Explain what the surgery entails and the amount of pain they should expect. “Patients have to understand what we’re doing hurts but we can manage that pain. It can make a big difference in their satisfaction … and also in how much medication they end up taking.”

In addition, perform preoperative risk screening for opioid abuse. “There is very good evidence that patients with addictions to other drugs, alcohol, or who have previous drug use, are much more likely to continue using prescription pain medications after a surgical encounter – 6 months to 12 months later.”

In addition, a paradigm shift in thinking is needed. “When we’re talking about pain control in the clinic and minimizing opioids during a surgical episode, we should be focusing on function,” he said. Orthopedic surgery is a prime example, where physicians encourage patients to start mobility exercises the same day of surgery because evidence shows it helps restore function faster.

Surgeons should tell patients that “the goal of how we are treating your pain is getting you to your optimal function.” Then check on function recovery postoperatively, he added. “We don’t follow-up – that is not part of our standard postoperative pathway in any way.”

Consider prescribing fewer pills postoperatively

If surgeons have a prescription feedback mechanism in place, they might know how many opioid pills patients are actually taking. “If I gave 20 pills to the last 10 patients but they only took 8 on average – can I go lower?” Dr. Stulberg said.

Researchers conducted a study to determine opioid needs for 80% of the patients at their institution after certain types of surgery (Ann Surg. 2017;265:709-14).

The study determined the number of pills that 80% of patients found controlled their pain: after partial mastectomy, 5; after partial mastectomy with sentinel lymph node biopsy, 10; after laparoscopic cholecystectomy, 15; after laparoscopic inguinal hernia repair, 15; and after open inguinal hernia repair, 15. These numbers represent about 43% of the actual number prescribed overall, so many patients are getting more medications than they require.

Dr. Stulberg suggested that surgeons could use the data from this study to counter any pushback from others at their institution reluctant to prescribe fewer opioids for their patients.

 

 

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NEW YORK – Surgeons prescribe approximately 10% of the 280 million schedule II prescriptions written every year. Because patients report taking on average 20%-30% of their opioid pills, a large amount of these drugs end up being diverted to nonpatients and contributing to the opioid epidemic in the United States, said Jonah J. Stulberg, MD.

”You can’t turn on the television, pick up the newspaper, do anything on social media without seeing a lot of headlines about the tragedies occurring because of opioid abuse,” said Dr. Stulberg, assistant professor of surgery at Northwestern University in Chicago.

The majority of opioid abusers are obtaining the drugs through diversion, he said. “So the prescriptions we’re writing and the excess pills we have available, they do make a difference. They’re making it down the pipeline.”

Some practical steps

There are practical actions surgeons can take to try to reduce the sheer volume of prescription opioids that end up in the hands of people for whom they are not intended, Dr. Stulberg said at the American College of Surgeons Quality and Safety Conference.

Sign up for a prescription monitoring program, he suggested. These programs are now available in 49 states (Missouri is the exception). “It’s really easy to create an account as a provider.” Just search online for your state’s prescription monitoring program and enter your contact information, he said. The state will then ask you for some basic information.

Take it one step further and integrate your prescription monitoring program into your electronic medical records, Dr. Stulberg said. “We’re starting to integrate it in all hospitals in Illinois. That means when the surgeon or the nurse providers look up the patient, they will know if the patient got two other prescriptions in the last 2 weeks.” He added, “You can ask if they need more pills before adding to the surplus.”

Another practical strategy is to give patients better access to opioid disposal. Find out where the nearest drug return receptacle or kiosk is located – a pharmacy, police station, or elsewhere – and inform your patients. “We put opioid retrieval boxes in our clinic. When patients are educated about this, they bring [excess pills] back.”

Minimizing opioid prescribing in surgery

“This is not a problem of one individual specialty,” Dr. Stulberg said. “We have a problem of culture, a problem of mindset. So we need to approach solving this problem, in my opinion, from that perspective.”

Start with setting patient expectations in the preoperative period. Explain what the surgery entails and the amount of pain they should expect. “Patients have to understand what we’re doing hurts but we can manage that pain. It can make a big difference in their satisfaction … and also in how much medication they end up taking.”

In addition, perform preoperative risk screening for opioid abuse. “There is very good evidence that patients with addictions to other drugs, alcohol, or who have previous drug use, are much more likely to continue using prescription pain medications after a surgical encounter – 6 months to 12 months later.”

In addition, a paradigm shift in thinking is needed. “When we’re talking about pain control in the clinic and minimizing opioids during a surgical episode, we should be focusing on function,” he said. Orthopedic surgery is a prime example, where physicians encourage patients to start mobility exercises the same day of surgery because evidence shows it helps restore function faster.

Surgeons should tell patients that “the goal of how we are treating your pain is getting you to your optimal function.” Then check on function recovery postoperatively, he added. “We don’t follow-up – that is not part of our standard postoperative pathway in any way.”

Consider prescribing fewer pills postoperatively

If surgeons have a prescription feedback mechanism in place, they might know how many opioid pills patients are actually taking. “If I gave 20 pills to the last 10 patients but they only took 8 on average – can I go lower?” Dr. Stulberg said.

Researchers conducted a study to determine opioid needs for 80% of the patients at their institution after certain types of surgery (Ann Surg. 2017;265:709-14).

The study determined the number of pills that 80% of patients found controlled their pain: after partial mastectomy, 5; after partial mastectomy with sentinel lymph node biopsy, 10; after laparoscopic cholecystectomy, 15; after laparoscopic inguinal hernia repair, 15; and after open inguinal hernia repair, 15. These numbers represent about 43% of the actual number prescribed overall, so many patients are getting more medications than they require.

Dr. Stulberg suggested that surgeons could use the data from this study to counter any pushback from others at their institution reluctant to prescribe fewer opioids for their patients.

 

 

 

NEW YORK – Surgeons prescribe approximately 10% of the 280 million schedule II prescriptions written every year. Because patients report taking on average 20%-30% of their opioid pills, a large amount of these drugs end up being diverted to nonpatients and contributing to the opioid epidemic in the United States, said Jonah J. Stulberg, MD.

”You can’t turn on the television, pick up the newspaper, do anything on social media without seeing a lot of headlines about the tragedies occurring because of opioid abuse,” said Dr. Stulberg, assistant professor of surgery at Northwestern University in Chicago.

The majority of opioid abusers are obtaining the drugs through diversion, he said. “So the prescriptions we’re writing and the excess pills we have available, they do make a difference. They’re making it down the pipeline.”

Some practical steps

There are practical actions surgeons can take to try to reduce the sheer volume of prescription opioids that end up in the hands of people for whom they are not intended, Dr. Stulberg said at the American College of Surgeons Quality and Safety Conference.

Sign up for a prescription monitoring program, he suggested. These programs are now available in 49 states (Missouri is the exception). “It’s really easy to create an account as a provider.” Just search online for your state’s prescription monitoring program and enter your contact information, he said. The state will then ask you for some basic information.

Take it one step further and integrate your prescription monitoring program into your electronic medical records, Dr. Stulberg said. “We’re starting to integrate it in all hospitals in Illinois. That means when the surgeon or the nurse providers look up the patient, they will know if the patient got two other prescriptions in the last 2 weeks.” He added, “You can ask if they need more pills before adding to the surplus.”

Another practical strategy is to give patients better access to opioid disposal. Find out where the nearest drug return receptacle or kiosk is located – a pharmacy, police station, or elsewhere – and inform your patients. “We put opioid retrieval boxes in our clinic. When patients are educated about this, they bring [excess pills] back.”

Minimizing opioid prescribing in surgery

“This is not a problem of one individual specialty,” Dr. Stulberg said. “We have a problem of culture, a problem of mindset. So we need to approach solving this problem, in my opinion, from that perspective.”

Start with setting patient expectations in the preoperative period. Explain what the surgery entails and the amount of pain they should expect. “Patients have to understand what we’re doing hurts but we can manage that pain. It can make a big difference in their satisfaction … and also in how much medication they end up taking.”

In addition, perform preoperative risk screening for opioid abuse. “There is very good evidence that patients with addictions to other drugs, alcohol, or who have previous drug use, are much more likely to continue using prescription pain medications after a surgical encounter – 6 months to 12 months later.”

In addition, a paradigm shift in thinking is needed. “When we’re talking about pain control in the clinic and minimizing opioids during a surgical episode, we should be focusing on function,” he said. Orthopedic surgery is a prime example, where physicians encourage patients to start mobility exercises the same day of surgery because evidence shows it helps restore function faster.

Surgeons should tell patients that “the goal of how we are treating your pain is getting you to your optimal function.” Then check on function recovery postoperatively, he added. “We don’t follow-up – that is not part of our standard postoperative pathway in any way.”

Consider prescribing fewer pills postoperatively

If surgeons have a prescription feedback mechanism in place, they might know how many opioid pills patients are actually taking. “If I gave 20 pills to the last 10 patients but they only took 8 on average – can I go lower?” Dr. Stulberg said.

Researchers conducted a study to determine opioid needs for 80% of the patients at their institution after certain types of surgery (Ann Surg. 2017;265:709-14).

The study determined the number of pills that 80% of patients found controlled their pain: after partial mastectomy, 5; after partial mastectomy with sentinel lymph node biopsy, 10; after laparoscopic cholecystectomy, 15; after laparoscopic inguinal hernia repair, 15; and after open inguinal hernia repair, 15. These numbers represent about 43% of the actual number prescribed overall, so many patients are getting more medications than they require.

Dr. Stulberg suggested that surgeons could use the data from this study to counter any pushback from others at their institution reluctant to prescribe fewer opioids for their patients.

 

 

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Outcomes improved with ERAS pathway tailored to colorectal surgery

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NEW YORK – A protocol that standardizes care before, during, and after colorectal surgery cut average hospital stays from almost 6 days to less than 3, reduced complications, and slashed costs an estimated $11,227 per procedure.

“We decided to take a look at our own data, and we saw that a couple of variables were higher than we wanted them to be,” said Deepa Bhat, MD, a second year surgery resident at Advocate Illinois Masonic Medical Center in Chicago. Length of stay was one. Colorectal surgery patients were staying in the hospital an average 5.65 days, for example.

Their surgical site infection rate also warranted attention, Dr. Bhat said during a poster session at the American College of Surgeons Quality and Safety Conference. The overall complication rate was 6.45%.

“So, we decided to implement this enhanced recovery pathway in the hope that it would, one, get patients out of the hospital faster and allow them to recover at home and, two, decrease the rate of complications, including surgical site infections.”

Prior to the protocol, individual surgeons chose when to initiate fluids, when to discharge a patient, and many other preoperative factors. “Now, care is standardized so that every patient experiences the same pre-, intra-, and postoperative protocol, which leads to better outcomes,” Dr. Bhat said.

The multidisciplinary Enhanced Recovery After Colorectal Surgery (ERACS) pathway also now emphasizes more patient education prior to surgery. “The patients go into surgery having a very clear idea of what they can expect, such as how their pain will be controlled, when they can start liquids, and what their expectations are for ambulation,” she said. “By making patients active participants in their own care, they tend to do better.”

The investigators studied 246 elective colorectal surgery patients at their large, urban, community teaching hospital. They compared outcomes in 2014, versus 2015, to gauge the effectiveness of the ERACS. “The change in length of stay was really rather remarkable,” Dr. Bhat said. In fact, the typical number of days in the hospital decreased by about half from 5.65 to 2.89 days, a statistically significant difference (P less than .0001).

Historically, “the whole reason we don’t send patients home sooner is we’re worried they’re going to bounce right back, and that’s an issue for the 30-day readmission rate,” Dr. Bhat said. However, the enhanced recovery protocol was designed to minimize that risk, and the study verified that it works. “We wanted to show that you can send patients home safely and also not worry that they would come back more often.”

Patient satisfaction seems higher too. Dr. Bhat added, “Who doesn’t feel better at home?”

“It is pretty remarkable that you can send somebody home in less than 3 days and they don’t come back to the hospital with complications, versus having them stay double that amount of time,” Dr. Bhat said. The direct variable cost was approximately $3,705 lower with the ERACS, and total hospitalization costs decreased by up to $11,227 per patient. For the institution overall, that outcome translated into savings of approximately $1 million for the year.

Dr. Bhat continues to see increasing gains from the protocol ERACS since the study period ended. “Our enhanced recovery pathway is getting better and better and more efficient.” The institution is now looking to expand enhanced recovery protocols to other types of surgery.

Dr. Deepa Bhat had no relevant financial disclosures.

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NEW YORK – A protocol that standardizes care before, during, and after colorectal surgery cut average hospital stays from almost 6 days to less than 3, reduced complications, and slashed costs an estimated $11,227 per procedure.

“We decided to take a look at our own data, and we saw that a couple of variables were higher than we wanted them to be,” said Deepa Bhat, MD, a second year surgery resident at Advocate Illinois Masonic Medical Center in Chicago. Length of stay was one. Colorectal surgery patients were staying in the hospital an average 5.65 days, for example.

Their surgical site infection rate also warranted attention, Dr. Bhat said during a poster session at the American College of Surgeons Quality and Safety Conference. The overall complication rate was 6.45%.

“So, we decided to implement this enhanced recovery pathway in the hope that it would, one, get patients out of the hospital faster and allow them to recover at home and, two, decrease the rate of complications, including surgical site infections.”

Prior to the protocol, individual surgeons chose when to initiate fluids, when to discharge a patient, and many other preoperative factors. “Now, care is standardized so that every patient experiences the same pre-, intra-, and postoperative protocol, which leads to better outcomes,” Dr. Bhat said.

The multidisciplinary Enhanced Recovery After Colorectal Surgery (ERACS) pathway also now emphasizes more patient education prior to surgery. “The patients go into surgery having a very clear idea of what they can expect, such as how their pain will be controlled, when they can start liquids, and what their expectations are for ambulation,” she said. “By making patients active participants in their own care, they tend to do better.”

The investigators studied 246 elective colorectal surgery patients at their large, urban, community teaching hospital. They compared outcomes in 2014, versus 2015, to gauge the effectiveness of the ERACS. “The change in length of stay was really rather remarkable,” Dr. Bhat said. In fact, the typical number of days in the hospital decreased by about half from 5.65 to 2.89 days, a statistically significant difference (P less than .0001).

Historically, “the whole reason we don’t send patients home sooner is we’re worried they’re going to bounce right back, and that’s an issue for the 30-day readmission rate,” Dr. Bhat said. However, the enhanced recovery protocol was designed to minimize that risk, and the study verified that it works. “We wanted to show that you can send patients home safely and also not worry that they would come back more often.”

Patient satisfaction seems higher too. Dr. Bhat added, “Who doesn’t feel better at home?”

“It is pretty remarkable that you can send somebody home in less than 3 days and they don’t come back to the hospital with complications, versus having them stay double that amount of time,” Dr. Bhat said. The direct variable cost was approximately $3,705 lower with the ERACS, and total hospitalization costs decreased by up to $11,227 per patient. For the institution overall, that outcome translated into savings of approximately $1 million for the year.

Dr. Bhat continues to see increasing gains from the protocol ERACS since the study period ended. “Our enhanced recovery pathway is getting better and better and more efficient.” The institution is now looking to expand enhanced recovery protocols to other types of surgery.

Dr. Deepa Bhat had no relevant financial disclosures.

 

NEW YORK – A protocol that standardizes care before, during, and after colorectal surgery cut average hospital stays from almost 6 days to less than 3, reduced complications, and slashed costs an estimated $11,227 per procedure.

“We decided to take a look at our own data, and we saw that a couple of variables were higher than we wanted them to be,” said Deepa Bhat, MD, a second year surgery resident at Advocate Illinois Masonic Medical Center in Chicago. Length of stay was one. Colorectal surgery patients were staying in the hospital an average 5.65 days, for example.

Their surgical site infection rate also warranted attention, Dr. Bhat said during a poster session at the American College of Surgeons Quality and Safety Conference. The overall complication rate was 6.45%.

“So, we decided to implement this enhanced recovery pathway in the hope that it would, one, get patients out of the hospital faster and allow them to recover at home and, two, decrease the rate of complications, including surgical site infections.”

Prior to the protocol, individual surgeons chose when to initiate fluids, when to discharge a patient, and many other preoperative factors. “Now, care is standardized so that every patient experiences the same pre-, intra-, and postoperative protocol, which leads to better outcomes,” Dr. Bhat said.

The multidisciplinary Enhanced Recovery After Colorectal Surgery (ERACS) pathway also now emphasizes more patient education prior to surgery. “The patients go into surgery having a very clear idea of what they can expect, such as how their pain will be controlled, when they can start liquids, and what their expectations are for ambulation,” she said. “By making patients active participants in their own care, they tend to do better.”

The investigators studied 246 elective colorectal surgery patients at their large, urban, community teaching hospital. They compared outcomes in 2014, versus 2015, to gauge the effectiveness of the ERACS. “The change in length of stay was really rather remarkable,” Dr. Bhat said. In fact, the typical number of days in the hospital decreased by about half from 5.65 to 2.89 days, a statistically significant difference (P less than .0001).

Historically, “the whole reason we don’t send patients home sooner is we’re worried they’re going to bounce right back, and that’s an issue for the 30-day readmission rate,” Dr. Bhat said. However, the enhanced recovery protocol was designed to minimize that risk, and the study verified that it works. “We wanted to show that you can send patients home safely and also not worry that they would come back more often.”

Patient satisfaction seems higher too. Dr. Bhat added, “Who doesn’t feel better at home?”

“It is pretty remarkable that you can send somebody home in less than 3 days and they don’t come back to the hospital with complications, versus having them stay double that amount of time,” Dr. Bhat said. The direct variable cost was approximately $3,705 lower with the ERACS, and total hospitalization costs decreased by up to $11,227 per patient. For the institution overall, that outcome translated into savings of approximately $1 million for the year.

Dr. Bhat continues to see increasing gains from the protocol ERACS since the study period ended. “Our enhanced recovery pathway is getting better and better and more efficient.” The institution is now looking to expand enhanced recovery protocols to other types of surgery.

Dr. Deepa Bhat had no relevant financial disclosures.

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Key clinical point: An Enhanced Recovery After Colorectal Surgery (ERACS) protocol cut colorectal surgical site infections and reduced length of stay.

Major finding: The intervention decreased the hospital stays from an average of 6 days to 3 days and saved an estimated $11,227 per surgery.

Data source: A retrospective study of 246 patients undergoing elective colorectal surgery at a large, urban, community teaching hospital.

Disclosures: Dr. Deepa Bhat had no relevant financial disclosures.

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Senate parliamentarian upends GOP hopes for health bill

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The official rules keeper in the Senate tossed a bucket of cold water July 21 on the Senate Republican health bill by advising that major parts of the bill cannot be passed with a simple majority, but rather would require 60 votes. Republicans hold only 52 seats in the Senate.

Senate Parliamentarian Elizabeth MacDonough said that a super-majority is needed for the temporary defunding of Planned Parenthood, abortion coverage restrictions to health plans purchased with tax credits, and the requirement that people with breaks in coverage wait 6 months before they can purchase new plans.

Alicia Ault/Frontline Medical News
The Senate is using a budget process called reconciliation that allows Republicans to pass a bill with only 50 votes (and the potential tie to be broken by Vice President Mike Pence). But there are strict rules about what can and cannot be included, and those rules are enforced by the parliamentarian. Those rules can be waived, but that requires 60 votes, and all the chamber’s Democrats have vowed to fight every version of the bill to “repeal and replace” the Affordable Care Act, which is set for a possible vote next week.

The list was released by Democrats on the Senate Budget Committee and later confirmed by a spokesman for the committee Republicans. It is the result of what is called the “Byrd Bath,” a process in which the parliamentarian hears arguments from Democrats and Republicans and then advises on which provisions comply with the Byrd Rule. That rule requires that only matters directly pertaining to the federal budget are included. The rule is named for former Senate Majority Leader Robert Byrd (D-W.Va.), who first wrote it.

Senate Republicans were quick to point out that the document is “guidance” that they can use to try to rewrite impermissible language. The guidance “will help inform action on the legislation going forward,” said a spokesman for Senate Budget Committee Chairman Mike Enzi (R-Wyo.).

Among the other provisions that the parliamentarian has advised should require 60 votes are ones that would eliminate Medicaid requirements to provide 10 “essential health benefits.” Also on the list is a provision to repeal a requirement that insurers spend a minimum amount of each premium dollar on direct medical services, rather than administration or profits.

The determination also pertains to a part of the bill that would continue payments for “cost-sharing subsidies” to insurers for 2 more years. Those subsidies help lower-income people afford out-of-pocket costs such as deductibles. The parliamentarian said that duplicated existing law.

Ms. MacDonough also said that a provision in the House version of the bill that pertains directly to New York violates the Byrd Rule. That measure would change the way the state collects money for Medicaid. That could suggest efforts by Senate Majority Leader Mitch McConnell (R-Ky.) to offer state-specific changes to gain support for the bill might meet the same fate.

Minority Leader Chuck Schumer (D-N.Y.) said that decision could have “the greatest effect on Republicans’ ability to pass this bill.” He predicted it would “tie the majority leader’s hands as he tries to win over reluctant Republicans.”

Some of the provisions that didn’t pass muster with Ms. MacDonough were key to getting the bill through the House. And if they are dropped, it might make it difficult for the House to approve a final version of the bill.

Not all the decisions went the Democrats’ way. Ms. MacDonough found that only a simple majority is needed for language allowing states to impose work requirements for Medicaid recipients. She also said that a provision that will ban abortions if the services are paid through a new fund provided to states would be allowed. That’s because that fund will be governed by existing rules that already ban abortion in most cases.

A few provisions remain under review, according to the list. Those include allowing states to waive a long list of insurance protections, including the ACA’s essential health benefits and preexisting coverage guarantees. Also still under review is language allowing small businesses to pool together to purchase insurance as well as a provision changing requirements related to how much more insurers can charge older adults.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

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The official rules keeper in the Senate tossed a bucket of cold water July 21 on the Senate Republican health bill by advising that major parts of the bill cannot be passed with a simple majority, but rather would require 60 votes. Republicans hold only 52 seats in the Senate.

Senate Parliamentarian Elizabeth MacDonough said that a super-majority is needed for the temporary defunding of Planned Parenthood, abortion coverage restrictions to health plans purchased with tax credits, and the requirement that people with breaks in coverage wait 6 months before they can purchase new plans.

Alicia Ault/Frontline Medical News
The Senate is using a budget process called reconciliation that allows Republicans to pass a bill with only 50 votes (and the potential tie to be broken by Vice President Mike Pence). But there are strict rules about what can and cannot be included, and those rules are enforced by the parliamentarian. Those rules can be waived, but that requires 60 votes, and all the chamber’s Democrats have vowed to fight every version of the bill to “repeal and replace” the Affordable Care Act, which is set for a possible vote next week.

The list was released by Democrats on the Senate Budget Committee and later confirmed by a spokesman for the committee Republicans. It is the result of what is called the “Byrd Bath,” a process in which the parliamentarian hears arguments from Democrats and Republicans and then advises on which provisions comply with the Byrd Rule. That rule requires that only matters directly pertaining to the federal budget are included. The rule is named for former Senate Majority Leader Robert Byrd (D-W.Va.), who first wrote it.

Senate Republicans were quick to point out that the document is “guidance” that they can use to try to rewrite impermissible language. The guidance “will help inform action on the legislation going forward,” said a spokesman for Senate Budget Committee Chairman Mike Enzi (R-Wyo.).

Among the other provisions that the parliamentarian has advised should require 60 votes are ones that would eliminate Medicaid requirements to provide 10 “essential health benefits.” Also on the list is a provision to repeal a requirement that insurers spend a minimum amount of each premium dollar on direct medical services, rather than administration or profits.

The determination also pertains to a part of the bill that would continue payments for “cost-sharing subsidies” to insurers for 2 more years. Those subsidies help lower-income people afford out-of-pocket costs such as deductibles. The parliamentarian said that duplicated existing law.

Ms. MacDonough also said that a provision in the House version of the bill that pertains directly to New York violates the Byrd Rule. That measure would change the way the state collects money for Medicaid. That could suggest efforts by Senate Majority Leader Mitch McConnell (R-Ky.) to offer state-specific changes to gain support for the bill might meet the same fate.

Minority Leader Chuck Schumer (D-N.Y.) said that decision could have “the greatest effect on Republicans’ ability to pass this bill.” He predicted it would “tie the majority leader’s hands as he tries to win over reluctant Republicans.”

Some of the provisions that didn’t pass muster with Ms. MacDonough were key to getting the bill through the House. And if they are dropped, it might make it difficult for the House to approve a final version of the bill.

Not all the decisions went the Democrats’ way. Ms. MacDonough found that only a simple majority is needed for language allowing states to impose work requirements for Medicaid recipients. She also said that a provision that will ban abortions if the services are paid through a new fund provided to states would be allowed. That’s because that fund will be governed by existing rules that already ban abortion in most cases.

A few provisions remain under review, according to the list. Those include allowing states to waive a long list of insurance protections, including the ACA’s essential health benefits and preexisting coverage guarantees. Also still under review is language allowing small businesses to pool together to purchase insurance as well as a provision changing requirements related to how much more insurers can charge older adults.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

 

The official rules keeper in the Senate tossed a bucket of cold water July 21 on the Senate Republican health bill by advising that major parts of the bill cannot be passed with a simple majority, but rather would require 60 votes. Republicans hold only 52 seats in the Senate.

Senate Parliamentarian Elizabeth MacDonough said that a super-majority is needed for the temporary defunding of Planned Parenthood, abortion coverage restrictions to health plans purchased with tax credits, and the requirement that people with breaks in coverage wait 6 months before they can purchase new plans.

Alicia Ault/Frontline Medical News
The Senate is using a budget process called reconciliation that allows Republicans to pass a bill with only 50 votes (and the potential tie to be broken by Vice President Mike Pence). But there are strict rules about what can and cannot be included, and those rules are enforced by the parliamentarian. Those rules can be waived, but that requires 60 votes, and all the chamber’s Democrats have vowed to fight every version of the bill to “repeal and replace” the Affordable Care Act, which is set for a possible vote next week.

The list was released by Democrats on the Senate Budget Committee and later confirmed by a spokesman for the committee Republicans. It is the result of what is called the “Byrd Bath,” a process in which the parliamentarian hears arguments from Democrats and Republicans and then advises on which provisions comply with the Byrd Rule. That rule requires that only matters directly pertaining to the federal budget are included. The rule is named for former Senate Majority Leader Robert Byrd (D-W.Va.), who first wrote it.

Senate Republicans were quick to point out that the document is “guidance” that they can use to try to rewrite impermissible language. The guidance “will help inform action on the legislation going forward,” said a spokesman for Senate Budget Committee Chairman Mike Enzi (R-Wyo.).

Among the other provisions that the parliamentarian has advised should require 60 votes are ones that would eliminate Medicaid requirements to provide 10 “essential health benefits.” Also on the list is a provision to repeal a requirement that insurers spend a minimum amount of each premium dollar on direct medical services, rather than administration or profits.

The determination also pertains to a part of the bill that would continue payments for “cost-sharing subsidies” to insurers for 2 more years. Those subsidies help lower-income people afford out-of-pocket costs such as deductibles. The parliamentarian said that duplicated existing law.

Ms. MacDonough also said that a provision in the House version of the bill that pertains directly to New York violates the Byrd Rule. That measure would change the way the state collects money for Medicaid. That could suggest efforts by Senate Majority Leader Mitch McConnell (R-Ky.) to offer state-specific changes to gain support for the bill might meet the same fate.

Minority Leader Chuck Schumer (D-N.Y.) said that decision could have “the greatest effect on Republicans’ ability to pass this bill.” He predicted it would “tie the majority leader’s hands as he tries to win over reluctant Republicans.”

Some of the provisions that didn’t pass muster with Ms. MacDonough were key to getting the bill through the House. And if they are dropped, it might make it difficult for the House to approve a final version of the bill.

Not all the decisions went the Democrats’ way. Ms. MacDonough found that only a simple majority is needed for language allowing states to impose work requirements for Medicaid recipients. She also said that a provision that will ban abortions if the services are paid through a new fund provided to states would be allowed. That’s because that fund will be governed by existing rules that already ban abortion in most cases.

A few provisions remain under review, according to the list. Those include allowing states to waive a long list of insurance protections, including the ACA’s essential health benefits and preexisting coverage guarantees. Also still under review is language allowing small businesses to pool together to purchase insurance as well as a provision changing requirements related to how much more insurers can charge older adults.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

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